Better than expectedRevenue DKK 524m compared to guidance of DKK 500mResult before tax loss of DKK 296m compared to guidance of DKK 350m (loss)Cash preparedness DKK 704m compared to revised guidance (after USD25m milestone payment) of DKK 650m
Presented data from multiple studies of PROSTVAC in combination with other modalities.Consistently show additive or synergistic effect of PROSTVAC in combination AND opportunity to broaden use outside first label
Six ongoing studies, whereof five are sponsored and conducted by NCI.Will provide news flow over the next years.NCI-funded studies are beyond BN control and thus anticipated dates for reporting of data are uncertain.
Provided more detailed guidance than previously.
If you split the patients who are with Halabi predicts the one below 18 months and above 18 months, you will see that the patients have data or that Halabi predicts survival of more than 18 months have a very large effect more than the one on previous page Most of the patients predicted by the Halabi are more than 29.9 months predicted survival. What they did observe and if the medium is not yet reached and if it 37.3 months and growing. So, there is a very large effect there and that is most prominent in the better prognosis patients.
Bavarian - Kapitalmarkedsdag marts 2012
DELIVERING THE VACCINE PROMISE1 Anders Hedegaard, CEO | 27 March 2012
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 USA2
Main strategic business areas Infectious Diseases Cancer Smallpox Prostate cancer Anthrax Breast cancer Full value chain Partnerships3
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
2011 Financials Better Than ExpectedRevenue DKK 524 mResult (loss) before tax DKK -296 mCash preparedness at year-end DKK 704 m5
Cancer Vaccines - HighlightsPROSTVAC®• 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 mCRPCCV-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 future6
Cancer VaccinesTherapeutic vaccine platform for major cancers PC Ph1 Ph 1/2 Ph 2 Ph 3 Next milestone7 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
Prostate cancer – a large unmet medicalneed• 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 population1) Global Cancer Facts & Figures 2007, American Cancer Society8
Driving PROSTVAC® into Early Stage Prostate CancerTumorvolume Start of chemotherapy Death andactivity Hormone treatment PROSTVAC® Local treatment No pain Pain Hormone dependent Hormone refractory Non-metastatic Metastatic 9
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 ExpansionSource:1 American Cancer Society2 Decision Resources, 2008. Not including primary therapy such as surgery or radiotherapy. Major EU countries include France, Germany, Italy, Spain, and the UK10
PROSTVAC® - asset with solid dataJournal of Clinical Oncology Clinical trial overviewMarch 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 IIRandomized Controlled Trial of aPoxviral-Based PSA-TargetedImmunotherapy in MetastaticCastration-Resistant Prostate Cancer11
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 201012
PROSTVAC® Phase 2 Resultssurvival(% 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 60Source: Kantoff et al., Journal of Clinical Oncology, January 201013
PROSTVAC®Phase 3 Design and Endpoints Agreed in SPADesign 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 death14
Ongoing PROSTVAC® StudiesStage Study design Target EndpointPh3 Randomized, double-blind, placebo- Asymptomatic or Overall survivaln=1,200 controlled efficacy trial of PROSTVAC® minimally symptomatic +/- GM-CSF mCRPC NCI funded studies:Ph2 Comparison of docetaxel (chemo) Metastatic prostate cancer Survivaln=144 with/without PROSTVAC® mCRPCPh2 Comparison of flutamide (antihormone) Non-metastatic prostate Time to progressionn=65 with/without PROSTVAC® cancer (TTP)Ph2 Comparison of samarium (radioactive Metastatic prostate cancer 4 month progressionn=68 drug) with/without PROSTVAC® free survivalPh2 Investigate PROSTVAC® in men with PSA After local therapy PSA progression at 6n=50 progress (surgery and/or radiation) monthsPh1 Investigate PROSTVAC® by Progressive or locally Safety, PSA andn=21 intraprostatic injection recurrent prostate cancer immune responsePROSTVAC® has more clinical data from combination trials and trials in earlier disease stages thanother prostate cancer immunotherapies15
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 Society16
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-30117
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 alone18 Study Protocol ID: NCT00179309, NCI-6977
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 strategy19
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 individuals20
Infectious DiseasesLeading 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 rules21
IMVAMUNE® US Government Contracts Secured OptionalRFP-1 Early clinical and technical developmentRFP-2 500,000 doses of IMVAMUNE® delivered >US$144m Clinical studies will support Emergency UseRFP-3 20 million doses of IMVAMUNE®Base contract Licensing for at-risk individuals US$513m Development for immune compromisedOption 60 million doses of IMVAMUNE® >US$1,100m Validation of production processRFP Preclinical and clinical studies to support US$94mFreeze-dried advanced development >US$751m >US$1,100m22
IMVAMUNE® Delivery StatusDeliveries to the US Strategic National Stockpile 2010Delivered in 2010 2m doses 2013 2011Delivered in 2011 4m doses Planned deliveries in 2012 7m doses 2012Planned deliveries in 2013 7m doses
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 201624
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 EU26
Financial Outlook 2012Revenue DKK 850mResult (loss) before tax DKK -200mCash preparedness at year-end DKK 350mAssumptions:Deliver and revenue recognize 7 million doses of IMVAMUNE®R&D costs - GROUP DKK 400m *Infectious Disease Division, EBIT DKK 110m to 130mbefore allocation of internal chargesCancer Vaccines Division, EBIT DKK -250m to -270mbefore allocation of internal chargesAll numbers are approximate* R&D costs include approximately DKK 100 million in contract expenses(stated under production costs in the profit and loss statement).
Anticipated Future MilestonesCANCER 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 projects28
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 includestatements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We 29undertake 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.
Financial StatementsDKK million FY 2011 FY 2010Revenue 524 314Production costs 403 444Gross profit 120 (130)Research and development costs 262 189Distribution and administrative costs 167 155Total operating costs 428 344Income before interest and taxes (308) (474)Financial income/loss 12 (9)Income before company tax (296) (483)Tax 28 94Net profit for the period (268) (390)Cash preparedness (end of period) 704 46031
RFP-3 Contractas 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 269Based on 6.048 million doses delivered32
Overview of USG IMVAMUNE® Contractsas 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 35733
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 34Gulley et al. Cancer Immunol Immunother 2009 Nov 5 (Epub ahead of print)