Slide 1: Valneva Presents its 9M 2019 Financial Results
Valneva Presents its 9M 2019 Financial Results Analyst Presentation October 31, 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 Key R&D Updates Financial Report 9M 2019 Outlook Q&A Valneva 9M 2019 Analyst Presentation October 31, 2019 3
Slide 4: Valneva raises FY 2019 product sales guidance following strong nine-month results and R&D execution
Valneva raises FY 2019 product sales guidance following strong nine-month results and R&D execution ✔ ▪ Completion of patient recruitment for Phase 2 studies of Significant R&D Lyme disease vaccine candidate VLA15 milestones ▪ Up to $23.4 million awarded by CEPI for the late-stage announced developm
Slide 5: Agenda
Agenda Introduction Key R&D Updates Financial Report 9M 2019 Outlook Q&A Valneva 9M 2019 Analyst Presentation October 31, 2019 5
Slide 6: Lyme disease is a serious and growing unmet medical need
Lyme disease is a serious and growing unmet medical need VLA15 is the only vaccine candidate in clinical development today 1 Multivalent vaccine (six serotypes) to protect against Lyme disease in N. America and Europe Targets OspA of Lyme borrelia, preventing spirochetes from migrating through the t
Slide 7: Lyme disease vaccine candidate VLA15: development on track
Lyme disease vaccine candidate VLA15: development on track Phase 2 well underway Patient recruitment for both Phase 2 studies completed September 2019 Process for a late stage development & commercialization partner initiated Phase 2 on track to provide first data by mid 2020 ▪ Initial Data: Day 85
Slide 8: Chikungunya is a major public health threat
Chikungunya is a major public health threat VLA1553 is a unique, differentiated single-shot vaccine candidate 1 Currently no preventive vaccines or effective antiviral treatments exist for chikungunya VLA1553 is a monovalent, single dose, live attenuated1 prophylactic vaccine targeting 2 chikungunya
Slide 9: Chikungunya vaccine candidate VLA1553: progression on track
Chikungunya vaccine candidate VLA1553: progression on track Status update Up to $23.4m/ €20.3m awarded by CEPI for late-stage development of VLA1553 ▪ Accelerate regulatory approval for use in regions where outbreaks occur ▪ Support WHO prequalification to facilitate broader access in lower/middle i
Slide 10: Agenda
Agenda Introduction Key R&D Updates Financial Report 9M 2019 Outlook Q&A Valneva 9M 2019 Analyst Presentation October 31, 2019 10
Slide 11: Strong operational performance for 9M 2019
Strong operational performance for 9M 2019 DUKORAL® Product sales growth €19.8m 22% AER / 18% CER Net product sales TPP1 Direct sales €2.4m 86% €86.4m Gross margin2 IXIARO®/ 65.2% JESPECT® €64.2m CER: at constant exchange rates; 1 Third party products sold by Valneva‘s commercial organization, 2 Gro
Slide 12: IXIARO generated > 70% of nine-month sales and continues to be our primary top line growth driver
IXIARO® generated > 70% of nine-month sales and continues to be our primary top line growth driver €m (CER1) 9M 2019 9M 2018 CER 9M 2018 (unaudited) CER % Actual Actual IXIARO®/JESPECT® 64.2 51.7 24% 50.0 DUKORAL® 19.8 18.8 5% 18.6 Third party products 2.4 2.5 -1% 2.4 Total 86.4 72.9 18% 71.1 1 CER
Slide 13: GSK SAA termination has impacted total revenues by €10.7m
GSK SAA termination has impacted total revenues by €10.7m Net revenue effect according to IFRS €m Total revenues (excl. effect of GSK SAA termination) 92.1 Settlement Fee (One time, fixed) (9.0) Settlement Fee (Milestone related, conditional; discounted)1 (6.0) Release of SAA related contract liabil
Slide 14: Financial results highlights (IFRS, € million)
Strong year on year financial performance Financial results highlights (IFRS, € million) incl. GSK SAA termination effects Total revenues Net product sales 92.1 10.7 GSK SAA termination effects 81.4 86.4 78.3 71.1 9M 2019 9M 2018 9M 2019 9M 2018 EBITDA Net profit/(loss) Cash 67.4 13.7 8.3 10.7 6.1 3
Slide 15: Excellent underlying business performance
Excellent underlying business performance Profit & Loss Report 9M comparison incl. GSK SAA termination effects (at AER) * excluding SAA termination accounting / revenue recognition effect €m 9M 2019 9M 2019 9M 2018 unaudited excl. SAA effect Product sales 86.4 71.1 Revenues from collaboration, licen
Slide 16: Gross margin continues to improve
Gross margin continues to improve Gross margin on product sales revenues 9M (at AER) Gross Margins 9M 2019 9M 2018 TOTAL PRODUCT SALES REVENUES (€m) 86.4 71.1 Total Product Sales Gross Margin (IXIARO®, DUKORAL® and Third Party Products) 65.2% 59.7% Valneva 9M 2019 Analyst Presentation October 31, 20
Slide 17: Net operating margin underpins strong business productivity
Net operating margin underpins strong business productivity Net operating margin 9M (at AER) €m 9M 2019 9M 2018 Product sales 86.4 71.1 Cost of goods and services (30.1) (28.6) Commercial costs1 (28.4) (28.6) Net operating margin 28.0 14.0 as % Revenues 32.4% 19.7% 1 S&M, G&A, R&D, Other income/cost
Slide 18: Agenda
Agenda Introduction Key R&D Updates Financial Report 9M 2019 Outlook Q&A Valneva 9M 2019 Analyst Presentation October 31, 2019 18
Slide 19: 2019 product sales guidance raised following strong 9M results
2019 product sales guidance raised following strong 9M results All other guidance confirmed despite GSK SAA termination impact 2018 2019 Product sales €103.5m €125m - €130m revenues Total revenues €113.0m €125m - €130m R&D investments €25.3m €35m - €40m Gross margin 60.7% > 60% Net operating 24.1% 2
Slide 20: Upcoming newsflow
Upcoming newsflow Valneva to attend forthcoming chikungunya VRBPAC1 meeting Lyme partnering process Lyme disease vaccine candidate VLA15: Phase 2 execution on track for initial data mid-2020 Chikungunya vaccine candidate VLA1553: progressing towards potential accelerated development strategy; aiming
Slide 21: Agenda
Agenda Introduction Key R&D Updates Financial Report 9M 2019 Outlook Q&A Valneva 9M 2019 Analyst Presentation October 31, 2019 21
Slide 22: Thank you
Thank you Merci Danke Tack WAvalneva