Q2 2024 Eisai Co Ltd Earnings Call
1023 by Eisai Company limited.
Hi.
Oh I didn't know if they can make money on that.
Presentation is holding a hybrid four formats, including in person attendance at virtual attendance. Those of you who are attending in person. Please make sure that you have the handout materials, including the slide presentation. All Flash report and those of you who are participating online. Please continue to watch the.
Sure let me introduce the presenter.
Representative corporate officer, and CEO, Mr. Adriano NATO.
And I guess, the NATO as opposed as yours.
Let me begin our presentation on the financial results for the second quarter of fiscal year 2023, first let me review the consolidated statement of income.
As you can see in the subtitle, we achieved increase in revenue and operating profit through steady growth of LM bema and the baby girl.
And also close to a controlled within so called a financial.
Simply.
That is to say control or close to a controlled within the growth of D. A.
Gross profit.
So operating profit.
It was increased by about six fold when compared to the level recorded last year.
This.
What's their characteristics.
Well the first half results if you look at top line.
Very much.
These numbers include.
Got it.
Global products and no one.
One time revenues.
And impacts of weaker yen.
And then revenue grew by 4% year on year.
Cost of sales.
Morning.
James was reduced by four three percentage points.
Yeah.
This was due to an improvement of product mix.
Revenue recorded one time.
Yes.
<unk> go ahead.
Now turning to R&D expenses or a commitment too expensive.
The allocation of resources into R&D expenses were almost the same level as last year.
SG&A expenses in terms of the ratio.
Hi.
The ratio of reduced it by two four points from a year earlier.
Because and then B mall continued to grow.
For the expenses regarding share the proceeds of lumpy amount paid to muck increased.
But other SG&A expenses were well controlled.
Pretty much.
As I said earlier.
Total expenses.
Well almost a flat from a year earlier.
And this was well controlled due within the growth in gross profit within 10% from a year earlier and therefore operating profit increased by six votes profit for the period.
There was the.
Shrinkage of the tax charge recorded last year because of the impact of repayment of paid in capital from a consolidated U S subs to the company. Therefore, we ended up at the $24 2 billion for the profits.
For the period and we have resolved on the 85 and two <unk> per share as dividend.
We did not think that there is any change to the full year dividend of the full year dividends of 160 Yan there are no changes in the financial metrics I'll describe it at the bottom now a breakdown of the revenue migration than bema increased by $23 2 billion yen year on year and de Vigo, particularly.
In Japan.
Increased by $5 8 billion yen year on year.
And in other.
You may notice six minus 16.8 billion yen as I see in the footnotes. This was because of the spread of exploration of the co promotion agreement in Japan for Humana, but all becoming a decent negative factors we achieved goes.
Yes.
In addition to these.
Hello.
There was a one time revenue recorded because of the transfer of all future economic rights for this trend and therefore it.
Top line grew by $14 9 billion yen with 4% year on year.
Operating profit is explained here first the frontline business or pharmaceutical business.
There was a increase of operating profit by 12 billion Yuan.
And the ratio improved from 49, 1% in the previous year to 52%.
If you turn to R&D expenses.
In the last year, there were expenses related to auto helm, which was reduced in the first half this was a big factor.
Yeah.
And group headquarters management costs and other expenses in there.
This area there was a reduction in the auto home it related expenses, which was another oh.
Factor for increasing the profit and a 12.1 video and get any other business was added and therefore, there was an increase by $26 2 billion in getting operating profit, which recorded a 598% year on year growth in the.
Bottom half so they can be.
R&D and G&A expenses invested in Nick N. B was at 45 billion yen level for the first half.
So at the moment.
Yeah.
Today.
I would like to focus on that can be in my presentation.
<unk>.
Sure.
First.
The appropriate approval or regulatory status, including subsequent submissions.
Yeah.
After approval in the United States on September 25th.
They can be was approved in Japan.
And currently.
No denigration needs being made of the social insurance essential Central Medical Council.
As regards to the NHI price listing once it is completed we would like to.
<unk> launched a product here, we are making preparations.
And in China.
The review process is ongoing steady as expected therefore, we anticipate to get approval in the by the end of this fiscal year and.
And in the bottom half.
As you see the 25 countries and regions such as the EU are lifted in these countries and regions.
Submission so it will be achieved.
Already in the countries and regions until Hong Kong in color shaded boxes or these are the countries and regions, where we have already achieved our submission therefore it globally.
In order to provide or they can be to patients with C. D.
The opportunities are expanding globally.
Sure.
Now turning to the approval in Japan.
Following a full approval in the United States, Japan, Whats the second country, where that can be was approved in this home ground market for laser I. This was a very significant approval for us.
Indication for use in dosage and administration and warnings.
N D.
Contents are almost the same as the contents in the package insert in the United or prescribing information in the United States in the Japanese label, there a contradiction indications changed and these three countries indications in are identical to the exclusion criteria in our phase III study clarity.
D a D.
So these three items are listed as contra indications in Japan.
In the bottom of the slide.
So.
Okay surveillance is going to be conducted.
Considering the number of patients as well as the duration of the surveillance will be determined of subject to the negotiation with the regulatory authorities.
But this is going to be the first.
They have a drug in Japan as well as in the world originated in this country like N B E.
Our drug therefore, there needs to be secure introduction of this drug into the Japanese market in terms of efficacy as well as safety such as ARIA management, such management must be done securely. So that we can minimize any potential accidents or events.
Got it.
Innovation needs to be security grown and developed change upon that if perhaps the judgment by the public authorities. Therefore.
Such old case surveillance, it's determined to be introduced therefore, we are currently making preparations for such a surveillance going forward.
Sorry.
At the time of NHI price missing there'll be optimal usage guideline to be issued.
So by the end of this calendar year 'twenty two 'twenty three we plan to launch and that can be in this market.
Yeah.
On this slide.
Great.
And yeah future how that can be.
It's going to be.
Evolved as option.
The treatment that is describe it in the top half and the bottom half.
I thought your muscles.
Diagnostics that diagnosis, which is expected to play a very important role in 80 treatment.
So how a diagnostic advancement will be made.
So land escape is prescribed describe it here firstly, if you look at top half treatment advancement, we can that can be in FY 2020 three IV formulation was launched and shortly.
No.
Maintenance therapy for intravenous dosing will be filed before.
Approval, so what we intend to do here is <unk>.
After a certain period after initial treatment no after turning into the I mean really to pay the negativity and that amyloid beta level needs to be maintained so that is the purpose of.
Having this maintenance therapy by reducing the frequency from biweekly two monthly dosing.
I V a maintenance therapy.
Should be provided therefore, we are planning to submit for approval of this therapy.
I would like to explain this later in detailed even after amyloid beta level is reduced but gradually there'll be the inception of the accumulation of amyloid beta in the brain.
According to two or one or three year old one study or L. E studies. So we have found as such.
Oh in fact or data of course that is shown by pet.
Particularly I'm only debate of 40 to 40.
Cochran Biomarkers.
So just that even after removing amyloid beta in the brain, but that'll be it.
Again, we accumulation of dominantly better therefore, the significance of a maintenance therapy is very important.
Hi.
Scott So following that.
Dainius formulation or SC formulation. This will be administered using auto injector submission will be filed by the end of this fiscal year.
For this.
<unk> formulation.
Yeah.
Utilizing excellent auto injector.
We expect that the.
The burden on the patient will be minimal therefore without.
Needing to visit the hospitals, so they are able to do.
Do self injection at home or other locations and therefore, it will increased patient convenience and eliminate lockbox facility based on patients with geographical locations.
And in 'twenty, 'twenty six or so.
Even before M C. I at the earlier stage of 80, so called a preclinical AZ where people are cognitively normal has however, having signs of amyloid accumulation.
Such patients at high risk.
Apparently.
Phase III trial is ongoing targeting such patients based upon the results of which 20 could equal a D indication will be.
Filed.
In submission.
And if you turn to the bottom half of this is about diagnostics.
On October 13, this year there was a.
Great Advancement.
Luca.
CMS, which is in charge of the Medicare reimbursement in the United States before I'm going to lead to pet, whereas only reimbursed only once in a lifetime. However, such restriction of the number of times when I'm in the pet tests can be conducted is lifted so that the determination.
<unk> made therefore restriction of amyloid pet.
Right.
He's very much.
And we expect that this lifting of the restriction.
It will lead to the increase of number of patients who are treated with <unk> they can be.
We are sure about that but actually there is a delay of about two months.
I read a time long ago with two months. So we believe that there will be a increase in the number of patients treated with like M. B.
Using Amit.
You.
Better pet.
The diagnostics shipment is a drastically increase so that is the information we have.
Court.
Okay.
Now, let's see touch held in Boston recently, there was a great presentations about blood biomarkers.
Mark.
As you can see here, but that's biomarkers.
They included two types of tests.
Okay.
So called a screening or triage.
Uh-huh, we believe a triage is more appropriate name therefore recently.
Triage test is more used.
Nowadays so their foundational blood biomarker.
Okay.
<unk> has very high precision or accuracy.
I'm annoyed.
Negativity, therefore, using black biomarker tests.
We can identify.
The negative Ah patients. Therefore, this may reduce the number of patients who need a pet towards CSS.
That's simply find that diagnosis pathway. This kind of a triage tests will be used more widely.
Maybe next year.
That is our expectation based upon that.
Confirmatory test is anticipated pets or CSS it can be replaced by blood Biomarkers.
To that extent blood biomarker will gain the trustee in actual clinical setting.
That situation will be realized in a round of 'twenty 'twenty six.
If that becomes reality.
P C P or so called primary care physicians will be able to prescribe the therapy to patients.
That is it.
Therefore, the advancement made in the blood biomarker technologies is going to be a very critical factor for it.
The future.
Sure.
Since the full approval obtained in July.
We have been making preparation for the launch in the markets in the United States.
So the current status and also our anticipation of the revenue towards the end of this fiscal year I would like to explain these now.
At the end of this fiscal year, we are expecting to make contributions to 10000 patients in the United States towards that there are three momentum.
Did you see on this slide.
Most of them.
Firstly on the left hand side.
We are enhancing go to market structure currently those people who are in the field.
And there's almost no hold our sales reps.
Or other people with different.
She analogies.
Comprising go to market structure, we just being.
Even more enhanced.
For the expansion of the number of patients treated with this therapy. We believe that this is going to be a big one and momentum in the middle you can see progress of market readiness in 80 market. This is not the well established market.
For example, cholesterol lowering or do you see the therapy or a diabetes therapy or a rheumatologist or their beef.
In such a disease area, that's their established markets.
This is the market.
As a pioneer we are making great efforts in order to create and ramp up of the market itself.
Of course with the cooperation of the suffers no medical institutions in our health care providers in order to establish the market properly. We are currently in the midst of the efforts being made a full building up the market.
Such results will be explained later, but.
The steady and also rapidly we are seeing the buildup of the airports under achievement.
What do we needed to do.
That is a listed here for example, the simple a cognitive function test at the Pcbs.
And what is expected to play an important role in the 80 treatment.
And integrated delivery networks, mainly comprising of the larger hospitals P. Under T pharmacy, and therapeutic committee is needed to approve a therapy that process needs to be passed and also a D. I b.
The number of neurology is ready for it can be the once the prescription needs to be increased amyloid beta testing, including pet CSF and blood biomarker I believe for testing and our readiness to accept patients at infusion centers and are you monitor it must be done through MRI. These factor.
<unk> have to be.
In place so that a D treatment market can be built up.
So these are the efforts we are doing.
And we are seeing very rapid ramping up of the market, but we are not able to say this is completed yet we are currently in the process of building markets and a third momentum is thought of expansion.
That's the reason to see that clarity a D. Open label extension studies results total pet sub study and a subcutaneous sub study very important.
Data sets.
Were presented at <unk> Dot, which will be explained later in more details.
Based upon these situations.
If you'll turn to the bottom half.
How many.
Sheets are currently being treated with like M. B. This is our estimated numbers currently.
<unk> 800 patients with a D are treated with like can be.
That is R.
Estimate I do see in the graph.
Of course compared to the level.
The time accelerated approval the number of patients treated is increasing dramatically and on the right hand side of this is what we assimilate towards the end of this fiscal year at the end of March because of the pit and a C. D. Lifting as I said earlier, we expect to see a rapid increase in the number of patients.
Treated it to reach 10000 level.
Yeah.
So the first the momentum.
We are enhancing go to market structure in the United States.
Let him explain about this first of momentum.
Yeah.
When it comes to so called a D treatment on the right hand side there are various stakeholders.
There are multiple.
Our professionals such as in neurology.
Okay, and as I said earlier throughout the United States. There are about 120 large networks, mainly comprising of larger hospitals and medical networks, I D and integrated delivery networks, and they're all hospitals and community.
We're a P C P R existent or community based of practitioners or general neurologist in communities.
And infusion centers, who are providing therapy actually to the patient and the pit MRI Stuffers and health care professionals and also reimbursement processors are also very important stakeholders. They are all related.
For them.
There needs to be a proper and thorough explanation and education in some cases.
So we have deployed people in charge of those tasks in the field. If you look at the left hand side. These are the field.
Deploy the personnel.
As either a six types of professionals.
And including <unk>.
Integrating these schools.
At one point or one stop.
In the Middle you can see neurology account specialists in US no professionals, who are professional in the neurology area the specialty M R or sales reps.
All located in the middle of this structure.
The health system account executive on the left hand side that they are in charge of a calculating wholesale economics.
In most of many of the medical institutions in the United States until it can be it's about you. He's a calculated to the sun whether it is a positive for the patients on the benefits and of course, they're analyzed.
To seek the balance.
So that information is required and therefore that is provided by the top one in this list H S. H E and the second one is access and reimbursement of monitors for CMS.
Great.
Suppose that a patient would like to know the procedures for REIT getting reimbursement for all it can be or pets or ugly for whether it is possible to get the reimbursement for a playful. So that information is provided by a R M and IV and adoption or approval by a P. N T. They are playing a very.
Important roles and clinical educators are medical for a medical stuffer, it's other than physicians. They are in charge of educating or providing information to those normal physician stuffers and original thought leader.
In regions, they're all opinion leaders and also there are many different.
Different patient groups and they like to be aligned with them Medical science liaisons are needless to say to provide the cutting edge does that just started presented I'd see that recently they are very busy now they needed to explain so I started to the.
Physicians throughout the country and our patient navigators for those who are in sufficiently covered by insurance and also low income people.
B.
To provide a cure.
And also explanation will be provided regarding the patient assistant program or free of charge.
Treatment.
So all of these information will be concentrated integrated offers enough.
And that will be the centralized point of contact to.
However, the relationship with stakeholders on the right hand side, so no I.
I got my go to market structure is being built a thought.
So in the bottom half of this slide I tried to explain this in text I have been to the United States five or six times this year and a D. A diagnosis and treatment situation is America is.
Now well understood by myself, and Alzheimer's disease diagnosis and treatment.
Scott as Ive explained in this takes let me to read it.
On a D diagnosis and treatment require the involvement of mouth multiple stakeholders are described on the right hand side sharing the same direction and the establishment of a collaborative system procedures, such as simple cognitive function test, including digital methods. That's P. C P.
Primary care physicians.
Our network of our referrals to neurology.
Such network is important.
And I'm going to lead to better test.
In urology, such as pet CSF.
The blood biomarker as auction and upper Eagle Ford test.
Laura just these have to be conducted.
<unk>.
Now turning to the stage of infusion.
Infusion for treatment is necessary there for.
The infusion facility, maybe available at the same hospital or facility or external infusion centers will be chosen as an option and we are monitoring which would be done through MRI.
After infusion.
This may be conducted at the same facility or other locations.
These need to be conducted in a sequence that precede Gordon.
Efficiently and promptly before the 80 diagnosis and treatment.
That's.
Furthermore, Hcp's Oh.
Hcp's and a medical institutions reimbursement procedures are indispensable and essential.
Procedures and.
Furthermore supports are provided to patients themselves.
If they are in need of patient navigator, a patient assistant program, if they need them, we are providing support to them.
So in this go to market structure. We are currently working on establishing these processes. So that's a D.
Proper and appropriate market is being built.
In the bottom.
Most of them most of them.
I D N a week or will play a significant role in a D treatment, such a Duke University or most of the University hospitals. All are included in the idea of an integrated delivery network and stage run hospitals and also private hospitals are belonging to <unk>.
And I D and we needed to establish such processes as I mentioned earlier.
We can fit.
Each idea and a husband and a T O.
The pharmacy and Therapeutics committee it is necessary to receive P. M. T Committee approvals at idea and so there is.
One step here.
So.
That's the basis of these airports.
There are they can't be daughter or communication with the patient groups and regions through medical science liaison M. S. L mainly.
Ducting and these tasks or HSA, we just describe it at the top and these are going to form a an indispensable base for all of these airports very broad raging and multiple steps needed to be done.
In order to.
Our build healthy sound 80 market, which is we believe very important we are currently in the medicine. These airports and we are making utmost efforts and we are seeing the city achievements derived from these airports.
No.
Regarding the metrics of market readiness.
First street.
There are a number of neurologists ready for it once the prescription has been increased by about 1.8 fold compared to the level recorded in June and also I'm a little bit of tests.
In combination to about pets.
He is a fan of blood biomarkers at the end of August It was increased by about 1.3 times and going forward, it's going to be increased by about 10 fold because of the limitation of the amyloid pet coverage was listed before it. We believe that this number is going to be increased sharply.
So.
And the number of P&C Committee approval for like can be was increased by about six fold compared to the time of accelerated approval.
Approximately 60% of our top 100, IBM targets I D N. The P&G committee and it can be approvals are obtained it. Therefore once these are in place. We believe that the number of prescriptions will increase sharply many patients are still waiting for the therapy.
Now turning to revenue from that can be shown in the middle.
In the first half of 2023 in fiscal 'twenty to 'twenty three revenue was 400 million again this is as planned.
And we believe are really did a good job, but I.
I understand that there are some voices of disappointment in the market and I'm concerned about that is all reflected in the share price, but we don't think the situation is such that there should be a disappointment that leads to sales of our shares.
We are accumulating the results of which are resulted in 400 million of young revenue place do not see this as a negative surprise.
On the left side of this is weekly average revenue.
In comparison to the time when accelerated approval was given currently that level is approximately 11 times and digest. The recent data and the growth achieved is a faster pace than shown here.
I mentioned earlier, we have three momentum and we are making progress at the end of March of this fiscal year, we expect to achieve contribution to 10000 patients and it's a G. About 10 billion yen level revenue, mainly in the United States and I would like to convey to you that.
We are confident of achieving these objectives.
Regarding the third momentum expansion of data.
I see that new findings for presented there are three.
Phase III clarity 80.
L E study data in Tau Pet sub study data subcutaneous sub study data.
Those are the three.
And the details of our these are free data will be explained.
Later, but one.
Inclusive message is the.
The importance of early start treatment and long term treatment. After the removal of amyloid plaque we believe that the importance of Cid.
Confirmed and Furthermore, subcutaneous administration a treatment option.
Funds from a potential was suggested.
First I like Panama assertion I see that.
There are of course, the van Dyke represents a mode of action.
Yeah.
Mccallum Oh, a characteristic inc.
<unk> not only rapid removal of plaque bog removal of a protein fibril. So door action mechanism of action was introduced by a doctor and van Dyke.
Like N B live this outdoor auction continues to support the function.
Oh, great new launch by removing soluble highly toxic in prototyping. It also can cause neuronal injury and death, even after plaque removal.
Chris sent this message.
Strongly and all that kind of them up.
Ooh Ooh.
Yeah.
It was also observed that the cut them up delayed Tau pathology progression I will come back to this later, but especially in early stage.
According to Dr. Brock the Bronx stage is determined and typical early about region is pathology Tau pathology progression in temporary Lope and he was observed that this progression was delayed doctors on bikes conclusive message was that.
The Panama removed a plug and it also has the door auction of removing protein fibril.
And a delayed tau pathology progression.
Hum.
The three studies, a god I will be describing are good.
Targeting the third of the population and our analysis of these data are also very important so it may be somewhat tedious.
But please be patient first clarity 80 core study is shown at the center and Purple box at the right is open label extension of that.
Uh huh.
Study.
Uh huh.
Are given our active.
Active drug and the continuation of study.
Those who were originally randomized to placebo arm will be receiving like them.
Got him up in open label extensive study.
Expansion study and the sample size is very large at 1414 and Tau Pet sub study was Uh huh.
It's all about.
About sub study within the core study are on 342, who received a tau imaging and placebo and look at them up for almost all want him on randomized and shooting as a sub study a bright glow.
Right.
Had about 320 patients are that transitioned from course studying.
Those are included a patient to transition from IV administration or those are transitioning from IV administration to subcutaneous as for sample size 72. These are like on them up naive patients.
Yes.
And are these are naive patients were given a subcutaneous were kind of up in the novel setting and those are there for those who transition from core study directly to subcutaneous and also those from outside of other course study and the sample size in total for subcutaneous subsidy of Us 300.
94 patients and please keep in mind this study design.
First of all about O L E rate chart.
Shows overall results very well.
Our focus on this chart I've I will be going over three bullet points.
In OA study. This is the graph shows up to a month 24, but say that presentation. Also included preliminary results up to month 30.
Hey, Todd.
Didn't.
Lisa.
But.
Oh look.
Presented these results and the first double that of course.
Of course study active drug group the Green line are the top green line in the graph.
And O L E study active drug group.
Patients are very different placebo and of course that ear buds are receiving active drug after transitioning to oil heat study if that is the second line in there.
The graph.
And the divergence between these two groups were maintained.
The divergence did not diminish.
The same gap was maintained.
Therefore, the earlier or the started up the treatment the greater the dream and the efficacy is that was that what was suggested at.
And the importance of early starting to treatment Ah was demonstrated.
Bullet point is about the bottom blue line.
In the graph.
Okay.
There is no placebo in O L E and Adani a data.
Matching a similar baseline characteristics it was used for modeling and.
Well see.
Ooh.
Much underneath participants and active drug or groups.
The top if you compare the two lines C. D. R. S. B a difference continues to become.
Become greater and I once again long term treatment significantly it was demonstrated in the third bullet point and plays out.
Look at this second line in the graph.
Are those who were given placebo and of course that he and who switched to the active drug in O. L. E. In six months time efficacy in this group was demonstrated.
The conclusion is that based on 24 months or L. E vapor importance of early start of treatment and significance of long term treatment where it demonstrated.
Yes.
Yeah.
The second data is a dataset from top pet sub study, but there are three figures and comments for each figure you are giving on the left side.
First our overall startups Tau pet.
Buddy sub study.
Included lower Tau Pet group and intermediate plus high Tau Pet a group.
There were analysis Oh for these two subs are sub groups as well as sub study Oh group analysis.
Red is intermediate pie Tau pet are at the top and Blue low Tau pet at the bottom in the Middle East Tau Pet sub study on <unk>.
And in all groups or subgroups amyloid reduction was a mature observed.
And.
Efficacy you suggested to the not affected by the accumulation of Tau figure to disburse much talked about.
Lower Tau pet population.
That is to say amongst the M C I a population.
Earlier stage almost might be early E 80.
80 stage patients.
Such in such little town population as shown in the left chart under in figure two in.
76%.
C D arent S. B score it was maintained in the placebo it was maintaining 55%.
And 60% as shown on the right side improvement was observed whereas a it was a 28% in placebo sample size is not very large but a P. A shows a pin number shows statistical significance.
And in early stage administration of like in a mob suggested a possibility of improvement this was much talked about.
Got it.
Uh huh.
This is also somewhat related to pathology as shown on the right chart in Tau pet.
So.
Tempered a little bit too frontal lobe of various parts of the brain or captured an image to measure the improvement are sort of measurement of Tau accumulation. After they can be administration in early Brock stage patients in test for LOE.
Oh in early stage, it said that Tau accumulation will start in a temporal lobe medial temporal and a part of the a temporary little aware of tower well accumulate the early on are indeed, our regions. Other of other significant suppression of Tau pathology that was observed and P.
Number is close to a significant and they call them up Tau pathology.
Suppression effect was observed and so in addition by administering in early stage patient efficacy was observed.
Third our dataset is from subcutaneous administration sub study.
As shown at the top.
Safety.
He's assessed.
In this population.
Safety population numbering 394 was examined and there is a PK population number bring 65 as shown on the right to analyze PK profile.
There were 65 patients who were analyzed who switched from IV to subcutaneous and four P D.
Great.
Is done always a decrease in a beta.
Population is shown on the left.
Where are those patients who were given the economy in subcutaneous form for the first time I mean these are naive patients.
Yeah.
First a PK pharmacokinetics.
Let's see.
S. C administration in comparison to IV administration showed 11% higher AUC.
But it was within the acceptance range of bio equivalents 90, 590% confidence interval.
Meaning that our PK bio equivalence was demonstrated.
And central Lloyd a reduction.
In SC grip.
In comparison to IV group.
Higher.
I mean, what would the removal by 14% and this was also comparable at 90% confidence interval in PK and PD and see bio equivalence to I V was established and so we believe that we are able to final submission for it.
C administration.
Safety first systemic injection reactions.
So we should not localized but systemic injection reactions.
Sure.
Often times with our injectable drugs are such reactions are served and a systemic fatigue I may occur after vaccination about such incidence rate was significantly low oil and a subcutaneous sub study I saw area.
Incidents.
Sure.
S C population.
So it says the sample size was very small.
The confidence interval was very broad.
Yeah.
However.
Okay.
The frequency at the timing and severity.
Sure.
Similar between SC and IV in critical and imaging evaluation.
The range for Etsy patient was very large.
And sample size for small so.
Our ratio was affected by a number of changing for similar subject. It is difficult to have a.
Director comparison, but it is a considering a similar.
And.
I I E predict or for I V was considered to be C. Max However in F C.
Do you see is considered to be a better predictor for incidence of ARIA E.
Overall.
We believe that we are able to file for submission for SC administration and I believe next week. We are scheduled to begin consultations with FDA on this possibility there are great benefits from the administration.
Asian, depending on the patient situation, we will have expanded treatment options.
It is to stay at home or in a care center.
At home administration is possible infusion of will no longer be necessary and it will lead to overall cost reduction it will lead to better.
Better convenience and allow for a longer treatment.
This is an overview of the pipeline.
The biology and disease stage are shown on the vertical and horizontal axis, we have pipelines covering different areas and 2814 and anti MTB our tau antibody.
MTB our town.
Is involved in propagation of tower, a tower species and this is the focus of attention. These days and it will be trapped in the so quest a by a 28 to 14 the dyad cohort.
The base. The study is done after treatment with the kind of mob by giving a 28 or 14 antibodies. What happens is observed in phase two three and there is also a monotherapy study ongoing two studies currently ongoing ongoing and there's much attention paid to <unk> 28 and 14.
Hey, Todd MTB, Artal 243, a biomarker of what's presented but the new biomarker.
And Oh this is a biomarker specific to tower neurosurgery, Larry Tangled thing a D and andi add patients.
When he 28 14 is administered it was confirmed that MTV, our Tau 243 decreases.
And that helped.
To help increase.
The increase our attention to the 28 2014.
In Japan.
Basic act on dementia to promote an exclusive vitally was enacted and Prime Minister Cheetah himself is exerting our leadership to promote inclusive society.
And digital tools are towards the end or develop personal the cartel.
You may have received various eye health checkups and there are different formats of data.
So quick Kartik if you.
Take the.
A quick.
Just real quickly the camera it will be recorded a N D up and.
Chronologically for example, systolic blood pressure change it can be shown in this up no. No is now installed in quick cart and self check a simple no no function is available.
60, local governments are institutions companies.
Of adopted and up a 100000 per ear are in excess of that number of tests using nano are expected.
M C I risk prediction too is.
Another Oh two.
For example, at such a screen won't come up.
What is the level of risk of cognitive function.
Got declines into the Earth for you and the risk is not high but.
Moving a such and such behavior is recommended to further and further reduce the risk that screen count come up and this is a close to being commercialized.
Natural course of treatment effect prediction too is all Saundra's development.
Right extreme column is society too.
Uh huh.
The frequency of visits to the physician may differ for dementia patients. It may be an interval of two weeks to several months and in the meantime in between a physician consultation how ADL changes.
In the patient these are difficult to thoroughly described during the consultation.
This change can be recorded on the up so that it can be understood. A glass that is the purpose of the theater. The screenshots are example, it's Sean and are there are 10 types of Adl's. For example use of home of plants. This is a very important item how real kind of person who is a home appliance.
And this is an example, it says 2.1 a score of 2.1 and this is a decline from the previous score of 2.6.
And total score is 19.4.
Out of a possible.
30, and below 20 points a little bit.
Need to alert and on the right side of the trend of this total score is Sean and I are glass.
Attending physicians will be able to see the recent trends in the patient instantaneously and this will lead to a better efficiency of treatment and effectiveness of treatment, we would like to roll this out nationwide.
This is for your appeal forecast.
Today, we have announced a upward revision a guide us stop buying Ah was about 27 billion again I hope I'm my.
Number is correct the revision by 'twenty Julien.
Revision is 529 billion and for top line.
They can be a we will be making adequate spending on they can be.
Operating profit.
This is a revision by how much.
Julian 1 billion, we made a 1 billion upward revision for operating profit and profit for the year are there was an increase of we expect increase in interest income and we made a full billing again upward revision for profit for the year. So we gave guidance on upward revision.
Today that concludes my presentation.
Sure.
Now we'd like to start the Q&A session. If you have any questions. Please raise your hand and please mention your affiliation and name before asking a question due to the interest of time. Please limit the number of questions. You can ask at one time to one question.
This is Rocco I'm from JP Morgan. Thank you for your presentation.
Wow.
I have a question about this 10000 patients to be at the probability of achieving this number.
Could you. Please explain the factors for achieving this because this is a novel drug and the because of this the initial movement I think that this will affect the share price trend. Therefore could you. Please explain the probability of achieving 10000.
On page nine amyloid beta test.
<unk> conducted its increased tenfold recently, so could you. Please explain what do you mean by this increase.
Compared to the level of June and then this was.
This I should've been 8000, and then simplify the tests are received.
To identify patients with the potential early amyloid Alzheimer's disease out of beta amyloid beta tests will be conducted and is therefore, a large number of patients should go through this test so 10 times increase.
Do you think it will become one.
Prospects or factor for achieving that 10000 patients.
Yeah.
According to your question I'd like to ask Mr. He asked another to respond.
Thank you very much for your question I am in charge of our Americas business. My name is a yes or no and.
And regarding your question I would like to respond but before that.
I'd like to recap.
But that situation being activated in the United States, the commercialization activities, which are becoming a much more on the more active day by day in the United States, Let us explain first to US, let's see you explained it today in the United States.
They can be in the United States.
It's growing Asbury in the plan and also the monthly plan is exceeded and also targets.
The achievement of the full year target after the full approval in July the number of affiliations ready for they can be treatment a number of amyloid beta tests conducted and also I D. N. A number a number of ideas as we thought so I decided to adopt or they can be.
All expanding all of these kpis are showing rapid growth.
Hmm.
And as we see the weekly average revenue in October compared to the pre Ah full approvals. It has increased by 11 fold.
Therefore, it is also exceeding well above the plan, which was formulated at the time of full approvals and on October 13th.
The amyloid beta pit N C D was lifted.
And after that.
The number of patients who are able to receive amyloid beta test is increasing in accelerated a mother.
Uh huh.
So I said 10 times do you think that the eye it was exaggerated.
Regarding the number but it tastes are each being increased by about tenfold in the kind of some mention of it can be challenging but is it correct. Yes that is correct. According to a simulation. We assimilated 10 time has increased a lot.
I explained this later according to the external data up until August.
No.
As you can see here pet CSF and blood Biomarkers are conducted in these numbers.
So when it comes to apply the insurance claim as a C. M. S. A claims both are included in these numbers therefore.
This is according the purple labs. Therefore, this is not exhausted.
With that in your mind and then according to the level of our June about 800 about the out of which half is a CSF says.
And eat Feeney increased it by tenfold not CSS budge pets is increasing.
I've seen you mentioned earlier regarding pet. The this is based upon the shipment of the tracer from the pet manufacturer, which is increasing dramatically country and if it amyloid centers.
Oh sites the number of such sites.
He is increasing by the civil fold therefore at.
The number of patients who are eligible for up the amyloid beta test is increasing rapidly, but amyloid beta positive is found and then decided to receive the treatment by a week. So they can be and before administration upper Eagle Ford test that needs to be explained it to patients.
So with their consent then.
Referred to infusion center, and our slots will be secure it and therefore in that sense. There is about two months time lag so.
Our members are trying to shorten that period about currently that time lag is about two months. Therefore, the revenue growth as well as the increase in the number of patients will become more visible from around December that is our expectation.
Uh huh.
So based upon these and also in addition to these.
As has been explained it stay at sea Tac the oily data and also it's a C data, which have drawn a lot of attention attribute that to the other day.
Our members are in very highly motivated because we are dealing with a new and a first in the world that there'll be two.
To be established and together with health care providers.
In the market.
That is a making a surge of our momentum in the market.
At our various hospitals such as those in the idea in policy and they saw BS are being developed.
In order to be ready for it starting the.
Treatment for patients and actually treatment has been started at many hospitals and according to the media report or you may have heard a very famous larger hospital in the United States that can be administration had started so this is happening here and there.
As we explained there are three momentum.
In addition to that towards the achievement of a 10000 patient and also achieved a new 10 billion yen in revenue.
We have a very strong confidence.
Now in achieving this I'm sorry about lengthy response.
If I may continue a little bit.
It's a great opportunity because you were here so I would like to explain further regarding the further expansion of access by patients to therapy as we have been trying we needed to simplify patient journey.
Simplifying youre shortening patient journey that is what we have been trying to achieve as we have mentioned the various policies as well as test to be prepared that it is going to be very complicated in a complex situation, but simplifying beef market readiness will be enhanced.
And we are seeing such market readiness, a huntsman, but even with us.
When a patient with a D visits the medical institution for the first time and until they start administration that was there can be several months or Atlanta.
Our longest the one year will be necessary before studying the actual administration in order to shorten this period.
We needed to achieve the operational maturity in our words.
People in the field needed to be get used to do operation and the proficiency in operation must be enhanced so that they can smooth.
We have even more smooth operation or flow of patients.
<unk> patients are waiting for it.
Treatment.
Hum.
The physicians are trying to receive or accept a patient a gradually so we are very sorry for this situation, but there are many patients who are waiting we like to improve feeds the looseness of the flow of patients of course standardization will be necessary.
Yeah.
In addition.
The important role is played as we said earlier by BBB and blood based biomarker.
G. This is considered to be triage or like in the screening. It has started to be used.
Even at that stage.
I'm going to lead to better positivity I didnt can be identified so that the burden of going through paired with CSL will be reduced and this is expected to be used as confirmatory diagnosis and if that is achieved and this will replace mid C. S. F. N B B B M will be used more widely that will simplify the.
His diagnosis and also access to that can be will be much easier.
And P. C P. If b b b M can be available at our primary care physicians and then.
The there is a limit or a stringent capacity of neurologists.
Burdened the capacity of a neurologist or can be mitigated and so therefore, it will make the patient journey much smoother here.
Currently we are trying to simplify patient journey, so that as soon as possible and for as many patients as possible, we would like to deliver they can be administration.
So.
So regarding pets.
So we know the number but pet test.
Increased it by tenfold.
Regards to the time of luck.
Well I think that that has been the well.
Come across very well I think you can finish. Thank you very much sorry about the time constraint, we would like to configure it up to Q&A.
Next question please.
As you can see from Daiwa securities about there can be a topic study interpretation.
Oh no.
Okay.
Put that study Ah patient demographics.
As I see the demographics. It was not included in our presentation today, but according to what was presented at seats out Little Tao group and intermediate Hideout group.
Good morning.
Hot a city.
RSP Adas cog or these are cognitive function scores of which we're not too different between these two subgroups NCI and a mild dementia a D patient proportion in active drug arm.
Yeah.
Well intermediate Teitell had more NCI patients in low tow there were more E D patients.
Looking at this Ah patients that background, what can you say from the data.
A bit of positive and at the same time low tow patients are the efficacy was a confirmed that interpretation is I think possible, but our early eighties stage efficacy what suggested how can you make that interpretation.
Okay.
And that question will be addressed by a doctor linked Kramer in the U S.
Yes.
Lynn.
Clinical officer Dee.
B L.
Thank you for the question.
The.
Overall study.
Illustrated significant effects in all critical areas.
All biomarker endpoints and all quality of life endpoints.
And the Tau sub study.
We had specifically.
<unk> looked at the final levels in addition to amyloid.
The power levels, which are located.
And we won't have patients.
Rival cortex, which means they're very localized.
Sure Barry.
Large responses as shown in slide.
<unk>.
However.
Sure.
Also in the intermediate.
A very positive effect as well.
As seen in the overall population.
I think that answer your question.
Yeah.
Yeah.
Yeah, Mike. So you know it's about my next question is from the person.
By the window please.
My name is Sakai from UBS Securities regarding the domestic market immediately after approval you are planning to launch the product here.
According to the reports in the media that can be dropped pricing, Japan will be determined based upon that.
Usual rules apply to two other drugs.
You have mentioned.
This is regarded as our innovative drugs innovation, how innovation that will be evaluated I think this is going to be a very crucial appoint sofa.
So for you you are the ASI whatever price will be assigned.
You're essentially you're are you going to prioritize launching the timing or do you think that that there will be another round of negotiation with the regulatory authorities not only limited to the drug price will they can be alone, but also your future pricing strategy going forward could you. Please elaborate on that.
Okay.
I kind of sudden is going to it.
Bond. Thank you very much my name is I cannot I am in charge of our policy.
Uh huh.
We have been.
I was saying that regarding Panama video needs to be assessed or body agent value based pricing is advocated globally now as you know in the United States.
This value is being evaluated on the.
A concept that 60% of the body will be returned to the public and the annual value is calculated at the 37600 and the annual price for initial administration was set at $26500.
We do not think that there are any debate regarding this price was saying that this is too high but I believe that that is a V. P. A body of base to pricing. The concept is well received in the United States turning to Japan.
In May this year and up here revised are reviewed on a paper or the economy by the value was published.
The us for the characteristics of what they call them up and the social impact as well.
Such as a it is that it is likely to significantly reduce burden on the public long term care services and finally in addition to the medical and clinical benefit based on good clinical ethics, such social impact. It was will evaluated in the paper published so there's social impact is about <unk>.
Based upon the concept of value based pricing.
No.
Regarding this concept that we are discussing with various stakeholders, including regulatory authorities no at the two eco or central Medical Council.
Where the discussions are ongoing now they're kind of them up at the TUI kiln is being discussed are based upon the concept of the high price pharmaceutical category.
So call that peak sales annual sales exceeding a 150 billion yen.
So that is a criteria for voting under in this high price pharmaceutical and the Bud now discussions are ongoing to how to include the our long term care cost in the drug price calculation in Japan after approval within six days 60 days or at latest and 90 days after.
The approval the NHI price listing needs to be done so within that time frame. How are the long term care costs there needs to be about it. It is very difficult to reach conclusion within 90 days or.
So as the U S could be in your question. The first initial pricing will be done under the current rules. However regarding the long term care closer there it'll be a more sufficient of discussion which is our current ongoing at the TUI killed based upon including the reviewing of the of course the benefit of variation.
It was.
Regarding the specific drugs.
Such a discussion.
Regarding how to handle the social value.
I think that that discussion is take place taking place for the first time at the Jewish guilt.
Because of our Air force that we have been making in consolidation of its various stakeholders I think that that has been everybody aided to some extent.
And there has been certain progress and Prime Minister. She does has mentioned this therapy at all times and indexed towards a recession of the diet in October. He made his policy speech. He did say I did not know considering the advent of a new era with that approach.
The approval of <unk>, there needs to be the infrastructure to be promoted including that.
Necessity for the early detection and testing and medical services I know so the comprehensive economic measures, which were announced last week. A these majors were included there for it and the economy is expected to play a very important role in the majors are related to the debenture and under the.
They probably still economic on physical money spent in 'twenty to 'twenty three.
In order to enhance further okay.
<unk> develops innovative pharmaceutical products in order to strengthen the innovative capabilities in drug discovery.
The drug price major shall be promoted including the appropriate evaluation of the innovation. So that is mentioned so innovation originated in Japan under the first thing the world there should be appropriate evaluated next question. Please.
Okay.
Okay.
At Dawn.
About the preclinical Adrian could you give us your name.
So far it C. Bernstein scheme is my name.
Clinical.
A D. A I have a question on that I had a study is ongoing.
And I believe a primary completion is expected in November 2027 before that prior to that.
Uh huh.
Is there going to be pre clinical data that will be published similar to the recently published a little dog group data.
And.
I think a preclinical.
Stage will be very important for treatment as well as for prevention.
And business wise.
Do you expect the business to grow after 2027 I believe that that is your expectation and if that is the case the timing of a L. L O E. Although it can be or.
And through our lifecycle strategies really have other products. So what is the strategy of ACI, our doctor linked Kramer will address that question.
Yes. Thank you.
Firstly.
Let me try and answer your first question about the.
Three four.
A large study.
This study has.
About 1400 patients expected.
It has an interim analysis.
Could be used for accelerated approval.
After the first 400 patients have received two years of therapy. This is based on Biomarkers.
We have the ability to just discuss that.
Yes.
And consider an application.
Then we have the full examination of data as you discussed.
After a four year completion of the 1400 patients.
We do have other.
Approaches to this and our pipeline.
Mhm.
Some I think we have wide.
I'm sorry.
Pardon.
Alright.
Sure.
Seven two.
We do have other.
Programs that are in development.
Take our kidney molecule.
Take.
Take those learnings.
Hello.
Other.
Products that would.
So down the progression.
Oh.
Does that answer your question you had several different questions in there.
Yes, thank you very much.
Okay.
How would you can almost think they must be the most we have pass the time to enter the conference, but we have seen several other hence range. Therefore, we like to continue.
The person in the third row from the front please have the floor.
Okay.
Okay.
My name is Kimberly am I am a nonfiction author novelists.
I have two questions and I think that executive officer earlier mentioned.
Before starting administration it takes one year.
It all.
Occidental.
Accelerated approval was obtained in January so now we are in November so after accelerated approval and.
Ah patients who wish to receive the treatment.
Then what.
Bumpers. This process. So why are they able to receive their treatment, yes, no speaking yes.
One ear are necessary for studying the administration about weather.
Or rather it takes us several months to get the appointment at the Neurology standard then the administration will be started so Patrick.
Particularly in local areas, where a sponsor distribution of our hospitals and then it may take one year.
Oh, Thank you very much in the United States, our go to market and hence structure is being enhanced I understood. It that very well, but regarding the current started senior bonds.
In Japan approval is already.
Given and therefore, it sales and marketing activities can be initiated as I believe you have started those activities.
And.
Similarly.
No.
My friend from my High School days.
Enough of a district and they are working he is working for our hospital and our heat.
Ah wrote to me that he appreciates as is our efforts to develop such a new touring a treatment.
And those patients who are receiving care at a local hospitals are in the moderate stage.
Oh that disease. So those are health care providers as well as the care providers in the field.
Got it.
Not stuff.
Still seeing the actual patients eligible for it can be so those patients are not visible to the health care providers, so changing gear here.
There was a significant sort of delaying the progression.
Of the patients with <unk>.
So I discuss it is.
And as is the MRO or sales reps and the other people are struggling.
In a raising awareness because of the car to head up the.
Cause I cited in Asahi or Nikkei newspaper, I think that because of the improper inappropriate media coverage in Japan, I think there is a misleading information spreading.
I'm pleased another criticize other media outlets gives us I'm. Please.
Yes. Thank you very much I am in charge of a commercial operation and to find my name as you start. Thank you very much for your question as you pointed out.
22, Silver September the MAA age was granted in Japan as well as well as you said are in principle 60 days after approval or they just 90 days after approval NHI price testing will be done so by the end of the year. This year, we believe that the decision will be made regarding.
The price testing for NHI, and we have the especially the MRE so of biogen's MRO as well.
In the dementia area. So centering on then we are we have started the our information provision activities AZ, Japan has been a very strong in the neurology area and we have MRO groups.
And they are making utmost efforts in providing information to H C beads, and so far it as of today, we have already covered about 18000 physicians for the first round of information provision so far as Mr. Shim Oyama mentioned.
Those are patients who are indicated for they can be.
Package insert information is correctly communicated.
First ever.
Treatment for MSCI, and a mild dementia in Japan.
Our specialist or D. D neurologist do understand those indications however, as you pointed out patient themselves.
All right.
I.
I do not understand that once they reached a moderate stage of the disease, they're not eligible or indicated for this therapy in order to fill the gap more specifically safety as well as the biomarker related web seminars, which are being actively held and we have held such swept seminar six times already Oh.
In which about as many as 3000 physicians have viewed those seminars and this was well above our.
Expectation.
Many more.
If conditions than expected are viewing the seminar, so and I think that the awareness about the drug itself will be enhanced.
Addition area of diagnosis in our management and also as you pointed out eligible appropriate eligible patients.
For them to start treatment earlier, particularly in hospital and in Central Illinois facility.
Facility Inter facility collaboration is being promoted such a environmental establishment that he's been promoted and we are continuing to work on this.
If I may add my question.
Physicians and hospitals information is being provided right, yes that is correct.
So those patients are in the early stages of the disease.
I think only 1% of those patients are actually seeing doctors hospitals. So there are many more patients who are in early stages, but not seeing doctors, how can you bring them to seek medical treatment.
Mr Shimada or ask a question no M C I, well or 10% well less than 10% of the patients in the M. C. I stage are actually visiting the hospitals. According to the epidemiological study and others.
M C I pacings.
I see all explained for achieving the inclusive society no no. Other tools are provided and not to mentioned here today, but with local governments are the brain checkups or are being promoted together with local governments through such brain.
Pick ups.
In the horizontal networking among local government.
Government about 600 local governments are participating in that network and bring a check up it is not the medical service in Japan, but there are many people who are receiving the brain checkup.
No no is abducted four such as the.
Ah the brain check up so that we can get a earlier awareness raising among patients.
In order to bring them to seek the medical treatment and <unk>.
After our launch of the product M C I relate to that awareness raging camping activities will be conducted.
So by doing this we like to increase the treatment the ratio.
So towards the the inclusive society. The basic act on dementia on the municipality level for prevention of dementia and also take up of the coconut dysfunction planning and needs to be made on the municipality level. Because this is a requirement under the law.
Although the anti cancer basically.
The basic diagnostics are now available.
Available based upon the public on instead of feet.
Public funding, so that has changed or the Oh.
Oncology treatment very much. Therefore, we can expect the same thing may happen in the dementia area. Thank you very much.
Okay.
Yes next question please.
Children from Toyo Keizai.
Well about the detailed our issue in Japan similar to the U S. So there'll be a insurance reimbursement of genetic testing for it I believe.
And.
Oh God.
100% Foster marketing survey that was required at the time of all that can be approval is this a level such that people will affect our profitability that you estimated.
Questions will be addressed by needs in Oklahoma.
Yeah.
Okay.
Thank you for your question.
No.
I am stuck at home are responsible for regulatory affairs in Japan first about our insurance reimbursement of up way for testing.
According to the current package insert before that can be administration Ah boy for a test is not required.
E irrespective of a boy.
They got typing as a risk of countermeasure and treatment after onset or there are no differences irrespective of Ah boy genetic type so irrespective of Ah boy type of safety measures and should be thoroughly taken and we will be asking them.
Health care professionals to do so and I do understand that some companies are planning to develop such a diagnostics.
And as much as possible, we would like to collaborate in such a development activities.
And if physicians or patients. So wish we would like to be able to offer a boy for test, which is covered by insurance reimbursement towards that and we would like to cooperate.
Regarding your second question I'll, Oh patient survey post our marketing.
Yeah.
What's the question.
Thank you.
Oh Ah patient survey a seal explained earlier.
This is an innovative new drugs originating from Japan.
And immediately after the launch of like M. D. We would like to ensure save yourself, the drug and we would like to cultivate and nurture that can't be together in Japan, and we believe that the best way, our inquiries mm 100% of patient survey.
And.
For that purpose, we will be implementing that survey.
Yeah.
As for the impact of that expense a company wide.
And she went on Toyota.
Yes.
About the testing items and a number of patients who will be receiving the treatment. We are still consulting with the author of DS.
But this is a postal marketing survey.
Mhm organized.
And we did not expect such a major impact on the business of our company.
By utilizing this survey.
I would like to ensure safety after the launch and would also like to collect the efficacy data and make a good use of that data. Thank you for your question.
Got it.
Any other questions.
Depression in the second row from fund please have the floor. Thank you.
My name is the succor and even from Jaco Juniper.
Regarding the Internet launch of Delta can be into the Japanese market as husband asks by another person earlier go to market structure in the United States, maybe replicated in Japan as well is it correct understanding.
As you know.
And also the tests for a diagnosis, it's a area of concern for many people. So what extent do you think there's a environment for diagnostics testing Hudson established.
Mr. Yu said he is going to respond. Thank you very much for your question are they said you saw speaking let me respond in Japan as well as you can see on the slide we have a specialist I'm ours in a general MRO sales reps on a key account manager.
And of course oncology area.
We are facing the aging issues into society. So we are utilizing in various channels like omni channel in order to promote or they can be.
So there is no change in that and regarding the structure could you. Please.
Say your question again.
Okay.
This kind of a structure will be replicated in Japan.
Are you going to make the similar approach yes, there is not a significant change. So we are almost completing the preparation for that and regarding diagnostic tests.
And how well the environment the husband prepared regarding diagnosis.
No I'm not really the beta testing.
It's not it's already approved.
But however, the reimbursement is not a given it yet for that are we are making coordination with various companies and the regulatory authorities, but we'd like to make it available.
For the launch of the light can be even for the reimbursement and also kept paucity himself and we started our airports and investigation since three years ago. So at latest during.
During the at least during the initial stage of our launch we believe that there would be no problem. So at the medical institutions do you think that that they are they have a enough capacity for conducting tests, yes. It depends on the regions. However.
There are some areas, whereas such capacity is not well established but our specialty M. RSO sales reps are discussing with the physicians in order to prepare them in place, but overall all in at least in the initial phase. After launch we don't think that would be inappropriate problem.
I see the pound has been resolved for a very long time, Oh from online participant.
Yamaguchi San from Citi Group. Please can you hear me, yes, we can.
Thank you. Thank you for taking my question despite everyone being busy just one question subdue data and submission that is my question in sub Q data ARIA incidents I think I was a higher.
Got you and in terms of patient background, those who are more likely to have a area in terms of properly work are smaller in number in subcutaneous study and so this suggest a higher plus a risk of area and is there going.
To be a need of that you will have to do those findings once again because of this result doctor linked Kramer will respond.
Yes. Thank you for the question.
Additional dose finding we will need to be done.
We do believe that as we have no very good data.
It indicates exactly.
Yeah.
PK and PD.
For the subcutaneous formulation.
What all this information along with our IV to <unk>.
Pretty big area.
Exactly the correct dosing, we will be discussing this with the FDA very shortly.
Paired with MSR.
Thank you.
So this is going to the last question for the day for Morgan Stanley Muraoka San.
Mr. Murali <unk> of Morgan Stanley Please mute yourself.
This is Morgan Stanley Muraoka speaking.
Thank you very much for calling me for raising a question regarding the revision of the guidance.
Sales revenues.
How should I interpret the breakdown of the revenue I think there was a discrepancy in my calculation 29 billion, increasing our revenue, but then be mahalo, Ben and others are subtracting these items and at the time of Mei.
Budget included or they can be americas' revenue Ana Japans revenue budget and under this revised guidance <unk> America and the Japan. So it can be a sales a budget, which seem to be reduced or more reduction is seen in Japan's budget or guidance for Japan that can be.
Is this correct understanding.
For your question.
Mr Chairman is going to respond.
Thank you very much for your question. This is Sherman speaking.
Let me respond.
As we explained earlier regarding the revenue.
29 billion yen west the upward revision to our 704.
The 1 billion yen and breakdown.
We rounded number it's a full disclosure, but we haven't changed significantly the numbers for the M. D. MA. Please understand as such so that means that they can be projections I have stayed unchanged for both Japan and United States. When you project published our half year ago right that is.
Correct, we haven't made any significant change thank you very much.
With that we would like to and the earnings presentation. A meeting. Thank you very much once again for taking part despite your very busy schedule. Thank you.
Yeah.