COPENHAGEN, Denmark, November 11, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results for the first nine months of 2020 and business progress for the third quarter of 2020. The Company raises its EBITDA guidance from DKK 675 million to DKK 725 million and upgrades year-end guidance on cash.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “While during the third quarter of 2020 we successfully continued the transformational initiatives linked to the commercialization of Bavarian Nordic, the global COVID-19 pandemic has unfortunately impacted many parts of our business. The markets for Rabipur/RabAvert and Encepur have been adversely impacted by the measures taken to combat COVID-19 and the decline in the travel segment. In contrast, the sales of JYNNEOS have been more robust and resilient allowing us to maintain our revenue expectations for the year and with operational savings we are pleased to upgrade this year’s EBITDA guidance, as well as our year-end cash position. Due to the expected continued challenges from COVID-19 and the added risks associated with potentially low rates of RSV next year, we have decided to postpone the planned Phase 3 efficacy trial for our RSV vaccine candidate. To maintain the momentum of this program we are planning to conduct a human challenge trial to evaluate the efficacy of our promising RSV vaccine candidate. Data from this trial, which is expected during the second half of 2021, will provide the first insights into the protective efficacy of our vaccine, while also further de-risking the planned Phase 3 trial that will now commence in 2022.”
Total revenues in the first nine months were DKK 1,623 million comprised of DKK 1,434 million from combined product sales, DKK 67 million from a milestone payment from Janssen related to the European approval of the Ebola vaccine and DKK 123 million from contract work.
Revenues in third quarter totaled DKK 558 million comprised of DKK 188 million from sale of Rabipur/RabAvert, DKK 160 million from sale of JYNNEOS, DKK 110 million from sale of Encepur, DKK 67 million from the milestone payment from Janssen and DKK 33 million from contract work.
EBITDA in the first nine months was DKK 1,001 million, including other operating income of DKK 628 million from the sale of Priority Review Voucher.
Strong cash position of DKK 2,569 million at end of the period, excluding unutilized credit facilities of DKK 244 million.
Full-year guidance on revenue maintained at DKK 1,900 million, EBITDA guidance raised from DKK 675 million to DKK 725 million. The securities, cash and cash equivalents at year-end is now expected to be DKK 1,600 million, DKK 100 million higher than previously guided, as result of improved EBITDA and changes in working capital assumptions.
Securities, cash and cash equivalents
* Cash guidance includes the EUR 30 million loan from the European Investment Bank as cash, which is currently not drawn upon.
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. Bavarian Nordic is seeking funding to accelerate the further development of the vaccine.
In August, positive topline results from the Phase 3 study of freeze-dried MVA-BN® smallpox vaccine were reported. This Phase 3 study is required to support the licensure of the freeze-dried formulation by the FDA, anticipated in 2022.
Events after the reporting date
In October, Bavarian Nordic announced the appointment of Ms. Anu Helena Kerns to the position of Executive Vice President, People and Organization effective from November 2020. In this newly established role, Ms. Kerns will drive the organizational development of Bavarian Nordic through the ongoing commercial transformation of the company.
The Company has today decided to postpone the initiation of the Phase 3 study of its RSV vaccine candidate until 2022. This decision follows an assessment of the potential adverse impact from the social distancing measures related to COVID-19 which has reduced the prevalence of other respiratory viruses, including RSV, and this may very likely continue into the 2021/22 season. To maintain the momentum of the program despite the challenges faced by COVID-19, a Phase 2 human RSV challenge study has been planned for initiation in 2021, which will generate the first efficacy data against RSV during 2021 and potentially further de-risk the Phase 3 efficacy trial.
In accordance with the shareholder authorization for the board of directors and the Company’s guidelines regarding incentive programs, the board of directors has today decided to issue warrants to executive management and certain employees in the Bavarian Nordic Group. A total of 1,280,258 warrants are issued, which entitle the warrant holders to subscribe for up to 1,280,258 shares in total with a nominal value of DKK 10 each at an exercise price of DKK 206.82 per share.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am ET) 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=5692. 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 9341969.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, email@example.com, Tel: +1 781 686 9600
Company Announcement no. 47 / 2020
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines 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.
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.