Bavarian Nordic Announces First Half 2023 Results

COPENHAGEN, Denmark, August 23, 2023 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first half of 2023 and released its financial calendar for 2024.

• Revenue increased by 278% to DKK 3,239 million for the first half and the operating profit (EBITDA) increased to DKK 1,171 million.
• For the first half, revenue comprised of DKK 2,182 million from sale of JYNNEOS^®/IMVANEX^®/IMVAMUNE^® mpox/smallpox vaccine, DKK 555 million from sale of Rabipur^®/RabAvert^®, DKK 299 million from sale of Encepur^®, DKK 35 million from sale of Vivotif^® and Vaxchora^®, DKK 81 million from sale of third-party products, and DKK 87 million in other revenue.
• Revenue for the second quarter was DKK 1,987 million and comprised of DKK 1,334 million from sale of JYNNEOS^®/IMVANEX^®/IMVAMUNE^® mpox/smallpox vaccine, DKK 313 million from sale of Rabipur^®/RabAvert^®, DKK 211 million from sale of Encepur^®, DKK 35 million from sale of Vivotif^® and Vaxchora^®, DKK 38 million from sale of third-party products, and DKK 56 million in other revenue.
• Cash and cash equivalents at end of the period was DKK 1,385 million.
• Financial guidance for the full year is maintained at revenue of approximately DKK 6,900 million and EBITDA of approximately DKK 2,300 million.

* Numbers are approximate

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "The strong results are a resounding endorsement of our commercial strategy that has allowed us to report our best half year results to date. As guided, our mpox vaccine continues to generate a significant revenue stream in 2023, but importantly our travel vaccines have performed stronger quarter by quarter as result of market growth and strong brand performance. We are looking to further expand and diversify this business via our recent acquisition, adding two marketed vaccines and a promising vaccine candidate against chikungunya, creating the world’s largest travel vaccine company. With two successful Phase 3 readouts for our chikungunya vaccine, we are forging ahead towards licensure, and this will be a significant future asset when launched in 2025 preventing a severe and incapacitating disease. While the disappointing Phase 3 results from our RSV program has led to the discontinuation of the program, we have established a strong foundation for further growth, and we remain focused on a continued strong commercial execution.”

Highlights from the period

• In May, Bavarian Nordic completed its acquisition of the travel vaccine portfolio from Emergent BioSolutions, thereby assuming ownership of two marketed vaccines – Vivotif^® for the prevention of typhoid fever and Vaxchora^® for the prevention of cholera as well as CHIKV VLP, a Phase 3 vaccine candidate for the prevention of chikungunya virus. The acquisition further included a Swiss-based manufacturing facility and US-based research and development facilities and personnel. Upon closing, Bavarian Nordic made a cash payment to Emergent BioSolutions of USD 274 million, which included estimated adjustments for net working capital, debt and other customary closing adjustments.
• In June, Bavarian Nordic reported Phase 3 topline results of its COVID-19 booster vaccine candidate, ABNCoV2. While the study met its primary objective, demonstrating non-inferiority to an approved mRNA-vaccine in terms of neutralizing antibodies against the original SARS-CoV-2 virus (Wuhan wild type), this may be insufficient to support licensure as the ability of the vaccine to provide efficacy at more distant circulating variants will also be important in the assessment by the authorities of the overall efficacy of ABNCoV2. Also, long-term follow-up results from a Phase 2 trial of ABNCoV2 were reported, showing persistent antibody levels associated with protection against the SARS-CoV2 index virus (Wuhan) 12 months post the booster vaccination with ABNCoV2, while lower levels were seen against a circulating Omicron variant (XBB.1.1), associated with a reduced level of efficacy.
• In June, Bavarian Nordic reported initial results from the first Phase 3 trial of CHIKV VLP, showing that CHIKV VLP was immunogenic in healthy adults =65 years of age, as demonstrated by a strong induction of CHIKV neutralizing antibodies against chikungunya in 87% of vaccinees 22 days after vaccination, thus meeting the primary endpoint of the study.
• In June, Bavarian Nordic announced a contract award of EUR 10 million to supply smallpox vaccines to rescEU, a strategic reserve within the European Union (EU) which aims to strengthen the EU’s ability to respond to biological threats in the future.

Events after the reporting date

• In July, Bavarian Nordic announced that the Phase 3 trial of MVA-BN^® RSV, its respiratory syncytial virus (RSV) vaccine candidate for adults =60 years of age did not meet all the primary endpoints of preventing lower respiratory tract disease (LRTD) from RSV. Based on this outcome, the RSV program has been discontinued, including the partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.
• In August, Bavarian Nordic announced positive topline results from a randomized, double-blind, placebo-controlled Phase 3 clinical trial of CHIKV VLP in adults and adolescents aged 12 to 64 years of age. The study met its primary endpoint, demonstrating a strong induction of chikungunya neutralizing antibodies in 98% of vaccinees in the active group 22 days post vaccination. Importantly, neutralizing antibodies were observed in 97% of the subjects at 2 weeks post vaccination, confirming a rapid onset of protective levels of immunity. The results from this study and the Phase 3 study in older adults, reported in June, will form basis for submissions to the U.S. and EU regulatory authorities in 2024.
• In August, Bavarian Nordic received a new contract valued at USD 120 million from the U.S. government. The contract will support manufacturing of new bulk vaccine to partly replenish the inventory used for the mpox outbreak, which will enable the Company to fulfil its long-term commitment to supply a freeze-dried vaccine to strengthen the U.S. smallpox preparedness.

Financial calendar 2024
2023 Annual Report                          March 6, 2024
Three-month report (Q1)                  May 8, 2024
Half-year report (Q2)                        August 22, 2024
Nine-month report (Q3)                    November 15, 2024

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/3KdbHjU. To join the Q&A session, please register in advance via https://bit.ly/44ULhLC.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Company Announcement no. 31 / 2023

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company focused on the research and development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox and mpox vaccines, which have been developed through our long-standing partnership with the U.S. Government 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.

Attachment

• Interim Report H1 2023