b2s – hecolcap
TRANSCRIPT
Copyright COHiTEC, 2015 Final Presenta;on 2
B2S – HECOLCAP TEAM
Mentors
Susana Sousa Nilza Ribeiro João Cortez
Jorge Oliveira Joaquim Valente
50 years of combined research experience
Pedro Fraga MBA
Technologists
Copyright COHiTEC, 2015 Final Presenta;on 3
B2S – HECOLCAP NEED
OsteomyeliGs Bone infec;on, associated to: • diabe;c foot ulcers; • prostheses; • open fractures…
8.5 million in USA & EU 150 million worldwide
Copyright COHiTEC, 2015 Final Presenta;on 4
B2S – HECOLCAP NEED
STANDARD TREATMENT
Surgery -‐ ;ssue debridement
Intravenous an;bio;c administra;on
Possible addi;onal round of surgery/treatment
Final surgery for bone replacement
Copyright COHiTEC, 2015 Final Presenta;on 5
• Up to 40 % recurrence • High risk of amputaGon
• EffecGveness -‐ difficult to eradicate infec;on
• HospitalisaGon -‐ prolonged stay (4-‐6 weeks) • Impaired long-‐term bone regenera;on
• Pa;ent pain and impaired mobility
MAJOR ISSUES raised by specialists
B2S – HECOLCAP NEED
Copyright COHiTEC, 2015 Final Presenta;on 6
B2S – HECOLCAP PROBLEM
NO EFFICIENT SOLUTION TO ERADICATE BONE
INFECTION AND PROMOTE BONE REGENERATION
THROUGH A SINGLE INTERVENTION
Eradica;on of infec;on
Start of bone growth
Copyright COHiTEC, 2015 Final Presenta;on 7
B2S – HECOLCAP TECHNOLOGY
HECOLCAP: the one step soluGon
enables sustained, local delivery of an anGbioGc
promotes bone regeneraGon
Copyright COHiTEC, 2015 Final Presenta;on 8
STANDARD TREATMENT
Surgery -‐ ;ssue debridement
Intravenous an;bio;c administra;on
Possible addi;onal round of surgery/treatment
Final surgery for bone replacement
B2S – HECOLCAP BENEFITS
HECOLCAP
Surgery -‐ ;ssue debridement
HECOLCAP applica;on
SINGLE SURGERY
Copyright COHiTEC, 2015 Final Presenta;on 9
ANTIBIOTIC RELEASE
TIME
pH < 5 pH ~ 7.4
B2S – HECOLCAP TECHNOLOGY
pH changes during treatment
Effec;ve for 14 days
NEW BONE FORMATION
Binder An;bio;c
Copyright COHiTEC, 2015 Final Presenta;on 10
HECOLCAP: the one step soluGon
Unique in combining both capabiliGes
PCT ApplicaGon WO2015052916
B2S – HECOLCAP PRODUCT
Copyright COHiTEC, 2015 Final Presenta;on 11
Bone growth
HECOLCAP enables a one-‐step soluGon for osteomyeliGs treatment
and bone regeneraGon
v v v v v v v v v
B2S – HECOLCAP PRODUCT
Bone infec;on
Copyright COHiTEC, 2015 Final Presenta;on 12
B2S – HECOLCAP COMPETITION
Standard treatment HECOLCAP
4 -‐ 6 weeks 2-‐3 weeks
at least 2 surgeries 1 surgery
High an;bio;c dose Op;mised an;bio;c dose
Copyright COHiTEC, 2015 Final Presenta;on 13
B2S – HECOLCAP COMPETITORS & DIFFERENTIATION
Product features / customer benefits
Standard treatment
Elu;Bone (ElutInc)
Cerament V (Bonesupport)
HECOLCAP (B2S)
Combined anGbioGc delivery/ bone formaGon - + + +++
Sustained an;bio;c delivery -‐ + + 14 days
Incorpora;on into bone + ++ ++ +++
Promotes new bone forma;on - -‐ -‐ ++
Number of surgeries ≥2 1-‐2 1-‐2 1
Price for 10mL dose (€) -‐ 1,500 1,500 1,750
Copyright COHiTEC, 2015 Final Presenta;on 14
B2S – HECOLCAP MARKET
(30,000 € / pa;ent)
1.27 B € Market for AnGbioGc Delivery and Bone RegeneraGon:
Revenue at year 5
Market Growth Rate = 6.8% (Webmed)
Costs of severe cases of OsteomyeliGs (USA & EU) 25.5 B €
(2 % of market share in USA & EU) 17.8 M €
Copyright COHiTEC, 2015 Final Presenta;on 15
B2S – HECOLCAP BUSINESS MODEL
Orthopedic Surgeons
Direct Sales force
• Biomet • Spinesurgical GmbH • Cherry_Med Medical
Solutions e.U.
Technical Support team
ProducGon
PROTEIN PRODUCERS
• Advanced BioMatrix
• BioIberica
• Celsus Biomedical
HYDROXYAPATITE PRODUCERS
• Bioceram
• Fluidinova SA
• HIMED
ANTIBIOTIC PRODUCERS
• ViroPharma
• Flynn Pharma
• Sandoz
Distributors
Suppliers / Partners
Customer
B2S
Copyright COHiTEC, 2015 Final Presenta;on 16
B2S – HECOLCAP ROADMAP
Product development
In vivo in large animals
OpGmisaGon & Quality
Clinical trials and CerGficaGon (USA & EU)
Clinical Trials Regulatory approval: FDA and CE mark
CommercialisaGon & sales
0,30 M €
4,72 M €
1,09 M €
0,29 M €
6.4 M € investment
R&D HR IP
5 years 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
0.6 M €
Clinical Manufacturing
Copyright COHiTEC, 2015 Final Presenta;on 17
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Revenue EBITDA Cumula;ve Cash-‐Flow
B2S – HECOLCAP FINANCIALS
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Clinical trials and Certification (USA & EU) Commercialisation & sales
6.4 M € of investment
17.8
M €
-‐6.4
Year 5 aler 1st sale: • Price (-‐40% for Distributors) = 1.050€/10mL • Revenue = 17.8 M € • Payback period 3 years
25
0
Copyright COHiTEC, 2015 Final Presenta;on 18
B2S – HECOLCAP WRAP UP
Orthopedic surgeons now have a product that:
ü Op;mises an;bio;c delivery/dosage
ü Maximizes bone forma;on
ü Reduces overall treatment ;me and cost
HECOLCAP -‐ one step soluGon for osteomyeliGs