Smallpox vaccine(Bavarian Nordic A/S)

COPENHAGEN, Denmark, November 15, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results for the first nine months of 2024 and business progress for the third quarter of 2024. Revenue for the first nine months was DKK 3,622 million, and the operating profit (EBITDA) was DKK 692 million.Revenue from Travel Health increased by 18% to DKK 1,892 million compared to the first nine months of 2023 and revenue from Public Preparedness was DKK 1,549 million, which is in line with the Company’s expectations. Other revenue was DKK 181 million.The financial guidance for the full year, which was upgraded on September 26 as a result of additional mpox vaccine orders and improved performance in the Travel Health business, is maintained at a revenue between DKK 5,400 million and DKK 5,800 million and EBITDA between DKK 1,450 million and DKK 1,700 million. The intervals represent uncertainty related to logistics and supply timing of deliveries of mpox vaccines dictated by among others the level of preparedness to receive and handle the vaccines in the receiving countries.For 2025, the Company has so far secured revenue from mpox/smallpox vaccine orders of approximately DKK 2,400 million, including previously announced deferred revenue. DKK millionQ3 2024Q3 20239m 20249m 20232024 GuidanceRevenue1,3631,3763,6224,6155,400 - 5,800EBITDA2503806921,5521,450 - 1,700 Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We have had a busy, but highly purposeful and rewarding third quarter, where we have worked intensively to support the efforts to curb the ongoing mpox outbreak in Africa. Only a few weeks after the declaration of mpox as a public health emergency, the first vaccines arrived early September in the Democratic Republic of Congo, the epicenter of the outbreak. With speed and flexibility, we have once again demonstrated our ability to step up in support of a global health crisis. We have acted with global stakeholders to ensure the availability of nearly 3 million doses of our mpox vaccine to Africa through donations and agreements. In parallel, we have continued to work with nations globally to strengthen their mpox/smallpox preparedness, helping to build resilience beyond the current outbreak, and enabling countries to make donations from their existing stockpiles. To ensure the continued equitable access to our vaccine we are exploring options to expand our capacity for increased demand, including transferring the process to a manufacturer in Africa and we applaud the support provided by the Africa CDC and other stakeholders in this endeavor. The committed orders for next year, combined with improved performance in our Travel Health business, and the launch of our chikungunya vaccine in Europe and the U.S. have set us up for another exciting and eventful year in 2025 in line with our vision to expand our reach and impact through life-changing solutions.” Highlights from the third quarter Public Preparedness In response to the public health emergency declarations by the Africa CDC and WHO in August, Bavarian Nordic has intensified its collaboration with global stakeholders in efforts to curb the ongoing mpox outbreak in Africa. Importantly, the Company has been working towards maximizing the manufacturing capacity for the MVA-BN mpox vaccine to meet the short- to medium-term demand.The Company’s donation of vaccines, together with donations from the European Commission and the U.S. government were the first to arrive in the Democratic Republic of Congo (DRC) in September, ahead of their vaccination campaign. Nearly 3 million doses of MVA-BN have been pledged to Africa by governments and organizations to-date.Several new orders, including multi-year orders, were announced during the third quarter, and included among other orders from UNICEF, the U.S. government, the European Health Emergency Preparedness and Response Authority (HERA), as well as from several undisclosed countries. Bavarian Nordic retains sufficient capacity to fulfil the requirement as stated by Africa CDC for at least 10 million doses by the end of 2025 and could even further scale up capacity for future demand if needed.Several regulatory approvals were obtained for MVA-BN during the third quarter. Most importantly, the vaccine received prequalification from the WHO, representing an important step in making the vaccine available for African countries. Furthermore, the vaccine received a full approval in Singapore and Mexico and a provisional approval in New Zealand. In Europe, real-world effectiveness data from the global 2022 mpox outbreak was included in the marketing authorization, which also was extended to include adolescents 12 to 17 years of age – a decision also adopted in the WHO prequalification. Several clinical studies are now ongoing to generate clinical data in a pediatric population (2-11 years), aiming to further expand the approval for this group. Travel Health The Travel Health business has continued its strong performance, demonstrating an overall growth of 18% in the first nine months compared to 2023, primarily driven by higher sales of Rabipur/RabAvert and Encepur. The combined revenues from both products have reached levels exceeding the original expectations at the time of acquisition, thus triggering a sales milestone of DKK 186 million to GSK in the third quarter. The expected revenue from the Travel Health business for the full year was recently upgraded from DKK 2,100 million to DKK 2,200 million.The bulk manufacturing process for Rabipur/RabAvert was approved by the regulators in October, thus completing the entire technology transfer for the product to Bavarian Nordic, as the fill and finish process had already been established and approved. The technology transfer for Encepur is progressing as planned with anticipated completion and approval in 2025.Preparations for launch of the chikungunya vaccine in 2025 are being intensified with a regulatory review underway in both the U.S. and Europe. Following grant of priority review for the BLA in August, the FDA is targeting a decision in February 2025, and in Europe, the MAA is being reviewed under accelerated assessment, with anticipated decision in the first half of 2025.Commercial presence is currently being expanded into new territories to support both the launch of the chikungunya vaccine in 2025 and the ongoing relaunch of Vivotif and Vaxchora, as well as the gradual take-back of Rabipur/RabAvert and Encepur sales and marketing in markets currently managed by Valneva. Conference call and webcastThe management of Bavarian Nordic will host an investor/analyst call today at 2 pm CET (8 am EST) 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/bavaQ32024. To join the Q&A session, please register in advance via https://bit.ly/bavaQ32024reg. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 Company Announcement no. 35 / 2024 About Bavarian Nordic Bavarian 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 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. Attachment Interim Report Q3 2024

Bavarian Nordic is facing a double-edged sword following the election of Donald Trump in the US. While the company may benefit from an increase in biodefense funding, the recent nomination of Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) will raise some concerns."It doesn't help when you've got a health secretary who's sceptical of vaccines in convincing the public to take vaccines," Bavarian Nordic chief executive Paul Chaplin said Friday.Along with a number of travel vaccines — for diseases such as cholera, rabies and typhoid — Bavarian Nordic's public preparedness portfolio comprises a jab for smallpox and mpox. "When I look back at his first administration, it was some of the most successful years in terms of the public preparedness business with the US government," Chaplin said. "I think the incoming administration is going to be very positive for that part of the business."Mpox jab sales fallDespite Chaplin's upbeat tone, shares in Bavarian Nordic fell more than 16% on Friday — mirroring declines across vaccine manufacturers following the news of Kennedy's nomination (see Vital Signs: RFK for HHS slams vax companies, and shocks everyone else). Analysts also suggested that the stock dip was partly due to the company's lacklustre third-quarter results.In the three-month period, sales of the smallpox/mpox vaccine — marketed as Jynneos, Imvanex and Imvamune — dropped 26% to DKK 525 million ($74 million). Bavarian Nordic continues to expect sales of the shot to be between DKK 3 billion and DKK 3.4 billion this year, while it has so far secured orders of approximately DKK 2.4 billion for 2025.($1 = DKK 7.05166)