Valneva Se · EURONEXT:VLA
Valneva — Investor Day (October 2024)
78 slides from Valneva's investor day presentation, Oct 10, 2024
Slide 1: Investor Day 2024
Investor Day 2024 October 10th, 2024
Slide 2: Today’s Agenda
Today’s Agenda Joshua Drumm, Ph.D. Welcome & Introduction VP Global Investor Relations Thomas Lingelbach Company Strategy & Value Drivers Chief Executive Officer Thomas Lingelbach Lyme Disease Vaccine Program Chief Executive Officer Dipal Patel Commercial Portfolio & IXCHIQ® Launch Chief Commercial
Slide 3: Today’s Agenda
Today’s Agenda Susanne Eder-Lingelbach Chikungunya Vaccine Program VP Clinical Development Juan Carlos Jaramillo, M.D. Shigella Vaccine Program & Opportunity Chief Medical Officer Susanne Eder-Lingelbach Second-Generation Zika Vaccine VP Clinical Development Thomas Lingelbach Pipeline Strategy / Pre
Slide 4: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an facts but are forward-looking statements, including with respect to business offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any partnerships, the progress, timing, resu
Slide 5: Company Strategy & Value Drivers
Company Strategy & Value Drivers Thomas Lingelbach Chief Executive Officer
Slide 6: A Leading Specialty Vaccine Company
A Leading Specialty Vaccine Company Focused on vaccines that make a difference We develop, manufacture, & commercialize prophylactic vaccines for infectious diseases addressing unmet medical needs ▪ Proven Expertise: Three in-house vaccine approvals; three proprietary commercialized travel vaccines
Slide 7: Valneva’s Augmented Commercial and R&D Portfolio
Valneva’s Augmented Commercial and R&D Portfolio Further extending a unique, differentiated portfolio Program Vaccine Design Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial IXIARO® Only U.S./ EU approved vaccine against Japanese encephalitis Commercial DUKORAL® Established Cholera (ETEC1) vaccine ap
Slide 8: Our Strategy to become a Globally Recognized Vaccine Company
Our Strategy to become a Globally Recognized Vaccine Company Contribute to a world where no one dies or suffers from a vaccine preventable disease Drive Maximize Commercial Capture integrated Growth R&D Upside biotech model ▪ Unlock IXCHIQ® value by building ▪ Leverage proven R&D engine ▪ Build cont
Slide 9: Track Record of Strong Execution
Track Record of Strong Execution Key Recent Accomplishments Regulatory Strategic • U.S., European and Canadian approvals for IXCHIQ® • Augmented clinical pipeline with Phase 2 Shigella vaccine • Submitted for label extension (12yrs +) and inclusion of data candidate on antibody persistence to enhanc
Slide 10: World’s leading Lyme Disease Vaccine Candidate
World’s leading Lyme Disease Vaccine Candidate Thomas Lingelbach Chief Executive Officer
Slide 11: Lyme Disease Represents A Major Medical Need And Market Opportunity
Lyme Disease Represents A Major Medical Need And Market Opportunity No vaccine is currently available to prevent Lyme disease in humans Population Living in Endemic Regions1,2 Commercial opportunity for Valneva U.S. Europe 87 million 202 million ▪ >$1 billion estimated global market6 Annual Burden o
Slide 12: Incidence of Lyme disease in Europe and the United States
Incidence of Lyme disease in Europe and the United States Average national incidence of Lyme borreliosis in the most Incidence of surveillance-reported Lyme disease, recent three-year period in Europe by state, United States, 2022 High incidence states (Incidence >10/100,000) Europe: adapted from Bu
Slide 13: Mechanism of OspA vaccines
Mechanism of OspA vaccines 1. Tick ingests antibodies from the host blood upon feeding 2. In the tick gut, OspA antibodies bind to B. burgdorferi’s OspA 3. OspA-bound antibodies inhibit the dissemination of bacteria in the tick, blocking transmission to the host Wormser GP et al. Diagn Microbiol Inf
Slide 14: Prior monovalent serotype vaccines validated the vaccine mechanism in humans
Prior monovalent serotype 1 vaccines (North America) validated the vaccine mechanism in humans Lymerix (GSK) Phase 3 efficacy study1 GSK Lymerix (ST1) (schedule: 0-1-12 months) OspA Placebo Lymerix Vaccine Efficacy (N = 5467) (N = 5469) (95% CI) Year 1 cases 43 22 49% (15-69) Year 2 cases 66
Slide 15: VLA15 designed to cover >97% of Borrelia in North America and Europe
VLA15 designed to cover >97% of Borrelia in North America and Europe Serotypes 1-6 included in VLA15 ST7 snd snd ST6 ST1 Included in VLA15 ST1 B. burgdorferi ss ST5 ST2 B. afzelii Europe North America ST4 B. bavariensis ST3 VLA15 covers VLA15 covers ST3, 5, 6 B. garinii 97.8% of 99.5% of ST4 genospe
Slide 16: VLA15 hexavalent vaccine based on the C-terminal fragment of OspA
VLA15 hexavalent vaccine based on the C-terminal fragment of OspA ST1- ST6 linked in pairs, forming 3 fusion proteins Lymerix/Imulyme full length ST1 VLA15 fusion protein VLA15* Location of ST2 protective epitopes ST1 Disulfide ST3 bond Disulfide bond ST4 ST6 ST5 1, Golde et al. 1997 Inf. Imm. 65:88
Slide 17: VLA15 Protects Against Infection in Tick Challenge Mouse Model
VLA15 Protects Against Infection in Tick Challenge Mouse Model Proof-of-concept Active Immunization Passive Transfer VLA15 was as efficacious as native full-length OspA High dilutions of VLA15 human sera were protective Immunization Infection (infected/total) Human serum GMT post Infection P value B
Slide 18: VLA15-202: Increased GMTs against all six serotypes with a 4th dose
VLA15-202: Increased GMTs against all six serotypes for adults immunized with a 4th dose of VLA15 Month 7 OspA-specific IgG antibodies GMT [U/mL] Month 19 10000 1000 100 10 1 ST1 ST2 ST3 ST4 ST5 ST6 VLA15-202:BSP Final Analysis Version 2 Table 14.7.3.1.4-9: ELISA: GMTs for OspA ST1-6-specific IgG by
Slide 19: VLA15-221: A 5th dose significantly increases ST1 IgG GMT titers
VLA15-221: A 5th dose of VLA15 significantly increases OspA-specific ST1 IgG GMT titers in all age groups OspA-specific IgG antibodies GMT [U/mL] 10000 5 to 11 years old 12 to 17 years old 1000 18 to 65 years old 100 10 D1 D85 D180 D208 D365 M18 M19 M23 M26 M30 M31 VLA15-221: Analysis 4 Table 14.4.3
Slide 20: VLA15-221: VLA15 candidate was well tolerated
VLA15-221:VLA15 candidate was well tolerated Most adverse reactions were mild or moderate with similar frequencies after any VLA15 vaccination Solicited Local (Injection Site) Adverse Reactions Solicited Systemic Adverse Reactions Grade 4 after 1st VLA15 vaccination after 1st VLA15 vaccination Grade
Slide 21: Phase 3 pediatric safety study design
Phase 3 pediatric safety study design Evaluate safety in pediatric population Age Group Dose Schedule 5-17 years VLA15 180 µg w/ Alum Month 0-2-6-18 (N=3550) Randomized 3:1 VLA15: Placebo Safety Safety Visit Phone Call Visit Phone Call Month Month Month Month Month Month Month Month 0 2 6 7 12 18 19
Slide 22: Phase 3 study vaccination schedule
Phase 3 study vaccination schedule designed to provide maximal immunogenicity through the LD season 22 Pfizer Confidential
Slide 23: C4601003: Phase 3 efficacy, safety and lot consistency trial of VLA15
C4601003: Phase 3, multicenter, placebo-controlled, randomized, observer-blinded trial to evaluate the efficacy, safety, tolerability, immunogenicity, and lot consistency of VLA15 in healthy participants ≥5 years of age Primary efficacy endpoint post dose 4 (season 2) Sites Age Schedule Dose 86 site
Slide 24: Lyme vaccine Phase 3 diagnostic algorithms
Lyme vaccine Phase 3 diagnostic algorithms Trial Case Definition: Clinical Suspicion of Lyme Disease (signs/symptoms) and At Least One Confirmatory Diagnostic Test Primary Endpoint – Symptomatic Suspected Cases Exploratory Endpoint – Otherwise Undiagnosed (all subjects) (Sera, plasma, punch biopsy,
Slide 25: Valneva and Pfizer’s Collaboration to Co-Develop and Commercialize VLA15
Valneva and Pfizer’s Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine VLA15 2021- 2023- 2020 2026 2027 2028+ 2022 2025 Established co- Positive Phase 2 results VALOR study U.S./European 1st potential Global development and execution (ongoing) regulatory filings, approvals and comme
Slide 26: Valneva Commercial Business
Valneva Commercial Business Dipal Patel Chief Commercial Officer
Slide 27: Valneva has a Growing Presence in Travel Medicine
Valneva has a Growing Presence in Travel Medicine Driven by portfolio of differentiated products1 Only Japanese encephalitis vaccine approved in U.S. and Europe Vaccine requirement for U.S. military deployed to parts of Asia First and only approved single-shot chikungunya vaccine Only Cholera and ET
Slide 28: Traveler from U.S. and EU: History and Forecast
Traveler from U.S. and EU: History and Forecast Recovering from pre-COVID-19; strong growth anticipated 2030 vs 2024: + 22% (Chik) + 29.5 % (JE) 2024 vs 2019: + 5.5% (Chik) - 5.2% (JE) Data source: IATA data – last update August 2024 Valneva Investor Day 2024 28
Slide 29: Strong Travel Revenue Recovery and Growth Post-Pandemic
Strong Travel Revenue Recovery and Growth Post-Pandemic Surpassed Pre-Pandemic Levels by 12% in 20231; continued growth in H1 20242 Targeting ~2X Growth by 2026/7 160 – 1802 IXCHIQ® ▪ Continued travel sales growth for IXIARO® 145 and DUKORAL® 130 € millions 104 115 ▪ Double-digit CAGR for IXIARO® fo
Slide 30: IXCHIQ Builds on Key Differentiators to Drive Growth
IXCHIQ® Builds on Key Differentiators to Drive Growth The 1st and only vaccine against chikungunya providing a strong and persistent immune response with only one dose ▪ 98.9% seroresponse rate at Day 29 - Sustained seroresponse rate at 97% after two years (EU label) ▪ Only chikungunya vaccine to
Slide 31: Promising Lead Metrics in IXCHIQ Launch
Promising Lead Metrics in IXCHIQ® Launch Focus on building HCP confidence and establishing IXCHIQ® as a differentiated brand Successful Efforts Driving Awareness Insurance coverage continues to grow What Gives Us Confidence in the Launch and Intent to Utilize IXCHIQ® ▪ Stronger uptake, driven by gre
Slide 32: Accessing the Global Market for Chikungunya Vaccines
Accessing the Global Market for Chikungunya Vaccines Current Focus U.S./ACIP Priority Certain Travelers1 Expand Population Travelers $500 million Global Opportunity - Additional launches (CA/EU) - Label expansion Improve Access - Improved surveillance Endemic / LMIC - Efficacy data to drive confiden
Slide 33: Upcoming and Future Opportunities to Capture Greater Penetration
Upcoming and Future Opportunities to Capture Greater Penetration Upcoming and Future Opportunities ▪ MMWR1 publication to drive further retail growth in U.S. ▪ European and Canadian launches ▪ Additional ACIP2 and European recommendations ▪ Travel software protocol updates ▪ Significant label update
Slide 34: Q&A Break
Q&A Break Investor Day 2024 October 10th, 2024
Slide 35: The World’s First and Only Chikungunya Vaccine
The World’s First and Only Chikungunya Vaccine Susanne Eder-Lingelbach VP, Clinical Development
Slide 36: Chikungunya: A Major Public Health Threat
Chikungunya: A Major Public Health Threat Mosquito-transmitted outbreak disease with potentially debilitating consequences Substantial quality-of-life and Often causes large, health-economic impact explosive outbreaks Nearly half (43%) of those Affecting up to 75% of the infected develop local popul
Slide 37: IXCHIQ / VLA1553 - Strong and Sustained Response Regardless Of Age
IXCHIQ® / VLA1553 - Strong and Sustained Response Regardless Of Age Immunological profile Seroresponse sustained at highest levels up to 24 Months 100 * 90 80 70 60 50 40 30 20 10 0 D 15 D 29 M6 M 12 M 24 Phase 1 Study, Low Dose; N=23 Phase 3 Pivotal Study; N=266 Phase 3 Adolescent Study, Phase 3 Do
Slide 38: Two-year Antibody Persistence Further Supports Target Product Profile
Two-year Antibody Persistence Further Supports Target Product Profile Seroresponse in adults aged ≥ 18 years (VLA1553-303) 10,000 3 537 3 568 Seroresponse 1 031 892 1 056 1 055 757 949 CHIKV-Specific 1,000 Neutralizing Antibody Titers ≥ 150 GMT 100 (95%CI) n= n= n= n= n= n= n= n= 307 53 309 53 10 29
Slide 39: IXCHIQ: Focused on Expanding Access, Label Extension, Product Profile
IXCHIQ®: Focused on Expanding Access, Label Extension, Product Profile Robust clinical program supported by new $43.1 million CEPI grant1 Post-Marketing Effectiveness2 (Phase 4) To confirm effectiveness following licensure based on an immunological surrogate of protection and to optimize description
Slide 40: IXCHIQ is approved under the accelerated licensure pathway
IXCHIQ® is approved under the accelerated licensure pathway1 Phase 4 aims to verify the clinical benefit in two2 key post-marketing effectiveness studies VLA1553-402 VLA1553-404 Pragmatic randomized controlled effectiveness and safety Observational effectiveness study in population in study in adult
Slide 41: IXCHIQ targeted to be made available for all age-groups
IXCHIQ® targeted to be made available for all age-groups1 Staggered pediatric development program until 2030/1 (incl. below 1yr of age) VLA1553-321 VLA1553-221 Randomized, controlled, double-blinded pivotal study in Randomized, controlled, double-blinded study in children adolescents aged 12 years t
Slide 42: Strong and Sustained Seroresponse Rates in Adolescents
Strong and Sustained Seroresponse Rates in Adolescents VLA1553 response is similar to baseline seropositive individuals _FDA non-acceptance threshold___________________________________________________________________________________________ Seroresponse is defined as μPRNT50 ≥150 for all participant
Slide 43: Only CHIKV vaccine to achieve target immunogenicity with a single shot
Only CHIKV vaccine to achieve target immunogenicity with a single shot Differentiated vaccine shows rapid, long-lasting immunity across all age groups tested1,2,5 Immunogenicity Data Safety Data ▪ 99% Seroresponse3 Rate (SRR) after ▪ Generally well tolerated by >3,600 adults single vaccination → mai
Slide 44: World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate Juan Carlos Jaramillo, M.D. Chief Medical Officer
Slide 45: Shigellosis: Significant Unmet Medical Need
Shigellosis: Significant Unmet Medical Need1 No approved vaccine is currently available ▪ Caused by species of Shigella bacteria ▪ Second-leading cause of fatal diarrheal disease worldwide ▪ Estimated to cause up to 165 million cases and 600,000 deaths each year, particularly among children in LMICs
Slide 46: Shigellosis: A Worldwide Public Health Threat
Shigellosis: A Worldwide Public Health Threat Global Incidence • Strongly linked to economic development. • Predominantly in the global South, especially eastern sub-Saharan Africa. • Less common in the global North due to better infrastructure. Lower-Income Countries • High spread risk due to poor
Slide 47: Strategic partnership with LimmaTech Biologics
Valneva Gains Exclusive Worldwide Rights to Tetravalent Shigella Vaccine Strategic partnership with LimmaTech Biologics (“LMTB”) Vaccine candidate “S4V” Key Aspects of Partnership ▪ World’s most clinically advanced tetravalent ▪ €10 million upfront payment to LMTB Shigellosis vaccine candidate ▪ Up
Slide 48: Shigella Vaccine Candidate Bioconjugation technology
Shigella Vaccine Candidate Bioconjugation technology DNA encoding glycan, protein and conjugating enzyme Culturing and purification Purified, homogeneous conjugate vaccine Bioconjugate produced in component engineered E. Coli strain ▪ O-antigen polysaccharides of the serotypes S. flexneri 2a, ▪ O-an
Slide 49: Optimized Multivalent Vaccine Candidate
Optimized Multivalent Vaccine Candidate Proof-of-concept studies with 4-valent bioconjugates ongoing; expected H2 2025 Past Imminent Monovalent Optimized Human S. flexneri 2a Multivalent Challenge Repeating unit of Phase 2b study* the glycan structure (4-valent) Study ▪ 37% vaccine efficacy Challeng
Slide 50: Historical and Planned Clinical Studies
Historical and Planned Clinical Studies Multiple catalysts and decision points for envisaged development strategy Monovalent vaccine (S. flex 2a) Multivalent vaccine (S. flex 2a, 3a, 6, sonnei) Phase 2 First Approval Phase 1 CHIM, S.sonnei ~2030/1 Phase 2b Phase 2 CHIM, S.Flex 2a CHIM, S.Flex ADULTS
Slide 51: Anticipated Regulatory Strategy
Anticipated Regulatory Strategy Human challenge studies in adults combined with pediatric field efficacy studies Adults (Initial Indication) Children (Extension) ▪ Leverage existing CHIM models for S. sonnei and ▪ Field efficacy studies will expand indication by S. flexneri 2a providing data on ▪ Ex
Slide 52: Shigella vaccine market estimated to peak at ~€500 million
Commercial Assessment of Shigella vaccine Shigella vaccine market estimated to peak at ~€500 million1 Children in endemic Traveler (~23%) Military (<1%) countries (~76%) 20-50% 30-100% 70-90% Recommendation (Med-high risk destinations) (OOP-reimb.) (Med-high risk destinations) 30% 15-60% (OOP) Accep
Slide 53: Second-Generation Zika Virus Vaccine Candidate
Second-Generation Zika Virus Vaccine Candidate Susanne Eder-Lingelbach VP, Clinical Development
Slide 54: Current Zika Outbreaks and Travel Warnings
Current Zika Outbreaks and Travel Warnings / WHO / CDC / PAHO Notable outbreaks in several countries, particularly in the Americas Quantifying the Impact of Climate Change on Human Health Insight Report January 2024 ▪ Cases in The Americas: 40,528 in 2024 (as of Sept. 29th) vs 36,748 in 2023 Warmer
Slide 55: Zika Virus Infections: Short-Term and Long-Term Complications
Zika Virus Infections: Short-Term and Long-Term Complications Severity and nature of complications vary depending on age, health status, and pregnancy Transmission and Impact: Short-Term Guillain-Barré Syndrome Meningoencephalitis and Long-Term Complications in Complications: (GBS): Myelitis: Childr
Slide 56: ZIKA Virus: Evidence of Waning Immunity
ZIKA Virus: Evidence of Waning Immunity Robust immunity following infection may diminish over time; reports of repeat infections Non-Human Primate & Human Studies Cross-Immunity • Antibody levels decline over months to years, possibly • Prior dengue exposure may alter the immune response lowering pr
Slide 57: Re-Activation of Our Zika Program
Re-Activation of Our Zika Program Based on emerging epidemiology and learnings on the severity and nature of health impairments from ZIKV infection 1st-Gen. Vaccine Candidate VLA1601 Key Conclusions from Phase 1 ▪ Vero cell culture derived N=67 (18-49 yrs); two doses; two schedules : ▪ Excellent saf
Slide 58: Creating a Second-Generation Zika Vaccine
Creating a Second-Generation Zika Vaccine Key consideration and vaccine improvements Considerations Improvements ▪ Prior Phase 1 indicated the need for improving ▪ Keep inactivated whole virus technology immunogenicity and antibody persistence ▪ Apply learnings from COVID vaccine ▪ Safe and effectiv
Slide 59: Current Phase 1 Study
Current Phase 1 Study VLA1601-102 Double-blind, randomized safety and immunogenicity trial Key consideration for data evaluation in the U.S. and progression ▪ To investigate safety and immunogenicity across different ▪ Safety and tolerability profile doses and formulations ▪ ~150 healthy flavivirus-
Slide 60: Zika Vaccine Pivotal Development
Zika Vaccine Pivotal Development1 Considerations ▪ Vaccination should prevent infection and protect against severe complications ▪ May require post-licensure surveillance studies to generate clinical evidence and long-term safety data ▪ Potential for non-dilutive grant funding Randomized Phase 3 Fie
Slide 61: Pipeline Strategy & Pre-Clinical Priorities
Pipeline Strategy & Pre-Clinical Priorities Thomas Lingelbach Chief Executive Officer
Slide 62: Valneva’s Guiding Principles in R&D
Valneva’s Guiding Principles in R&D Balancing our expertise with unmet need and risk Risk Profile Criteria for pipeline entry High risk-High gain Innovative vaccine approaches to address huge market opportunity Unmet Commercial Need Core specialty Value Build upon Valneva’s existing expertise and ca
Slide 63: Our Current R&D Strategy at a Glance
Our Current R&D Strategy at a Glance Provide R&D upside to investors by investing in new vaccines that address unmet needs 1 • Continue working closely with Pfizer to ensure timely execution, licensure and ACIP Lyme & Chik recommendation • Execute on Chik territory, label extensions and PMC’s 2 • In
Slide 64: Prevention of Epstein-Barr Virus Infection is an Unmet Medical Need
Prevention of Epstein-Barr Virus Infection is an Unmet Medical Need Market potential: $600 million - $1.3 billion annual peak sales Epstein-Barr Virus (EBV) o Gammaherpesvirus, human herpesvirus 4 o Transmitted through saliva and other bodily fluids o >95% of population infected by age 25 o Stays wi
Slide 65: Potential Points of Intervention for Vaccine Development
Potential Points of Intervention for Vaccine Development Potential blocking of infection of epithelial cells and B cells Prevent infection and carcinomas by blocking infection of epithelial cells ▪ Viral glycoprotein gH/gL binds integrins to enable infection of epithelial cells1 ▪ gH/gL-specific ant
Slide 66: Prior Vaccine Candidate Reduced Incidence Of Mononucleosis But Not Infection
Prior Vaccine Candidate Reduced Incidence Of Mononucleosis But Not Infection Informs design of second-generation vaccine candidates ▪ GSK developed a gp350 subunit protein vaccine adjuvanted with AS04 to Phase 2 ▪ Vaccine recipients had a statistically significant 78% lower incidence of infectious m
Slide 67: Enterotoxigenic E. coli (ETEC): Significant Unmet Medical Need and Opportunity
Enterotoxigenic E. coli (ETEC): Significant Unmet Medical Need and Opportunity Market potential: $600 million - $1.3 billion annual peak sales Causes ~30% of travelers' diarrhea Gram-negative enteric bacteria ▪ Estimated 10 million cases/year (2011) ▪ Young children in LMIC at greatest risk for seve
Slide 68: Valneva's ETEC Program Prioritized in Pre-Clinical R&D
Valneva's ETEC Program Prioritized in Pre-Clinical R&D Targeting a Differentiated Approach Based on Validated Properties ETEC – Vaccine Candidate Rationale to Support Differentiation ▪ ETEC adheres to intestinal epithelial cells using ▪ ETEC infection induces immunity against re-infection with colon
Slide 69: Financial Highlights
Financial Highlights Peter Bühler Chief Financial Officer
Slide 70: Successful ~€60 million Capital Raise Strengthens Financial Position
Successful ~€60 million Capital Raise Strengthens Financial Position ▪ Led by new U.S. healthcare specialist investor Top Holders (% share capital1) ▪ Strong support from new and existing shareholders Groupe CDC 8.68% ▪ Provides greater flexibility to invest in our future growth: Pfizer Inc. 5.89% ▪
Slide 71: H1 2024 Financials: Product Sales of €68.3 million
H1 2024 Financials: Product Sales of €68.3 million Commercial business on track for continued, significant growth €m (audited) H1 H1 % 2024 2023 Change IXIARO®/JESPECT® 41.9 30.3 +38% DUKORAL® 14.9 17.1 -13% IXCHIQ® 1.0 -- -- Third party products 10.5 16.5 -37% Total product sales 68.3 64.0 +7% COVI
Slide 72: H1 2024 Financials: Income Statement
H1 2024 Financials: Income Statement €m (unaudited) H1 2024 H1 2023 Product sales 68.3 69.7 Other Revenues 2.5 4.1 Revenues 70.8 73.7 Cost of goods and services (45.6) (53.8) Research and development expenses (29.7) (26.0) Marketing and distribution expenses (23.2) (20.0) General and administrative
Slide 73: Debt Financing Agreement with Deerfield and OrbiMed
Debt Financing Agreement with Deerfield and OrbiMed Leading U.S. healthcare investors Total Amount $200M (December 31st, 2023) €180M $100M $100M Tranches €90M €90M Year of Borrowing 2020 2023 Interest Rate 9.95% Repayments Begin Q1 2026 Q1 2027 Maturity Date Q1 2027 Q4 2028 ▪ Terms per recent amendm
Slide 74: Valneva Remains Solidly Funded with Strong Near- and Mid-term Financial Outlook
Valneva Remains Solidly Funded with Strong Near- and Mid-term Financial Outlook Confirmed 2024 Guidance Mid-Term Outlook ▪ Product Sales: €160 - €180 million* ▪ Commercial business expected to be cash-flow positive (including IXCHIQ®) from 2025 ▪ Total Revenues: €170 - €190 million ▪ Continued trave
Slide 75: Valneva’s Near- and Mid-Term Value Drivers
Valneva’s Near- and Mid-Term Value Drivers VLA15 Success • Potential for major value inflection with key study conclusions next year • Sustained profitability upon potential approval, driven by substantial commercial milestones and royalties Growing commercial revenues • Near term: continued growth
Slide 76: Q&A Break
Q&A Break Investor Day 2024 October 10th, 2024
Slide 77: Key Upcoming Catalysts and News Flow
Key Upcoming Catalysts and News Flow Chikungunya vaccine ▪ Upcoming potential approvals: Anvisa (Brazil), MHRA (UK) ▪ 36-month antibody persistence data expected in Q4 2024 ▪ Initiate Phase 4 clinical program Lyme disease vaccine candidate VLA15 ▪ Key study conclusions by year end 2025 ▪ Potential F
Slide 78: Thank you
Thank you Merci Danke Tack valneva