Takeda Pharmaceutical Q3 2025 Earnings Call Transcript

Quartr
Provided by Quartr
January 30, 2025

Key Takeaways

  • Takeda raised its full‐year revenue, core operating profit, and margin guidance again for FY2024 and announced a JPY 100 billion share buyback, reflecting strong cash flow and business momentum.
  • Q3 year‐to‐date revenue grew 4.5% at constant exchange rate, driven by a 14.6% CER increase in gross & launch products, while the core operating profit margin improved by 1.6 percentage points to 28.5%.
  • The company recorded one‐off charges including a JPY ~30 billion FX inventory adjustment and JPY 107.4 billion of post‐trial access costs for terminated clinical programs, impacting COGS and OpEx.
  • Takeda’s late‐stage pipeline remains robust with the licensing of a potential best‐in‐class oncology asset (AtelCept) and three Phase 3 data readouts expected in 2025 for indications including polycythemia vera, neurogenic pain, and psoriasis.
  • CEO Chris Weber will retire in June 2026 and be succeeded by Julie Kim—currently President of the U.S. business—which the board approved to ensure continuity ahead of major product launches and board transitions.
AI Generated. May Contain Errors.
Earnings Conference Call
Takeda Pharmaceutical Q3 2025
00:00 / 00:00

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Christopher O'Reilly
Head of Investor Relations at Takeda

Thank you for joining us today despite a very busy schedule for FY24 Q3 earnings call by Takeda. I'm the master of ceremonies today, head of IR. My name is O'Reilly. Thank you for this opportunity. I would like to explain about the language setting first. Please find the button for the language selection at the bottom of the Zoom window. If you wish to listen in Japanese, please select Japanese. If you wish to listen to English, please select English. Or if you want to listen to the original language, please keep it off.

Please select English in the Zoom language select button. [foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

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 actual results to differ materially are discussed in our most recent Form 20-F and 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.

Christophe Weber
CEO at Takeda

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 the 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 Shareholders in June 2026 and will then be nominated as President and CEO. The unanimous decision to select Julie was made after a very robust multi-year process assessing both internal and external candidates.

Christophe Weber
CEO at Takeda

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 timeframe also aligns with the anticipated retirement of several external independent directors, allowing both Julie and me to be actively involved in the board member selection process. Now, I wanted 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 three years. Prior to that, Julie led our Plasma-Derived Therapy Business Unit. With over 30 years of healthcare experience, Julie is uniquely qualified for this role.

Christophe Weber
CEO at Takeda

The board and I have absolute confidence in Julie's 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.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Now I would like to start the presentation from our CFO, Milano Furuta, and this will be followed by a Q&A session. Furuta-san, the floor is yours.

Milano Furuta
CFO at Takeda

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 Q3, 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 and an increase of 1.6 percentage points. This reflects the strength of our growth and launch products, slower-than-anticipated LOE events generating 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 an ADC, a late-stage potential best-in-class oncology program.

Milano Furuta
CFO at Takeda

As we introduced at our R&D Day in December, 2025 will be an important year for our pipeline, with three Phase 3 data readouts expected this calendar year: Rusfertide in polycythemia vera, oral orexin 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 margin growth this year. 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 nine months of FY 2024. Revenue was over JPY 3.5 trillion, an increase of 9.8% versus prior year, or 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.

Milano Furuta
CFO at Takeda

Reported operating profit was JPY 417.5 billion, growing at 86%. Core EPS and reported EPS were 443 JPY and 134 JPY, respectively. Operating cash flow was JPY 835 billion, an increase of 90.8% year-on-year, reflecting profit growth, lower cash taxes, and a 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 two specific factors. First, there was a higher baseline for Q3 growth due to shipment timing last year.

Milano Furuta
CFO at Takeda

On top of that, we booked a gross-to-net adjustment in Q3 this year of approximately $50 million. This adjustment was a 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 continue 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 planned and temporary shutdown of production lines, we also observed the cost containment measures in China, which is influencing the growth rate. In oncology, Fruzaqla is expanding very well.

Milano Furuta
CFO at Takeda

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, revenue growth. Our growth and launch products more than offset loss of exclusivity impact mainly by 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 Iclusic 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.

Milano Furuta
CFO at Takeda

Slide 7 shows a year-on-year bridge for core operating profit. There was a positive gross profit 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 2023. 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.

Milano Furuta
CFO at Takeda

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

Milano Furuta
CFO at Takeda

Next, our updated outlook for FY 2024. We are upgrading management guidance. Revenue and core operating profit are both expected to increase at low single-digit %. This is a remarkable change from our initial outlook for revenue and core OP to decline this year. Core EPS guidance has also improved to flat to slightly declining at CER. Our 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 USD, our assumption for the EUR is unchanged. On a reported basis, we forecast operating profit to be JPY 344 billion and reported EPS to be JPY 75.

Milano Furuta
CFO at Takeda

We are also raising our free cash flow forecast range to JPY 550 billion-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 updated 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.

Milano Furuta
CFO at Takeda

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 cost 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.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Now we would like to entertain questions from you, Christophe, Milano, and R&D President Andy Plump. We'll be joining in this session. If you want to ask a question, please let us know with a raised hand. If you're listening on the English channel, ask in English, and if you're on Japanese, please ask in Japanese. If you're listening to the original, either language is okay. Please ask up to two questions, and please address your questions, two questions upfront. The first is from Jefferies. Mr. Baker, please.

Milano Furuta
CFO at Takeda

Unmute and ask your question.

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

Yes, Steve Baker from Jefferies. Thanks very much. 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 devaluing 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? Yeah, so two accounting questions, please. Thank you.

Christophe Weber
CEO at Takeda

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

Milano Furuta
CFO at Takeda

Yes. Hi, Steve. Thank you for the questions. So the first one is COGS one. So it's a little bit technical, so bear with me. So as you know, there is in the intercompany transactions, we're going to have some internal markups. And then within the consolidation accounting process, there is a process of eliminating these markups. Sometimes, due to the different functional currencies and high-volume transactions, this kind of adjusting accounting account will be used to appropriately reflect our inventories. And then this account has 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 an accounting process to recognize this accumulated foreign currency impact of the inventories. And then as a kind of one-time recognition of about 26 billion JPY for the past ones.

Milano Furuta
CFO at Takeda

Then for this fiscal quarter three, like about JPY 39 or JPY 3.9 billion of the recognition. That's a kind of combination of the recognition of the FX impact in the inventories.

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

Right, so really a one-off.

Milano Furuta
CFO at Takeda

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

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

Right. It won't build up anymore.

Milano Furuta
CFO at Takeda

No.

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

Thank you.

Milano Furuta
CFO at Takeda

For the 611, 609, these programs were. We had decided to terminate or stop the development, the programs based on the clinical trial results. But based on a patient's request, we decided to offer access to these molecules to the patients who want to have a kind of post-trial access. So then with this decision, we made an accrual for this post-trial access cost, which booked in Q3, which is almost like JPY 116 billion, which we booked in other operating expense. So it's kind of one-off, the one-time for this program.

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

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.

Milano Furuta
CFO at Takeda

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

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

Yes.

Milano Furuta
CFO at Takeda

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

Stephen Baker
Stephen Baker
Managing Director and Healthcare Equity Research at Jefferies

Understood. Thanks very much.

Milano Furuta
CFO at Takeda

Thank you, Steve.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Moving on to the next question. Citi, Yamaguchi-san, please ask your question.

Hidemaru Yamaguchi
Hidemaru Yamaguchi
Equity Research Analyst at Citigroup

Can you hear me? Yes, we can hear you. Thank you. Thank you. So two questions from Yamaguchi for Citi. The first question is regarding the management change. And my sense was, Christophe, for me at least, it sounds like you're trying to do the management up until the Entyvio cliff, which is around the 2030s. But you decided to change the management next year. Is there any kind of trigger 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? That's the first question. The second question is that this year's earnings is getting stronger and stronger because of the residuals, the buy-backs, and also currency. But at the same time, it does mean that next fiscal year hurdle is getting a little bit higher.

Hidemaru Yamaguchi
Hidemaru Yamaguchi
Equity Research Analyst at Citigroup

Can you give me—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 a flat issue or slight decline? Or it depends 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 profits concerned? Thanks.

Milano Furuta
CFO at Takeda

Thank you, Yamaguchi-san. 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?

Christophe Weber
CEO at Takeda

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, which is quite a long period. So 2032 will not have been impossible, but it will have been very, very long. But it's also a good window now because we are at the end of the Vyvanse impact, actually. I'll come back to that in your second questions. And we are before a wave of new product launch. You don't want to make management change during a new product launch. You want to do that early before. And that's why we are also announcing now with this transition period that will give us time to find and select the successor of Julie, who will be in place with the most stable leadership before we launch this product in the US.

Christophe Weber
CEO at Takeda

It also coincides with some change that will happen with our board. At our board, we do have a 10-year limit for our external director, 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.

Christophe Weber
CEO at Takeda

So even though we had some upside, 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 yet we will see some Vyvanse impact, but it will be a residual impact, and we expect our growth and launch product to continue to grow in the future. Thank you.

Hidemaru Yamaguchi
Hidemaru Yamaguchi
Equity Research Analyst at Citigroup

Thank you very much.

Milano Furuta
CFO at Takeda

Thank you. Okay, we'd like to take the next question from TD Cowen, Michael Nedelcovych. Michael, please unmute and ask your question.

Michael Nedelcovych
Michael Nedelcovych
Director at TD Cowen

Hi everybody. Thank you for the question. I have two, both on the topic of zasocitinib's Phase 3 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 zasocitinib trial? And what result might make you feel a little more concerned? Just as an example, should we focus on PASI 75, the primary endpoint, 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 3 psoriasis trials, Latitude 3002, is actually a couple of months past its primary completion date on ClinicalTrials.gov. Should we take this to mean that the 16-week primary endpoint has been recorded?

Michael Nedelcovych
Michael Nedelcovych
Director at TD Cowen

If so, do you have data in-house, or do you remain blinded until the longer-term endpoints readout? Thank you.

Milano Furuta
CFO at Takeda

Thank you, Mike. Andy, would you like to take those two questions, please?

Andrew Plump
President, R&D at Takeda

Sure, Chris, and hi, Mike, 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've mentioned, as of November of last year, we've completed enrollment of the two primary Phase 3 studies. These are the pivotal and registration-enabling studies with apremilast as a comparator. As you've mentioned, the primary endpoint is a 16-week endpoint, but the studies are completely blinded until week 52 for one of the studies and week 60 for the second study, and so that's to ensure that we maintain the full integrity of these studies and that we have a one-year safety database.

Andrew Plump
President, R&D at Takeda

The direct answer to your question is that we don't have data in-house, and we're not planning an interim analysis. We are 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 endpoint for this study is PASI 75. There are historical reasons why we've used PASI 75 as the primary endpoint. The study is very well-powered to see benefits on most of the key secondary endpoints. 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 subcutaneous and IV agents, where patients are now really focused on clear skin. That's where we really see our clear advantage.

Andrew Plump
President, R&D at Takeda

Christophe, I'll hand it back to you if you have additional comments.

Christophe Weber
CEO at Takeda

Yeah. Thank you, Andy. Thank you, Mike. Our goal with the zasocitinib is to redefine what an oral product can do against psoriasis in terms of efficacy and safety, so we will look at significant efficacy, whether it is PASI 100 or 75, compared to what oral products have been able to deliver in the past, and being much closer to a biologic efficacy, and that's what we believe will redefine the oral 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.

Michael Nedelcovych
Michael Nedelcovych
Director at TD Cowen

Thank you. And congratulations on your upcoming retirement.

Christophe Weber
CEO at Takeda

Thank you.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Moving on to the next question. Nomura Securities? Matsubara-san, please ask your question.

Hiroyuki Matsubara
Hiroyuki Matsubara
Senior Equity Analyst at Nomura Securities

Yes, this is Matsubara. Nomura Securities, can you hear me? Yes, we can hear you. Thank you. I have two questions. First question is about Entyvio. Compared to the previous quarter, the 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.

[foreign language]

Hiroyuki Matsubara
Hiroyuki Matsubara
Senior Equity Analyst at Nomura Securities

The second question, sorry, 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 in the global arena, 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?

Milano Furuta
CFO at 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.

Christophe Weber
CEO at Takeda

Thank you for the question. For Entyvio, I think you need to take out one of the effects that Milano mentioned, phasing of shipment. So Q3 last year was very strong for phasing issue or phasing pattern. And then one of adjustment that we mentioned on the gross-to-net price, the 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 there has been some effect with year-end, which was especially long this year, the 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 two one-offs, we are at a bit more than 9%. So a bit short of our 11% new guidance and forecast, but we see how things are evolving.

Christophe Weber
CEO at Takeda

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 prescribers prescribing the drug, 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 the 90% plus. I think there is still some work to do there. Overall, the pattern has not changed. Entyvio is keeping its leading position, especially in first-line biological treatment. We have lost some market share in the second and third line, but we are growing faster than the market. We are pleased with the performance. Obviously, as we discussed in the past, the launch of the pen is very much important in the life cycle of Entyvio.

Christophe Weber
CEO at Takeda

For your second question, I would 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 time. We will look internally and externally. So no distraction, very much focus 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 TT 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. So don't expect major change of direction, but she will respond herself to a question like that from 2026 onward.

Christophe Weber
CEO at Takeda

I think that's the way to see the timing. Thank you.

Andrew Plump
President, R&D at Takeda

Thank you very much, Matsubara-san. So for the next question, I'd like to call on Tony Ren from Macquarie. Tony, please unmute and ask your question.

Tony Ren
Head of Asia Healthcare Research at Macquarie Capital

Great. Yeah, thank you for the opportunity to post my questions. 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 price negotiation. So how does that affect your clinical development or commercialization plans for zasocitinib? Thank you.

Milano Furuta
CFO at Takeda

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 zasocitinib because of Otezla's inclusion. I'd like to ask Christophe to comment on that one, please.

Christophe Weber
CEO at Takeda

Hi, Tony. Thank you. So again, this adjustment is related to our gross-to-net adjustments calculation, like, in essentially government pricing calculations. And then we are sharing this information with a CMS in the US. But this impact is, unfortunately, we didn't, of course, we didn't forecast it, or we had not anticipated when we developed this guidance of 11%. So 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 the internal plan.

Christophe Weber
CEO at Takeda

For the IRA, yes, Otezla is among the products selected in this second wave. It reinforces; it doesn't change our clinical development plan. It just reinforces the fact that we believe that we will have a very different profile in terms of efficacy. And therefore, we'll be able to really differentiate ourselves from previous overall product. The fact that it is in the IRA doesn't change our strategy. It just reinforces the fact that we need to be differentiated, and we believe we will be in terms of efficacy and safety. Not only by the way against a product like Otezla, but also, as you mentioned earlier, against Sotyktu because we are doing this head-to-head study against Sotyktu later on. Thank you.

Tony Ren
Head of Asia Healthcare Research at Macquarie Capital

Thank you very much.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Thank you very much. Moving on to the next question. Morgan Stanley, Muraoka-san. Please unmute and ask your question.

Shinichiro Muraoka
Shinichiro Muraoka
Equity Analyst at Morgan Stanley

Good evening. This is Muraoka, Morgan Stanley. I hope you can hear me. Yes, we can hear you. Thank you. My first question is about next fiscal year, which is coming in three months. How do you see the next fiscal year? 100 to 250 basis points 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 an 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 your progressive policy, do you think the dividend could increase? Or can we be confident that the dividend will increase?

Shinichiro Muraoka
Shinichiro Muraoka
Equity Analyst at Morgan Stanley

That's my first question. And the second question is about Entyvio, biosimilar. Alvotech Teva started their Phase 3 program recently, and it is becoming more crowded, it seems. Timing-wise, well, you always maintained that you'll 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 you please help me organize my thoughts around this?

Milano Furuta
CFO at Takeda

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 Christopher to comment on that.

Christophe Weber
CEO at Takeda

Muraoka-san, good morning.

Christopher O'Reilly
Head of Investor Relations at Takeda

Good evening, Muraoka-san. Thank you for your question. First of all, with regard to OP margin, 100-250 basis points improvement, and this is the basic thinking, and the 23% is the base number that we're thinking about for this fiscal year. However, based on the latest outlook, 25.1% landing for OP margin is expected, which means that we're now putting together the budget for next fiscal year, so we will take a close look at that, and we would like to make an 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. With regard to dividend, dividend payment is different from the share buyback that we have announced recently.

Christopher O'Reilly
Head of Investor Relations at Takeda

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. Thank you. Could you please respond to the question about Entyvio?

Christophe Weber
CEO at Takeda

Sure, sure. Thank you very much, 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 biosimilar entry will be between 2031 and 2032. We have quite a strong set of patents expiring in 2032. So we'll see what happens when there is litigation around this patent. But just doing the development plus the litigation process takes a lot of time. So if you are optimistic about the 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 others might not.

Christophe Weber
CEO at Takeda

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 the U.S., our position is very clear. Thank you.

Christopher O'Reilly
Head of Investor Relations at Takeda

Thank you very much. Thank you. Next question from J.P. Morgan. Wakao-san, please go ahead.

Christopher O'Reilly
Head of Investor Relations at Takeda

Hi, J.P. Morgan. Wakao from J.P. Morgan.

Seiji Wakao
Seiji Wakao
Senior Analyst at J.P. Morgan

Wakao from J.P. Morgan. I have two questions. First, about share buyback. So could you explain the background behind the decision to implement the share buyback this time? Is it simply because the share price was very low? What is the message of this decision? And could you tell me the timing of phase three data readout for TAK-861 and TAK-279, Psoriasis, Psoriatic Arthritis, SLE, please?

Christophe Weber
CEO at Takeda

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 3 for TAK-861 and TAK-279?

Milano Furuta
CFO at Takeda

Thank you, Wakao-san. So we updated, if you remember, we updated the capital allocation policy two years ago. And we set the framework that within given that we keep the investment grade credit rating, basically the two primary pillars for our capital allocation is investment for growth and then show the return. So with the current performance this year, we are generating more cash flow than we originally had planned. And we have been allocating this 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 this in a late-stage pipeline. And then it comes to the show of the return.

Milano Furuta
CFO at Takeda

And with this, the upside, we thought this is the good timing or the appropriate to do this share buyback, allocate almost half of the incremental cash flow in terms of the upgrade of the guidance. So we think it's appropriate to do that according to the capital allocation policy.

Andrew Plump
President, R&D at Takeda

Wakao-san, this is Andy on timing of each of the studies. So as you know from the R&D Day, we have three major Phase 3 readouts coming this year for Rusfertide, oral orexin, and zasocitinib. We haven't disclosed specific timing for those studies. For oral orexin or for Rusfertide, we're expecting top-line data this quarter. So we're very excited about that. For oral orexin, we have two ongoing Phase 3 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 two 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. That's a study to garner additional safety. That study continues to enroll.

Andrew Plump
President, R&D at Takeda

So you can kind of do the math on what we would expect data from the first two pivotal studies. And then, as Christophe alluded to earlier, we'll be starting a head-to-head study against deucravacitinib sometime mid-year. That study won't be part of our original filing. Our hope is to have data from that study available to support the launch.

Seiji Wakao
Seiji Wakao
Senior Analyst at J.P. Morgan

Okay, very clear. Thank you.

Milano Furuta
CFO at Takeda

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Thank you. Moving on to the next question. SMBC Nikko. Wada-san, please unmute and ask your question.

Hiroshi Wada
Research Analyst at SBMC Nikko Securities

Yes, this is Wada, SMBC Nikko. Can you hear me? Yes. Thank you. 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?

Milano Furuta
CFO at Takeda

The possibility of Entyvio inclusion in IRA in 2028. Christophe, if you'd like to comment on that.

Christophe Weber
CEO at Takeda

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 we were not sure that we would launch a pen, that we had a CRL, etc., 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.

[foreign language]

Hiroshi Wada
Research Analyst at SBMC Nikko Securities

Thank you. That's clear. That's all from me.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Next, Hashiguchi-san from Daiwa Securities. Go ahead.

[foreign language]

Kazuaki Hashiguchi
Kazuaki Hashiguchi
Senior Analyst at Daiwa Securities

Thank you for taking my question. In the US 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 industries, seems some new policies 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? Thank you.

Milano Furuta
CFO at Takeda

Thank you, Hashiguchi-san. So Christophe, if you'd like to answer that question on potential impact of changes in the U.S. environment.

Christophe Weber
CEO at Takeda

Yeah, thank you, Hashiguchi-san. Yes, there will be some changes in the U.S. environment. Healthcare is one of the topics that any administration will focus on. 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, keep in mind that as part of the IRA, there was also for Medicare patients an out-of-pocket cap, which is a positive for many diseases, but especially oncology. So there are plus and minus, if you like. We believe that the U.S. country will remain absolutely vital for innovative companies and R&D-driven companies like Takeda. This is the country where new innovative medicine has the fastest launch.

Christophe Weber
CEO at Takeda

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

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Next is a Sogi-san from Bernstein. Please go ahead.

Miki Sogi
Miki Sogi
VP at Bernstein

Can you hear me? This is Miki from Bernstein.

Milano Furuta
CFO at Takeda

Yes, we can hear you.

Miki Sogi
Miki Sogi
VP at Bernstein

Great. Thank you very much. I have two 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 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 significantly higher than the inflation rate? So that's the first question. And the second question is the R&D spending. We understand that the R&D spending, despite the post-trial drug, the cost removed to the other expense, it's still the spending seems to be 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?

Milano Furuta
CFO at Takeda

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.

Christophe Weber
CEO at Takeda

Thank you, Miki. Yeah, 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 mechanics. 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 another mechanism. Thank you.

Milano Furuta
CFO at Takeda

Hi, Hashiguchi-san. So thank you for the question about R&D spending. So just to be clear, we are not seeing any slowness in operation. Actually, we are accelerating. We are gearing up the R&D operations development. We are driving the development with a very operational efficiency mindset since we have had the efficiency program since the beginning of this fiscal year. In the fourth quarter, we always have that a little bit of seasonality in the increase in R&D spending in the fourth quarter. But on top of that, we are expecting. Actually, we are starting the two Phase 3 programs for the zasocitinib for psoriasis and the mezagitamab for the ITP. So actually, with these two new programs or clinical trials, we also anticipate gearing up the R&D spend.

Miki Sogi
Miki Sogi
VP at Bernstein

Great. Thank you very much. Very clear. Thank you.

[foreign language]

Christopher O'Reilly
Head of Investor Relations at Takeda

Because of the time constraints, next question would be the last. From UBS, Sakai-san, please go ahead and ask your question. Thank you very much.

Atsushi Sakai
Atsushi Sakai
Managing Director and Counsel at UBS

This is more like a general question for Dr. Plump. IRA has started impacting the industry and likely to remain for some time, and the industry is screaming about squeezing the R&D 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 or 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 a must condition for her to be appointed as CEO? That's my second question.

Milano Furuta
CFO at Takeda

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.

Andrew Plump
President, R&D at Takeda

Thank you very much, Sakai-san. It's a great question to end the call on. So 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, 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 two 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 in 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.

Andrew Plump
President, R&D at Takeda

We're approaching it in a parallel way. As you know, we have four 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.

Christophe Weber
CEO at Takeda

Thank you, Sakai-san, for your questions. 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 two locations 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 this Tokyo-Boston location. That's part of the agreement, if you like. Yeah. Thank you.

Atsushi Sakai
Atsushi Sakai
Managing Director and Counsel at UBS

Thank you. Thank you very much.

Analysts
    • Andrew Plump
      President, R&D at Takeda
    • Atsushi Sakai
      Managing Director and Counsel at UBS
    • Christophe Weber
      CEO at Takeda
    • Christopher O'Reilly
      Head of Investor Relations at Takeda
    • Hidemaru Yamaguchi
      Equity Research Analyst at Citigroup
    • Hiroshi Wada
      Research Analyst at SBMC Nikko Securities
    • Hiroyuki Matsubara
      Senior Equity Analyst at Nomura Securities
    • Kazuaki Hashiguchi
      Senior Analyst at Daiwa Securities
    • Michael Nedelcovych
      Director at TD Cowen
    • Miki Sogi
      VP at Bernstein
    • Milano Furuta
      CFO at Takeda
    • Seiji Wakao
      Senior Analyst at J.P. Morgan
    • Shinichiro Muraoka
      Equity Analyst at Morgan Stanley
    • Stephen Baker
      Managing Director and Healthcare Equity Research at Jefferies
    • Tony Ren
      Head of Asia Healthcare Research at Macquarie Capital
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