Full Year 2024 Eisai Co Ltd Earnings Call
Question by ACI.
It is sometimes we would like to begin the brief.
But on that too much time on that but I'm Iot is like I wish you guys shot you can't usually you'll know in the K started to make our York I say that's your my.
Briefing session by ACI Company limited on sooner.
Joe: Oh, Hi, Joe the online not hybrid okay ski that Oakland Nightmare.
Financial results and business update for fiscal 'twenty 'twenty four.
Speaker Change: Hi, Joe.
Now someone you up but it didnt Dashon shiel kiss, sometimes gene tank OCD all goodbye to you guys. So much that one name that autonomy not something a lot greater unless you do push out later cycle. They woke up and he said I keep myself on that.
Those of you who are in attendance in person.
Please find materials, including the presentation and.
Flash report.
Those of you who are virtually attending please find these materials on the website.
Speaker Change: So as it came out that she's picky agreeing or Osaka duchemin.
The speaker, Mr. Huddle night, the representative corporate officer and C E O.
Speaker Change: I can assure you could see all night, though how do I deal with IMS.
Speaker Change: Do I feel.
No.
To report on the financial results for its fiscal year 'twenty 'twenty four for.
Speaker Change: Should we be wrong in June.
Speaker Change: Good for me.
Yes.
Speaker Change: A report on the financial results for its fiscal year 2024.
That is true we do the P and L for FY 'twenty to 'twenty four.
Speaker Change: First minister, we do the P and L for FY 2024.
Revenue.
And the profit.
Speaker Change: Yes.
<unk>.
Speaker Change: Can you.
And of course it.
While we continue to.
Speaker Change: Both.
Invest resources into like can be.
Speaker Change: Okay.
Speaker Change: While we continue to.
How about the increase in both revenue and <unk>.
Invest resources into law it can be.
Profits.
How 'bout chiefs the increase in both revenue and.
As we have already announced.
Speaker Change: Perfect.
Speaker Change: Hum.
The forecast for FY, 'twenty, 'twenty, four, but both revenue and profit exceeded that forecast.
Speaker Change: We have already.
Speaker Change: Yes.
The forecast for FY 2020, full but both revenue and profit exceeded that forecast.
If you look at the stable cost of sales.
If you look at the stable cost of sales.
Increased buys opened five percentage point.
Speaker Change: Yeah.
Okay.
This is due to what is described above other business or one time decrease over revenue.
Speaker Change: Increased it buys open five percentage point.
Speaker Change: This is due to what is described above other business or one time decrease of the revenue.
Which increased the cost the sales ratio.
And if you turn to the expense side R&D expenses.
Speaker Change: Which increased the cost the sales ratio.
Speaker Change: And if you turn to the expense side R&D expenses.
Accounted for.
The ratio, which was reduced by one six percentage points in terms of its ratio to the revenue.
Speaker Change: Accounted for.
Speaker Change: The ratio, which was reduced by one six percentage points in terms of fleet ratio to the revenues.
<unk> in the United States.
Research Laboratory.
Speaker Change: Mainly in the United States.
Outside of Japan.
Speaker Change: Research Laboratory.
Outside of Japan.
There are some.
Yeah.
Active research laboratory.
Yeah.
Yeah.
Or obsolete Duh research of liabilities was decided to be closed, but among the themes of research.
Speaker Change: There are some.
Speaker Change: In active research laboratory.
Speaker Change: Or obsolete or that we start to lap what are these was decided to be closed but among the themes of research.
What drops or read some impairment losses of.
Absorbing those.
What drops well, we had some impairment losses.
R&D expense ratio.
Absorbing that goes.
Speaker Change: Okay.
Two revenue was reduced by one point to two percentage points and S. G&A expenses.
Yes.
Speaker Change: The expense ratio.
Speaker Change: Two revenue was reduced by 1.0 percentage points and S G&A expenses.
Increased by one two percentage point.
Yeah.
<unk> increased by one two percentage points.
Because we continue to invest resources into that can be particularly marketing resources were invested.
Speaker Change: Yes.
Speaker Change: You bet.
Speaker Change: Because we continue to invest resources into that can be particularly marketing resource seats were invested.
And this S G&A expenses, which includes.
Speaker Change: In this S G&A expenses, which include.
The expenses related to the structural reforms in the United States that was carried out during the year under review.
Speaker Change: Uh huh.
Speaker Change: Expenses related to the structural reforms in the United States that was carried out during the year under review.
There was a temporary increase in expenses related to the U S structure reform, which are related to the termination benefits.
And there was a temporary increase in expenses related to the U S structure reform, which are related to the termination benefits.
Such increase was observed.
Two can take control or in S. G&A expenses.
Speaker Change: Such increase was absorbed.
Speaker Change: Yeah.
Speaker Change: Two can take control on a S G&A expenses.
Whose increase was a controlled with a one two percentage points.
Speaker Change: This increase was a controlled with a one two percentage points.
Now turning to the revenue migration.
Speaker Change: Mhm.
No.
Speaker Change: Now turning to the revenue migration.
We have three global brands, three Els Lima, limbo like assigned or de Vigo and the link can be.
Speaker Change: No.
Speaker Change: We have three global brands, three Elk land Lima, nimble like a science or they they go and the link can be.
In total these three global product as you see.
In total it was these three global product as you see.
Speaker Change: How 'bout achieved.
Speaker Change: The $426 5 billion Y O Y increase was a 24%.
Yeah.
Speaker Change: How 'bout achieved.
Speaker Change: The $426 5 billion Y O Y increase was a 24%.
Speaker Change: What contributed mostly to the garage was the increase of about 40 billion of any of that can be in the 38 billion increasingly bema ended 12 billion yen increasing de Vigo.
Speaker Change: Yeah.
Well, it's contributed most to the garage was the increase of about 40 billion of anything that can be in the 38 billion increase in EM bema, and the 12 billion yen increasing day vehicle.
Speaker Change: So in the overall pharmaceutical business revenue.
Speaker Change: Okay.
Speaker Change: So in the overall pharmaceutical business revenue.
Speaker Change: Increased by 57.6 billion yen.
Speaker Change: Increased by 57 6 billion yen.
And the bottom half.
Speaker Change: We described it at one time income or changes from the previous term, which was minus $9 9 billion gang.
Speaker Change: And the bottom half.
Speaker Change: We describe these at one time income or changes from the previous term, which was minus nine 9 billion Yang.
Speaker Change: But as you see on the left hand side.
Speaker Change: We achieved a 106% of the previous year by increase of $47 6 billion yen to reach $789 4 billion in new revenues next turning to the operating profit migration.
But I do see on the left hand side.
Speaker Change: We achieved the 106% of the previous year, but an increase of $47 6 billion yen to reach $789 4 billion in new revenues next turning to the operating profit migration.
In pharmaceutical business.
Speaker Change: By proactively investment into that can be.
In pharmaceutical business.
Speaker Change: By proactive investment into it it can be.
Speaker Change: Although we continue to such proactive investment but.
Speaker Change: We could have achieved increasing our P by $26 3 billion yen in pharmaceutical business turning to R&D business expenses.
Speaker Change: Although we continue to such proactive investment but.
Speaker Change: We could have achieved increasing our P by $26 3 billion yen in pharmaceutical business turning to R&D business expenses.
Speaker Change: As I said earlier as you see on the right.
Speaker Change: B B, one seven or one impairment loss was.
As I said earlier as you can see on the right.
Speaker Change: B B, one seven or one impairment loss.
Speaker Change: Recorded but.
Yes.
Speaker Change: Which increased the profit by about $4 7 billion yen.
Speaker Change: Recorded bumps.
Speaker Change: She has creased.
Speaker Change: Our profit by about $2 7 billion yen.
Speaker Change: And payment of assured a profit of <unk> two.
Speaker Change: Muck in accordance with the expansion of the Olympias business increased as such.
Speaker Change: And the payment of the share of profit of <unk> two.
Speaker Change: Muck.
Speaker Change: Coordinates with the expansion of the Olympia My business increased a touch.
Speaker Change: And the other business included upfront payments and others and we achieved a $54 4 billion, gaining operating profit which was up two percentage.
Speaker Change: And the other business included upfront payments and others.
Speaker Change: And we achieved a $54 4 billion, gaining operating profit, which was up two percentage.
Speaker Change: Percent from a year earlier.
Speaker Change: Now, let me share with you.
Percent from a year earlier now let me share with you.
Speaker Change: There can be situations.
Unknown Executive: attend the financial results briefing session by Eisai. It is now time we would like to begin the briefing session by Eisai Company Limited on financial results and business updates for fiscal 2024.
Speaker Change: This was carried in the local TV program in Boston in the United States, which featured a Boston Marathon.
Speaker Change: There can be situations.
This was carried in the local TV program in Boston and in the United States, which featured a Boston Marathon.
Speaker Change: There is a runner in Blue Forum uniformed.
Speaker Change: Who achieved the full marathon running.
There's a runner in Blue Forum uniform.
Speaker Change: And this continued with the interview with him but this bus.
Speaker Change: To achieve the full marathon running.
Unknown Executive: Those of you who are in attendance in person, please find materials, including deck of presentation and Flash Report.
Speaker Change: This continued with the interview with him, but this person participated in delek can be like kind of up a clinical trial.
Speaker Change: Got it.
Speaker Change: Clinical trial.
Speaker Change: And as you see here he is a man from Portland in Maine.
Unknown Executive: Those of you who are virtually attending, please find these materials on the website.
Speaker Change: About 100 miles away from.
And as you see here is a mess on Portland in Maine.
Haruo Naito: Let me introduce the speaker, Mr. Haruo Naito, Representative Corporate Officer and CEO. Now, we would like to report on the financial results for ISESCO year 2024. First, let us share with you the P&L for FY 2024. Revenue In a profit both, while we continue to invest resources into Rekenbi, have achieved an increase in both revenue and profit . As we have already announced, the forecast for FY 2024, but both revenue and profits exceeded that forecast.
About 100 miles away from.
Speaker Change: Hospital the hospital in Boston, but he continue to visit the Dod Hospital biweekly for about 10 years.
Speaker Change: Hospital the hospital in Boston, but you continue to visit the Doctor or hospital biweekly for about 10 years.
And if you could run through the whole distance of the marathon after which he was interviewed.
Speaker Change: And if you could run through the whole distance of the marathon after which he was interviewed.
Speaker Change: During the clinical trial.
Speaker Change: He did not know what.
Speaker Change: During the clinical trial.
Speaker Change: Each of the placebo or active drug was administered but the there were.
He did not know whether.
Which of the placebo or active drug was administered but there.
Speaker Change: Our various improvements in their daily activities.
Speaker Change: There were.
Speaker Change: Boarded by caregivers and after that in 2023 FDA approved a drug.
Speaker Change: Our various improvements in their daily activities as reported by caregivers and after that in 2023 FDA approved a drug.
Speaker Change: He realized that the drug he was receding was actually they can be.
Speaker Change: And he realized that the drug he was receiving was actually it can be.
Speaker Change: In the media coverage he made that comment.
Unknown Executive: If you look at this table, cost of sales.
Speaker Change: In the media coverage he made that comment.
Sean: Sean as shown in this case.
Unknown Executive: Thank you for joining us. Increased by 0.5 percentage points. This is due to what is described above, other business, or one-time decrease of revenue, which increased the cost of sales ratio.
Speaker Change: Yeah, Sean as shown in this case.
Sean: There have been various reports on improvement in the behaviors or activities of daily living.
Speaker Change: There have been various reports on improvement in the behaviors or activities of daily living.
Sean: For example, the patient they're now able to go for a shopping in the neighborhood or they have been able to start enjoying our hobbies. These are cold or a nice messaging C. D. R b and not subject clinical endpoints, but rather there have been reports on improvements in activities of daily lives.
Speaker Change: For example, the patients are now able to go for a shopping in the neighborhood or they have been able to start enjoying the hobbies. There's a cold I showed a nice messaging C. D. R. S b and not such a clinical endpoint, but rather there have been reports on the improvements in activities of daily.
Unknown Executive: And if you turn to the expense side, R&D expenses, Accounted for The ratio which was reduced by 1.6 percentage points in terms of its ratio to the revenue mainly in the United States research laboratories. Outside of Japan. There are some inactive research laboratories. or obsolete research laboratories were decided to be closed but among the themes of research were dropped with some impairment losses. Absorbing those... Out-On-Day Expense Ratio to Increased by 1.2 percentage points.
Sean: There are also improved increasing a number of such reports and the medical side and then it sort of social media, both in Japan, and United States, such a number of our reports are increasing in number recently.
There are also improved increasing number of such reports in the medical side and the S N S or social media, both in Japan, and United States such number of our reports are increasing in number recently.
Sean: Yeah.
Sean: For like can be.
Speaker Change: Yeah.
Sean: In Europe.
Speaker Change: For them it can be.
Sean: That can be was approved in Europe 23 straight is southern countries in Europe, plus three and in total in 30 countries that can be has been approved.
And in Europe.
Speaker Change: That can be was approved in Europe, 23, 27 countries in Europe, plus three and in total in 30 countries that can be has been approved.
Sean: More recently in the Middle East.
Sean: <unk> was approved as well.
Speaker Change: More recently in the Middle East that can be was approved as well.
Sean: So country day in 44 countries. It is approved and is under regulatory review in 12 countries.
Speaker Change: So currently today in 44 countries. It is approved and it is under regulatory review in 12 countries.
Sean: And in 44 countries worldwide.
Speaker Change: Okay.
Unknown Executive: Because we continue to invest resources into Rekenbi, particularly marketing resources were invested in this SG&A expenses in which includes Expenses related to the structural reforms in the United States that was carried out during the year under review. There was a temporary increase in expenses related to the U.S. structural reform, which are related to the termination benefits. Such increase was absorbed. to control R&SG and A expenses. whose increase was controlled within 1.2 percentage points.
Sean: They can be.
Sean: Approved therefore, it can be harder Judah globally.
Speaker Change: In 44 countries worldwide.
They can be husband that approved therefore, it can be has achieved a global reach and are making steady progress.
Sean: And are making steady progress.
Sean: Towards a really global drug.
Sean: Now turning to the approval in Europe.
Speaker Change: Toward a truly global drugs.
Sean: As many as 26 months.
Speaker Change: Now turning to the approval in Europe.
Sean: As they say submission was filed.
Speaker Change: As many as 26 months have passed since submission was filed.
Sean: That suggests that there are a lot of our discussions and deliberations.
Speaker Change: That suggest that there are a lot of our discussions and deliberations.
Sean: One after another and the process of correspondence under their review.
Speaker Change: One after another in the process of correspondence under the reboot.
Sean: But.
Sean: On April 15th 2025, and it can be was granted approval in.
Speaker Change: But.
Blessed on April 15th 2025, and it can be was granted approval in Europe.
Sean: Right.
Sean: It can be as the first therapy in Europe that targets, an underlying cause of a D C.
Unknown Executive: Now, turning to the revenue migration. We have three global brands, three L's, LENVIMA, LENBO RECUSANT, or DAIVIGO, and LENKEMBI. In total of these three global products, as you see, have achieved. The 426.5 billion yen, YOY increase was 24%. What contributed most to the growth was the increase of 40 billion yen in Kenpi, and a 30.8 billion yen increase in Renvima, and a 12 billion yen increase in Daivigo. So in the overall pharmaceutical business, revenue... Increased by 57.6 billion yen and a bottom half We described a one-time income or changes from the previous term, which was minus 9.9 billion yen But as you see on the left-hand side...
Speaker Change: It can be as the first therapy in Europe that targets, an underlying cause of a D. How do you see after the second bullet point in Europe.
Sean: After the second bullet point in Europe.
Sean: I believe for homozygous.
Sean: Okay.
Sean: Okay.
Speaker Change: Ah boy for almost cycle.
Sean: Which account for about 15% of patients with a D.
Speaker Change: Hum.
Speaker Change: Okay.
Which accounts for about 15% of patients with already a D.
Sean: These people are not included in that.
Speaker Change: Well.
Sean: Ah patients eligible for receiving the drug in Europe.
Speaker Change: These people are not included in the Ah patients eligible for receiving the drug in Europe.
Sean: Having said that.
Sean: In the U S, Japan, China, and Europe, so called the four major agency.
Sure.
Speaker Change: Having said that.
Speaker Change: In the U S, Japan, China and Europe.
Sean:
Sean: Hi.
Speaker Change: So called a full major agency.
Sean: Lived like can be around the world.
Speaker Change: Well.
Sean: This European regulatory approval may serve as a reference.
Speaker Change: <unk> approved let can be around the world.
Speaker Change: This European regulatory approval may serve as a reference.
Sean: For regulatory authorities.
Sean: In other countries, where they can be submissions are filed under being viewed as you see at the bottom there.
Speaker Change: For regulatory authorities.
Speaker Change: In other countries, where there can be submissions are filed under being reviewed as you see at the bottom.
Sean: The first thing launching country.
Sean: First of all the countries in Europe are going to be Germany, and Australia, we are aiming at.
Speaker Change: The first thing of launching country first launching countries in Europe are going to be Germany, and Australia, we are aiming at getting the.
Sean: Getting.
Sean: The truck to be launched in the second half of fiscal year 2025, we are making preparations now.
Speaker Change: The drugs to be launched in the second half of fiscal year 2025, we are making preparations now.
Unknown Executive: We achieved 106% of the previous year by increase of 47.6 billion yen to reach 789.4 billion yen in revenue.
Sean: Global that can be revenue.
Sean: For FY 'twenty 'twenty four it was $44 3 billion again.
Speaker Change: So global that can be revenue.
Sean: Do you see this exceeded the full year for us.
Speaker Change: For FY 'twenty 'twenty four it was $44 3 billion yen.
Unknown Executive: Next, turning to the operating profit migration in pharmaceutical business by proactive investment into Rakenbi. Although we continued such proactive investment, but... We could achieve the increase in RP by 26.3 billion yen in pharmaceutical business, turning to R&D business expenses. As I said earlier, as you see on the right, BB1701 impairment loss was... Recorded but which increased the profit by about 3.7 billion yen. and payment of a shared profit of LENVIMA to Merck in accordance with the expansion of the LENVIMA business increased as such. and other business included upfront payments and others and we achieved 54.4 billion yen in operating profit which was up two percentage percent from a year earlier now let me share with you Rekenbi situation.
Do you see this exceeded our full year forecast.
Sean: In America.
Sean: Revenue was 26.1 billion yen in Japan revenue was $12 7 billion $4 7 billion in China the point.
Speaker Change: In America.
Revenue was 26.1 billion yen in Japan revenue was $12 7 billion footprint for video and gaming in China.
Sean: In others, it means Israel, and South Korea as well.
Speaker Change: Seven in others means Israel, and South Korea as well.
Sean: <unk> started to record revenue. So in total of $44 3 billion was recorded as a global revenue for us.
Speaker Change: <unk> started to record revenues totaled $44 3 billion yen was recorded as a global revenues for us.
Sean: I'll spend the first the full year.
Speaker Change: It is being the first full year.
Sean: In 2024.
Mhm.
Sean: Fiscal year 2024, therefore at $44 3 billion yen as the revenue for the first full year.
Speaker Change: In 2024.
Speaker Change: Okay.
Fiscal year 2024, therefore at $44 3 billion yen us the revenue for the first full year.
Sean: Shows that we have been able to make a steady start seeing.
Speaker Change: Shows that we have been able to make a steady start in <unk>.
Sean: Building up revenue.
Sean: Now turning to the growth trajectory for that can be how should we get back that tragically, which is explained on this slide.
Speaker Change: Building up revenue.
Now turning to the growth trajectory for that can be how should we get back that tragically, which is explained on this slide.
Sean: We are able to divide the timing into.
Speaker Change: We are able to divide the timing into.
Sean: Three major periods, namely pathway establishment phase demand stimulation phase under demand expansion phase.
Unknown Executive: This was carried in the local TV program in Boston in the United States, which featured Boston Marathon. There is a runner in blue uniform who achieved the full marathon running and this continued with the interview with him. But this person participated in the Kenbi Rekanema clinical trial and as you see here he is a man from Portland in Maine. about 100 miles away from Hospital, the hospital in Boston, but he continued to visit that hospital bi-weekly for about 10 years and he could run through the whole distance of the marathon after which he was interviewed.
Speaker Change: Three major periods, namely pathway establishment phase demand stimulation phase under demand expansion phase.
Sean: We would like to ask you to understand that such under relate to organize ourselves and thinking in this way first anda pathway establishment phase.
Speaker Change: Yeah.
Speaker Change: We would like to ask you to understand that such under relate to organize ourselves and thinking in this way first Angel crossway establishment phase. She runs we needed to start from scratch in terms of establishing a diagnosis and treatment pathway for Alzheimer's disease.
Sean: We needed to start from scratch in terms of establishing a diagnosis and treatment pathway for Alzheimer's disease.
Sean: But I often mentioned.
Speaker Change: <unk>.
Sean: Is that the this is can be emulated to the work which is as we are.
But I often mentioned ace.
Speaker Change: Is that the this is can be emulated to the work which is as we are.
Sean: Removing a big rock in that.
Sean: Building a bridge over a large river in a dig a tunnel penetrating our large mounting the most one of the most difficult.
Removing a big rock in that.
Speaker Change: Building a bridge over a large labor in a big old tunnel penetrating our large mounting the most one of the most difficult.
Sean: And the most burdensome pathway.
Sean: In our modern.
Unknown Executive: During the clinical trial, He did not know which of the placebo or actually the drug was administered, but there were Various improvements in the daily activities, as reported by caregivers, and after that, in 2023, FDA approved the drug. And he realized that the drug he was receiving was actually Lekembe. In the media coverage, he made that comment. shown as shown in this case There have been various reports on improvements in the behaviors or activities of daily living. For example, the patients are now able to go for shopping in the neighborhood or they have been able to start enjoying the hobbies.
Speaker Change: Most of the burdensome pathway.
Sean: Borrowed so which requires a pioneer like airports.
Speaker Change: And a modern.
Speaker Change: Road, so which requires a pioneer like airports.
Sean: We believe that we are the pioneer in the dementia treatment and we.
We believe that we are the pioneer in that they may show treatment and do we.
Sean: Believe that the we have a dedicated ourselves to establishing in the pathway.
Speaker Change: Believe that the we have a dedicated ourselves to establishing the pathway.
Sean: <unk> needs to be done more specifically, how do you see after the second bullet point you needed to create a flow of diagnosis and treatment of J D.
Speaker Change: Needs to be done more specifically as you can see after the second bullet point.
Sean: Another function testing upper E testing amyloid beta testing Petra CSF, where needed. Therefore, it will be very expensive and invasive administration, which requires infusion. Therefore, it infusion needed to be attended by nurses.
Speaker Change: Needed to create a full of diagnosis and treatment of J D.
Speaker Change: Without the function testing for E testing.
Speaker Change: Beta testing it to see if it were needed. Therefore, it will be very expensive and invasive administration, which requires infusion therefore as infusion needed to be attended by nurses.
Sean: For the sake of infusion patients had to visit infusion centers.
Unknown Executive: These are called a humanized messaging, CDRSP, and not such a clinical endpoints, but rather there have been reports on the improvements in activities of daily living. There are also improved increasing number of such reports in a medical side and the SNS or social media, both in Japan and the United States, such number of reports are increasing in number recently. for Le Kenbi in Europe. Rekenbi was approved in Europe, 27 countries in Europe plus 3, and in total in 30 countries Rekenbi has been approved. More recently, in the Middle East, Rekenbi was approved as well. So currently, today, in 44 countries it is approved and it is under regulatory review in 12 countries.
For the sake of infusion patients had to visit infusion centers.
Sean: So there was a quite a combo some step.
And are you monitoring utilizing MRI will be conducted.
Speaker Change: So there was a quite accomplish some steps.
Speaker Change: And are we are monitoring utilizing MRI will be conducted.
Sean: So firstly this flow.
Sean: Consisting of Oh these are steps.
Speaker Change: So first of these flows.
Sean: It needs to be created undisturbed each step has to be established and before realizing that you needed to get the reimbursement.
Speaker Change: Consisting of Oh these are the steps needed.
We needed to be created undisturbed each step has to be established before realizing.
Sean: All of these medical procedures, you have to be covered by reimbursement under each system of health insurance in each country.
You needed to get the reimbursement.
All of these medical procedures, you have to be covered by reimbursement under each system of health insurance in each country.
Sean: In order to minimize the burden on the patient.
Speaker Change: In order to minimize the burden on the patient.
Sean: So all doing all of these are required in the possibly establishment phase needless to say.
Speaker Change: So all doing all of these are required in the possibly establishment things needless to say.
Sean: What is supporting each step.
Sean: It's done by HCP, So you needed to consider deploying and education for Hcp's with cannot be done by <unk> alone.
Speaker Change: What is supporting each step.
It's done by HCP, So you needed to consider deploying and education for Hcp's, which cannot be done by <unk> alone.
Unknown Executive: In 44 countries worldwide, Rekenbi has been approved. Therefore, Rekenbi has achieved global reach and making steady progress. toward a truly global drug. Now turning to the approval in Europe, as many as 26 months have passed since submission was filed. That suggests that there are a lot of discussions and deliberations. one after another in the process of correspondence under the review.
Sean: Through collaboration that leads.
Sean: Hcp's at medical institutions.
Speaker Change: Through collaborations.
Sean: We are conducting these efforts at the same time, we needed to promote market introduction of <unk> can be.
Speaker Change: Hcp's like medical institutions.
Speaker Change: There are conducting as these efforts at the same time, we needed to promote market introduction of blood can be.
Sean: There are so called a formulary at each medical institutions and they are committed to decide adoption of the drug's explanation of the safety and efficacy needed to be provided in order to convince the committee to adopt it.
Speaker Change: There are so called a formulary at each medical institutions and they are a committee to decide our adoption of the drug's explanation of the safety.
Speaker Change: So you needed to be provided in order to.
Sean: The drug and now that is the busway establishment in phase after this.
Permit me to adopt.
Speaker Change: Uh huh.
Speaker Change: No that is the best way establishment phase after this.
Sean: And the pathway has been established now turning to demand stimulation kept safe.
Unknown Executive: But at last, on April 15th, 2025, Elekin-B was granted approval in Europe. Rekenbi is the first therapy in Europe that targets an underlying cause of AD. As you see, after the second bullet point, in Europe... Apoi for homozygotes. which accounts for about 15% of patients with early AD. These people are not included in the patients eligible for receiving the drug in Europe. Having said that, in the U.S., Japan, China, and Europe, so-called four major agencies, have approved LECMB around the world. This European regulatory approval may serve as a reference. For regulatory authorities in other countries where the Kenbi submissions are filed and being reviewed.
Speaker Change: And the pathway husband established now turning to demand stimulation.
Sean: You needed to establish capacity to accommodate or a certain number of patients for each step in the pathway.
Speaker Change: Great.
You needed to establish capacity to accommodate or certain number of patients for each step in the pathway.
Sean: Then.
Sean: They indicated patients.
Sean: Or patients with early a D. You need to do support introduction of such patients to pathway. During this phase.
Then.
The indicated patient.
Speaker Change: Or patients with early a D you'd need to do support introduction of such patients who passed away during this stage.
Sean: Efficacy and safety profile of it can be harder to be established.
Speaker Change: Efficacy and safety profile of well it can be harder to be established.
Sean: So that means that the administration of light can be it can be promoted under safe environment, such environment has to be in place as I said mentioned humanize the message is being conveyed.
Speaker Change: So that means that the administration of that can be can be promoted under safe environment.
Speaker Change: The environment has to be in place as I said mentioned humanize the message is being conveyed.
Sean: Many of these states.
Sean: And accumulation in the academic presentation.
Speaker Change: During this phase.
Well it can be a real world data by specialists are being done.
Speaker Change: And accumulation and they make the presentation.
Sean: And on the right and side do you see demand expansion phase.
Speaker Change: Well it can be real world data by specialists are being done.
Speaker Change: And on the right insight or use the demand expansion phase.
Sean: What is needed here is to have coordination network with PCP primary care physicians.
Speaker Change: So what is needed here is to have coordination network with PCP primary care physician.
Unknown Executive: As you see at the bottom, the first thing launching country, first launching countries in Europe are going to be Germany and Australia. We are aiming at getting the drug to be launched in the second half of fiscal year 2025. We are making preparations now. Global Kenbi revenue for FY 2024 was 44.3 billion yen. As you see, this exceeded the full year forecast. Revenue was 26.1 billion yen in Japan. Revenue was 12.7 billion yen, 4.7 billion yen in China. 0.7 in others means Israel and South Korea as well. We have started to record revenues, so in total 44.3 billion yen was recorded as global revenue.
Sean: Nearby physicians.
Sean: And.
Especially on neurologist there needs to be established a network between the two.
Speaker Change: Nearby physicians.
Hum.
Specialists neurologists there needs to be established a network between the two.
Sean: That is the condition for the states that means the PC PS will play certain roles in diagnosis testing and treatment. So not everything is left to specialists.
Speaker Change: So that is the condition for the states that made the PCP will play certain roles in diagnosis testing and treatment. So not everything is left to specialists.
Sean: But.
Sean: Whenever a diagnosis by specialists is unnecessary referral should be made.
Speaker Change: But nonetheless.
Speaker Change: Whenever a diagnosis by especially is a necessary referral should be made.
Sean: Right.
Sean: So the time for referral can be significantly reduced.
Speaker Change: Two months ago.
Speaker Change: So the time for referral can be significantly reduced.
Sean: That is one.
Sean: One of the important conditions for demand expansion phase.
Speaker Change: That is.
Speaker Change: One of the important condition for demand expansion phase.
Sean: And the coordination between initiation of introduction facilities and a follow up facilities, which is applicable to Japan. During the first six months initial introduction facilities are in charge of a treatment for patients and another different medical institution is engaged in the fall of a fast follower but treatment.
Speaker Change: And the coordination between initiation introduction facilities and a photo facilities, which is applicable to Japan. During the first six months and it'll introduction facilities are in charge of a treatment for patients and another different medical institution is engaged in the follow up.
Unknown Executive: For us, it has been the first full year. in 2024. Fiscal year 2024, therefore 44.3 billion yen as the revenue for the first full year. It shows that we have been able to make a steady start in building up revenue. Now turning to the growth trajectory for the Kenbi, how should we depict the trajectory, which is explained on this slide. We are able to divide the timing into three major periods, namely pathway establishment phase, demand stimulation phase, and demand expansion phase. We would like to ask you to understand as such and we would like to organize ourselves in thinking in this way.
Sean: After that and that is well described in the rules in Japan. So we believe that we have been able to establish such system in Japan already second bullet point, if DTC direct to consumer advertisements for disease awareness.
Speaker Change: The follow up of treatment after that and that is what is driving in the rules in Japan. So we believe that we have been able to establish such system in Japan already second bullet point is DTC direct to consumer advertisements.
Sean: Yeah.
Sean: In most cases this awareness campaigns are conducted under the brand it method.
Speaker Change: Our disease awareness.
Speaker Change: Uh huh.
In most cases this awareness campaigns are conducted under the brand it method.
Sean: I do see below in order to streamline the pathway there are various innovations.
Speaker Change: Others see below the knee.
Speaker Change: Order to streamlined pathway there are various innovations.
Sean: For example.
Sean: A b b M will be utilized for confirmatory testing.
Speaker Change: For example.
Sean: Changed from infusion to see AI, and utilizing voice and others for conducting digital cognitive function testing.
Speaker Change: B M will be utilized for confirmatory testing.
Unknown Executive: First, in the pathway establishment phase, we needed to start from scratch in terms of establishing diagnosis and treatment pathway for Alzheimer's disease. What I often mention is that this can be emulated to the work as if we are removing a big rock and building a bridge over a large river and dig a tunnel, penetrating a large mountain. This is one of the most difficult and most burdensome pathway. in a modern world, so which requires a pioneer-like effort. We believe that we are the pioneer in the dementia treatment and we... believe that we have dedicated ourselves to establishing the pathway.
Speaker Change: Changed from infusion to S. G. A I N utilizing voice and others for conducting digital coconut dysfunction testing.
Sean: Yeah.
Sean: And MRI will be utilized for assisting.
Speaker Change: Yeah.
Sean: And I will be utilized for assisting am I right reading.
Speaker Change: And MRI.
Tomorrow, it will be utilized for assisting.
Speaker Change: May I will be utilized for assisting MRI readings.
Sean: These are becoming visible and during this phase these innovations shall be implemented. So these are thought to be the condition for this expansion say demand expansion phase.
Speaker Change: These are becoming visible.
Speaker Change: And during this phase these innovations shall be implemented. So these are thought to be the conditions for this expansion say demand expansion phase.
Sean: In FY 2025, or five regions, where we are rolling out this therapy.
In FY 2025, or five regions, where we are rolling out this therapy.
Sean: Below you can see which position each region is now.
Speaker Change: So below you can see which position each region is now.
Sean: Europe, and Asia, where our recent G. D. There can be was approved and if these regions are in the pathway establishment phase and.
Speaker Change: Europe and Asia were recently dealer can be was approved and if these regions are in the past why establishment phase.
In private market and that can be therapy is being provided so in China, which is positioned in their demand is stimulation faith in the United States.
And in private markets and that can be therapy is being provided so in China.
Unknown Executive: What needs to be done more specifically, as you see after the second bullet point, you needed to create a flow of diagnosis and treatment of AD, cognitive function testing, APOE testing, amyloid beta testing, PET or CSF were needed. Therefore, it will be very expensive and invasive. Administration, which requires infusion, therefore, infusion needed to be attended by nurses. For the sake of infusion, patients had to visit infusion centers. So there was a quite a cumbersome step and area monitoring utilizing MRI will be conducted. So, first, this flow... consisting of all these steps needs to be created and a step each step has to be established and for realizing this you needed to get the reimbursement all these medical procedures have to be covered by reimbursement under each system of health insurance in each country in order to minimize the burden on the patients you So, doing all these are required in the pathway establishment, say, needless to say.
<unk> is positioned in the demand stimulation faith in the United States, which is in between the demand the stimulation phase or towards the end of a demand stimulation phase.
Sean: It is in between the demand stimulation phase or towards the end over demand stimulation phase.
Sean: Because it is in between stimulation phase in expansion states unfortunate pun, which we believe has already entered demand expansion phase.
It is in between stimulation phase an expansion phase unfortunate pun, which we believe has already entered a demand expansion phase.
Sean: Now turning to next fiscal year.
Sean: The U S is expected to enter demand expansion phase so fourth fiscal year 'twenty to 'twenty six.
Speaker Change: Now turning to next fiscal year.
Speaker Change: The U S is expected to enter demand expansion phase for fiscal year 'twenty to 'twenty six.
Sean: Revenue and the penetration of a it can be is expected to be boosted.
Revenue and the penetration of the light can be is expected to be boosted.
Sean: Because of this.
Sean: Yeah.
Speaker Change: Because of this.
Sean: No they can be in the United States.
Speaker Change: Great.
Sean: What are we going to do for this fiscal year.
Speaker Change: No they can be in the United States.
Sean: Pope AIDS.
Speaker Change: What are we going to do for this fiscal year.
Sean: To convey the core evidence of it it can be.
Speaker Change: Pope AIDS.
Sean: In Alzheimer's disease, which is a progressive and fatal disease.
To convey a more evidence of the hem b.
Speaker Change: In Alzheimer's disease, which is a progressive and fatal disease.
Sean: Which will continue to progress Unfortunately, India and the patient will die because of this.
Speaker Change: Alright.
Speaker Change: Which will continue to progress Unfortunately, and then the patient will die because of that.
Sean: Disease, therefore early initiation of treatment and the continuation of treatment is necessary and the discontinuation of treatment is not desirable so such core evidence that needs to be conveyed and also message is related to the improvement in the activities of daily living will be conveyed.
Speaker Change: Disease, therefore early initiation of treatment and the.
Speaker Change: Continuation of treatment is necessary and the discontinuation of treatment is not desirable for such core evidence that needs to be conveyed and or so messages related to the improvement in the activities of daily living will be conveyed this is going to be the basic tasks that we will continue to do in the middle.
Unknown Executive: What is supporting each step is done by HCP, so you needed to consider deploying and education for HCPs which cannot be done by Eisai alone through collaboration with HCPs at medical institutions, we are conducting these efforts. At the same time, we need to promote market introduction of Lecambe. There are so-called formulary at each medical institutions and there are committees to decide adoption of the drugs. Explanation of the safety and efficacy needed to be provided in order to convince the committee to adopt the drug. And now that is the pathway establishment phase. After this, a pathway has been established.
Sean: This is going to be the basic tasks that we will continue to do in the middle of the ear National educational event is considered.
Oh, the ear national educational event is considered.
Sean: So in summary, or coverage of that data will be conducted on a national level.
Speaker Change: A summary or coverage of that data will be conducted on a national level.
Sean: The second bullet.
Sean: Is it related to the IV maintenance dosing.
Speaker Change: The second bullet.
Speaker Change: It's related to the IV maintenance dosing.
Sean: Changing to every four weeks.
Sean: Approval of which has been already obtained but what is the significance of this.
Speaker Change: [laughter] changing two every four weeks.
Speaker Change: Approval of which has been already obtained but what is the significance of this.
Sean: If you look at the right hand side.
Sean: Every day he has recognized that for a D. Long term treatment is necessary onto treatment should be continued.
If you look at the right hand side.
Speaker Change: If it'd be a has recognized that for a D. Long term treatment is necessary onto treatment should be continued.
Sean: So this approval.
Unknown Executive: Now turning to demand stimulation phase. You need to establish capacity to accommodate a certain number of patients for each step in the pathway. Then, The indicated patients, or patients with early AED, you need to support introduction of such patients to pathway. During this stage, Efficacy and safety profile of legume bee had to be established. So that means that the administration of Lekenbi can be promoted under safe environment. Such environment has to be in place, as I said, mentioned, humanized message is being conveyed during this phase. And accumulation and academic presentation of Lekenbi real-world data by specialists are being done.
Sean: Indicates that EBITDA has recognized such necessity of long term treatment and the benefits of a longer term administration was confirmed.
Speaker Change: So this approval.
Indicates that FDA has recognized fudge necessity of long term treatment.
Sean: Of course after 18 months.
Speaker Change: The benefits of a longer term administration was confirmed.
Streamlining administration.
Speaker Change: Of course after 18 months.
Sean: Will be achieved and that is one of the advantages.
Speaker Change: Maligning administration.
Sean: But this shows the necessity to continue long term treatment that is being.
Speaker Change: It will be achieved and that is one of the advantages.
Speaker Change: But this shows the necessity to continue long term treatment that is being.
Sean: In a sense authorized to buy this or regulatory authority.
Speaker Change: In a sense authorized to buy this or regulatory authorities.
Sean: Actually at the medical institutions initiation of treatment is being provided have shown the effect of increasing number of patients initiating treatment next one is a potential I V D approval for B B M for confirmatory testing.
Speaker Change: Actually at the medical institutions initiation treatment is being provided.
Sean the effect of increasing number of patients initiating treatment next one is a potential IV the approval for B B M for confirmatory testing.
Sean: It used to be done through pet, which was very expensive C. S S, which was very invasive.
Unknown Executive: and on the right hand side you see demand expansion phase. What is needed here is to have coordination network with PCP, Primary Care Physicians. Nearby physicians and Specialists or neurologists, there needs to be established a network between the two. That is the condition for this phase. That means the PCPs will play certain roles in diagnosis, testing, and treatment. So not everything is left to specialists. Whenever diagnosis by specialists is necessary, referral should be made. So, the time for referral can be significantly reduced. That is one of the important conditions for demand expansion phase. and the coordination between initiation introduction facilities and follow-up facilities which is applicable to Japan.
Speaker Change: He used to be done through pets, which was very expensive she asked which was the invasive.
Sean: This could be replaced with a simple blood based testing.
Speaker Change: This could be replaced with a simple blood based testing.
Sean: This is thought to be around the corner.
Sean: And for how to use this method Alzheimers Association of the United States is planning to publish the clinical guidelines and a draft version is husband already circulated. So we believe that this guideline.
Speaker Change: This is a thought it to be around the corner.
Speaker Change: And for how to use this method Alzheimers Association of the United States is planning to publish the clinical guidelines and a draft version is husband nobody shortly so we believe that this guideline will be published soon.
Sean: Be published soon.
Sean: And B B M.
Sean: Maybe utilize the full confirmatory testing, which maybe.
Speaker Change: B B M.
Speaker Change: She may be utilized for confirmatory testing, which may be.
Sean: Implemented a bite them this fiscal year, which will lead to streamlining and generalizing amyloid beta testing now turning to S. C. A I.
Speaker Change: Implemented a bite in this fiscal year, which will lead to streamlining and generalizing amyloid beta testing now turning to our C. H I G.
Sean: Currently being utilized with 360 milligram dosing for maintenance treatment are actually.
Country being utilized with 360 milligram dosing for maintenance treatment are actually.
Sean: The submission has been filed and not utilized yet, but the submission has been filed.
Speaker Change: The submission has been filed and not utilized yet, but the submission has been filed.
Sean: And inspections is are completed or in the process of being inspected by the regulatory authorities Purdue for.
Unknown Executive: During the first six months, initial introduction facilities are in charge of treatment for patients and another different medical institution is engaged in the follow-up treatment after that. And that is prescribed in the rules in Japan. So we believe that we have been able to establish such system in Japan already. Second bullet point is DTC, direct-to-consumer advertisement for disease awareness. In most cases, these awareness campaigns are conducted under the branded method. As you see below, in order to streamline pathway, there are various innovations, for example, BBM will be utilized for confirmatory testing, and change from infusion to SCAI, and utilizing voice and others for conducting digital cognitive function testing, and MRI will be utilized for assisting.
Speaker Change: And inspections are completed or in the process of being inspected by the regulatory authorities.
Sean: The date is scheduled for August 31 of this year towards which we believe the way I'm, making steady progress.
Speaker Change: The date is scheduled for August 31st of this year towards which we believe the way I'm, making steady progress.
Sean: After obtaining this and then we will potentially submit for the approval of <unk> S. A I with 500 milligram dosing for initiation of treatment, we are making consultation with regulatory authorities.
After obtaining this and then we will potentially submit for the approval of our C. A R.
Speaker Change: With 500 milligram dosing for initiation treatment, we are making on foundation with regulatory authorities.
Sean: And over this fiscal year or in early next fiscal year.
Speaker Change: The end of this fiscal year or in early next fiscal year.
Sean: This is C. H I me be utilized the full covering all the entire treatment period.
Speaker Change: This is C. I me be utilized the full covering all the entire treatment period.
Sean: So far up to 36 months long term daughter is provided but.
Speaker Change: So far up to 36 months long term daughter is provided but.
Sean: 48 months data is being prepared.
Sean: So going forward there'll be conferences, such as a I see in the seat that.
48 months, daughter is being prepared.
Speaker Change: So going forward there'll be conferences, such as IC en suite that.
Sean: Such a longer term benefit or advantage is we'd be shown on such occasions.
Speaker Change: Such a longer term benefit or advantage is a would be shown on such occasions.
Sean: Next our targeted the DTC and the P. C. P. P. C peds will be explained in the following slides.
Good morning.
Speaker Change: Next the targeted the B C and D. C. P. P. C piece will be explained in the following slides.
Unknown Executive: AI will be utilized for assisting MRI reading. These are becoming visible, and during this phase, these innovations shall be implemented. So these are thought to be the conditions for this expansion phase, demand expansion phase. In FY 2025, five regions where we are rolling out this therapy, so below you can see which position each region is now. Europe and Asia where recently the Lekenbi was approved and these regions are in the pathway establishment phase and in private market Lekenbi therapy is being provided so in China which is positioned in the demand stimulation phase in the United States which is in between the demand stimulation phase or towards the end of the demand stimulation phase because it is in between stimulation phase and expansion phase and for Japan which we believe has already entered demand expansion phase.
Sean: This shows the new formulation and administration method.
Speaker Change: Okay.
This shows the new formulation and administration method.
Sean: Maintenance dosing currently under discussion with the authorities in Japan, and China and for S. C. A I initiation in Japan, and China preparations are being made for submission.
Speaker Change: The maintenance dosing currently under discussion with the authorities in Japan, and China and for S. E I initiation in Japan, and China preparations are being made for submission.
Sean: And the formulation as you see in the picture of underwriters on site, the cutting edge technology provided by <unk>.
Speaker Change: Sure.
Speaker Change: And the formulation as you see in the picture on the right hand side, the cutting edge technology provided by Cerullo.
Sean: At least the painful these very safe a pen type auto injector will be used which we believe it will become the key factor for a changing their treatment.
Speaker Change: At least the painful.
Speaker Change: These are very safe a pen type auto injector will be used which we believe it will become the key factor for a changing their treatment.
I get it the D T C.
Sean: Why do we call it targeted.
Targeted to PTC.
Sean: In this case.
Speaker Change: Why do we call it targeted.
Sean: What we mean by targeted AIDS.
Speaker Change: In this case.
Sean: For those patients.
What we mean by targeted AIDS.
Sean: Who have been diagnosed with a D actually after getting diagnosis until starting the treatment. It still takes several months.
For those patients who have been diagnosed with already a D actually after getting diagnosis until starting the treatment. It just feel it takes several months.
Sean: In the meantime.
Unknown Executive: Now turning to next fiscal year The U.S. is expected to enter demand expansion phase, so for fiscal year 2026, revenue and the penetration of the Rekinbi is expected to be boosted. which will continue to progress. Unfortunately, in the end, the patient will die because of this disease. Therefore, early initiation of treatment and continuation of treatment is necessary, and the discontinuation of treatment is not desirable. So such co-evidence needs to be conveyed, and also messages related to the improvement in the activities of daily living will be conveyed. This is going to be the basic task that we will continue to do.
Sean: What kind of a drug that can be eat.
Speaker Change: In the meantime.
Sean: Needs to be understood by the patients who are diagnosed with already a D through addressable TV.
Speaker Change: What kind of a drug that can be either.
Speaker Change: <unk> needs to be understood by the patients who are diagnosed with already a D through addressable TV.
Sean: As a secure a target.
So that we would be able to contribute to shortening the time until the initiation of the treatment or.
Speaker Change: He's a secure a target.
Speaker Change: So that we would be able to contribute to shortening the time it until the initiation of the treatment or.
Sean: As a pulling the factor we may ask the patients.
Speaker Change: Right.
Speaker Change: As a pulling the factor, but we may ask the patient.
Sean: Through this campaign to be interested in.
Speaker Change: Uh huh.
Sean: Getting the treatment that can be and we have seen the certain.
Speaker Change: Through this campaign to be interested in.
Speaker Change: Getting the treatment to be flat can be and we have seen a certain effect.
Sean: So far and we'd like to continue on this next fiscal year onward, now turning to B B M.
Speaker Change: So far and we'd like to continue on this next fiscal year onwards, now turning to B B M.
Sean: Please look at the right hand side country, the number or the triage test, which are utilized for pre screening.
Please look at the right hand side trying to treat a number of other PRT tests, which are utilized for pre screening.
Sean: After the full approval was granted in the United States as you can see here the number of triage tests is dramatically increasing.
Speaker Change: After the full approval was granted in the United States as you can see here the number of triage test is dramatically increasing.
Sean: In the testing of our P Tau to one seven not seeing the accumulated up.
In the testing of our P Tau to one seven not seeing the accumulated loss.
Unknown Executive: In the middle of the year, national educational event is considered. The summary or coverage of the data will be conducted on a national level. The second bullet is related to the IV maintenance dosing, changing to every four weeks. approval of which has been already obtained but what is the significance of this if you look at the right hand side fda has recognized that for ad long-term treatment is necessary and treatment should be continued so this approval Indicates that FDA has recognized such necessity of long-term treatment And the benefits of a long-term administration was confirmed Of course after 18 months Streamlining Administration will be achieved.
Sean: Debate.
Sean: Such patients are to be excluded by conducting this test.
Speaker Change: We debate that as.
As such patients are to be excluded by conducting the study.
Sean: And as you see on the left hand side for confirmatory testing.
Speaker Change: And as you see on the left hand side for confirmatory testing.
Sean: If I may repeat not utilizing the very expensive pet or invasive C. S. F for a confirmation of the amyloid better not doing these tests, but more simple and easy blood based test can be conducted.
If I may repeat not utilizing big very expensive pet or invasive C. F for a confirmation of the Italy, better not doing these tests, but more simple and easy blood based test.
Sean: Which is a soon to be.
Sean: And implemented.
Can be conducted.
Speaker Change: Which is soon to be.
Sean: As for approach towards P C. Pete.
Speaker Change: Scene and implemented.
Speaker Change: Yeah.
Sean: Earlier, please recall the timing one of the conditions of expansion phase currency about 80% of the patients are 80% of M. C. I patients are currently under the care of PCP.
Speaker Change: As for approach towards P. C P.
Speaker Change: Earlier, please recall the timing one of the conditions of expansion phase.
Speaker Change: Currency about 80% of our patients 80% of Mci patients are currently under the care of PCP.
Sean: But they are not diagnosed.
Unknown Executive: And that is one of the advantages. But this shows the necessity to continue long-term treatment that has been In a sense, authorized by this regulatory authority. Actually, at the medical institutions, initiation treatment is being provided, have shown the effect of increasing number of patients initiating treatment. Next one is a potential IVD approval for BBM, for confirmatory testing. It used to be done through PET, which was very expensive. CSF, which was very invasive. This could be replaced with a simple blood-based testing. This is thought to be around the corner. And for how to use this method, Alzheimer's Association of the United States is planning to publish the clinical guideline and a draft version has been already circulated, so we believe that this guideline will be published soon.
Sean: But with M C I.
Speaker Change: But they are not diagnosed.
Sean: Therefore.
Sean: We have to make sure that they are diagnosed so that occur.
Speaker Change: With M C I.
Therefore.
Speaker Change: We have to make sure that as they are diagnosed so that care.
Sean: Can be thought of by these patients.
Sean: This fiscal year.
Speaker Change: Can be thought of by these patients.
Sean: Neurology account specialists that.
Speaker Change: This fiscal year.
Sean: Main component of our sales force around 2000.
Speaker Change: Neurology account specialists.
Speaker Change: The main components of our sales force around 2000.
Sean: It's just in the U S and or rather around 2000 hypothetical pcbs in the U S. Having identified in N. A S will be targeting these P C piece.
Speaker Change: If this in the U S and or rather around 2000 high potential pcbs in the U S. Having identified and we'll be targeting these PCP exact.
Exactly what are they going to do Pcbs and neighboring specialist institutions. Oftentimes. These are called <unk> and a very large in scale and help our building our coordination between Pcbs and specialized institutions.
Speaker Change: Exactly what are they going to do.
Speaker Change: <unk> and our neighboring specialist institutions oftentimes these are gold ideas and a very large in scale and helped our building of coordination between Pcbs and specialist institutions.
Sean: Pcbs.
Sean: Can contribute to identify patients with Mci and filed a D using cognitive testing to diagnose them or just confirmatory b b M testing to identify such patients and then if these patients are referred to the specialist.
The PCP.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Counting contracted so identify patients with Mci and filed a D.
Unknown Executive: And BBM. may be utilized for confirmatory testing, which may be implemented by them this fiscal year, which will lead to streamlining and generalizing amyloid beta testing. Now turning to SCAI, currently being utilized with 360 milligram dosing for maintenance treatment. And actually, the submission has been filed and not utilized yet, but the submission has been filed and inspections are completed or in the process of being inspected by the regulatory authorities. PDUFA date is scheduled for August 31st of this year, towards which we believe we are making steady progress after obtaining this. And then we will potentially submit for the approval of SCAI with 500 milligram dosing for initiation treatment.
Using alternative testing to diagnose them or use confirmatory b b M testing to identify such patients and then if these visions I referred to a specialist.
Sean: Our referral scheme should be built so referrals will be a quick depending on their situation P C pace themselves.
Our referral scheme should be built so referral will be a quick depend.
Sean: May I give a treatment with S C a I.
Depending on the situations pcp's themselves.
Sean: There are these 80 diagnosis and treatment.
Speaker Change: May I give a treatment, which is C. A I assure these 80 diagnosis and treatment should.
Sean: Have become generally available and that is the major focus in this approach.
Speaker Change: <unk> become generally available and that is the major focus in this approach.
Sean: Turning to Japan.
Sean: Demand expansion phase is the faith in Japan actually when we look at monthly sales for April It is already above 2 billion yen demand is a strongly expanding in Japan.
Speaker Change: Turning to Japan.
Speaker Change: Demand expansion phase.
Speaker Change: Faith in Japan actually when we look at monthly sales for April is already above 2 billion yen demand is a strongly expanding in Japan.
Sean: I would like to further analyze that what is included in this red bound.
Unknown Executive: We are making consultation with regulatory authorities at the end of this fiscal year or in early next fiscal year. This SCAI may be utilized for covering all the entire treatment period. So far, up to 36 months long-term daughter is provided, but 48-month daughter is being prepared.
Speaker Change: I would like to further analyze that what is included in the spread.
Sean: That's the basis of their history of 80 research.
<unk>.
Sean: In Japan Aricept.
Speaker Change: That's the basis of their history of 83.
Sean: In 1999, it is about a quarter century ago since then.
Speaker Change: In Japan Aricept.
Speaker Change: Launched in 1999, it is about a quarter century ago. Since then.
Sean: Even during the Covid pandemic.
Speaker Change: Even during the Covid pandemic.
Sean: There is like Japan Alzheimers disease.
Unknown Executive: So, going forward, there will be conferences such as AAIC and CTAT. Such longer-term benefits or advantages will be shown on such occasions.
Speaker Change: Mhm.
Sean: <unk> Academy and this was held without missing a.
Speaker Change: There is like Japan, Alzheimers disease Academy and this was held without missing.
Sean: Any session even during the Covid pandemic 80, Richard jurors, the doctors and technicians nurses.
Any session even during the Covid pandemic 80, researchers adult birds and technicians nurses.
Sean: And recently even patients are participating.
Unknown Executive: Next, the targeted DTC and the PCPs will be explained in the following slides. This shows the new formulation and administration method. IV maintenance dosing currently under discussion with authorities in Japan and China. And for SCAI initiation in Japan and China, preparations are being made for submission. And the formulation, as you see in the picture on the right-hand side, the cutting-edge technology provided by Terumo, the least painful, the very safe pen-type auto-injector will be used, which we believe will become the key factor for changing the treatment. Targeted DTC. Why do we call it targeted? In this case...
Sean: And multifaceted continuous discussions are underway.
Speaker Change: And recently, even patients are participating and multifaceted continuous discussions are underway.
Sean: I believe this is a very strong foundation on top of that as shown on the left.
Speaker Change: Yeah.
Speaker Change: I believe this is a very strong foundation on top of that are shown on the left.
Sean: The time of the initiation.
Sean: I was afraid that this is going to have a suppressive effect, Oh case surveillance and when it's a goal institutions a requirement under the more clinical use guidelines, but on the contrary these have to be satisfied. So long as these are satisfied he can be a pathway as such model of us clearly indicated.
Speaker Change: At the time of the initiation.
Speaker Change: I was afraid that this is going to have a suppressive effect, okay surveillance and when it's cold institutions a requirement under the more clinical use guidelines, but on the contrary they have to be satisfied. So long as these are satisfied he can be a pathway as such model of us clearly indicated.
Sean: As a result nationwide I believe there was a good progress and possibly establishment.
As a result nationwide I believe there was a good progress and possibly establishment.
Sean: Currently.
Sean: A number of patients who have been treated for more than six months is increasing.
Speaker Change: Currently.
Speaker Change: Yeah.
Speaker Change: A number of patients who have been treated for more than six months is increasing.
Sean: Its initiation our initial introduction facilities and full of facilities are cooperating and others a good cycle between these two types of facilities based on trust relationship. A referral is made a diagnosis is given and eye care is provided and then Ah patients.
Unknown Executive: What we mean by targeted is... for those patients who have been diagnosed with early AD. Actually, after getting diagnosis, until starting the treatment, it still takes several months. In the meantime... What kind of a drug can we eat? needs to be understood by the patients who are diagnosed with early A.D. through addressable T.V. with a secure target. so that we will be able to contribute to shortening the time until the initiation of the treatment or As a pooling factor, we may ask the patient... through this campaign to be interested in getting the treatment with Lekembi.
Speaker Change: Its initiation.
Initial introduction facility example of facilities are cooperating and others a good cycle between these two types of facilities based on trust relationship.
Sean: Eventually come back to follow up facilities Fulham facilities are encouraged to refer to patients. Our two initial introduction facilities and we see this first just cycle.
Speaker Change: Or what is made the diagnosis is given and Dr carriers provide it and then Ah patients eventually come back to follow up facilities or facilities are encouraged to refer patients to ensuring production facilities and we see this virtuous cycle.
Sean: Large number of patients are receiving treatment and the safety information is provided as a result, and including humanize the message of the value of receiving care is communicated.
A large number of patients are receiving treatment and the safety information is provided as a result, and including humanize the message of the value of receiving care.
Sean: Amongst five regions, Japan, what's the first to enter into demand expansion phase.
Speaker Change: Is communicated.
Amongst five regions Japan.
Sean: This is the forecast for fiscal 2025 and forecast that revenue was $76 5 billion 40 billion.
Speaker Change: What's the first to enter into demand.
Speaker Change: Yeah.
Speaker Change: Okay.
The forecast for fiscal 2025 are forecasting revenue of $76 5 billion 40 billion in the United States about 50% increase 24 billion in Japan, One nine times nine 5 billion in China.
Sean: The United States about 50% increase 24 billion in Japan, One nine times nine 5 billion in China.
Unknown Executive: And we have seen a certain effect so far, and we would like to continue on this next fiscal year onward. Now turning to BBM, please look at the right-hand side. Currently, the number of triage tests which are utilized for pre-screening. After the full approval was granted in the United States, as you can see here, the number of TRIAS tests is dramatically increasing in the testing of P-Tau 217, not seeing the accumulated amyloid beta. Such patients are to be excluded by conducting this test. And as you see on the left hand side, for confirmatory testing, if I may repeat, not utilizing the very expensive PET or invasive CSF for confirmation of the amyloid beta, not doing these tests, but more simple and easy blood-based tests can be conducted.
Sean: And you are mainly in EU and some of the Asia included a 3 billion total of $76 5 billion is the revenue forecast before they can be globally.
Speaker Change: And you are mainly in EU and some of the Asia included 3 billion.
Total of $76 5 billion is the revenue forecast before like MBA globally.
The basis of this was ex us as I mentioned earlier pathway establishment Memphis demand stimulation phase demand expansion phase of based on that analysis. This forecast. This made this has allowed us to fight them. They can be they can be has the potential to expand a better treatment for patients.
Speaker Change: The basis of this most of US as I mentioned earlier Osprey establishment men face demand stimulation face demand expunge all face are based on that analysis. This forecast just made this is allowed to fight on like M. B B.
Sean: Round the world first.
Speaker Change: They have the potential to expand a bit.
John: Oh John.
Speaker Change: For patients around the world first.
John: Looking at our drugs.
Speaker Change: Oh sure.
Speaker Change: In the second full fiscal year of 500 million U S dollars or in excess of 500 million U S dollars, a will be a blockbuster drug and they can be will satisfy the criteria this fiscal year.
Yes.
Speaker Change: Looking at our drugs.
Speaker Change: In the second full fiscal year of 500 million U S dollars or in excess of 500 million U S dollars will be a blockbuster drug and other can be though satisfy that criteria. This fiscal year in terms of global approval currently including major agencies fully.
Unknown Executive: which is soon to be seen and implemented. As for approach towards PCPs, earlier, please recall the timing, one of the conditions of expansion phase. Currently, about 80% of the patients, 80% of MCI patients are currently under the care of PCPs. but they are not diagnosed. With MCI Therefore... We have to make sure that they are diagnosed so that care... can be thought by these patients. This fiscal year, Neurology Account Specialist, the main component of our sales force, around 2000... exist in the U.S. and or rather around 2,000 high potential PCPs in the U.S. have been identified and NAS will be targeting these PCPs.
Speaker Change: In terms of global approvals currently including major agencies fully 44 countries have given approvals on the left side efficacy and safety. These are established data is enriched us.
Speaker Change: For the full Hungary's up given approval on both the left side efficacy and safety they are established.
Speaker Change: For administration method maintenance administration have dosing and a S. A I rehash them progress as shown at the very bottom preclinical 18. This is a high potential indication.
Speaker Change: Celebration and they've already sandwiched.
Speaker Change: For administration method maintenance administration, with Housebuilding, and see and I reaffirm progress as shown at the very bottom preclinical <unk>, but this is a high potential indications.
Speaker Change: Where treatment stage I won't be abroad earlier by one stage and Oh, we are steadily accumulating our findings and knowledge to prepare a submission.
Speaker Change: Where treatment stage will be abroad are earlier by one stage and Oh, we are steadily accumulating of knowledge.
Speaker Change: Admission and are in agreement with your Foodies preparations are underway and I believe that they can be has the potential to further expand to a beta of treatment now briefly I would like to share with you.
Speaker Change: The prepare a submission.
Speaker Change: And I agree with Joe for PREPA.
Speaker Change: Preparations are underway and I believe that they can be has the potential to further expand a bit on treatment now briefly I would like to share with you.
Speaker Change: Following our themes in neurology in particular I would like to give an update on 28 and 14 anti body left side shows Ah study on dyad.
Speaker Change: Growing our teams in neurology in particular I would like to give an update on 28 2014 antibody left side shows Ah study on Diane.
Unknown Executive: Exactly what are they going to do? PCPs and neighboring specialist institutions oftentimes these are called IDNs and very large in scale and help building a coordination between PCPs and specialist institutions. Noguchi Peace. Peace. can contribute to identify patients with MCI and mild AD using cognitive testing to diagnose them or use confirmatory BBM testing to identify such patients. And then if these patients are referred to specialists, the referral scheme should be built so referral will be quick. Depending on the situation, PCPs themselves may give treatment with SCAI. Through these, ADA diagnosis and treatment should become generally available and that is the major focus in this approach.
Speaker Change: These are familiar familiar.
Speaker Change: Hereditary alzheimers disease population.
Speaker Change: These are familiar familiar.
Speaker Change: Okay.
Speaker Change: Targeting study, which is a phase one study.
Speaker Change: They read the dairy Alzheimers disease population.
Speaker Change: Yeah.
Speaker Change: Our.
Speaker Change: Looking at top of apology.
Speaker Change: Targeting study, which is a phase one study.
Speaker Change: And it has become clear that we should be looking at these two tau pathology is early tau pathology by using pay it out to one seven and to use MTBE are tied to for three or four laid out by phonology was confirmed but confirmed that both are reduced.
Speaker Change: Looking at top of apology.
Speaker Change: And it has become clear that we should be looking at these two tower pathologies early tau pathology by using feet up to one seven and they use MTBE or tell them to the 434 late Tau pathology confirmed by confirmed the book.
Speaker Change: Radick early a D a.
Speaker Change: On the right.
Speaker Change: Just.
Speaker Change: Yeah.
Speaker Change: Sporadic early M D and as shown on the right.
Speaker Change: Targeting phase two study is also starting in.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: In combination with all of that can be 18 months of administration is how the study is designed the features are shown in the middle of the box ASI data from clarity a D and other clinical studies.
Speaker Change: Targeting face. This study is also starting to.
Speaker Change: In combination with all of that can be 18 months Oh by the administration is how the study is designed the features are shown in the middle of the box ASI has data from clarity a D and other clinical studies.
Speaker Change: Based on this data we have biomarker algorithm.
Unknown Executive: According to Japan, demand expansion phase is the phase in Japan. Actually, when we look at monthly sales for April, it is already above 2 billion yen. Demand is strongly expanding in Japan.
Speaker Change: They are based on this data we have biomarker algorithm.
Speaker Change: Based on that biomarker algorithm.
Speaker Change: Currently we are able to screen patients to be entered into the study MTB artal divorce vary and Tau pet are used to.
Speaker Change: Based on that biomarker algorithm.
Speaker Change: Accuracy, we are able to screen patients to be entered into the study.
Speaker Change: To confirm a therapeutic hypothesis Innsbruck sporadic 88 that is the objective and we also plan to achieve it'll be I before the end of this fiscal year.
Speaker Change: M P P ourselves Unfortunately, and Tau pet are used.
Unknown Executive: I would like to further analyze that, what is included in this red band. As the basis, there is a history of A.D. research. In Japan, Aricept was launched in 1999. It is about a quarter century ago. Since then... Even during the COVID pandemic, there is a Japan Alzheimer's Disease Academy and this was held without missing any session even during the COVID pandemic. AD researchers, the doctors and technicians, nurses. And recently, even patients are participating and multifaceted continuous discussions are underway. I believe this is a very strong foundation. On top of that, as shown on the left.
Speaker Change: To confirm a therapeutic hypothesis Innsbruck sporadic 80, if that is the objective and we also plan to achieve L. P. I before the end of this fiscal year.
Speaker Change: And another topic any thought about we've.
Sure if with your own or are other occasions de Vigo is AR antagonist and on the other side on the flip side. There is a agonist a daily access the sweetness of falling asleep or.
Speaker Change: And another or a big any thought about we've.
Sure if with your own or other occasions.
Speaker Change: The vehicle is a <unk> antagonist and on the other side on the flip side. There is oh goodness daily access to sleep less falling asleep or.
Speaker Change: Falling unconscious AR, which is narcolepsy.
Speaker Change: Article Loveseat type fun and development for that is a steadily underway as shown in the middle of the page.
Speaker Change: Now I'm conscious which is narcolepsy.
Speaker Change: Narcolepsy type one and the development for that is a steadily under way ive shown in the middle of the page.
Speaker Change: This compound was found.
Speaker Change: The library of 250000 compounds, we identified this as one true agonist.
This compound was.
Speaker Change: Phones are from the library of 250000 compounds.
Speaker Change: Yeah.
Speaker Change: And then there was a further synthetic or development to improve activity by 10000 fold.
We identified this as one true agonist.
Unknown Executive: at the time of the initiation. I was afraid that this is going to have a suppressive effect on all case surveillance and clinical institutions' requirements under optimal clinical use guidelines. But on the contrary, these have to be satisfied. So long as these are satisfied, it can be a pathway. A such model was clearly indicated. As a result, nationwide, I believe there was good progress in pathway establishment. Currently, A number of patients who have been treated for more than six months is increasing. Initial introduction facilities and follow-up facilities are cooperating, and there is a good cycle between these two types of facilities based on trust relationship.
Speaker Change: And then there was a further synthetic or development has improved activity by Tim.
This is similar to the drug discovery history of Aricept.
Speaker Change: And fold.
Speaker Change: So we weren't able to find this compound which is quite a lucky and inclusive of my.
Speaker Change: This is similar to the drug discovery history of Aricept.
Speaker Change: So we were able to find this compound which is quite a lucky and inclusive of my.
Memory of Aricept I have much hopes for this once daily administration may be possible given in the morning.
Speaker Change: Memory of Aricept I have much hopes for this once daily administration may be possible given in the morning.
He can fight sweetness during the day about during the night equal allow a sleep and there'll be a plan to obtain top line results from P. O M study in first half fiscal 2025, now a revenue driver than female than bema is celebrating the 10th.
Speaker Change: It sounds like fitness during the day about.
Speaker Change: During the night.
Speaker Change: We'll allow a sleep and we plan to obtain top line results from the.
Speaker Change: Study in first half 2025, now a revenue driver and then bema.
Speaker Change: Anniversary and has been administered to more than 500000 patients.
Speaker Change: And celebrating the 10th anniversary and has been administered to more than 500000 patients.
Speaker Change: Since launch.
Unknown Executive: Referral is made, diagnosis is given, and care is provided, and then patients eventually come back to follow-up facilities. Are encouraged to refer patients to initial introduction facilities, and we see this virtuous cycle. A large number of patients are receiving treatment, and the safety information is provided as a result, and including humanized message, the value of receiving care is communicated. and EU, mainly in EU, and some of the Asia included, 3 billion. Total of 76.5 billion is the revenue forecast for the Canby globally. The basis of this was, as I mentioned earlier, pathway establishment phase, demand stimulation phase, demand expansion phase.
Speaker Change: This fiscal year, our global revenue is in excess of 328 billion again, achieving double digit growth and major driveways Americas, you're on air growth was 28%. What is noteworthy is that amongst these four accounts are types are all cancer types are.
Speaker Change: Since launch.
Speaker Change: This fiscal year, our global revenue is in excess of 328 billion yen.
Speaker Change: Achieving double digit growth and major driveways Americas.
You're on air growth was 28% and what is noteworthy is that amongst these four accounts are types are all counts right.
Speaker Change: Growth was achieved all of these cancer types are seeing new competition entering into the market.
Speaker Change: Growth.
Speaker Change: All of these cancer types are seeing new competition entering into the market.
Speaker Change: 10 years ago.
Speaker Change: The first counselor and type of thyroid cancer, and then HCC followed in these two cancer types. The indication is monotherapy not in combination immunotherapy and despite a very fierce competition in monotherapy setting growth is achieved steadily.
Speaker Change: 10 years ago.
The first transfer type of thyroid cancer, and then HCC followed in these two cancer types. The indication is monotherapy not in combination that spot in monotherapy at this.
Speaker Change: This shows the power of this drug.
Speaker Change: It's a very fierce competition in monotherapy setting growth is achieved steadily this shows the power of this drug.
Speaker Change: I believe.
Speaker Change: Yes.
Speaker Change: As for our C C.
Speaker Change: I believe.
Speaker Change: Yes.
Speaker Change: Oh.
Speaker Change: As for our C C.
Speaker Change: In combination with Merck's, Oh that they found in triplet and doublet.
Speaker Change: In combination with Merck's, Oh that they found in triplet and doublet a combination studies are underway to obtain our indication and HCC in combination with Tas is shown at the bottom of the page.
Speaker Change: A combination.
Speaker Change: Ladies aren't underway to obtain our indication and HCC in combination with Tas is shown at the bottom of the page.
Unknown Executive: Based on that analysis, this forecast is made.
Speaker Change: This shows our full scale timeline, but there will be interim analysis, depending on the results of.
Unknown Executive: This is the last slide on the Canby. The Canby has the potential to expand a beta treatment for patients around the world. Old Jarl we are steadily accumulating findings and knowledge to prepare submission and in agreement with the authorities, preparations are underway and I believe that it can be, has the potential to further expand A-beta treatment.
Speaker Change: This shows our full scale timeline, but there will be interim analysis, depending on our results.
Speaker Change: It may be possible to shorten the timeline.
Speaker Change: Now turning to the structural reform.
<unk>.
It may be possible to shorten that timeline.
Speaker Change: Got it.
Speaker Change: Yeah.
Speaker Change: Now turning to structural reforms.
Speaker Change: Earlier.
Speaker Change: On the occasion of the information meeting medium term target for fiscal 2027 was presented.
Yes.
Speaker Change: Okay.
Speaker Change: Earlier.
Speaker Change: On the occasion of the information meeting mid.
Speaker Change: Medium term target for fiscal 2027 was presented.
Speaker Change: 30 billion yen.
Speaker Change: SG&A improvement target was also included and the details of that is shown already in amerigas and basically they can be and bema to brown.
Speaker Change: 30 billion yen.
Speaker Change: SG&A improvement target was also included and the details of that is shown already in amerigas and basically they can be and bema to brown.
Speaker Change: Our structure.
Speaker Change: The structure.
Speaker Change: Exist.
Speaker Change: Regarding the Ma.
Speaker Change: Yeah.
Speaker Change: Structure is.
Speaker Change: Sure.
Speaker Change: Many large scale many reps.
Regarding the FEMA.
Speaker Change: Are not and required anymore in large scale.
Speaker Change: Many large scale many reps.
Speaker Change: Yeah.
Speaker Change: Are not required anymore in large scale.
Speaker Change: Depending on the stage of each drug we have streamlined regarding they can be to a certain degree market introduction phase has been completed so stuff that were necessary to achieve access.
Speaker Change: Depending on the stage of each drug.
Speaker Change: We have streamlined regarding what they can be to a certain degree market introduction phase has been completed so stuff that were necessary to achieve access.
Speaker Change: We are now in a phase two downsides.
In addition, our neurology oncology may have did we get the functions, which can be eliminated and we have also streamlined and administrative department America's structural reform is almost complete tourist.
Speaker Change: We are now in the base to downsize.
Unknown Executive: Now briefly, I would like to share with you following themes in neurology.
Speaker Change: In addition, our neurology oncology may have duplicate functions, which can be eliminated and we have also streamlined in administrative department America's structural reform is almost complete tourists.
Unknown Executive: In particular, I would like to give an update on E2814 antibody. Left side shows a study on DIAD. These familial Hereditary Alzheimer's Disease Population Targeting Study, which is a phase one study. Looking at topophology... And it has become clear that we should be looking at these two tau pathologies, early tau pathology, by using p-tau 217 and to use MTBR tau 243 for late tau pathology. It was confirmed that both are reduced. Sporadic early AD, shown on the right. Targeting Phase 2 Study is also starting. In combination with Alecambi, 18 months of administration is how the study is designed.
Speaker Change: Yes.
Speaker Change: Fiscal 2020 five evil.
Speaker Change: Fiscal 'twenty 'twenty five evil be effective that's the expectation and then we will be focusing on structural reform in Europe.
Speaker Change: The effective that is the expectation and then we will be focusing on structural reform in Europe.
Speaker Change: We have already begun our efforts.
Speaker Change: This fiscal year.
Speaker Change: We have already begun our efforts.
Speaker Change: But towards the end of this fiscal year, we expect to complete the structural reform in Europe. These.
Speaker Change: This fiscal year.
Speaker Change: Hum.
Speaker Change: Towards the end of this fiscal year, we expected.
These two regions are there'll be therefore, it undergoing or have undergone structural reform and as a result, we expect to achieve the financial benefits as shown at the bottom of this page in China and and E. G. S. A we are also conducting organizationally.
Speaker Change: The structural reforms in Europe.
Speaker Change: These two regions are will be therefore undergoing or have undergone structural reform and as a result, we expect to achieve the financial benefits as shown at the bottom of this page.
Speaker Change: In China and in E. G. S. A we are also.
Speaker Change: Since formation.
Speaker Change: In commercial area are there structural reform, but not limited to that in R&D. We are also pursuing streamlining.
Speaker Change: Hum.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Area, there is structural reform, but not limited to that in R&D. We are also pursuing streamlining.
Unknown Executive: The features are shown in the middle of the box. Eisai has data from Clarity AD and other clinical studies. Based on this data, we have biomarker algorithm. Based on that biomarker algorithm...
Speaker Change: D H B O have shown at left atop deep human biology learnings.
Speaker Change: D. H E. L are shown on the left top deep human biology learnings.
Speaker Change: Based on human Biology research and development is carried out that is a.
Speaker Change: Based on human Biology research and development is carried out that is a.
Speaker Change: Why the R&D organization is named as such please understand that we are now in the second phase and the core of that is the technology to a profile molecule using cutting edge technologies and translational research organization Mr. Jorge.
Speaker Change: Why the R&D organization is named as such please understand that we are now in the second phase and a core of that is the technology to profile molecule using cutting edge technologies and translational research organization.
Speaker Change: Gave a presentation on previous occasion. He is also in attendance today and extra of discovery and clinical will be bridged over that translational research so that development.
Speaker Change: Michelle what are you are in it.
Speaker Change: I gave a presentation on a previous occasion, he supposed screen attendance today and excellence.
Unknown Executive: And another topic is what we've shared with you on other occasions. Day Vigil is antagonist and on the other side, on the flip side, there is agonist, daily excessive sleepiness, falling asleep or falling unconscious, which is narcolepsy type 1. And the development for that is steadily underway. As shown in the middle of the page, this compound was found from the library of 250,000 compounds. We identified this as one true agonist. And then there was further synthetic development to improve activity by 10,000-fold. This is similar to the drug discovery history of erythema. So we were able to find this compound, which is quite lucky and inclusive of my memory of Aricept.
Speaker Change: Covering a clinical will be bridged over that translational research.
Speaker Change: Can be a quick one.
Speaker Change: R&D streamlining ease of pursued are mainly through these efforts.
Speaker Change: So that development.
Speaker Change: A quick one.
Speaker Change: R&D streamlining ease of pursued are mainly through these efforts.
Speaker Change: D H B O top leadership.
Speaker Change: No include a.
Speaker Change: Did you feel the leadership.
Speaker Change: Younger leaders.
Speaker Change: Okay.
Speaker Change: The forum is stable supply of finished products and reduction of cost.
No include a.
Younger leaders.
Speaker Change: We have to also consider a geopolitical situation of late this importance is growing as a result, they can be supply chain, what's improved in the United States as well as supply chain was enhanced regarding David since it is an unexplained yafei.
Speaker Change: The forum is stable supply of finished products and reduction of cost.
Speaker Change: We have to also consider a geopolitical situation of late.
Speaker Change: This importance is growing as a result, they can be supply chain was improved in the United States as well as supply chain with enhanced regarding David go with sensors.
And it's not directly impacted by geopolitical factors about drug substance and drug product there'll be produced are utilizing oversees our pants to.
Joe Fay: It is an unexplained Joe Fay.
Joe Fay: And it's not directly impacted by geopolitical factors for drug substance and drug product will.
Speaker Change: To improve supply chain and to achieve a reduction in cost of sales.
Joe Fay: Hope we produced are utilizing oversees our bonds.
Unknown Executive: I have much hopes for this. Once daily administration may be possible, given in the morning it can fight sleepiness during the day, but during the night it will allow sleep. And we plan to obtain top line results from POM study in first half fiscal 2025.
Syncrude supply chain and achieve a reduction in cost of sales.
Speaker Change: No I'm coming to almost the end of my presentation.
Joe Fay: Yeah.
Speaker Change: Okay.
Joe Fay: No I'm coming to almost the end of my presentation.
This shows resources are invested into anti a beta antibody drugs over the.
Joe Fay: This shows resource invested into anti a beta antibody drugs over the.
Speaker Change: Past five years.
Speaker Change: Since fiscal 2021 to this fiscal year in five years, our cumulative cumulatively around a 370 billion again was invested in R&D and SG&A in fiscal 'twenty 'twenty. One this was the final era of other economies.
Joe Fay: Five years.
Joe Fay: Since fiscal 2021 to this fiscal year in five years, our cumulative cumulatively around 370 billion again was invested in R&D and SG&A in fiscal 2020. One just what's the final era of undercut them up.
Unknown Executive: Now revenue driver LENVIMA, LENVIMA is celebrating the 10th anniversary and has been administered to more than 500,000 patients since launch. This fiscal year, global revenue is in excess of 328 billion yen, achieving double-digit growth and major driver is America's. Year-on-year growth was 28%. What is noteworthy is that amongst these four cancer types, all cancer types, growth was achieved. All of these cancer types are seeing new competition entering into the market.
Speaker Change: And we source our investment it was a double.
Speaker Change: The usual level.
Joe Fay: And we source our investment it was double the.
Speaker Change: As shown at the bottom.
Speaker Change: And as I described earlier.
Joe Fay: The usual level.
Speaker Change: Simers disease is the most difficult disease and the contemporary society and ASI has introduced drugs that target the underlying causes of to achieve global contribution that is our restaurant, that's our and our mission and in order to fulfill our mission we have invested resources.
Joe Fay: As shown at the bottom.
Joe Fay: And as I described earlier Alzheimers disease is the most difficult disease and the contemporary society and ASI has introduced drugs that target the underlying causes.
Joe Fay: To achieve global contribution that is or isn't better and our mission and in order to fulfill our mission we have invested resources.
Unknown Executive: Ten years ago... The first cancer type was thyroid cancer, and then HCC followed. In these two cancer types, the indication is monotherapy, not in combination. But in monotherapy, despite a very fierce competition, in monotherapy setting, growth is achieved steadily. This shows the power of this drug. I believe. As for RCC, in combination with Merck's Bell-Zutiphan in triplet and doublet combination, studies are underway to obtain indication, and HCC in combination with TAIS is shown at the bottom of the page. This shows a full-scale timeline, but there will be interim analysis depending on the results. It may be possible to shorten the timeline.
Speaker Change: And.
Speaker Change: That is what we have been doing and naturally this will impact operating.
And does that.
Joe Fay: That is what we have been doing and naturally this will impact operating.
Speaker Change: P L.
Speaker Change: The trajectory of operating profit as shown in line.
Joe Fay: P L.
Joe Fay: The trajectory of operating profit as shown in line at the bottom fiscal 'twenty 'twenty six our projection is that we will have a balanced or breakeven operating income situations.
Speaker Change: Bottom fiscal 'twenty 'twenty six the projection is that we will have a balanced or breakeven operating income situation.
Speaker Change: That is the expectation and finally two more pages. This is J P. L. For this fiscal year first please oh got cost of sales.
Joe Fay: But is the expectation and finally two more pages. This is <unk> for this fiscal year.
Speaker Change: One seven percentage point increase of cost of sales.
Paper cuts will still fail.
Joe Fay: One seven percentage point.
Speaker Change: And what is included there is a I R. A related to lend them, our inflation reduction act related expenses for a lengthy MA and drug price revisions in Japan, especially David go and Halloween, we're subject to the drug price revision and onetime revenue, which is above that.
Joe Fay: Increase of cost of sales.
Joe Fay: And what is included there is a I R. A.
Joe Fay: It related to lithium or inflation reduction.
Joe Fay: Related expenses for Lindsay MA and drug price revisions in Japan, especially they did go and Halloween or subject to drug price revision and onetime revenue, which is a one time revenue line.
Unknown Executive: Now turning to structural reform. Earlier, on the occasion of the information meeting, medium-term target for fiscal 2027 was presented. 30 billion yen. SG&A improvement target was also included and the details of that is shown already in America. Basically, there can be and then VIMA two brand structure exists. Regarding Len Dima... many large-scale many reps are not required anymore in large scale. Depending on the stage of each drug, we have streamlined. Regarding the Kenbi, to a certain degree, market introduction phase has been completed, so staff that were necessary to achieve access, we are now in a phase to downsize.
Speaker Change: One time revenue declined and there was also an impact from product mix because of these four factors cost of sales.
Joe Fay: And there was also an impact from product mix because of these four factors.
Speaker Change: Increased.
Joe Fay: Sales.
Speaker Change: However.
Joe Fay: Yeah.
Speaker Change: Please look at R&D expenses decreased by <unk> six percentage points and this is mainly because they can be R&D expense.
Joe Fay: Thanks.
Joe Fay: Power.
Joe Fay: However.
Joe Fay: Please.
It decreased by <unk> six percentage points and this is mainly because mackenzie R&D extend.
Speaker Change: Has passed the peak stage.
Speaker Change: Stage.
Speaker Change: S G&A.
Joe Fay: Uh huh.
Peak state.
Joe Fay: Fitch.
Speaker Change: The <unk> also declined is forecasted to decline by one six percentage point.
Joe Fay: SG&A.
Joe Fay: Yeah.
Joe Fay: The.
Joe Fay: Decline.
Speaker Change: Structural reforms are.
Joe Fay: Forget it did decline by one six percentage point U S structural reforms.
Speaker Change: The fact is the main factor.
Speaker Change: In SG&A in Europe.
In fact, if I mean power center.
Yeah.
Joe Fay: In SG&A in Europe.
Due to various reforms they will be expenditures. These are included in the forecast of SG&A expenses and still the forecast is that it will decline.
Joe Fay: Okay.
Joe Fay: Due to various reforms they will be expenditures. These are included in the forecast of SG&A expenses and still the forecast is that it will decline.
Unknown Executive: In addition, neurology, oncology may have duplicate functions which can be eliminated, and we have also streamlined in administrative department. America's structural reform is almost complete. Fiscal 2025, it will be effective. That is the expectation. And then we will be focusing on structural reform in Europe. We have already begun our efforts this fiscal year. Towards the end of this fiscal year, we expect to complete the structural reform in Europe.
Speaker Change: Okay.
The profit for the ear also as forecasted the decline, but in the previous fiscal year. There was a reduction in capital in the United States.
Joe Fay: No.
Joe Fay: The profit for the ear also as forecasted the decline, but in the previous fiscal year. There was a reduction in capital in the United States.
Speaker Change: As a result that there was a tax effect in the previous year.
But it will be back to a normal tax rate in fiscal 'twenty five.
Joe Fay: As a result, there was a tax effect in the previous year.
Joe Fay: But it will be back to a normal tax rate in fiscal 'twenty five.
Speaker Change: And that is the reason that this is the final slide conclusion.
Joe Fay: And if that is the reason of this is the final slide conclusion.
Speaker Change: In fiscal 'twenty to 'twenty, four we proactively allocated resources still like M B business.
Joe Fay: In fiscal 'twenty 'twenty, four we proactively allocated resources still it can be business.
And as I briefly mentioned, we have a subsequent pipeline is in neurology area.
Joe Fay: Okay.
Joe Fay: And as I briefly mentioned, we have a subsequent pipeline isn't neurology area.
Speaker Change: And we achieved revenue and profit growth driven by the expansion of major global products.
Joe Fay: And we achieved revenue and profit growth driven by the expansion of major global product.
Speaker Change: After 26 months or since the submission in Europe and after much interaction.
After 26 months or since the submission in Europe and after much interaction.
Speaker Change: Let them be approval was obtained in Europe.
Speaker Change: Now we have in all major regions are launched and it can be and in Japan has entered into demand expansion phase next fiscal year, we expect U S to enter into the demand expands your faith in fiscal 'twenty. Six we expect are they can be business to turn profitable in fiscal 'twenty five.
Joe Fay: Let them be approval was obtained in Europe.
Joe Fay: No we have.
Unknown Executive: In commercial area, there is structural reform, but not limited to that. In R&D, we are also pursuing streamlining DHBL, as shown at the left top, deep human biology learning. Based on human biology, research and development is carried out. That is why the R&D organization is named as such. Please understand that we are now in the second phase and the core of that is the technology to profile molecule using cutting edge technologies and translational research organization.
Joe Fay: Our regions are launched other can be and in Japan has entered into the amount of expression.
Joe Fay: Netflix courtyard, just entering into the amount of funds you face in fiscal 'twenty six we expect they can be a business to turn profitable in fiscal 'twenty five.
Speaker Change: We'll maintain investment of resources amongst my so it can be but we will also carry out organizational transformation and regions accelerate innovation creation and strengthened our global supply chain. Thank you.
Joe Fay: We will maintain investment of resources amongst my so it can be but we will also carry out organizational transformation C region accelerate innovation creation and strengthened our global supply chain. Thank you.
Speaker Change: Now we would like to open the floor for Q&A session.
Speaker Change: Like to receive questions from analysts and then we liked the often the Florida for media.
Joe Fay: Now we would like to open the floor for a Q&A session. We would like to receive questions from analysts and then we'd like to often to floor for media.
Speaker Change: If you wish to ask question. Please mention your name and affiliation before asking a question.
Unknown Executive: Mr. Horie gave a presentation on previous occasion. He is also in attendance today. Discovery and clinical will be bridged with translational research so that development can be quickened. R&D streamlining is pursued mainly through these efforts, DHBL top leadership. now include younger leaders. The bottom is stable supply of major products and reduction of cost. We have to also consider geopolitical situation of late. This importance is growing as a result. There can be supply chain was improved in the United States as well. Supply chain was enhanced regarding Dave Eagle since it is in an expansion phase. And it's not directly impacted by geopolitical factors, but drug substance and drug products will be produced utilizing overseas plants to improve supply chain and to achieve reduction in cost of sale.
Joe Fay: If you wish to ask a question. Please mention your name and affiliation before asking a question.
Speaker Change: To take a question from us that many people as possible we like to ask you to limit the number of questions to one at each time. If you have any questions. Please raise your hand first analysts.
Joe Fay: I'd like to take a question from us that many people as possible we like to ask you to limit the number of questions to one at each time. If you have any questions. Please raise your hand first analysts.
Speaker Change: The person in the third Oh, please have the floor.
Speaker Change: Yes.
Joe Fay: A question in the third a little piece of the floor.
Josh: My name is Josh you could see him from Daiwa securities regarding dose that can be revenue in the United States.
Joe Fay: Yeah.
Joe Fay: Okay.
Joe Fay: My name is Josh you could treat them from diabetic community is regarding the <unk> that can be revenue in the United States.
Josh: According to the information meeting held at towards the end of March Mr. Ek said that you wanted to aim at more than double and then Mr huddle not as well.
Joe Fay: According to the information meeting held at towards the end of March we used that 8-K.
Speaker Change: You wanted to aim at more than double and let me start on that as well.
Josh: <unk> said that he was Oh, you were confident in achieving more than double.
Joe Fay: <unk> said.
Speaker Change: Said that he was Oh, you were confident in achieving more than doubled.
Josh: So 153% on a yen denominated from considering the Forex and it's only increasing by one six times.
Speaker Change: So 153% on a yen denominated determine considering the phonics and it's only increasing by one six times.
Josh: And during the past, one and a half months what happened.
Speaker Change: And they're doing the past, one and a half months what happens.
Josh: Changing your phone caused us from doubling the revenue.
Speaker Change: Oh I made a downward revision could you please give us the background or.
Speaker Change: Changing your phone so from doubling the revenue.
Speaker Change: So I made a dumb dumb.
Josh: Reasons for this.
Speaker Change: And could you please give us the background or.
Josh: Utilizing the slide we suggested the slide could you. Please show you the slide here.
Speaker Change: Reasons for this.
Unknown Executive: Now, I'm coming to almost the end of my presentation. This shows resources invested into anti-A-beta, antibody drugs over the past five years. Since fiscal 2021 to this fiscal year, in five years, cumulatively around 370 billion yen was invested in R&D and SG&A. In fiscal 2021, this was the final year of Adekanumab. and research investment was double. The usual level, as shown at the bottom, and as I described earlier, Alzheimer's disease is the most difficult disease in the contemporary society, and Eisai has introduced drugs that target the underlying causes to achieve global contribution. That is our raison d'etre and our mission, and in order to fulfill our mission, we have invested resources.
Speaker Change: Yeah.
Speaker Change: Utilizing the fly do we suggested that slight could you. Please show that slide here.
Josh: The U S.
Josh: Is now approaching the end of demand stimulation fades.
Speaker Change: The U S.
Speaker Change: It is now approaching the end of demand stimulation phase.
Josh: That is how we see they're kind of a situation now that is the biggest reason.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: That is how we see the current situation.
Josh: So boosting or doubling.
Speaker Change: So that is the biggest reason.
Speaker Change: Gotcha.
Josh: The revenue is not something which has become a reachable yet but for fiscal year 2026.
Speaker Change: So boosting or doubling.
Speaker Change: Revenue is not something which has become a reachable yet but full fiscal year 2026.
Josh: I explained in details today the U S is expected to enter demand expansion phase as well.
Speaker Change: Explain in details today.
Josh: So by following this grocer trajectory.
Speaker Change: U S is expected to enter demand expansion phase as well.
Josh: We are confident.
Speaker Change: By following this growth trajectory.
Josh: Actually in April our revenue in the United States and the number of vials shipped out.
Speaker Change: We are confident.
Speaker Change: Oh no.
Speaker Change: Actually in April our revenue in the United States and the number of vials shipped out.
Josh: Have shown steady growth and expansion and therefore, we believe that the U S market is immediately before entering into the demand the expansion phase.
Unknown Executive: and uh that that is what we have been doing naturally this will impact operating The trajectory of operating profit is shown in line at the bottom. Fiscal 2026 projection is that we will have a balanced or break-even operating income situation. That is the expectation.
Speaker Change: Have shown steady growth and expansion. Therefore, we believe that the U S market is they needed you before entering into the demand the expansion phase.
Josh: That is the reason for.
Josh: Are the numbers that has been downwardly revised from the previous ones.
Speaker Change: That is the original four.
Are the numbers that has been downwardly revised from the previous one.
Josh: What happened recently.
Josh: You may now think that that there needs to be further airports that I should be done in order to expand the demand are there any such airports to be taken.
Speaker Change: What happened recently.
Speaker Change: You may now think that that there needs to be first or airports that I should be done in order to expand the demand other than you thought you are forced to be taken.
Unknown Executive: And finally, two more pages. This is the PL for this fiscal year. First, please look at cost of sales. 1.7 percentage points increase of cost of sales and what is included there is the IRA related to LENVIMA, Inflation Reduction Act related expenses for LENVIMA and drug price revision in Japan especially David and Halvin were subject to drug price revision and one-time revenue declined and there was also impact from product mix because of these four factors cost of sales Increase However, please look at R&D expenses. It decreased by 0.6 percentage points, and this is mainly because the Kenbi R&D expense has passed the peak .
Josh: If so please share them with us.
Josh: Thank you for your question as we have shown here.
Speaker Change: So share them with us.
Josh: Below the demand expansion phase G C. B B M. S C, a I or utilization with digital technology.
Speaker Change: Thank you for your question as we have shown here.
Speaker Change: Below the demand expansion phase.
Speaker Change: G C B B M. A C D E I or utilization with digital technology.
Josh: These are starting to be implemented.
Speaker Change: Sure.
Josh: So implementing all these will be necessary for expanding the demand.
Speaker Change: These are starting to be implemented.
Speaker Change: So implementing all these will be necessary for expanding the demand.
Josh: And many patients.
Josh: Our senior P C Pete's.
Speaker Change: And many patients.
Josh: D C piece needs to be activated by means of a participating into the treatment and diagnosis otherwise the U S cannot enter securely decided demand expansion phase that was another I'll. Let analysis. Thank you very much yeah each month.
Speaker Change: Oh.
Speaker Change: Are you seeing a T P M.
Speaker Change: The PCP who needs to be activated.
Speaker Change: By means of our parties by eating into the treatment on a diagnosis.
Speaker Change: Otherwise the U S cannot enter security these demand expansion phase that would or not I'll. Let another just thank you very much.
Josh: Attendees in the first row. Please.
Josh: Yes.
70 in the first row please.
Josh: Blackout from J P. Morgan.
Speaker Change: Yes.
Josh: Regarding the U S. Like can be I also have a question.
Speaker Change: Yeah.
Speaker Change: <unk> from Jpmorgan.
Josh: According to what you have just mentioned I understand why you have the forecast for this fiscal year, but I would like to understand the competitive situation is a cause I'm not a threat or is it going to become a threat.
Speaker Change: Regarding the U S. Like can be I also have a question.
Unknown Executive: will also decline. It's forecasted to decline by 1.6 percentage point. U.S. structural reform Effect is the main factor. in SG&A in Europe. Due to VERSA reforms, there will be expenditures. These are included in the forecast of SG&A expenses, and still, the forecast is that it will decline. The profit for the year also is forecasted to decline, but in the previous fiscal year there was a reduction in capital in the United States. As a result, there was a tax effect in the previous year, but it will be back to a normal tax rate in Fiscal 25.
Speaker Change: According to what you have just mentioned I understand why you have the forecast for this fiscal year, but I would like to understand the competitive situation.
Speaker Change: Biogen's briefing session.
Speaker Change: I guess I'm, a threat or is it going to become a threat.
Speaker Change: It sounded as though it it is not impacting much that is my impression, but looking at the sale of Rockefeller in comparison to your corner cells.
Speaker Change: Cogent briefing session.
Speaker Change: It sounded as though.
Speaker Change: It is not impacting much that is my impression, but looking at the sales comparisons in your corner sales.
Speaker Change: Because some of the sales is stronger so I'm concerned that it may become a threat to the insight I believe the benefit of our ACI is the longtime administration.
Because some of them are sales is stronger so I'm concerned that it may become a threat to the insight I believe the benefit of our ACI is the.
Speaker Change: Possibility, but looking at the current market environment.
Long term administration.
Speaker Change: Von Dutch shares be taken by some of because of convenience.
Speaker Change: Possibility, but looking at the current market environment.
Vaughan: Vaughan shares they take them back if somehow because of convenience.
Speaker Change: I would like to answer in general terms, and then I would like to have people who are responsible for our commercial business in the U S and Japan respond to your question.
Speaker Change: No.
Unknown Executive: And that is the reason.
Speaker Change: I would like to Oh, sorry in general terms, and then I would like to have people who are responsible for commercial.
Unknown Executive: This is the final slide. Conclusion. In Fiscal 2024, we proactively allocated resources to the can-be business. And as I briefly mentioned, we have a subsequent pipeline in the neurology area. and we achieved revenue and profit growth driven by the expansion of major global products. After 26 months since the submission in Europe and after much interaction, the Genbi Approval was obtained in Europe. Now we have, in all major regions, launched Lekenbi, and Japan has entered into demand expansion phase. Next fiscal year, we expect U.S. to enter into the demand expansion phase. In fiscal 26, we expect Lekenbi business to turn profitable.
Speaker Change: Earlier about Europe.
Speaker Change: In the U S and Japan respond to your question.
Speaker Change: Yeah.
Speaker Change: Oh, I talked about Europe, and as for the review in Europe of our kitchen Oh. This is out on the website. Our official website of E N E and I believe that everything installed there.
Speaker Change: Earlier about Europe.
Yeah.
Speaker Change: So I talked about Europe, and that's what the review in Europe of a consumer. This is on the website. Our official website of E N E and I believe that every child.
Speaker Change: But I think it's.
Speaker Change: <unk>.
Speaker Change: Sure.
Speaker Change: The zinc recollection. So please.
Speaker Change: Yeah.
Speaker Change: But if I took it.
Speaker Change: Bear with me.
Speaker Change: Yes.
Speaker Change: I bought a four nine carrier population.
Speaker Change: Blake for collection so please.
Speaker Change: Bear with me, but.
Speaker Change: Even in the.
Speaker Change: Apple <unk> for non carrier population.
Speaker Change: Ah boy for a carrier so all in I believe for non carrier population equals not found to be clinically meaningful.
Even in an upward for Carryout. So I believe for an Ontario population. It was not found to be clinically meaningful.
Unknown Executive: In fiscal 25, we will maintain investment of resources to maximize Lekenbi, but we will also carry out organizational transformations in regions, accelerate innovation creation, and strengthen the global supply chain.
Speaker Change: Data showing long term usefulness was also lacking I believe the comment to that effect are found a this is a public domain information. So please I referred to that yourselves.
Okay.
Speaker Change: Data showing long term usefulness was also.
Speaker Change: Lacking I believe so comments to that effect.
Speaker Change: Our phone this is a public domain information. So please I referred to that yourself.
Speaker Change: The basic but for us is that.
Speaker Change: Eight Alzheimer's disease is a progressive disease and the fatal disease.
Speaker Change: The basic before us is that.
Unknown Executive: If you wish to ask a question, please mention your name and affiliation before asking a question. In order to take questions from as many people as possible, we'd like to ask you to limit the number of questions to one at each time. If you have any questions, please raise your hand.
Speaker Change: Eight alzheimers disease is a progressive disease and fatal disease.
Speaker Change: Yeah.
Speaker Change: It is a progressive disease and the cause of the Progressiveness.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: It is a progressive disease and the cause of the progressive snack.
Speaker Change: Or pathology is that causes progressiveness is brutal fibril.
Unknown Executive: First, analysts. The person in the third row, please have the floor.
Speaker Change: Or pathology is most progressiveness is brutal fibril.
Speaker Change: They can be.
Speaker Change: Targets prototypical that accelerates the neuro degeneration. It is the only antibody that pause affinity to Protos liberal.
Speaker Change: They can be.
Kazuaki Hashiguchi: My name is Hashiguchi. I am from Daiwa Securities. Regarding the Kenbi revenue in the United States, according to the information meeting held towards the end of March, Mr. Iike said that you wanted to aim at more than double, and Mr. Haruna as well. said that he was, you were confident in achieving more than double. So, 153% on a yen denominated term, considering the forex, and it's only increasing by 1.6 times.
Speaker Change: Targets photo fibril that accelerates the neuro degeneration. It is the only anti body that cause affinity subroto phibro.
Speaker Change: And a little town population early treatment Hutch are shown a remarkable efficacy in clinical trials and as shown in maintenance dosing. There's also usefulness and long term administration, we have data that shows sustained effect.
Speaker Change: And a little town population early treatment.
Speaker Change: Such shown a remarkable efficacy in clinical trials and as Johnny mentioned I still think there is also useful messaging long term administration. When we have data that shows sustained effect.
Speaker Change: I believe that is the basic regarding the usefulness of I can be.
Speaker Change: Yeah.
Speaker Change: I believe that is the basic regarding the usefulness of if I can be.
Speaker Change:
Speaker Change: We made regarding the U S. Mr. Harding, our and regarding Japan, I missed I used a will discuss the commercial aspect.
Kazuaki Hashiguchi: And during the past one and a half months, what happened? changing your forecast from doubling the revenue or made a downward revision.
Speaker Change: Hmm.
Speaker Change: We made regarding the U S. Mr Hutton and regarding Japan, I missed I used a will discuss I think partial aspect. Thank you for your question I'm hard enough are responsible for the <unk> can be in the U S. And then I'm sorry, the situation regarding the United State.
Speaker Change: For your question I'm Hot enough are responsible for the <unk> can be in the U S. And then I'm sorry, the situation regarding the United States.
Haruo Naito: Could you please give us the background or reason for this? Utilizing the slide, we suggested the slide, could you please show the slide here, the U.S. is now approaching the end of demand stimulation phase. That is how we see the current US situation now.
Speaker Change: The impact from a competitive product we feel is limited even now.
Speaker Change: <unk>.
Speaker Change: The impact from a competitive product we feel is limited even now.
Speaker Change: Mr. Naito CEO explained like can be growth is continuing and in.
Speaker Change: Uh huh.
Speaker Change: <unk> see you explained like can be growth.
Speaker Change: In April our monthly revenue was a record high and he may.
Speaker Change: Is continuing and.
Speaker Change: Growth is continued as we have seen in early part of May.
Speaker Change: In April our monthly revenue was a record high and he may.
Haruo Naito: That is the biggest reason. So, boosting or doubling. The revenue is not something which has become reachable yet, but for fiscal year 2026, as I explained in detail today, the U.S. is expected to enter a demand expansion phase as well. So, by following this growth trajectory, we are confident. Actually, in April, a revenue in the United States and a number of vials were shipped out. have shown steady growth and expansion. Therefore, we believe that the U.S. market is immediately before entering into the demand expansion phase.
Speaker Change: And what double your most are paying attention to is prescribers more than prescribers more than 70% of prescribers are prescribing only like can be in the United States.
Speaker Change: Growth is continuing as we have seen in early part of May.
Speaker Change: And a lot of we're not paying attention to is <unk>.
Speaker Change: Scrubbers more than prescribers more than 70% of prescribers are prescribing only like can be in the United States.
Speaker Change: It just shows.
Speaker Change: How.
Speaker Change: Much more like M. B is chosen in the United States. Even today convenience was also included in the question but.
Speaker Change: If this shows.
Speaker Change: How.
Speaker Change: It's much more like can be chosen in the United States. Even today convenience was also included in our question about.
Speaker Change: Okay. According to what is what we hear about consenting process in a clinical setting.
Speaker Change: Let's see.
Speaker Change: According to <unk>, what we hear about consenting process in a clinical setting.
Speaker Change: Maybe convenient that it's a one time administration, but a low incidence of ARIA if that is understood well.
Speaker Change: It may be convenient that had a one time administration, but a low incidence of ARIA is but if I understood well.
Speaker Change: They can be by far is chosen and there is also the experience of the physicians rich also the patients are interested in they can be has a long term experience. There's a long term experience. So far as I can be and I think this is a compelling reason for them they can be to be chosen.
M B a by far is chosen and their social experience of the positions, which also the patients are interested in that can be have a long term experience there.
Haruo Naito: That is the reason for... The numbers that has been downwardly revised from the previous ones.
Haruo Naito: What happened recently? You may now think that there needs to be further efforts that should be done in order to expand the demand.
Speaker Change: There is a long term experience of how that can be and I think that this is a compelling reason for that can be to be chosen.
Speaker Change: So nice to see you mentioned a D is faisal its a long term chronic disease, and therefore long term treatment and early treatment or through they can be I'm sure we'll be selected as a gold standard drug.
Haruo Naito: Are there any such efforts to be taken? If so, please share them with us. Thank you for your question, as we have shown here. Below the demand expansion phase, as you see, BBM, SCAI, or Utilization of Digital Technology These are starting to be implemented. So implementing all these will be necessary for expanding the demand. and many patients. are seeing a PCP. and the PCPs need to be activated by means of participating into the treatment and diagnosis. Otherwise, the U.S. cannot enter securely this demand expansion phase.
Speaker Change: It's nice to see you mentioned a D. If people, it's a long term chronic disease, and therefore long term treatment and early treatment through like M. B I'm sure, we'll be selected as a gold standard drugs.
Speaker Change: And therefore, I believe that they can be will continue to travel on the growth trajectory.
Speaker Change: And therefore, I believe that they can be we'll continue to have trouble on the growth trajectory.
Speaker Change: Right.
Speaker Change: Thank you for your question.
Speaker Change: You saw responsible for Japan business, let me share with you the situation in Japan.
Speaker Change: Thank you for your question.
Speaker Change: Yes are responsible for Japan business.
Speaker Change: Mentioned regarding the U S by my colleague a the impact from competitor a competitor competition as you find yourself in a very limited. This is a progressive disease and it's a fatal disease.
Speaker Change: Sure.
Speaker Change: The situation in Japan.
Speaker Change: I mentioned that regarding the U S by my colleague.
Speaker Change: The impact from competitor compete competition as you'll find it is also very limited. This is a progressive disease and it's a fatal disease.
Speaker Change: As such for a D treatment when consenting patients.
Speaker Change: As such for <unk>.
Speaker Change: When amyloid beta has turned down negative after one year and the Ottomans, Jason will be stopped if such explanation is given by physicians oftentimes patients and families become concerned and the continuous treatment Ah is possible with all that can be in the end are oftentimes looking.
Speaker Change: Treatment when consenting patients.
Haruo Naito: That was our analysis.
Speaker Change: When a member of.
Haruo Naito: Thank you very much.
The house don't go negative after one year and the administration will be stopped if such explanation is given by physicians oftentimes patients and families become concerned and the continuous treatment.
Seiji Wakao: Next, attending in the first row, please. Wakao from J.P. Morgan, regarding the U.S. Lakembi, I also have a question. According to what you have just mentioned, I understand why you have the forecast for this fiscal year. But I would like to understand the competitive situation. Is Kesella a threat, or is it going to become a threat? Biogen's briefing session... Sounded as though it is not impacting much, that is my impression, but looking at the sales of Akisuma in comparison to your quarter sales, Kasuma's sales is stronger, so I'm concerned that it may become a threat to Eisai.
Speaker Change: It is possible without that can be in the end are oftentimes can be effected as a result.
Speaker Change: He is elected as a result.
Speaker Change: Hum.
Speaker Change: For more than one year are they can be has been administered and the experience of abusing all that can be for more than one year is a very is having an impact when they can be chosen by doctors and patients and families.
Speaker Change: For more than one year. They can be has been administered and the experience of using a that can be for more than one year.
Speaker Change: He is a very.
Speaker Change: Is having an impact when it can be chosen by doctors Ah patients and families.
Speaker Change: Doctors are more familiar with the use of the drug and patients may I forgot that question and after that a question often times moral from like M. B has chosen us be our adult there is also a optimum are going to go up demand.
Speaker Change: Doctors are more familiar with the use of the drug and patients may ask that question and after that a question often times Oh.
Seiji Wakao: I believe the benefit for Eisai is the long-term administration possibility, but looking at the current market environment, won't the shares be taken by Kasuma because of convenience?
Speaker Change: More often that can be chosen us be ours hold and there is also a optimum.
Speaker Change: Our guideline in Japan.
Speaker Change: And M. S. E score is different Ah 29, and 30 in and M. A C score only they can be it is possible to be used so N C I and earlier.
Speaker Change: Clinical optimal treatment guideline in Japan.
And M. S E score is different.
Speaker Change: <unk> nine and a 36 or only they can be irresponsible to be used so N C. I.
Haruo Naito: I would like to answer in general terms and then I would like to have people who are responsible for commercial business in the U.S. and Japan respond to your questions.
Speaker Change: A more mild patients may come to seek out treatment and only they can be can be given at Ford and M. A C score of 29 to 30 patients.
Speaker Change: And earlier.
Speaker Change: A more mild patients may come to seek out treatment and only they can be can be given aboard and M. A C score of 29 to 30 day patient.
Haruo Naito: Earlier about Europe So I talked about Europe and as for the review in Europe of Kesuna, this is on the website, official website of EMA and I believe that everything is told there. It's, I, the, it's, uh... vague recollections so please bear with me but ApoE4 non-carrier population you Even in non-ApoE4 carrier, so in ApoE4 non-carrier population, it was not found to be clinically meaningful. Data showing long-term usefulness was also lacking. I believe comments to that effect are found. This is a public domain information, so please refer to that yourselves.
Speaker Change: Uh huh.
Speaker Change: And regarding the frequency of visit.
Okay.
Speaker Change: Okay.
Speaker Change: And regarding the.
Speaker Change: Biweekly ER visits are actually is felt as a beneficial by patients and families and there is also a actual evidence that are going out is a beneficial for dementia patients.
Speaker Change: Frequency of visit.
Speaker Change: Biweekly visit Oh.
Speaker Change: Actually is.
Speaker Change: I felt of a beneficial by patients and families and there is also a actual evidence that are going out is a beneficial for dementia patients.
Speaker Change: So about patients who have difficulty visiting our clinics every two weeks, but then from the beginning they can be they'll not be selected.
Speaker Change: So about patients who have difficulty visiting our clinics every two weeks, but then from the beginning they can be a little not be selected so we believe the impact on that can be sales is minus skill.
Speaker Change: So we believe the impact on a that can be sales is minus skill.
Speaker Change: And that's Michel and I don't see you mentioned April this year, we had that 2 billion yen revenue or on a daily basis close to <unk>.
Speaker Change: And that's Michel and I don't see you mentioned April this year, we had about 2 billion in revenue or on a daily basis a bushel.
Speaker Change: Hundreds of millions of sales that is the pace of we started out this fiscal year. So we are very confident of achieving the number Oh 2 billion for Japan.
Speaker Change: 100 million in sales that is the pace of we started out this fiscal year. So we are very confident of achieving the number Oh 2 billion for Japan.
Haruo Naito: The basic for us is that... Alzheimer's disease is a progressive disease and a fatal disease. It is a progressive disease, and the cause of the progressiveness... or pathology that causes progressiveness is protofibril. Rukenbi targets protofibril that accelerates neurodegeneration. It is the only antibody that has affinity to protofibril. And low tau population, early treatment has shown a remarkable efficacy in clinical trials. And as shown in maintenance dosing, there is also usefulness in long-term administration. We have data that shows sustained effect. I believe that is the basic regarding the usefulness of the Kempei.
Speaker Change: That's clear. Thank you long term administration, which is a strength is clearly understood by physicians and patients I can see that and is it correct to understand that you are siddeley decreasing our.
Speaker Change: That's clear. Thank you long term administration, which is our strength is clearly understood by physicians and patients I can see that and is it correct to understand that you are suddenly decreasing.
Speaker Change: Cost of sales, yes, if all.
Speaker Change: The details are necessary. Please catch a person responsible later or should that be a responded to enough.
Speaker Change: Our cost of sale yes.
Speaker Change: Got.
Speaker Change: The details are necessary. Please catch a person responsible later or should that be a responded to announce.
Speaker Change: Yes, we are making steady progress in reducing our cost of sales.
Speaker Change: Yes.
Speaker Change: Please rest assured if I'm right about that.
Speaker Change: Steady progress in reducing our cost of sales.
Speaker Change: The rest are reassured.
Speaker Change: My name is <unk> from UBS Securities regarding the graph on page 23.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Honestly speaking from 370 billion yen husband invested.
Speaker Change: Suddenly from UBS securities regarding the graph on page two.
Speaker Change: Okay.
I'm surprised and I think that there has been no other companies in Japan, which are committed to make such a big investment but during the time.
370, Julien and the husband invested.
Speaker Change: I'm surprised and I think that there has been no other kind of uneasy in Japan, which are committed to make such a big investment, but during the time, you'll have a continue to run a one standalone products in a lossmaking as thought is and that is dragging down the business as a whole of the U S.
Speaker Change: Have a continue to run a one standalone products in a lossmaking as thought is and that is dragging down the business as a whole of the ASI and it has been affecting the evaluation of the investors and our stakeholders and that has affected the stock price and how this is actually the image die.
Haruo Naito: We may.
Katsuya Haruna: Regarding the U.S., Mr. Haruna, and regarding Japan, Mr. Yusa will discuss the commercial aspect. Thank you for your question. I'm Haruna, responsible for the license in the U.S., and I'll answer the situation regarding the United States. The impact from a competitive product, we feel, is limited even now. As Mr. Naito, CEO, explained, there can be growth. It is continuing. In April, monthly revenue was a record high, and in May, growth is continued, as we have seen in the early part of May. And what we are most paying attention to is prescribers. More than 70 percent of prescribers are prescribing only Lakembi in the United States.
Speaker Change: And it has been.
Speaker Change: Affecting the evaluation of the investors and our stakeholders and that has the effect of the stock price I know this is actually the image diagram, but for example in five to 10 years from today.
Speaker Change: Graham, but for example in five to 10 years from today do you think that they'll be able to obtained a retired exceeding is that amount that has been invested.
Speaker Change: Do you think that they'll be able to obtain that we time exceeding is that amount that has been invested.
Speaker Change: So could you. Please give me as I take a seat.
Speaker Change: In the meantime.
Speaker Change: So could you. Please give me as I take a field.
Speaker Change: Okay.
Speaker Change: In the meantime.
Speaker Change: We have.
Speaker Change: Okay.
Speaker Change: Our fully dedicated ourselves to.
Speaker Change: So for me.
Speaker Change: Be held accountable.
We have.
Speaker Change: For what we have been doing.
Speaker Change: Fully dedicated ourselves to be held accountable.
Speaker Change: Perhaps all of which I have not been understood by the market.
Speaker Change: For what we have been doing.
Speaker Change: Perhaps all the way to have not been understood.
Katsuya Haruna: It just shows how... Much more Rekenbi is chosen in the United States even today. Convenience was also included in the question, but according to what we hear about consenting process in clinical setting, it may be convenient that it's a one-time administration, but low incidence of aurea, if that is understood well, Rekenbi by far is chosen, and there is also experience of the physicians, which also the patients are interested in. Rekenbi has a long-term experience. There is long-term experience of Rekenbi, and I think this is a compelling reason for Rekenbi to be chosen. As Mr. Naito mentioned, AD is fatal.
Speaker Change: Or there may have been some over expectation.
Speaker Change: By the market.
Or there may have been some over expectation.
Speaker Change: And two high expectation may have been invited in the last year, we had to make.
Speaker Change: Yeah.
Speaker Change: Sure.
Speaker Change: The two high expectation may have been invited in the last year, we had two.
Speaker Change: Make a significant downward revision to our forecast, which was quite embarrassing for me.
Speaker Change: Make a significant downward revision to our forecast, which was quite embarrassing for me.
Speaker Change: And.
Speaker Change: We haven't been able to gang satisfactory.
Speaker Change: Yes.
Speaker Change: <unk> from the market.
Speaker Change: We haven't been able to gang satisfactory.
Speaker Change: We are very.
Speaker Change: Sorry for that but regarding the accountability are explaining.
Speaker Change: Confidence from the market we are very.
Speaker Change: Sorry for that but regarding accountability are explaining.
Speaker Change: To the market at every potential occasions, we have made all out there for it and trying to explain.
Speaker Change: To the market of every potential occasions, we have made all out there for it and trying to explain.
Speaker Change: And what we have are drawn here at the bottom.
Katsuya Haruna: It's a long-term chronic disease, and therefore long-term treatment and early treatment through Rekenbi, I'm sure, will be selected as a gold standard drug. And therefore, I believe that Rikenbu will continue to travel on the growth trajectory.
Speaker Change: And what we have are drawn here at the bottom.
Speaker Change: These are at four it required us to put a lot of resources under our partnership model through collaboration with Biogen.
Speaker Change: These are it for it's a required us to put a lot of resources under our partnership model through collaboration with Biogen.
Speaker Change: We have been able to achieve these.
Speaker Change: Globally.
Speaker Change: Okay.
Speaker Change: We have been able to achieve at least.
But both of us.
Speaker Change: Globally.
Katsuya Haruna: Thank you for your question.
Speaker Change: Sure.
Speaker Change: And the dotted line for extension.
Speaker Change: But both of us.
Akinori Ueda: I am Yusa, responsible for Japan business. Let me share with you the situation in Japan. As mentioned regarding the U.S. by my colleague, the impact from competition in Japan is also very limited. This is a progressive disease and it's a beta has turned negative after one year and the administration will be stopped. If such explanation is given by physicians, oftentimes patients and families become concerned and the continuous treatment is possible with Lecambe. In the end, oftentimes Lecambe is selected as a result. For more than one year, Rekenbi has been administered, and the experience of using Rekenbi for more than one year is having an impact when Rekenbi is chosen by doctors, patients, and families.
Speaker Change: Okay.
Speaker Change: To achieve that balance to profit and loss.
Speaker Change: And the dotted line for extension.
Speaker Change: And reaching the breakeven point in our fiscal year 2020 six so we are committed to achieve that.
Speaker Change: Two achieved a balanced the profit and loss.
Speaker Change: And reaching the breakeven point in our fiscal year 2026, So we are committed to achieve that.
Speaker Change: Yes.
Speaker Change: And actually in R&D expenses.
Speaker Change: Already in FY 'twenty to 'twenty five R&D expenses.
Speaker Change: Yes.
Speaker Change: And actually in R&D expenses.
Speaker Change: Already in FY 'twenty to 'twenty, five R&D expenses invest.
Speaker Change: They invested in there can be have already started to reduce.
Speaker Change: And as gender age we'll of course, probably of course peak out in FY 'twenty to 'twenty five.
Speaker Change: We invested in there can be have already started to reduce.
Speaker Change: And as gender age we'll of course, probably of course peak out in FY 2025.
Speaker Change: So the expenses.
Speaker Change: I'm sure it will be reduced going forward. So.
Speaker Change: So the expenses.
Speaker Change: We will be able to commit ourselves to achieving the breakeven point or a turning this business into a profit double business in FY 'twenty to 'twenty six thank you very much for your answer.
Speaker Change: Sure will be reduced going forward so.
Speaker Change: We will be able to commit ourselves to achieving the breakeven point or turning this business into a profit several businesses in FY 'twenty to 'twenty six thank you very much for your answer.
Speaker Change: And you are making it before it was in <unk> in Europe. So after getting approval and you immediately after getting approval you started a reform.
Speaker Change: You are making it before and it's in <unk> or in Europe.
Speaker Change: So after getting approval and you need a G. After getting approval you started the reform.
Speaker Change: I was not comfortable in hearing that and it is all the symbolic.
Akinori Ueda: Doctors are more familiar with the use of the drug, and patients may ask that question. And after that question, oftentimes, more often, Rekenbi is chosen, as we are told. There is also a clinical optimum treatment guideline in Japan, and MSE score is different, 29 and 30 in MSE score, only Rekenbi is possible to be used. So MCI and earlier, more mild patients may come to seek a treatment, and only Rekenbi can be given for MSE score of 29 to 30 patients.
Speaker Change: I was not comfortable interfering with that and it is on the symbolic.
Speaker Change: And with the minimum you would like to achieve that contribution to profit.
Speaker Change: With the minimum you would like to achieve that contribution to profit.
Speaker Change: But you need to negotiate for the reimbursement I don't think that the very high price that will be granted in Europe like you did in the United States. So having considered all of these have you made that decision to do.
Speaker Change: But you needed to negotiate for the reimbursement I don't think that the very high price that will be granted in Europe like it did in the United States.
Speaker Change: Do those structural reform.
Speaker Change: All of this have you made about this decision.
Speaker Change: No.
Speaker Change: Thank you for your question in order to get reimbursement approval in each country in Europe.
Speaker Change: Due to a structural reform.
Speaker Change: No.
Speaker Change: Thank you for your question in order to get reimbursement approval in each country in Europe.
Speaker Change: Longest it may take a three year, it's as I said earlier in Germany, and Austria for the first six months that are free.
Speaker Change: The longest it may take us three years as I said earlier in Germany, and Austria for the first six months of free pricing.
Speaker Change: Pricing will be applied in launching so we believe that are in these two markets, we will be able to launch first in Europe. After that you needed to we needed to start a negotiation of pricing and reimbursement.
Speaker Change: Pricing will be applied in launching so we believe that in these two markets, we will be able to launch first in Europe. After that though you needed to we needed to start a negotiation of pricing and reimbursement.
Akinori Ueda: And regarding the frequency of visit. by weekly visit actually is felt as beneficial by patients and families and there is also actual evidence that going out is beneficial for dementia patients. But patients who have difficulty visiting clinics every two weeks, then from the beginning they can be, will not be selected. So we believe the impact on they can be sales is minuscule. And as Mr. Naito CEO mentioned, April this year, we had 2 billion yen revenue, or on a daily basis close to 100 million sales. That is the pace we started out this fiscal year.
Speaker Change: There are uncertainties.
Speaker Change: Ooh.
Speaker Change: And that.
Speaker Change: There are uncertainties.
Speaker Change: And also that are somewhat geopolitical.
Speaker Change: Got it.
Speaker Change: And also that are somewhat geopolitical.
Speaker Change: Around the end of last week, there was an announcement.
Speaker Change: Around the end of last week, there was an announcement.
Speaker Change: In the United States.
Speaker Change: Yeah.
Speaker Change: Looking at all of these.
Speaker Change: In the United States.
Speaker Change: Movements.
Speaker Change: It was.
Speaker Change: Looking at all these.
Speaker Change: We needed to manage well the developments in Europe.
Speaker Change: Movements we.
Speaker Change: We needed to manage well the developments in Europe.
Speaker Change: Yeah.
Speaker Change: For them Bema.
Speaker Change: In Europe.
Speaker Change: Okay.
Speaker Change: I smell.
Speaker Change: Full name Bema.
Speaker Change: In Europe.
Speaker Change: Oh no.
Speaker Change: We believe that the phase the required us to invest a lot of our marketing power has ended.
Speaker Change: Yeah.
Speaker Change: So do you believe that.
Speaker Change: The phase the required us to invest a lot of our marketing power has ended.
Speaker Change: So in that sense, we like to pursue optimization understood. Thank you very much.
Akinori Ueda: So we are very confident of achieving the number of 2 billion for Japan. That's clear.
Speaker Change: So in that sense, we like to pursue optimization understood. Thank you very much.
Speaker Change: Does it give us that thank you next attendees, who did the second from the edge on the fourth row.
Speaker Change: Hi.
Akinori Ueda: Thank you. Long-term administration, which is a strength, is clearly understood by physicians and patients. I can see that.
Speaker Change: Thank you our next attendees, who did the second from the edge on the fourth row.
Speaker Change: From Goldman Sachs.
Company wide our expenses and your plan for that is my question.
Speaker Change: Lit up from Goldman Sachs.
Unknown Executive: And is it correct to understand that you are steadily decreasing the cost of sales? Yes.
Speaker Change: Company wide, our expenses and your pump without is my question.
Speaker Change: Going forward, our research and development cost or you have shown a slide earlier I would suggest that peaking out of Alzheimers disease are spending is going to pick up this fiscal year and are you also mentioned about SG&A, maybe peaking out and by optimizing sales.
Unknown Executive: If details are necessary, please catch the person responsible later, or should that be responded to now? Yes, we are making steady progress in reducing cost of sales. Please rest assured.
Speaker Change: Going forward, our research and development cost.
Speaker Change: We'll have shown a slide earlier, which suggests that speaking out of Alzheimers disease are spending isn't going to be felt this fiscal year and you also mentioned about SG&A, maybe peaking out and by optimizing sales org.
Speaker Change: Organization without.
Speaker Change: Increasing our expenses do you expect to increase our revenue and profit are it seems that optimization is underway are for both aspects of this fiscal year, but what is the Oh go going forward.
Speaker Change: Organization without.
Fumiyoshi Sakai: My name is Sakai from UBS Securities. Regarding the graph on page 23, honestly speaking, 370 billion yen has been invested. I'm surprised and I think there has been no other companies in Japan which are committed to make such a big investment, but during the time you have continued to run one stand-alone product in a loss-making status. And that has dragged down the business as a whole of the ASI and it has been affecting the evaluation of the investors and the stakeholders and that has affected the stock price.
Speaker Change: Increasing our expenses do you expect to increase our revenue and profit.
Speaker Change: It seems that optimization is underway.
Speaker Change: For both aspects of this fiscal year, but what do you see Oh go going forward.
Speaker Change: In fiscal 'twenty 'twenty, six Ari of 8%.
Speaker Change: In fiscal 2026 Ari of 8%.
Speaker Change: He is the target.
Speaker Change: Operating profit level for the east.
Speaker Change: He's still targets.
Speaker Change: More than 80 billion at around 83 billion yen or <unk> 85 billion again I believe that is the range of operating profit required tourists that we should make steady progress.
Speaker Change: Operating profit level for the east.
Speaker Change: More than 80 billion at around 83 billion yen or <unk> 85 billion again I believe that is the range of operating profit required tourists that we should make steady progress.
Speaker Change: And are we are on that.
Haruo Naito: And this is actually the image diagram, but for example, in 5 to 10 years from today, do you think that they will be able to obtain the return exceeding the amount that has been invested? So, uh, could you please give us a take at CEO?
Speaker Change: Trajectory.
Speaker Change: And we are on that.
Speaker Change: Understood. Thank you taking my staff.
Speaker Change: Dori.
Speaker Change: Next I'd like to receive questions from participants online Mr. Yamaguchi other citigroup could you please mute yourself.
Speaker Change: Understood. Thank you.
Speaker Change: Next I'd like to receive questions from participants online.
Mr. Yamaguchi: Mr. Yamaguchi other Citigroup could you please mute yourself.
Haruo Naito: In the meantime... We have fully dedicated ourselves to be held accountable for what we have been doing. Perhaps all of which have not been understood by the market. Or there may have been some over-expectation. We haven't been able to gain satisfactory confidence from the markets. We are very sorry for that, but regarding the accountability or explaining. to the market at every potential occasion. We have made all our efforts in trying to explain. and why we have a drone here at the bottom These efforts required us to put a lot of resources under a partnership model through collaboration with Biogen.
Yamaguchi: This is Yamaguchi from Citi speaking can you hear me, yes, we can.
Mr. Yamaguchi: Okay.
Mr. Yamaguchi: This is Yamaguchi from Citi speaking can you hear me, yes, we can.
Speaker Change: Oh, you did not mention assumptions for the financial results are it will be difficult to set assumptions, but what is your evaluation of the impact of Forex rates.
Speaker Change: Oh, you did not mention assumptions for the financial results it will be difficult to set assumptions, but what is your evaluation of the impact from Forex rate.
Mr. Ek: Mr. Ek is going to respond.
Mr. Ek: Thank you very much for your question Mr. Yamaguchi.
Speaker Change: Is that 8-K is going to respond.
Speaker Change: Thank you very much for your question Mr. Yamaguchi.
Mr. Ek: Yeah.
Mr. Ek: That tariff policy of the United States is making the headlines the news lately.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: The tariff policy of the United States is making the headlines the news slightly.
Mr. Ek: You know the pharmaceutical industry has not been subject to tariffs and response to that is not yet there's still such and so the guidance for fiscal year 'twenty 'twenty five has not incorporated this potential impact by tariff yet, but in the United States, mainly like them.
Speaker Change: So you know the pharmaceutical industry has not being subject to tariff and response to that.
Speaker Change: It's not yet there's still such and so the guidance for fiscal year 2025 has not incorporated the potential impact by tariff yet, but in the United States, mainly like them that they can be angled M. Bema, we are trying to control inventory and also improve the supply chain.
Mr. Ek: And they can be under them bema, we are trying to control inventory and also improve the supply chain. We have been taking measures. So whatever measures we are able to take now.
Speaker Change: We have been taking measures so whatever measures we are able to take now.
Mr. Ek: And also in China.
Mr. Ek: And our U S tariff.
Speaker Change: And also in China.
Mr. Ek: Creation is being discussed.
Speaker Change: I'm, sorry U S tonnage.
Mr. Ek: In China, as well management of inventory as well as improvement of supply chain are being done. Therefore, we do not think that there'll be any impact by tariffs on China. Thank you. Thank you very much because it gave us that what is.
Speaker Change: Retaliation is being discussed.
Speaker Change: Yeah.
Speaker Change: In China, as well management of inventory as well as improvement of supply chain are being done. Therefore, we did not think that there'll be any impact my tariffs on China. Thank you. Thank you very much.
Haruo Naito: We have been able to achieve these. globally. But both of us in the dotted line for extension to achieve the balanced profit and loss. and reaching the break-even point in fiscal year 2026. We are committed to achieve that. Actually in R&D expenses Already in FY 2025, R&D expenses invested in the Kimbe have already started to reduce and HG&A will probably peak out in FY 2025. So the expenses I'm sure will be reduced going forward, so... We will be able to commit ourselves to achieving the break-even point or turning this business into a profit double business in FY2026.
Muraoka: Next from Morgan Stanley Muraoka, San please Mr. Muraoka from Morgan Stanley. Please on mute.
Speaker Change: Next from Morgan Stanley Muraoka, San please.
Speaker Change: And visa.
Speaker Change: Oh from Morgan Stanley Please on mute.
Muraoka: Give us your question. Thank you for taking my question I met all come from Morgan Stanley.
Speaker Change: Uh huh.
Speaker Change: Give us your questions. Thank you for taking my question I met all come from Morgan Stanley.
Speaker Change: About the cost of sales.
Speaker Change: And the budget for this fiscal year.
Speaker Change: About our cost of sales.
Speaker Change: As a mentioned several reasons.
Speaker Change: In our budget for this fiscal year.
Speaker Change: Our sales cost ratio will increase.
Speaker Change: I mentioned several reasons that our sales cost ratio will increase.
Speaker Change: Ah I I'm not still fully convinced.
Speaker Change: Uh huh.
Speaker Change: Uh huh.
Speaker Change: That'd be my day Beagle.
Speaker Change: Still a fully convinced.
Speaker Change: Uh huh.
Speaker Change: One thing income these are almost a zero sales cost items are that may see fluctuation in revenue about a 15 billion again increase in cost of sales.
Speaker Change: That'd be my Baby girl.
Speaker Change: A one time income these.
Speaker Change: These are almost a zero sales cost items that may see fluctuation in revenue about a 15 billion again, an increase in cost of sales.
Speaker Change: Appears only to be linked to like can be.
Speaker Change: But so my question is S. C. A I am launch is.
Speaker Change: Appears only have to be linked to like can be so my question is S.
Unknown Executive: Thank you very much for your answer.
Speaker Change: These are scheduled.
Unknown Executive: and you are making a reform in Europe, so after getting approval and immediately after getting approval you started the reform. I was not comfortable in hearing that and it is only symbolic. With the minimum, you would like to achieve the contribution to profit. But you needed to negotiate for the reimbursement. I don't think that a very high price will be granted in Europe like you did in the United States.
Speaker Change: C H I M launch.
Speaker Change: And so the those as different volume of devices different I.
Speaker Change: These are scheduled and so the dosage different a volume a device is different.
Speaker Change: I felt looking at these numbers or that this is affecting the cost of sales number.
Speaker Change: I felt looking at these numbers. This is affecting the cost of sales number. If this one right off the mark or is this a close to the actual startup.
Speaker Change: Is this a right right off the Mark or is this a close to the actual start of.
Speaker Change: I, usually do not.
Speaker Change: I, usually do not.
Speaker Change: I'll provide a right on the Mark answer it but the recent main reason is I R. A inflation reduction act.
Haruo Naito: So having considered all this, have you made that decision to do the structural reform? Thank you for your question. In order to get reimbursement approval in each country in Europe, at longest, it may take three years. As I said earlier, in Germany and Austria, for the first six months, the free pricing will be applied in launching. So we believe that in these two markets, we'll be able to launch first in Europe. After that, we needed to start a negotiation of pricing and reimbursement. there are uncertainties in that and also there are somewhat geopolitical At around the end of last week, there was an announcement.
Speaker Change: I'll provide a right on the Mark answer but are the recent main reason he's I R E inflation reduction Act.
Speaker Change: And Lindsay MA will be impacted by the increase in expense.
Speaker Change: And lengthy MA will be impacted by the increase in it.
Speaker Change: And that is the reason Oh increase in cost of sales is the biggest reason. The next is a drug with a drug price revision and a reduction of one time income and change in product mix.
Speaker Change: Yes.
Speaker Change: And that is the reason Oh increase in cost of sales the biggest briefing and next is a drug with a drug price revision and the reduction of one time income and change in product mix.
Speaker Change: These factors are equally impacting.
Speaker Change: These factors are equally impacting.
Speaker Change: I hope by this I'm sure satisfies your question.
Speaker Change: Yeah.
Speaker Change: I hope this oh sure satisfies your question.
Speaker Change: Sorry, I'm persistent in asking about the lumpy my I R. A.
Speaker Change: I'm, sorry, I'm persistent in asking about the lumpy my I R. A.
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: Due to our increase in cost is it Oh I.
Speaker Change: All right.
Speaker Change: Uh huh.
Speaker Change: No.
Speaker Change: I thought this was a net sales so.
Speaker Change: Due to an increase in cost is it.
Haruo Naito: in the United States. looking at all these. Movement We needed to manage well the developments in Europe.
Speaker Change: It will be neutral or revenue may decline, but for cost I think its neutral am I mistaken.
Speaker Change: I thought this was a net sales so evil.
Speaker Change: It will be neutral or revenue may decline, but for cost I think it's a literal am I mistaken, but then I missed I ethanol can you I'm, sorry, or Mr. Hosaka Casaca.
Speaker Change: And I'm, just like ethanol can you I'm, sorry, or Mr. Hosaka Casaca missed.
Speaker Change: Mr. Sakai will address that question can you Oh, sorry, Mr. Kozak.
Haruo Naito: Forlendima. in Europe. as well. We believe that the phase that required us to invest a lot of our marketing power has ended. So in that sense, we would like to pursue optimization.
Mr. Kozak: Mr. <unk> will address the question can you Oh, sorry, Mr. Kozak.
Speaker Change: Responsible for supply chain strategy that says Casaca speaking as for a lengthy Ma.
Speaker Change: I'm responsible for supply chain strategy. This is of course offer speaking as for a lengthy mark.
Speaker Change: <unk> are a impact exists in the United States on the other hand, our gross to nets.
Mr. Kozak: E R a impact our interest in the United States.
Speaker Change: Price.
Unknown Executive: Understood, thank you very much. Hai, tsuzukimashite. Thank you.
Mr. Kozak: On the other hand, our gross to net.
Speaker Change: When we look at that.
Speaker Change: In the end, our sales cost ratio increases and Uh huh.
Mr. Kozak: Price.
Shinichiro Muraoka: Next attendee seated second from the edge on the fourth row. I'm Ueda from Goldman Sachs. Company-wide expenses and your plan for that is my question. Going forward, research and development cost, you have shown a slide earlier which suggested peaking out of Alzheimer's disease spending. Is it going to peak out this fiscal year? And you also mentioned that SG&A may be peaking out. And by optimizing sales organization without increasing expenses, do you expect to increase revenue and profit? It seems that optimization is underway for both aspects this fiscal year. But what is the output going forward?
Mr. Kozak: But when we look at that.
Mr. Kozak: In the end the sales cost ratio increases and Uh huh.
Speaker Change: That is the reason.
Speaker Change: I see thank you and I have a related question.
Mr. Kozak: That is the reason I.
Speaker Change: This morning, a nikkei there was a report.
Speaker Change: I see thank you and I have a related question on.
Speaker Change: About the U S about API production of like M, B, and maybe partially transferred to the United States.
Mr. Kozak: This morning indicate there was a report.
Speaker Change: Both the U.
Speaker Change: The U S about API production of like M, B, and maybe partially transferred to the United States and but I think the cost of that will be borne by biogen and not by any sorry. That's my understanding is that correct.
Speaker Change: But I think the cost of that will be borne by biogen and not buy a site. That's my understanding is that correct.
Speaker Change: Mr. Sakai once again, we will respond.
Speaker Change: Hum.
Speaker Change: Mr of course, I've got one for gambro respond.
Speaker Change: Thank you for your question.
Speaker Change: Once again this is of course a class speaking.
Speaker Change: Thank you for your question.
Speaker Change: So your question is about expense.
Speaker Change: Once again this is of course a class speaking.
Speaker Change: Or investment.
Speaker Change: So your question is about <unk> 10.
Speaker Change: Last month and.
Speaker Change:
Speaker Change: Or investment.
Speaker Change: Increase in manufacturing cost.
Speaker Change: Investment and.
Unknown Executive: in fiscal 2026, RE of 8%. He's the target. Operating profit level for that is... more than 80 billion around 83 billion yen or 85 billion yen I believe that is the range of operating profit required towards that we should make steady progress and we are on that trajectory Next we would like to receive questions from participants online.
Speaker Change: The increase.
Speaker Change: That kind of be held about who is going to bear that cost is that that is a question. Thank you for the quantification.
Speaker Change: Increase in manufacturing cost.
Speaker Change: Yeah.
Speaker Change: Is that kind of built about who is going to bear that cost that is my question.
Speaker Change: Drug substance a site a lunch it does not require investment existing lines will be used.
Speaker Change: For the quantification.
Speaker Change: Drug substance.
Speaker Change: Fight launch does not require investment existing life will be used.
Speaker Change: And there's no increase in our cost of sales are with this launch of the new line I see Thank you bet Mark audio show from Macquarie Tawny Lam.
Speaker Change: And there's no increase in cost of sales.
Speaker Change: This launch of the new line I see thank you.
Tony: Tony them from Macquarie Securities. Please on mute yourself.
Speaker Change: Got it.
Tawny Lam: From Macquarie Tawny Lam Tony.
Speaker Change: Tony them from Macquarie Securities. Please on mute yourself.
Tawny Lam: You all hear me yes.
Speaker Change: Yes, we can hear you.
Speaker Change: Okay. Yeah perfect. So you also wanted to follow up on Leila can be I noticed the working capital the inventory.
Hidemaru Yamaguchi: Mr. Yamaguchi of Citi Group, could you please unmute yourself? This is Yamaguchi from Citi speaking. Can you hear me? Yes, we can.
Speaker Change: Hi can you hear me.
Speaker Change: Yes.
Speaker Change: Okay. Yeah perfect. So you also want to follow up on like having B I noticed the working capital the inventory.
Speaker Change: What can be has increased a bit.
Speaker Change: Just wanted to see if it's because of our deliberate.
Speaker Change: Can be has increased a little bit.
Terushige Iike: You did not mention assumptions for the financial results. It will be difficult to set assumptions, but what is your evaluation of the impact of forex rates?
Speaker Change: Just wanted to see if it's because of our deliberate.
Speaker Change: Inventory of planning for example, inventory building ahead of the possible tariffs or is it because of a weaker sales than you have anticipated yeah. Thank you.
Speaker Change: Inventory of planning for example, inventory building ahead of the possible tariffs or is it because of a weaker side.
Terushige Iike: Mr. Iike is going to respond. Thank you very much for your question, Mr. Yamaguchi. The tariff policy of the United States is making headlines in news widely. As you know, the pharmaceutical industry has not been subject to tariff. And response to that is not yet still certain. So the guidance for fiscal year 2025 has not incorporated the potential impact by tariff yet. But in the United States, mainly Rekenbi and Renvima, we are trying to control inventory and also improve the supply chain. We have been taking measures, whatever measures we are able to take now. and also in China.
Speaker Change: And I'm on all I know she's like Oh My God.
Speaker Change: <unk> done that now you have anticipated yeah. Thank you.
Mr. Ek: Regarding your question about the inventory Mr show them on is going to respond.
Mr. Shoman: Although even though I know she's cycle me confident regarding your question about the inventory Mr show them on is going to respond Mr.
Mr. Casaca: Mr Chairman Mr Casaca.
Speaker Change: Excuse me Mr. Kozak AR is going to respond. Thank you very much for your question. My name is of course, I've got I'm going to answer your question regarding the inventory in biologics from production start until the completion it takes longer time with full production. So all in.
Speaker Change: Mr Show among or Mr. Casaca.
school soccer: Excuse me Mr. Kozak, our is going to respond. Thank you very much for your question. My name is school soccer I'm going to answer your question regarding the inventory in biologics from production storage and build the completion it takes longer time to full production. So.
Speaker Change: Order to prepare for the expected expansion of our demand our production is ongoing steadily for the medium to longer term the cost.
school soccer: Order to prepare for the expected expansion of our demand. Our production is ongoing go steadily for the medium to longer term they'll close.
Speaker Change: They are in line with the expansion of its revenue.
Speaker Change: The manage secure management of inventory is expected. Therefore, there is no concern.
school soccer: They are in line with the expansion of its revenue.
school soccer: The managed secure management of inventory is expected. Therefore, there is no concern.
Terushige Iike: and the U.S. tariff retaliation is being discussed. In China as well, management of the inventory as well as improvement of supply chain are being done. Therefore, we do not think that there will be any impact by tariff on China.
Speaker Change: Thank you for your question.
Ms Day: Thank you Ms day.
school soccer: Thank you for your question.
Speaker Change: That's S M D C.
Speaker Change: Can you give us a date.
Speaker Change: F N B C securities or other sound. Please on mute please start.
Speaker Change: S M D C.
Speaker Change: F N B's integrated another sound. Please on mute please start.
Speaker Change: Thank you I invite up from Smbs and of course, the great East can you hear me, yes, we can thank you.
Unknown Executive: Thank you. Thank you very much.
Speaker Change: You are invited from SM can equally great East can you hear me, yes, we can.
Shinichiro Muraoka: Next, from Morgan Stanley, Muraoka-san, please.
Speaker Change: Yeah.
Speaker Change: I have a question from a very different perspective G O P. One in obesity treatment.
Shinichiro Muraoka: Mr. Muraoka from Morgan Stanley, please unmute and please give us your question. Thank you for taking my question. I'm Muraoka from Morgan Stanley.
Yeah.
Speaker Change: I have a question from a very different perspective, J O P. One in obesity treatment.
Speaker Change: They are used in our phase III clinical trial for Alzheimers disease, and is it plus or minus on Israel Novo Nordisk, a goofy Alzheimer's a phase III study I think is expected to be completed in September is this going to.
Unknown Executive: About cost of sales in the budget for this fiscal year, you've mentioned several reasons that sales cost ratio will increase, but I am not still fully convinced. One time income, these are almost zero sales cost items that may see fluctuation in revenue. But 15 billion yen increase in cost of sales, it appears only to be linked to the Kenbi.
Speaker Change: They are used in our phase III clinical trial for Alzheimer's disease, and is it plus or minus on Israel Novo Nordisk out Ogilvy.
Speaker Change: I'll, primarily a phase III study I think is expected to be completed in September.
Speaker Change: Have a positive negative or neutral impact on the revenue and profit of like M. B could you also discuss positioning Mr. Ito can you answer.
Speaker Change: It's going to.
Speaker Change: Have a positive negative or neutral impact on the revenue and profit but can be cause you also discussed positioning Miss that you don't can't even answer.
Speaker Change: This is Don responsible for a D H B L.
Speaker Change: That's helpful.
Speaker Change: You pointed out a G. L. P. One can you speak closer to speak into the microphone.
Speaker Change: This is responsible for a D H B L.
Unknown Executive: So my question is, SCE launch is scheduled and so the dose is different, volume device is different. I felt looking at these numbers that this is affecting the cost of sales number. Is this right off the mark or is this close to the actual status?
Speaker Change: You pointed out a G. L. P. One can you speak closer to speak into the microphone.
Speaker Change: This is it'll speaking I'm responsible for D. H B L. As you pointed out G. L. P 180 indication a D. Ah study is underway, but correct me.
Speaker Change: This is <unk> speaking I'm responsible for the H B L. A few pointed it out G. L. P 180 indication a D. Ah study is underway, but correct me.
Speaker Change: Clearly elucidation of biology is not obtained and the prototypical fibril. This is Steve toxic species that is captured by our product and as such are understanding does not exist for G. O. P. One. So currently we don't consider it to be a threat.
Speaker Change: Clearly elucidation of biology is not obtained and the prototypical fibril, but this is steve toxic species, but he's sceptre it they buy our product and as such understanding does not exist for G. O P. One. So currently we don't consider it to be a threat.
Unknown Executive: I usually do not... I'll provide a right-on-the-mark answer, but the reason, main reason is IRA, Inflation Reduction Act, and LENFIMA will be impacted by the increase in expense. And that is the reason of increase in cost of sales. The biggest reason. The next is drug price revision and reduction of one-time income and change in product mix. These factors are equally impacting.
Speaker Change: Mr. <unk> would you like the odd.
Speaker Change: Yes, I'm responsible for translational my name's East ODM first I'm looking at mechanism of action. It is completely different and they can be targets are clearly a toxic proto fibril.
Speaker Change: Mr. <unk> would you like the odd.
Speaker Change: Yes, I'm responsible for translational my name's East 40 at first time looking at mechanism of action it is completely different.
Speaker Change: Can be targets are clearly toxic proto fibril.
Speaker Change: And others a wealth of evidence.
Speaker Change: <unk> of human biology has been confirmed and therefore, it will be consider that they will be.
Speaker Change: And others a wealth of evidence.
Speaker Change: Of human biology has been confirmed.
Speaker Change: And there will be absolutely no impact thank you.
And therefore, it will be closer to that there will be.
Speaker Change: The way it is used Oh go V phase three.
Speaker Change: There will be absolutely no impact thank.
Speaker Change: Thank you.
Speaker Change: The standard of care such as they can be there'll be a continued and up.
Speaker Change: The way it is used Oh go V phase III.
Unknown Executive: I hope this answer satisfies your question. I'm sorry I'm persistent in asking, but Len Wima, IRA... Due to IRA increasing cost, I thought this was a net sales, so it will be neutral or revenue may decline, but for cost, I think it's neutral, am I mistaken?
Speaker Change: But again the standard of care, such as I can be there'll be some opinions and Google.
Speaker Change: We'll go there is added on top so basically do you think that the Gobi will be used in combination.
Speaker Change: We're gonna be added on top of basically a do you think that the Gobi will be used in combination.
Speaker Change: This is a nut.
Speaker Change: Yet approved so it is difficult to comment on that.
Speaker Change: No.
Speaker Change: It's not.
Speaker Change: Not.
Speaker Change: You have approved so it is difficult to comment on that.
Speaker Change: Okay.
Speaker Change: I see.
Speaker Change: Thank you.
Speaker Change: Alright.
Speaker Change: Like does it give us.
Speaker Change: I see.
Speaker Change: From Sanford Bernstein Soggy song Soggy song from Sanford Bernstein. Please on mute yourself. Thank you very much.
Speaker Change: Thank you.
Unknown Executive: Then Mr. Yasuno, can you answer, or Mr. Kosaka, Mr. Kosaka will address the question. Can you answer, Mr. Kosaka?
Speaker Change: Does it give us data.
Speaker Change: From some Florida bonds spine Soggy song Soggy song from some forward a bond Stein. Please on mute yourself. Thank you very much.
Speaker Change: Regarding that can be I have two questions. My first question.
Kosaka: I'm responsible for supply chain strategy. This is Kosaka speaking. As for Len Rima, IRA impact exists in the United States. On the other hand, a growth to net Price When we look at that, in the end, sales cost ratio increases. And that is the reason.
Speaker Change: Regarding if it can be I have two questions. My first question.
Speaker Change: Earlier in January maintenance dosing at legs approved and.
Speaker Change: Earlier in January maintenance dosing it was approved.
Speaker Change: [noise] infusion capacity was to be expanded as you have continued to mention.
Speaker Change: And in.
Speaker Change: Infusion capacity was to be expanded as you have continued to mention a bump up on up until the end of April has there been any impacts of such airports onto the revenue.
Speaker Change: Ramp up on up until the end of April have there been any impact of such airports onto the revenue.
Speaker Change: Mr HUD or not is going to respond. Thank you very much for your question I am in charge of our U S business. My name is a hot or not let me respond.
Unknown Executive: I see. Thank you.
Speaker Change: Mr. <unk> is going to respond. Thank you very much for your question I am in charge of our U S business. My name is I have not let me respond.
Unknown Executive: And I have a related question. This morning in Nikkei, there was a report about the U.S. that API production of Lakembi may be partially transferred to the United States. But I think the cost of that will be borne by Biogen and not by ASI. That's my understanding.
Speaker Change: At the end of January I V maintenance treatment was approved IV maintenance at <unk>.
Speaker Change: At the end of January IV maintenance treatment was approved.
Speaker Change: Demand.
Speaker Change: E maintenance treatment.
Speaker Change: Is used to buy a new introduced by increasing number of medical institutions, and AC see peds and a patient.
Speaker Change: Okay.
Kosaka: Is that correct? Mr. Kosaka, once again, will respond. Thank you for your question. Once again, this is Kosaka speaking. So your question is about expense or investment or investment and increase in manufacturing costs That can be helped, but who is going to bear that cost? That is the question.
Speaker Change: It's used to buy and are introduced by increasing number of medical institutions and HCP and patient.
Speaker Change: Half and I'm coming to understand better the benefits of long term administration of treatment as they can be.
Speaker Change: And I'm coming to understand better the benefits of long term administration of treatment that can be.
Speaker Change: And.
Speaker Change: The other thing just medical institutions, where the maintenance that there'll be is being conducted at seeing the increasing number of patients who initiate treatment and as you pointed out the infusion chats.
Speaker Change: And.
Speaker Change: The other thing just medical institutions, where the maintenance that there'll be is being conducted at seeing the increasing number of patients who initiated treatment and as you pointed out the infusion check.
Speaker Change: I believe that the that issue or challenge of has been resolved.
Speaker Change: All right.
Speaker Change: I believe that the about the issue or challenge of has been resolved.
Speaker Change: And the record high sales and a shipment.
Kosaka: Thank you for the clarification. Drug substance site launch does not require investment. Existing line will be used, and there's no increase in cost of sales with this launch of the new line.
Speaker Change: And at a record high in sales and shipment.
Speaker Change: For the months of April was achieved as we mentioned earlier and thank you very much.
Speaker Change: For the month of.
Speaker Change: April was achieved.
Speaker Change: Maybe this is a follow up question for Mr hard enough.
Speaker Change: We mentioned earlier I. Thank you very much.
Speaker Change: Okay.
Unknown Executive: I see. Thank you.
Speaker Change: Maybe this is a follow up question for Mr. <unk>.
Tony Ren: From Macaulay, Tony Ren from Macaulay Securities, please unmute yourself. you hear me? Yes, we can hear you. Okay, yeah, perfect. So yeah, I also want to follow up on Lakembi. I noticed the working capital, the inventory on Lakembi has increased a little bit. I just wanted to see if it's because of deliberate inventory planning, for example, inventory building ahead of the possible tariffs, or is it because of weaker sales than you have anticipated? Regarding your question about the inventory, Mr. Shoman is going to respond. Mr. Shoman or Mr. Kosaka? Excuse me.
Speaker Change: And the demand expansion phase.
Speaker Change: Okay.
Speaker Change: When involvement by Pcbs are is expected or with U S. C. I P. C piece will be able to prescribe.
Speaker Change: And the demand expansion phase.
Speaker Change: When involvement by Pcbs Ah is expected or with U S. C. I P cities will be able to prescribe <unk>.
Speaker Change: Which may lead to the future further growth.
Speaker Change: But according to market research or your discussion it was BCP is in the field.
Speaker Change: Which may lead to the future further growth.
Speaker Change: But according to market research or your discussion it was BCP zynga field.
Speaker Change: Do you think that.
Speaker Change: BCP.
Speaker Change: Yes.
When you think back.
Speaker Change: Are going to start the prescription of the S C I or what kind of hurdles or challenges do they feel in doing that.
Speaker Change: P C P R.
Speaker Change: Are going to start the prescription of D C I or what kind of hurdles are trying to debate it feels in doing that.
Speaker Change: Had or not is going to respond.
Speaker Change: And the demand expansion phase the PCP. The involvement is considered to be very important.
Speaker Change: Hum is going to respond.
Speaker Change: And the demand expansion phase piece of PS involvement is considered to be very important.
Speaker Change: If I make sure we do some examples in the east.
Speaker Change: The United States, the largest the idea and.
Speaker Change: If I make sure we do some examples in the east.
Kosaka: Mr. Kosaka is going to respond. Thank you very much for your question. My name is Kosaka. I'm going to answer your question. Regarding the inventory in biologics, from production start until the completion, it takes longer time for production. So in order to prepare for the expected expansion of demand, the production is ongoing steadily. For the medium to longer term, in line with expansion of revenue, the secure management of inventory is expected. Therefore, there is no concern. Thank you for your question.
Speaker Change: Current G about 600 patients are being prescribed like can be and what is the reason for that Pcbs are neurologists are collaborating very closely therefore.
Speaker Change: The United States the largest the IDM.
Speaker Change: Brian G about 600 patients are being prescribed and it can be.
Speaker Change: The reason for that Pcbs, and the neurologists are collaborating very closely.
Speaker Change: Therefore, as a result, there has been increasing number of referrals and the time it to referral is shortened.
Speaker Change: Therefore, as a result, there has been increasing number of referrals and the time it to referral is shortened.
Speaker Change: Being shortened and therefore that has led to the expansion of the prescription therefore participation or involvement of P. C piece is very important in the demand expansion states. We believe that this is going to be a key factor.
Speaker Change: Being shortened and therefore that has an attitude the expansion of the prescription.
Speaker Change: Therefore, our participation and involvement of BCP is very important in the demand expansion phase. We believe that this is going to be a key factor.
Speaker Change: As you said in your question P. C P.
Speaker Change: If they are going to started a prescription of the there can be among TCP, but what is important for them is that they're not able to diagnose, particularly the testing on the I'm only debate or is not the something easily done by themselves, but the BB and for confirmatory testing.
Hiroshi Wada: Next, SNBC, SNBC Securities, Wada-san, please unmute and please start. Thank you. I'm Wada from SMBC Nikoji Greetings. Can you hear me? Yes, we can. Thank you.
Speaker Change: As you said in your question P. C. P R.
Speaker Change: If they are going to starved prescription of the they can be.
Speaker Change: PCP, but what is important for them is that they are not able to diagnose, particularly the testing on the amyloid beta is not that something easily done by themselves, but the BB M for confirmatory testing.
Unknown Executive: I have a question from a very different perspective. GLP-1 in obesity treatment... May, are used in phase 3 clinical trial for Alzheimer's disease and is it plus or minus or neutral? Novo Nordisk Ugovi, Alzheimer's phase 3 study I think is expected to be completed in September. Is this going to have a positive, negative or neutral impact on the revenue and profit of Black Envy? Could you also discuss positioning?
Speaker Change: <unk> being potentially approved under reimbursed by the end of this fiscal year and together with S. C. A R.
Speaker Change: <unk> being potentially approved under reimbursed by the end of this fiscal year and together with S. C H I.
Speaker Change: Hi.
Speaker Change: Which will allow P C piece to start prescribing on themselves.
Speaker Change: Which will allow P C piece to start prescribing on themselves.
Speaker Change: And they can be as of as I had such a uniqueness AR, which is considered Jamaica and they've gone to a contribution to that based upon our market research P. C. P.
Speaker Change: And if they can be of ASI has such a uniqueness, which is considered can make significant contribution to that based upon our market research you see peaks.
Speaker Change: Who think that they are willing to.
Speaker Change: Yeah.
Speaker Change: <unk> started the prescription.
Speaker Change: Who think that they are willing to.
Although there can be and we mentioned that that there are high potential about 2000 high potential piece of pizza today, but these are people are paid physicians.
Katsutoshi Ido: Mr. Ido, can you answer? This is Ido, responsible for DHBL. As you pointed out, GLP-1. Can you speak closer? Speak into the microphone. This is Ido speaking. I'm responsible for DHBL. As you pointed out, GLP-1 AD study is underway, but currently clear elucidation of biology is not obtained. And the protofibril, this is the toxic species that is captured by our product. And such understanding does not exist for GLP-1, so currently we don't consider it to be a threat.
<unk> started the prescription.
Speaker Change: Although there can be and we mentioned that that there are high potential about 2000 high potential P. C seats today, but these are the people.
Speaker Change: So how could you. Please thank you very much for you I'm sorry could you. Please explain how you are doing to find new high potential Pcbs, well, let me how to now continue to respond.
Speaker Change: Physician.
Speaker Change: So how could you. Please thank you very much for your answer could you. Please explain how you are identifying high potential pcbs.
Speaker Change: Like to refrain from disclosing details on the PCP high potential EPC piece, but the based upon the claims data and the diet season.
Speaker Change: Well, let me how to now continue to response I'd like to refrain from disclosing details on the obesity high potential EPC beach, but based upon the claims data and the.
Speaker Change: These are the three ige for amyloid beta is being done already and there or is it the number of P. C piece of who are willing to be involved in the diagnosis and treatment and not only the quantity, but it was.
Speaker Change: Nowadays and the three eyes for amyloid beta is being done already.
And there are a number of D. C piece of who are willing to be involved in the diagnosis treatment and not only the quantity, but it was.
Katsutoshi Ido: Mr. Horie, would you like to add? Yes, I'm responsible for translational. My name is Oriye. First, looking at mechanism of action. It is completely different. They can be targets, clearly, toxic protofibrile force. it and others wealth of evidence of human biology has been confirmed and therefore we consider that there will be there will be absolutely no impact. Thank you. The way it is used, Lugowi Phase 3... The standard of care, such as Rekenbi, will be continued and Ugobi is added on top. So basically, do you think that Ugobi will be used in combination? This is not yet approved, so it is difficult to comment on that.
Speaker Change: So the number besides J P C b b b M and cutting edge our treatment.
Speaker Change: So the number of besides J P C D B B M.
Speaker Change: Where they are willing to participate in those the cutting edge of treatment. We have confirmed this at high potential abusive fees based upon the claims data.
Speaker Change: Affirmative shut to high potential obviously is based upon the claims data that we'd like to open the floor for from the media people. Please raise your hand, if you have any questions.
Speaker Change: We'd like to open the floor for at all from the media people. Please raise your hand, if you have any questions.
Speaker Change: My name is spun off from Nikkei.
Speaker Change: Yeah.
Speaker Change: One of the most.
Speaker Change: U S market is quite uncertain and how do you plan to respond earlier regarding tariff out there was already a question and answer about a.
Speaker Change: My name is spun off from Nikkei.
Speaker Change: U S market is quite uncertain and how do you plan to respond earlier regarding tariff out there was already a question and answer.
Speaker Change: Reduction of our drug price, how do you understand the impact from most favorite nation, and you've mentioned organizational reform in Europe about depending on the situation in the U S. A as the management are is it possible to make a decision to focus more on Europe.
About.
Speaker Change: Reduction of our drug price, how do you understand the impact from most of favorite our nation and you've mentioned organizational reform in Europe about depending on the situation in the U S as the.
Unknown Executive: I see. Thank you. Itadakimasu.
Speaker Change: Management is it possible to make a decision to focus more on Europe.
Speaker Change: First let me say ethanol.
Katsuya Haruna: from Sanford Bernstein, Sogi-san, Sogi-san from Sanford Bernstein, please unmute yourself. Thank you very much. Regarding the Kenbi, I have two questions. My first question... Earlier in January, maintenance dosing was approved, and... Infusion capacity was to be expanded, as you have continued to mention, and up until the end of April, have there been any impact of such efforts onto the revenue?
Speaker Change: They have fallen below responded to that question. Thank you for your question on the ethanol responsible for Americas business.
Speaker Change: Good morning.
Speaker Change: First let me say ethanol.
Speaker Change: I found it responded to that question. Thank you for your question I'm definitely responsible for our Americas business.
Speaker Change: What else on a Monday.
Speaker Change: President Trump.
Speaker Change: What else on a Monday.
Speaker Change: Find executive order delivering most favorite nation prescription drug pricing to American patients.
President Trump: President Trump.
President Trump: Find executive order that will bring most favored nation prescription drug pricing to American patients.
Speaker Change: President Trump signed an executive order.
Speaker Change: Within 30 days.
President Trump: President Trump signed an executive order.
Speaker Change: It is expected that the government will be communicating.
President Trump: Within 30 days.
President Trump: It is expected that the government will be.
Speaker Change: To pharmaceutical companies.
Katsuya Haruna: Mr. Haruna is going to respond. Thank you very much for your question. I am in charge of U.S. business. My name is Haruna. Let me respond. At the end of January, IV maintenance treatment was approved. IV maintenance treatment... is used by and introduced by increasing number of medical institutions and ACCPs and patients. have now come to understand better the benefits of long-term administrational treatment with Lecambe. and at the medical institutions where the maintenance therapy is being conducted it's seeing the increasing number of patients who initiate a treatment and as you pointed out the infusion chairs I believe that that issue or challenge has been resolved.
Speaker Change: The target price based on and F N most favorite nation.
President Trump: Communicating.
President Trump: To pharmaceutical companies.
President Trump: The target price based on N F N most favorite nation.
Speaker Change: However, other than that.
Speaker Change: In what way before what products.
President Trump: However, others on that.
Speaker Change: Okay.
President Trump: One way.
Speaker Change: Will that price be indicated what countries will be the reference countries, which will be in a scope Medicare Medicaid commercial insurance.
President Trump: For what product.
President Trump: Hum.
Speaker Change: Well the price they indicated what countries will be the reference countries.
Speaker Change: Which will be in a scope Medicare Medicaid commercial insurance.
Speaker Change: Once our target prices that then in actual transaction.
Speaker Change: Awesome.
Speaker Change: All right.
Speaker Change: Once our target prices that.
Speaker Change: What level of price is going to be adjusted specifics.
Speaker Change: But then in actual transaction.
Speaker Change: What level of price is going to be adjusted specifics.
Speaker Change: Are quite uncertain.
Speaker Change: Furthermore, it.
Speaker Change: Are quite uncertain.
Speaker Change: It also says that there will be rules, making but how rules will be made is also quite uncertain.
But furthermore.
Speaker Change: It also says that they will be rule, making about how the rules will be made it also quite uncertain.
Speaker Change: And Furthermore, if this M. S N is to be applied broadly.
Speaker Change: And Furthermore, if this is.
Katsuya Haruna: And the record high in sales and shipment for the month of April was achieved, as we mentioned earlier.
Speaker Change: Yeah.
Speaker Change: Just to be applied broadly.
Speaker Change: The new legislation.
Speaker Change: <unk> may be necessary and.
Speaker Change: Okay.
Speaker Change: The new legislation.
Speaker Change: That would require approval by the Congress.
Maybe necessary and.
Katsuya Haruna: Thank you very much.
Speaker Change: So given that situation.
Speaker Change: Doubled require approval by the Congress.
Katsuya Haruna: Maybe this is a follow-up question for Mr. Haruna. in the demand expansion phase. When involvement by PCPs is expected, or with SCAI, PCPs will be able to prescribe, which may lead to the future further growth. But according to market research or your discussion with PCPs in the field. Do you think that... PCPs are going to start prescription of the SEI or what kind of hurdles or challenges do they feel in doing that?
Speaker Change: And currently the like M B list price.
Speaker Change: So given that situation.
Speaker Change: And is that the same level in Europe Asia, and Japan is in the U S. That's for Lindsay Mann.
Speaker Change: And currently the light can be list price.
Speaker Change: And it has the same level in Europe, Asia, and Japan I was in the U S.
Speaker Change: In the United States.
Speaker Change: Under Medicare part D D. As in dog a there is a sales under at the first a Trump administration. When there was also an attempt for M. S N.
Lindsay Mark: For Lindsay Mark.
Speaker Change: In the United States.
Speaker Change: Under Medicare part D D. As in dog a there is a sales under the first a Trump administration. When there was also an attempt for M. S N <unk>.
Speaker Change: When Medicare part D was not included in the scope.
But they can be and then B mall are also are used in very small a part and mitigate.
Speaker Change: When Medicare part D was not included in the scope.
Speaker Change: It can be and then be more oh so.
Speaker Change: In any event to be broken.
Speaker Change: Are you starting in very small part in Medicaid.
Speaker Change: Through continuous engagement with the Trump administration, we would like to understand better the details of the program and will implement necessary measures.
Speaker Change: In any event to people.
Katsuya Haruna: Haruna is going to respond. In a demand expansion phase, the PCP's involvement is considered to be very important. If I may share with you some examples, in the east of the United States, the largest IDN Currently, about 600 patients are being prescribed Leken-B. And what is the reason for that? PCPs and neurologists are collaborating very closely. Therefore, as a result, there has been increasing number of referrals, and the time to referral is shortened, being shortened. And therefore, that has led to the expansion of the prescription. Therefore, participation or involvement of PCPs is very important in the demand expansion phase.
Speaker Change: Okay.
Speaker Change: Through continuous engagement with the Trump administration, we would like to understand better the details of our program and they'll they'll implement unnecessary measures.
Speaker Change: Once the situation becomes clear or if a impact becomes clear when necessary, we will provide update.
Speaker Change: Once the situation becomes clear or if a impact becomes clear when necessary, we will provide updates.
Speaker Change: Turning to <unk>.
Speaker Change: Europe I believe uncertainty is becoming greater.
Speaker Change: Turning to <unk>.
Speaker Change: Europe I believe uncertainty is becoming greater.
Speaker Change: In Europe as well.
Speaker Change: After the announcement of the tariffs.
Speaker Change: In Europe as well.
Speaker Change: E <unk>.
Speaker Change: After the announcement of the tariffs.
Speaker Change: Is are worried about.
Speaker Change: You can use.
Speaker Change: Industries in EU, maybe hollowed out.
Speaker Change: You use.
Speaker Change: Is are worried about.
Speaker Change: And our competition competitiveness may become weaker.
Speaker Change: Industries in EU, maybe hold those out.
Speaker Change: The competition competitiveness may become weaker.
Speaker Change: European Policymakers I believe became most concerned about these.
Speaker Change: Okay.
Katsuya Haruna: We believe that this is going to be the key factor. As you said in your question, PCPs... and there can be of Eisai has such a uniqueness which is considered to make significant contribution to that based upon our market research PCP . . who think that they are willing to start the prescription of Rekenbi.
Speaker Change: European Policymakers I believe became most concerned about these.
Speaker Change: Industrial policies.
Speaker Change: Yes.
Speaker Change: Industrial policies.
Speaker Change: May be.
Speaker Change: That's fine.
Speaker Change: Sure.
Adopted in or positive industrial policies may start to be adopted in life industry.
Speaker Change: Okay.
Speaker Change: May be.
Speaker Change: The bidding or.
Speaker Change: Or positive industrial policies may start to be adopted in life industry.
Speaker Change: I believe there are such potential signs FBR industry Association.
Speaker Change: I believe there are such potential fines FBR industry Association.
Speaker Change: In Europe.
Speaker Change: Is taking such an approach to EU authorities or two.
Speaker Change: In Europe.
Speaker Change: If I'm, taking that such an approach to EU authorities.
Speaker Change: The member States.
Speaker Change: Or two.
Speaker Change: The member States.
Speaker Change: In the midst of this in the executive order.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: In the midst of this in the executive order.
Speaker Change: It also mentions the need to increase price in E shoes OECD GDP per capita.
Speaker Change: No.
Speaker Change: He also mentioned the need to increase price in Asia OECD GDP per capita.
Katsuya Haruna: And we mentioned that there are a high potential, about 2,000 high potential PCPs today, but these are the people or physicians who, so how, could you please, thank you very much for your answer, could you please explain how you are identifying high potential PCPs? Well, let me, Haruna, continue to respond. I'd like to refrain from disclosing details on the PCPs, high potential PCPs, but based on the claimed data and diagnosis and triage for amyloid beta is being done already, and there are a certain number of PCPs who are willing to be involved in the diagnosis and treatment, and not only the quantity but also...
Speaker Change: The drug spending I forgot the details, but the ratio was mentioned.
Speaker Change: The drug spending I forgot the details, but the ratio was mentioned.
Speaker Change: And it calls for an increase in price in Europe.
Speaker Change: Otherwise, it's a free ride situation.
Speaker Change: It calls for an increase in price in Europe.
Speaker Change: Uh huh.
Speaker Change: Otherwise, it's a free ride situation.
Speaker Change: On the U S a.
And he is enjoying our innovation are taking a free ride.
Speaker Change: Uh huh.
Speaker Change: On the U S a.
Speaker Change: And EU is enjoying a innovation taking.
Speaker Change: Yeah.
Speaker Change: Oh well.
Speaker Change: Taking a free ride.
What responses will be taken.
Speaker Change: Okay.
Speaker Change: Oh, what responses will be taken.
Speaker Change: Including by EU.
Speaker Change: He spoke we are paying very close attention to.
Speaker Change: Including by EU.
Speaker Change: Is what we are paying very close attention to.
Speaker Change: On the part of the industry.
Speaker Change: In E U industry is seeking a change in industrial policy and is approaching the authorities they want.
Speaker Change: Okay.
Speaker Change: On the part of the industry.
Speaker Change: But in your industry is seeking a change in the industrial policy and is approaching the authority.
Katsuya Haruna: So the number of such PCPs, BBM and cutting-edge treatments, where they are willing to participate in those cutting-edge treatments, we have confirmed such high-potential PCPs based upon the claimed data.
Speaker Change: Uh huh.
Speaker Change: Next question.
Speaker Change: Okay.
Speaker Change: Next question.
Speaker Change: My name is system she Myanmar.
Speaker Change:
Tatsuyuki Yasuno: We'd like to open the floor from the media people. Please raise your hand if you have any questions. My name is Banno from Nikkei. U.S. market is quite uncertain, and how do you plan to respond earlier regarding tariff? There was already a question and answer about reduction of drug price. How do you understand the impact from most favored nation? And you've mentioned organizational reform in Europe. But depending on the situation in the U.S. as the management, is it possible to make a decision to focus more on Europe?
Speaker Change: Non fiction writer could you. Please explain this ain't easy to understand it better.
Speaker Change: No.
Speaker Change: My name is system she Myanmar.
Speaker Change: Non fiction writer.
Speaker Change: They can be approval in the United States accelerated approval was in January 2020, 'twenty three and since then you have established a pathway and a sales force.
Speaker Change: Please explain this ain't easy to understand that matter.
Speaker Change: They can be approval in the United States Oxidate approval was in January 2020, 'twenty three and since then you have established a pathway and the sales force.
And then September approval was granted in Japan. So there was a time lead of eight months between the U S and Japan, having said that why.
Speaker Change: And then September approval was granted in Japan. So there was a time lead of eight months between the U S and Japan.
Speaker Change: The penetration of that can be treatment in the United States was slower than that in Japan could you. Please explain any easy to understand.
Speaker Change: Having said that why.
Speaker Change: The penetration of that can be treatment in the United States was slower than that in Japan could you. Please explain any easy to understand.
Speaker Change: I mean, especially in Myanmar. Thank you for your question.
Speaker Change: Accelerated approval and the traditional approval are different in terms of what the scope of activities which are allowed.
Speaker Change: Especially in Myanmar. Thank you for your question actually is solvable and traditional approval of difference in terms of what scope of activities, which are allowed.
Tatsuyuki Yasuno: First, Mr. Yasuno will respond to that question. Thank you for your question. I'm Yasuno, responsible for America's business. As you are aware of, on Monday... President Trump signed executive order delivering most favored nation prescription drug pricing to American patients. President Trump signed the executive order within 30 days. It is expected that the government will be communicating to pharmaceutical companies the target price based on NFN, most favored nation. However, other than that, in what way, for what product? Will the price be indicated? What countries will be the reference countries which will be in the scope of Medicare, Medicaid, commercial insurance?
Speaker Change: Therefore in many medical institutions under the.
Speaker Change: Therefore in many medically detrition I'm dirty.
Speaker Change: Accelerated approval.
Speaker Change: The passage of that drug through.
Speaker Change: Accelerated approval.
Speaker Change: Ah the formulary cannot be done therefore investment of resources in order to establish pathway.
Speaker Change: The passage of that drug through.
Speaker Change: The formulary cannot be done therefore investment research.
Speaker Change: Not also a possible under the accelerated approval I do helm was which was the predecessor to they can be was an example.
Speaker Change: She was established pathway.
Speaker Change: Not also.
Speaker Change: Possible under the accelerated approval I do helm was which was a predecessor to like N. B was an example.
Speaker Change: And therefore, there was a concern that.
Speaker Change: Such examples may be reproduced so pathway establishment. There was started during the full fleet day Muhtar.
Speaker Change: And therefore, there was a concern that.
Speaker Change: Such examples may be reproduced.
Speaker Change: So pathway establishment, there was started though into a full fledged muhtar.
Speaker Change: After the full approval was obtained in July.
Speaker Change: And as you know.
Speaker Change: After the full approval was obtained in July.
Speaker Change: In the United States.
Speaker Change: And as you know.
Speaker Change: The health systems or medical services.
Speaker Change: In the United States.
Speaker Change: Yeah.
Speaker Change: Services are very different from a state to another.
Speaker Change: The health systems or medical services.
Speaker Change: Florida, California, or a mid west have very different systems.
Speaker Change: Services are very different from a state to another.
Tatsuyuki Yasuno: Once a target price is set, then in actual transaction... What level of price is going to be adjusted specifically? are quite uncertain. Furthermore, it also says that there will be rules making, but how rules will be made is also quite uncertain. Furthermore, if this NSN is to be applied broadly, New legislation may be necessary. that would require approval by the Congress, so given that situation... And currently, the Legambi list price... is at the same level in Europe, Asia, and Japan as in the U.S. As for Len Wimmer, in the United States, under Medicare Part D, D as in dog, there is a sales under the first Trump administration where there was also an attempt for MFN.
Speaker Change: Florida, California, or Midwest have very different systems.
Speaker Change: Therefore.
Speaker Change: Uniform pathway model cannot be applicable.
Speaker Change: Before.
Speaker Change: For example.
Speaker Change: Uniform pathway modal cannot be applicable.
Speaker Change: Infusion can be done at some in house chain or ambulatory infusion center or outside the dedicated infusion sites may be utilized to buy other medical institution. Therefore, when it comes to establishing the pathway that style of.
Speaker Change: For example.
Speaker Change: Yes.
Speaker Change: Infusion can be done at some in house chain or ambulatory infusion center or outside the dedicated infusion sites may be utilized by other medical institutions. Therefore, when it comes to establishing the past weight of style over.
Speaker Change: Plus we can be very different from one to another.
Speaker Change: And based upon the situation in each area.
Speaker Change: Last week can be very different from us.
Speaker Change: Therefore, it might have been a very.
Speaker Change: And based upon the situation in each area.
Speaker Change: Challenging task, but as has been mentioned earlier.
Speaker Change: Therefore, it must have been a very challenging.
Speaker Change: Challenging task, but as has been mentioned earlier.
Speaker Change: Country.
Speaker Change: Over 500 patients.
Speaker Change: Country.
Speaker Change: Are you being treated.
Speaker Change: Over 500 patients.
Speaker Change: Diagnosed and treated.
Speaker Change: Ari being treated or die.
Speaker Change: By one.
Speaker Change: I've noticed undertreated.
Speaker Change: I D N or hospital groups.
Speaker Change: Hi, Juan.
Speaker Change: But actually there are many other such examples.
Speaker Change: I D N or hospital groups.
Speaker Change: But actually there are many other such examples.
Speaker Change: Okay.
Tatsuyuki Yasuno: Medicare Part D was not included in the scope. Kenbi and Len Wimmer also are used in very small part in Medicaid. In any event, through continuous engagement with the Trump administration, we would like to understand better the details of the program and will implement necessary measures. Once the situation becomes clear, or if the impact becomes clear, when necessary, we will provide updates. According to Europe, I believe uncertainty is becoming greater. in Europe as well. After the announcement of the tariff Industries in EU may be hollowed out and competitiveness may become weaker. European policy makers, I believe, became most concerned about these.
Speaker Change: Yes.
Speaker Change: We're a pathway is being has been established and therefore, we have a very promising.
Speaker Change: We're a pathway is being husband established and therefore, we have a very promising.
Speaker Change: Prospect and when we can have P C piece getting involved.
Speaker Change: <unk> and when we can have PCP getting involved.
Speaker Change: In other diseases for example, D N diabetes mellitus.
Speaker Change: In other diseases like simple D M diabetes mellitus.
Speaker Change: Yeah.
Speaker Change: With the introduction of the blood based.
Speaker Change: Yes.
Speaker Change: Yeah.
Speaker Change: Testing and diagnosis PCP started to be engaged in that a treatment are very rapidly. So such a situation is about to come for a D.
Speaker Change: The introduction of the Bill that's based.
Speaker Change: This thing in diagnosis BCP started to be engaged in that a treatment are very.
Speaker Change: Rapidly so such a situation is about to come for a b.
Speaker Change: I have on that question about the E 2086.
Speaker Change: Oh, that's good.
Speaker Change: I think this is what you are repeating what you experienced in the orange that.
Speaker Change: I Hope I ended up question about the E 2086.
Speaker Change: I think this is what you are repeating what you experienced in the Orange and the.
Speaker Change: Aesthetic thing are the <unk>.
Speaker Change: Okay.
Speaker Change: Compound from that library, all of our 250000 compounds and a 10000 at a time is more.
Speaker Change: <unk> a b.
Speaker Change: Compound from that library, all of our 250000 compounds and a 10000 times more.
Speaker Change: Potency.
Speaker Change: But compared to 19 eighties and 2000 Twenty's today what is different.
Speaker Change: Potency.
Speaker Change: That compares to 19 eighties and 2000 Twenty's today what is different.
Speaker Change: Or do you think that the.
Tatsuyuki Yasuno: Industrial Policies Maybe... Adopted in or positive industrial policies may start to be adopted in life industry. I believe there are such potential signs, FBI, industry association in Europe. is taking such an approach to EU authorities or to member states. In the midst of this, in the executive order... It also mentions the need to increase price in EU, OECD, GDP per capita, drug spending, I forgot the details, but the ratio was mentioned, and it calls for increase in price in Europe. Otherwise, it's a free ride situation. on the U.S. and EU is enjoying innovation, taking a free ride.
Speaker Change: In principle similar in the days of by Mr. Sugimoto.
Speaker Change: Or do you think that the.
Speaker Change: In principle similar in a days or by Mr. Sidney model.
Speaker Change: I could feel that.
Speaker Change: One of them.
Speaker Change: I could feel that.
Speaker Change: Yeah.
Speaker Change: They relied on intuition.
Speaker Change: Bye.
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: But I think that the rather than intuition along do you think that there are other methods that you could apply in 2020.
Speaker Change: Yeah.
Speaker Change: They relied on intuition.
Speaker Change: But I think that the rather than intuition alone do you think that there are other methods that you could apply in two months be 'twenty.
Mr. Ito: Mr Ito.
Mr. Ito: I will talk about that intuition thing it later, but.
Mr. Ito: Mr Ito.
Mr. Ito: Thank you very much.
Mr. Ito: I will talk about that intuition thing it later, but thank.
Speaker Change: My name is it at all I am in charge of D. H B O. Let me respond.
Speaker Change: Thank you very much.
Speaker Change: My name is it at all I am in charge of D. H B O. Let me respond.
Mr. Ito: As we mentioned through high throughput screening.
Speaker Change: As we mentioned through high throughput screening.
Speaker Change: Very interesting.
Mr. Ito: Thing, which was not mentioned.
Speaker Change: Very interesting.
Mr. Ito: The our essence of the medicinal chemistry.
Thing, which was not mentioned.
Speaker Change: The our essence of the medicinal chemistry.
Mr. Ito: That's embodied in our materialized into this project.
Mr. Ito: And in the process recombined, our characteristic unique screening com.
Was embodied in our materialized into this project and in the process.
Mr. Ito: Combination of US and I was also applied a lot, particularly when it comes to sleep platform and the development of our Lindbergh Center, we established with our platform the brainwave analysis.
Speaker Change: Combined our characteristic unique screening.
Speaker Change: Combination of US and I was also applied a lot, particularly when it comes to sleep.
Speaker Change: Platform, India Development Center.
Speaker Change: And we established without platforms the brainwave analysis.
Mr. Ito: Yeah.
Mr. Ito: Required a lot of our manpower. Therefore, it was not available readily for screenings, but in house work was done within it.
Speaker Change: [noise] require dialogue manpower. Therefore, it was not available readily for screenings, but in house work was done within it are in combining this technology was AI and it can be as well.
Tatsuyuki Yasuno: How, what responses will be taken, including by EU is what we are paying very close attention to. on the part of the industry. in EU industry is seeking a change in industrial policy and is approaching the authorities.
Mr. Ito: Combining this technology with AI and chemists as well, there's a three D complex structure.
Mr. Ito: The metric a appoints.
Speaker Change: Three D complex substructure.
Mr. Ito: We're hoping to add had dozens or hundreds of lot positions or sites.
Speaker Change: As she metric are appalling.
Speaker Change: Since.
Speaker Change: We're hoping to add dozens or hundreds of lot positions or sites.
Mr. Ito: Through these are complex our processes, we were able to find at this final compound.
Speaker Change: Through these are complex our processes, we were able to find at this final compound with.
Unknown Executive: Next question. My name is Susumu Shimoyama, non-fiction writer. Could you please explain this in an easy to understand manner? The Kenbi approval in the United States, Accelerator approval, was in January 2023, and since then you have established a pathway and sales force. In September, approval was granted in Japan, so there was a time lead of eight months between the U.S. and Japan. The penetration of the Kenbi treatment in the United States was slower than that in Japan. Could you please explain in easy-to-understand manner?
Mr. Ito: We do we have a lot of our pride.
Mr. Ito: Confidence in I think a which is the same.
Speaker Change: <unk> do we have a lot about price.
Mr. Ito: In the days of them, especially model.
Our confidence in <unk>.
Speaker Change: Think of it which is the same.
Mr. Ito: And as I said.
Speaker Change: In the days of them, especially the model.
Mr. Ito: Well he was the one who was very lucky.
Speaker Change: And I already said.
Speaker Change: Okay.
Mr. Ito: So.
Speaker Change: But he was the one who was very lucky.
Mr. Ito: Yeah.
Speaker Change: Yeah.
Mr. Ito: So what kind of person who will be able to receive such.
Speaker Change: So.
Speaker Change: Cool.
Speaker Change: So what kind of person that would be able to receive such.
Mr. Ito: Fortunately more than.
Speaker Change: I think that to me, especially Myanmar, you'll have been written that in your books.
Speaker Change: Fortunately more than.
I think that's I mean, especially Myanmar, you'll have been waived and that in your books.
Speaker Change: I would like to ask you to write another book featuring on that point.
Speaker Change: I would like to ask you to write another book featuring on that point.
Speaker Change: Our third days and nights scientists are always making efforts, but there are some scientists who can encounter happy moments or lack or others, who never.
Speaker Change: No.
Haruo Naito: Mr. Shimoyama, thank you for your question. Accelerated approval and traditional approval are different in terms of the scope of activities which are allowed. Therefore, many medical institutions under the accelerated approval The passage of the drug through the formulary cannot be done. Therefore, investment of resources in order to establish pathway was not also possible under the accelerated approval. Aduhelm, which was a predecessor to Lekembi, was an example. And therefore, there was a concern that such example may be reproduced. So Pathway Establishment was started on the full-fledged manner, was after the full approval was obtained in July.
Speaker Change: For two.
Speaker Change: So days on ninth scientists are always making airports, but there are some scientists who can encounter happy moments or lack or others, who never have such that.
Speaker Change: Such locks.
Speaker Change: I have been thinking about what kind of a scientist would have such.
Speaker Change: I have been thinking about what kind of a scientist so it would have such.
Speaker Change: Forging.
Speaker Change: Over the past 30 years.
Speaker Change: Forging.
Speaker Change: And our collective knowledge.
Speaker Change: Yeah.
Speaker Change: Over the past 30 years.
Speaker Change: Held by the group led by Mr. Sidney model that kind of a collective knowledge.
Speaker Change: And our collective knowledge.
Speaker Change: Hell divide the groups led by specialty model that kind of a collective knowledge.
Speaker Change: Consistent with the individuals knowledge.
Speaker Change: The level of our collective knowledge is high.
Speaker Change: Consistent with the individuals knowledge.
Speaker Change: With such group I think that such serendipity.
Speaker Change: The level of our collective knowledge is high.
Speaker Change: With.
Speaker Change: Fortunate moment may come.
Speaker Change: Such group I think that such serendipity.
Speaker Change: In this kind of a hole.
Speaker Change: Fortunate momentum may come.
Speaker Change: Strong leaders may be available, but the entire group may be motivated very highly.
Speaker Change: In this kind of a hole.
Speaker Change: Strong leaders may be available, but the entire groups may be motivated very highly.
Haruo Naito: And as you know... in the United States. The health systems or medical services are very different from a state to another. Florida, California, or Midwest have very different systems. Therefore, uniform pathway model cannot be applicable. For example, infusion can be done at some in-house chain or ambulatory infusion center or outside the dedicated infusion sites may be utilized by other medical institutions. Therefore, when it comes to establishing the pathway, the style of a pathway can be very different from one to another. Based upon the situation in each area, therefore it might have been a very challenging task.
Speaker Change: So I.
Speaker Change: I hope that the system is Jim Oyama next a new book.
Speaker Change: So.
Speaker Change: May utilize this as a hint.
Speaker Change: I had hoped that the system is Jim Oyama next a new book.
Speaker Change: For what type of scientists Serendipity may come.
Speaker Change: May utilize this as a hint.
Speaker Change: For what type of by scientists Serendipity may come.
Speaker Change: Yes, I will keep watching it thank you.
Speaker Change: What did you call until we have gone beyond the scheduled time, we apologize.
Speaker Change: Yes, I will keep watching it and guess what.
Speaker Change: We have gone beyond the scheduled time, we apologize.
Speaker Change: With that we would like to conclude today's briefing session. Thank you very much for taking the time today.
Speaker Change: We would like to conclude today's briefing session. Thank you very much for taking the time today.
Haruo Naito: But as has been mentioned earlier, Country over 500 patients. are being treated or diagnosed and treated. Bai, Wang but actually there are many other such examples. where a pathway is being has been established therefore we have a very promising prospect and when we can have PCPs getting involved In other diseases, for example, DM, Diabetes Meritus... With the introduction of the blood-based testing and diagnosis, PCPs started to be engaged in the treatment very rapidly. So such a situation is about to come for AD.
Katsutoshi Ido: I have another question about E-2086. I think this is what you are repeating, what you experienced in the ARIZETA. Selecting the compound from the library of 250,000 compounds and 10,000 times more potency. But compared to 1980s and 2020s today, what is different? Or do you think that the in principle similar in the days of Mr. Sugimoto. I could feel that. They relied on intuition. But I think that rather than intuition alone, do you think that there are other methods that you could apply in 2020?
Katsutoshi Ido: Mr. Ido, I will talk about that intuition thing later, but... Thank you very much. My name is Ido. I am in charge of DHBL. Let me respond. As we mentioned, through high-throughput screening... Very interesting. thing which was not mentioned the our essence of the medicinal chemistry was embodied and materialized into this project and in the process we combined characteristic unique screening combination with AI was also applied a lot particularly when it comes to sleep platform in the development of a limber accent we established that platform the brain wave analysis Through these complex processes, we were able to find this final compound into which we have a lot of pride or confidence in, I think, which is the same in the days of Mr. Sugimoto and Arisa Well, he was the one who was very lucky, so...
Katsutoshi Ido: So what kind of person would be able to receive satsang? ...unfortunate Moriben I think that Mr. Shimoyama, you have been written that in your book. I would like to ask you to write another book featuring on that point. Through days and nights, scientists are always making efforts, but there are some scientists who can encounter happy moments, or luck, or others who never have such luck. I have been thinking about what kind of scientists would have such a 4June over the past 30 years. and Collective Knowledge. held by the group led by Mr. Sugimoto, that kind of collective knowledge.
Katsutoshi Ido: Consisting of individual knowledge. The level of collective knowledge is high. With such group, I think that such serendipity, fortunate moment may come. In this kind of a hope... Strong leaders may be available, but the entire group... may be motivated very highly. So, I hope that Susumu Shimoyama's next new book may utilize this as a hint. For what type of a scientist's serendipity may come? Yes, I will keep watching it.
Unknown Executive: Thank you.
Unknown Executive: We have gone beyond the scheduled time. We apologize.
Unknown Executive: With that, we would like to conclude today's briefing session. Thank you very much for taking the time today.