COPENHAGEN, Denmark, May 22, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and business progress for the first three months of 2019.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “As outlined in our strategy, 2019 and 2020 will be transitional years for Bavarian Nordic with significant investments in R&D and our new fill and finish facility, all with the objective to secure future revenue, growth and profitability. We have prepared for an eventful year, and while we have already shared several news during the first quarter, there are more exciting news to come, including the anticipated first U.S. approval, which will solidify our position as the global leader in the smallpox vaccine space and create new commercial opportunities ahead. Also, the approval will trigger the award of a Priority Review Voucher which, when sold, will contribute to maintaining a strong financial position. We also look forward to presenting a finalized plan for Phase 3 development of our RSV vaccine, and to report Phase 2 data from our immuno-oncology programs later this year. So, we are moving forward within all four strategic pillars of the company as planned and are reporting a first quarter fully in line with our expectations and guidance, both financially and operationally.”

OPERATIONAL HIGHLIGHTS

Delivering our strategy

Our strategy is four-fold, and aims to secure and reinforce a sustainable foundation, while also expanding the commercial opportunities:

  • MAINTAIN global leadership of our smallpox vaccine business
  • EXPAND and rapidly ADVANCE the pipeline of infectious disease programs
  • ESTABLISH a broad and deep cancer immunotherapy portfolio
  • EXPAND the commercial footprint and capabilities

Smallpox

  • We have seen continued strong progress for our smallpox vaccine program, reinforcing our global leadership position.
  • The approval of the liquid-frozen formulation and award of a Priority Review Voucher are anticipated in September of 2019.
  • We have continued manufacturing for the ongoing contract for freeze-dried MVA-BN and will have produced bulk vaccine worth USD 333 million by year-end, of which USD 50 million are part of our 2019 revenues.
  • In January, we were awarded USD 44 million by the U.S. Government for qualification of our new fill and finish facility, as well as for transfer and validation of the production process for freeze-dried MVA-BN, which are all activities that will occur during 2020 before starting production of the current order (conversion of bulk vaccine to approx. 13 million final vaccine doses).
  • The pivotal Phase 3 lot consistency trial of the freeze-dried formulation of MVA-BN is planned to initiate in the second quarter of 2019. Based on the successful completion of this trial, we expect to submit a BLA supplement in 2021 with anticipated approval in 2022 of freeze-dried MVA-BN.

Infectious diseases

  • We remain at the forefront of RSV vaccine development with our differentiated, broad-spectrum vaccine candidate, which has successfully concluded Phase 2 development in elderly. We are currently in discussions with U.S. regulatory authorities on licensure requirements and expect to outline the Phase 3 development plan around mid-2019.
  • In February, our partner Janssen initiated a Phase 1/2a of the therapeutic HPV vaccine regimen. This is the first of three commercial programs under our partnership to initiate clinical trials. The second program, HIV, is also expected to initiate clinical trials later this year. Collectively, these programs, along with our Ebola collaboration represent USD 1 billion in potential future milestone payments, in addition to royalties on future sales.
  • Our partnership with the U.S. Department of Defense on the development of a prophylactic vaccine against the equine encephalitis virus - a rare, but potentially deadly illness – further evolved, as we received funding to support a Phase 1 clinical trial, which we expect to initiate later this year. Successful trial results could lead to additional funding of clinical development towards licensure.

Cancer immunotherapy

  • In January, our pivotal Phase 2 trial of BN-Brachyury for the treatment of chordoma completed the recruitment of patients for the first stage ahead of schedule. The first results from this study are expected by the end of this year.
  • Our other immune-oncology candidate, CV301, is currently subject of three Phase 2 trials in multiple cancers, where the vaccine is combined with different immune checkpoint inhibitors. The first results from one of these trials, where CV301 is combined with atezolizumab in bladder cancer, is expected to become available later in 2019.
  • Both vaccine candidates will be employed in new trials later this year to investigate new routes of administration as part of our strategy to further enhance our immuno-oncology platform.

Commercial

  • Construction of our fill and finish facility is progressing according to plan, and we expect the building to be completed by end of 2019, which is also the peak investment year with approximately DKK 270 million in total investments. Subsequently, qualification and validation activities will begin and continue into late 2020 before initiating production.

FINANCIALS AND OUTLOOK

Financial results for the first quarter in line with expectations

  • Revenue generated for the three months ending March 31, 2019 was DKK 127 million/USD 19 million (DKK 11 million/USD 2 million in the first three months of 2018).
  • The income before interest and tax (EBIT) was a loss of DKK 104 million/USD 16 million (loss of DKK 173 million/USD 26 million in the first three months of 2018.
  • As of March 31, 2019, the Group’s cash preparedness was DKK 2,172 million/USD 327 million (DKK 2,314 million/USD 327 million as of December 31, 2018), including unutilized credit lines of DKK 244 million/USD 37 million (DKK 244 million/USD 37 million as of December 31, 2018).

Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.64 per 1.00 USD, which was the exchange rate as of March 31, 2019.

Outlook for 2019 maintained

We maintain our financial expectations for 2019 as announced on March 21, 2019 with revenues of approximately DKK 600 million/USD 92 million for the full year, a loss before interest and tax (EBIT) of approximately DKK 360 million/USD 55 million and a cash preparedness at year-end of approximately DKK 1,600 million/USD 246 million. 

While the Company anticipates the award of a Priority Review Voucher upon the expected approval of MVA-BN smallpox vaccine by the FDA in 2019, income from the sale of this voucher has not been included in the guidance.

The financial expectations are based on an exchange rate of DKK 6.50 per 1.00 USD. For further details regarding assumptions behind the guidance see the Annual Report 2018.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CEST (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 http://www.bavarian-nordic.com/investor/events.aspx?event=5503. 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 3096344.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Graham Morrell
Paddock Circle Advisors (US)
graham@paddockcircle.com
Tel: +1 781 686 9600 

Company Announcement no. 08 / 2019 

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our IMVAMUNE® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Registration studies are currently underway in the U.S. In addition to our long-standing collaboration with the U.S. government on the development of IMVAMUNE® and other medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

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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