The document discusses Bavarian Nordic's vaccine programs for cancer and infectious diseases. For cancer vaccines, their lead product PROSTVAC is in a pivotal Phase 3 trial for prostate cancer. They also have a vaccine candidate CV-301 that targets multiple cancers. For infectious diseases, their smallpox vaccine IMVAMUNE has delivered millions of doses to the US stockpile and a freeze-dried version is in development. Key upcoming milestones include completing enrollment in the PROSTVAC Phase 3 trial and obtaining marketing approval for IMVAMUNE.

1. DELIVERING THE
VACCINE PROMISE
1 Anders Hedegaard, CEO | 27 March 2012

2. Bavarian Nordic
Vaccines for cancer and
infectious diseases
• Founded in 1994
• Lead product in Phase 3
• Strong IP position
• Listed on NASDAQ OMX
Copenhagen
• Market cap (Mar-2012):
DKK 1.3bn
• 450+ employees in
Denmark, Germany and
USA
2

3. Main strategic business areas
Infectious Diseases Cancer
Smallpox Prostate cancer
Anthrax Breast cancer
Full value chain Partnerships
3

4. Major Goals Achieved
 PROSTVAC - Phase4Q 2011
®
• Phase 3 initiated in
3 initiated
• Recruitment currently ongoing at centres across the U.S.
• Planned to enrol 1,200 patients at approx. 300 centres in 20 countries
 Expanded cancer pipeline through collaboration with NCI
• Includes rights to vaccine candidate (CV-301) – applicable in multiple cancers
• Includes Ph1 and Ph2 data and ongoing NCI-funded studies
• Offers long-term opportunity to develop cancer portfolio in major cancers (breast,
lung and ovarian)
 IMVAMUNE ® - producing successfully at 4 batches per week
• Delivered 4 million doses as planned
• Performance-based milestone of USD 25m received after successful scale up of
production
• RFP-3 contract modifications adds USD 8m to total value
• Phase 3 clinical protocol approved
• Submitted marketing application in Canada and Europe
4

5. 2011 Financials Better Than Expected
Revenue  DKK 524 m
Result (loss) before tax  DKK -296 m
Cash preparedness at year-end  DKK 704 m
5

6. Cancer Vaccines - Highlights
PROSTVAC®
• Initiated the pivotal Ph3 trial in mCRPC
• Attractive news flow from NCI studies
• Initiated randomized Ph2 combination study with chemotherapy in mCRPC
• Presented data at ASCO from Ph1 study in locally recurrent PC by intraprostatic injection
• Presented preliminary data at GU-ASCO from Ph2 combination study (flutamide) in non-
metastatic prostate cancer
• Data published from Ph1 combination study with ipilimumab in mCRPC
CV-301
• Expanded pipeline through NCI collaboration
• Broadly applicable technology platform – targeting major cancers
• Off-the-shelf product candidates: PROSTVAC® and CV-301
• Investigated in 1000+ patients in more than 30 clinical studies
• Multiple NCI-funded studies – ongoing and future
6

7. Cancer Vaccines
Therapeutic vaccine platform for major cancers
PC Ph1 Ph 1/2 Ph 2 Ph 3 Next milestone
7
PROSTVAC® Prostate cancer Enrolment (2013)
CV-301 breast Breast cancer Data (2H 2012)
MVA-BN® PRO Prostate cancer Data (1H 2012)
MVA-BN® HER2 Breast cancer Await CV-301 data
CV-301 lung Lung cancer Data update (2012)
CV-301 ovarian Ovarian cancer Data update (2012)
7

8. Prostate cancer – a large unmet medical
need
• 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
8

9. Driving PROSTVAC® into Early Stage
Prostate Cancer
Tumor
volume Start of chemotherapy Death
and
activity Hormone
treatment
PROSTVAC®
Local treatment
No pain Pain
Hormone dependent Hormone refractory
Non-metastatic Metastatic
9

10. The PROSTVAC® Opportunity
Sizeable Prostate cancer therapies market in the US, Japan, and major EU countries
Market of US$3.3 billion (2007), forecasted to grow to US$4.5 billion by 20172
Premium
Cancer market is occupied by products at premium prices
Prices
Shaped
Opportunity to enter a vaccine-receptive market shaped by first entrant
Market
Advantageous
A standardized therapeutic vaccine with clear advantages to competition
Product
Market
Potential application in both early and late-stage prostate cancer
Expansion
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
10

11. PROSTVAC® - asset with solid data
Journal of Clinical Oncology Clinical trial overview
March 1, 2010 vol. 28 no. 7 1099-1105
Published Ongoing/
Not yet
published
Phase 1 4 3
Phase 2 8 4
Phase 3 - 1
Total studies 12 8
Total pts. 580 + 1,470 +
Overall Survival Analysis of a Phase II
Randomized Controlled Trial of a
Poxviral-Based PSA-Targeted
Immunotherapy in Metastatic
Castration-Resistant Prostate Cancer
11

12. PROSTVAC® specifications
• Off-the-shelf vial vaccine Phase 2 results demonstrated
extended overall survival of 8.5
• Sequentially dosed combination months
of two different Poxviruses • Decreased risk of death by 44% (HR = 0.56)
• Targets a unique cancer cell Multicenter Phase 21
antigen (PSA) and encodes co- • Randomized, placebo-controlled
stimulatory molecules • Double-blind
• 125 patients enrolled in 43 sites
• Subcutaneous injection
• 83 PROSTVAC® + GM-CSF
Vaccinia-PSA TRICOM Fowlpox-PSA-TRICOM • 41 placebo
1) Kantoff et al., Journal of Clinical Oncology, January 2010
12

13. PROSTVAC® Phase 2 Results
survival
(% of patients)
100 Significantly extended
overall survival
80 N Deaths Median
Control 40 37 16.6
25.1
months PROSTVAC® 82 65 25.1
60
Δ 8.5 months
40 16.6
months Hazard ratio
0.56 (95% CI 0.37–0.85)
20
p=0.0061
0 months
0 12 24 36 48 60
Source: Kantoff et al., Journal of Clinical Oncology, January 2010
13

14. PROSTVAC®
Phase 3 Design and Endpoints Agreed in SPA
Design Endpoints
• Strongly powered, single global, placebo- • Primary endpoint is overall survival (OS)
controlled study • Either one or both of the treatment arms must
• ~1,200 patients - asymptomatic or minimally be superior to placebo
symptomatic, metastatic castration-resistant • Each comparison requires 534 deaths
prostate cancer with sensitivity for estimated
• Three study arms: death hazard ratios of 0.82 or less
• PROSTVAC® • Phase 3 clinical trial costs — US$150m:
• PROSTVAC® + GM-CSF • CRO cost
• Manufacturing cost
• Placebo
• BN internal cost
SPA allows for broad margin to be successful
Phase 2 results SPA terms for Phase 3
Demonstrated hazard ratio 0.56 Required hazard ratio 0.82 or less
44% reduction in risk of death 18% reduction in risk of death
14

15. Ongoing PROSTVAC® Studies
Stage Study design Target Endpoint
Ph3 Randomized, double-blind, placebo- Asymptomatic or Overall survival
n=1,200 controlled efficacy trial of PROSTVAC® minimally symptomatic
+/- GM-CSF mCRPC
NCI funded studies:
Ph2 Comparison of docetaxel (chemo) Metastatic prostate cancer Survival
n=144 with/without PROSTVAC® mCRPC
Ph2 Comparison of flutamide (antihormone) Non-metastatic prostate Time to progression
n=65 with/without PROSTVAC® cancer (TTP)
Ph2 Comparison of samarium (radioactive Metastatic prostate cancer 4 month progression
n=68 drug) with/without PROSTVAC® free survival
Ph2 Investigate PROSTVAC® in men with PSA After local therapy PSA progression at 6
n=50 progress (surgery and/or radiation) months
Ph1 Investigate PROSTVAC® by Progressive or locally Safety, PSA and
n=21 intraprostatic injection recurrent prostate cancer immune response
PROSTVAC® has more clinical data from combination trials and trials in earlier disease stages than
other prostate cancer immunotherapies
15

16. CV-301
• Stimulates immune system to destroy tumors by targeting two
tumor-associated antigens (TAA):
• CEA: Carcinoembryonic antigen
• MUC-1: Mucin 1
• CEA and MUC-1 are over-expressed in multiple cancers
Selected cancers – U.S. figures
Type Incidence Mortality CEA+ MUC-1+
Breast 233,000 40,000 50% >90%
Lung 221,000 157,000 70% >80%
Ovarian 22,000 15,000 15-65%* >90%
*Non-Mucinous: Mucinous
Cancer Facts & Figures 2011, American Cancer Society
16

17. Broadly applicable technology platform
PROSTVAC® CV-301
• Prostate cancer • Breast, Lung, Ovarian,
Gastric, Bladder, Liver
and Renal cancer
PSA CEA MUC-1
TRICOM
TRIad of CO-stimulatory Molecules
LFA-3 ICAM-1 B7.1
VF
Prime-boost: Vaccinia + Fowlpox
GM-CSF can be used as adjuvant in both PROSTVAC® and CV-301
17

18. CV-301 breast cancer – ongoing trial
• NCI-funded, open-label Ph2 study (n=48) in metastatic breast cancer
• Docetaxel naïve
• Treatment with Docetaxel with/without CV-301
• Primary endpoint: Time to progression (TTP)
• Enrolment has been completed
• Data expected in 2H 2012
Arm A: Weekly Docetaxel + CV-301
RANDOMIZE
Arm B: Weekly Docetaxel alone
18 Study Protocol ID: NCT00179309, NCI-6977

19. Cancer Vaccines - Short Term Objectives
• Complete enrolment in the PROSTVAC® Phase 3 trial
• Establish PROSTVAC® partnership before market commercialisation
• Report preliminary data from five NCI-funded Phase 1 and 2 studies with
PROSTVAC®
• Report breast cancer data from CV-301 studies and determine future
development strategy
19

20. Infectious Diseases - highlights
• Delivered 4 million IMVAMUNE® doses to the US Strategic National Stockpile
as planned
• Received a USD 25 million milestone payment under the RFP-3 contract
after a successful scale-up of production
• Extended the contract for development of a freeze-dried version to a total
value of USD 94 million
• Clinical Phase 3 trial plan agreed with the FDA
• Marketing Authorization Application submitted in Canada and Europe
• If found acceptable, IMVAMUNE® (IMVANEX® in Europe) will be indicated for active
immunization against smallpox in persons aged 18 and older, including immune compromised
individuals
20

21. Infectious Diseases
Leading supplier of vaccines for biodefense
PC Ph1 Ph 1/2 Ph 2 Ph 3 Market Next milestone
IMVAMUNE® Smallpox Phase 3 (2H 2012)
IMVAMUNE® freeze-dried Smallpox New Phase 2 (1H 2013)
MVA-BN® Anthrax Anthrax Phase 1 (1H 2012)
MVA-BN® RSV RSV Phase 1 (2013)
Sold to government stockpiles under national emergency rules
21

22. IMVAMUNE® US Government Contracts
Secured Optional
RFP-1 Early clinical and technical development
RFP-2 500,000 doses of IMVAMUNE® delivered >US$144m
Clinical studies will support Emergency Use
RFP-3 20 million doses of IMVAMUNE®
Base contract Licensing for at-risk individuals US$513m
Development for immune compromised
Option
60 million doses of IMVAMUNE® >US$1,100m
Validation of production process
RFP Preclinical and clinical studies to support US$94m
Freeze-dried advanced development
>US$751m >US$1,100m
22

23. IMVAMUNE® Delivery Status
Deliveries to the US Strategic National Stockpile 2010
Delivered in 2010 2m doses
 2013
2011
Delivered in 2011 4m doses

Planned deliveries in 2012 7m doses 2012
Planned deliveries in 2013 7m doses

24. IMVAMUNE® Freeze-dried
• Contract expanded from USD 40m to USD 94m
• Validation of production process
• Preclinical and clinical studies to support advanced development
• New Ph2 study planned for 1H 2013 to support emergency use
• Anticipated data availability for stockpiling in 2016
24

25. IMVAMUNE® - Anticipated Developments
2012 2013 2014-
Deliver RFP-3 base
Maintenance orders (LF), Replacement (FD)
Approval
Approval
LF: Liquid-frozen
FD: freeze-dried
25

26. Infectious Diseases - Short Term Objectives
• Deliver 14 million doses of IMVAMUNE® to the US Strategic National
Stockpile in 2012-2013 (7 million in 2012)
• Obtain profitability in division
• Secure new IMVAMUNE® orders in the USA
• Initiate pivotal Phase 3 trial of IMVAMUNE®
• Obtain marketing authorisation for IMVAMUNE® in Canada
• Obtain marketing authorisation for IMVANEX® (IMVAMUNE®) in the EU
26

27. Financial Outlook
2012
Revenue DKK 850m
Result (loss) before tax DKK -200m
Cash preparedness at year-end DKK 350m
Assumptions:
Deliver and revenue recognize 7 million doses of IMVAMUNE®
R&D costs - GROUP DKK 400m *
Infectious Disease Division, EBIT DKK 110m to 130m
before allocation of internal charges
Cancer Vaccines Division, EBIT DKK -250m to -270m
before allocation of internal charges
All numbers are approximate
* R&D costs include approximately DKK 100 million in contract expenses
(stated under production costs in the profit and loss statement).

28. Anticipated Future Milestones
CANCER VACCINES INFECTIOUS DISEASES
• PROSTVAC® Ph3 complete enrolment (2013) • Deliver 14m doses of IMVAMUNE® to US
• Data from PROSTVAC ® NCI studies government in 2012-2013
• Phase 1 recurrent PC • IMVAMUNE® Ph3 initiation (2H 2012)
• Phase 2 PSA progression • IMVAMUNE® licensure in Canada (2H 2012)
• Phase 2 non-metastatic PC • IMVANEX® (IMVAMUNE®) licensure in Europe
• Phase 2 metastatic PC (2013)
• Phase 2 mCRPC
• Anthrax Ph1 funding and initiation (1H 2012)
• CV-301 Ph2 data in metastatic breast cancer
• RSV Ph1 initiation (2013)
(2H 2012)
• Government funding opportunities, current and
• MVA-BN® PRO final Ph1/2 data (1H 2012)
future projects
28

29. 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
29
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.

30. APPENDIX
30

31. Financial Statements
DKK million FY 2011 FY 2010
Revenue 524 314
Production costs 403 444
Gross profit 120 (130)
Research and development costs 262 189
Distribution and administrative costs 167 155
Total operating costs 428 344
Income before interest and taxes (308) (474)
Financial income/loss 12 (9)
Income before company tax (296) (483)
Tax 28 94
Net profit for the period (268) (390)
Cash preparedness (end of period) 704 460
31

32. RFP-3 Contract
as of 31 December 2011
USD million P&L Cash Flow
Contract Revenue To be To be
value recognised recognised Received received
Upfront & Milestone 183 109 74 181 2
Deliveries 2010-2013 270 85 185 56 214
Hold-back 50 - 50 - 50
Security 10 7 3 7 3
TOTAL 513 201 312 244 269
Based on 6.048 million doses delivered
32

33. Overview of USG IMVAMUNE® Contracts
as of 31 December 2011
USD million P&L Cash Flow
Contract Revenue To be To be
value recognised recognised Received received
RFP-3 513 201 312 244 269
RFP-2 116 113 3 112 4
RFP Freeze-dried 95 13 82 11 84
TOTAL 724 327 397 367 357
33

34. PROSTVAC® Extends Survival in Patients
with Less Advanced Disease
Open-Label Phase 2 in 32 mCRPC patients
Median survival (months)
All patients Patients with Patients with
Halabi-predicted Halabi-predicted
survival <18 months survival ≥18 months
Predicted by Halabi 17.4 12.3 20.9
model
With PROSTVAC® 26.6 14.6 ≥37.3
(n=32) (not yet reached)
Δ 9.2 months Δ 2.3 months Δ ≥16.4 months
Patients surviving 22 of 32 (69%) 10 of 17 (59%) 12 of 15 (80%)
longer than
predicted
34
Gulley et al. Cancer Immunol Immunother 2009 Nov 5 (Epub ahead of print)