valn-20240331

0001628280-24-020920.txt : 20240507 0001628280-24-020920.hdr.sgml : 20240507 20240507120912 ACCESSION NUMBER: 0001628280-24-020920 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 22 CONFORMED PERIOD OF REPORT: 20240331 FILED AS OF DATE: 20240507 DATE AS OF CHANGE: 20240507 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Valneva SE CENTRAL INDEX KEY: 0001836564 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: I0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40377 FILM NUMBER: 24920667 BUSINESS ADDRESS: STREET 1: 6, RUE ALAIN BOMBARD CITY: SAINT-HERBLAIN STATE: I0 ZIP: 44800 BUSINESS PHONE: 33 2 28 07 37 10 MAIL ADDRESS: STREET 1: 6, RUE ALAIN BOMBARD CITY: SAINT-HERBLAIN STATE: I0 ZIP: 44800 6-K 1 valn-20240331.htm 6-K valn-20240331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

Date of Report: May 7, 2024

Commission File Number: 001-40377

VALNEVA SE

(Translation of registrant's name into English)

6 rue Alain Bombard

44800 Saint-Herblain, France

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

On May 7, 2024, the Registrant announced its results from the three months ended March 31, 2024 and issued a press release and unaudited interim condensed consolidated financial statements, copies of which are attached hereto as Exhibits 99.1, and 99.2, respectively, and incorporated herein by reference. The information contained in this Form 6-K, including Exhibits 99.1 and 99.2, is hereby incorporated by reference into the registrant's Registration Statement on Form F-3 (File No. 333-266839).


Exhibits
Exhibit 99.1			Press release dated May 7, 2024
Exhibit 99.2			Unaudited Interim Condensed Consolidated Financial Statements as at March 31, 2024 and for the three months ended March 31, 2024

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Valneva SE (Registrant)

Date: May 7, 2024

/s/ Thomas Lingelbach Thomas Lingelbach Chief Executive Officer and President




						Unaudited interim condensed consolidated financial statements as at March 31, 2024
						Valneva SE


I.			UNAUDITED INTERIM CONSOLIDATED STATEMENTS OF INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)

Unaudited Interim Condensed Consolidated Statements of Income (Loss)


	Three months ended March 31,
in € thousand	2024	2023
Product sales	32,149	32,100
Other revenues	604	1,408
REVENUES	32,753	33,508
Cost of goods and services	(22,160)	(20,480)
Research and development expenses	(13,131)	(14,065)
Marketing and distribution expenses	(11,333)	(8,986)
General and administrative expenses	(11,670)	(10,038)
Gain from sale of Priority Review Voucher, net	90,833	—
Other income and expenses, net	2,917	3,488
OPERATING PROFIT/(LOSS)	68,208	(16,574)
Finance income	266	253
Finance expenses	(7,045)	(5,096)
Foreign exchange gain/(loss), net	(2,512)	3,170

PROFIT/(LOSS) BEFORE INCOME TAX	58,918	(18,247)
Income tax benefit/(expense)	(8)	120
PROFIT/(LOSS) FOR THE PERIOD	58,909	(18,127)

EARNINGS/(LOSSES) PER SHARE
for profit/(loss) for the period attributable to the equity holders of the Company (expressed in € per share)
Basic	0.42	(0.13)
Diluted	0.41	(0.13)

Unaudited Interim Condensed Consolidated Statements of Comprehensive Income (Loss)


		Three months ended March 31,
in € thousand		2024	2023
PROFIT/(LOSS) FOR THE PERIOD		58,909	(18,127)
OTHER COMPREHENSIVE INCOME/(LOSS)
Items that may be reclassified to profit or loss
Currency translation differences		(57)	1,628


Other comprehensive income/(loss) for the period, net of tax		(57)	1,628
TOTAL COMPREHENSIVE INCOME/(LOSS) FOR THE PERIOD	58,853	(16,500)




Unaudited interim condensed consolidated financial statements as at March 31, 2024
Valneva SE


II.			UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION



in € thousand	March 31, 2024	December 31, 2023
ASSETS
Non-current assets	196,588	197,238
Intangible assets	24,853	25,567
Right of use assets	19,267	20,392
Property, plant and equipment	136,696	136,198

Deferred tax assets	7,006	6,592
Other non-current assets	8,766	8,490
Current assets	306,241	262,824
Inventories	48,585	44,466
Trade receivables	27,285	41,645
Other current assets	53,732	50,633
Cash and cash equivalents	176,640	126,080

TOTAL ASSETS	502,829	460,062
EQUITY
Share capital	20,892	20,837
Share premium	593,948	594,003
Other reserves	67,162	65,088
Retained earnings/(Accumulated deficit)	(551,682)	(450,253)
Profit/(Loss) for the period	58,909	(101,429)
TOTAL EQUITY	189,230	128,247
LIABILITIES
Non-current liabilities	197,515	172,952
Borrowings	159,035	132,768
Lease liabilities	27,547	29,090

Refund liabilities	6,350	6,303
Provisions	810	1,074
Deferred tax liabilities	3,704	3,638
Other liabilities	70	79
Current liabilities	116,085	158,863
Borrowings	22,413	44,079
Trade payables and accruals	33,506	44,303
Income tax liability	746	632
Tax and Employee-related liabilities	17,271	16,209
Lease liabilities	2,676	2,879
Contract liabilities	5,291	5,697
Refund liabilities	24,258	33,637
Provisions	9,553	10,835
Other liabilities	371	592

TOTAL LIABILITIES	313,600	331,815
TOTAL EQUITY AND LIABILITIES	502,829	460,062




						Unaudited interim condensed consolidated financial statements as at March 31, 2024
						Valneva SE


III.			UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS


	Three months ended March 31,
in € thousand	2024	2023

CASH FLOWS FROM OPERATING ACTIVITIES
Profit/(Loss) for the period	58,909	(18,127)
Gain from sale of Priority Review Voucher, net	(90,833)	—
Adjustments for non-cash transactions	15,072	8,438
Changes in non-current operating assets and liabilities	(529)	(269)
Changes in working capital	(10,923)	(13,935)
Cash generated/(used) in operations	(28,303)	(23,893)
Income tax paid	(129)	(433)
NET CASH GENERATED FROM/(USED IN) OPERATING ACTIVITIES	(28,432)	(24,326)

CASH FLOWS FROM INVESTING ACTIVITIES

Purchases of property, plant and equipment	(4,498)	(3,846)
Proceeds from sale of property, plant and equipment	146	33
Purchases of intangible assets	(34)	—



Proceeds from sale of Priority Review Voucher	90,833	—
Interest received	266	253
NET CASH GENERATED FROM/(USED IN) INVESTING ACTIVITIES	86,713	(3,561)

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds/(payments) from issuance of common stock, net of costs of equity transactions	—	(194)

Proceeds from borrowings, net of transaction costs	(944)	—

Payment of lease liabilities	(677)	(933)
Interest paid	(5,836)	(2,689)
NET CASH GENERATED FROM/(USED IN) FINANCING ACTIVITIES	(7,457)	(3,816)

NET CHANGE IN CASH AND CASH EQUIVALENTS	50,824	(31,703)
Cash and cash equivalents at beginning of the year	126,080	286,532
Exchange gains/(losses) on cash	(264)	(344)

CASH AND CASH EQUIVALENTS AT END OF THE PERIOD	176,640	254,485




Unaudited interim condensed consolidated financial statements as at March 31, 2024
Valneva SE


IV.			UNAUDITED INTERIM CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY


in € thousand	Share capital	Share premium	Other reserves	Retained earnings/ (Accumulated deficit)	Profit/(loss) for the period	Total equity
BALANCE AS AT JANUARY 1, 2024	20,837	594,003	65,088	(450,253)	(101,429)	128,247
Total comprehensive income/(loss)	—	—	(57)	—	58,909	58,853
Income appropriation	—	—	—	(101,429)	101,429	—
Share-based compensation expense:
Value of services	—	—	2,130	—	—	2,130
Exercises	55	(55)	—	—	—	—



BALANCE AS AT MARCH 31, 2024	20,892	593,948	67,162	(551,682)	58,909	189,230


in € thousand	Share capital	Share premium	Other reserves	Retained earnings/ (Accumulated deficit)	Profit/(loss) for the period	Total equity
BALANCE AS AT JANUARY 1, 2023	20,755	594,043	55,252	(306,974)	(143,279)	219,797
Total comprehensive income/(loss)	—	—	1,628	—	(18,127)	(16,500)
Income appropriation	—	—	—	(143,279)	143,279	—
Share-based compensation expense:
Value of services	—	—	1,489	—	—	1,489
Exercises	(3)	—	—	—	—	(3)



BALANCE AS AT MARCH 31, 2023	20,752	594,043	58,369	(450,253)	(18,127)	204,783

EX-99.1 2 q12024pressrelease.htm EX-99.1 Document

VALNEVA SE

Campus Bio-Ouest | 6, Rue Alain Bombard

44800 Saint-Herblain, France

Valneva Reports First Quarter 2024 Financial Results and

Provides Corporate Updates

Q1 financial highlights

•Total revenues of €32.8 million, including sales of €32.1 million, on track to meet anticipated

full year guidance

•Cash position of €176.6 million, including €95 million from sale of Priority Review Voucher (PRV)1.

◦Significantly extended cash runway with recent update of debt financing agreement2

◦Substantially lower cash burn expected in 2024 as Valneva expects to complete its cost contributions for the Lyme disease Phase 3 study in the second quarter

•Net Profit of €58.9 million, reflecting PRV sale

2024 financial guidance confirmed

•Expected total revenues between €170 million and €190 million, including:

▪€160 million to €180 million of sales driven by growth of Valneva’s proprietary products

•Expected R&D investments between €60 million and €75 million, mostly dedicated to ongoing chikungunya development activities, the Zika trial and advancement of pre-clinical programs

•Expected Other income between €100 million and €110 million, reflecting €95 million in proceeds from the PRV sale

Strong R&D execution

•Single-shot chikungunya vaccine IXCHIQ® recommended by ACIP and adopted by U.S. CDC3; Regulatory processes with the European, Canadian and Brazilian authorities on track;

•Six-month data for Phase 3 adolescent study of IXCHIQ® to be reported shortly and label extensions to be submitted based on results; Enrolment of children for pediatric Phase 2 study on track;

•Primary vaccinations for all participants in the VALOR Lyme disease Phase 3 trial expected to be completed in Q2;

•Phase 1 clinical trial for second-generation Zika vaccine candidate initiated4.

Financial Information

1 Valneva Announces Sale of Priority Review Voucher for $103 Million - Valneva

2 Valneva Announces Extension of the Interest-Only Period of Its Debt Facility with Deerfield and OrbiMed - Valneva

3 ACIP Vaccine Recommendations and Schedules | CDC

4 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate - Valneva

May 7, 2024 VALNEVA SE

(Unaudited results, consolidated per IFRS)


€ in million	3 months ending March 31
	2024	2023
Product sales	32.1	32.1
Total revenues	32.8	33.5
Net profit/(loss)	58.9	(18.1)
Adjusted EBITDA (profit/loss)	73.0	(12.3)
Cash	176.6	254.5

Saint-Herblain (France), May 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2024, and provided corporate updates. The condensed consolidated interim financial results are available on the Company’s website (Financial Reports – Valneva).

Valneva will host a live webcast of its first quarter 2024 results conference call
at 3 p.m. CEST/9 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/wrc2a7s3.

Peter Bühler, Valneva’s Chief Financial Officer, commented, “The first quarter performance has been in line with our expectations. We are aiming to further capitalize on the travel industry recovery during the rest of the year including ramping-up sales for IXCHIQ® to support our commercial sales growth while executing on our key R&D milestones. The successful sale of our PRV and deferral of our loan reimbursement in Q1 allowed us to maintain a solid cash position and, with the expected completion of our payments for the Lyme Phase 3 trial in the second quarter, we anticipate a significantly lower cash burn in 2024.”

Commercial Portfolio

Valneva’s commercial portfolio is composed of three travel vaccines, IXIARO®/JESPECT®, DUKORAL® and IXCHIQ®. The Company also distributes certain third-party products in countries where it operates its own marketing and sales infrastructure.

JAPANESE ENCEPHALITIS VACCINE IXIARO®/JESPECT®

In the first quarter of 2024, IXIARO®/JESPECT® sales were €16.6 million compared to €17.4 million in the first quarter of 2023. Sales to the U.S. military counterbalanced most of the supply constraints experienced during the period. These constraints have now been resolved, and as communicated last month in its full-year publication5, Valneva expects double-digit annual growth for IXIARO® sales for at least the next three years.

5 Valneva Reports Full Year 2023 Results and Provides Business Updates and Outlook - Valneva

CHOLERA / ETEC6-DIARRHEA VACCINE DUKORAL®

In the first quarter of 2024, DUKORAL® sales increased by 10.3% to €11.3 million compared to €10.2 million in the first quarter of 2023, as the vaccine continued to benefit from the significant recovery in the private travel markets.

CHIKUNGUNYA VACCINE IXCHIQ®

IXCHIQ® is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. Following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations7 by the U.S. Centers for Disease Control and Prevention (CDC)8 at the beginning of March 2024, Valneva has focused on launching its single-dose chikungunya vaccine in the U.S. and recorded initial sales of €0.2 million in the first quarter.

IXCHIQ® is also under regulatory review in Canada, Brazil and Europe, where it was granted accelerated assessment by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP). Decisions on these submissions are expected in 2024.

A clinical study in adolescents, VLA1553-321, is ongoing. Valneva reported initial safety data in August 20239 and expects to report six-month data in the coming weeks. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in Brazil in collaboration with Instituto Butantan, the VLA1553-321 adolescent trial is intended to support the label extension to this age group following initial approvals in adults. The trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in endemic populations. Additionally, the Company initiated a Phase 2 pediatric trial, VLA1553-221, in children aged 1 to 11 years, in January 202410. This is designed to support a Phase 3 pivotal pediatric study and potentially extend the label to this age group following initial regulatory approvals in adults and possibly in adolescents.

THIRD-PARTY DISTRIBUTION

Valneva distributes certain third-party vaccines in countries where it operates its own marketing and sales infrastructure. During the first quarter of 2024, third-party sales decreased by 8.9% to €4.1 million compared to €4.5 million in the first quarter of 2023 as a result of anticipated supply constraints. Valneva expects that third-party sales will gradually wind down to less than 5% of overall product sales by 2026/2027, allowing the Company to improve gross margins.

Clinical Stage Vaccine Candidates

LYME DISEASE VACCINE CANDIDATE – VLA15

Phase 3 study ongoing

Valneva and Pfizer are developing VLA15, a Phase 3 vaccine candidate targeting Borrelia, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that

6 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.

7 ACIP Vaccine Recommendations and Schedules | CDC

8 ACIP Vaccine Recommendations and Schedules | CDC

9 Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate - Valneva

10 Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine - Valneva

targets six serotypes of Borrelia representing the most common strains found in the United States and Europe. VLA15 is the only Lyme disease program in late-stage clinical development today and has received Fast Track designation from the FDA.

Vaccinations across the two cohorts of the Phase 3 trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) are on track and Valneva and Pfizer expect all participants (9,437) to complete primary vaccinations (three doses) in the coming weeks.

Topline data from the VALOR trial are expected by the end of 2025, with the aim for Pfizer to submit a Biologic License Application (BLA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in 2026, subject to positive data.

Valneva’s cost contributions for the Lyme disease Phase 3 study are expected to be completed in the second quarter of 2024. All remaining payments to Pfizer are included in current refund liability at December 31, 2023, and will not impact the Profit & Loss statement in 2024.

ZIKA VACCINE CANDIDATE – VLA1601

Phase 1 ongoing with second-generation vaccine candidate

VLA1601 is a second-generation adjuvanted inactivated vaccine candidate against the mosquito-borne viral disease caused by the Zika virus (ZIKV). In March 2024, Valneva initiated a Phase 1 clinical trial to investigate the safety and immunogenicity of VLA160111. The randomized, placebo-controlled, Phase 1 trial, VLA1601-102, is planned to enroll approximately 150 participants aged 18 to 49 years in the United States. Participants will receive a low, medium or high dose of VLA1601. In addition, the low dose of VLA1601 will be evaluated with an additional adjuvant. Topline data from the trial are expected in the first half of 2025.

Zika disease outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, since 2015, in the Americas. Zika virus transmission persists in several countries in the Americas and in other endemic regions. To date, a total of 89 countries and territories have reported evidence of mosquito transmitted Zika virus infection12; however, surveillance remains limited globally. There are no preventive vaccines or effective treatments available and, as such, Zika remains a public health threat and is included in the FDA’s Tropical Disease Priority Review Voucher Program13.

A vaccine against ZIKV would be a valuable addition to Valneva’s portfolio of travel vaccines against mosquito-borne diseases, which already includes IXCHIQ® and IXIARO®.

First Quarter 2024 Financial Review

(Unaudited, consolidated under IFRS)

Revenues

Valneva’s total revenues were €32.8 million in the first quarter of 2024 compared to €33.5 million in the first quarter of 2023.

11 Valneva Initiates Phase 1 Trial of Second-Generation Zika Vaccine Candidate - Valneva

12 Zika virus disease (who.int)

13 Tropical Disease Priority Review Voucher Program | FDA

Valneva’s sales reached €32.1 million in the first quarter of 2024 and remained comparable to the first quarter of 2023. Currency fluctuations had an immaterial impact on sales compared to the comparator period.

IXIARO®/JESPECT® sales were €16.6 million in the first quarter of 2024 compared to €17.4 million in the first quarter of 2023. The 4% decrease in sales is primarily the result of constrained supplies, which temporarily impacted sales during the first quarter and are now resolved.

DUKORAL® sales were €11.3 million in the first quarter of 2024 compared to €10.2 million in the first quarter of 2023. This 10% increase results from the continued recovery in the private travel markets primarily driven by Canada, and price increases.

IXCHIQ® sales were €0.2 million in the first quarter of 2024. The U.S. CDC adopted recommendations by the ACIP14 at the beginning of March 2024.

Third Party product sales were €4.1 million in the first quarter of 2024 compared to €4.5 million in the first quarter of 2023, a 9% decrease which was mainly driven by supply constraints of Rabipur®/RabAvert® and Encepur® sold under the distribution agreement with Bavarian Nordic.

Other revenues, including revenues from collaborations, licensing and services amounted to €0.6 million in the first quarter of 2024 compared to €1.4 million in the first quarter of 2023 with the reduction mainly resulting from lower revenue recognition related to the R&D collaboration activities for chikungunya with Instituto Butantan.

Operating Result and adjusted EBITDA

Costs of goods and services sold (COGS) were €22.2 million in the first quarter of 2024. The gross margin on commercial product sales amounted to 43.9% (excluding IXCHIQ®) compared to 48.4% in the first quarter of 2023. COGS of €8.0 million related to IXIARO® sales, yielding a product gross margin of 52.0%, which was impacted by €1.7 million recorded as write-offs for failed batches. COGS of €7.0 million related to DUKORAL® sales, yielding a product gross margin of 37.9%. Of the remaining COGS in the first quarter of 2024, €3.0 million related to the third-party products distribution business, €0.8 million to IXCHIQ®, €1.0 million to idle capacity costs and €2.4 million to cost of services. In the first quarter of 2023, overall COGS were €20.5 million, of which €17.9 million related to cost of goods and €2.6 million related to cost of services.

Research and development expenses amounted to €13.1 million in the first quarter of 2024, compared to €14.1 million in the first quarter of 2023. This decrease was mainly driven by lower spend on Valneva’s COVID-19 vaccine, VLA2001 as well as lower spend on IXCHIQ® following licensure in the fourth quarter of 2023. At the same time, costs related to the ongoing transfer of operations into the new Almeida manufacturing facility resulted in higher R&D spend on commercial products. Marketing and distribution expenses in the first quarter of 2024 amounted to €11.3 million compared to €9.0 million in the first quarter of 2023. The increase is mainly related to €4.9 million of expenses associated with launch activities for IXCHIQ® (first quarter of 2023: €3.4 million). In the first quarter of 2024, general and administrative expenses increased to €11.7 million from €10.0 million in the first quarter of 2023, mainly resulting from higher costs related to the Company’s stock-based employee compensation program, higher recruiting charges and higher costs for digitalization & automation initiatives.

14 ACIP Vaccine Recommendations and Schedules | CDC

During the first quarter of 2024, a net gain of €90.8 million from the sale of the PRV was recorded in the income statement. The net proceeds of $103 million were reduced by transaction costs as well as contractual payment obligations related to the sale of the PRV.

Other income, net of other expenses, decreased to €2.9 million in the first quarter of 2024 from €3.5 million in the first quarter of 2023. The decrease was mainly driven by lower R&D tax credits recorded in the first quarter of 2024 following the reduction in eligible R&D spend.

Valneva recorded an operating profit of €68.2 million in the first quarter of 2024 compared to an operating loss of €16.6 million in the first quarter of 2023. The significant improvement is largely related to the proceeds from the sales of the PRV recorded in the income statement in the first quarter of 2024. Adjusted EBITDA (as defined below) profit in the first quarter of 2024 was €73.0 million, compared to an EBITDA loss of €12.3 million in the first quarter of 2023.

Net Result

In the first quarter of 2024, Valneva generated a net profit of €58.9 million compared to a net loss of €18.1 million in the first quarter of 2023.

Finance expenses and currency effects in the first quarter of 2024 resulted in a net finance expense of €9.3 million, compared to a net finance expense of €1.7 million in the first quarter of 2023. The increase in finance expenses, net was mainly due to foreign exchange losses of €2.5 million in the first quarter of 2024 compared to a profit of €3.2 million in the first quarter of 2023, primarily related to the development of the USD / EUR exchange rate. In addition, interest charges increased to €7.0 million in the first quarter of 2024 compared to €5.1 million in the first quarter of 2023 following the increase of the Deerfield Management Company and OrbiMed (D&O) loan facility during the second half of 2023.

Cash Flow and Liquidity

Net cash used in operating activities amounted to €28.4 million in the first quarter of 2024 compared to €24.3 million in the first quarter of 2023. Cash outflows in the first quarter of 2024 were mainly a result of the net loss for the period excluding proceeds from the sale of the PRV and by increases in working capital.

Cash inflows from investing activities amounted to €86.7 million in the first quarter of 2024 compared to cash outflows of €3.6 million in the first quarter of 2023. Cash inflows in the first quarter of 2024 were driven by €90.8 million net proceeds from the sale of the PRV, partly offset by construction activities in the Almeida manufacturing site in Scotland as well as equipment purchases.

Net cash used in financing activities increased to €7.5 million in the first quarter of 2024 from €3.8 million in the first quarter of 2023. The increase in cash outflows in the first quarter of 2024 were primarily due to increased interest payments and transaction costs resulting from the upsized loan facility provided by D&O.

Cash and cash equivalents were €176.6 million as at March 31, 2024, compared to €126.1 million as at December 31, 2023.

Non-IFRS Financial Measures

Management uses and presents IFRS results as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition.

Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provide additional analytical tools. Adjusted EBITDA is defined as earnings (loss) for the period before income tax, finance income/expense, foreign exchange gain/(loss), amortization, depreciation, and impairment (excluding impairment loss of disposal).

A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below:


€ in million	Three months ending March 31
(consolidated per IFRS)	2024	2023
Profit/(Loss) for the period	58.9	(18.1)
Add:
Income tax expense	-	(0.1)
Total Finance income	(0.3)	(0.3)
Total Finance expense	7.0	5.1
Foreign exchange gain/(loss) – net	2.5	(3.2)
Amortization	1.3	1.6
Depreciation	3.5	2.6
Impairment	-	-
Adjusted EBITDA	73.0	(12.3)

About Valneva SE

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

About IXCHIQ®

In the U.S., IXCHIQ® is a live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. As for all products approved under FDA’s accelerated approval pathway, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory studies.

Please click here for full Prescribing Information for IXCHIQ®.


Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 investors@valneva.com			Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to guidance for certain financial results in fiscal year 2024 and mid-term outlook on financial results, cash position, and other business developments, including results of ongoing clinical trials, the timing and possible occurrence of further or initial regulatory approvals of its product candidates, the anticipated size of markets for its approved products and sales of those products, receipt of funding from external sources, supply of products sold by Valneva, and relationships with current business partners. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. These risks and uncertainties include those developed or identified in any public documents filed with the French financial markets authority (Autorité des marchés financiers) and the U.S. Securities and Exchange Commission made or to be made by Valneva. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines (including in relation to organic or strategic expansion of Valneva’s clinical pipeline), unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis and other global economic or political events, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, the impact of a pandemic, and changes in the regulatory environment in which Valneva operates. The occurrence of any of these risks and uncertainties could substantially harm Valneva’s business, financial

condition, prospects and results of operations. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Unaudited Interim Condensed Consolidated Statements of Income (Loss) - EUR (€)
€ in Thousands
3 Months Ended

Mar. 31, 2024

Mar. 31, 2023

Profit or loss [abstract]

Product sales € 32,149 € 32,100

Other revenues 604 1,408

REVENUES 32,753 33,508

Cost of goods and services (22,160) (20,480)

Research and development expenses (13,131) (14,065)

Marketing and distribution expenses (11,333) (8,986)

General and administrative expenses (11,670) (10,038)

Gain from sale of Priority Review Voucher, net 90,833 0

Other income and expenses, net 2,917 3,488

OPERATING PROFIT/(LOSS) 68,208 (16,574)

Finance income 266 253

Finance expenses (7,045) (5,096)

Foreign exchange gain/(loss), net (2,512) 3,170

PROFIT/(LOSS) BEFORE INCOME TAX 58,918 (18,247)

Income tax benefit/(expense) (8) 120

PROFIT/(LOSS) FOR THE PERIOD € 58,909 € (18,127)

Earnings/(losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (expressed in € per share)

Basic earnings (losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (in euro per share) € 0.42 € (0.13)

Diluted earnings (losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (in euro per share) € 0.41 € (0.13)

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Unaudited Interim Condensed Consolidated Statements of Comprehensive Income (Loss) - EUR (€)
€ in Thousands
3 Months Ended

Mar. 31, 2024

Mar. 31, 2023

Statement of comprehensive income [abstract]

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Items that may be reclassified to profit or loss

Currency translation differences (57) 1,628

Other comprehensive income/(loss) for the period, net of tax (57) 1,628

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XML 13 R4.htm IDEA: XBRL DOCUMENT v3.24.1.u1

Unaudited Interim Condensed Consolidated Statement of Financial Position - EUR (€)
€ in Thousands

Mar. 31, 2024

Dec. 31, 2023

ASSETS

Non-current assets € 196,588 € 197,238

Intangible assets 24,853 25,567

Right of use assets 19,267 20,392

Property, plant and equipment 136,696 136,198

Deferred tax assets 7,006 6,592

Other non-current assets 8,766 8,490

Current assets 306,241 262,824

Inventories 48,585 44,466

Trade receivables 27,285 41,645

Other current assets 53,732 50,633

Cash and cash equivalents 176,640 126,080

TOTAL ASSETS 502,829 460,062

EQUITY

Share capital 20,892 20,837

Share premium 593,948 594,003

Other reserves 67,162 65,088

Retained earnings/(Accumulated deficit) (551,682) (450,253)

Profit/(Loss) for the period 58,909 (101,429)

TOTAL EQUITY 189,230 128,247

LIABILITIES

Non-current liabilities 197,515 172,952

Borrowings 159,035 132,768

Lease liabilities 27,547 29,090

Refund liabilities 6,350 6,303

Provisions 810 1,074

Deferred tax liabilities 3,704 3,638

Other liabilities 70 79

Current liabilities 116,085 158,863

Borrowings 22,413 44,079

Trade payables and accruals 33,506 44,303

Income tax liability 746 632

Tax and Employee-related liabilities 17,271 16,209

Lease liabilities 2,676 2,879

Contract liabilities 5,291 5,697

Refund liabilities 24,258 33,637

Provisions 9,553 10,835

Other liabilities 371 592

TOTAL LIABILITIES 313,600 331,815

TOTAL EQUITY AND LIABILITIES € 502,829 € 460,062

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Unaudited Interim Condensed Consolidated Statement of Cash Flows - EUR (€)
€ in Thousands
3 Months Ended

Mar. 31, 2024

Mar. 31, 2023

CASH FLOWS FROM OPERATING ACTIVITIES

Profit/(Loss) for the period € 58,909 € (18,127)

Gain from sale of Priority Review Voucher, net (90,833) 0

Adjustments for non-cash transactions 15,072 8,438

Changes in non-current operating assets and liabilities (529) (269)

Changes in working capital (10,923) (13,935)

Cash generated/(used) in operations (28,303) (23,893)

Income tax paid (129) (433)

NET CASH GENERATED FROM/(USED IN) OPERATING ACTIVITIES (28,432) (24,326)

CASH FLOWS FROM INVESTING ACTIVITIES

Purchases of property, plant and equipment (4,498) (3,846)

Proceeds from sale of property, plant and equipment 146 33

Purchases of intangible assets (34) 0

Proceeds from sale of Priority Review Voucher 90,833 0

Interest received 266 253

NET CASH GENERATED FROM/(USED IN) INVESTING ACTIVITIES 86,713 (3,561)

CASH FLOWS FROM FINANCING ACTIVITIES

Proceeds/(payments) from issuance of common stock, net of costs of equity transactions 0 (194)

Proceeds from borrowings, net of transaction costs (944) 0

Payment of lease liabilities (677) (933)

Interest paid (5,836) (2,689)

NET CASH GENERATED FROM/(USED IN) FINANCING ACTIVITIES (7,457) (3,816)

NET CHANGE IN CASH AND CASH EQUIVALENTS 50,824 (31,703)

Cash and cash equivalents at beginning of the year 126,080 286,532

Exchange gains/(losses) on cash (264) (344)

CASH AND CASH EQUIVALENTS AT END OF THE PERIOD € 176,640 € 254,485

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Total

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Share premium

Other reserves

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Total comprehensive income/(loss) (16,500) 1,628 (18,127)

Income appropriation 0 (143,279) 143,279

Share-based compensation expense:

Value of services 1,489 1,489

Exercises (3) (3)

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Equity, beginning balance at Dec. 31, 2023 128,247 20,837 594,003 65,088 (450,253) (101,429)

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Income appropriation 0 (101,429) 101,429

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Exercises 0 55 (55)

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Name: ifrs-full_IncreaseDecreaseThroughAppropriationOfRetainedEarnings

Namespace Prefix: ifrs-full_

Data Type: xbrli:monetaryItemType

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Period Type: duration

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- Definition
The increase (decrease) in equity resulting from share-based payment transactions. [Refer: Equity]
+ References
Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Name IAS
-Number 1
-IssueDate 2023-01-01
-Paragraph 106
-Subparagraph d
-Clause iii
-URI https://taxonomy.ifrs.org/xifrs-link?type=IAS&num=1&code=ifrs-tx-2023-en-r&anchor=para_106_d_iii&doctype=Standard
-URIDate 2023-03-23
+ Details

Name: ifrs-full_IncreaseDecreaseThroughSharebasedPaymentTransactions

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- Definition
Increase (Decrease) Through Share-Based Payment Transactions, Value Of Services, Equity
+ References
No definition available.
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Data Type: xbrli:monetaryItemType

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- Definition
Share-Based Compensation
+ References
No definition available.
+ Details

Name: valn_ShareBasedCompensationAbstract

Namespace Prefix: valn_

Data Type: xbrli:stringItemType

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Cover	3 Months Ended
Cover	Mar. 31, 2024
Cover [Abstract]
Document Type	6-K
Entity Registrant Name	VALNEVA SE
Entity Central Index Key	0001836564
Amendment Flag	false
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q1
Current Fiscal Year End Date	--12-31
Document Period End Date	Mar. 31, 2024

Unaudited Interim Condensed Consolidated Statements of Income (Loss) - EUR (€) € in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Profit or loss [abstract]
Product sales	€ 32,149	€ 32,100
Other revenues	604	1,408
REVENUES	32,753	33,508
Cost of goods and services	(22,160)	(20,480)
Research and development expenses	(13,131)	(14,065)
Marketing and distribution expenses	(11,333)	(8,986)
General and administrative expenses	(11,670)	(10,038)
Gain from sale of Priority Review Voucher, net	90,833	0
Other income and expenses, net	2,917	3,488
OPERATING PROFIT/(LOSS)	68,208	(16,574)
Finance income	266	253
Finance expenses	(7,045)	(5,096)
Foreign exchange gain/(loss), net	(2,512)	3,170
PROFIT/(LOSS) BEFORE INCOME TAX	58,918	(18,247)
Income tax benefit/(expense)	(8)	120
PROFIT/(LOSS) FOR THE PERIOD	€ 58,909	€ (18,127)
Earnings/(losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (expressed in € per share)
Basic earnings (losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (in euro per share)	€ 0.42	€ (0.13)
Diluted earnings (losses) per share for profit/(loss) for the period attributable to the equity holders of the Company (in euro per share)	€ 0.41	€ (0.13)

Unaudited Interim Condensed Consolidated Statements of Comprehensive Income (Loss) - EUR (€) € in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Statement of comprehensive income [abstract]
PROFIT/(LOSS) FOR THE PERIOD	€ 58,909	€ (18,127)
Items that may be reclassified to profit or loss
Currency translation differences	(57)	1,628
Other comprehensive income/(loss) for the period, net of tax	(57)	1,628
TOTAL COMPREHENSIVE INCOME/(LOSS) FOR THE PERIOD	€ 58,853	€ (16,500)

Unaudited Interim Condensed Consolidated Statement of Financial Position - EUR (€) € in Thousands	Mar. 31, 2024	Dec. 31, 2023
ASSETS
Non-current assets	€ 196,588	€ 197,238
Intangible assets	24,853	25,567
Right of use assets	19,267	20,392
Property, plant and equipment	136,696	136,198
Deferred tax assets	7,006	6,592
Other non-current assets	8,766	8,490
Current assets	306,241	262,824
Inventories	48,585	44,466
Trade receivables	27,285	41,645
Other current assets	53,732	50,633
Cash and cash equivalents	176,640	126,080
TOTAL ASSETS	502,829	460,062
EQUITY
Share capital	20,892	20,837
Share premium	593,948	594,003
Other reserves	67,162	65,088
Retained earnings/(Accumulated deficit)	(551,682)	(450,253)
Profit/(Loss) for the period	58,909	(101,429)
TOTAL EQUITY	189,230	128,247
LIABILITIES
Non-current liabilities	197,515	172,952
Borrowings	159,035	132,768
Lease liabilities	27,547	29,090
Refund liabilities	6,350	6,303
Provisions	810	1,074
Deferred tax liabilities	3,704	3,638
Other liabilities	70	79
Current liabilities	116,085	158,863
Borrowings	22,413	44,079
Trade payables and accruals	33,506	44,303
Income tax liability	746	632
Tax and Employee-related liabilities	17,271	16,209
Lease liabilities	2,676	2,879
Contract liabilities	5,291	5,697
Refund liabilities	24,258	33,637
Provisions	9,553	10,835
Other liabilities	371	592
TOTAL LIABILITIES	313,600	331,815
TOTAL EQUITY AND LIABILITIES	€ 502,829	€ 460,062

Unaudited Interim Condensed Consolidated Statement of Cash Flows - EUR (€) € in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES
Profit/(Loss) for the period	€ 58,909	€ (18,127)
Gain from sale of Priority Review Voucher, net	(90,833)	0
Adjustments for non-cash transactions	15,072	8,438
Changes in non-current operating assets and liabilities	(529)	(269)
Changes in working capital	(10,923)	(13,935)
Cash generated/(used) in operations	(28,303)	(23,893)
Income tax paid	(129)	(433)
NET CASH GENERATED FROM/(USED IN) OPERATING ACTIVITIES	(28,432)	(24,326)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment	(4,498)	(3,846)
Proceeds from sale of property, plant and equipment	146	33
Purchases of intangible assets	(34)	0
Proceeds from sale of Priority Review Voucher	90,833	0
Interest received	266	253
NET CASH GENERATED FROM/(USED IN) INVESTING ACTIVITIES	86,713	(3,561)
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds/(payments) from issuance of common stock, net of costs of equity transactions	0	(194)
Proceeds from borrowings, net of transaction costs	(944)	0
Payment of lease liabilities	(677)	(933)
Interest paid	(5,836)	(2,689)
NET CASH GENERATED FROM/(USED IN) FINANCING ACTIVITIES	(7,457)	(3,816)
NET CHANGE IN CASH AND CASH EQUIVALENTS	50,824	(31,703)
Cash and cash equivalents at beginning of the year	126,080	286,532
Exchange gains/(losses) on cash	(264)	(344)
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD	€ 176,640	€ 254,485

Unaudited Interim Condensed Consolidated Statement of Changes in Equity - EUR (€) € in Thousands	Total	Share capital	Share premium	Other reserves	Retained earnings/ (Accumulated deficit)	Profit/(loss) for the period
Equity, beginning balance at Dec. 31, 2022	€ 219,797	€ 20,755	€ 594,043	€ 55,252	€ (306,974)	€ (143,279)
Total comprehensive income/(loss)	(16,500)			1,628		(18,127)
Income appropriation	0				(143,279)	143,279
Share-based compensation expense:
Value of services	1,489			1,489
Exercises	(3)	(3)
Equity, ending balance at Mar. 31, 2023	204,783	20,752	594,043	58,369	(450,253)	(18,127)
Equity, beginning balance at Dec. 31, 2023	128,247	20,837	594,003	65,088	(450,253)	(101,429)
Total comprehensive income/(loss)	58,853			(57)		58,909
Income appropriation	0				(101,429)	101,429
Share-based compensation expense:
Value of services	2,130			2,130
Exercises	0	55	(55)
Equity, ending balance at Mar. 31, 2024	€ 189,230	€ 20,892	€ 593,948	€ 67,162	€ (551,682)	€ 58,909