Latest news with #OmnibusDirective
Irish Examiner
30-05-2025
- Business
- Irish Examiner
Accountability and clearer government strategies key to incentivise action
Ireland's sustainable future is at a crossroads. For businesses, sustainability has moved from a niche topic to a crucial factor directly influencing their financial health and operational future. As tough EU regulations loom, Irish companies are wrestling with complex legal requirements, financial risks, and the urgency of meaningful action. Liam McKenna, partner at Forvis Mazars, actively guides Irish businesses through this intricate sustainability landscape. The firm itself has evolved to meet global business demands. Initially known simply as Mazars, the Irish operation was part of a vast international network but lacked visibility in the critical US market. The strategic merger with Forvis, the eighth-largest financial advisory firm in the United States, filled this gap. Liam McKenna, partner at Forvis Mazars. 'US clients frequently needed international expertise, but Mazars had a relatively low profile stateside," says McKenna. "On the other hand, Forvis had substantial recognition in the US but lacked global reach. The network made perfect sense because of our aligned geographic interests and similar corporate cultures." Since June 2024, Forvis Mazars has leveraged this combined strength, helping clients navigate increasingly rigorous global sustainability requirements. EU regulation and the Omnibus Shift Central to current business anxieties is the EU's Corporate Sustainability Reporting Directive (CSRD), originally designed to increase corporate transparency. However, McKenna highlights that it has been controversial, particularly due to heavy burdens placed on SMEs. The Omnibus Directive, inspired by Mario Draghi's EU competitiveness report, seeks to ease these burdens by significantly scaling back and delaying reporting obligations. Initially, CSRD requirements applied to companies with over 250 employees; this threshold will now rise to over 1,000 employees, and enforcement timelines will extend by two years. Yet McKenna warns against complacency. 'Yes, the reporting obligations were tough, but they brought clarity and urgency,' he says. 'Without them, there's a risk companies will lose momentum toward real sustainability.' The bigger picture: Financial enalties and Irish Preparedness Ireland faces broader sustainability obligations under the national Climate Action Plan, closely tied to EU climate goals. With stringent emission targets approaching, McKenna points out the genuine risk of massive financial penalties. "Current estimates suggest Ireland could face fines ranging between €12 billion to €26 billion," McKenna says. "The irony is clear, taking action now would be considerably cheaper than paying huge fines later." Despite this logic, both Irish businesses and government actions have lagged. McKenna emphasizes the need for accountability and clearer government strategies to incentivise action. Gross EU consumption of renewable energy per type, figures supplied by the South East Energy Agency. Source: European Commission "The question we need answered is how the government intends to pass potential EU penalties onto businesses to encourage meaningful sustainability changes," he says. One discussed measure is significantly increasing carbon taxation. Currently at €63 per tonne, the tax could rise dramatically if Ireland faces EU fines. "We could see carbon taxes soar to €300 or €400 per tonne, drastically impacting business costs," McKenna says. From reporting to action: Genuine sustainability strategies With reporting pressures potentially easing, McKenna sees an opportunity for businesses to focus more on real sustainability initiatives. He advocates practical measures such as 'double materiality' assessments, a key CSRD element, which help businesses understand both their environmental impact and how climate change could affect their operations. "Double materiality assessments offer genuine business insights, far beyond ticking compliance boxes," McKenna says. "They guide strategic planning, help businesses anticipate climate-related impacts, and uncover efficiencies and growth opportunities." Voluntary standards and business opportunities Despite regulatory shifts, many companies are adopting voluntary sustainability frameworks aligned with CSRD principles. Forvis Mazars advises clients on such adopting standards tailored to their specific business needs and stakeholder expectations. "Many companies voluntarily report sustainability data because their stakeholders including banks, investors, and customers, value sustainable credentials," McKenna says. "Increasingly, sustainability translates directly into competitive advantage, lower costs, and stronger market positions." McKenna stresses that Irish businesses, although behind their international peers, must urgently shift from reactive compliance toward proactive sustainability strategies. "Even if sustainability seems a lower priority right now, global market expectations are rapidly shifting. Companies that fail to adapt will soon face serious disadvantages," he says. Time to act is now Ireland's approach to sustainability remains inconsistent, frequently distracted by immediate crises rather than addressing the underlying urgency of climate action. McKenna sees this as deeply problematic, suggesting Ireland has lost around five critical years due to delays. "Climate change doesn't pause for economic or political convenience," McKenna says. "We're already experiencing significant impacts, from extreme weather events to soaring insurance claims and infrastructure damage. Every delay makes solutions more expensive and complicated." He urges immediate action from businesses, independent of regulatory timelines, arguing sustainable practices aren't just ethically necessary, they're financially prudent. "Sustainability isn't just a regulatory hurdle; it's essential to future-proofing businesses," McKenna says. As Irish companies navigate uncertainty around regulation, McKenna's message is straightforward: sustainability must become a competitive advantage, not just a compliance obligation. "The risk of inaction isn't hypothetical," he says. "It's a certainty of future financial pain and operational challenges. Irish businesses face a stark choice, and the moment to act decisively is now.'
Yahoo
14-05-2025
- Business
- Yahoo
GENFIT: Publication of the 2025 Extra-Financial Performance Report (fiscal year 2024)
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 14, 2025- GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the publication of its 2025 Extra-Financial Performance Report (fiscal year 2024). Since 2022, GENFIT has published a detailed Extra-Financial Performance report in response to the growing interest of institutional and individual shareholders, financial analysts, analysts specializing in corporate social responsibility (CSR) issues, company employees and candidates wishing to join the Company, industrial and strategic partners, and public institutions. The 2025 report (fiscal year 2024) is available on GENFIT's website. Pascal Prigent, CEO of GENFIT, commented: 'Our approach to sustainable development is rooted in our corporate culture and has been integral to our strategy since the early days of GENFIT. The creation by the board of directors of a dedicated ESG Committee in 2021 has brought about a more structured process, with an annual roadmap, which translates into concrete actions, binding policies, and the monitoring of indicators linked to our priority issues. In 2025, while closely monitoring developments in reporting standards, we will continue to focus our efforts on what matters most for GENFIT, with a view to maximizing the positive impact of our actions, managing risks, and seizing opportunities. Building sustainably, investing in diverse teams, and operating with transparency strengthens trust with patients, regulators and investors, and we believe that GENFIT has demonstrated how ESG helps us progress towards our goals.' In 2024, GENFIT remained steadfast in its commitment to social and environmental responsibility and strengthened its momentum toward continuous improvement. The roadmap approved at the beginning of the year by the ESG Committee was implemented in accordance with the established objectives. The progress made reflects the collective involvement of all teams, departments, and levels of the organization. Developments in 2024 included a significant increase in engagement with and for patients through awareness initiatives, accelerated production of educational content on ACLF involving a wide range of international experts in the field, a comprehensive assessment of gender equality in the workplace, and, of course, the pursuit of numerous initiatives launched in the past. GENFIT has been monitoring regulatory developments and has prepared a progressive compliance plan for non-financial reporting under the CSRD framework, until the Omnibus Directive published at the beginning of 2025 led to the suspension of our transition plan to the ESRS standards associated with this directive1. This regulatory development does not, however, call into question our desire to move closer to European standards, as part of a voluntary approach tailored to our corporate profile. Our 2025 sustainability roadmap will be a continuation of the 2024 roadmap, and of what has been done in previous years. We'll be capitalizing on the experience we've gained and building on the feedback we've received to consolidate our commitment. Caroline Bendavid at HOMA Capital, commented: 'At HOMA Capital, we are particularly sensitive to the social issues of the companies in which we invest. We therefore closely follow GENFIT's initiatives in this area, and appreciate its commitment to the quality of life and working conditions of its employees. Its breast cancer prevention campaign, for example, is a concrete example of how simple actions can be implemented to prevent risks, make it easier for employees to take action and, indirectly, contribute to the dynamics of the organization. More generally, we find GENFIT's creative approach to meeting all the challenges associated with Corporate Social Responsibility to be very interesting.' Jon Potter, ACLF transplant patientdeclaredI'm very pleased to see GENFIT progressing with its clinical trials in ACLF, a severe liver syndrome, with the aim of developing a treatment that can truly improve patients' lives. Joining GENFIT's ACLF Patient Advocacy Council was an important step for me, as it represents real hope for all those fighting the disease. This hope goes beyond the patients themselves: it also involves their families, loved ones and friends. I feel I share a genuine common desire with GENFIT to move things forward in a positive way.' ABOUT OUR CSR COMMITMENT Our commitment is driven, above all, from our determination to act as a socially responsible company. As a biopharmaceutical company, this commitment goes beyond our core activity whose purpose it is to respond to the societal need of developing innovative, effective and safe therapeutic solutions for patients suffering from rare and severe liver diseases with a high unmet medical need. This is aligned with the third Sustainable Development Goal of the United Nations. GENFIT recognizes that there is a correlation between its long-term financial performance and its extra-financial performance in that the societal impact of its research and development programs, as well as its rigorous governance practices (particularly in relation to the demands of the relevant health authorities and financial market regulators), the social impact of its activity, and its low environmental footprint, could create meaningful long-term value for patients, healthcare systems, employees and shareholders, and assure the Company's growth and long-term future. ABOUT GENFIT GENFIT is a late-stage biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, G1090N, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor2) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, such as "believe", "potential", "expect", 'target', 'may', 'will', "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company's management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our 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 "Risk Factors and Internal Control" of the Company's 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website ( and the AMF's website ( and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company's 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company 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 press release. 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. CONTACT GENFIT | InvestorsTel: + 33 3 20 16 40 00 | investors@ GENFIT | Press relationsStephanie BOYER | Tel : + 33 3 20 16 40 00 | GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | 1 Companies subject to the European Corporate Sustainability Reporting Directive have to report according to European Sustainability Reporting Standards (ESRS). For more information, visit the European Commission website2 Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo®. Attachment GENFIT: Publication of the 2025 Extra-Financial Performance Report (fiscal year 2024)
Yahoo
04-03-2025
- Business
- Yahoo
EU's Omnibus directive needs careful consideration, says ACCA
The Association of Chartered Certified Accountants (ACCA) has highlighted the necessity for careful evaluation of the European Union's (EU) 'Omnibus' directive. Announced in February 2025, the directive proposes changes to the European Green Deal, aiming to reduce the number of companies required to publish sustainability details and delay implementation by a year. The proposals also aim to decrease the number of companies needing to audit their supply chains and limit information required from small and medium sized enterprises (SMEs). As a result, around 80% of businesses will no longer fall under the Corporate Sustainability Reporting Directive (CSRD). Instead, compliance requirements will primarily affect the largest corporations, given their significant social and environmental impact. ACCA said that it supports the directive's intent to save costs, reduce burdens on SME's, and enhance competitiveness. However, Mike Suffield, ACCA's policy and insights director, stressed the need for clarity and consistency. He said: 'While we welcome the intent of the directive, businesses need consistency, clarity, and certainty; the Omnibus Directive needs careful consideration to ensure that it delivers on these requirements, while acknowledging the need to drive climate action.' The global accountancy body added that it has supported robust sustainability reporting frameworks and voluntary disclosures globally. It is assisting accountants and businesses with understanding and complying with the CSRD. ACCA also underscored the importance of aligning European sustainability reporting with IFRS Sustainability Disclosure Standards to prevent regulatory divergence and minimise global market friction. Suffield added that: 'ACCA will be analysing the Omnibus Directive in greater detail to fully understand the impact on our global membership and our partners. We stand ready to assist the EU in their development and implementation of proposals, and to ensure globally consistent and clear sustainability reporting requirements for business.' Meanwhile, the Institute of Chartered Accountants in England and Wales views the Omnibus proposals as a significant retreat from original sustainability reporting goals. "EU's Omnibus directive needs careful consideration, says ACCA " was originally created and published by The Accountant, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
03-03-2025
- Business
- Yahoo
EU's Omnibus directive needs careful consideration, says ACCA
The Association of Chartered Certified Accountants (ACCA) has highlighted the necessity for careful evaluation of the European Union's (EU) 'Omnibus' directive. Announced in February 2025, the directive proposes changes to the European Green Deal, aiming to reduce the number of companies required to publish sustainability details and delay implementation by a year. The proposals also aim to decrease the number of companies needing to audit their supply chains and limit information required from small and medium sized enterprises (SMEs). As a result, around 80% of businesses will no longer fall under the Corporate Sustainability Reporting Directive (CSRD). Instead, compliance requirements will primarily affect the largest corporations, given their significant social and environmental impact. ACCA said that it supports the directive's intent to save costs, reduce burdens on SME's, and enhance competitiveness. However, Mike Suffield, ACCA's policy and insights director, stressed the need for clarity and consistency. He said: 'While we welcome the intent of the directive, businesses need consistency, clarity, and certainty; the Omnibus Directive needs careful consideration to ensure that it delivers on these requirements, while acknowledging the need to drive climate action.' The global accountancy body added that it has supported robust sustainability reporting frameworks and voluntary disclosures globally. It is assisting accountants and businesses with understanding and complying with the CSRD. ACCA also underscored the importance of aligning European sustainability reporting with IFRS Sustainability Disclosure Standards to prevent regulatory divergence and minimise global market friction. Suffield added that: 'ACCA will be analysing the Omnibus Directive in greater detail to fully understand the impact on our global membership and our partners. We stand ready to assist the EU in their development and implementation of proposals, and to ensure globally consistent and clear sustainability reporting requirements for business.' Meanwhile, the Institute of Chartered Accountants in England and Wales views the Omnibus proposals as a significant retreat from original sustainability reporting goals. "EU's Omnibus directive needs careful consideration, says ACCA " was originally created and published by The Accountant, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
