Otsuka Holdings Co., Ltd. (4578) Earnings Call Transcript & Summary

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.]