DESROUSSEAUX Valentin DUBOS Clément GALLANT Victor LAURENT Julien LEMAITRE Pierre • This is an independent presentation made by students from the Faculté des Sciences Pharmaceutiques of Lille • The opinions expressed are our own and not necessarily those of Bavarian Nordic INTRODUCTION HUMAN RESOURCES TECHNOLOGY PLATFORMS PIPELINE FINANCIAL STATEMENT SWOT CONCLUSION About Pipeline & Partners Financial Situation Multinational biotech company focused on the development and manufacturing of Cancer immunotherapy Vaccines for infectious diseases • • Founded in 1994 (1,43MDKK) IPO in 1998 • Leader in Vector-Based Active Immunotherapy with Two Platforms • MVA-BN : 650 Granted patents • VF-TRICOM : 170 Granted patents • 1 approved product (Imvamune - 2013) & 7 active programs • 2 Phase 3 products and near term value drivers • Trial supply to commercial product • > $1 billion from US government in past 10 years (long term contract); $271 million Janssen (Ebola Therapy), BMS collaboration potential of ~$975 million • Headquarters in Denmark • Manufacturing • Kvistgaard • Government Relations • Washington DC • Research Centers in • Mountain View (CA) • Munich (Germany) PH1 Imvanex/Imvamune Smallpox BARDA Imvamune freeze-dried Smallpox BARDA Prostvac Prostate Cancer BMS Prostvac + enzalutamide Prostate Cancer NCI Prostvac + ipilimumab Prostate Cancer NCI CV-301 bladder Bladder Cancer NCI MVA-BN Brachyury Solid Tumors NCI MVA-BN Filo Ebola/Marburg Janssen MVA-BN RSV RSV 2015 PH2 PH3 Market Imvanex/Imvamune Prostvac Human Ressources Executive Management Board of Directors Employees • • Ph.D. in Immunology from Bristol University Worked for several years both in the UK and Australia developing vaccines against infectious diseases • Co-chair of the Alliance for BioSecurity • Joined Bavarian Nordic in 1999 • Executive vice president in 2004 and President & CEO in 2014 • M.Sc. in economics and business administration from Copenhagen Business School • Joined Bavarian Nordic in 2008 • • • M.D. and Ph.D. degrees from Washington University School of Medicine Board certified in Internal Medicine and Oncology Clinical and teaching positions at the Dana Farber Cancer Institute and Harvard Medical School • Former board member of Zogenix, Inc • Joined Bavarian Nordic in 2013 from Cadence Pharmaceuticals Inc 900 675 450 225 0 2010 2011 2012 2013 2014 2015 Technology platforms Smallpox MVA-BN = Infectious Diseases VF-TRICOM = Cancer immunotherapy • • • • • Acute contagious disease caused by Variola virus Declared eradicated in 1980 by WHO (Global WHO-led immunization campaign) No longer occurs naturally Stocks of the virus are still kept in two high-containment laboratories Vaccines needed in case of resurgence Replicating vaccinia virus • • • • Dryvax® ACAM2000 LC16m8 Elstree-BN Serious side effects • • • • Myocarditis,pericarditis Encephalitis Eczema Inadvertent infection CI Populations • Immunodeficiency • Immunosuppresive medications • Exfoliative skin disorders Non-replicating virus Well tolerated • even in immune compromised patients No serious adverse events reported Approved in EU and Canada • 7,500 individuals have been vaccinated Pipeline IMVAMUNE ® / IMVANEX ® MVA-BN Filo ® / RSV ® PROSTVAC ® CV-301 BLADDER ® Technology MVA-BN Indications Smallpox Partnerships BARDA 2 Phases III Studies (Study vs ACAM2000) Phase II for Freeze dried Developpement Approved in EU and Canada Already sold in USA (SNS) 30M doses sold worldwide Results Financial Benefits 1 Billion $ contract • • • • Global leadership in smallpox Long term revenues Complete studies Validate freeze dried manufacturing Technology MVA-BN Indications Ebola and Marburg (Filovirus) Partnership Janssen (J&J DC) Developpement Results Phase I study •With adVac (Janssen) •With cAd3 EBO Z (GSK) 2M doses delivered Financial Benefits 271M$ (developpement and delivery of 2M doses) Establish a global leadership in Ebola preparedness and treatment through collaboration with Janssen Technology MVA-BN Indications RSV Partnership Pending Phase I study planed in 2015 Developpement NIH sponsored toxicity study Results Financial expectations Favorable pre IND discussion with FDA Blockbuster market •64M people infected globally •350,000 hospitalizations in US • Expand the infectious disease vaccine pipeline to meet high unmet medical needs Technology VF-TRICOM Indications Prostate cancer Partnership Bristol Myer Squibb 1 Phase III studies Developpement 4 Phases II studies CRADA with NCI • Finalize validation of the commercial manufacturing process and prepare launch material • Advance clinical studies exploring the therapeutic potential of PROSTVAC in combination with Yervoy and other potential checkpoint inhibitors as part of the clinical collaboration with BMS • Combined with Enzalutamide : • • • • To treat metastatic castration – resistant prostate cancer To treat non metastatic castration sensitive prostate cancer Combined with Flutamide vs Flutamide alone As neoadjuvant therapy for patients with prostate cancer undergoing treatment with radical prostatectomy Technology VF- TRICOM ( CEA / MUC1) Indications Bladder cancer & NSCLC Partnership Developpement Phase I in 2016 for NSCLC Phase II for Bladder Results Financial expectations Global market = 8 billion $ in 2020 • Create a balanced pipeline • Global leadership position in the rapidly growing field of cancer immunotherapy Financial Statement USD Million 2014 2013 2012 2011 2010 Revenue 183.4 182.84 153.30 78.96 47.37 72.22 74.84 51.29 39.46 28.44 39,4 % 41 % 33,5 % 49,98 % Net profit 3.91 (7.04) (36.19) (40.47) (58.80) Equity 188.81 147.22 150.75 182.10 122.21 Cash 147.74 80.24 82.92 88.07 53.64 Earnings per share 0.15 (0.27) (1.39) (1.82) (3.88) 1,07 1,62 2,23 1,89 R&D costs Burn Rate 60 % SWOT Analysis •Advanced pipeline •Multipurpose facility •Strong patent portfolio •In house expertise •Multiple partners •High share value •Fundraising •Partnerships •Indications expansions •Freeze dried •Complementarity aquisition •No usual therapeutics •No owned products •Partnership dependance •Competition •Market fluctuation •Currency fluctuation •Patent loss •Authorities decision •Loss of capable employees Conclusion • Transition • Technological platforms : MVA-BN & VF-TRICOM • Imvamune on Market, Prostvac soon to be •Focus on employee’s well being •Employement stability •Will to retain key personnel •Extensive opportunities for pharmacists in various fields Thank You