investor presentation - i.ceram€¦ · sternum replacement by a porous alumina ceramic prosthesis....
TRANSCRIPT
I.CERAM
Investors Presentation
August 2018
INVESTOR PRESENTATIONAUGUST 2018
« Ceramic excellence for the treatment
of bone infections and bone tumors »
I.CERAM
Investors Presentation
August 2018
Your contacts
André KERISITCEO, Founder
Christophe DURIVAULT
Financial Director
▪ 32 years of experience in orthopaedic devices
▪ Sales manager and Product developper
▪ Founder of 2 companies
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Eric DENES, M.D
Scientific Director
I.CERAM
Investors Presentation
August 2018
Where do we come from?
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I.CERAM
Investors Presentation
August 2018
Ambition: the whole skeleton
« Becoming the leader in bone
replacement for infection & cancer
with our innovative implants, made of porous alumina ceramic »
CE marked in July 2018
Our vision, our goal
I.CERAM
Investors Presentation
August 2018
Short-term investment plan
▪ Sternal prosthesis was CE marked in July
2018 ▪ → A. Commercialization investments for the EU market
including France
▪ → B. Investments, including a new production facility in the
Limoges area
▪ Next regulatory step to address U.S. markets▪ → C. Begin U.S. FDA approval process
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I.CERAM
Investors Presentation
August 2018
CERAMIC IMPLANT
(+ Active molecule)
DISEASED PART:
- Infection
- Cancer
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Our technology: Summary
CERAMIC IMPLANT
(Mechanical properties)
I.CERAM
Investors Presentation
August 2018
Our technology:
Ceramil®
Alumina ceramic
I.CERAM
Investors Presentation
August 2018 8
Céramil® Cancellous bone
Bone mimicker
I.CERAM
Investors Presentation
August 2018 9
Main characteristics
Unique capacity of
bone integrationPorosity range from
100 to 900 μm
Proved
biocompatibility, inert
Mechanical strength
more than 20 MPa3 times cancellous bone
strength in compression
Radiolucency and
compatibility
with radiotherapy
Pure alumina Al2O3
Interconnected
porosity without
dead endA certain level of
resistance to
bacterial infection
Non resorbable
I.CERAM
Investors Presentation
August 2018 10
Ceramic track record
First implantation:1995
Several patents
CE mark since:1997
Renewed by I.CERAM
since 2006
Implantations:>6000
Knee wedges: >3000 (first pieces)
Cervical cages: >1700
Lumbar cages: >250
Trepan filling: >130
Various orther shapes
No infection No material vigilance
I.CERAM
Investors Presentation
August 2018
▪ In vitro▪ Colony forming unit stuck to
several materials
▪ A : Staphylococcus aureus
▪ B : Pseudomonas aeruginosa
▪ Strains forming biofilm
Dr T.S Ouk, MCU-Ph - Laboratoire de Chimie des Substances Naturelles, University of Limoges
* : p<0,05
* : p<0,05
** : p<0,001
A
B
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Low bacterial adhesion
**
**
Amount of S. aureus adherent to different materials
I.CERAM
Investors Presentation
August 2018 12
MC3T3-E1 cells. Nucleus marked with DAPI.
Great osseointegration
Bone cells colonize pores and secrete
and mineralize bone matrix
Histology of bone tissue observed at 2 different stages in 2 close
pores at M7
Mature bone (light pink area) New bone formation (dark pink area)
J3 J7
I.CERAM
Investors Presentation
August 2018
The family tree
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No more development but a strong basement:
> 6000 implantations without any complication
Investments
Joint
replacement
Every boneBone
Tumor
Bone
Infection
Antibiotic loading
I.CERAM
Investors Presentation
August 2018
Antibiotic loading
Our technology: Ceramil®
I.CERAM
Investors Presentation
August 2018
Material colonisation
H+2Adhesion
H+4Beginning of
biofilm formation
H+8Biofilm over all
the surface
H+24Bacteriarelease
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Olson ME, et al. J Biomed Mater Res. 1988 Jun; 22: 485–95.
I.CERAM
Investors Presentation
August 2018
In vitro release
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Gentamicin Vancomycin
I.CERAM
Investors Presentation
August 2018
Natural antibiotic spectrums
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S. aureus
S. epidermidis
Streptococcus ssp.
I.CERAM
Investors Presentation
August 2018 18
BoneDefect
INFECTION
•Native bone
•Prosthesis
CANCERAGENESIS
I.CERAM
Investors Presentation
August 2018
- Unloaded sternum (Tumour & Agenesis)
- Antibiotic loaded sternum
- Antibiotic loaded bone flap
I.Ceram answers to clinical
challenges:
I.CERAM
Investors Presentation
August 2018
Sternal metastasis
Chest wall reconstruction after metastasis removal
I.CERAM
Investors Presentation
August 2018
Bone agenesis (Sternum)
9 year-old girl
Down syndrome
Cardiac neonate surgery
Surgery performed in
MarseilleDischarged on day 6
I.CERAM
Investors Presentation
August 2018
Deep sternal wound infection
after cardiac surgery
After 10 months of hospitalisation 1 week after surgery 3 weeks after surgery, day of discharge
Reportage : Magazine de la santé / 13 avril 2018 (M22 post opératoire)
Antibiotic (gentamicin) loaded device
I.CERAM
Investors Presentation
August 2018
Chronic OsteomyelitisResistant Staphylococcus (MRSA)
Bone fistula and diseased bone
Bone flap impacted and anchored
Bone fistula
Skin fistula
M11 Follow-up (June 2018)
Bacteriology samples:
All positive with MRSA
Loaded with gentamicin
I.CERAM
Investors Presentation
August 2018
▪ Local dosages▪ Comparison with the required concentration for efficacy:
▪ Blood samples:▪ No or very low concentrations
▪ Reduced toxicity24
Device Loaded
gentamicine
dose
H1 H5 H24
Sternum * 320 mg1500 mg/L
> 175
395 mg/L
> 50
Sternum * 160 mg2100 mg/L
> 260
36,9 mg/L
> 4.6
Bone flap ** 160 mg184 mg/L
> 50
13 mg/L
> 4
* For an MIC of 1 mg/L
** MRSA MIC for
gentamicin < 0.5 mg/L
Concentration (mg/L)
Bone Sample H1 H3 H6 H12 H24 H48
# 1 Sternum Blood < 0,5 < 0,5 < 0,5 < 0,5 < 0,5 < 0,5
# 2 Sternum Blood < 0,5 0,6 0,6 < 0,5 < 0,5
#3 Femur Blood < 0,5 < 0,5 < 0,5 < 0,5 < 0,5
#4 Sternum Blood < 0,5 < 0,5
In vivo
I.CERAM
Investors Presentation
August 2018
Focus on Sternum
▪ To date:▪ 13 implantations
▪ Of which 3 loaded with gentamicin
▪ Mean follow-up : 20 months
▪ First one : more than 3 years of follow-up
▪ CE marking obtained in July 2018
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I.CERAM
Investors Presentation
August 2018
Partnerships for distribution
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I.CERAM
Investors Presentation
August 2018
Scientific publications
▪ 2 articles accepted for publication in
international journals:▪ F. Bertin, E. Deluche, J. Tricard, A. Piccardo, E. Denes. First case of sternal replacement of bioceramic with
bioceramic prosthesis after radio-induced sarcoma. Curr Oncol. 2018
▪ F. Bertin, A. Piccardo, E. Denes, G. Delepine, J. Tricard. Porous alumina ceramic sternum: A reliable option for
sternal replacement. Annals of Thoracic Medicine. 2018
▪ Oral communications▪ Jérémy Tricard, Alessandro Piccardo, Nicolas Pichon, Denis Asselineau, François Bertin. Résultats des premières
implantations de la prothèse CERAMIL®, un nouveau dispositif de remplacement sternal - SFCTCV (Société Française de
Chirurgie Thoracique et Cardio-Vasculaire), Journées d'Automne 2016
▪ Posters▪ F. Bertin, E. Denes, G. Levêque, F. Fiorenza, J. Tricard, D. Setton, C. Mage, F. Sturtz. Sternum replacement by a porous
alumina ceramic prosthesis. Poster 169 - 29th EMSOS (European Musculo-Skeletal Oncology Society) 2016, La Baule
▪ François Bertin, Jérémy Tricard, Claire Eveno, Eric Denes, Alessandro Piccardo. Porous alumina ceramic sternum as an
option for sternal replacement. About 7 cases - 25th European Conference on General Thoracic Surgery Innsbruck,
Austria, 28 – 31 May 201727
I.CERAM
Investors Presentation
August 2018
Presentation to surgeons
▪ International meetings attendance for sternum présentation▪ 26th European Conference on General Thoracic
Surgery (ESTS)
▪ 2018 – Ljubljana (Slovenia)
▪ 52nd Annual Meeting of the Association for European Paediatric and Congenital Cardiology
▪ 2018 – Athens (Greece)
▪ 71st Congrès de chirurgie thoracique et cardio-vasculaire
▪ 2018 – Lille (France)
▪ Vivatechnology – Paris 2018
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I.CERAM
Investors Presentation
August 2018
Regulation
▪ Beginning of:▪ CE marking for the antibiotic loaded sternum
▪ Our objective: 2020
▪ Antibiotic file review: max 210 days
▪ FDA approval
▪ Mean time for class III (PostMarket Approval): 400 days
▪ Thus, our objective: 2021
▪ Submission cost: ~250,000 $
▪ Global budget: 1,000,000 $
I.CERAM
Investors Presentation
August 2018
Same bone, different diseases
Infection
Cancer
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AgenesieI.Ceram :
The solution
Agénésie
Infection
Cancer
: One solution for all sternal pathologies
I.CERAM
Investors Presentation
August 2018
Participation in 3D printing
company
▪ Minority shareholder (49%)
▪ For single use ancillaries
▪ Metal and plastic 3D printing
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I.CERAM
Investors Presentation
August 2018
The future
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Main
axes
• New shapes, volumes & structure
• Loaded sternum CE marking
• FDA
• Other molecules
• Worldwide distribution
I.CERAM
Investors Presentation
August 2018
Financial figures
I.CERAM
Investors Presentation
August 2018
I.Ceram stock
▪ Listed in Paris
▪ Market Place:
Euronext Growth
▪ Mnemonics:
ALICR
▪ Average daily
volume: 2,600
I.CERAM
Investors Presentation
August 2018
I.Ceram Shareholding
35
André
KERISIT
50%
Xale
Finance (Belgium)
36,5%
Ernée
Gestion (Luxembourg)
13,5%
Private investors
43,5%
Investissement Développement
56,5%
SA I.CERAM
ADDIDREAM
49%
I.Ceram PT
(Portugal)
100%
I.Ceram SRO
(Czeck
Republic)
100%
I.Ceram
South Africa
33%
Limousine de
Brevet
100%
I.Ceram UF
(SASU)
100%
3D Printing Commercial/Business IP New factory
project
I.CERAM
Investors Presentation
August 2018
P&L
K€Year 2017
Audited
Year 2016
Audited
Turnover 1 479 1 506
Ebitda -1 385 -1 198
Operating profit -2 125 -1 716
Financial profit 53 -126
Exceptional profit - 85 - 53
Yearly Net Loss -2 157 -1 895
I.CERAM
Investors Presentation
August 2018
2016 Dec. 31st
Balance Sheet (K€)
Assets
Short Term
Receivables
3 191
1 300
11 219 K€
Liabilities
11 219 K€
Assets
8 688
Available Cash
2017 Dec. 31st
3 573
3 606
Equity
Loans1 858
9 586 K€
Liabilities9 586 K€
Assets
6 514
2 407
Equity
Loans
4 057
3 971
Other debtsOther debts1 214 1 231
I.CERAM
Investors Presentation
August 2018
To summarize the pitch
▪ A disruptive technology protected by patents
and secrets
▪ It’s just the good time to adress new big markets
▪ A complete and complementary team
▪ A complete in-house business model for the
greatest value for shareholders