Call Girls Jaipur Just Call 9521753030 Top Class Call Girl Service Available
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
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.