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OFF THE SHELF
    DELIVERING THE VACCINE PROMISE




    Rolf Sass Sørensen, VP Investor Relations & Communications
    September 2010

1
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

120

100

    80

    60

    40

    20

    0
    maj-11    jun-11      jul-11     aug-11   sep-11

                       BAVA   DNDN


4
Value creation

                                                                         DKK million
    Market cap1)                                                              1,170
    Cash & cash equivalents2)                                                   570
    Value of buildings, projects, patents etc.                                  600
    1) As of 12-Sep-2011
    2) Estimated upon cash as of 30 June 2011 with projected cash burn




5
Cancer Vaccines
Therapeutic vaccine platform for major cancers

Lead product                                               Objectives
PROSTVAC®     — off-the-shelf immunotherapy for            • Initiate PROSTVAC® Phase 3
advanced prostate cancer
                                                           • Commercial partner for PROSTVAC®
• Strong Phase 2 data in billion US$ market:
  8.5 months survival benefit = 44% reduction              • Expansion of cancer vaccine pipeline
  in risk of death
                                                           • Develop new targets
• Phase 3 to be initiated H2 2011




                                             Preclinical   Phase 1   Phase 1/2   Phase 2   Phase 3       Next milestone
6

PROSTVAC®                  Prostate cancer                                                              Phase 3 (H2 2011)

MVA-BN® PRO                Prostate cancer                                                            Final data (H1 2012)

MVA-BN® HER2               Breast cancer                                                             Initial data (H2 2011)




6
1 Preparationsmen
                in 6 on track
             PHASE 3
             •
            gets expected: H2 2011
             • Initiation


            prostate cancer
             NEW PHASE 2 STUDY
             • Combination study in mCRPC with
               chemotherapy in 144 pts.

            1 in 6 of them
             • Primary endpoint: Overall Survival

            EARLY STAGE DATA HOLDS PROMISE
            dies from with flutamide in
            • Ph2 combination study
              non-metastatic disease
            prostate cancer group
            • Preliminary results suggest delayed
              disease progression in PROSTVAC  ®



             ASCO
             • New data from Ph1 study in early stage
               presented at 2011 ASCO Annual Meeting

PROSTVAC®    • Increased awareness of immunotherapy




7
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




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

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


9
PROSTVAC® - asset with solid data

Journal of Clinical Oncology              Patients enrolled (completed)
March 1, 2010 vol. 28 no. 7 1099-1105
                                          • 580 +
                                          Patients enrolling (active studies)
                                          • 270 +


                                          Clinical trials
                                             • Published data
                                                 • Phase 1: Four
                                                 • Phase 2: Eight
                                             • Ongoing/not yet published data
Overall Survival Analysis of a Phase II          • Phase 1: Three
Randomized Controlled Trial of a                 • Phase 2: Four
Poxviral-Based PSA-Targeted
                                             • Scheduled to start
Immunotherapy in Metastatic Castration-
Resistant Prostate Cancer                        • Phase 3: One



10
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




11
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

12
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):

                                                                                                              1)
                                                            Taxotere                    Provenge   PROSTVAC
      Rate of death reduction                               24%                         22,5%      44%
                                                                                                         2)
      3 year Overall Survival (OS)                          31%                         40%        76%
      extension vs. placebo
      Median OS benefit (months)                            2.9                         4.1        8.5
      Stop treatment 2ºAE                                   11%                         1,5%       ~2%


•    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

     (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
13
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” 2011
Stock is expected to grow due to new efficient therapeutics

350.000

                                                                                                                 293.000
300.000

250.000

                                                                                                                           195.000
200.000
                                                                                                   154.743
150.000
                                                                   118.000

100.000                                                                         78.000
                         64.554                         61.537
 50.000        33.720                 40.407


     0
                          USA                                          EU                                         RoW

                          Mortality       asym. mCRPC Prevalence (1)        mildly & sym. mCRPC Prevalence (1)




          Prevalence: number of occurrences of a disease
          Source; Evaluate Pharma Epidemiology, (1) Company estimation
          PC = Prostate cancer; mCRPC = metastatic Castration Resistant Prostate Cancer


15
Advanced PC ”New Cases” 2011
Incidence of mCRPC is expected to grow



 180.000
 160.000
                                                                            154.743
                                                                                          • In RoW countries incidence
 140.000
                                                                                            rates are low due to low rate
 120.000
 100.000
                                                                                            of PSA testing!
     80.000
                                                   61.537                                 • In USA, incidence of mCRPC
     60.000
     40.000        32.128   33.720
                                          47.168
                                                                   40.704                   is growing by 2%
     20.000
         0
                                                                                      *
                        USA                       EU                    RoW

                                mCRPC Incidence        Mortality




              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


16
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




    17
PROSTVAC® clinical studies overview
• 13 completed clinical Phase 1 and Phase 2 studies in 475 pts.
• 6 ongoing, NCI-funded studies in 378 pts.

Ongoing studies
Stage     Study design                                        Target                             Endpoint
Ph2       Comparison of docetaxel (chemotherapy)              Metastatic prostate cancer         Survival
n=144     with/without PROSTVAC®                              mCRPC
Ph2       Comparison of flutamide (antihormone therapy)       Non-metastatic prostate            Time to progression (TTP)
n=65      with/without PROSTVAC®                              cancer
Ph2       Comparison of samarium (radioactive drug)           Metastatic prostate cancer         4 month progression free
n=68      with/without PROSTVAC®                                                                 survival
Ph2       Investigate PROSTVAC® in men with PSA progress      After local therapy (surgery       PSA progression at 6
n=50                                                          and/or radiation)                  months
Ph1       Dose-escalation, combination study with PROSTVAC®   Metastatic prostate cancer         Safety, PSA response
n=30      and MDX-010 (CTL4-antibody)                                                            CT response
Ph1       Investigate PROSTVAC® by intraprostatic injection   Progressive or locally recurrent   Safety, PSA response
n=21                                                          prostate cancer                    Immune response

PROSTVAC® has more clinical data from combination trials and trials in earlier disease stages than
other prostate cancer immunotherapies


18
Ongoing PROSTVAC® Studies in Earlier Stage
 Disease Suggest Slower Disease Progression
  Non-metastatic disease

 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




 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
Source: Gulley, Schlom et al. 2011 Genitourinary Cancers Symposium




 19
Infectious Diseases
Leading supplier of vaccines for biodefense
Lead product                                            Objectives
IMVAMUNE® —   next generation smallpox                   • Successful continued delivery of
vaccine with superior safety and efficacy                  IMVAMUNE® to the US government
 • Fully-funded development programme and                • Achieve new government contracts
   delivery contracts with US government
                                                         • Expand pipeline with new projects
     •   20m doses ~ US$505m
     •   + option 60m doses ~ US$1.1bn




                                          Preclinical   Phase 1   Phase 1/2   Phase 2   Phase 3    Next milestone

IMVAMUNE®                      Smallpox                                                           Phase 3 (H2 2012)

MVA-BN® Anthrax                Anthrax                                                            Phase 1 (H1 2012)

MVA-BN® RSV                    RSV                                                                Phase 1 (H1 2012)

MVA-BN® HIV multiantigen       HIV                                                                  Phase 2 partner




20
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


IMVAMUNE®

21
IMVAMUNE® Deliveries to the US

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
                                                                  2010:
Total delivered as of 31 Aug 2011      2.7m doses                delivered
                                                                 2m doses
• Currently producing at 4 batches per week after                       2011
                                                                      expected:
  recent scale up                                                     4m doses
• 1.1m doses awaiting final release
                                                       2012-
                                                     2013: 14m
                                                       doses




22
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
                                                              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$505m
                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$743m   >US$1,100m



25
Financial Statements

DKK million                             6m 2011    6m 2010   FY 2010
Revenue                                      58        175       314
Production costs                            120        212       444
Gross profit                               (62)       (37)     (130)
Research and development costs              120         92       211
Distribution and administrative costs        73         60       133
Total operating costs                       193        151       344
Income before interest and taxes          (254)      (188)     (474)
Financial income/loss                       (20)         9        (9)
Income before company tax                 (275)      (179)     (483)
Tax                                          48         31        94
Net profit for the period                 (227)      (148)     (390)

Cash preparedness (end of period)           800        219       460



26
Financial Outlook

Full-year guidance maintained

                                                                               2011
Revenue                                                                   DKK 500 m
Result (loss) before tax                                                 DKK -350 m
Cash preparedness at year-end                                             DKK 525 m

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
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                                         INFECTIOUS DISEASES
•    PROSTVAC® Ph3 initiation (H2 2011)                 •   Deliver 4m doses of IMVAMUNE® to US
•    Data from PROSTVAC ® NCI studies                       government in 2011
       • Ph1, combo (ipi), metastatic PC (H2 2011)      •   IMVAMUNE® Ph3 initiation (H2 2012)
       • Ph1, intra-prostatic, recurrent PC (H2 2011)   •   IMVAMUNE® licensure in Canada (2012)
       • Ph2 PSA progression (H2 2011)                  •   Anthrax Ph1 funding and initiation (H1 2012)
       • Ph2, combo (flutamide), non-metastatic PC
         (2012)
                                                        •   RSV Ph1 initiation (H1 2012)
       • Ph2, combo (samarium), metastatic PC (2012)    •   Government funding opportunities, current and
       • Ph2 combo (docetaxel), mCRPC (enrol by 2012)       future projects
•    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




29
Summary
               PROSTVAC® - innovative off-the-shelf prostate cancer vaccine candidate with blockbuster potential
PROSTVAC®      •   Excellent safety and efficacy results previously reported
               •   Phase 3 initiation 2H11 with attractive terms agreed in SPA


               IMVAMUNE® - smallpox vaccine awarded US government contracts worth up to US$1.8bn
IMVAMUNE®      •   Successfully developed from idea to delivery of product to the US government
               •   Currently producing and shipping vaccines


               Proprietary MVA-BN® platform provides an engine for new opportunities
     MVA-BN®   •   Additional vaccines for various cancers and infectious diseases



       IP      Strong IP protection on lead products and MVA-BN® technology


               Additional news flow anticipated over next 12-18 months
 News flow     •   Additional PROSTVAC® Phase 2 data and PROSTVAC® Phase 3 initiation
               •   Continued IMVAMUNE® successful supply and additional contracts


               Experienced management team focused on long-term value creation
Management     •   Track records of translating science into commercially successful late-stage drug candidates
               •   Complementary expertise in research, production, clinical development, business development and finance




30
Share price (9 Sep 2011)                         DKK 48
250                                                                                                            High/low 52 weeks                               227/ 45
                                                                                                               Market cap                                    DKK 1.2bn
                                                                                                               Net free liquidity per share       DKK 26 (30 Jun 2011)
200                                                                                                            Volume (3m, daily average)                        56,000
                                                                                                               No. of shares, 93% free-float                       26m
                                                                                                               No. of registered shareholders                    21,000
150
                                                                                                               Largest shareholders                         ATP (> 10%)
                                                                                                                                                A.J. Aamund A/S (> 5%)
                                                                                                                                                   BB Biotech AG (> 5%)
100


                                                                                                                   13%                                    15%
50                                                                                                                                                      6%
                                                                                                                24%                                    11%
                                                                                                                            63%                                   68%
  0
  Sep-10    Oct-10   Nov-10   Dec-10   Jan-11   Feb-11   Mar-11   Apr-11   May-11   Jun-11   Jul-11   Aug-11
                                                                                                                  Institutions, Funds                       Denmark
       31                                                                                                                                                   US
                                                                                                                  Private
                                                                                                                                                            UK
                                                                                                                  Non-registered                            RoW
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
        32
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.

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Bavarian nordic pro investor life science seminar 14 sep 2011

  • 1. OFF THE SHELF DELIVERING THE VACCINE PROMISE Rolf Sass Sørensen, VP Investor Relations & Communications September 2010 1
  • 2. 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
  • 3. 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
  • 4. Share price 120 100 80 60 40 20 0 maj-11 jun-11 jul-11 aug-11 sep-11 BAVA DNDN 4
  • 5. Value creation DKK million Market cap1) 1,170 Cash & cash equivalents2) 570 Value of buildings, projects, patents etc. 600 1) As of 12-Sep-2011 2) Estimated upon cash as of 30 June 2011 with projected cash burn 5
  • 6. Cancer Vaccines Therapeutic vaccine platform for major cancers Lead product Objectives PROSTVAC® — off-the-shelf immunotherapy for • Initiate PROSTVAC® Phase 3 advanced prostate cancer • Commercial partner for PROSTVAC® • Strong Phase 2 data in billion US$ market: 8.5 months survival benefit = 44% reduction • Expansion of cancer vaccine pipeline in risk of death • Develop new targets • Phase 3 to be initiated H2 2011 Preclinical Phase 1 Phase 1/2 Phase 2 Phase 3 Next milestone 6 PROSTVAC® Prostate cancer Phase 3 (H2 2011) MVA-BN® PRO Prostate cancer Final data (H1 2012) MVA-BN® HER2 Breast cancer Initial data (H2 2011) 6
  • 7. 1 Preparationsmen in 6 on track PHASE 3 • gets expected: H2 2011 • Initiation prostate cancer NEW PHASE 2 STUDY • Combination study in mCRPC with chemotherapy in 144 pts. 1 in 6 of them • Primary endpoint: Overall Survival EARLY STAGE DATA HOLDS PROMISE dies from with flutamide in • Ph2 combination study non-metastatic disease prostate cancer group • Preliminary results suggest delayed disease progression in PROSTVAC ® ASCO • New data from Ph1 study in early stage presented at 2011 ASCO Annual Meeting PROSTVAC® • Increased awareness of immunotherapy 7
  • 8. 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 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 8
  • 9. 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 9
  • 10. PROSTVAC® - asset with solid data Journal of Clinical Oncology Patients enrolled (completed) March 1, 2010 vol. 28 no. 7 1099-1105 • 580 + Patients enrolling (active studies) • 270 + Clinical trials • Published data • Phase 1: Four • Phase 2: Eight • Ongoing/not yet published data Overall Survival Analysis of a Phase II • Phase 1: Three Randomized Controlled Trial of a • Phase 2: Four Poxviral-Based PSA-Targeted • Scheduled to start Immunotherapy in Metastatic Castration- Resistant Prostate Cancer • Phase 3: One 10
  • 11. 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 11
  • 12. 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 12
  • 13. 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): 1) Taxotere Provenge PROSTVAC Rate of death reduction 24% 22,5% 44% 2) 3 year Overall Survival (OS) 31% 40% 76% extension vs. placebo Median OS benefit (months) 2.9 4.1 8.5 Stop treatment 2ºAE 11% 1,5% ~2% • 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 (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 13
  • 14. 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
  • 15. Advanced PC ”Patient Stock” 2011 Stock is expected to grow due to new efficient therapeutics 350.000 293.000 300.000 250.000 195.000 200.000 154.743 150.000 118.000 100.000 78.000 64.554 61.537 50.000 33.720 40.407 0 USA EU RoW Mortality asym. mCRPC Prevalence (1) mildly & sym. mCRPC Prevalence (1) Prevalence: number of occurrences of a disease Source; Evaluate Pharma Epidemiology, (1) Company estimation PC = Prostate cancer; mCRPC = metastatic Castration Resistant Prostate Cancer 15
  • 16. Advanced PC ”New Cases” 2011 Incidence of mCRPC is expected to grow 180.000 160.000 154.743 • In RoW countries incidence 140.000 rates are low due to low rate 120.000 100.000 of PSA testing! 80.000 61.537 • In USA, incidence of mCRPC 60.000 40.000 32.128 33.720 47.168 40.704 is growing by 2% 20.000 0 * USA EU RoW mCRPC Incidence Mortality 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 16
  • 17. 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 17
  • 18. PROSTVAC® clinical studies overview • 13 completed clinical Phase 1 and Phase 2 studies in 475 pts. • 6 ongoing, NCI-funded studies in 378 pts. Ongoing studies Stage Study design Target Endpoint Ph2 Comparison of docetaxel (chemotherapy) Metastatic prostate cancer Survival n=144 with/without PROSTVAC® mCRPC Ph2 Comparison of flutamide (antihormone therapy) Non-metastatic prostate Time to progression (TTP) n=65 with/without PROSTVAC® cancer Ph2 Comparison of samarium (radioactive drug) Metastatic prostate cancer 4 month progression free n=68 with/without PROSTVAC® survival Ph2 Investigate PROSTVAC® in men with PSA progress After local therapy (surgery PSA progression at 6 n=50 and/or radiation) months Ph1 Dose-escalation, combination study with PROSTVAC® Metastatic prostate cancer Safety, PSA response n=30 and MDX-010 (CTL4-antibody) CT response Ph1 Investigate PROSTVAC® by intraprostatic injection Progressive or locally recurrent Safety, PSA response n=21 prostate cancer Immune response PROSTVAC® has more clinical data from combination trials and trials in earlier disease stages than other prostate cancer immunotherapies 18
  • 19. Ongoing PROSTVAC® Studies in Earlier Stage Disease Suggest Slower Disease Progression Non-metastatic disease 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 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 Source: Gulley, Schlom et al. 2011 Genitourinary Cancers Symposium 19
  • 20. Infectious Diseases Leading supplier of vaccines for biodefense Lead product Objectives IMVAMUNE® — next generation smallpox • Successful continued delivery of vaccine with superior safety and efficacy IMVAMUNE® to the US government • Fully-funded development programme and • Achieve new government contracts delivery contracts with US government • Expand pipeline with new projects • 20m doses ~ US$505m • + option 60m doses ~ US$1.1bn Preclinical Phase 1 Phase 1/2 Phase 2 Phase 3 Next milestone IMVAMUNE® Smallpox Phase 3 (H2 2012) MVA-BN® Anthrax Anthrax Phase 1 (H1 2012) MVA-BN® RSV RSV Phase 1 (H1 2012) MVA-BN® HIV multiantigen HIV Phase 2 partner 20
  • 21. 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 IMVAMUNE® 21
  • 22. IMVAMUNE® Deliveries to the US 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 2010: Total delivered as of 31 Aug 2011 2.7m doses delivered 2m doses • Currently producing at 4 batches per week after 2011 expected: recent scale up 4m doses • 1.1m doses awaiting final release 2012- 2013: 14m doses 22
  • 23. 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
  • 24. 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
  • 25. 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$505m 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$743m >US$1,100m 25
  • 26. Financial Statements DKK million 6m 2011 6m 2010 FY 2010 Revenue 58 175 314 Production costs 120 212 444 Gross profit (62) (37) (130) Research and development costs 120 92 211 Distribution and administrative costs 73 60 133 Total operating costs 193 151 344 Income before interest and taxes (254) (188) (474) Financial income/loss (20) 9 (9) Income before company tax (275) (179) (483) Tax 48 31 94 Net profit for the period (227) (148) (390) Cash preparedness (end of period) 800 219 460 26
  • 27. Financial Outlook Full-year guidance maintained 2011 Revenue DKK 500 m Result (loss) before tax DKK -350 m Cash preparedness at year-end DKK 525 m 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
  • 28. 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
  • 29. Anticipated Future Milestones CANCER VACCINES INFECTIOUS DISEASES • PROSTVAC® Ph3 initiation (H2 2011) • Deliver 4m doses of IMVAMUNE® to US • Data from PROSTVAC ® NCI studies government in 2011 • Ph1, combo (ipi), metastatic PC (H2 2011) • IMVAMUNE® Ph3 initiation (H2 2012) • Ph1, intra-prostatic, recurrent PC (H2 2011) • IMVAMUNE® licensure in Canada (2012) • Ph2 PSA progression (H2 2011) • Anthrax Ph1 funding and initiation (H1 2012) • Ph2, combo (flutamide), non-metastatic PC (2012) • RSV Ph1 initiation (H1 2012) • Ph2, combo (samarium), metastatic PC (2012) • Government funding opportunities, current and • Ph2 combo (docetaxel), mCRPC (enrol by 2012) future projects • 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 29
  • 30. Summary PROSTVAC® - innovative off-the-shelf prostate cancer vaccine candidate with blockbuster potential PROSTVAC® • Excellent safety and efficacy results previously reported • Phase 3 initiation 2H11 with attractive terms agreed in SPA IMVAMUNE® - smallpox vaccine awarded US government contracts worth up to US$1.8bn IMVAMUNE® • Successfully developed from idea to delivery of product to the US government • Currently producing and shipping vaccines Proprietary MVA-BN® platform provides an engine for new opportunities MVA-BN® • Additional vaccines for various cancers and infectious diseases IP Strong IP protection on lead products and MVA-BN® technology Additional news flow anticipated over next 12-18 months News flow • Additional PROSTVAC® Phase 2 data and PROSTVAC® Phase 3 initiation • Continued IMVAMUNE® successful supply and additional contracts Experienced management team focused on long-term value creation Management • Track records of translating science into commercially successful late-stage drug candidates • Complementary expertise in research, production, clinical development, business development and finance 30
  • 31. Share price (9 Sep 2011) DKK 48 250 High/low 52 weeks 227/ 45 Market cap DKK 1.2bn Net free liquidity per share DKK 26 (30 Jun 2011) 200 Volume (3m, daily average) 56,000 No. of shares, 93% free-float 26m No. of registered shareholders 21,000 150 Largest shareholders ATP (> 10%) A.J. Aamund A/S (> 5%) BB Biotech AG (> 5%) 100 13% 15% 50 6% 24% 11% 63% 68% 0 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Institutions, Funds Denmark 31 US Private UK Non-registered RoW
  • 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 32 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.