Eisai Co Ltd. (ESALF) Q4 2024 Earnings Call Transcript _ Seeking Alpha

5/17/24, 10:30 AM Eisai Co Ltd.
(ESALF) Q4 2024 Earnings Call Transcript _ Seeking Alpha
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Eisai Co Ltd. (ESALF) Q4 2024 Earnings Call

Transcript
May 16, 2024 9:14 PM ET | Eisai Co., Ltd. (ESALF) Stock, ESAIY Stock
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Eisai Co Ltd. (OTCPK:ESALF) Q4 2024 Results Conference Call May 16, 2024 2:00 AM ET
Company Participants
Haruo Naito - CEO, Representative Corporate Officer & Director

Keisuke Naito - SVP, Chief Strategy, Planning & Ecosystem Officer and Acting Global
Alzheimer's Disease Officer
Lynn Kramer - VP & Chief Clinical Officer, Alzheimer's Disease and Brain Health
Kazuhiko Tamura - VP & President of Eisai Demand Chain Systems
Toshitaka Asano - VP and Head of Corporate Planning & Business Development HQs
Yasushi Okada - Representative Corporate Officer, COO, Industry Affairs, China Business &
Data Integrity
Conference Call Participants
Seiji Wakao - JPMorgan
Kazuaki Hashiguchi - Daiwa Securities
Fumiyoshi Sakai - UBS
Akinori Ueda - Goldman Sachs
Shinichiro Muraoka - Morgan Stanley
Unidentified Company Representative
https://seekingalpha.com/article/4694014-eisai-co-ltd-esalf-q4-2024-earnings-call-transcript 1/27
5/17/24, 10:30 AM Eisai Co Ltd. (ESALF) Q4 2024 Earnings Call Transcript _ Seeking Alpha
Thank you very much for taking your time out of your busy schedule to attend the financial
results presentation session by Eisai Co. Ltd. We would now like to begin the meeting to
present financial results from fiscal 2023.
This will be held in hybrid format. Those of you who are in this room, please find four
presentation materials, including the presentation deck, financial report and press release that
was announced today and the start of the rolling submission for subcutaneous injection and
change in the personnel -- or rather announcements of new appointments.
I would now like to introduce the presenter, Mr. Haruo Naito, Representative Corporate Officer
and CEO. Mr. Naito, the floor is yours.
Haruo Naito
Let me start my presentation on the financial results for fiscal year 2023. Firstly, please look at
the statement of income. Revenue stayed almost flat from a year earlier. The cost of sales has
reduced by 3 percentage points. This is due to the ongoing effort for reducing costs and also
the improvement of the product mix. As a result, gross profit was up 4% year-on-year and
profitability has improved by 3 percentage points.
As regards to expenses, such as R&D expenses, which accounted for 22 points of the
revenue, that was the reduction by about 0.5 percentage points. Over the past 2 years or so,
Oncology and Neurology Business Group R&D have been integrated. Human biology-based
integrated approach has adopted for integration, and as a result, the benefits are now arising
as the effect of such integration.
Now for SG&A expenses, which have increased, the major driver for the increase was one
thing due to the expansion of LENVIMA. Therefore, there was an increase of expenses
regarding shared profit of LENVIMA paid to partner. Currently, we are making utmost efforts in
development of LEQEMBI. So with these two major positive investments, we are making SG&A
expenses increase.
However, if you look at expenses in total, which was 1% up from a year earlier, so these have
been controlled within the increase of gross profit.
Therefore, operating profit was ¥53.4 billion, up 33% increase, which was a significant increase
year-on-year. Profitability has improved as well.
Profit for the year has decreased. However, in the previous year, there was the repayment of
paid-in capital from a consolidated U.S. subsidiary. Therefore, there was the reduction of the
tax expenses in the previous year. Excluding that impact, profit for the year should have
increased. Therefore, there is no change to the sound structure of the financials.
Given these, now take a look at the revenue migration. As you see in the headline, 3L:
LENVIMA, DAYVIGO because generic name of DAYVIGO is lemborexant therefore l is taken
and LEQEMBI. With these 3Ls, which I believe have contributed to the expansion of
pharmaceutical business, LENVIMA increased by ¥48 billion year-on-year, DAYVIGO by ¥12.4
billion and then LEQEMBI increased by ¥4.2 billion from a year earlier. Therefore,
pharmaceutical business increased by ¥7 billion in its revenue. There were some decrease in
onetime income, however, overall, revenue was almost flat.
Now a breakdown of operating profit migration is provided here on this space. The profitability
of our pharmaceutical business was increased from 47.6% to 49.7%. There was an
improvement in the profitability because of the adjustments in head count in various areas and
also better efficiency of spending.
And R&D expenses, as I said earlier, integration of the areas of R&D activities have given rise
to more efficiency and ¥8 billion in pharmaceutical and ¥4 billion in the more -- improved
efficiency R&D activities. So these were the contributing factors for improving the operating
profit.
And the offsetting the decrease in the onetime income, operating profit increased by ¥13.4
billion which was up 33% year-on-year. There was a significant increase in operating profit.
As you see in the bottom right, for LENVIMA -- LEQEMBI total investment in R&D and SG&A
expenses were at ¥110 billion level, as planned.
Now today, I would like to put focus on LEQEMBI in my presentation. Now Eisai has been
rolling out globally with what mission as a pharmaceutical company, we are rolling out our
business operations worldwide. That is shown here, Eisai has paved the way as a pioneer in
the treatment of Alzheimer's disease worldwide and it will continue to play this role. 1997 by
Aricept exactly 25 years ago with Aricept as the first-ever treatment for Alzheimer's disease has
been provided to the world; and 2023 by LEQEMBI, about 1/4 of a century later. Again, similar
pioneering role is played by us.
At the very bottom, you can see we are aiming for more treatments for more pathologies,
including tau and other various pathologies are being addressed in the pipeline.
Now as pioneer, we are and have been paving the way. But this is not merely drawing a
beautiful picture on a white canvas, it's not like that. You needed to remove large rocks, you
have to build a bridge over a large river and you need to dig a tunnel into mountain. So you
needed to do such enormous, huge work. The poem written by Takamura Kotaro called Dotei,
which I read many times recently, "There is no way before us, but there will be a way after us,"
as the poem said.
Particularly in today's world, diagnosis and care for AD has progressed a lot. There are a lot
more tests to be conducted, and also nuclear medicine is used and -- nuclear medicine is used
for monitoring of the ADR. So very important pathway needs to be established in today's
treatment for AD. So pathway establishment is very important today.
As a pioneer, we have put ourselves into such areas of work. Particularly in the United States
over the past one year, we have been working on this.
So first of all, what we are doing and have been doing, I would like to seek your understanding
of what we have been working on.
For fiscal year 2023, in the past one year, what about venue of LEQEMBI in the global market,
which was ¥4.26 billion. There may be various opinions saying this is a lot or small, but here
you can see the trend of revenue on a quarterly basis. During the fourth last year, compared to
the immediate last quarter, it has sharply increased by 2.7x. This trend, the angle of the
increase has become sharper from the beginning of this fiscal year. I would say the sales have
been increasing.
So looking at these trends. Now I'd like to talk about the status of LEQEMBI in the U.S., Japan
and China. First, in the United States, we are moving towards a new phase, that is to say, the
pathway establishment has seen a certain level of progress. Now at last, on this pathway, the
patients will be able to smoothly follow the path of a treatment, therefore, reaching the
prescription expansion phase. Then appropriate go-to-market structure for prescription
expansion phase needs to be established in the field. The front line should be strengthened.
We, the LEQEMBI in the U.S., has entered such new phase.
Similarly, the LEQEMBI revenue in the United States for fiscal year 2023 is shown here. If you
compare Q3 and Q4, again, you can see the rapid expansion. On the right, you can see the
number of vials sold to medical institutions on a weekly basis. As you see, again, week by
week, an accelerated manner. The number of vials sold to sites has been increasing in an
accelerated manner.
The foundation, including the pathway has been almost established and reaching a certain
level. On the left, you can see the map of the United States. Although this seems to be very
busy, but you can see the areas where prescribing facilities, the established pathway are
located with our field people location. Therefore, you can see the very dense map. This pink
shaded area covers almost the entire nation. Therefore, in most parts of the United States, the
prescriptions have been initiated.
On the right-hand side, from three aspects we are showing the status of pathway
establishment. First, we identified important targets. IDN, if you could turn to the bottom of the
page, IDN is integrated delivery network. Large-scale hospital group had such systems to
provide health care. For example, Washington University IDN in St. Louis perhaps have
dozens of hospitals under it sharing the common policy or protocol to provide health care
services. There are such IDNs like that. In the United States, they are playing very important
roles in providing health care service in a business model. Most of the top 100 target IDNs
have established pathways.
And the target physicians, in the second box, they are the physicians or neurologists who
belong to IDNs and also other physicians who are providing care in the community practice. In
the ordinary communities, there are neurology clinics or hospitals and those physicians who
have experience in AD consultations and treatments whom we understand very well and
asking them whether their pathway for prescription being established or not, and 100% of them
said that they have their pathway ready for treatment.
Another is AIC. You may not be familiar with this term, but this stands for ambulatory infusion
center. In the neighborhood of where patients live, this is the facilities dedicated for infusion.
They are not dealing with patients with AD, but also patients with immunology and oncology as
well. So they are one of the very important medical institutions, which are providing infusion
and most of them are managed and ran by companies. 82% of AICs or infusion centers said
that they are ready for infusion of LEQEMBI. Therefore, the establishment of foundation is
largely completed in our opinion.
Given these circumstances, what we are trying to do now is provided here. We call this system
as a go-to-market structure in the United States, but front line people in the sales in Japan. In
the second target box, there are NAS, ARM and HSAE. You may not be familiar with this, but if
you could look at the footnotes, NAS stands for neurology account specialists. MRs, medical
reps specializing in neurology. They are playing a central role in go-to-market structure. ARM
stands for access and reimbursement manager, including IDN and all medical institutions in the
United States are meant to make profits. Therefore, AD-related treatment or health care
services need to be reinsured -- reimbursed. They needed to confirm in details whether their
services are reimbursed. So what should be done is advised and they are seeking such advice
from us. These are the people, ARMs, are deployed all over the nation to provide such support.
And the next, HSAE, accounts for -- stands for health system account executives. They are
responsible for thinking about how established the pathway can be made more efficient. It has
taken 2 months for studying treatment how this can be shortened to 1 month. It has taken a lot
of time for first referral how can it be shortened further. So they are the ones who are providing
information and advice on these. They are rolled out throughout the country.
If you could look at in the left-hand side, this NAS is going to be increased by 30%. Half of
them are going to be the staff of Biogen. Where we can have key accounts with a greater
potential have been already identified with bias, so we are collaborating with them. ARM who
are providing advice on the reimbursement and then FTEs of ARM will be doubled -- increased.
Also the HSAE personnel will be also doubled.
And on the right, you can see three bullets. We have been targeting 100 IDNs so far, but we
are going to expand the target IDNs to 150. Particularly under pathway from diagnosis to the
start of treatment, it used take a lot of time and a larger IDN used to take 8 months, that has
been shortened to 2 months. Therefore, with various IDNs, we would like to adopt a similar
shortening of the duration. Given the increased number of patients, we needed to refer the
nearby infusion center or a patient assistance program or support for reimbursement because
the need for support is increasing as well. Therefore, we have to strengthen our patient support
system. Now by this, go-to-market structure in the U.S. is going to be strengthened so that we
will be able to achieve the expansion of the prescription.
And next is about omnichannel marketing. This is quite a well-known -- widely known
marketing method nowadays and it is being used widely. But omnichannel marketing was first
used in Oncology or LENVIMA in the United States. Over the past 3 years, we have seen a
great effect of this.
Simply put, what we are aiming to do is as follows. On the left, you can see data lake.
Proprietary data lake is going to be established, which will contain the digital promotion
information for health care professional or patients and consumers and information about in-
person contact in the field and information about the major academic societies. If amyloid beta
test or ApoE4 tests are required or ordered, such information are all put into a data lake and AI
is used for comprehensive analysis.
As you see in the right bottom corner, in the end, they will come up with recommendation on
the next best action. Among recommended actions, in-person field force will be given the
recommendation on what the promotion for Dr. A or IDN A, what kind of actions need to be
taken. Rather than having in-person contact peer-to-peer, health care providers communication
should be conducted, or without time, you needed to rely on [S&S] such a recommended
action package will be provided.
This, I believe, will enhance the efficiency, not depending on the share of voice. More efficient
marketing will become possible in our sales force activity. So we would like to accelerate this.
Next. Direct-to-patient campaign is something that I would like to explain now. Now we see
pathways being established. Therefore, we now believe they have to directly communicating
with the patients and families. The slogan here is, You Still Can Be With LEQEMBI.
Please look at the bottom. You still can be social with LEQEMBI. You still can be authentic with
LEQEMBI. You still can be relatable with LEQEMBI. You still can be empowering with
LEQEMBI. To raise awareness for earlier visit to physician's diagnosis.
As you can see at the website, omnichannel or digital marketing and video or display or print
advertisements in waiting rooms, this message will be carried. A DTP campaign was rolled out
and started from February and disease awareness can be raised, and we can encourage the
patients to seek earlier consultation with physicians.
Another point I would like to ask you to understand here is the progress we are making in
enhancing the value of LEQEMBI by adding new formulation dosage form and also
maintenance therapy on top of initial treatment. Early AD and the clinical AD are shown. For
early AD, if you look at the right-hand side chart, IV initial treatment with 10-milligram per
kilogram biweekly dosing. This has been already approved. So this is the treatment regimen in
Japan and the U.S. and China. In other jurisdictions or countries where review is ongoing,
submission have been already made -- submission is going to be made for this IV initial
treatment.
And in the middle, IV maintenance treatment, 10-gram milligram per kilogram monthly. With
half dose, which will be used for maintenance treatment, the submissions have been filed.
So before maintenance treatment, what about initial treatment? And this will be consulted with
regulatory agencies.
And today, we made a press release. SC-AI, subcutaneous autoinjection, maintenance

treatment submission has been initiated. The Fast Track designation has been granted for this
SC-AI maintenance treatment and rolling submission is allowed. Therefore, we immediately
started submission.
We are aiming for maintenance treatment with 360-milligram weekly dosing. This is going to be
manufactured by Terumo pen-type autoinjector.
This is prototype, rather this is almost the drug product but without any label indicating the
name of the therapy. So please understand that this is a model, and Terumo-made AI dosage
form has benefits. Having one thing, tapered needle. Tip of the needle is tapered, therefore,
this reduces pain a lot. And syringe itself is made of plastic, therefore, at home and at nursing
care facilities. This is not made of glass, therefore, this does not break, not causing any injury
to patients or caregivers. This is very safe. This syringe, in order to make it smoother, usually
silicon oil is applied to silicon, but this does not use that at all. Therefore, it is difficult to have
any aggregation of drug substance. Administration shall be done within 15 seconds. Therefore,
this shows it is very usable at home and at nursing care facilities. Patients themselves or
carers are able to safely administer the drug with this syringe.
There are several patents obtained by Terumo in this autoinjector. Current IV, under the current
formulation, the patients have to go to the infusion center. In the case of United States, some
patients have to drive a car by 1.5 hours. Therefore, it will be very burdensome for patients to
visit center and recommended infusion time is one hour. Therefore, pretreatment process and
also posttreatment time for monitoring the condition of the patients, you needed to have nurses
to monitor and take care of patients and it is also burdensome for nurses.
So considering all these, SC-AI formulation may potentially reduce such burdens significantly
and we believe that it is very important to continue treatment with AD-DMT.
In order to realize long-term administration, we believe that this is going to be a mainstay

formulation or dosage form going forward, as you see at the bottom, for both initial and
maintenance treatment, we like to replace the current dosage form with SC-AI. We are
preparing such programs. We aim to attain approval by FY 2026 for this.
And in the left bottom, you can see preclinical AD. As you know, this is the stage before MCI
development. Therefore, patients will not feel subjective symptoms, but if you conduct an
amyloid beta test and the position of amyloid beta is about to start or is starting.
So AHEAD 3-45 study, Phase III study is ongoing for patients with such status. The duration of
treatment is long and it was expected to have difficulties to enroll patients. However, with
enormous speed we have been able to enroll a lot of patients. We are targeting enrolling 1,400
patients, which we think that will be completed by the end of this fiscal year. Even one step
before MCI, that initiation of treatment can be earlier than MCI. Therefore, we can expect an
enormous effect of this.
Now safety. I would like to share with you the current status of ARIA the United States. Please
look at the first bullet because the reports of ARIA from real-world clinical practice were
consistent with what was observed in the clinical trials or as described in the U.S. package
insert. Most reports of ARIA in real-world clinical practice in the U.S. are nonserious
asymptomatic and it occurred early in treatment. Reported symptoms, as you see here, include
headache and others, as you see.
Given these in the real-world clinical practice in the U.S., prescribing doctors are following the
instructions concerning monitoring and performing of MRI for symptoms described in USPI and
the management of such conditions.
At Eisai, we are providing a website called understanding ARIA, where we provide educational
materials, and this website has been already accessed by over 15,000 health care
professionals. Therefore, attention has been drawn duly to ARIA and health care providers are
following such instructions. Therefore, we believe that safely LEQEMBI is being administered
in the real-world setting.
Now turning to LEQEMBI in Japan. Establishment of the pathway has been fast in Japan,
faster than we expected. Diagnosis and treatment for eligible patients are progressing faster
than expected. Within four months of launch, this is what has been achieved. Bar chart
includes a pale purple bars. In almost 600 facilities, diagnostic and treatment pathway
establishment has been completed and treatment has been initiated in all of 47 prefectures in
Japan.
And optimal usage guidelines, OUG, as noted at the bottom of the page, in all case
surveillance are being complied to as we are expanding the entry of LEQEMBI in the market.
On the right side, cumulative sales is shown and about ¥600 million of sales was recorded.
Cumulatively by April and in May, the pace is further picking up and we are seeing progress,
which is faster than we expected.
In Japan, we are making efforts by the entire Japan team. What are we doing? Left-hand side,
the pyramid shows that we are layering facilities in Japan to four layers. OUG has stringent
requirements for initiating -- facilities initiating LEQEMBI treatment. There are facilities that
qualify by satisfying such requirements are at the top two layers. Facilities initiating LEQEMBI
treatment at top layers are led by many top key opinion leaders. We have specialized medical
reps, including Biogen's reps, approaching these top two layers of facilities. These two layers
at the top of LEQEMBI as well as the bottom two layers of the pyramid who are PCPs are
important. PCPs are playing a very important role of referring patients to the initiating --
facilities initiating treatment. PCPs are greater in number, and initiating treatment is for 6
months.
And to follow up after the initiating treatment can be given not at the top layer treatment
facilities, but in facilities qualifying at the bottom two layers, and therefore, information
communication amongst these facilities is very important. Around 650 million MRs who are
regional cooperation MRs are supporting the communication/coordination amongst these
facilities. Referral, initial treatment and follow-up flow is established by specialized medical
reps and regional cooperation medical reps and are achieving results.
Another characteristic in Japan is that we have a history of Aricept and we are able to leverage
that history made through Aricept. This year, we already have organized two large-sized
academic symposiums on LEQEMBI.
The second one, in red, Academic Symposium of the Japan Academy for Alzheimer's disease.
This academy was established at the time when Aricept was launched. It was launched in 2000
and it was attended by 290 people when the first symposium was organized in St. Marianna
University. Professor Kazuo Hasegawa was the leader of this academy. Professor Hasegawa is
known as the father of Alzheimer's disease in Japan.
For 25 years -- 24 years, efforts have continued steadily. This year, more than 500 physicians
were attending in person as well as those attending virtually. The number of members has
grown to about 4,800. Physicians have contributed to the activities of the academy. This is
playing a very core role in AD care.
We believe that a very important role was played by this Japan academy for Alzheimer's
disease. Various topics are discussed, but every year patients of Alzheimer's disease,
especially in younger age, also appear as speakers. These days, dementia patients are caring
dementia patients. Peer-to-peer care is the most modern type of care. This is set to be a most
invigorating treatment for patients.
We have a program that aims for inclusive society by inviting AD patients as speakers and that
has been the feature of the academic symposium from the very beginning. In each medical
version, we also have smaller-sized gatherings organized.
In Japan, this has served as a major backbone. As noted at the bottom of the page, we have
solid, strong relationship of trust with dementia specialists. We take pride in having established
such relationship, and LEQEMBI introduction is faster than planned or expected. The important
background factor is this history made through Aricept.
In Japan, as well, we are promoting efficient omnichannel marketing, which will be contributing
in a similar manner in Japan.
Now as for LEQEMBI in China, we are planning for launch in July. Pathway that differs from
Japan and the U.S. is aimed to be established. The characteristics include industry
collaboration and digital technology.
With the next page, I would like to describe. The headline says, pathway establishment through
online-merge-offline strategy. Next line, screening stage, diagnosis stage and treatment stage.
The screening stage has a major role, which is that commercial insurance, private health
checkup and private nursing home will be playing that role in commercial insurance. Quite
soon, benefit card insurance will be launched. AD prescreening opportunities can be provided
under the insurance. There will be also a recommendation to seek physician consultation for
people at high risk and it also has an element of reducing economic burden of patients. This
will be on sale quite soon.
The private health checkup includes cognitive functions and ApoE4 test and MRI. At nursing
home, there is also early screening. As a result of these screenings, patients at risk can seek
diagnosis through two different channels. First is referral to hospitals.
There is another channel shown below. We have Yin Fa Tong, which we started with JD group.
This is dementia online platform. On this platform already, more than 400,000 people have
become members and there are 6,080 specialists registered. This is a very active platform.
On this platform, referrals can be made. Memory map is one example of an app. In the
neighborhood of the person using the app, hospitals, specialist doctors can be identified and
recommended and A beta test sites can also be identified in physician centers as well. Arrow
pointing upwards indicates that there will be a switch from online to off-line.
Diagnosis in China in such that PET and CSF are not so widely available. From the beginning,
we are doing a diagnosis model, mainly using BBBM. We are establishing diagnostic network
with ICLDT and IVD companies.
In Yin Fa Tong, in the middle, there is patient care package as shown in this diagram. Online
consultation and service to company patients can also be provided. Once there is a definitive
diagnosis, it will be shifting to right side treatment. Infusion itself will be, of course, off-line with
diverse options for LEQEMBI administration. There's potential sites for LEQEMBI
administration can be accessed or ARIA monitoring this is also done off-line, but guidance can
be given by Yin Fa Tong. Using a long-term management app memory care center from Yin Fa
Tong, what infusion center, what we are monitoring is provided. Such information can be
accessed and ARIA monitoring reminder can also be sent as a service on this app.
By merging online and off-line, we are going to provide a platform from the very beginning in
China.
As a result of these efforts, we estimate ¥56.5 billion to be revenue from LEQEMBI, about
¥43.5 billion from the U.S., ¥10 billion from Japan and ¥3 billion from the rest of the world,
mainly China.
Now this is the core message of my presentation today. Thus far, we have established the
value of LEQEMBI. I would like to take time to describe the value of LEQEMBI. As noted in the
first bullet, LEQEMBI possesses potentially one of the most extensive treatment data set on
EAD, early AD. Represented by Clarity AD, we have wealth of information from clinical trial
data and open-label extensions are run in these clinical trials. Day by day, the data is
expanding.
After accelerated approval, for about 18 months, real-world data has been accumulated and
we have a very large volume of data, extensive data. As for EAD indication for LEQEMBI, well,
LEQEMBI is not looking at a subset of patients, for example, stratified by tau. But to broader
group of EAD patients, safety and efficacy have been demonstrated. This is a distinct
characteristic setting that can be apart from other AD-DMT.
And as for the number of patients with MCI, we are unparalleled. In low tau group in MCI, when
we look at the improvement of cognitive function -- or including the improvement of cognitive
function, we have outstanding data. This suggests a greater benefit for early start of the
treatment. This brings about hope for patients.
We also have a growing volume of data for long-term administration. We have seen sustained
the treatment up to 3 months -- 30 months and enhancement of treatment effect. EAD is a
progressive neurodegenerative disease and a continuous treatment is important, this goes
without saying. That importance, once again, is demonstrated from this long-term treatment
data. Early start of the treatment and continuous treatment will provide the best outcome for
EAD patients, as shown by LEQEMBI data.
Thus far, we have established the value of LEQEMBI. In this way, we believe this is the
greatest value of LEQEMBI. The second value is that dosage and administration -- value from
dosage and administration. We are continuously improving the dosage and administration. For
example, IV maintenance is under submission. The dose is less frequent, by half. SC-AI, as I
mentioned earlier, will provide reduction of burden on caregivers and patients substantially and
it will make it more convenient to continue treatment with LEQEMBI. We are continuously
expanding value through developing various dosage and administration routes.
The third bullet, as I mentioned a little bit earlier, is that we have started 25 years ago and the
treatment initiation was at the stage of mild AD. At that time, there was no concept of MCI. 25
years later, MCI is not opposed as a condition to be treated by anyone. MCI is now the stage
where treatment is initiated, as shown in the approval. With that, treatment effect is expanded.
Preclinical AD will be an earlier stage where treatment may be started earlier, and if that
becomes possible, AD treatment landscape can dramatically change and in some cases cure
may be within our vision.
In the real world, the last bullet point, the status of ARIA seems to be within the range
described in the package insert. Appropriate monitoring is ensuring safety. That is also an
important point in terms of value of LEQEMBI.
This one page shows the status of LENVIMA. Already, as you may be aware of, currently,
regarding high-purity LENVIMA patent, and this is a substance patent or material patent, we
have a very strong patent. We are challenged by ANDA generic manufacturers, and we have
pending lawsuit in the United States. The key company in that litigation, one of which is Sun
Pharma, we have entered into settlement agreement with Sun Pharma. Under LENVIMA
brand, there is a possibility to continue to contribute to patients in the medium to long term. We
consider this to be an important step forward.
LOE. How long will LOE be extended? The details I'm not able to comment since there is still
an ongoing litigation with other companies, but I would like to report that there has been an
important step forward.
As shown in the second bullet point, we would like to further expand indications. We have three
LEAP studies that may lead to expanded indication: upper gastrointestinal cancer, HCC and
esophageal carcinoma. For two of these, LPI is already achieved. We are adding values to
LENVIMA and capabilities to add value to LENVIMA from these results will be great.
The last bullet point is about RCC. Currently in multiple indications of LENVIMA, RCC is the
fastest-growing indication.
First choice drug, LENVIMA as a first choice drug for RCC is what we would like to establish
and strengthen. To strengthen that position, LITESPARK studies, two studies are underway.
Merck's HIF-2 alpha inhibitors will be given in combination with LENVIMA in these studies. In
these two studies, we have achieved LPI plus patients. As a result, if these are successful,
then we believe that it will have a very positive impact on the performance as it only may be
extended. Going forward, we would like to continue to contribute to patients in the mid- to long
term as well as continue to generate ¥300 billion level of revenue.
Going back to 3Ls, in fiscal 2024 revenue forecast is 18%, over ¥400 billion with 3Ls in terms
of revenue.
Today, at the Board, acquisition of own shares was resolved. This will be up to 6.5 million
shares and it will be 2.3% as a percentage of total number of issued shares. Total amount of
acquisition cost is up to ¥30 billion. It will be from May 16, 2024, to November 15, 2024. The
background of this is that, so far, we have focused on cash return and dividend in terms of
shareholder returns. But we will be entering the phase of expanding revenues, growing
revenues and we have to also be mindful of equity capital ratio as we continue to provide
returns to shareholders. From the point of capital -- equity capital management, we believe that
acquisition of owned shares is the safest effort to realize shareholder return.
Therefore, we are implementing this measure as one dimension higher level method of
providing return to shareholders. KPI improvement will be what we will continue to work on.
Our determination to increase shareholder value remains unchanged.
And the final page is the consolidated financial forecast.
Question-and-Answer Session
A - Unidentified Company Representative
We will now open the floor for questions. We will have about 20 minutes of Q&A for analysts
before opening the floor to members of the media. If you have a question, please give us your
name and affiliation before your question. From analysts, investors, if you have a question,
please raise your hand.
Seiji Wakao
Thank you for your presentation. My name is Wakao. I am from JPMorgan. My first question is
for this fiscal year 2024, revenue plan for LEQEMBI. Assumptions for the forecast as well as
the reasons why you believe such target can be achieved by region. For the United States,
$300 million, I think. The number of vials growing in a linear way achievable to reach this target
number or do you have more rapid expansion, such exponential growth, inclusive of the
number of potential eligible patients, the patients receiving treatment, please?
And in Japan, it seems that you are performing well. According to the available materials, last
year or this year, Eisai has shown the potential assumed the growth of the quarterly number of
patients.
Haruo Naito
By region, Mr. Haruna and Mr. [Yusa] are going to explain.
Katsuya Haruna
Thank you very much. I am in charge with commercial aspect of LEQEMBI in the United
States. My name is Haruna. I would like to give you the status of the LEQEMBI in the United
States. First, as for forecast, current trend as well as what we explained today, the effect of the
rolling out of our strategy being considered and the forecast is going to be with high probability.
For the month of May, we believe that the performance is exceeding, therefore, we are very
confident in achieving the plan.
If I may supplement, for FY 2023, we focused on the establishment of pathways. Now we are
transitioning to prescription expansion phase.
As was explained in today's presentation, let me share with you some example on what we
explained. At the site in Midwest in the United States, over 200 patients have received
treatment and about -- a little less than 200 patients are also currently under screening.
Therefore, growth is continuing.
In even more accelerated manner, so-called loyalist bias, the sites with 51 more patients are
expanding in number. There are also increasing number of potential loyalist candidate sites.
And last week, we could have an opportunity to talk with a patient who is undergoing the
LEQEMBI treatment. Before initiation of the treatment, the person said he was very frustrated
because of the worry or fear of losing memory and also lowering of the ADL or activity level
lowering that was felt strongly by the patient himself.
But after initiation of LEQEMBI, his ADL could be improved. Also, he could start to see or fee
zest for living, and he was pleased to have such changes.
As regards to the infusion, to visit the hospital has become a routine of his daily living and this
person has continued treatment with LEQEMBI over -- more than -- longer than one year. With
this, we believe that we are very confident that this target can be achievable with high
probability.
Haruo Naito
Now [Mr. Yusa], who is responsible for LEQEMBI in Japan.
Unidentified Analyst
Thank you very much, Mr. Wakao. As you said, in Japan, as has been already published in the
press, that size of the market and also if we can achieve the number of patients by quarter, we
believe that -- and we are confident in achieving ¥10 billion in Japan, particularly for this fiscal
year 2024.
So far, we have established a very strong relationship with KOLs that's why we have been able
to successfully start the initial stage. But for this fiscal year 2024, first, for patients with MCI, we
needed to raise awareness about the disease. The number of patients receiving prescription
exceeds 70% in Japan. There are some sites, which have already treated AD patients
moreover.
We have touched about the potential number of patients in Japan. By adding the education to
raise awareness of the disease, I think that the mild AD and MCI patients will start to seek
treatment. With increased number of patients at each site where pathway will be established,
capacity will be increased by such efforts.
For this fiscal year 2024, there will be patients who will be receiving treatment for over 6
months then at the sites where they started the initial treatment and also follow-up facilities or
sites where LEQEMBI will be dosed to patients, that means that even with the existing patient
pool, capacity for treatment will be expanded. Therefore, with these in mind, we are very much
confident in achieving the target in Japan in revenue.
Seiji Wakao
I'd like to ask for further follow-up on the U.S. and Japan as well. Regarding the trend of the
number of patients receiving LEQEMBI in the U.S., as of quarter 3 there are potentially 8,000
patients. What about the update? And 10,000 was also mentioned earlier, what is the current
status?
Haruo Naito
Wakao-san, regarding the number of patients, we would like to refrain from talking about the
number of patients because it is quite difficult to actually grasp the number of patients. If the
reimbursement claims data is available, that may be possible. But from calculating backwards
from the number of vials shipped, we cannot reach accurate number of patients on treatment,
for example. The number of vials shipped or sales data, these are real figures. Therefore, we
would like to utilize such real data, real numbers to discuss if you could understand this. I don't
know whether you agree with me, but that's our position.
Seiji Wakao
Understood. All right. Need in the United States are increasing. If you could give us your gut
feeling, I would like to seek your comment on that. Then for Japan, patients who are receiving
treatment over -- for over 6 months, are there enough sites for receiving such patients.
Haruo Naito
Okay. The gut feeling regarding the United States, Mr. Haruna is going to respond.
Katsuya Haruna
Thank you for your question. I am in charge of LEQEMBI in the United States. My name is
Haruna. Regarding the needs and also expectation for LEQEMBI going forward, we believe
that it is rising. As has been introduced by our CEO, we are seeing an increase in revenue
week by week. That has been obvious and shown in data. On a weekly basis, there is ongoing
upward trend. Therefore, as gut feeling, we believe we are feeling very powerful growth. Thank
you for your question.
Haruo Naito
Thank you for your question. In Japan, follow-up sites for accepting or receiving patients who
are receiving treatment for longer than 6 months.
Yes, of course. In each region or area, we have started a discussion in order to prepare follow-
up facilities and we are going to make adjustments as necessary in some regions.
As you see in this diagram, regarding the area where we are going to establish follow-up
facilities, we will hold the regional lecture meetings and initiating the sites as well as the follow-
up facilities, how to refer the patients to follow-up facilities, and that explanation briefing
session is being held throughout Japan. Therefore, I think that we will be ready to prepare
follow-up facilities responding to those who are on treatment for over 6 months.
Seiji Wakao
Thank you very much. I don't think that you have explained this, but regarding the changes of
the representative corporate officer, there will be two representative corporate officers. That
has been released today. What is the background for this at this timing. Although it was
mentioned in the press release, but why now? As the candidate to be the CEO after the current
CEO, is this the plan for the company to consider the most powerful candidate as the next
CEO, Keisuke Naito.
Haruo Naito
Considering the business model and the networking and hiring of talents, these are very
fundamental aspects of the company's business. We needed to change dramatically the
conventional way of doing business. This is not something applicable only to Eisai, but
applicable to -- commonly to all the companies in all industries. We -- also that there is a
necessity to do so. Therefore, for the succession of CEO means the generational change.
So tens of age should be the magnitude of change in succession. So in consultation with the
Board of Directors, we are making thorough preparation for the change. As a part of which is,
as announced today, to appoint a new representative corporate officer.
Did you ask when CEO is going to be changed? Are you asking about that as well? I'm not able
to respond to that question.
We are now entering in the very invention expansion phase for LEQEMBI and also the patent
extension period for LENVIMA as well. Therefore, at such a crucial, we'd like to refrain from
making any comment on when the CEO is going to be changed.
Next question from the attendee seated at the front of the room.
Kazuaki Hashiguchi
I'm Hashiguchi from Daiwa Securities. I have two questions on LEQEMBI. First, about the
impact from the competitive product, what is your expectation? And how is that taken into
account in the plan? The competitor's product may be approved in Japan as well as in the
United States even within this month. What is the estimated impact in terms of volume and
value?
Haruo Naito
My response -- the responses may be long, but Keisuke Naito will respond first.
Keisuke Naito
This is Keisuke Naito responsible for global LEQEMBI. I will be speaking at some length. There
is no direct comparison between LEQEMBI and donanemab, and clinical protocols are different
and I believe it is difficult to make a head-to-head comparison.
But in order to evaluate the available data, there are certain characteristics of LEQEMBI that
we consider to be important. First, regarding in the broad group of EAD patient as consistently
safety and efficacy have been demonstrated. Rather than selecting most responsive patient
group that is the most likely to respond, we consider it important to consistently show safety
and efficacy in large group of EAD subjects. There has been no tau stratification, and
irrespective of tau level, clinically significant results are shown. LEQEMBI not only in subset
based on tau level, but in broad subject group of -- broad patient group of EAD, safety and
efficacy have been demonstrated.
And the second clinical benefit is suggested for people who are receiving early treatment. At
least at last the fall in [indiscernible] subgroup, based on that data, according to our definition in
low-tau patient, 60% of such patients, CDR-SB improvement included a very favorable clinical
outcome was published at CTAD. Alzheimer's disease is progressive and irreversible
neurodegenerative disease. And earlier the diagnosis and earlier the start of the treatment, the
greater potentially the benefit. Therefore, in early stage in low-tau patient, favorable data was
shown and that is the uniqueness of LEQEMBI.
In addition, in low-tau patients, in order to identify low-tau patients, we are also focused on
biomarker research. A liquid biomarker, we believe, will be enhancing the value of LEQEMBI.
And the third is a favorable safety profile. There's no data comparing head-to-head LEQEMBI
and other drug, but ARIA incidents and timing we consider to be different from drug to drug and
that is also noted in the U.S. package insert. ARIA mostly caused LEQEMBI occur in early
stage of the treatment and mostly asymptomatic and nonserious and that is shown in actual
clinical usage.
In AD/PD 2024 held in spring this year, Professor Lannfelt presented the results using human
sample that showed lower binding of lecanemab to CAA than other anti-Abeta antibody. We
believe that this scientifically supports the clinical study results.
And the fourth is the efficacy, safety-related point. AD is progressive, chronic and
neurodegenerative. Even after the removal of plaque, the disease continues to progress. We
believe that this is very important in considering the treatment period.
In case of LEQEMBI, until the complete on Clarity AD study, treatment-emergent ADA

incidence was 10%. There is no effect of immunogenicity on efficacy, safety and
pharmacokinetics. It is suggested that ADA is not a limiting factor for continued treatment.
And regarding the efficacy and safety in case of continuous treatment over 18 months with
LEQEMBI, Clarity AD open-label extension study, 24-month data was presented at CTAD last
autumn. We expect to be able to present even longer-term results in future academic
congresses.
In order to reduce burden for the patients and caregivers, we are also developing SC-AI, which
will be less burdensome on patients. We believe that because of these, we can be confident
that LEQEMBI is the drug of choice for patients and HCPs.
And we anticipated the launch of donanemab and have taken that into consideration to a
certain degree in the revenue level of LEQEMBI going forward. But the four characteristics that
I've discussed about LEQEMBI can be a very important advantage for LEQEMBI.
As CEO discussed earlier in establishing pathway, we have made tremendous efforts on a

daily basis with HCPs. Infusion centers, CMS payers, efficacy groups and various other
stakeholders, with them, we have been able to build very strong relationship. Through
commercial activities every day after the launch, we have continued to make efforts and we are
confident of the evaluation of LEQEMBI in actual clinical use. Therefore -- and of course, we do
anticipate that a gradual pace donanemab may increase here, but we are also confident that
LEQEMBI will be able to maintain its strong share in the immediate quarters.
Kazuaki Hashiguchi
Second question between initial and maintenance treatment, what is the distinction between
the two in your submission? After how many doses will it be a maintenance dose? Or what is
the degree of reduction of amyloid plaque that is required to switch to maintenance dose?
Haruo Naito
That question will be addressed by Dr. Lynn Kramer.
Lynn Kramer
Yes. Thank you. I'm Dr. Lynn Kramer. I'm the Clinical -- Chief clinical Officer at Eisai. We are
discussing with health authorities the duration that would be needed with initial therapy before
converting to maintenance therapy. We expect that to be in the 18 to 24-month time frame, but
that's a review issue related to discussions with health authorities, which would include PMDA,
for example, and FDA. Thank you.
The person in the third row, please.
Fumiyoshi Sakai
My name is Sakai from UBS Securities. I'm sorry, I still wanted to ask a question about
LEQEMBI. You have shown numbers for LEQEMBI, spending ¥110 billion for this fiscal year
considering the SG&A expenses and R&D as a total and then this accounts for 20% of the total
SG&A and R&D expenses.
So are you -- do you want to continue this level of spending? pathway has been established
and SC will be introduced. The remainder of work is how the drug is going to be used.
Expansion of indications and monitoring on the safety will remain. Then the investment or
expenditure is expected to reduce or do you need to maintain a certain level of investment?
You touched upon competitors. Competitors are making a lot of money with different drugs. So
maybe they can double, but they can invest, double the amount of Eisai's investment in the
initial year after launch. So not maybe -- you don't have to talk about if. But if we are -- you are
making excessive investment into LEQEMBI, some analysts and investors may be concerned.
So that's why I think is hovering down dragging your share price down. How do you think?
Haruo Naito
Mr. Sakai, you always ask us very difficult question to answer. So I am wondering what to offer
in my answer.
For example, in fiscal year 2025, product P&L of LEQEMBI in the United States will be turned
into the black ink. The global product P&L, LEQEMBI product PL will be achieved in 2026. Of
course, we have to be careful in investing resources. For example, manpower resources in the
United States has reached almost maximum level. In my opinion, therefore, we do not intend to
further increase more than to date.
And in Japan as well, we do not intend to increase further than the current level. In other major
areas, which is Europe, in Europe, as well, by reallocating the manpower from Oncology to
Neurology, we do not intend to increase the total manpower. Therefore, we do not think that
there will be further expansion of SG&A expenses. I believe that we are at the peak in
expenditures for SG&A for this fiscal year.
In R&D expenses, preclinical A3-45, now once we see the completion of last patient in, in these
studies, then the R&D expenditures will end the peak. Therefore, I think that this fiscal year is
going to be the peak for both SG&A and R&D expenditures. And in '25, we would like to turn
into the blank ink in the United States. In the following year, we would like to turn into term
profitable in global markets.
Fumiyoshi Sakai
Understood. You have not taken into account the sales in Europe, but SAG, Science Advisory
Board, Neurology, once review is done and then approval is expected. However, regarding the
reimbursement, which may be delayed. Therefore, you do not incorporate the number in the
revenue for this fiscal year, right?
Haruo Naito
I think this has been already published, so I can say this. SAG was held once. However,
because of the review of other drugs, European Court of Justice, because of the background of
reviewers, some of them had the experience of getting involved in the review of competitors'
products, thus it was ruled not acceptable. Therefore, the members of the SAG was reviewed
again and then it was founded to be problematic.
Therefore, a result of the previous SAG meeting was canceled. With new members again, SAG
will be held again. We have not heard of the date yet. But inclusive of that, for EMA in the first
half of this fiscal year 2024 -- towards the end of the first half of this fiscal year, the results will
be provided. The result of the review will come around at the end of the first half.
In Israel, for example, the sales is being generated, although it is minor. The drugs are
purchased in the United States and that is included in the number for Europe. But massive
recording of the sales is not included in this number.
Next question, please.
Akinori Ueda
I'm Ueda from Goldman Sachs. First question is about your plan and your assumption for cost
of goods sold. This year -- this fiscal year, you assume that the cost of goods sold will increase.
Are there onetime factors leading to that? Or for this year, I think that there will be increase in
LEQEMBI, is there an impact from changing product mix?
Haruo Naito
That answer the question will be addressed by Mr. Tamura.
Kazuhiko Tamura
I am Tamura responsible for production. Thank you for your question. As you rightly mentioned,
in this fiscal year, LEQEMBI sales and cost of goods sold are estimated here. In comparison to
the actual -- from last fiscal year, cost of goods sold is higher this fiscal year and that is
because of a slight deterioration in the mix. Thank you for your question.
Akinori Ueda
As a follow-up. In the future, as volume increases, do you expect improvement, substantial

improvement?
Kazuhiko Tamura
Once again, Tamura speaking. Going forward, regarding the cost of LEQEMBI, large part of the
cost is accounted for by drug substance and partner, Biogen, that we have been working on
reduction of costs through various different measures.
I would like to cite some examples. Right now, drug substance is a manufacturer, the Swiss
plant of Biogen. This plant is highly automated. By continuing to produce drug substance at
some scale, we expect cost reduction. Yield improvements may be also achieved through
process improvement and we are making efforts towards that end. The trend we anticipate is a
declining cost over medium to long term.
As for formulation, the second CMO is already launched as a second place of production and
we expect the initiation of production. That will also will be -- that will also be reducing cost over
the medium to long term. With these efforts, we are reducing our cost of goods sold.
In the interest of time, we would like to now turn to media for their questions. If you have any
questions in the media, please raise your hand.
We do not see any raised being -- hand raised in this venue. So we are receiving questions
from those participating online.
Mr. Muraoka of Morgan Stanley.
Shinichiro Muraoka
My name is Muraoka, I am from Morgan Stanley. Regarding expenses for LEQEMBI, you said
that this fiscal year is the peak in expenditure. How much is included in the guidance for this
fiscal year? Actual result was ¥110 billion and ¥60 billion before that and ¥150 billion in total of
two companies. So how much is included in the budget. Could you please give us a ballpark?
Haruo Naito
Mr. Asano is going to respond to the question.
Toshitaka Asano
My name is Asano. I am in charge of planning. Regarding the complete numbers, we would like
to refrain from disclosure. But SG&A expenditure will be over the level recorded in last fiscal
year.
Shinichiro Muraoka
So as SG&A expenses will be up, but R&D expenditure will be down, is this correct?
Toshitaka Asano
We'd like to refrain from specifying numbers, but SG&A expenditures are expected to be more
than the record in last fiscal year.
Shinichiro Muraoka
Understood. I'd like to ask you another question, if I may, please. Regarding the subcutaneous
rolling BLA submissions have been initiated. But if you continue and then approval of the
subcutaneous formulation in the United States, when can we expect to get that before summer
next year or even earlier than that? What is the image?
Haruo Naito
Dr. Lynn Kramer is going to respond.
Lynn Kramer
Yes. Thank you for the question. I'm Lynn Kramer, Chief Medical Officer. As you recognized,
the subcutaneous autoinjector maintenance therapy rolling submission was initiated a day ago.
And in that submission, we have requested a priority review. We won't know whether our
priority review is granted until we hear from the FDA that the dossier is formally accepted,
which takes about 60 days. And at that time, we would know whether we have a priority review
or not. If we are granted priority review, that would mean we would expect approval 6 months
after -- approximately 6 months after that. So that's all I can say at this time.
Haruo Naito
Rolling submission was initiated, so various modules will be made in a rolling manner. And the
final submission will come in October. So then the time schedule, as has been explained now,
is expected for the completion of the review.
Shinichiro Muraoka
Well, it was hard to hear. So by October, rolling submission will be completed. And within 2
months, the rolling priority review will be confirmed, and then 6 months, will kick off from that.
Haruo Naito
Please check with the secretariat later.
Are there any questions from the members of the media?
I'm [Bano] from Nikkei newspaper. I have a question on China. This fiscal year, do you expect
¥3 billion revenue under other. PET, CSF are not widely available in China, but you still expect
this level of revenue? How will BBBM be used? And who will be the patients that will be able to
receive treatment?
Haruo Naito
Mr. Okada will respond.
Yasushi Okada
I'm Okada responsible for China business. Thank you for your question. As for the figure, ¥3
billion, this is a number in the pie chart presented by Mr. Naito, CEO. Mostly ¥3 billion is from
China, but that also includes Europe. So China, per se, is smaller than ¥3 billion.
And as presented today using the slides, centering on BBBM, screening will be carried out in
China. That is the plan that we are pursuing. There are three approaches to screening.
Patients who actually come to hospitals in comparison to those healthy, high-end patients are
target for screening. Then as a result of the screening, there will be a pathway to seek
consultation and care, the medical institutions.
PET and CSF are not so widely available, and therefore, we are preparing for BBBM. As for
scientific validity of BBBM as a screening method with Chinese KOLs, including retrospective
data, we are preparing a paper publication. It is not that what we are doing in China is
exceptional. Based on scientific data, we are making efforts to establish BBBM as a
scientifically valid screening method.
Who will be the target.
Yasushi Okada
Those who will be identified through the screening and it will not be covered under an IDL
immediately after the launch. So it will be out of the pocket. Therefore, a drug price will be high
at around ¥3 million. So in China, I believe our initial target will be high-end people. People
who are living in the cities on the coastal regions, such high-end people will be the initial
targets. That is already sufficient, and we have begun activities and potentially we expect a
very large number of potential target patients.
One more point, if I may, and this is a clarification question. Subcutaneous switch. By 2026, I
thought Mr. Naito, CEO, mentioned that you expect switching to be completed by fiscal 2026.
Do you mean that approval is expected by 2026?
Yasushi Okada
Launch and approval are being pursued with the target timing of fiscal '26.
From [Kakoho], Watanabe-san could you please unmute yourself?
My name is Watanabe, I am from [indiscernible]. Can you hear me?
Yes.
As a follow-up on the question of the previous person regarding manufacturing system, the
plant in Switzerland and the second side of production, CMO has been contracted. I'm sorry, I
may have misheard. I'd like to clarify. So that means that the CMO, drug substance will be
produced as well or filling into vials will be conducted by the second site at CMO. Is this
correct? This is my first question.
And the name of the specific CMO may not be disclosed, but Japanese company or is it foreign
capital affiliated or in each -- which region the production will be conducted. Could you please
share with us such information.
Haruo Naito
Mr. Tamura is going to respond.
Kazuhiko Tamura
Thank you very much for your question. My name is Tamura, I am in charge of manufacturing.
For drug substance, the U.S. plant of Biogen is being developed as the second site for drug
substance. For drug product, CMO in Europe is going to be utilized and it is being ramped up.
Unfortunately we have run out of time. We would like to conclude the financial results
presentation session. If you have further questions, please contact IR or PR of Eisai. With that,
we would like to end today's presentation session. We thank your attendance.
Read more current ESALF analysis and news
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5/17/24, 10:30 AM Eisai Co Ltd.

(ESALF) Q4 2024 Earnings Call Transcript _ Seeking Alpha

Eisai Co Ltd. (ESALF) Q4 2024 Earnings Call

Play Earnings Call

Haruo Naito - CEO, Representative Corporate Officer & Director

Conference Call Participants

Seiji Wakao - JPMorgan

Kazuaki Hashiguchi - Daiwa Securities

Fumiyoshi Sakai - UBS

Akinori Ueda - Goldman Sachs

Shinichiro Muraoka - Morgan Stanley

Unidentified Company Representative

And today, we made a press release. SC-AI, subcutaneous autoinjection, maintenance

In order to realize long-term administration, we believe that this is going to be a mainstay

And the final page is the consolidated financial forecast.

A - Unidentified Company Representative

By region, Mr. Haruna and Mr. [Yusa] are going to explain.

Now [Mr. Yusa], who is responsible for LEQEMBI in Japan.

Unidentified Company Representative

In case of LEQEMBI, until the complete on Clarity AD study, treatment-emergent ADA

As CEO discussed earlier in establishing pathway, we have made tremendous efforts on a

That question will be addressed by Dr. Lynn Kramer.

Unidentified Company Representative

The person in the third row, please.

Unidentified Company Representative

Next question, please.

That answer the question will be addressed by Mr. Tamura.

As a follow-up. In the future, as volume increases, do you expect improvement, substantial

Unidentified Company Representative

Mr. Muraoka of Morgan Stanley.

Mr. Asano is going to respond to the question.

Dr. Lynn Kramer is going to respond.

Please check with the secretariat later.

Unidentified Company Representative

Are there any questions from the members of the media?

Mr. Okada will respond.

Who will be the target.

Unidentified Company Representative

From [Kakoho], Watanabe-san could you please unmute yourself?

My name is Watanabe, I am from [indiscernible]. Can you hear me?

Unidentified Company Representative

Mr. Tamura is going to respond.

Unidentified Company Representative

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