BVNRY Bavarian Nordic AS (PK)

• Revenue for the period was DKK 286 million (2013: DKK 206 million) and the result was a net profit of DKK 1 million (2013: DKK 34 million loss)
• Financial expectations for the full year are maintained
• Regulatory approvals for the PROSPECT study have been received in Germany and the Netherlands, where the first centers are now open for enrollment. Thus the trial has now opened in all 15 planned countries with more than 190 investigative sites currently active
• In February, the Company was awarded a contract valued at USD 0.5 million by the Defense Threat Reduction Agency (DTRA), a division of the U.S. Department of Defense (DOD) for the development of an MVA-BN-based vaccine against Burkholderia
• In April, the National Cancer Institute initiated a Phase 2 study of the Company's CV-301 immunotherapy candidate in bladder cancer patients
• In April, the Biomedical Advanced Research and Development Authority (BARDA) exercised an option at a value of USD 21.9 million under the existing development contract for freeze-dried IMVAMUNE smallpox vaccine. This will fund the transfer of the validated manufacturing process to a new manufacturing line with a larger commercial capacity
• In April, Gerard van Odijk was elected new chairman of the board. He succeeds Asger Aamund who had chosen to resign from the board after having served as chairman since 1994. Furthermore Anders Gersel Pedersen was elected deputy chairman of the board
• Lower contribution margins were seen on IMVAMUNE smallpox vaccine sales in the first quarter due to temporary higher production costs relating to a shorter period in 2013. However, as previously communicated, the overall contribution margin for the full year is expected to be at the same level as 2013

Anders Hedegaard, President & CEO said: "In both our divisions, we are making strong progress towards the objectives set out for the year. We recently received regulatory approvals for the PROSPECT Phase 3 study in the two remaining countries; Germany and the Netherlands and through a new NCI-sponsored Phase 2 study of CV-301 in bladder cancer, we also expanded the cancer immunotherapy pipeline as planned. We were also pleased to report the recent exercise of a contract option by BARDA, which funds the transfer of the IMVAMUNE freeze-dried production process to a large-scale facility." 

Selected upcoming milestones

• Complete enrollment in the PROSPECT Phase 3 clinical study (H2, 2014)
• Secure the second portion of IMVAMUNE delivery contract with the U.S. government (USD 118 million) (H1, 2014)
• Complete Phase 2 study of freeze-dried IMVAMUNE to support a pre-EUA submission (requirement for stockpiling) (2015)
• Initiate final Phase 3 study of IMVAMUNE (H1, 2014)
• Continue research to maximize the potential of PROSTVAC in combination with checkpoint inhibitors, androgen deprivation therapies and radiotherapy
• Initiate NCI-sponsored Phase 1 study of MVA-BN Brachyury (H1, 2014)
• Finalize development plan for CV-301 in colorectal cancer based upon feedback from the FDA (H2, 2014) followed by initiation of randomized, controlled clinical study depending on availability of funds
• Potential IMVANEX/IMVAMUNE orders from rest of world

Financials

Danish kroner (DKK) is the Company's functional currency. All USD figures provided above are based upon a USD/DKK exchange rate of 5.4.

The Company maintains its 2014 full-year expectations with revenues in the level of DKK 1,200 million and a break-even result before interest and tax (EBIT). The Infectious Diseases division is expected to generate an EBIT of approximately DKK 400 million, which will be offset by total costs of DKK 400 million in the Cancer Immunotherapy division, primarily relating to the global Phase 3 study of PROSTVAC(r). The Group's cash preparedness at year-end is expected to be approximately DKK 600 million.

Group key figures are found at the end of this announcement. The full financial statements for the period can be downloaded from the Company's website: www.bavarian-nordic.com along with a spreadsheet containing selected accounting figures.

Anders Hedegaard, President & CEO.

Contacts Rolf Sass Soerensen, Vice President Investor Relations (EU). Phone +45 61 77 47 43 Seth Lewis, Vice President Investor Relations (US). Phone + 1 978-298-5654

Webcast and conference call The Company will host a conference call today at 2.00 pm CET (8.00 am EST). President and CEO, Anders Hedegaard will present the interim results followed by a Q&A session with participation of the Company's executive management. Dial-in numbers for the conference call are: Denmark: +45 32 72 80 18, UK: +44 (0) 844 571 8957, USA: +1 866 682 8490. A webcast of the conference call will be broadcast simultaneously at http://www.bavarian-nordic.com/investor/events.aspx?event=2872. On this page, the accompanying presentation will be available prior to the conference call.

About Bavarian Nordic Bavarian Nordic is an international biotechnology company developing and manufacturing novel cancer immunotherapies and vaccines for infectious diseases. Lead product candidates are PROSTVAC(r), an immunotherapy product candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 clinical trial, and IMVAMUNE(r), a non-replicating smallpox vaccine candidate in Phase 3 development, which is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. IMVAMUNE(r) is approved in the European Union under the trade name IMVANEX(r). 

Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the U.S. (OTC) under the symbol BVNRY.

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. 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.

Bavarian Nordic AS (PK) (USOTC:BVNRY)
Historical Stock Chart
From Nov 2024 to Dec 2024

Bavarian Nordic AS (PK) (USOTC:BVNRY)
Historical Stock Chart
From Dec 2023 to Dec 2024