Transcript Présentation PowerPoint

DESROUSSEAUX Valentin
DUBOS Clément
GALLANT Victor
LAURENT Julien
LEMAITRE Pierre
• This is an independent presentation made by
students from the Faculté des Sciences
Pharmaceutiques of Lille
• The opinions expressed are our own and not
necessarily those of Bavarian Nordic
INTRODUCTION
HUMAN RESOURCES
TECHNOLOGY PLATFORMS
PIPELINE
FINANCIAL STATEMENT
SWOT
CONCLUSION
About
Pipeline & Partners
Financial Situation
Multinational biotech company focused on the development and manufacturing of
Cancer immunotherapy
Vaccines for infectious diseases
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Founded in 1994 (1,43MDKK)
IPO in 1998
• Leader in Vector-Based Active Immunotherapy with Two Platforms
• MVA-BN : 650 Granted patents
• VF-TRICOM : 170 Granted patents
• 1 approved product (Imvamune - 2013) & 7 active programs
• 2 Phase 3 products and near term value drivers
• Trial supply to commercial product
• > $1 billion from US government in past 10 years (long term contract); $271 million
Janssen (Ebola Therapy), BMS collaboration potential of ~$975 million
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Headquarters in Denmark
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Manufacturing
• Kvistgaard
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Government Relations
• Washington DC
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Research Centers in
• Mountain View (CA)
• Munich (Germany)
PH1
Imvanex/Imvamune
Smallpox
BARDA
Imvamune freeze-dried
Smallpox
BARDA
Prostvac
Prostate Cancer
BMS
Prostvac + enzalutamide
Prostate Cancer
NCI
Prostvac + ipilimumab
Prostate Cancer
NCI
CV-301 bladder
Bladder Cancer
NCI
MVA-BN Brachyury
Solid Tumors
NCI
MVA-BN Filo
Ebola/Marburg
Janssen
MVA-BN RSV
RSV
2015
PH2
PH3
Market
Imvanex/Imvamune
Prostvac
Human Ressources
Executive Management
Board of Directors
Employees
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Ph.D. in Immunology from Bristol University
Worked for several years both in the UK and Australia developing
vaccines against infectious diseases
• Co-chair of the Alliance for BioSecurity
• Joined Bavarian Nordic in 1999
• Executive vice president in 2004 and President & CEO in 2014
• M.Sc. in economics and business administration from
Copenhagen Business School
• Joined Bavarian Nordic in 2008
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M.D. and Ph.D. degrees from Washington University School of Medicine
Board certified in Internal Medicine and Oncology
Clinical and teaching positions at the Dana Farber Cancer Institute and
Harvard Medical School
• Former board member of Zogenix, Inc
• Joined Bavarian Nordic in 2013 from Cadence Pharmaceuticals Inc
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2011
2012
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2014
2015
Technology platforms
Smallpox
MVA-BN = Infectious Diseases
VF-TRICOM = Cancer immunotherapy
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Acute contagious disease caused by Variola virus
Declared eradicated in 1980 by WHO (Global WHO-led immunization campaign)
No longer occurs naturally
Stocks of the virus are still kept in two high-containment laboratories
Vaccines needed in case of resurgence
Replicating vaccinia virus
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Dryvax®
ACAM2000
LC16m8
Elstree-BN
Serious side effects
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Myocarditis,pericarditis
Encephalitis
Eczema
Inadvertent infection
CI Populations
• Immunodeficiency
• Immunosuppresive
medications
• Exfoliative skin disorders
Non-replicating virus
Well tolerated
• even in immune
compromised patients
No serious adverse events
reported
Approved in EU and
Canada
• 7,500 individuals have been
vaccinated
Pipeline
IMVAMUNE ® / IMVANEX ®
MVA-BN Filo ® / RSV ®
PROSTVAC ®
CV-301 BLADDER ®
Technology
MVA-BN
Indications
Smallpox
Partnerships
BARDA
2 Phases III Studies
(Study vs ACAM2000)
Phase II for Freeze dried
Developpement
Approved in EU and Canada
Already sold in USA (SNS)
30M doses sold worldwide
Results
Financial Benefits 1 Billion $ contract
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Global leadership in smallpox
Long term revenues
Complete studies
Validate freeze dried manufacturing
Technology
MVA-BN
Indications
Ebola and Marburg (Filovirus)
Partnership
Janssen (J&J DC)
Developpement
Results
Phase I study
•With adVac (Janssen)
•With cAd3 EBO Z (GSK)
2M doses delivered
Financial Benefits 271M$ (developpement and delivery of 2M doses)
Establish a global leadership in Ebola preparedness
and treatment through collaboration with Janssen
Technology
MVA-BN
Indications
RSV
Partnership
Pending
Phase I study planed in 2015
Developpement NIH sponsored toxicity study
Results
Financial
expectations
Favorable pre IND discussion with FDA
Blockbuster market
•64M people infected globally
•350,000 hospitalizations in US
• Expand the infectious disease vaccine pipeline to meet high
unmet medical needs
Technology
VF-TRICOM
Indications
Prostate cancer
Partnership
Bristol Myer Squibb
1 Phase III studies
Developpement 4 Phases II studies
CRADA with NCI
• Finalize validation of the commercial manufacturing process and
prepare launch material
• Advance clinical studies exploring the therapeutic potential of
PROSTVAC in combination with Yervoy and other potential
checkpoint inhibitors as part of the clinical collaboration with
BMS
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Combined with Enzalutamide :
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To treat metastatic castration – resistant prostate
cancer
To treat non metastatic castration sensitive
prostate cancer
Combined with Flutamide vs Flutamide alone
As neoadjuvant therapy for patients with prostate
cancer undergoing treatment with radical
prostatectomy
Technology
VF- TRICOM ( CEA / MUC1)
Indications
Bladder cancer & NSCLC
Partnership
Developpement
Phase I in 2016 for NSCLC
Phase II for Bladder
Results
Financial
expectations
Global market = 8 billion $ in 2020
• Create a balanced pipeline
• Global leadership position in the rapidly growing field of cancer
immunotherapy
Financial Statement
USD Million
2014
2013
2012
2011
2010
Revenue
183.4
182.84
153.30
78.96
47.37
72.22
74.84
51.29
39.46
28.44
39,4 %
41 %
33,5 % 49,98 %
Net profit
3.91
(7.04)
(36.19)
(40.47)
(58.80)
Equity
188.81
147.22
150.75
182.10
122.21
Cash
147.74
80.24
82.92
88.07
53.64
Earnings per share
0.15
(0.27)
(1.39)
(1.82)
(3.88)
1,07
1,62
2,23
1,89
R&D costs
Burn Rate
60 %
SWOT Analysis
•Advanced pipeline
•Multipurpose facility
•Strong patent portfolio
•In house expertise
•Multiple partners
•High share value
•Fundraising
•Partnerships
•Indications expansions
•Freeze dried
•Complementarity aquisition
•No usual therapeutics
•No owned products
•Partnership dependance
•Competition
•Market fluctuation
•Currency fluctuation
•Patent loss
•Authorities decision
•Loss of capable employees
Conclusion
• Transition
• Technological platforms : MVA-BN & VF-TRICOM
• Imvamune on Market, Prostvac soon to be
•Focus on employee’s well being
•Employement stability
•Will to retain key personnel
•Extensive opportunities for pharmacists in various fields
Thank You