Takeda Pharmaceutical Co Ltd

TSE:4502

[Interpreted] Thank you for joining us today, despite your very busy schedule, for FY '24 Q3 Earnings Call by Takeda. I'm the master of ceremony today, Head of IR. My name is O'Reilly. Thank you for this opportunity.

[Operator Instructions]

[Interpreted] [ Before starting ], I'd like to remind everyone that we'll be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings. Please also refer to the important notice on Page 2 of the presentation, regarding forward-looking statements and our non-IFRS financial measures which we'll also be discussing during this call. Definitions of our non-IFRS measures and their reconciliations with comparable IFRS financial measures are included in the appendix of the presentation. Please refer to Page 2 as well for important notices.

We will begin the call. First of all, we would like to invite our CEO, Christophe Weber, to comment.

Thank you, Chris. Hello, everyone, and thank you for joining us.

As you might have seen from our press release, today marks an important announcement regarding our Q3 results. Milano will speak to that and my retirement from Takeda and succession. After 12 fulfilling years with Takeda, the Board and I have agreed on June 2026 as date of my retirement from Takeda. I will no longer be on the Board of Takeda after June 2026.

I'm very pleased to announce that the Board has selected Julie Kim, president of our U.S. business unit, as my successor. Julie will be proposed as a new candidate for the Board at the ordinary general meeting of shareholder in June '26 and will then be nominated as President and CEO.

The unanimous decision to select Julie was made after a very robust multiyear process assessing both internal and external candidates. To ensure a smooth transition, we are sharing this decision now, a timing aligned with our exciting growth outlook on potential drug launches which may start as early as the second half of 2026. It will allow us to select and nominate Julie's successor, obviously a key role, as the U.S. represents 50% of our revenue. This time frame also aligned with anticipated retirement of several external independent directors, allowing both Julie and me to be actively involved in the Board member selection process.

Now I want to share some words about Julie. Julie joined the Takeda executive team in 2019. She has been the President of the U.S. business unit and U.S. Country Head for the past 3 years. Prior to that, Julie led our plasma-derived therapy business unit. With over 30 years of health care experience, Julie is uniquely qualified for this role. The Board and I have absolute confidence in Julie capabilities and leadership qualities. She embodies our corporate values, ensuring decisions are patient first, inclusive and thoughtful. Importantly, her commitment to Takeda's purpose is unwavering. I have witnessed firsthand that she also has the right character and grit to lead a complex global company like Takeda.

For now, nothing changed. We are focused on advancing our promising late-stage pipeline and preparing for future launches. I couldn't be more excited about what lies ahead for Takeda.

Back to you, Chris.

[Interpreted] Now we would like to start the presentation from our CFO, Milano Furuta. And this will be followed by Q&A session [indiscernible].

Thank you, Chris. Hello, everyone. This is Milano Furuta speaking.

It's my pleasure to give an update on Takeda's Q3 results for FY 2024. The positive momentum of our portfolio has continued into quarter 3 with year-to-date revenue growth of 4.5% at constant exchange rate or CER, driven by our Growth and Launch Products which grew by 14.6% at CER. In addition to top line growth, we also delivered margin improvements with 28.5% core operating profit margin, an increase of 1.6 percentage points. This reflect the strengths of our Growth and Launch Products, slower-than-anticipated VYVANSE generic erosion and OpEx savings from the efficiency program we initiated in May 2024.

We are also very excited about our late-stage pipeline. This month, we completed the licensing agreement for elritercept, a late-stage potential best-in-class oncology program. And as we introduced at our R&D Day in December, 2025 will be an important year for our pipeline, with 3 Phase III data readouts expected this calendar year: rusfertide in polycythemia vera, oveporexton in narcolepsy type 1 and zasocitinib in psoriasis.

Based on our positive business momentum, we are raising our full year management guidance again this quarter; and now expect revenue, core operating profit and core OP margin growth this year. And with the extra cash flow generated from this upside, we also plan to initiate a share buyback of up to JPY 100 billion.

Slide 4 summarizes our financial results for the first 9 months of FY '24. Revenue was over JPY 3.5 trillion, an increase of 9.8% versus prior year or a 4.5% growth at CER. Core operating profit reached JPY 1 trillion, a year-on-year increase of 16.3%, or 10.1% at CER. Reported operating profit was JPY 417.5 billion, growing at 86%.

Core EPS and reported EPS were JPY 443 and JPY 134, respectively.

Operating cash flow was JPY 835 billion, an increase of 90.8% year-on-year, reflecting profit growth, lower cash taxes and smaller increase of working capital. Adjusted free cash flow was JPY 568.3 billion.

Slide 5 shows a breakdown of our key business areas and the Growth and Launch Products which are driving our performance. These products represent 47% of total revenue and grew by 14.6% at CER year-to-date.

Within GI, Entyvio growth was 6.6% at CER. Although underlying demand remained strong and in line with our plan, the growth rate was impacted by 2 specific factors. First, there was a higher baseline for Q3 growth due to shipment timing last year. On top of that, we booked a gross-to-net adjustment in Q3 this year of approximately USD 50 million. This adjustment was correction of our past statutory government price calculations that had accumulated over 10 quarters since mid-2022. If we exclude the impact of shipment timing and this gross-to-net adjustment, year-to-date Entyvio growth would have been 9.4% at CER.

Next, rare disease, where TAKHZYRO continues to lead the HAE prophylaxis market, delivering 16.4% growth at CER. LIVTENCITY and ADZYNMA also continued their strong launch momentum. Within Plasma-Derived Therapies, immunoglobulin and albumin grew by 11.9% and 2.2%, respectively. For albumin, on top of our plan and temporary shutdown of production lines, we also observed cost containment measures in China, which is influencing the growth rate.

In Oncology, FRUZAQLA is expanding very well. Most of the revenue is currently from the U.S., but we recently launched in Japan. And we are making progress with approvals and reimbursement in Europe. In Vaccines, QDENGA is now available in 27 countries. And we see strong global demand in both endemic and non-endemic markets. We have sold over 10 million doses since launch in 2022, and we remain focused on further expanding access to these important vaccines.

From Slide 6, I'll explain more about year-on-year growth dynamics. First, a revenue growth. Our Growth and Launch Products more than offset loss of exclusivity impact, mainly VYVANSE and Adderall XR in the U.S. and Azilva in Japan. In addition, net positive growth in other brands such as GATTEX, Trintellix, ADCETRIS and Iclusig contributed to 4.5% revenue growth at CER. The depreciation of the yen versus major currencies contributed JPY 171.9 billion, resulting in 9.8% growth on actual FX basis.

Slide 7 shows year-on-year bridge for core operating profit. There was a positive gross profits contribution from revenue dynamics, partially offset by a JPY 29.9 billion adjustment due to implementation of an accounting process to recognize accumulated FX impact of inventories. Moving to OpEx: We had a year-on-year reduction in spend, at CER, with lower R&D expenses primarily due to the termination of several programs during our pipeline prioritization at the end of FY '23. We are also starting to see the benefits of our efficiency program on OpEx.

Overall, core operating profit grew by 10.1% at CER; or 16.3%, including the benefit from FX.

Next, reported operating profit. In addition to core OP growth, the main driver of the 86% increase was lower impairment costs compared to the last year. Restructuring costs primarily related to the efficiency program or JPY 107.4 billion, on track with our plan.

Next, our updated outlook for FY '24. We are upgrading management guidance. Revenue and core operating profit are both expected to increase at low single-digits percentage. This is a remarkable change from our initial outlook for revenue and core OP decline this year. Core EPS guidance has also improved to flat to slightly declining at CER.

Updated forecast is now JPY 4.59 trillion of revenue, JPY 1.15 trillion of core operating profit and JPY 507 of core EPS. It means our core OP margin is now expected to be 25.1%, an increase over last year. This also reflects our updated currency assumptions for the year, now with JPY 153 to the U.S. dollar. Our assumption for the euro is unchanged. On a reported basis, we forecast operating profit to be JPY 344 billion and reported EPS to be JPY 75.

We're also raising our free cash flow forecast range to JPY 550 billion to JPY 650 billion. This is due to the uplift in core OP; and expected proceeds as a part of the upcoming sale of Takeda Teva, our joint venture in Japan. With this performance and cash flow, we have decided to implement a share buyback of up to JPY 100 billion.

Slide 10 shows the moving parts in our upgraded forecast. We are upgrading revenue by JPY 110 billion, mainly reflecting year-to-date performance versus the previous forecast. Based on year-to-date trends, we expect VYVANSE upside of around JPY 40 billion versus our prior forecast. We also expect a net positive impact from the rest of the portfolio. FX is also a benefit to our revised revenue forecast.

For core OP, the majority of the JPY 100 billion increase is driven by product performance and R&D savings, partially offset by the accounting change impact to cost of goods that was not included in our prior forecast. Of the reduction in R&D expense forecast, approximately half is due to post-trial access costs for TAK-611 and TAK-609 previously expected as R&D expense but now in other operating expenses. The remaining benefit is due to efficiency savings.

This brings our Q3 earnings presentation to an end, and we would like to welcome your questions. Thank you.

[Interpreted] Now we would like to entertain questions from you. Christophe, Milano and R&D President Andy Plump will be joining in this session.

[Interpreted] [Operator Instructions] The first is from Jefferies, Mr. Barker.

Steve Barker from Jefferies. So my question is around some of the accounting issues. So you have a negative impact on your forecasts because you -- I just want to understand that a little bit more. So you're devaluating the yen-denominated value of inventory, so that's going to boost your COGS. And then I also -- there was the R&D question. Is that going to be -- is that a one-off where you -- is it related to specific clinical trials and we won't expect to see that increase in other expenses going forward? Yes, so 2 accounting questions, please.

Okay, thank you, Steve. Milano, would you like to answer those questions?

Yes. Steve, thank you for the questions. So the first one is a COGS one. So it's a little bit technical, so bear with me. So the -- as you know, there is -- in intercompany transactions, we're going to have some internal markups. And then within -- in the consolidation accounting process, there is a process of eliminated -- eliminate these markups. Sometimes, due to the different functional currencies and high-volume transactions, this kind of adjusting accounting like -- accounts will be used to appropriately reflect our inventories. And then these accounts have been accumulated with -- we believe this is largely due to the FX impact in the past movement. And then this time, we decided to implement kind of an accounting process to recognize this accumulated foreign currency impact of the inventories and then as a kind of onetime recognition of the -- about JPY 26 billion for the past ones; and then for this fiscal quarter 3, like, about JPY 39 -- or sorry, JPY 3.9 billion of the recognition. That's a kind of combination of the recognition of the FX impact for the -- in the inventories.

Right, so really a one-off.

Yes, but we are now introducing this, the process of recognizing this FX impact kind of automatically, like, systematically through the COGS, like amortization. So the -- it's going to be the -- it will not be this big amount. Actually we are recognizing like a 2 years equivalent amount, so this will be much smaller amount, will be recognized kind of regularly throughout quarters.

Right. It won't build up anymore.

No. And for the 611, 609, this is -- these programs were -- we had decided to contaminate or stop the development, the programs based on the clinical trial results, but based on a patient request, we decided to offer access to these molecules to the patients who wants to have a kind of post-trial access. So -- and then we -- with these decisions, we made a accrual for this post-trial access cost, which booked in Q3, which is almost like -- so JPY 16 billion which we booked in other operating expense. So it's kind of one-off, the onetime for this program.

Understood. And a related question, could you help me understand the Entyvio issue? So gross-to-net true-up adjustment. I don't understand what that is.

Yes. So there is a gross-to-net adjustment, the -- in U.S. market, right?

Yes.

And then that's going to be the referred to the -- especially the government pricing. And there is some -- we identified some miscalculation in the past 10 quarters. And all these things is -- it's not material. The accumulated number is about USD 50 million over the -- more than 2 years, but we identified this kind of miscalculation, so we are now addressing or correcting this kind of variances. And then we are booking as a kind of negative to the revenue.

[Interpreted] Moving on to next question, Citi, Yamaguchi-san.

Can you hear me?

Yes, we can hear you.

So 2 questions, please, from -- Yamaguchi from Citi. The first question is regarding the management change. And then my sense was the -- Christophe, you -- for me at least, it sounds like you're trying to do the management up until the Entyvio cliff, which is around 2030s. And -- but you decided to change the management next year. Is there any kind of trigger or -- from the fundamentals of the company is concerned? So can you tell me, why now? I mean next year. But can you tell me the kind of trigger point you think about this time? The first question.

And the second question is that this year's earnings is getting stronger and stronger because of the residuals of VYVANSE and also currency, but at the same time, it does mean that next fiscal year hurdles are getting a little bit higher. Can you give me some -- I know you don't have any guidance at the moment, but can you give me, what's the pros and cons for next fiscal year, starting from next April? And is that -- OP-wise, is it flattish or a slight decline? Or it's depend on a lot of factors, but can you give me, what do you see at the moment for the next fiscal year's trend, as far as sales and operating profit is concerned?

So the first question, on the rationale behind the management change; and second, on outlook for 2025. So Christophe, would you like to take those questions?

Yes. Thank you very much, Yamaguchi-san. On the management change, we feel that this is a good timing. In 2026, I will have been 12 years. So it's huge. It's quite a long period. So 2032 will not have been impossible, but it will have been very long. But it's also a good window now because we are at the end of the VYVANSE impact actually. I -- that's I'll come back to that in your second questions. And we are before the wave of new product launch. You don't want to make management change during a new product launch. You want to do that before, and that's why we are also announcing now with this transition period. It will give us time to find and select the successor of Julie who will be in place who will -- and with a more stable leadership before we launch this product in the U.S. It also coincide with some change that will happen on at -- with our Board, at our Board. And we do have a 10 years tenure limit for our external directors, so there will be some rotation happening in 2026. And we feel it's good to have the future Board and the future CEO, in a way, synchronized, so that's also another consideration that we discussed. And that's why we decided for June 2026.

On the second question, Yamaguchi-san. Of course, the upside: 40% of the upside is VYVANSE, but 60% is non-VYVANSE. So we shouldn't forget that we have a good dynamic with our Growth and Launch Product. Obviously VYVANSE is a big upside this year. The residual impact of VYVANSE in next year will be more limited. If you look at the generic penetration today, it's 65% of the molecule, so even though we had some upside, we -- the generic penetration has happened, and today, we are at 65%. So we have not reached the bottom, but we are getting close to it. So that's why we feel confident that next year will be a growth year in revenue and bottom line. Why? Because once -- yet we will see some VYVANSE impact, but it will be a residual impact. And we expect our Growth and Launch Products to continue to grow in the future. Thank you.

Okay, we'd like to take the next question from TD Cowen, Mike Nedelcovych.

I have 2, both on the topic of zasocitinib's Phase III psoriasis program. So first, when we see the first readout, what would you define as success? Or put another way, what result would make you feel more confident in your head-to-head deucravacitinib trial? And what result might make you feel a little more concerned? Just as an example: Should we focus on PASI 75, the primary end point? Or would you urge us to scrutinize PASI 100? That's my first question.

And then my second question is on timing. One of zasocitinib's Phase III psoriasis trials, LATITUDE 3002, is actually a couple months past its primary completion date on ClinicalTrials.gov. Should we take this to mean that the 16-week primary end point has been recorded? And if so, do you have data in house, or do you remain blinded until the longer-term end points read out?

Andy, would you like to take those 2 questions, please?

Sure, Chris. And actually maybe Christophe can also, when I'm done, provide some thoughts in terms of the overall profile of zasocitinib and what we would consider differentiated. So Mike, let me start with your second question first, which is timing. So as we mentioned, as of November of last year, we've completed enrollment of the 2 primary Phase III studies. These are the pivotal and registration-enabling studies, with apremilast as a comparator. As you mentioned, the primary end point is a 16-week end point, but the studies are completely blinded until week 52 for 1 of the studies and week 60 for the second study. And so that's ensured that we maintain the full integrity of these studies and that we have a 1-year safety database. So the direct answer to your question is that we don't have data in house and we're not planning an interim analysis. And quite excited about the speed at which we've enrolled these studies, and we're looking forward to seeing data at the end of the year.

Before I hand it over to Christophe, I'll mention that the primary end point for the study is PASI 75. And there are historical reasons why we've used PASI 75 as the primary end point, but the study is very well powered to see benefits on most of the key secondary end points. And the one that we're most enthusiastic about will be PASI 100. There's been a trend in psoriasis particularly driven by some of the [ efficacious ] parenteral agents, the subcu and IV agents, where patients are now really focused on clear skin. And that's where we really see our clear advantage. Christophe, I'll hand it back to you, if you have additional comments.

Yes. Thank you, Andy. Thank you, Mike. I -- our goal with zasocitinib is to redefine what an overall product can do, again, with psoriasis in term of efficacy and safety. So we will look at a significant efficacy, whether it is PASI 100 or 75, compared to what overall have been able to deliver in the past; and being much closer to a biological efficacy. And that's what we believe will redefine the overall segment and the role of oral product in the treatment of psoriasis. So I think that's really our mindset. And that's what we are looking for when we look at the result of the study.

Congratulations on your upcoming retirement.

Thank you.

[Interpreted] Moving on to the next question, Nomura Securities, Matsubara-san.

[Interpreted] Yes, this is Matsubara, Nomura Securities. Can you hear me?

[Interpreted] Yes, we can hear you.

[Interpreted] I have 2 questions. First question is about Entyvio. Compared to the previous quarter, growth of Entyvio is not very clear. I don't think it's growing. Is this because of the holidays pushing down the shipment? Or is it due to the competitive environment changing? That's my question. And the second question is about the CEO. I understand you have thought about the timing of switching to the new CEO. Now, under the new CEO, what do you expect to happen? I understand that Julie has experience in business in the United States [ and immunoglobulin ]. So those aspects of the company may grow, but what is the growth strategy under her? What do you expect her to do for Takeda?

Thank you, Matsubara-san, for the questions. So the first one was on Entyvio quarter-on-quarter growth. Is there anything of note here in terms of competitive dynamics changes? And then the second question, on expectations for Julie as the incoming CEO. So I'd like to ask Christophe to answer those questions, please.

Thank you for the question. For Entyvio, I think you need to take out the one-off effect that Milano mentioned, phasing of shipment. So Q3 last year was very strong for phasing issue or phasing pattern. And then the one-off adjustment that we mentioned on the gross-to-net price [ ASP ]. If you take that out, our year-to-date growth is 9.2%. And our quarter growth is much higher, a bit lower than Q2. And we do believe that -- indeed that there has been some effect with year-end which was especially long this year as a break between Christmas and New Year's Eve, but I think it's really important to look at the year-to-date. If you take out these 2 one-off, we are at a bit more than 9%. So a bit short of our 11% new guidance and forecast, but we will see how things are evolving.

We are quite pleased with the response that we are seeing on the pen launch. Quarter-to-quarter, we have seen a 30% increase of prescribers, number of prescriber prescribing the drug and the pen. And also our access has improved significantly, but it's not at the maximum yet. We have a bit more than 70% access at the moment and we want to reach a 90%-plus, so I think there are still some work to do there.

So overall, the pattern has not changed. Entyvio is keeping its leading position, especially in the -- in first-line biological treatment. We have lost some market share in second and third line, but we are growing faster than the market, so we are pleased with the performance. And obviously, as we discussed in the pan -- in the past, the launch of the pen is very much important in the life cycle of Entyvio.

For your second question, I will -- just want to reemphasize that Julie will lead our U.S. business until we have a successor joining us, a successor of Julie. That will take some times. We will look internally and externally. So no distraction, very much focused on that business. And then once we have a successor for Julie, she will be able to focus on the transition and progressively take the lead. So I think she has been part of the [ team ] for -- since 2019, so she has been extremely involved in our overall strategy, direction. She is leading our U.S. business today, which is 50% of our total revenue. So directionally, she has been very much in favor and supportive of our strategy. And so don't expect major change of direction, but she will respond herself to a question like that from 2026, onward. I think that's the way to see the timing. Thank you.

So for the next question, I'd like to call on Tony Ren from Macquarie.

My first question is again on Entyvio, the gross-to-net true-up adjustment. I think I heard Milano saying that it was due to selling Entyvio to the U.S. government over the last 10 quarters. I just want to confirm that I heard it correctly. With that, would you say that the 11% CER growth rate you initially guided would not be possible? So that is on Entyvio. The other question is on the U.S. IRA price negotiation. So Amgen's Otezla is now officially included in the 15 drugs for the 2025 pricing negotiations, so does -- how does that affect your clinical development or commercialization plans for zasocitinib?

Thank you, Tony. So the first question, on some more detail on the gross-to-net for Entyvio. And any impact on the 11% full year that we previously disclosed for Entyvio? So Milano, if you'd like to follow up on that one. And then the second question, on the IRA. Any impact on zaso because of Otezla's inclusion? I'd like to ask Christophe to comment on that one, please.

Tony, thank you. So this -- again, this adjustment is related to our, like, gross-to-net calculation, like [ subsidy ] government pricing calculations. And then we are kind of sharing this information with CMS in the U.S., but this impact is, unfortunately, we didn't -- of course, we didn't have forecasted or like we didn't -- we had not anticipated when we developed this guidance of 11%, so the -- if the -- by this amount, maybe it might be a little bit challenging to reach 11%, but basically if we take out this impact, overall we are in line with our internal, like, plan.

And for the IRA. Yes, Otezla is among the product selected in this second wave. It reinforced -- it doesn't change our clinical development plan. It just reinforced the fact that we believe that we will have a very different profile in term of efficacy. And therefore, we'll be able to really differentiate ourselves from previous oral product. The fact that it is in the IRA doesn't change our strategy. It just reinforced the fact that we need to be differentiated. And we believe we will be in term of efficacy and safety, not only, by the way, against a product like Otezla but also, as you mentioned earlier, with -- against deucra. Because we are doing this head-to-head study against deucra later on. Thank you.

[Interpreted] Moving to the next question, Morgan Stanley, Muraoka-san.

[Interpreted] This is Muraoka, Morgan Stanley. I hope you can hear me.

[Interpreted] Yes, we can hear you.

[Interpreted] My first question is about next fiscal year, which is coming in 3 months. And how do you see the next fiscal year? 100 to 250 basis point OP margin improvement that you have always talked about, do you think you can sustain that for next fiscal year? Can we expect that to happen? And another question is what about dividend? This year, you made upward revision twice, but the dividend was the same. It stayed the same, but if the OP margin improves in the next fiscal year, based on our progressive policy, do you think the dividend could increase? Or can we be confident that the dividend will increase? That's my first question.

[Interpreted] And the second question is about Entyvio biosimilar. Alvotech, Teva started a Phase III program recently. And it is becoming more crowded, it seems. Timing-wise, well, you always maintain that you will be okay up until 2030. Maybe that is still true, but if you really focus on the timing, are you going to be okay up until 2030 or 2032 in terms of biosimilar entry timing? Can we please -- can you help me organize my thoughts around this?

[indiscernible] question, on outlook for margin improvement in 2025. I'd like to -- and also thoughts around the dividend for next year. I'd like to ask Milano to comment on that. And then the second question, on biosimilar assumptions for Entyvio, if there's any change around entrant timing. I'd like to ask Christophe to comment on that.

[Interpreted] Thank you for your question. First of all, with regard to OP margin, 100 to 250 basis points improvement. And this is the basic thinking. And 23% is the base number that we were thinking about for this fiscal year. However, based on the latest outlook, 25.1% landing for OP margin is expected, which means that -- we are now putting together the budget for next fiscal year, so we will take a close look at that. And we would like to make a official announcement in May. Core OP margin is something that we always want to improve. This is always the policy of the management, so we will be finalizing the numbers in order to help improve that.

[Interpreted] With regard to dividend. Dividend payment is different from the share buyback that we have announced recently. We want to do something that is stable for long term; and also progressive, sustaining the level or increasing if possible. It is very difficult to comment at this point in time, but I don't think you have to worry about reducing of the dividend, at the very least.

[Interpreted] Could you please respond to the question about Entyvio?

Sure, sure. Thank you very, Muraoka-san. It's Christophe. Regarding Entyvio, there is more -- we do see more activity of development of biosimilar, for sure, but as far as we see, for the U.S. market, we still believe that it's -- that biosimilar entry will be between 2030 and 2032. We have quite a strong set of patent expiring in 2032, so we'll see what happen when there is a litigation around this patent, but just doing the development plus the litigation process takes a lot of time. So if you are optimistic about our strength of our patent, you take an assumption of 2032. If you are not optimistic, you take an assumption of 2030-plus, between the two. I think that's always has been how we describe the situation. We believe that it's 2032 because we believe into our patent set, but other might not, so for now, no change in our assumption regarding biosimilar entry, especially in the U.S. In Europe, it's a slightly different legal system depending on the country, but for U.S. it's our position is very clear. Thank you.

[Interpreted] Next question, from JPMorgan, Wakao-san.

[Interpreted] Wakao from JPMorgan.

This is Wakao from JPMorgan. I have 2 question. First, about share buyback. So could you explain background behind the decision to implement a share buyback this time? Is it simply because the share price was very low? What is the message of this decision? And could you elaborate on the -- could you tell me the timing of Phase III data readout for TAK-861 and TAK-279 [indiscernible] or [ FRUZAQLA ] or [indiscernible]?

Thank you, Wakao-san. So the first question, on thinking behind the buyback, I'd like to ask Milano to comment on that. And then the second question: Andy, any further detail you can provide on timing of Phase III for TAK-861 and TAK-279?

Thank you, Wakao-san. So we updated. If you'll remember, we updated the capital allocation policy 2 years ago. And we set the framework that within -- given that we keep the investment-grade credit rating, basically the 2 primary pillars for the capital allocation is investment for growth and then shareholder return. So with the current performance this year, we are generating more cash flow than we originally had planned. And we have been allocating these cash. And then as you have seen, we have done a few business development deals, very selectively. And then we are kind of adding in the pipeline and we are now focusing on developing these in a late-stage pipeline. And then we -- it comes to the shareholder return. And with this, the upside, we thought this is the good timing or appropriate to do these share buybacks, allocate almost half of the incremental cash flow in terms of the upgrade of the guidance. So the -- we think it's appropriate to do that according to our -- the capital allocation policy.

Wakao-san, this is Andy, on timing of each of the studies. So as you know from the R&D Day, we have 3 major Phase III readouts coming this year for rusfertide, oveporexton and zasocitinib. We haven't disclosed specific timing for those studies. For oveporexton -- or for rusfertide, we're expecting top line data this quarter, so we're very excited about that. For oveporexton, we have 2 ongoing Phase III studies in type 1 narcolepsy; and enrollment for each of those studies has exceeded our forecasts. And while we haven't given exact dates, we're hoping to have data mid-2025. And then for zasocitinib, we have 2 primary registration-enabling studies. As I mentioned earlier, those have completed screening and enrollment as of November of last year. We have a third study that's ongoing. It's a study to garner additional safety -- that study continues to enroll. So you can kind of do the math on what we would expect either from the first 2 pivotal studies. And then as Christophe alluded to earlier, we'll be starting a head-to-head study against deucravacitinib sometime midyear. That study won't be part of our original filing. Our hope is to have data from that study available to support the launch.

[Interpreted] Moving on to the next question, SMBC Nikko, Wada-san.

[Interpreted] Yes, this is Wada, SMBC Nikko. Can you hear me?

[Interpreted] Yes.

[Interpreted] Just one question, IRA and price negotiation. 2028, I think Entyvio might be included. What is your read on the situation? Do you think Entyvio will be included?

[indiscernible] on the possibility of Entyvio included in IRA in 2028. Christophe, would you'd like to comment on that?

Wada-san, it's a possibility. That's why actually we kept our peak range between [ 7.5 and 9 ]. Initially we had this range because it was -- we are not sure that we would launch a pen. You know that we had a CRL, et cetera, but we launched a pen. But then we kept that range to include the possibility of an IRA inclusion in the future. So it's a possibility that we have in mind, yes. Thank you.

[Interpreted] Next, Hashiguchi-san from Daiwa Securities.

[Interpreted] Hashiguchi speaking -- in the U.S. and the business environment changes and how that impacts your business. I would like to have your idea. Not limited to pharma industry but in various industry, it seems some new policies are recently shown from various players. And by that kind of change, how that could impact your business, including opportunities and risks. For example, PBM may be redesigned; and that could impact your pricing. What -- about that.

So Christophe, would you like to answer that question on potential impact of changes in the U.S. environment?

Yes. Hashiguchi, yes. I mean there will be some changes in the U.S. environment. Health care is one of the topic that, well, any administration will focus on. And the Trump administration just announced that they are committed to carry on with IRA. That's one point. And therefore, this pricing system will carry on for now. It might be adjusted in the future. We will see. That's something to take into consideration. On the other hand, well, keep in mind that, as part of IRA, there was also for Medicare patient an out-of-pocket cap, which is a positive in -- for many disease but especially oncology. So there are plus and minus, if you like. We believe that the U.S. country will remain absolutely vital for a innovative company and R&D-driven company like Takeda. And this is -- it's a country where new innovative medicine have the fastest launch. And this is where we have the highest level of innovation recognition and reward for innovation. It's very important, especially as we are contemplating the launch of our new product, but yes, the environment is changing, like in other countries.

Another element that we are also watching are more geopolitics. Will there be tariff, for example, impacting pharmaceutical medicines? It could be. And obviously, at Takeda, we have a manufacturing network focused on U.S., Europe, Singapore and Japan. So it has been -- it's a global network which was built on the premise of free trade. If there are more forces against free trade, we'll have to adapt over time. Thank you.

[Interpreted] Next is Sogi-san from Bernstein.

Can you hear me? This is Miki from Bernstein.

Yes, we can hear you.

Great. I have 2 questions. First of all, Entyvio. We recently saw a report saying that the -- Entyvio's listing price was increased by 8%, so could you tell me, that listing price increase, what is the impact to the actual net price to -- that is more relevant to your actual net sales? And also does it have any consequence in terms of the rebate for the government because it's higher than the -- it's significantly higher than the inflation rate? So that's first question.

And the second question is the R&D spending. We understand that R&D spending -- despite this, the post-trial drug [indiscernible] the costs were moved to the other expense. The -- it's still the spending is -- seemed to -- the -- slower than we had expected, but is it still the plan that you will be spending more on the fourth quarter so that you reach the budget that you have shared with us?

Thank you, Miki. So the first question, on Entyvio price increase, I'd like to ask Christophe to comment. And then the second question, on the R&D budget and progress towards the full year forecast, Milano, if you could please comment on that.

Thank you, Miki. Yes, this price increase is more a reflection of the rebate mechanism that is happening in the U.S. market. In order to be competitive, you need to give rebate. And that's really the mechanic, so you don't see this increase on the net price. And government price is calculated on the net price. So I think that's really the effect of the rebate mechanism. And by the way, this is something we think should be fixed. And there is a lot of discussion right now about PBM and rebate. We are advocating for this rebate to be replaced by other mechanism. Thank you.

So thank you for the question about R&D spending. So the -- just to be clear: We are not seeing any slowness in operation. Actually we are accelerating. We are gearing up the R&D operations developments. And we are driving these, the development, with a very, like, operational efficiency mindset since we had -- have had the efficiency program since the beginning of this fiscal year. And in quarter -- fourth quarter, we always have that, a little bit seasonality in -- increase in R&D spending in fourth quarter, but on top of that, we are expecting -- actually we are starting the 2 Phase III programs for the zaso or the PSA and the mezagitamab for the ITP. So actually these -- with these 2 new programs or clinical trials, we also anticipate gearing up the R&D spend.

[Interpreted] Because of the time constraint, next question would be the last; from UBS, Sakai-san.

2 questions. This is more like a general question for Dr. Plump. IRA has started impacting the industry, and likely it remain for some time. And the industry is screaming about the squeezing the raw molecule development. Do you think that, that is going to impact your pipeline strategy going forward? Especially I'm interested in the zasocitinib life cycle management, extra indication strategy. Can you comment anything interesting on this topic? That's my first question. The second question is: Weber-san, thanks for your service, I must say, but Julie Kim, is she going to be stationed in Tokyo? Is that going to be must condition for her to be appointed as CEO? That's my second question.

Thank you, Sakai-san. So the first question, to Andy, on IRA impact on pipeline strategy, specifically on zasocitinib. And then second question, to Christophe, on Julie, where she'll be located.

Thank you very much, Sakai-san. It's a great question to end the call on. So I mean I can't say that IRA won't affect the R&D strategies across the industry. Of course, it has an effect on R&D strategies. I would say that the strategy that we've adopted for our organization in Takeda withstands the IRA in the sense that we've always focused on innovation and high unmet medical need in everything that we do. I think that, in order to be competitive in the world of IRA, those are 2 features that every company will need to focus on, innovation and high unmet medical need.

With respect to zasocitinib, I would say that, yes, IRA has effects on how we strategically approach zasocitinib. This is a molecule with the potential for many indications. Historically, companies might have approached a program like this strategically in a more sequential way. We're approaching it in a parallel way. As you know, we have 4 ongoing indications today, psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease. And we're in the process of looking at additional indications. And over the course of the coming months, you'll hear more of our strategy to expand for zasocitinib.

Thank you, Sakai-san, for your questions. So first, I would like to say that I started a few years ago, to be based in Tokyo the majority of the time, and in Boston. so I am between these 2 location because our global hub in Boston is so important. So I want to stress that out. So my location today is Tokyo and Boston. And Julie is very much committed to also have these Tokyo, Boston location. That's part of the agreement, if you like, yes. Thank you.

[Interpreted] That's all for today's webinar. Thank you very much for your participation despite your very busy schedule. And we look forward to your continued support. Thank you.

[Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]