Profile
Sector:
HealthcareIndustry:
BiotechnologyCountry:
FranceIPO:
05 May 2021Website:
http://valneva.comNext earnings report:
20 March 2025Last dividends:
N/ANext dividends:
N/APrice
regular market | Wed, 20 Nov 2024 14:30:00 GMTDividend
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VALN Latest News
Saint Herblain (France) and Schlieren (Zurich) , November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world's most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech1.
Nine-Month Key Financial Highlights Total revenues of €116.6 million, including product sales of €112.5 million Net Profit of €24.7 million, including proceeds from the Priority Review Voucher (PRV)1 sale Operating profit of €34.2 million compared to an operating loss of €57.2 million in the first nine-months of 2023 Cash position of €156.3 million Includes €61.2 million in gross proceeds from recent private placement2 Lower cash burn expected in the second half of 2024 as cost contributions to the agreed R&D budget for partnered Lyme disease program were completed in the second quarter of the year Full-year 2024 Financial Guidance Narrowed Expected total product sales according to guidance between €160 million to €170 million and currently anticipated total revenues between €170 million and €180 million Expected R&D investments between €65 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Launch of the world's first chikungunya vaccine in Canada and Europe underway; Further potential approvals expected in Brazil (Q4 2024) and the UK (Q1 2025); Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution Secured exclusive worldwide license for S4V2 Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline3 - recently granted FDA Fast Track4 Submitted key label extension(s) for IXCHIQ® in Europe and Canada5 Published IXCHIQ® two-year antibody persistence and safety data in the Lancet Infectious Diseases6 further demonstrating the vaccine's highly differentiated immunological profile Awarded new $41.3 million CEPI grant7 to contribute significantly to IXCHIQ® Phase 4 costs and other studies supporting broader access to the vaccine Pfizer completed primary vaccination (three doses) in Phase 3 VALOR Lyme disease trial8 Advancing Phase 1 clinical trial for second-generation Zika vaccine candidate toward expected data readout and further decision on potential development path in 20259 Financial Information (Unaudited results, consolidated per IFRS) € in million Nine months ended September 30, 2024 2023 Total Revenues 116.6 111.8 Product Sales 112.5 106.1 Net profit/(loss) 24.7 -69.3 Adjusted EBITDA10 48.6 -46.0 Cash 156.3 171.3 Saint-Herblain (France), November 7, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported consolidated financial results for the first nine months of the year, ended September 30, 2024. The condensed consolidated interim financial results are available on the Company's website ( Financial Reports – Valneva ).
Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world's first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conferences during the fourth quarter of 2024.
Saint Herblain (France), October 3, 2024 –Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it will host an investor day at the Lotte New York Palace Hotel in New York, NY on Thursday, October 10, 2024 at 10:00 AM ET (4:00 pm CET). The meeting will be conducted in a hybrid way – in person and webcast. To register, click here.
To potentially include adolescents and antibody persistence up to two years Saint Herblain (France), September 18, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada. The Canadian label extension application also includes two-year antibody persistence data, which is a key differentiator for IXCHIQ® that was already included in the initial EMA filing.
Saint-Herblain (France), September 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces the successful pricing of its Private Placement (as defined below) for a final amount of €61,180,000.
Saint-Herblain (France), September 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (“Valneva” or the “Company”), a specialty vaccine company, today announces its intention to issue, subject to market conditions, approximately 22.6 million new ordinary shares (the “Offer Shares”) at a price of €2.66 per Offer Share to certain categories of investors via a private placement through an accelerated bookbuilding process starting immediately.
Valneva and Pfizer report positive immunogenicity and safety data from their Phase 2 study of the VLA15 vaccine. Phase 3 trials for VLA15 are in progress.
The consensus price target hints at a 150.4% upside potential for Valneva (VALN). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
First-Half Sales Performance in Line with Full-Year 2024 Guidance Total revenues of €70.8 million, including product sales of €68.3 million, in line with anticipated supply and sales phasing Net Profit of €34.0 million, including proceeds from PRV sale Operating profit of €46.7 million compared to an operating loss of €35.0 million in the first half of 2023 Cash position of €131.4 million Substantially lower cash burn expected in the second half of 2024 as Valneva completed its cost contributions to the agreed R&D budget for its partnered Lyme disease program in the second quarter Significantly extended cash runway with update of debt financing agreement1 Full-year 2024 Financial Guidance Confirmed Expected total revenues between €170 million and €190 million, including €160 million to €180 million of product sales Expected R&D investments between €60 million and €75 million Expected Other income between €100 million and €110 million, including €95 million from the PRV sale Strategic Pipeline Expansion, Strong Clinical and Regulatory Execution Exclusive worldwide license for S4V Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to Valneva's R&D pipeline without impacting full-year or mid-term financial guidance2 Additional marketing authorizations for single-shot IXCHIQ® granted in Europe and Canada ahead of initial guidance; Ongoing regulatory reviews in the UK and Brazil; Recommended by ACIP and adopted by U.S. CDC3 New CEPI grant4 of $41.3 million contributes significantly to Phase 4 costs and other studies supporting broader access to the world's first chikungunya vaccine Reported positive six-month data for Phase 3 adolescent study of IXCHIQ® 5; expects to submit label extensions for 12 to 17 years old in the U.S., Europe and Canada in the second half of 2024 IXCHIQ® two-year antibody persistence data published in the Lancet Infectious Diseases IXCHIQ® pediatric Phase 2 study fully enrolled Completed primary vaccinations (three doses) of VALOR Lyme disease Phase 3 trial participants6 Initiated Phase 1 clinical trial for second-generation Zika vaccine candidate7 Financial Information (Unaudited results, consolidated per IFRS) € in million 6 months ended June 30, 2024 2023 Total revenues 70.8 73.7 Product sales 68.3 69.7 Net profit / loss 34.0 (35.0) Adjusted EBITDA8 56.2 (28.3) Cash 131.4 204.4 Saint-Herblain (France), August 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its consolidated financial results for the first half of the year, ended June 30, 2024. The half year financial report, including the condensed consolidated interim financial report and the half year management report, is available on the Company's website (Financial Reports – Valneva).
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What type of business is Valneva SE?
Valneva SE, a specialty vaccine company, develops, manufactures, and commercializes prophylactic vaccines for infectious diseases with unmet needs. It offers IXIARO, an inactivated Vero cell culture-derived Japanese encephalitis vaccine indicated for active immunization against Japanese encephalitis; DUKORAL, an oral vaccine for the prevention of diarrhea caused by Vibrio cholera and/or heat-labile toxin producing enterotoxigenic Escherichia coli bacterium; IXCHIQ, a single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus; and VLA2001, an inactivated whole-virus COVID-19 vaccine. The company also develops VLA15, a vaccine candidate, which is in Phase III clinical trial against Borrelia, the bacterium that causes Lyme disease; VLA1553, a vaccine candidate, which is in Phase III clinical trial against the chikungunya virus; VLA1554, a vaccine candidate targeting human metapneumovirus; and VLA2112, a vaccine candidate to treat patients with epstein-barr virus. It sells its products in the United States, Canada, Germany, Austria, Nordics, the United Kingdom, France, rest of European countries, and internationally. Valneva SE has collaborations with Pfizer, Inc. to co-develop and commercialize its Lyme disease vaccine; and Instituto Butantan for the development, manufacturing, and marketing of single-shot chikungunya vaccine. The company was founded in 1998 and is based in Saint-Herblain, France.
What sector is Valneva SE in?
Valneva SE is in the Healthcare sector
What industry is Valneva SE in?
Valneva SE is in the Biotechnology industry
What country is Valneva SE from?
Valneva SE is headquartered in France
When did Valneva SE go public?
Valneva SE initial public offering (IPO) was on 05 May 2021
What is Valneva SE website?
https://valneva.com
Is Valneva SE in the S&P 500?
No, Valneva SE is not included in the S&P 500 index
Is Valneva SE in the NASDAQ 100?
No, Valneva SE is not included in the NASDAQ 100 index
Is Valneva SE in the Dow Jones?
No, Valneva SE is not included in the Dow Jones index
When was Valneva SE the previous earnings report?
No data
When does Valneva SE earnings report?
The next expected earnings date for Valneva SE is 20 March 2025