Latest news with #PaulChaplin
Yahoo
09-05-2025
- Business
- Yahoo
Bavarian Nordic Announces Interim Results for the First Three Months of 2025
COPENHAGEN, Denmark, May 9, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first three months of 2025. Revenue for the first three months increased by 62% to DKK 1,347 million, reflecting a strong performance in both Travel Health and Public Preparedness. Travel Health revenue increased by 52% to DKK 680 million compared to the first quarter of 2024, primarily driven by increased demand for rabies and tick-borne encephalitis (TBE) vaccines. Public Preparedness revenue increased by 83% to DKK 629 million compared to the first quarter of 2024. This exceeded initial expectations due to successful efforts to advance the deliveries of a few, but larger, existing orders into the first quarter. Other revenue was DKK 37 million. The operating profit (EBITDA) was DKK 420 million, corresponding to an EBITDA margin of 31%. Financial guidance for the full year is maintained at a revenue of DKK 5,700-6,700 million and an EBITDA margin of 26-30%. DKK million 3m 2025 3m 2024 2025 Guidance Revenue 1,347 831 5,700 – 6,700 EBITDA margin 31% 3% 26-30% Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: 'A very strong first quarter for our Travel Health business, demonstrating a 52% growth year-over-year and puts us ahead of our strategic goal of an average annual growth rate of 10-12% for this part of the business until 2027. We also recorded our first US sales of the chikungunya vaccine after its approval in February and ahead of the April recommendation from ACIP. Our phased launch plan for the vaccine is progressing as planned with the first European markets coming online over the next couple of months while we also continue our efforts to expand the regulatory approvals to other territories. Chikungunya represents an increasing public health threat across the globe, and we are proud to have entered our first partnership to improve access to the vaccine for low- and middle-income countries. In Public Preparedness, we also delivered above expectations. While this was largely due to a number of deliveries occurring ahead of plans, it goes to show the strength and scale of our manufacturing setup to meet the increased demand for our mpox/smallpox vaccine.' Highlights from the first quarter Travel Health Vimkunya was approved in the US and EU in February as the first virus-like particle (VLP)-based chikungunya vaccine and the first chikungunya vaccine for persons aged 12 years and older. Additionally, regulatory submissions were filed in the UK and Canada. Vimkunya was launched commercially in the US in March and will be launched in the first European markets later during the first half of 2025. Concurrently with the US approval of Vimkunya, Bavarian Nordic was granted a Priority Review Voucher, which the Company intends to monetize when appropriate. A strategic partnership was entered with Biological E. Limited in February, initially comprising a contract manufacturing agreement with the aim to provide capacity for the future supply of chikungunya vaccines to endemic low- and middle-income countries. Public Preparedness The freeze-dried version of JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in March for prevention of smallpox and mpox disease in adults 18 years of age and older. The approval supports the ongoing contract with the US government for stockpiling of the vaccine. Other business In January, Bavarian Nordic launched and completed a share buy-back program of DKK 150 million, with the purpose of adjusting the capital structure. Events after the reporting date In April, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Vimkunya™ for the prevention of disease caused by chikungunya virus for US persons aged 12 and older traveling to regions with an outbreak or elevated risk of chikungunya, as well as for laboratory workers with potential for exposure to chikungunya virus. In May, the UK Medicines and Healthcare products Regulatory Agency granted marketing authorization in the United Kingdom for Vimkunya® for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. In May, the US government exercised additional options valued at USD 143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine, with planned delivery in 2026. Conference call and webcastThe management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via To join the Q&A session, please register in advance via Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 03 Company Announcement no. 16 / 2025 About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Attachment Interim Report Q1 2025
Yahoo
09-05-2025
- Business
- Yahoo
Bavarian Nordic Announces Interim Results for the First Three Months of 2025
COPENHAGEN, Denmark, May 9, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first three months of 2025. Revenue for the first three months increased by 62% to DKK 1,347 million, reflecting a strong performance in both Travel Health and Public Preparedness. Travel Health revenue increased by 52% to DKK 680 million compared to the first quarter of 2024, primarily driven by increased demand for rabies and tick-borne encephalitis (TBE) vaccines. Public Preparedness revenue increased by 83% to DKK 629 million compared to the first quarter of 2024. This exceeded initial expectations due to successful efforts to advance the deliveries of a few, but larger, existing orders into the first quarter. Other revenue was DKK 37 million. The operating profit (EBITDA) was DKK 420 million, corresponding to an EBITDA margin of 31%. Financial guidance for the full year is maintained at a revenue of DKK 5,700-6,700 million and an EBITDA margin of 26-30%. DKK million 3m 2025 3m 2024 2025 Guidance Revenue 1,347 831 5,700 – 6,700 EBITDA margin 31% 3% 26-30% Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: 'A very strong first quarter for our Travel Health business, demonstrating a 52% growth year-over-year and puts us ahead of our strategic goal of an average annual growth rate of 10-12% for this part of the business until 2027. We also recorded our first US sales of the chikungunya vaccine after its approval in February and ahead of the April recommendation from ACIP. Our phased launch plan for the vaccine is progressing as planned with the first European markets coming online over the next couple of months while we also continue our efforts to expand the regulatory approvals to other territories. Chikungunya represents an increasing public health threat across the globe, and we are proud to have entered our first partnership to improve access to the vaccine for low- and middle-income countries. In Public Preparedness, we also delivered above expectations. While this was largely due to a number of deliveries occurring ahead of plans, it goes to show the strength and scale of our manufacturing setup to meet the increased demand for our mpox/smallpox vaccine.' Highlights from the first quarter Travel Health Vimkunya was approved in the US and EU in February as the first virus-like particle (VLP)-based chikungunya vaccine and the first chikungunya vaccine for persons aged 12 years and older. Additionally, regulatory submissions were filed in the UK and Canada. Vimkunya was launched commercially in the US in March and will be launched in the first European markets later during the first half of 2025. Concurrently with the US approval of Vimkunya, Bavarian Nordic was granted a Priority Review Voucher, which the Company intends to monetize when appropriate. A strategic partnership was entered with Biological E. Limited in February, initially comprising a contract manufacturing agreement with the aim to provide capacity for the future supply of chikungunya vaccines to endemic low- and middle-income countries. Public Preparedness The freeze-dried version of JYNNEOS was approved by the U.S. Food and Drug Administration (FDA) in March for prevention of smallpox and mpox disease in adults 18 years of age and older. The approval supports the ongoing contract with the US government for stockpiling of the vaccine. Other business In January, Bavarian Nordic launched and completed a share buy-back program of DKK 150 million, with the purpose of adjusting the capital structure. Events after the reporting date In April, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Vimkunya™ for the prevention of disease caused by chikungunya virus for US persons aged 12 and older traveling to regions with an outbreak or elevated risk of chikungunya, as well as for laboratory workers with potential for exposure to chikungunya virus. In May, the UK Medicines and Healthcare products Regulatory Agency granted marketing authorization in the United Kingdom for Vimkunya® for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. In May, the US government exercised additional options valued at USD 143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine, with planned delivery in 2026. Conference call and webcastThe management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via To join the Q&A session, please register in advance via Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 03 Company Announcement no. 16 / 2025 About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Attachment Interim Report Q1 2025Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-05-2025
- Business
- Yahoo
Bavarian Nordic Awarded Contract Options from the U.S. Government for Production and Supply of Freeze-dried Smallpox/Mpox Vaccines
Bavarian Nordic A/S Exercised options total USD 143.6 million Secures manufacturing and supply of freeze-dried JYNNEOS® to the U.S. in 2026 COPENHAGEN, Denmark, May 6, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), has exercised additional options valued at USD 143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine. The options support the manufacturing and supply of freeze-dried JYNNEOS by conversion of bulk vaccine, previously manufactured under other contract options, as well as supplemental payments for all doses procured under the freeze-dried contract, triggered by the demonstration of an extended shelf-life. The supplemental payments will be invoiced pro rata with deliveries of the freeze-dried vaccines. Deliveries under the new contract options are planned for 2026. Bavarian Nordic's financial guidance for 2025 remains unchanged at total revenues of DKK 5,700-6,700 million and an EBITDA margin of 26-30%. From the Public Preparedness business, revenue of DKK 3,000-4,000 million is still expected, of which DKK 2,650 million has been secured, which is an increase of DKK 150 million following exercise of the options. Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Following the recent FDA approval of the freeze-dried formulation of our smallpox/mpox vaccine, we applaud the U.S. government's steadfast commitment to improving national health security through the exercise of these options. The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect U.S citizens against life-threatening diseases.' About our contracts with the U.S. government Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox and mpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. Approved by the FDA in 2019, JYNNEOS was the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) threats through public-private partnerships.
Yahoo
06-05-2025
- Health
- Yahoo
US government exercises $144m option for smallpox
Amid a US measles outbreak the US government has placed a $143.6m order for Bavarian Nordic's smallpox/mpox jab Jynneos to bolster its infectious disease preparedness. The order is part of a ten-year contract awarded to vaccine-developer Bavarian Nordic by the US government's Biomedical Advanced Research and Development Authority (BARDA). The agreement between the pair includes options valued at $299m for the fill and finish of freeze-dried vaccines. Deliveries under the new contract options are planned for 2026. The additional options exercised by BARDA support the manufacturing and supply of freeze-dried Jynneos by conversion of bulk vaccine, as well as supplemental payments for all doses procured under the freeze-dried contract. The latter was triggered after the freeze-dried formulation's extended shelf life was demonstrated. The freeze-dried formulation of Jynneos provides greater flexibility in stockpiling. The US Food and Drug Administration (FDA) approved this version in March 2025 after Bavarian Nordic demonstrated comparability to the older liquid formulation in terms of immune responses. Bavarian Nordic has supplied a liquid-frozen formulation of its vaccine to the US government for stockpiling since 2010 and ramped up production in response to the mpox outbreak in 2022-2023. Liquid-frozen formulations require a temperature-controlled supply chain that keeps them frozen between production up until being used on a patient. Freeze-dried formulations have fewer supply chain limitations, conferring advantages such as easier transportation, storage conditions, and extended shelf life. Freeze drying is a dehydration process to extend its shelf life and molecular stability. Bavarian Nordic's CEO Paul Chaplin said: 'The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect US citizens against life-threatening diseases.' The ten-year contract for the freeze-dried version came amid calls to stockpile vaccines with longer shelf-lives. With the $144m order, Bavarian Nordic stated that $284m of the $299m has been exercised to-date. For a time, Jynneos was the only FDA-approved vaccine for the prevention of mpox. Emergent BioSolutions' ACAM2000 then became the second vaccine for the infectious disease, winning FDA approval to prevent mpox in those at high risk of infection in August 2024. Bavarian Nordic's product, also known as MVA-BN and Imvanex in other regions, has been a key pillar of fighting the ongoing mpox outbreak in Africa. The biotech has sent more than a million doses of the vaccine to countries experiencing outbreaks and promised further ramp-ups in vaccine production.
Yahoo
02-05-2025
- Health
- Yahoo
Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom
COPENHAGEN, Denmark, May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approvals from certain other regulatory bodies, in this case the recent approval by the European Commission. Bavarian Nordic is targeting launch of the vaccine in the UK during the summer of 2025. 'Chikungunya mostly represents a risk for UK citizens traveling overseas to affected regions in the Americas, Africa and Asia, but as recent research has shown, invasive mosquitos known to carry the disease have established themselves in many parts of Southern Europe and are moving further north due to climate change1,' said Paul Chaplin, President and CEO of Bavarian Nordic. 'The mosquitos cannot be stopped, but with preventative measures such as vaccines, we can mitigate the impact of emerging diseases like chikungunya for those at risk, and we look forward to launching our vaccine in the UK later this year.' The UK approval of VIMKUNYA marks the third approval of Bavarian Nordic's chikungunya vaccine, which was approved by the U.S. Food and Drug Administration (FDA) and the European Commission in February 2025.2,3 Bavarian Nordic has also submitted an application to Health Canada, potentially supporting approval of the chikungunya vaccine in the first half of 2026. About chikungunyaChikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years4. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover within 1-2 weeks, but 30-40% of those affected may develop chronic arthritis that can last for months or even years5. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide6. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile7. About VIMKUNYA® Chikungunya vaccine (recombinant, adsorbed)VIMKUNYA is a single dose, prefilled, adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. The US, EU and UK approvals of VIMKUNYA (CHIKV VLP vaccine) were all based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals, (97.8% in individuals 12 years to 64 and 87.3% in over 65 year olds). The key secondary endpoint of seroresponse rate at day 8 post vaccination was 46.6% and 96.8% at day 15 in the 12-64 year old population and 82.3% at day 15 for the over 65 population. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature. The most common side effects were pain at the injection site, fatigue, headache, and muscle pain. About Bavarian NordicBavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. Contact investors:Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@ Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@ Tel: +1 781 686 9600 Contact media:Nicole Seroff, Vice President Corporate Communications, nise@ Tel: +45 53 88 06 031 European Centre for Disease Prevention and Control. Increasing risk of mosquito-borne diseases in EU/EEA following spread of Aedes species. 2 Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 3 Bavarian Nordic Receives Marketing Authorization in Europe for Chikungunya Vaccine for Persons Aged 12 and Older. 4 Centers for Disease Control and Prevention. Areas at Risk for Chikungunya. 5 European Centre for Disease Prevention and Control. Chikungunya virus disease. 6 European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 7 Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr 30;34:100753. doi: 10.1016/ PMID: 38711542; PMCID: 2025-05-02-enSign in to access your portfolio
