Message from the COO

FY2025 marked a major turning point for our research and development. In oncology and neurology, for the first time in some years, our in-house drug discovery efforts led to projects achieving proof of concept (POC), with efficacy signals confirmed clinically. This was a tangible sign that the R&D reforms we have pursued are beginning to generate concrete results. Within Ono, we have gained a real sense of momentum toward our next stage of growth, and confidence and energy are beginning to build. Externally, we are also beginning to hear that growth beyond OPDIVO is taking shape. What I consider truly important, however, is not simply the success of individual projects, but evolving our R&D system and organizational capabilities so that we can deliver such results consistently.

Drug development is inherently uncertain. At Ono, our ambition goes beyond creating new medicines that offer only incremental improvements over existing therapies. We aim to create new treatment options that can address the unmet medical needs of patients living with disease. For that reason, while continuing to pursue breakthroughs, it is essential that we also build a system that improves the probability of success. In the past, the efficacy of an innovative drug candidate often could not be confirmed until the middle or later stages of clinical development. Today, however, advances in measurement technologies, including biomarkers, and in translational research are beginning to enable us to assess at much earlier stages whether a drug is reaching the target tissue or molecule where it is intended to act in the human body, and whether the expected mechanism of action is working as intended in humans. We are actively incorporating these technologies and know-how as we transition to a model in which research and development work together from the earliest stages of drug discovery to test hypotheses.

This allows us to invest management resources boldly in promising projects, while using scientific evidence to identify at an early stage those with limited potential and reallocate resources to areas where greater value creation can be expected. Through this disciplined allocation of resources, we will enhance the value of the development pipeline as a whole while continuing to take on more ambitious projects. By bringing together perspectives and ideas from both research and development, appropriately incorporating technological advances, and improving the accuracy of hypothesis testing, I believe we can steadily increase the probability that each challenge will lead to the next success.

To me, true drug discovery capability lies in an organization’s ability to capture the thinking and processes behind each success and failure as organizational knowledge and carry that knowledge forward into the next challenge. Our goal is to build an R&D organization that does not allow achievements to remain isolated or one-off, but connects them to continuous value creation. I am convinced that the accumulation of this organizational knowledge will be the source of Ono’s ability to continue generating innovation and delivering new treatment options to patients around the world.

believe one of Ono’s strengths lies in the way we have created new value by drawing on the strengths of both in-house drug discovery and open innovation. We have long placed the ideas and know-how cultivated through our own drug discovery at the core of our efforts while actively collaborating with academic institutions, biotechnology companies, and pharmaceutical companies around the world. Our commitment to fully embracing outstanding science from around the world and developing it into distinctive value that only Ono can create will remain unchanged.

Today, the foundation for delivering the value created through drug discovery to patients around the world is steadily taking shape. That foundation is our integration with Deciphera.

Through this integration, Ono has gained not only products such as QINLOCK and ROMVIMZA, but also an organization capable of seamlessly advancing late-stage clinical development, regulatory approval, launch, and market penetration across the U.S. and Europe. Going forward, we will make full use of this platform to maximize the value of QINLOCK and ROMVIMZA, as well as VELEXBRU, for which an application for approval is under review in the U.S. We will also use it to maximize the value of our in-house pipeline and newly in-licensed assets through global development and business expansion. At the same time, we will circulate the knowledge and development experience gained through each product, our commercial capabilities, and our relationships with healthcare institutions back into the next R&D programs and business opportunities, thereby strengthening our competitiveness on a sustainable basis.

I believe that continuing to build on these efforts and drive further innovation will enable us, as a Global Specialty Pharma, to deliver greater hope to patients around the world.

I find that bringing the “value chain” to life is no easy task. Because pharmaceutical companies are made up of organizations with highly specialized expertise in each function, those organizations can readily become siloed. From the patient’s perspective, however, Ono is one company.

Research, development, manufacturing, sales and marketing, post-marketing activities, and the corporate functions that support them do not form a simple linear process. Each function must influence the others and circulate knowledge in ways that continually enhance value. For example, insights from clinical practice gained after launch can inspire new research themes. Feedback received by sales and marketing and medical affairs teams from healthcare professionals and patients can inform development strategies and clinical trial design. Knowledge about quality cultivated in manufacturing supports advances in formulation technologies and manufacturing processes.

Corporate value does not become greater simply because each function delivers its own results. It is only when knowledge and experience connect across functions, regions, and areas of expertise and reinforce one another that they ultimately result in greater value. That is why I believe organizational silos are one of the most important issues we must avoid. As an organization grows, its functions become increasingly specialized and fragmented. At the same time, the perspective of what is best for the organization as a whole can weaken, the broader purpose can be lost, and people can begin to focus only on the results and optimization of their own functions. What society expects from us, however, is for Ono to deliver the best possible value as one company—One Ono.

Essential to achieving this is a culture in which functions understand and respect one another’s work. Researchers should understand the perspectives of development, manufacturing, and sales and marketing, while sales and marketing personnel should understand the challenges researchers take on and the aspirations behind them. A “Trust Chain” and a “Respect Chain” provide the foundation on which we can expect more of one another and rise to those expectations. I believe that these relationships are what create a true value chain and lead to new value creation.

To deliver new treatment options to patients, we need people who continue to venture into uncharted territory. I want Ono to be a company where every employee can genuinely feel that their own work contributes to value for patients. That sense of connection fosters initiative and a sense of ownership, and it becomes the driving force that turns each individual’s strengths into results for the Company as a whole.

At the foundation of this is our corporate philosophy, “Dedicated to the Fight against Disease and Pain.” It serves as a guidepost that keeps every employee focused on patients and brings our individual challenges together toward a common purpose. Our mission statement, “Be Passionate Challengers,” is not simply a call to take on challenges without fear of failure. It expresses our desire for every individual to think for themselves, act on their own initiative, and create new values by collaborating with diverse colleagues. True breakthroughs cannot be achieved through individual effort alone. They emerge through dialogue and collaboration among people with different areas of expertise and different values. I believe the accumulation of these efforts is both Ono’s competitive strength and the very essence of our corporate culture.

To grow as a global company, it is also essential that we remain an organization in which people with diverse values and cultural backgrounds learn from one another and continue taking on challenges. Through collaboration with Deciphera, personnel exchanges with our overseas affiliates, and joint projects, we will continue developing human resources capable of succeeding internationally.

Rapid advances in AI and digital technologies, robotics, and computing power have become important factors that can determine the competitiveness of pharmaceutical companies. Across a wide range of activities, from drug discovery and development to business operations, these technologies are dramatically improving both the quality and speed of decision-making.

At Ono, we view these technological advances as opportunities for growth. Rather than trying to rely solely on our own capabilities, we are expanding our use of Digital & IT while actively incorporating leading external technologies and expertise. AI, for example, is being used increasingly across each stage of the drug discovery process, including target identification, the search for drug discovery seeds, compound design, and antibody design. By capturing biological information that has previously been difficult to discern and improving the accuracy of our hypotheses, we will translate these advances into greater R&D productivity.

The importance of advanced computing infrastructure and effective use of data is also increasing. By leveraging collaboration with external partners, we are strengthening our analytical and processing capabilities and upgrading the technology infrastructure required for R&D. Through these efforts, we will dramatically advance each stage of the drug discovery process while enabling faster, higher-quality decision-making.

Our use of Digital & IT also extends across business operations, including manufacturing, sales and marketing, and corporate functions, where we are enhancing data-driven business processes and accelerating decision-making. By leveraging accumulated information across functions, we will continue evolving Digital & IT as a foundation that supports management, business operations, and R&D.

Going forward, we will continue to use Digital & IT as an accelerator of corporate transformation to improve R&D productivity, enhance business operations, and increase the efficiency of organizational management. In doing so, we will strengthen the organization and systems needed to deliver the value we create to patients more quickly and more reliably.

Our investments in R&D, people, and our global business foundation are all important management resources that support future value creation. By organically connecting these resources, I intend to achieve sustainable growth and enhance corporate value.

By evolving Ono into a Global Specialty Pharma that continues to deliver innovative treatment options to patients around the world, I want us to remain a company trusted by society and continually chosen by colleagues and partners who share our commitment to taking on challenges.

Together with our shareholders and investors, as well as all other stakeholders, we are determined to shape the future of medicine. With that determination firmly in mind, Ono will continue moving forward toward the realization of our corporate philosophy, “Dedicated to the Fight against Disease and Pain.”

R&D, people, and our global business all require time to develop and build value. That is why we will not pursue short-term results alone. Instead, by focusing on creating value for patients, we will enhance corporate value and grow into a company trusted by society. I hope our stakeholders will continue to follow our progress from a long-term perspective. Our aspiration is to remain a company that inspires people to say, “I want to take on challenges together with Ono.”