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Bacthera Company Presentation October 2020
PAGE 2
We are a leading CDMO in the LBP
industry, supporting our customers
with microbiology know-how,
process expertise and industry
changing innovation
PAGE
BACTHERA AT A GLANCE
3
3 manufacturing
sites in DK & CH
67 employees
+123% growth
Industry changing
innovation
From lab-to-
market services
PAGE
OUR HERITAGE
4
– World-leading know how in manufacturing &
processing living microbes
– Extensive strain-, growth media- and cryo-libraries
– Innovative drug substance downstream processes
– Leading in analytical characterization of bacteria
– Highest quality standards & world-leading know-how in
GMP manufacturing
– World’s only capsule with enteric attributes (enTRinsic®)
– (Large-scale) commercialization options (e.g. IBEX®)
– Access to global manufacturing presence (e.g. USA,
China, etc.)
– Best-practice CDMO principles
PAGE
OUR JOURNEY
5
Chr. Hansen & Lonza saw
opportunity to join forces
and establish Bacthera
New management
appointed
Foundation of Bacthera:
Chr. Hansen & Lonza
know-how, teams &
assets transferred. First
operation started.
2019 2020 2021
Expanding operational &
commercial readiness
GMP certifications of
DK and CH sites
Chr. Hansen & Lonza
had complementary
expertise in the LBP
industry
2014
PAGE
END-TO-END SOLUTIONS DELIVERED FROM OUR SITES
6
Copenhagen, Denmark
Basel, Switzerland
Visp*, Switzerland
– Drug Substance manufacturing
– Clinical & commercial supply
– Head Quarter
– Drug Product manufacturing
– Packaging
– Clinical & small-scale
commercial supply
– Operational from 2022
– Drug Substance & Drug
Product manufacturing
– Packaging & Serialization
– (Large scale-) Commercial
supply
*Site operated by Lonza, Bacthera
has access to the IBEX® complex
for commercial production.
Workspace to be set-up yet
PAGE
CONTRIBUTION TO YOUR LBP JOURNEY
7
From lab-to-market:
Drug
discovery
Pre-
clinical
Phase I Phase II Phase III
Approval &
Commercial
Bacthera offers CMC development services and supply of Drug Substance &
Drug Product for (pre-)clinical studies and commercial demand.
PAGE
CONTRIBUTION TO YOUR LBP JOURNEY
8
Bacthera will manufacture cell banks and develop the DS & DP processes
interdependently with strong analytics package embedded, resulting in
the best possible product for the customer’s development journey
Pre-
clinical
Phase I Phase II Phase III
Approval &
commercial
Cell banking &
early stage process and
analytical development
(DS & DP)
Commercial
supply
Customer
Late stage process
& analytical dev.
(DS & DP)
Process
validation
Reg.
filing
PC-
supply
PI supply
PII
supply
PIII
supply
Analytical validation
Manufacturing
Development
PAGE
Integrated
DS/DP &
analytical
development
Strong
microbiology
& process
expertise
VALUE CONTRIBUTION TO YOUR LBP JOURNEY
9
first time
right
+
fast
delivery
From lab-to-
market:
One-stop
CDMO
PAGE
WE CAN WORK WITH
10
Strict & facultative
anaerobes
BSL 1/2 GMO’s
PAGE 11
Strain intake
& Cell
Banking
DS
Development
DP
Development
DS Production
Analytical
Development
DS+DP
DP Production
Packaging
Shipment to customer
QC & QA Release
Stability
OUR SERVICES IN PRODUCT DEVELOPMENT
PAGE 12
Large-scale manufacturing in
Lonza IBEX® complex in Visp (CH)*
up to 20’000 L
fermenters
up to 150’000
capsules/h
- 30 months
time-to-market**
globally scalable concept
- 30%
CapEx spending**
used & well-known by global
pharma players (e.g. Sanofi)
*Site operated by Lonza, Bacthera has access to the IBEX® complex
for commercial production. Workspace to be set-up yet.
**compared to a typical industry approach
OUR COMMERCIAL MANUFACTURING SOLUTION
PAGE
OUR LEADERSHIP IN INNOVATION
13
Strains,
Media & Cryo
AnalyticsDrying
Bacthera’s customers can benefit from a variety of innovations, technologies and
background know-how that can make the essential difference in drug development &
registration
enTRinsic®
PAGE
WHY WORK WITH BACTHERA?
14
Well-established
expertise in LBP
manufacturing
Right first time,
from pre-clinical
to commercial
Winning
innovations &
technologies
World-class
experts & work
mentality
PAGE
YOUR CONTACTS WITHIN BACTHERA
15
Felix Faupel
Chief Commercial
Officer
ffel@bacthera.com
Alain Heron
Head of Commercial
Development
alhe@bacthera.com
Gemma Henderson
Head of Project &
Portfolio Management
gehe@bacthera.com

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Bacthera Company Presentation October 2020

  • 2. PAGE 2 We are a leading CDMO in the LBP industry, supporting our customers with microbiology know-how, process expertise and industry changing innovation
  • 3. PAGE BACTHERA AT A GLANCE 3 3 manufacturing sites in DK & CH 67 employees +123% growth Industry changing innovation From lab-to- market services
  • 4. PAGE OUR HERITAGE 4 – World-leading know how in manufacturing & processing living microbes – Extensive strain-, growth media- and cryo-libraries – Innovative drug substance downstream processes – Leading in analytical characterization of bacteria – Highest quality standards & world-leading know-how in GMP manufacturing – World’s only capsule with enteric attributes (enTRinsic®) – (Large-scale) commercialization options (e.g. IBEX®) – Access to global manufacturing presence (e.g. USA, China, etc.) – Best-practice CDMO principles
  • 5. PAGE OUR JOURNEY 5 Chr. Hansen & Lonza saw opportunity to join forces and establish Bacthera New management appointed Foundation of Bacthera: Chr. Hansen & Lonza know-how, teams & assets transferred. First operation started. 2019 2020 2021 Expanding operational & commercial readiness GMP certifications of DK and CH sites Chr. Hansen & Lonza had complementary expertise in the LBP industry 2014
  • 6. PAGE END-TO-END SOLUTIONS DELIVERED FROM OUR SITES 6 Copenhagen, Denmark Basel, Switzerland Visp*, Switzerland – Drug Substance manufacturing – Clinical & commercial supply – Head Quarter – Drug Product manufacturing – Packaging – Clinical & small-scale commercial supply – Operational from 2022 – Drug Substance & Drug Product manufacturing – Packaging & Serialization – (Large scale-) Commercial supply *Site operated by Lonza, Bacthera has access to the IBEX® complex for commercial production. Workspace to be set-up yet
  • 7. PAGE CONTRIBUTION TO YOUR LBP JOURNEY 7 From lab-to-market: Drug discovery Pre- clinical Phase I Phase II Phase III Approval & Commercial Bacthera offers CMC development services and supply of Drug Substance & Drug Product for (pre-)clinical studies and commercial demand.
  • 8. PAGE CONTRIBUTION TO YOUR LBP JOURNEY 8 Bacthera will manufacture cell banks and develop the DS & DP processes interdependently with strong analytics package embedded, resulting in the best possible product for the customer’s development journey Pre- clinical Phase I Phase II Phase III Approval & commercial Cell banking & early stage process and analytical development (DS & DP) Commercial supply Customer Late stage process & analytical dev. (DS & DP) Process validation Reg. filing PC- supply PI supply PII supply PIII supply Analytical validation Manufacturing Development
  • 9. PAGE Integrated DS/DP & analytical development Strong microbiology & process expertise VALUE CONTRIBUTION TO YOUR LBP JOURNEY 9 first time right + fast delivery From lab-to- market: One-stop CDMO
  • 10. PAGE WE CAN WORK WITH 10 Strict & facultative anaerobes BSL 1/2 GMO’s
  • 11. PAGE 11 Strain intake & Cell Banking DS Development DP Development DS Production Analytical Development DS+DP DP Production Packaging Shipment to customer QC & QA Release Stability OUR SERVICES IN PRODUCT DEVELOPMENT
  • 12. PAGE 12 Large-scale manufacturing in Lonza IBEX® complex in Visp (CH)* up to 20’000 L fermenters up to 150’000 capsules/h - 30 months time-to-market** globally scalable concept - 30% CapEx spending** used & well-known by global pharma players (e.g. Sanofi) *Site operated by Lonza, Bacthera has access to the IBEX® complex for commercial production. Workspace to be set-up yet. **compared to a typical industry approach OUR COMMERCIAL MANUFACTURING SOLUTION
  • 13. PAGE OUR LEADERSHIP IN INNOVATION 13 Strains, Media & Cryo AnalyticsDrying Bacthera’s customers can benefit from a variety of innovations, technologies and background know-how that can make the essential difference in drug development & registration enTRinsic®
  • 14. PAGE WHY WORK WITH BACTHERA? 14 Well-established expertise in LBP manufacturing Right first time, from pre-clinical to commercial Winning innovations & technologies World-class experts & work mentality
  • 15. PAGE YOUR CONTACTS WITHIN BACTHERA 15 Felix Faupel Chief Commercial Officer ffel@bacthera.com Alain Heron Head of Commercial Development alhe@bacthera.com Gemma Henderson Head of Project & Portfolio Management gehe@bacthera.com