Growth Strategies（Second period Medium-term management plan）

Strengthen the management foundation and implement the four growth strategies

▽ Maximization of product value - From a patient-centered perspective -
We will work together with healthcare professionals to realize the wellbeing of patients and their families (a state of fulfillment in terms of physical, mental, social, and life satisfaction), and as a result, we will strive for speedy and effective development, competitive marketing, and the provision and collection of sophisticated information to achieve the rapid penetration of new drugs. In marketing and the provision and collection of information, we cultivate specialty human resources who engage in their activities from the patient’s perspective with healthcare professionals in response to medical issues. We are also working to maximize the potential of our products by utilizing digital technology to provide and collect information effectively and efficiently. In development, we are currently working on numerous clinical trials, the number of which is almost 100, mainly in our key strategic area of oncology.
With OPDIVO, one of our flagship product in the area of oncology, we will work with our partner Bristol-Myers Squibb Company of the U.S. to maximize product value by expanding the number of indicated tumors and treatment lines, and developing combination therapies. With FORXIGA, one of our main products in the primary area, we will work with our partner, AstraZeneca of the U.K., to quickly and surely deliver it not only to patients with diabetes, but also to patients with chronic heart failure and chronic kidney disease, for which the indication has been expanded, thereby taking on the challenge of extending healthy life expectancy.

▽ Reinforcement of pipelines and acceleration of global development
There are many people in the world suffering from diseases for which there is no cure even today. We aim to become a Global Specialty Pharma that can respond to unmet medical needs. We have designated oncology, immunological diseases, central nervous system diseases, and specialty areas with high medical needs as priority research areas, and we will accumulate disease know-how in each area to create new drugs that will bring innovation to medicine on-site. We will strengthen and expand research and drug discovery alliances with world-leading universities, research institutions, and biotech startups, and aim to enhance a highly original pipeline that can aim for first-in-class status.
In addition, we will continue to take on the challenge of creating highly original in-house drugs by utilizing a variety of drug discovery modalities according to the theme of drug discovery, and strive to improve the certainty of R&D by actively using nonclinical data from human-derived samples and data from clinical trials to verify drug targets and strengthen translational research. Additionally, we will actively pursue the in-licensing of innovative compounds and the acquisition of new technologies in areas of high medical need. As for global development, we will not only strengthen the system with an eye toward conducting our own sales in Europe and the U.S. and accelerate the development of numerous projects, including the Bruton’s tyrosine kinase inhibitor ONO-4059 (Japanese name: VELEXBRU Tablets) in the US.

▽ Realization of direct sales in the US and Europe
In order to provide new drugs throughout the world, we are promoting efforts for our own sales organizations overseas. We have already established local subsidiaries in South Korea and Taiwan to begin marketing our own products. In Europe and the U.S., we are working to develop a sales structure for own sales with an eye on launching several projects, such as ONO-4059.
ONO Pharma USA, Inc. is taking the opportunity of its office relocation to Cambridge, Massachusetts in April 2021 to acquire talented human resources with extensive experience in the pharmaceutical industry and create a competitive organizational structure.
In addition, in light of the status of ongoing clinical trials, we are also moving forward with an examination of the establishment of our own sales organization, including medical affairs, marketing, sales, etc., in Europe.

▽ Expansion of business domains
We are working to expand our business domains to meet the needs of the expanding healthcare sector and continue to provide new value. In addition to developing and commercializing products and services that take full advantage of the assets we have accumulated through research and development of prescription drugs , we launched REMWELL, which is a sleep supplement that has been approved in Japan as foods with function claims, in 2022. As a pioneer in lipid research, we will further work to solve various health issues in the future through Lipid-supply business.
We established michiteku Co., Ltd., in 2022 to take on the challenge of creating new value by utilizing digital technology to address unresolved issues faced by our customers. In parallel with these activities, we aim to create and expand new businesses through investment in startups in the healthcare field by establishing Ono Digital health Investment, GK.

▽ Corporate transformation through Digital & IT
In the midst of a drastically changing business environment, we are transforming the company to have high dynamic capability by leveraging digital and IT throughout the Group. This requires a flexible IT infrastructure supported by the latest technologies, a data utilization platform including internal and external data, and the capability of data analysis from company-specific perspectives. This foundation enables us to detect and assess business issues and new opportunities accurately and timely, and turn them into business transformation initiatives.

▽ Management infrastructures to Support Growth Strategies – Expansion of Intangible Assets –
To support our four growth strategies and achieve dramatic growth, we will work to improve and expand our intangible assets: human capital, corporate brand, digital and IT infrastructure, etc. By increasing the human capital, we will work to develop talent to promote each element of the growth strategy while fostering talent throughout the Group. In addition, with respect to raising corporate recognition, which is a major issue, especially when expanding into Europe and the U.S., we will strive to enhance corporate value by working to spread the corporate brand of “innovative drugs,” “Pharma,” and “a corporation required by society.”

Material Issues（Priority Management Issues）

Address the priority management issues which integrate financial and non-financial issues

To promote management that integrates financial and non-financial aspects based on our growth strategy and Sustainable Management Policy, we have identified 18 material issues. By promoting initiatives for each material issue, we aim to improve the sustainability of both ONO and society.

ONO’s Value Creation Process

We will realize a sustainable society by delivering original and innovative medicines to the world.

Policy on Medium- to Long-term Investment

The medium- to long-term financial policy is to balance strategic investments, including R&D, and shareholder return in order to achieve sustainable growth.
While securing stable investment resources by continually expanding operating cash flows through greater revenue, we work to increase asset efficiency by reducing cross-shareholdings, and the cash flows we generate are used for growth investments, including R&D while considering return on investments. We will provide a stable shareholder return while generating additional growth and ensuring sound financial foundation.

Investment Policy

Even as we make aggressive R&D and strategic investments, we will strictly apply our investment adoption criteria to ensure value creation and profitability. For the five years from FY2022 to FY2026, we will strive to expand revenue at an revenue CAGR in the high single digits compared to FY2021. We will then aim to maintain an operating income to revenue ratio of at least 25% while investing about 20-25% of revenue in R&D. With revenue growth and expanding profits through aggressive R&D investment as targets, we believe we can achieve ROE that exceeds the cost of shareholders’ equity without falling into a short-term orientation.
Regarding fund procurement, the Group will ensure the liquidity necessary for smooth business activities, and will do so effectively and flexibly, taking into consideration market conditions and other factors. The Group’s current assets far exceed current liabilities, and the source of funds is allocated between funds generated from operations and internal funds.

Growth Investments

Strategic investments are essential for sustainable growth. Although R&D expenses will increase due to aggressive growth investments, we will raise the level of ROE by expanding profits through revenue growth. We will also maintain an appropriate level of shareholders’ equity by balancing shareholder returns.

We are aggressively investing in R&D to create original and innovative new drugs and expand our development pipeline. Along with the expansion of revenue, we plan to increase R&D expenditures to the 100 billion yen-level first, and then in the five years from FY2022 to FY2026, invest a total of 600 billion yen in R&D.
Specifically, in addition to drug discovery alliances with biopharmaceutical companies that possess the world’s most advanced technologies, we are actively pursuing research alliances that lead to drug discovery research with universities and other research institutions. At the end of FY2022, we were carrying out more than 300 cooperative research projects in Japan and overseas, and we plan to do even more going forward. In addition to compounds in the late development stage, which are expected to be launched within a few years, we are also strengthening our licensing activities to actively acquire attractive compounds even in the early development stage (preclinical and Phase I). In addition, Ono Venture Investment Fund I, L.P., established in July 2020, is investing in drug discovery ventures in the seed stage. In addition to regular R&D expenditures, we intend to invest 150-200 billion yen over the next five years starting in FY2022 to strengthen our drug discovery business by acquiring global rights to compounds with established PoC.
We will also actively invest in IT and digital technology, and research and production facilities sufficient to maintain the latest drug discovery activities and safe and efficient production activities over the medium-to-long term.
With regard to expanding our overseas development bases and sales network, we will accelerate construction of our own sales system with an eye toward introducing BTK inhibitor VELEXBRU Tablets in the U.S.. Furthermore, we will examine building an organization in Europe for our own sales, which includes marketing and sales, while keeping in mind progress in development.
Ono Pharma Healthcare Co., Ltd., established in February 2021, Ono Digital health Investment, GK. in March 2022, and michiteku Co., Ltd., established in November 2022, plan to invest in new healthcare businesses, DX funds, and information processing and provision service businesses in the healthcare field, and other business domain expansion, and together with the expansion of our overseas development bases and sales network, and also the strengthening of corporate foundations, plan to invest 30 to 50 billion yen over five years, starting in FY2022.

Capital Cost and Capital Profitability

We are working on the following measures about Action to Implement Management that is Conscious of Cost of Capital and Stock Price.