Laboratorios Farmacéuticos Rovi
Material Topics
ESRS 2 – General Disclosures
GOV-1The role of the administrative, management and supervisory bodiesReported
Rovi describes its governance structure for sustainability. The General Shareholders' Meeting is the highest governance body. The administrative, management and supervisory bodies are the Board of Directors and two board committees, the Nomination and Remuneration Committee (NRC) and the Audit Committee, plus an internal Management Committee and a Sustainability Committee. The Board has seven directors, three executive and four non-executive, three of whom are independent (42.86 percent). Three of the seven Board members are women (42.86 percent); women make up 66 percent of the committees, 30.76 percent of the Management Committee and 71.4 percent of the Sustainability Committee. No worker representative sits on the Board. Three directors have sustainability experience, and in 2024 the Board received specific training on CSRD, double materiality results and related regulation. The Audit Committee oversees financial and non-financial risks including sustainability risks, and the Sustainability Committee implements the ESG Master Plan 2023-2025. Rovi notes no person responsible for supervising impacts, risks and opportunities has yet been appointed. Reference: page 140.
GOV-2Information provided to and sustainability matters addressed by the undertaking's administrative, management and supervisory bodiesReported
Rovi discloses how its administrative, management and supervisory bodies are informed on sustainability matters. The Sustainability Committee informs the Board annually on progress in the ESG Master Plan and other relevant sustainability matters and is aware of the Company's material impacts, risks and opportunities. In 2024 the Sustainability Committee reported the results of the double materiality process at the December board meeting, presenting a summary of the assessment process, its phases and its final results in terms of material topics, sub-topics and sub-sub-topics. Rovi notes that after the ESG Master Plan is updated in 2025, the Board will consider the material impacts, risks and opportunities by reviewing and approving that Plan. In 2024 the Board did not take the material IROs into account when supervising sustainability strategy, since the ESRS were first analysed internally and the ESG Master Plan remains in force until 2025. The Sustainability Committee addresses ESG-related material IROs at its quarterly meetings, and the Audit Committee considers sustainability risks on the corporate risk map. Reference: page 6.
GOV-2(was GOV-3)Integration of sustainability-related performance in incentive schemesReported
Rovi discloses the integration of sustainability-related performance in incentive schemes. The Director Remuneration Policy establishes remuneration criteria for board members and reflects the most updated and valued criteria of the pharmaceutical industry. The variable remuneration of executive directors includes social, environmental and corporate governance sustainability indicators, such as compliance with the Company's codes of conduct and internal procedures. These criteria represent 10 percent of the variable remuneration. Three goals are included, each assigned to an executive director: implementation of an Internal Control over Non-Financial Reporting (ICNFR) system, offsetting 100 percent of Scopes 1 and 2 emissions and 20 percent of Scope 3, and compliance with the Code of Good Practice for the Pharmaceutical Industry. The Director Remuneration Policy was approved at the General Shareholders' Meeting on 14 June 2022 and applied to 2022, 2023 and 2024. On 25 June 2024 the Meeting approved the Remuneration Policy applicable for 2025, 2026 and 2027. Reference: page 7.
GOV-3(was GOV-4)Statement on due diligenceReported
Rovi provides a statement on its due diligence process for sustainability matters. Due diligence, as described in ESRS 1 Chapter 4, is an ongoing process that allows the Company to prevent, mitigate and account for actual and potential negative impacts related to the environment and people in the value chain. The process derives from the UN Guiding Principles on Business and Human Rights and the OECD Guidelines for Multinational Enterprises. To comply with due diligence, Rovi took the preparation of its double materiality assessment as a starting point to determine which impacts, risks and opportunities are material. Rovi maps the key due diligence elements to sections of the Report: integration in governance, strategy and business model (GOV-2, GOV-3, SBM-3), engagement with affected stakeholders (GOV-2, SBM-2, IRO-1, MDR-P), identification and assessment of adverse impacts (IRO-1, SBM-3), adoption of measures to address adverse impacts (MDR-A and topical ESRS), and monitoring the efficacy of efforts and communication (MDR-M, MDR-T and topical ESRS). Reference: page 7.
GOV-4(was GOV-5)Risk management and internal controls over sustainability reportingReported
Rovi discloses its risk management and internal controls over sustainability reporting. In 2023 the Company implemented an Internal Control over Non-Financial Reporting (ICNFR) system involving the whole organisation, which structures and formalises controls to detect and correct irregularities, provides the Board with reasonable certainty when issuing the Report, ensures the transparency and reliability of information processes, and supports regulatory compliance. The ICNFR was designed as an extension of the Internal Control over Financial Reporting (ICFR) system, following the COSO 2013 framework. The main risks identified were failures in data compilation or calculation, incorrect data consolidation and failures in the automatic reading system. A technological platform supports implementation and monitoring, reducing data processing errors, centralising data compilation, automating indicator calculation and report generation, and monitoring compliance in real time. Rovi developed two reporting manuals, one on the environment and one on human resources. Once the ICNFR was adopted, the bodies were informed and a periodic notification process was not considered necessary. Reference: page 8.
SBM-1Strategy, business model and value chainReported
Rovi describes its strategy, business model and value chain. It is a pan-European pharmaceutical company present directly in Spain, Portugal, Germany, France, the United Kingdom, Italy, Austria and Poland, listed on Spanish stock exchanges since 2007 and on the Ibex-35 since December 2021, with most employees in Spain (2,072). Growth is based on three areas: specialty pharmaceuticals (a portfolio of over 40 products across nine therapeutic areas, including low-molecular-weight heparins bemiparin and the enoxaparin biosimilar, and Okedi based on ISM technology), contract manufacturing (CDMO through subsidiary ROIS, including a ten-year agreement with Moderna for mRNA vaccines), and R&D&I focused on the ISM drug-delivery technology, patent protected until 2033. Rovi belongs to NACE Code 21, manufacture of pharmaceutical goods, and does not operate in fossil fuels, chemicals, controversial weapons or tobacco. Its value chain is divided into upstream (procurement and strategic manufacturing agreements), own operations (pre-manufacturing, manufacturing, commercial activity and out-licensing) and downstream (distribution, customers and product use), across ten activities. Reference: page 9.
SBM-2Interests and views of stakeholdersReported
Rovi discloses the interests and views of stakeholders. It identifies key stakeholder groups: employees, suppliers, shareholders and investors, customers, patients and healthcare professionals, the scientific community, society, and public and regulatory bodies, describing communication mechanisms and the responsible area for each. During the double materiality assessment, stakeholders participated in three of the four phases. In the identification phase, workforce representatives helped validate the IROs. In the assessment phase, 15 area managers contributed through questionnaires, 21 employees took part in a focus group assessing impacts, and 13 entities representing external stakeholders participated, giving 49 total participants; regulatory bodies were not engaged as public bodies. In the determination phase, material topics and IROs were validated with internal stakeholders. Rovi undertakes to integrate stakeholder interests from the assessment into the design of its new ESG Master Plan in 2025. The final results were shared with Senior Management and presented to the Board of Directors in December 2024. Reference: page 15.
SBM-3Material impacts, risks and opportunities and their interaction with strategy and business modelReported
Rovi discloses the material impacts, risks and opportunities resulting from its double materiality assessment. As a result of the identification phase, nine of the ten topical ESRS had associated IROs, with S3 Affected communities discarded during the understanding phase because Rovi's activity has no impact on local or distant communities or indigenous peoples. A total of 260 IROs were identified (164 impacts, 32 opportunities, 64 risks). After assessment, eight of the ten topical ESRS were found material: E1, E2, E3, E5, S1, S2, S4 and G1. E4 Biodiversity and ecosystems was not material, and S3 Affected communities was not material. An entity-specific topic, Digitalisation and artificial intelligence, was material with three opportunities. A total of 143 material IROs remained (121 impacts, 9 opportunities, 13 risks). Rovi describes material IROs per topic, covering climate change, pollution, water, circular economy, own workforce, value chain workers, consumers and end-users, and business conduct. In 2024 no risks or opportunities required adjustments to the consolidated accounts. Reference: page 21.
IRO-1Description of the processes to identify and assess material impacts, risks and opportunitiesReported
Rovi describes the processes used to identify and assess material impacts, risks and opportunities through a double materiality methodology divided into four phases: understanding, identification, assessment and determination. The understanding phase analysed the business model, business lines and value chain and defined key stakeholders. The identification phase drew on understanding of the Group, sector analysis, internal and external sources (including SASB, WBCSD, WEF and legislation), sustainability ratings (MSCI, Sustainalytics), the corporate risk map and the ESG Master Plan. Impacts were assessed using severity (magnitude, scope, irremediable character) multiplied by likelihood, and risks and opportunities using financial effect multiplied by likelihood, each on scales of 1 to 5. In the determination phase, the ESG team's assessment was weighted 60 percent and other stakeholders 40 percent, with thresholds set at the 50th percentile (value 2.6) for impact materiality and the 30th percentile (value 1.2) for financial materiality. The assessment found E1, E2, E3, E5, S1, S2, S4 and G1 material, while E4 Biodiversity and S3 Affected communities were not material. Reference: page 28.
IRO-2Disclosure requirements in ESRS covered by the undertaking's sustainability statementReported
Rovi discloses the ESRS disclosure requirements covered by its Report, based on assessment of all topics, sub-topics and sub-sub-topics in AR 16 of ESRS 1 under the double materiality principle. It reports the cross-cutting ESRS 2 requirements (BP-1, BP-2, GOV-1 to GOV-5, SBM-1 to SBM-3, IRO-1, IRO-2) and the minimum disclosure requirements MDR-P, MDR-A, MDR-M and MDR-T, together with topical standards for the material topics E1, E2, E3 and E5 (environmental) and the social and governance standards. Topic Affected communities (S3) was considered not applicable from the beginning of the assessment, as was E4 Biodiversity and ecosystems, which was not found material. Several sub-topics were excluded, including various E3 water and E4 biodiversity sub-topics, S1 and S2 adequate housing, E2 pollution of living organisms and substances of very high concern, S1 working time, S4 privacy and freedom of expression, and G1 whistleblower protection. The Report includes a table listing each disclosure requirement, the section in which it is reported and its page. Reference: page 34.
E1 – Climate Change
E1-1Transition plan for climate change mitigationReported
ROVI reports that it has a corporate action framework promoting actions to avoid, reduce and offset greenhouse gas emissions, but it has not formally drawn up a transition plan at corporate level that includes GHG emission reduction targets. The framework covers assessing and proposing energy-saving and efficiency measures, defining a renewable energy and guarantee of origin management plan, taking action on the supply chain and other indirect emission sources, and defining offsetting strategies and capture alternatives. In 2024, ROVI worked on specific studies at the Alcala de Henares and San Sebastian de los Reyes industrial plants to establish GHG emission reduction measures. These facilities were selected first because they generate the most Scope 1 emissions, though the plan will later be rolled out to all plants since many proposed actions can be extrapolated. The results of the 2024 studies will help the Group assess its capacity to prepare a corporate transition plan, though no specific date has been set for preparing, approving and adopting such a plan. Reference: page 63.
E1-4(was E1-2)Policies related to climate change mitigation and adaptationReported
ROVI reports a Corporate Climate Change Policy signed by the company chairman, covering all group companies and identifying specific aspects of climate change mitigation and adaptation. The Policy was updated in 2024 to reflect the latest developments. It sets three principles for action. AVOID: the priority is a net result of zero GHG emissions, balancing tCO2eq emitted with removal, working on the transition to renewable energy sources. REDUCE: neutrality is attained through emission reduction measures, energy efficiency projects and decarbonisation plans to cut fossil fuel energy consumption, plus consideration of raw material composition alternatives and efficient waste management prioritising recovery over elimination. COMPENSATE: Scopes 1 and 2 emissions that cannot be avoided or reduced are offset in their totality, and Scope 3 emissions are gradually offset through socially and environmentally responsible projects. The Policy addresses the material topics of climate change mitigation and adaptation and energy, and management of physical and transition risks. ROVI also has an Energy Policy for the Granada complex, approved by the Group's Industrial Manager, establishing principles to reduce energy consumption-related emissions and implement an energy management system. Reference: page 69.
E1-5(was E1-3)Actions and resources in relation to climate change policiesReported
ROVI reports that because it has no corporate transition plan, it cannot disclose mitigation actions with specific 2030 and 2050 targets. In 2024 it worked on studies to identify and plan actions to reduce its carbon footprint at the Alcala de Henares and San Sebastian de los Reyes plants, which generate most of the Group's emissions. ROVI is working on decarbonisation levers including energy efficiency, renewable energy use and fuel-change analysis. It installed solar panels and vehicle charging points at San Sebastian de los Reyes, entailing taxonomy CapEx of 46,628.64 euros and 10,394.72 euros respectively. Certifying the Escuzar complex under ISO 14001 in 2024 completed environmental management system certification, costing 4,791.60 euros. Numerous Scope 1 and Scope 2 energy-efficiency actions were implemented across the five industrial complexes (monitoring, boiler and LED upgrades, thermal insulation, photovoltaic installation), with self-consumption of energy reaching 6% in 2024. Scope 3 actions include requiring logistics operators to submit decarbonisation plans and evaluating alternative packaging. Mitigating 100% of 2023 Scopes 1 and 2 emissions cost 50,616 euros. Reference: page 70.
E1-6(was E1-4)Targets related to climate change mitigation and adaptationReported
ROVI reports that it does not currently have measurable targets aimed at specific GHG emission reduction, since it lacks a corporate transition plan. The Group has committed to adhere to the SBTi (Science Based Targets Initiative) in 2025. Although no targets have been fixed for 2030 and 2050, ROVI will continue with its annual corporate goal of reducing 100% of the Scopes 1 and 2 emissions that have not been avoided or reduced, as well as increasing the reduction of Scope 3 emissions, thereby monitoring the efficacy of its climate change policy and the actions linked to the material impacts, risks and opportunities. Energy consumption targets are defined at the start of each year after analysing the prior period. For Escuzar, the defined goal is to generate at least 260,528 kWh/year more energy for self-consumption in 2025 compared with total energy consumed in 2024. For the Granada complex, the goal is to reduce electricity and gas consumption by 2.2% and 2.87% respectively compared with 2024. Reference: page 73.
E1-7(was E1-5)Energy consumption and mixReported
ROVI reports that it belongs to a high climate impact sector, as pharmaceutical manufacturing is classified in NACE section C. In 2024, total energy consumption was 79,728.26 MWh. Total energy consumption from fossil sources was 44,325.00 MWh (56% of the total), comprising natural gas of 35,935.98 MWh, crude oil and petroleum products of 8,279.59 MWh, and 109.43 MWh of purchased non-renewable electricity. Total renewable energy consumption was 35,403.26 MWh (44.40%), all from purchased or acquired electricity, heat, steam and cooling from renewable sources. There was no coal, nuclear or biomass consumption. ROVI states that 100% of electricity consumed by all its production complexes and main offices comes from renewable sources with guarantee of origin. Renewable energy generated on-site via photovoltaic panels totalled 2,153.68 MWh in 2024. For comparison, 2023 consumption was 71,007,947.50 kWh and 2022 was 63,333,105.00 kWh. Energy intensity from pharmaceutical manufacturing per net revenue was 104.39 MWh. Reference: page 74.
E1-8(was E1-6)Gross Scopes 1, 2, 3 and Total GHG emissionsReported
ROVI reports gross GHG emissions by scope for 2024. Gross Scope 1 emissions were 9,565.80 tCO2eq (up 26.51% from 8,240.43 in 2023). Gross location-based Scope 2 emissions were 9,243.18 tCO2eq (up 15.79%), while gross market-based Scope 2 emissions were 37.46 tCO2eq (down 94.39% from 50.84 in 2023). Total gross Scope 3 emissions were 12,099.63 tCO2eq (up 13.66%), with the main categories being purchased goods and services of 5,186.28, waste generated in operations of 3,352.12, employee commuting of 2,377.91, business travel of 578.03, downstream transportation of 474.83, and upstream transportation and distribution of 130.46. Total location-based emissions were 30,908.61 tCO2eq (up 18.02%) and total market-based emissions were 21,702.89 tCO2eq (up 14.98%). ROVI confirms no Scopes 1 and 2 biogenic emissions. GHG intensity per net revenue was 12.10 tCO2e location-based and 0.05 tCO2e market-based. Emissions were consolidated using the control approach with MITECO, DEFRA 2024 and other emission factors. Reference: page 75.
E1-9(was E1-7)GHG removals and GHG mitigation projects financed through carbon creditsReported
ROVI reports that in 2024 it carried out two national and international CO2 offset projects. With a national scope, it took part in the "Ibereucaliptos, S.A." forest restoration and sustainable forest management project to recover land affected by a 2019 fire on the "El Vinagre" property in Paterna del Campo and Berrocal, Huelva. Through it, ROVI obtained the "Compensate" seal linked to the Carbon Footprint Register of MITERD. The carbon credits from this removal project come from biogenic sinks and represented a total cost of 49,676.55 euros, offsetting 1,500 tCO2. With an international scope, ROVI participated in the Zhejiang Tangcun hydroelectric project, expanding the 9.13 MW plant to 32 MW. The credits from this reduction project come from the UNFCCC and represented a total cost of 10,064.25 dollars, offsetting 13,500 tCO2. The disclosed carbon credits cancelled totalled 15,000 tonnes of tCO2, with 10% from removal projects and 90% from reduction credits (10% MITERD, 90% UNFCCC, 10% in the EU). ROVI has not defined the total future carbon credits it intends to cancel. Reference: page 77.
E1-10(was E1-8)Internal carbon pricingReported
ROVI reports that it does not currently have an internal carbon pricing system and, therefore, the disclosure of the rest of the information associated to this Disclosure Requirement is not applicable. Reference: page 78.
E1-11(was E1-9)Anticipated financial effects from material physical and transition risks and potential climate-related opportunitiesReported
ROVI reports that, in accordance with Appendix C of ESRS 1 (the list of phased-in Disclosure Requirements), in the present year it is applying the exemption from disclosing the quantification of the anticipated financial effects in monetary terms related to physical and transition risks. The company may omit the information to which this Disclosure Requirement refers in the first year of preparation of its Report, and may disclose only qualitative information for the first three years of preparation of the statement. Accordingly, ROVI states it will not provide a description of the effects considered or the basic assumptions used to quantify the anticipated financial effects. Reference: page 78.
E2 – Pollution
E2-1Policies related to pollutionReported
ROVI does not currently have a corporate policy that specifically addresses the prevention and control of pollution, the pollutants or specific substances emitted by its industrial activity, contribution to the EU action plan "Zero pollution for air, water and soil", or reduction of its pollution footprint. No corporate policy addresses the mitigation of negative impacts, the prevention of incidents and emergency situations derived from pollution, or the minimisation or replacement of substances of concern and of very high concern. Notwithstanding, the Environmental Management Policy and the Environmental and Social Sustainability Policy address ROVI's impact on the environment in general terms, including the prevention of pollution. The Group has emission and discharge control procedures and specific environmental monitoring plans based on its environmental authorisations. These plans cover the control of pollutant emissions to air, the remediation of environmental damages, and soil pollution. The procedures form ROVI's management framework for operational decision-making on pollution and are reviewed periodically to ensure compliance with environmental rules and standards. Reference: page 80.
E2-2Actions and resources related to pollutionReported
ROVI's pollution actions focus on its own operations, since the Group is unable to act on upstream or downstream value chain phases. The potentially material pollution activity is carried out at its five industrial plants, where ROVI complies with its environmental and emission authorisations and does not exceed any established thresholds, making the actions mainly preventive. For air pollution, controls are set according to boiler power. At the Granada Complex, elimination of VOC emissions from truck manholes during solvent waste tanker loading was achieved, representing an investment of 2,272.19 euros. As of December 2024, Total Organic Carbon levels (source P1G4) were kept 12% below the legal limit of Royal Decree 117/2003 (20 mg/m3), an expense of 139,700 euros. Diffuse emissions from storage installations were reduced versus 2023 at a total expense of 3,167.40 euros. For water, visual inspections are conducted where chemical products are stored; a diesel oil pocket remediation at Julian Camarillo is being concluded. Soil pollution is not material in own operations, though a control process runs every 5-8 years; at San Sebastian de los Reyes, absorbent supervision actions were doubled at a cost of 653.70 euros. ROVI takes no action on microplastics. Reference: page 80.
E2-3Targets related to pollutionReported
ROVI's approach to air pollution focuses on ensuring pollutant emissions stay within legal limits and, in many cases, well below them. For 2025, the Escuzar Complex has set a target of eliminating, compared to 2024, the emissions of volatile organic compounds (VOCs) generated through the manholes of trucks during the loading process of solvent waste tankers. For both the Escuzar and Granada Complexes, a goal has been set to maintain, as of December 2025, the VOC emission levels (emission source P1G4) 10% and 12% respectively below the applicable legal limits established in Royal Decree 117/2003 on the limitation of VOC emissions due to the use of solvents (20 mg/m3). Given that the industrial environment in Spain is highly regulated, ROVI monitors possible pollutants of air, water and soil and keeps emissions below legal limits. Therefore, ROVI does not consider it necessary to set specific targets related to the control of air pollutants, emissions to water, pollution of soil, and substances of concern and very high concern. At all plants, emissions to air come from combustion points such as boilers, which are habitually below the permitted limits. Reference: page 81.
E2-4Pollution of air, water and soilReported
This Disclosure Requirement identifies the pollutants ROVI emits from its industrial activity and the microplastics it generates. Regarding the pollutants emitted to air, water and soil listed in Annex II of Regulation (EU) 166/2006, the amounts emitted are not reported since, in 2024, the applicable threshold values specified in that Annex were not exceeded. The data are gathered from regulatory spot measurements and the calculation is made in accordance with the Recovery, Transformation and Resilience Plan. In 2023, 9,589 kg/year of NOx (9,759 in 2022) and 1,445 kg/year of SOx (1,551 in 2022) were emitted. Reference: page 82.
E2-5Substances of concern and substances of very high concernReported
This Disclosure Requirement requires information on the total amount of substances of concern generated as a result of the production, use, distribution, marketing, importation and exportation of pharmaceutical or healthcare products. For 2024, ROVI will not report information in this respect since, as a result of the double materiality assessment, only one negative impact related to substances of concern downstream was found to be material, namely the end of the useful life of ROVI products. Reference: page 82.
E2-6Anticipated financial effects from pollution-related impacts, risks and opportunitiesReported
ROVI has not identified any material pollution-related risks or opportunities and, therefore, the quantification of their anticipated financial effects would not be applicable. Reference: page 82.
E3 – Water and Marine Resources
E3-1Policies related to water and marine resourcesReported
At present, ROVI does not have a corporate water resource-related policy that specifically considers questions such as the use and sourcing of water resources in its own operations, water treatment as a step towards more sustainable sourcing of water, or the prevention and abatement of water pollution resulting from its activity, although these are implicit in ROVI's sustainable and efficient resource management. Notwithstanding, the Environmental Management Policy and the Environmental and Social Sustainability Policy consider the sustainable use of resources, including water resources, although the impacts and risks identified as material for ROVI are not considered explicitly. ROVI has two manufacturing facilities in Granada currently subject to water-stress climate risk, which will become significant in 2050 and could give rise to interruptions in activity due to a potential lack of supply. In its Environmental Management Policy, ROVI confirms its commitment to establishing plans for mitigating and reducing water consumption in high water-stress areas. These locations are included under a certified environmental management system and a water-stress risk mitigation plan that establishes specific measures to mitigate a manufacturing interruption caused by a potential cut in the water supply to the Granada facilities, as well as water consumption reduction targets. Reference: page 83.
E3-2Actions and resources related to water and marine resourcesReported
ROVI has five industrial production facilities that consume water for manufacturing, which may affect water resource availability. Water consumption is not a significant environmental aspect at the Alcala de Henares facility, where only control, monitoring and measurement are applied. As a general principle, in new projects or the acquisition of water-intensive equipment, ROVI strives to optimise and reduce water use. In 2024, at the two Granada centres in high water-stress areas, ROVI worked on a mitigation plan; for 2025 a measure proposes installing a 40 m3 water storage tank at both facilities, with an estimated CapEx of 65,000 euros. At the Julian Camarillo complex, ROVI updated its Sustainable Water Management Plan (2022-2025); 2024 actions included thermal insulation of steam tubes (CapEx of 1,620 euros for insulating blankets and 1,138 euros for insulation jackets), weekly meter readings, and daily leak monitoring. At San Sebastian de los Reyes, water meters were installed on watering tanks and water-intensive equipment, with CapEx of 10,344 euros in 2024. ROVI operates a condensate recovery system, and 100% of water rejected by vial washers and purifying plants is stored for watering. Reference: page 84.
E3-3Targets related to water and marine resourcesReported
At present, the Group only has measurable, time-bound and outcome-oriented targets to manage the material impacts and risks identified at the Julian Camarillo complex under the legally required Sustainable Water Plan (2022-2025), validated by the relevant authority. For the San Sebastian de los Reyes complex, an objective of reducing water consumption by 2% compared to 2024 has been established. At Julian Camarillo, water serves commercial and industrial use; a forecast annual reduction target of 10-15% of the initial annual consumption (2022) has been set for commercial consumption. This goal is absolute and not based on scientific evidence. As of 31 December 2024, the reduction in consumption had been 23% compared with 2020 consumption, basically due to the replacement of one chiller by a higher-performance unit with lower water consumption. At the rest of the plants, ROVI monitors the efficacy of actions, though reducing water consumption is complex given that water is an essential resource in medicine manufacturing. The Group plans short- and medium-term targets adapted to each location, including future targets for Julian Camarillo, San Sebastian de los Reyes, Alcala de Henares, and medium-term water consumption reduction targets for the Granada complexes aligned with the water-stress risk. Reference: page 85.
E3-4Water consumptionReported
In 2024, ROVI's water consumption totalled 227,272.23 m3, of which 53,811.80 m3 was consumed in high water-stress areas (23,844.80 m3 at Escuzar and 29,967.00 m3 at Granada). Total consumption by site was Escuzar 23,844.80 m3, Granada 29,967.00 m3, Madrid 36,867.84 m3, SSRR 69,214.08 m3, Alcala de Henares 61,023.00 m3, and Distribution 6,355.52 m3. By comparison, 218,584 m3 was consumed in 2023 and 206,487 m3 in 2022. The specific technical requirements for water used in injectables manufacturing and equipment cleaning considerably limit ROVI's capacity to recycle process water. In 2024, ROVI did not recycle any water but reused 2,472.00 m3 (all at SSRR) for activities such as watering, and stored 7,858.00 m3 (all at SSRR). Figures for variations in stored water will be shared next year, since the meters were installed in the tanks in 2024. Water intensity was 70.46 m3 per million euros of revenue. ROVI uses direct meter readings, with some months estimated where devices were installed in 2024 or where invoices are issued every two months. Reference: page 86.
E3-5Anticipated financial effects from water and marine resources-related impacts, risks and opportunitiesReported
In accordance with Appendix C of ESRS 1 (List of phased-in Disclosure Requirements), in the present year ROVI will not disclose the quantification of the anticipated financial effects related to water resources in monetary terms, given that the Company may omit the information related to this Disclosure Requirement in the first year of preparation of the Report. Additionally, ROVI may disclose only qualitative information for the first three years of preparation. Neither will it provide a description of the effects considered or the basic assumptions used to quantify the anticipated financial effects. Reference: page 87.
E5 – Resource Use and Circular Economy
E5-1Policies related to resource use and circular economyReported
ROVI has two corporate policies that address resource use and circular economy. The Environmental and Social Sustainability Policy covers efficient resource management in general terms. The Environmental Management Policy includes an analysis of the raw materials used in the Group's processes with the objective of seeking sustainable alternatives. Both policies have been signed by the company chairman and apply to all Group companies. The principles for action set out in these policies are directly linked to the material topics derived from the double materiality assessment: resource inflows, resource outflows and waste. Reference: page 89.
E5-2Actions and resources related to resource use and circular economyReported
ROVI does not have formally established sustainable purchasing criteria but operates processes for purchasing management and control from supplier selection through to waste leaving its facilities. In 2022 it incorporated the joint venture Glicopepton Biotech, S.L. to achieve greater vertical integration in heparin supply through a circular economy model, reducing dependence on pig mucosa suppliers. Four production lines have replaced plastic packaging with cardboard for one customer, and recycled and recyclable blister packaging is being studied. In 2024, 100% of hazardous waste from rejected medicines was recovered and 12.05% of non-hazardous waste (paper, cardboard, plastic trays and racks). The Group applied the Prevention and Ecodesign Business Plan (PEPE 2024-2028), adhered to SIGRE (total expenses of 88,303.92 euros) and its extended producer responsibility system, and ran the vial recovery initiative Plan Recicla. The distribution area increased non-hazardous waste recycling by 23.08% against a 10% target. Reference: page 89.
E5-3Targets related to resource use and circular economyReported
ROVI does not currently have measurable, time-bound and outcome-oriented targets for the material topic resource inflows, and purchasing criteria do not include environmental objectives such as increasing circular product design or circular material use rate. The Group is working on a new waste minimisation plan for 2025-2028 with time-bound and outcome-oriented targets to address resource and waste outflows. Following failure to meet certain 2020-2024 objectives, targets carried forward include a 5% reduction in biosanitary waste and 2% reduction in shrink-wrap plastic at Alcala de Henares, reductions in medicine waste packaging plastic (20%) and filters at Julian Camarillo, and at Escuzar reductions of at least 5% in laboratory reagent waste (EWC 160506), 10% in contaminated waste (EWC 150202), 2% in contaminated absorbents, and 20% in non-hazardous saline waste (EWC 161002). Reference: page 91.
E5-4Resource inflowsReported
In 2024 the total weight of materials used was 5,236.71 tonnes, up from 3,998 tonnes in 2023 and 4,928 tonnes in 2022. This comprised 1,202.59 tonnes of biological material (recycled paper and cardboard from certified forests) and 4,034.12 tonnes of technical material of synthetic origin. Biological products represented 23% of the total. Within the breakdown, active ingredients accounted for 68.10 tonnes, excipients 392.90 tonnes, reagents 0.01 tonnes, primary packaging materials 791.70 tonnes, secondary packaging materials 1,910.41 tonnes and tertiary packaging materials 871.00 tonnes. For reused and recycled components and materials, secondary materials totalled 3,113 tonnes, reported at 100%, while reused or recycled secondary components and secondary intermediate products were not applicable and shown as not available. Reference: page 92.
E5-5Resource outflowsReported
ROVI does not set forecast durability or repairability measures because its specialty pharmaceutical products have specific durability and consumption periods, but it is analysing packaging alternatives containing recycled material. Total hazardous waste generated in 2024 was 4,658.53 tonnes (5,163 tonnes in 2023; 5,223 tonnes in 2022) and total non-hazardous waste was 5,225.74 tonnes (4,215 tonnes in 2023; 3,703 tonnes in 2022). Hazardous waste not intended for disposal (diverted) totalled 1,317.34 tonnes, of which 561.45 tonnes recycling and 755.89 tonnes other recovery. Non-hazardous waste not intended for disposal totalled 2,749.78 tonnes, of which 993.88 tonnes recycling and 1,755.90 tonnes other recovery. The total percentage of non-recycled waste was 25.89%. Hazardous waste for disposal was 3,339.36 tonnes and non-hazardous waste for disposal 2,375.16 tonnes. A change in Granada liquid halogenated waste management shifted a high percentage to disposal. Reference: page 93.
E5-6Anticipated financial effects from resource use and circular economy-related impacts, risks and opportunitiesReported
Pursuant to Appendix C of ESRS 1 (List of phased-in Disclosure Requirements), ROVI will not disclose the quantification in monetary terms of the anticipated financial effects of material resource use and circular economy-related risks for this year, since the Company may omit this information in the first year of preparation of the Report. Additionally, ROVI may disclose only qualitative information for the first three years of preparation. The Company also will not provide a description of the effects considered or the basic assumptions used to quantify the anticipated financial effects. In other words, the anticipated financial effects cannot yet be quantified and are not disclosed. Reference: page 98.
E5-5(was E5-5-Waste)WasteReported
In 2024 ROVI generated 4,658.53 tonnes of hazardous waste (down from 5,163 tonnes in 2023) and 5,225.74 tonnes of non-hazardous waste (up from 4,215 tonnes in 2023) across its Escuzar, Granada, Madrid, SSRR, Alcala de Henares and Distribution sites. Waste diverted from disposal (not intended for disposal) reached 1,317.34 tonnes of hazardous waste, split between 561.45 tonnes recycling and 755.89 tonnes other recovery, and 2,749.78 tonnes of non-hazardous waste, split between 993.88 tonnes recycling and 1,755.90 tonnes other recovery. The total percentage of non-recycled waste was 25.89%. Waste intended for disposal comprised 3,339.36 tonnes of hazardous waste (including 3,112.52 tonnes other disposal operations, 113.80 tonnes incineration without energy recovery, 67.98 tonnes incineration with energy recovery and 45.06 tonnes to dump) and 2,375.16 tonnes of non-hazardous waste. Reference: page 93.
S1 – Own Workforce
S1-1Policies related to own workforceReported
ROVI reports a suite of policies related to its own workforce, all connected to the material impacts and risks from its double materiality assessment. These include the Human Rights Policy, the Code of Ethics, the Occupational Risk Prevention Management Policy, the Environmental and Social Sustainability Policy, the Work-Life Balance Policy, the Director Remuneration Policy, the Equality Plan (in force until 2026), the Training Policy, the Protocol for Preventing and Handling Cases of Moral and Sexual Harassment, the Working Day Register Policy and the Policy on Use of ICT Resources. Most were signed by the Company chairman and apply to all Group companies. ROVI reaffirms its commitment to the Universal Declaration of Human Rights, the United Nations Global Compact and the ILO Fundamental Conventions. A Protocol against harassment of the LGBTI community is under preparation, pending agreement with the Works Council. ROVI supports the workplace inclusion of people with disabilities but notes it has not yet made policy commitments regarding workers in groups at special risk of vulnerability. Reference: page 103.
S1-2Processes for engaging with own workforce and workers' representatives about impactsReported
ROVI describes its processes for engaging with its own workforce and workers' representatives through social dialogue based on transparency, legal compliance and respect. This engagement lets the Company understand workers' perspectives in its decision-making, although the Group does not evaluate the efficacy of this engagement. Communication is maintained through regular meetings for negotiation, information and consultation, with the aim of resolving incidents through negotiation and agreement, taking matters to court only as a last resort. The Ethics Channel is available as a reporting mechanism, and the Works Council takes part in investigations unless the whistleblower requests otherwise. Ultimate responsibility for handling cases sits with the Human Resources Manager, the Internal Audit Manager and the Head of Compliance, while the relationship with workers' representatives is held by the Human Resources Manager. No formal evaluation of engagement is currently made. ROVI also uses suggestion boxes for anonymous input, checked periodically by the Performance Team, and implements accessibility measures for workers with disabilities. Reference: page 104.
S1-2(was S1-3)Processes to remediate negative impacts and channels for own workforce to raise concernsReported
ROVI reports several internal channels for its workforce to raise suggestions, complaints or queries, using both physical and digital mailboxes. The main remediation channel is the Ethics Channel, managed by an external party that receives all communications and allows whistleblowers to remain anonymous through a secure mailbox. Confidentiality and non-retaliation are ensured by the Policy on the Internal Whistleblowing and Whistleblower Protection System, approved by the Board of Directors. Reports are investigated and resolved by the Ethics Channel Management Committee, formed by the Internal Audit Manager, the Head of Compliance and the Human Resources Manager, which proposes action plans to correct proven infringements. Cases are notified to the Audit Committee every four months and summarised annually to the Board. The Ethics Channel Policy was updated in 2024. ROVI does not evaluate the degree of trust its workers place in these mechanisms. The Social Performance Team meets management and workers' representatives at least every six months. In 2024, 117 communications were received through this channel. A health and safety procedure, SOPc811 Accident Investigation, lets workers report unsafe actions and conditions. Reference: page 105.
S1-3(was S1-4)Taking action on material impacts on own workforceReported
In 2024 ROVI implemented actions to promote positive impacts and address risks for its own workforce. It notes no actions were taken to remediate negative impacts, as none were identified in the materiality process. Workday was implemented to strengthen talent management, representing an investment of 1,499,185.16 euros. Leadership and team management training was provided to professionals in new roles. In collaboration with consultant Lukkap, ROVI ran a study to improve employee experience and an analysis of rising employee turnover, together costing 42,425.02 euros. In health and safety, the Group ran an accident prevention campaign for the World Day for Safety and Health at Work and underwent audits to certify the non-industrial business under ISO 45001:2015. Complex-level actions included risk reductions and training increases at Alcala de Henares, San Sebastian de los Reyes, Julian Camarillo, Granada and Escuzar, with itemised investments such as 7,860 euros for tilting guardrails and 22,000 euros for noise reduction. Accessibility works in Pozuelo de Alarcon cost about 1,350 euros. The responsible area monitors completion and evaluates efficacy. Reference: page 106.
S1-4(was S1-5)Targets related to own workforceReported
ROVI reports that it does not currently have measurable, time-bound and outcome-oriented targets to manage the material impacts and risks identified for its own workforce, and does not plan to establish them in the short term, partly because its double materiality process did not identify any material negative impact requiring mitigation. Notwithstanding this, the Group has set health and safety objectives at complex level, including risk reductions from moderate to tolerable at Alcala de Henares and a 30% risk reduction for logistics personnel positions at San Sebastian de los Reyes, plus training increases at Escuzar and Granada. At Group level, targets for 2025 are to attain accident incidence rates of 1% with days lost and 2% without days lost, and an accident rate of 3% for temporary employment company and external employees. For 2025 and 2026, ROVI aims to optimise human capital management and develop internal talent by extending career plans and performance evaluation, and to launch an integrated training plan through Workday. The risk map will be updated in 2025 and targets added to the ESG Master Plan on its update after 2025 expiry. Reference: page 107.
S1-5(was S1-6)Characteristics of the undertaking's employeesReported
ROVI reports 2,197 total employees as of 31 December 2024, with 2,072 in Spain and the remainder across Germany (52), Italy (44), Portugal (15), France (6), Austria (4), the United Kingdom (3) and Poland (1). By gender there were 1,043 men and 1,154 women, with 0 in the Other and Not reported categories (up from 2,111 in 2023 and 1,993 in 2022). By contract type, 1,994 employees were permanent and 203 were temporary, with 0 non-guaranteed hours employees. Permanent full-time employees numbered 1,927 and permanent part-time 67, while temporary full-time were 171 and temporary part-time 32. In Spain, 1,870 were permanent and 202 temporary. Temporary contracts cover situations such as partial retirements, training contracts, and cover for absences and seasonal production needs. During 2024, 146 people left voluntarily (56 men, 90 women), and the turnover rate, including voluntary departures, dismissals, retirements and deaths, was 10.74%. The Group notes 2023 data by country are not available. Reference: page 108.
S1-6(was S1-7)Characteristics of non-employee workersReported
ROVI reports the characteristics of non-employees in its own workforce, which it defines as workers hired through temporary employment companies (ETTs). At the reporting date there were 132 non-employees, comprising 42 men and 90 women, with 0 in the Other and Not reported categories. The average number of non-employees in the workforce during 2024 was 308.17, made up of 121.50 men, 186.67 women and 0.00 in the Other and Not reported categories. These figures relate to non-employees working at the centres in Spain and at the subsidiaries. Elsewhere in the chapter, the Group notes that most ETT workers carry out tasks related to filling injectables and manufacturing solid products, usually concentrated in periods of higher seasonal demand, and that its non-employee workforce also includes one self-employed person who holds the position of Security Manager. Reference: page 111.
S1-7(was S1-8)Collective bargaining coverage and social dialogueReported
ROVI reports on collective bargaining coverage and social dialogue in the European Economic Area. In Spain, all Group workers are covered by the Collective Agreement of the Chemical Industry, a national agreement that has improved on the conditions of the Workers' Statute. Workers at the European subsidiaries follow the collective agreements at each geographical location, except in jurisdictions where general labour law applies by law, which affects locations where the Group has a low number of employees. In the disclosed coverage table, Spain falls in the 80-100% band for both collective bargaining coverage and social dialogue for employees in the EEA. The Group notes that in previous years 100% of employees in Spain were subject to a collective bargaining agreement. Reference: page 112.
S1-8(was S1-9)Diversity metricsReported
ROVI reports diversity metrics covering gender in top management and the age distribution of its workforce. On the Management Committee, which is defined as top management, there were 9 men and 4 women in 2024 (0 in the Other and Not reported categories), giving a total of 13 members and a women's share of 30.77%, unchanged from 30.77% in 2023 and up from 25% in 2022. By age, the workforce of 2,197 employees comprised 494 aged under 30, 1,223 aged 30 to 50, and 480 aged over 50. The Group notes that age ranges were adjusted to meet CSRD requirements, so the data are not directly comparable with the previous brackets used in 2023 and 2022. Reference: page 112.
S1-9(was S1-10)Adequate wagesReported
ROVI reports on adequate wages, confirming that all its employees receive an adequate wage in accordance with the benchmarks applicable in each country. The Group states there are no cases in which employees receive wages lower than the amount defined by the legislation in any of the countries where it operates. This aligns with the material positive impact identified in the assessment relating to the Group's commitment to the well-being of its workers, and with the average wage rise of 4.6% for all employees under the collective agreement noted elsewhere in the chapter. Reference: page 113.
S1-10(was S1-11)Social protectionReported
ROVI reports that, in accordance with Appendix C of ESRS 1 on the list of phased-in Disclosure Requirements, it will not disclose the information on social protection in relation to 2024. The Company states it may omit the information on this Disclosure Requirement in the first year of preparation of the Report and has chosen to apply that phase-in provision. Reference: page 114.
S1-11(was S1-12)Persons with disabilitiesReported
ROVI reports the number of persons with disabilities in its own workforce as of 31 December 2024, covering both the Spanish centres and the subsidiaries. There were 30 employees with disabilities in total, comprising 16 men and 14 women, with 0 in the Other and Not reported categories. This represents 1.36% of the workforce. The Group notes that, unlike previous years, the Report includes the additional Other and Not reported categories, and that 35 employees had disabilities in 2023 and 37 in 2022. Reference: page 114.
S1-12(was S1-13)Training and skills development metricsReported
ROVI reports training and skills development metrics for its own workforce. In 2024, 43.18% of employees received performance reviews, broken down as 38.84% of men and 47.11% of women. The average number of training hours per employee was 28.09, comprising 27.77 hours for men and 28.40 hours for women. The Other and Not reported categories are shown as not applicable for both metrics. Gender is as specified by the employees themselves. These metrics support the Group's stated commitment to ongoing training and development under its Training and Development Policy. Reference: page 114.
S1-13(was S1-14)Health and safety metricsReported
ROVI reports health and safety metrics for 2024. Its health and safety management system covered 94.31% of employees and 100% of non-employee workers. There were 86 recordable work-related accidents among employees (43 men, 43 women), with a frequency rate of 13.43%, a severity rate of 0.41% and an incidence rate of 3.91%. Of the total, 18 were in itinere, 38 occurred in the workplace with days lost and 30 did not lead to lost days. There were 0 work-related fatalities and 0 cases of work-related ill health, consistent with 2023 and 2022. The number of days lost was 33,340, of which 2,648 were due to work-related accidents. For non-employee workers (temporary employment company workers) whose work or workplaces are controlled by the organisation, there were 0 fatalities and 30 recordable accidents, with a frequency rate of 52.01%, a severity rate of 0.22%, an incidence rate of 22.73% and 128 days lost. The Group notes 2024 figures are not comparable with prior years due to a change in scope. Reference: page 115.
S1-14(was S1-15)Work-life balance metricsReported
ROVI reports work-life balance metrics for 2024, covering entitlement to and take-up of family-related leave. All employees were entitled to family-related leave, with 100% entitlement for both men and women, giving a total of 100%. During 2024, 6.57% of employees took family-related leave in total, broken down as 6.57% of men and 6.56% of women. The Other and Not reported categories are shown as not applicable. Gender is as specified by the employees themselves. Working time was assessed as not a separate material sub-topic; work-life balance is reported as a material positive impact linked to the best employment practices. Reference: page 117.
S1-15(was S1-16)Compensation metrics (pay gap and total compensation)Reported
ROVI reports remuneration metrics, including the gender pay gap and the total remuneration ratio. The pay gap for 2024 was 4.46%, calculated as the difference between the average gross hourly remuneration of male and female employees divided by the average gross hourly remuneration of male employees. This compares with 6.35% in 2023 and 7.13% in 2022, though the Group notes the figures are not comparable because the calculation methodology changed from the previous GRI-based approach and now includes remuneration in kind in the 2024 average. The remuneration ratio, comparing the total compensation of the highest-paid person to the median, was 2,519.21. The data relate to employees at the centres in Spain and at the subsidiaries, and the average wage used includes basic wage, variable remuneration and payment in kind. Reference: page 118.
S1-16(was S1-17)Incidents, complaints and severe human rights impactsReported
ROVI reports incidents, complaints and severe human rights impacts within its own workforce for 2024. There were 10 total incidents of discrimination (including harassment) received, of which 0 were classified as harassment after investigation. A total of 7 complaints were submitted through channels for the own workforce. The total amount of fines, penalties and compensation for damages resulting from these incidents and complaints was 0. On human rights, there were 0 severe human rights incidents related to the own workforce, 0 classified as human rights violations after investigation, and 0 in fines, penalties and compensation. The Group notes that no reports were received through the Ethics Channel in relation to possible human rights violations in previous years. Reference: page 118.
S2 – Workers in the Value Chain
S2-1Policies related to value chain workersReported
In 2024, ROVI developed and implemented a Human Rights Policy, signed by the company chairman, which sets out principles derived from the Group's commitment to international human rights standards, aiming to prevent its activities and business relations from causing or contributing to negative human rights impacts. Its scope covers ROVI workers as well as the workers of suppliers, distributors, consultants and other value chain business partners, who must comply with all human rights aspects. The Group has a mandatory supplier evaluation procedure with metrics linked to the policy, applied before any contract is signed, and a confidential Ethics Channel to report conduct that violates human rights. Related corporate policies include the Supplier Evaluation and Approval Procedure, the Environmental and Social Sustainability Policy, and the Code of Ethics for Suppliers. The mandatory Code of Ethics for Suppliers establishes principles covering elimination of forced or compulsory labour and child labour, respect for freedom of association and collective bargaining, equal opportunities and non-discrimination, a fair workplace free from violence, and compliance with working hours and remuneration legislation. As a member of the United Nations Global Compact, ROVI promotes its principles and the ILO Fundamental Conventions. Reference: page 122.
S2-2Processes for engaging with value chain workers about impactsReported
ROVI has an Ethics Channel as a communication mechanism applicable to all value chain workers, through which employees and any stakeholder, including suppliers and customers, may report irregularities relating to regulatory compliance or ethics. For non-employee workers on ROVI sites, a specific coordinator designated by the collaborating entity acts as the point of contact between the worker and ROVI, receiving reports and requests about the service provided. There is continuous collaboration during the workers' stay at ROVI facilities. For workers at industrial plants, the management of each complex is responsible for collaboration, and for the non-industrial area it is the Human Resources Department, with the corporate Health and Safety Department overseeing compliance with Coordination of Business Activities in both cases. The Coordination of Business Activities procedure ensures health and safety, defining the information exchange required before any job begins and the safety measures to adopt. A platform reviews documentation from hired companies and authorises external access to facilities. An incident investigation procedure requires subcontracted workers to report and record accidents, with an accident rate target and action plans if exceeded. ROVI evaluates collaboration efficiency through access control monitoring, work authorisations, safety inspections and internal audits. Reference: page 123.
S2-2(was S2-3)Processes to remediate negative impacts and channels for value chain workers to raise concernsReported
To help remediate negative impacts, ROVI uses the Ethics Channel. The Group has appointed an external Ethics Channel manager who receives all communications, allowing whistleblowers to remain anonymous if they wish and providing a secure communications mailbox. To ensure whistleblower privacy, ROVI has established a Policy on the Internal Information System and Whistleblower Protection, approved by the Board of Directors and published on the Group's website, which recognises the confidentiality of all communications made through the channel, and channel users are protected by rights of confidentiality and non-retaliation. Reports are investigated by the Ethics Channel Committee, formed by the Internal Audit Manager, the Head of Compliance and the Human Resources Manager. The Audit Committee is informed of the channel's content every four months and a summarised report is submitted to the Board of Directors annually. Value chain workers are aware of the channel and of the Policy on the Internal Information System and Whistleblower Protection, which was updated in 2024, since both are available on the ROVI Group website in the Ethics Channel section. Suppliers can find a detailed explanation in the Code for Suppliers, and some contracts include a specific clause on this. Reference: page 124.
S2-3(was S2-4)Taking action on material impacts on value chain workersReported
ROVI does not have a Human Rights Due Diligence process and, therefore, has not identified potential adverse impacts it could be generating on value chain workers. Consequently, it has not taken specific actions to mitigate risks or pursue opportunities relating to these workers, and has not described whether its actions aim to prevent, mitigate or remediate the negative impacts identified. Notwithstanding, the Group is progressing towards supply chain sustainability by controlling and monitoring suppliers. It seeks supplier adherence to the mandatory Code of Ethics for Suppliers, whose content is equivalent to ROVI's internal Code of Ethics. As a novelty in 2024, a Sustainable Purchasing Questionnaire for suppliers was implemented to help mitigate potential adverse impacts in ethical, social and environmental areas; a self-declaration questionnaire addressing respect for employees' fundamental rights is mandatory before any contract is signed. Since 2020, ROVI has used the EcoVadis platform, evaluating suppliers on Environment, Human Rights and Labour Practices, Ethics, and Sustainable Purchasing. The ESG and Quality areas review scores, focusing on high-risk suppliers (below 25 out of 100), for whom action plans are established and monitored. EcoVadis expense totalled 25,965.89 euros. As in 2023, no serious human rights problems were reported in the value chain in 2024. Reference: page 124.
S2-4(was S2-5)Targets related to managing material negative impacts, advancing positive impacts, and managing material risks and opportunitiesReported
At present, the Group does not have measurable, time-bound and outcome-oriented targets for managing the material impacts and opportunities identified in relation to value chain workers, and it does not plan to establish them in the short term. However, ROVI monitors the efficacy of the measures relating to the identified impacts, risks and opportunities by establishing future actions. Regarding the Sustainable Purchasing Questionnaire implemented in 2024, it will be sent to suppliers with whom a business relationship already exists, in order to gradually increase the proportion of suppliers who complete it. Additionally, as in previous years, ROVI undertakes to strive to achieve the adhesion of a higher number of suppliers to the EcoVadis platform in the years to come, reviewing their respective scores annually. Lastly, ROVI will monitor its Human Rights Policy in a similar way to its other policies, identifying the need to revise and update it when necessary. Reference: page 125.
S4 – Consumers and End-Users
S4-1Policies related to consumers and end-usersReported
ROVI has several policies related to consumers and end-users, accessible on its corporate website. The Quality Policy, signed by the chairman and applicable to all Group companies, establishes quality as a strategic pillar with consumers and users as the main priority. The Code of Ethics is the basis for all Group policies and commits ROVI to offering innovative, high-quality products. The Policy on access to medicines sets out principles governing society's access to ROVI's medicines and health services. The Ethical Marketing Policy, approved by the Compliance Committee and mandatory for all Group companies, sets ethical criteria for marketing strategies. The Human Rights Policy establishes principles regarding the human rights of stakeholders, including consumers and end-users. The Pharmacovigilance Policy addresses risks associated with marketed medicines, and a Pharmacovigilance Privacy Policy describes the processing of personal data obtained for pharmacovigilance purposes. Further policies include the Environmental and Social Sustainability Policy and the Policy on the Internal Information System and Whistleblower Defence. The Group also follows the Quality Manual (GLP), a Pharmacovigilance protocol, WHO Ethical Criteria for Medicinal Drug Promotion, and the EFPIA, AKG and APIFARMA codes, applying GMP, GLP and GCP standards for clinical trials. Reference: page 129.
S4-2Processes for engaging with consumers and end-users about impactsReported
ROVI has channels for engaging with patients and healthcare professionals, since active communication is essential to providing product quality and safety with transparency and integrity. Through this engagement, both negative impacts and consultations, which make up a large part of communications received, are addressed. The consultation and complaint control procedure drawn up by the Quality area sets out responsibilities and the handling of consultations and complaints, with Quality Department personnel informing the Quality Manager and managing investigations and providing solutions. In complaints involving patients, the Pharmacovigilance Department must be notified within 24 hours; where necessary, Product Management and the Incident Department are informed, samples are sent to the manufacturer, documentation is reviewed and the product may be removed from the market, with the outcome notified to the complainant and a weekly report sent to the Quality Manager. Relationships with healthcare professionals occur through sales representative visits, congresses and training, with activities subject to prior internal review against the Ethical Marketing Policy and applicable laws. The Deontological Supervision Department reviews sampled activities, and Internal Audit conducts quarterly audits, with results reported to the Sales and Marketing Departments. ROVI identifies consumers with rare diseases as especially vulnerable and created Terafront Pharmatech to develop advanced therapies. Reference: page 130.
S4-2(was S4-3)Processes to remediate negative impacts and channels for consumers and end-users to raise concernsReported
ROVI's main potential negative impact relates to product quality, which directly affects patient health and safety, and the Group has several processes to address it. It maintains pharmacovigilance processes to monitor the benefit/risk balance of its medicines, with the Group head of Pharmacovigilance as the qualified person responsible. Healthcare professionals, patients or any person can report adverse reactions through several channels, including telephone, fax, email or postal service, listed on the corporate website and product leaflets. The Pharmacovigilance Department collects and evaluates the information and notifies the health authorities when required, monitoring reports individually. In 2024, no incident managed by the department led to a change in composition, removal of medicines or related studies. Complaints on parallel imports are handled like any other case, indicating the parallel import status to contact the importer. The Company also has the Ethics Channel, accessible through the corporate website, allowing anonymous reporting with a secure mailbox, managed under the Policy on the Internal Information System and Whistleblower Defence and investigated by the Ethics Channel Management Committee, with reference to G1-1 on whistleblower protection. Adverse effects for products manufactured or licensed out are managed through the relevant company or ROVI's pharmacovigilance area. ROVI does not evaluate the degree of trust consumers place in these mechanisms. Reference: page 131.
S4-3(was S4-4)Taking action on material impacts on consumers and end-users, and approaches to managing material risks and pursuing material opportunities related to consumers and end-users, and effectiveness of those actionsReported
Actions on consumers and end-users span the entire value chain and are managed through five areas: Quality, Intellectual Property, Pharmacovigilance, Regulatory Compliance and R&D&I. In 2024, the Quality area reviewed 2023 action plans, updated the OpenText GxP Suite document management system (296,000 euros), carried out more than 1,000 quality training actions (5,990 euros), and improved documentary support including allergen declaration controls. The Intellectual Property area acts continuously to address parallel imports, requiring prior notification, physical samples, correct labelling identifying the import status, unique identifiers, updated leaflets and security seals, and may request precautionary measures if conditions are not met. The Pharmacovigilance area worked to keep the benefit/risk balance favourable, with mandatory annual training (11,105 euros). In licensing-in, safety profile is a key selection criterion. The Regulatory Compliance area supervised product promotion against the Ethical Marketing Policy and applicable codes, conducted reviews in German subsidiaries (30,000 euros), and continued Ethical Marketing Policy training for all relevant employees. The R&D&I area progressed clinical development of Letrozole LEBE and quarterly Risperidone, integrated AI (including Cells AI), and advanced Terafront advanced therapies and glycomics work. Prevention measures for clinical trial information include the Quality Management Policy, Informed Consent Form and GCP compliance. As in 2023, no serious human rights problems were reported. Reference: page 132.
S4-4(was S4-5)Targets related to managing material negative impacts, advancing positive impacts, and managing material risks and opportunitiesReported
The Quality area analyses the results of its objectives once the previous year (2024) has finished and, in the first quarter of 2025, works to establish time-bound and outcome-oriented targets related to product quality, in order to address the material impacts, risks and opportunities related to consumers and end-users. In relation to pharmacovigilance, the Group has internal metrics and indicators to measure compliance with reporting time periods for incidents and other safety information to health authorities, subsidiaries and partners, as well as compliance of other activities, and monitors the efficacy of its processes through periodic audits confirming that the risk-benefit balance remains favourable and maintaining marketing authorisations. The final objective of pharmacovigilance is to protect users from adverse reactions and guarantee safe medicine use in special situations such as pregnancy, children, incorrect use or after expiry. Regarding ethical marketing, ROVI has set the objective of carrying out supervision activities in the subsidiaries of Portugal and Italy from the corporate Compliance Department, additional to reviews carried out by the individual countries. Lastly, in R&D&I, specific time-bound and outcome-oriented objectives will not be disclosed due to the sensitive nature of the information, although projects related to the ISM technology platform will continue to advance. Reference: page 135.
G1 – Business Conduct
G1-1Business conduct policies and corporate cultureReported
ROVI's corporate culture is grounded in its Code of Ethics, reinforced through specific training and communications. In 2024, online training ran through the Campus ROVI platform, and the Company developed an annual compliance training plan naming the people to be trained and the topics covered. An Ethics Point exists at every work centre with informational leaflets, and the annual compliance campaign focused on data protection. ROVI ran an employee experience study with the firm Lukkap and maintains physical and digital mailboxes under SA-8000. It operates an Ethics Channel for reporting irregularities. The Group lists numerous good-governance policies, including an Anti-Bribery and Anti-Corruption Policy consistent with the UN Convention against Corruption, a Supplier Evaluation and Approval Policy, and a Policy on the Internal Information System and Whistleblower Defence. The Ethics Channel is managed by an external manager who never discloses the whistleblower's identity unless requested, with reports investigated by an Ethics Channel Committee. Anti-corruption training is provided annually to the highest-risk groups. Reference: page 142.
G1-2Management of relationships with suppliersReported
ROVI bases supplier relationships on solvency, commitment and alignment with its principles, applying financial as well as environmental, social and governance criteria. Suppliers must accept a mandatory Code of Ethics for Suppliers reflecting the Group's human rights commitment. A Supplier Evaluation and Approval Procedure sets selection criteria, including an initial evaluation, periodic re-evaluations, and verification of supplier and raw-material certifications. Initial evaluation includes a risk assessment based on the supplier's activity, which may trigger audits at the supplier's facilities or specific clauses in quality agreements, feeding a list of approved suppliers with GMP impact managed by the Quality Department. ROVI conducts physical and remote audits and uses an annual risk-based plan. Since 2020 it has used the EcoVadis platform to score supplier sustainability from 0 to 100, and in 2024 introduced a mandatory Sustainable Purchasing Questionnaire for new suppliers. The Order Management and Supplier Payment Procedure requires a signed contract for suppliers whose annual revenue exceeds 100,000 euros. In 2024 ROVI launched a sustainability-linked confirming programme with BBVA offering reduced early-payment discount rates to suppliers scoring 45 or above on EcoVadis. Reference: page 144.
G1-2(was G1-3)Prevention and detection of corruption and briberyReported
ROVI operates under a "zero tolerance" principle towards bribery and corruption, supported by two main mechanisms: the Ethics Channel and the Crime Prevention Model. The Model was developed around ROVI's two principal activities, the promotion and sale of medicines and the manufacturing of its own and third-party products, and every two years an independent third party reviews its operation. Any Ethics Channel Committee member involved in a matter is excluded from that investigation. Channel communications are reported to the Audit Committee every four months and summarised for the Board annually. Anti-corruption and anti-bribery policy information is shared in the onboarding pack, published on the website, and reinforced by campaigns and training. In 2024, anti-corruption training was provided to 85.95% of employees identified as belonging to the group exposed to corruption risk, covering the Management Committee, Industrial Committee, department managers and heads, the Sales Network and the Purchasing Department. ROVI also maintains anti-money-laundering mechanisms and strictly controls the organisation of congresses following the Farmaindustria Code of Good Practice. Reference: page 145.
G1-4Incidents of corruption or briberyReported
For 2024, ROVI reports that it received no convictions or sanctions for infringing anti-corruption and anti-bribery laws. However, during 2024 the Ethics Channel received one report that could involve acts of corruption between individuals and may have caused financial damage to ROVI. As at the date of presentation of the Report, the investigation into this incident was still in progress. Reference: page 146.
G1-5Political influence and lobbying activitiesReported
ROVI notes that no material risks or opportunities were identified in relation to political influence and lobbying activities. The Group conducts this type of activity through Farmaindustria, the national business association for the pharmaceutical industry in Spain, which groups most innovative pharmaceutical laboratories in the country and accounts for practically all sales of patented prescription medicines. ROVI's CEO, Juan Lopez-Belmonte, as the Group's chief representative, supervises its Farmaindustria activities, which concern pharmaceutical regulation and are decided collectively. ROVI is registered in the EU Transparency Register in connection with a European Commission working group on essential medicines, with the Head of Communication and Corporate Social Responsibility as contact. The Company has also adhered to the codes of ethics of Portugal (APIFARMA) and Germany (AKG) and follows WHO and EFPIA recommendations. ROVI makes no direct or indirect contributions to political campaigns, parties or candidates, and no member of its administrative, management or supervisory bodies held a comparable public administration position in the two years before appointment. Reference: page 146.
G1-6Payment practicesReported
ROVI monitors its value chain to ensure proper management and prompt payment of supplier invoices, and in 2024 remained in constant contact with all its suppliers. The Group works with over 2,076 suppliers from 32 different countries. In 2024 the average payment period was 47.48 days, compared with 54.70 days in 2023. ROVI's usual payment periods are between 30 and 60 days, with 90% of payments made within 60 days, in line with the maximum legal periods set out in Law 3/2004 of 29 December and subsequent amendments on combating late payment in commercial transactions. The figure was calculated applying the criteria in the third additional provision of Law 15/2010 of 5 July, which amended Law 3/2004. In 2024, ROVI had no legal proceedings pending due to payment delays of this type. Reference: page 147.