Genfit S.A. (GNFT) Bundle
When you evaluate a late-stage biopharmaceutical company like Genfit S.A. (GNFT), are you looking at a risky R&D pipeline or a defintely de-risked commercial engine?
The company's first-half 2025 results show a clear pivot, with total revenues and other income hitting €35.7 million-a figure heavily bolstered by the €26.5 million milestone payment from Ipsen for Iqirvo® (elafibranor) achieving pricing approval in three major European markets.
This cash flow, plus a projected runway extended beyond 2028, changes the valuation math, so you need to understand how their core mission-now focused on rare and life-threatening liver diseases like Acute-on-Chronic Liver Failure (ACLF)-translates into sustainable value beyond those one-off payments.
Genfit S.A. (GNFT) History
You're looking for the bedrock of Genfit S.A., the story behind the current focus on rare liver diseases like Acute-on-Chronic Liver Failure (ACLF). The direct takeaway is that Genfit S.A. started as a broad biotech in 1999, pivoted sharply after a major clinical setback in 2020, and has since transformed into a financially stable, focused player with a strong asset, Iqirvo® (elafibranor), licensed to Ipsen, and a deep pipeline in ACLF, supported by a €130.0 million royalty financing deal completed in early 2025.
Given Company's Founding Timeline
Year established
The company was founded in 1999, establishing a scientific heritage that now spans over two decades in liver disease research.
Original location
Genfit S.A.'s original headquarters were established in Lille, France, specifically within the Parc Eurasanté cluster. The company later expanded its presence to the US, creating a subsidiary, Genfit Corp., in Cambridge, Massachusetts, in 2003.
Founding team members
The company was co-founded by Jean-François Mouney, who served as CEO for 20 years and is now the Chairman of the Board, alongside Pr. Bart Staels and Florence Séjourné, who was the company's Chief Operating Officer for nine years.
Initial capital/funding
While the exact initial seed capital isn't public, the early years (1999-2005) were focused on developing R&D know-how through collaborations with Big Pharma, which provided the foundational funding and expertise. The company's first major public funding came with its listing on the Alternext Market of Euronext Paris in 2006.
Given Company's Evolution Milestones
| Year | Key Event | Significance |
|---|---|---|
| 2003 | Creation of Genfit Corp. subsidiary in Cambridge, MA. | Established a US footprint for clinical and business development. |
| 2019 | Listing on the Nasdaq Global Select Market. | Secured access to US capital markets, increasing visibility and liquidity. |
| 2020 | Discontinuation of elafibranor's Phase 3 NASH program (RESOLVE-IT®). | A major strategic shift away from the competitive NASH space to focus on rare liver diseases. |
| 2021 | Exclusive licensing agreement with Ipsen for elafibranor (Iqirvo®) in Primary Biliary Cholangitis (PBC). | Validated the asset's potential in a rare disease, securing a long-term global partnership. |
| 2022 | Acquisition of Versantis AG. | Immediately expanded the pipeline with multiple assets targeting Acute-on-Chronic Liver Failure (ACLF). |
| 2025 | Completion of non-dilutive Royalty Financing with HCRx. | Secured €130.0 million in upfront funding, extending the cash runway beyond 2028. |
Given Company's Transformative Moments
The company's trajectory has been defined by two major pivots: the shift away from NASH (Non-Alcoholic Steatohepatitis) and the aggressive build-out of the Acute-on-Chronic Liver Failure (ACLF) pipeline.
The 2020 decision to terminate the elafibranor NASH program was a tough but necessary call. It meant cutting the workforce by 40% and reducing the cash burn by more than 50% by 2022. That's a brutal reset, but it freed up capital and focus.
This led directly to the 2021 Ipsen licensing deal for elafibranor in PBC, which has proven to be a financial lifeline. In the first half of 2025 alone, Genfit S.A. reported total revenues and other income of €35.7 million, with €26.5 million coming from a milestone payment after Iqirvo® secured pricing and reimbursement in three major European countries (UK, Germany, and Italy).
The 2025 financial moves have been defintely transformative:
- Securing the €130.0 million royalty financing in Q1 2025 provided a massive cash injection, boosting cash and cash equivalents to €129.5 million as of March 31, 2025.
- The September 2025 decision to discontinue the VS-01 program in ACLF, despite the disappointment, was a realist's move. They stopped a program that wasn't working and immediately projected the cash runway would extend beyond 2028, offering optionality for new business development.
This focus on ACLF-a high-unmet-need area-is now the core strategy, with assets like G1090N (a new formulation of NTZ) becoming the lead program. To understand how these strategic moves impact the investor landscape, you should be Exploring Genfit S.A. (GNFT) Investor Profile: Who's Buying and Why?
Genfit S.A. (GNFT) Ownership Structure
The ownership of Genfit S.A. is a mix of strategic corporate partnership, founder stakes, and a large public float, which is typical for a European biopharmaceutical company. This structure is currently undergoing a shift as the company streamlines its public status, transitioning away from the US Nasdaq listing to focus on its primary listing on Euronext Paris.
Genfit S.A.'s Current Status
Genfit S.A. is a public biopharmaceutical company, but its trading status is changing in late 2025. While it has been dual-listed, the company announced its intention to voluntarily delist its American Depositary Shares (ADSs) from the Nasdaq Global Select Market, with delisting anticipated to be effective prior to the opening of trading on November 20, 2025. This move is a strategic decision to simplify the corporate structure and improve operational efficiency, according to CEO Pascal Prigent. Post-delisting, Genfit S.A. will remain listed on the regulated market of Euronext Paris (GNFT) as its primary trading venue. The company had 50,002,890 ordinary shares outstanding as of September 1, 2025.
Genfit S.A.'s Ownership Breakdown
The company's shareholder base is anchored by a key strategic partner and a founder-led holding company, with the majority of shares held by the public (the float). The most recent available data shows a significant portion is held by its licensing partner, Ipsen, reflecting a deep commercial connection. Here's the quick math on the breakdown:
| Shareholder Type | Ownership, % | Notes |
|---|---|---|
| Strategic Partner (Ipsen) | 8.00% | Acquired in 2021; a major institutional shareholder and commercial partner for Iqirvo® (elafibranor). |
| Founders/Management (Biotech Avenir SAS) | 3.79% | Holding company for co-founders and employees, as of April 1, 2024. |
| Public Float (Retail & Other Institutional) | 88.21% | The remaining shares held by the public and other institutional investors. |
That large public float means the stock is defintely sensitive to market sentiment and news, so you need to keep a close eye on clinical trial updates and regulatory milestones. For a deeper dive into the financials, check out Breaking Down Genfit S.A. (GNFT) Financial Health: Key Insights for Investors.
Genfit S.A.'s Leadership
The company is steered by a seasoned executive team focused on rare and life-threatening liver diseases, particularly Acute-on-Chronic Liver Failure (ACLF). The leadership has been stable, with a recent, significant change in the scientific role in late 2025, signaling a renewed focus on their research pipeline.
- Pascal Prigent, Chief Executive Officer (CEO): CEO since September 2019, Prigent is the primary executive driving the company's strategy, including the focus on its ACLF pipeline and the recent Nasdaq delisting.
- Jean-François Mouney, Chairman of the Board of Directors: A co-founder and former CEO for 20 years, he provides long-term strategic oversight from the board level.
- Sakina Sayah-Jeanne, Chief Scientific Officer (CSO): Appointed to this role on September 30, 2025, she leads the R&D and translational science efforts, replacing the retiring Dean Hum.
This team is managing a significant financial position, with cash and cash equivalents totaling €107.5 million as of June 30, 2025, which helps fund their R&D efforts beyond the end of 2028. They also secured a €26.5 million milestone payment in July 2025 from Ipsen, tied to the pricing and reimbursement approval of Iqirvo® in major European markets.
Genfit S.A. (GNFT) Mission and Values
Genfit S.A.'s core purpose is to develop innovative therapeutic solutions for rare and life-threatening liver diseases, focusing intently on areas with high unmet medical needs. This commitment is grounded in core values that prioritize patient service, rigorous ethics, and a culture of respect and diversity.
You're looking at a company that is defintely driven by a societal mission, not just the bottom line. Their focus on Acute-on-Chronic Liver Failure (ACLF) and Urea Cycle Disorder (UCD) shows they are tackling the hardest, most critical patient populations. The pipeline is the mission.
Given Company's Core Purpose
The corporate purpose, formally adopted in 2022 and reaffirmed, positions Genfit S.A. as a late-stage biopharmaceutical company committed to improving the lives of patients with severe liver diseases. This commitment is three-fold: as an economic contributor, an innovative biotech, and a corporate citizen.
This goes beyond a simple R&D goal; it's a commitment to creating value for their entire ecosystem-patients, employees, and shareholders. For instance, their financial health, supported by a cash and cash equivalents position of €129.5 million as of March 31, 2025, gives them the runway to pursue these long-term, high-risk, high-reward programs.
Official mission statement
The mission is precise: to develop therapeutic solutions targeting rare and life-threatening liver diseases with high unmet medical needs.
- Develop solutions for rare diseases (affecting less than 200,000 individuals in the U.S.).
- Focus on life-threatening conditions associated with high mortality in the near-term.
- Capitalize on scientific, clinical, and regulatory expertise to move assets from early development to pre-commercial readiness.
Vision statement
While a single-sentence vision statement isn't explicitly published, the company's long-term ambition is clear from its 2025 strategic outlook. It centers on maximizing positive impact and building trust with all stakeholders.
- Maximize the positive impact of actions, manage risks, and seize opportunities.
- Build sustainably, invest in diverse teams, and operate with transparency.
- Create meaningful long-term value for patients, healthcare systems, employees, and shareholders.
Here's the quick math on their focus: revenues and other income amounted to €35.7 million in the first half of 2025, largely driven by milestone payments, which directly funds the high-risk, high-impact research. If you want a deeper dive into how they manage that capital, check out Breaking Down Genfit S.A. (GNFT) Financial Health: Key Insights for Investors.
Given Company slogan/tagline
Genfit S.A. most often describes itself as: a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases.
Their core values reinforce this descriptive tagline, serving as the cultural DNA for how they execute their mission:
- Innovation to Serve Patients: Seek new ways to advance science and optimize patient care.
- Ethics: Deliver true and accurate information with honesty and transparency.
- Respect and Diversity: Value diversity and ensure fair treatment for all employees and third parties.
Genfit S.A. (GNFT) How It Works
Genfit S.A. operates as a late-stage biopharmaceutical company, creating value by identifying and developing therapeutic solutions for rare and life-threatening liver diseases with high unmet medical needs. Its business model centers on advancing drug candidates through clinical trials and then securing revenue through licensing agreements, like the one for Iqirvo® with Ipsen, plus continued investment in its proprietary pipeline, primarily focused on Acute-on-Chronic Liver Failure (ACLF).
The company made €35.7 million in total revenues and other income in the first half of 2025, largely driven by a significant milestone payment. That's defintely a strong cash injection.
Genfit S.A.'s Product/Service Portfolio
| Product/Service | Target Market | Key Features |
|---|---|---|
| Iqirvo® (elafibranor) | Primary Biliary Cholangitis (PBC) | Licensed to Ipsen; generates royalty revenue and milestone payments; approved in the U.S. and granted pricing/reimbursement in three major European countries in 2025. |
| ACLF Franchise (G1090N, SRT-015, CLM-022) | Acute-on-Chronic Liver Failure (ACLF) | Pipeline of five assets with complementary mechanisms of action; G1090N is the lead asset; aims to address a critical, life-threatening condition with no approved treatment. |
| GNS561 | Cholangiocarcinoma (CCA) | Small molecule candidate in a Phase 1b clinical trial; data from this trial is expected by the end of 2025. |
| NIS2+® | Metabolic dysfunction-Associated Steatohepatitis (MASH) | Non-invasive diagnostic technology; used to monitor disease evolution and treatment response in patients with fibrotic MASH. |
Genfit S.A.'s Operational Framework
The company's operational framework is a focused, two-pronged approach: maximizing returns from its commercialized asset and aggressively developing its proprietary pipeline for high-unmet-need indications.
- Revenue Generation: The primary near-term income source is the licensing and collaboration agreement with Ipsen for Iqirvo® in PBC. This generated €6.9 million in royalty revenue and a €26.5 million milestone payment in the first half of 2025.
- R&D Focus: Research and development efforts are concentrated on the Acute-on-Chronic Liver Failure (ACLF) franchise, which includes assets like G1090N and SRT-015. Cash utilization in the first half of 2025 stemmed mainly from these R&D efforts.
- Pipeline Management: Genfit S.A. actively manages its pipeline, as seen with the September 2025 decision to discontinue the VS-01 program in ACLF to refocus it on Urea Cycle Disorder (UCD), a different rare disease. This is a realist move to mitigate risk.
- Financial Stability: A Royalty Financing agreement completed in March 2025 provided a substantial cash injection, extending the company's projected cash runway beyond the end of 2028. As of June 30, 2025, cash and cash equivalents totaled €107.5 million.
Genfit S.A.'s Strategic Advantages
Genfit S.A.'s market success is rooted in its deep specialization and strategic financial planning, which allows it to pursue high-risk, high-reward drug development.
- Specialized Expertise: Over two decades as a pioneer in liver disease research and development, providing a solid scientific heritage and the know-how to bring high-potential molecules from early to advanced stages.
- Focus on Orphan Indications: The company targets rare, life-threatening liver diseases like ACLF, PBC, and Cholangiocarcinoma (CCA). These indications often qualify for orphan drug status, which offers valuable incentives and potentially accelerated market access due to the high unmet medical need.
- De-risked Commercial Asset: The partnership with Ipsen for Iqirvo® provides a stable, commercialized revenue stream (royalties and milestones) that funds the riskier, earlier-stage pipeline development. Exploring Genfit S.A. (GNFT) Investor Profile: Who's Buying and Why?
- Extended Cash Runway: The non-dilutive royalty financing significantly extended the cash runway beyond 2028, providing crucial financial flexibility for pipeline execution and potential business development.
Genfit S.A. (GNFT) How It Makes Money
Genfit S.A. primarily generates revenue not from direct product sales, but through a licensing and collaboration agreement with Ipsen, which commercializes the drug Iqirvo® (elafibranor) for Primary Biliary Cholangitis (PBC). This revenue is a mix of recurring royalties on net sales and non-recurring, but substantial, milestone payments tied to regulatory and commercial achievements.
Genfit S.A.'s Revenue Breakdown
As of the first half of 2025 (H1 2025), Genfit S.A.'s total revenue and other income amounted to €35.7 million. The revenue structure is heavily weighted toward milestone payments, which are critical but irregular, while the royalty stream represents the future sustainable income base.
| Revenue Stream | % of Total (H1 2025) | Growth Trend |
|---|---|---|
| Milestone Revenue (Ipsen) | 74.2% | Fluctuating (Event-Driven) |
| Royalty Revenue (Iqirvo® Sales) | 19.3% | Increasing |
| Other Income (e.g., Research Tax Credit) | 6.5% | Stable/Variable |
Business Economics
The company's financial engine is built on a smart de-risking strategy: monetizing its flagship asset, elafibranor, early via the Ipsen partnership, and using that capital to fund its next-generation pipeline in Acute-on-Chronic Liver Failure (ACLF). This model shifts the commercial risk for Iqirvo® to Ipsen, securing a royalty stream for Genfit S.A. that is pure profit margin.
A key economic factor in 2025 was the non-dilutive Royalty Financing agreement with HCRx, which provided an upfront €130.0 million installment in Q1 2025. This financing is repaid using a portion of the future Iqirvo® royalties, but it immediately extended the company's cash runway beyond the end of 2028. This is defintely a strategic move to insulate the R&D pipeline from short-term market volatility.
The milestone payments, such as the €26.5 million received in H1 2025 following Iqirvo®'s pricing and reimbursement approval in three major European countries (UK, Germany, and Italy), are significant lump sums that validate the asset and provide immediate, non-recurring cash injections. That's a great way to fund a biotech pipeline. The core business is now focused on advancing its portfolio of six programs in ACLF, including GNS561 and G1090N, where the long-term value lies in developing a novel therapeutic option in an underserved indication.
Genfit S.A.'s Financial Performance
Analyzing the H1 2025 results provides a clear picture of the company's financial health and capital allocation. While the total revenue figure saw a decline of 41.7% year-over-year due to the timing of large milestone payments in 2024, the underlying royalty revenue from Iqirvo® is a new, growing source of recurring income. The company is in a heavy investment phase, which is typical for a late-stage biopharma company.
- Cash Position: Cash and cash equivalents stood at €107.5 million as of June 30, 2025, excluding the €26.5 million milestone payment received in July 2025.
- Net Loss: The first half of 2025 resulted in a net loss of €10.0 million, a significant improvement from the previous year's net profit, which was inflated by a large milestone payment.
- Operating Expenses: Operating expenses were €35.6 million in H1 2025, driven primarily by increased Research and Development (R&D) spending, which amounted to €25.1 million.
- R&D Focus: The R&D increase reflects the commitment to the ACLF pipeline, with significant spending on clinical trials like UNVEIL-IT® and preclinical work for GNS561 and G1090N.
- Balance Sheet Health: The company's debt-to-equity ratio is high at 255.9%, reflecting the nature of the Royalty Financing agreement, which is a form of debt. Short-term assets, however, exceed short-term liabilities, indicating good liquidity for near-term obligations.
To understand the sustainability of this model and the potential for the ACLF pipeline, it's crucial to look deeper into the cash burn rate and future milestones. Breaking Down Genfit S.A. (GNFT) Financial Health: Key Insights for Investors
Genfit S.A. (GNFT) Market Position & Future Outlook
Genfit S.A.'s market position in late 2025 is defined by a strategic pivot: they are transitioning from a single-product company (via royalties from Iqirvo®) to a high-risk, high-reward pure-play in the Acute-on-Chronic Liver Failure (ACLF) space, which currently has no approved therapies. This focus, backed by a projected cash runway extended beyond 2028, positions the company as a speculative leader in a critical, unmet medical need, but one whose valuation is highly dependent on upcoming Phase 1b and Phase 2 data readouts.
Competitive Landscape
In the second-line Primary Biliary Cholangitis (PBC) market, where Genfit S.A. earns its revenue through its partner Ipsen's sales of Iqirvo® (elafibranor), a major competitive shift occurred in 2025. The withdrawal of a key rival from the U.S. market has drastically altered the landscape, leaving a duopoly with Gilead Sciences' Livdelzi (seladelpar). Meanwhile, the ACLF pipeline is a race against other biotech and large pharma players.
| Company | Market Share, % | Key Advantage |
|---|---|---|
| Genfit S.A. (Iqirvo®) | ~18% | First-mover advantage in Europe; Stronger biochemical response data. |
| Gilead Sciences (Livdelzi) | ~14% | Superior safety profile; Clinically proven to reduce pruritus (itching). |
| Promethera Biosciences (HepaStem) | 0% | Advanced cell therapy approach (Phase II) targeting liver regeneration in ACLF. |
Here's the quick math: the PBC market is now essentially a two-horse race for new second-line patients, since the market-leading drug, OCALIVA® (obeticholic acid), which held about 68% market share in Q1 2025, is being withdrawn from the U.S. market. This massive vacuum is a huge opportunity for Iqirvo® and Livdelzi to capture that market share, but Livdelzi's better pruritus data could give it an edge in patient switches.
Opportunities & Challenges
You need to weigh the immediate, tangible opportunity in PBC against the long-term, binary risk of the ACLF pipeline. That's the core decision here.
| Opportunities | Risks |
|---|---|
| Competitor Market Exit: Intercept's OCALIVA® withdrawal from the U.S. market in September 2025 creates a massive revenue opportunity for Iqirvo®. | Pipeline Attrition: Discontinuation of the VS-01 program in September 2025 due to a Serious Adverse Event (SAE) highlights the inherent high risk of ACLF drug development. |
| Extended Cash Runway: Royalty Financing in March 2025, plus the €26.5 million milestone payment in July 2025, extends the cash runway beyond 2028. | High-Risk Focus: The company is now 'all-in' on ACLF, an indication with no approved treatments and a critically ill patient population, making success speculative. |
| Pipeline Catalysts: Phase 1b data for GNS561 in Cholangiocarcinoma (CCA) and safety data for G1090N in ACLF are both expected by the end of 2025. | Royalty Dependence: Revenue is heavily reliant on a single product, Iqirvo®, which is marketed and commercialized by a partner, Ipsen, limiting direct control over sales strategy. |
Industry Position
Genfit S.A. is positioned as a specialized, late-stage biopharmaceutical company focusing on rare, life-threatening liver diseases. The company is defintely a leader in the nascent Acute-on-Chronic Liver Failure (ACLF) space, a distinction solidified by its acquisition of Versantis and the licensing of SRT-015 in 2025, giving it a deep pipeline of five complementary ACLF assets.
- Dominant Niche: The company holds a strong, and now rapidly growing, position in the second-line PBC market through its partner's product, Iqirvo®.
- Pipeline Depth: The ACLF franchise-G1090N, SRT-015, CLM-022, and VS-02-HE-provides multiple shots on goal in a market projected to be worth $3.89 billion by 2033, according to some analyses.
- Financial Stability: The €107.5 million cash position as of June 30, 2025, plus the extended cash runway, provides the necessary capital to weather clinical trial volatility, which is crucial for a biotech its size (Market Cap of ~$207.68 million as of late 2025).
For a deeper dive into who is betting on this pivot, you should read Exploring Genfit S.A. (GNFT) Investor Profile: Who's Buying and Why?

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