Slide 1: Valneva presents its FY 2018 financial results
Valneva presents its FY 2018 financial results Analyst Presentation February 21, 2019
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The Valneva shares may not be offered or sol
Slide 3: Agenda
Agenda Introduction Financial Report FY 2018 R&D Portfolio Update Outlook Q&A Valneva FY 2018 Analyst Presentation February 21, 2019 3
Slide 4: Key Business and R&D Milestones Completed in 2018
Key Business and R&D Milestones Completed in 2018 + Product Sales +16% CER vs. 2017, according to guidance ✔ Strong financial results + + 2018 Gross Margin 60.7% vs. 56.3% in 2017 EBITDA €13.1m vs. €10.8m in 2017 + Net profit €3.3m; first ever profitable annual result for Valneva ✔ Major R&D milesto
Slide 5: Agenda
Agenda Introduction Financial Report FY 2018 R&D Portfolio Update Outlook Q&A Valneva FY 2018 Analyst Presentation February 21, 2019 5
Slide 6: Valneva's profitable commercial business funding key R&D programs
Valneva’s profitable commercial business funding key R&D programs Repeated double digit product sales growth Innovative R&D pipeline in areas of 16% CER in 2018 vs. 2017 high unmet medical need 2018 Full-year results Product sales €103.5m DUKORAL® €30.4m Direct sales 81.2% IXIARO®/ Total JESPECT® Ly
Slide 7: Revenue analysis
Revenue analysis €m (CER1) FY 2017 FY 2018 (unaudited) 2019 Guidance Actual CER Actual CER growth Product sales revenues IXIARO®/JESPECT® 60.0 58.3 69.6 19% DUKORAL® 28.5 27.1 30.4 12% Third party products 3.9 3.9 3.5 Product revenues 92.6 89.3 103.5 16% 115 - 125 Other revenues 12.7 12.4 9.6 Total
Slide 8: Product sales growth expected to continue in 2019
Product sales growth expected to continue in 2019 US and Canada driving top line growth, supported by other markets IXIARO®/JESPECT®: North America is the biggest DUKORAL®: Canada is the biggest contributor contributor Split of 2018 product sales Split of 2018 product sales Others Other 12 % Germany
Slide 9: FY 2018 Profit & Loss Report (all figures at AER)
FY 2018 Profit & Loss Report (all figures at AER) Strong financial performance €m 12 months ended December 2018 (unaudited) 2017 Product Sales 103.5 92.6 Revenues from collaboration, licensing and services 9.6 12.7 Revenues1 113.0 105.3 Cost of goods and services (44.4) (46.0) Research and developme
Slide 10: Cash and debt position
Cash and debt position €m December 2018 December 2017 (unaudited) CASH & CASH EQUIVALENTS 1 81.7 38.1 Finance Lease Liabilities (25.8) (26.7) -/- Cash Deposit (Finance Lease related) 2 11.3 11.3 Non current borrowings (14.3) (27.4) TOTAL NON-CURRENT LIABILITIES (>1 year) (28.8) (42.8) Finance Lease
Slide 11: Agenda
Agenda Introduction Financial Report FY 2018 R&D Portfolio Update Outlook Q&A Valneva FY 2018 Analyst Presentation February 21, 2019 11
Slide 12: Valneva's R&D pipeline
Valneva’s R&D pipeline Focusing on innovative vaccine candidates with high unmet medical need Product Candidate Discovery Pre- IND Phase 1 Phase 2 Phase 3 Market Partner research clinical enabling research Japanese Marketed vaccines encephalitis Cholera (ETEC1) Proprietary, Lyme disease GSK opt-in2
Slide 13: Key R&D progress reported in 2018 and early 2019
Key R&D progress reported in 2018 and early 2019 January 2019 + Positive initial booster data & final Phase 1 data for Lyme disease vaccine candidate (VLA15) + Positive Phase 1 interim results for Chikungunya vaccine candidate (VLA1553) December + Initiation of Phase 2 for Lyme disease vaccine candi
Slide 14: VLA15: the only Lyme disease vaccine in clinical development
VLA15: the only Lyme disease vaccine in clinical development Lyme disease Valneva’s vaccine candidate + Transmitted by Ixodes scapularis ticks (Northeastern & + Only active clinical program, no Midwestern US) and Ixodes ricinus ticks (Europe)1 vaccine on the market + Most common vector borne illness
Slide 15: VLA15 (Lyme): Phase 2 study (VLA15-201)
VLA15 (Lyme): Phase 2 study (VLA15-201) Observer-blind, randomized, placebo-controlled, multicenter study Phase 2 study conducted in US and EU Main Study Phase: 3 groups (2 adjuvanted dose levels and placebo) ▪ Primary objective: Immunogenicity data at Month 3 Run-in Phase: 120 healthy volunteer
Slide 16: Lyme (VLA15) – Development
Lyme (VLA15) – Development Key milestones Current Development Assumptions Phase 2 initiation (VLA15-201) end 2018 ✔ Phase 1 final data (D365) and initial Booster data Q1 / 2019 ✔ Run-in Phase (Phase 2) completed mid 2019 Second Phase 2 initiation (VLA15-202) mid 2019 Phase 2 data (primary) mid 2020
Slide 17: VLA15: Outlook
VLA15: Outlook Striving towards first BLA submission in 20231 Phase 3 – Current Hypothesis2 Pivotal, double-blind, placebo controlled field efficacy study in endemic countries Key objective: › Efficacy against Lyme disease (all serotypes) with vaccine at final dose and schedule › Adults (18-70 yrs)
Slide 18: VLA1553: A differentiated Chikungunya vaccine candidate
VLA1553: A differentiated Chikungunya vaccine candidate Potential single-shot vaccine against a severe, growing threat Chikungunya Valneva’s vaccine candidate + Mosquito-borne viral disease caused by the Chikungunya + Monovalent, single dose, live virus (CHIKV), a Togaviridae virus attenuated prophy
Slide 19: VLA1553: Chikungunya vaccine candidate, Phase 1 study design
VLA1553: Chikungunya vaccine candidate, Phase 1 study design Blinded, randomized, dose-escalation study 3.2x103 / 3.2x104 / 3.2x105 / -21 Vaccination Schedule + Single-dose vaccination (Day 0) + Re-vaccination with highest dose (Month 6 and 12) (1) to show that single-shot is sufficient to induce hi
Slide 20: Chikungunya Phase 1 study (VLA1553-101) Interim Results
Chikungunya Phase 1 study (VLA1553-101) Interim Results Excellent immunogenicity with acceptable safety profile1 Immunogenicity Safety 100% Seroconversion Rate (SCR)2 at day 28 No Serious Adverse Events (SAEs) up to day after single dose1 281 96.5% of subjects achieving ≥ 16 fold rise in No
Slide 21: Agenda
Agenda Introduction Financial Report FY 2018 R&D Portfolio Update Outlook Q&A Valneva FY 2018 Analyst Presentation February 21, 2019 21
Slide 22: Financial Outlook
Financial Outlook Continued double-digit sales growth and positive EBITDA, higher R&D investment driven by clinical development progression 2018 2019 (unaudited) Product sales €103.5m €115m - €125m revenues Total revenues €113.0m €125m - €135m R&D investments €25.3m €35m - €40m Gross margin 60.7% >
Slide 23: An exciting year ahead – Further double-digit product sales growth
An exciting year ahead – Further double-digit product sales growth and significant R&D progress expected in 2019 15-20% CER product sales growth expected in 2019 Major confirmatory and supportive data points for the Lyme vaccine candidate (VLA15) Development acceleration of chikungunya vaccine candi
Slide 24: Agenda
Agenda Introduction Financial Report FY 2018 R&D Portfolio Update Outlook Q&A Valneva FY 2018 Analyst Presentation February 21, 2019 24
Slide 25: Thank you
Thank you Merci Danke Tack WAvalneva