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 July 2026.

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, Senior Director, Sustainability Promotion as Corporate Officer 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 Corporate Officer in Charge of the Environment. Subsequently, these matters are proposed to the Sustainability Strategy Meeting also chaired by the Corporate Officer 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 oversight.
In this way, biodiversity initiatives are consistently led and coordinated from the operational level by the Corporate Officer in Charge of the Environment, and are overseen by 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.

In FY2024, we assessed our dependencies and impacts on nature within the pharmaceutical manufacturing sector using the online tool ENCORE*. In FY2025, we expanded the scope of the ENCORE* assessment to cover our entire value chain, including both upstream and downstream activities, and conducted a comprehensive assessment of our business-related dependencies and impacts on nature. Based on the results, we developed assessment indicators to identify priority areas where significant dependencies on, or impacts to, nature are likely to occur. In addition, we newly conducted scenario analysis and evaluated the potential financial impacts of the identified nature-related risks.

  • 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).
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.
STEP 1:
Identification of key nature-related dependencies and impacts across the value chain
Level of dependency/impactLowMediumHigh
Dependencies on nature Impacts on nature
Biological resources Water resources Nature's regulation service* Natural disaster (flood) mitigation Pollination and pest control Climate change (GHG emissions) Land/
Sea-use change
Overexploitation of water resources Pollution Waste generation
Upstream Pharmaceutical formulation ingredients Agricultural products (plant-based pharmaceutical excipients) Low High Medium Medium High Low Low Medium Medium Medium
Wood (raw material for cellulose and pulp) High High Medium Medium High High Medium Low High High
Chemicals (solvents, active pharmaceutical ingredients, etc.) Low Medium Low Medium Low Medium Low Medium High Medium
Product packaging Glass products Low Medium Medium Medium Low Medium Low Medium Medium Medium
Paper products Low Medium Medium Medium Low Medium Low Medium High High
Plastic and rubber products Low Medium Low Medium Low Medium Low Low High Medium
Metal products Low High Low Medium Low High Low Medium High Medium
Direct operation Research and development Low Medium Low Low Low Low Low Medium Low Medium
Pharmaceutical manufacturing Medium High Low Medium Low Medium Low Medium Medium Medium
Downstream Transportation and warehousing services Low Low Low Low Low Medium Low Low Low Low
Healthcare facilities Low Medium Low Medium Low Low Low Low Low Medium
  • Nature's purification, decomposition, and regulating functions
Using ENCORE, we identified and assessed the key nature-related dependencies and impacts across our entire value chain.
  • Key nature-related dependencies: “Water resources” and “Natural disaster (flood) mitigation”
  • Key nature-related impacts: “Overexploitation of water resources”, “Pollution” and “Waste generation”
STEP 2:
Comprehensive assessment of water-related risk (water stress and flood risk) and biodiversity risk (pollution and waste generation)
Targets: Upstream value chains (suppliers of pharmaceutical formulation ingredients and product packaging, and contract manufacturing organizations, etc.), direct operations (ONO Group), downstream value chains (storage and transportation providers and pharmaceutical wholesalers)
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.
  • 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/).
STEP 3:
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 withdrawal/water consumption by source and/or whether there has been flood damage in the past, respectively, through desk surveys. For the upstream value chain related to pharmaceutical formulation ingredients and manufacturing, 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. In addition, for sites identified in STEP 2 as being located in areas of high biodiversity vulnerability, we used IBAT* to assess nearby protected areas within a 20-km radius and indicators related to species threat abatement and restoration (STAR), in order to evaluate their importance for biodiversity conservation. 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.
  • IBAT (Integrated Biodiversity Assessment Tool) is an assessment tool that integrates key biodiversity datasets provided by the IBAT Alliance (https://www.ibat-alliance.org/about).
STEP 4:
Identification of risks and opportunities, and consideration of countermeasures
To identify potential future nature-related risks and opportunities, we developed four scenarios in accordance with the TNFD guidance on scenario analysis*. While we aspire to achieve Nature Positive described in Scenario #1, we selected Scenario #2, under which nature-related risks are expected to be most severe for our business operations, to identify and assess potential risks and opportunities.
figure
Assessment results
Based on the results of the assessments in STEPs 1 through 3, we identified 3 sites in direct operations and 5 sites in upstream value chains as priority locations that are critical to our business and have concerns about serious dependences and impacts on nature.
figure
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 conservation
  2. Risk of ecosystem degradation due to pollution
Our main manufacturing plant
Yamaguchi Plant
  1. Risk of ecosystem degradation due to pollution
Our main manufacturing plant
Minase Research Institute
  1. Risk of ecosystem degradation due to pollution
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
A supplier of pharmaceutical raw materials
Supplier 3 India
  1. Areas for flood risk
A supplier of pharmaceutical raw materials
Supplier 4 USA
  1. Areas important for biodiversity conservation
A supplier of pharmaceutical raw materials
Supplier 5 USA
  1. Risk of ecosystem degradation due to pollution
A supplier of pharmaceutical raw materials

In STEP 4, under Scenario #2, we comprehensively identified potential nature-related risks and opportunities. Taking into account the priority areas identified through the LEAP approach, we determined the material nature-related risks and opportunities that require priority attention. For the identified risks, we assessed their potential financial impacts and likelihood of occurrence. In addition, we considered measures to mitigate risks and realize opportunities.

〈Risks related to biodiversity〉

TNFD Risk Categories Contents of Risks Financial impacts Likelihood Main Countermeasures
Short* Medium* Long*
Physical Risks Acute
  1. Increased procurement costs for plant-based pharmaceutical excipients due to the drought
Negligible Low
  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 shortage risk in the business partner selection process, etc.
  1. Ecosystem restoration costs due to pollution caused by natural disasters (leakage of hazardous substances) and the spread of genetically modified organisms, etc.
Negligible Negligible Negligible Low
Chronic
  1. Impact of water shortage on production activities (interruption of manufacturing plant operations and increase in production costs)
Moderate Moderate Low
  1. Increased procurement costs for plant-based pharmaceutical excipients and packaging materials due to water shortage and biodiversity loss
Minor Minor
(excipient)
Moderate
(product packaging)
Medium
Transition Risks Policy
  1. Increased costs of responding to stricter regulations and their introduction in each country and region
  2. Mandatory disclosure of pharmaceutical environmental risks and environmental footprints
Negligible Medium
  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
Minor Low
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
Negligible Low
Reputational
  1. Decrease in corporate value due to lack of biodiversity initiatives
Minor Low
Liability
  1. Decrease in corporate value due to lack of biodiversity initiatives
Minor Minor Minor Low
  • Financial impacts were evaluated in alignment with the Enterprise Risk Management (ERM) framework using common risk assessment criteria: Negligible (〈 JPY 100 million), Minor (JPY 100 million–1 billion), Moderate (JPY 1–10 billion), and Major (JPY 10–100 billion).
  • 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).

No nature-related risks with the potential to materially affect the continuity of our business were identified in the FY2025 assessment. We will continue to monitor trends in the international community and, in accordance with the LEAP approach, regularly evaluate our nature-related dependencies and impacts, identify related risks and opportunities, assess their financial implications, and examine appropriate mitigation and response measures.

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 FY2025 Targets References
- Climate change Green house gas (GHG) emissions
  1. Scope 1
  1. 9.4 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. 0.3 thousand tons
  1. Scope 3
  1. 239.6 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 FY2025 (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. 153.4 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. 1.8 tons
C2.2 Waste generation and disposal
  1. Total weight of industrial waste generated (ONO’s manufacturing plants/research institutes/logistics centers)
  1. 479.8 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. 144.2 tons
  1. Total landfill weight of our industrial waste (Final landfill rate of our industrial waste)
  1. 0.3 tons(0.05%)
  1. Recycling rate of waste (ONO’s manufacturing plants/research institutes/logistics centers)
  1. 66.0%
   
   
   
C2.3 Plastic pollution
  1. Total weight of plastic used in packaging of our pharmaceuticals sold
  1. 206.8 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
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. 5.7 tons
  1. Smoke dust
  1. 0.3 tons
  1. Amount of volatile organic compounds released into the atmosphere
  1. 0.4 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. 186.0 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, FY2025 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 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