Bavarian nordic pro investor life science seminar 14 sep 2011

32
DELIVERING THE VACCINE PROMISE 1 Rolf Sass Sørensen, VP Investor Relations & Communications September 2010 OFF THE SHELF

description

 

Transcript of Bavarian nordic pro investor life science seminar 14 sep 2011

Page 1: Bavarian nordic pro investor life science seminar 14 sep 2011

DELIVERING THE VACCINE PROMISE

1

Rolf Sass Sørensen, VP Investor Relations & Communications

September 2010

OFF THE SHELF

Page 2: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 3: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 4: Bavarian nordic pro investor life science seminar 14 sep 2011

Share price

0

20

40

60

80

100

120

maj-11 jun-11 jul-11 aug-11 sep-11

BAVA DNDN

4

Page 5: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 6: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 7: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 8: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 9: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 10: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 11: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 12: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 13: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 14: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 15: Bavarian nordic pro investor life science seminar 14 sep 2011

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)

Page 16: Bavarian nordic pro investor life science seminar 14 sep 2011

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%

Page 17: Bavarian nordic pro investor life science seminar 14 sep 2011

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®

Page 18: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 19: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 20: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 21: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 22: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 23: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 24: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 25: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 26: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 27: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 28: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 29: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 30: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 31: Bavarian nordic pro investor life science seminar 14 sep 2011

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

Page 32: Bavarian nordic pro investor life science seminar 14 sep 2011

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.