Valneva Se · EURONEXT:VLA
Valneva — Q1 2023 Earnings Presentation
20 slides from Valneva's earnings presentation, May 4, 2023
Slide 1: First Quarter 2023 Results & Corporate Update
A LEADING SPECIALTY VACCINE COMPANY FIRST QUARTER 2023 RESULTS & CORPORATE UPDATE ANALYST PRESENTATION MAY 04, 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 Q1 2023 Financial Outlook Newsflow Q&A Valneva Q1 2023 Analyst Presentation May 4, 2023 3
Slide 4: Valneva Reports Q1 2023 Results and Provides Corporate Updates
Valneva Reports Q1 2023 Results and Provides Corporate Updates Good momentum driven by strong sales performance; clarity on catalysts Product sales nearly doubled year-over-year €32.1 million this period vs. €16.2 million in Q1 2022 − Driven by IXIARO® and DUKORAL® sales, both of which more than qua
Slide 5: Agenda
Agenda Introduction Business Update Financial Report Q1 2023 Financial Outlook Newsflow Q&A Valneva Q1 2023 Analyst Presentation May 4, 2023 5
Slide 6: Potential to Deliver the World's First Chikungunya Vaccine in Q3
Potential to Deliver the World’s First Chikungunya Vaccine in Q3 VLA1553* - Live-attenuated vaccine candidate under FDA priority review Pioneering Vaccine Development in an Area of High Unmet Need – Preparing for Success • First and only chikungunya vaccine candidate to report positive Phase 3 data
Slide 7: 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; Pivotal trial design and timeline conf
Slide 8: Phase 3 Efficacy Study Design
Phase 3 Efficacy Study Design ▪ Population: ~9000 total participants ≥5 years of age at high risk of Lyme disease (LD) (by residence and occupational/recreational activities) in U.S., Canada and Europe (randomization approx. 1:1 VLA15/Placebo and 2:1 U.S./EU) ▪ Primary endpoint: Rate of confirmed1 L
Slide 9: Clinical Portfolio
Advanced, Focused and Differentiated Clinical Pipeline and promising early stage targets R&D pipeline overview Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Next Inflection Point Partners Potential CEPI/ VLA15532: Potentially Butantan eligible for PRV BLA approval Chi
Slide 10: Agenda
Agenda Introduction Business Update Financial Report Q1 2023 Financial Outlook Newsflow Q&A Valneva Q1 2023 Analyst Presentation May 4, 2023 10
Slide 11: First Quarter 2023 Financials: Total Revenues of €33.5 million
First Quarter 2023 Financials: Total Revenues of €33.5 million Driven by Continued Recovery of Travel Vaccine Market Third party products3, €4,5m DUKORAL®, €10,2m €33.5m €32.1m Net product sales €32.1m €21.8m €16.2m IXIARO®/JESPECT® U.S. Military, €0,2m IXIARO®/JESPECT®, €17.1m Q1 2023 Q1 2022 Q1 20
Slide 12: First Quarter 2023: YoY Product Sales Doubled to €32.1 million
First Quarter 2023: YoY Product Sales Doubled to €32.1 million Private Travel Markets Continue to Show Significant Recovery €m (unaudited) Q1 2023 Q1 2022 Q1 2022 Q1 2023 Q1 2023 at CER1 vs. vs. Q1 2022 Q1 2022 at CER IXIARO®/JESPECT® 17.4 4.2 4.2 +315.2% +314.5% DUKORAL® 10.2 2.5 2.4 +302.6% +317.3
Slide 13: First Quarter 2023 Financials: Adjusted EBITDA of -€12.3 million
First Quarter 2023 Financials: Adjusted EBITDA of - €12.3 million Higher Sales Revenues Balanced by Increased Expenses Related to VLA1553 Launch Preparation1 €m (unaudited) Q1 2023 Q1 2022 Product sales 32.1 16.2 Other Revenues 1.4 5.7 Revenues 33.5 21.8 Cost of goods and services (20.5) (13.9) Rese
Slide 14: Agenda
Agenda Introduction Business Update Financial Report Q1 2023 Financial Outlook Newsflow Q&A Valneva Q1 2023 Analyst Presentation May 4, 2023 14
Slide 15: Valneva 2023 Financial Guidance
Valneva 2023 Financial Guidance Expect Product Sales to Reach or Exceed Pre-Pandemic Levels this year 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 agreemen
Slide 16: Agenda
Agenda Introduction Business Update Financial Report Q1 2023 Financial Outlook Newsflow Q&A Valneva Q1 2023 Analyst Presentation May 4, 2023 16
Slide 17: 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 in H2 2023 ▪ Initiate additional ex-U.S. regulatory submissions in 2023 Lyme disease vaccine candidate VLA15 ▪ Ad
Slide 18: 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 VLA15 ▪ Continued recovery of travel volumes toward pre-COVID levels and beyond Today VLA1553 VLA1553 ▪ New U.S. DoD contract for IXIARO® expected in the coming mon
Slide 19: Q&A
Q&A
Slide 20: Thank you
Thank you Merci Danke Tack ‘WAvalneva