GENFIT Provides Corporate Update and Financial Insights for 2024

GENFIT Financial Results and Corporate Developments Overview

As of June 30, 2024, GENFIT has achieved significant milestones, with cash and cash equivalents amounting to €61.6 million. This figure excludes a notable milestone of €48.7 million, invoiced in June 2024, triggered by the successful launch of Ipsen’s Iqirvo® (elafibranor) in the U.S. for the treatment of Primary Biliary Cholangitis (PBC).

Financial Performance Highlights

In the first half of 2024, GENFIT reported an impressive €59.0 million in revenues, which includes the key milestone payment. The approval of Iqirvo marks a pivotal moment for GENFIT and the treatment landscape of PBC.

European Medicines Agency's Positive Opinion

In July 2024, GENFIT received a favorable opinion from the European Medicines Agency (EMA) Committee. This sets the stage for anticipated marketing authorization of Iqirvo, expected in late 2024, paving the way for an additional €26.5 million milestone payment following pricing and reimbursement approvals across three European nations.

Operational Milestones and Partnerships

Pascal Prigent, CEO of GENFIT, expressed pride in the team’s efforts, emphasizing the impact that Iqirvo can have on PBC patients. After a robust partnership with Ipsen, the company is well-positioned for continued growth in developing groundbreaking therapies for liver-related diseases.

1H24 Business Developments

The rapid advancement of the Iqirvo project, which received accelerated approval from the U.S. FDA in June 2024, reflects GENFIT’s commitment to addressing significant medical needs. Ipsen reported positive feedback from healthcare professionals shortly after Iqirvo’s launch, indicating strong prescription interest.

Investment in Research and Clinical Trials

GENFIT’s UNVEIL-IT® Phase 2 trial for VS-01 continues to progress, albeit with some recruitment challenges anticipated in patient logistics and comorbidities. Recent protocol adjustments should streamline participant enrollment, ensuring the timeline for preliminary results remains intact.

Strategic Collaborations

A new research collaboration with the European Foundation for the Study of Chronic Liver Failure (EF CLIF) was initiated, showcasing GENFIT's commitment to enhancing knowledge and treatment options for Acute on-Chronic Liver Failure (ACLF).

Future Outlook and Important Milestones

Looking ahead, key milestones for the remainder of 2024 are on the horizon. This includes potential regulatory decisions on Iqirvo in Europe and further development of GENFIT's extensive pipeline, which focuses on critical liver conditions.

Financial Highlights and Projections

By the end of June 2024, GENFIT’s financial landscape shows a net profit of €30.3 million relative to a loss of €20.9 million in the first half of 2023, emphasizing an operational turnaround.

Cash Flow Management

Overall, cash flows utilized in operations during the first half of 2024 reflect significant investments in research and development, indicating the company’s focus on innovative therapies while maintaining a solid cash position into late 2025.

Corporate Governance Updates

Recent changes in the board followed the passing of Vice-Chairman Mr. Xavier Guille des Buttes, with Mr. Éric Baclet stepping into the role and Ms. Katherine Kalin appointed to the ESG Committee. These adjustments demonstrate GENFIT's dedication to governance and operational excellence.

Frequently Asked Questions

What recent financial milestones has GENFIT achieved?

GENFIT has achieved €61.6 million in cash equivalents and €59.0 million in revenues for the first half of 2024, bolstered by substantial milestone payments from Ipsen.

What is the significance of Iqirvo's approval?

Iqirvo’s approval marks a significant step in addressing the treatment of PBC, with potential for acquiring additional revenue through European marketing authorizations.

How is GENFIT positioned for future growth?

With strategic partnerships, a strong financial position, and impactful drug development, GENFIT is well-prepared for future innovations in liver disease treatments.

What are the next steps for GENFIT’s clinical trials?

GENFIT aims for critical regulatory approvals for Iqirvo in Europe and anticipates significant data outputs from various ongoing clinical trials in the near future.

How can investors stay informed about GENFIT’s developments?

Investors can access detailed reports and updates on corporate activities through GENFIT’s official website and by following public filings with regulatory agencies.

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