Makoto Inoue
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 one 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 toward 2035, and how we plan to strengthen our business portfolio to achieve that vision.
First, I would like to explain the progress of the fourth Medium-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 fourth Medium-Term Plan.
Focusing on healthcare-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 near-business pillar. In the long term, we will allocate 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 the 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 commercialization of Abilify, we have overcome what had 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 toward commercialization within about 7 to 8 years. Among the external science we have brought in, 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 toward curative treatment. In addition, for diseases that still lack any approved therapies, we will continue taking on new challenges using innovative approaches emerging from our drug discovery platforms.
These efforts are expected to lead to new breakthroughs. 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 possesses small molecule discovery technologies targeting previously undruggable 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 for Sjögren's disease and also considering additional indications for the LN. Our current pipeline spans a broad set of targets, including B-cells, complement, 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. Toward 2030, we aim to achieve three BRC milestones, steadily advancing to position autoimmune diseases as a future core area.
We have been carefully making preparations while evaluating 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 the specialty area. Through self-experience of Jinarc here, we have built a business foundation by accumulating know-how such as networks with specialists, regulatory strategy, and market access.
We have acquired assets to utilize this business foundation, and repinatrabed is expected to become a blockbuster. Repinatrabed, 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 US, we are working to embed the new concept of caring and hydration among consumers through Pocari Sweat and taking on the challenge of creating a 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 heatstroke. 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.
Thanks to this, many programs that leverage the strengths of each company are advancing toward 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 fourth Medium-Term Plan, we announced our intention to launch a new product that enhances 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 the development of this product was the research foundation we have cultivated as a total healthcare company.
In drug discovery research, we take the approach of breaking down underlying elements of diseases into organs, cells, and molecules to clarify their pathologies. Meanwhile, NC business has adapted the perspective of integrated life science and focused on deepening our understanding of the networks between organs and cells that support life phenomena.
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. 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 its 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.
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 ¥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.
Yuko Makino
Thank you very much for your attention. Next page, please.
I would 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 ¥2,468.9 billion, with growth across all business segments.
Business profit increased by 3.6% to ¥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 ¥479.4 billion, reflecting higher business profit, gain from the sales of Microbion shares as well as the impact from the reversal of impairment losses recorded in the previous year.
Net profit increased by 5.8% to ¥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 ¥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 repinatrabed, ulotaront, and zipalertinib, which are expected to drive performance beyond the fifth Medium-Term Plan. As a result, business profit increased by 3.6% to ¥446.1 billion.
Next, pharmaceutical business. Revenue increased by 7.1% to ¥1,744.2 billion.
In addition to the robust performance of Rexulti, overall growth was fueled by launch of Abilify Maintena, higher royalty income, and domestic products. Sales of Rexulti rose 23.9% to ¥331.3 billion, supported by growing prescriptions for MDD and agitation in Alzheimer's disease in both US and Japan.
Abilify Maintena and Asimtufii continued to perform steadily due to increased prescriptions. In Japan, revenue increased with the strong contribution of Rexulti, Moizerto, and others.
Overall, major products 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 ¥577.7 billion. Centered on Women's Health and Healthier Life, revenue increased across all three major categories.
By area, growth mainly came from North America and Europe. Sales in Climate and Environmental Risk category increased by 1.6% to ¥201.7 billion.
Although Pocari Sweat sales in Japan were affected by lower consumer activities due to extreme summer heat, strong performance in Asia led to overall growth. In Europe, Nutrition & Santé achieved solid performance with its main brands.
Sales in Women's Health rose 7.4% to ¥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 S-equol, 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 ¥234.7 billion. In the US, Nature Made achieved growth through continued consumer-focused promotion and the strong sales via e-commerce and large retail stores.
NC business made steady progress across all three categories by social challenges. Here is the consolidated forecast for 2026.
Revenue is expected to increase 2.1% to ¥2,520 billion, driven by growth in Global 10+2 products 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 the 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 three 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 products, business profit before R&D investment and business profit are expected to significantly increase the target in Medium-Term 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 ¥355 billion, exceeding MTP target of ¥270 billion by ¥85 billion. Next, please refer to the reference material.
Next, I will explain the factors behind business profit variances for FY 2025 and 2026. As mentioned earlier, while revenue is expected to increase in 2026, business profit is expected to decline by 20.4% to ¥355 billion due to the impact of generic of major products.
Gross profit is expected to decrease by ¥19.8 billion, as growth in Global 10+2 products and NC business is projected to offset LOE impact on major products 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 two-year cumulative achievements for cash generation, growth investment, and shareholder returns from 2024 and 2025 of the Medium-Term Plan.
Operating profit before R&D investment for the two years has progressed above the level announced in the Medium-Term Plan, supported by strong business performance. It reached about 50% of the five-year plan, totally ¥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.
Tomohiro Emura
I would like to present updates on our pharmaceutical development and growth drivers. I will cover these six items today.
This table shows the key progress in the fourth quarter of FY 2025. First, sibeprenlimab, brand name Voyxact, received accelerated approval in the US for the treatment of IgA nephropathy.
In addition, filing for approval was made in the US for centanafadine for the treatment of ADHD, and was accepted for priority review, with the target action date set for July 24, 2026. Zipalertinib initiated an NDA rolling submission in the US.
ASTX777, ENP11, OPC-1485EL filed regulatory applications in Europe, Japan, and China, respectively. As you see here, several assets have advanced to the next development phase, with MSB20000 having initiated a clinical trial as a psychedelic.
On the other hand, we discontinued projects related to TAS-115, TAS-303, and OPC-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.
Next slide shows key projects that were scheduled for NDA, MAA submissions, and start of Phase 3 studies in FY 2025. As shown in red, all the scheduled submissions were completed, and all the Phase 3 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 US. This slide shows key projects scheduled for NDA, MAA submissions, and start of Phase 3 studies in FY 2026.
We are planning two regulatory filings and four Phase 3 study starts. Now, I would like to explain the progress on our key growth drivers.
First, about Voyxact. After receiving approval as 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 US, 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 ¥100 billion during the fourth Medium-Term period. The 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 the US, and the filing process is set to be completed in February 2026. Following that, REZILIENT3, a Phase 3 study for first-line treatment, is underway, and we plan to obtain the topline 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 3 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 this 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 two 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 3 studies in 2026. As for schizophrenia, clinical development is progressing smoothly.
We expect a launch for this indication during the fourth Medium-Term Plan. With its use in schizophrenia and GAD, ulotaront is expected to achieve growth in the fourth Medium-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 this asset with a novel non-dopaminergic mechanism of action. I have explained the three projects so far, and this is the overall progress of our growth drivers, including those projects.
There are different phases 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 Voyxact is now expected in 2028 at the earliest.
However, by combining the projects that are progressing ahead of schedule with those that 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 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 fourth Medium-Term Plan.
In addition, we are making investment 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 deep 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, 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.
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