Transgene SA · EURONEXT:TNG
Transgene SA — FY2006 Earnings Presentation
33 slides from Transgene SA's earnings presentation, Mar 7, 2007
Slide 1: 2006 Achievements, 2007 Outlook
2006 ACHIEVEMENTS 2007 OUTLOOK transgene L’immunothérapie appliquée au traitement des cancers et des maladies infectieuses Immunotherapy to fight cancer and infectious diseases Paris, March 7, 2007 London, March 8, 2007
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward-looking statements, including statements regarding Transgene’s objectives for progress in its clinical trials and product candidate development. Statements that are not historical facts are based on the Company's current expectations, beli
Slide 3: 2006 was successful
2006 was successful: Clinical developments TG 4001 positive efficacy results in CIN2/3 – First proof of concept of therapeutic vaccination in infectious diseases Initiation of Phase IIb clinical study for TG 4010 in NSCLC Initiation of Phase II clinical study for TG 1042 in CBCL Initiation of Phase
Slide 4: Clinical Developments
Clinical Developments Drug Candidate Indication Preclinical Phase I Phase II Phase III Current Status Next milestones TG 4001 Prevention of Phase IIb Initiation Phase III (MVA –HPV-IL2) Cervical Cancer completed Q2 Q4 2007-Q1 2008 2006 TG 4010 Non-Small Cell Phase II b Phase IIb interim (MVA- MUC1-I
Slide 5: TG 4001 (MVA-HPV-IL2)
TG 4001 (MVA-HPV-IL2) 5 transgene
Slide 6: TG 4001 Treating Precancerous Cervical Lesions
TG 4001 (MVA-HPV-IL2) Treating Precancerous Cervical Lesions Product: Antigen-specific therapeutic vaccine. Target: Prevention of cervical cancer by treating precancerous cervical lesions (CIN 2/3) caused by Human Papilloma Virus 16 (HPV 16) and HPV16-related infections. Market potential: Treatment
Slide 7: TG 4001 2006 Achievements
TG 4001 (MVA-HPV-IL2) 2006 Achievements April 2006: Positive Phase II results. 10 surgeries avoided on 21 patients (no more CIN2/3 lesions) All 10 women with no CIN2/3 had no HPV16 mRNA detected. November 2006: Sustainability of the results at 12 months All 7 evaluable patients at Month 12 had no CI
Slide 8: TG 4001 2007 Objectives
TG 4001 (MVA-HPV-IL2) 2007 Objectives Conclusion of a strategic partnership in the first half of 2007. Authorization from EMEA and FDA to conduct Phase III studies in Europe and US (expected in Q2 2007) 500 patients Placebo controlled Endpoint: disappearance of CIN2/3 lesions twelve months after vac
Slide 9: TG 4010 (MVA-MUC1-IL2)
TG 4010 (MVA-MUC1-IL2) 9 transgene
Slide 10: TG 4010 in Non Small Cell Lung Cancer (NSCLC)
TG 4010 (MVA-MUC1-IL2) in Non Small Cell Lung Cancer (NSCLC) Product: Antigen-specific therapeutic vaccine. Target: NSCLC: MUC1 is overexpressed in 60% of NSCLC patients First line treatment in combination with chemotherapy. Market potential: Worldwide incidence = 1.1 million per year Estimated mort
Slide 11: Positive TG 4010 Phase IIa Results
Positive TG 4010 (MVA-MUC1-IL2) Phase IIa Results Clear clinical benefit from the combination therapy as compared to the standard cisplatin/vinorelbine chemotherapy 35 evaluable patients # patients Response rate (%) Partial responses 13/35 37% Stable disease 12/35 34% Clinical benefit 25/35 71% 1-ye
Slide 12: TG 4010 controlled study
TG 4010 controlled study (initiated beginning 2006) Primary objective: to assess the efficacy of TG 4010 combined with chemotherapy in comparison with chemotherapy alone. 140 patients (67 evaluable/arm) to be recruited: Patients recruited to date: 100 Planned completion of recruitment: April 2007. F
Slide 13: TG 1042 (Ad-IFNγ)
TG 1042 (Ad-IFNγ) 13 transgene
Slide 14: TG 1042 in Cutaneous Lymphoma
TG 1042 (Ad-IFNγ) in Cutaneous Lymphoma Product: Non-specific therapeutic vaccine (immune enhancement). Target: Cutaneous lymphoma (a skin malignancy), either T-cell or B-cell. Other cancer indications are under evaluation. Potential market: Cutaneous B-cell Lymphoma (CBCL). Orphan indication. Preva
Slide 15: Positive TG 1042 Phase I/II Results in Cutaneous Lymphoma
Positive TG 1042 Phase I/II Results in Cutaneous Lymphoma Open-label multicenter, dose-escalation phase I/II trial with 39 patients (31 evaluable) with relapsing primary cutaneous T-cell or B-cell lymphoma. Repeated monthly cycles of 3 intratumoral injections. Complete Partial Total Evaluable Respon
Slide 16: TG 1042: 2006 Achievements
TG 1042: 2006 Achievements Pivotal Phase II Study Open label, multicentre, two-step trial 41 patients with relapsing CBCL following radiotherapy US, France, Switzerland First centers opened in Q4 2006 (US) 16 transgene
Slide 17: TG 1042: 2007 Perspectives
TG 1042: 2007 Perspectives First patients recruited in Q1 2007 Results expected late 2007 Commercial launch expected in 2009 after accelerated review by regulatory authorities 17 transgene
Slide 18: TG 4040 (MVA-HCV)
TG 4040 (MVA-HCV) 18 transgene
Slide 19: TG 4040: Therapeutic Vaccine for Hepatitis C Chronic Carriers
TG 4040 (MVA-HCV): Therapeutic Vaccine for Hepatitis C Chronic Carriers Product: Antigen-specific therapeutic vaccine. Target: Chronic hepatitis C infection. Market potential: 170-200 million people infected worldwide, 12 million people infected in the US, EU and Japan. In France, 500,000 people inf
Slide 20: TG 4040: 2007 Perspectives
TG 4040: 2007 Perspectives Initiation of Phase I in France in Q1 2007 Recruitment of 15 treatment-naïve patients by year-end Safety data: by year-end 2007 Immune response and viral load impact by Q3 2008 30% funded by government grant through Lyonbiopôle competitiveness cluster. Initiation of Phase
Slide 21: ADNA Project
ADNA Project Funding from Agence de l’Innovation Industrielle for Transgene: Grants € 17.8 M Loans € 7.2 M € 25.0 M (Transgene’s share) i.e. 45% of eligible costs Subject to approval by the European Commission Four partners under the coordination of Merieux Alliance: bioMérieux, Généthon, Genosafe,
Slide 22: 2006 Financial Results
2006 Financial Results 22 transgene
Slide 23: Statement of Operations
Statement of Operations IAS/IFRS; in € million (except for share data) 2006 2005 Revenues 5.5 4.2 Operating expenses (28.0) (25.6) R&D (24.2) (21.0) G&A (3.8) (4.6) Loss from operations (22.5) (21.4) Interest income 0.5 0.4 Income tax - - Net loss (22.0) (21.0) Basic and diluted loss per share (1.41
Slide 24: Revenues
Revenues IAS/IFRS; in € million 2006 2005 Variation Manufacturing contracts 1.4 1.5 - 7% A.F.M. 1.7 1.3 + 30% Licenses 0.6 0.7 - 15% Grants 0.3 - N/A R&D tax credit 1.5 0.7 + 115% 5.5 4.2 + 31% 24 transgene
Slide 25: Contracts (excl. AFM)
Contracts (excl. AFM) New contracts in 2006: ANRS € 800 000 (to be recognized in revenues in 2008) IAVI and Innogenetics (2005) to be recognized in revenues in 2007. Deferred revenues at December 31, 2006: 2.1 M€ Cash received (M€) 2006 2005 2.7 1.0 è+ 1.7 M€ 25 transgene
Slide 26: Operating Expenses
Operating Expenses Research & Development costs AFM costs +0.6 HCV team +0.5 Contract manufacturing +0.5 Medical expenses +0.3 Reallocation of « project management » to R&D +0.4 Increase in personnel costs +0.5 General & Administrative Reallocation of « projects management » to R&D (0.4) Nasdaq deli
Slide 27: Net cash expenditures
Net cash expenditures Outlook 2005 2006 2007 Operating cash burn (excluding capital increase, partnerships and ADNA grant) -20.7 -20.6 -25 (M€) Capital increase through exercise of warrants in July 2006 (M€) +14.3 76% exercised (strike: € 8.05) 27 transgene
Slide 28: 2006 Cash expenditures
2006 Cash expenditures IAS/IFRS; in € million - 20.6 35 + 0.5 30 + 5.6 25 20 - 25.7 15 + 26.5 + 14.4 10 + 20.3 - 0.7 - 0.3 5 0 Cash , cash Revenues Interest Operating Capital Capital lease Capital Cash, cash equivalent & received income expenditures expenditures and debt increase equivalent & short-
Slide 29: Stock markets
Stock markets Share price and technology value as from 2005 Technology Value Share Price in M€ in € 250 16 Share Price x 2.0 14 Tech Value 200 x 3.8 12 10 150 8 100 6 4 50 2 0 0 j-05 f-05 m-05 a-05 m-05 j-05 j-05 a-05 s-05 o-05 n-05 d-05 j-06 f-06 m-06 a-06 m-06 j-06 j-06 a-06 s-06 o-06 n-06 d-06 j-
Slide 30: Transgene vs Indexes in 2006
2/ 1/ 70% 90% 110% 130% 150% 170% 190% 210% 06 17 /1 /0 6 1/ 2/ 06 transgene 16 /2 /0 6 3/ 3/ 06 18 /3 /0 6 2/ 4/ 06 17 /4 /0 6 2/ 5/ 06 17 /5 /0 Stock Markets 6 Transgene vs Indexes in 2006 1/ 6/ Transgene 06 16 /6 /0 6 1/ 7/ 06 16 /7 /0 6 31 /7 /0 6 Small CAC90 15 /8 /0 6 30 /8 /0 6 14 /9 /0 6 29
Slide 31: 2007 Clinical Objectives
2007 Clinical Objectives Phase III launch for TG 4001 end of 2007. Complete recruitment for TG 4010 in April 2007 in order to get first interim results before year end. Get first results for TG 1042 by year end. Get first interim results for TG 4040 by year end. 31 transgene
Slide 32: 2007 Strategic Objectives: transforming year for Transgene
2007 Strategic Objectives: transforming year for Transgene TG 4001 partnership Establish a leadership position in the field of immunotherapy of cancer and infectious diseases. Consequently 3 product candidates should be in Phase III in 2008 (TG 4001, TG 4010, TG 1042). Bring a new product in the cli
Slide 33: Contacts Transgene
11, rue de Molsheim 67082 Strasbourg Cedex France Contacts Transgene Tél. : + 33 (0) 3 88 27 91 21 Philippe Archinard, CEO Fax. : + 33 (0) 3 88 27 91 11 Philippe Poncet, CFO www.transgene.fr +33 3 88 27 91 00 33