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olivLaw · European equity research

SA GENFIT GNFT.PA

France · Euronext Paris · ISIN FR0004163111 · Vertical: Listed companies from France

11.44EUR+2.69% · 1 dayClose 05 Nov 2026

SA GENFIT is a French biotechnology company developing therapies and diagnostics for serious liver diseases. Its relevance now comes from the Ipsen partnership for elafibranor and the portfolio expansion through new licences and the 2025 acquisition of GNS561 rights, as shown in its official filings.

At the close of 05 Nov 2026, SA GENFIT (GNFT.PA) stock was 11.44 EUR (+2.69% on the day), with market capitalisation 574.7 m EUR, P/E 381.3 on diluted EPS of 0.03 EUR over the last 12 months, beta 0.81, 52-week range 3.42–14.66 EUR.

Data as of · AI analysis dated · Source: ESEF annual reports and closing prices, computed by olivLaw.

Market cap
574.7 m EUR
shares as of 31 Dec 2024
P/E (TTM)
381.3
Diluted EPS TTM 0.03 · TTM to 31 Dec 2024
E/P (TTM)
0.26%
TTM to 31 Dec 2024
Dividend yield
unavailable
Beta (2y)
0.81
Volatility (1y) 64%
52-week range
3.4214.66

Price history

Loading chart…

Technical reading

RSI (14)
61.6
strong (55–70)
Bollinger (20, 2)
6.88 – 12.14
in the upper half of the band · %B 0.87 · band width 55.4%
SMA 50 / 200
10.66 / 10.08
uptrend (price > SMA50 > SMA200)
MACD (12, 26, 9)
0.32 / -0.03
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyEURO STOXX 50vs EURO STOXX 50Vertical median
1 month+23.0%−0.6%+23.7 pp—
3 months−16.6%−4.2%−12.5 pp—
6 months+36.2%+4.3%+31.9 pp—
Year to date+117.3%+7.5%+109.8 pp—
1 year+225.0%+9.9%+215.1 pp−6.8%
3 years+276.9%+49.8%+227.1 pp−15.9%
5 years+262.9%+42.8%+220.1 pp—
Max drawdown (1y)
−46.6%
31 Jul 2026 → 14 Oct 2026
Max drawdown (5y)
−49.1%
17 Oct 2024 → 10 Apr 2025
Compound annual growth (5y)
+29.4%
EURO STOXX 50 +7.4%

Price returns, dividends excluded.

Quarterly results

ESEF annual reports carry no quarters: the results are annual (below).

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Today's P/E sits at the 100 percentile of its own 1-quarter history (min 117.8, median 117.8, max 117.8; quarters with earnings only).

Fiscal years

Fiscal year2021202220232024
Revenueunavailable26.6 m38.2 m70.9 m
Revenue YoYunavailableunavailable+43.7%+85.8%
Net income67.3 m-23.7 m-28.9 m1.5 m
Net income YoYunavailable−135.3%unavailableunavailable
Diluted EPSunavailable-0.48-0.580.03
Diluted EPS YoYunavailableunavailableunavailableunavailable
net %unavailable-89.3%-75.7%2.1%
Free cash flowunavailable-72.9 m-55.8 m14.6 m

Balance sheet & financial health

Fiscal year 2024 · 31 Dec 2024

Cash
81.8 m EUR
Financial debt
unavailable EUR
Net debt
unavailable EUR
Equity
69.2 m EUR
Total assets
151.4 m EUR
Debt / equity
unavailable
Current ratio
1.23x
ROE
2.2%
ROA
0.9%
FCF margin
20.5%

Financial statements (source on every figure)

Revenue and net income (EUR)

Margins

Income statement · EUR

Revenue
2022
26.6 m
2023
38.2 m
2024
70.9 m

esef· 07 May 2025verified

Research & development
2022
35.8 m
2023
46.5 m
2024
47.2 m

esef· 07 May 2025verified

Operating income
2022
-27.3 m
2023
-26.6 m
2024
3.3 m

esef· 07 May 2025verified

Interest expense
2022
4.8 m
2023
5.6 m
2024
4.8 m

esef· 07 May 2025verified

Pre-tax income
2022
-23.8 m
2023
-28.5 m
2024
1.8 m

esef· 07 May 2025verified

Income tax
2022
-116.0 k
2023
380.0 k
2024
340.0 k

esef· 07 May 2025verified

Net income
2022
-23.7 m
2023
-28.9 m
2024
1.5 m

esef· 07 May 2025verified

Diluted EPS
2022
-0.48
2023
-0.58
2024
0.03

esef· 07 May 2025verified

Balance sheet · EUR

Cash
2022
136.0 m
2023
77.8 m
2024
81.8 m

esef· 07 May 2025verified

Receivables
2022
15.9 m
2023
32.7 m
2024
7.6 m

esef· 07 May 2025verified

Inventories
2022
4.0 k
2023
4.0 k
2024
4.0 k

esef· 07 May 2025verified

Current assets
2022
158.5 m
2023
113.1 m
2024
92.8 m

esef· 07 May 2025verified

Property, plant & equipment, net
2022
8.2 m
2023
7.9 m
2024
7.6 m

esef· 07 May 2025verified

Intangibles (excl. goodwill)
2022
44.0 m
2023
48.8 m
2024
48.0 m

esef· 07 May 2025verified

Total assets
2022
215.5 m
2023
173.9 m
2024
151.4 m

esef· 07 May 2025verified

Accounts payable
2022
14.8 m
2023
18.8 m
2024
18.4 m

esef· 07 May 2025verified

Long-term debt
2022
49.9 m
2023
52.2 m
2024
—

esef· 10 Apr 2024verified

Current liabilities
2022
39.4 m
2023
38.5 m
2024
75.2 m

esef· 07 May 2025verified

Equity
2022
94.5 m
2023
68.0 m
2024
69.2 m

esef· 07 May 2025verified

Shares outstanding at year end
2022
49.4 m
2023
49.8 m
2024
50.2 m

esef· 07 May 2025derived

Cash flow · EUR

Operating cash flow
2022
-72.6 m
2023
-55.4 m
2024
15.5 m

esef· 07 May 2025verified

Capex
2022
-251.0 k
2023
414.0 k
2024
979.0 k

esef· 07 May 2025verified

Free cash flow
2022
-72.9 m ≈
2023
-55.8 m ≈
2024
14.6 m ≈

esef· 07 May 2025derived

Investing cash flow
2022
-46.3 m
2023
2.2 m
2024
-1.0 m

esef· 07 May 2025verified

Financing cash flow
2022
-3.8 m
2023
-5.1 m
2024
-10.6 m

esef· 07 May 2025verified

Computed indicators

Growth

Revenue growth (YoY)
85.8%
computed by olivLawFY 2024
Revenue CAGR 3Y
unavailable
input data missing
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
-71.8%
computed by olivLawFY 2021 → FY 2024
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
input data missing
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
input data missing
EBIT margin
4.6%
computed by olivLawFY 2024
Net margin
2.1%
computed by olivLawFY 2024
FCF margin
20.5%
computed by olivLawFY 2024

Returns

ROE
2.2%
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
ROA
0.9%
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
ROIC
unavailable
input data missing
ROCE
4.3%
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
unavailable
input data missing
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
input data missing
Interest coverage
0.7x
computed by olivLawFY 2024

Liquidity

Current ratio
1.2x
computed by olivLawbalance sheet at 31 Dec 2024
Quick ratio
1.2x
computed by olivLawbalance sheet at 31 Dec 2024
Cash ratio
1.1x
computed by olivLawbalance sheet at 31 Dec 2024

Cash

Operating cash flow
15.5 m EUR
computed by olivLawFY 2024
Capital expenditure
979.0 k EUR
computed by olivLawFY 2024
Free cash flow
14.6 m EUR
computed by olivLawFY 2024
FCF conversion
966.8%
computed by olivLawFY 2024
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
104 days
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
574.7 m EUR
computed by olivLawbalance sheet at 31 Dec 2024
Enterprise value
unavailable
input data missing
Market cap / net income TTM
381.3x
computed by olivLawFY 2024
P/E (TTM)
381.3x
computed by olivLawFY 2024
Earnings yield
0.3%
computed by olivLawFY 2024
P/B
8.3x
computed by olivLawbalance sheet at 31 Dec 2024
P/S
8.1x
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
39.4x
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
FCF yield
2.5%
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • score weight coverage: 41.7% of at least 60%

A scoring methodology on indicators and valuation, not investment advice.

Closing price

11.44 EUR

05 Nov 2026Source: olivLaw, closing series

Market cap: 574.7 m EUR

Key indicators

Market capitalisation
574.7 m EUR
computed by olivLawbalance sheet at 31 Dec 2024
P/E (TTM)
381.3x
computed by olivLawFY 2024
P/B
8.3x
computed by olivLawbalance sheet at 31 Dec 2024
EV/EBITDA
unavailable
input data missing
ROE
2.2%
computed by olivLawFY 2024 · balance sheet at 31 Dec 2024
Net margin
2.1%
computed by olivLawFY 2024
Revenue growth (YoY)
85.8%
computed by olivLawFY 2024
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

25/37 reporting lines present
Latest full fiscal year: 2024
Latest reported period: 31 Dec 2024
Latest balance sheet date: 31 Dec 2024
Share count (cover of the latest filing), as of: 31 Dec 2024
Source: esefpublished 07 May 2025
verified 75derived 3

The data is older than the freshness threshold.

Score by group

42% · Insufficient data

Estimated value range

Low
0.33
EUR per share
Mid
0.51
EUR per share
High
0.89
EUR per share
Price: 11.44 EUR
The price is above the range
Potential to the central value: -95.5% (value / price − 1)
Margin of safety: -2,126.0% (1 − price / value)
Agreement between methods: single method · 1 methods used · 1 independent bases

The combined range = the median of the valid methods' low, central and high values; it is not a probability interval and does not cover every result. Envelope of all methods: 0.33 – 0.89 EUR.

Valuation assumptions are editorial choices, not measured; beta is not measured.

Method ranges (EUR per share)

— — Mid · ▏ Price

Valuation methods

  • DCF (discounted cash flow)unavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: P/E0.33 – 0.89 (Mid 0.51)
    20 companies used · median multiple 17.1x · quartiles 11.1x – 29.8x
    74SW.PA, ABEO.PA, AC.PA, ADP.PA, AF.PA, AI.PA, ALBON.PA, ALCIS.PA, ALCLA.PA, ALFER.PA, ALHEX.PA, ALO.PA, ALPWG.PA, ALSOG.PA, ANTIN.PA, ARAMI.PA, ATE.PA, AUB.PA, AURE.PA, BB.PA
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

Assumptions (illustrative, editorial)

Risk-free rate
3.0%
Equity risk premium
5.5%
Beta (default)
1.00
Cost of equity
8.5%
Terminal growth
2.0%

Factor scorecard

Insufficient data

Minimum-evidence gate: score weight coverage: 41.7% of at least 60%

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Quality2.1%64 (vs peers)15%
FCF conversion · Quality966.8%100 (on a fixed band)15%
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet0.7x0 (on a fixed band)15%
Current ratio · Balance sheet1.2x36 (on a fixed band)10%
P/E (TTM) · Valuation381.3x0 (vs peers)25%
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation2.5%32 (on a fixed band)20%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet14/100 · 2/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality82/100 · 2/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation14/100 · 2/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

SA GENFIT (GNFT.PA). Latest full fiscal year: 2024; data up to 2024-12-31.

Figures computed from the financial statements: revenue 70.9 m EUR in 2024; YoY growth 85.8%; net margin 2.1%; ROE 2.2%.

The estimated value range is 0.33–0.89 EUR per share (median of 1 methods, agreement: single method); assumptions are illustrative. Against the central value of 0.51 EUR, the price of 11.44 EUR leaves a potential of -95.5% (value / price − 1) and a margin of safety of -2,126.0% (1 − price / value). The range is the median of the methods' low, central and high values, not a probability interval.

Insufficient data for a verdict (score weight coverage: 41.7% of at least 60%).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • FCF conversion: 966.8%

What contradicts it

  • Interest coverage: 0.7x
  • P/E (TTM): 381.3x
  • The price is above the estimated value range

Not assessed (insufficient data or a ratio without meaning): ROIC, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Listed companies from France · same country · compared with 39 companies

Multiples and returns vs the median

P/E
381.3x
vertical median 18.3x
above median (+1,987.6%)
EV/EBITDA
—
vertical median 6.3x
P/S
8.1x
vertical median 0.5x
above median (+1,482.6%)
P/B
8.3x
vertical median 1.1x
above median (+686.5%)
ROE
2.2%
vertical median 4.2%
below median (−47.1%)
Net margin
2.1%
vertical median 1.1%
above median (+88.5%)
EBIT margin
4.6%
vertical median 3.2%
above median (+45.6%)
Revenue YoY
85.8%
vertical median 0.6%
above median (+14,479.2%)
Net debt/EBITDA
—
vertical median -1.2x
Dividend yield
—
vertical median 1.7%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
AI.PAL'air Liquide Societe Anonyme Pour L'etude Et L'exploitation Des Procedes Georges Claude109.3 bn33.212.9%12.2%−2.0%+26% / +32%
AC.PAAccor13.8 bn30.79.6%8.0%+0.6%+6% / +56%
ADP.PAAeroports De Paris11.7 bn34.17.8%5.6%+12.1%−7% / +4%
AKE.PAArkema7.1 bn115.40.9%0.7%−5.0%+12% / −37%
ALO.PAAlstom5.8 bn18.33.1%1.7%+3.7%−51% / −4%
AF.PAAir France - Klm4.3 bn13.6—1.0%+4.8%+20% / +9%
ATE.PAAlten3.1 bn29.54.8%2.6%−1.1%+33% / −29%
BB.PASociete Bic2.7 bn31.35.0%4.1%−4.8%+32% / +5%
ANTIN.PAAntin Infrastructure Partners1.4 bn13.021.9%36.6%−8.1%−24% / −35%
74SW.PA74software792.7 m20.98.9%8.5%+44.8%−13% / +41%
AUB.PAAubay667.4 m17.813.6%6.3%+11.3%+3% / +45%
GNFT.PASA Genfit574.7 m381.32.2%2.1%+85.8%+157% / +276%
ASY.PAAssystem507.1 m69.92.5%1.1%+7.4%−19% / −18%
ATO.PAAtos Se483.0 m—-23,400.0%-17.5%−16.5%−45% / −94%
ARAMI.PAAramis Group298.8 m15.010.0%0.8%+6.3%−33% / −16%
ARVEN.PAArverne Group246.1 m—-14.0%-115.3%+27.0%+20% / −35%
BGO.PACompagnie Chargeurs Invest189.4 m—-8.6%-5.7%−2.9%unavailable / unavailable
ALCIS.PACatering International & Services145.0 m28.49.3%1.9%+5.8%+39% / +107%
ALCGM.PACegedim144.6 m—-2.6%-1.2%+10.9%−26% / −49%
ATEME.PAAteme144.0 m151.32.8%1.0%+2.2%+82% / +77%
ALHEX.PAHexaom144.0 m6.79.9%2.2%+13.1%−32% / +7%
ALBON.PACompagnie Lebon111.7 m16.54.2%8.8%−17.9%+6% / +8%
ALHYF.PALhyfe75.8 m—-33.4%-570.5%+287.2%unavailable / unavailable
ALFER.PASergeferrari Group61.5 m11.55.1%1.5%+7.4%−33% / −27%
ABEO.PAAbeo60.8 m7.36.9%3.0%+12.6%−13% / −54%

1- and 3-year price returns: for GNFT.PA from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.

Bear
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Base
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Bull
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Nothing is saved.

Estimated price (EUR)

Estimated priceBearBaseBull
1 years
7.48
Total return -35% · Per year -35%
13.16
Total return 15% · Per year 15%
19.73
Total return 73% · Per year 73%
3 years
8.87
Total return -22% · Per year -8%
17.40
Total return 52% · Per year 15%
28.42
Total return 148% · Per year 35%
5 years
10.52
Total return -8% · Per year -2%
23.01
Total return 101% · Per year 15%
40.92
Total return 258% · Per year 29%
What moves the 3-year price the most
  • Exit P/E± 4.35
  • Net margin± 3.04
  • Annual revenue growth± 2.27
  • Annual dilution± 0.26

AI analysis

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

In brief

SA GENFIT is a French biotechnology company developing therapies and diagnostics for serious liver diseases. Its relevance now comes from the Ipsen partnership for elafibranor and the portfolio expansion through new licences and the 2025 acquisition of GNS561 rights, as shown in its official filings 1.

SWOT

Strengths

  • The company has partnerships with major pharmaceutical companies that bring funding and commercial capacity. Its portfolio covers both therapies and diagnostics, enabling an integrated strategy.
  • The polymersome technology behind TS-01 is protected through an exclusive worldwide licence, and the NIS4 platform already has distribution partners.
  • Medical need in liver disease is large, and companies with related therapies and diagnostics can build a clear position in an area with few approved competitors.

Weaknesses

  • Revenue depends on partner payments and on reaching milestones that are uncertain. If milestones are delayed, cash flows could be affected.
  • The company relies on external suppliers and research and manufacturing organisations, which limits control over quality and timing.
  • Many products are still in early clinical phases and TS-01 is still in development, so most of the value depends on future success.

Opportunities

  • If clinical validation of TS-01 succeeds, the device could be used at home and in emergency rooms, where demand for rapid tests is high.
  • The withdrawal of a competing treatment from the EU could open room for elafibranor if its approval advances in relevant markets.
  • The 2025 acquisition of GNS561 rights could allow more direct development without dependence on the former licensor.

Threats

  • Competitors with approved therapies for primary biliary cholangitis could quickly limit GENFIT's market share.
  • Regulatory changes, as in the Ocaliva case, can abruptly shift the benefit-risk balance of a treatment and affect the whole category.
  • Geopolitical tensions and rising raw material costs could increase development and manufacturing costs.

Risks

  • Partner dependencehigh

    Ipsen and other partners control the pace of development and commercialization. If they shift priorities, revenue and timing could be affected.

  • Dependence on external suppliershigh

    CROs and CMOs run clinical studies and manufacturing. Their failures or delays could compromise product development.

  • Regulatory riskhigh

    Regulatory authority decisions can change a product's status, as in the Ocaliva case, and approval of candidates can be delayed or refused.

  • Competitive riskmedium

    The emergence of new treatments or diagnostic technologies could reduce the market share of GENFIT products.

  • Technological risk for TS-01medium

    Miniaturization and validation of the TS-01 device are complex steps. If they fail, the device could be delayed or never reach the market.

Investment thesis

What would need to be true (bull case)

  • If elafibranor develops successfully through Ipsen, GENFIT could receive milestone and royalty payments that would strengthen its balance sheet.
  • Combining diagnostics with therapy could raise the value of each product, especially if TS-01 reaches patients and emergency rooms.
  • Licences with several partners spread risk and could bring revenue from different regions, including Greater China.

What would break the thesis

  • Revenue depends on payments tied to clinical and regulatory results that are not yet confirmed, which makes cash flows hard to predict.
  • The company does not directly control many development and manufacturing steps, and supplier problems could delay projects.
  • Competition in primary biliary cholangitis is growing, and the Ocaliva withdrawal shows that a product's status can change quickly.

What to watch

  • Progress of elafibranor at Ipsen and any milestone payments2025
  • Results of the ongoing Phase 2 trial of VS-01 in ACLF2025
  • Progress on miniaturization of TS-01 and launch of the planned clinical study2025
  • FDA final decision on Ocaliva status and impact on the PBC marketnext 10-K

Products, market & competition

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

The business

GENFIT focuses on liver diseases, where medical needs remain unmet and few approved options exist. The company combines drug candidates such as elafibranor with diagnostic technologies, including the NIS4 platform and the TS-01 device for ammonia measurement. Its model relies largely on licensing partnerships, under which partners take over development and commercialization 1.

Ipsen holds the exclusive global licence for elafibranor, excluding Greater China, which was licensed to Terns. Ipsen handles later clinical development and commercialization, while GENFIT received an upfront payment of 120 million euros in 2021 and can receive further milestone and sales-linked payments 1.

Development depends heavily on external providers such as contract research organisations and contract manufacturers, which shifts part of quality and timing control to third parties. This can reduce fixed costs but limits direct control over execution 1.

Segments

Drug candidates

The pipeline includes elafibranor, licensed to Ipsen for primary biliary cholangitis, as well as SRT-015, CLM-022 and GNS561, which are in clinical or early preclinical stages. Potential milestone payments reach 100 million euros for Seal Rock and 160 million euros for Celloram, but most of that depends on clinical results not yet confirmed 1.

Diagnostics

Diagnostics include the NIS4 platform, licensed to Labcorp and Q2 for clinical research and laboratory tests, and TS-01, a portable device for home ammonia measurement still in development. The idea is that diagnostics and therapy complement each other in managing hepatic encephalopathy 1.

Market context

Hepatic encephalopathy generates high costs, estimated at about 11.9 billion dollars a year in the United States, while the point-of-care ammonia diagnostics market is led by PocketChem, used mainly in research. If more accurate devices gain acceptance, demand could grow, particularly in emergency rooms 1.

The rare liver disease market is fragmented, with approved therapies for primary biliary cholangitis but shifting regulatory positions. The Ocaliva situation in the European Union and the United States shows how sensitive these markets can be to regulatory decisions 1.

Trends

  • Ocaliva withdrawal in the EUmixed

    The withdrawal from the European Union of a competing treatment for primary biliary cholangitis could open room for elafibranor, if its approval advances. The effect, however, depends on authority decisions and developments in the United States 1.

  • Competition in primary biliary cholangitisheadwind

    Seladelpar, approved in the US through an accelerated procedure and conditionally in the EU, adds competitive pressure in the same indication on which elafibranor relies. The pace of adoption of new treatments could limit GENFIT's market share 1.

  • Interest in ammonia measurementtailwind

    The literature points to rising use of blood ammonia tests, and a point-of-care device could save time and costs for medical staff. This trend supports the TS-01 position if clinical validation succeeds 1.

  • Geopolitical tensions and supply chainsheadwind

    Conflicts in Ukraine and the Middle East, as well as trade tensions between the EU and the US, could raise raw material and manufacturing costs. These pressures could weigh on the company's development budgets 1.

Competitive position

GENFIT operates in therapeutic areas with few approved options, but competition comes from pharmaceutical and biotechnology companies, academic institutions and research institutes. The company acknowledges that new drugs and technologies may intensify competitive pressure 1.

In ammonia diagnostics, the main available point-of-care device is PocketChem, which has a narrow quantification range and interference issues. The advantage claimed by the company rests on its polymersome technology and a wider measurement range 1.

  • Gilead SciencesGILD

    Gilead obtained US accelerated approval for seladelpar in primary biliary cholangitis, competing directly with elafibranor.

  • Intercept Pharmaceuticals

    Ocaliva, originally developed by Intercept, was withdrawn from the EU and remains under accelerated approval in the US, changing PBC market dynamics.

  • LabcorpLH

    Labcorp is a licensing partner for NIS4 and also a competitor through its own diagnostic and clinical research services.

  • PocketChem

    PocketChem is the only point-of-care ammonia device on the market, used mainly in research, with accuracy limitations.

News & filings

In the press

No news in our archive over the last 180 days.

Annual reports (ESEF)

Sources

  1. [1] Annual report, fiscal year ended 2024-12-31 (ESEF) · SEC / SA GENFIT · 31 Dec 2024

Figures computed by olivLaw from ESEF annual reports and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.