Bavarian Nordic A/S · OMXCOP:BAVA
Bavarian Nordic A/S — Q1 2005 Earnings Presentation
21 slides from Bavarian Nordic A/S's earnings presentation, May 10, 2005
Slide 1: Q1-2005 Results
Q1-2005 Results Peter Wulff President & CEO 10 May 2005
Slide 2: Bavarian Nordic: Company Profile
Bavarian Nordic: Company Profile • International biopharmaceutical company founded in 1994 • Sites in Denmark, Germany and USA • Supplied > 60 million doses of smallpox vaccines to governments • Developed MVA-BN® as vector since 1995 • Invested in the development of MVA-BN® (IMVAMUNE™) as a safe sma
Slide 3: MVA-BN - a New Modified Vaccinia Virus
MVA-BN® - a New Modified Vaccinia Virus Increased attenuation & MVA-BN® 1998: Monoclonal and serum free safety MVA 575 MVA 572 1976: Pre-vaccine in 120,000 individuals 1960-1974: Continual MVA 517 1974: Clinical studies in high risk groups passage in CEF cells MVA 516 1974: Re-named MVA 516 CVA 371
Slide 4: Post-Vaccination Complications with Traditional Smallpox Vaccines
Post-Vaccination Complications with Traditional Smallpox Vaccines Post-vaccinal Generalised Eczema Autoinoculation Progressive Encephalitis Vaccinia Infection vaccinatum Vaccinia 25% of the population cannot receive the current smallpox vaccine • High risk groups: Young, elderly, HIV+, atopic dermat
Slide 5: MVA-BN – Platform Technology
MVA-BN® – Platform Technology JEV Neonatal research IMVAMUNE™ Cancer smallpox Immunotherapy Dengue HIV MVA-BN DNA Antigen DNA 1994 1995 1997 1999 2000 2001 2004 5
Slide 6: IMVAMUNE Global Development Programme
IMVAMUNE™ Global Development Programme 1999 2000 2001 2002 2003 2004 2005 2006 2007 Pre-clinical - Efficacy in mice models - Pivotal mouse studies - Monkeypox challenge studies - Pivotal monkey studies -Toxicity (safety) studies Production - MSV established - First GMP batch produced/released - Vali
Slide 7: IMVAMUNE – Clinical results in 400+ subjects
IMVAMUNE™ – Clinical results in 400+ subjects Two completed clinical studies in Europe y Phase l study in 86 healthy volunteers y Phase ll dose-finding study in 165 healthy volunteers Three ongoing studies with IMVAMUNE™, in which enrolment and vaccination have almost been completed in the first two
Slide 8: US HHS – MVA Safe Smallpox Vaccine Program
US HHS – MVA Safe Smallpox Vaccine Program Time Milestone RFP-l-A* Issued August 2002 Production of 5,000 doses (prototype Awarded February 2003 to MVA vaccine) IND, Phase I clinical trial, Bavarian Nordic preclinical studies RFP-l-B Issued August 2002 Phase II studies in healthy populations, Awarde
Slide 9: IMVAMUNE vs. DryVax
IMVAMUNE™ vs. DryVax® Safety – Superior safety profile - suitable for general population IMVAMUNE™ demonstrated safety persons contra-indicated for DryVax® - HIV-infected persons - People with active eczema or history of atopic dermatitis Further Phase II studies will be initiated in 2005 > 2,000 pe
Slide 10: IMVAMUNE Manufacturing Capacity
IMVAMUNE™ Manufacturing Capacity IMVAMUNE™ - manufactured under a global BN/GSK partnership 38,000 m2 site, North of Copenhagen Only MVA industrial-scale facility in world Facility has been visited by European authorities, US NIH and GMP auditors 60 million doses from September 2005 Partner with Gla
Slide 11: IMVAMUNE Smallpox Vaccine Program
IMVAMUNE™ Smallpox Vaccine Program IMVAMUNE™ is the best characterised 3rd generation vaccine y Advanced clinical development program (initiated in 1999) ¾ IMVAMUNE™ safe for those contra-indicated to DryVax® (safe for all) ¾ IMVAMUNE™ most suitable for use in an emergency (induces faster protective
Slide 12: IMVAMUNE
IMVAMUNETM 12
Slide 13: The Vaccine Market
The Vaccine Market • Customers are usually governments and international organisations • Prices are under pressure • Regulatory demands are sharply increasing • Major consolidation of the vaccine industry - over the last 30 years • Market is now driven by only 5 players (control 85% of the market) •
Slide 14: Infectious Diseases
Infectious Diseases Infectious diseases were, are and will continue to be a major problem The second half of the 20th century offered some optimism in the fight against infectious diseases with availability of penicillin, new vaccines, and the eradication of smallpox in 1980. After smallpox, WHO dec
Slide 15: Bavarian Nordic HIV Vaccine Programmes
Bavarian Nordic HIV Vaccine Programmes MVA nef-vaccine MVA-BN® polytope vaccine MVA-BN® multiantigen vaccine HIV-1 Nef-gene Epitope Multiple HIV-1 genes 15
Slide 16: MVA nef vaccine
MVA nef vaccine MVA nef clinical data y Phase I/ll trial to evaluate the safety and immunogenicity of MVA nef in 14 HIV-infected persons ¾ 7 out of 14 HIV-infected persons off HAART-therapy for 11 months ¾ 5 out of 14 HIV-infected persons off HAART-therapy for 34 months • Phase II has started - inte
Slide 17: Cancer Immunotherapy
Cancer Immunotherapy New data from earlier trial with MVA vector expressing tyrosinase against melanoma cancer: • Broke tolerance against the self-antigen • Induced prolonged therapeutic immune response for more than 1 year BN ImmunoTherapeutics Inc. (USA) • Vaccines that target humoral and cellular
Slide 18: Financials – Q1 2005
Financials – Q1 2005 DKK million Q1 2005 Q1 2004 FY 2004 Revenue 70.7 113.8 164.8 ___ Production costs 38.7 36.3 70.3 Development costs 25.7 11.0 85.1 Research costs 7.3 7.0 35.3 16.2 9.8 56.4 Sales and administration costs__ _____________________________ __ Earnings before tax (EBT) 52.9 -17.9_____
Slide 19: Public Rights Offering to Grow the Business
Public Rights Offering to Grow the Business Complete transformation from biotech to biopharmaceutical (2003-2005) Public Rights Offering of DKK 400 million to be completed June 2005 Use of Proceeds: y Finance start-up of manufacturing – working capital in inventory and receivables y Vaccine filling
Slide 20: News Flow - 2005
News Flow - 2005 • Safety data - IMVAMUNE™ in persons with atopic disorders • Safety data - IMVAMUNE™ in HIV-infected persons • Completion of Public Rights Offering • Production on-line summer 2005 • RFP-lll award • Issuance of more patents • Interim result - MVA nef Phase II study • 3 Phase ll tria
Slide 21: Forward-looking statements notice
These slides accompany an oral presentation by Bavarian Nordic A/S which contains forward-looking statements. The company’s actual results may differ materially from what is suggested here.