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Executives

Haruo Naito – President, Representative Corporate Officer and CEO

Hideki Hayashi – Deputy President and Chief Product Creation Officer

Analysts

Ryoichi Urushihara – Nomura Securities Co., Ltd

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

Atsushi Seki – Barclays Securities Japan Limited

Eisai Co Ltd (OTC:ESALF) Q4 2013 Earnings Conference Call May 13, 2014 8:00 AM ET

Unidentified Company Representative

We would now like to begin Financial Results Presentation of Eisai Co., Ltd for Fiscal 2013. Thank you for taking your time. First please make sure that you have the materials; PowerPoint presentation and financial reports and reference materials. If any of the documents is missing, please raise your hand.

I would now like to introduce the attendees; President, Representative Corporate Officer and CEO Mr. Haruo Naito. We would like to ask Mr. Naito to begin presentation right away.

Haruo Naito

[Interpreted]

I'd like to begin my explanation from the outline for the financial results for FY 2013 as well as policy and direction on operation for FY 2013. First FY 2013 results was ¥600.4 billion which was up 5% from the previous year. [Indiscernible] over ¥40 billion has impacted by the weaker Yen is included in this result.

Gross margin, the value was up 3% from the previous year. We have resulted improvements out of the expenses. It was up 8% from the previous year, due to the major pipelines, where we have held promising results; therefore we have invested our results in these pipelines.

SG&A expenses decreased by 1.3% almost flat from the previous year. But looking into the details, alliance still was decreased significantly on the other hand in the United States launches of FYCOMPA, BELVIQ in the United States took place, therefore resources were invested in expanded manner in United States.

Therefore SG&A expenses have stayed almost flat from the previous year. Operating income was up 1%. On this level of income, we could achieve increased income as well as net sales, but before below that line, there are several items that I needed to report to you today. One is about the structure reforms that took place to bring this FY 2013. There are three major reforms that we made structurally during this year.

One of which was; R&D function which is expanded in Europe as well as in the United States, we made a consolidation and reorganization of the R&D function. Several section in a division workload were integrated as well as the facilities, which had been maintained in Andover, which was a process research facility, we decided to shut down that facility.

These things were implemented last year. Another item is – as we have reported to you and later planned in Japan, the Misato plant. We decided to transfer the business operation at the plant. Contract and manufacturing company, Bushu was the proper, to whom we transferred operations as well as the transfer the employees who are working at the Misato plant.

Third item, is at the parent company, Eisai Co Ltd. We voluntary retirement from employees working at the headquarters. These three measures combined the extraordinary loss related through the sub-plant of the R&D facility is not by included however, there was the impact of the structuring reform ¥ 13 billion over and including the cost of the facility shutdown, the impacts of the structure reforms is over ¥14 billion.

Another one-time charge then, was as you're aware the special reconstruction corporation tax as abolished a year ahead of the original schedule, due to this the deferred tax asset reversal was carried out, therefore it increased a tax charge of about ¥2.3 billion from LP to NP ¥33 billion was the net income results, which was 68% of the 2013.

Excluding that one-time charge, you can see the numbers as well on the chart. And our metric center indicated EPS was ¥115, ROE was 6.8%. Please look at pharma EBIT, the ratio was increased slightly. Now I would like to talk about more qualitative aspect. We could achieve and excel and operating income increase of fiscal year 2012 and we made a proactive investment into R&D operations and while we achieve to be a formation to results.

Factors for growth include the growth of the next generation fixed product that have been already mentioned and Asia business and generic business centering on element Eisai as a growing segment. These business operations have expanded and you'd have to create the product and by the fourth quarter. There were two very epic making events that I'm delighted to report it to you today. One of which is the next generation Alzheimer's disease treatment based on small molecule agents and antibodies agent.

Regarding these two agents, we reached an agreement for joint development and commercialization with Biogen Idec Inc. This agreement was concluded and similarly in the oncology franchise following Halaven, which is deemed to become the flagship drug Lenvatinib. We could obtain the very good promising results from the Phase III Study SELECT. So these were noteworthy special events achieved during the year.

In order to develop global brand two agents, BELVIQ and FYCOMPA we at last launched these products in the US. DOE clearance, it took much more time than we expected. However, we at last to launch these two products. So we invested our resources in these areas in the US.

As I will report it to you later, since the fourth quarter of last fiscal year. So called, Aricept and Pariet shifting from two brands era to multi-brand era. So in order to create newer business models for managing such models. We have studied global business matrix from May, 2014.

We have shifted officially to this business matrix. Looking at Asia, an AY style strategic market. Which I'll explain later. These markets are rapidly growing and our entry strategy as we go particularly to these markets. We will make entries with new brand.

So new products will be utilized for entering to these markets and implement companywide transformation towards operational excellence. We believe that, we will see the benefits when results will be kind of reverse body blow as a positive result or impact by these methods. For example for FY 2014, about a little more than ¥9 billion in personnel cost that will be reduced during this fiscal year.

As represented in this year, these structure reforms will be important in contributing to strengthening the corporate structure in the mid-to-long term. As regards growing areas, Halaven, Fycompa, BELVIQ, Humira, Lyrica, Lunesta. These six next generation products have grown 37% year-on-year achieving over ¥90 billion.

As regards, Asia business as you can see here. In East Asia, South Korea and China are very important market for us. In China, for the first time exceeded ¥30 billion and South Korea exceeded ¥10 billion in these sizable growth. These markets continue to grow and the entire Asia growth rate was up high as 41% year-on-year.

On the other hand, a wide operation for generic business in Japan has exceeded ¥20 billion for the first time achieving ¥ 23.4 billion expansion of this business was also shown during the fiscal year 2013.

In Japan, now surfacing the net sales grew 1% year-on-year and the profit expanded significantly. In domestic markets, as for handsets. As for Aricept, we continue to be very particular about this product for expansion as you may have heard. The report in the media yesterday over 10,000 people with dementia are missing and there are still above 2 million patients, who are not treated yet with pharma therapy and access to early diagnosis and early treatment is now open and then how will play that role to deliver such treatment among pharmaceutical companies, that is us; who has led the path for a treatment of this dementia.

So we have such sense of mission in expanding these access to patient. LOE was weak, but for example. A new dementia treatment albeit new type of dementia with Lewy bodies, which was discovered by Japanese researcher indication it's related to the expanded to include this, that there are many patients and so have difficulties in swallowing drugs and then, the suspension formulation which can be swallowed easily together with the food, milk and drinks and through such development new formulations at Eisai.

We would like to continue to contribute to maximize the value of this product. Oncology area, mainly Halaven is three product grew 22% year-on-year and three products Humira and Lyrica and Lunesta grew by 30% over 30%. Therefore, while we defend our existing business. We are also focusing on the growth of promising area.

Bio agreement with Biogen Idec, this is the next topic I will like to discuss. If I may repeat, what I have said, the probability of success it shall be increased and accelerate speed of development that is the aim of our agreement at Eisai. We have conducted 19 double-blind studies all over the world. This is overwhelmingly very robust experience a knowledge of Eisai and Biogen at MS or Multiple Sclerosis area.

They are kind of pioneer companies and they are very much bursting the, clinical studies for this area that means that in which area, in switch patient group. They have the knowledge of what is experienced at the both companies. We believe that this agreement will lead to their significant improvement in the probability of success, ¥560 billion or so will be necessary for R&D expenditure for the clinical development program.

Therefore these expenses can be shared by both companies. Therefore it will lead to acceleration of development. We believe that this alliance will provide a very strong advantage for us. As we have reported to you recently in Japan. We are aiming at developing, the similar alliance. Therefore, we have exercised our options in Japan.

Now I would like to give you the breakdown of our net sales. Net sales for last fiscal year with six next generation products. We have about a little less than ¥25 billion upside in growth segment. Asia generic business, a little over ¥18 billion as was the increment and Dacogen global right was divested therefore it brought about positive over ¥17.7 billion.

Aricept and Pariet and AcipHex due to the impact of LOE, which was downside impact and therefore the results here was ¥600.4 billion. As recorded OP, operating income level with six next-generation products ¥14 billion upside was achieved and ¥6.7 billion in gross of the growing segment ¥5.2 billion in others and investment of a launching expenditures in the US that was negative ¥15 billion and R&D investment was ¥10.2 billion, which was increment to the previous year.

So the results on the operating income level for the year was ¥71.1 billion. Now another new business model, in order to develop a market brand business. Asia global business matrix is being implemented right now. The background for implementing this model is, if I may repeat at Eisai was the promising candidate compounds to be developed on the one-single market or region that is not what we are aiming at.

Everything we develop will be global brand. Therefore, simultaneous submission as well as approval will be our policy. Therefore, globally integrated product development has become a common practice. Looking at the overall global markets, pricing in a single country it cannot be contained within that country.

For example, international reference pricing is one typical example of this trend. The Greek price will be referred by Turkey and Turkish price will be referred by Greece. So these kind of things is happening all over the world. We're referring the Japanese [indiscernible] are referring to the reference prices in the five other countries in the world, that is also included as the standard in the reinvestment and pricing policy.

Reinvestment and pricing has been communized globally. So single market, with single country. It cannot implement its own pricing or investment policy on its own. Medical price practice, at the end of this month. [Expo] will be held in Chicago in the United States about 40,000 oncology researchers will gather from all over the world.

They will listen to the same presentation at the same time. Also look at the same data sets. Journals such as New England Journal of Medicine and the Lancet. Oncologist in the referred countries as well as advance nation will all look at those journals. Therefore, the medical practice is being standardized rapidly and reinvestment agencies such as PMDA, cycle time has been shortened, even faster than FDA cycle time at PMDA.

So the global agencies ENA and agent major reviewing agencies have gathered, but they discussed the short services or mutual recognition. One final dossier could be utilized before filing for the simultaneous approval. It may take some time but regulatory offers these collaboration. It's taking place and will be accelerated.

And what is represented as UHC, Universal Health Coverage. Like in the National Health Insurance Coverage in Japan with the longest history with the most experience. We have such system, which we can be proud of course. We are faced with many issues such as the Asia population with the less birth rate and it is also expanding globally.

At the UHC, another typical example is UHC is in the United Kingdom. NHS, National Health Services system. Looking at those different factors, what can be said about this in fact? There is no single policy, which can be only used to one single country as well as in one region that means that such different strategies or policy were device to risk.

Therefore, we needed to have an operation under integrated global brand strategy activities and action. This is a background we came at with this global business matrix. So this is the structure, by region, every stage unchanged. In each region, local brand are existing in each region.

Therefore under each regions, it's responsibility. These locals' brands, they should be grown and developed under their own responsibilities. However, there are global brands, which are common brands throughout the different regions, then horizontal business unit will be responsible for launching as well as LCM and P&L for global brand.

In this business unit, medical affairs group is included not mainly the commercial units. They're responsible for real business. In Oncology business unit, Halaven and Lenvatinib. One is not approved yet before, this is still the investigation of drug and these two drugs will be dealt with – by oncology business unit Fycompa, 5-HT2c.

This can be a classified into neurology and Inovelon, Zonegran, BELVIQ. These are epileptic drugs. Therefore these four brand are handled by this global neurology business unit. It may be a cliché, but think globally, act globally. This is well said. I just reminded myself of this cliché. The leader of each region, cannot only think of his own region.

He or she has to think about what is happening, in other regions and his. Sharing such knowledge and then he has to come up with the idea on what should be done in his own region. Global business heads have to think not only, what is going on in globally but also, what is going on in each respective region.

In order to come up with a strategy, with this common and integrated globally. So business unit and regions shall be implemented and realized with the interactive communication. This is one of the major objective, so that we can securely develop and grow global and regional bends, that's our expectation.

Based upon these actions, so what about today as of now. We have these three strategic intentions that is definitely I want to explain to you today. One is, that once we would like to focus on the re-ignition of the US market. The world's largest market. The US is back. Japan is back, is a statement made by Prime Minister, Shinzō Abe and LOEs of Aricept and AcipHex has been reached at last.

After LOEs, the world's largest market in the United States. We would like to revive ourselves, that is still our expectation or strong wish or intention, including this aspect. The long turned expansion of the global brand, where we would like to focus our investment in going forward.

The second is to invest in the industry scope level product creation, which has a potential for this fiscal year, 2014. We will like to continue to invest further resources in this creation, so that we can reap the fruits of this during fiscal year, 2015 and for sure and future, the core market in the future of pharmaceutical industries will be in Asia and other studied markets including M&A.

We'd like to make further strong commitments to these markets. These are the three things or strategic intentions that we would like to implement right now. Going into further details, additional investment of resources will be implemented during this fiscal year, during its fiscal year, 2014.

The fruits of such investments will be coming in the next fiscal year. I will be able to present to you the benefit and results of such investment since from 2014 onward. We shall be getting back on the possible track of growth. Therefore, we will make additional investment resources during this fiscal year.

I would appreciate, you understanding on this. For long-term expansion of global brands. Halaven, Fycompa, BELVIQ and Lenvatinib which will be launched in the future. We are going to make investment in the level of ¥45 billion. Of course including marketing and expenses, that investment will be implemented.

For product creation, there are eight assets Halaven, Avatrombopag, E2609 and two next-generation Alzheimer's treatment E2006 and [Fycompa], Lenvatinib. Eight assets, where we would like to further make investment which will reach ¥35 billion level.

In Asia and strategic market including M&A opportunities. We would like to make investment of ¥30 billion level in resources. Overall, the level of ¥110 will be invested. The capital investment for M&A is included in this amount. Therefore, that will be affected on the P&L will be about a little over ¥80 billion.

The proper site now is, the second line in Europe. Quick churn the authorities will make decision in that. We have obtained approval in 53 countries and in fiscal 2014, we plan to launch in 15 additional countries. For emerging countries, renting policies based on income level will be applied to increase patient access in India and Thailand, we have seen achievement through these programs.

In Lung Cancer and soft-tissue sarcoma results laying results within fiscal 2014. And for HER2-negative early line treatment, study ongoing. Now for Lenvatinib. Radioactive iodine refractory differentiated thyroid cancer in this study, we met the primary influence with highly statistical and incident improvement.

On June 2, our heading next exhibition at ASCO we were given chance to give oral presentation and improve .we hope that, our abilities will be focused on that oral presentation that will be given in June as per current submission schedule in Japan. We would like to file submission by June, in Japan and Europe and US to submit by the end of second quarter fiscal 2014.

And we would like to achieve launch in Japan, US in year between fiscal 2014 to fiscal 2015. And I forgot to mention at ASCO, regarding Halaven 301 and 305 studies were proved pulling data from these two studies, will be presented in first presentation.

Regarding Lenvatinib at ASCO, lung cancer Phase II study data will also be presented and we hope that attention will be given to these presentations. Now as for Lenvatinib, HCC, hepatocellular carcinoma are studied are ongoing and patient entry is smoothly progressing in the fiscal 2016.

Regarding BELVIQ, currently we have 400 medical representatives, but from July we will 600. The 200 additional medical representatives will be deployed. On July 7, with 600 medical rep, we will have a gathering for re-launch of BELVIQ and I plan to attend that session and target doctors will increase to 90,000. As for its' direct response to do this was begun with much response.

On an accumulated research this is more than several hundred million, viewed this in voucher application increase 3.5 fold and build it .com site that has increased two-fold, throughout the year we will continue with this, the DRTV.

According to the recent data, we have seen jump up in prescription number and the DRTV we believe has been quite effective in increasing prescription. We have Frank Ciriello, who is responsible for BELVIQ globally, so I'll ask him to discuss BELVIQ later.

In insurance coverage is also expanding, current is Fycompa. In the United States, we have the increased the number of representatives to 90 in the United States and in Germany, pricing negotiation are not successful before and as you're aware of Placebo-controlled Study was carried out, but with that kind of study the pricing is not satisfactory. And now pricing is not satisfactory, so withdrew so taking back to this program free of charge, drug was supplied from Switzerland to taken to Germany.

Even under such circumstances, the patient number has increased in Germany with more than 2,000 patients through this scheme are received in Fycompa and once again, we have agreed that with the authority to resubmit additional benefit assessment finding and we believe that results will be available within about six months’ time and we would like to see steady increase in number of countries for we have achieved the launch.

Epilepsy franchise we have very strong in-house original FIC drug. Now as far the pipeline, how much are we going to achieve. This year with the additional investment, everybody showing me, red letter in China for submission. We are accelerating the date of study, which is ongoing and for lung cancer sarcoma able to possible to file submission in fiscal 2014.

As per Lenvatinib, we hope that approval is anticipated in fiscal 2015 and there is also steady progress of hepatocellular carcinoma to a Fycompa PGTC approval is anticipated in 2015 and as far as Japan global Phase III study is carried out with many patients in Asia enrolled.

Regarding this study, PMDA we have had consultation with PMDA. For the pipe other than Phase III study, we have asked the PMDA's review ahead of time and we have already planned to move in fiscal 2015, although result of this and as per BELVIQ placebo-study is ongoing.

This is smoothly going on and obesity in Japan. We have submitted CTN and in China, we have submitted CTA. The Authority and as for small thing in session, Phase II study is started and completion is anticipated in fiscal 2014. So these are the progress as we have seen in the pipelines and that we have two joint developments over Biogen, as per top line results were around 24.

It is expected in 2015 and in-house developed based inhibitor in the first quarter. We believe that, the Phase II study can be cited in the first quarter, 2014 as for lexin receptor antagonist. The [NT] has recommended early completion because of high usefulness, this is quite rare, very pronounced usefulness and unless other, how statistical significant such an early completion recommendation do not come from DMC but based on that suffice, we have finished LTI and we expect it complying results quite soon and Phase III study after consultation with the authorities. We plan to initiate in the first quarter of fiscal, 2014.

Regarding Avatrombopag, we enter the mix globally in fiscal 2015. Now turning to strategic Asian countries and strategic markets. This is a third domain for our strategic investment and first about Asia. This fiscal year, the target is increase of 16% and to achieve ¥83 billion in fiscal 2015.

Mergers and acquisition opportunities are also included in these projections. In Asia, the main focus is Methycobal, Aricept, Pariet; these are established brands. And Halaven, Fycompa, on top of them. These are new drugs with strategic pricing policy will be introduced. In China, Korea in East Asia in addition to these major markets in East Asia as for next core market in Asia, Indo-China and our total is that we're focused upon.

Of course, Indo-China which include Thailand or Vietnam, Myanmar, Cambodia and also the have introduced markets already and we'd like to strengthen our position and in Indonesia, we have a factor in Bogor. In Indonesia, there are many people who have strong sense of ability to possibly also like to strengthen our position in that country as well.

As per strategic market, with newer drugs. These six countries regions define a strategic markets. We will be making effort especially in Russia and Canada. We have started operations. We have our operations, which manage directly in-house operations. Of course for sales and distribution we need partnering Russia. This is indispensable, so we are tying with a partner, but for core operations. Okay, that by ourselves.

Next is Mexico. For several products we have bio submission and in Middle East business has grown to a certain size which refers in size of revenue. Now this is prediction for fiscal 2014, I'm going to add some explanation, before stop going if concerned. ¥22 billion any price revision impact and receptor, LOE impact also taken into consideration. So 94% year-on-year.

In gross margins, we were decreased ¥39 billion as per the cost items. This is ¥8 billion or rather ¥57 billion, ¥56 billion cost savings were achieved and therefore ¥56 billion minus ¥39 billion were, ¥17 billion can be included in operating profit line but because of the reasons that I had to explain before, ¥ 30 billion additional expenditure.

We've right to make that additional expenditure and that is why, OP line will decrease by ¥13 billion, that is growth ideally, I think in the financial performance. With the strategic domains, have received above ¥57 billion investment and it will increase ¥87 billion investment in fiscal 2014.

And structural reform investment in alliances and other corporate beyond that ¥13 billion operating income reduction is 11%. Regarding dividend, yearend dividend of ¥80 was approved at Board of Directors meeting today and it was for the year dividend will be ¥ 150 and for fiscal 2014. We plan to link in dividend of ¥150. That concludes my presentation, thank you for your kind interest.

I forgot to discuss the last slide, this is the final slide which is quite important. I have been explaining from fiscal 2015, we determined be back on the track for growth [transactionary] and that is why, there will be proactive investment of resources in fiscal 2014 and there are three areas, where we will be making investments, global brand expansion Asia and strategic market development and pipeline development to expand territory, we are including mergers and acquisitions opportunities.

And in addition, we also would like to sustain ¥150 dividend in an approval fashion and 8% level DOE and the management is stated confident that we'll be able to achieve all of these. And regarding these, we will be culminating robust going through IR efforts. We will be disclosing information to reduce risk on the flight of investors.

In the background to this, is that we have a strong balance sheet. We have been able to improve the strength of the balance sheet, net DER is 0.14 in, 2013. We expect the 2.1 level and net debt to EBITDA is 0.6 from that portion, it can be paid in full with the cash generated in the year and as far as shareholders equity. It is above ¥500 billion and this is 54%, which is the level equivalent up to pre-purchase of the MGI.

And I believe, the board offers the same thinking, from fiscal 2015, we have strong determination to go back to the growth trajectory and ¥150 dividend, which shows focus on shareholder that is signaling effect of our strong determination into go back to the growth trajectory in fiscal 2015, that concludes my presentation. Thank you for your kind attention.

President, Eisai Global Neurology Business Unit, Frank Ciriello and he will make additional comments on BELVIQ. Can we BELVIQ, slide.

Unidentified Company Representative

Recap in connection with BELVIQ in the US situation. So Frank, before you speak in this yourself.

Frank Ciriello

Good afternoon, my name is Frank Ciriello. I'm currently the President from the Global Business Neurology Unit here at Eisai. I've been with Eisai with 10 years. Now different roles in the commercial, who are here with Eisai and previously 19 years with a pharmaceutical years. And certainly gives me pleasure today to share with you, some additional information relating to BELVIQ. As you heard from Mr. Naito.

We are very excited about the opportunity to bring BELVIQ to patients worldwide. There are three key fillers; to the growth of BELVIQ in fiscal year 2014. Number one; healthcare professionals; the physicians. Number two; the consumer; the patient. Number three is the overall commercial coverage in the United States.

Allow me to share a few information with you. As it relates to the healthcare professionals. We believe that increasing the number of physicians or patients. They've represented it to 600 in July, will allow us to do two things. Increase our reach of physicians to approximately 93,000 targets. As well as to increase the frequency on key physicians.

This will allow us to aim to improve the relationship between the physician and the patients as they talk about obesity. I'm very pleased to let you know, that during the week ending May, 2. We've had the highest number of prescriptions for BELVIQ since launch at approximately 8,200. We are very pleased with that but we are not fully satisfied. We've reached to aim more and higher numbers.

With that in mind, in the fourth quarter of fiscal year 2014. We have been able to prescribe 77,000 prescription of BELVIQ up 31% versus the previous quarter. When you look at physician environment in the United States. It is crucial that we continue to talk to physicians and share with them, the key messages of BELVIQ with safety and the efficacy of the product.

Let's move to physicians, the consumer. They play a very important role, as it relates to obesity because they have to make the first step in talking to physicians and going to their offices. With that in mind, we believe that the Direct Response Television commercial, which we started on April 14, has already received very strong response. It has aired over 1,000 times over 45 channel networks and one of the key things is that we have doubled our web-based as well as the total number of redemption for the vouchers has increased by 47%.

We will continue the DRTV commercial as a key foundation as we move into fiscal year 2014. Along with that, we are also working on commercial coverage. It is very important, then when a patient goes to the pharmacy to fill their prescription, they will receive coverage from the managed care organization.

In fiscal year 2013, we've reached 60% coverage and now we are on our way to reach 70% by the end of fiscal year 2014. What is very important than if you remove the three trial prescription 70% of all prescriptions today are covered by managed care organization in the United States.

So when you look at this three key fillers for BELVIQ. We are very excited about the opportunity that BELVIQ can bring not only in the US, but worldwide. Thank you.

Unidentified Company Representative

Thank you. Frank [Foreign Language]

Question-and-Answer Session

Unidentified Company Representative

Then we would like to entertain questions from the floor in this room first, before moving onto audience, who are participating via phone lines.

Ryoichi Urushihara – Nomura Securities Co., Ltd

Thank you very much for your explanation. My name is Ryoichi Urushihara of Nomura Securities. I've two questions. One is about, at the very last stage of your presentation material, Mr. Naito mentioned about the ¥150 dividend regarding the shareholders return that will next fiscal year. You also mentioned that, you're expecting to see the growth in these profits and ¥150 dividend will be maintained in the next fiscal year, is that correct?

Haruo Naito

[Interpreted]

Dividend of ¥150 for sure is net minimum. So as we expect the profitability to increase and then of course, it's merrier to expect increase in dividend should be also considered, that's what I think. Thank you very much.

Ryoichi Urushihara – Nomura Securities Co., Ltd

Next question is on Page 12, of your presentation slide. It says that, ¥110 billion resources will be invested during fiscal year. Next year and ending in March, 2016 how much investment will be planned.

So how much will be planned for next fiscal year in corresponding to the ¥110 billion and R&D on the IFRS and I think that, [¥1271.5 billion] for this year, next year Phase III studies will be ongoing. Therefore how much is planned for R&D expenditures for next fiscal year?

Haruo Naito

[Interpreted]

I'm not able to mention detailed number, but we expect to see increase in sales as well as profit, but be assured that we will see that result.

Ryoichi Urushihara – Nomura Securities Co., Ltd

And in terms of expenditure, could you please describe. How much expense that you're planning for next fiscal year?

Haruo Naito

[Interpreted]

Roughly speaking, is that all right. R&D expenditure. How much do you plan to invest? Mr. Kaneko, please introduce yourself?

Unidentified Company Representative

[Interpreted]

My name is [Kaneko]. I'm in-charge of Corporate Business Operations. As regards, R&D expenditure for next fiscal year, which we expect to see slight entry from this fiscal year, that is our calculation we made in generally about ¥130 billion or so, shall be forecasted.

Ryoichi Urushihara – Nomura Securities Co., Ltd

Compared to this fiscal year, what will be the incremental additional expenses?

[Interpreted]

You see, next fiscal year such as promotion a cost for BELVIQ.

Ryoichi Urushihara – Nomura Securities Co., Ltd

Do you believe that, these will be reduced, Project MAX and [indiscernible] alliance most on payment?

Unidentified Company Representative

[Interpreted]

For fiscal year 2015, we do not expect to see such expenditures. Therefore any additional major items to increase R&D expenses. I do not think that's where any big items. Hayashi san, can you expect?

Hideki Hayashi

[Interpreted]

Regarding Project MAX, which has certain uncertainties that as Mr. [Kaneko] mentioned that we'd like to make investment and deliver over ¥130 billion. And you're investing ¥110 billion this fiscal year, so next year the total investment amount maybe reduced although, you see increase in R&D expenditures, there will be reduction in other expenditure items.

Unidentified Company Representative

Yes, for this fiscal year 2014, one-time or additional expenses will be reaching the climax and could you please elaborate o this Mr. [Kaneko], please?

Unidentified Company Representative

[Interpreted]

Except for R&D expenses. We believe that investment is related for this fiscal year, will be the maximum and will turn around the corner and so I believe that the SG&A and other expenditures will be controlled well.

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

This is Sakai from Credit Suisse. I have two questions towards the very end of the presentation there is reference materials that shows the impact of introduction of IFRS. In one, ¥13.70 billion of one-time expense. It will be on operating income or above operating income in IFRS?

So rather than ¥66 billion operating income for this fiscal year, the projection is ¥53 billion and this ¥53 billion resisted operating income are very expensive included for example expenses for structural form, that were incurred in 2014, is similar expenditure included.

Unidentified Company Representative

[Interpreted]

This is [Kaneko] speaking again. For fiscal 2014, of the introduction of IFRS, but the re-backs were was as far as top line, similar to 2013. There was minimal impact, negligible impact. As for operating income, there are some ups and downs, but the biggest impact is non-amortization of goodwill and they will be impacting fiscal 2014 as well.

Next fiscal year, I think it will be about ¥8 billion that will be the impact shift from J-GAAP to IFRS. That is the impact which is increase in profit. That will be seen this year.

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

Now I'm trying to compare against ¥66 billion operating income. The amortization of goodwill, is already outside of this figure and ¥53 billion under IFRS that also excludes impact of goodwill. So this is an apple-to-apple comparison. Excluding item

Unidentified Company Representative

[Interpreted]

That was one-time expenditure in the fiscal year that just ended.

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

But that is operating income in IFRS and similar expenses in ¥53 billion, are there any extraordinary items?

Unidentified Company Representative

[Interpreted]

Extraordinary profit of ¥1 billion or so but we do not expect any extraordinary item. So impact will be quite negligible.

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

Then this is apple-to-apple comparison.

Unidentified Company Representative

Yes, that is correct

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

Mr. Naito regarding next year. You've discussed that, the company will be going back growth trajectory, but what I'm concerned about is LOE of Aloxi I think it was in April, 2015.

Haruo Naito

[Interpreted]

In regarding Aloxi, LOE you cannot avoid this but at least pediatric indication, what is the progress and for next fiscal year, Aloxi will be suffering from erosion of generics. It's not the assumption that we should take into consideration. Chief Product Creation Officer, rather Mr. Matsue, Chairman of the Americas, go respond.

Yuji Matsue

[Interpreted]

This is Matsue, who is responsible for Americas. It is already a generic market in Aloxi is doing well, despite market being quite generic-sized, already and the question was that, LOE maybe in April, 2016 and that is however, pediatric exclusivity is what we are thinking about and we believe that, we will be able alleviate the impact and within the generic-sized market. The product is doing well and we are also developing combination product, in combination product. Probably will be possible this fiscal year and CIMB, we would like to look at that market.

Fumiyoshi Sakai – Credit Suisse Securities (Japan) Limited

Pediatric, I understand but combination drug of what, with [Lexicipiton]?

Yuji Matsue

[Interpreted]

In Americas, [Lexicipiton] combination drug.

Unidentified Company Representative

And next question please.

Atsushi Seki – Barclays Securities Japan Limited

My name is Seki. I'm from Barclays Securities. I've two questions for fiscal year 2014 operating income forecast. IFRS basis ¥53 billion, but as I heard. They got ¥45 billion was the J-GAAP based plan for the year, is that correct? So there is a GAAP of ¥8 billion?

Unidentified Company Representative

[Interpreted]

Yes, that's correct. ¥45 billion level is operating income because of mainly the GAAP posted by the goodwill amortization.

Atsushi Seki – Barclays Securities Japan Limited

And I'm not correct, it's about based inhibitor 2609 Phase II, it took much time and I believe that, for the third quarter. It has taken much more time than expected. What is taking time, than expected?

Hideki Hayashi

[Interpreted]

We are discussing with the regulatory authorities and we have made the appropriation enough and the degree what's little as three months, therefore not much delay and on the other hand. We would like to complete a product called, well and we have the alliance with Biogen Idec, it therefore we are going to share all related to these developments.

Therefore overall, we do not believe that there has been any much delay. So we would like to accelerate to cover to the rate.

Unidentified Company Representative

That was response from Mr. Hayashi. Thank you very much. Any other questions?

Unidentified Company Representative

Could it that, speaking about BELVIQ in the United States, ¥2.5 billion sales. How do you asses this sales figure and next year of projection cannot be made available because of partnership, but what is the peak anticipated figure?

Haruo Naito

Frank Ciriello, will respond.

Frank Ciriello

Thank you. As it relates to fiscal 2013, as you mentioned is approximately $25 million. It is in line with the growth, as I mentioned to you before. When you look at the market, this is very interesting market. It is a market, where physician and consumer stations, they're very interesting relationships as it relates to obesity.

So our focus has been indeed to not only train the physicians but also the consumer on how to talk to each other. We believe, whatever is moving fiscal 2014 with the three pillar that I shared with you before will be able to grow. Our goal is to probably reach approximately 600,000 patients as moving in fiscal 2014 and then continue to grow into the future. Thank you.

Unidentified Company Representative

Thank you.

Unidentified Analyst

My name is [indiscernible] from Tokio Marine Asset Management. Regarding your alliance with the Biogen Idec for ADAR, who has approached first to which start and for these two, current candidates or the only targets for this alliance or do you believe that for Alzheimer disease is the comprehensive alliance, can be considered in the future to expand the target.

Unidentified Company Representative

The candidate. I'd like to ask, Mr. Hayashi for BD to respond to your question.

Hideki Hayashi

[Interpreted]

Thank you for these two assets for Alzheimer's disease. We would like to implement partnership development, which was started a year ago and there were many companies who are interested in our assets in Alzheimer's disease and including the some big pharma companies and this was particular partner, who approached to us strongly and regarding these two assets, based inhibitor and antibody and also Biogen Idec, inhibitor and anti-TNF monoclonal antibody being developed by Biogen Idec.

So these four products are the target candidate compound and covered by this alliance. If anything happens to these two candidates, during the development. We have some projects to have a backup. However, there are no other projects to be included in the alliance.

Unidentified Analyst

If I may supplement, at the time of Aricept. We allowed with the Pfizer and I thought, that you wanted to sole develop market of Arcipet in the end. And you're going to share and feel some perfect with the Biogen and I believe that so market being promoting strategy will be the basic stance of Eisai, is that correct for this product as well?

Hideki Hayashi

[Interpreted]

I think it is now appropriate to mention that, these are the disease modifiers, during the Phase II study about 18 months necessary for administration duration compared to the symptomatic agent Aricept, ¥150 billion will be necessary for R&D expenditures for this. If we can find an excellent probably to market it, that story will be different so however.

For this candidate, we need to consider different partnership, but various timing at the development phase.

Unidentified Company Representative

I believe that there are and many other questions, so please refer your questions to IR Department. There are no question, through telephone. Therefore, we would like to conclude today's presentation meeting. Thank you very much once again for taking time out of your busy schedule to attend this meeting.

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