Saint-Herblain, France, November 9, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a company specialising in vaccines, today published its consolidated monetary effects for the first nine months of the monetary year ended 30 September. 2023. Condensed consolidated interim monetary effects will be disclosed on the Company’s website (Financial Reports – Valneva).
Valneva will livestream its 2023 nine-month earnings convention at 3:00 p. m. m. CET/9 a. m. ET today. This webcast will also be available to watch on the company’s website. Check out this link: https://edge. media-server. com/mmc/p/do4mozxx.
Peter Bühler, CFO of Valneva, commented: “In the third quarter, we continued to increase our advertising sales and are confident that we will reach our sales target for the year. We remain focused on advancing our key R&D programs.
Clinical-stage vaccine candidates
VLA1553 is a single-dose live attenuated vaccine candidate against chikungunya virus (CHIKV), a mosquito-borne virus that has spread to more than 110 countries4 and has the potential to spread rapidly. The Pan American Health Organization issued an epidemiological alert in February 2023 as the number of chikungunya cases and deaths continues to rise in the Americas5. With no preventive vaccine or quick fix available yet, chikungunya is considered a major public health threat.
VLA1553 is ultimately the world’s first and only chikungunya vaccine candidate for which regulatory review processes are underway. A BLA is lately under precedence review through the U. S. FDA. The Prescription Drug User Fee Act (PDUFA) action date is expected to expire in November 20237.
In addition, a marketing application submitted to the EMA in October 20238 and the EMA’s CHMP showed an accelerated assessment of the application based on “the primary interest of the candidate vaccine for innovation in public health and cure. “A marketing application is also under review. through Health Canada. 9
If approved, the VLA1553 could be the first vaccine authorized against chikungunya to address this unmet medical need.
The pivotal data from Phase 3 was published in The Lancet, the world’s leading peer-reviewed medical journal, in June 202314. The article provides a detailed study of the effects of Phase 3 showing that the VLA1553 demonstrated a very high serological response rate of 98. 9% in participants. 28 days after receiving the single dose.
Previous clinical data, published in Lancet Infectious Diseases, showed an immediate immune reaction with a single dose of VLA1553 between 7 and 14 days after vaccination15. This was later demonstrated through additional investigations of Phase 1 data, which showed that 100 percent of vaccinated Americans met the immune threshold16 set with the FDA through day 1417.
In addition, VLA1553 was able to demonstrate a physically powerful immune reaction that was sustained for 12 months in 99 percent of participants and was equally durable in younger and older adults. 18 This antibody patience trial (VLA1553-303) will continue to compare patience for an era. at least five years. VLA1553 uses live attenuated virus vaccine technology, which is known to induce long-lasting immunity after a single dose. Examples of live attenuated vaccines include the combination of measles, mumps, and rubella (MMR), yellow fever, and chickenpox vaccines.
An adolescent clinical study, VLA1553-321, is underway in Brazil, for which Valneva reported first-line protection data in August 202319. Funded through the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in collaboration with the Butantan Institute, the VLA1553- A clinical study of 321 adolescents is underway in Brazil. The trial aims to extend the label in this age organization following potential initial FDA approval in adults. The trial is also expected to license the vaccine in Brazil, which would be the first prospective approval for its use. in endemic populations.
To make VLA1553 more available to low- and middle-income countries (LMICs), Valneva and the Butantan Institute signed an agreement in January 2021 for the development, manufacturing, and commercialization of the VLA155320. This collaboration is part of the agreement signed between CEPI and Valneva. in July 201921, which foresees an investment of up to $24. 6 million under the European Union’s Horizon 2020 programme.
VLA1553 earned Fast Track, Breakthrough Therapeutics, and Priority Review designations from the FDA in 2018, 2021, and 2023, respectively. The sponsor of the first chikungunya vaccine, BLA, to be approved in the U. S. A U. S. citizen will be eligible for a Priority Review Voucher, or PRV. The program also granted PRIority MEdicine (PRIME) designation through the EMA in 2020 and an accelerated assessment in October 2023.
Valneva intends to advertise the VLA1553, if approved, by leveraging its existing advertising and advertising infrastructure. The global chikungunya vaccine market is expected to exceed $500 million by 203222.
LYME DISEASE VACCINE CANDIDATE: Phase VLA15 Study Underway and First Positive Booster Results Reported in Children and Adolescents
Valneva and Pfizer have published the effects of three phase 2 clinical trials of VLA15 in adult and pediatric populations, in which peak levels of antibodies against all six strains were observed. 23,24,25 These come with the September 2023 announcement of positive phase 2. immunogenicity and protection data in children and adolescents after booster vaccination with VLA15. These effects from the Phase 2 VLA15-221 study showed a strong anamnestic antibody reaction for all serotypes in pediatric (5 to 11 years) and adolescent (12 to 17 years) patients. participants, as well as adults (18 to 65 years of age), one month after a booster dose (month 19). The protection and tolerability profile of VLA15 after a booster dose is consistent with previous studies. 26
In August 2022, the corporations initiated a Phase 3 clinical study, “Lyme Vaccine for Outdoor Recreation (VALOR),” to investigate the efficacy, safety, and immunogenicity of VLA15 in participants aged five years and older in highly endemic settings in the United States. States. States and Europe27.
The VALOR study is recently underway and aims to limit participants vaccinated for two consecutive tick seasons. Participants enrolled in the first cohort will receive their booster shot as scheduled in the second quarter of 2024, ahead of the 2024 tick season. Recruitment for the issue: A vaccination of the second cohort began in the second quarter of 2023 and the general continuation of trials will be with the 2025 tick season.
Pfizer aims to submit a BLA to the FDA and a Marketing Authorization Application (MAA) to the EMA in 2026, subject to information.
VLA1601 is a highly purified, inactivated, and adjuvanted vaccine candidate that opposes mosquito-borne viral disease via Zika virus (ZIKV). Outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, and, since 2015, the Americas. Zika virus transmission persists in several countries in the Americas and other endemic regions. To date, a total of 89 countries and territories have reported evidence of mosquito-borne Zika virus infection28; However, surveillance remains limited on a global scale. There is no effective vaccine or preventative treatment, and as such, Zika remains a public health threat.
VLA1601 is being developed on Valneva’s original licensed Japanese encephalitis vaccine production platform, IXIARO, which has been optimized to expand the company’s® adjuvanted inactivated COVID-19 vaccine, VLA2001, the first to obtain marketing authorization in Europe29.
Valneva expects to restart the clinical phase in the first quarter of 2024.
Preclinical Vaccine Candidates
In R
Other early-stage activities come with vaccine applicants who oppose other enteric diseases.
Valneva continues to explore potential partnership opportunities for VLA1554, its human metapneumovirus (hMPV), a global primary respiratory pathogen that causes acute upper and lower respiratory tract infections33.
Commercial Vaccines
IXIARO® is an inactivated Japanese encephalitis (JE) vaccine derived from the Vero mobile culture, which is the only Japanese encephalitis vaccine licensed and available in the United States, Canada, and Europe. IXIARO® is indicated for active immunization against Japanese encephalitis, the common leading cause of viral encephalitis in Asia, in adults, adolescents, youth, and infants two months of age and older.
In the first nine months of 2023, IXIARO/ ® JESPECT® sales increased by 119. 4% to €50. 3 million compared to €22. 9 million in the first nine months of 2022, benefiting from a significant recovery in personal markets following the fall of the Covid-19 pandemic, as well as price increases.
In September 2023, Valneva announced the signing of a one-year contract with the U. S. Department of Defense. U. S. Department of Homeland Security (DoD) for the IXIARO® source. Under the new contract, the Department of Defense will acquire a minimum value of $32 million worth of IXIARO® vaccines and has the option to procure more doses through the 12-month contract. The first doses were delivered in September.
CHOLERA VACCINE/ETEC34-DIARRHEA (DUKORAL) ®
In the first nine months of 2023, DUKORAL’s® sales increased by 128. 5% to €21. 1 million from €9. 2 million in the first nine months of 2022, and also benefited from the significant recovery in personal markets and increased value. The first nine months of 2023 surpassed pre-COVID-19 sales levels in the first nine months of 2019.
INACTIVATED WHOLE VIRUS VACCINE AGAINST SARS-CoV-2
Valneva’s COVID-19 vaccine, VLA2001, is the only total inactivated virus COVID-19 vaccine approved in Europe36 and the first COVID-19 vaccine to obtain full marketing authorisation from the EMA.
Due to the relief in order volume due to the decline of the COVID-19 pandemic, Valneva suspended production of the vaccine in August 2022 and inventories were fully amortized as of December 31, 2022. In addition to licensing fees, Valneva recently applied for the withdrawal of the marketing authorization of VLA2001 in Europe. The withdrawal has been accepted through the EMA and will come into effect on December 1, 2023.
DISTRIBUTION TO THIRD PARTIES
Valneva distributes safe third-party vaccines in countries where it operates its own marketing and sales infrastructure. In the first nine months of 2023, sales of third-party products increased by 58% to €29. 1 million, to €18. 4 million in the first nine months of 2022.
Financial review for the first nine months of 202337 (consolidated and unaudited IFRS)
Revenue Valneva’s total sales were €111. 8 million in the first nine months of 2023, up from €249. 9 million in the first nine months of 2022. The 55. 3% reduction is similar to the company’s non-recurring revenue recorded the prior year, similar to the COVID-19. 19 program.
Sales of IXIARO/® JESPECT® products amounted to €50. 3 million in the first nine months of 2023, compared to €22. 9 million in the first nine months of 2022. The increase of 119. 4 % in sales is basically the result of the continued recovery of the travel market as well as the accumulation of value. The accumulation of sales of IXIARO®/JESPECT® products includes an unfavorable currency effect of 0. 7 million euros. DUKORAL® sales amounted to 21. 1 million euros in the first nine months of 2023 compared to 9. 2 million euros in the first nine months of 2022. This 128. 5% increase is also the result of significant recovery in the personal travel and value accumulation markets. Currency fluctuations reduced DUKORAL® sales by €0. 5 million. Sales of third-party products amounted to €29. 1 million in the nine months ended September 30, 2023, compared to €18. 4 million in the comparative era of 2022, an increase of 58. 0% driven primarily by sales of Rabipur/ RabAvert® and Encepur®® under the distribution agreement with Bavarian Nordic.
Other revenue, including revenue from collaborations, licensing and services, amounted to €5. 7 million in the first nine months of 2023, compared to €175. 5 million in the first nine months of 2022. The first nine months of 2022 included exceptional COVID-like effects. €200. 2 million consisting of repayment obligations released as a result of the agreement with the UK Government, as well as non-repayable advances released through EU Member States, partially offset by €34. 7 million of negative revenue source resulting from a building. in payment liability similar to the modified VLA15 license and collaboration agreement with Pfizer.
Operating profit and adjusted EBITDA Cost of goods and facilities sold (COGS) was €74. 8 million for the nine months ended September 30, 2023. Gross margin on sales of advertising products, excluding sales of vaccines against COVID-19, rose to 43. 7% compared to 55. 4% in the first nine months of 2022. A COGS of 26. 6 million euros was connected to sales of IXIARO® products, generating a margin gross product of 47. 2%. The COGS of €12. 7 million was related to sales of DUKORAL® products, generating a gross product margin of 39. 8%. IXIARO® gross margin was affected by batch cancellations at the Scottish production site. Additionally, the gross margins of IXIARO® and DUKORAL® were negatively affected by major indirect sales in markets where Valneva sells through distributors. Of the remaining COGS for the first nine months of 2023, €17. 3 million were similar to third-party product distribution activity, €1. 7 million to sales of COVID-19 products, and €9. 3 million to euros to the initial COGS related to the agreements for the launch of the Company Program. chikungunya vaccine candidate, as well as charges for unused capacity. The remaining COGS was similar to the service. For the nine months ended September 30, 2022, total COGS was €202. 7 million, of which €196. 6 million was similar to the goods charge and €6. 2 million was similar to the facilities. COGS for the first nine months of 2022 included cancellations similar to significant relief in sales volumes similar to those of EC Member States due to COVID-19.
Research and development expenses amounted to 42. 2 million euros in the first nine months of 2023, compared to 75. 4 million euros in the first nine months of 2022. This cut is exclusively due to the drop in spending on Valneva’s COVID-19 vaccine, VLA2001. At the same time, prices similar to those of the Zika vaccine candidate rose as the company worked to resume clinical progression. Marketing and distribution expenses for the first nine months of 2023 amounted to 33. 9 million euros compared to 13. 1 million euros for the first nine months of 2022. Marketing and distribution expenses for the first nine months of 2023 specifically include €13. 8 million of expenses related to release agreements for the chikungunya vaccine candidate, VLA1553, compared to €4. 3 million in the first nine months of 2022. During the first nine months In 2023, general and administrative expenses increased to €35. 1 million from €23. 3 million in the first nine months of 2022. During the first nine months of 2022, COGS, studies and progression, marketing and distribution, as well as general and administrative expenses, benefited from a regularization adjustment income source of 30. 6 million euros related to the favorable effect of the substitution. in the Company’s inventory value over the percentage of employees. service-based payment programs.
Valneva recorded an operating loss of €57. 2 million in the first nine months of 2023, to an operating loss of €57. 1 million in the first nine months of 2022. Adjusted EBITDA loss for the first nine months of 2023 amounted to €46. 0 million, to an operating loss of €57. 2 million in the first nine months of 2023. Adjusted EBITDA loss of €38. 0 million in the first nine months of 2022 (as explained below).
Net source of revenue In the nine months ended September 30, 2023, Valneva generated a net loss of €69. 3 million compared to a net loss of €99. 1 million in the nine months ended September 30, 2022.
Financial fees and exchange rate effects in the first nine months of 2023 resulted in a net financial expense of €13. 2 million, compared to a net financial expense of €39. 8 million in the first nine months of 2022. The difference is primarily due to a €25. 1 million minimization of the revaluation effects of non-euro-denominated balance sheet positions to a net foreign exchange loss of €1. 4 million in the first nine months of 2023, compared to €26. 5 million in the first nine months of 2022. Interest expense net of interest: Revenue amounted to €11. 8 million in the first nine months of 2023, compared to €13. 3 million in the first nine months of 2022.
Cash and liquidity Net money used in operating activities amounted to €136. 8 million in the first nine months of 2023, compared to €189. 5 million in the first nine months of 2022. Cash withdrawals in the first nine months of 2023 are basically the result of lost operations, as well as invoices for payment obligations to Pfizer similar to the R collaboration agreement
Net money generated from financing activities amounted to €26. 1 million in the first nine months of 2023, mainly due to proceeds from the additional tranche added to the existing credit facility with US healthcare investment firms Deerfield Management Company.
Non-IFRS Financial Measures
Management uses and reports IFRS results, as well as the non-IFRS measure of adjusted EBITDA, to compare and discuss its functionality. Although non-IFRS measures are not considered opportunities for IFRS measures, the control believes that non-IFRS measures are useful. into a greater understanding of Valneva’s existing functionality, functionality trends, and monetary condition.
Adjusted EBITDA is a measure of additional functionality used by investors and money analysts. Management believes this measure provides additional analytical tools. Adjusted EBITDA is explained as gains (losses) for the era before income tax source, monetary source of income/expenses, foreign exchange gain/(loss), effects of investments in associates, depreciation, amortization, impairment and impairment (excluding disposal price loss).
Subsequent Events:
Following the expiry of the lease, the subsidiary of Valneva Austria GmbH acquired on 31 October 2023 the legal entity that owns the Viennese assets that it had leased in the past on the basis of the security deposit. The acquisition price, the security deposit and the bank’s cash is approximately €10. 9 million. The Company is considering the option of a sale-leaseback transaction.
As an update to note 5. 17 of the half-yearly monetary statements 202338, the litigation similar to the acquisition of Humalys has now ended, as no appeal has been filed before the statutory deadline.
About Valneva We are a specialized vaccine company that develops, manufactures and markets prophylactic vaccines against infectious diseases that address unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise to vaccine modalities, focusing on delivering first-class, best-in-class or best-in-class vaccine solutions. We have a strong track record, having several complex vaccines in place since the early stages of R.
1 Valneva announces extension of existing loan agreement – Valneva2 Valneva submits marketing application for chikungunya vaccine to EMA and announces accelerated evaluation of CHMP3 For more information on Adjusted EBITDA, see the segment “Non-monetary measures IFRS” at the end of PR4 https: //www. who. int/news-room/fact-sheets/detail/chikungunya5https://www. paho. org/en/documents/epidemiological -alert-chikungunya-increase-region- americas6 FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review – Valneva7 Valneva Announces Extension of PDUFA Date for Its Chikungunya Virus Vaccine Candidate – Valneva8 Valneva Submits Chikungunya Vaccine Marketing Application to EMA Announces Accelerated Evaluation of CHMP9 Health Canada Accepts Valneva Chikungunya Vaccine Review Application – Valneva10 Valneva Successfully Completes Phase 3 Chikungunya Vaccine Pivotal Trial Valneva Successfully Completes Batch-to-Batch Consistency Trial of its single-shot chikungunya vaccine candidate12 Valneva reports positive 12-month antibody patience results for its single-shot vaccine candidate Chikungunya vaccine candidate: Valneva13 Valneva reports positive initial phase 3 protection data in adolescents for its single-shot chikungunya vaccine candidate – Valneva14 Valneva announces publication of Phase 3 data for its chikungunya vaccine candidate in The Lancet – Valneva15 Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, Bézay N, Klingler A, Lingnau K, Schneider M, Lundberg U, Meinke A, Larcher-Senn J, Čorbic-Ramljak I, Eder-Lingelbach S, Dubischar K, Bfinisher W. “Live attenuated single-injection chikungunya vaccine in healthy adults: a trial “randomized controlled phase 1. ” Lancet ID, 2020: 20(10):1193-1203. 16 Seroresponse17 McMahon R, Töpfer S, Schneider M, Hadl S, Hochreiter R, Kosulin K, Mader R, Zoihsl O, Wressnigg N, Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. “A year of patience with antibodies and protection from a live attenuated chikungunya virus (CHIKV) vaccine candidate (VLA1553) in adults over 18 years of age. ” CISTM. Basel, 2023. 18 Valneva publishes positive 12-month antibody persistence data for its single-shot chikungunya vaccine candidate – Valneva19 Valneva publishes positive early phase 3 safety data in adolescents for its single-shot chikungunya vaccine candidate – Valneva20 Valneva and Butantan Institute point out latest agreement on chikungunya vaccine – Chikungunya vaccine for low and middle-income countries21CEPI awards up to $23. 4 million to Valneva for the development of a single-dose chikungunya vaccine22 VacZine Analytics Analysis of global demand for vaccines against chikungunya virus. February 20, 2023 Valneva and Pfizer Release Six-Month Data on Antibody Persistence in Children and Adults for Lyme Disease Vaccine Candidate – Valneva24Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 – Valneva25 Valneva and Pfizer Announce New Positive Phase 2 Results Including Booster Response for Lyme Disease Vaccine Candidate – Valneva26 Valneva and Pfizer Announce Positive Phase 2 Booster Results in Children and Adolescent Adults for Vaccine Candidate against Lyme disease – Valneva27 Pfizer and Valneva launch phase 3 examination of Lyme disease vaccine candidate VLA15 – Valneva28 Zika virus disease (which . int) 29 Valneva receives marketing authorization in the European market for the total inactivated virus vaccine against COVID-19 VLA2001 – Valneva30https://www. cdc. gov/epsteinbarr/index. html#:~:text=EBV%20can %20cause%20infectious%20mononucleosis, not unusual %20parmi% 20teens%20and%20adults. 31https://www. cancer. org/healthy/cancer-reasons/infectious-agents/infections-that-can-lead-to cancer/viruses . html#:~:text= EBV %20infection% 20increases%20a%20person’s,some%20cases%20of%20stomach%20cancer. 32https://www. nih. gov/news-events/nih-research-matters/examine-suggests-epstein-barr-virus-could-cause- multiple-sclerosis#:~:text=Infection%20with%20Epstein%2DBarr%20virus, might%20help%20prevent%20multiple%20sclerosis33https://www. cdc. gov/ ncird/human-metapneumovirus. html34 Indications differ by country . Please refer to the approved product/prescription data (PI)/medication consultant in your respective countries for total data incl. Dose, protection and age groups for which this vaccine is authorized, ETEC = enterotoxigenic Escherichia coli bacteria (E. Coli). 35 Enterotoxigenic Escherichia coli (ETEC) is a form of Escherichia coli and one of the main bacterial causes of diarrhea in the future. countries. world, as well as the most common cause of traveler’s diarrhea. 36 Valneva receives marketing authorization in Europe for the inactivated whole virus COVID-19 vaccine VLA200137 Although the monetary figures included in this initial announcement, the provisional effects have been calculated according With International Financial Reporting Reporting Standards (IFRS Accounting Standards) applicable to interim periods, this press release does not involve sufficient data to constitute an interim monetary report as that term is explained in IFRS accounting criteria.
38 Financial Report H1 2023 EN (valneva. com)
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