Valneva Se · EURONEXT:VLA
Valneva — H1 2014 Earnings Presentation
24 slides from Valneva's earnings presentation, Aug 8, 2014
Slide 1: Analysts Presentation: Q2 / H1 2014
Valneva SE Analysts Presentation: Q2 / H1 2014 August 8, 2014
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer Forward Looking Statements These materials contain certain forward-looking statements relating to the business of Valneva SE (the “Company”), including with respect to the progress, timing and completion of the Company’s research, development and clinical trials for product candidates, th
Slide 3: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 4: Valneva's Newsflow – H1 2014
Valneva‘s Newsflow – H1 2014 May 2014 + Valneva announces the first marketing approval in Europe for an EB66®-based veterinary vaccine April 2014 + Valneva and Adimmune Corporation partner to commercialize Japanese encephalitis vaccine in Taiwan March 2014 + New research agreement and transfer of an
Slide 5: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 6: Key figures Q2 2014
Key figures Q2 2014 IFRS unaudited, EUR million Q2 2013 Q2 2013 pro forma* Revenues & grants Cost of goods and services R&D expenses Q2 2014 Q2 2013 Q2 2014 Q2 2013 11.3 -1.6 -3.6 -4.2 9.4 -4.8 -5.7 7.8 -8.1 Q2 2014 Q2 2013 EBITDA*** Net loss Cash** Q2 2014 Q2 2013 Q2 2014 Q2 2013 -3.3 -5.6 37.3 -0.
Slide 7: Q2 2014 Profit & Loss
Q2 2014 Profit & Loss IFRS, EUR in thousands Actual Actual Proforma* Q2 2014 H1 2014 HY1 2013 HY1 2013 Product sales 5,942 9,764 5,332 9,305 Revenues from collaborations, licensing & grants 3,434 6,707 4,339 8,060 Revenues and Grants 9,376 16,471 9,671 17,365 Cost of goods and services (1,566) (3,92
Slide 8: HY1 2014 Financial Analysis
HY1 2014 Financial Analysis Compared to HY1 2014 pro forma figures * + Revenues › IXIARO® sales growth offset by change in revenue recognition for US military sales › Slight overall decrease in revenues and grants of 5.2% in HY1 due to lower collaboration and licensing revenues + Cost of goods and s
Slide 9: Full year 2014 & outlook
Full year 2014 & outlook Significant EBITDA improvement and reduction of net loss expected in 2014, EUR million Revenues & grants EBITDA Cash position 40.2 37.3 HY1 2014 actual HY1 2013 pro forma* 16.5 17.4 -3.6 -12.7 HY1 2014 actual 23.1* HY1 2013 pro forma* H1 2014 actual 23.1*actual Q4 2013 + Sig
Slide 10: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 11: IXIARO / JESPECT: A marketed, unique product licensed in 35+ countries
IXIARO®/ JESPECT® A marketed, unique product licensed in 35+ countries7 Global Marketing and Japanese Encephalitis (JE): Most Common Viral Encephalitis in Asia1 Distribution Agreements + JE is caused by a Flavivirus (like Dengue, Yellow Fever, Tick-borne US, EU, Asia6 Encephalitis)2 + JE is the lead
Slide 12: IXIARO / JESPECT: Towards continued growth of in-market sales
IXIARO®/ JESPECT® Towards continued growth of in-market sales and increased profitability Product sales revenues in EUR m H1 2014 sales analysis Business potential + Product sales show slight + Valneva expects product H1 increase in H1 2014 vs H1 sales revenues of above EUR FY 17 m in H2 2014. 2013
Slide 13: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 14: EB66: A highly efficient platform for vaccine production
EB66®: A highly efficient platform for vaccine production Over 35 agreements with the world‘s biggest pharmaceutical companies EB66® cell line A growing, revenue-generating franchise + Alternative to embryonated chicken eggs for + EUR 30m in upfront, milestones and research large scale manufacturing
Slide 15: VIVA|Screen: A monoclonal antibody microarray-based discovery platform
VIVA|Screen® A monoclonal antibody microarray-based discovery platform VIVA|Screen® + Allows for the rapid high throughput discovery of rare fully human therapeutic antibodies directly from human donors + License agreement with Sanofi-Pasteur since 2010 in a number of selected infectious disease tar
Slide 16: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 17: Valneva's pipeline of commercialized and R&D assets
Valneva’s pipeline of commercialized and R&D assets From discovery through to market – in-house and with partners IND 1 Approved/ Product(s) / Candidates Discovery enabling PH I PH II PH III Marketed Partner IXIARO®/JESPECT® JE vaccine Novartis, CSL, Biological E Proprietary vaccines Pseudomonas aer
Slide 18: Pseudomonas aeruginosa
Pseudomonas aeruginosa Targeting an unmet medical need in hospital acquired infections VLA43 vaccine candidate (Phase II/III) + Represents ~20% of all nosocomial infections1,2 + Pseudomonas aeruginosa colonization of ventilated patients is associated with increased mortality rate3 + Target populatio
Slide 19: Clostridium difficile
Clostridium difficile Main cause of nosocomial diarrhea VLA84 vaccine candidate (Phase I) + 470,000 cases of Clostridium difficile (C. diff) estimated globally in 2013*,1 › 75 % of total cases reported in the US > linked to 14,000 deaths/yr (US)2 › Based on current incidence growth rates, number of
Slide 20: Borrelia
Borrelia Lyme borreliosis, a second emerging threat which comes with ticks VLA15 vaccine candidate (pre-clinical development) + Lyme borreliosis is the most common vector borne illness in the Northern Hemisphere + Europe: ~85,0001 cases annually (WHO) + US: ~300,0002 cases annually (CDC) + Only tran
Slide 21: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 22: 2014/15 Expected Key Milestones
2014/15 Expected Key Milestones Significant potential value inflection points 2014 2015 + Phase II/III study continuation Pseudomonas aeruginosa + First Japanese stockpiling for EB66® based Pandemic influenza vaccine + Market approval and launch of first + Clinical entry (Phase I/II) for EB66® b
Slide 23: Table of contents
Table of contents 1. Introduction – key events Q2 / H1 2014 – Thomas Lingelbach 2. Financial report Q2 / H1 2014 & outlook – Reinhard Kandera 3. Product (Ixiaro®) – Franck Grimaud 4. Technology & Licensing business (EB66®, VIVA|Screen®) – Franck Grimaud 5. Product candidates, R&D pipeline – Thomas L
Slide 24: Thank you
Thank you Danke Merci WAvalneva