Oxford BioMedica plc · LSE:OXB
Oxford BioMedica — FY2007 Earnings Presentation
28 slides from Oxford BioMedica's earnings presentation, Mar 10, 2008
Slide 1: Annual Results 2007
Annual Results 2007 10 March 2008
Slide 2: Disclaimer
Disclaimer This presentation does not constitute an offer to sell or a solicitation of offers to buy Ordinary Shares (the “Securities”). Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable,
Slide 3: 2007: A Year of Transformation
Overview Oxford BioMedica 2007: A Year of Transformation Key operational objectives achieved • Collaboration with sanofi-aventis for TroVax, value >€518 million • Three successful DSMB reviews of TroVax Phase III TRIST study in renal cancer • Completed patient recruitment for TRIST study, results an
Slide 4: Advanced Product Candidates
Pipeline Advanced Product Candidates Expanding Clinical Pipeline • Four products in clinical development PRODUCT PRECLINICAL PH I PH II PH III TECHNOLOGY PARTNER/FUNDING TroVax® Renal Cancer MVA poxvirus sanofi-aventis TroVax® Colorectal Cancer mid 2008 MVA poxvirus sanofi-aventis TroVax® Prostate C
Slide 5: Other Product Candidates
Pipeline Other Product Candidates Breadth and Depth • Eight products in preclinical development • Funding from commercial partners and other organisations PRODUCT DISEASE TECHNOLOGY PARTNER/FUNDING StarGen™ Stargardt Disease LentiVector® Foundation Fighting Blindness MoNuDin® Motor Neuron Disease Le
Slide 6: TroVax: Recruiting Patient's Immune System to Fight Cancer
TroVax TroVax Recruiting Patient’s Immune System to Fight Cancer Cancer 5T4 Frequency (%) Renal 90 Colorectal 85 >$7bn1 Prostate 78 Breast 84 NSC Lung 86 Ovarian 71 Gastric 74 • 5T4 is a proprietary tumour associated antigen • Broadly expressed on solid tumours and no expression on essential organs
Slide 7: TroVax Clinical Development
TroVax Clinical Development Best in Class Cancer Vaccine • Ten Phase I/II & II trials in >190 patients with renal, colorectal or prostate cancer • Primary endpoints of safety and immunology • All endpoints achieved • Both antibody and/or cellular responses induced in >90% of patients • Dose and regi
Slide 8: Sanofi-Aventis Collaboration
TroVax Sanofi-Aventis Collaboration Partnership with Leader in Oncology and Vaccines • Global alliance signed in March 2007 • Initial payment €29m (~£20m) • Two development milestones achieved in first 12 months, triggered €19m (~£14m) • Additional milestone payments potentially >€470m • Additional
Slide 9: Sanofi-Aventis Collaboration
TroVax Sanofi-Aventis Collaboration High Profile Positioning in Oncology Pipeline 9
Slide 10: Phase III TRIST Study
TroVax Phase III TRIST Study First Line Advanced and Metastatic Renal Cancer TRIST: TroVax Renal Immunotherapy Survival Trial • Placebo-controlled, randomised Phase III trial • TroVax + first line standard therapy1 vs. placebo + first line standard therapy1 • 700 patients in USA, EU & Eastern Europe
Slide 11: Phase III TRIST Study: Current Status
TroVax Phase III TRIST Study Current Status • Patient recruitment completed in March 2008 • Three successful DSMB reviews recommended continuation of TRIST • Recent DSMB review in February 2008 followed 100 events • Next DSMB review triggered by 200 events • Trial completes after 309 events, anticip
Slide 12: Phase III Development: Colorectal Cancer
TroVax Phase III Development Colorectal Cancer • Sanofi-aventis to start Phase III trial in metastatic colorectal cancer • 1,300 patients • TroVax + first line standard therapy vs. placebo + first line standard therapy • First patient anticipated in mid 2008 • QUASAR to start Phase III trial in earl
Slide 13: TroVax: Moving Towards Commercialisation
TroVax TroVax Moving Towards Commercialisation • Excellent safety profile lowers hurdles for efficacy • Endorsement by #2 oncology company with leading cancer vaccine expertise • Supported by independent clinical trial groups • Phase III TRIST study on track for completion in H1 2009 • Potential app
Slide 14: Parkinson's Disease: The Opportunity
ProSavin Parkinson’s Disease The Opportunity • Disease is well understood - caused by loss of ability to make dopamine • In early stages systemic L-DOPA (dopamine precursor) is efficacious BUT • Patients progressively lose ability to convert L-DOPA to dopamine • Long term (1-4 years) L-DOPA treatmen
Slide 15: ProSavin: Dopamine Replacement for Parkinson's Disease
ProSavin ProSavin Dopamine Replacement for Parkinson’s Disease • ProSavin carries genes for dopamine production using LentiVector technology • Restores dopamine production in the brain • Single treatment provides long-term benefit • Current market >$3bn1 • Scope to increase market with potent, innov
Slide 16: ProSavin Preclinical Results
ProSavin Preclinical Results Proof of Principle Demonstrated • Statistically significant recovery of movement in two weeks • Return to normal by 5-8 weeks; maintained to latest time point (~27 months) • Similar efficacy in all other behavioural assessments 7000 6000 Total Distance Moved ProSavin 500
Slide 17: ProSavin Clinical Development
ProSavin ProSavin Clinical Development Accelerated Plan • Phase l/ll trial underway in France • Patients failing on L-DOPA but not experiencing disabling side-effects • Creative trial design - 18 patients, dose escalation1, placebo controlled2 • Anticipate data from first cohort of patients in mid-2
Slide 18: Advanced Product Candidates: Anti-Cancer Products in Phase II
Cancer Advanced Product Candidates Two Anti-Cancer Products in Phase II Trials Hi-8 MEL: immunotherapy for melanoma based on DNA and MVA technology • Phase II trial conducted in 41 patients with Stage III/IV melanoma • Median survival of 100wks for immune responders vs. 37wks for non-responders • Pr
Slide 19: Next Major Opportunities
RetinoStat Next Major Opportunities Preclinical Proof of Principle RetinoStat: LentiVector system delivering two anti-angiogenic genes • Targeting vision loss caused by aberrant blood vessel growth (wet AMD) • Collaboration with Foundation Fighting Blindness and Johns Hopkins University • Plan to fi
Slide 20: Financial Highlights for 2007
Finance Financial Highlights for 2007 Collaboration Strengthens Balance Sheet • Revenue £7.2m (2006: £0.8m) • R&D costs increased 13% to £22.1m (2006: £19.5m) • Loss for the year decreased 13% to £15.3m (2006: £17.6m) • Positive operational cash flow £5.9m (2006: cash burn £15.9m) • Net cash1 £38.1m
Slide 21: Income Statement
Finance Income Statement Loss Narrowed £m 2003 20041 20051 20061 20071 Revenue 0.4 0.5 0.8 0.8 7.2 Cost of sales - - - - (0.4) R&D costs (10.8) (9.0) (9.3) (19.5) (22.1) Administrative costs (2.9) (2.8) (2.9) (2.7) (4.3) Exceptional costs - (1.6) - - (0.3) Operating loss before except’l (12.7) (10.9
Slide 22: Balance Sheet
Finance Balance Sheet Bolstered Cash Reserves £m 2003 20041 20051 20061 20071 Cash and short term investments 31.8 22.4 43.8 28.5 38.1 Debtors 2.4 3.3 2.9 4.5 7.3 Non-current assets 2.5 2.9 2.5 2.5 15.7 Total assets 36.7 28.6 49.2 35.5 61.1 Deferred income - 0.1 0.1 0.1 18.9 Other current liabilitie
Slide 23: Cash Flow
Finance Cash Flow Positive Operational Cash Flow £m 2003 20041 20051 20061 20071 Cash used/generated in operations (11.5) (10.8) (10.1) (17.7) 2.3 Net interest received 0.6 1.1 1.0 1.4 1.6 Net tax received 1.3 0.4 1.7 0.6 2.4 Capital expenditure - (0.4) (0.3) (0.2) (0.4) Cash burn/generated (9.6) (9
Slide 24: Financial Outlook
Finance Financial Outlook Focus on High Value Opportunities • Strategic review of pipeline to define key development priorities • Investment focused on products with greatest potential value • Plan to maintain operational spend at 2007 level • Second TroVax development milestone in February 2008, tr
Slide 25: Looking Forward
Summary Looking Forward • Continue management of TroVax TRIST study • Sanofi-aventis planning significant investment in TroVax development • Preliminary Phase I/II data with ProSavin in Parkinson’s disease • Prepare RetinoStat for clinical development in wet AMD • Evaluate various collaboration oppo
Slide 26: Anticipated Events
News Anticipated Events March 08 TroVax Phase II prostate cancer results at Targeted Anticancer Therapies conf May 2008 TroVax Phase II renal cancer results at ASCO Mid 2008 Sanofi-aventis to initiate TroVax Phase III trial in metastatic colorectal cancer Mid 2008 QUASAR & sanofi to initiate TroVax
Slide 27: Summary
Summary Summary • Leading company in cancer immunotherapy and gene-based products • Developing innovative treatment approaches for unmet medical needs • Four products in clinical development • TroVax “best in class” cancer vaccine in Phase III, endorsed by sanofi-aventis • ProSavin novel treatment f
Slide 28: Oxford BioMedica plc contact details
Oxford BioMedica plc BioMedica Inc Medawar Centre 11622 El Camino Real Robert Robinson Avenue Suite 100 The Oxford Science Park San Diego Oxford OX4 4GA CA 92130 United Kingdom USA Tel: +44 (0) 1865 783000 Tel: +1 858 677 6500 Fax:+44 (0) 1865 783001 Fax:+1 858 677 6505 www.oxfordbiomedica.co.uk www