Bavarian nordic pro investor life science seminar 14 sep 2011


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Bavarian nordic pro investor life science seminar 14 sep 2011

  1. 1. OFF THE SHELF DELIVERING THE VACCINE PROMISE Rolf Sass Sørensen, VP Investor Relations & Communications September 20101
  2. 2. Bavarian NordicVaccines for cancer andinfectious 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 USA2
  3. 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 platform3 * As of 30 June 2011
  4. 4. Share price120100 80 60 40 20 0 maj-11 jun-11 jul-11 aug-11 sep-11 BAVA DNDN4
  5. 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 burn5
  6. 6. Cancer VaccinesTherapeutic vaccine platform for major cancersLead product ObjectivesPROSTVAC® — off-the-shelf immunotherapy for • Initiate PROSTVAC® Phase 3advanced 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 milestone6PROSTVAC® 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. 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 MeetingPROSTVAC® • Increased awareness of immunotherapy7
  8. 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 cancerSource: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 UK8
  9. 9. 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 Society9
  10. 10. PROSTVAC® - asset with solid dataJournal 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 dataOverall Survival Analysis of a Phase II • Phase 1: ThreeRandomized Controlled Trial of a • Phase 2: FourPoxviral-Based PSA-Targeted • Scheduled to startImmunotherapy in Metastatic Castration-Resistant Prostate Cancer • Phase 3: One10
  11. 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 201011
  12. 12. 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 201012
  13. 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 controls13
  14. 14. Phase 3 Design and Endpoints Agreed in SPADesign• 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 PlaceboEndpoints• Primary endpoint is overall survival (OS)• Either one or both of the treatment arms must be superior to placeboPhase 3 estimated costs: US$150m:• CRO costs, Manufacturing costs, BN internal costs14
  15. 15. Advanced PC ”Patient Stock” 2011Stock is expected to grow due to new efficient therapeutics350.000 293.000300.000250.000 195.000200.000 154.743150.000 118.000100.000 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 Cancer15
  16. 16. Advanced PC ”New Cases” 2011Incidence 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 Cancer16
  17. 17. 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 17
  18. 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 studiesStage Study design Target EndpointPh2 Comparison of docetaxel (chemotherapy) Metastatic prostate cancer Survivaln=144 with/without PROSTVAC® mCRPCPh2 Comparison of flutamide (antihormone therapy) Non-metastatic prostate Time to progression (TTP)n=65 with/without PROSTVAC® cancerPh2 Comparison of samarium (radioactive drug) Metastatic prostate cancer 4 month progression freen=68 with/without PROSTVAC® survivalPh2 Investigate PROSTVAC® in men with PSA progress After local therapy (surgery PSA progression at 6n=50 and/or radiation) monthsPh1 Dose-escalation, combination study with PROSTVAC® Metastatic prostate cancer Safety, PSA responsen=30 and MDX-010 (CTL4-antibody) CT responsePh1 Investigate PROSTVAC® by intraprostatic injection Progressive or locally recurrent Safety, PSA responsen=21 prostate cancer Immune responsePROSTVAC® has more clinical data from combination trials and trials in earlier disease stages thanother prostate cancer immunotherapies18
  19. 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 monthsSource: 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 daysSource: Gulley, Schlom et al. 2011 Genitourinary Cancers Symposium 19
  20. 20. Infectious DiseasesLeading supplier of vaccines for biodefenseLead product ObjectivesIMVAMUNE® — next generation smallpox • Successful continued delivery ofvaccine 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 milestoneIMVAMUNE® 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 partner20
  21. 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 affectedIMVAMUNE®21
  22. 22. IMVAMUNE® Deliveries to the USDeliveries to the US Strategic National StockpileDelivered in 2010 2m dosesDelivered in H1 2011 0.3m dosesTotal delivered as of 30 Jun 2011 2.3m dosesDelivered 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 doses22
  23. 23. IMVAMUNE® Phase 3Continued 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 201223
  24. 24. IMVAMUNE® Filed for Approval in CanadaMarketing 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 settings24
  25. 25. 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$505m 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$743m >US$1,100m25
  26. 26. Financial StatementsDKK million 6m 2011 6m 2010 FY 2010Revenue 58 175 314Production costs 120 212 444Gross profit (62) (37) (130)Research and development costs 120 92 211Distribution and administrative costs 73 60 133Total operating costs 193 151 344Income before interest and taxes (254) (188) (474)Financial income/loss (20) 9 (9)Income before company tax (275) (179) (483)Tax 48 31 94Net profit for the period (227) (148) (390)Cash preparedness (end of period) 800 219 46026
  27. 27. Financial OutlookFull-year guidance maintained 2011Revenue DKK 500 mResult (loss) before tax DKK -350 mCash preparedness at year-end DKK 525 mAll numbers are approximateIn 2012-2013, the accumulated free cash flow for the Infectious Disease Division isexpected to be positive by approximately DKK 350 million including costs for the Phase3 trial for IMVAMUNE®, but excluding the cash from the hold back of USD 50 million.27
  28. 28. On track for major 2011 goals• Strong focus on execution in both divisions• Full-year financial guidance maintainedInfectious Diseases• Scale up to 4 batches/week completed – continue focus on streamlining process (bulk, filling, release)• Deliver 4 million doses of IMVAMUNE® to the USCancer Vaccines• Finalize regulatory preparations and selection of centres for PROSTVAC® Phase 3 trial• Release of vaccines for trial• Study initiation by H2 201128
  29. 29. Anticipated Future MilestonesCANCER 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 ongoing29
  30. 30. Summary PROSTVAC® - innovative off-the-shelf prostate cancer vaccine candidate with blockbuster potentialPROSTVAC® • 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$1.8bnIMVAMUNE® • 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 creationManagement • Track records of translating science into commercially successful late-stage drug candidates • Complementary expertise in research, production, clinical development, business development and finance30
  31. 31. Share price (9 Sep 2011) DKK 48250 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 21,000150 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. 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 includestatements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We 32undertake 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.