Okay, so let's get started with Takeda. My name is Shinichiro Muraoka, a research analyst at Morgan Stanley. Before starting this, for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. Yeah, let's get started with Takeda. The speaker is CFO, Mr. Milano Furuta. Thank you for joining us. Thank you for having me here. Thank you. So yeah, you have many pipelines from the last year's R&D, the investors' awareness, interest on your pipeline have evolved significantly in the last one year. And yesterday, today, you have a new update of Oveporexton Narcolepsy Type 1 results. I would like to start with about Oveporexton. First of all, so how can I say? So what's your appealing point of the molecule in the phase three study? No, thank you, Shinichiro Muraoka. Hello everyone. My name is Milano Furuta, CFO of Takeda. Just before we start, last question specifically, Shinichiro Muraoka, you mentioned a very important point. Takeda is now bringing six late-stage assets, which we project peak sales combined $10 billion-$20 billion. Our total revenue of Takeda is now a bit more than $30 billion. You can see the magnitude of the potential of these late-stage assets. We have six late-stage assets. This year, 2025, is quite an exciting year for us because we have the three readouts among those six. So one is Rusfertide, the molecule for polycythemia vera. Fantastic data. We can talk about it later. And then now this morning, we presented at the World Sleep Conference in Singapore about TAK-861 for narcolepsy type 1. We expect another big one. That's That's Zasocitinib for psoriasis in the later fiscal year. That's why we are quite excited in this year. We are very happy to announce or present the detailed data of the TAK-861 this morning. Narcolepsy Type 1 is the orexin deficiency disease. TAK-861 is the first agent or the medicine to be medicine that we are developing, which addresses these root causes of Narcolepsy Type 1. Our phase 3 programs hit all the endpoints, the 14 endpoints across the primary endpoints, secondary endpoints, with all the data. All the efficacy data was with the statistically significant results. Starting from the MWT, which is the primary endpoint. But beyond that, we measured the multiple different efficacy endpoints, and then we hit all of them. And if you think about this narcolepsy patients are facing in day-to-day, it's extremely important that the treatments will address not only the symptoms, but how the patients feel day-to-day. So full spectrum of the quality of life. That's extremely important. That's why we are so much excited to share this data because it demonstrates this agent's potential to address the full spectrum of the narcolepsy patient needs. Yeah, great. Thank you. Yeah, that's the point. So yeah, I fully agree with you that. So orexin drugs can change the current landscape of Narcolepsy Type 1, maybe even the type 2 treatments significantly from the current existing stimulant to more efficacious and more safe treatments. And actually, today's announcement and the complete announcement as well, the orexin drugs can change the treatment standard of care. I fully agree that. But our discussion points with investors are which of the two current viable treatments of orexins are which were better or have pros and cons. Yeah. Yeah. Roughly speaking, your product looks pretty safe. On the other hand, on the surface, some clinical endpoints, competitors look slightly better. But the drug value, the value of the drugs are the totality of the data. So I would like to know what's your potential competitive advantage you expect from your clinical results. No, thank you, Shinichiro Muraoka. I have a slightly different view on how you compare, how you see data. I think the very important objective of this treatment of narcolepsy is to normalize the symptoms or life of the patient. And then it's pretty hard to, how to call it, normalize more than normal. So if you normalize the patient, their symptoms, day-to-day life, feelings, things, I think that's fine. It's just a marginal numerical difference. It's going to be less important. Rather, those excessive daytime sleepiness, cataplexy, cognition, so nighttime symptoms, those holistic elements should be addressed. And then all of them, if you can normalize all of them, then you achieve the objective. That's what we're bringing to the market and then for the patient's life. Yeah, I agree that. Actually, in some endpoints, you said you have met all the endpoints. But some other products, even with phase 2, cataplexy data were insufficient. So, you are directed to be quite promising one. But in the market discussion, the phase 2 data, for example, MWT numbers were quite high. But this time, around 20 minutes, slightly higher. So some investors say somewhat disappointing. Do you have any? The MWT is our primary endpoint. It's a very important measurement. At the same time, it's one of the endpoints. If you think about how we measure that MWT, the setting, you are put in a dark, quiet room, do nothing, and then stay awake. If you think about that setting, how much you can relate to the real life. Basically, if you can stay more than 20 minutes, then you are seen as normal. It's going to be a bit difficult. We're going to argue what is more normal than normal. If you reach that 20-minute threshold, we think it's very relevant for patients. That's how we set the endpoints. We believe that's quite clinically meaningful. We achieve that with all other parameters. Okay, great. In terms of the safety profile, so yeah, your molecule looks quite clean in 22 milligram and 11 milligram as well. But to visual disturbance, according to your experience on this morning, it was 1%. 1% is okay, I think. But your competitor results are quite high, high number, around over 10%. But I don't want to ask you about the competitor's results. But do you think the certain safety profile of visual disturbance will be quite critical or important in the clinical settings? Yeah, so in this, well, like many other medications, safety is extremely important, and we are glad to see we don't see the treatment-related severe adverse events, and all of the adverse events is basically the mild to moderate and then transient. We don't have a concern on this visual disturbance, but given the market, many investors are quite interested in this topic, we had to proactively search the case, and eventually, we found some case, but which was very limited, low number, and then the comparable in both arms, in the placebo and then the active arm, so we don't see the visual disturbance is a concern for Oveporexton. I like it. And it's another quite common discussion of your molecule is twice daily. Competitors or followers are once daily. I think it's manageable. But could you elaborate to us that twice daily is not the challenge for your future commercial activities? Yeah. So we tested during the course of development. We tested different dosing. And then also eventually, we thought this is the best dosing to do combination. The first one is our thesis is kind of mimicking orexin dynamics and diurnal dynamics. And then with the BID regimen or BID dosing, we'll help patients mimic the orexin dynamics. Then if you look at our phase 2 data, and then the different dosing, and then the 22-milligram, two-milligram combination was we thought is the best approach. And then maybe the patients might have a little bit of flexibility depending on their day-to-day life. Maybe they might have some plan during the day. And then maybe there's room for flexibility. But in the end, we think that's the best for patients. Okay, and in terms of the regulatory steps going forward, yeah, could you let me know the future schedule of the filing for launch project three? I think you can launch before the end of next year, but please explain that. Yes. We try to run as fast as possible. We deliver this transformational treatment to patients as soon as possible. We are projecting our filing is within this fiscal year. When we say fiscal year, our fiscal year starting from April and then March. So that's cycle. You are fine. You are fine. You are fine. Yes. Before March 2026, that's our fiscal, the filing timeline. So second half of fiscal year. And then hopefully, we can get approval to launch next year. Next year? Yes. Priority level? We have to look at that. But that's the kind of timing we are looking at. But anyway, so you can launch in 2026. And after the launch, what's your expectation of the trajectory of the sales momentum after that? Steep, steep, hike, or gradual step up? We expect the strong update, of course. Because again, Oveporexton, it's going to be the first agent. I would say it's opening the new era of treatment for the Narcolepsy Type 1, addressing root cause of this disease, and there is currently some products in the market, but we cannot address the root cause of the Narcolepsy Type 1, so there is a market there, and then there's a diagnosed patient there, so we first prioritize or deliver these medicines to those diagnosed patients and possibly not controlled well, and then in the same time, also we start with improving the diagnosis of this Narcolepsy Type 1. Why? Because we expect we are now estimating the diagnosis rate is around 50%, and we are aiming to lift this diagnosis rate. Treatment rate is about 70%. And again, with this transformative medicine product, we are also aiming to lift this treatment rate as well. So all in all, if we can achieve it, and then we believe we can do that. And then we project the big sales to be $2 billion-$3 billion, and it could be more. So $2 billion-$3 billion plus. That's good. That's our expectation. So in terms of the replacement from the current treatment of Xyrem or stimulants, do you think there's such a replacement to be quite fast or quite challenging? If you look at the Oveporexon data, again, if we pick just MWT, it's quite differential. And then biology-wise, it's addressing root cause. And then again, I'm repeating this one, but addressing in a clinical trial setting, like 14 different endpoints. So it's very addressing holistic needs of the patient. And why not? So of course, eventually, it's in the patient and then the doctors, the healthcare professionals' choice. But we strongly believe that Oveporexon is offering a completely different level of the treatment. Following today's announcement, you are confident on $2 billion-$3 billion plus. Yeah. Hard to become more concrete, right? Yeah. Great. Thank you very much. So sorry, we talked too much about all that background, but it's quite important. But going forward, you said so the Zasocitinib data readouts to come in. Could you let me know the timeline and your expectation of the profile of the product in the competitive landscape? Yes. So the Zasocitinib is highly selective to our agents for a thrust, which we are developing first. And we expect the data readouts to be in, again, later this year, so toward the end of this calendar year or maybe next calendar quarter. So that's the first milestone to hit. And then with that, we believe we expect we're going to have a positive readout, and then we're going to file the next year. So in this case, in this field of oral psoriasis treatment, oral IL-23 has some advantage in timeline to you. What's your business commercial plans to catch up or compete against? Our thesis on this treatment, kind of value proposition of this Zasocitinib, is we want to expand this oral segment in advanced therapy. Now about maybe 15%-16% of advanced therapy is in the oral. We see there's headroom for the growth in this space. If we can bring biologic-like oral option to patients, that is exactly what we are aiming to. If we can bring that level of efficacy, biologic-like, not just a convenience agent, then in part, we can double the size of the oral segment before injectables. There's another competitor drug ahead. We acknowledge that. It's not that bad to have those two new molecules, new two classes, or two companies to create that space. We are quite excited to create an open space. So other oral molecules are not just a competitor, but not a collaborator. Yeah. We're going to compete. We're going to compete. But we're going to create a space. I think that's another point. If we can create a space, and then we're going to do the healthy competition. But then we can make it that Zasocitinib quite a big product. And then we are confident on the competition as well. Because if you look at the phase 3 data in psoriasis, PASI 100 score is Zasocitinib is quite high number, almost 1 to 3, like 33% of the patients achieve clear skin in PASI 100, which is quite good in efficacy. So if we can that's phase 3 data. So there is some variability. But if we can replicate to some extent in the phase 3, we see quite good competitiveness in the Zasocitinib. But anyway, so data readouts coming maybe soon or months. And can you file soon after that? Maybe in the next year. Yeah. Well, let me say in the next year, but early next year. Maybe let's say six months or after the readouts, let's say. But we definitely want to file in the next year. Yeah, and of course, under the other molecule of this portfolio, very good results were presented at ASCO in June. When do you plan to file it? It's not filed yet. That's going to be within this fiscal year. That's also, so it's quite a lot of things going to happen in the latter fiscal year. Next three to six months. This is another agent. We are quite excited. This is another new treatment for the Polycythemia Vera. And we presented the data in ASTRO. And one of the experts was calling this a practice change, practice changing the treatments. In 2026 and 2027, the three molecules to be commercialized or lifting towards that big success. My question is from pipeline. In terms of the earnings was. New drug, big new drug, three molecules to start to contribute from the next year. But in the last couple of years, you were struggling of some deterioration of the legacy product. Can we expect you can turn to the growth phase again from the next fiscal year? We have been growing. We have been growing until this year, which, this year, a lot of exclusivity by Vyvanse hit significantly this year. Until that quarter, we have been actually growing despite some loss of exclusivity. The major driver has been we have growth on launch products, which is almost like 50% of the total revenue, which has been growing the double digit. Now our objective is, but this growth on launch product was mainly our biggest product is Entyvio. Will we expect to have a biosimilar entry around 2031 or 2032? This biggest product in LOE, loss of exclusivity, how we can overcome it. That's why we are talking a lot about this new product. It was Rusfertide, $1-$2 billion, Oveporexton $2-$3 billion plus. Then the Zasocitinib is $6 billion. So we combined all these three products. We are now quite confident to overcome the Entyvio's future loss of exclusivity or biosimilar entry. Great. So you talked about NPDO. Just some current earnings-wise, so a bit saturated or disappointed about the slow penetration of the NPDO 10. Of course, there are many challenges in insurance or something else, but going forward, can we expect you can go back to the quite good sales momentum of NPDO? Or are there any remaining challenges going forward? No. We are super happy with NPDO. NPDO has been growing quite a good pace. Despite it, it's like now it's been on the market more than 10 years, and then it's still growing quite well. This year, we are expecting 9% growth. Q1 is a little bit in our first quarter was a little bit slow start, but we expect to recover that momentum, mainly driven by the SADIQ 10 launch. We had some initial challenges on payer coverage, but we have addressed that one. In some authorization reimbursement pathway on the ground, there was some complexity, but we addressed that one. As this SADIQ or 10 regains momentum, accelerated growth, NPDO will grow. Okay. So yeah, Q1, as you said, Q1 was a bit slow, but from the Q2, so ending in September this month, so we can expect. We need to look at that. Yeah. Okay. Great. And in terms of the Vyvanse is also okay. But in terms of the bottom line or efficiency program, it looks quite well. But could you elaborate what you are doing and what's your target to lift your margin going forward? Yeah. So in the efficiency program, which we worked a lot the last year, we have three elements, key pillars. One is an organizational agility, and then the second is net procurement, external spend optimization. And the third one is leveraging the digital technologies. And mostly so far, the optimization impact is coming from the first two. The third one is improving productivity, so it's more like an indirect impact in terms of the margin improvement. But we made significant savings in the last year, last fiscal year, from the organizational agility improvement and then the procurement savings. That's actually creating a good financial space capacity to invest for these six late-stage programs as well as the new product launches. So the good thing is the big challenge is with this accelerated drug development. And then all the new drug launches coming in 2026, our attention is going to how we can finance, how we can fund these investments. We don't want to compromise investment for the future growth. So we are investing heavily to make sure we maximize the potential of these assets. But at the same time, we do not want to deteriorate or damage our operating profit margin. So that's why this exclusivity program plays a very important role to create a financial capacity so that we can invest for the future growth. Okay. Yeah. And your core operating margin target is low to mid-30. What's the timeline? We don't specify a timeline, but it has to come up with the new product launches. In our industry, in our business, that should be a driver of the margin improvements. We launch new products, and then that's going to basically those top-line growth-driven margin improvement should be the way we achieve the higher margin, and then that's why now we are in the phase, so now we're going to launch. We have to see the associated new data, but we expect we're going to launch next year and then more to come, so we are in a good path to drive top-line growth and then improve margin. Right. The time has come, but my last question is on top management. Julie Kim to take over in June next year. Are there any potential changes to your take on that direction or strategy going forward or what? What could be changed? When you change, there's many things can change. But the good thing is Julie has been in the executive team in the past six years. So she has been fully part of the developing basic fundamental strategy. And in that sense, perhaps we don't expect completely flipping the house, like the dramatic change. But what we are discussing is more how we can execute the faster. Yeah. Yeah. Yeah. Of execution from the CEO. Yes. And then maximize the potential of the assets. Yes. And And then further how we can accelerate the total company's growth. Okay. Great. So you are entering in the next chapter of the growth from the next year. Yeah. So with orexin, we opened a new era for the Narcolepsy Type 1 patients. But at the same time, also the entry into the new era of the growth. Thank you very much. So time has come. Thank you very much. Thank you for joining us. Thank you.