On November 12, 2021 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results for the first nine months of 2021 and business progress for the third quarter of 2021 (Press release, Bavarian Nordic, NOV 12, 2021, View Source [SID1234595439]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We continued to experience a challenging market environment for our travelers vaccine business during the third quarter, due to COVID-19. Despite these headwinds, we remain on track to meet our guidance as both our smallpox and Ebola vaccine sales remain unaffected. This truly highlights the importance of a broader and more diversified product portfolio. We are very pleased with the strong pipeline progress seen during the quarter, where highly promising results for our COVID-19 booster vaccine candidate were reported and funding for the remaining phases was secured. Likewise, we have presented strong results for our RSV vaccine candidate, which showed remarkable efficacy in reducing symptomatic RSV infections in a challenge study. These assets provide an encouraging outlook for Bavarian Nordic, and we look forward to providing more updates as the work progresses."

Financial highlights

Total revenue in the first nine months was DKK 1,354 million comprised of DKK 1,323 million from combined product sales and DKK 31 million from contract work.
Revenue in the third quarter totaled DKK 449 million comprised of DKK 214 million from sales of MVA-BN smallpox vaccine, DKK 160 million from sales of Rabipur/RabAvert, DKK 72 million from sales of Encepur and DKK 3 million from contract work.
EBITDA in the first nine months was DKK 44 million.
Strong cash position of DKK 2,182 million** at the end of the period.
Full-year guidance maintained with expected 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.

EBITDA in the first nine months of 2020 was positively impacted by the sale of the Priority Review Voucher (DKK 628 million).
** Unutilized credit facilities of DKK 243 million not included. Repo pledged securities deducted.

Other highlights

In August, initial results from the first-in-human trial of the COVID-19 vaccine candidate, ABNCoV2 were reported, which demonstrated that the vaccine candidate was well tolerated and induced a strong antibody response, higher than currently approved vaccines. Results from the high dose groups are now available and suggest a plateau in the responses as similar high antibody titers were shown for these groups. Importantly, a strong neutralization response was demonstrated against SARS-CoV-2 variants, including the Delta variant.
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. Initial results from the study are expected in December 2021.
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. The agreement was finally executed in September upon approval from the Finance Committee of the Danish Parliament.
In September, Bavarian Nordic reported positive results from the human challenge trial of MVA-BN RSV. The trial achieved the primary endpoint of the pivotal study by demonstrating a statistically significant reduction in viral load in vaccinated versus control (placebo) treated volunteers. The vaccine demonstrated a 79% efficacy in reducing symptomatic RSV infections. Preparations for a phase 3 trial in 2022 continue, pending a final decision driven by regulatory discussions and feedback on the trial design and funding/partnering considerations.
Events after the reporting date

In accordance with the shareholder authorization for the board of directors and the Company’s remuneration policy, the board of directors has today decided to issue warrants to executive management and certain employees in the Bavarian Nordic Group. In accordance with the Company’s remuneration policy, President and CEO, Paul Chaplin will receive an extraordinary grant as further explained on page 6 in the interim report. A total of 716,256 warrants have been issued, which entitle the warrant holders to subscribe for up to 716,256 shares in total, with a nominal value of DKK 10 each at an exercise price of DKK 353.06 per share.
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 View Source 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 2839609.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, [email protected], Tel: +1 781 686 9600

Company Announcement no. 35 / 2021