Encephalitis, Tick-Borne

While Bavarian Nordic's public preparedness sales dropped in 2024, the vaccine specialist’s travel health business—which includes shots for rabies and tick-borne encephalitis (TBE), among others—grew 22%. While the ebb and flow of mpox outbreaks may have taken a toll on Bavarian Nordic’s 2024 sales performance, the year also validated, in large part, the travel vaccines business the Danish company has been building out since the start of the decade.In the years to come, Bavarian Nordic foresees that more commercially minded-business taking the lead over the sort of government supply contracts that have been the company’s bread and butter thus far, Bavarian Nordic CEO Paul Chaplin said in an interview.Last year, Bavarian Nordic’s total revenue dropped 19% to 5.7 billion Danish kroner (around $527 million), the company reported Wednesday.That drop is largely explained by the fact that Bavarian Nordic’s public preparedness business, which includes its smallpox and mpox vaccines and makes up nearly 60% of the company’s revenue, plunged around 44% to 3.2 billion kroner ($295 million) last year.Still, there was a silver lining for Bavarian Nordic, as the vaccine specialist’s travel health business—which includes shots for rabies and tick-borne encephalitis (TBE), among others—grew 22%. “We started a journey, back in 2020 really, to become a much more robust, profitable vaccine company,” Chaplin told Fierce Pharma. “[20]24 was our fifth consecutive year now of reporting profitable growth.”That said, “the issue with public preparedness is it’s a little lumpy in terms of the revenue,” Chaplin explained. “It’s not a classical revenue stream.”As it stands, Bavarian Nordic assumes base sales from its public preparedness business between 1.5 billion to 2 billion kroner with “some spikes” from outbreaks of disease such as mpox.“To be honest, from an investor point of view, that is a very difficult one to model or to appreciate,” Chaplin admitted.In turn, Bavarian is looking to continue to expand its commercial business in earnest, both through the launch of vaccines like the company’s newly approved chikungunya shot Vimkunya, and by acquiring more commercial assets via M&A, the CEO said.Ultimately, Chaplin anticipates Bavarian Nordic’s “more traditional portfolio” of vaccines to become the dominant one, with public preparedness becoming a “smaller component” of the firm’s overall strategy.That should “create less noise in terms of the revenue swings that we see from year to year,” Chaplin explained.“Before 2020, we really only had smallpox and mpox, and it was direct sales to governments,” Chaplin explained. “We want to add more, what I would call, regular revenue streams into the business.”That desire prompted Bavarian Nordic to purchase its rabies and TBE vaccines from GSK, followed by a transaction for Emergent Bio’s travel health business in 2023, which added shots for typhoid, cholera and chikungunya to Bavarian’s vaccine armamentarium.“That was a bold move at the time, because we had no real commercial setup,” Chaplin said of the GSK deal.Since then, the company has built out commercial infrastructure in places like Germany and the U.S., navigated marketing during COVID, and is now in the process of expanding its commercial base into countries like the U.K., France, Austria, Switzerland and Canada, Chaplin said.As for why those travel vaccines are now proliferating under Bavarian Nordic, the shots simply “weren’t that meaningful to a company the size of GSK that had a portfolio of 30-plus vaccines,” Chaplin speculated.“I think they fit better in a smaller company like Bavarian Nordic than they do in a larger company with different growth agendas,” he said.Looking ahead, much of Bavarian Nordic’s focus in 2025 will hinge on the rollout of its commercial chikungunya shot. To build the market for Vimkunya, education of healthcare professionals will be key, Chaplin said, highlighting two types of HCPs in particular: Those who know about the virus but may not be aware of its severity, and those are largely oblivious to chikungunya altogether.While Bavarian Nordic is already seeing demand for Vimkunya start to build in Europe and the U.S., the company’s prospects in the States are slightly less clear at the moment, given the recent cancellation of a Centers for Disease Control and Prevention advisory committee meeting that would have determined whether to recommend Vimkunya, Chaplin noted.As Bavarian holds out hope that the meeting gets rescheduled, the lack of a positive recommendation will likely diminish sales, Chaplin said. Nevertheless, the CEO stressed that the company continues to go full speed ahead with its awareness efforts.Speaking to the current uncertainty around U.S. immunization policy going forward, Chaplin acknowledged that vaccine hesitancy has been on the rise globally for some time now, with the issue exacerbated even further by the COVID-19 pandemic.Even still, Bavarian Nordic has witnessed a “rebound” in vaccine uptake in more recent years and is seeing “strong growth in our sector against the backdrop of some vaccine skepticism,” Chaplin said.Whatever happens with U.S. vaccine policy, “we will all be in the same boat as vaccine manufacturers, and we’ll have to adapt to the situation,” he added. Looking ahead to the rest of the year, Bavarian Nordic aims to grow earnings some 26% to 30% over that same span.As for what could be next in the company’s travel health portfolio, Bavarian Nordic on Wednesday unveiled two new early-stage pipeline programs for Lyme disease and Epstein-Barr virus.Despite high unmet need for a vaccine in both conditions, both candidates are backed by existing, validated technologies and Bavarian Nordic has been working on each asset for around 3 years now, Chaplin pointed out. Bavarian Nordic’s Lyme and Epstein-Barr prospects are slated to enter the clinic next year. 

COPENHAGEN, Denmark, December 11, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced its intent to launch a share buy-back program of up to DKK 150 million in the first quarter of 2025. This decision should be viewed in the context of improved visibility around the Company’s Travel Health business, driven by a number of completed and near-term expected events, including: A better-than-expected performance of the Travel Health business, as demonstrated by the recent guidance upgrade.The near-term completion of the tech-transfer of the rabies and TBE vaccines from GSK on time and on budget (Rabipur/RabAvert has already been completed, while Encepur is to be completed near-term). Improved gross margins from 2026 and onwards following completion of the tech transfer. A significantly improved cash flow following the payment of final considerations of ~DKK 1,700 million during the first half of 2025 related to the acquisitions from GSK and Emergent BioSolutions.The near-term completion of the integration of assets acquired from Emergent BioSolutions in 2023, including a final restructuring of the R&D organization, which will generate annual savings of DKK 50-75 million from 2025 and onwards, not previously announced. Paul Chaplin, President and CEO of Bavarian Nordic, said: “We are eyeing the finish line for the transformative five-year integration plan for our first acquisition from GSK, which we have successfully managed to complete on time and on budget. This transaction catalyzed our global commercial presence and laid the groundwork for our leading position in travel vaccines, which we have continued to expand via new acquisitions. By 2025, we will have completed this transformation, providing a strong platform for profitable growth. Given our capital allocation policy and strong financial position, we believe now is a good time to do the share buyback.” Bavarian Nordic intends to hold the shares bought back as treasury stock, for the purpose of adjusting the capital structure and meeting the long-term obligations relating to the Company’s share-based incentive programs for the Board of Directors and Executive Management. The share buy-back program will be carried out in accordance with the authorization granted by the general meeting of shareholders to the Board of Directors and will be subject to safe harbour regulations. Additional details, including the key terms of the program will be provided upon the final decision of the Board of Directors to launch the program, expectedly in the first quarter of 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 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. 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. 38 / 2024 Attachment 2024-38-en

Gloved hand holding a vial of mpox vaccine iStock, angelp The Danish biotech on Thursday reported stronger-than-expected earnings and forecasts hitting the upper range of its full-year revenue target amid the ongoing mpox outbreak. Bavarian Nordic announced second-quarter 2024 earnings on Thursday that beat expectations and a new order for 440,000 doses of orthopoxvirus vaccine Jynneos, as the global effort to stem the current mpox outbreak ramps up. The order was placed by “an undisclosed European country,” CEO Paul Chaplin said in a statement, noting that the batch “was anticipated as part of the 2024 guidance and as such, has no impact on the remaining vaccine capacity.” Bavarian Nordic is preparing to boost manufacturing to ensure that countries and communities in need will have “continued equitable access to our mpox vaccine,” Chapin said. In addition to its standing orders, the company can supply up to two million more doses this year and produce 10 million additional doses by the end of 2025. The undisclosed European country is only the latest purchaser of Bavarian Nordic’s Jynneos. Last week, the European Commission’s Health Emergency Preparedness and Response Authority ordered 175,420 doses of the mpox vaccine, slated for donation to Africa’s Centers for Disease Control and Prevention. Previously, the U.S. government paid Bavarian Nordic $156.8 million for the bulk manufacture of Jynneos—a transaction that will be fulfilled and invoiced this year. Bavarian Nordic also previously received funding from the Coalition for Epidemic Preparedness and Innovations to conduct a trial of its mpox vaccines in African populations, including children aged two years and older. According to the company, the study is meant to support the approval of Jynneos in the region. Bolstered by these recent deals, Bavarian Nordic confirmed its guidance for 2024, with the company now expecting revenue in the upper end of its previously announced range. For the full year, the vaccine developer now expects to earn around $800 million or 5.3 billion Danish Kroner. In Q2, Bavarian Nordic recorded revenue of around $210 million or 1.427 billion Kroner, which according to Jefferies analyst Peter Welford came ahead of the consensus analyst estimate of 1.34 billion Kroner. The strong performance was driven by sales of the rabies vaccine Rabavert and the tick-born encephalitis shot Encepur, revenues from which “have reached levels exceeding expectations,” Welford wrote in a note to investors. Bavarian Nordic acquired Rabavert and Encepur from GSK in 2019.