Bavarian Nordic A/S. (5/4/17). "Press Release: Bavarian Nordic Announces Interim Results for the First Three Months of 2017". Copenhagen.

	Organisation	Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY)
	Group	Bavarian Nordic (Group)
	Organisation 2	National Cancer Institute (NCI) (US)
	Group	United States (govt)
	Product	Prostvac®
	Product 2	Tecentriq®
	Person	Birk, Henrik (Bavarian Nordic 201701– COO joined in 2008 before Coloplast)
	Person 2	Chaplin, Paul (Bavarian Nordic 201410 CEO)

Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results for the first three months of 2017. Below is a summary of the financial performance for the period and business progress for the last quarter. The full interim report is attached as a PDF file and can be found on the company's website, www.bavarian-nordic.com.

Key highlights from the report

In April, a Phase 2 combination study of PROSTVAC, ipilimumab and nivolumab was initiated at the National Cancer Institute.

In March, a drug supply agreement was entered with Roche, providing Tecentriq® (atezolizumab) for a planned Phase 2 combination trial of CV301 in bladder cancer.

In February, updated Phase 1 data for MVA-BN RSV were reported, demonstrating that the vaccine induced a durable immune response lasting at least 6 months; a period spanning a normal RSV season. Furthermore, additional T cell responses were reported, showing that MVA-BN RSV induced a strong (3-5 fold) booster response to all five RSV proteins included in the vaccine.

In January, Henrik Birk was appointed Chief Operating Officer

“I am very pleased with the progress at the company, year to date. We continue to execute on our CV301 strategy, with the addition of Roche as a clinical collaborator, and we are preparing for the numerous milestones throughout the rest of the year. With key events including proof of concept data for RSV, interim and final readout for PROSTVAC, as well as final phase 3 data for liquid-frozen IMVAMUNE, we have a diverse and rich pipeline and remain very excited about the prospects to come,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.

Financial performance

Revenues in the first quarter of 2017 were largely derived from the sale of IMVAMUNE bulk drug substance to U.S. Government, contributing to a break-even result for the period, which was in line with the Company’s expectations. There were no revenues from sale of IMVAMUNE bulk drug substance during the same period in 2016.

DKK million
3m 2017
3m 2016

USD million
3m 2017
3m 2016

Revenue

198
23

28
3

EBIT

(3)
(153)

0
(22)

Cash preparedness, period-end

2,448
1,365

352
196

Outlook for 2017

The Company maintains its financial expectations for 2017. For detailed assumptions, refer to the 2016 Annual Report.

2017E
DKK million
USD million

Revenue
1,300
187

EBIT
350
50

Cash preparedness, year-end *
2,400
345

* Cash preparedness includes cash, cash equivalents, investments in securities and the aggregate amount of undrawn credit lines.This includes a EUR 50 million unsecured loan from the European Investment Bank, which the Company anticipates drawing on.

Danish kroner (DKK) is the Company’s functional currency. All USD figures provided above are based upon an assumed exchange rate of DKK 6.96 per 1.00 USD, which was the exchange rate as of March 31, 2017.

Conference call and webcast

The management of Bavarian Nordic will host a conference call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. Dial-in numbers for the conference call are: Denmark: +45 32 71 16 60, UK: +44 (0) 20 3427 1911, USA: +1 646 254 3364. Participant code is 7659153. A live and archived webcast of the call and relevant slides will be available at /investor/events.aspx?event=5049.

About Bavarian Nordic

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company’s live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. 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.

Contacts

Rolf Sass Sørensen

Vice President Investor Relations (EU)

Tel: +45 61 77 47 43

Seth Lewis

Vice President Investor Relations (US)

Tel: +1 978 341 5271

Company Announcement no. 11 / 2017
Published on May 04, 2017, 7:38 CET

Record changed: 2023-06-05