Environment

Information Disclosure Based on the TNFD Recommendations

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In July 2024, we announced our support for the recommendations of the Task Force on Nature-Related Financial Disclosures (TNFD) and registered as a TNFD Adopter*. In line with the framework of the final TNFD recommendations (v.1.0), we assess the dependences and impacts of our business activities on nature, identify risks and opportunities based on the assessment results, consider countermeasures, and disclose information in an appropriate manner.

* For the TNFD Adopter, please refer to the TNFD homepage.

ONO PHARMACEUTICAL CO.,LTD., ONO PHARMACEUTICAL CO.,LTD., system

Information Disclosure in line with TNFD

Governance

  • This structure is as of August 2025.

We recognize the conservation of the global environment, including biodiversity, as one of our important management issues (materiality). Led by our Representative Director, President & COO as Chief Environmental Management Officer and Representative Director, Executive Vice President as Executive Director in Charge of the Environment, we are working to achieve our medium- to long-term environmental targets under our medium- to long-term environmental vision, “ECO VISION 2050.”
The assessment of the dependences and impacts on nature and the identification and management of risks and opportunities are reviewed by the TNFD Working Group (TNFD-WG) and reported to the Environment Management Committee which is chaired by the Executive Director in Charge of the Environment. Subsequently, these matters are proposed to the Sustainability Strategy Meeting also chaired by the Executive Director in Charge of the Environment. The identified nature-related risks and opportunities, and their countermeasures are reported or proposed to the Management Meeting, which is attended by senior management and others. The matters reported or approved by these senior meetings are reported to the Board of Directors at least once every half year for its management and supervision.
In this way, biodiversity initiatives are consistently overseen from the field level by the Executive Director in Charge of the Environment, under the supervision of the Board of Directors. Please refer to the “Governance” section of the "Information Disclosure Based on the TCFD Recommendations" for the roles of each committee.

In July 2020, we established the Ono Group Human Rights Global Policy (revised in June 2023) based on the “United Nations (UN) Guiding Principles on Business and Human Rights” to ensure that we understand and respect the human rights, diverse values, personalities, and individuality of all stakeholders, including indigenous peoples and local communities, in all our business activities, both in Japan and abroad, and that we act accordingly. Furthermore, we established a system of human rights due diligence in accordance with the “the UN Guiding Principles on Business and Human Rights” to identify, prevent, and mitigate any adverse human rights impact that we may have on our stakeholders. In the process of advancing our human rights initiatives, we engage in sincere dialogue and consultation with our stakeholders.
For initiatives for human rights, please click here.

Strategy
- Analysis and evaluation of risks and opportunities related to biodiversity -

In line with the LEAP approach* recommended by the TNFD, the TNFD-WG took the lead in assessing the dependences and impacts of our business activities on nature, identifying risks/opportunities, and considering countermeasures.

  • The LEAP approach is a systematic approach to assessing nature-related risks and opportunities and consists of four phases: Locate, Evaluate, Assess, and Prepare.

First, to understand how our business depends on and affects natural capital such as biodiversity, we assessed the dependences and impacts of our pharmaceutical business on nature, referring to the recommendations of the TNFD and the "Business and Biodiversity Interrelationship Map" developed by the Japan Business Initiative for Biodiversity (JBIB).

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In FY2024, as in the previous fiscal year, we assessed the dependences and impacts of our business activities on nature in each of the processes of “raw material procurement,” (upstream value chains), “research and manufacturing” (direct operations), and “transportation and sales” (downstream value chains) in accordance with the procedures described below. Based on the assessment results, we identified risks and opportunities, and considered countermeasures.

Assessing the dependences and impacts of our business activities on nature, identifying risks and opportunities based on the assessment results, and considering countermeasures
Assessment procedureWe identified nature-related risks and opportunities in our business activities in accordance with STEPs 1 through 4, below.
STEP1:
Assessment of the dependences and impacts on nature, which is of high importance to the pharmaceutical business, using ENCORE*
  • ENCORE (Exploring Natural Capital Opportunities, Risks and Exposure) is a tool to assess dependence and impact of individual sectors on natural capital (https://encorenature.org/en).
STEP2:
Comprehensive assessment of water-related risk (water stress and flood risk) and biodiversity risk
Targets: Upstream value chains (179 companies, 202 sites), direct operations (13 groups, 90 sites), downstream value chains (63 companies, 118 sites)
Criteria for assessing as “at risk”
  • Water-related risk:
    We use the water risk assessment tool “Aqueduct*1” to assess the water stress (baseline/2050 [Pessimistic scenario, RCP 8.5]) and flood risk (river/coastal) for each site. Sites where any of these values are rated “High” or higher are confirmed for water-related risks using the WWF Water Risk Filter*2.
  • Biodiversity risk:
    The WWF Biodiversity Risk Filter*2 is used to assess “Protect/Conserved Area” and “Key Biodiversity Area” for each site. In addition, TNFD-IBAT*3 is used to assess each site's "Indicators for Species Threat Reduction and Recovery (Resolution: 5 km, classified into 5 layers). Sites rated 4 or higher in the former 5-layer scale, or 3 or higher in the latter scale, were considered at risk.
  • Aqueduct is an assessment tool developed by the World Resources Institute (WRI) that can identify global water risks based on location information (latitudes and longitudes) of business establishments (https://www.wri.org/aqueduct).
  • WWF Water Risk Filter and WWF Biodiversity Risk Filter are assessment tools for water risks and biodiversity risks developed by World Wide Fund for Nature (https://riskfilter.org/).
  • TNFD-IBAT is an assessment tool published in collaboration with TNFD and the Integrated Biodiversity Assessment Tool (IBAT) Alliance that can identify biodiversity risks (https://tnfd.global/guidance/locate-assessment-tools/).
STEP3:
Identification of sites (priority locations) that are critical to our business continuity where there is concern about serious dependences and/or impacts on nature
For sites assessed as being at risk of water stress and/or flooding in STEP 2, we check the amount of water intake/water consumption by water source and/or whether there has been flood damage in the past, respectively, through desk surveys. In addition, when it comes to business partners involved in the manufacture of pharmaceuticals (71 companies, 79 sites), we conduct desk surveys to clarify environmental pollution risks while taking into account factors such as the chemical substances handled by searching for whether they have acquired an environmental management system (EMS) and whether they have had any past environmental accidents or violations. For sites assessed as being at risk of biodiversity in STEP 2, we check whether there are any protected areas in the surrounding area (within a 10-km radius). Even when it comes to our directly operated sites, we assess whether there are any protected areas in the surrounding area (within a 10-km radius), and we also evaluate the risk of environmental pollution due to our business activities. Based on the above assessments, we identify sensitive locations on nature, and determined priority locations where a significant dependence or impact on nature is a concern, including in relation to our business activities.
STEP4:
Identification of risks and opportunities, and consideration of countermeasures
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Assessment results
Based on the results of the assessments in STEPs 1 through 3, we identified 4 sites in direct operations and 4 sites in upstream value chains as priority locations that are critical to our business and have concerns about serious dependences and impacts on nature.
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Our priority locations that are critical to our business and have concerns about serious dependences and impacts on nature, identified in accordance with STEPs 1 through 3
NA: Not applicable
Value chains Site Country Factors for determining that the site is a sensitive location Relationship with our business
Direct operation Fujiyama Plant Japan
  1. Areas important for biodiversity
  2. Risk of ecosystem destruction due to pollution
Our main manufacturing plant
Yamaguchi Plant
  1. Risk of ecosystem destruction due to pollution
Our main manufacturing plant
Minase Research Institute
  1. Risk of ecosystem destruction due to pollution
Our main research institute
Deciphera Research Office USA
  1. Areas important for biodiversity
Our main research institute
Upstream Supplier 1 China
  1. Areas for flood risk
A supplier of pharmaceutical raw materials
Supplier 2 India
  1. Areas for water shortage and flood risks
A supplier of pharmaceutical raw materials
Supplier 3 USA
  1. Areas important for biodiversity
A supplier of pharmaceutical raw materials
Supplier 4 USA
  1. Areas important for biodiversity
  2. Risk of ecosystem destruction due to pollution
A supplier of pharmaceutical raw materials

In STEP 4, for the identified priority locations, we reconfirmed the interface with nature, and consider possible nature-related risks. After comprehensively identifying nature-related risks and opportunities based on our business activities, we prioritized them using the magnitude of their impacts on our business as an indicator, thereby identifying nature-related risks and opportunities that we believe should be addressed as a priority. For each nature-related risk and opportunity identified, we also examined measures to mitigate the risk and realize the opportunity.

〈Risks related to biodiversity〉

TNFD Risk Categories Contents of Risks Duration* Main Countermeasures
Physical Risks Acute
  1. Increased procurement costs for plant-based pharmaceutical excipient
  2. Ecosystem restoration costs due to pollution caused by natural disasters (leakage of hazardous substances) and the spread of genetically modified organisms, etc.
Short, medium and long term
  1. Thorough implementation of business continuity plan (BCP) measures (securing sufficient API and product inventories/establishing a multiple-supplier system)
  2. Enhanced management of chemical substances and genetically modified organisms, etc.
  3. Efficient use of water resources
  4. Identification of natural disaster risk and water scarcity risk in the business partner selection process, etc.
Chronic
  1. Impact of water scarcity on production activities (interruption of manufacturing plant operations and increase in production costs)
Medium and long term
Transition Risks Policy
  1. Increased costs of responding to stricter regulations and their introduction in each country and region
Medium and long term
  1. Determining strategies and implementing responses that reflect regulatory trends
  2. Reducing greenhouse gas emissions
  3. Reducing the environmental impact of product packaging
  4. Improving waste recycling rate
  5. Thorough management of hazardous substances and wastewater
  6. Identifying risks and promoting risk mitigation efforts in line with TNFD recommendations
  7. Making efforts to achieve medium- to long-term environmental targets, etc.
Market
  1. Loss of sales opportunities due to delays in responding to the shift in society's interest toward biodiversity-conscious products
Long term
Technology
  1. Increased costs to comply with mandatory wastewater analysis of chemical substances, etc.
  2. Stagnation of business activities due to increased competition for the use of innovative technologies that reduce the impact on nature
Medium and long term
Reputational
  1. Decrease in corporate value due to lack of biodiversity initiatives
Medium and long term
Liability
  1. Liability in the event of environmental pollution due to natural disasters, accidents, etc.
Short, medium and long term
  • Short term (up to 3 years), medium term (3-10 years), and long term (10-30 years)

〈Opportunities related to biodiversity〉

TNFD Opportunities Categories Contents of Opportunities Duration* Main Countermeasures
Resource Efficiency
  1. Reduction in costs, waste, etc. through efficient production activities
Medium and long term
  1. Saving resources by adopting highly efficient production processes such as continuous production methods
  2. Promoting drug discovery technology in consideration of the concept of green and sustainable chemistry
  3. Promoting biodiversity initiatives and information disclosure
  4. Promoting biodiversity conservation activities (contributing to nature positive), etc.
Markets
  1. Creation of new businesses linking biodiversity and healthcare
Medium and long term
Capital Flow and Financing
  1. Potential for inclusion in ESG index and financing through sustainable finance
Short, medium and long term
Reputational
  1. Enhancing corporate value through advanced biodiversity initiatives
Short, medium and long term
  • Short term (up to 3 years), medium term (3-10 years), and long term (10-30 years)

The identification of risks and opportunities for FY2024 did not identify any items that would have significant impacts on the continuity of our business. Going forward, we will continue to closely monitor trends in the international community, and in line with the LEAP approach, we will regularly assess the dependences and impacts of our business activities on nature, identify risks and opportunities based on the assessment results, and consider countermeasures. We will also identify nature-related risks and opportunities arising from the use of pharmaceuticals by medical institutions and patients in the downstream value chain (use of pharmaceuticals), while taking the trends in TNFD and the Science Based Targets Network (SBTN) into account.

Risk and Impact Management

The TNFD-WG and the Environment Management Committee manage the identified nature-related risks, opportunities, and countermeasures, while the Board of Directors manages and supervises the management of these risks and opportunities through the environmental governance system described in the “Governance” section, above. Nature-related risks and opportunities will be reviewed at least once every two years by the TNFD-WG. If an item is identified that could have a significant impact on finance and business continuity, it will be shared with the Risk Management Committee to manage the risk. For more details about risk management system, please click here.
In addition, in the upstream value chain, when a new contract is entered into, STEPs 1 through 3 described in the strategy above will be followed to identify the presence or absence of nature-related risks, and engagement to mitigate the identified risks will be conducted.

Metrics and Targets

To strengthen and accelerate our efforts to address global environmental issues, we have been promoting activities under our medium- to long-term environmental targets (more information on our mid- to long-term environmental targets, please click here). While minimizing the negative impact of our business activities on nature, we will promote initiatives to contribute to the realization of nature positive by 2030 through the development of green spaces on company-owned land and positive activities for nature through new biodiversity conservation activities.
In addition, among the indicators established to assess and manage our dependences and impacts on nature, risks, and opportunities, those for which we have not yet established targets will be considered and disclosed in due course.

〈Comparison table of TNFD core global disclosure metrics〉

Metrics for dependences and impacts on nature
Metrics No. Driver of Nature Change Indicator Metrics Results of FY2024 Targets References
- Climate change Green house gas (GHG) emissions
  1. Scope 1
  1. 7.7 thousand tons
  1. Scope 1+2
    Achieve zero GHG by FY2035
  1. Scope 3
    Reduce by 30% by FY2030
    Reduce by 60% by FY2050
    (Base year: FY2017)
  1. Realization of a decarbonized society
  2. ESG Data
  1. Scope 2
  1. 1.2 thousand tons
  1. Scope 3
  1. 100.5 thousand tons
   
   
C1.0 Land/freshwater/ocean-use change Total spatial footprint
  1. Total surface area controlled/ managed by our company
  1. 0.32 km2
  1. Annual securities report for FY2024 (Japanese)
    p.37, Status of major facilities/Submitting company
  1. Total disturbed area
  1. 0 km2
  1. Total rehabilitated/restored area
  1. 0 km2
C1.1 Extent of land/freshwater/ocean-use change
  1. Total surface area of green space controlled/managed by our company
  1. 0.10 km2
C2.0 Pollution/pollution removal Pollutants released to soil split by type
  1. Total amount of substance of very high concern (SVHC) under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation released to soil
  1. 0 tons
  1. No soil pollution incidents
  1. Number of soil pollution incidents
  1. 0 case
  1. Periodic training to prevent environmental pollution for applicable employees
  1. Completed
C2.1 Wastewater discharged
  1. Total volume of discharged water
  1. 171.9 thousand m3
Water pollution risk
  1. Conduct Whole Effluent Toxicity tests at all ONO’s manufacturing plants & research institutes by FY2025
  2. Evaluate effects of development compounds and pharmaceuticals on aquatic organisms and disclose the results by FY2030
  3. Maintain stricter management of wastewater than that required by laws and regulations
  4. No violations of related laws and regulations
Upstream value chains risk
  1. Initiate comprehensive water-related risk management for business partners that are critical to our business continuity by FY2026
  1. Realization of a water recycling society
  2. Biodiversity
  1. Discharged water volume including SVHC under REACH regulation and/or substances causing antimicrobial resistance (AMR)* discharged into public sewage and water bodies
  1. 0 m3
  • We have not manufactured any product causing AMR.
  1. Number of deviations from the reference values of the Water Pollution Control Act and the Sewerage Act
  1. 0 case
  1. Number of water pollution accidents due to handling of active pharmaceutical ingredient, etc.
  1. 0 case
  1. Periodic training to prevent environmental pollution for applicable employees
  1. Completed
   
   
   
Use of hazardous chemicals
  1. Amount of SVHC under REACH regulation used in the manufacture of in-house pharmaceuticals
  1. 0 tons
  1. Amount of PRTR Class 1-designated chemical substances (Handled in an amount of 1 ton or more)
  1. 1.7 tons
C2.2 Waste generation and disposal
  1. Total weight of industrial waste generated (ONO’s manufacturing plants/research institutes/logistics centers)
  1. 818.6 tons
  1. Final landfill rate of our industrial waste: Maintain 1% or less every year
  2. Recycling rate*:
    60% or more (FY2025)
    80% or more (FY2030)
  • Calculation is based on the calculation rules of the Federation of Pharmaceutical Manufacturers' Associations of JAPAN (Coverage: wastes, valuables, free materials, etc.)
  1. Reduce the environmental impact of product packaging: Use 100% eco-friendly materials for individual packing boxes of our pharmaceuticals (FY2030)
  1. Realization of a resource recycling society
  1. Total weight of special management industrial waste (Hazardous waste)
  1. 128.4 tons
  1. Total landfill weight of our industrial waste (Final landfill rate of our industrial waste)
  1. 0.0 tons(0.0%)
  1. Recycling rate of waste (ONO’s manufacturing plants/research institutes/logistics centers)
  1. 81.4%
   
   
   
C2.3 Plastic pollution
  1. Total weight of plastic used in packaging of our pharmaceuticals sold
  1. 207.6 tons
  1. Realization of a resource recycling society
  1. Usage rate of recycled plastic or biomass-derived plastic in plastic packaging for our pharmaceuticals sold
  1. Calculating
C2.4 Non-GHG air pollutants
  1. SOx
  1. 0.0 tons
  1. ESG data
  • In-house data based on PRTR system in Japan
  1. NOx
  1. 6.0 tons
  1. Smoke dust
  1. 0.3 tons
  1. Amount of volatile organic compounds released into the atmosphere
  1. 1.4 tons*
C3.0 Resource use/replenishment Water withdrawal and consumption from areas of water scarcity
  1. Water withdrawal and consumption from areas of water scarcity area
  1. 0 m3 (No in-house worksite in water scarcity area)
  1. Initiate comprehensive water-related risk management for business partners that are critical to our business continuity (FY2026)
  1. Realization of a water recycling society
  1. Number of business partners that are critical to our business continuity and are operating in water scarcity area concerned by Aqueduct (Baseline/Future 2050)
  1. One company
Reference (Direct operations)  
  1. Water withdrawal volume
  1. 202.8 thousand m3
  1. Number of days when water withdrawal was restricted due to drought
  1. 0 day (In-house manufacturing plants & research institutes)
C3.1 Quantity of high-risk natural commodities sourced from land/ocean/freshwater
  1. Quantity of high-risk natural commodities
  1. Under survey
C4.0 Invasive alien species and other Measures against unintentional introduction of invasive alien species
  1. Usage rate of disinfected wood packing materials used for raw material import
  1. 100%
  1. Prevent introduction of invasive alien species by 100% use of disinfected wood packing materials
C5.0 State of nature Ecosystem condition
  1. Area covered by nature conservation activities
  1. 0.1 km2
  • The metrics, FY2024 results and targets for Ono Pharmaceutical Co., Ltd. on a non-consolidated basis are shown in this table.

General Requirements (References)

Six general requirements considered in the disclosure of information in line with the TNFD recommendations
Requirements Considered content
Application of materiality In order to realize the “conservation of the global environment,” which we have identified as one of our key management issues (materiality), we have set medium- to long-term environmental targets under “ECO VISION 2050” and continue to take on the challenge of passing on a rich global environment for future generations. In this report, we assessed our dependence, impacts, risks and opportunities on nature based on a double materiality approach.
Scope of disclosures In addition to direct operations (including group companies), this covers the unconsolidated ONO's upstream and downstream value chain. Note that downstream of the value chain, we have not been able to analyze the impact of stakeholders such as healthcare professionals and patients. In the future, we will deepen our analysis and expand the scope of disclosure to include the above stakeholders and the value chain of group companies.
Location of nature-related Issues In the Ono Pharmaceutical Group's core pharmaceutical business, we used the ENCORE and LEAP approaches to assess how much our direct operations and upstream/downstream value chain operations depend and have an impact on nature.
For more information about the analytic method, please see the “Strategy” section of this report.
Integration with other sustainability-related disclosures We recognize that biodiversity initiatives are closely related to measures against climate change. In the future, we will consider how to integrate these with the TCFD recommendations.
Time horizons considered The target period is from now until around 2050. Short-term is defined as within 3 years, medium-term as 3 to 10 years, and long-term as 10 to 30 years.
Engagement of indigenous peoples, local communities and affected stakeholders To learn more about ONO’s stakeholder engagement, please click here.
For more information about our basic policy on human rights for all stakeholders, including Indigenous Peoples and local communities, as well as our promotion of human rights due diligence, please click here.
ONO PHARMACEUTICAL CO.,LTD., ONO PHARMACEUTICAL CO.,LTD., system