Earnings Labs

Takeda Pharmaceutical Company Limited (TAK)

Q1 2013 Earnings Call· Wed, Jul 31, 2013

$16.37

-0.30%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+3.33%

1 Week

+4.93%

1 Month

+1.07%

vs S&P

+4.06%

Transcript

Operator

Operator

Please note that this telephone conference contains certain forward-looking statements and other projected results which involve known and unknown risks, delays, uncertainties and other factors not under the company’s control, which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these projections. Such factors include economic and market conditions, political events and investor sentiments, liquidity of secondary markets, level and volatility of interest rates, currency exchange rates, security valuations, competitive conditions and size, number and timing of transactions. During the presentation from the company, all the telephone lines are placed for listening-mode only and the question-and-answer session will be held after the presentation. This conference call is being broadcasted through internet online, but only for listening-mode. Now we start the conference with the presentation.

Christopher Hohman

Management

Thank you very much for joining the conference call of the First Quarter FY2013 Results for Takeda Pharmaceuticals. My name is Christopher Hohman, Senior Vice President of the Corporate Communications Department. Now please let me introduce today’s presenters and panel. Mr. Iwaaki Taniguchi, Senior Vice President of Corporate Finance and Controlling Department; and Mr. Tsudoi Miyoshi, Senior Vice President, Head of CMSO Office. First the Q1 results will be presented followed by the topics of R&D. After that, we will have a Q&A session. Please refer to the presentation materials as you listen. First, Taniguchi will start.

Iwaaki Taniguchi

Management

I am Iwaaki Taniguchi, Senior Vice President in-charge of Corporate Finance and Controlling. I would like to report our consolidated financial results for the first quarter of fiscal 2013. This is the consolidated summary for the first quarter FY2013. The net sales were up 12 billion yen or 3.0% from the same period last year to 410.3 billion yen. Operating income went down 14.9 billion yen or 23.8% to 47.7 billion yen. Net income went down 58.5 billion yen or 66.8% to 29.1 billion yen. Excluding extraordinary income or loss, such as intangible assets, goodwill amortization and special factors such as tax refund from the transfer price tax system agreed last year, net income was up 1.4 billion yen or 2.2% to 62.4 billion yen. Let me explain more in detail in the following slides. This slide shows changes in net sales by business segment. For the domestic ethical drugs, contributions from new products such as Lotriga and Azilva could not offset the decline in existing products such as Actos and Blopress impact by the termination of distributorship agreement of some items also pushed down sales. As a result, sales went down 5.3 billion yen from the same period last year for overseas. In spite of the Actos sales declined by generic erosion, sales contribution of 11.2 billion yen by URL Pharma and Multilab acquired last year, and the yen depreciation positively impacted sales by about 40 billion yen. Altogether overseas sales were up 16.7 billion yen from last year. Next slide please. This slide shows changes in sales by products. Global sales of Actos were down by 45.2 billion yen from last year, but Velcade from Millennium and sales in emerging markets increased. The yen depreciation also helped to achieve an increase in other products by 32.8 billion yen.…

Christopher Hohman

Management

Now, Miyoshi would like to make presentation.

Tsudoi Miyoshi

Management

My name is Miyoshi, Head of CMSO Office. I would like to talk about updates related to R&D activities. And today I’d like to cover recent stage-ups in the pipeline and MLN0002, vedolizumab and data from Phase 3 trials of TAK-875, fasiglifam and Lu AA21004, vortioxetine. Before I introduce the latest stage-ups in the pipeline, I’d like to explain about the withdrawal of our marketing authorization application in Europe for the anemia treatment peginesatide. In February, Takeda voluntarily recalled all lots of peginesatide OMONTYS from the U.S. market, as a result of new post-marketing reports of serious to hypersensitivity reactions including anaphylaxis. Well Takeda has been working actively to investigate the root cause of these hypersensitivity reactions. The investigations and the root cause analysis and the determination of the risk mitigation plan is to be completed during the European MAA procedure timeframe. Therefore Takeda withdraw the European MAA and will determine at a later date the appropriate direction for the product. As for TAK-700, MPC-5 trial for post-chemo metastatic castration resistant prostate cancer, the interim analysis by the Independent Data Monitoring Committee indicated that the TAK-700 would likely not meet the primary endpoint of improved overall survival when compared to the controlled placebo arm. So we decided to un-blind the trial based on the recommendation of the committee. And there are no safety points regarding the TAK-700 and the decision underlined the MPC-5 trial is not expected to impact other ongoing company-sponsored clinical trials with TAK-700. Next, I would talk about the stage-ups, since the last FY2013 financial results announcement on May 9. As we just introduced you today in our announcement, in China, we received a CFDA’s IDL, Import Drug License for NESINA, alogliptin for the treatment of Type 2 diabetes. We think that this will expand our options…

Christopher Hohman

Management

Now, we would like to have a Q&A session. We would like to entertain your questions.

Operator

Operator

We have a question-and-answer session now. (Operator Instructions) The first question is from Citigroup Securities Company, Mr. Yamaguchi. Go ahead. Hidemaru Yamaguchi – Citigroup: Hello, this is Yamaguchi from Citi. Do you hear me?

Iwaaki Taniguchi

Management

Yes. Hidemaru Yamaguchi – Citigroup: Regarding the progress of the first quarter, it’s a regular question because of those expenses, operating income is relatively higher in terms of the progress and by region Japan, U.S. and the emerging markets, there are some ups and downs, if you noted any particular situation. Can you comment?

Iwaaki Taniguchi

Management

This is Taniguchi. Overall, regarding sales, there is a positive upside but when you breakdown overseas, upside was significant. On the other hand for Japan, compared to our expectations, it was slightly lower than our original forecast. Hidemaru Yamaguchi – Citigroup: Thank you. And regarding NESINA and AZILVA in Japan. In case of AZILVA, it can be switching the NESINA. It looks like it’s not really achieving up to the expectation. You had mentioned particular definitive [ph] numbers, you think it’s going to be able to recover or do you think that’s going to be challenging?

Tsudoi Miyoshi

Management

Well, let me first talk about NESINA. It is true. When you just look at the past three months, definitely there is a big slow against the plan, but prescription is on an increasing trend, and towards the end of the year in the second half, we expect good growth, three years past since launching. And efficacy is shown in the clinical data and based on our (inaudible) we are strengthening our marketing activities and I think we are seeing some good result out of that. And for hypertension, AZILVA and Blopress between those two agents, and when you compare them together, it is within our expectation. It is to the pickup of AZILVA in terms of switch from Blopress, it’s behind Hidemaru Yamaguchi – Citigroup: TAK-700 in your pipeline. I have a question on this. The basic idea here is regarding post-chemo patients, filing maybe a bit difficult but pre-chemotherapy if you had good data then you will have the findings?

Tsudoi Miyoshi

Management

This is Miyoshi speaking. Regarding TAK-700 post-chemotherapy, it is un-blinded, but it does not mean that filing is difficult. But you look at the data regarding the PFS progression-free survival, we do have good data. And plus the pre-chemo data from blind will be the basis for our consideration in future. So regarding PFS post-chemotherapy, that strategy is still there. With regard to OS, we can’t really comment on that specifically, but we are analyzing the data in detail. While OS, overall survival was not significant by age, by region, by ethnic groups and sex, we will analyze furthermore, and together with pre-chemotherapy segmentation, our population we want to further analyze our strategy, thank you. Hidemaru Yamaguchi – Citigroup: Regarding the FX sensitivity, you had made a revision for FX assumptions. So what’s the sensitivity level now?

Iwaaki Taniguchi

Management

Are you talking about operating income level? Hidemaru Yamaguchi – Citigroup: Yes.

Iwaaki Taniguchi

Management

In the dollar basis, one yen 800 million and for the euro, that’s 200 million yen on the new FX assumption. Yes, that’s right. So that’s not a big change. Hidemaru Yamaguchi – Citigroup: Thank you.

Christopher Hohman

Management

We would like to entertain the next question please.

Operator

Operator

Next question is Mr. Urushihara from Nomura Securities. Ryoichi Urushihara – Nomura Securities: Hello, may I ask you a question?

Iwaaki Taniguchi

Management

Yes, please give us all the questions that you have. Ryoichi Urushihara – Nomura Securities: I have four questions. The first question is about TAK-875. In order to look at the SCV [ph] event, you were trying to include 5,000 patients. And since the study started, I think already one you have passed, but could you really show the results of SCV [ph] with enough data with 5,000 subjects, that’s my first question? May I continue?

Iwaaki Taniguchi

Management

Yes. Ryoichi Urushihara – Nomura Securities: The second question is Contrave, the filing timing. In May, a financial announcement in our handout materials, it was said, it would be filed soon, but what is actually the timing, could you tell that? That’s my second question. Third question is the China risk in the case of GSK, whether or not, you have been receiving any investigation as much as you can, disclose it please? And number four is about the cost control. And here I have two questions. After sales has been down, but the gross margin is still 72%. It’s not worsened. So have you been making the efforts to cut the costs? And also in page six of the slide, SG&A, FX – because of FX impact, it increased, but actually the 9 billion yen cost cut seems to be achieved, is it really the right accurate interpretation?

Christopher Hohman

Management

Miyoshi would like to answer to your question first.

Tsudoi Miyoshi

Management

Regarding the TAK-875, 5,000 subjects. Whether or not, this number of subjects is enough? According to FDA guideline, of course we’d like to meet the FDA guideline requirements and statistically, we reviewed and we believe that this 5,000 sample size is good enough. We wouldn’t expect any problem with this. Ryoichi Urushihara – Nomura Securities: And do you know actually what would be the rate of the events at the onset?

Tsudoi Miyoshi

Management

No, we cannot disclose that at this moment of time. Your second question was regarding Contrave, the filing timing. Orexigen our alliance partner announced that in the beginning of this year, it will be in the second half of this year. That is the timing of NDA filing and we announced that – our partner announced and we haven’t changed the timing since then.

Iwaaki Taniguchi

Management

Regarding China, and from the Chinese also update to us, we didn’t receive any notification of any investigation. And since last year, we have set the Group policy to prevent any – the briberies. Therefore, we wouldn’t accept or allow those to happen currently. And your number four question regarding the cost, 72% roughly is this times figure and actually after the sales went down, and it went down by 3% at one time and compared with the two years ago, and FX actually impacted positively by 1%. So compared with same quarter of the last fiscal the – we were able to probably bridge from between 74.1% and 71.9% and of course we have been making every efforts to cut the costs, and part of them have been already producing the results. Ryoichi Urushihara – Nomura Securities: With the accelerated for every quarter to come, do you think that cost cut results will be accelerated to be manifesting?

Iwaaki Taniguchi

Management

No, I am not sure, but the cost rate will be improving and that’s one of the important thing of our Project Summit, therefore we would like to continue to make that efforts. And SG&A, you are right, that because of FX impact 25.3 billion yen minus was there. So as SG&A itself, we tried to cut the cost and now we see the part of the fruits. Ryoichi Urushihara – Nomura Securities: Thank you very much.

Christopher Hohman

Management

Next question please.

Operator

Operator

From Barclays Securities Mr. Seki. Atsushi Seki – Barclays Securities: Hello, do you hear me?

Iwaaki Taniguchi

Management

Yes. Atsushi Seki – Barclays Securities:

Iwaaki Taniguchi

Management

Regarding emerging market trend, these emerging markets are very important growth drivers. Because of macro economy, there could be some transient impact, but over the five years for the long-term horizon, the growth rate that we promised can be achieved in the emerging markets. It is excluding FX 10.4% as addressed [ph], and throughout the year, if you looked at the growth for the year, we think there is some room for growth furthermore. It’s not that the momentum in the emerging market in the mid to long-term is underlined, what maybe a tender impact versus significant factor? No, I don’t think so, not for this quarter. Atsushi Seki – Barclays Securities: Thank you.

Iwaaki Taniguchi

Management

And regarding stock price, the incentive plan, as you mentioned the accounting is based on the March end stock price level, based on that we have the calculation, then every quarter we have the numbers from each month. And at the end of June the stock price is down compared to March end. Therefore there is a decline compared to the March end. Atsushi Seki – Barclays Securities: Do you disclose numbers?

Iwaaki Taniguchi

Management

No, we don’t disclose, but for the quarter as a whole, for this long-term incentive plan cost for this three month is plus minus zero. Atsushi Seki – Barclays Securities: Thank you.

Tsudoi Miyoshi

Management

This is Miyoshi speaking. So TAK-700 data disclosure, overall survival details, as of now today, we do – we cannot disclose that data. And in future, at academic meetings, we will disclose the numbers and the data. And the second question was, what was that? Atsushi Seki – Barclays Securities: Regarding the timing of filing.

Tsudoi Miyoshi

Management

The discussing strategy for filing, and as of now we have made no changes, but going forward when the strategy is decided in the second quarter, opportunity we will show you the…

Unidentified Company Representative

Analyst

Overall, we are engaging our employees with fairness, transparency and communication and appropriate compensation, so we can contribute to maintain a track and develop the best people possible for this important field of oncology. [Foreign Language]

Christopher Hohman

Management

Thank you very much. The next question please.

Operator

Operator

Mr. Fumiyoshi Sakai of Credit Suisse Securities. Sakai sir, please. Fumiyoshi Sakai – Credit Suisse Securities: Thank you. I have two questions. First is MLN0002 for ulcerative colitis and Crohn’s disease is the indication, and I believe that the remission rate is very high. Have you disclosed the data on remission rate somewhere? That’s my first question. And also in the U.S., the filing will be made in June, but PDUFA is it fixed? That’s my first question. Second question is TAK-700. Actually the same happened in the other companies that FDA, even without recognizing the OS improvement, would it be really approved? Including the post-chemo, there seems to be potentials in your view, but could you specific what is your ideas regarding this situation, and this is interim analysis, therefore the patients on placebo and TAK-700, I think that the data is at that time point, the close over hasn’t been performed yet, is that the right understanding?

Tsudoi Miyoshi

Management

First regarding MLN0002 data. As I told you earlier – which data are you talking about, GEMINI I? In GEMINI I, the week six, the remission improvement, at week 52 excuse me, vedolizumab every four weeks to every eight weeks regimen, every four weeks 44.8% and every eight weeks 48.1%, and the placebo 15.9%. And at DDW we made announcement. And next was about TAK-700. Fumiyoshi Sakai – Credit Suisse Securities: Yes. Yes, you couldn’t show the good results?

Tsudoi Miyoshi

Management

Yes, we didn’t show the significant difference in terms of OS. It was the interim analysis, and we un-blinded the trial this time. So from now on, TAK-700 will be provided to the patients. And with existing data, how can we make filings? And well not only with this data, but pre-chemo data should be also reviewed, so that we’re able to come up with a good strategy. So we may need sometime to decide how to do. It’s only after short time, since it’s announced or disclosed. Fumiyoshi Sakai – Credit Suisse Securities: Regarding 0002, filing timing. It says here in June, but PDUFA, has it been fixed?

Tsudoi Miyoshi

Management

PDUFA hasn’t been fixed yet. So no notification from FDA, no, not yet, but the approval is expected to be in FY2014. We haven’t changed that timing. Fumiyoshi Sakai – Credit Suisse Securities: Thank you.

Christopher Hohman

Management

Next question please.

Operator

Operator

From Morgan Stanley MUFG Securities, Mr. Muraoka Shinichiro Muraoka – Morgan Stanley MUFG Securities: Hello this is Muraoka speaking. I have three questions. Regarding the revision – upward revision and I want to ask about the background of that. The yen depreciation and in your case, operating profits in the dollar is negative factor, but for Non-GAAP base income expectation is higher. Is that you have changed some conservative to neutral? There are several positive factors in the three months ended tax income upside, can you clarify on that? That’s the first question. TAK-700 in Japan, FY2015 is the submission timing according to the cable, and Japan has a different clinical study from global. I think it was a different study, and so strategy in Japan? The (inaudible) is my next question. You did not mentioned today that sexual function – in terms of sexual function, it is considered better compared to the other agent. So you can you clarify that?

Iwaaki Taniguchi

Management

Regarding the first question let me clarify. Regarding the revision upward, this is based on J-GAAP. And regarding the sales FX impacts, well on sales side our consolidation is in Japan, therefore the sales will be positively impacting. That is about 80 billion yen, by products and upside sales of 10 billion yen, therefore altogether 90 billion for the year for the operating profit. However, expenses tend to be shifted in the second half. And in operating income, the yen depreciation was negative in our company, but with cost reduction efforts, we hope to maintain as before so that for the Japan side at 140 billion yen. For the first half, the sales is going to be increased compared to our original expectation, and also expenses to be shifted in the second half, especially in R&D. So for the first half on the operating income will be up by 10 billion yen, that is J-GAAP base. On IFRS base, it’s really amortization of goodwill and that is in the dollar basis, as it are all the dollar denominated. In the IFRS goodwill will come into the operating come and FX impact will be positive. So for the IFRS, there is upside of 150 to 150 [ph], that’s the different from the J-GAAP numbers. Is this clear now? Shinichiro Muraoka – Morgan Stanley MUFG Securities: I understand that, but actually the cost in the second half is going to be heavy, and I think that may mean that you have some upside furthermore, but it’s too early to say that?

Iwaaki Taniguchi

Management

But as of now regarding the operating income in ordinary income and net income level, we – I’ll just show you what we think is going to be now.

Tsudoi Miyoshi

Management

Okay, regarding the second and third question. This is Miyoshi. Regarding TAK-700 for Japan, pre-chemo and post-chemo, we are conducting the same studies. Therefore, together we need to consider our strategy going forward. So it’s the same as in U.S. And vortioxetine, sexual dysfunction aspect, was the question and whether that can be reflected in the labeling? What we are going to discuss – we need to discuss this with FDA. As of now, we can’t answer clearly whether it’s going to be reflected in the label or not. And advisory board, whether we are going to have that? Well we will have discussion with – we had discussions with FDA and in March, there is interim review meetings and FDA is saying that they are not planning advisory meeting. Shinichiro Muraoka – Morgan Stanley MUFG Securities: Thank you very much.

Christopher Hohman

Management

There aren’t any more questions. So therefore we’ll just – we’d like to conclude the questions and answer session. And with this, we’d like to finish the conference call today. Thank you very much for joining us in this conference call. We would like to ask for your continuous support. Thank you very much.

Operator

Operator

Thank you for your time. And that concludes today’s conference call. You may now disconnect your lines.