Otsuka Holdings Aktie

Good morning. I'm Watanabe. Nice to meet you.

So let me start. Today, in the first half, I'd like to talk about acquisitions and how it happened, the introduction of the company we acquired and also our strategic intent. In the second half, we will talk about TSND-201, the characteristics, clinical data and the characteristics.

So Transcend Therapeutics company, it's a company listed in New York. And the company has this product, the rapid-acting treatment products. And this is the company to develop the rapid-acting treatment product. And now our process for acquisition is completed, and we are waiting for the clearance by the authority. And Otsuka subsidiary, Otsuka America, Inc. will have another company to acquire 100% of the stakes of the company. And USD 700 million will be upfront payments. In addition to that, we will have the conditional milestones payments with the sales of the products up to the USD 525 million when the product was sold as we speak.

And then Kevin is one of the founders and he's venture capitalist. And Blake Mandell is one of the co-founder and is the CEO today. And Dr. Benjamin Kelmendi is the psychiatrist from Yale University. And Dr. Benjamin is working on the ketamine and TSND-201. He works on that plus psilocybin, ketamine, psilocybin, 201, and he drove to get clinical data, not just the efficacy. Why it happened the neuro circuits platforms. Those are the areas of his basic research. And now it is working -- we are working on the Phase III TSND-201 study and labeling products, prodrug for TSND-201, those 2 substances they own.

And I'd like to give you the strategic ideas with 3 slides from here. And the first one is our -- strengthening of our portfolio with the late development stage product. That is our core areas of the businesses and also next-generation products, especially next-gen psychiatric treatments and I would like to have a sufficient approach in that field in order to get sufficient options. And after the Mindset company, we'd like to win another option for that.

And third point is in our CNS areas, psychiatry, we'll be working in this area for 25 years and I'd like to make the best out of this platform to maximize the value out of these businesses. And one is the strengthening our core areas with the late-stage products together. And we have REXULTI and ABILIFY MAINTENA and ASIMTUFII. We have those CNS products going on at the moment. And then we have a high level of the revenues out of this area. And whilst we have those revenue, we'd like to make sure that we have a good investment on P&L side for the upcoming late-stage products.

And we have a centanafadine, it's already filed. And we have a good collaboration with the company. And ulotaront, it's another investment for the late-stage product. At the moment, the revenue that we get today is to be invested for the next one, which now is the TSND-201, and it is a good strategic decision. And then in order to get this late-stage product be approved to have a commercial stage. And whilst we have good revenues of the ongoing products, we'd like to make sure that we get those profit to be invested in the next portfolio.

And next-generation approach. So there's a high expectation of the next-generation treatment approach, and it is important to strengthen the portfolio in a strategic fashion. And for us, when we say strategy or strategic, we can explain that word in 3 ways. One is the indication. Second is a variety of the mechanism. And third point, as I said before, continuity and the timing of the businesses.

And let me explain with the indications. PTSD in the U.S. is to come with the TRD, resistant depression (sic) [ treatment-resistant depression ], and there are many people suffer from that. And there are 2 SSRIs, which were approved 22 years ago, only 2 drugs indicated for that condition for the PTSD. And half of those patients have resistant conditions for those drugs. Because of that, as you know, REXULTI would now completed PTSD Phase III, and we are working on the conversation with the FDA responses and inquiries and so on. And we actually had those processes. However, it wasn't approved, unfortunately. But the knowledge we have acquired now will be utilized for the upcoming project.

And second point is the mechanism or science. So when we say next generation in a different context, probably when we say that in the psychiatry field, you would imagine a little bit differently, maybe the doctors' understanding may be different from that of patients, the high efficacy and rapid acting and persistence. And basically, patients will come and then get a prescription. And when they leave the office of the doctor, the doctor can say, after a week, you can get good efficacy, feeling better. So the rapid action is expected. And also the doctor could say, maybe you could stay at home for 2, 3 months with the drug so that if you're feeling unwell, you can come back 3 months later, meaning that persistence of the efficacy is expected. As Dr. Benjamin researched, probably in this stage -- in that stage of the patients after the prescription, there could be the neuroplasticity happening that will probably change the pathology in a way.

And then on the right-hand side, so out of the new generation psychiatry portfolio, the optionality or variety of the product could be looked for. So we had acquisition of the 2020 -- MSP-2020 to [ 2013 ], and we are working on the various studies at this moment. And then out of that product, we would now to get more research for the products without the hallucination and so on. And actually, this product has a totally different mechanism. It is categorized as the monoamine releaser, and I'll give you more information about this product in the second half.

And third point, in the United States, in the 25 years until now, we have been working on the commercialization and the clinical development of various products for the schizophrenia, Alzheimer's and so on. And we, of course, worked on the PTSD as well in addition to AD agitation, schizophrenia and so on. And we have good experiences and would like to take advantage of our experiences in the regulatory processes. And also for the commercialization processes, we would like to see the interventional clinics and those treatments will be provided in those clinics because of -- which you might think that our sales efforts could be contained in a different -- in a limited arena. However, in this case, the general psychiatric specialists will be looking after those patients, not just those clinics. And we have established a very broad psychiatry platform in the United States by which we can discover patients, and it is important to be able to deliver the products to those patients.

Let me go into the overview of the compound. Next page, please. Regarding this drug, this is monoamine releaser to -- with MOA to promote release of monoamines such as dopamine, serotonin, norepinephrine. As you can see in the footnote, regarding the selectivity, which is high, there is no serotonin 5-HT2A agonist activity. And VMAT2 inhibition is not existent, which will lead to the conditions. Other GPRC (sic) [ GPCR ] is also being screened, and we confirm there is no interaction. Biology-wise, this would promote the reorganization of neuronal circuits in PTSD patients to induce neuroplasticity as we have confirmed in nonclinical studies.

By administering this drug in nonclinical studies, BDNF would be increased. And neuronal process number and length would be increased by 2x or 3x, and we are expecting the reorganization of the neuronal circuits. We are promoting the development in PTSD in nonclinical settings, PTSD, depression, anxiety, the 3 models are demonstrating high effectiveness, robust effectiveness.

Next page, please. As you know, PTSD patients in 2030 are expected to reach 14 million in the United States, as I said at the outset, regardless of the time, it's twice as much compared to TRD patient population. There has been no new approved drugs for more than 20 years.

Next page, please. TSND-201 Phase II study is already completed. Let me talk about it. Regarding this drug, based on the Phase II study results in the United States, breakthrough therapy designation was granted in the U.S. This is a clinical study. Please look at the scheme at the bottom of this page. IMPACT-1 is the name of the Phase II study. More than 60 patients were randomized 1:1 to the active drug, the placebo. The active drug or placebo, to get the drugs -- this is Friday.

Patients come, for example, on Friday. And in the office, oral capsule will be obtained 150-milligram capsule would be obtained. After 90 minutes, the second capsule 100 milligram would be obtained. And in the reclining chair, there's going to be safety monitoring, and then they can go home on the same day for this treatment. And this is repeated 4 times. That's considered 1 cycle. So they would come back next Friday as well as the Friday, the following week, and they would come again to complete this treatment cycle. And after about 6 weeks, primary endpoint would be measured. Primary endpoint is PTSD primary endpoint, CAPS-5 clinical score.

In this study, at each study site, the investigators would not perform the rating. If there is a lot of interaction with the patients, a lot of information could be obtained. So at central centers, monitor physicians who have not met the subjects would interview with the subject to rate the CAPS-5. This is the central rater system. Also in Phase III to avoid any possible bias, we are planning to use the central rater system. The study results were published already in JAMA Psychiatry. As for the study sites, as I mentioned, it's going to be specialized centers and J&J SPRAVATO as commercial products twice a week. They have to come to specialized centers. There is about 2-hour safety monitoring before they go home. So that's continued twice a week. This is clinically applied already.

Based on those results, 6,000 clinics in the United States have been launched in these settings. Already, Phase III is completed for compassion, psilocybin, which also requires monitoring. So similar clinics are going to be utilized. This is clinical data, 201 Phase II study, primary endpoint with CAPS-5. TSND-201 is the curve, which is a declining trend. The upper curve is for the placebo. There are a few points to note. First, the timing of administration. If you look at the left bottom, there is an upper arrow 4 time administration with a 1-week interval, respectively. After the -- without waiting for the 4 administrations, there is an early separation compared to the placebo. After the fourth administration, there's going to be no more treatment. But even after that, treatment effectiveness is sustained, as you can see here. And regarding this drug, in this clinical study, placebo curve behavior, REXULTI Phase III successful study and the placebo effect here is almost similar.

Next page, please. This is about safety. There was no discontinuation due to adverse events and favorable tolerability was confirmed. Many of the adverse events were mild to moderate and exposure period was not so long. If you look at the blood concentrations, the events were transient and they were resolved within a short period of time. Serotonin agonist, there is no action activity.

So there is no hallucinogenic effects we didn't capture in the study. So the typical hallucinogenic effects known to be associated with psychedelic agents were observed. No hallucinogenic effect was seen and the rationale for monitoring based on the following symptoms: blood pressure elevation, 1.3%, but it was a mild blood pressure elevation of which it was transient. And also, there can be elevation in the feelings. So we have monitoring period for Phase II and Phase III studies as well.

Phase III clinical study is shown on this page. As I mentioned, breakthrough therapy designation was granted. So with FDA, Type B meeting was held to discuss the Phase III study design already. Transcend Therapeutics clinical development team has a similar clinical development philosophy like Otsuka Pharmaceutical. So if the study is successful, Phase III study is implemented without changing the study design. That's their belief. So other than the increase of the number of arms to 3, Phase II study design is being followed in Phase III as well. One Phase III study, EMPOWER-1, we have a sample size of 300, and it's going to be a randomization 1:1:1. And for dosings will be planned as Phase II.

More recently, likewise treatment received CRL from FDA. The reason for CRL was disclosed. Like, advisory meeting discussions occurred. And based on those, and also, we had a Type B meeting with FDA, and we determined the study design. Primary endpoint is going to be CAPS-5 and functional unblinding is something we are going to avoid as much as possible based on this study design. CAPS-5 demonstrated a very good response in Phase II, but CAPS-5 total score, I think -- we think it is very good. But if you have a breakdown of CAPS-5, JAMA Psychiatry carried the breakdown there.

There are 4 major segments in CAPS-5. One is the intrusion of the past memories, which patients cannot handle on their own, that past memory would intrude. This is the intrusion category. Maybe because of that, alertness is very high. Patients are very sensitive all the time. Alert level is very high. If there is somebody knocks on the door, they may be very surprised or they may not be able to fall asleep. And this is an alertness related segment.

Number three, something can be a trigger to have the bad experiences coming into them. So they try to avoid triggers. They don't go to a certain place. They don't try not to smell a certain odor. So there is the escape intended avoidance symptom. Number four, to lose their self-esteem because of this. There are 4 components in CAPS-5. In particular, the intrusion is the first cluster. Memories would reemerge in your mind. In order to avoid it, they place -- they avoid places or behaviors. So escape is a very specific symptom of PTSD, not just the total score of CAPS-5, but there is a very good response for each of the components. So we judged this is a very good compound.

Next page, please. This is a future plan. Now Phase III was initiated last month in March 2026. In 2023, in June, FDA issued the psychiatric guidance, we are referring to that. And based on the agreement with FDA, we'd like to implement an appropriate development program. Phase III study, 2 Phase III studies would be required according to understanding. We are aiming to launch in the United States in around 2030.

Last page, please. With the acquisition of Transcend Therapeutics, we acquired late-stage asset, TSND-201. Together with mindset, we can expand the optionalities for next-generation psychiatric treatment approaches. REXULTI, MAINTENA are using a big psychiatric business platform with which we'd like to maximize the value by leveraging the platform. That's all from me.

Thank you for taking time to join Otsuka Holdings financial results briefing today. I am Inoue, President and CEO. Before getting into the details of our FY 2025 financial results, I would like to begin by sharing our mid- to long-term strategies. It has now been about 1 year since I assumed the role of President. During this time, we have made several important decisions ranging from research and development initiatives to asset acquisitions and strategic alliances. While we have previously discussed these topics individually, today, I would like to present how all of these actions fit together within the broader context of our sustainable growth. I hope you will consider them within this strategic framework as you listen to the explanations from our CFO, Makino, as well as the pipeline update from Emura of IR.

As a starting point, I would like to outline our fundamental idea, how we envision Otsuka's growth towards 2035 and how we plan to strengthen our business portfolio to achieve that vision. First, I'd like to explain the progress of the 4th mid-term plan. In FY 2025, we achieved significant results in pharmaceutical and nutraceutical businesses, leading to record highs in both revenue and business profit. In FY 2026, both Pharma and NC businesses are set to continue driving growth. Although profit is expected to decrease due to the LOE impact on key products and aggressive growth investments, we remain committed to investing for sustainable growth. With the various measures we have implemented so far, we expect to return to a growth trajectory at an early stage.

Today, I would like to talk about the strategies that involve various initiatives we are promoting to address the issues beyond the 4th mid-term plan. Focusing on health care-related social issues and leveraging our unique scientific capabilities, we are working to strengthen our business portfolio to achieve mid- to long-term growth through combining internal and external sciences. We will strive to acquire external assets from multiple perspectives to ensure an optimal portfolio balance. At the same time, we will continue implementing initiatives to establish a new business pillar. In the long term, we will allocate the necessary management resources to enable our research organization to consistently generate original pipeline assets and products. From a mid- to long-term perspective, we are deepening existing businesses while expanding our portfolio by building next-generation core areas.

Today, I would like to explain strategy of each therapeutic area. First, I would like to explain the future direction of one of our areas of strength, psychiatry and neurology. Many disorders in this area still lack well-established treatments due to the inherent challenges in both clinical development and disease complexity. We believe this is precisely why Otsuka should continue to take on this challenge. Through the development and the commercialization of ABILIFY, we have overcome what has long been considered insurmountable, achieving clinical trial successes and approvals of difficult indications where no treatment options had previously existed. The know-how we accumulated through this experience is a tremendous asset for Otsuka and now forms the foundation for our next stage of growth.

Leveraging this foundation, we have been able to acquire significant external science. The assets based on such science are progressing towards commercialization within about 7 to 8 years. Among the external science we have brought in, our psychedelics have the potential to drive a true paradigm shift in psychiatry. For example, depression often remains difficult to treat, and we are pursuing the development of a novel mechanism of action drug that can deliver sustained effect with a single administration, aiming to offer intervention towards curative treatment. In addition, for diseases that still lack any approved therapies, we will continue taking on new challenges using innovative approaches emerging from drug discovery platforms. These efforts are expected to lead to new breakthrough.

Going forward, to further strengthen our leadership position, we are actively engaging in unique and pioneering scientific approaches that go beyond conventional drug discovery theories. Through these continued efforts to create innovation, we will deliver new value to society. Next, I would like to discuss our efforts in the autoimmune space. Through the acquisition of external innovative science, Visterra in 2018 and Jnana Therapeutics in 2024, which poses small molecule discovery technologies targeting previous anted proteins, we have significantly strengthened our scientific foundation. We have also welcomed talent with MD degree with proven track record of developing key autoimmune products, thereby enhancing our organizational capabilities for commercialization.

Visterra's VOYXACT achieved approval for IgA nephropathy approximately 7 years after our acquisition, demonstrating the effectiveness of our approach. We believe the sales penetration of VOYXACT is progressing well, performing favorably compared with existing therapies. Looking ahead, we are advancing development of for disease and also considering additional indication for the LCM. Our current pipeline spans a broad set of targets, including B cells, complements and cytokines, while focusing on mechanisms that address the root causes of autoimmune diseases. We feel increasingly confident that these programs have the potential to position Otsuka as a top player in this field. Towards 2030, we aim to achieve 3 PoC milestones, steadily advancing to position autoimmune diseases as a future core area. We have been carefully making preparations while reflecting market developments and have further been accelerating our initiatives following Jnana acquisition.

We now believe that the foundation required to compete and succeed in the autoimmune space is firmly in place, and we will continue driving our efforts to make sure that we generate meaningful results. The last part of pharmaceutical business strategy is a specialty area. Through sales of experience in JYNARQUE, we have built a business foundation by accumulating know-how such as networks, specialists, regulatory strategy and market access. We have acquired assets to utilize this business foundation and repinatrabit is expected to become a blockbuster. Repinatrabit acquired in 2024 is set to be filed for approval in FY 2028. Accordingly, we are accelerating development in the rare disease area, aiming to bring acquired programs to commercialization within roughly 5 years of acquisition.

Next, I will explain NC global expansion initiatives, taking POCARI SWEAT strategy as an example. POCARI SWEAT has been steadily building brand equity, notably in Asia. In particular, overseas sales volume has exceeded 60% of the total, becoming a growth driver. To achieve further growth, in addition to expanding geographic areas, we will establish plants to develop production and supply chain infrastructure to support mid- to long-term growth. In the U.S., we are working to embed the new concept of caring hydration among consumers through POCARI SWEAT and taking on the challenge of creating value based on evidence in collaboration with KOLs, government agencies and others. We will also promote initiatives to offer science-based products that address escalating global social issues such as heat stroke.

Next, I would like to introduce our innovation creation system. Otsuka's management style is based on horizontal collaborations that enable each group company to fully leverage its strengths. The Otsuka Group as a whole work together organically, combining diverse expertise and technologies to build a robust foundation for drug discovery. Currently, many programs that leverage the strengths of each company are advancing for potential launches beyond 2030 with 5 new drug candidate approvals planned by 2030. Going forward, we will deepen collaborations within the group, strengthen partnerships on external science and enhance the speed and success rate of clinical development to bring an even greater number of programs to market.

Here, I would like to explain NC research policy going forward. In the 4th mid-term plan, we announced our intention to launch a new product that enhance the utilization of oxygen in the body in addition to the products we have traditionally focused on. Currently, preparations for the launch are in the final stage, and we will introduce the new product to you at the launch event soon. Behind development of this product was the research foundation we have cultivated as a total health care company. In drug discovery research, we take the approach of breaking down underlying elements of diseases into organs so that molecules clarify their pathologies. Meanwhile, NC business has adopted the perspective of integrated life science and focused on deepening our understanding of the networks between organs and cells that support the life phenomenon.

Specifically, we have established cyclical research framework of human to model multi-omics analysis, network analysis and back to human. This new product has the potential to contribute to the advancement of this integrated understanding of life. Going forward, we will continue our efforts to connect drug discovery science with integrated life science, combining the strengths of each to create new value and to support the ways people live. So far, I have explained the growth strategies and initiatives for innovation of each business. Even in a highly uncertain business environment, Otsuka aims for sustainable growth by refining these strengths and advancing investment and execution in our priority areas.

We will continue to manage the company with the goal of becoming an indispensable company that contributes to people's health worldwide. So far, I have explained our long-term strategies. and we have been able to implement them due to the recent strong performance. As we announced today, we have decided to acquire treasury stock for JPY 50 billion, given the increased certainty of future growth due to the recent strong performance and the progress of Next 8 products, including VOYXACT. We will continue to evaluate additional shareholder returns considering progress of business and other factors. Ms. Makino will now explain our current business results and the capital policies that support our long-term strategy. I sincerely appreciate your continued support. Thank you very much for your attention.

Next page, please. I'd like to present the consolidated financial results for FY 2025. These are the items. First, an overview of our consolidated results. Revenue increased by 6.0% to JPY 2,468.9 billion with growth across all business segments. Business profit increased by 3.6% to JPY 446.1 billion, mainly driven by global products royalty income in Pharma business and the strong performance of NC business. Operating profit increased by 48.2% to JPY 479.4 billion, reflecting higher business profit gain from the sales of MicroPort shares as well as the impact from the reversal of impairment losses recorded in the previous year. Net profit increased by 5.8% to JPY 363.2 billion. ROE reached 12.6%, exceeding the initial plan of 10%, supported by steady business performance. For FY 2025, revenue and all profit items reached record highs.

Next, I'll explain year-on-year variance on business profit. In FY 2025, despite the impact of JYNARQUE generic entry in the second quarter, gross profit increased by JPY 100.3 billion, driven by strong sales of REXULTI and ABILIFY MAINTENA as well as higher royalty income in Pharma and revenue growth in NC business. In Pharma business, SG&A expenses increased due to higher co-promotion fee associated with sales growth as well as launch-related costs for VOYXACT and other new products. In NC business, SG&A expenses also increased, reflecting continued growth investment, particularly women's health category and incremental expenses linked to revenue growth. However, in the ratio of revenue improved by 1.2 percentage points. R&D expenses increased due to accelerated development of key product drivers such as repinatrabit, ulotaront, and zipalertinib, which are expected to drive performance beyond 5th mid-term plan. So as a result, business profit increased by 3.6% to JPY 446.1 billion.

Next, Pharmaceutical business. Revenue increased by 7.1% to JPY 1,744.2 billion. In addition to the robust performance of REXULTI, overall growth was fueled by Lonsurf, ABILIFY MAINTENA, higher royalty income and domestic products. Sales of REXULTI rose 23.9% to JPY 331.3 billion, supported by growing prescriptions for MDD and agitation in Alzheimer's disease in both U.S. and Japan. ABILIFY MAINTENA and ABILIFY ASIMTUFII continued to perform steadily due to increased prescriptions. In Japan, revenue increased with the strong contribution of REXULTI and Moizerto and others. Overall, major product progressed steadily in line with the full year plan, exceeding the forecast announced in October.

Next, the performance of NC business. Revenue increased by 3.7% to JPY 577.7 billion. Centered on Women's Health and Healthier Life, revenue increased across all 3 major categories. By area, growth mainly came from North America and Europe. Sales in climate and environmental risks category increased by 1.6% to JPY 201.7 billion. Although POCARI SWEAT sales in Japan were affected by lower consumer activities due to extreme summer heat, a strong performance in Asia led to overall growth. In Europe, Nutrition & Sant� achieved a solid performance with its main brands. Sales in women's health rose 7.4% to JPY 60.8 billion. Bonafide, which addresses the increasingly diverse needs of women, started retail sales in August in addition to e-commerce. Moreover, the strong performance of Thermella, a plant-based supplement for menopausal women launched in September 2024 contributed to growth.

Sales of EQUELLE also grew in Japan due to an increase in subscription consumers supported by increased brand awareness through wide-ranging activities such as the women's health seminars. Sales in Healthier Life were up by 7.0% to JPY 234.7 billion. In the U.S., Nature Made achieved growth through continued consumer-focused promotion and strong sales via e-commerce and large retail stores. NC business made steady progress across all 3 categories by social challenges. Here is the consolidated forecast for 2026. Revenue is expected to increase 2.1% to JPY 2,520 billion, driven by growth in Global 10+2 product and higher revenue in NC business. In Pharma business, although sales of major products, including JYNARQUE will be affected by generic entries, Overall, revenue is expected to remain at a similar level to last year's due to growth of REXULTI, ABILIFY ASIMTUFII, VOYXACT and others as well as higher royalty income.

In NC business, revenue is expected to remain solid and grow across all 3 categories positioned as key growth drivers led by products such as POCARI SWEAT, Bonafide and Nature Made. Although profit-related items are entering an adjustment phase due to the generic impact on major product, business profit before R&D investment and business profit are expected to significantly increase the target in midterm plan. Despite expected increase in SG&A expenses due to revenue growth and higher development costs for new businesses, business profit is projected to reach JPY 355 billion, exceeding MTMP target of JPY 270 billion by JPY 85 billion.

Next, please refer to the reference material. Next, I will explain the factors behind business profit variances for FY '25 and '26. As mentioned earlier, while revenue is expected to increase in 2026, business profit is expected to decline by 20.4% to JPY 355 billion due to the impact of generic of major products. Gross profit is expected to decrease by JPY 19.8 billion as growth in global 10+2 product in NC business is projected to offset LOE impact on major product and drug price revision in Japan. SG&A expense and R&D expenses are expected to increase, reflecting active investment and launch preparation for Next 8 and other next-generation growth drivers. Although 2026 will be an adjustment phase, we are committed to taking actions to quickly return the business to growth trajectory.

Lastly, I will explain the 2-year cumulative achievements for cash generation, growth investment and shareholder returns from 2024 and 2025 of the mid-term plan. Operating profit before R&D investment for the 2 years has progressed above the level announced in the mid-term plan, supported by strong business performance. It reached about 50% of the 5-year plan, totaling JPY 1.4 trillion. The additional cash generated beyond the initial plan has been allocated evenly to growth investment and shareholder returns. We will continue to allocate the generated cash in a well-balanced manner and remain committed to sustainably enhance corporate value. Thank you.

I would like to present updates on our pharmaceutical development and growth drivers. I will cover these 6 items today. This table shows the key progress in the fourth quarter of FY 2025. First, sibeprenlimab received -- brand name VOYXACT, received accelerated approval in U.S. for the treatment of IgA nephropathy. In addition, filing for approval was made in the U.S. for centanafadine for the treatment of ADHD and was accepted for priority review with the PDUFA action date set for July 24, 2026. Zipalertinib initiated an NDA rolling submission in U.S. ASTX727, EN-P11, and OPC-1085EL filed regulatory applications in Europe, Japan and China, respectively. As you see here, several assets have advanced to the next development phase with MSP-2000 having initiated a clinical trial as a psychedelic.

On the other hand, we discontinued projects related to TAS-115, TAS-303 and OPS-2071 for strategic reasons. Lastly, as an event after the fourth quarter, donidalorsen, brand name Dawnzera was approved for the treatment of hereditary angioedema in Europe in January. This slide shows key projects that were scheduled for NDA/MAA submissions and start of Phase III studies in FY 2025. As shown in red, all the scheduled submissions were completed and all the Phase III studies were initiated as planned by the end of the year. Key projects currently under NDA/MAA review are shown here. The projects in red have been approved during FY 2025. As you can see, sibeprenlimab has been approved in the U.S. This slide shows key projects scheduled for NDA/MAA submissions and start of Phase III studies in FY 2026. We are planning 2 regulatory filings and 4 Phase III study starts.

Now I would like to explain the progress on our key growth drivers. First, about VOYXACT. After receiving approval of the world's first anti-APRIL antibody in November 2025, we have been actively implementing promotional activities that fully leverage VOYXACT's competitive advantages. Although VOYXACT is still in the early launch phase, it has achieved broad adoption, including among treatment-naive patients with IgA nephropathy. In the U.S., the number of new patient start forms has reached about 500, indicating steady expansion of our activities. We aim to establish VOYXACT firmly in the market at an early stage by emphasizing its value and build a strong market position while targeting sales of over JPY 100 billion during the first midterm period, a first-in-class drug that is expected to offer high efficacy and safety. We are committed to delivering VOYXACT to as many patients as possible.

Next, I would like to introduce the development plan for zipalertinib. Currently, we are strategically conducting multiple clinical trials for zipalertinib. First, based on the results of REZILIENT1 for EGFR exon 20 insertion mutation-positive non-small cell lung cancer, we have initiated a rolling submission for second-line treatment in U.S. and the filing process is set to be completed in February 2026. Following that, REZILIENT3, a Phase III study for first-line treatment is underway, and we plan to obtain the top line results by the end of 2026. In addition, REZILIENT2, currently underway for uncommon mutations, is scheduled to be completed in August 2026. Furthermore, REZILIENT4, a Phase III study to evaluate the efficacy of zipalertinib as an adjuvant therapy, and REZILIENT5, which explores the potential of combination therapy with our in-house products targeting common mutations were initiated last year.

Through the strategy of advancing multiple clinical trials in parallel, we aim to expand the indications for zipalertinib and maximize its value, aiming to deliver treatments to more patients. In addition to the 2 assets mentioned earlier, I would like to explain the development status of ulotaront. We have been advancing the programs with MDD and GAD as additional indications. But unfortunately, for MDD, we could not achieve the initial target. Going forward, we will thoroughly review the study results and consider the next steps. On the other hand, as we obtained favorable results for GAD, which still has a significant unmet medical need, we will proceed with Phase III studies in 2026. As for schizophrenia, clinical development is progressing smoothly. We expect the launch for this indication during the 4th mid-term plan.

With its use in schizophrenia and GAD, ulotaront is expected to achieve growth in the 4th mid-term plan and beyond, becoming one of the key assets indispensable for our mid- to long-term growth. We will continue our efforts to deliver new solutions in psychiatry and neurology space through its asset with a novel, non-dopaminergic mechanism of action. I have explained the 3 projects so far. And this is the overall progress of our growth drivers, including those projects. There are differences in the way each project is progressing. For example, schedule for centanafadine has been moved up due to its priority review, while the broad insurance reimbursement of uRDN is now expected in 2028 at the earliest. However, by combining the projects that are progressing ahead of schedule, with those we are advancing more cautiously, we believe our overall portfolio is well positioned for steady and sustainable growth.

Please also note that any changes in the development plans or status are indicated as update in this document. Going forward, we will keep our focus on priorities and accelerate projects with potential to generate results quickly while continuously strengthening areas that require time and nurture them as key pillars that support our mid- to long-term growth. This is the last slide. I would like to explain the status of our efforts to develop growth drivers for sustainable growth. We have actively invested in the development of the next-generation growth drivers, including Next 8 assets. During this process, there were some studies that did not progress as expected and projects that required a review of the launch timing. At the same time, however, several assets have shown stronger growth potential since the initial announcement of the 4th mid-term plan.

In addition, we are making investments in specialty autoimmune space as a new core area, which we expect will lead to the creation of new value beyond what could be achieved within our existing areas alone. Going forward, by combining the deeper expertise of established areas with expansion into new areas, we will further solidify the foundation for future growth. In this way, while building the foundation to keep creating unique innovations, we aim to further elevate our long-term growth prospects even further. Related documents are also provided as reference materials, so please refer to them as well. Going forward, we remain committed to steadily bringing our products to market so that we can deliver them to many patients as quickly as possible. This concludes my presentation. Thank you very much for your attention.

[Statements in English on this transcript were spoken by an interpreter present on the live call.]

Now I would like to present the consolidated financial results for the second quarter of FY 2025. These are the 2 agenda items I will cover today. First, I would like to explain an overview of our consolidated results. Revenue increased 6.5% to JPY 1,180.8 billion and business profit increased 12% to JPY 239.2 billion, largely attributable to increased sales of Global 10+2 products in pharmaceutical business. In the first half of the fiscal year, although the yen appreciated compared to the previous year, we achieved year-on-year growth in both revenue and all profit items and exceeded the plan for the first half of FY 2025.

Next, I will explain year-on-year differences in business profit. Following the first quarter, gross profit increased by JPY 62.6 billion, driven by higher sales and a decrease in the cost of goods sold ratio, mainly in pharmaceutical business. SG&A expenses increased mainly due to higher co-promotion expenses associated with strong sales in pharmaceutical business and the acceleration of growth investments in new indications and new products as well as expansion into women's health and new areas in nutraceutical business.

R&D expenses increased due to the acquisition of Jnana in September 2024, along with active development activities for repinatrabit and increased expenses related to a Phase III trial of ulotaront. We will continue our development efforts to maximize the value of growth drivers that will lead our business performance beyond the fifth midterm plan. As a result, the increase in gross profit absorbed the rise in SG&A and R&D expenses, leading to a JPY 25.6 billion increase in business profit to JPY 239.2 billion. Excluding the impact of ForEx rates, business profit increased by JPY 31.5 billion to JPY 245.1 billion.

I will now explain Pharmaceutical business. Revenue increased 8.7% to JPY 833.8 billion. In addition to robust performance of REXULTI in North America and Japan, overall growth was driven by ABILIFY MAINTENA, JYNARQUE, increased royalty income and domestic products. Sales of REXULTI increased 26.5% to JPY 154.8 billion, driven by growth in prescriptions for major depressive disorder and agitation associated with Alzheimer's disease. Sales of LONSURF declined in the U.S. due to increased corporate burden following the redesign of the health care system. However, prescriptions for bevacizumab combination therapy for colorectal cancer increased. As a result, sales decreased by 4.1% to JPY 49.7 billion.

Next, I will explain revenues by region. Overseas revenue went up due to robust performance of REXULTI, JYNARQUE and increased royalty income as well as revenue from Otsuka ICU Medical, which operates IV therapy business in the U.S. The company was included in the financial consolidation starting in May this fiscal year and revenue is recorded from the second quarter. In Japan, revenue increased due to strong performance of REXULTI, Moizerto and other products. In particular, prescriptions for REXULTI for AD agitation grew due to active promotional activities. Each major product in Pharmaceutical business is making steady progress in line with the full year plan.

Next, I will explain the performance of Nutraceutical business. Revenue increased by 1.6% year-on-year to JPY 276.1 billion. By category, growth was centered on Women's Health and Healthier Life with Japan and North America leading other regions. Sales in Climate and Environmental Risks increased, excluding ForEx impacts, driven by Pocari Sweat's strong performance in the Philippines and Japan. Sales in Women's Health increased 7.8% to JPY 29 billion, driven by enhanced product awareness through aggressive promotional activities of Bonafide, which addresses diversified needs of women and steady growth of EQUELLE due to the wide-ranging efforts to provide useful information.

Sales in Healthcare Life increased 2.3% to JPY 109.7 billion. In the U.S., we have continued consumer-focused promotional activities for Nature Made, leading to the significant growth in e-commerce sales. Calorie Mate sales also rose, mainly driven by increased younger consumers as a result of continued marketing efforts that promote the products as nutrition support for various occasions such as entrance exams and school club activities.

Lastly, I will explain the consolidated financial forecast for FY 2025. We have revised upwards the full year forecast announced in February, taking into account the first half results of Pharmaceutical and Nutraceutical businesses as well as gains from the partial sale of shares of an equity-method affiliate in the second half. Revenue is expected to remain at JPY 2.308 trillion as initially announced, while business profit is projected to increase by JPY 25 billion to JPY 400 billion, or JPY 410 billion, excluding the impact of ForEx rates. SG&A expenses are expected to be on the press of the initial plan, excluding ForEx impacts.

R&D expenses are also in line with the initial plan, excluding ForEx impacts and the research and development activities for future growth are progressing steadily. Operating profit is projected to increase by JPY 75 billion from the initial plan to JPY 450 billion due to estimated gains of JPY 40 billion to JPY 50 billion from the purchases of MicroPort shares.

This concludes the presentation of consolidated financial results. Mr. Inoue will explain the mid- to long-term strategies for each business.

Now I would like to explain the progress we have made so far and the future outlook for FY 2025.

First, the positioning of the fourth midterm plan and the current status of our KPIs. As informed, we have revised our FY 2025 plan. Despite the impact of LOE, we are making steady progress toward 2025 plan and business profit before R&D investment is expected to exceed the 2025 plan in the midterm plan. And we aim to achieve an ROE of over 12% by enhancing capital efficiency in line with strong business performance.

We are accelerating investment in new business expansion and next-generation growth drivers. And we will continue to implement measures to minimize and shorten the performance adjustment phase following LOE with aim of achieving a swift return to regrowth.

First, I would like to discuss an update on Pharmaceutical business. In our latest revision for FY 2025, our Global 10 Plus 2, a group of our growth drivers are expected to achieve a year-on-year increase of 15.2% and our overall pharmaceutical business to grow by 2.1% despite the impact of LOE of JYNARQUE. We will continue to focus on expanding new business opportunities and nurturing these growth drivers in the midterm plan.

Next is the sales situation of REXULTI for AD agitation. In the U.S., as of April this year, the proportion of prescription of AD agitation among all REXULTI prescriptions has solidly grown to 21.7%, and probably most recent number is around 25%. And the treatment with REXULTI has increasingly gained recognition. In Japan, we have initiated comprehensive approach to addressing the environment surrounding Alzheimer's dementia, such as a cross-factor collaboration with primary care physicians and inclusion in the clinical treatment guidelines. As a result, REXULTI has been prescribed to about 100,000 patients in 10 months after approval.

Also, the Advisory Committee meeting for PTSD was held on July 18. Although the outcome was disappointing, we will continue to cooperate with the FDA to make sure that the review will proceed smoothly and be completed.

From here, I would like to explain our mid- to long-term growth strategy for the next midterm plan and beyond. The chart shows the progress of the Next 8 products that we have positioned in the current plan as next growth drivers in the fifth midterm plan and beyond. We are beginning to see the results of our proactive investment made since the third midterm plan with several assets now filed for approval or in late development stage.

So to be more specific, I would like to show you our initiatives for sibeprenlimab. Sibeprenlimab is currently under review by the U.S. FDA with the PDUFA action date set on November 28 this year. We are actively pursuing life cycle management, including disease awareness activity for IgA nephropathy, a global marketing expansion and initiation of Phase II study for Sjögren's disease, with the goal of early maximization of the product value. We are accelerating efforts in a speedy fashion to make sibeprenlimab a first-in-class and best-in-class drug.

Next, I would like to explain the therapeutic area expansion based on the drug discovery technology. We have been strategically expanding our business in the autoimmune space based on our know-hows in the specialty business gained through JYNARQUE for ADPKD.

In 2018, we acquired Visterra with the aim of strengthening our pipeline in the renal space and acquiring a unique antibody drug discovery platform. And since then, we have enhanced our pipeline in the autoimmune space by creating multiple assets, including sibeprenlimab through its excellent antibody drug discovery technology.

Furthermore, in 2024, we acquired Jnana, through which we have obtained its small molecule pipeline in autoimmune field as well as small molecule drug discovery technology for undruggable targets. In June of this year, we acquired HBM7020 from Harbour Biomed and in July, CAN10 from Cantargia. These 2 assets have diversified our portfolio in terms of both MOA and modalities. In this way, we will enrich our pipeline in the autoimmune field through asset acquisitions and alliances that can utilize our drug discovery platform and will promote innovation to establish the next-generation core area.

This is our mid- to long-term growth strategy for oncology area. Among the growth drivers called Next 8 products, zipalertinib, INQOVI and ASTX030 have made significant progress in FY 2025. In addition, our acquisition of Araris in March this year has added a new modality of ADC technology to our oncology portfolio, enabling us to pursue first-in-class ADC drug discovery. We are committed to creating new value to elevate our oncology business to the second pillar of our core revenue.

Here, I would like to show our ecosystem to create innovation. Otsuka's management style features horizontal collaboration, leveraging the strength of each group companies to the fullest. Through organic collaboration across the group companies, we will integrate knowledge and technology to build a robust drug discovery platform. In addition to our unique platform, we will continue to generate innovation by taking social issue centered approach and co-creation efforts with our partners. By solving social issue through innovation and supporting individual well-being, we aim to enhance our existing value as an indispensable company.

Now let me explain our idea on how to achieve sustainable growth in pharmaceutical business. We have diversified and expanded our growth drivers in the midterm plan, resulting in strengthened business foundation with long-term perspective across a broader range of disease areas. Looking ahead to the next midterm plan, we are steadily enhancing into the specialty autoimmune field, starting with JYNARQUE and sibeprenlimab, while accumulating commercial expertise and advancing our drug discovery technologies. We are also accelerating efforts to further strengthen other core areas such as psychedelics and next-generation ADCs to drive innovation. We are laying the groundwork for establishing solid base to develop our business and feel quite confident of realizing sustainable growth.

Next is Nutraceutical business update. First, I would like to talk about the progress of business performance. FY 2025 forecast for nutraceutical business has been revised to JPY 567 billion, which exceeds the previous year results, reflecting continued solid performance in women's health and supplement as well as changes in market conditions of POCARI SWEAT in Asia and ForEx impacts. We will continue to work to appeal brand value tailored to each region and hold global perspective toward resolving the social issues around the world.

Next, I would like to introduce for women's health category. For women's health category, we are focusing on is expected to grow by 17% during the fourth midterm plan period. We are steadily growing this category by creating new markets to achieve our goal of over JPY 100 billion in the fifth midterm plan. Driven by the product features of high reliability supported by scientific evidence, our brand has earned strong recognition from medical professionals and continues to cultivate a strong base of loyal users. We will continue to contribute to resolving social issues by providing products and support that attentively address consumers' needs.

Next is let me explain our initiative for Nature Made. With a long-standing commitment to product quality and brand line of broad line of products, Nature Made has been expanding its share as the #1 brand in the supplement market. To better meet customer needs and further solidify our position as category leader, we have built a factory for gummy supplements and strengthened our R&D capabilities to further accelerate value creation.

Lastly, I would like to talk about management conscious of cost of capital and a new plan for shareholder returns. Since the third midterm plan, we are promoting the understanding of ROIC-based management and its implementation. For 2025, our overall business is progressing strongly toward achieving the goals set in the fourth midterm plan, and both revenue and profits are expected to reach record highs.

As a result of this strong performance, both ROIC and ROE are expected to exceed 12%. To further improve capital efficiency, we have been reviewing cross-shareholdings and business assets from the perspective of elevating corporate value. We have also conducted share buybacks as one of the -- our flexible shareholder return measures. We will continue to promote management conscious of cost of capital.

This shows our shareholder return policy. As you can see from my talk on the current business status and our mid- to long-term strategy, growth certainty going forward is now visible with the good progress of Next 8 products, including sibeprenlimab and the growth of Nutraceutical business. Based on this situation, we have decided to increase annual dividend to JPY 140 per share in FY 2025. We will continue to implement shareholder returns in line with the fourth midterm plan, while promoting flexible capital policies that respond to changes in the business environment from multiple perspective.

This is a summary of my presentation. We would greatly appreciate your continued support. Thank you very much for your attention.

I would like to present an update on our pharmaceutical development. I will cover these 4 items today. The table shows the key progress in the second quarter of FY 2025. As a highlight, I would like to explain sibeprenlimab, which we filed with the FDA for accelerated approval for IgA nephropathy. The application was accepted in May and is under priority review with the PDUFA action date set on November 28 this year. At the European Renal Association meeting in June, the results of the interim analysis of Phase III study basis of the registration data were presented. And the sibeprenlimab-related IR event was also held in June.

The lower part of the table shows the progress of other assets under development. Centanafadine Phase II/III studies was initiated in Japan for adult patients with ADHD. Sibeprenlimab Phase II study for Sjögren's disease was initiated in the U.S. Zipalertinib Phase I study, RESILIANT5 was initiated in Japan as an exploratory study to evaluate the effect of combination therapy with a MET inhibitor gumarontinib, an HSP90 inhibitor pimitespib, and CD73 inhibitor quemliclustat in patients with EGFR mutation positive NSCLC.

On the other hand, as a result of the development of a strategic review, the following licensing out deals and discontinuation decisions were made. ASTX029, ASTX295 were licensed out to Mosaic Therapeutics, while TAS1440 was licensed out to Benz Sciences. Developments for centanafadine's MTD and OPC-131461 were discontinued.

Finally, as an event after the second quarter, we filed an sNDA of INQOVI, oral decitabine and cedazuridine combination with the FDA for additional indication of venetoclax combination therapy for AML, and the application has been accepted.

Next, as the first topic, I would like to talk about the data on zipalertinib and INQOVI among the 5 data presented at ASCO meeting in May as well as their current status. First, about zipalertinib. Zipalertinib was evaluated in a REZILIENT1 study, Phase IIb study in 176 patients with EGFR Exon20 insertion mutation-positive NSCLC who had received prior platinum therapy. Primary endpoint of overall response rate was 35.2% and the median duration of response was 8.8 months. Since clinically relevant efficacy was confirmed with no safety issue, an approval application is planned based on this data.

Next is an update on INQOVI. The Phase I/II study evaluated the safety and efficacy of an oral administration of regimen of INQOVI paired with venetoclax in 101 AML patients who were ineligible for first-line induction chemotherapy. The primary endpoint of complete response rate was 46.5%. Based on this data, we filed for approval in the U.S., which was accepted by the FDA. The PDUFA action date is now set on February 25, 2026. As for our hematologic cancer strategy, as we presented in the fourth midterm plan, we will continue our efforts to maximize the value of our oral hematologic cancer assets.

As the second topic, I would like to introduce 2 antibody assets in autoimmune space that we acquired in June and July. Currently, in the drug discovery of autoimmune diseases, antibody drugs are the mainstream approach to target proteins that are considered undruggable. Against this background, in addition to Visterra's drug discovery platform technology, we licensed in and acquired 2 new antibody drugs, HMB7020 and CAN10.

HMB7020 is a bispecific T cell engager that binds to both BCMA and CD3. Favorable safety and efficacy profile have been confirmed in preclinical studies, and we are currently preparing for Phase I study as we expect its potential application in autoimmune diseases. CAN10 is an anti-IL-1RAP antibody that can simultaneously block multiple cytokine signals of IL-1, 33 and 36. It is expected to have a broad and potent anti-inflammatory effect. Phase I study is currently underway.

Furthermore, we will accelerate the development of new therapies in the field of autoimmune diseases by utilizing Jnana's unique small molecule drug discovery platform for targeting intracellular and druggable target proteins. By combining the drug discovery technologies of Visterra and Jnana with the synergistic effect of the 2 new assets we acquired this time, we will further promote innovation in the field of autoimmune diseases. We have positioned this autoimmune area as our next-generation core field and will continue to contribute to solving various social issues.

This shows the key NDA and MAA submissions and Phase III transitions scheduled for FY 2025. The project in red are those in NDA/MAA submissions completed or ones advanced to Phase III. This is the last slide, which shows the key project under NDA/MAA review. The one in red is also the project that received approval this year.

As a major progress in Japan, the approval of uRDN system was recommended at the medical device and extracorporeal check medicine section council of the MHLW on July 18, and approval is expected soon. We are preparing for the launch of uRDN system, hoping to make contributions to patients with refractory hypertension as a new treatment option. For our major development project by therapeutic area, please refer to the appendix.

This concludes my presentation on the pharmaceutical development update. Thank you very much for your attention.