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DELIVERING THE VACCINE PROMISE
1
Rolf Sass Sørensen, VP Investor Relations & Communications
September 2010
OFF THE SHELF
Bavarian Nordic
Vaccines for cancer and
infectious diseases
• Founded in 1994
• Two late–stage products moving
into Phase 3
• Strong IP position on lead products
and MVA-BN® technology
• Listed on NASDAQ OMX
Copenhagen
• Market cap (Sep-2011): DKK 1.2bn
• 450+ employees in Denmark,
Germany and USA
2
Key Investment Highlights
Strong financial position – DKK 800m in cash preparedness*
• Profitable ongoing contracts: >DKK 3.5bn + DKK 6bn option
• Near-term cash flow positive (Infectious Diseases Division)
Phase 3 with PROSTVAC® in prostate cancer imminent
• Strong data in blockbuster market
• Fully funded Phase 3 programme – to be initiated H2, 2011
• Ongoing partner discussions
Full value chain
• Own commercial scale manufacturing facility for viral vaccines
• Broadly applicable technology platform
3 * As of 30 June 2011
Share price
0
20
40
60
80
100
120
maj-11 jun-11 jul-11 aug-11 sep-11
BAVA DNDN
4
Value creation
5
DKK million
Market cap1) 1,170
Cash & cash equivalents2) 570
Value of buildings, projects, patents etc. 6001) As of 12-Sep-2011
2) Estimated upon cash as of 30 June 2011 with projected cash burn
Cancer Vaccines
Objectives
• Initiate PROSTVAC® Phase 3
• Commercial partner for PROSTVAC®
• Expansion of cancer vaccine pipeline
• Develop new targets
Objectives
• Initiate PROSTVAC® Phase 3
• Commercial partner for PROSTVAC®
• Expansion of cancer vaccine pipeline
• Develop new targets
6
Lead productPROSTVAC® — off-the-shelf immunotherapy for
advanced prostate cancer
• Strong Phase 2 data in billion US$ market:
8.5 months survival benefit = 44% reduction
in risk of death
• Phase 3 to be initiated H2 2011
Lead productPROSTVAC® — off-the-shelf immunotherapy for
advanced prostate cancer
• Strong Phase 2 data in billion US$ market:
8.5 months survival benefit = 44% reduction
in risk of death
• Phase 3 to be initiated H2 2011
Therapeutic vaccine platform for major cancersTherapeutic vaccine platform for major cancers
Final data (H1 2012)
Phase 3 (H2 2011)PROSTVAC®PROSTVAC®
MVA-BN® PROMVA-BN® PRO
Phase 1 Phase 1/2 Phase 2 Phase 3 Next milestone
Prostate cancerProstate cancer
Prostate cancerProstate cancer
Initial data (H2 2011)MVA-BN® HER2MVA-BN® HER2 Breast cancerBreast cancer
Preclinical
6
7
1 in 6 men
gets
prostate cancer
1 in 6 of them
dies from
prostate cancer
PROSTVAC®PROSTVAC®
PHASE 3• Preparations on track
• Initiation expected: H2 2011
NEW PHASE 2 STUDY• Combination study in mCRPC with
chemotherapy in 144 pts.
• Primary endpoint: Overall Survival
EARLY STAGE DATA HOLDS PROMISE • Ph2 combination study with flutamide in
non-metastatic disease
• Preliminary results suggest delayed
disease progression in PROSTVAC® group
ASCO• New data from Ph1 study in early stage
presented at 2011 ASCO Annual Meeting
• Increased awareness of immunotherapy
PHASE 3• Preparations on track
• Initiation expected: H2 2011
NEW PHASE 2 STUDY• Combination study in mCRPC with
chemotherapy in 144 pts.
• Primary endpoint: Overall Survival
EARLY STAGE DATA HOLDS PROMISE • Ph2 combination study with flutamide in
non-metastatic disease
• Preliminary results suggest delayed
disease progression in PROSTVAC® group
ASCO• New data from Ph1 study in early stage
presented at 2011 ASCO Annual Meeting
• Increased awareness of immunotherapy
The PROSTVAC® Opportunity
• Prostate cancer therapies market in the US, Japan, and major EU countries
of US$3.3 billion (2007), forecasted to grow to US$4.5 billion by 20172
• Cancer market is occupied by products at premium prices
• Opportunity to enter a vaccine-receptive market shaped by first entrant
• A standardized therapeutic vaccine with clear advantages to competition
• Potential application in both early and late-stage prostate cancer
8
Source:
1 American Cancer Society
2 Decision Resources, 2008. Not including primary therapy such as surgery or radiotherapy. Major EU countries include France, Germany, Italy, Spain, and the UK
Prostate cancer – a large unmet medical
need
9
• Metastatic disease is incurable
• Common cause of death in men
• >250,000 deaths/year (WW)1
• Increase in cases
(780,000 annually)1
• Treated with chemotherapy
(limited life-extension and
severe side effects)
• Provenge approved in 2010 as
first immunotherapy for this
patient population
• Metastatic disease is incurable
• Common cause of death in men
• >250,000 deaths/year (WW)1
• Increase in cases
(780,000 annually)1
• Treated with chemotherapy
(limited life-extension and
severe side effects)
• Provenge approved in 2010 as
first immunotherapy for this
patient population
1) Global Cancer Facts & Figures 2007, American Cancer Society
PROSTVAC® - asset with solid data
Patients enrolled (completed)
• 580 +
Patients enrolling (active studies)
• 270 +
Clinical trials
• Published data
• Phase 1: Four
• Phase 2: Eight
• Ongoing/not yet published data
• Phase 1: Three
• Phase 2: Four
• Scheduled to start
• Phase 3: One
10
Journal of Clinical OncologyMarch 1, 2010 vol. 28 no. 7 1099-1105
Overall Survival Analysis of a Phase II
Randomized Controlled Trial of a
Poxviral-Based PSA-Targeted
Immunotherapy in Metastatic Castration-
Resistant Prostate Cancer
Journal of Clinical OncologyMarch 1, 2010 vol. 28 no. 7 1099-1105
Overall Survival Analysis of a Phase II
Randomized Controlled Trial of a
Poxviral-Based PSA-Targeted
Immunotherapy in Metastatic Castration-
Resistant Prostate Cancer
PROSTVAC® specifications
Phase 2 results demonstrated
extended overall survival of 8.5
months
• Decreased risk of death by 44% (HR = 0.56)
Multicenter Phase 21
• Randomized, placebo-controlled
• Double-blind
• 125 patients enrolled in 43 sites
• 83 PROSTVAC® + GM-CSF
• 41 placebo
11
• Off-the-shelf vial vaccine
• Sequentially dosed combination
of two different Poxviruses
• Targets a unique cancer cell
antigen (PSA) and encodes co-
stimulatory molecules
• Subcutaneous injection
• Off-the-shelf vial vaccine
• Sequentially dosed combination
of two different Poxviruses
• Targets a unique cancer cell
antigen (PSA) and encodes co-
stimulatory molecules
• Subcutaneous injection
Vaccinia-PSA TRICOM Fowlpox-PSA-TRICOM
1) Kantoff et al., Journal of Clinical Oncology, January 2010
PROSTVAC® Phase 2 Results
12
p=0.0061
Δ 8.5 months
N Deaths Median
Control 40 37 16.6
PROSTVAC® 82 65 25.1
Hazard ratio
0.56 (95% CI 0.37–0.85)
0 12 24 36 48 60
survival
(% of patients)
0
20
40
60
80
100
months
Source: Kantoff et al., Journal of Clinical Oncology, January 2010
Significantly extended
overall survival
16.6 months
25.1 months
What Really Matters?
• Important figures to a man who needs to decide whether to take the
treatment or not, are the "extending life" figures and adverse events (AE):
• Median OS benefit has little real world significance and is a statistical
measurement which is only consistently used in research because it is clean
and easily used as a shorthand comparison tool
13
Taxotere Provenge PROSTVAC1)
Rate of death reduction 24% 22,5% 44%
3 year Overall Survival (OS)
extension vs. placebo
31% 40% 76% 2)
Median OS benefit (months) 2.9 4.1 8.5
Stop treatment 2ºAE 11% 1,5% ~2%
(1) Kantoff et al., JCO, March 2010 (Phase 2 data)
(2) Overall Survival (OS) (evaluated 3 years post study):
PROSTVAC patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls
Phase 3 Design and Endpoints Agreed in SPA
Design
• Randomized, placebo-controlled study
• ~1,200 patients - asymptomatic or minimally symptomatic mCRPC
• Three study arms:
• PROSTVAC® + GM-CSF
• PROSTVAC® + GM-CSF Placebo
• PROSTVAC® Placebo + GM-CSF Placebo
Endpoints
• Primary endpoint is overall survival (OS)
• Either one or both of the treatment arms must be superior to placebo
Phase 3 estimated costs: US$150m:
• CRO costs, Manufacturing costs, BN internal costs
14
Advanced PC ”Patient Stock” 2011Stock is expected to grow due to new efficient therapeutics
15
Prevalence: number of occurrences of a disease
Source; Evaluate Pharma Epidemiology, (1) Company estimation
PC = Prostate cancer; mCRPC = metastatic Castration Resistant Prostate Cancer
33.720
61.537
154.743
64.554
118.000
293.000
40.407
78.000
195.000
0
50.000
100.000
150.000
200.000
250.000
300.000
350.000
USA EU RoW
Mortality asym. mCRPC Prevalence (1) mildly & sym. mCRPC Prevalence (1)
Advanced PC ”New Cases” 2011Incidence of mCRPC is expected to grow
16
Source; Evaluate Pharma Epidemiology, and (*) Edison Investment Research on Algeta, August 2011
Incidence: number of new cases during a year
PC = Prostate cancer; mCRPC = metastatic Castration Resistant Prostate Cancer
*
32.12847.168
40.70433.720
61.537
154.743
0
20.000
40.000
60.000
80.000
100.000
120.000
140.000
160.000
180.000
USA EU RoW
mCRPC Incidence Mortality
• In RoW countries incidence
rates are low due to low rate
of PSA testing!
• In USA, incidence of mCRPC
is growing by 2%
Driving PROSTVAC® into Early Stage
Prostate Cancer
17
Tumor
volume
and
activity
Hormone dependent Hormone refractory
No pain Pain
DeathStart of chemotherapy
Hormone
treatment
Local treatment
Non-metastatic Metastatic
PROSTVAC®
PROSTVAC® clinical studies overview
• 13 completed clinical Phase 1 and Phase 2 studies in 475 pts.
• 6 ongoing, NCI-funded studies in 378 pts.
18
Stage Study design Target Endpoint
Ph2
n=144
Comparison of docetaxel (chemotherapy)
with/without PROSTVAC®
Metastatic prostate cancer
mCRPC
Survival
Ph2
n=65
Comparison of flutamide (antihormone therapy)
with/without PROSTVAC®
Non-metastatic prostate
cancer
Time to progression (TTP)
Ph2
n=68
Comparison of samarium (radioactive drug)
with/without PROSTVAC®
Metastatic prostate cancer 4 month progression free
survival
Ph2
n=50
Investigate PROSTVAC® in men with PSA progress After local therapy (surgery
and/or radiation)
PSA progression at 6
months
Ph1
n=30
Dose-escalation, combination study with PROSTVAC®
and MDX-010 (CTL4-antibody)
Metastatic prostate cancer Safety, PSA response
CT response
Ph1
n=21
Investigate PROSTVAC® by intraprostatic injection Progressive or locally recurrent
prostate cancer
Safety, PSA response
Immune response
PROSTVAC® has more clinical data from combination trials and trials in earlier disease stages than
other prostate cancer immunotherapies
Ongoing studies
Ongoing PROSTVAC® Studies in Earlier Stage
Disease Suggest Slower Disease Progression
Phase 2 study, comparing flutamide (antihormone therapy) with/without PROSTVAC®
Preliminary results, n=26 (will enrol 65 patients) Time To Progression (TTP)
Without PROSTVAC® (n=13) 85 days
With PROSTVAC® (n=13) 223 days
19
Source: Gulley, Schlom et al. 2011 Genitourinary Cancers Symposium
Phase 2 study of PROSTVAC® in patients with PSA progression after local therapy
n=29 Median PSA Doubling Time
Pre-vaccination 4.4 months
Post-vaccination 7.7 months
Source: DiPaola, Gulley, Schlom et al., 2009 Genitourinary Cancers Symposium
Non-metastatic disease
Infectious Diseases
Objectives
• Successful continued delivery of
IMVAMUNE® to the US government
• Achieve new government contracts
• Expand pipeline with new projects
Objectives
• Successful continued delivery of
IMVAMUNE® to the US government
• Achieve new government contracts
• Expand pipeline with new projects
20
Phase 2 partner
Phase 1 (H1 2012)
Phase 3 (H2 2012)IMVAMUNE® IMVAMUNE®
MVA-BN® AnthraxMVA-BN® Anthrax
MVA-BN® HIV multiantigenMVA-BN® HIV multiantigen
Phase 1 Phase 1/2 Phase 2 Phase 3 Next milestone
Lead productIMVAMUNE® — next generation smallpox
vaccine with superior safety and efficacy
• Fully-funded development programme and
delivery contracts with US government
• 20m doses ~ US$505m
• + option 60m doses ~ US$1.1bn
Lead productIMVAMUNE® — next generation smallpox
vaccine with superior safety and efficacy
• Fully-funded development programme and
delivery contracts with US government
• 20m doses ~ US$505m
• + option 60m doses ~ US$1.1bn
SmallpoxSmallpox
AnthraxAnthrax
HIVHIV
Leading supplier of vaccines for biodefenseLeading supplier of vaccines for biodefense
Phase 1 (H1 2012)MVA-BN® RSVMVA-BN® RSV RSVRSV
Preclinical
IMVAMUNE®IMVAMUNE®
PRODUCTION• Delivered 0.7m doses in 2011 to-date
• Additional 1.1m awaiting final release
• On track for delivering 4m doses in 2011
FREEZE-DRIED CONTRACT• Expanded from USD 40m to USD 94m
CANADA APPROVAL PENDING• Application for marketing authorization in
Canada submitted for approval of
IMVAMUNE® in general population
NEW SUPPLY CONTRACTS• Denmark and another European NATO
country have procured IMVAMUNE® -
full-year guidance not affected
PRODUCTION• Delivered 0.7m doses in 2011 to-date
• Additional 1.1m awaiting final release
• On track for delivering 4m doses in 2011
FREEZE-DRIED CONTRACT• Expanded from USD 40m to USD 94m
CANADA APPROVAL PENDING• Application for marketing authorization in
Canada submitted for approval of
IMVAMUNE® in general population
NEW SUPPLY CONTRACTS• Denmark and another European NATO
country have procured IMVAMUNE® -
full-year guidance not affected
21
IMVAMUNE® Deliveries to the US
• Currently producing at 4 batches per week after
recent scale up
• 1.1m doses awaiting final release
22
2010: delivered 2m doses
2011 expected: 4m doses
2012-2013: 14m
doses
Deliveries to the US Strategic National Stockpile
Delivered in 2010 2m doses
Delivered in H1 2011 0.3m doses
Total delivered as of 30 Jun 2011 2.3m doses
Delivered in Jul/Aug 2011 0.4m doses
Total delivered as of 31 Aug 2011 2.7m doses
IMVAMUNE® Phase 3
Continued dialogue with FDA on regulatory pathway
• FDA scheduled a public workshop in September 2011 to discuss regulatory
pathway for licensing under animal rule
• Clinical study design essentially agreed with the FDA – larger than BN
originally proposed
• Phase 3 will now include approx. 4,000 patients
• Additional costs covered under RFP-3 contract
• Pre-study activities to start in 2011, whereas recruitment is expected to
commence in 2H 2012
23
IMVAMUNE® Filed for Approval in Canada
Marketing Authorization Application submitted to Health Canada
• New Drug Substance (NDS) submission made to Health Canada in March
2011, based on clinical indicators of efficacy
• If found acceptable, IMVAMUNE® will be indicated for active immunization
against smallpox in persons aged 18 and older
• Indication includes individuals with immune deficiencies and skin disorders (e.g.
HIV, atopic dermatitis)
• IMVAMUNE® may be used for primary vaccination and re-vaccination, in
emergency and non-emergency settings
24
IMVAMUNE® US Government Contracts
25
RFP-1
RFP-2
RFP-1
RFP-2
Early clinical and technical development
500,000 doses of IMVAMUNE® delivered
Clinical studies will support Emergency Use
RFP-3 Base contract
Option
RFP-3 Base contract
Option
20 million doses of IMVAMUNE®
Licensing for at-risk individuals
Development for immune compromised
RFP Freeze-dried
RFP Freeze-dried
Validation of production process
Preclinical and clinical studies to support
advanced development
>US$144m>US$144m
US$505mUS$505m
>US$743m>US$743m >US$1,100m>US$1,100m
Secured Optional
60 million doses of IMVAMUNE® >US$1,100m>US$1,100m
US$94mUS$94m
Financial Statements
26
DKK million 6m 2011 6m 2010 FY 2010
Revenue
Production costs
Gross profit
58
120
(62)
175
212
(37)
314
444
(130)
Research and development costs
Distribution and administrative costs
Total operating costs
120
73
193
92
60
151
211
133
344
Income before interest and taxes (254) (188) (474)
Financial income/loss
Income before company tax
(20)
(275)
9
(179)
(9)
(483)
Tax 48 31 94
Net profit for the period (227) (148) (390)
Cash preparedness (end of period) 800 219 460
Financial Outlook
Full-year guidance maintained
All numbers are approximate
In 2012-2013, the accumulated free cash flow for the Infectious Disease Division is
expected to be positive by approximately DKK 350 million including costs for the Phase
3 trial for IMVAMUNE®, but excluding the cash from the hold back of USD 50 million.
27
2011
Revenue DKK 500 m
Result (loss) before tax DKK -350 m
Cash preparedness at year-end DKK 525 m
On track for major 2011 goals
• Strong focus on execution in both divisions
• Full-year financial guidance maintained
Infectious Diseases
• Scale up to 4 batches/week completed – continue focus on streamlining
process (bulk, filling, release)
• Deliver 4 million doses of IMVAMUNE® to the US
Cancer Vaccines
• Finalize regulatory preparations and selection of centres for PROSTVAC®
Phase 3 trial
• Release of vaccines for trial
• Study initiation by H2 2011
28
Anticipated Future Milestones
CANCER VACCINES
• PROSTVAC® Ph3 initiation (H2 2011)
• Data from PROSTVAC ® NCI studies
• Ph1, combo (ipi), metastatic PC (H2 2011)
• Ph1, intra-prostatic, recurrent PC (H2 2011)
• Ph2 PSA progression (H2 2011)
• Ph2, combo (flutamide), non-metastatic PC
(2012)
• Ph2, combo (samarium), metastatic PC (2012)
• Ph2 combo (docetaxel), mCRPC (enrol by 2012)
• MVA-BN® PRO final Ph1/2 data (H1 2012)
• MVA-BN® HER2 prel Ph1/2 data (H2 2011)
• New NCI/CRADA opportunity targeting other
cancers, Ph1 and Ph2 data available –
dialogue ongoing
INFECTIOUS DISEASES
• Deliver 4m doses of IMVAMUNE® to US
government in 2011
• IMVAMUNE® Ph3 initiation (H2 2012)
• IMVAMUNE® licensure in Canada (2012)
• Anthrax Ph1 funding and initiation (H1 2012)
• RSV Ph1 initiation (H1 2012)
• Government funding opportunities, current and
future projects
29
PROSTVAC®PROSTVAC®
30
Summary
PROSTVAC® - innovative off-the-shelf prostate cancer vaccine candidate with blockbuster potential
• Excellent safety and efficacy results previously reported
• Phase 3 initiation 2H11 with attractive terms agreed in SPA
PROSTVAC® - innovative off-the-shelf prostate cancer vaccine candidate with blockbuster potential
• Excellent safety and efficacy results previously reported
• Phase 3 initiation 2H11 with attractive terms agreed in SPA
IMVAMUNE®IMVAMUNE®IMVAMUNE® - smallpox vaccine awarded US government contracts worth up to US$1.8bn
• Successfully developed from idea to delivery of product to the US government
• Currently producing and shipping vaccines
IMVAMUNE® - smallpox vaccine awarded US government contracts worth up to US$1.8bn
• Successfully developed from idea to delivery of product to the US government
• Currently producing and shipping vaccines
MVA-BN®MVA-BN®Proprietary MVA-BN® platform provides an engine for new opportunities
• Additional vaccines for various cancers and infectious diseases
Proprietary MVA-BN® platform provides an engine for new opportunities
• Additional vaccines for various cancers and infectious diseases
News flowNews flowAdditional news flow anticipated over next 12-18 months
• Additional PROSTVAC® Phase 2 data and PROSTVAC® Phase 3 initiation
• Continued IMVAMUNE® successful supply and additional contracts
Additional news flow anticipated over next 12-18 months
• Additional PROSTVAC® Phase 2 data and PROSTVAC® Phase 3 initiation
• Continued IMVAMUNE® successful supply and additional contracts
ManagementManagementExperienced management team focused on long-term value creation
• Track records of translating science into commercially successful late-stage drug candidates
• Complementary expertise in research, production, clinical development, business development and finance
Experienced management team focused on long-term value creation
• Track records of translating science into commercially successful late-stage drug candidates
• Complementary expertise in research, production, clinical development, business development and finance
IPIP Strong IP protection on lead products and MVA-BN® technologyStrong IP protection on lead products and MVA-BN® technology
0
50
100
150
200
250
Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11
Share price (9 Sep 2011) DKK 48
High/low 52 weeks 227/ 45
Market cap DKK 1.2bn
Net free liquidity per share DKK 26 (30 Jun 2011)
Volume (3m, daily average) 56,000
No. of shares, 93% free-float 26m
No. of registered shareholders 21,000
Largest shareholders ATP (> 10%)
A.J. Aamund A/S (> 5%)
BB Biotech AG (> 5%)
63%24%
13%
Institutions, Funds
Private
Non-registered
68%
11%
6%
15%
Denmark
US
UK
RoW
31
32
This presentation includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control,
that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include
statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We
undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made,
except as required by law.