Eisai Co., Ltd.

Eisai Co., Ltd.

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Eisai Co., Ltd.US flagOther OTC
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Q1 2016 · Earnings Call Transcript

Jul 31, 2015

APIChat

Executives

Ryohei Yanagi - Chief Financial Officer, Chief IR Officer Hideki Hayashi - Corporate Strategy and Planning; Chief Information Officer, CEO Office Takashi Owa - Chief Innovation Officer, Eisai Product Creation Systems Teiji Kimura - Deputy President, Neuroscience and General Medicine PCU, Eisai Product Creation Systems; Head of Global Discovery Research Kenji Matsumae - President, Eisai Japan; President, Integrated Community hhc Unit, Eisai Japan Terushige Iike - Chief Product Creation Officer, Eisai Product Creation Systems; President, Japan/Asia Clinical Research PCU, Eisai Product Creation Systems Ivan Cheung - Deputy President, Asia Oncology Head and Lenvima Global Lead; Eisai Global Oncology Business Unit; Deputy President and Fycompa Global Lead, Eisai Global Neurology Business Unit

Analysts

Ryoichi Urushihara - Nomura Securities Co., Ltd. Kazuaki Hashiguchi - Daiwa Securities Fumiyoshi Sakai - Credit Suisse Securities Japan Limited Atsushi Seki - Barclays Securities Japan Limited Hidemaru Yamaguchi - Citigroup Global Markets Japan Inc.

Shinichiro Muraoka - Morgan Stanley MUFG Securities Co., Ltd.

Unidentified Company Representative

[Interpreted] Thank you very much for gathering out of your busy schedule. Now it’s time to begin the financial briefing for the results for the first quarter of fiscal year 2015.

Before we invite the speaker for presentation, please make sure that you have the handouts. There is presentation materials, the deck of slides, press report and reference materials, and news release that were announced today.

There are two news releases today. Do you have all of the materials?

If any of the documents is missing please raise your hand. Next, I would like to introduce the directors who are in attendance today.

Hideki Hayashi, Representative Corporate Officer; CFO, Chief IR Officer, Bill-Hei [ph] Yanagi. We invite the speakers for presentation.

The first part, the financial part, will be discussed by Mr. Yanagi; and operational part will be presented by Mr.

Hayashi. Mr.

Yanagi, please.

Ryohei Yanagi

[Interpreted] I like to cover the financial section of the presentation. Thank you.

This is the first slide. Here is the result to consolidated statement of income based upon IFRS for our first quarter fiscal year 2015.

First, revenue, our top line, ended at ¥139.2 billion, due to the growth of the global footprint, up 5% year-on-year. We achieved the business plan and against the focus for the first-half we have been starting the year strongly.

And cost of sales improved from 36.2% last year to 35.5% this year due to the improvement of product mix. As a result, gross profit ended at ¥89.8 billion, which was up 6% year-on-year.

At Eisai in order to maximize the future enterprise value, we have been making proactive investment in R&D activities particularly focusing on oncology and dementia area. We have been making proactive investment at ¥32.7 billion, which was 12% up from the previous year and accounting for 23.5% of revenue.

Among global pharmaceutical companies we are one of the top tier companies in terms of R&D expenses. From a different viewpoint, increase in R&D expense is in the amount of ¥3.6 billion was due to the upfront payment of ¥3.6 billion from Biogen in the first quarter last year for Alzheimer’s disease programs, the same amount.

Therefore, there was such upfront payment last year but not in this year. Therefore without this factor, the R&D expense is still almost flat from the previous year.

For your information, impacts of Forex excluded from that and then that was only 90% of the previous year. And dementia area and oncology are areas where we make proactive investments but through the selection and concentration we have made controlled expenditures in R&D activities.

As for SG&A expenses, as you are aware, during the first quarter in the United States we carried through the structural reforms that incurred about ¥1 billion as a one-time cost, including this impact ¥49.9 billion was the results for the SG&A expenses for the term up 6% from a year earlier. This was contained within the increased ratio of gross profit, therefore not harming the profitability.

Through organizational effort to reduce our expenses, particularly in the optimization of the marketing investment for BELVIQ in the United States, these were helpful in improving the profitability. Operating profit stood at ¥7.6 billion, which was 90% of the previous year.

However, which are over achieved via internal business plans as well as we have made a very strong start for the year and compared to the first-half forecast. And ¥2.1 billion was the impact from Forex, although this was 90% of the previous year.

On a CR basis, operating profit grew 14% from the previous year, so still showing the potential of double-digit growth. Accordingly, profit for the period was ¥5.5 billion, which was 96% of the previous year.

The ¥1.1 billion was the Forex for your information, considering that and 16% up growth year-on-year was the potential for growth. Compared to the focus for the first-half as well the business plan, we made a very solid start of the year during the first quarter.

Next slide. Here is the waterfall chart explaining the breakdown revenue migration.

Last year, ¥132.8 billion was the revenue recorded last year. In Japan, due to the measures to promote generics taken by the Japanese government, the Japanese business could not recover.

However, this impact was contained within the plan due to the expansion of global brands, achieving ¥4 billion increase and expansion of business in China and Asia, adding ¥5.1 billion and these overcome the impacts in Japan, and up ¥6.4 billion year-on-year. And the result of the - revenue for the quarter was ¥139.2 billion.

Next, breakdown of operating profit migration, again, shown in this waterfall chart, ¥8.5 billion operating profit was recorded last year. Accordingly to the changes in the revenue we were impacted negatively in Japan due to the measures to promote generics.

However, expansion of global brands brought about ¥3.1 billion and ¥2 billion was contributed by expansion of business in China and Asia. As I said earlier, optimization of marketing investment for BELVIQ in the United States brought about the positive impact of ¥2.3 billion.

All-in-all excluding the one-time factors, the ¥13.2 billion was the operating profit for the first quarter. However, as I said earlier, during the first quarter last year there was an upfront payment from Biogen of ¥3.6 billion in the R&D expenses in a contra account and also lump sum payments were made due to the structural reforms in the first quarter in the United States, ¥2 billion as a one-time payment.

So subtracting ¥5.6 billion one-time cost and then the difference from the previous year was ¥0.9 billion year-on-year and the result was ¥7.6 billion operating profit for the first quarter. At Eisai, we have advocated management based upon ROE.

They are strongly co-related with shareholders’ value, margin, leverage and turnover. As for our financial strategy, we are trying to optimize this.

First margin or ROS of Fixed Asset Monetization or FAM projects are implemented. We are implementing continuously over several years projects to monetize fixed assets including securities and we are also implementing several projects this year as well.

And interest rates to be reduced through refinancing and on the average about - there has been a reduction of interest rates of 2.5 percentage points and generating about ¥1 billion cash for the year. As for leverage focusing the financial soundness, whereas, in the balance sheet management has been focused over several years.

In June this year, ¥30 billion was of straight bonds were redeemed and now the balance of straight bond is almost zero. And now gross debt is ¥217 through, almost all through in just financing or from financial institutions.

Next, turnover. In order to resolve the imbalance of the cash globally and we’ve implemented repayment of capital of $0.5 billion from the U.S.

subsidiary last year. And in order to resolve the cash imbalance between Japan and the U.S.

And through global cash management system we tried to improve the circulation of cash in group to reduce borrowing from outside. And for working capital management, CCC or cash conversion cycle is to be controlled through projects.

We are watching AR, AP and inventory level, particularly for the days in accounting receivable outstanding in Japan now comes from whom - our AR is collected within 90 days, accounts for almost the half, and through such working capital management. And now ¥14 billion cash were generated during the fiscal year of 2014.

And we target about ¥10 billion cash generation during this fiscal year as well. Margin, leverage, turnover are being simultaneously controlled in order to enhance the enterprise value through ROE management.

Next, balance sheet, here you see the safety or soundness index, KPI. A year earlier, the equity was about ¥500 billion, now it’s up to almost ¥600 billion this year.

And shareholders’ equity ratio at the end of June was almost at 60%, showing the very sound and healthy structure. However, over the time axis you can tell that, during the first quarter every year, due to the year-ended dividend payment, net debt tends to be increased during the first quarter.

However, at the end of June, net DER was 0.11, extremely healthy level. Furthermore, towards the end of March next year, we believe that this index will continue to be improved.

As I said earlier, fixed asset monetization projects are being implemented already. North Carolina plant has been already announced because of the transfer of the plant to Biogen.

According to the progress of these measures and by the end of this year or next fiscal year, net cash zero maybe achievable or profitable going forward. Based upon this, based strong balance sheet and proactive investment for growth and stable dividend will be maintained.

And dementia and oncology will be the area of focus. And M&A and partnership will be considered in conducting proactive investment.

For financing this, ¥200 billion level of debt capacity is secured based upon the strong balance sheet, and a credit line of ¥200 billion has been secured. For making this decision on the investment, VCIC, Value-Creative Investment Criteria, net present value or IRR spread based upon risk-adjusted hurdle rate, in order to select investment that will improve enterprise or shareholders’ value.

As for dividend policy, there are various opinions as regards to policy, but at Eisai we will not aim for fluctuating dividend policy based upon P&L of our one-term but stable dividend based up mid- to long-term balance sheet. So KPI it should be DOE 8%, above our capital costs.

Therefore based upon balance sheet we will determine the dividend. And dividend is not a transaction on P&L, but it’s a part of the capital transaction, therefore, the optimal dividend policy based on optimal capital structure.

These have been announced and supported through the literature globally from MediIntel [ph] report, also mentioned this optimal dividend policy based on the optimal capital structure. As we have a very strong balance sheet, proactive investment for growth, as well as the stable dividend policy will be maintained in order to enhance the shareholders’ value in mid- to long-term.

Next, this is the last slide of my part. As I said today, we had a very strong and steady result for the first quarter.

Therefore, there have been no changes to the P&L items. As regards to the focus for the full-year, ROE level is not satisfactory currently.

However, we will conduct the management based upon ROE in the mid- to long-term basis and 8% above capital cost. And double-digits ROE will be aim at over 2% of the equity spreads, and our equity spread was 4% on average past ROE, excluding [indiscernible] factors was 12% over the past 10 years.

As I said earlier, based upon the soundness of the finance structure and also the balance sheet, and we have not changed the policy to pay ¥150 per share as a dividend for the full-year. Thank you.

Hideki Hayashi

[Interpreted] For my point, I’d like to present our activities on our return to growth trajectory I would like to cover four global brands, Japan pharmaceutical business, China, Asia and next generation Alzheimer’s disease treatments. I will report on each of these topics.

Halaven, Lenvima, BELVIQ, Fycompa these are four global brands. In the first quarter, revenue was ¥14.3 billion, it was 145% year-on-year, strong growth was achieved.

I would like to discuss in detail each of these products. First Halaven, the first quarter revenue was ¥10.1 billion, 124% year-on-year, on a quarterly basis, ¥10 billion for the first time.

In Japan, in addition to oncology medical reps 130, 630 Integrated Community HHC unit sales-force are deployed. With this duet formation we were able to achieve ¥1.8 billion revenue, 117% year-on-year.

In Americas, after the launch in the United States and Canada, in Brazil and Mexico, Halaven was launched in EMEA. In Asia 130% year-on-year, a 199% year-on-year growth respectively were achieved with the approval of indication for second line treatment for metastatic breast cancer.

As it was announced yesterday, in Japan, U.S. and Europe, we achieved simultaneous submission for soft tissue sarcoma.

This was announced in June at ASCO. This is a comparative study of Halaven combined with the Dacarbazine.

Dacarbazine is a standard of care drug. And in comparison to that - this is a comparison between Eribulin and Dacarbazine, and in comparison to the standard of care, statistically significant two-month extension was demonstrated for OS.

For the first time, the extension of OS was demonstrated; in monotherapy, support the efficacy on overall survival was demonstrated. Next Lenvima, in February, after launching in the United States in Japan in May, and EU in June a launch was achieved.

In the first quarter, the revenue was $1.3 billion. It was above the plan.

And globally more than 900 patients are given Lenvima for thyroid cancer. And we have received a number of positive feedbacks.

In May this year NCCN thyroid cancer guidelines was adopted with positive statement. In Nature Reviews and in a renowned journal Lenvima was introduced.

So far, we were able to make a very smooth start of global launch of Lenvima. As for lifecycle management of Lenvima, we have also seen some major progress.

This was also announced in ASCO in June this year in oral presentation. This is the second line renal cell carcinoma study in combination with Everolimus.

As shown here Lenvatinib plus Everolimus arm in comparison to Everolimus single monotherapy, it demonstrated nine months extension of PFS. Objective response rate in overall survival, secondary endpoints, favorable efficacy results were also obtained, in addition to PFS at the primary endpoint.

There are two important signaling pathways for malignant growth in renal cell carcinoma mTOR and VEGF. And these two are inhibited at the same time and this led to incremental efficacy.

And this is the first combined therapy of molecule targeted agent. With this data on Monday this week from FDA breakthrough therapy designation was granted.

Going forward, based on this data, we would like to consult with the authority, and I would like to explore possibility of submission using this data. In addition to RCC, Lenvima additional indication development is underway.

Therefore, Hepatocellular carcinoma, 940 subjects enrollment was achieved in this month. In fiscal 2016, we plan to file submission.

Combination regimen with immune checkpoint inhibitor KEYTRUDA with regard to this, for many cancer types are showing here. Phase Ib or Phase II studies are initiated this month.

Next Fycompa, for generalized tonic-clonic seizure for adjunctive indication, additional indication, in the United States and in EU, in June, we obtained approval. And for partial-onset seizures and PGTC for these two indications, in Japan, we filed submission for adjunctive therapy as for this GTC, generalized tonic-clonic seizures.

This is one of the most severe epilepsy seizure types, and this may lead to potential risk of severe injury from sudden falls or SUDEP, sudden death from epilepsy. And in the United States, due to SUDEP, approximately 3,000 die per year.

And these patients are in their 30s to 40s, and they are young. And therefore, in cumulative life years lost, it is a 100,000 potential life years lost, but this is the second highest after the stroke.

This is an intractable disease and against this GTC with Fycompa, frequency of seizure was reduced by about 77%, and for 13 weeks, in more than 30% of the patients seizure free status was achieved. Such high efficacy was demonstrated with the existing therapy, poorly controlled patients may benefit greatly.

By having additional indication for PGTC, Fycompa may be used for 80% of epilepsy population. With this good efficacy with additional indication, we would like to accelerate the pace of growth.

Next BELVIQ. In the first quarter, it was a - revenue was a 145% year-on-year at ¥1.5 billion.

SG&A was controlled to approximately 60% year-on-year. Based on the past experience, we have improved the efficiency of marketing and we have promoted laser-focused commercial mix to be more specific.

Number of sales force was optimized about 90 Eisai sales force and 230 syndicated sales force are used to optimize. And the patients are paying no more than 75% under a program to improve affordability for patients and we are also implementing DRTV focused on high seasons.

And as a result of these more efficient commercial activities, we were able to achieve these results. And once daily dosing formulation, submission is also planned this year.

Regarding BELVIQ, we will continue to expand expenses in a balanced fashion. As for Japan Pharmaceutical Business, ¥69.8 billion was revenue for the first quarter, segment profit was ¥31.3 billion.

Towards achieving annual target, we were able to have a very good start. In oncology, in addition to Halaven and Lenvima was launched, and with these two products, ¥5 billion, or 129% year-on-year was achieved.

Lunesta, HUMIRA, and Lyrica are also steadily expanding in sales. Aricept is - with Aricept, we are promoting a contribution to patients with dementia with Lewy bodies and we’re progressing close to schedule.

As for generic business, clopidogrel tablets and docetaxel intravenous infusion are launched. And we are also making efforts to improve expenses, cost efficiency efforts I made, and we were able to achieve better than last year results.

As for China and Asia, revenue in the segment of profits, both achieved double-digit growth. In China, in the first quarter, revenue was ¥12.9 billion, a 141% year-on-year, towards annual target of ¥50 billion.

The progress is very good, and we are making smooth progress with newly established local management structure in autonomy model in Asia higher than 20% growth is continued. Especially in the next-generation core market, India, Indonesia, Vietnam, business growth is accelerated.

And at the same time in Asia, Halaven, Fycompa, these new products are launched in increasing number of countries. Halaven included, we have available pricing to improve patient access.

Next, I would like to discuss the development of next-generation Alzheimer’s disease treatment. First, Anti-A-beta protofibrils antibody BAN2401, in June this year, seven interim analysis of 500 subjects was carried out.

Before the end of the year, top line results of Phase II study is expected. As for in-house developed BACE inhibitor E2609 has a Stage A or Safety stage of Phase II study ongoing.

And before the end of the year, we expect top line results from Stage A. As for our strategic partner in Biogen, it is developing Aducanumab in regarding Aducanumab recently at AAIC, Phase Ib data interim analysis related latest data was presented.

And this shows that with Aducanumab administration, amyloid plaque was decreased in dose-dependent fashion and not only that amyloid plaque decreased and slowing of cognitive decline was shown to have significant correlation for the first time. This is a very interesting and encouraging result.

Amyloid plaque reduction and the correlation with the slowing of cognitive decline were difficult to be shown before. But with this amyloid hypothesis wise supported, and the probability of developing a drug and obtaining approval was in-housed.

Next month with early Alzheimer’s disease patients, Phase III studies will be started. This is my last slide.

Fiscal 2015 business plan towards achieving this plan Halaven, Lenvima, BELVIQ, Fycompa, these four global brands will be expanded and will be grown. And we have also sustained growth of Japan Pharmaceutical Business.

And in China and Asia, we aim to continue high level of growth. With these, we aim to return to the growth trajectory in core business.

In dementia and in oncology, these higher priority franchises there will be focus on R&D investments to control cost, and structural reforms were implemented this year in the United States. And as we have already announced, our North Carolina plant will be transferred and strategic options - a multiple strategic options are implemented in determinant fashion.

And with these, we aim to return to growth trajectory in both revenue and operating profit in fiscal 2015. Thank you for you kind patience.

Operator

[Interpreted] [Operator Instructions] Are there any questions?

Ryoichi Urushihara

[Interpreted] Thank you very much for your presentation. My name is Urushihara.

I’m from Nomura Securities. I have three questions.

One, first question is about the lenvatinib and PD-L1 antibody, combination therapy study. So do you see any possibilities of conducting studies in the future?

Ryohei Yanagi

[Interpreted] Chief Scientific Officer, Dr. Owa, is going to respond to your question.

Takashi Owa

[Interpreted] My name is Owa. Thank you very much for your question.

My first answer to the question, PD-L1 antibody and the lenvatinib, but there is a possibility of conducting study in the future, based on the combination therapy. PD-L1 antibodies are being developed by several countries.

But at this moment, we don’t have any specific as regards to - with whom we are going to partner with in connecting clinical studies. But we would like to a take proactive stance towards conducting studies and mitigating the possibility.

Ryoichi Urushihara

[Interpreted] So you have the intention to conduct the study during the future?

Takashi Owa

[Interpreted] Scientifically, we believe that we have a high-level of intention to conduct the study during the future. However, PD-1 antibody, as well as the PD-L1 antibody for which types of cancer and which company’s players are going to develop their products in which markets?

We needed to review closely before implementing the studies actually, otherwise we cannot make a clear pathways towards approval and submission. And we needed to take into account that preclinical data, as well before considering the actual implementation of clinical study.

Ryoichi Urushihara

[Interpreted] And then I would like to ask a question of Alzheimer’s disease, plaque reduction, as well as the correlated with the reduction of the slowing down or the impairment of the cognition and using that this will be conducted by - through the - confirmed through the Phase III studies? In the second quarter presentation, further on or even before, the patients with even before prodrome period will be captured in that studies.

And then in the FDA discussion with Eisai, do you think that - how long do you think that these process will pick?

Ryohei Yanagi

[Interpreted] Neuroscience and General Medicine PCU, Head, Mr. Kimura is going to be respond.

Teiji Kimura

[Interpreted] My name is Kimura. Thank you very much for your question.

Currently, based upon our discussion with our FDA and for symptoms of AD, symptoms are needed to be improved. Otherwise, drugs used for the treatment of AD is cannot be approved or reduction of the A-beta plaque or through MRI and autopsy of a brain was confirmed.

Even only with that - only with that the drug could not be approved as a treatment. However, for the future, there will be many more knowledge.

Therefore, the will impact the FDAs position. However, based upon the current situation, FDA is looking at the symptoms or changes in the symptoms.

Ryoichi Urushihara

AR.

Hideki Hayashi

[Interpreted] And now, cash position will be generated in the amount of ¥10 billion during this fiscal year.

Ryoichi Urushihara

[Interpreted] Next year, do you think that cash over double digit number will be continued to be generated from next year onward?

Hideki Hayashi

[Interpreted] CFO, Ms. Yanagi will respond.

Ryohei Yanagi

AR

We have been taken these measures in a considerate manner. If there are any loss of opportunity and then we stop that.

We do not intend it to shorten possibly the AR collection dates even with the loss of opportunity, so based upon the assumption that there are no - or loss of opportunity and taking enough time to gradually implement - to improve the competition of the cash position. And therefore please understand that there has been no loss of opportunities.

In response to your next question, ¥14 billion in cash was generated in the last fiscal year, because it was the first-year of implementation, therefore, we enjoy the balance-amount [ph]. And this year we expected to see ¥10 billion generated, because we have extended - expanded the scope of the project to other accounts that were not included in the last fiscal year, and but we have not identified a final target yet.

But we will have an update going forward.

Ryoichi Urushihara

[Interpreted] And next fiscal year onward, is it possible to generate the same level of a double-digit cash generation?

Ryohei Yanagi

ARs

Hideki Hayashi

[Interpreted] Attendees seated in the third row please.

Kazuaki Hashiguchi

[Interpreted] I’m Hashiguchi from Daiwa Securities. I have a number of questions.

First, regarding the business performance. The presentation was in comparison to the previous year, but against the plan, what is the progress.

In the first-half operating profit, plan was ¥10 billion and the - under the impression that progress is a high and accelerated pace. Could you describe this?

Hideki Hayashi

[Interpreted] As we presented earlier, there are a number of expense items. As represented by BELVIQ, we have been very disciplined in expense control, and expenses are controlled below the pace of growth of gross profit.

And I think we were able to see the effect of that. And in comparison to what was expected initially in the United States, the cost for structural reform was lower, and because of these multiple factors, these multiple factor is impacted.

And we were able to achieve more than 10 out of 10 in multiple regions against the plan. And, therefore, in comparison to originally planned first quarter numbers, we were able to achieve higher.

Regarding revenue, as for Aricept in Japan, it seems that it is doing strong. But what is the latest performance.

The government’s target is that generics should be 80%. And after that government policy was announced, some of your competitors or peers are saying that they have seen some difference.

Mr. Matsumae, Eisai Japan will respond.

Kenji Matsumae

[Interpreted] I’m Matsumae, responsible for Japan Pharmaceutical Business. Thank you for your question.

Regarding Aricept, in Japan for the promotion of a generic to achieve 80% level against that government policy, the current situation is that, well, certainly the number of generics we expect will grow. And, therefore, we consider the environment.

We don’t - I think that the environment is easy. However, regarding Aricept, in last year on September 20, the approval for additional indication of dementia with Lewy body was given and we have been conducting disease education efforts.

As a result of the efforts in comparison to last year, DLB, dementia with Lewy body patients’ administration of Aricept is increasing. And we believe that we were able to mitigate the impact of promotion of generics.

As for Aducanumab in the much information meeting, research and development expense prospects were discussed and what was expected.

Kazuaki Hashiguchi

[Interpreted] Then in R&D level that you’re considering right now, is there going to be a difference or change?

Hideki Hayashi

[Interpreted] Chief Product Creation Officer, Mr. Iike will respond.

Terushige Iike

levy

Hideki Hayashi

[Interpreted] Any other questions?

Fumiyoshi Sakai

[Interpreted] My name is Sakai. I’m from Credit Suisse.

I have two questions. First question is about how to focus the second-half?

And during the second quarter, the one-time payment will be incurred from the transfer of the North Carolina Plant to Biogen. But in the first-half, Aloxi generics will enter into the market.

You have not disclosed the numbers, but therefore we cannot know the number of the impacts yet? So for profit plant and through the structure reform efforts that have been accounted for in the second-half forecast, that’s my understanding.

Is my understanding correct, that means that we would like to avoid seeing surprise, could you please confirm on your position?

Hideki Hayashi

[Interpreted] Through the structural reforms in the U.S., the personnel cost will be reduced, that is one thing. As I said earlier, there are several strategic options, which will be carried out in a resolute manner.

We are not able to disclose specifics. There are various plants outside, but these are already incorporated plants.

And global four brands, business plan more than the first quarter and second quarter and more in third quarter, we are going to expand the sales, particularly in the sales of Lenvima and Aloxi generics evolution [ph] is expected. However, we’d like to take other options and measures in order to overcome the negative impact.

Fumiyoshi Sakai

[Interpreted] Thank you, understood. BAN2401, according to your slide, interim analysis has been conducted for 500 subjects.

I believe that’s what design study was implemented. So a group of 50 patients will be involved.

And then every time they are involved and then those will be determined after conducting interim analysis. And then, I think that you’re targeting 800 subjects and there will be three more interim analysis going forward, is it correct?

Hideki Hayashi

[Interpreted] I do not understand this very well. But out of the 800 patients, I think, 66 sites, that means the 10 patients per site or 12 or 13 patients per site will be enrolled.

Then when the analysis are good, then those will be allocated to the effective arms, and then responders and non-responders will be identified by the site monitors.

Fumiyoshi Sakai

[Interpreted] So how do you block such un-blinding effect of these interim analysis?

Hideki Hayashi

[Interpreted] Mr. Iike is going to respond.

Terushige Iike

[Interpreted] Thank you very much for your question. First, regarding the mechanism by interim analysis, your understanding is correct.

Every time 50 patients are involved, interim analysis will be conducted 650, 700 enrolled and the maximum 800 patients are to be enrolled. So at such time interim analysis will be conducted.

Fumiyoshi Sakai

And you pointed out the possibility that site monitor may identify they are responder or non-responder. The independent data monitoring committee is making decision or adjudication the result is not informed to us.

Terushige Iike

[Interpreted] Continuation or discontinuation, that’s the only adjudication they would tell us. So other than that, we cannot be informed and then active six groups are now run, and we do not have this specific information for the each dose of the each group.

So site monitors cannot tell allocation of doses to each arm and the result of each arm.

Hideki Hayashi

[Interpreted] Are there any other questions. Yes, attendees seated in the back row, please?

Atsushi Seki

[Interpreted] I’m Seki from Barclays. I have few questions.

First about Alzheimer’s disease, drug Aducanumab Phase III design, in what way is Eisai involved in designing Phase III study? And Phase Ib data that was presented at AAIC, ARAH [ph] was not mentioned.

So is there something that you could share with us, please.

Hideki Hayashi

[Interpreted] Mr. Kimura will respond.

Teiji Kimura

[Interpreted] Thank you for your question. As Mr.

Iike mentioned, we Eisai have the right to exercise options and basically Biogen Phase III planning is done. As for ADI, Biogen will be reporting, it will be up the judgment of Biogen.

So it will be difficult for Eisai to give instructions. Second question on Lenvima, on metastatic RCC breakthrough status was given.

With this new filing will be submitted, although submission would be filed at an earlier timing, Dr. Owa will respond.

Takashi Owa

[Interpreted] Thank you for your question. So first of all, well this goes without saying for, Mr.

Seki, while breakthrough its therapy, the monotherapy or combination therapy. In comparison to existing therapy, by far the strong efficacy has to be shown in one or two or more endpoints.

And if that is shown priority review or accelerated approval potential are also taken into consideration by the authority. And as of now, looking at the data of Phase IIdata alone regarding submission, we believe that it is possible to help a forward looking or positive negotiation with the authority.

But it’s the nature of the data and we’ve almost had similar data. And this primary endpoint PFS was a shift with other drugs.

Afinitor and Everolimus head-to-head comparison results were announced. And this area is very crowded place in terms of regulatory strategy and it has become quite tight.

So timeline is something that we’re keenly aware of. If we are slow, we will lose opportunities.

So with the data that we have, we have to be proactive, that is my thinking. Thank you.

Breakthrough therapy startups maybe cancelled. So I hope that you will make progress sooner.

Third question on medium-term plan, I believe a responsible person was named, and press release was announced to that effect.

Atsushi Seki

[Interpreted] And this is a question regarding formality, but for how many years, operating profit or CAGR, what are the indicia indicators that will be used? What is the thinking behind the achievement of medium-term plan?

Hideki Hayashi

[Interpreted] Medium-term plan will begin from next year and we have just begun discussion. And as of now including the points that you’ve included KPIs, we are evaluating a number of factors.

And as of now, there is nothing that we can report to you in specific terms. Thank you.

Any other questions?

Unidentified Analyst

[Interpreted] My name is Misno [ph]. I’m from the Tokio Marine Asset Management.

I have a question about the submission for SPC. For Halaven, how - what is - how big the patient population is for soft tissue sarcoma?

Hideki Hayashi

Owa

Takashi Owa

Owa,

However, there are not - there are no treatment for this. And often designation in Japan, as well as in the United States has been granted.

Therefore, we would like to utilize this often designation, in order to meet the medical needs and to make contribution to patients and extending the reexamination period and utilizing this merits we would like to maximize the potential of Halaven. Thank you very much.

Unidentified Analyst

RS

Takashi Owa

As for Breakthrough Therapy designation, based upon a data for the second-line treatment at least prior a TKI treatment is conducted and [indiscernible]. These two are - the two TKI treatments approved, and then those patients who failed with these TKI treatment on second-line therapy regimen, Everolimus, the Afinitor combination.

It’s the scope for which designation is granted.

Unidentified Analyst

Another question as regards to Alzheimer’s disease, Alzheimer’s compound has been dropped, and one has been upgraded in terms of phases of development. Could you please describe, I believe, it is already a compound and Mr.

Iike is going to address your question.

Terushige Iike

[Interpreted] In our pipeline, are you asking about our pipeline?

Unidentified Analyst

[Interpreted] Yes.

Terushige Iike

[Interpreted] In the briefing of financial result, thank you for reviewing our appendix to the briefing. Alzheimer’s symptoms improving treatments are included in our pipeline.

And I don’t think that we have enough time to explain the mechanism action. But based upon the different mechanism action, the compound that has been dropped faced the trouble in Phase I.

Therefore, the development for that compound has been discontinued. And another different program now in Phase I with different memo-A is now included in our chart.

Thank you very much.

Hideki Hayashi

[Interpreted] Thank you. Are there any other questions, please?

Are there questions from participants on the phone?

Unidentified Company Representative

[Interpreted] There are two, who wish to ask questions. First, from Citigroup Securities, Mr.

Yamaguchi. Mr.

Yamaguchi, please. Citigroup Securities, Mr.

Yamaguchi, are you online?

Hidemaru Yamaguchi

[Interpreted] Yes, this is Yamaguchi, Citi, speaking, Can you hear me?

Unidentified Company Representative

[Interpreted] Yes, please go on.

Hidemaru Yamaguchi

[Interpreted] I have one question. Market cap of Eisai has been high.

After partnership with Biogen there is much expectations from the investors. But market cap is high with that.

Equity financing may be possible to improve balance sheet. Such an option maybe expected.

There may be high expectations for such an option. If you could, comment on this please.

Unidentified Company Representative

[Interpreted] Mr. Yanagi will address your question.

Ryohei Yanagi

[Interpreted] As we reported today, net cash position, we are almost close to net cash position. And as for our financing, according picking-order-theory [ph] cash and then debt, we have debt capacity of ¥200 billion.

As of now it is not immediately urgent to do equity financing. So no immediate possibility, however, depending on the changes in the circumstances and investment possibilities, we do not deny the possibility of equity financing.

However, because of a very strong balance sheet that we have right now it is not contemplated at the moment. Thank you.

Unidentified Company Representative

[Interpreted] Thank you. From Morgan Stanley, Morgan Stanley Mitsubishi UFJ Securities, Mr.

Muraoka. Are you connected?

Are you on the line? Mr.

Muraoka, are you on the line.

Shinichiro Muraoka

[Interpreted] Yes, hello, this is Muraoka speaking. Thank you very much for the opportunity.

About Lenvima I have a question. Earlier, you mentioned that you are looking for a marketing partner for Lenvima.

Currently, the value of Lenvima is being expanded. Are you going to market this product - sorry [ph], or Lenvima, [ph] Ivan Cheung?

At the end of March, you got the 2,500 people, but now you mentioned 1,000 in the United States, what is the more realistic number based upon the current situation?

Unidentified Company Representative

[Interpreted] Lenvima Global Lead, Mr. Cheung, Ivan Cheung, will respond.

Ivan Cheung

Thank you for the question. Your first point about partner from a marketing standpoint, this is Eisai’s crown jewel in the oncology portfolio.

We have every confidence that we can conduct Lenvima business by ourselves, extremely sufficiently as you can see in the first quarter results, very, very good. For your second question about the patient number of 2,500 patients, this number is a global number including the U.S., Japan and Europe.

On the slide you saw 1,000 patients. That’s for the U.S.

market only. That’s the difference and I’m happy to report that so far the progress is doing very well.

Of course, on the slide you saw the first quarter sales result. Actually, July is doing even better.

So I think that we are on a very good track. Thank you.

Shinichiro Muraoka

[Interpreted] I have one question. This time the poison pill was extended, the so called poison pill was extended.

And I think this was done according to the general practice, but are any acquisition offers or risk of acquisition, is that in the background of extending the poison pill.

Unidentified Company Representative

[Interpreted] Mr. Yanagi will address your question.

Ryohei Yanagi

[Interpreted] Thank you for your question. This is Yanagi speaking.

At least for now, to the best of our knowledge the hostile or friendly there is no takeover offer. And as for the extension of the plan, there is an independent committee composed entirely of outside directors.

And after a fair voting it was decided that the plan, it should be extended. Thank you.

Thank you very much for your questions, Mr. Muraoka

Unidentified Company Representative

[Indiscernible] Are there any questions from the floor in the auditorium? If not, with this we’d like to conclude the financial results presentation section for Eisai Co.

Ltd. Thank you very much for coming here in such a hot weather.