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Edited Transcript of 4503.T earnings conference call or presentation 27-Apr-17 6:00am GMT

Thomson Reuters StreetEvents

Full Year 2017 Astellas Pharma Inc Earnings Presentation and Conference Call

Tokyo May 3, 2017 (Thomson StreetEvents) -- Edited Transcript of Astellas Pharma Inc earnings conference call or presentation Thursday, April 27, 2017 at 6:00:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Yoshihiko Hatanaka

Astellas Pharma Inc. - CEO, President and Representative Director

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Conference Call Participants

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* Akinori Ueda

Goldman Sachs Group Inc., Research Division - Equity Analyst

* Fumiyoshi Sakai

Crédit Suisse AG, Research Division - Research Analyst

* Hidemaru Yamaguchi

Citigroup Inc, Research Division - MD and Analyst

* Kazuaki Hashiguchi

Daiwa Securities Co. Ltd., Research Division - Research Analyst

* Shinichiro Muraoka

Morgan Stanley, Research Division - Research Analyst

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Presentation

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [1]

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Good afternoon, ladies and gentlemen. My name is Hatanaka from Astellas Pharma. Thank you very much for your attendance at our company's financial results presentation meeting. I appreciate your attendance.

For the next 30 minutes or so, I would like to present the outline of our financial results, progress in the pipeline, the status of our pipeline and initiatives for sustainable growth.

Next slide, please. This is the cautionary statement.

Next slide, please. This is the agenda that I would present in my talk. First, on FY '2016 highlights. Next, please.

Now, FY '2016 financial performance was in line with the forecast we presented in October. We were able to meet the forecast. Excluding Forex impact and dermatology business transition or divestiture, our sales grew 2% year-on-year. Our core operating profit up 9%, according to our analysis. ROE stood at 70.32%. I will present the details on this later.

No steady progress was made in 3 strategic initiatives we outlined in the midterm business plan as well. In terms of maximizing product value, we increased our sales in XTANDI as well as maximized the OAB franchise and we launched Repatha and LINZESS in Japan. To create innovation and through the acquisition of Ganymed and Ogeda, we enhanced our pipeline. And in clinical development as well, we hit many milestones including a number of approvals and submissions.

Now to pursue operational excellence, we transferred our U.S. manufacturing subsidiary as well as long-listed products in Japan and optimized resource allocation.

There was progress made in Access to Health-related initiatives and so we're also focusing on creating social value as well.

The next slide, please. This variation, I would like to explain the fiscal year '16 financial results and fiscal year '17 forecast. First, and this is the core-based performance of -- for fiscal year 2016. Net sales were JPY 1,311.7 billion, down 4.4% year-on-year, but core operating profit was JPY 274.6 billion, up 2.7% year-on-year. As is shown at the bottom of the slide, yen appreciated against both the dollar and the euro. And because of that, there was a negative Forex impact on sales of JPY 94.7 billion, JPY 36.3 billion on core operating profit, respectively.

Now on top of this, as a factor specific to this year, there was a positive factor upon divestiture of our dermatology business. So excluding these factors, net sales were up 2% year-on-year. Our core operating profit up 9% year-on-year, according to our analysis. And the analysis will be given to you in the subsequent slides.

In comparison to the forecast we announced in October last year, although there was greater impact than expected upon the cheaper yen, we were able to meet both our sales and profit forecasts.

The next slide, please. Now this slide shows the comparison of the net sales year-on-year. We were able to steadily grow the sales of key products -- mainstay products, including XTANDI and OAB, our products. The impact of Japan's NHI price revision was negative JPY 225 billion. As a specific factor for this turn, there was a positive factor of amortization of deferred profit from divestiture of dermatology business. But then on the other hand, there was a negative impact from the high yen. Now excluding these two factors, net sales were up by 2% year-on-year.

Now on this slide, as shown, is the year-on-year comparison of core operating profit. From each of the items, we have excluded the Forex impact for comparison and we have also excluded the impact from the divestiture of dermatology business from gross profits. Because of growth in the sales of mainstream products, gross profits also grew.

For SG&A, we made investments into strengthening the organization and functions related to sales, and we also posted a provision for that accounts. But these impacts were offset by optimization of expense use.

On R&D, we solidly promoted developmental projects and have also continued making investments into new opportunities. Because of completion of some heavy late stage development projects, there was a reduction here this year. Just like sales, if we exclude negative Forex impact and positive dermatology business divestiture, the number was up 9% year-on-year.

Now, this page shows our performance on a full basis. Just as we saw in the core-based performance, on a full base as well there was an increase.

Now for the core-based performance, the factors that I excluded include impairment from the sales of U.S. production subsidiary or impairment from intangibles related to products and compounds under development. On the other hand, there were some sales made of -- for financial assets, including the policy shareholdings. So a financial income of JPY 22.9 billion was posted as a result. So as a result of this, operating profit was up 4.8% year-on-year to reach JPY 260.8 billion, net income up 12.9% to reach JPY 280.7 billion. This is the sales of 3 key areas.

Now third on the table, as shown is the graph excluding Forex impact. For oncology as well as urology, OAB franchise, it is growing steadily. Excluding the Forex impact for Prograf and transplant franchise, it is moving more or less flat. So quite robust.

Now other than the 3 key areas, including global products, we have been focusing on products, which are growth drivers in the Japanese market. With the 4 products including Suglat and Symbicort, which are growing, the sales exceed JPY 100 billion. And Repatha, which was launched April last year, and LINZESS, which was launched March of this year, we would like to increase adoption of these products and free promotion is appropriate use.

Our Lexiscan continues to be robust in the Americas, and the sales of CRESEMBA are steadily growing as well. So these are positioned as important revenue sources, and we will continue to look to maximize value for these products.

From this page onward, I would like to share with you our fiscal year 2017 forecast. Before I get into the numbers, I would like to provide a summary of the forecast. First, for net sales, we will continue to grow, on a global basis, products such as XTANDI end OAB franchise products. Prograf is also expected to grow quite steadily.

In the Japanese market, however, we are expecting a decline in sales from Micardis sales, whose patent expired in January of this year, and there will be a reduction in sales from 16 long-listed products, which were announced at the end of this month to be transferred. And optimize -- rather, our revenue recognized from dermatology, our business divestiture, which was a positive factor this year, will also be declining in the next year. We will continue to optimize some management resource allocation and reduce expenses for dividend increase of JPY 2 per share is expected to reach JPY 36 per share.

Now this is the forecast on the numbers. Net sales forecast of JPY 1,279,000,000,000, down 2% year-on-year. Core operating profit JPY 254 billion, down 7% year-on-year. R&D expenses JPY 218 billion, which is an increase of JPY 9.9 billion. For our Core net profit, we are expecting a decline to be JPY 195 billion. For Forex rates, our assumption is JPY 110 to the dollar, JPY 120 to the euro.

Compared to the fiscal year 2016, the impact from Forex fluctuation is expected to be smaller for fiscal year '17. And so excluding Forex impact and the impact from business transfers and assignments, we are expecting good growth in income.

On this slide, shown is the breakdown with the analysis of forecast for net sales and core operating profit for fiscal year '17. We will continue to focus on key products such as XTANDI and OAB-related products. But with the expiry of patent for Micardis, sales is expected to decline partially, so even after adjusting for these factors, in terms of net sales, a decline of sales is expected. For core operating profit excluding the factors of Forex impact and divestiture, we are expecting an increase. And as I said, we will maximize sales and make efficiency enhancements in expenditures.

Now this is the sales forecast of -- for 3 key areas. For fiscal year '17, we're expecting a lower or smaller Forex impact on a Japanese yen basis. We are to see growth in oncology as well as urology/OAB and transplant franchises robustly to proceed. XTANDI and OAB, I would like to give you details in a moment.

On this page, I would like to talk about sustainable growth-related initiatives. This is the overview of the strategy that we have overall as part of our management plan. We will continue to maximize product value that we have derived from investments, and we will also continue with necessary and sufficient investment the create innovation and of course pursue operational excellence continuously. And we will also proactively explore and acquire external business opportunities. These initiatives will be steadily promoted to ensure mid- to long-term sustainable growth.

First about maximization of product value in detail. Now this shows the status of XTANDI. The real demand for this product in the United States is rising, but we were affected by patients support program. And so the size of the sales of new hormone therapy market composed of the XTANDI and Zytiga is declining. And we are expecting that this trend will continue into fiscal year '17. So our forecast sales for XTANDI is going to be flat in the United States. But outside of the U.S., we are still expecting expansion and growth. So XTANDI total growth expected is 10%. And we're feeling a traction in the tearing data so the strategy remains. We will continue to promote the penetration of this product for early treatment. Now this is about XTANDI. Again, as I said in the earlier slide, while the growth of the product is slowing down in the U.S., in Europe, Africa and other regions outside of the U.S., there has been a steady growth. So XTANDI, overall, is still growing.

In the first half of the fiscal year in Japan, we were affected by NHI price revision but we are expecting double-digit growth in fiscal year '17. To look at the regional breakdown, outside of the U.S. is going to account for 50% -- or over 50% of the overall sales. And so with XTANDI's growth, a highly-profitable business, outside of the U.S. is going to contribute to the profit.

This is the OAB franchise. On a yen basis, double-digit growth is expected in FY '17 in Betanis and Myrbetriq BETMIGA and we will be focusing on these products to drive overall growth in sales. In line with our strategy, these (inaudible) background will exceed 50% of the OAB overall sales.

Next, please. This is for IBS-C, irritable bowel syndrome with constipation indication. A drug called LINZESS, which was launched in March this year. 2.9% of adults in Japan are said to have IBS-C. So for the first time here in Japan, we have acquired an indication approval for this by providing a therapy option. We do hope that we can contribute to the well-being of patients who are suffering from this disease.

Next, please. Now as a part of our create innovation initiative, I'd like to introduce you our pipeline. Next, please. Witness some progress in the March products in these 3 months. And the info for Solifenacin was submitted to the FDA for the indication of neurogenic detrusor overactivity in pediatric patients, ASP-6294 for bladder pain syndrome and interstitial cystitis, and another 2 products, in total 3, work for this 2 -- Phase II.

I'm going to go into, now, detail about ASP-4070 and the CK-2127107 rather later.

ASP-7713 went into Phase I with indication of underactive bladder. And for (inaudible), the code ASG-22ME, is that it is already in Phase II, and they are at this stage, and we're going to initiate a study in Japan as well. Next, please.

With such promises combining with acquisition of external innovations, we have been making our pipeline enriched because that is the foundation of our growth. In this slide, you see new chemical entities with circle. There are 20 of them in Phase II or later, and there are more than 30 of them when Phase I is added.

Next, I'd like to update each project. Next slide, please.

First, Enzalutamide. Three Phase III studies are going for all for prostate cancer. Prosper study for nonmetastatic CRPC and other studies are proceeding quite well. Next, please.

As for breast cancer, the result of Phase II study for ER/PR+ became available. In either Cohort 1 with hormone therapy naïve patients or Cohort 2 with a progression following 1 prior hormone therapy, the study didn't meet its primary endpoint in the ITT preparations subjects in all the patients randomized.

On the other hand, Biomarker+ patients in Cohort 1, progression for its survival was statistically significantly extended in the enzalutamide arm compared to placebo arm. In Cohort 2, the trend of extension of PFS was observed with Biomarker+ patients as well. We'll conduct further assessment to discuss next steps.

The detailed results are plan to be published at the relevant scientist's meetings. The result of the Phase II study targeting ER/PR+ breast cancer is likely to be available in the first half of this year. Next, please.

This is about gilteritinib. A cross-treatment paradigm potential of this product was rightly evaluated. A (inaudible) study targeting the highest medical recent and other statistics are proceeding quite well.

GOSSAMER study, at the very bottom of this chart, is to validate the potential as a post-chemo maintenance therapy and the patient recruitment has already started.

We are planning to report additional analysis of Phase I, II clinical trials targeting a relapsed or refractory patients in ASCO in the United States this June. Next, please.

Multiple Phase III study ongoing for ROXADUSTAT. Enrollment was completed in the first studies and the results of 2 Japanese studies targeting the patients in dialysis and an outpost study in Europe are expected to be available within this 1-year time. Next, please.

We are working hard for new therapeutic areas and modalities. First, there muscle diseases area. CK-2127107, Phase II study targeting ALS, or amyotrophic lateral sclerosis, will be started in mid of this year.

We will make a progress in the therapeutic area with a high unmet medical needs targeting ALS, SMA, COPD and others. On that (inaudible), a next-generation vaccine platform, ASP4070 for cedar allergy and ASP-0892 for peanut allergy, are in a clinical phase. New Phase II study for ASP4070 will be started soon in Japan.

Next, please. There are many compounds that already achieved POC in our pipeline. In this slide, you see specially potential projects to drive our growth in the future. We will carry forward these developments steadily to solidify our growth. Next please.

These are expected key pipeline events within a year. We have many important milestones from POC through to registration. Next, please.

From here, I would like to touch upon our new initiatives to create innovation. Next, please.

We've concluded a contract to acquire Ogeda in Belgium in this March. That front payment is EUR 500 million, and up to EUR 300 million will be paid as further contingent payments based upon our progress and the development of fezolinetant targeting menopausal-related vasomotor symptoms, or MR-VMS. After several customary closing procedures, acquisition process will be completed within this first quarter.

Next, please. This acquisition is a good strategic fit for us in 2 primary ways. First, it adds to the Astellas pipeline of promising late stage medicine for the treatment of -- for MR-VMS with high unmet medical need due to a dramatic reduction in the use of hormone replacement therapy to treat menopause-related hot flashes and night sweats following the women's health initiative guidance in 2001. So again, hormone replacement therapy usage is on the trend of the reduction. And there, new option of the treatment is now demanded.

Second, MR-VMS is expected to bring a synergistic effect to overactive bladder, or OAB franchise, as there is overlap in treating physician types. For example, in the United States, 74% of physicians who treat MR-VMS are OB-GYNs or PCPs, whereas 54% of physicians who treat OAB are also OB/GYN or PCPs.

In the United States, there are about 400 reps currently dedicated to calling on 5,500 such physicians division in this OAB franchise. Thus, logistic effects can be expected. On top of that, OAB is started around the age of 40 and affects many post-menopausal women. Astellas has long marketing experience in OAB, which is a strength to be made use of.

Next slide, please. The most advanced development program is Fezolinetant. Phase II study is positive and this result was reported at ENDO 2017, the Endocrinology Congress, this April. In 80 patients with menopausal-related hot flash, statistically significant improvement is observed in the Fezolinetant arm compared to placebo arm. The frequency of the moderate to severe hot flashes reduced by 88% and 93% from baseline at post-dose week 4 and week 12, respectively. The severity of hot flash was reduced by 60% and 70% from baseline at post-dose week 4 and week 12, respectively. No severe adverse events were reported in other treatment groups. The mild to moderate adverse events is 67% of displayed in Fezolinetant arm. After the completion of the acquisition process, we will accelerate this development to provide new treatment option to our patients.

Next, please. From here, I'd like to talk about pursue operational excellence initiatives. Next please. As it's been already announced, we closed the deal to transfer a long list of products to LTL Pharma. There are 16 products, including Gaster, Nasea and so on. These were the products contributing to Astellas' revenue for a long time, but with this transfer, we are going to reallocate our internal resources to the activities that drive our competitive advantage.

Transitional products and marketing authorization will be completed to continuously and stably supply the procedures to our customers. Next, please. Astellas is strengthening management's structure to cope with a change of the business environment. Exec committee is voting to discuss important management matters for Astellas as a whole. This is the management committee. So for the 5 top management as standing member, and this time, General Counsel is added as a member.

Also, last April, the legal and compliance functions are structurally divided and a new global function to integrate and manage compliance is established. And this April, legal and intellectual property functions are established to manage the regional, legal and IP functions, respectively. They are all to further enhance our global management structure.

Next, please. Astellas will continue to create social value related regarding initiatives or access to health. They've been working on new agreements for Chagas' disease; a collaborative development agreement of a rice-based oral vaccine for cholera and enterotoxigenic E. coli; participation and access accelerated to advance access to non-communicable disease prevention, diagnostics and treatment; and supporting of action on fistula. We are also cooperating international activities to prevent misuse and abuse of medicines for doping in sports, based on the agreement with the World Anti-Doping Agency, or WADA, as has been described on the right side of this slide.

Next, please. Last but not least, I will explain our profit distribution policy. Next, please.

We are working to boost the shareholders' returns through sustained growth in enterprise value. As you see our basic policy here, our top priority is the investment for the growth. On top of that, we'll continuously work to boost the shareholders' returns and improvement of capital efficiency.

The annual dividend of FY '16 is estimated to be JPY 34 per share, increased by JPY 2 from FY '15. And as I mentioned, for FY '17, it's going to be up by JPY 2 to JPY 36.

The share buybacks is totaled JPY 91.4 billion in F1 '16, in this one year.

Next, please. As you know, the market environment for pharmaceutical industry has been changing continuously. Astellas rather would like to transform this change to the value for the patients to realize long-term growth. Current growth drivers for Astellas is oncology and OAB. In the short time, I have mentioned projects with POC established are going to be our new drivers for the growth.

In mid- to long-term, new products in current priority therapeutic areas and products in new therapeutic areas and products with new technology and therapeutic modalities will start to contribute to our growth.

To accelerate our growth in the future, (inaudible) will bolster strategically allocated and we will actively acquire strategically fit external resources. With accumulating these activities, we are going to realize continuous growth.

Thank you so much for your attention.

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Questions and Answers

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Operator [1]

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(Operator Instructions)

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [2]

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My name is Yamaguchi from Citi. First we heard about XTANDI access program and which our price will be reduced, a coupon is issued and that has had an effect. At this time, the impact from the program has been strong. So as far as the U.S. is concerned, it's been affected greatly. Until it settles down, it's going to take another year or so. Do you think that it would take another year for the impact settle?

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Unidentified Company Representative, [3]

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Well, thank you for the question. The assumption for the for the forecast is such that we have looked at the fourth quarter status in fiscal year '16. We believe that the impact of the patient access program will continue throughout the year and the access program and commercial market size, there was a 15% growth there in fiscal year '16. So these 2 factors are trends we believe will continue. Based on these assumptions we calculated and came up with a forecast that in the United States the business will remain flat. So the label has been changed and the promotion for that will be tailored.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [4]

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And on that point, is there something that you can say?

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Unidentified Company Representative, [5]

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Well, this is according to our internal analysis, but since mid- last year -- well, urology and (inaudible) have been mobilized and we have started promotion vis-a-vis urologists and we are seeing a positive impact from that gradually. And from this fiscal year, Pfizer, they have a highly commended specialist group of urologists and so utilizing their customer base, we're going to increase our access to urologists. So we believe that we can make the maximum use of the TERRAIN data.

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Unidentified Analyst, [6]

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Two more questions. With respect to breast cancer, ERP are positive patients, primary endpoints were not met, although there are conditions attached. Given the mechanism of the drug, we believe that this an area there was highest likelihood of success. Given the results, would you think that it would be difficult to get a breast cancer indication? Or if you look at the biomarkers, there is still hope for promise?

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Unidentified Company Representative, [7]

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We had co-primary imports. And again, this was a trial that was actually run by Pfizer innovation, not by Astellas. There were co-primary endpoints. The one endpoint was the overall patient ITT analysis. The second co-primary endpoint were in patients who were positive for a gene signature. In one of the cohorts, the cohorts were patients who hadn't seen previous hormonal therapy. The gene signature cohort was positive -- had a positive P value, right? So at the moment where we are it is, obviously, most of these data have just come out. We're in the process of having discussions with Pfizer on next steps. Unfortunately, we can't give you very much more detail of this trial because clearly it would inhibit our presentation at the scientific meeting. So the intention is to disclose more fully those data. At the same time, obviously, we will be discussing with Pfizer what the next steps will be.

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Unidentified Analyst, [8]

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And overall, the midterm business plan, this will be the last year. The last time, it was a 3-year plan, so going forward in the next 3 years, new drugs will be developed and launched, but they're going to be patent expiries, both positives and negatives. So with respect to the timing of the next midterm business plan, if there's anything that you can share with us?

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Unidentified Company Representative, [9]

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Internally, inclusive of the guidance, well, I'm now looking at the next midterm business plan. How or in what form we can share that with you, discuss that with you, we would like to let you know later. As you said, from fiscal year '19, we will start to be impacted by patent expiries. But there are projects where approvals are forthcoming and so inclusive of such factors, we will be putting together our midterm business plans.

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Unidentified Analyst, [10]

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So you will come out with a plan, although the number of years covered and the timing is yet not determined?

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Unidentified Company Representative, [11]

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Well, inclusive of the details, we're still discussing internally. Once this year is out, we will be summarizing and looking at the results of the past 3 years and, one way or the other, we will be coming up with some form of midterm outlook, as you rightly pointed it out. There are going to be patent expiries and we are also scheduled to have launches from late development projects, so one way or the other, we will be able to share with you some sort of outlook. Thank you.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [12]

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Daiwa securities, my name is Hashiguchi. Have a couple of questions. First, again, extend date. Usually, quarter-over-quarter, actual demand increases and extent or your focus about that is explained. So once again, here as well on quarter-on-quarter basis, would you please introduce the actual and the plan for this fiscal year?

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Unidentified Company Representative, [13]

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Thank you. First, the Q-on-Q in the United States, again, there is the patient access program. When that is included in total, volume is 5% increased. But when it comes to [Seoul's]that's 7% decrease. Since we have managed to issue this patient access program that is increasing. Therefore, the patients with the free goods is on the trend of increase. That's the current situation.

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Unidentified Analyst, [14]

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So this patient access program, what's the factors of increase of this patient access program patient? Well, I think a little while ago, you mentioned that this struggle is likely to continue and that is increasing in the third quarter and the fourth quarter. There is on the trends of the usage of patient access program. What's the factor of that?

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Unidentified Company Representative, [15]

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Well, first of all, the total number of the patients using XTANDI, that itself is growing greatly. For example, if we do the comparison from a commercial market come paired to Zytiga, XTANDI's share is higher. So first of all, overall, the number of the patients is increasing. That's why of course, the number of the patients on the patient access program is on the trend of increase.

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Unidentified Analyst, [16]

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I see. Next, about trying data that is accepted as a positive for you?

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Unidentified Company Representative, [17]

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Trying. The primary end point is the office. So relatively looking at the short-term outcome. But in their retrospective analysis or the research, probably in ASKUL GU in February the data was published, that is veteran community dataset, and there in OS -- this androgen-blocker, there was no difference in NOS compared to the (inaudible). And this was a retrospective for separate [relations]. So I don't know to what extent should be accepted or interpreted.

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Unidentified Analyst, [18]

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But for your activity in the pre-chemo patient or the chemo naive patient, are you going to do some long-term study to show the efficacy of XTANDI?

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Unidentified Company Representative, [19]

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Let me make sure I understand the question. So your question relates to the fact that in TERRAIN, we showed a PFS benefit of the Casodex. And then how does extrapolate to overall survival, right? And I guess the best way to answer your question is that we have already shown in the pre-chemo setting an overall survival benefit, right? So we did that in the Proventil trial. So in terms of overall survival benefit of XTANDI, that has been proven versus placebo in terms of OS. On basis of comparison to Casodex, we've shown a fairly significant improvement in PFS with the understanding that that's the setting where we already have an OS evidence.

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Unidentified Analyst, [20]

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On top of that, as you pointed out, another data -- that is a retrospective data...

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Unidentified Company Representative, [21]

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And about that point, we are not in the position to make any comment about that.

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Unidentified Analyst, [22]

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So, OS benefit, you are confident about OS benefit of XTANDI, therefore, higher evidence level? Are you planning to do some other type of the trials so that you can enhance this good benefit of this product in terms of OS?

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Unidentified Company Representative, [23]

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So again, in terms of overall survival outcomes-based trials, we've got 2 large studies both in terms of Affirm and Prevail in the metastatic castrate resistant prostate cancer population. We already achieved those to get and the population. So we have that churn in terms of OS, right? As you move to earlier lines of therapy, which we are currently studying, so, for example, in the case of PROSPER, the practicalities of OS is significant, right? And that's what we're trying to do. With the prosper study, our intention is to have metastatic progression-free survival as the primary endpoint, but to follow patients through to overall survival. But I'm sure you appreciate the earlier we move up the treatment paradigm, sir, we are looking at M0. And then when we look at patients who are M0 but are hormone sensitive, so in other words biochemical chemical recurrencies of patients who've just had definitive therapy and now, they're starting to show increases in their PSAs, these are patients that are a long way off overall survival concerns, if you like, from the patient perspective. The intention is to try and follow them, but the longer the time to overall survival, as has been shown by numerous overall survival trials, the more confounded the outcome may be, right? So, we've shown it definitively in the metastatic setting. We are attempting to capture it in the PROSPER studies. We will do our best in terms of the other trials that we are studying, right? But the primary endpoints of those largely are based on either metastatic progression-free survival or PFS in the case of patients who have M1 and are hormone sensitive, right? In the [Archer] study. So we have some very large studies ongoing to capture definitive data. But it's difficult to do when you're doing comparative like trials, as we've done with Casodex, to make every trial an OS-based trial. And that's a very complicated and significant investment in terms of endeavor. And certainly, the agencies, the health authorities, have recognized the PFS as being a relative endpoint in that population, largely on the basis that we've shown an OS benefit in the Prevail trial.

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Unidentified Analyst, [24]

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Lastly, about Repatha. What is the situation of the business in Japan in recent times? There has been many changes in the environment. The CVS Arkham study results have been published, an optimal use guideline is determined and where it was unclear, the standard has been clarified in terms of communication. And the self-injection is also approved. So there has been many changes made in recent times. So how motivated are Japanese doctors to prescribe by Repatha? Has their motivation increased? Or is that going to take time to happen? So if you can share with us numbers as well, we would appreciate it -- I would appreciate it.

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Unidentified Company Representative, [25]

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Yes. With respect to the results, the plan for the product, we have a relationship with the partners. So we are prevented from disclosing the numbers. A flurry of study results and optimal use guideline has been clarified and self-injection is going to be allowed. I understand that it's going to start in May. So from these 3 factors, on a continuous basis, we would like to promote optimal use and PCS K9 value should be communicated and promoted vis-à-vis the physicians. That is the overall plan for now. And so in order to achieve that, we would like to continue to participate in academic meetings, and we have a plan ongoing that is being implemented.

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Unidentified Analyst, [26]

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So you're trying to promote this going forward? Rather than being worried about the changes, you are going to continue to positively promote this?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [27]

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Well, of course. The number of hospitals who have adopted the product as part of the patient line, we are seeing various positive signals already. Whether they translate into the actual performance, we will have to wait and see. Thank you. I see another hand. Go ahead, please.

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Unidentified Analyst, [28]

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My name is Seki from UBS. I have 3 questions. The first about XTANDI. Earlier, Mr. Hatanaka said that volume prescriptions were up 5% but value down 7%. So the price has been down 12 points, according to a rough calculation. Just to clarify, a 12-point reduction in price will continuing in the next fiscal year? And the volume, however, will be up about the same? And so the market or the business will remain flat overall? Is that a correct assumption?

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Unidentified Company Representative, [29]

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Well, just to be precise, the number of prescriptions, including commercial inpatient access program, with the 2 combined, q-on-q, it was up 5% between January and March. If we exclude a patient access program, commercial-only is down 7%. So it's down 7% as for the commercial. While patient assist program is expanding, on the other hand, and it is substituting the decline in the commercial segment and step edit. Prior to XTANDI, Zytiga is used. There are payers that have that regulation, or PNs who have such regulation. We're trying to negotiate with them. So step edit payers are there being reduced in number as a result of negotiations. So on the one hand, there is going to be expansion or growth, but on the other hand, there's also going to be discount. That will also slightly increase. So those are the dynamics. With all of them included, commercial is down 7%. That is where we are. Thank you.

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Unidentified Analyst, [30]

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And this is just a mere speculation by an outsider, but with respect to the net price, are you making a strategic move to reduce that? For XTANDI, there's a lot of debate about the price and there could be powerful generics being launched in the market. XTANDI is a product that's going to be used for the long-term. So would you say that?

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Unidentified Company Representative, [31]

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Well, are we trying to reduce the overall price for XTANDI? That is not the case. Each payer, each PBN, we're negotiating with them individually. In the negotiations, in some cases, prices may have come down. And so what we're seeing is the net aggregate of that effect.

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Unidentified Analyst, [32]

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Understood. The second point is again about XTANDI. Recently, Roche PD-L1 product (inaudible) is the product that they have and CRPM, CRPC, a Phase III study, (inaudible) [2 50]. That's what they started recently. Now, listening to Roche, what you're doing is totally relevant to what they are doing according to them. But considering the maximization and value of XTANDI, perhaps you should look to proactively think about having a concurrent therapy with an IL. Is that wrong thinking?

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Unidentified Company Representative, [33]

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Are we thinking about doing combination therapies? The answer is yes. I'm sorry, I struggled desperately with the translation of the third question. I think the translator did great until the third question. So if your question is, do we -- have we considered or do we consider...

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Unidentified Analyst, [34]

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Roche recently initiated (inaudible) in a combination trial in the CRPC. And Roche says, our staff is not involved in the clinical study. So, I'm wondering why your company is aggressively starting combination therapy with IO?

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Unidentified Company Representative, [35]

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When someone else is doing for us? Well, I mean, so the reality is we have a partner in Pfizer, right? We have constant discussions with our partners to what the best strategies are for the further development of our compound. Combinations, as we've talked of about previously, are something that we've actively considered. Of course, there is nothing to stop, because it's a commercialized product. It's nothing to stop anyone else. Purchasing XTANDI and running their own trials, and that is happening to a large degree. And if Roche chooses to do that, then we obviously wish them well.

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Unidentified Company Representative, [36]

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Together with Pfizer going forward, we would like to continue to debate how to maximize the value of XTANDI. We will continue to engage in that discussion with Pfizer.

So in that discussion, we will of course potentially discuss combinations.

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Unidentified Analyst, [37]

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My last question, the third question, when the guidance came out, operating profit saw a slight decline. 4 years ago, I think you made an announcement about the restriction of the R&D organization. You have reviewed how R&D are allocated. And so I think you have increased the external resources, therefore, XTANDI, it's been 4 years since. And biotech companies' valuation's been too high. I think I was a miscalculation on your part, perhaps, seen from the outside. So as a strategy, 2, 3 years from now, your purchased assets that are to contribute to the bottom line, that's VESIcare Tarceva, if you had that idea, that would've been more successful. But what do you think is the assessment of your decision to shift resource allocation back then?

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Unidentified Company Representative, [38]

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Well, thank you for the question. As you said, we would like to capture and utilize external resources as much as possible to be more efficient. That's true. We have 20 research projects. We have many early development projects that are starting.

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Unidentified Analyst, [39]

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With that idea in mind, what about late development projects? To what extent have we been able to utilize external resources? I think that is the key part of the question.

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Unidentified Company Representative, [40]

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What's already in the market where Phase III studies are ongoing, results produced for such projects, it could be somewhat difficult because of the competition being very intense. Valuations are very expensive for such projects if they're in the late stage or Phase III. So for (inaudible) and Ganymed, under those circumstances, we have acquired these unique companies. They are unique but very promising. Fiscal year 2019, will we make it by that time with the acquisitions? Well, we will have to look at the time line. Are we (inaudible) the top line being reckless or blind? No. We have tried to avoid doing that. So we look at the growth drivers that we have already. That are being submitted, those where POC is already established. We look at them overall. And can we have a growth that's near in the future with what we have today? And we believe that we can grow in the future thank you. After the next question, we would like to entertain questions from the teleconference system.

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Fumiyoshi Sakai, Crédit Suisse AG, Research Division - Research Analyst [41]

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[Fumiyoshi] Sakai is my name. Ganymed, that's pointed out. First question is for Ganymed. IMBA, this is drug for the gastric cancer and a Phase II was already completed in Western countries. So that's in Europe. I think that was updated and I believe you have seen the result of our OS. And what's the current status of the progress? And how you go into the office if about 250 patients is likely to be necessary for the study? So how are you going to manage the study? Would you please share with us your idea about this next phase of this product?

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Unidentified Company Representative, [42]

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Sure. So we closed the Ganymed deal at the end of December. We're in the process of assimilating all the data that Ganymed had collected in the first trial. As you pointed out, the trial was than predominantly in Europe. It was actually done in probably Eastern Europe, the majority of the sites. One of the things that we are planning for is clearly next steps. An important component of that will be to open an IND in the U.S. So we have to do all of the assimilation of all of the data which was in Ganymed right now to make sure that we can file the IND and be successful and then at the same time, plan the trials of the next step, which would probably be the IND opening study. So those are the activities that are under way. So it's not an inconsiderable amount of work that's being planned. So our next step, the activity we're doing now is to continue the integration to assimilate all of the data that is necessary to successfully open the IND, as well as planning for the next study. And so we expect to have regulatory interactions probably towards the middle of this year.

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Fumiyoshi Sakai, Crédit Suisse AG, Research Division - Research Analyst [43]

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Another question. That is Fezolinetant. Fezolinetant. The study here is said only conducted in a Western country, most specifically Europe, as Phase II data. So I think there were 3 Phase IIa studies conducted and the data shown this time here is the data aggregated all of those 3 studies? And in the United States, this is also going to be the data to be used for IND opening in the United States. Is this understanding right?

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Unidentified Company Representative, [44]

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We ran 3 studies. The studies that we're particularly interested is the VMS studies, so the vasomotor symptoms, right, which was in postmenopausal basal mortar. The other trial that is ongoing is the study on polycystic ovary disease, or polycystic ovary syndrome. The third study, I believe, was a fibroid study but that had been discontinued, right? In fact, our interest -- our primary interest is obviously in vasomotor symptoms, because it's a large, mostly underserved especially considering the really only effective therapeutic is hormone replacement therapy, which have significant issues associated with it. As well as the polycystic ovary syndrome. Those are the 2 major indications. Now, VMS can also be iatrogenic. So either from surgeries or from hormone depletion in treating cancers. So a large bucket of vasomotor symptoms and polycystic ovary syndrome. Those are the major. There is actually an IND open for this particular compound. The trial was run in Belgium but an IND has been opened. So the dialogue has already happened with the FDA for this compound. And as we progress towards closing and finalization, we'll be able to communicate more plans going forward.

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Fumiyoshi Sakai, Crédit Suisse AG, Research Division - Research Analyst [45]

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(foreign language) So there are long-term listed products that transfer to other company? And the micro disc HD. Well, the IR right is obtained by the counterpart. Therefore, if you do (inaudible) on a generically, you would do (inaudible) generic. And you might like to talk about is in the midterm plan, but if it's in the Symbicort and there is the other one, what was that? Symbicort and (inaudible) -- the 2009 -- well, 2019 probably the patents in Japan are going to be expired. Probably you haven't decided how you're going to do about them. Well, but in currently, the sales of those products have relatively large. So how are you going to deal with the situation?

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Unidentified Company Representative, [46]

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Well, currently for this, with a partner company, what we do after the patent is expired are not really discussed. Therefore, today, we cannot tell you what's likely to happen in the future. But concerning the penetration of generic these days, in a very quick speed, in some product classes, the generics will be appeared and it will be coming to the market so quickly and some are not. Depending on the types of products or the class, the situation will be different. And when it comes to authorized generic, or AG, and of course those of the products and not with our right. Definitely in that case, we've continue to discuss the partner companies, that is only the level I can answer to you today. Thank you.

(foreign language) Those of you who are participating over the phone, we would like to take questions from them. May I ask operator to take the questions?

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Operator [47]

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We would like to take questions from participants on the phone. (Operator Instructions)

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Unidentified Analyst, [48]

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Just one question, with respect to XTANDI, your positive study results Biomarker, is this the same as triple marker Biomarker+? Is the biomarker the same? Was that used for triple negative?

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Unidentified Company Representative, [49]

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(foreign language) So it's a different biomarker. Understood, thank you. Did that answer the question? The next question please. (foreign language) There are no questions, no persons who have questions. So we were late to go back to the venue. There are no questions via teleconference, so if there is a question on this floor, please raise your hand. The lady in the second row please.

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Unidentified Analyst, [50]

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Nikkei Biotech, my name is [Kubota]. One question, what happened in the past. The UMM Pharma influenza, so culture Vaccine, you discontinued that development. You announcement the discontinue of the development. The reason for that? And why you decide in that way? It was not really explained. Would you please explain why you stopped development of that? And the next question. From this experience, if you've learned something about the forthcoming vaccine development, would you please share that with us?

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Unidentified Company Representative, [51]

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Well, the information is just as it's been published. Overall development and also status of the submission considering all the factors as Astellas have decided to discontinue the development. And that's all from us. There's nothing more to say. And something that we've learned from this experience? Well, of course, just like our usual development projects, we think about the study designs and end points efficacy safety interpretation. For those, all in all, we have learned a lot. But specifically, what exactly that was, that's something we would rather would like to refrain from telling you here today.

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Unidentified Analyst, [52]

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Thank you, another question is about Ogeda that you acquired. So the meaning of this acquire -- acquisition is to gain a pipeline. But GBCR drug discovery is also what they are doing. So as the platform of the disc technology, how do you evaluate that? And because their platform is now gained, are you going to do some GBCR in your development projects?

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Unidentified Company Representative, [53]

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So I would just reiterate to the primary reason for the acquisition related to the lead compound that they have, which has produced really quite exceptional results. So that's the primary reason. The fact that they actually have the GPCR component. This is the GPCR that they've operated on in the first place. There were 2 other candidates that are in preclinic, which is an organization we began to evaluate. And clearly, our DER colleagues will interact with that organization to glean whatever we can on this particular technology. But again, just to reiterate, the primary reason for the acquisition is the fact that there are very robust Phase II data in an area where we think is of high unmet need where we think there's a real opportunity to serve patients and an opportunity for Astellas.

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Operator [54]

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We have a hand up in the third row, please go ahead.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [55]

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My name is Muraoka from Morgan Stanley. Regarding XTANDI, every quarter, we asked this question. Just to clarify. The way to the urology franchise. I think before, about 3 months ago, you said that's around 20% to 22% or 23% and that was due partially to the impact from a patient-access program. Is the ratio up? Can you share a number?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [56]

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With respect to the weight of the franchise, we do not disclose such numbers. Urologists who prescribed the drug as of February, the numbers actually of urologists is up. Compared to Zytiga, I think we have greater penetration of the product among urologists.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [57]

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Well, before, I think the number of urologists that were prescribing this around 1,500, is it increasing?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [58]

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Well, urologists who constantly prescribe the drug is over 1,400. It's about the same. And according to the data, the same statistics as Zytiga's doctors, 400 in number.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [59]

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Well, sorry for being persistent. But in the last few months, in terms of the number of urologists prescribing the drug has not increased all that much?

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Unidentified Company Representative, [60]

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Well, there are fluctuations. It's sometimes up or down. In total, it has not increased all that much, perhaps. But according to internal data that we have, TERRAIN data is reflected in the label and we have mobilized urology-specialized MRs for marketing and we're seeing positive signals. So we're seeing traction and a positive sign. So as I said earlier, urology's specialized MRs from Pfizer will also be mobilized and so it's going to go positive. Thank you.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [61]

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In terms of the pipeline, what said do you said (inaudible)? What set is that? Other competitors of yours are purchasing competitive products and as an advantage of your product, what would you say is the competitive advantage that compared to the follower drugs? I know that the frequency of these of the drug is different, but what are the other advantages that your product offers? Roxadustat compared to the following drugs?

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Unidentified Company Representative, [62]

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(inaudible) GSK compound or if you are talking about the Akebia?

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [63]

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(foreign language) Akebia compound.

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Unidentified Company Representative, [64]

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It's going to be the Akebia compound. So I mean, if you like, the other HIF, [profile] hydroxinlaise inhibitors is going to be the GSK compound, is going to be the Akebia compound. And then candidly, the biggest advantage that we have is we are first. That's the biggest advantage we have. And our intention is to be as expeditious as possible in moving these programs forward. We are -- we've completed recruitment for the major studies in Europe and competition for patients is obviously an issue, especially with very large studies going on and with now a number of pharma companies involved in this space. So our major focus is on execution right now. It's very difficult. It will always be very difficult until the head-to-head trials. And it will be interesting to see about frequency of dosing because I think GSK's assumed a different option in terms of dosing frequency. And at the end of the day, the data will read out, right? And the data will speak for itself. We believe that the frequency we've chosen is optimal. But again, as we said, I think, in the major presentation, we'll start to see some of the data from the pivotal trials this fiscal year. Any other questions? If not...In the fourth row.

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Unidentified Analyst, [65]

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(foreign language) [Kamio] is my name. A couple of questions about the Japanese market. First, ICT. The usage is promoted by the government, and digital technology is now available for collecting and providing information. And many companies are trying to adopt that kind technology, but as Astellas, what's your view about usage of data technology? Have you already introduced and went live? Or are you going to do some pilot programs?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [66]

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Well, ICT technology -- ICT, the technology itself we are on top of that real-world informatics technologies are trying to be used in our company as well in the Japanese market sales and marketing as well. We are trying to do -- use this technology to do something new and, currently, a pilot program is ongoing. And this segment is likely to be accelerated quite quickly. So when time comes, then I would like to introduce some to you.

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Unidentified Analyst, [67]

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The second question, Japanese market. In the FY '18, your forecast. Well, there's expiration of the [Mycaldis] Patent and reduction of the earnings by 2 digit is something you would expect. But in the Japanese market, when do you think you will hit the bottom? That's the first question. And I just wonder, does this situation lead to the reduction of a number of human resources especially in the case of -- especially in the MRs?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [68]

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Well, overall, as we mentioned, we have some projects already approved and launched in the market. And we have projects in the late phase; that includes Repatha, [indiscernibile]. And within the fiscal year, we believe that we can submit for romosozumab. Excuse me, that is already submitted to -- for the GMDA. So likewise, we have many promising products available in the Japanese market. And as pointed out, [Mycaldis], this year its patent is going to be expired and next year, [vonoteo] is going to be impacted. But within this combination of the product and patented situations continuously, once again, XTANDI is expected to grow and in Japan, Betanis is going to grow. Therefore, in total, rather than if we hit the bottom or not, the -- these products are now launched. The products are just after the launch and the products plan to be launched. We are going to maximize those product. And by doing so we can manage the Japanese market as a continuously important market. With regards to the number of MRs, well, first we need to look at the portfolio at that time and the status of the -- our newly-launched products. So depending on that, we would always like to think about the optimization of MRs and if that opposes what we are pursuing all the time. I think and -- the longtime listed products that you have in the marketing authorization and you continue to do this transfer or divestiture of this products? Or this time, we have to deal with LTL and that is like the how the package -- or the package deal with LTL. But in the past as well, in various ways, we transferred our market authorization to other companies. So this is nothing new and this is not only what's happening in Japan and with some countries, such as the United States, Europe or in Asian portfolio as well so that we can realize the optimal investment. We are always thinking about this as one of the options. Any other questions? I see a hand over there. Please go ahead.

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Unidentified Analyst, [69]

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My name is [Shimamura] from [Nikai Yakugyou]. About long-listed products, you have signed an agreement with LTL Pharma. I think it's a rare case where you haven't been able to do so. Well, LTL Pharma is a fund-based company given that it's rather rare. So how did you choose the partner?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [70]

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Well, as to the circumstances leading up to the agreement, I can only say that we have come to an agreement -- a mutual agreement. That's the only thing we can say. So long-listed products of ours, continuously, we want to have them offered to patients in the best possible manner. What would be the best way to do so? We thought hard and long and we're continuing to think about it. So when we're thinking about that, we had this opportunity, which resulted in a mutual agreement with LTL. So not that we're interested in the format or the partner that we do business with, the partner that we have transferred our products to, they can continuously and safely provide the long-list of products. From that perspective, we decided on the partner.

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Unidentified Analyst, [71]

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Well, additionally, is there a possibility that you will offer long-listed products more than to LTL in the future?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [72]

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I'm not reel out -- I'm not ruling out any possibility but we haven't deciding anything more.

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Unidentified Analyst, [73]

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Regarding Sigler, what is the (inaudible) of the sales? And with respect to the potential of combination -- (inaudible) that is combination, what is the potential?

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Unidentified Company Representative, [74]

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Well, there has been revision made to the guidance. So SGL 2 the market overall for diabetes, it's now accounting for 10% of the diabetes market, now, although not our product, but if we look at the overseas data of these drugs, for good SGLT2, we're starting to see a better data, which is a tailwind. Among that SGLT product, competition is intensifying and so our product is based on the greatest Japanese data. The Japanese data we have is the largest so we would like to make maximum use of the Japanese data available to us. And with Januvia, the combination that we're looking at with Januvia and we're planning to make a submission by the end of the year. Compared to other competitive combinations, there may be some delay for our product perhaps. But with that included, we believe that we can maximize the benefit. And the uptake in terms of sales is slower than initially expected. But gradually, the sales are increasing. So we would like to concentrate resources to further drive the sales. (foreign language) Any other questions? The person on the second row, please.

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Akinori Ueda, Goldman Sachs Group Inc., Research Division - Equity Analyst [75]

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Goldman Sachs, my name is Ueda. The question is again about XTENDI. So that patient access program and also commercial quarter-on-quarter number is explained. But overall, in XTENDI in the United States, what's the current trend of the quantity sold and your plan? What kind of focus do you have?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [76]

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Thank you. Overall, well, again, the new hormone therapy field, I know we have like XTENDI and Zytiga is included. That is the whole market. And in this perspective for the quantities increasing, but this is probably not something that I would say but the Johnson & Johnson first quarter information on the disclosure also include the issues that we are experiencing as well. So totally, there is an increase, but in the commercial market it is not as it's been expected. So that's the overall and situation. So our own products situation and overall market situation are nearly equal. So the trend are the same between these two.

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Akinori Ueda, Goldman Sachs Group Inc., Research Division - Equity Analyst [77]

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So what's your conditions or prerequisite in your plan?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [78]

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Well first of all, total quantity increase that is 15%. 15% growth is forecasted. And the fourth quarter and the fiscal year, the commercial and the patient access program percentage is going to be available. And if that share is going to continue for the full year, based upon that, we came up with that plan. And internally, we believe that this is going to be the flat. That's our focus and plan. Thank you.

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Akinori Ueda, Goldman Sachs Group Inc., Research Division - Equity Analyst [79]

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So is there any risk that the plan, the number might go up higher than the plan or lower than the plan -- planned? Once again, this question on access program and in the past, there's a trend of the increase. So do you see any risk that this program is going to be expanded further? You talked about the corporation of Pfizer, revision of packaging size. It might be difficult for you today discuss all those such information. But is there any expectation that your current plan number is going to go up?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [80]

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Well, as of now, what you can -- what we can tell you that is the current number is our best effort number. Of course depending on the market situation, it could be both going up or down. But the current plan is whether we are confident. So please do understand that in that way. Thank you. The last question?

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Akinori Ueda, Goldman Sachs Group Inc., Research Division - Equity Analyst [81]

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That is about the return to the shareholders?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [82]

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Well, at this time, if we look at Page 49, well, the…

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Akinori Ueda, Goldman Sachs Group Inc., Research Division - Equity Analyst [83]

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You are going to do the share buyback in a mobilized manner. That is what is described here and if there is a previous information, that's not much different. But now, you are facing the expiration of the patent so your position for that is going to be different. And also prepare to catch your standard. How do you view about that?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [84]

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Well, we haven't really changed our direction about that. The graph there is likely to be quite busy, therefore, we intentionally excluded the information of the share buyback, only the number is there -- so there is no change about our positioning and also the direction to go. Therefore, the cash balance JPY 150 billion to JPY 200 billion exactly is to be quite optimal for us to always obtain our hands. And in order to do the acquisition, we would like to do additional 15 -- JPY 150 billion to JPY 200 billion in total. We would like to have that JPY 300 billion to JPY 350 billion as our cash to do our operation. And if there's something extra and if there is no opportunity in front of us to use that money, I would like to think about the share buyback in a flex manner and that position is no different from the past. Thank you. (foreign language)

Time to close is approaching. If there is no further question, this -- the next one will be the last question. Any question please?

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Unidentified Analyst, [85]

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My name is [Hamaguchi] from [Research Center]. In the morning paper, it was written that National Cancer Center Research is ongoing. It's a research for cancer patients who are the elderly. For age 75 and onward, the results were not all that good. Could this impact business, for example?

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Yoshihiko Hatanaka, Astellas Pharma Inc. - CEO, President and Representative Director [86]

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We have not done a similar analysis internally so I cannot say anything definitive at this moment with respect to the results that were published from National Cancer Center.

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Unidentified Analyst, [87]

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There's another question that I have. About the presentation meeting, you are convening this meeting in April, why? And will you have meetings earlier than you had in the past for quarterly meetings?

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Unidentified Company Representative, [88]

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Let me answer. We would like to make disclosures at the earliest possible stage. That is a request from TSE. And internally, we believe that our early communication is best. And because of that, we decided to make the disclosure earlier than we -- what we did in the past.

For quarterly meetings, we would like to study internally and let you know when to convene them.

With that, time is up. So we would like to conclude the meeting. Thank you very much for your attendance once again.