Bavarian Nordic Announces First Half 2019 Results

COPENHAGEN, Denmark, August 15, 2019 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and business progress for the first half of 2019 and releases its financial calendar for 2020.

Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We have made important progress in our strategic objectives during the first half of this year with the initiation of a Phase 3 study for the freeze-dried formulation of MVA-BN and the expansion of our proof of concept Phase 2 study for BN-Brachyury. Our financial results are fully in line with our guidance and expectations and we are looking forward to the rest of the year with a rich news flow ahead of us. We expect to report additional clinical oncology data for CV301; finalize our registration plans for RSV; obtain our first ever US approval together with a priority review voucher for MVA-BN and lastly complete the construction of our fill and finish plant that will unlock higher future revenues and return the company to profitability. It is a very exciting time to be at Bavarian Nordic”.

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

• The BLA review for liquid-frozen MVA-BN is continuing, with an anticipated approval and award of a Priority Review Voucher in September 2019.
• In June, we initiated the pivotal and fully funded Phase 3 trial of the freeze-dried formulation of MVA-BN as planned. This randomized and double-blind study will enroll 1,110 healthy subjects into 3 groups and investigate the safety and immunogenicity of 3 different lots of freeze-dried MVA-BN. The study is expected to be completed by the end of 2020 and will support the subsequent approval of the freeze-dried formulation.
• In June, the U.S. Government passed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA) of 2019. This bill improves the funding for critical federal biodefense programs and agencies, including Biomedical Advanced Research and Development Authority (BARDA) and the Strategic National Stockpile (SNS) at 1.2 billion annually for the next five years, while the Project BioShield Special Reserve Fund (SRF) will be funded at US$ 710 million annually over the next 10 years. This strong financial support creates a more sustainable market place for companies like ours developing biological countermeasures.
• The production of the bulk vaccine for the current BARDA order for freeze-dried MVA-BN has been initiated and is running smoothly, however the majority of the batches will only be invoiced in the second half of 2019 adding up to a total of USD 50 million included in our guided 2019 revenues. By year-end we will then have produced bulk vaccine worth USD 333 million since our first order in 2015.
• 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. These activities will be finalized in 2020 before starting production of the current order to convert the bulk vaccine to approx. 13 million freeze-dried doses.

Infectious diseases

• We remain at the forefront of RSV vaccine development with our differentiated vaccine candidate, which has successfully concluded Phase 2 development in elderly subjects. We continue to prepare for initiating a Phase 3 trial in 2020 and plan to announce the final plans once the Phase 3 design has been confirmed with the US regulatory authorities.
• 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 enter clinical trials. The second program for a therapeutic HIV vaccine, is also expected to enter a Phase1/2a clinical trial 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 June, we reported the first results from the ongoing Phase 2 trial of BN-Brachyury for the treatment of chordoma. A partial response was observed in one of the first 10 patients recruited and treated with the vaccine in combination with radiation, thereby reaching the threshold for advancing the study into stage 2, where enrollment will be expanded to a total of 29 patients. We have seen strong support from the chordoma community for this study and expect to see a rapid enrollment of patients. For the study to be considered successful, a minimum of four out of the 29 patients with objective responses are required.
• 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 also 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 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 of MVA-BN.

OTHER DEVELOPMENTS

• The Danish tax authority decided in July to withdraw the proposed adjustment of the allocation of the PROSTVAC development costs between Bavarian Nordic A/S and its U.S. subsidiary, Bavarian Nordic, Inc. for the income years 2012-2016. The transfer pricing tax audit for 2012-2016 has thereby been completed without any changes to taxable income.

FINANCIALS AND OUTLOOK

Financial results for the first half in line with expectations

• Revenue generated for the six months ending June 30, 2019 was DKK 228 million/USD 35 million (DKK 98 million/USD 15 million in the first six months of 2018).
• The income before interest and tax (EBIT) was a loss of DKK 201 million/USD 31 million (loss of DKK 280 million/USD 43 million in the six months of 2018).
• As of June 30, 2019, the Group’s cash preparedness was DKK 1,882 million/USD 287 million (DKK 2,314 million/USD 353 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 6.56 per 1.00 USD, which was the exchange rate as of June 30, 2019.

Outlook for 2019 maintained

The majority of our 2019 revenues are related to the production and release of bulk smallpox vaccine for the U.S. Government, which will occur in the second half of 2019. Hence, 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. 

Financial calendar 2019 and 2020

The 2020 dates for announcement of the Company’s financial reports and the annual general meeting have now been determined, and planned future reporting dates are as follows:

* Pursuant to Article 12 of the Articles of Association, shareholders who wish to submit a request for proposals for consideration at the annual general meeting must lodge this with the Company no later than Wednesday, March 11, 2020.

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=5504. 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 5278296.

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. 14 / 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.

Attachment

• Interim Report H1 2019