Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates Total nine-month revenues of 249.9 million, a 3.5-fold increase compared to 2021 Product sales of 74.4 million (vs 45.5 million in the first nine mon

Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates

Total nine-month revenues of 249.9 million, a 3.5-fold increase compared to 2021

Product sales of 74.4 million (vs 45.5 million in the first nine months of 2021) driven by a continued recovery of travel vaccine sales and by COVID-19 vaccine sales in Europe. Product sales outside of COVID-19 grew by double digits (11.2%) vs. prior period

175.5 million of other revenues (vs 24.4 million in the first nine months of 2021) mainly driven by revenue recognition related to previous COVID-19 vaccine supply agreements

Cash and cash equivalents of 261.0 million at the end of September 2022

Excludes 102.9 million of gross proceeds received in October 2022 from an upsized global offering1

Includes drawing the final tranche ($20 million) from Deerfield Orbimed loan agreement2

Continued progression of late-stage clinical programs as guided

Lyme Disease Vaccine Candidate VLA15

Phase 3 study recruitment ongoing enrollment completion expected in the second quarter of 2023

Single-Shot Chikungunya Vaccine Candidate VLA1553

Ongoing rolling submission for Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) submission completion expected by end of 2022

Progression of pre-clinical assets and focus on strengthening the Company's clinical pipeline

VLA1554 (human metapneumovirus) and VLA2112 (Epstein-Barr virus) currently prioritized

Updated FY 2022 Financial Guidance

Valneva reiterates expected total revenues of 340 million to 360 million, noting continued recovery of travel vaccine sales, further revenue recognition linked to payments received under the Advance Purchase Agreement (APA) with each of the European Commission (EC) and United Kingdom (UK) and the expected sales from the revised EC APA.

Product sales of the Company's travel vaccines are still expected to reach 70 million to 80 million despite supply challenges and COVID-19 product sales are expected to reach 30 million to 40 million.

Other Revenues are expected to reach approximately 240 million. They will be mainly related to COVID-19 revenue recognition in relation to the UK and EC APAs and will have no impact on cash. Other Revenues not related to COVID-19 will be negative in 2022 due to the increased refund liability resulting from the amendment of the VLA15 collaboration and license agreement with Pfizer.

Given phasing of clinical trial expenses and accelerated wind-down of VLA2001 related activities, Valneva now expects lower R D expenses of 95 million to 110 million compared to the 120 million to 135 million previously communicated. The Company remains committed to advancing its late-stage vaccine candidates and to further expanding its R D pipeline, including, but not limited to, through the advancement of some of the Company's pre-clinical candidates towards clinical entry.

As part of the communicated reshape strategy, Valneva is in the process of re-sizing its operations which is expected to result in a reduction of approximately 20% to 25% of its existing workforce. Post restructuring, the Company's total workforce is expected to be approximately 25% above pre-COVID levels enabling the Company to retain key talents and additional expertise to successfully execute on its strategy. This re-sizing and re-focusing is expected to result in annualized savings of approximately 12 million.

Financial Information

(unaudited results, consolidated per IFRS)

Saint-Herblain (France), November 10, 2022 - Valneva SE (Nasdaq VALN Euronext Paris VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2022. The condensed consolidated interim financial results are available on the Company's website (Financial Reports - Valneva).

Valneva will provide a live webcast of its nine months financial results conference call beginning at 3 p.m. CET 9 a.m. EST today. This webcast will also be available on the Company's website. Please refer to this link https edge.media-server.com mmc p cay4shas

Thomas Lingelbach, Valneva's Chief Executive Officer, commented, "Valneva is continuing to successfully execute on its key activities. Raising over 100 million in the current economic environment, attracting new investors, and maintaining support of our existing shareholders clearly underlines the value of the Company's fundamentals, its R D pipeline and our strategic ambitions. We will continue to fully pursue the Company's strategic priorities, including advancing our chikungunya vaccine candidate towards marketing approval and launch, completing the Phase 3 trial of our Lyme disease vaccine candidate, progressing pre-clinical assets, and focusing on strengthening our clinical pipeline. The re-sizing of our operations will allow us to increase efficiency and focus on achieving our operational and strategic business objectives."

Clinical Stage Vaccine Candidates

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 bacteria that cause Lyme disease. The vaccine candidate covers the six OspA serotypes expressed by Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe.

Recruitment of approximately 6,000 participants five years of age and older for the Phase 3 clinical study "VALOR" (Vaccine Against Lyme for Outdoor Recreationists) is currently ongoing in highly endemic regions in the United States and Europe3. Enrollment for the study, which investigates the efficacy, safety, and immunogenicity of VLA15, is expected to be completed in the second quarter of 2023. As per the terms of the collaboration agreement between the two companies, Valneva received a $25 million milestone payment from Pfizer in October following initiation of the Phase 3 study.

Pending successful Phase 3 completion, Pfizer could potentially submit a Biologics License Application (BLA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2025.

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA154. 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 Agreement5. Valneva will continue to pay its 40% contribution to the Phase 3 activities over 2022 and 2023.

If approved, Pfizer will commercialize VLA15 and Valneva will be eligible to receive substantial milestone and royalty payments.

1 Valneva Announces Closing of Upsized 102.9 Million Global Offering - Valneva

2 Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed - Valneva

3 Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 - Valneva

4 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15

5 Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

CHIKUNGUNYA VACCINE CANDIDATE - VLA1553

BLA rolling submission with U.S. FDA initiated

VLA1553 is a live-attenuated, single-dose vaccine candidate against the chikungunya virus (CHIKV), a mosquito-borne virus that has spread to more than 120 countries with the potential to rapidly expand further. There are currently no preventive vaccines or effective treatments for the chikungunya virus available, and VLA1553 is currently the only chikungunya vaccine candidate that successfully completed pivotal Phase 3 studies6,7 and the first chikungunya vaccine candidate for which a regulatory filing process has been initiated with the U.S. FDA.

Valneva initiated BLA rolling submission with the FDA for approval of VLA1553 in persons aged 18 years and above in August 20228. This BLA submission is part of the accelerated approval pathway agreed with the FDA in 20209 and follows final pivotal Phase 3 data in March 202210 and final lot-to-lot consistency results in May 202211.

Valneva expects to complete its BLA submission by the end of 2022. Once completed, and if the FDA accepts the filing, the FDA will determine priority review eligibility along with the action due date upon which it will complete its evaluation. 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 EMA in 2020. Valneva currently plans to make additional regulatory submissions for VLA1553 in the first half of 2023.

Valneva has presented and will continue to present clinical data for VLA1553 at high-profile medical and scientific congresses12. Recently, the Company highlighted additional immunological results from an expanded panel of serological samples from adults over 65 years of age who received VLA1553 at the American Society for Tropical Medicine and Hygiene (ASTMH) Annual Meeting. Similar to the pivotal data presented previously, the results from the expanded cohort continue to show that older adults generated similarly high seroresponse rates compared to younger adults in the pivotal Phase 3 study13. The Company is also expecting to report twelve-month antibody persistence data in late 2022.

At the recent meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), Valneva presented an overview of VLA1553 safety and immunogenicity results and the chikungunya working group provided a preliminary review and timeline towards ACIP's recommendation decision. Ahead of the anticipated February 2024 ACIP vote, the working group plans to present further on CHIKV traveler epidemiology and disease burden, a more comprehensive review of immunogenicity and safety data as part of its Grading of Recommendations, Assessment, Development and Evaluation (GRADE) assessment, and longer-term additional data in younger age groups.

A clinical trial of VLA1553 in adolescents is also ongoing in Brazil14 for which topline results are expected in the first half of 2023. This trial may support future regulatory submissions and label extensions following a potential initial regulatory approval in adults in the U.S. This ongoing clinical trial conducted by Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in an endemic region.

Pre-Clinical Vaccine Candidates

The Company continues to progress select pre-clinical assets and focus on strengthening its future clinical pipeline. The Company is currently focused on two pre-clinical assets, VLA1554 and VLA2112. The hMPV candidate, VLA1554, is a pre-fusion recombinant protein subunit vaccine targeting the human metapneumovirus (hMPV), which is a major worldwide respiratory pathogen that causes acute upper and lower respiratory tract infection in children and is a common cause of morbidity and mortality in immunocompromised patients and in older adults. VLA1554 is currently in pre-clinical proof of concept studies. VLA2112 is a vaccine candidate targeting the Epstein-Barr virus (EBV), which is one of the most common human viruses and can cause infectious mononucleosis and other illnesses. VLA2112 is currently in a late-stage evaluation phase.

JAPANESE ENCEPHALITIS VACCINE (IXIARO JESPECT )

IXIARO is the only Japanese encephalitis vaccine licensed and available in the U.S., Canada and Europe.

In the first nine months of 2022, IXIARO JESPECT sales were 22.9 million compared to 33.7 million in the first nine months of 2021, as a result of the planned delivery schedule to the U.S. Department of Defense. This decrease was partly offset by the private travel markets, which showed significant recovery with IXIARO JESPECT private sales reaching 19.4 million in the first nine months of 2022 compared to 4.6 million in the first nine months of 2021.

CHOLERA ETEC15-DIARRHEA VACCINE (DUKORAL )

DUKORAL is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and or heat-labile toxin producing ETEC16, 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.

In the first nine months of 2022, DUKORAL sales increased to 9.2 million compared to 0.5 million in the first nine months of 2021, also benefitting from the significant recovery in the private travel markets.

SARS-CoV-2 INACTIVATED WHOLE-VIRUS VACCINE

Valneva's COVID-19 vaccine, VLA2001, is the only inactivated whole-virus COVID-19 vaccine approved in Europe17 and was the first COVID-19 vaccine to receive a full marketing authorization from the European Medicines Agency (EMA). It is produced using Valneva's established Vero-cell platform, leveraging the manufacturing technology for the Company's commercial Japanese encephalitis vaccine, IXIARO .

In addition to its marketing approval in Europe, Valneva's COVID-19 vaccine received conditional marketing authorization in the United Kingdom18 and emergency use authorization in the United Arab Emirates19 and Kingdom of Bahrain20. During the third quarter of 2022, the World Health Organization (WHO) also issued recommendations for use of the vaccine, including for a booster dose of VLA2001 four to six months after completion of the primary series. The vaccine generated sales of 23.9 million during the first nine months of 2022.

Following a revised purchase agreement with the EC in July 2022, which included VLA2001 orders of 1.25 million21, Valneva has been delivering doses to participating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria). Valneva has retained inventory for potential additional supply to these EU Member States should demand increase and, in parallel, is continuing discussions on potential additional supply and financing agreements with various other governments around the world to deploy remaining inventory. VLA2001's shelf life is expected to be extended to up to 24 months, compared to 15 months currently.

6 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate - Valneva

7 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate - Valneva

8 Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate - Valneva

9 Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting with the U.S. FDA Sets Stage for Phase 3 Study

10 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate - Valneva

11 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate - Valneva

12 Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate at Leading Scientific Conferences - Valneva

13 Presentation at ASTMH Chikungunya Phase 3 Clinical Development of a Single-shot Live-Attenuated Vaccine

14 Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate - Valneva

15 Indications differ by country - Please refer to Product Prescribing Information (PI) Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC Enterotoxigenic Escherichia coli (E. Coli) bacterium.

16 Enterotoxigenic Escherichia coli (ETEC) is a type of Escherichia coli and one of the leading bacterial causes of diarrhea in the developing world, as well as the most common cause of travelers' diarrhea.

17 Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001

18 Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine - Valneva

19 Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine

20 Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001 - Valneva

21 Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva's Inactivated COVID-19 Vaccine - Valneva

Valneva reported first positive heterologous booster results for VLA2001 in August 202222 and expects additional heterologous booster data following primary vaccination with an mRNA vaccine or natural COVID-19 infection in the fourth quarter of 2022.

Subject to regulatory assessments, heterologous booster results may support label extensions for VLA2001, additional product approvals and or additional scientific recommendations.

In light of the reduced order volume from EU Member States, Valneva suspended internal and terminated external manufacturing of VLA2001. Valneva is executing its "reshape" strategy including re-sizing which will allow the Company to increase efficiency and focus on its operational and strategic business objectives.

THIRD-PARTY DISTRIBUTION

Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. In June 2020, the Company entered into a distribution agreement with Bavarian Nordic, pursuant to which it agreed to commercialize Bavarian Nordic's marketed vaccines for rabies (Rabipur RabAvert ) and tick-borne encephalitis, leveraging its commercial infrastructure in Canada, the United Kingdom, France and Austria. In September 2022, Valneva also announced a partnership with VBI Vaccines for the marketing and distribution of the only 3-antigen Hepatitis B vaccine, PreHevbri , in select European markets23. Valneva and VBI expect PreHevbri to be available in these countries in early 2023.

In the first nine months of 2022, third party product sales increased by 64.6% to 18.4 million from 11.2 million in the first nine months of 2021.

Nine-Month 2022 Financial Review

(Unaudited, consolidated under IFRS)

Valneva's total revenues were 249.9 million in the first nine months of 2022 compared to 69.8 million in the first nine months of 2021, an increase of 257.8%.

Product sales, including COVID-19 vaccine sales, increased by 63.7% to 74.4 million in the first nine months of 2022 compared to 45.5 million in the first nine months of 2021. Foreign currency fluctuations contributed positively to 4.9 million of the change in product sales. Product sales from commercial products amounted to 50.6 million in the first nine months of 2022, an increase of 11.2% compared to the first nine months of 2021. Product sales related to COVID-19 amounted to 23.9 million.

IXIARO JESPECT sales decreased by 32.1% to 22.9 million in the first nine months of 2022 compared to 33.7 million in the first nine months of 2021, primarily as a result of the planned delivery schedule to the DoD during the period. This decrease was partly offset by the private travel markets, which showed significant recovery with IXIARO JESPECT sales reaching 19.4 million in the first nine months of 2022 compared to 4.6 million in the first nine months of 2021. Foreign currency fluctuations also contributed positively for 4.6 million to the change in IXIARO product sales. DUKORAL also benefited from this recovery in the private travel market as sales increased significantly to 9.2 million in the first nine months of 2022 compared to 0.5 million in the first nine months of 2021. COVID-19 vaccine sales amounted to 23.9 million resulting from shipments to participating EU Member States and Bahrain. Third Party product sales increased by 64.6% to 18.4 million in the first nine months of 2022 from 11.2 million in the first nine months of 2021, driven by growth related to Valneva's distribution agreement with Bavarian Nordic for the sale of Rabipur RabAvert and Encepur .

Other Revenues, including revenues from collaborations, licensing and services, amounted to 175.5 million in the first nine months of 2022 compared to 24.4 million in the first nine months of 2021. This increase is attributable to 89.4 million of released refund liability as a result of the settlement with the UK government as well as a release of non-refundable advance payments from EU Member States amounting to 110.8 million. This was partially offset by 36.1 million of negative revenue resulting from an increase in the refund liability linked to the amendment to the VLA15 collaboration and license agreement with Pfizer. Valneva's future contribution to the VLA15 Phase 3 study will go against the refund liability included in the balance sheet.

Operating Result and adjusted EBITDA

Costs of goods and services sold (COGS) were 202.7 million in the first nine months of 2022. The gross margin on commercial product sales amounted to 55.4% compared to 37.8% in the first nine months of 2021. COGS of 6.4 million related to IXIARO product sales, yielding a product gross margin of 72.0%. COGS of 3.7 million related to DUKORAL product sales, yielding a product gross margin of 60.0%, which was positively impacted by provision releases resulting from reduced expiry risks on inventory. Of the remaining COGS in the first nine months of 2022, 12.4 million were related to the Third-Party products distribution business, 174.0 million to the COVID-19 vaccine business and 6.2 million to cost of services. COGS of the COVID-19 vaccine program included effects from the significant reduction of sales volumes to EU Member States. In the first nine months of 2021, overall COGS were 159.6 million, of which 142.4 million related to cost of goods and 17.2 million related to cost of services.

Research and development expenses amounted to 75.4 million in the first nine months of 2022, compared to 117.2 million in the first nine months of 2021. This decrease was mainly driven by lower clinical trials costs for Valneva's chikungunya vaccine program advancing towards licensure as well as reduced spend on the COVID-19 program. Marketing and distribution expenses in the first nine months of 2022 amounted to 13.1 million compared to 15.0 million in the first nine months of 2021. Marketing and distribution expenses in the first nine months of 2022 notably included 4.3 million of expenses related to the launch preparation costs for Valneva's chikungunya vaccine candidate, VLA1553, compared to 2.8 million in the first nine months of 2021. In the first nine months of 2022, general and administrative expenses declined to 23.3 million from 31.7 million in the first nine months of 2021. COGS, research and development, marketing and distribution as well as general and administrative expenses benefited from a non-cash accrual adjustment of 30.6 million related to the positive effect of the Company's share price development on the employee share-based compensation programs. This income compares to a cost of 13.7 million in the first nine months of 2021.

Other income, net of other expenses, reduced to 7.5 million in the first nine months of 2022 from 16.0 million in the first nine months of 2021. This decrease was mainly driven by reduced R D tax credits directly resulting from lower R D spending and an increase of other expenses related to the provision for the ongoing Vivalis Intercell merger litigation proceedings.

Valneva recorded an operating loss of 57.1 million in the first nine months of 2022 compared to 237.6 million in the first nine months of 2021, of which the COVID-19 operating loss represented 14.2 million and 194.4 million in the first nine months of 2022 and 2021, respectively and the other segments represented 42.9 million in the first nine months of 2022 compared to 43.2 million in the first nine months of 2021. Adjusted EBITDA (as defined below) loss in the first nine months of 2022 was 38.0 million compared to an adjusted EBITDA loss of 227.6 million in the first nine months of 2021.

In the first nine months of 2022, Valneva generated a net loss of 99.1 million compared to a net loss of 245.9 million in the first nine months of 2021.

Finance expense and foreign currency effects in the first nine months of 2022 resulted in a net finance expense of 39.8 million, compared to a net finance expense of 6.6 million in the first nine months of 2021. This was mainly a result of a foreign exchange loss amounting to 26.5 million in the first nine months of 2022, primarily driven by non-cash revaluation results of non-Euro denominated balance sheet positions, compared to a net foreign exchange gain of 5.3 million in the first nine months of 2021. Interest expenses net of interest income were 13.3 million in the first nine months of 2022 compared to 11.9 million in the first nine months of 2021.

Cash Flow and Liquidity

Net cash used in operating activities amounted to 189.5 million in the first nine months of 2022 compared to 36.5 million of cash generated by operating activities in the first nine months of 2021. Cash outflows in the first nine months of 2022 were mainly related to the operating loss generated in the period and non-cash revenues (cash received in previous periods), while during the first nine months of 2021 cash inflows mainly resulted from pre-payments received related to the vaccine supply agreement signed with the UK government.

Cash outflows from investing activities amounted to 22.5 million in the first nine months of 2022 compared to 69.9 million in the first nine months of 2021, both mainly a result of COVID-19-related construction activities across production sites in Scotland and Sweden, as well as equipment purchases.

22 Valneva Reports Further Positive Phase 3 Immunogenicity and the First Heterologous Booster Results for its Inactivated, Adjuvanted COVID-19 Vaccine VLA2001 - Valneva

23 Valneva and VBI Vaccines Announce European Partnership for Marketing and Distribution of PreHevbri - Valneva

Net cash generated from financing activities amounted to 121.6 million in the first nine months of 2022, which was mainly a result of proceeds from the equity subscription agreement with Pfizer as well as a draw-down in September on the credit facility provided by Deerfield Orbimed24. Cash inflows in the first nine months of 2021 amounted to 74.6 million which was mainly a result of proceeds from issuance of new shares in the U.S. initial public offering and European private placement in May of 2021.