Valneva Se · EURONEXT:VLA
Valneva — FY2022 Earnings Presentation
24 slides from Valneva's earnings presentation, Mar 23, 2023
Slide 1: Full Year 2022 Results & Corporate Update Analyst Presentation
A LEADING SPECIALTY VACCINE COMPANY FULL YEAR 2022 RESULTS & CORPORATE UPDATE ANALYST PRESENTATION MARCH 23, 2023
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. Valneva is a European company. Information d
Slide 3: Agenda
Agenda Introduction Business Update Financial Report FY 2022 Financial Outlook Newsflow Q&A Valneva – FY 2022 Analyst Presentation March 23, 2023 3
Slide 4: Valneva Reports Full Year 2022 Results and Provides Corporate Updates
Valneva Reports Full Year 2022 Results and Provides Corporate Updates Continued progress across R&D Pipeline ▪ Chikungunya: BLA under review ▪ Lyme disease: Phase 3 VALOR study with Pfizer ongoing ▪ COVID-19: First full MAA by EMA; No further investments ▪ Acceleration of pre-clinical activities: Bu
Slide 5: Agenda
Agenda Introduction Business Update Financial Report FY 2022 Financial Outlook Newsflow Q&A Valneva – FY 2022 Analyst Presentation March 23, 2023 5
Slide 6: Most advanced Chikungunya program in development worldwide
Most advanced Chikungunya program in development worldwide VLA1553 - Live-attenuated CHIKV vaccine candidate targeting long- lasting, high sero-response with a single shot CHIKV Vaccine Candidate VLA1553 Development Status – Under FDA Review • Live-attenuated, single dose • Pivotal Phase 3 Trials me
Slide 7: VLA1553: Clinical Highlights
VLA1553: Clinical Highlights1,2 Key data Immunogenicity Data Safety Data1 ▪ Seroresponse3 Rate (SRR) in 99% of ▪ VLA1553 was generally well tolerated participants after a single vaccination among the 3,082 subjects evaluated for safety ▪ Immunogenicity profile maintained over time: 99% SRR after 12
Slide 8: VLA1553 Fits Perfectly Within our Existing Commercial Infrastructure
VLA1553 Fits Perfectly Within our Existing Commercial Infrastructure High-caliber team with significant experience in the vaccine space Highly experienced teams with deep Commercial Footprint expertise in vaccine commercialization Commercial infrastructure established in most key travel markets; foo
Slide 9: Only Lyme Disease Vaccine in Advanced Clinical Development Today
Only Lyme Disease Vaccine in Advanced Clinical Development Today VLA15: multivalent recombinant protein vaccine candidate Phase 3 study initiated by Pfizer1 supported by positive results for three Phase 1 2 clinical trials2,3,4, including first pediatric data5; Trial design and timelines under revie
Slide 10: Strong Immunogenicity Shown in More Than 1000 People
Strong Immunogenicity Shown in More Than 1000 People Key data across adult and pediatric trial participants VLA15-221: First positive pediatric data (April 20221) ▪ Strong immunogenicity profile in adult 2 (ages 18-65) and pediatric participants (ages 5-17) ▪ More immunogenic in pediatric participan
Slide 11: Advanced, Focused and Differentiated Clinical Pipeline
Advanced, Focused and Differentiated Clinical Pipeline and promising early stage targets R&D pipeline overview Next Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Partners Inflection Point Potential CEPI/ VLA15532: Potentially Butantan BLA approval Chikungunya eligible
Slide 12: Agenda
Agenda Introduction Business Update Financial Report FY 2022 Financial Outlook Newsflow Q&A Valneva – FY 2022 Analyst Presentation March 23, 2023 12
Slide 13: Full Year 2022 Financials: Total Revenues of €361.3 million
Full Year 2022 Financials: Total Revenues of €361.3 million Growth driven by significant increase in product sales DUKORAL®, €361.3m €348.1m VLA2001 €17,3m (COVID-19), €29,6m Net product sales €114.8m Third party IXIARO®/JESPECT® products, U.S. Military, €12,5m €26,5m €114.8m €63.0m IXIARO®/JESPECT®
Slide 14: Full Year 2022 Financials: Product Sales of €114.8m
Full Year 2022 Financials: Product Sales of €114.8m Strong growth driven by recovery of travel segment and performance of 3rd-party products €m (unaudited) FY 2021 % FY 2022 FY 2021 at CER* % at CER IXIARO®/JESPECT® 41.3 45.1 50.8 -8.4% -18.6% DUKORAL® 17.3 2.4 2.4 +610% +629% Third party products 2
Slide 15: Full year 2022 Income Statement
Full year 2022 Income Statement Adjusted EBITDA of - €69.2m €m (2022 audited) FY 2022 FY 2021 Product sales 114.8 63.0 Other Revenues 246.5 285.1 Revenues 361.3 348.1 Cost of goods and services (324.4) (187.9) Research and development expenses (104.9) (173.3) Marketing and distribution expenses (23.
Slide 16: Full Year 2022 Financials: Impact of COVID-19 Program on P&L
Full Year 2022 Financials: Impact of COVID-19 Program on P&L COVID-19 reported as separate segment as of 2021 €m (2022 audited) FY 2022 FY2022 FY 2022 Group COVID only excl. COVID Product sales 114.8 29.6 85.2 Other Revenues 246.5 280.0 (34.3) Revenues 361.3 309.6 51.7 Cost of goods and services (32
Slide 17: Full Year 2022 Financials: Balance Sheet 2021/2022
Full Year 2022 Financials: Balance Sheet 2021/2022 Net assets impacted by COVID write-downs December 31st, December 31st, €m (2022 audited) 2022 2021 NON-CURRENT ASSETS 196.7 231.5 - Property, Plant & Equipment 112.4 125.5 - Other Non-current Assets 84.2 106.0 CURRENT ASSETS 424.7 585.8 - Inventory
Slide 18: Full Year 2022 Financials: Balance Sheet 2021/2022 (cont.)
Full Year 2022 Financials: Balance Sheet 2021/2022 (cont.) Liabilities and equity impacted by COVID/Lyme contracts and public offering December 31st, December 31st, €m (2022 audited) 2022 2021 EQUITY 219.8 170.6 NON-CURRENT LIABILITIES 124.2 277.8 - Refund Liabilities 6.6 159.0 - Borrowings and Othe
Slide 19: Agenda
Agenda Introduction Business Update Financial Report FY 2022 Financial Outlook Newsflow Q&A Valneva – FY 2022 Analyst Presentation March 23, 2023 19
Slide 20: Valneva 2023 Financial Guidance
Valneva 2023 Financial Guidance Substantial growth expected from anticipated COVID business Total revenues and other income expected between €220 to €260 million, including: • €130 to €150 million of product sales, including marginal COVID-19 vaccine sales under the Bahrain supply agreement • €90 to
Slide 21: Agenda
Agenda Introduction Business Update Financial Report FY 2022 Financial Outlook Newsflow Q&A Valneva – FY 2022 Analyst Presentation March 23, 2023 21
Slide 22: Key Upcoming Catalysts and News Flow in 2023
Key Upcoming Catalysts and News Flow in 2023 Chikungunya vaccine candidate VLA1553 ▪ First adolescent study results mid-2023 ▪ Potential BLA approval and first launch, Potential PRV sale ▪ Additional ex-U.S. regulatory submissions in H2 Lyme disease vaccine candidate VLA15 ▪ Clarity on Phase 3 clini
Slide 23: Valneva is Poised for Substantial Growth
Valneva is Poised for Substantial Growth Led by potential new product launches 3-4 years Additional potential growth drivers: 1-2 years ▪ Continued recovery of travel market VLA15 to pre-COVID levels and beyond Today ▪ New U.S. DoD contract for IXIARO® VLA1553 VLA1553 expected 2023 IXIARO® IXIARO® I
Slide 24: Thank you
Thank you Merci Danke Tack