Valneva Reports H1 2021 Financial Results and Provides Business Update

Key R&D Milestones Achieved

• Optimistic topline Section Three outcomes for single-shot chikungunya vaccine candidate VLA1553

• Recruitment accomplished for Section 2 trial VLA15-221 of Lyme illness vaccine candidate together with pediatric age group

• Recruitment accomplished for pivotal Section Three trial of inactivated, adjuvanted COVID-19 vaccine candidate VLA2001

Robust monetary place

• $107.6 million of gross proceeds raised in a US preliminary public providing and a concurrent non-public placement in Europe

• Money and money equivalents of €329.Eight million at June 30, 2021

2021 monetary steering (excluding COVID) reconfirmed

• Complete revenues, excluding VLA2001, of €80 million to €105 million

• R&D bills, excluding VLA2001, of €65 million to €75 million

Thomas Lingelbach, Valneva’s Chief Govt Officer, commented, “Valneva is persevering with to hit its main R&D goals. We have now simply reported nice leads to the world’s first ever Section 3 trial for a chikungunya vaccine alongside glorious progress for our distinctive COVID and Lyme illness applications. Our profitable Nasdaq itemizing marked a big strategic step for Valneva as we glance to proceed to construct our Company. Our staff has delivered phenomenally nicely this yr already and I wish to thank them for his or her continued dedication and dedication.”

Monetary Data
(unaudited outcomes, consolidated beneath IFRS)

Saint Herblain (France), August 10, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine firm targeted on the event and commercialization of prophylactic vaccines for infectious illnesses with vital unmet medical wants, at the moment reported its consolidated monetary outcomes for the primary half of the yr, ended June 30, 2021. The half yr monetary report, together with the condensed consolidated interim monetary report and the half yr administration report, is obtainable on the Firm’s web site www.valneva.com.

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Valneva will present a dwell webcast of its first half monetary outcomes convention name starting at Three p.m. CEST at the moment. This webcast may also be obtainable on the Firm’s web site. Please consult with this hyperlink: https://edge.media-server.com/mmc/p/qror7sgm

Medical Stage Vaccine Candidates

LYME DISEASE VACCINE CANDIDATE – VLA15
Acceleration of Pediatric Development

Valneva is growing VLA15, a vaccine candidate focusing on Borrelia, the bacterium that causes Lyme illness. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the commonest strains present in the USA and Europe. VLA15 is presently the one vaccine present process scientific trials towards Lyme illness.

Valneva has beforehand introduced a collaboration with Pfizer for late part growth and, if accepted, commercialization of VLA15¹. Valneva has reported optimistic preliminary outcomes for 2 Section 2 scientific trials of VLA15 in over 800 wholesome adults.

To speed up VLA15’s pediatric growth, Valneva and Pfizer initiated an extra Section 2 trial in March 2021, VLA15-221. In July 2021, Pfizer and Valneva introduced recruitment completion for VLA15-221 with a complete of 625 individuals, 5 to 65 years of age, randomized within the trial. The target of the trial is to indicate security and immunogenicity down to five years of age and to judge the optimum vaccination schedule to be used in Section 3. Topline outcomes for VLA15-221 are anticipated within the first half of 2022.

CHIKUNGUNYA VACCINE CANDIDATE – VLA1553
Optimistic Section 3 Outcomes reported

VLA1553 is a live-attenuated, single-dose vaccine candidate towards the chikungunya virus, a mosquito-borne virus that has unfold to greater than 100 nations with the potential to quickly develop additional. There are presently no preventive vaccines or efficient therapies for the chikungunya virus obtainable and, to Valneva’s data, VLA1553 is the one chikungunya vaccine candidate in Section Three scientific trials worldwide.

Initially of August 2021, Valneva introduced optimistic topline outcomes for the Section Three pivotal trial of VLA1553. The trial, involving 4,115 adults, aged 18 years and above, throughout 44 websites within the U.S., met its main endpoint inducing protecting CHIKV neutralizing antibody titers in 98.5% of individuals 28 days after receiving a single shot (264 of 268 topics from the per-protocol subgroup examined for immunogenicity, 95%CI: 96.2-99.6). The seroprotection fee results of 98.5% exceeded the 70% threshold (for non-acceptance) agreed with the FDA. The seroprotective titer was agreed with the FDA to function a surrogate of safety that may be utilized in a possible FDA submission of VLA1553 beneath the accelerated approval pathway. The vaccine candidate was extremely immunogenic with a Geometric Imply Titer of roughly 3,270, confirming the immunogenicity profile seen within the Section 1 trial.

Moreover, VLA1553 was additionally extremely immunogenic in aged research individuals, who achieved equally excessive seroprotection charges and neutralizing antibody titers as youthful adults, in addition to an equally good security profile.

VLA1553 was typically nicely tolerated among the many 3,082 topics evaluated for security. An impartial Information Security Monitoring Board constantly monitored the research and recognized no security considerations. The security profile is per outcomes from the Section 1 scientific trial. The vast majority of solicited hostile occasions had been delicate or average and resolved inside Three days. 1.6% of research individuals reported extreme solicited hostile occasions, mostly fever. Roughly 50% of research individuals skilled solicited systemic hostile occasions, mostly headache, fatigue and myalgia (seen in additional than 20% of topics). The native tolerability profile confirmed that roughly 15% of individuals skilled solicited native hostile occasions. The trial will proceed in direction of closing evaluation together with the six-month security information. Last trial outcomes are anticipated throughout the subsequent six months.

Valneva’s chikungunya program was awarded Breakthrough Remedy Designation by the FDA in July 2021. This new milestone got here along with the FDA Quick Observe designation and the European Medicines Company (EMA)’s PRIME designation which the Firm acquired in December 2018 and in October 2020, respectively. The sponsor of the primary chikungunya vaccine accepted within the U.S. might be eligible to obtain a Precedence Overview Voucher (PRV).

To make VLA1553 extra accessible to Low- and Center-Earnings International locations (LMIC), Valneva and Instituto Butantan in Brazil signed an settlement in January 2021 for the event, manufacturing and advertising and marketing of VLA1553². The collaboration falls throughout the framework of the funding settlement between Valneva and the Coalition for Epidemic Preparedness Improvements (CEPI) signed in July 2019³, which gives funding of as much as $23.Four million with help from the European Union’s Horizon 2020 program.

SARS-CoV-2 VACCINE CANDIDATE – VLA2001

Recruitment Accomplished for Pivotal Section 3 Trial

VLA2001 is presently the one entire virus, inactivated, adjuvanted vaccine candidate in scientific trials towards COVID-19 in Europe. It’s produced utilizing Valneva’s established Vero-cell platform, leveraging the manufacturing know-how for Valneva’s licensed Japanese encephalitis vaccine, IXIARO^®.

Initially of June 2021, Valneva introduced that recruitment had been accomplished for VLA2001’s pivotal Section Three trial “Cov-Examine” (VLA2001-301) with over 4,00Zero randomized individuals. Within the Section half scientific trial, VLA2001 confirmed excessive immunogenicity and was typically nicely tolerated, with no security considerations recognized⁴. Cov-Examine part Three topline information are anticipated early within the fourth quarter of 2021. Valneva expects to start rolling submission with the UK Medicines and Healthcare merchandise Regulatory Company within the coming weeks and, topic to the Section Three information, believes that preliminary approval could also be granted by the top of 2021.

In parallel to the Cov-Examine trial, Valneva is learning COVID-19 variants to be able to fabricate variant-based vaccines. Valneva can also be taking part in a UK Authorities-funded scientific trial taking a look at completely different COVID-19 “booster” vaccines. The COV-Enhance trial, led by College Hospital Southampton NHS Basis Belief, appears at seven completely different COVID-19 vaccines, together with VLA2001, as potential boosters, and can also be evaluating dosage ranges. It will likely be the primary trial on this planet to supply important information on how efficient a booster of every vaccine is in defending people from the virus. The COV-Enhance trial is totally recruited. Valneva has additionally commenced manufacturing of VLA2001 at its services in Scotland and Sweden with a purpose to optimize the timeline for potential deliveries of the vaccine.

Though vaccines towards SARS-CoV-2 have already been accepted, given the potential benefits typically related to inactivated entire virus vaccines, Valneva believes its vaccine candidate might play a job within the total portfolio of SARS-CoV-2 vaccines that can tackle the worldwide want throughout the pandemic and sooner or later.

In September 2020, Valneva introduced a collaboration with the UK Authorities, which has the choice to buy as much as 190 million doses via 2025⁵. Up to now, the UK Authorities has ordered 100 million doses for provide in 2021 and 2022.

Industrial Vaccines

JAPANESE ENCEPHALITIS VACCINE (IXIARO^®/JESPECT^®)
IXIARO^® is the one Japanese encephalitis vaccine licensed and obtainable in the USA, Canada and Europe.

Gross sales of IXIARO^® had been €25.Four million within the first half of 2021 in comparison with €28.Four million within the first half of 2020. Whereas the COVID-19 pandemic is continuous to adversely impression the journey business and vaccine gross sales to the non-public market, the impression on IXIARO^® gross sales throughout the first half of 2021 was mitigated by the Firm’s contract with the U.S. Authorities’s Division of Protection (DoD).

CHOLERA / ETEC⁶-DIARRHEA VACCINE (DUKORAL^®)

DUKORAL^® is an oral vaccine for the prevention of diarrhea brought on by Vibrio cholerae and/or heat-labile toxin producing ETEC, the main explanation for vacationers’ diarrhea. DUKORAL^® is permitted to be used within the European Union and Australia to guard towards cholera and in Canada, Switzerland, New Zealand and Thailand to guard towards cholera and ETEC⁵.

DUKORAL^® recorded gross sales of €0.Four million within the first half of 2021 in comparison with €12.1 million within the first half of 2020. First half 2021 gross sales continued to be considerably affected by the COVID-19 pandemic’s impression on the journey business.

First Half 2021 Monetary Overview
(Unaudited, consolidated beneath IFRS)

Revenues
Valneva’s whole revenues had been €47.5 million within the first half of 2021 in comparison with €47.9 million within the first half of 2020. Product gross sales declined by 22.4% to €31.Eight million within the first half of 2021 in comparison with €40.9 million within the first half of 2020. On a continuing trade fee (CER) foundation, product gross sales declined by 18.6% within the first half of 2021 in comparison with the primary half of 2020 as a result of impression of the COVID-19 pandemic on the journey business. IXIARO^®/JESPECT^® gross sales declined by 10.6% (3.5% at CER) to €25.Four million and DUKORAL^® gross sales by 96.5% (96.6% at CER) to
€0.Four million within the first half of 2021 in comparison with €28.Four million and €12.1 million respectively within the first half of 2020. Third Social gathering product gross sales grew to €5.9 million within the first half of 2021 from €0.Four million within the first half of 2020. The rise in Third Social gathering product gross sales was pushed by incremental gross sales associated to Valneva’s distribution settlement with Bavarian Nordic for the gross sales of Rabipur^®/RabAvert^® and Encepur^® in sure territories that commenced in 2021.
Different Revenues, together with revenues from collaborations, licensing and providers, amounted to €15.7 million within the first half of 2021 in comparison with €7.Zero million within the first half of 2020. This enhance was attributable to greater revenues associated to the Lyme R&D collaboration settlement with Pfizer, incremental revenues associated to the collaboration with Instituto Butantan for offering VLA1553 in LMICs in addition to greater revenues generated within the CTM Manufacturing unit in Sweden.

Working Outcome and EBITDA
Prices of products and providers offered (COGS) had been €34.Eight million within the first half of 2021. Gross margin on product gross sales was 39.2% in comparison with 55.7% within the first half of 2020. The decline was primarily associated to idle capability prices mixed with compressed product gross sales, each impacting gross margin as a proportion of gross sales. COGS of €11.7 million had been associated to IXIARO^®/JESPECT^® gross sales, yielding a product gross margin of 54.1%. COGS of €3.6 million had been associated to DUKORAL^® gross sales, inflicting a unfavourable product gross margin. Of the remaining COGS within the first half of 2021,
€4.1 million had been associated to the Third-Social gathering product distribution enterprise, €4.2 million to start-up prices of the COVID-19 enterprise and €11.Three million to value of providers. Within the first half of 2020, total COGS had been €22.5 million, of which €18.1 million associated to value of products and €4.Four million associated to value of providers.
Analysis and growth investments continued to extend within the first half of 2021, rising to €78.7 million in comparison with €33.1 million within the first half of 2020. This was primarily pushed by investments in Valneva’s COVID-19 vaccine candidate VLA2001 in addition to Section Three scientific research prices for Valneva’s chikungunya vaccine program VLA1553. Excluding COVID-19, analysis and growth investments amounted to €32.6 million within the first half of 2021 in comparison with
€31.5 million within the first half of 2020. Advertising and marketing and distribution bills within the first half of 2021 amounted to €9.6 million in comparison with €10.Zero million within the first half of 2020. The lower was the results of decrease advertising and marketing and distribution spend throughout all Valneva’s direct markets as a result of diminished gross sales exercise on account of the COVID-19 pandemic. Advertising and marketing and distribution bills within the first half of 2021 notably included €2.Zero million of bills associated to the launch preparation prices of the chikungunya vaccine candidate (in comparison with none within the first half of 2020). Within the first half of 2021, normal and administrative bills elevated to €20.9 million from €10.6 million within the first half of 2020, primarily pushed by elevated prices to help company transactions and initiatives together with elevated sources in help of incremental COVID actions.
Different revenue, web of different bills, elevated to €10.Four million within the first half of 2021 from
€6.5 million within the first half of 2020. This enhance was primarily pushed by elevated R&D tax credit immediately ensuing from elevated R&D spending.
Valneva recorded an working lack of €86.2 million within the first half of 2021 in comparison with an working lack of €21.9 million within the first half of 2020. EBITDA loss within the first half of 2021 was €80.1 million in comparison with an EBITDA lack of €17.2 million within the first half of 2020.

Web Outcome
Within the first half of 2021, Valneva generated a web loss amounting to €86.Four million in comparison with a web lack of €25.6 million within the first half of 2020.
Finance prices and foreign money results within the first half of 2021 resulted in a web finance revenue of €0.5 million, in comparison with a web finance expense of €5.6 million within the first half of 2020. This was primarily a results of international trade features amounting to €8.7 million within the first half of 2021 primarily pushed by revaluation features of non-Euro denominated stability sheet positions in comparison with a web international trade loss (web of features on by-product monetary devices) of €1.7 million within the first half of 2020. Curiosity expenses elevated to €8.Four million within the first half of 2021 in comparison with €3.9 million in the identical interval of 2020. This development was pushed by elevated curiosity expenses associated to refund liabilities in addition to elevated curiosity expenses associated to the financing settlement with U.S. healthcare funds Deerfield & OrbiMed entered into in 2020.

Money Stream and Liquidity
Web money generated by working actions amounted to €84.2 million within the first half of 2021 in comparison with €113.2 million within the first half of 2020 primarily derived by milestone funds associated to the COVID provide settlement concluded with the UK Authorities in September 2020. The online money generated by working actions within the first half of 2020 primarily derived from the $130 million upfront fee acquired from Pfizer associated to the Lyme R&D collaboration settlement.
Money outflows from investing actions amounted to €39.9 million within the first half of 2021 in comparison with €1.Eight million within the first half of 2020 primarily on account of purchases of apparatus associated to the location growth actions for COVID vaccine manufacturing in each Scotland and Sweden.
Web money generated from financing actions amounted to €78.7 million within the first half of 2021 which was primarily a results of proceeds from issuance of latest shares within the U.S. preliminary public providing and European non-public placement (World Providing). Money inflows within the first half of 2020 amounted to €24.5 million and primarily consisted of web proceeds from the financing association with U.S. healthcare funds Deerfield and OrbiMed, offset by €20.Zero million of repayments of borrowings to the European Funding Financial institution.
Liquid funds elevated to €329.Eight million as of June 30, 2021 in comparison with €204.Four million as of December 31, 2020. The primary modifications associated to funds made by the UK Authorities throughout the framework of the UK COVID-19 partnership in addition to the proceeds from the World Providing in Might 2021.

Non-IFRS Monetary Measures

Administration makes use of and presents IFRS outcomes in addition to the non-IFRS measure of EBITDA to judge and talk its efficiency. Whereas non-IFRS measures shouldn’t be construed as options to IFRS measures, administration believes non-IFRS measures are helpful as an support to additional perceive Valneva’s present efficiency, efficiency tendencies, and monetary situation.

EBITDA is a standard supplemental measure of efficiency utilized by buyers and monetary analysts. Administration believes this measure present extra analytical instruments. EBITDA is outlined as earnings (loss) from persevering with operations earlier than curiosity expense, revenue taxes, depreciation and amortization.

A reconciliation of EBITDA to working loss, essentially the most immediately comparable IFRS measure, is ready forth under:

About Valneva SE
Valneva is a specialty vaccine firm targeted on the event and commercialization of prophylactic vaccines for infectious illnesses with vital unmet medical want. The Firm takes a extremely specialised and focused strategy to vaccine growth, starting with the identification of lethal and debilitating infectious illnesses that lack a prophylactic vaccine resolution and for which there are restricted therapeutic remedy choices. It then applies its deep understanding of vaccine science, together with its experience throughout a number of vaccine modalities, in addition to its established vaccine growth capabilities, to develop prophylactic vaccines to deal with these illnesses. Valneva has leveraged its experience and capabilities to efficiently commercialize two wholly owned vaccines and quickly advance a number of vaccine candidates into late-stage scientific growth, together with candidates towards Lyme illness (partnered with Pfizer), the chikungunya virus and COVID-19.

Ahead-Wanting Statements

This press launch accommodates sure forward-looking statements regarding the enterprise of Valneva, together with with respect to anticipated whole revenues and R&D bills for full fiscal yr 2021, the progress, timing and completion of analysis, growth and scientific trials for product candidates, the power to fabricate, market, commercialize and obtain market acceptance for product candidates and estimates for future efficiency. As well as, even when the precise outcomes or growth of Valneva are per the forward-looking statements contained on this press launch, these outcomes or developments of Valneva will not be indicative of future efficiency. In some instances, you possibly can determine forward-looking statements by phrases corresponding to “might,” “ought to,” “could,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “goals,” “targets,” or comparable phrases. These forward-looking statements are based mostly largely on the present expectations of Valneva as of the date of this press launch and are topic to plenty of identified and unknown dangers and uncertainties and different elements that will trigger precise outcomes, efficiency or achievements to be materially completely different from any future outcomes, efficiency or achievement expressed or implied by these forward-looking statements. Specifically, the expectations of Valneva may very well be affected by, amongst different issues, uncertainties concerned within the growth and manufacture of vaccines, surprising scientific trial outcomes, surprising regulatory actions or delays, competitors generally, foreign money fluctuations, the impression of the worldwide and European credit score disaster, and the power to acquire or preserve patent or different proprietary mental property safety, in addition to these dangers and uncertainties mentioned or recognized in Valneva’s public filings with the Autorité des Marchés Financiers (AMF) in France, together with these listed within the Firm’s 2020 Common Registration Doc filed with the AMF on April 9, 2021, which is obtainable on the Firm’s web site and on the web site of the AMF (www.amf-france.org), and public filings and reviews filed with the U.S. Securities and Trade Fee. In mild of those dangers and uncertainties, there might be no assurance that the forward-looking statements made on this press launch will in reality be realized. Valneva is offering the data in these supplies as of this press launch, and disclaims any intention or obligation to publicly replace or revise any forward-looking statements, whether or not on account of new data, future occasions, or in any other case.

1 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15
2 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries
³CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine
4 Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
5 Valneva Confirms Participation in UK Government COVID-19 Vaccine Response Program
6 Indications differ by nation – Please consult with Product / Prescribing Data (PI) / Treatment Information accepted in your respective nations for full data, incl. dosing, security and age teams through which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium.

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