Bavarian Nordic Announces First Half 2021 Results

COPENHAGEN, Denmark, August 25, 2021 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the first half of 2021 and releases its financial calendar for 2022.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We are very pleased to confirm the successful execution of our commercial strategy with nearly 30 Rabipur/RabAvert and Encepur markets now transferred to Bavarian Nordic. Our objective during this transition was to stop the historical market share losses before the acquisition of these products, start gaining more ground and increase the awareness of Bavarian Nordic among health care professionals and we are pleased that we today can tick all these boxes, despite that the markets are still impacted by COVID-19. Both the rabies and TBE markets are still suffering from a low level of international travel and limited availability of physicians for non-COVID vaccinations in certain markets and due to this alone, we are firming up our financial guidance for 2021 to reflect the lower end of the previously guided intervals.

So far this year, we also received new orders for our Ebola and smallpox vaccines and saw very important advancements in our pipeline assets with our promising COVID-19 vaccine candidate, ABNCoV2 entering Phase 2 after reporting highly promising clinical results. The recent agreement with the Danish Ministry of Health to provide aid for developing ABNCoV2 is a strong recognition of the technology and Bavarian Nordic to develop a highly promising general booster against COVID-19.  With this funding, together with our existing commitment to fund the program to the end of Phase 2, we have sufficient funds to execute the existing plans to develop ABNCoV2 through to licensure. We look forward to reporting the Phase 2 results for ABNCoV2, as well as additional pivotal results from the RSV human challenge trial later this year.” 

Financial highlights

• Total revenue in first half year was DKK 905 million comprised of DKK 877 million from combined product sales and DKK 28 million from contract work.
• Revenue in second quarter totaled DKK 370 million comprised of DKK 146 million from sale of Encepur, DKK 127 million from sale of Rabipur/RabAvert, DKK 89 million from sale of Mvabea to Janssen and DKK 8 million from contract work.
• EBITDA in first half year was a loss of DKK 8 million.
• Strong cash position of DKK 2,208 million at the end of the first half, excluding unutilized credit facilities of DKK 243 million and after deduction of repo pledged securities.
• Full-year guidance maintained at the lower end of the previously guided ranges, due to the continued COVID-19 impact on the TBE and rabies markets. Thus, revenue of approximately DKK 1,900 million, EBITDA of approximately DKK 100 million and securities, cash and cash equivalents at year-end of approximately DKK 1,400 million are expected.

* EBITDA in H1 2020 was positively impacted by the sale of the Priority Review Voucher (DKK 628 million).

** Repo pledged securities deducted.

Events in the second quarter

• In April, new preclinical results for the COVID-19 vaccine candidate, ABNCoV2 were announced, confirming its potential to offer broad protection against variants of the SARS-CoV2 virus.
• In April, Bavarian Nordic received a new Ebola supply order from Janssen, valued at approximately USD 28 million. Manufacturing and delivery will occur during 2021. The Johnson & Johnson Ebola vaccine regimen, which includes Mvabea^® from Bavarian Nordic also received Prequalification from the World Health Organization, which along with the July 2020 approval from the European Commission, will help accelerate its registration in countries where Ebola is a persistent public health threat.
• In May, the US government exercised the final USD 12 million option remaining under the USD 202 million order for JYNNEOS^® awarded in April 2020.
• In May, Bavarian Nordic entered an agreement with Dynavax on marketing and distribution of their HEPLISAV B^® hepatitis B vaccine in Germany 

Events after the reporting date

• In August, Bavarian Nordic entered a funding agreement with the Danish Ministry of Health, under which the Company will be eligible to receive up to DKK 800 million to further advance the development of ABNCoV2 as a booster vaccine for COVID-19.
• In August, Bavarian Nordic initiated a Phase 2 clinical trial of ABNCoV2 to investigate the vaccine’s potential as a universal booster vaccine for individuals with existing immunity from prior COVID-19 disease or vaccination.
• In August, initial results from the first-in-human trial of ABNCoV2 were reported, showing that the vaccine candidate was well tolerated and induced a strong antibody response, superior to current approved vaccines. Importantly, a strong neutralization response was demonstrated against SARS-CoV2 variants, including the Delta variant.
• The Company has today published its financial calendar for 2022, which is available on page 8 in this report.

Conference call and webcast
The management of Bavarian Nordic will host a conference 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 can be accessed via /investor/events.aspx?event=6096. To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 8569159. 

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. 28 / 2021

About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS^®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX^® and in Canada under the trade name IMVAMUNE^®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur^®/RabAvert^® against rabies and Encepur^® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN^®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, Mvabea^®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. 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.