Valneva Reports Full Year 2022 Results and Provides Corporate Updates

Valneva Reports Full Year 2022 Results and Provides Corporate Updates

Total revenues of 361.3

million in 2022 compared to 348.1

Driven by product sales of 114.8 million (82.3% increase compared to 2021), including

million of travel vaccine sales and 29.6 million of COVID-19 vaccine sales

246.5 million of Other Revenues, primarily driven by revenue recognition related to previous COVID-19

vaccine supply agreements

Strong cash position of 289.4

million at December 31, 2022

Raised over 190 million in equity:

102.9 million of gross proceeds from an upsized global offering1 in a challenging economic

90.5 ($95) million equity investment by Pfizer

Included drawing a total of $40 million from the Deerfield & OrbiMed loan agreement2

2023 financial guidance

Expected total revenues and other income between 220 million and 260 million:

130 million to 150 million of product sales, including marginal COVID-19 vaccine sales under

an existing supply agreement with the Kingdom of Bahrain

Between 90 million and 110 million of other income

R&D expenses expected between 70 million and 90 million

Financial Information

(Audited3 2022 results, consolidated per IFRS)

Saint-Herblain (France), March

23, 2023 - Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine

company, today reported its consolidated financial results for the year ending December 31, 20224 and provided corporate updates.

Valneva will provide a live webcast of its full-year 2022 results conference call beginning

a.m. EDT today. This webcast will also be available on the Company's website. Please refer to this link: https://edge.media-server.com/mmc/p/n2f4om2y

Peter B hler, Valneva's Chief Financial Officer, commented,

"In 2022, Valneva successfully executed on key strategic objectives despite a difficult economic environment. After achieving clinical

and regulatory success, we decided to wind-down our COVID-19 activities and focus on our lead programs. We were agile in reactivating

production of our commercial vaccines to capitalize on the travel industry recovery. We also managed to strengthen our cash level and

shareholder base, attracting leading investors and maintaining the support of existing shareholders. With close to

in cash, we entered 2023 in a strong position to support expected commercial growth and R&D programs."

Clinical Stage Vaccine Candidates

CHIKUNGUNYA VACCINE CANDIDATE - VLA1553

FDA Priority Review of vaccine license

VLA1553 is a live-attenuated, single-dose vaccine candidate against the chikungunya virus (CHIKV), a mosquito-borne

virus that has spread to more than 100 countries with the potential to rapidly expand further. The Pan American Health Organization (PAHO)

issued an epidemiological alert last month as the number of cases and deaths due to chikungunya continues to rise in the Americas5.

With no preventive vaccine or specific treatment yet available, chikungunya is considered a major public health threat.

Valneva announced last month that the U.S. Food and Drug Administration (FDA) accepted the filing of a Biologics License

Application (BLA)6 for approval of VLA1553 in persons aged 18 years and above and granted priority review for the application7.

Under this priority review, VLA1553 has currently been assigned a Prescription Drug User Fee Act (PDUFA) review goal date at the end of

August 2023, which is the date by which the FDA intends to take action on the application subject to progress of the BLA review. VLA1553

is currently the only chikungunya vaccine candidate worldwide for which a regulatory review process is underway8 and, if approved,

it could become the first chikungunya vaccine available to address this unmet medical need.

Valneva's BLA application follows final pivotal Phase 3 data in March 20229, final lot-to-lot consistency

results in May 202210 and positive twelve-month persistence data in December 202211. A clinical study of VLA1553

in adolescents is ongoing in Brazil12, for which Valneva reported enrollment and vaccination completion in February 202313.

This trial, conducted by Valneva's partner Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations

(CEPI), may support future regulatory submissions in this age group, if VLA1553 is initially approved in adults, as well as licensure

of the vaccine in Europe and Brazil, which would be the first potential approval for use in an endemic population. Topline results are

The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was

also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020. Valneva currently plans to make additional

regulatory submissions for VLA1553 in the second half of 2023. The sponsor of the first chikungunya vaccine approved in the U.S. is eligible

to receive a Priority Review Voucher (PRV)14.

LYME DISEASE VACCINE CANDIDATE - VLA15

Phase 3 study initiated

Valneva and Pfizer are developing VLA15, a Lyme disease vaccine candidate that targets the outer surface protein A

(OspA) of Borrelia burgdorferi, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that

targets six serotypes of Borrelia representing the most common strains found in North America and Europe. VLA15 is the only Lyme disease

vaccine program in advanced clinical development today and has received Fast Track designation from the FDA.

Valneva and Pfizer reported results for three Phase 2 clinical trials of VLA15 in both adult and pediatric populations,

in which high levels of antibodies against all six strains were observed15,16,17.

In August 2022, the companies initiated a Phase 3 clinical study, "Vaccine Against Lyme for Outdoor Recreationists (VALOR)", to investigate

the efficacy, safety and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States

In February 2023, Pfizer, as the study sponsor, decided to discontinue half of the total enrolled participants in the

trial following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator19.

The clinical trial remains ongoing at sites not operated by the third party. The companies intend to work with regulatory authorities

and, as previously announced, aim for Pfizer to potentially maintain the original submission timelines, pending successful completion

of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

According to the terms of Valneva's collaboration with Pfizer, Pfizer leads late phase development of VLA15 and,

if approved, Pfizer will have sole control over its commercialization with Valneva eligible to receive up to $408 million in milestones,

plus royalty payments. In June 2022, the terms of this collaboration were updated, and Pfizer invested 90.5 ($95) million in Valneva

as part of an equity subscription agreement20. As per the terms of the collaboration agreement, Valneva received a $25 million

milestone payment from Pfizer in 2022 following initiation of the Phase 3 study.

Pre-Clinical Vaccine Candidates

Valneva continues to progress select pre-clinical assets and focus on strengthening its future clinical pipeline. The

Company is currently focused on VLA2112, a vaccine candidate targeting the Epstein-Barr virus (EBV), which is one of the most common human

viruses. EBV can cause infectious mononucleosis21 and is strongly associated with the development of several types of cancer22

and multiple sclerosis23. Valneva has also been working on a vaccine candidate targeting the human metapneumovirus (hMPV),

which is a major worldwide respiratory pathogen that causes acute upper and lower respiratory tract infection24 and is currently

exploring potential partnering opportunities. Additionally, Valneva initiated pre-clinical work on vaccine candidates targeting parvovirus

B19, a virus most commonly causing fifth disease25, and Campylobacter, a bacterium often associated

with food poisoning26.

JAPANESE ENCEPHALITIS VACCINE (IXIARO /JESPECT )

IXIARO is an inactivated Vero cell culture-derived Japanese encephalitis that is the only Japanese encephalitis

vaccine licensed and available in the United States, Canada and Europe. IXIARO is indicated for active immunization against

Japanese encephalitis, the most prevalent cause of viral encephalitis in Asia, for adults, adolescents, children and infants aged two

IXIARO /JESPECT sales were 41.3 million in 2022 compared to 45.1 million

in 2021. This decrease was the result of lower sales to the U.S. Department of Defense. The significant recovery of the private travel

markets partly offset this impact, with IXIARO /JESPECT private sales reaching 28.8 million in

2022 compared to 7.1 million in 2021.

CHOLERA / ETEC27-DIARRHEA VACCINE (DUKORAL )

DUKORAL is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae

and/or heat-labile toxin producing ETEC28, the leading cause of travelers' diarrhea. DUKORAL

is authorized for use in the European Union and Australia to protect against cholera, and in Canada, Switzerland, New Zealand and Thailand

to protect against cholera and ETEC.

DUKORAL sales increased to 17.3 million in 2022 compared to 2.4 million in 2021,

also benefitting from the significant recovery in the private travel markets.