KVISTGAARD, Denmark, May 5, 2015 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today publishes its interim financial results for the first three months of 2015.
Significant achievements in the first three months of 2015 and up to the reporting date
- Revenue for the period was DKK 235 million (2014: DKK 286 million), the income before interest and tax (EBIT) was a loss of DKK 40 million (2014: DKK 3 million profit) and the net profit was DKK 45 million (2014: DKK 1 million profit).
- Financial expectations for the full year are maintained.
- In January, the first-in-human trial investigating the MVA-BN® Filo/AdVac® Ebola prime-boost vaccine regimen was initiated in the U.K. Subsequent trials have been initiated in the U.S. and Kenya.
- In February, updated long-term survival data from an NCI sponsored combination study of PROSTVAC® and Yervoy® were presented. For patients receiving PROSTVAC and high doses of Yervoy, a median overall survival of 37.2 months was shown, compared to a predicted survival of 18.5 months. Furthermore, approximately 20% of these remain alive at 80 months.
- In March, Bavarian Nordic entered into an exclusive agreement with Bristol-Myers Squibb for PROSTVAC, under which the Company could receive up to USD 975 million, inclusive of USD 60 million upfront and potential exercise payment; potential development, regulatory and commercialization milestone payments; additional tiered double-digit royalties on future sales. In addition, the companies will collaborate to explore the combination of PROSTVAC with agents from Bristol-Myers Squibb's immune-oncology portfolio.
- During the first quarter, Bavarian Nordic has delivered the final doses of IMVAMUNE® smallpox vaccine to the U.S. Strategic National Stockpile under the replenishment contract awarded by BARDA in 2014. Furthermore, the Company has delivered 45,700 doses of IMVAMUNE to the Public Health Agency of Canada as part of the contracts awarded in 2014.
Paul Chaplin, President & CEO of Bavarian Nordic said: "The company passed a historical milestone during the first quarter of 2015 by entering into a partnership with Bristol-Myers Squibb for the commercialization of PROSTVAC. Partnering with one of the world leaders in cancer immunotherapy provides validation of our Phase 3 program and manufacturing capabilities, but importantly will provide the vital support to perform additional studies to position PROSTVAC as an important treatment of men with prostate cancer in combination with other synergistic products, such as Bristol-Myers Squibb's own checkpoint inhibitors. The 2015 guidance remains on track with the recent initiation of deliveries of MVA-BN Filo to Janssen to support the collaboration and development of an Ebola vaccine, while we expect to report results and activities supporting the progression of our pipeline programs in smallpox, filoviruses and RSV in the coming months."
Selected upcoming milestones
- Manufacture and deliver MVA-BN Filo vaccine to Janssen (targeting 2 million doses to contribute to the MVA-BN/AdVac Ebola prime-boost vaccine regimen) (2015)
- Phase 1 results of the Ebola prime-boost vaccine regimen
- Initiation of Phase 2 and Phase 3 clinical trials of the Ebola prime-boost vaccine regimen
- Potential expanded collaboration with Janssen on additional infectious disease targets
- Complete Phase 2 study of freeze-dried IMVAMUNE to support a pre-EUA submission (requirement for stockpiling) (2015)
- Complete transfer of validated freeze-dried manufacturing process to a commercial scale facility (2015)
- Secure IMVANEX/IMVAMUNE orders from rest of world
- Investigational New Drug submission for MVA-BN RSV followed by initiation of Phase 1 study (H1, 2015)
- Advance clinical studies exploring the therapeutic potential of PROSTVAC in combination with Yervoy and other potential checkpoint inhibitors as part of the clinical collaboration with Bristol-Myers Squibb
- Finalize validation of the PROSTVAC commercial manufacturing process and prepare launch material
- Interim analyses of the PROSTVAC Phase 3 clinical trial
Financials
Danish kroner (DKK) is the Company's functional currency. All USD figures provided below are based upon a USD/DKK exchange rate of 7.00.
| 3m 2015 DKK million | 3m 2014 DKK million | 3m 2015 USD million | 3m 2014 USD million | |
| Revenue | 235 | 286 | 34 | 41 |
| EBIT | -40 | 3 | -6 | 0 |
| Cash preparedness | 1,619 | 535 | 231 | 76 |
Bavarian Nordic maintains its 2015 full-year financial expectations with revenue at the level of DKK 1,000 million and a break even result before interest and tax (EBIT). Revenue will primarily be generated from deliveries of bulk material totaling approximately 2 million doses of MVA-BN Filovirus vaccine under the Janssen license agreement and 0.3 million doses of IMVAMUNE to the U.S. Strategic National Stockpile, the Public Health Agency of Canada and Canadian Department of National Defence. Additional revenue is expected from ongoing research and development contracts including the additional funding awarded for the Phase 3 trial for IMVAMUNE, the contract for freeze-dried IMVAMUNE and the contracts for Ebola/Marburg. The upfront payment from the PROSTVAC option- and license agreement with Bristol-Myers Squibb will be revenue recognized when the option matures.
The cash preparedness at year end is expected to be in the level of DKK 1,100 million.
As of the reporting date, all known external USD exposure is hedged.
Group key figures are found at the end of this announcement. The full financial statements for the period can be downloaded from the Company's website: www.bavarian-nordic.com along with a spreadsheet containing selected accounting figures.
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. Dial-in numbers for the conference call are: Denmark: +45 32 72 80 18, UK: +44 (0) 844 571 8957, USA: +1 866 682 8490. A live and archived webcast of the call and relevant slides will be available at http://www.bavarian-nordic.com/investor/events.aspx?event=4208.
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
About Bavarian Nordic
Bavarian Nordic is a biopharmaceutical company focused on the development and manufacturing of cancer immunotherapies and vaccines for infectious diseases. Through a long-standing collaboration with the U.S. Government, Bavarian Nordic has developed a portfolio of biological countermeasures, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the U.S. and other governments. The vaccine is approved in the EU (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its partner Janssen are pioneering the development of an Ebola vaccine, which has been fast-tracked by authorities in response to the current situation in West Africa. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies based on its versatile pox-virus based technologies, 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. 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.
Consolidated Key Figures
| DKK million | 3m 2015 | 3m 2014 | FY 2014 |
| un-audited | un-audited | audited | |
| Income statements | |||
| Revenue | 234.8 | 285.9 | 1,216.8 |
| Production costs | 92.1 | 144.4 | 495.1 |
| Research and development costs | 118.6 | 89.3 | 478.9 |
| Distribution costs | 17.4 | 10.8 | 45.1 |
| Administrative costs | 46.9 | 38.0 | 181.0 |
| Income before interest and taxes (EBIT) | (40.2) | 3.4 | 16.7 |
| Financial items, net | 103.2 | 0.7 | 47.7 |
| Income before company tax | 63.0 | 4.1 | 64.4 |
| Net profit for the period | 45.4 | 1.2 | 25.9 |
| Balance sheet | |||
| Total non-current assets | 540.0 | 560.5 | 568.1 |
| Total current assets | 1,923.9 | 771.9 | 1,319.2 |
| Total assets | 2,463.9 | 1,332.4 | 1,887.3 |
| Equity | 1,268.9 | 978.7 | 1,252.1 |
| Non-current liabilities | 51.4 | 84.5 | 51.9 |
| Current liabilities | 1,143.6 | 269.2 | 583.3 |
| Cash flow statements | |||
| Securities, cash and cash equivalents | 1,607.5 | 414.9 | 979.7 |
| Cash flow from operating activities | 599.4 | (79.8) | 338.8 |
| Cash flow from investment activities | (14.4) | (37.7) | (503.7) |
| - Investment in intangible assets | (9.0) | (21.2) | (53.6) |
| - Investment in property, plant and equipment | (0.4) | (12.9) | (52.4) |
| Cash flow from financing activities | 11.2 | (2.1) | 216.3 |
| Financial Ratios (DKK) 1) | |||
| Earnings (basic) per share of DKK 10 | 1.6 | 0.0 | 1.0 |
| Net asset value per share 2) | 45.8 | 35.3 | 45.2 |
| Share price at period-end | 357 | 99 | 198 |
| Share price/Net asset value per share | 7.8 | 2.8 | 4.4 |
| Number of outstanding shares at period-end | 27,732 | 26,094 | 27,671 |
| Equity share | 51% | 73% | 66% |
| Number of employees, converted to full-time, at period-end | 421 | 426 | 422 |
1) Earnings per share (EPS) is calculated in accordance with IAS 33 "Earning per share". The financial ratios have been calculated in accordance with "Anbefalinger og Nøgletal 2010" (Recommendations and Financial ratios 2010)
2) Due to issue of new shares in 2015, net asset value per share for 2014 has been recalculated based on outstanding shares end Q1 2015.
