Bavarian Nordic Announces Interim Results for the First Nine Months of 2018 - Seite 2

Financial results
Financial results for the first nine months were in line with our expectations.

• Revenue generated for the nine months ending September 30, 2018 was DKK 319 million/USD 50 million (DKK 1,329 million/USD 206 million in the first nine months of 2017).
• The income before interest and tax (EBIT) was a loss of DKK 261 million/USD 41 million (profit of DKK 531 million/USD 82 million in the first nine months of 2017).
• As of September 30, 2018, the Group's cash preparedness was DKK 2,401 million/USD 373 million (DKK 2,604 million/USD 404 million as of December 31, 2017).

Outlook for 2018 maintained
The majority of revenues in 2018 relate to our contract with the U.S. Government for the manufacture of MVA-BN bulk vaccine, all of which have already been produced as of the reporting date. Therefore, we remain on track to fulfill our financial expectations for 2018, with revenues of approximately DKK 500 million/USD 78 million for the full year and a loss before interest and tax (EBIT) of approximately DKK 385 million/USD 60 million. The expected cash preparedness at year-end was upgraded in August from approximately DKK 1,850 million/USD 287 million to approximately DKK 2,100 million/USD 326 million after being granted an unsecured loan facility of EUR 30 million from the European Investment Bank.

Danish kroner (DKK) is the Company's functional currency. Solely for information purposes, figures above have also been converted into USD using an assumed exchange rate of DKK 6.44 per 1.00 USD, which was the exchange rate as of September 30, 2018.

Anticipated selected pipeline developments 

MVA-BN smallpox vaccine

• FDA acceptance of the Biologics License Application (BLA) for liquid-frozen MVA-BN (Q4, 2018)
• Anticipated FDA approval and award of a Priority Review Voucher (2019)
• Initiation of a Phase 3 MVA-BN freeze-dried lot consistency study (H1, 2019)

RSV

• Continue discussions with the FDA on the regulatory pathway for approval (H1, 2019)
• Initiate Phase 3 study in 2020

Janssen partnership

• Initiate Phase 1/2a study of MVA-BN HPV + AdVac (H2, 2018*)
• Initiate Phase 1 study of MVA-BN HIV + AdVac (H2, 2018*)

CV301

• Report clinical results of NSCLC combination Phase 1/1b (H2, 2018)
• Initiate a Phase 1 intra-tumoral administration in patients with solid tumors (H1, 2019)

BN-Brachyury

• Report clinical results from Phase 1 study (H2, 2018)
• Initiate Phase 1 intravenous administration (H1, 2019)
• Report clinical results from Phase 2 in chordoma (H2, 2019)

* Janssen is responsible for the clinical development