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1 CORPORATE PRESENTATION March 2019 MARCH2019 II. LEADERSHIP IN NASH & PBC I. CORPORATE HIGHLIGHTS

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Page 1: CORPORATE PRESENTATION - genfit.com · •this presentation has been prepared by genfit and is for information purposes only. •certain of the information contained herein concerning

1

CORPORATE PRESENTATION

March 2019

MAR

CH20

19

II. LEADERSHIP IN NASH & PBC

I. CORPORATE HIGHLIGHTS

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Disclaimer Important Information and Forward Looking Statements

IMPORTANT NOTICE - YOU MUST READ THE FOLLOWING BEFORE CONTINUING •THIS PRESENTATION HAS BEEN PREPARED BY GENFIT AND IS FOR INFORMATION PURPOSES ONLY. •CERTAIN OF THE INFORMATION CONTAINED HEREIN CONCERNING ECONOMIC TRENDS AND PERFORMANCE IS BASED UPON OR DERIVED FROM INFORMATION PROVIDED BY THIRD-PARTY CONSULTANTS AND OTHER INDUSTRY SOURCES. WHILE GENFIT BELIEVES THAT SUCH INFORMATION IS ACCURATE AND THAT THE SOURCES FROM WHICH IT HAS BEEN OBTAINED ARE RELIABLE, GENFIT HAS NOT INDEPENDENTLY VERIFIED THE ASSUMPTIONS ON WHICH PROJECTIONS OF FUTURE TRENDS AND PERFORMANCE ARE BASED. IT MAKES NO GUARANTEE, EXPRESS OR IMPLIED, AS TO THE ACCURACY AND COMPLETENESS OF SUCH INFORMATION. •THIS PRESENTATION CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS OR INFORMATION. ALTHOUGH THE COMPANY BELIEVES ITS EXPECTATIONS ARE BASED ON REASONABLE ASSUMPTIONS, THESE FORWARD-LOOKING STATEMENTS OR INFORMATION ARE SUBJECT TO NUMEROUS 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 OTHER THINGS, THE UNCERTAINTIES INHERENT IN RESEARCH AND DEVELOPMENT, INCLUDING RELATED TO BIOMARKERS, PROGRESSION OF, AND RESULTS OF CLINICAL DATA FROM, THE RESOLVE-IT TRIAL, REVIEW AND APPROVALS BY REGULATORY AUTHORITIES, SUCH AS THE FDA OR THE EMA, REGARDING IN PARTICULAR, ELAFIBRANOR IN NASH AND PBC, AS WELL AS OTHER DRUG CANDIDATES IN OTHER INDICATIONS, AND BIOMARKERS, THE SUCCESS OF ANY INLICENSING STRATEGIES, THE COMPANY’S CONTINUED ABILITY TO RAISE CAPITAL TO FUND ITS DEVELOPMENT, AS WELL AS THOSE DISCUSSED OR IDENTIFIED IN THE COMPANY’S PUBLIC FILINGS WITH THE AMF, INCLUDING THOSE LISTED UNDER SECTION 4“MAIN RISKS AND UNCERTAINTIES” OF THE COMPANY’S 2018 REGISTRATION DOCUMENT REGISTERED WITH THE FRENCH AUTORITÉ DES MARCHÉS FINANCIERS (AMF) ON FEBRUARY 27, 2019 UNDER NO. D.19-0078, WHICH IS AVAILABLE ON GENFIT’S WEBSITE (WWW.GENFIT.COM) AND ON THE WEBSITE OF THE AMF (WWW.AMF-FRANCE.ORG) OTHER THAN AS REQUIRED BY APPLICABLE LAW, THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE OR REVISE ANY FORWARD-LOOKING INFORMATION OR STATEMENTS. •WE HAVE FILED A REGISTRATION STATEMENT WITH THE SECURITIES AND EXCHANGE COMMISSION ("SEC") IN CONNECTION WITH THE OFFERING TO WHICH THIS PRESENTATION RELATES. BEFORE YOU INVEST, YOU SHOULD READ THE REGISTRATION STATEMENT, THE PRELIMINARY PROSPECTUS INCLUDED WITHIN THE REGISTRATION STATEMENT, AND OTHER DOCUMENTS WE HAVE FILED WITH THE SEC FOR MORE COMPLETE INFORMATION ABOUT US AND THIS OFFERING. YOU CAN OBTAIN THESE DOCUMENTS FOR FREE BY VISITING EDGAR ON THE SEC WEBSITE AT WWW.SEC.GOV. ALTERNATIVELY, COPIES OF THE PRELIMINARY PROSPECTUS MAY BE OBTAINED BY CONTACTING SVB LEERINK LLC, ATTENTION: SYNDICATE DEPARTMENT, ONE FEDERAL STREET, 37TH FLOOR, BOSTON, MA 02110, OR BY TELEPHONE AT (800) 808-7525, EXT. 6132, OR BY EMAIL AT [email protected]; OR FROM BARCLAYS CAPITAL INC., C/O BROADRIDGE FINANCIAL SOLUTIONS, ATTENTION: PROSPECTUS DEPARTMENT, 1155 LONG ISLAND AVENUE, EDGEWOOD, NY 11717, OR BY TELEPHONE AT (888) 603-5847, OR BY EMAIL AT [email protected].

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I. CORPORATE HIGHLIGHTS

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Company Profile

BACKGROUND

• Public company focused on metabolic diseases and associated complications, including liver related disorders • World-leading expert in nuclear receptor based drug discovery • Lead drug candidate discovered in-house • Founded in 1999 (Lille, Paris, France – Cambridge, United States) – 150+ employees • Since 2006, Euronext Paris – compartment B (GNFT) – Market capitalization of ~€700M • €207 million cash balance (End of Year 2018) MAIN PROGRAMS • Elafibranor: First-in-class molecule

• NASH – Phase 3 enrolled (Subpart H), accelerated approval process (Subpart H with FDA; Conditional approval with EMA) and fast-track designation

• PBC – 12-week Phase 2 trial completed with positive top line results • In-Vitro Diagnostic (IVD) for non-invasive diagnosis of NASH • Strong IP protection with full worldwide rights

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Experienced Management Team and Highly Respected Advisory Board

• Jean-François Mouney, Chief Executive Officer, co-founded the company in 1999

• The executive team and board of directors have a deep experience at leading

biotech companies, large pharmaceutical companies and academic institutions

• Pr. Bart Staels, chair of the scientific advisory board and co-founder of the company, is a world-renowned expert in nuclear receptors

• The scientific advisory board is comprised of internationally recognized key opinion leaders in the field of metabolic and inflammatory diseases, with a particular focus on the liver and gastroenterology

• The expertise, leadership and strength of the company’s relationships within the academic and clinical communities are critical to its ability to execute on its mission as it progresses its development pipeline

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A Comprehensive Strategy in Liver and Metabolic Healthcare

1. TREATMENT 2. DIAGNOSIS

3. AWARENESS

Providing THERAPEUTIC SOLUTIONS

Identifying PATIENTS ELIGIBLE FOR TREATMENTS

Optimizing STANDARD of CARE

4. LAUNCH EXCELLENCE Preparing for COMMERCIALIZATION

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Robust Pipeline Focused on Liver and Metabolic Diseases With Near-Term Clinical Milestones

• License agreement with LabCorp – January 2019 • LDT anticipated release in 2019 • Regulatory submission for IVD in 2020

• Currently finalizing analytical and clinical study designs • 2018: alignment with FDA on path forward to validate NIS4 • Discovery of two key miRNA biomarkers in 2015

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Upcoming Expected Catalysts

2019 2018

PBC (elafibranor) PHASE 2 – DATA READOUT

NASH (elafibranor) PHASE 3 – INTERIM DATA READOUT

NASH Diagnostic (biomarkers) PARTNERSHIP

NASH Pediatric (elafibranor) PHASE 2 – 1st PATIENT

2020

NASH Fibrosis (nitazoxanide) PHASE 2 – POC START

PBC (elafibranor) PHASE 3 – LAUNCH

NASH Diagnostic (biomarkers) NIS4 – START COMMERCIALIZATION (LDT)

for ACCELERATED MARKET APPROVAL

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II. LEADERSHIP IN NASH AND PBC

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A Potential to Become a Leader in NASH and PBC

1. TREATMENT NASH & FIBROSIS Elafibranor Combinations Nitazoxanide PBC Elafibranor

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NASH, a Disease Leading to Cirrhosis and HCC, Represents a Large and Untapped Market

Matteoni, Gastro 1999 – Adams, Gastro 2005 – Ekstedt, Hepatol 2006 – Ong, J Hepatol 2008 – Dunn, AJG 2008 – Sorderberg, Hepatol 2010 – Targher, NEJM 2010 – Williams, Gastro 2011 Chalasani, Gastro 2012 – Torres, Clin Gastro Hepatol 2012 – Wree, Nat. Rev Gastroenterol Hepatol 2013 – Rinella, JAMA 2015 – Bazick, Diabetes Care 2015

› Leading cause of liver disease in developed countries; ~20 million in the United States suffer from NASH and advanced fibrosis › Cardiovascular events are the leading cause of death in NASH › Multifaceted disease › Market estimations: up to $20bn by 2025

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Elafibranor, First-in-class, has Pluripotent Activities

PPARα and δ Regulate Multiple Pathways Essential in NASH

Elafibranor, First-in-class, has Pluripotent Activities: PPARα/δ Regulate Multiple Pathways Essential in NASH

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Elafibranor Is One of the Most Advanced NASH Product Candidates

2021 2020 2019

PHASE 3 interim DATA READOUT

• Elafibranor (Genfit) • Ocaliva (Intercept) • Selonsertib (Gilead) • Cenicriviroc (Allergan)

Potential NDA Submission

2018

PHASE 2 DATA READOUT

• MGL-3196 (Madrigal) • Aramchol (Galmed) • NGM-282 (NGM) • VK2809 (Viking)

FIRS

T w

ave

cand

idat

es

SECO

ND

wav

e ca

ndid

ates

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Evidence from Phase 2 NASH Trials

Elafibranor1

(GENFIT) Ocaliva2

(INTERCEPT) Selonsertib

(GILEAD)

N/A 20% vs 6%

(p-value 0.03) 26% vs 5%

(p-value 0.02)

Cenicriviroc (ALLERGAN)

N/A

MGL-31962

(MADRIGAL) Aramchol2

(GALMED) NGM-2822

(NGM)

TOP LINE COMPARISON on EFFICACY for "NASH RESOLUTION without worsening of fibrosis"

(approved/relevant endpoint for Phase 3 trials and market approval)

11% (no placebo)

17% vs 5% (p-value >0.05)

25% vs 6% (p-value 0.03)

VK28092 (VIKING)

N/A

1st wave candidates

2nd wave candidates

(1) Ratziu et al, 2016 Gastroenterology (centers with randomization in all arms, to take into account the well known heterogeneity in the standard of care of NASH patients in different centers) (2) Source: Corporate publications/presentations. Data not published in peer-reviewed scientific journals

Elafibranor is the only product candidate from the first wave in NASH to have demonstrated all four of (i) EFFICACY ON "NASH RESOLUTION WITHOUT WORSENING OF FIBROSIS" (ii) IMPROVEMENT

OF LIPID PROFILE (iii) IMPROVEMENT OF METABOLIC PROFILE (iv) TOLERABILITY

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Elafibranor in NASH GOLDEN-505 Phase 2 Results*

› Data published in peer-review journal

› Elafibranor resolved NASH without worsening of fibrosis, which has been recommended as primary endpoint for Phase 3 pivotal trials in NASH1: Ballooning = 0; Inflammation = 0 (or 1); No worsening of fibrosis (1 stage)

› Elafibranor showed improvement in the cardiometabolic risk profile of NASH patients

› Elafibranor showed favorable safety and tolerability results

Elafibranor Phase 2b Results: A Solid Ground for RESOLVE-IT Phase 3 trial

(1) Draft guidance presented by the FDA on 12/3/18

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Elafibranor in NASH GOLDEN-505 Phase 2 Results*

Elafibranor Phase 2b Results: Additional Key Benefits for NASH Patients

Beneficial effect on Lipid Markers

in NASH patients

Beneficial effect on - Glucose Homeostasis

- Insulin Sensitivity in T2D NASH Patients

ON TOP OF STANDARD of CARE

LDL-c ("bad” cholesterol) TG (triglycerides) HDL-c (“good” cholesterol)

ON TOP OF STANDARD of CARE

HbA1c (glucose homeostatis) HOMA-IR (insulino resistance)

“It is imperative that any drug developed for NASH be at least neutral from a cardiovascular risk perspective and ideally also reduce cardiovascular risks” (Hepatology 2015)

“Even using a low assumption for NAFLD prevalence in T2D patients, it is estimated that 84MM people in the U.S. live with prediabetes or T2D and NAFLD. Moreover, the coexistence of NAFLD and T2DM results in a worse metabolic profile and a higher cardiovascular risk.“ (Bril, Cusi, Diabetes Care 2017)

Favorable - Safety profile

- Tolerability profile

Crucial for a chronic and silent

disease

SAFETY clinical outcomes TOLERABILTY compliance efficacy in real world

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Elafibranor 120mg Placebo

FIRST TREATMENT PERIOD 18 MONTHS

Elafibranor Phase 3 Design: Details and Timing

2:1

> 250 centers (worldwide)

TRIAL INITIATION Q1 2016

Study population: patients at risk of progression to clinical events › NASH with a NAS ≥4 › Fibrosis stage F2 and F3 › (F1 + cardiometabolic risk)

End of enrollment first ~1000 patients for Subpart H: April 2018

Read-out first ~1000 patients: End of 2019

72-WEEK INTERIM ANALYSIS

Histological key secondary endpoint improvement of histological fibrosis (to be considered as an additional labeling claim)

ACCELERATED MARKET AUTHORIZATION • SUBPART H (FDA) • CONDITIONAL APPROVAL (EMA)

Histological primary endpoint NASH RESOLUTION WITHOUT WORSENING OF FIBROSIS (central reading for all biopsies): › Ballooning = 0 › Inflammation = 0 (or 1) › Without worsening fibrosis (1 stage)

~ 1000 patients

EXTENSION PERIOD

Elafibranor 120mg Placebo

~ 2000 patients

2:1

Prevention of NASH associated clinical events, including cirrhosis cancer, all cause mortality

Read-out ~2000 patients: based on occurrence of a pre-defined

number of events

END OF STUDY

DSMB 18-month DSMB 24-month DSMB 30-month

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Clinical Requirements for Future Combinations: Elafibranor Shows Potential as Backbone Therapy

ANTI-NASH drug candidates

PURE ANTI-FIBROTIC drug candidates

Addressing NASH (the underlying cause)

Addressing FIBROSIS (the consequence)

Ensuring a clean SAFETY/TOLERABILITY

Among product candidates in Phase 3, only ELAFIBRANOR and OCALIVA have the potential to address both NASH and fibrosis

ELAFIBRANOR has demonstrated a favorable safety and tolerability profile

in Phase 1 and Phase 2 clinical trials

1

2

3

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Proactive Evaluation of Potential "Add-on" Drug Candidates for Elafibranor in NASH

ELAFIBRANOR DRUG X BACKBONE Add-On

ELAFIBRANOR FXR

ELAFIBRANOR ACC

+

+

ELAFIBRANOR NTZ +

ELAFIBRANOR ANTI-T2D +

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Nitazoxanide (NTZ): GENFIT’s Pure Anti-Fibrotic Drug Candidate

3

› A new anti-fibrotic drug candidate, part of GNFT’s discovery program › Currently approved as an anti-parasitic › Early pre-clinical studies have shown promising anti-fibrotic activity › A wholly owned IP position in NASH-related fibrosis › Currently being evaluated in a Phase 2a investigator-led study

Nitazoxanide (NTZ)

CSAA CDAAc NTZ 30mpk NTZ 100mpk Preventive protocol in the CDAA/c model (12 wks)

EASL 2017

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Nitazoxanide (NTZ): Investigator-initiated Phase 2a

Evaluate the safety and efficacy of NTZ

NASH patients with fibrosis Stage 2 (significant fibrosis) or 3 (severe fibrosis)

Non-invasive readout related to fibrosis to assess the changes from baseline to the end of treatment:

de novo collagen synthesis through Fractional Synthesis Rate of circulating plasma proteins circulating markers of fibrosis fibrosis scores based on circulating markers imaging techniques

OBJECTIVE

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PBC (Primary Biliary Cholangitis): Elafibranor Well Positioned to Address Unmet Needs in this Severe Chronic Liver Condition

HIGH UNMET NEEDS

Significant proportion of non/partial responders with current treatments in PBC patient population Major symptom in PBC is pruritus and is not addressed by current PBC therapies

• Cholestatic chronic autoimmune disease • Affecting intrahepatic bile ducts • Severe liver disease • Prevalence in the general population: 0.05% • Patient profile: women 40-60 years old

Elafibranor consistently showed positive effects on ALP in all studied populations

+

Clinical evidence of beneficial effects induced by PPARα and PPARδ in PBC populations, supported by a pluripotent mechanism of action

+

Recent evidence showing the potential of PPARα to alleviate pruritus, a major symptom of PBC

RATIONALE for ELAFIBRANOR

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Phase 2a Study with Elafibranor in PBC (Primary Biliary Cholangitis)

UDCA + Elafibranor 80mg UDCA + Placebo

TREATMENT PERIOD 12 WEEKS

2:1

1st Patient enrolled May 2017

End of enrollment 45 patients: July 2018

Study population

adult patients with PBC and inadequate response to

ursodeoxycholic acid (UDCA)

Primary Endpoint achieved: December 2018

12-WEEK ANALYSIS

UDCA + Elafibranor 120mg

Primary endpoint

effect of daily oral administration of elafibranor on

serum alkaline phosphatase (ALP) from baseline

Secondary endpoints include: ALP < 1.67 × upper limit of normal (ULN) and total bilirubin within normal limit and > 15% decrease in ALP Paris, Toronto, UK PBC scores Pruritus and QoL (Quality of Life) Safety of elafibranor in a PBC population

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Elafibranor in NASH GOLDEN-505 Phase 2 Results*

› Elafibranor successfully meets PRIMARY ENDPOINT (“change at week 12 in serum alkaline phosphatase (ALP) from baseline”) with:

› High statistical significance (p<0.001) › Substantial reductions in alkaline phosphatase in patients receiving elafibranor

› -52% (80 mg) and -44% (120 mg) when compared to placebo

› Significant response rate on COMPOSITE ENDPOINT previously used for REGULATORY APPROVAL of existing PBC therapies (“Serum ALP<1.67xULN, an ALP >15% from baseline, and total bilirubin (TB)< ULN”) with:

› High statistical significance (p<0.001) › 67% (80 mg) and 79% (120 mg) responders vs. 6.7% for placebo

Elafibranor Phase 2 Results: Positive Data Readout in PBC – Key Takeaways

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Elafibranor in NASH GOLDEN-505 Phase 2 Results*

Elafibranor Phase 2 Results: A Highly Competitive Profile

Elafibranor1

(GENFIT) Ocaliva2

(INTERCEPT) Seladelpar3 (CYMABAY)

TOP LINE COMPARISON EFFICACY in PHASE 2 (12-week data)

ALP (% change vs baseline)

% responders ALP<1.67ULN; Bili<ULN

and Delta ALP<-15%

-48%

80mg 120mg pbo 10mg pbo 5mg 10mg pbo

-41% +3% -24% +3%

1. Company press release 2. Hirshfield et al. 2015 Gastroenterology 148:751-761 3. Poster Ap. 2018 - EASL-Hirshfield at al. (Pres Nov 2017 AASLD, Hirshfield et al.)

-33% -45% N/A

67% 79% +6.7% 23% +10% N/A

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Elafibranor in NASH GOLDEN-505 Phase 2 Results*

Elafibranor Phase 2 Results: Positive Data Readout in PBC – Additional Key Benefits

Improvements in: Markers of PBC › Gamma-glutamyl

transferases (GGT)

Beneficial effect: › Early indication of

improvement in pruritus to be confirmed in a longer study

Favorable: › Safety profile › Tolerability profile

Clear clinical evidence to further advance Elafibranor in PBC

Metabolic Markers › Total cholesterol, low-

density lipoprotein-C, and triglycerides.

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A Pioneering & Proactive Approach to Unlock the NASH Market

2. DIAGNOSIS Towards a large scale industrial solution

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Non-invasive, but limited

Imperfect "Gold Standard"

NASH Diagnosis: A Need for Simple Blood-based Solutions

BIOPSY

IMAGING TECHNIQUES

Current bottleneck

“…there is an urgent unmet need to develop biomarkers that facilitate the diagnosis, identification of populations at risk, assessment of disease progression or regression, and/or response to treatment.” Page 1401

Ideal situation

BLOOD TEST Potential for large scale adoption in the clinic

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GENFIT’s Approach Designed to Ensure the NASH Market Can Reach its Full Potential

HEALTHY CIRRHOSIS

NO NASH NASH

TO BE TREATED N/A NAS ≥ 4 F2 or higher

Steatosis ≥1 Ballooning ≥1 Inflammation ≥1

NAFLD

Focus on a specific and relevant clinical question:

LDT anticipated release in 2019 Regulatory submission for approval anticipated in 2020 (US, EU)

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NIS4 Commercialization: Planned Strategy and Objectives

2021 2020

Prepare IVD for FDA Submission

2019

• LDT for Clinical Research • Expansive Research

PART

NER

SHIP

RE

GU

LATO

RY

• IVD Approval

U.S. Commercial Licensing Agreement

E.U. Commercial

Licensing Agreement

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The Future Patient Journey with IVD Test, for Better Clinical Management of NASH Patients

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A Pioneering & Proactive Approach to Unlock the NASH Market

3. AWARENESS

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The NASH Education ProgramTM

www.the-nash-education-program.com The NASH Education ProgramTM

NASH (Non-Alcoholic

SteatoHepatitis)

Serious liver condition

Unprecedented rise in prevalence

Sub-Optimal PATIENT CARE

Silent, by nature

Diagnostic = bottleneck

No approved treatment yet

Yet still little known, because… HIGH UNMET NEEDS

1

2

3

PHYSICIANS Incl. DIABETOLOGISTS, ENDOCRONOLOGISTS, CARDIOLOGISTS, GPs

PATIENTS Individuals at risk, Families

For BETTER CARE

33

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A Worldwide Success for the Inaugural Edition of International NASH Day, in 25+ Countries

A large coalition of 20+ stakeholders, across the United States, Europe,

and LATAM, including:

• Patient associations • Learned societies • Companies

34

ROADMAP 2019

New and larger leadership

Focus on education

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A Relevant Approach to Market Access to Prepare for Commercialization

1. TREATMENT Ideal drug profile 1st line treatment monotherapy Cornerstone combination therapies

2. DIAGNOSIS Market Enabler (patient identification)

3. AWARENESS Market Enabler (physicians’ knowledge)

4. LAUNCH EXCELLENCE

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A Strategy to Maximize Sales Uptake and Transform the Company

Elafibranor: uniquely positioned in the first wave of NASH products Objective: transform GENFIT into a biopharma, with a mixed revenue stream from:

Direct sales of elafibranor Royalties from potential licensing deal

World class launch plan

Currently recruiting a team of experienced pharma leaders in the field of marketing and market access

People who have joined the team have worked on several global launches and have years of combined experience in big pharma in Europe and the US

Commercialization strategy

Open to explore potential alliance with large pharma company, preferably with a solid footprint in metabolic diseases