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Edited Transcript of 4508.T earnings conference call or presentation 29-Jul-19 10:59am GMT

Q1 2020 Mitsubishi Tanabe Pharma Corp Earnings Call

Osaka Aug 3, 2019 (Thomson StreetEvents) -- Edited Transcript of Mitsubishi Tanabe Pharma Corp earnings conference call or presentation Monday, July 29, 2019 at 10:59:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Eizo Tabaru

Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director

* Yoshiaki Takai

Mitsubishi Tanabe Pharma Corporation - VP & Head of Corporate Communications Department

* Yoshihiro Kobayashi

Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director

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Conference Call Participants

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* 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

* Seiji Wakao

Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst

* Shinichiro Muraoka

Morgan Stanley, Research Division - Research Analyst

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Presentation

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Operator [1]

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Good evening, everyone. This is a conference call by Mitsubishi Tanabe Pharma Corporation to announce its business results for the first quarter of fiscal year 2019. First of all, we will have a presentation on the overview of the first quarter results for about 15 minutes, and then we will have a Q&A session.

We are planning to hold this meeting for about 45 minutes in total. Before we start the conference, we have a cautionary statement. The statements contained in the presentation are based on a number of assumptions and beliefs in light of information currently available to management of the company and are subject to significant risks and uncertainties.

Now I'd like to hand over to Mr. Takai, Vice President, Head of Corporate Communications Department.

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Yoshiaki Takai, Mitsubishi Tanabe Pharma Corporation - VP & Head of Corporate Communications Department [2]

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We now would like to start our meeting on the business results for the first quarter of fiscal year 2019. Today, we have the attendance of Eizo Tabaru, member of the Board, Managing Executive Officer, responsible for Finance and Accounting Department; Yoshihiro Kobayashi, member of the Board, Managing Executive Officer, Head of Ikuyaku, Integrated Value Development Division; and Yasutoshi Kawakami, Executive Officer, Head of Sales and Marketing Division.

I am Takai, Vice President, Head of Corporate Communications Department. Thank you for your time today. First, Mr. Tabaru is going to give you an overview of the business results for the first quarter of fiscal year 2019, and then we will entertain your questions. Mr. Tabaru, please.

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [3]

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Thank you very much for participating in this meeting on our business results for the first quarter of fiscal year 2019 despite your very busy schedule today. I am Eizo Tabaru, member of the Board, Managing Executive Officer of Mitsubishi Tanabe Pharma Corporation. Today, I am going to explain our first quarter results and the progress of our development pipeline.

First, an overview of our first quarter business results. Please turn to Page 2. Revenues from high priority products in Japan increased in the first quarter. On the other hand, revenue declined as MTPC decided not to recognize as sales revenue some of the Gilenya royalty amount in line with IFRS 15 as we are in the arbitration proceeding with Novartis.

As a result, our revenue declined by 6.9% or JPY 7.2 billion year-on-year to JPY 98.1 billion. Gross profit was down JPY 9.6 billion to JPY 53.3 billion. Core operating profit decreased by JPY 9.5 billion to JPY 9.7 billion. Net profit attributable to owners of the company was down JPY 7 billion to JPY 6.8 billion.

Let me now explain about revenue trends using a graph. Domestic ethical drugs recorded a year-on-year growth of JPY 6.4 billion, driven by STELARA, for which we changed the sales framework with Janssen Pharma in July 2018 and by growth of SIMPONI, Rupafin, CANALIA, CANAGLU and other priority products. Among overseas ethical drugs, RADICAVA fell by JPY 200 million from the year before. Overseas ethical drugs as a whole went down by JPY 300 million. The total number of patients who are administered with RADICAVA reached about 4,000 as of the end of June. Royalty revenue, et cetera, dropped by JPY 13.4 billion year-on-year, mainly due to the decline in Gilenya as was explained before. As a result, revenues for this quarter totaled JPY 98.1 billion, down JPY 7.2 billion year-on-year.

I'd like now to move to cost of sales, SG&A expenses and core operating profit. Cost of sales increased by JPY 2.4 billion, and sales cost ratio went up by 5.4 percentage points from a year before to 45.6% due to a decline in royalty revenue and changes in the product mix. SG&A and R&D expenses were almost unchanged year-on-year. Consequently, the core operating profit was JPY 9.7 billion, down JPY 9.5 billion.

As for the items after the core operating profit, the operating profit declined by JPY 9.6 billion to JPY 9.6 billion. Financial income and expenses are as shown in the slide. Thus, the net profit attributable to owners of the company was JPY 6.8 billion, down JPY 7 billion.

Next, let me explain the status of our development pipeline. Please turn to Page 7. This shows the progress of our major development pipeline. The progress since the announcement of our fiscal 2018 results is highlighted in blue. As you can see here, we started Phase I clinical trial of MT-3921 in healthy adults in the field of CNS. Spinal cord injury is expected as target indication in our development.

In the diabetes and kidney area, which is a priority area in Japan, we filed our submission of MT-6548 for renal anemia in Japan as we announced in our press release on July 23. I will explain the details of these 2 compounds later on.

Next, I'd like to explain the status of our growth drivers and the progress of each project. Regarding RADICAVA for ALS, we are expanding market through preparation of application for approval in each country and region in parallel. In Europe, we withdrew our submission as was announced in our press release. We are carefully discussing our future action right now.

As for MT-1186, as the oral suspension of RADICAVA for ALS, we are implementing clinical trials aiming for approval by the end of fiscal year 2021. After consultation with FDA, we are planning to start a long-term safety study by the end of the current fiscal year.

Regarding ND0612, we accepted FDA's advice and finalized a Phase III study design. We plan to start a clinical trial in August.

For MT-2271, a VLP vaccine for seasonal flu, we will obtain the results of Phase III study for the elderly by the end of the second quarter in the current fiscal year. We will aim for filing by the end of fiscal 2019.

Next, let me share some topics related to our pipeline. Regarding Vadadustat, MT-6548, we filed our submission this month for renal anemia. This is an overview. Its mechanism of action is hypoxia-inducible factor prolyl hydroxylase inhibitor. We licensed in this compound from Akebia Therapeutics in the United States in 2015 for development in Japan. Phase III studies are ongoing in the United States and Europe. We filed our submission first in Japan, ahead of the rest of the world.

Next, let me show you the results of the Phase III studies in Japan for Vadadustat. Positive results were confirmed in its efficacy in improving anemia and safety in both non-dialysis and dialysis periods. In 2 active-controlled studies, the differences in mean hemoglobin at weeks 20 and 24 achieved the non-inferiority criteria, thus meeting the primary endpoints.

Next, I would like to discuss our initiatives in diabetes and kidney products in Japan. We have launched 3 antidiabetic drugs, TENELIA, CANAGLU and CANALIA so far. And in this fiscal year, we started a public experimental trial of TOMOCO, a diabetes care app as the first step in our digital medicine initiatives.

In renal area, we signed a collaborative agreement with Japan Kidney Disease Association in an effort to overcome renal diseases. Furthermore, as a drug to follow KREMEZIN, we filed for approval for Vadadustat in Japan. In order to obtain additional indication of diabetic nephropathy for CANAGLU, a Phase III clinical study is underway in Japan. We will reinforce both areas by launching new products adding to indications for the existing products and creating more evidence.

Next, I would like to explain about MT-3921, for which we started a clinical trial as the next driver to enhance the CNS area. MT-3921 is a humanized anti-RGMa antibody co-discovered with Osaka University. A Phase I clinical trial for healthy adults was initiated in the first quarter of 2019. RGMA is expressed in glial and immune cells and inhibits the growth of neuron axons. This drug can promote the growth of axons by blocking the actions of RGMa. RGMa is also involved in inflammation and therefore, this drug inhibits information as well. Through these mechanisms, it is expected to promote neuroregeneration after the spinal cord injury.

Please move to Page 13. This drug is planned to be targeted at traumatic spinal cord injuries. The number of people who get injured in the spinal cord is about 18,000 per annum in the U.S. and 4,000 to 5,000 in Japan. Therapies available are mostly surgical stabilization of the spine and intensive neurological rehabilitation, and there is no regulatory approved effective drug. The extent of symptoms varies depending on the severity of the injury, but patients with complete lack of motor and sensory function will not recover mobility after the injury. With increased burden on the patient as well as on their caregivers, this is a disease with extremely high unmet medical need.

The patient population for the clinical trial for MT-3921 will range from most severe cases with complete lack of motor and sensory function to those with incomplete lack of motor function. In order to deliver an innovative drug to patients with the disease with high unmet medical needs, where there is still no effective therapy, we'll move this development project forward as quickly as possible.

Last but not least, this is the development and launch plan of major products to achieve the management target. Indicated in orange are global products and their first planned year of launch. That is it from me. Thank you for your attention.

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Questions and Answers

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Operator [1]

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(Operator Instructions) First, Mr. Hashiguchi from Daiwa Securities.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [2]

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Hashiguchi speaking. I have a few questions. First, on Gilenya royalty. You said Gilenya royalty income was JPY 1.6 billion. Are you receiving the payment you think you're entitled to receive?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [3]

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Yes. For now, for the January-March period, we received the payment.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [4]

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I think that amount paid to you is booked as liabilities on the balance sheet.

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [5]

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Current liabilities are not increasing much, but non-current liabilities are going up. You may have a view that it may take around a year until you can recognize this as sales revenue when this arbitration is over according to my estimation.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [6]

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Is that too much to assume?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [7]

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We are making appropriate accounting. You can imagine based on that.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [8]

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Secondly, Vadadustat. This time have you filed your submission to obtain simultaneous approval for both dialysis and non-dialysis-dependent CKD as a package?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [9]

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Kobayashi speaking. Yes, you're right. As was shown on Page 10, we filed JNDA for both dialysis and non-dialysis patients, as I said.

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Kazuaki Hashiguchi, Daiwa Securities Co. Ltd., Research Division - Research Analyst [10]

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Next on MT-8554 for hot flash. Phase II data is already published somewhere? And also, when do you start Phase III study? And how long do you think it's going to take? Do you have any prospect? This compound was not included in your launch plan today.

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [11]

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As for MT-8554, we will announce our Phase II POC study results at an appropriate timing according to the plan. In addition, we are also preparing for a study in the next phase. As we said before, we are also considering the possibility of partnering in parallel. We will develop this compound based on that accordingly.

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

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Okay. Understood. Lastly, with regards to MT-3921, you mentioned today, another company enters the clinical stage for an anti-RGMa antibody before. I think it was AbbVie. I don't know whether it worked or not, but it entered the clinical stage a long time ago. Do you know what happened to that compound in the end? How you have been able to differentiate from this competitive product in your view?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [13]

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We heard that AbbVie is developing an antibody with a similar mechanism, but we are not aware of the full details of their development status as it's about a different company. As for the differentiation, if we can get good clinical data for POC, we can differentiate in our view. It's too early to talk about what kind of differentiation we can realize.

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Operator [14]

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Next, Mr. Yamaguchi from Citigroup.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [15]

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I am Yamaguchi from Citigroup. Can you hear me?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [16]

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Yes.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [17]

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It's not really about the first quarter forecast numbers, but your business results are almost as much as full year forecast already. Of course, there are various factors behind. Originally, your numbers started from a low level, so there can be a big fluctuation. The achievement rate is extremely high. How should I interpret this?

Expenses not incurred in the first quarter may be spent in the second quarter or later. I haven't been able to check in detail. How do you view this situation?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [18]

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Tabaru speaking. SG&A costs and R&D expenditure didn't progress as much as we planned. That's why core operating profit had high numbers. There is some difference amongst sales items, but SG&A costs and R&D expenditures are mostly behind. On a full year basis, there was a slow start at the beginning, but we are going to spend the money later on. That's our forecast.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [19]

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Your numbers look high, but will not deviate so much overall, just a slow start at the beginning.

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [20]

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Yes, your understanding is correct.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [21]

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All right. Next, I have 2 questions about MT-3921. First, there is a mention of chronic patients, but in terms of the mechanism, this drug is given to patients with acute inflammation before worsening to prevent it. That's how the drug is going to be used. Correct?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [22]

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Kobayashi speaking. Yes, you're right. This drug is administered when acute inflammation or injuries is still continuing aiming for recovery.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [23]

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Understood. Under those circumstances, I don't know whether a placebo-controlled study is ethically possible or not. It could be difficult to demonstrate difference. Based on the assumption that the disease is going to worsen, in general, is it possible to design a study to judge good or bad based on a curve?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [24]

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We will consult with FDA or the regulatory authorities in each country to discuss study designs for Phase II and beyond. We will report to you when it's clear.

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Hidemaru Yamaguchi, Citigroup Inc, Research Division - MD and Analyst [25]

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Understood. As for Vadadustat, global CV outcome studies are hot topics for competitive products. Sorry, for my naive question, do you already have such data for Vadadustat or it's not necessary yet in Japan? Could you share your view?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [26]

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As you know, globally, Akebia is conducting global studies, including the CV outcome study. Such results will be available in late 2020 according to the announcement on their website. Like diabetes, CV outcome data is not a mandatory condition for approval in Japan.

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Operator [27]

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Next, Mr. Wakao from Mitsubishi UFJ Morgan Stanley Securities.

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [28]

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Wakao speaking. Thank you for your explanation. First, I have a question on RADICAVA. I'd like to know the number of patients between April and June. And you withdrew your submission in Europe. How much impact should we assume? It's going to be mainly the oral suspension in the midterm business plan, but I am sure you developed your targets. By including the injectable in the European region, how much impact from the withdrawal of your submission in Europe in the mid- to long-term?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [29]

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First, on the number of patients on RADICAVA, a total of 1,840 patients were continuing their treatment as of the end of June.

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [30]

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What about the monthly number of new patients?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [31]

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From April [100, 80 and 70].

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [32]

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Okay. Could you comment on the potential impact from the submission withdrawal in Europe?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [33]

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We incorporated our European sales forecast in the mid-term business plan to a certain extent. But please allow us to refrain from answering with specific numbers. We think we need to revisit our plan to a certain degree.

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [34]

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Understood. As for the oral suspension, I believe you reached your agreement with FDA based on your own original plan. Bioequivalence study is to be completed at the end of May. Are you planning to present this data soon, any particular timing?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [35]

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Also for this, we are considering an appropriate timing at academic society meetings. We are not able to disclose clearly yet.

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [36]

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Another question is about ND0612 Phase III study design. Are you sure this is a non-inferiority study compared to levodopa, among others? I thought you were trying to demonstrate efficacy. Could you give us more details about this study?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [37]

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Thank you for the question. We have published the design of this study at World Parkinson Congress held in June in Kyoto. It is a double-blind, double-dummy parallel group study to compare the carbidopa and levodopa arm and the ND0612 arm.

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [38]

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I thought you had originally planned to conduct a non-inferiority study, but now you ended up with a simple comparison study. Does that mean that the bar has been raised slightly for this study?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [39]

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No, I don't think so.

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Seiji Wakao, Mitsubishi UFJ Morgan Stanley Securities Co., Ltd., Research Division - Senior Analyst [40]

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I see. My last question is about Vadadustat. I think uncertain results were observed in studies of other drugs with regard to MACE. As far as Japan is concerned, MACE may be irrelevant, but more recently, should we assume that lack of MACE data may affect your marketing activities after the approval was granted? And that in its effort to penetrate into the market, if the drug has not demonstrated non-inferiority or superiority over ESA drugs, it may face difficulty in making inroads into the market. So my question is, what is your thoughts on the relationship between the marketing in Japan and the MACE data?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [41]

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In terms of regulatory approval, as I said, it is not mandatory, but global MACE or CV data will become one of the differentiating factors in marketing the drug.

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Operator [42]

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Next, Sakai from Crédit Suisse Securities.

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

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Sakai from Crédit Suisse Securities. I have 2 questions. First, on royalty on Gilenya. I was not able to clearly hear you at the outset. I think I heard you say, payment was received for January-March period. Since there is 3 months' time lag, the payment was for January-March period, if [substance] pay -- patent was valid until February 2019, and therefore I thought the payment you received for January-March period has nothing to do with the arbitration proceedings.

If you look at the cash balance, it has not increased that much from the end of March. I was wondering whether the amount that you decided not to recognize earlier was received in cash. I understand you will not disclose the amount, but what kind of accounting processing have you gone through? Are you expecting more payment receipt going forward? Could you enlighten me again?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [44]

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On the question of whether payment was received in accordance with the contract, the answer is yes. The payment for January-March was actually received in April-June period. On the question of whether we have received only for the period while the patent was valid, our understanding is that payment was done for the amount, including the portion Novartis has protested the validity for. For the future, we believe the payment will be done in accordance with the contract.

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

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So you're saying that the full amount, including the portion Novartis has protested the validity for, has been paid, and that your understanding is that this practice will continue for the payments for April onward. Am I correct?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [46]

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Yes, you are correct.

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Fumiyoshi Sakai, Crédit Suisse AG, Research Division - Research Analyst [47]

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And the amount will be posted in the balance sheet, will it not?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [48]

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Yes. Since we do receive cash, we follow the due accounting process.

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Fumiyoshi Sakai, Crédit Suisse AG, Research Division - Research Analyst [49]

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Another question is MT-3921. Life Science Institute, a Mitsubishi Chemical Group company, issued a press release in July that it will start developing the MUSE cell therapy, which is talked about from time to time, to treat the spinal cord injury, the same target as your product, though yours is an antibody. Originally, you seem to have had no rights or interest in MUSE cell therapy, but now your product is in direct competition. Am I correct to understand that both bodies are in agreement to stay at arm's length, so to speak, and engage in competition?

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Yoshihiro Kobayashi, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer, Division Manager of Ikuyaku & Director [50]

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Kobayashi speaking. On our part, based on the result of animal model experiments, we decided to target as its first indication acute spinal cord injury, for which the compound was found likely to be most effective. On the other hand with regard to MUSE cell, although we are not in a position to refer to it, according to the press releases and other information, it is targeting a subacute spinal cord injury. Therefore, our target segments are different, or there may be some synergy between us.

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Operator [51]

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Moving to the next question, Mr. Muraoka from Morgan Stanley.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [52]

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Muraoka from Morgan Stanley. I need to get back to Gilenya royalty again. From the viewpoint of us, the analysts, can we assume ultimately that JPY 1.6 billion or something around that figure times 4 will be recognized as sales for the full year, and that the total amount of about JPY 6.4 billion in royalty revenue will be in line with your full year forecast announced at the beginning of the fiscal year?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [53]

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Yes. The amount we posted in the first quarter is expected to be more or less maintained.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [54]

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Is there anything more that you can share with us about the breakdown of JPY 1.6 billion?

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [55]

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We cannot disclose the breakdown, and so cannot comment on that. I am sorry.

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Shinichiro Muraoka, Morgan Stanley, Research Division - Research Analyst [56]

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I see. Another question is about the oral formulation of RADICAVA. The other day, Biohaven Pharmaceuticals received a complete response letter for its sublingual form of Rilutek after it has changed the formulation. It was reported that their problem had to do with API, but what I am concerned about is such unexpected risks may arise by changing the formulation. Looking at such recent news on similar drugs, if you have found something to worry about with something that needs more consideration, could you share that with us? If you have not, we can just forget about this question.

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Eizo Tabaru, Mitsubishi Tanabe Pharma Corporation - Managing Executive Officer & Director [57]

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With regard to the oral formulation of RADICAVA, as indicated in the slide, we reached agreement with FDA, and there's nothing to be mindful of at this moment.

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Operator [58]

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We are running out of time. And so I would like to end the Q&A session. Lastly, I would like to ask Mr. Takai to give us closing remarks.

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Yoshiaki Takai, Mitsubishi Tanabe Pharma Corporation - VP & Head of Corporate Communications Department [59]

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Thank you very much for joining us for our conference call today despite a busy schedule. That concludes the conference call. Thank you all for staying with us till the end.