Astellas Pharma Inc.

Astellas Pharma Inc.

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Q3 2014 · Earnings Call Transcript

Feb 2, 2015

APIChat

Executives

Yoshihiko Hatanaka - President and CEO Yasumasa Masuda - Senior Corporate Executive

Analysts

Hidemaru Yamaguchi - Citigroup Kazuaki Hashiguchi - Daiwa Securities Atsushi Seki - Barclays Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Ryoichi Urushihara - Nomura Securities Yasuhiro Nakazawa - SMBC Nikko Securities Takashi Akahane - Tokai Tokyo Research Center Fumiyoshi Sakai - Credit Suisse

Operator

Yasumasa Masuda

[Interpreted]. Ladies and gentlemen, good afternoon.

Thank you very much for participating in the conference call for the Fiscal Year 2014 Third Quarter results of our company despite a busy schedule. I would like to take about 25 minutes to explain about the performance and about the update of our pipeline.

Please turn to the next slide. Well these are the disclaimers.

And then, so please go to page 2. This is the fiscal year 2014, third quarter core base results.

In third quarter, we saw an increase in sales and increase in core operating profit and core profit for the period. Sales was ¥152.8 billion, a 9.7% of increase.

Sales in Japan declined and was offset by the growth in the Americas, Europe and Asia and Oceania, saw an increase of sales. But the increase of sales and the decline of course of sales, the increase of gross profits surpassed the increase of SG&A and R&D expenses.

The core operating profit was ¥202.2 billion at 24.7% of increase. The core profit of the period was ¥140.3 billion to 24.6% of increase.

In terms of the progress against our outlook, it was 78.7% for sales for the core operating profit and core profit for the period was 95.3% and 91.1% respectively. In terms of the exchange rate for the third quarter, as shown on the lower part of the slide, again was weaker year-over-year for the average, for the term against the dollar and the Euro.

Well this had a positive impact for the sales, was ¥36.4 billion and a positive impact of ¥14.8 billion for the core operating profit. Please turn to page 3.

This is an analysis of the change of sales compared to the period here, we saw ¥84.5 billion of increase. This includes the global products like Vesicare, Mirabegron, and XTANDI which are a major global drivers, increased strongly by ¥80.6 billion.

And Prograf, Harnal and Funguard Mycamin, other global products solely increased by ¥9.4 billion. For the Japanese local products, excluding global products, due to the NHI drug price invasions and generics.

And the impact coming from one of demand-supply fluctuations due to the concept increase has declined by ¥24.7 billion. For the Europe, the Americas local products, has increased by ¥19.2 billion.

This is page 4, this is analysis of the change of the operating profit on the core basis. On top of the increase of sales, the COGS ratio has decreased and gross profit year-over-year has increased by ¥85.7 billion.

The COGS ratio, because of the change of the product mix compared to the previous year, declined by 2.8 points at 27.2%. For SG&A, it increased by ¥34.2 billion, the reason of this because of the FOREX situation and the increase co-promotion cost for XTANDI, and besides the change of achievement of the U.S.

pharma fee. Excluding the SG&A, the SG&A excluded in the co-promotion cost of XTANDI year-over-year, the SG&A ratio has gone down.

In terms of R&D increased by ¥9.4 billion. On top of the exchange rate, because of the slow increase of cost to the progress of development projects, the R&D ratio -- expense ratio year-over-year declined by 0.4 points to 15.5%.

As a result, the core operating income as said in the beginning of the presentation has increased by 24.7% year-over-year. Let’s go to page 5.

This is the third quarter 2014 full base results. For the third quarter, we saw increase of sales in each of the profit lines has increased.

But we exclude as other expenses from the core profit that is restructuring cost, impaired losses and the loss for foreign exchanges and litigation cost is booked as other cost at ¥42.6 billion. As the foreign exchange for us was ¥10 billion mainly this is related to the western group based transactions.

For the litigation cost, we booked ¥11 billion this is mainly for the settlement for the cross section to the civil petition for U.S. Prograf.

As a result, year-over-year, operating profit has increased by 43.2%. The profit for the period was ¥114.7 billion year-over-year, and increase of ¥31.3 billion at 37.5% of increase.

Please go to page 6, this is the buy region sales on a local currency basis. In Japan’s market sales as for the reasons I have mentioned, year-over-year it declined by 6% at ¥375.3 billion.

On the other hand, for the Americas, Europe and Asia Oceania, in each of the regions, we saw a double-digit growth. In the Americas and Europe, XTANDI, Vesicare and Mirabegron were the growth drivers.

In Asia and Oceania all the other major products has steadily grown. Please go to page 7, this shows the key therapeutic franchise results from this page onwards.

First the urology OAB franchise. Mirabegron has grown strongly, and with Vesicare the global sales was increased 19% year-over-year at ¥142 billion.

By region, excluding Japan, all other regions saw a high growth of double-digit. The decline in Japan was due to the one-off impact of demand and supply fluctuation due to the increase of consumption tax, but compared to the second quarter, the pace of decrease has further slowed down.

We’re now selling Mirabegron in 32 countries around the world. Please go to page 5, this is oncology franchise.

XTANDI had decent GDP growth and had the steady performance of Tarceva in regard in connect, it’s four major oncology products in total accounted to ¥149 billion and year-over-year sales grew by 73%. XTANDI on top of the growth in the United States and Europe, in Japan, since its launch in May, we are trying to target the growth in the market.

For the XTANDI in September last year, in the U.S. in December, in Europe, we have been able to get additional indication PKMO [ph].

And in Japan, in October, it was the revision of package insert has been approved. And we are now trying to expand the section to the patients.

Right now we are selling XTANDI in 31 countries. Going to the transplantation franchise.

Prograf, on a global basis, we are maintaining sales. In Japan, due to the impact of NHI drug price revisions and generics, has declined, but Asia Oceania has continued to achieve a double digit growth.

In Americas, the one-off factors such as, in the Americas recent announcement of the provision for the repeat for the past fiscal years, we have been seeing a year-over-year increase. Going to page 10, this is the Japan’s major product excluding global products.

Micardis, has declined slightly because of the impact of the initial drug revisions. On a volume basis, whether it be monotherapy or the combination drugs, it has grown.

For the growth products there was one-off impact of the demand supply fluctuations due to the increase of consumption tax had declined. But Suglat has been launched in April.

And with these new products we saw sales increase. And this has offset the decline of the growth products.

We will continue to maximize sales of the new products and the growth products and offset the impact of generics. From this page onwards, we’d like to talk about the progress of the new drug pipeline.

Please turn to page 12. So, this is the service pipe and user pipeline by stage.

But as we’ve had big domains, we have categorized it by colors, so new molecular entities are, we sell yellow circle behind it. And the following three slides, we’ll give you the update as with the most recent changes from the second quarters.

Page 13 please. It shows the approved and filed products.

And additional indication of XTANDI 4 came on 90 patients was approved in Europe in December. In Japan, Orfadin was approved for tyrosinemia type 1, defining had been done based on the request for development from the council of unapproved drug and off-label use.

Application was filed for capsizing additional indication of peripheral diabetic neuropathy in Europe. With regard with Isavuconazonium which is a product for Isavuconazole, FDA Advisory Committee adopted a recommendation for approval for invasive aspergillosis and the invasive zygomycosis.

Page 14 shows projects with progressive. Phase II part of the Phase I/II study of ASP8273 for non-small cell lung cancer started in Japan.

Phase II part of the Phase I/II study of AMG337 for gastric cancer also started in Japan. Three compounds entered Phase II stage that are SP2205 for stress urinary incontinence, SP5094 for RA and SP6858 for chronic kidney disease.

Page 15, shows other updates. SP4901 was under development for urinary disturbance associated with PPH, but its development was discontinued because the Phase II study did not demonstrate the expected efficacy.

We had a license agreement with Yang SymbioTec for global development and commercialization of ASP015K except Japan. Janssen Biotech announced Society to write to terminate their agreement in January, we are now considering the future plan after Japan and the Phase III study for the compound is ongoing in Japan.

With regard to rilotumumab, as we announced before, Amgen decided to terminate all Amgen sponsored clinical studies of rilotumumab based on the safety variations. Basic things, shows our oncology pipeline.

13 projects are going on right now, there are multiple promising compounds including sun in early development, we will do our best to promote these projects steadily and to enrich our pipeline. Page 17, shows the progress of Enzalutamide.

In October we announced the start of Embark study M0 BCR Non-metastatic prostate cancer with biochemical recurrence and dosing started in January. Top line results of Terrain study and interim results of the study for triple negative breast cancer are now available.

Let me discuss them in the next two slides. Page 18 please.

In Terrain study, enzalutamide and bicalutamide were compared in patients with metastatic castration-resistant prostate. Enzalutamide demonstrated a statistically significant improvement in its primary endpoint, PFS over by bicalutamide and the hazard ratio was 0.44.

Medium PFS was 15.7 months for enzalutamide group and 5.8 months for bicalutamide group. Medium dose and period was 11.7 months for enzalutamide and 5.8 months for bicalutamide.

SAE was observed in 31.1% in enzalutamide group and 23.3% in bicalutamide group. Cardiac AE of grade 3 or higher were reported in 5.5% in enzalutamide group and 2.1% in bicalutamide group.

Two seizures were reported in enzalutamide and one in the bicalutamide group. The full results including second endpoints and the safety data will be presented to in a scientific conference in the near future.

Terrain study confirmed the efficacy of enzalutamide that is consistent with existing data. With the accumulation of these type of data, we expect the enzalutamide will make further contribution to the treatment of patients in the future.

Page 19, shows the interim results of a study in triple-negative breast cancer patients. These results were presented in San Antonio Breast Cancer Symposium in December, 42 patients were enrolled in the Stage 1 of the study and 26 of them were deemed available.

Primary endpoint clinical benefited the week 16 was achieved in 42% among the 26 available women. We anticipate that full data analysis of stage 2 will be done within 2015.

On page 20, let me show you the data for ASP8273 that entered the Phase II stage in Japan. Phase I/II study is ongoing in Japan and ASP8273 was well tolerated across 25 to 400 milligram dose levels in Phase I part.

Recommended Phase II dose was established based upon the data between so far and the Phase II parties currently ongoing. Page 21 summarizes the progress of late phase compound.

Many projects showed progresses during the current fiscal year as shown by the arrows. We will continue our efforts to promote the swift and steady progresses of these late phase compounds as well as early phase projects.

Starting from page 22, let me walk you through our efforts to ensure sustainable growth. Page 23 please.

In order to resiliently respond to changing environment and enforce sustainable growth Astellas is working on the three strategic challenges shown on the slide. They are to maximize value of new products, to enhance innovation and to pursue operational excellence.

Let me discuss our recent efforts on each of these challenges. Regarding the maximization of value of new products, in addition to the work on expanding an OAB drug, we have reinforced our business bases in emerging countries by establishing a company in Dubai.

It manages the Middle East, North Africa and sub-Sahara Africa. As for enhancing the innovation, we have made several new alliances and I will discuss the individual projects later.

Thus we are actively making business investments to realize growth. As for operational excellence, we have reorganized sales officers in Japan and changed medical information department to a group that reports directly to CEO.

Page 24 please. This slide summarizes our, continues effort to introduce new products in each region since April this year.

Red letters show new approval and launches of products in different regions since our last financial announcement. Page 25 please.

In order to enhance innovation, we continue to work on new therapeutic areas and novel technology platform based on our new network type research system. We have made agreements for research alliance Astellas with Dana-Farber Cancer Institute and Proteostasis since our last announcement of the financial results.

We have also expanded the scope of collaboration with Cytokinetics. Let me walk you through this with the next two slides.

In addition, as we announced today, we have established the department of translation our self therapy at Osaka University. We aim at developing a new technology platform to advance practical use of therapies which are expected to be the next generation therapies.

Now page 26 please. With our collaborative research with Dana-Faber Cancer Institute, we aim at creating new inhibitors of mutated dealing to promising and anti-cancer drugs.

With the collaborative research with Proteostasis we will take advantage of Proteostasis’ proprietary technology platform to discover compounds that the selectively modulate the unfolded protein response or UPR pathway which is responsible for quality control of proteins. On page 27, let me explain the expansion of our collaboration with Cytokinetics.

As target indication of fast skeletal troponin activator including CK2127107 that is most advanced in development, spinal muscular atrophy and other neuromuscular indications was at it. In addition, collaborator research program was extended to 2016.

Regarding CK2127107, Phase II study is planned to start in the second half of 2015 for spinal muscular atrophy which is the new added, newly added indication. Page 28 please.

Apart of our effort to enhance our development pipeline, we have in-licensed our therapeutic vaccine for Japanese red cedar pollinosis from Immunomic Therapeutics for Japan as the territory. This vaccine has, a unique characteristics and we have high hopes for it because it showed convenient dosing regimen may lead to long-lasting regimen remission of the symptoms.

So page 29, I’d like to explain about the profit distribution and shareholders return. Our basic policy is unchanged as shown in this slide.

As we had explained, we will proactively engage in and put the highest priority in business investments for growth realization such as research alliances and licensing activities, in terms of the shareholder return and the improvement of the capital efficiency we’d like to continue this. For the full year 2014, we did on the after tax rate basis, it’s going to increase by ¥3 to ¥30 per share.

In terms of share buybacks, they have already conducted ¥30 billion for this fiscal year, but have decided at today’s board meeting that we are going to conduct further share buybacks and disclose this accordingly. In page 30, I would like to expand out line of business.

In terms of the acquisition, the maximum bids add 50 million stocks and ¥30 billion. And the period will be between 3, February up until 17, March in terms of share buybacks, based on our basic policy, we will conduct this in a flexible manner.

In page 31, this is page 31, Astellas will flexibly adapt to the changes in the business environment and target a mid-to-long term sustainable growth. In terms of the 2014 full year performance outlook, we have revised this in October and this is sales ¥1.21 trillion, the core operating profit ¥210 billion.

And this time we are not changing the previous outlook. On the global XTANDI business and this came in a big loan, this away bid drugs are going to drive this growth.

This overall is proceeding very smoothly. On top of that we have been focusing on the optimization of the cost, and we have some positive impact coming from the exchange rate.

There is a possibility that we will be exceeding the previous projections. We will aim to securely achieve the projections and realize mid-to-long term sustainable growth.

Page 32, is the last slide of our presentation. This is the schedule of the further announcement.

The full year 2014 where business outlook could be announced on 11, May and the new mid-term management plan is going to be or planning to be held on 27, May. Thank you for your attention.

Yoshihiko Hatanaka

[Interpreted]. Mr.

Masuda, thank you very much. This ends my presentation.

Next we’d like to receive questions from the listeners. Please limit your questions to two by person.

Please.

Operator

[Operator Instructions]. From Citigroup, Mr.

Yamaguchi, first question. Mr.

Yamaguchi, please.

Hidemaru Yamaguchi

[Interpreted]. Can you hear me?

Yoshihiko Hatanaka

[Interpreted]. Yes, we can hear you.

Hidemaru Yamaguchi

[Interpreted]. Well, my first question is XTANDI, especially in the United States, is very strong even compared to all of its predictions.

So, including the inventory and something basically you’re looking at the year-end, do you have any other those types of factors including inventory?

Yasumasa Masuda

[Interpreted]. Masuda, I’m going to answer your question.

Well, for inventories, of course, there is always some ups and downs. And December normally is the period when the inventory tends to be high.

So, there is some of these factors that come into play. And in terms of the gross net ratio, we repeat that each quarter so there is some practice as well.

But the majority of the sales is basically coming from the volume growth of sales. So, in terms of these factors I have mentioned, let’s just not disclose the volume of those factors.

But on the volume basis, quarter-on-quarter we saw a 20% growth of volume, this is one thing I want to mention. Thank you.

Hidemaru Yamaguchi

[Interpreted]. The second question is, or maybe in a head with a new mid-term plan, you’re going to hold a presentation for taking the mid-term plan.

So this will include how many years at this point? Can you give us any indication of what this plan is going to be about?

Yasumasa Masuda

[Interpreted]. Well, this is Masuda.

Thank you very much taking interest in Mid-term plan. We are discussing about these issues.

And in terms of I would like to refrain from mentioning anything about that at this point.

Hidemaru Yamaguchi

[Interpreted]. So you’re not going to refute any contents of this plan at this point?

Two, as you have said, how many years in terms of contest?

Yasumasa Masuda

[Interpreted]. We’re still discussing it so we’ll refrain from mentioning it.

Hidemaru Yamaguchi

[Interpreted]. Thank you so much.

Operator

Thank you very much. This is from Daiwa Securities, Mr.

Hashi. Please.

Kazuaki Hashiguchi

[Interpreted]. Hashiguchi speaking.

Regarding the result of the Terrain study for XTANDI, and I’d like to ask about the CV related adverse events. And there needs to be some difference from the bicalutamide.

And what’s your understanding regarding the difference, and especially the impact on the potential of the additional indication? Please refer to that.

Yasumasa Masuda

[Interpreted]. The first, this is Masuda to answer to you.

Currently, we are currently analyzing the content so we are not able to discuss the details. But as we mentioned in discussing the slide, the duration of the treatment or the dosing, it’s much longer for XTANDI.

And that’s one thing that we need to pay attention to. And Miyazawaalso have some comments.

Yasushi Miyazawa

And this is Mia Dawa. Well, there is not much to add to Masuda’s comment.

But currently we actually discussed the results of the primary endpoint and topline result. And the secondary endpoint results and safety are currently being analyzing so we are not able to discuss the specifics.

And also about the additional indication, for this study, those patients in the study were basically the same population covered by Prevail.

Kazuaki Hashiguchi

[Interpreted]. Maybe you may give the same answer but regarding the PFS and the duration of the treatment, in the case of bicalutamide it’s almost the same but in the case of enzalutamide the PFS is much longer than the treatment duration.

And what is the reason for that?

Yasumasa Masuda

[Interpreted]. Well, we have to look at the data more closely or scrutinize the data to answer to your question.

Kazuaki Hashiguchi

[Interpreted]. Another question.

Yasumasa Masuda

[Interpreted]. Yes.

Kazuaki Hashiguchi

[Interpreted]. Regarding the fast drug designation for your company, this is the second one, the following leader is P2215 and what is the second one, I believe - what is the second compound in receiving the fast drug designation?

Yasumasa Masuda

[Interpreted]. This is Masuda.

We have disclosed the first one. And at that time we may sound that if we get the designation, we designate the fast drug within the company.

We will not disclose the fact. So we like to refrain from disclosing what was designated as fast-drug in the company.

Kazuaki Hashiguchi

[Interpreted]. Thank you.

Operator

[Interpreted]. From Barclays Securities, Ms.

Seki please.

Atsushi Seki

[Interpreted]. I’m Barclay, Seki, so this is XTANDI.

So, in terms of your XTANDI the sales, it seems to be a little bit weaker than what the analyst has been saying. So Zytiga and XTANDI if consider launch in Europe, I think XTANDI is equivalent to Zytiga in Europe.

But in United States XTANDI seems to surpass Zytiga by far. So, the European launch of, ramp up of XTANDI, what is your take on that especially for the indication of pre-chemo anti reinvestment for the insurance, what’s the situation right now?

Yasumasa Masuda

[Interpreted]. Masuda speaking.

In terms of Europe, it’s basically in line with our expectations and it’s progressing smoothly. So, compared to Zytiga, what we think about that, at this point, at point we have no things that we want comment with you.

Atsushi Seki

[Interpreted]. No, the 30 and I believe that the blue should comment what mentioned about doctors and I understand, I think I heard that that you were not going to use this for the label changes but how about this.

Can it be useful, the marketing for the promotional purposes?

Yasumasa Masuda

[Interpreted]. Well, actually we have not done the analysis yet completed.

And so we will make a decision after we have the analysis. But basically what I can say is that the patient covered by this is covered by prevail.

Atsushi Seki

[Interpreted]. That in terms of the system or legally, you can use this?

Yasumasa Masuda

[Interpreted]. Well, our understanding is that it’s not really the case, but please wait until we get the full results.

Atsushi Seki

[Interpreted]. Thank you.

Operator

Next from Morgan Stanley MUFG Securities, Mr. Muraoka, question please.

Shinichiro Muraoka

[Interpreted]. I’m Muraoka, Morgan Stanley.

I have questions, both for, is for XTANDI. So, this is about XTANDI in Japan.

So certain quarter ended quarter was ¥4.1 billion to ¥4.6 billion. It seems that it hasn’t grown that much in Japan?

So the indication has been standard pre-chemo. But in terms of this growth, it seems a bit slow, can you explain the reason behind this?

This is the first question from me.

Yasumasa Masuda

[Interpreted]. Well, this is in-line with expectations and the sales, is growing very steadily that’s the point number one.

However, but the beginning of Phase II, this rapidly, the prescription expanded rapidly to patients who did not have any other ways of treatment. And so sometimes because of the patient in this situation, so the treatment was terminated.

So I think basically this has offset some of the increases in new prescription so it may on the surface it may seem that the growth is slowing down. But would the pre-chemo, little change?

Yasumasa Masuda

[Interpreted]. It is going to impact the sales, and we think that sales would grow smoothly.

So for the Japan, chemo from October to December, it’s not actually not having that full impact in terms of numbers, it’s not showing the full impact yet in Japan. Currently, so most of the cases would be post chemo right now.

But after the revision of the insert I think we have seen a steady increase.

Shinichiro Muraoka

[Interpreted]. Thank you.

Another point is, and the next question is about the Strive study. And I understand that this clinical trial will end around June this year.

And what’s your expectation currently? Thank you.

Yasumasa Masuda

[Interpreted]. And the enrollment has already been completed for this Strive study.

But as for the timing for the results, this is actually the event driven study. So, we do not have any timing for the completion of the study.

Shinichiro Muraoka

[Interpreted]. Thank you.

Operator

Thank you very much. Next, from Nomura Securities, Mr.

Urushihara. Please, hello.

Ryoichi Urushihara

[Interpreted]. I have one question.

So, the contract for Micardis what’s going to happen to that, that’s my question? According to you, your security reports, it seems that’s going to terminate at 2016 December.

Are you going to start to extend the contract or is it going to be fully terminated by December 2016?

Yasumasa Masuda

[Interpreted]. This is Masuda speaking.

Currently in terms of what’s going to happen after the current contract period, nothing has been decided. So, at this point there is nothing that we can comment about that.

Sorry about that.

Ryoichi Urushihara

[Interpreted]. That means that you won’t be able to sell?

That’s basically what you were saying?

Yasumasa Masuda

[Interpreted]. What I’m saying is that, it’s not decided what’s going to happen.

I can say whether yes or no to that question.

Ryoichi Urushihara

[Interpreted]. Thank you.

That’s all from me.

Operator

Thank you very much. From SMBC Nikko Securities Mr.

Nakazawa. The question please.

Yasuhiro Nakazawa

[Interpreted]. Hello.

This is Nakazawa speaking. I have two questions.

So, there is, rather questions about XTANDI. But in the United States, would the “pre-chemo sales group”.

I thought they would be stronger but -- for pre-chemo? So, is it a case that a pre-chemo prescription is growing steadily after the third quarter or is it the case that you want to take more time, actually the growth is going to take a bit more time then accelerate and more after?

Yasumasa Masuda

[Interpreted]. Well, in terms of the pre-chemo indication number of prescriptions, are growing steadily, that’s true.

But I think basically we are in the midst of the growth curve so to speak. What was the other question?

Yasuhiro Nakazawa

[Interpreted]. No, well, actually that was my question.

But you said that the 20% growth that’s on the second quarter, third quarter volume based growth, 20% growth. Was that the case?

Yasumasa Masuda

[Interpreted]. Approximately 20% volume growth, yes, that’s the volume growth.

Yasuhiro Nakazawa

[Interpreted]. And July you have increased your price once, and did you increase the prices in January?

Hello.

Yasumasa Masuda

[Interpreted]. Yes, we’re here.

In July, last year, since July of last year we have not increased prices.

Yasuhiro Nakazawa

[Interpreted]. Understood.

And in terms of the new mid-term planned image that we should have, so we have Vesicare, Tarceva, I think 2018 end this is going to, the plan is going to end. But well, up until 2020, for the new mid-term plan I think that will be your next target?

Yasumasa Masuda

[Interpreted]. This is Masuda speaking.

So, by 2018 Vesicare and Tarceva patent is going to be end. And of course we’d be looking at end, I will be, just various managerial tonnage issues.

And we have been seeing that from before at the new mid-term plan. We’d both be aware of that.

But as I have said, probably we haven’t - we can’t mention in terms of up until what year are we going to include this into this mid-term plan.

Yasuhiro Nakazawa

[Interpreted]. Well, I think DOE was your target in terms of managerial KPIs, are you going to review or change your KPIs that you’re going to target?

Yasumasa Masuda

[Interpreted]. Well, we’re going - revealing this from all perspectives.

But at this point, we have not decided which indicators that we are going to announce or not, we’ll refrain from commenting on that right now.

Yasuhiro Nakazawa

[Interpreted]. Thank you.

Operator

[Operator Instructions]. From Tokai Tokyo Research Center, Akahane sir please, Akahane sir, please.

Takashi Akahane

[Interpreted]. Yes, this is Akahane speaking.

So, the fourth quarter results forecast, how we should consider that?

Yasumasa Masuda

[Interpreted]. We have touched upon this field, 8.7% is our target, especially XTANDI in total, the U.S.

is about 83% is it, so I think basically you will be able to exceed that.

Takashi Akahane

[Interpreted]. But in the third quarter, the cost in itself has gone down.

If you just simply XTANDI’s gross fee basically it seems that the profitability is going to improve?

Yasumasa Masuda

[Interpreted]. Well, when I was explaining about the presentation, as I was said, up until the third quarter, performance has been quite robust.

And going forward to various factors there is a possibility that we are going to see upside in terms of the results. And of course there is a possibility that we’d be going to exceed our projections.

Beyond that we have no further information based on the third quarter results by product. Internally we are reviewing the outlook.

Takashi Akahane

[Interpreted]. But in terms of disclosure?

Yasumasa Masuda

[Interpreted]. At this point we have not seen any major upside that will lead to a revision of a forecast.

But there is possibility there will be some slight upside compared to our projection.

Takashi Akahane

[Interpreted]. Another question I have is that, on the 25, November, so, basically the government has passed the regenerative medicine log.

And has that changed your stance in terms of the your research?

Yasumasa Masuda

[Interpreted]. Can you repeat the question?

Takashi Akahane

[Interpreted]. Last year November, the bill for the regenerative medicine has been passed, I mean, it seems that the hurdle for the approvals has been lowered.

And you had been focusing on the IPS as well, so does that mean that the direction of your R&D has changed?

Yasumasa Masuda

[Interpreted]. Well, this is Masuda speaking.

There is no change in our R&D policies. So in terms of the regenerative medicine or drugs, this is another, this is the domain is that that we’re going to be proactive in looking at, at the next stage.

So, this -- it means another headwind has been added due to the change in the registration. But originally we have been very proactive in this area.

It means that we can further accelerate our initiatives. Beyond that there is nothing more that we can add.

Today we have announced this Osaka University has been bidding us. We have established a department of translational source therapy, at Osaka University.

So with the collaboration with external academia, we are taking this open innovation approach. So, with this regenerative drug that we challenge each domain, we have been proactive in engaging that.

Thank you.

Takashi Akahane

[Interpreted]. Thank you.

Operator

Thank you very much. Next is from Credit Suisse, Mr.

Sakai. Mr.

Sakai, please.

Fumiyoshi Sakai

[Interpreted]. This is Sakai.

One question. ASP1517 and YM, FibroGen compound, and when is the next data cut-off point?

And especially this year, is there going to be something for that this year? Could you give us an update?

Yasumasa Masuda

[Interpreted]. Well, currently what we have disclosed so far is that there are three Phase III studies in Europe.

And in Japan, Phase II is ongoing. And that’s the extent of our disclosure.

So I’m not able to discuss further.

Fumiyoshi Sakai

[Interpreted]. And is that about the 1517?

Yasumasa Masuda

[Interpreted]. Yes, that’s right.

Fumiyoshi Sakai

[Interpreted]. What about 311?

Yasumasa Masuda

[Interpreted]. And that’s too in Phase I and this seems to be taking a lot of time there.

Well, as you know 311 and ASP1517 are two compounds which we jointly develop with FibroGen. And so, and agreement, we have established our development strategy.

And that’s what we are following.

Fumiyoshi Sakai

[Interpreted]. So, in short, nothing new to disclose, no?

Yasumasa Masuda

[Interpreted]. Yes, that’s right.

Fumiyoshi Sakai

[Interpreted]. All right.

Thank you.

Yasumasa Masuda

[Interpreted]. Thank you.

Operator

This ends our questions, this ends the Q&A session. I’ll give the microphone back to Mr.

Masuda [ph].

Yasumasa Masuda

Thank you very much for participating to our conference call. We ask for your further support.

Thank you so much.