Operator
Operator
Now we will start the presentation. Please have the presentation materials to hand. First of all, we'd like to start with the presentation from Mr. Miyoshi. [Interpreted]
Takeda Pharmaceutical Company Limited (TAK)
Q2 2014 Earnings Call· Fri, Aug 1, 2014
$16.37
—
Same-Day
-1.29%
1 Week
-3.19%
1 Month
-1.64%
vs S&P
-5.80%
Operator
Operator
Now we will start the presentation. Please have the presentation materials to hand. First of all, we'd like to start with the presentation from Mr. Miyoshi. [Interpreted]
Tsudoi Miyoshi
Management
Good evening. My name is Tsudoi Miyoshi, Head of Chief Medical & Scientific Officer, Office. Today I'd like to give you an update of recent events in Takeda's R&D. I'll cover the following topics; pipeline stage-ups since FY, 2013 financial announcement, efficacy data of VELCADE in patients with previously Untreated Mantle Cell Lymphoma. BRINTELLIX data presented at the International College of Neuropsychopharmacology World Congress and American Society of Clinical Psychopharmacology Annual Meeting and details of our strategic alliance with MarcoGenics autoimmune diseases. Next slide please. As you can see from the stage perhaps since FY, 2013 financial announcement. We had some progress in our late stage pipeline. In May, we got approval of ENTYVIO for ulcerative colitis and Crohn's disease in the US and Europe. We understand that this is the first biologic to have been approved for the two indications simultaneously. And we have already launched the product in the US and several countries in Europe including UK, Germany and France. ENTYVIO is a groundbreaking new product that offers a new treatment option to patients with inflammatory bowel disease, who have failed to respond with existing products and we expect this product to become blockbuster global product for Takeda. ENTYVIO's Phase III trial is running in Japan. We will continue activities for launching this product in other regions including Japan. As you can see, we have already initiated tryouts of subcutaneous formulation of ENTYVIO. We are pushing forward to develop this product into a blockbuster. For VELCADE, we filed in the year – from by Mantle cell lymphoma and later I will introduce a beta that supported this filing which we presented at ASCO in Chicago in June. For MLN9708/ixazomib trials are currently ongoing in the refractory multiple myeloma and newly diagnosed Mantle Cell Lymph. And in this quarter,…
Unidentified Company Representative
Management
Now we would like to entertain questions for the audience. Those who are in the Japanese and English conference you can ask questions because of the time limitation, the number of the questions should be limited to two per person. Please address both of your questions upfront. Thank you for your cooperation.
Operator
Operator
We'll have our question-and-answer session now. (Operator Instructions) [Interpreted]
Unidentified Company Representative
Operator
The first question is from Citigroup Securities. Mr. Yamaguchi. Please go ahead. Hidemaru Yamaguchi – Citigroup Securities: Hi, this is Yama?
Unidentified Company Representative
Operator
Yes, go ahead. [Interpreted] Hidemaru Yamaguchi – Citigroup Securities: Yamaguchi from Citigroup. My first question is about Brintellix. Since disclosure is not available, but you mentioned seems in plan for $180 million yen for the year, it was the plan and according to the current pace, you're not going to reach that goal, but what's the reason, why you said that missing some of the according to the plan? That's the first question and the second question, is about the financial results. And this one to Mr. François Roger. In the first quarter especially the revenue is weak, you indicated that, but when you look out the expenses and cost in comparison to the annual cost for the year, the expenses are less. So probably our profit is not so bad, that's the impression, but still you think the performance was not very strong, is because sales was a bit weak and for the cost, you're going to spend more cost, is that reason? Those are two questions that, I would like to address. François Roger: Okay, regarding Brintellix as I said in, as of the end of June after or let's say roughly speaking about six months of, that was for Brintellix. We are basically nine ways, what we have built in the plan. Usually the amount that we had for 180 million yen for the full year is for 12 months and there is one popular [ph] in the year, it's too early to grow in conclusion. Anything that we could say is that we were close to what we expected in the first six months. As you can see on Slide 10, the amount of salaries increasing months after months and so we will provide more disclosure, but once again after six months we were in line…
Unidentified Company Representative
Operator
Next question, please? Next please.
Unidentified Company Representative
Operator
Mr. Seki from Barclays [Interpreted] Atsushi Seki – Barclays Capital: Thank you. I'm Seki from Barclays. François Roger: He was saying, the line was actually very bad so, we could not hear properly the question, you asked. Could you ask the question again? And sorry about that. [Interpreted] Atsushi Seki – Barclays Capital: Are you talking about my first question, should I repeat my last question? François Roger: Can you repeat both questions because we could not see, there was problem on the line? [Interpreted] Atsushi Seki – Barclays Capital: Excuse me, my first question was, can you hear me? François Roger: Yes. [Interpreted] Atsushi Seki – Barclays Capital: Now GSK, has been trying to sell the product to the EPP and I would like to ask you a question regarding your M&A, how those some old product portfolio, do you have any interest in projecting those older product portfolio, that's my first question and then, this week according to the express, there seems to be some change on the full listings expected this week. I would like to ask you that on your product position listed is it, some way is secured especially I'm interested in the current situation. François Roger: Okay, regarding the question, regarding natural products from GSK. We don't comment usually on M&A, but I can tell you anyway that this not, an option that we are pursuing the acquisition of the specific product line that you're mentioning and the second question, I'm not aware of any changes that is affecting the product you mentioned in Japan, at this stage.
Unidentified Company Representative
Operator
The participants on Japanese line, please ask the questions in Japanese because of the technical conditions. Thank you. [Interpreted]
Unidentified Company Representative
Operator
Next question is from Morgan Stanley MUFG Securities, Mr. Muraoka. Mr. Muraoka, please go ahead. [Interpreted] Shinichiro Muraoka – Morgan Stanley MUFG Securities: Good evening, this is Muraoka, speaking. Can you hear me? [Interpreted]
Unidentified Company Representative
Operator
Yes, go ahead. [Interpreted] Shinichiro Muraoka – Morgan Stanley MUFG Securities: The delay of 9708, and for the initial and approval timing, the data availability is difficult to predict, is that going to be the first half or second half of FY, 2015. Is the current pattern, when in 2015, I don't think this is decided yet but the – in the interim analysis possibly, you can answer or the submission or approval, that's the first question, regarding 9708. The second question is about Pantoprazole, according to your plan. It's going to decrease of 12% and it was very weak, but in the first quarter it was actually plus 12% with constant currency 7% to 8%. Is that because your initial estimate was about was consolidated, those are two questions? [Interpreted]
Unidentified Company Representative
Operator
Mr. Muraoka, regarding the question 9708. When the disclosure is going to be available for the data or when the analysis of data is completed, which timing are you talking about? [Interpreted] Shinichiro Muraoka – Morgan Stanley MUFG Securities: Both, so when can we have announcements regarding the data, when would be the first announcement from your side to us? [Interpreted]
Unidentified Company Representative
Operator
As I said before, Revinet [ph] plus take plus placebo and they submitted on, plus placebo and take Revinet [ph] plus 9708 those two answer compared as of now, the data is in advantage and the total event incidence is slower than our projection, the various reasons. It is blinded phase, so we don't really know the reason why, at the speed or the pace, where that's slow and in the or the company studies, we've been driven that is sometimes served as of now, we can't tell you exact n timing, when the data will be available. In fact, at least up to 12 months time frame, we would like to make submission amongst meaning from the original grant, that they will not be beyond 12 months. [Interpreted] Shinichiro Muraoka – Morgan Stanley MUFG Securities: Okay, so submission within 12 months, so that means next calendar year in the first half, you will at least have the result. [Interpreted]
Unidentified Company Representative
Operator
No, within FY, 2015. We will be able to file, we will be able submit, that's what I said. [Interpreted] Shinichiro Muraoka – Morgan Stanley MUFG Securities: Thank you very much and the second question. François Roger: Regarding Pantoprazole the performance was good in Q1, we think that we had done better than in terms of trend that what we expect for the full year is largely link to the trend that Pantoprazole is reaching LOE status in some emerging markets. So sales could decline in the future. It happened that Pantoprazole has been more resilient and what we expected initially. So I would say so far so good, but we can expect maybe more pressure going forward due to some LOE in selective emerging markets. [Foreign Language] [Interpreted]
Unidentified Company Representative
Operator
Next question, please?
Operator
Operator
Mr. [indiscernible] Management Investment. Yes, please. [Interpreted]
Unidentified Analyst
Analyst
My first question is regarding Brintellix. Cognitive function improvement seems to be due to more direct effect, not curing the depressive disease. Is this going through a very strong appealing point in medical practice? However, looking at the current data the current curve of the precision number increase, that seems to be too strong. Have you already completed your opening accounts activities in the US? [Interpreted]
Unidentified Company Representative
Operator
I think that your question is actually two-fold. I think, you're talking about managed care, right? From myself, from R&D perspective I'd like to talk about some data, yes. [Interpreted]
Unidentified Analyst
Analyst
Wasn't it showing the remarkable differences? [Interpreted]
Unidentified Company Representative
Operator
Not much, that you may be able to pursue indications that are down by the depression, is that what you said? About the data you mentioned, generally speaking in a company with a depression cognitive function, depends. Therefore is a data that, if depression improves then cognitive function also improves, however between Vortioxetine and BRINTELLIX. As a result of the test, for antidepressant treatment both were effective. There is Brintellix, didn't show the differences in terms of cognitive function treatment. However Brintellix did, therefore Brintellix seems to be having some direct effect onto cognitive function. However, in terms of promotion or indication, as the data it's not included, therefore in the US. The reps cannot promote it directly, so as of today what we can say is that, when the data is available, but today there it's not currently used in promotion. [Interpreted]
Unidentified Analyst
Analyst
I understand and in the future, don't you plan to promote the product using this data? [Interpreted]
Unidentified Company Representative
Operator
We don't have a plan to include this in our indication. However because we could have this very good data, how can we use this data effectively we are going to have to consult with the authorities and with the next to review and decide it. [Interpreted]
Unidentified Analyst
Analyst
Thank you very much. May I ask the second question? [Foreign Language] [Interpreted]
Unidentified Company Representative
Operator
Yes, please. [Interpreted]
Unidentified Analyst
Analyst
Second question, is about your alliance with MacroGenics and I would like to ask this question to, Mr. Miyoshi. So it is autoimmune disease relating to B-cells I think a typical one is SRE [ph] it's already introduced looking at website of the MacroGenics, but from more expanded business view point, what kind of other autoimmune diseases that you can possibly consider? [Interpreted]
Tsudoi Miyoshi
Management
As of today, we'd like to pursue a wide range of diseases. Therefore, it's not specifically limited. As you rightfully said, coming to the we like to pursue all the possible areas. Thank you.
Operator
Operator
Next question is from Mizuho [ph] Securities. Mr. Tanaka. Please go ahead. [Interpreted]
Unidentified Analyst
Analyst
Tanaka from Mizuho [ph] Securities. [Interpreted]
Unidentified Company Representative
Operator
Please go ahead. [Interpreted]
Unidentified Analyst
Analyst
I have only one question. 9708 is now in Phase III regarding the maintenance therapy trial, as long as I see the clinical trial February, 2018 is that right regarding the timing of clinical trial? [Interpreted]
Unidentified Company Representative
Operator
My, micro phone was off, so probably you could not hear me. I said, it started July already during, it would take five years because the primary endpoint is, that we will have interim analysis and based on interim analysis, we can make some initial handouts for timing that you mentioned. [Interpreted]
Unidentified Analyst
Analyst
This is comparison against placebo, I suppose Vipdomet. Is often for maintenance therapy according to what I understand and head to head comparison with Vipdomet, is that in your plan? [Interpreted]
Unidentified Company Representative
Operator
Vipdomet, does not have indication for maintenance therapy. For multiple myeloma, maintenance therapy is performed but the standard care is not quite established yet. [Interpreted]
Unidentified Analyst
Analyst
And in that sense, how 9708 can be used and be effective for maintenance therapy? [Interpreted]
Unidentified Company Representative
Operator
And that is focused in our comparison data Placebo? Thank you.
Unidentified Company Representative
Operator
Next question please?
Operator
Operator
This is Mr. Sakai, Credit Suisse [Interpreted] Fumiyoshi Sakai – Credit Suisse: I would like to ask you two questions. One is, emerging market sales. In Russia and Mexico, you mentioned about inventory levels reductions affected. In these markets, in order to improve their profitability, do you have already some plan on going and when you say inventory level reductions, what are the reasons behind? Especially, I'm concerned with Russia. Could you give us more specifically, what's happening in those markets? And looking at Slide 8, in quick note it says please refer to Page 27, but Page 27 shows core EPS. So I think, it's not the right page. If you modify, this later. Please update us. And my second is, regarding your disclosure of core earnings, that's the disclosed from two, you used this for a major performance indicator. And regarding stock orders contribution. I think that previously the present that the dividend level will be maintained until FY' 2017 and then the payout ratio or how to use cash including all those aspects. Did you come up with the disclosure of core earnings? Just simply showing core earnings is not so meaningful and therefore, I would like to ask this question to someone, the financial expert, please. François Roger: Okay, let me answer further question on the emerging market, inventory. They want just to reassure everybody the Russian situation has nothing to do with any, political situation in any country from a part what I mentioned in Venezuela or in Ukraine. In the Russia the situation is totally different, we had for some time for several years' rather high level of inventory with wholesalers in Russia and there are two reasons for it. One of them is a fact that we have moved from exports to local…
Unidentified Company Representative
Operator
You asked about the Slide number mentioned. It says, CFN express Slide number 27, in fact Slide number 27 and 28 are the only additional information we have about underlying growth. So this should say, please see Slide 27 and 28.
Unidentified Company Representative
Operator
Next question, please?
Operator
Operator
(Operator Instructions) and your next question is Mr. Tim Race, Deutsche Bank. Please go ahead. Tim Race – Deutsche Bank: This is Tim Race, here from Deutsche Bank in London. Just I wanted to clarify what you said on Brintellix, it wasn't quite clear on the translation. Are you definitely not filing for a label claim, the sexual dysfunction and the cognition given the bag of dates [ph] that you've got and if you're not filing for that, could you explain why wouldn't be filing for that or do you have [indiscernible] plan and that's all. Thank you. [Interpreted]
Unidentified Company Representative
Operator
It is not to be included in the label, that's our judgment, at present. This data alone is not sufficient to be included in the label. Going forward, how we can use this data in future, whether we would have additional study to support this, we will of course think about that, but this data alone is not strong enough to be included in the label, but this can be a differentiating data. So including that, we will discuss with the regulators and we will discuss among ourselves, furthermore. Tim Race – Deutsche Bank: Thank you.
Unidentified Company Representative
Operator
Next question, please?
Operator
Operator
(Operator Instructions)
Unidentified Company Representative
Operator
Thank you very much. It seems there are no more questions. We would like to close Q&A session. Thank you very much. This is end of the conference call today. Thank you very much for your participation.