On November 9, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results in line with guidance for the first nine months of 2018 and business progress for the third quarter of 2018 (Press release, Bavarian Nordic, NOV 9, 2018, View Source [SID1234531089]).

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Highlights

A Biologics License Application for MVA-BN smallpox vaccine (formerly IMVAMUNE) was submitted to the U.S. Food and Drug Administration (FDA). Pending acceptance of the BLA, the Company anticipates approval of the vaccine during 2019 with subsequent filing for a Priority Review Voucher.
IMVANEX smallpox vaccine was supplied to the Public Health England for vaccination of healthcare workers involved in first ever human cases of monkeypox in the U.K.
Following the positive Phase 2 results for our RSV vaccine candidate, MVA-BN RSV, we have initiated discussions with the FDA, which will continue into 2019 with an aim to agree on the design of Phase 3, which we plan to initiate in 2020.
Two studies of our cancer immunotherapy candidate, CV301, in combination with checkpoint inhibitors were initiated. This takes the total number of studies to three, which is in accordance with our strategy to seek rapid proof of concept for the combination of our platform and checkpoint inhibition in three indications. During 2019 we will further advance the potential of our platform by using other routes of administration, which are expected to provide an even broader and more potent anti-tumor response.
A Phase 2 study of BN-Brachyury was initiated in patients with chordoma, a rare cancer in the bones of the skull base and spine with limited treatment options. The vaccine has received orphan drug designation from the FDA for the treatment of chordoma, and the study could potentially provide pivotal results for registration of the vaccine.
Production and deliveries of MVA-BN smallpox vaccine remain on track to fulfil full year guidance.
As planned, Henrik Juuel joined the Company in November as new Chief Financial Officer and member of the executive management.
"The recent BLA submission for our smallpox vaccine highlights the competences and strengths of Bavarian Nordic today, which we proudly apply to advance our technology to develop new vaccines to meet the unmet medical needs that remain in both infectious disease and oncology. We have seen strong progress in our pipeline over the past months with several new studies initiating, seeking proof-of-concept for our immuno-oncology platform across major solid tumor types, but also in rare and underserved cancers, such as chordoma. Following the positive Phase 2 data from our RSV program, we have also recently initiated discussions with the FDA on the design of Phase 3, anticipated to start in 2020. Meanwhile, we continue our successful operations with production of bulk vaccines and construction of our new fill/finish facility going according to plan, securing the foundation for future revenues and success for Bavarian Nordic," said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

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

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the interim results followed by a Q&A session. A live and recorded webcast of the presentation can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 35 15 81 21, UK: +44 (0) 330 336 9411, USA: +1 323-794-2551. Participant code is 8332812