Extra-Financial Performance Report 2024
2023 Activity
Foreword - About This Report | ||
Editorial | ||
1 | Our Business, Our Purpose, Our Values, Our Commitment | |
1.1 | Our Activity | |
1.2 | Our Purpose | |
1.3 | Our Values | |
1.4 | Our Commitment | |
2 | The Fundamentals of our CSR Approach | |
2.1 | The Five Fundamental Principles | 10 |
2.2 | Voluntary Commitments | 10 |
2.3 | International Frameworks and Benchmarks | 11 |
2.4 | European and American Regulations | 12 |
3 | GENFIT's Materiality Analysis and CSR Objectives | 14 |
3.1 | Materiality Assessment | 15 |
3.2 | Objectives of our CSR Strategy | 17 |
3.2.1 Societal | 17 | |
3.2.2 Social | 18 | |
3.2.3 Governance | 18 | |
3.2.4 Environmental | 18 | |
4 | 2023 Roadmap: Objectives, Initiatives and Results | 19 |
4.1 | Our Societal Commitment | 21 |
4.1.1 Our Vision of Societal Commitment | 22 | |
4.1.2 Our Societal Policies and Commitments | 22 | |
4.1.3 Societal Initiatives - 2023 Roadmap | 25 | |
4.1.4 Societal Key Performance Indicators | 27 | |
4.1.5 Evolution of Societal Performance indicators | 27 | |
4.2 | Our Social Commitment | 31 |
4.2.1 Our Vision of Social Commitment | 32 | |
4.2.2 Our Social Policies and Commitments | 32 | |
4.2.3 Social Initiatives - 2023 Roadmap | 36 | |
4.2.4 Social Key Performance Indicators | 39 | |
4.2.5 Evolution of Social Performance Indicators | 39 | |
4.3 | Our Commitment in Terms of Governance | 51 |
4.3.1 Our Vision in Terms of Governance | 52 | |
4.3.2 Our Policies and Commitments in Terms of Governance | 52 | |
4.3.3 Initiatives in Terms of Governance - 2023 Roadmap | 57 | |
4.3.4 Governance Key Performance Indicators | 60 | |
4.3.5 Evolution of Governance Performance Indicators | 60 | |
4.4 | Our Environmental Commitment | 69 |
4.4.1 Our Vision of Environmental Commitment | 70 | |
4.4.2 Our Environmental Policies and Commitments | 70 | |
4.4.3 Environmental Initiatives - 2023 Roadmap | 71 | |
4.4.4 Environmental Key Performance Indicators | 74 | |
4.4.5 Evolution of Environmental Performance Indicators | 74 |
GENFIT | Rapport de performance extra-financière 2023 - Activité 2022 | 1 |
5 | 2023 Overview, 2024 Roadmap and Conclusion | 79 |
5.1
5.2
5.3
2023 Overview | 80 |
2024 Roadmap: Objectives, Initiatives and Trajectories | 80 |
5.2.1 Societal: Having a Positive Impact on Our Main Ecosystem | 81 |
5.2.2 Social: Maintain and Strengthen our Human Capital | 82 |
5.2.3 Governance: Ensure the Resilience of our Business Model | 83 |
5.2.4 Environmental: Reducing Our Carbon Footprint and Preserving Biodiversity | 83 |
5.2.5 Key Performance Indicators | 83 |
Conclusion | 84 |
6 | Appendices | 85 | |
86 | |||
6.1 | 2023 | Initiatives - "References and Materiality" Grid | |
6.2 | 2023 | ........................................................................................Key Performance Indicators - "References and Materiality" Grid | 86 |
6.3 | 2024 | Initiatives- "References and Materiality" Grid | 89 |
6.4 | 2022 | Initiatives | 90 |
6.5 | 2021 | Initiatives | 90 |
GENFIT | Extra-Financial Performance Report 2024 - 2023 Activity | 2 |
Foreword - About This Report
This 2024 Extra-Financial Performance Report provides a detailed account of GENFIT's Corporate Social Responsibility (CSR) activities in 2023 and includes some elements relating to the beginning of 2024.
With this new edition, our goal is to continue to share relevant and accurate information with our stakeholders about our CSR commitment: strategy, policies, resources and data. Our aim is for our stakeholders to have the ability to independently assess GENFIT's efforts, whilst also encouraging them to engage in open and frequent communication with us.
GENFIT is not yet subject to any significant obligation in terms of non-financial reporting, but we are committed to this publication, which is part of a voluntary and proactive transparency approach, as we believe that environmental, social, societal and governance issues are essential to our Company's sustainability and that of our core ecosystem.
Note on Methodology (GRI 2-2)
The scope of this edition mainly covers the Group's parent company, GENFIT SA, which is the main driver of the company's overall extra- financial performance. However, a large amount of information relating to the subsidiary GENFIT Corp (based in the United States) is also included in this report, as well as an increasing amount of information relating to the Company Versantis AG (based in Switzerland) that we acquired at the end of 2022.
Certain Key Performance Indicators (KPIs) are not taken into account to ensure representativeness. This is the case for environmental impact indicators, which are only assessed for GENFIT SA, given the relative size of the teams and buildings located outside of France.
Furthermore, in order to respect the confidentiality of personal data, certain social indicators cannot be shared for employees in the United States and Switzerland, so as to avoid any possible identification of the employees concerned.
Contact Information
- Website:www.genfit.com
- E-mail:rse@genfit.com
- Telephone: +33 (0)3 20 16 40 00
Disclaimer
This Extra-Financial Performance Report contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "potential," "expect", "target", "may", "will", "if" and similar expressions, is intended to identify forward-looking statements. This information is mentioned in various sections of this Extra- Financial Performance Report, and contains data relating to the Group's intentions, estimates and targets concerning, in particular, the market in which it operates, its strategy, growth, data on its results, financial and non-financial position, cash position and forecasts. Although the Company believes that its projections are based on the reasonable assumptions and expectations of its General Management, such forward-looking statements may be affected by a number of known and unknown risks and uncertainties, which could cause results to differ materially from those described in, or implied or projected by, such forward-looking statements. These risks and uncertainties include, among others, uncertainties related to the economic, financial, extra-financial, competitive and regulatory environment, uncertainties inherent in research and development, including those related to the safety of drug candidates, progress, costs and data from planned and ongoing clinical trials, U.S., European and worldwide regulatory reviews and approvals of drug candidates and diagnostic solutions, the potential commercial success of elafibranor should it be approved by regulatory authorities, currency fluctuations, the Company's ability to continue to raise capital for its development, as well as those risks and uncertainties discussed or identified in the Company's public filings with the AMF, including those listed in Chapter 2 "Main Risks and Uncertainties" of the Company's 2023 Universal Registration Document (n° D.24-0246) filed with the AMF on April 5, 2024, which is available on the Company's website (www.genfit.com) and on the website of the AMF (www.amf-france.org) and public filings and reports filed with the U.S. Securities and Exchange Commission ("SEC") including the Company's 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024. In addition, even if the Company's results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this document. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.
This Extra-Financial Performance Report contains information on the Group's markets and competitive position. In particular, this information is based on studies carried out by external sources. The publicly available information, which the Company considers to be reliable, has not been verified by an independent expert, and the Company cannot guarantee that a third party using different methods to gather, analyze or calculate data on these markets would obtain the same data. In addition, the Group's competitors may define markets differently.
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Editorial
Editorial by GENFIT's Chief Executive Officer
"GENFIT's goal is to develop effective and safe therapeutic solutions for patients. This also involves identifying patient populations that are eligible for these future treatments, using simplified diagnostic techniques.
To achieve our goal, we are capitalizing on our experience in clinical development of drug candidates, particularly in the field of liver diseases. In just a few years, we have established ourselves as an innovative stakeholder in the field of medical research and clinical development, notably bringing our drug candidate elafibranor through to Phase 3, with a positive outcome in June 2023. The potential approval date for elafibranor in the United States is fast approaching. This means that in 2024, GENFIT could see its first molecule, developed by our teams, arrive in pharmacies, to be made available to the many PBC patients who today still lack effective treatments to combat this disease. In 2023, GENFIT also continued to expand and diversify its R&D portfolio of programs in Acute-on-Chronic Liver Failure, adding two new assets to its franchise, which now includes 5 innovative assets.
Our role in the healthcare sector, and in research and development in particular, naturally places us at the hearts of a major social issue. We reinforce this commitment by complementing it with a proactive social and environmental policy that translates into specific initiatives every year. Our governance system ensures that all these initiatives are coordinated in accordance with the highest standards of ethics, responsibility and fairness. In order to ensure that our actions are in line with our mission and values, we have created an ESG Committee which meets at least twice a year to ensure that our roadmap is consistent with social and environmental issues, our data and our purpose.This explicitly states our ambition in terms of corporate responsibility.
At management level, CSR strategy is driven by our Chief Corporate Affairs Officer, Jean-Christophe Marcoux, a member of the Executive Committee. He has been leading our efforts in this area since the end of 2021."
Pascal Prigent
A Word from the Chairman of the Board of Directors
"Since its creation, GENFIT has demonstrated its sense of ethics and responsibility, which continues to be reflected today at each level of the company. This is both a motivating factor for the teams, and a solid basis for cooperation and partnership with the various stakeholders."
Jean-FrançoisMouney,Co-Founder of GENFIT
A Word from the Chair of the ESG Committee of the Board of Directors
"A company can create value for its shareholders while integrating a social and environmental dimension into its objectives and its mode of governance. All of GENFIT's employees and directors are committed to this approach and the company's growth dynamic is therefore strengthened. CSR initiatives - which help to materialize the company's social and environmental responsibility - contribute to the improvement of its overall performance and the motivation of its employees."
Catherine Larue
Pascal Prigent, | Jean-François Mouney, | Catherine Larue, |
Chief Executive Officer | Chairman of the Board | Chair of the ESG Committee |
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CHAPTER 1
Our Business, Our Values,Our Purpose, Our Commitment
GENFIT | Extra-Financial Performance Report 2024 - 2023 Activity | 5 |
1.1 Our Activity
GENFIT is a late-stage biopharmaceutical company primarily committed to improving the lives of patients suffering from hepatic diseases, including rare and/or severe diseases with unmet medical needs.
GENFIT's core mission is a response to the United Nations' 3rd Sustainable Development Goal ('Health and well-being'). Our particular expertise in the field of liver disease has led us, though not exclusively, to seek to meet the needs of populations which can sometimes be vulnerable, and/or whose vital prognosis may be at stake:
- This has led us to develop drug candidates designed to fight against certain rare diseases, which are sometimes under- diagnosed and the low prevalence of which may limit the amount of information available to guide patients and/or provide them with psychological support;
- Our current programs target patients who may be suffering from late-stage conditions, with potentially high short-term mortality;
- We are currently concentrating a significant part of our R&D effort on diseases for which patients have few, if any, therapeutic solutions at their disposal.
To learn more about GENFIT's therapeutic areas, see chapter 4.1.5 - Health and Well-Beingof Patients.
A Different Model to Pharmaceutical Groups
While our ambition is to one day bring our therapeutic and diagnostic solutions to market, our business model is different from that of large pharmaceutical companies that already have products on the market. While large pharmaceutical companies are financed by the revenues generated by the sales of their drugs, GENFIT must find other sources of capital to finance its research, since most of its programs are still at the pre-clinical research or clinical development stages. The company is primarily funded1 via two paths:
- by raising funds on capital markets through financial instruments that may vary according to the needs and context;
- or by signing partnership agreements, as we did in 2021 with the pharmaceutical group Ipsen.
Our Business Model
- Public funding can complement these two pathways from time to time.
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Our strategy serves our purpose. To build on this, we leverage our assets and strengths. To execute this strategy, we capitalize on the skills of our teams, our network of experts and our partners. Our objective is to achieve results that align with our commitments, while meeting our stakeholders' expectations, both internal (employees) and external (patients, associations, Key Opinion Leaders, partners, shareholders, etc.). These results help generate confidence and credibility, so our successes create favorable conditions to obtain funding. This in turn enables us to mobilize the resources needed to continue to move our programs forward, or launch new ones, to bring solutions to patients and physicians. In doing so, we secure the company's future by generating value for our employees and shareholders.
1.2 Our Purpose
At the Annual Shareholders' Meeting on May 25, 2022, GENFIT adopted a corporate purpose as set out below:
- The Company is a late-stage biopharmaceutical company committed to improving the lives of patients with severe liver diseases who have a significant unmet medical need. The Company's "Raison d'être" is based on the affirmation of its long-term commitment with regard to the position it wishes to occupy in society, not only as an economic contributor whose purpose is to be part of the long term and to create value for its counterparts and its ecosystem, but also as an innovative biotechnology company aiming to improve the quality of life of patients, and finally as a corporate citizen seeking to facilitate the professional and personal development of its employees."
In order to clarify the ambition of the Company's CSR approach, as well as the role played by the Board of Directors in this goal, it is proposed that the Company's shareholders complete this statutory purpose statement at the Annual General Meeting of May 22, 2024, by approving resolution no. 26. Should this resolution be approved, the corporate purpose would read as follows:
"The Company aims to generate a positive and significant social, societal and environmental impact in the course of its activities.
As part of this approach, the Board of Directors undertake to take into consideration (i) the social, societal, environmental consequences of its decisions on all of the company's stakeholders, and (ii) the consequences of its decision on the environment."
As part of this commitment, and in accordance with the recommendations of the MiddleNext governance code, the Company has set up a dedicated CSR committee of the Board of Directors, which meets at least twice a year to measure and monitor the Company's extra- financial performance, and communicate this to the public through an annual extra-financial performance report.
1.3 Our Values
Our core values reflect our convictions and define our principles of action. They guide and influence the choices of our employees on a daily basis and shape the relationships we develop with our ecosystem.
Innovation to Serve Patients
We are deeply committed to improving the health and quality of life of patients affected by rare and severe liver diseases characterized by high unmet medical needs. With a strong desire to leverage our agility and responsiveness, we and our employees strive to move our scientific and medical approaches forward and improve patient management in terms of diagnostics, prevention and care.
Respect & Diversity
We bring together talented employees with unique perspectives and experiences, we recognize and value diversity as a great strength, and we also ensure that all employees and third parties are treated fairly with dignity and respect.
Ethics
We deliver true and accurate information to our partners and stakeholders and build our business relationships with honesty and transparency. We hold ourselves and others to the highest ethical standards and we conduct our business in a socially and environmentally sustainable manner.
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1.4 Key Points and Summary of Our Commitment
As part of our CSR commitment and in accordance with the recommendation of the MiddleNext Governance Code, the Company has created a dedicated committee within the Board of Directors. This committee meets at least twice a year to measure and monitor the Company's extra-financial performance, validate the roadmap in this area and ensure transparent communication to the public and all stakeholders, through an annual extra-financial performance report covering (i) the social, societal and environmental consequences of its decisions on all of the Company's stakeholders, and (ii) the consequences of its decisions on the environment.
Among our commitments to national and international standards:
- We are committed to the 10 principles of the United Nations Global Compact
- We are committed to the UN's 17 Sustainable Development Goals
- We follow the new recommendations of the MiddleNext Governance Code
- Indications, included in our Extra-Financial Performance Report, refer to the main themes established by 4 major reference systems (ISO 26000, SASB, GRI and the Sustainable Development Goals/ODDs). As of 2024, elements linked to a 5th reference system (the future European CSRD) will be integrated into our correspondence grids
- Consideration of the LEEM "Responsibility and Reputation" commission's work
- We consider with interest the elements of the PACTE Law (Plan d'Action pour la Croissance et la Transformation des Entreprises).
- We are a signatory of the regional PAQTE
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CHAPTER 2
The Fundamentals of Our CSR Approach
2.1
2.2
2.3
2.4
The Five Basic Principles | 10 |
Voluntary Commitments | 10 |
International Frameworks and Standards | 11 |
European and American Regulations | 12 |
GENFIT | Extra-Financial Performance Report 2024 - 2023 Activity | 9 |
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Disclaimer
Genfit SA published this content on 25 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 April 2024 15:49:00 UTC.