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Bavarian Nordic announces results for the first half of 2024


Bavarian Nordic announces results for the first half of 2024

COPENHAGEN, Denmark, August 22, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced its preliminary financial results and business performance for the first half of 2024 and published its financial calendar for 2025.

  • Sales for the first half of the year amounted to DKK 2,259 million and operating profit (EBITDA) to DKK 441 million.
  • Revenue from travel health increased by 15% to DKK 1,119 million and revenue from public provision amounted to DKK 1,024 million, which is in line with the company’s expectations. Other revenue amounted to DKK 116 million.
  • Sales from Rabipur/RabAvert and Encepur have reached levels that exceed original expectations at the time of acquisition, triggering a sales milestone of DKK 186 million to GSK, payable in the third quarter of 2024.
  • Bavarian Nordic confirms its new forecast for the full year at the upper end of the range with total sales of approximately DKK 5,300 million and EBITDA of approximately DKK 1,350 million. The public pension income included in the new forecast is now largely secured by contracts.
Million DKK 2nd quarter 2024 2nd quarter 2023 1st half of 2024 1st half of 2023 Forecast 2024
revenue 1,427 1,987 2,259 3,239 ~5,300
EBITDA 420 690 441 1,171 ~1,350

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: “We are pleased to report strong developments for Bavarian Nordic in the first half of 2024. Unfortunately, Mpox is once again making global headlines due to the record number of cases in Africa. The situation has prompted the African CDC and WHO to declare a public health emergency and Bavarian Nordic is working closely with all stakeholders to ensure equitable access to our Mpox vaccine. Importantly, we have built a strong partnership with the Africa Centers of Disease Control (CDC), both in exploring supply and expanding our manufacturing network to Africa. We are also working with the WHO on a regulatory pathway to ensure access in all countries, while in parallel we are pursuing approval for use in adolescents and conducting clinical trials in Africa to expand use to children. A recent order of MVA-BN was secured from an undisclosed European country, which was expected as part of the 2024 guidance and therefore has no impact on remaining vaccine capacity. In response to recent events, the company plans to increase vaccine production to continue to ensure equitable access to our Mpox vaccine. Therefore, we have the capacity to produce 10 million doses by the end of 2025 in addition to our current orders and could already deliver up to 2 million doses this year. Bavarian Nordic is ready to work with the international community to play our role in protecting and saving lives around the world and to contain the recent outbreak.”

Highlights from this period

  • In April, Bavarian Nordic launched its mpox vaccine in the US, expanding access to JYNNEOS® for risk groups.
  • In April, Bavarian Nordic initiated a rolling BLA application for its chikungunya vaccine candidate to the U.S. Food and Drug Administration (FDA). The application was completed in June and in August, the FDA accepted the BLA with priority review.
  • In April, Bavarian Nordic received a contract worth EUR 65 million to supply smallpox vaccines for the rescEU stockpile in 2025.
  • In May, Bavarian Nordic announced the departure of Laurence de Moerlooze, Executive Vice President and Chief Medical Officer. A search process has been initiated to identify the next Chief Medical Officer.
  • In May, Bavarian Nordic received funding from CEPI to conduct a clinical trial of the Mpox vaccine in an African population. This could support an extension of the current regulatory approvals to children aged two and above and potentially also the approval of the vaccine in Africa.
  • In May, Bavarian Nordic submitted a supplemental BLA application to the FDA requesting approval of a freeze-dried formulation of the MVA-BN smallpox and mpox vaccine.
  • In June, Bavarian Nordic submitted a Marketing Authorization Application (MAA) for its chikungunya vaccine candidate to the European Medicines Agency (EMA). The MAA was accepted in July, marking the start of the centralized review process under the accelerated procedure.
  • In June, Bavarian Nordic announced a donation of Mpox vaccines to support the public health response in Africa led by a consortium of global partners including Gavi, WHO and UNICEF.

Events after the balance sheet date

  • In July, Bavarian Nordic announced the conversion of its existing undrawn revolving credit facility of DKK 1 billion into a Sustainability-Linked Loan (SLL).
  • In July, Bavarian Nordic received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommending the approval of a Type II variation for IMVANEX.® (MVA-BN) Smallpox and Mpox vaccine, including real-world efficacy data from the use of the vaccine during the global Mpox outbreak in 2022 under market authorization.
  • In August, Bavarian Nordic received a new contract from the US government worth USD 156.8 million, mainly for the production of additional mass products for JYNNEOS® Smallpox/mpox vaccine. Mass production and invoicing will take place in 2024.
  • In August, Bavarian Nordic received a new order from the European Health Emergency Preparedness and Response Authority (HERA) for 175,420 doses of the company’s mpox vaccine to donate to the Africa CDC. Bavarian Nordic will also donate 40,000 doses to this initiative.
  • In August, Bavarian Nordic submitted clinical data to the EMA seeking an extension of the IMVANEX® (MVA-BN®) Smallpox and Mpox vaccine indication to include adolescents aged 12 to 17 years. Subject to review, approval of the extension could occur in the fourth quarter of 2024.
  • In August, Bavarian Nordic received a new order to supply 440,000 doses of smallpox and Mpox vaccine to an undisclosed European country. The order was planned as part of the 2024 forecast and does not affect the remaining capacity for 2024/25 for our smallpox and Mpox vaccine.

Financial calendar 2025

Annual Report 2024 5 March 2025
Annual General Meeting 9 April 2025
Three-month report (Q1) May 9, 2025
Half-year report (Q2) August 22, 2025
Nine-month report (Q3) November 14, 2025

Conference call and webcast
Bavarian Nordic management will host a conference call for investors and analysts today at 2 p.m. CEST (8 a.m. EDT) to present the interim results, followed by a question and answer session. An audio version of the conference call and presentation slides is available on the following website: https://bit.ly/bavaQ22024To participate in the question and answer session, please register in advance via https://bit.ly/bavaQ22024reg.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, [email protected]Phone: +45 61 77 47 43
USA: Graham Morrell, Paddock Circle Advisors, [email protected]Phone: +1 781 686 9600

Company Announcement No. 25 / 2024

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are the world leader in smallpox and mpox vaccines, supply governments to improve public health, and have a strong portfolio of vaccines against travel and endemic diseases. For more information, visit www.bavarian-nordic.com.

Forward-looking statements
This announcement contains forward-looking statements that involve risks, uncertainties and other factors, many of which are beyond our control and which could cause actual results to differ materially from those discussed in the forward-looking statements. Forward-looking statements include statements about our plans, objectives, future events, performance and/or other information that is not historical information. All of these forward-looking statements are expressly qualified by this cautionary statement and any other cautionary statements that may accompany the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances after the date of this release, except as required by law.

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