Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (November 2022)
30 slides from Valneva's investor presentation, November 2022
Slide 1: Advancing Vaccines for Better Lives
Advancing Vaccines for Better Lives Company Presentation
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: Valneva in Summary
Valneva in Summary Fully integrated specialty vaccine company focused on development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need ◼ Highly specialized and targeted approach to development of unique prophylactic vaccines ◼ Advanced pipelin
Slide 4: Research & Development
Research & Development
Slide 5: Advanced Clinical Pipeline and Three Approved Products
Valneva has an Advanced Clinical Pipeline and Three Approved Products1 Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Next Inflection Point Partners VLA15532: Potentially Complete BLA - Chikungunya eligible for PRV submission by YE 2022 VLA153: Phase 3 enrolment Lyme d
Slide 6: Lyme Disease Vaccine – VLA15
Lyme Disease Vaccine – VLA15
Slide 7: Lyme Disease is a Major Health Issue
Lyme Disease is a Major Health Issue Severe Tick-transmitted Infection, Increasingly Common in the US and Europe Early signs include flu-like symptoms1 and Erythema migrans rash2 which, if left untreated, can spread to joints (arthritis), heart (carditis) and cause neurological problems Spread of Ly
Slide 8: VLA15: Multivalent Lyme Disease Vaccine Candidate
VLA15: Multivalent Lyme Disease Vaccine Candidate Only Lyme Disease Program in Advanced Clinical Development Today Phase 3 study initated1 following positive results for three Phase 2 clinical trials2,3,4, 1 including first pediatric data5 Exclusive, worldwide partnership with Pfizer; terms updated
Slide 9: VLA15: Phase 3 Efficacy Study Design
VLA15: Phase 3 Efficacy Study Design Randomized, Placebo-Controlled Phase 3 VALOR Study Currently Ongoing ▪ Population: 6,000 participants ≥5 years of age at high risk of Lyme disease (LD) (by residence and occupational/recreational activities) conducted in US and Europe (randomization approx. 2:1 U
Slide 10: VLA15: Three Positive Phase 2 Trials
VLA15: Three Positive Phase 2 Trials Continuing to demonstrate strong immunogenicity with acceptable tolerability profile across 1,030 adult and pediatric participants VLA15-221: First positive pediatric data (April 20221) ▪ Strong immunogenicity profile in adult 2 (ages 18-65) and pediatric partici
Slide 11: Chikungunya Vaccine – VLA1553
Chikungunya Vaccine – VLA1553
Slide 12: VLA1553: Single Shot Chikungunya Vaccine Candidate
VLA1553: Single Shot Chikungunya Vaccine Candidate Most Clinically Advanced Chikungunya Vaccine Program Worldwide Pre-Licensure Phase 3 clinical program successfully completed1,2; BLA rolling submission 1 initiated in August 20223; Targeting completion of BLA submission by end of 2022 FDA Breakthrou
Slide 13: Chikungunya: A Major Public Health Threat
Chikungunya: A Major Public Health Threat Mosquito-Transmitted Disease with Potentially Debilitating Consequences Symptoms include fever and debilitating joint and muscle pain; infection can progress to severe chronic symptoms in many patients and substantial health-economic impact1 Large, explosive
Slide 14: VLA1553: Clinical Data Highlights
VLA1553: Clinical Data Highlights1,2 Live-Attenuated CHIKV Vaccine Candidate Targeting Long-Lasting Immunity with a Single Shot Immunogenicity Data Safety Data1 ▪ Seroresponse3 Rate (SRR) in 98.9% of ▪ VLA1553 was generally well tolerated among participants after a single vaccination the 3,082 subje
Slide 15: Seroresponse Rate in Older Participants (VLA1553-301)
Seroresponse Rate in Older Participants (VLA1553-301) Additional Data in Adults >=65 Years Confirm High SRR Seen in Primary Analysis 18-64 years ≥ 65 years Subjects with VLA1553 Placebo VLA1553 Placebo Seroresponse N=269 N=94 N=107 N=33 Day 29a 251 88 104 33 n (%) 248 (98.8) 1 (1.1) 103 (99.0) 0 Day
Slide 16: Chikungunya Global Market Segments
Chikungunya Global Market Segments Global Market for Chikungunya Vaccines Estimated to Exceed $500 Million per Year by 20321 Segments Targeted Directly by Valneva Travelers from Non-Endemic Regions Endemic Region Use Travel vaccine for individuals travelling to areas with risk of Vaccine in endemic
Slide 17: Chikungunya Travelers Vaccine Market Segment
Chikungunya Travelers Vaccine Market Segment Launch to Leverage Existing Commercial Infrastructure & Travel Vaccine Experience Risk areas for chikungunya include popular tourist destinations in Latin America / Asia North to Central American air travel has recovered Post-COVID, there is increased lik
Slide 18: Chikungunya Vaccine Program Progressing toward FDA Filing
Chikungunya Vaccine Program Progressing toward FDA Filing Valneva Presented VLA1553 at the US CDC’s October ACIP1 Meeting Rolling submission initiated in August 20221 ▪ Pre-Licensure Phase 3 Clinical program completed, and all endpoints met 2,3 ▪ Breakthrough therapy designation: eligible for priori
Slide 19: VLA1553: Development Plan & Outlook
VLA1553: Development Plan & Outlook Further Regulatory Submissions to Commence in the First Half of 2023 Ongoing clinical trials supporting future regulatory submissions ▪ Antibody persistence trial, approx. 375 volunteers, follow-up for at least 5 years ▪ 12-months data expected late 2022 ▪ Adolesc
Slide 20: Commercial Products
Commercial Products
Slide 21: Product Sales: Strong Growth Anticipated
Product Sales: Strong Growth Anticipated, Driven by Recovery of Travel Segment and Performance of 3rd Party Products Travel Expected to Recover to Pre-COVID-19 Level by 20241 Global product sales €m DRIVERS + Pent-up travel demand + Re-establishment of Travel Medicine 130 clinics/ramping up of resou
Slide 22: Commercial Portfolio: Strong Sales Performance of €74.4 Million
Commercial Portfolio: Strong Sales Performance of €74.4 Million in the First Nine Months of 2022 Nine-Month 2022 product sales outside of COVID-19 vaccine sales COVID-19 grew by 11.2% vs. prior period Significant recovery in travel markets ▪ Product sales of the Japanese encephalitis vaccine ▪ The C
Slide 23: Commercial Strategy
Commercial Strategy Three Key Levers to Accelerate Commercial Performance Travel health recovery Expand vaccine portfolio VLA1553 launch preparedness Customer engagement Evaluation of new in-licensing Evolution of commercial through Valneva Travel Health and product acquisitions infrastructure ▪ Bui
Slide 24: SARS-CoV-2 (COVID-19) Vaccine – VLA2001
SARS-CoV-2 (COVID-19) Vaccine – VLA2001
Slide 25: Valneva's COVID-19 Vaccine
Valneva’s COVID-19 Vaccine VLA2001: Only Inactivated Whole-Virus COVID-19 Vaccine Approved in Europe Builds on Valneva’s IXIARO® manufacturing technology, combined with Dynavax’s CpG 1 1018 adjuvant1 2 First COVID-19 vaccine to receive standard marketing authorization in Europe 2; UK MHRA Conditiona
Slide 26: Valneva to Resize Operations to Reflect COVID-19 Program Evolution
Valneva to Resize Operations to Reflect the Evolution of the COVID-19 Program ▪ In light of the reduced order volume from EU Member States1, Valneva suspended internal and terminated external manufacturing of the vaccine ▪ Valneva retained inventory for potential additional supply to EU Members and
Slide 27: Corporate Highlights and Newsflow
Corporate Highlights and Newsflow
Slide 28: Delivering on Valneva's Value Proposition
Delivering on Valneva’s Value Proposition Optimizing the Organization and Sharpening its Focus on Investments that Will Create Value for the Company Continue Progress new Maximize value progressing candidates from from commercial Resize Valneva’s advanced pre-clinical to products operations programs
Slide 29: Key Upcoming Catalysts and News Flow
Key Upcoming Catalysts and News Flow Lyme disease vaccine candidate VLA15 ▪ Phase 3 trial enrollment completion expected in Q2 2023 Chikungunya vaccine candidate VLA1553 ▪ Completion of BLA submission expected at the end of 2022 ▪ 12-month antibody persistence data expected in late 2022 ▪ Adolescent
Slide 30: Thank you
Thank you Merci Danke Tack ‘WaAvalneva