Bavarian Nordic Announces First Half 2024 Results

COPENHAGEN, Denmark, August 22, 2024 - Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first half of 2024 and released its financial calendar for 2025.

Revenue for the first half was DKK 2,259 million, and the operating profit (EBITDA) was DKK 441 million.Revenue from travel health increased by 15% to DKK 1,119 million and revenue from public preparedness was DKK 1,024 million, which is in line with the Company's expectations. Other revenue was DKK 116 million.Revenues from Rabipur/RabAvert and Encepur have reached levels exceeding the original expectations at the time of acquisition, thus triggering a sales milestone of DKK 186 million to GSK, payable in the third quarter of 2024.Bavarian Nordic confirms its new guidance for the full year at the upper end of the range, with aggregated revenue of approximately DKK 5,300 million and EBITDA of approximately DKK 1,350 million. The public preparedness revenue included in the new guidance is now largely all secured by contracts.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We are pleased to report strong developments for Bavarian Nordic during the first half of 2024. Unfortunately, mpox is again making global headlines as a result of the record number of cases reported in Africa. The situation has urged the African CDC and the WHO to declare public health emergencies and Bavarian Nordic is working closely with all stakeholders to ensure the equitable access to our mpox vaccine. Importantly, we have built a strong partnership with the Africa Centers of Disease Control (CDC), both on exploring supply, but also expanding our manufacturing network to include Africa. We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and also conducting clinical studies in Africa to further expand the use to children. A recent order for MVA-BN was secured by an undisclosed European country, and this was anticipated as part of the 2024 guidance and as such, has no impact on the remaining vaccine capacity. Indeed, in response to recent events the company plans to ramp-up vaccine manufacturing to ensure the continued equitable access to our mpox vaccine. Consequently, we have the capacity to manufacture 10 million doses by the end of 2025, in addition to our current orders, and could already supply up to 2 million doses this year. Bavarian Nordic is prepared to work with the international community to play our role in protecting and saving lives around the World and to contain the latest outbreak."

Highlights from the period

In April, Bavarian Nordic launched its mpox vaccine in the U.S., thereby expanding access to JYNNEOS® for at-risk populations.In April, Bavarian Nordic initiated a rolling BLA submission for its chikungunya vaccine candidate to the U.S. Food and Drug Administration (FDA). The submission was completed in June, and in August, the FDA accepted the BLA with priority review.In April, Bavarian Nordic was awarded a contract valued at EUR 65 million for the supply of smallpox vaccines to the rescEU stockpile in 2025.In May, Bavarian Nordic announced the departure of EVP and Chief Medical Officer Laurence de Moerlooze. A search process to identify the next Chief Medical Officer has been initiated.In May, Bavarian Nordic received funding from CEPI to advance a clinical trial of the mpox vaccine in an African population, potentially supporting expansion of the current regulatory approvals to include children 2 years of age and older, as well as potentially supporting approval of the vaccine in Africa.In May, Bavarian Nordic submitted a supplemental BLA seeking FDA 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 procedure under accelerated assessment.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 reporting date

In July, Bavarian Nordic announced the conversion of its existing undrawn DKK 1 billion revolving credit facility into a sustainability-linked loan (SLL).In July, Bavarian Nordic received positive opinion from EMA's Committee for Medicinal Products for Human Use (CHMP), recommending approval of a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine, including real-world effectiveness data from the use of the vaccine during the global 2022 mpox outbreak in the marketing authorization.In August, Bavarian Nordic received a new order from the U.S. government valued at USD 156.8 million, primarily for the manufacture of additional bulk product for JYNNEOS® smallpox/mpox vaccine. The bulk product will be manufactured and invoiced in 2024.In August, Bavarian Nordic received a new order for 175,420 doses of the Company's mpox vaccine from the European Health Emergency Preparedness and Response Authority (HERA) for donation 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 to support an extension of the IMVANEX® (MVA-BN®) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age. Pending review, approval of the extension could occur during fourth quarter of 2024.In August, Bavarian Nordic received a new order to supply 440,000 doses of smallpox and mpox vaccines to a non-disclosed European country. The order was anticipated as part of the 2024 guidance and has no impact on the remaining 2024/25 capacity for our smallpox and mpox vaccine.

Financial calendar 2025

2024 Annual Report                          March 5, 2025
Annual General Meeting                   April 9, 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
The 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 https://bit.ly/bavaQ22024. To join the Q&A session, please register in advance via https://bit.ly/bavaQ22024reg.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +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 a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com.

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.

Vedhæftet fil

Interim Report H1 2024

\Hugin