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Wednesday 26 August, 2020

Bavarian Nordic A/S

Bavarian Nordic Announces First Half 2020 Results

Bavarian Nordic Announces First Half 2020 Results

COPENHAGEN, Denmark, August 26, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and business progress for the first half of 2020 and releases its financial calendar for 2021.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “The first half of 2020 has been a highly productive and successful period, despite the global challenges created by COVID-19. We remain fully on track to take over the commercial assets Rabipur®/RabAvert® and Encepur®; have received significant orders for our smallpox and Ebola vaccines; reported positive freeze-dried JYNNEOS Phase 3 data and accomplished our second MVA-based vaccine approval (MVABEA) in Europe that marked a significant milestone for our partnership with Janssen and the fight against Ebola. This year marks the beginning of our commercial transition and we have already taken over key markets and will continue to expand our global commercial presence over the next 18 months. While the travel vaccine sector has been negatively impacted by COVID-19, including sales for Rabipur/RabAvert, and the shut down in key markets like Germany has negatively impacted sales of Encepur, the strong outlook in other parts of our business has allowed us to maintain our full-year guidance. Lastly, we licensed an exciting technology against COVID-19 and plan the first human trials later this year and pending funding, will push for approval before the end of 2021.”

Financial highlights

  • Total revenues in first half year were DKK 1,065 million comprised of DKK 975 million from combined product sales and DKK 90 million from contract work.
  • Revenues in second quarter totaled DKK 700 million comprised of DKK 320 million from sale of MVA-BN smallpox vaccine bulk drug substance to U.S. Government, DKK 193 million from sale of Encepur, DKK 142 million from sale of Rabipur/RabAvert, and DKK 45 million from contract work.
  • Other operating income of DKK 628 million from sale of Priority Review Voucher.
  • EBITDA in first half was DKK 839 million.
  • Strong cash position of DKK 2,380 million at end of the first half, excluding unutilized credit facilities of DKK 244 million.
  • Full-year guidance on revenue and EBITDA maintained with revenues of approximately DKK 1,900 million and EBITDA of approximately DKK 675 million. The securities, cash and cash equivalents at year-end is now expected to be DKK 1,500 million, DKK 150 million higher than previously guided.
DKK million Q2 2020 Q2 2019 H1 2020 H1 2019 2020 Guidance
Revenue 700 101 1,065 228 1,900
EBITDA 197 (83) 839 (173) 675
Securities, cash and cash equivalents 2,380 1,638 2,380 1,638 1,500*

* Both previous and updated cash guidance includes the EUR 30 million loan from the European Investment Bank as cash, which is currently not drawn upon.

Other highlights

  • In April, Bavarian Nordic was awarded a new order for JYNNEOS smallpox vaccine from the U.S. government. The total order value of USD 202 million covers two years and includes the manufacturing of additional bulk vaccine and the supply of up to 1.4 million doses of liquid frozen JYNNEOS.
  • In June, topline results from the first-in-human trial of MVA-BN® WEV, a prophylactic vaccine against three equine encephalitis viruses (western, eastern and Venezuelan), were reported, showing that the vaccine was well tolerated and immunogenic across all dose groups. These clinically meaningful Phase 1 data warrant further clinical investigation, and Bavarian Nordic is in the process of obtaining additional funding from the U.S. authorities for the advancement of this vaccine candidate.
  • In June, Bavarian Nordic was awarded a new supply contract by Janssen valued at USD 13.9 million. Under the contract, Bavarian Nordic will manufacture and deliver bulk drug substance of MVA-BN Filo. While manufacturing of the vaccines will be initiated in 2020, supply and invoicing will not occur until 2021.
  • In June, Bavarian Nordic entered into a marketing and distribution partnership with Valneva, who will assume responsibility for the marketing and distribution of Rabipur/RabAvert and Encepur in selected European countries and Canada, and Bavarian Nordic will assume the marketing and distribution of IXIARO® and DUKORAL®, Valneva’s vaccines for Japanese Encephalitis and cholera in Germany and Switzerland.

Events after the reporting date

  • In July, the European Commission granted marketing authorization for MVABEA® (MVA-BN Filo), which was licensed to Janssen in 2014. MVABEA is the second component of Janssen’s Ebola vaccine regimen, which also consists of ZABDENO® (Ad26.ZEBOV), which gained European approval concurrently. In connection with the European approval of MVABEA, Bavarian Nordic received a milestone payment of USD 10 million under the license agreement with Janssen.
  • In July, Bavarian Nordic concluded a license agreement with AdaptVac that provides Bavarian Nordic the global commercialization rights to a COVID-19 vaccine based on AdaptVac’s proprietary capsid virus like particle (cVLP) technology. Under the terms of the agreement, Bavarian Nordic has made an upfront payment of EUR 4 million to AdaptVac and committed to potential future development and sales milestones and tiered royalties. A Phase 1/2a clinical study of the vaccine is planned to be initiated during the fourth quarter of 2020.
  • In August, positive topline results from the Phase 3 study of freeze-dried MVA-BN® smallpox vaccine were reported. This is the only Phase 3 study required to support licensure of the freeze-dried formulation and upon completion of the study, expected in 2021, the Company plans to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN, anticipated in 2022.

Conference call and webcast
The management of Bavarian Nordic will host a conference 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 can be accessed via https://www.bavarian-nordic.com/investor/events.aspx?event=5691. 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 9647956.

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. 43 / 2020

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacture 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. Strategic National Stockpile 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 market-leading vaccines 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, licensed to Janssen. 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.

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