COPENHAGEN, Denmark, August 16, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today its interim financial results and business progress for the first half of 2018 and releases its financial calendar for 2019.
- Positive RSV Phase 2 results recently confirmed the durability of broad vaccine responses after 1 year, which were rapidly increased following an annual booster vaccination.
- Compelling new research indicates a broader and more potent anti-tumor response after intra-tumoral and intravenous administration, which will broaden our strategy while we maintain our plans to evaluate CV301 in combination with checkpoint inhibitors in three indications. In-line with this strategy for CV301, the lung study will not continue into Phase 2.
- Financial results were in line with our expectations and outlook is maintained. Production and deliveries remain on track to fulfil full year guidance.
- Upgraded cash preparedness provides increased flexibility to execute on the Company's growth strategy.
"During first half of 2018, we have made important progress supporting the future growth of Bavarian Nordic. Several new studies have been initiated for our cancer vaccine candidates in collaboration with investigators and industry; but I am particularly excited to announce a broadening of our oncology strategy based on compelling new research data. The positive IMVAMUNE Phase 3 results have paved the way for a BLA submission later this year, and our recent RSV data have confirmed our strong position as a leading company in this field. We remain on track with the construction of a new fill/finish facility, which is key for our future revenue generation, and with the recent loan agreement from the European Investment Bank, backing this large investment, we maintain a strong financial flexibility" said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic.
Financial results
Financial results for the first half year were in line with our expectations.
- Revenue generated for the six months ending June 30, 2018 was DKK 98 million/USD 15 million (DKK 595 million/USD 93 million in the first six months of 2017).
- The income before interest and tax (EBIT) was a loss of DKK 280 million/USD 44 million (profit of DKK 99 million/USD 15 million in the first six months of 2017).
- As of June 30, 2018, the Group's cash preparedness was DKK 2,211 million/USD 346 million (DKK 2,604 million/USD 407 million as of December 31, 2017).
Outlook for 2018 maintained, cash preparedness upgraded
Bavarian Nordic maintains its financial expectations for 2018 as announced on March 12, 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 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. The expected cash preparedness at year-end was recently upgraded from approximately DKK 1,850 million/USD 289 million to approximately DKK 2,100 million/USD 329 million after being granted an unsecured loan facility of EUR 30 million from the European Investment Bank. This loan will support the Company's investments into a new fill-finish manufacturing facility, which is currently under construction and on track.
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 6.39 per 1.00 USD, which was the exchange rate as of June 30, 2018. The financial expectations are based on an exchange rate of DKK 6.60 per 1.00 USD.
Operational highlights and subsequent events
Broadening our immunotherapy strategy
- Based on new findings in research, Bavarian Nordic plans to initiate two clinical studies during first half of 2019 evaluating the intravenous administration of BN-Brachyury and the intra-tumoral administration of CV301 in patients with solid tumors. Preclinical studies have shown that both approaches have significant advantages in either stimulating larger numbers of killer T cells with heightened killer activity against cancer cells, induction of inflammatory cytokines, stimulating natural killer (NK) cells; another arm of the immune system, or changing the immunosuppressive environment within tumors supporting improved T cell killing of cancer cells.
- These studies will evaluate the safety and certain immune parameters, and together with additional preclinical activities, will inform the further development of intravenous and intra-tumoral vaccination, including the potential for next-generation constructs with improved activity.
Pipeline Developments
- Reported positive results from a Phase 2 extension study of our RSV vaccine, MVA-BN® RSV. The study revealed durable antibody and T cell responses against RSV one year post the original booster vaccination with MVA-BN RSV. These immune responses were significantly boosted following a further annual booster, particularly in the subjects with the weakest immunity at the baseline prior to the second vaccination. Results support an annual booster vaccination with MVA-BN RSV and will be important in discussions with the FDA concerning Phase 3 design later this year.
- Disclosed positive Phase 3 efficacy data for the IMVAMUNE® smallpox vaccine in comparison to ACAM2000, the replicating smallpox vaccine licensed in the U.S. The Company plans to file a BLA during 2018 and if approved, the Company would also be eligible to receive a Priority Review Voucher.
- Announced a partnership with the U.S. Department of Defense to develop a prophylactic vaccine against three separate strains of the equine encephalitis virus. The DoD will fund development of the MVA-BN® based vaccine, with total financial considerations potentially reaching USD $36 million.
- Our CV301 immunotherapy candidate has progressed into Phase 2 trials with the recent initiation of an investigator-led study in colorectal cancer evaluating the combination therapy of CV301, and Bristol Myers Squibb's checkpoint inhibitor, nivolumab (OPDIVO®). Two additional combination studies with other immune checkpoint inhibitors in patients with bladder and colorectal cancer are planned for initiation later this year, in-line with our strategy to seek rapid proof of concept for the combination of our platform and checkpoint inhibition.
- In line with our revised CV301 strategy to perform smaller studies with the potential for fast proof of concept, the Company will not be initiating the Phase 2 combination study of CV301 and pembrolizumab (KEYTRUDA®) in non-small cell lung cancer (NSCLC) as planned. The results of the Phase 1/1b combination study with nivolumab (OPDIVO®) or pembrolizumab (KEYTRUDA®) will be reported later this year.
- 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 multi-company collaborative NCI-sponsored trial was initiated evaluating BN-Brachyury with multiple combinations of experimental immune modulating candidates (a bifunctional anti-PDL1-TGF-beta fusion protein; IL-15/IL-15R superagonist and an IDO inhibitor), initially in patients with multiple solid tumors and expanding into men with metastatic castrate-resistant prostate cancer (mCRPC).
Corporate
- Obtained a non-dilutive, currently undrawn EUR 30 million (USD $35 million) loan from the European Investment Bank (EIB), providing Bavarian Nordic with the financial flexibility to enhance its manufacturing capabilities, while continuing to focus on its research and development
- Based on the loan commitment by the EIB, Bavarian Nordic raised its 2018 year-end cash preparedness from approximately DKK 1,850 million (USD $289 million) to DKK 2,100 million (USD $329 million).
- Henrik Juuel was appointed new CFO and Executive Vice President. He will join Bavarian Nordic in the fourth quarter of 2018.
Anticipated selected pipeline developments
IMVAMUNE
- Filing of Biologics License Application (BLA) for liquid-frozen IMVAMUNE (H2, 2018)
- Initiation of a Phase 3 IMVAMUNE freeze-dried lot consistency study (H1, 2019)
- Anticipated FDA approval and award of a Priority Review Voucher (2019)
RSV
- Initiate discussions with the FDA on the regulatory pathway for approval (H2, 2018)
- Decide on the feasibility of a human challenge study (H2, 2018)
Janssen partnership
- Initiate Phase 1 study of MVA-BN HIV + AdVac (H2, 2018*)
- Initiate Phase 1 study of MVA-BN HPV + AdVac (H2, 2018*)
CV301
- Initiate Phase 2 study in combination with atezolizumab in bladder cancer (H2, 2018)
- Initiate Phase 2 study in combination with durvalumab in colorectal cancer (H2, 2018)
- 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 2 study in patients with chordoma (H2, 2018)
- Initiate Phase 1 intravenous administration (H1, 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 CEST (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 http://www.bavarian-nordic.com/investor/events.aspx?event=5284. 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.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Graham Morrell
Paddock Circle Advisors (US)
graham@paddockcircle.com
Tel: +1 781 686 9600
Company Announcement no. 19 / 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.
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.