Valneva SE · EURONEXT:VLA
Valneva — Q3 2013 Earnings Presentation
29 slides from Valneva's earnings presentation, Nov 5, 2013
Slide 1: Q3 Analysts Presentation
Q3 Analysts Presentation November 5, 2013
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: Analysts Presentation Q3 2013 Agenda
Valneva: Analysts Presentation Q3 2013 1. Introductory note – Thomas Lingelbach 2. Financial Report Q3 – Reinhard Kandera 3. IXIARO®/JESPECT® Update – Franck Grimaud 4. R&D Programs Update – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A VALNEVA – Analysts Presentation Q3 2013 NOV 05, 2013
Slide 4: Valneva's Newsflow – Q3 2013/beginning Q4
Valneva‘s Newsflow – Q3 2013/beginning Q4 July 2013 + Successful completion of a EUR 40.2m capital increase, oversubscribed by 146% + New EB66® cell Line Research license agreement with Boehringer Ingelheim + Biological E’s Japanese Encephalitis vaccine prequalified by WHO August 2013 + Passing of C
Slide 5: Agenda: Financial Report Q3
Valneva: Analysts Presentation Q3 2013 1. Introductory Note – Thomas Lingelbach 2. Financial Report Q3 – Reinhard Kandera 3. IXIARO®/JESPECT® Update – Franck Grimaud 4. R&D Programs Update – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A VALNEVA – Analysts Presentation Q3 2013 NOV 05, 2013
Slide 6: Key financial figures Q3 / 9 months 2013
Key financial figures Q3 / 9 months 2013 in EUR '000 Three months ended Sept. 30 Nine months ended Sept. 30 2013 2012 2013 2012 Revenues and Grants 14,680 1,750 24,351 4,496 R&D expenses (7,816) (2,558) (14,841) (8,783) Net loss (9,968) (2,428) (18,082) (9,931) Net operating cash flow (14,928) (1,17
Slide 7: Q3 2013 Key Figures
Q3 2013 Key Figures IFRS (unaudited) EUR million revenues & grants net loss cash Q3 2013 Q3 2012 14.7 -2.4 18.2 15.6 -10.0 1.8 Q3 2013 Q3 2012 Q3 2013 Q3 2012 Pro forma adjusted* (non GAAP) EUR million revenues & grants net loss cash Q3 2013 Q3 2012 74.9 14.7 18.2 -10.0 -10.0 6.4 Q3 2013 Q3 2012 Q3
Slide 8: Q3 / 9 months 2013 Analysis & Outlook
Q3 / 9 months 2013 Analysis & Outlook + Revenues › IXIARO/JESPECT® quarterly net sales revenues of EUR 11.4m in Q3; nine months pro forma sales increased by 13.7% to EUR 20.7m › Increase in total revenues, both on reported and pro forma basis for Q3 and 9 months + Cost of goods sold › EUR 6.6m in Q3
Slide 9: Q3 / 9 months 2013 Analysis & Outlook – continued
Q3 / 9 months 2013 Analysis & Outlook – continued + Amortization of intangible assets › Non-cash amortization charges of EUR 2.0m in Q3 resulting from acquired intangible assets (mainly JEV) + Cash & securities › EUR 18.2m liquid funds at quarter end › To be further strengthened by - Ongoing debt-re
Slide 10: Agenda: IXIARO/JESPECT Update
Valneva: Analysts Presentation Q3 2013 1. Introductory Note – Thomas Lingelbach 2. Financial Report Q3 – Reinhard Kandera 3. IXIARO®/JESPECT® Update – Franck Grimaud 4. R&D Programs Update – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A VALNEVA – Analysts Presentation Q3 2013 NOV 05, 2013
Slide 11: IXIARO/JESPECT: a marketed, unique product licensed in 35+ countries
IXIARO®/ JESPECT®: a marketed, unique product licensed in 35+ countries Global Marketing and Japanese Encephalitis: Most Common Viral Encephalitis in Asia1 Distribution Agreements + JEV is a Flavivirus (like Dengue, Yellow Fever, Tick-borne Encephalitis) US, EU, Asia5 + JE is the leading cause of vi
Slide 12: IXIARO/JESPECT: Best quarterly sales for Valneva since launch
IXIARO®/ JESPECT®: Best quarterly sales for Valneva since launch Product sales revenues in EUR m Q3 sales analysis 26.8 + Sales revenues +13,7% (9months 2013 vs 2010 Q3 Sales 9months 2012) 2011 revenues 11.4m + In-market sales growth trend double-digit largely 2012 20.7 21.6 confirming 2013 18.2 + S
Slide 13: IXIARO/JESPECT: market exclusivity for Pediatric Indication in the US
IXIARO®/ JESPECT®: Valneva obtains market exclusivity for Pediatric Indication in the US* September 2012 May 2013 October 2013 + FDA grants a 7 years + US Food and Drug + FDA approves the orphan drug market Administration (FDA) pediatric indication exclusivity to IXIARO® grants Orphan drug of IXIARO
Slide 14: Agenda: R&D Programs Update
Valneva: Analysts Presentation Q3 2013 1. Introductory Note – Thomas Lingelbach 2. Financial Report Q3 – Reinhard Kandera 3. IXIARO®/JESPECT® Update – Franck Grimaud 4. R&D Programs Update – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A VALNEVA – Analysts Presentation Q3 2013 NOV 05, 2013
Slide 15: Valneva's R&D programs from discovery through to market
Valneva’s R&D programs from discovery through to market – in-house and with partners IND 1 Approved/ Product Candidate Discovery enabling PH I PH II PH III Marketed Partner EB66® partnered veterinarian Kaketsuken program * EB66® pandemic flu GSK / Kaketsuken * Pseudomonas aeruginosa Novartis IC43 Va
Slide 16: Pseudomonas aeruginosa: targeting a high unmet medical need
Pseudomonas aeruginosa: targeting a high unmet medical need IC43 vaccine candidate (Phase II/III) + Causes ~20% of nosocomial infections + No. 1 cause of ICU-related pneumonia + No. 2 cause of all nosocomial pneumonia + Pseudomonas aeruginosa colonization of ventilated patients is associated with in
Slide 17: Pseudomonas aeruginosa: key findings in Phase II
Pseudomonas aeruginosa: key findings in Phase II: reduction of mortality in all Pseudomonas vaccine groups vs. placebo Survival Rates IC43-201 % alive Day 14 Day 28 100% 90% 80% 70% selected for ongoing Phase II/III study 60% 50% 100 mcg w/o Alum (n = 100) 40% Emerging Statistically significant redu
Slide 18: Pseudomonas aeruginosa: key development results to date
Pseudomonas aeruginosa: key development results to date Current PhII/III interim analysis indicates further confirmation of previous findings Previous Key Findings Current Interim Findings** Pre-clinical: Phase II/III interim (394 patients): + Protective in a murine lethal P. aeruginosa challenge +
Slide 19: Phase II/III pivotal efficacy trial – next steps
Pseudomonas aeruginosa: Phase II/III pivotal efficacy trial – next steps + Development partners evaluating different trial progression scenarios + DMC will be consulted for potential modification of trial protocol + Trial continuation decision (further enrolment possible as of Q1 2014*) Study Design
Slide 20: Clostridium difficile: leading cause of nosocomial diarrhea
Clostridium difficile: leading cause of nosocomial Diarrhea IC84 vaccine candidate (Phase I) + Estimated 0.5 - 3m cases annually in the U.S. + Commensal bacterium of the healthy adult human intestine in 2- 5% of the population + Up to 60% of healthy neonates and infants are colonized without clinica
Slide 21: Clostridium difficile: positive Phase I results obtained
Clostridium difficile: positive Phase I results obtained Phase Ia and Ib completed with 81 healthy elderly subjects and 60 healthy adults + All trial endpoints met + Favorable safety and tolerability profile + Immunogenicity in elderly similar to responses to C.Diff toxins A and B observed in adults
Slide 22: VIVA|Screen: Partnership with Sanofi-Pasteur progressing well
VIVA|Screen®: Partnership with Sanofi-Pasteur progressing well VIVA|Screen® Q3 Update + A monoclonal antibody microarray-based platform + Successful completion of antibody discovery work + Allows for the rapid high throughput discovery of + Delivery of antibody candidates to partner Sanofi- rare ful
Slide 23: IC31 Adjuvant for Vaccines
IC31® Adjuvant for Vaccines Novartis’ Phase I ongoing, additional collaborations initiated IC31® Adjuvant Q3 Update + A unique synthetic adjuvant which stimulates + Novartis: Phase I clinical trial (combines an strong T-cell immune responses and shows undisclosed vaccine candidate with the IC31 ® pr
Slide 24: EB66 cell line for vaccine production: new agreements in Q3
EB66® cell line for vaccine production: 2 new EB66® agreements in Q3, 7 signed in 2013 to date Q3 Update: + Delta-Vir GmbH (Newcastle Disease Virus) › Expect to file Clinical Trial Application (EU) in H2/2014 + Boehringer Ingelheim › Research agreement for Animal Health Vaccines + Additional commerc
Slide 25: Tuberculosis and Borrelia vaccine candidates: towards next development stages
Tuberculosis and Borrelia vaccine candidates: towards next development stages Tuberculosis (Phase II – partner development) IC15 Borrelia vaccine candidate (pre-clinical) + 3 clinical vaccine candidates currently in phase II + Pre-clinical testing near completion and phase I studies + Process indust
Slide 26: Agenda: Outlook
Valneva: Analysts Presentation Q3 2013 1. Introductory Note – Thomas Lingelbach 2. Financial Report Q3 – Reinhard Kandera 3. IXIARO®/JESPECT® Update – Franck Grimaud 4. R&D Programs Update – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A VALNEVA – Analysts Presentation Q3 2013 NOV 05, 2013
Slide 27: Valneva's expected 2013/14 key milestones
Valneva’s expected 2013/14 key milestones significant potential value inflection points 2013 Completed 2014 + IXIARO® pediatric label extension granted + Market approval and launch of EB66® by EMA and in the US cell-based pandemic influenza vaccine in Japan + First NDA submission filed for a hum
Slide 28: Agenda: Q&A
Valneva: Analysts Presentation Q3 2013 1. Introductory Note – Thomas Lingelbach 2. Financial Report Q3 – Reinhard Kandera 3. IXIARO®/JESPECT® Update – Franck Grimaud 4. R&D Programs Update – Thomas Lingelbach 5. Outlook – Thomas Lingelbach 6. Q&A VALNEVA – Analysts Presentation Q3 2013 NOV 05, 2013
Slide 29: Merci Danke Thank you
Merci Danke Thank you WAvalneva