COPENHAGEN, Denmark, May 24, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and business progress for the first three months of 2018.
First quarter highlights and subsequent events
- Positive results of the Phase 3 study of IMVAMUNE® were announced. The study, which compared the efficacy of IMVAMUNE with ACAM2000®, the current U.S. licensed replicating smallpox vaccine, met both of its primary efficacy endpoints. This was the second and final phase 3 study required for licensure of the current formulation. Filing of a Biologics License Application is anticipated in the second half of 2018.
- Additional data from the Phase 2 study of MVA-BN® RSV showed that a single booster vaccination induced increased levels of IgA antibodies recognizing RSV in the nasal mucosa, which has been highly correlated with protection against RSV.
- A Phase 1 clinical trial of our novel cancer immunotherapy candidate, BN-Brachyury, was initiated in patients with several tumor types. The vaccine is targeting brachyury, a key driver of cancer metastasis. The study precedes a number of planned company and investigator sponsored Phase 2 trials later in the year.
- The use of BN-Brachyury for the treatment of chordoma, a rare bone cancer of the spine and base of the skull, received an orphan drug status with the FDA. Bavarian Nordic plans to initiate a Phase 2 study investigating BN-Brachyury in combination with radiation treatment in patients with chordoma in second half of 2018.
- A pharmaceutical collaboration with AstraZeneca was announced. The investigator led study will evaluate the combination of CV301 and durvalumab, AstraZeneca's PD-L1 inhibitor, in patients with metastatic colorectal or pancreatic cancers receiving maintenance chemotherapy.
- A second investigator study was announced, in collaboration with Bristol-Myers Squibb, and will test the combination of CV301 and nivolumab, Bristol-Myers Squibb's PD-1 inhibitor, in patients with oligometastatic, microsatellite stable colorectal cancer.
- A new alliance was signed with the United States Department of Defense (DoD) for the development of a prophylactic MVA-BN®-based vaccine against various strains of the equine encephalitis virus - a rare, but potentially deadly mosquito-borne illness, for which there is currently no preventative vaccine treatment available. The multi-year agreement has a total potential value of approximately USD 36 million.
- Four posters have been accepted at the 2018 ASCO Annual Meeting highlighting clinical achievements for CV301, BN-Brachyury, and PROSTVAC. In addition, the PROSPECT Phase 3 trial of PROSTVAC as monotherapy in men with metastatic, castration-resistant prostate cancer, which was discontinued in 2017 due to futility, has been accepted for an oral presentation, which will be held by Dr. James L. Gulley from the National Cancer Institute and principal investigator of the study.
Financial results for the first quarter were in line with our expectations.
- Revenue generated for the three months ending March 31, 2018 was DKK 11 million/USD 2 million (DKK 198 million/USD 33 million in the first three months of 2017).
- The income before interest and tax (EBIT) was a loss of DKK 173 million/USD 29 million (loss of DKK 3 million/USD 0 million in the first three months of 2017).
- As of March 31, 2018, the Group's cash preparedness was DKK 2,355 million/USD 392 million (DKK 2,604 million/USD 433 million as of December 31, 2017).
Outlook for 2018 maintained
Bavarian Nordic maintains its financial expectations for 2018 as announced on March 12, 2018 with revenues of approximately DKK 500 million/USD 83 million for the full year, a loss before interest and tax (EBIT) of approximately DKK 385 million/USD 64 million and a cash preparedness at year-end of approximately DKK 1,850 million/USD 308 million. The majority of the 2018 revenues are related to the production and release of IMVAMUNE vaccine for the U.S. Government, which will occur in the second half of 2018.
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 6.01 per 1.00 USD, which was the exchange rate as of March 31, 2018. The financial expectations are based on an exchange rate of DKK 6.60 per 1.00 USD.
"In the past several months we have been fortunate enough to witness some of the most significant progress in Bavarian Nordic's history. The positive phase 3 results from IMVAMUNE was a major accomplishment, and one we are very proud of. New collaborations with CV301 keep us well positioned to advance this program in multiple indications while minimizing internal costs, the additional clinical success seen with RSV continue to encourage us, and preparations are well under way for our brachyury vaccine to enter a significant trial in chordoma patients in the second half of this year. Our work on our fill/finish facility is progressing well and remains on track, setting the stage for future deliveries of freeze-dried IMVAMUNE and increased revenue generation." said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.
Anticipated selected pipeline developments
- Filing of Biologics License Application for liquid-frozen IMVAMUNE (H2, 2018)
- Anticipated BLA approval and award of a Priority Review Voucher (2019)
- Initiation of a Phase 3 IMVAMUNE freeze-dried lot consistency study (2019)
- Report clinical results from the annual booster-study (H1, 2018)
- Decide on the feasibility of a human challenge study (H2, 2018)
- Initiate Phase 1 study of MVA-BN HIV + AdVac (H2, 2018*)
- Initiate Phase 1 study of MVA-BN HPV + AdVac (H2, 2018*)
- Initiate Phase 2 study in combination with atezolizumab in bladder cancer (mid 2018)
- Initiate Phase 2 study in combination with durvalumab in colorectal cancer (H1, 2018)
- Initiate Phase 2 study in combination with nivolumab in colorectal cancer (H1, 2018)
- Report initial Phase 2 results (ORR) from combination with pembrolizumab in NSCLC (H2, 2018)
- Report clinical results from Phase 1 study (H2, 2018)
- Initiate Phase 2 study in patients with chordoma (H2, 2018)
* 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 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=5283. 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.
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Company Announcement no. 13 / 2018
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe 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.
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.