Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities...

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Implanet European Large and Midcap event Paris I October 14 th , 2019 www.implanet.com

Transcript of Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities...

Page 1: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

Implanet

European Large and Midcap event

Paris I October 14th, 2019

www.implanet.com

Page 2: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

1 Implanet presentation

4JAZZ®, a disruptive technology embedded in spine surgery

2 Markets and trends

3MADISON®, a comprehensive total knee prosthesis range

Agenda

5Value chain, international developments and partnerships

6 Strategic priorities

7 Appendices

Page 3: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

Implanet presentation1

Page 4: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

◼ Market: listed on

— Euronext Growth Paris

— OTCQX – New York

◼ Offices : Bordeaux, London, Frankfurt & Boston

◼ 2018 revenue: €6.7M 2019 revenue: Third straight quarter of growth(+2% on Q1, +8% on Q2 and +12% on Q3) Jazz activity +10% on Q3 YTD

Business overview

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◼ A medical technology company specialized in vertebraland knee-surgery implants.

About Implanet

A disruptive technology and a strong historical

expertise

Commercial presence in 17 countries around the world

39 employees 37 patents

JAZZ® Platform MADISON® TKP

✓ Exhaustive total knee prosthesis range

Knee revenue: €2.6M of which 69% in France

✓ Exhaustive product range to address 100% of fusion pathologies

Spine revenue: €4.1M of which 39% in France

and 47% in the United States of America

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Market and trends2

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◼ The spinal implants market is expected to reach $14.6bn in 2019 with a GAGR of 5.5 % on the 2015-2019 period3

IMPLANET is positioned in a promising market

Knee prosthesis and spinal implants market = 49% of the global market for orthopedic IMD1

◼ The knee prosthesis market is estimated at $8bn in 2017 and is expected to reach $10bn in 2024 with a GAGR of 3.7%2

Sources :(1) Xerfi (% over a revenue of 40.5 billions in 2016)(2) Global Market Insights(3) Technavio

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1) Ageing population

2) Changing lifestyles

Key market drivers

3) Improving access to healthcare in emerging countries

4) Medicine progress

22% of the global market for orthopedic IMD1

27% of the global market for orthopedic IMD1

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MADISON®, a comprehensive Total Knee

Prosthesis range

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MADISON® a new generation of knee prosthesis

▪ Exhaustive Total Knee Prosthesis range

▪ Bone preservation

▪ 17,000+ Madison implanted since 2010

▪ 2% market share in France / Fourth French player

▪ 7+ years of follow up and clinical evidence

Presentation PartnershipsWorldwide marking

Est. Q4 2019

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TGA Australia

Worldwide recognition of MADISON® TKP’s clinical value

▪ Partnership agreement with KICO KNEE INNOVATION COMPANY PTY LTD signed in November 2018(Australia, New Zealand and United States)

▪ OEM Partnership under discussion for the United States

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JAZZ®, a disruptive technology embedded

in spine surgery

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JAZZ ®, a standard of care in fusion technics

for complex spine surgeries

▪ Pediatric deformity

▪ Degen adult

▪ Trauma

▪ Degenerative diseases

✓ Exhaustive product range to address 100% of fusion pathologies

✓ Significantly better proven clinical results

✓ Security strengthened through this solution

✓ Cost-effectiveness

▪ Quantity of metal

▪ Screw misplacement

▪ Screw fixation

▪ X-ray exposure

▪ Cost of instrumentsets

CURRENT STANDARD OF CARE= ALL SCREW CONSTRUCTION

TOMORROW SOLUTION= JAZZ® PLATFORM

DISADVANTAGES OF SCREW CONSTRUCTIONS

+40,000JAZZ® sold since 2014

+7,500PatientsJAZZ® as of H1 2019 :

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JAZZ®

FRAME

Additional

diameters(3.5 – 6.35

mm)

Compatible

with 100% of

fixation

systems

Launch of

JAZZ® implant

in France and

the US

2014 2015 2016 2017

JAZZ®

LOCK

JAZZ® CLAW

JAZZ ®, an enlarged & established technological platform…

Steady pace of new product launches since inception

JAZZ® range

completion in

scoliosis

JAZZ® solutions less invasive and

dedicated to the degenerative market

JAZZ®

PASSER

JAZZ® EVO

2018

JAZZ®

CAP

JAZZ®

PASSER

BAND

29 granted International Patents

Regulatory clearance in 80% of the global commercial market: United States, Europe…

…positioned to fully address spinal fusion indications

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Capitalizing on JAZZ® success to accelerate the development in

degenerative bone disorders

Major growth opportunity for Implanet

Paediatric+

Adolescent

(Elderly patients)

VERTEBRAL FUSION 860,000 operations a year worldwide(1)(2)

Major deformities

Degenerative bone disorders

$480m1

$1.6bn2

x3

Aging population

Prevalence of chronic back pain

Poor bone quality negatively impacts surgical outcomes

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(1): sources i-Data 2010; Company(2): sources i-Data 2010; D. K. Chin and al. Osteoporos Int (2007) 18:1219–1224.; Company

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1. Securing screws

(1) : source : 2015 Health Advances study(2) : cf Sung Bae Park, M.D.1 and Chun Kee Chung, M.D. 2 Strategies of Spinal Fusion on Osteoporotic Spine. J Korean Neurosurg Soc. 2011 Jun; 49(6): 317–322. )(3) : sources i-Data 2010(4) : sources D. K. Chin et al. Osteoporos Int (2007) 18:1219–1224 13

2. Proximal Junctional Kyphosis

JAZZ® Band

JAZZ® connector

Screws

Adjacent disks

Degenerative bone disorders : JAZZ®, a complementary solution to screws

▪ Between 10 and 30% of cases classified as high risk (poor bone quality)(1) …

▪ …20 to 25% of which have osteoporosis as co-morbidity(2)

▪ 25% of cases involve complications associated with kyphosis or proximal junctional level following a spine fusion(1)

700,000 cases / year(3) = $1.6bn(4)

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Value chain, international developments

and partnerships

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A well-structured orthopedic company on quality, regulation and logistics

A proven regulatory platform

Operations & Quality processes

▪ ISO 13485 : 2016 certification, critical step to the MDR 2017/745 effective in May 2020

▪ CE marking valid until 2024

▪ Regulatory marking and authorizations on all targeted markets*:

510 (K) USA*

ANVISA Brazil

93/42/CE Europe

ISO 13485TGA Australia*

* En cours pour la gamme MADISON

Outsourcing

◼ Material control

◼ Casting, machining, sanding, plasma spay

◼ Laser marking

ValidationAssembly & sterilization

Certification & final control

Distribution

◼ Quality control team

◼ Sampling and control procedures

Total control over product traceability

Research & Development

Manufacturing

Outsourcing

◼ Assembly

◼ Final cleaning

◼ Packaging

◼ C

◼ C

◼ c

◼ Batch record

◼ Labeling

◼ Traceability

◼ Design

◼ Patents

◼ Biomechanical tests

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International commercial strategy: replicating a proven direct sales model

and execution of strategic partnerships

▪ 48% of its revenue coming from abroad since 2016

▪ Replication of a proven direct sales model (already inplace in France and the United States) for Europewith the recent opening of:

— A branch in the UK

— A subsidiary in Germany

▪ For the rest of the world, particularly Brazil, IMPLANEThas forged strong alliances with local distributors

▪ Setting up of strategic partnerships with internationalplayers to accelerate its geographical reach :

SeaSpine: partnerchip for the sale of the JAZZ®

platform in the United States

KICo: partnership for the sale of the kneeprosthesis in the United States and Australia

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International strategyCountries where Implanet has a commercial coverage

Direct sales Distributors

Brazil

PeruAustralia

United States

Belgium

Greece

Italy

Ireland

Lithuania

Morocco

Netherlands

Portugal

Spain

Switzerland

France

Germany

United Kingdom

Active in 17 countries

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KICo: a structuring knee partnership to accelerate international

development

▪ In November 2018, IMPLANET has forged adistribution agreement with KICo (Knee InnovationCompany) in order to market its MADISON® kneeprosthesis firstly in the United States and Australia

▪ KICo benefits from exclusive rights for the MADISON®

knee prosthesis when the threshold of1,000 MADISON® implants are sold over 12 months

▪ KICo will then have an option for a manufacturinglicencse

United States Australia

▪ KICo, founded in 2015, is specialized in theconception, development and sale ot total kneeprosthesis. KICo offers very personalized productadapted to each patient.

▪ The company sales its product mainly inAustralia, in New-Zealand and the UnitedStates.

Strategic partnership(Distribution agreement)

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SeaSpine: a Spine partnership to accelerate our development in the

United States

€143M (+9%)2018 revenue

327 Employees

▪ SeaSpine is specialized in the conception,development and sale of medical technologies forspinal surgery.

▪ The company realizes 90% of its sales in theUSA:

#6 the top US ranking

#7 the top global ranking

▪ SeaSpine has 327 employees of which 105 insales and marketing.

United States

▪ JAZZ® Private Label Distribution agreement with SeaSpine in the US, the world’s largest market for the treatment of spinal pathologies(current Implanet America accounts will continue to be directly managed by our subsidiary)

▪ Capitalize on SeaSpine’s Salesforce and training & education capabilities in the US

— 10 Area Managers

— Training & Education Specialists

— +200 Agents (1099 Reps)

▪ 6 years initial agreement with guaranteed annual minimum sales for Implanet

▪ SeaSpine & Implanet: same vision with a strong culture of innovation and education

▪ JAZZ Cap®: offering a unique and proprietary solution for securing pedicle screws in poor-quality bone. JAZZ Cap®

technology strengthens the offering of JAZZ® productsin the US to address a larger ‘mass market’.

Strategic Partnership (Private Label Distribution agreement)

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6Strategic priorities

Page 20: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

PROMOTING

▪ Ongoing innovation to JAZZ® platform

▪ Financing new co-developed products with OEM partners

CONTINUING TO DEMONSTRATE

▪ JAZZ ® : clinical studies in degenerative pathologies (Ohio State University)

▪ Madison: PMS follow up

▪ Reinforcing the Scientific Committee & clinical

SEEKING

▪ Developing direct sales in Europe

▪ Reinforcing JAZZ training academy

▪ Executing new strategic partnerships

FINANCING

▪ Financing working capital

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innovation and enlarge certifications

proven medical value based on clinical trials

efficient commercial expansion

Strategic priorities

Clear and focused growth levers

Page 21: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

7Appendices

Page 22: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

Latest financials

Page 23: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

Revenue of €5.6 million for the 9-months to end-September, 2019,

up 7%

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Revenue (€ thousands - IFRS*) 2019 2018 Variation

1st quarter revenue 1,904 1,867 +2%

2nd quarter revenue 1,915 1,765 +8%

Spine (JAZZ®) 1,189 1,056 + 13%

Knee 550 491 +12%

3rd quarter revenue 1,739 1,548 +12%

Spine (JAZZ®) 3,573 3,254 +10%

Knee 1,984 1,926 +3%

Total 9-months revenue 5,557 5,179 +7%

▪ Signature of a strategic partnership withSeaSpine, Inc. to market the JAZZ® range in theUSA

▪ JAZZ Cap® FDA clearance, offering a unique andproprietary solution for securing pedicle screwsin poor-quality bone

▪ Successful first JAZZ Cap® surgeries in theUnited States

▪ Recording of the first orders originating from thepartnerships established with Kico Knee andSeaSpine, Inc. (€0,3M to be delivered in thesecond half of 2019)

HighlightsEnd Sept. 2019

(*) Unaudited data

€1,867 €1,765€1,548

€1,904 €1,915 €1,739

2%8% 12%

1st quarter revenue 2nd quarter revenue 3rd quarter revenue

2018 2019 Variance (%)

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H1 2019 results

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▪ Proprietary implants range generating high gross margin

▪ Controlled operating costs to improve EBIT (reduced by €0.9M over H1’19)

▪ Operations restructured late 2018 which should enable a further saving of €0.8M on expenses over H2’19

Maintaining gross margin and operating result

trends improvements

(€ thousands - IFRS) H1 2019 (6 months)

H1 2018 (6 months)

Revenue 3,818 3,632

Gross margin 2,177 2,023

Gross margin as a % of revenue 57.0% 55.7%

Operating expenses -3,898 -4,772

Operating loss before non recurring items

-1,721 -2,750

Operating loss -1,550 -2,750

Net loss -1,825 -2,772

P&L statement

€4.1€3.7 €3.6

€3.1€3.8

€2.1 €1.8 €2.0 €1.7 €2.2

51%

49%

56%55%

57%

H1'17 H2'17 H1'18 H2'18 H1'19

Revenue Gross margin (€M) Gross margin (%)

Revenue and gross margin Operating costs and EBIT

€(5.6)

€(4.5)€(4.8)

€(4.3)€(3.7)

€(3.5)

€(2.7) €(2.7) €(2.6)

€(1.6)

H1'17 H2'17 H1'18 H2'18 H1'19

Operating expenses Operrating income

Page 25: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

-€(2.9)M-€(2.3)M

-€(3.1)M

-€(1.9)M-€(1.4)M

H1'17 H2'17 H1'18 H2'18 H1'19

Flux de trésorerie (M€)

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(€ thousands - IFRS) H1 2019(6 months)

H1 2018 (6 months)

Free Cash Flows (1,352) (3,102)

o/w cash flow (1,754) (2,420)

o/w change in WCR (-) (657) 422

o/w Capex (-) 255 260

Cash flow from investment activities 1,853 1,113

o/w Equity 1,937 1,000

o/w Loans & interests (332) 284

o/w other (factor and placements) 248 (170)

Changes in currency rates 32 4

Change in the cash position 533 (1,985)

Free Cash Flows

Cash flow statement▪ Improvement in WCR and not capital

intensive (limited JAZZ instrument costs)

▪ Decrease of cash needs from €3.1M in first half of 2018 to €1.4M in first half of 2019

▪ Cash and cash equivalents of €1.1M at June 30, 2019, no significant LT debts

▪ Stabilized cash position

▪ €3.0M convertible bond financing

arranged with Nice & Green on April 2019 (12 tranches of €250k)

▪ Loans from BPI for a total of €0,6M

Sufficient working capital for the next 12 months

to focus on operations

Free Cash Flows (€M)

Cash position as of 06/30/2019

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Team

Page 27: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

FranceÉtats-UnisRégis LE COUEDIC

R&D & RAQA Director 26 years of experience

Zimmer, Stryker Corporation,Spine Next, Abbott Spine

Ludovic LASTENNETCEOBoard Director25 years of experienceStryker Corporation, Kavo Dental (Danaher Corp. group)

Laurent PENISSON Knee BU Director23 years of experienceStryker Corporation, Arthrex

Shane DOYLEVP US Sales & Marketing20 years of experienceEtex Corporation, Stryker Corporation

Georges LEGALLOISBusiness Development EMEA Spine15 years of experienceZimmer, Stryker Corporation

David DIEUMEGARDCFO

23 years of experienceKot, Musiwave, ActivIdentity

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Nicolas MARINMarketing Director

20 years of experience Stryker Corporation

A company led by a highly experienced team

With strong international expertise

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History

Page 29: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

History

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2007

▪ Creation of IMPLANET

2010

▪ Obtaining CE approval

▪ First placement of the MADISON®Implant

2012

▪ First FDA approval 510(k) for the JAZZ® implant

2013 (Nov.)

▪ Initial public offering on Euronext Paris

2014

▪ End of the commercialization of hip prostheses

▪ First publication of “white papers” in favor of the JAZZ® implant

2015

▪ Obtaining regulatory approval from the Brazilian health authority

▪ Definitive intellectual property protection for JAZZ® technology

2017

▪ Obtaining CE and FDA 510(k) approval for the new products

▪ New patents granted in Europe and the United States

2019

▪ Strategic partnership with SeaSpine for distribution of JAZZ® platform in the United States

2013

▪ JAZZ® deployment in France and Europe

▪ Opening of a subsidiary in the United States and first surgery with JAZZ® in the United States

2016

▪ First surgery with JAZZ® in Brazil

▪ Marketing of the JAZZ® Lock implant

▪ Patent granted in the United States for the JAZZ® platform

2018

▪ Development of the direct sales strategy in Europe (opening of subsidiaries in UK and Germany)

▪ Strategic partnership with KICofor the distribution of MADISON®prosthesis

▪ Progressive stop of arthroscopic activity

Strategic refocusing on JAZZ® and MADISON products

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Disclaimer

References herein to this presentation (the “Presentation”) shall mean and include this document, any accompanying oral presentation and any question and answer session, as well as any further information made available in connection herewith.

This Presentation has been prepared by Implanet (the "Company") and is provided for information purposes only.

The information and opinions contained in this Presentation are provided as of the date of this Presentation only and may be updated,supplemented, revised, verified or amended, and thus such information may be subject to significant changes. The Company is not underany obligation to update the information or opinions contained herein which are subject to change without prior notice.

The information contained in this Presentation has not been subject to independent verification. No representation, warranty orundertaking, express or implied, is made as to the accuracy, completeness or appropriateness of the information and opinions contained inthis Presentation. The Company, its subsidiaries, its advisors and representatives accept no responsibility for and shall not be held liable forany loss or damage that may arise from the use of this Presentation or the information or opinions contained herein.

This Presentation contains information on the Company’s markets and competitive position, and more specifically, on the size of itsmarkets. This information has been drawn from various sources or from the Company’s own estimates. Investors should not base anyinvestment decision on the information in this Presentation.

The statements contained in this Presentation that are not purely historical are forward-looking statements. Such forward-lookingstatements include, but are not limited to, statements regarding the Company’s or its management’s expectations, hopes, beliefs,intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations offuture events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipates,” “believe,”“continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would”and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is notforward-looking. The forward-looking statements contained in this Presentation are based on the Company’s current expectations andbeliefs concerning future developments and their potential effects on the Company and its business. There can be no assurance that futuredevelopments affecting the Company will be those that have been anticipated. These forward-looking statements involve a number of risks,uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to bematerially different from those expressed or implied by these forward-looking statements. More specifically, such factors could include,without limitation, general economic and business conditions, global medical device market conditions, industry trends, competition,changes in law or regulation, changes in taxation regimes, the availability and cost of capital, the time required to commence and completeclinical trials, the time and process required to obtain regulatory approvals, currency fluctuations, changes in business strategy, andpolitical and economic uncertainty. Your attention is also drawn to the risks described in the reference document of Implanet filed with theAutorité des marchés financiers (the "AMF") on April 16th, 2018 under n°D.18-0337 to which you are invited to refer (a copy of which isavailable on the Company’s website).

This Presentation does not constitute an offer to sell or subscribe or a solicitation of an offer to purchase or subscribe for securities in anyjurisdiction. It is not a recommendation in any manner for the sale or purchase of securities, or intended to be used as the basis for anyinvestment decision in relation to the sale or purchase of the Company’s securities. All persons accessing this Presentation are deemed toagree to all the restrictions and limitations set out above.

The distribution of this Presentation may be restricted by law and persons into whose possession this Presentation comes should informthemselves about, and observe, any such restrictions.

By accessing this Presentation, you agree to be bound by the restrictions set out above. 30

Page 31: Implanet€¦ · 5 Value chain, international developments and partnerships 6 Strategic priorities 7 Appendices. Implanet presentation 1 Market: listed on — Euronext Growth Paris

www.implanet.com

IMPLANET

Ludovic Lastennet

CEO

Tel. : +33 (0) 5 57 99 55 55

[email protected]

NEWCAP

Investor Relations

Sandrine Boussard-Gallien /

Pierre Laurent

Tel. : +33 (0)1 44 71 94 94

[email protected]

David Dieumegard

CFO

Tel.: +33(0) 5 57 99 55 76

[email protected]