Genfit S.A. (GNFT): Business Model Canvas [Dec-2025 Updated]

You're trying to get a clear read on Genfit S.A. now that Iqirvo® is out there, and honestly, the business model has fundamentally shifted from a pure R&D play to a royalty-backed operation. As of late 2025, the engine is fueled by that €130.0 million upfront payment from HealthCare Royalty in Q1 and the €12.6 million already booked from Iqirvo® royalties in the first nine months, giving them a solid cash position of €119.0 million as of September 30th. My deep dive shows the key tension is balancing that new revenue stream against the heavy R&D spend-like the €25.1 million in H1 2025-to push the ACLF pipeline forward; I've mapped out the nine essential building blocks that show you exactly where Genfit S.A. is making money, where they are spending it, and how the Ipsen partnership dictates their entire structure, so let's look at the specifics below.

Genfit S.A. (GNFT) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Genfit S.A. has locked in to drive its commercial and R&D strategy, especially around its lead asset, Iqirvo® (elafibranor). These aren't just handshake deals; they involve significant capital flows and revenue sharing.

Ipsen: Global Licensing and Commercialization Partner for Iqirvo®

Ipsen is the engine for Iqirvo® commercialization outside of Greater China. This partnership is Genfit S.A.'s primary source of near-term revenue. As of the nine months ended September 30, 2025, Genfit S.A.'s revenue was €39.2 million, which was primarily driven by this agreement.

Here's a breakdown of the financial impact from the Ipsen deal through Q3 2025:

The €26.5 million milestone payment was a big one, unlocked when Iqirvo® received pricing and reimbursement in Italy, making it the third major European market alongside the UK and Germany. Ipsen itself reported 'accelerated sales growth of €59 million in the first half of 2025 in the U.S. and in Europe (mainly Germany & U.K.)' for Iqirvo®.

HealthCare Royalty (HCRx): Royalty Financing Partner

Genfit S.A. secured a major non-dilutive capital infusion from HCRx to strengthen its Acute-on-Chronic Liver Failure (ACLF) pipeline and resolve debt overhang. This deal, closed in March 2025, is worth up to €185 million.

The structure of the financing is concrete:

• Upfront payment received: €130 million.
• Potential additional installments: Up to €55 million based on near-term sales milestones.
• Debt resolution: €61.66 million used to repurchase 99% of the 2025 OCEANEs convertible bonds.
• Cash runway extension: Beyond the end of 2027.

To be fair, HCRx gets repaid out of a portion of the royalties Genfit S.A. receives from Ipsen on Iqirvo® sales, up to an agreed-upon cap, after which all future royalties revert back to Genfit S.A..

Clinical Research Organizations

Genfit S.A. relies on Clinical Research Organizations to execute its global clinical trials for pipeline assets, particularly in the ACLF franchise which includes VS-01, G1090N, SRT-015, CLM-022, and VS-02-HE. While the exact spend on CROs isn't itemized in the latest reports, operating expenses for the first half of 2025 were €35.6 million.

Academic Institutions

Collaboration with Academic Institutions is key for R&D expertise in liver disease. Genfit S.A. presented data at the European Association for the Study of the Liver (EASL) International Congress in May 2025, highlighting progress in ACLF. This shows active engagement with the broader scientific community to support pipeline development.

Finance: review the Q4 2025 cash forecast incorporating the €55 million HCRx tranche potential by end of January.

Genfit S.A. (GNFT) - Canvas Business Model: Key Activities

You're looking at the core engine driving Genfit S.A. right now, which is heavily weighted toward advancing its pipeline, especially after some significant shifts in late 2025. The key activities are all about managing high-stakes R&D, protecting the science, and maximizing the value from the existing commercial partnership.

Research and Development: Advance the Acute-on-Chronic Liver Failure (ACLF) pipeline

The R&D focus is laser-sharp on ACLF, though the pipeline saw a major change in September 2025 with the discontinuation of the VS-01 program in ACLF following a Serious Adverse Event in the UNVEIL-IT® Phase 2 trial. Still, the commitment to ACLF remains, supported by other assets. Cash utilization in the first nine months of 2025 was mainly the result of these research and development efforts. The company is pushing several other programs forward, aiming for crucial data readouts before the year closes.

Here's the quick math on the pipeline activity as of late 2025:

Clinical Trial Management: Run trials for G1090N (ACLF) and GNS561 (CCA)

Managing the active trials is a core operational task. Genfit announced plans to initiate two new ACLF clinical trials in the first quarter of 2025, building on 2024 insights to streamline execution. The focus is now heavily on generating data from the remaining key assets to inform next steps. The discontinuation of VS-01 in ACLF is expected to lead to a substantial reduction in operating expenses, which helps the financial runway.

The company is managing several critical data expectations for 2025:

• Safety data from the Phase 1 study of G1090N in healthy volunteers.
• Initial efficacy signals on key biomarkers from ex-vivo functional assays for G1090N.
• Data readout from the Phase 1b trial of GNS561 in cholangiocarcinoma.
• Data from the pivotal juvenile toxicology study for VS-02-HAC (pediatric indication).

Intellectual Property Protection: Maintain patents for drug candidates and diagnostics

Protecting the science is non-negotiable, especially when you have assets in development and a major licensing deal. A concrete IP action in 2025 was the completion of the acquisition of the full intellectual property rights for GNS561 from Genoscience Pharma in early 2025. This move consolidates control over the Cholangiocarcinoma (CCA) program. While specific patent counts aren't public, the activity shows active management of the portfolio underpinning future value.

Licensing Agreement Oversight: Manage the Ipsen collaboration for Iqirvo® royalties

This activity is currently the primary financial driver. The collaboration with Ipsen for Iqirvo® (elafibranor) is generating significant, non-dilutive cash flow. A major event was the pricing and reimbursement approval in Italy in May 2025, which was the third major European market (following the UK and Germany), triggering a €26.5 million milestone payment under the agreement. This milestone was invoiced in May 2025 and received in July 2025. The royalty revenue stream is also active.

Here's the financial impact from the Ipsen deal through the first nine months of 2025:

To further secure the pipeline funding, Genfit also closed a non-dilutive Royalty Financing agreement with HCRx in January 2025, triggering a €130.0 million first installment by March 31, 2025. This, combined with the Ipsen milestone, resulted in cash and cash equivalents reaching €119.0 million as of September 30, 2025, extending the projected cash runway beyond the end of 2028. Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Key Resources

You're looking at the core assets Genfit S.A. (GNFT) relies on to drive value right now, as of late 2025. It's a mix of hard cash, critical intellectual property, and the deep scientific know-how needed to push their pipeline forward.

Financial Capital

The balance sheet shows a solid foundation to fund operations beyond 2028, based on current assumptions, which is a key factor for a late-stage biopharma company. This projection assumes they receive expected future commercial milestone revenue from Ipsen and draw down installments from the Royalty Financing agreement with HCRx.

As of September 30, 2025, Genfit S.A. held €119.0 million in cash and cash equivalents. That's up from €107.5 million at June 30, 2025, and significantly higher than the €81.8 million at the close of 2024.

Intellectual Property and Pipeline Assets

The value here is tied up in their proprietary molecules and diagnostic tools. Their R&D is heavily concentrated on rare and life-threatening liver diseases, particularly Acute on-Chronic Liver Failure (ACLF). Here's a look at the key pipeline assets that represent this IP, along with the financial impact from their main licensed asset.

The revenue for the first nine months of 2025 totaled €39.2 million, largely driven by the Ipsen agreement. This included €26.5 million in milestone revenue received in July 2025 after Iqirvo® achieved pricing and reimbursement in three major European markets.

Here is a breakdown of the key financial and pipeline data points:

Scientific Expertise and Pipeline Focus

The deep R&D focus is on addressing high unmet needs in liver disease. You've got several active programs, even after the discontinuation of VS-01 in ACLF. This is where the company's human capital-the scientists and researchers-is deployed.

The current pipeline efforts include:

• Proprietary drug candidates for Acute on-Chronic Liver Failure (ACLF), notably G1090N, SRT-015, CLM-022, and VS-02 HE.
• Work on a novel formulation of NTZ being developed internally.
• Development of GNS561 for cholangiocarcinoma (CCA).

The development of Iqirvo® (elafibranor) itself is a key resource, having secured approvals from the FDA (June 2024), the European Commission (September 2024), and the MHRA (October 2024) for Primary Biliary Cholangitis (PBC).

Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Value Propositions

You're looking at the core value Genfit S.A. (GNFT) offers across its pipeline and financial structure as of late 2025. It's a mix of near-term commercial upside and long-term therapeutic potential.

Innovative Therapeutics: Address high unmet medical needs in ACLF and CCA

Genfit S.A. (GNFT) targets serious, life-threatening liver diseases where patient needs are still largely unmet. The R&D efforts are heavily concentrated on the Acute-on-Chronic Liver Failure (ACLF) franchise, which includes candidates like VS-01, G1090N², SRT-015, CLM-022, and VS-02 HE. GNS561 is the focus for cholangiocarcinoma (CCA). The company is re-calibrating the ACLF program after discontinuing VS-01; you can expect an update on the ongoing preclinical work for VS-01 before the end of 2025, with a potential first-in-human trial for a new approach as early as the second half of 2026.

• ACLF pipeline focus: VS-01, G1090N², SRT-015, CLM-022, VS-02 HE.
• CCA candidate: GNS561.
• Update on VS-01 preclinical work expected before end of 2025.

Commercialized Drug Royalties: Stable revenue from Iqirvo® sales worldwide

The value here is the established, albeit shared, revenue stream from Iqirvo® (elafibranor), commercialized by Ipsen for Primary Biliary Cholangitis (PBC). This product has secured approvals in key markets, which translates directly into milestone and royalty payments for Genfit S.A. (GNFT). For instance, the pricing and reimbursement approval in Italy, the third major European market after the UK and Germany, triggered a €26.5 million milestone payment in 2025. This revenue stream is crucial for offsetting R&D expenses.

Here's a look at the financial impact from the Ipsen agreement through the first nine months of 2025:

The company also retains rights to all future regulatory, commercial, and sales-based milestone payments from Ipsen under the original agreement.

Diagnostic Tool: NIS2+® for non-invasive detection of MASH

Genfit S.A. (GNFT) offers value through its diagnostic franchise, specifically NIS2+®, which is positioned for the non-invasive detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH). This tool addresses the need for better patient stratification and diagnosis in a condition with massive patient populations.

Extended Financial Runway: Royalty financing secures funding beyond 2028

The strategic royalty financing deal with HealthCare Royalty (HCRx) in March 2025 fundamentally changed the company's financial outlook. This non-dilutive capital infusion provides significant operational flexibility. You can see the impact on the balance sheet and runway projections.

The financing structure and resulting cash position are key:

• Total potential non-dilutive capital: up to €185 million.
• Upfront payment received: €130 million.
• Contingent installments: up to €55 million based on near-term sales milestones.
• Debt reduction: Used €61.66 million to repurchase 99% of 2025 OCEANEs convertible bonds.
• Remaining convertible debt nominal amount: €586,000.
• Projected cash runway: Extends beyond the end of 2028.
• Cash on hand (Q3 2025): €119.0 million as of September 30, 2025.

This transaction means Genfit S.A. (GNFT) can fund its operating expenses and capital expenditure requirements for its pipeline development without immediate shareholder dilution, based on current assumptions. Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Customer Relationships

You're looking at how Genfit S.A. manages its critical external relationships to support its pipeline and commercial efforts, which is key since much of its current financial stability relies on a single major partner. Honestly, these relationships are the lifeblood funding the next wave of drug development.

Strategic Partner Management: Long-term, high-touch relationship with Ipsen

The relationship with Ipsen, centered around Iqirvo® (elafibranor), is the most financially significant customer relationship for Genfit S.A. as of late 2025. This is a long-term, high-touch engagement, where Genfit S.A. relies on Ipsen's commercial reach for revenue generation.

Here are the hard numbers from the Ipsen collaboration for the first nine months of 2025:

This partnership is structured to provide non-dilutive capital, as the €26.5 million milestone payment received in July 2025 was specifically triggered by pricing and reimbursement approval in Italy, making it the third major European market alongside the UK and Germany. This revenue stream is designed to offset cash utilization from R&D efforts in the ACLF pipeline.

Investor Relations: Transparent financial updates and corporate news flow

Managing investor perception requires clear, timely communication, especially given the clinical risks inherent in the pipeline. Genfit S.A. has maintained a regular cadence of updates, culminating in the Q3 2025 financial report release on November 20, 2025.

Key financial metrics demonstrating the relationship health with the investment community include:

• Cash and cash equivalents as of September 30, 2025: €119.0 million.
• Cash and cash equivalents as of December 31, 2024: €81.8 million.
• Projected cash runway extends beyond the end of 2028 based on current programs.
• Voluntary delisting of American Depositary Shares from Nasdaq Stock Market announced November 20, 2025.

The expectation is that the current cash position, bolstered by the Ipsen milestone, provides sufficient runway to reach key pipeline milestones without immediate need for dilutive financing, which is a major point of focus for current shareholders.

Regulatory Engagement: Continuous interaction with FDA and EMA for approvals

Continuous interaction with regulatory bodies like the FDA and EMA is crucial for advancing the ACLF and other pipeline assets. While the focus is on pipeline development, recent market dynamics have also influenced the environment.

Genfit S.A.'s pipeline is targeted for several key data readouts by the end of 2025, which represent critical interaction points with regulators:

• Safety data and efficacy markers for G1090N (ACLF) expected by the end of 2025.
• Completion of Investigational New Drug-enabling nonclinical studies for VS-02-HE expected by the end of 2025.
• Data readout from the Phase 1b clinical trial for GNS561 (CCA) expected by the end of 2025.

Furthermore, the competitive landscape is shaped by regulatory actions; for instance, the FDA requested the withdrawal of OCALIVA® from the US market for PBC in September 2025, a decision that may create a favorable market dynamic for Iqirvo®.

Patient Advocacy: Commitment to rare disease communities

Genfit S.A. positions itself as dedicated to improving the lives of patients with rare, life-threatening liver diseases. This commitment translates into engagement with patient advocacy groups, particularly concerning the underserved indication of Acute-on-Chronic Liver Failure (ACLF).

The company's engagement is demonstrated through its pipeline focus and public statements:

• Six programs are currently underway, including those targeting ACLF, Urea Cycle Disorder (UCD), and cholangiocarcinoma (CCA).
• Engagement with patient associations was noted as a key part of the process leading up to the VS-01 program discontinuation.

Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Channels

You're looking at how Genfit S.A. gets its value propositions-like the potential of its pipeline and the commercial success of its partnered drug-out to the world. It's a mix of partnerships, direct research engagement, and public market access. It's not about selling directly to every patient; it's about leveraging others and the scientific community.

Licensing Agreements: Ipsen handles global commercialization and distribution

The primary channel for Genfit's current financial realization is the exclusive worldwide license granted to Ipsen for elafibranor (marketed as Iqirvo®) for Primary Biliary Cholangitis (PBC). This partnership is the engine driving near-term cash flow.

Here's a look at the financial flow from this key channel in the first half of 2025:

Genfit S.A. also uses a Royalty Financing agreement with HCRx, signed in March 2025, to access capital against future royalties. This deal provided up to €185 million non-dilutive capital, with €130 million upfront. This structure channels future revenue streams to fund pipeline development.

Clinical Trial Sites: Direct access to patients for pipeline development

For its internal pipeline, especially in Acute on-Chronic Liver Failure (ACLF), Genfit S.A. directly engages clinical trial sites. This is the channel for generating the data needed to prove value for future licensing or partnerships.

The 2025 plan heavily relied on site activation:

• Initiated 2 new ACLF clinical trials in the first quarter of 2025.
• Anticipated 3 to 4 clinical data readouts by the end of 2025 across the ACLF pipeline.
• One proof-of-concept study for VS-01 targeted 21 patients with specific ACLF/HE grades.
• The strategic development was informed by real-world evidence from a dataset of over 270,000 U.S. patients in 2024.

This network of sites is how Genfit S.A. moves its assets, like G1090N and VS-01, toward potential future commercialization channels.

Capital Markets: Nasdaq and Euronext for investor access and funding

Listing on both Nasdaq and Euronext serves as the channel for attracting equity investment and maintaining public visibility. This access is crucial for funding operations outside of licensing milestones.

Key financial metrics as of late 2025 show the market valuation:

The company's Basic EPS (TTM) was -0.778 EUR as of the last reported full year data. This public listing is defintely a two-way street for capital.

Scientific Conferences: Presenting data to Key Opinion Leaders (KOLs) and physicians

Conferences are the direct channel to the medical community-KOLs, investigators, and prescribing physicians-to build scientific credibility and support future market access for pipeline candidates.

Genfit S.A. actively used major medical meetings in 2025:

• Presented preclinical data on NTZ/G1090N at The Liver Meeting® 2025 on November 10, 2025.
• Participated at the EASL Congress 2025 in May 2025, presenting six posters on ACLF research.
• Ipsen presented data on elafibranor for Primary Sclerosing Cholangitis (PSC) at EASL Congress 2025 on May 10, 2025.
• Hosted a Key Opinion Leaders (KOL) ACLF Advisory Board meeting in May 2025 to discuss collaboration and Real-World data programs.

These events are critical for validating the science underpinning the assets that will eventually move through the Ipsen commercialization channel or be licensed out.

Genfit S.A. (GNFT) - Canvas Business Model: Customer Segments

You're looking at the key groups Genfit S.A. (GNFT) serves as of late 2025. It's a focused list, which makes sense for a company targeting rare diseases.

Pharmaceutical Partner (Ipsen): Commercializes the approved PBC drug.

Ipsen is the primary commercialization engine for Iqirvo® (elafibranor) in Primary Biliary Cholangitis (PBC), excluding Greater China. This relationship directly drives Genfit S.A.'s near-term revenue through royalties and milestones. Ipsen reported accelerated sales growth of €59 million in the U.S. and in Europe (mainly Germany & U.K.) for Iqirvo® in the first half of 2025. Genfit S.A. recognized royalty revenue of €12.6 million from worldwide sales (excluding Greater China) for the first nine months of 2025. Also, the market dynamic shifted when competitor OCALIVA® withdrew from the US Market in September 2025.

The financial relationship with Ipsen generated significant non-royalty income:

Patients with Rare Liver Diseases: Focus on ACLF, CCA, UCD, and PBC.

Genfit S.A. targets patients with serious, life-threatening liver diseases where medical needs are high. While Iqirvo® addresses PBC, the pipeline focus is heavily weighted toward other rare conditions. Note that the VS-01 program in Acute-on-Chronic Liver Failure (ACLF) was discontinued in September 2025, with development refocused on Urea Cycle Disorder (UCD).

The patient populations and associated market potential figures, based on earlier data, highlight the unmet need:

• ACLF franchise has pipeline assets including G1090N2, SRT-015, CLM-022, and VS-02 HE.
• Cholangiocarcinoma (CCA) program includes GNS561.
• Urea Cycle Disorders (UCD) program now includes the refocused VS-01 asset.
• The UCD/Organic Acidemia (OA) market was estimated at $0.6 billion across US+EU5, characterized as ultra-rare with 1900 HAC/year in US+EU5 and a very high mortality rate of 75% after 5 years for survivors.

Healthcare Payers/Regulators: Government bodies for pricing and reimbursement.

These entities control market access for Iqirvo®. Successful navigation here directly translates into Genfit S.A. revenue via contractual milestones. The approval of pricing and reimbursement for Iqirvo® in the UK, Germany, and Italy unlocked the €26.5 million milestone payment for Genfit S.A. in 2025, with the Italian approval occurring in May 2025. This shows the direct financial impact of regulatory and payer acceptance in major European markets.

Financial Investors: Shareholders and debt holders seeking biopharma growth.

Investors are focused on the company's cash position, runway, and the value derived from the Ipsen deal. The company closed a Royalty Financing transaction in March 2025 with HCRx, providing up to €185 million in non-dilutive capital, with €130 million upfront. This financing, combined with revenues, extends the expected cash runway beyond the end of 2028. You can track the cash position:

As of September 30, 2025, cash and cash equivalents stood at €119.0 million, up from €81.8 million as of December 31, 2024. Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Cost Structure

You're looking at the major outlays for Genfit S.A. as of late 2025, and honestly, the story is dominated by R&D spend and a significant debt maneuver. The main cost driver, as you'd expect for a biopharma firm, is Research and Development (R&D), which hit €25.1 million for the first half of 2025.

Here's a quick look at how those major costs stacked up for the half-year ended June 30, 2025, plus that big debt item:

The Clinical Contracting Costs saw increased spending, reflecting the activity levels in the pipeline programs like the VS-01 trial in ACLF. These costs totaled €13.4 million in H1 2025, up from €7.8 million in the first half of 2024. That €13.4 million figure is the same as the contracted R&D spend mentioned above, so you defintely see where the external spending is focused.

General and Administrative (G&A) costs are wrapped up within the total Operating Expenses, which were €35.6 million for H1 2025. While G&A isn't itemized separately from R&D in the top-line reports, the R&D employee expenses alone were €7.3 million. The company anticipated a substantial reduction in operating expenses following the discontinuation of the VS-01 program in ACLF.

You should also note the financial charges tied to the debt restructuring, which aren't part of the operating expenses but definitely impact the bottom line:

• Repurchase price for 2025 OCEANEs was set at €32.75 per bond.
• The total number of OCEANEs repurchased was 1,882,891 bonds.
• This repurchase was concurrent with the closing of the Royalty Financing deal with HCRx.
• Financial income for H1 2025 showed a loss of €10.2 million, up from a loss of €0.9 million in H1 2024, due to debt issuance costs and financial charges from the Royalty Financing agreement.

Finance: draft 13-week cash view by Friday.

Genfit S.A. (GNFT) - Canvas Business Model: Revenue Streams

You're looking at the core cash generation for Genfit S.A. as of late 2025, and it's heavily weighted toward partnership milestones and product sales royalties. Honestly, the numbers tell a clear story about the immediate financial impact of Iqirvo® (elafibranor) commercialization in Europe. For the first nine months of 2025, Genfit S.A. booked total revenue of €39.2 million.

This revenue profile is built on a few key, discrete events, which you can see clearly laid out here. This structure shows how much Genfit S.A. relies on its licensing agreement with Ipsen right now.

The €39.2 million in revenue for the nine months ended September 30, 2025, was primarily driven by the Licensing and Collaboration Agreement with Ipsen. Here's the quick math on what made up that top line:

• Milestone Revenue from Ipsen: €26.5 million following pricing and reimbursement approval of Iqirvo® (elafibranor) in three major European countries, which was received in July 2025.
• Royalty Revenue from Iqirvo® sales (excluding Greater China): €12.6 million across the first nine months of 2025.

To be fair, while not part of the operating revenue, the strategic financing deal with HCRx in Q1 2025 was a massive cash event that underpins the company's current financial stability. Genfit S.A. secured an upfront payment of €130.0 million from HCRx in Q1 2025 as part of a capped royalty financing agreement. This deal, which is defintely non-dilutive, provides financial visibility beyond 2027. Finance: draft 13-week cash view by Friday.