Bavarian Nordic’s results for 2004 were a revenue of DKK 164.8 million and loss before tax of DKK -76.7 million. Bavarian Nordic expects a revenue of approximately DKK 450-500 million in 2005 and a result of DKK 0.
Financial Results for 2004
Revenue was DKK 164.8 million (2003: DKK 524.5 million)
Loss before tax of DKK -76.7 million (profit; 2003: DKK 217.6 million).
Net income was a loss of DKK -53.0 million (profit; 2003: DKK 150.6 million)
Cash preparedness was DKK 165.1 million at the end of 2004
Milestones - Smallpox Vaccine Franchise in 2004
The US Government awarded Bavarian Nordic a contract with the potential value of more than USD 141 million for the further development and purchase of IMVAMUNE™ as a safe smallpox vaccine.
A global agreement with GlaxoSmithKline on the manufacturing and marketing of IMVAMUNE™ was established.
The US Patent and Trademark Office (USPTO) issued a patent to Bavarian Nordic on the company’s MVA-BN® virus and derivatives thereof.
The US Food and Drug Administration (FDA) granted “fast-track” status to IMVAMUNE™ - the first-ever for a smallpox vaccine.
Positive results were reported from a Phase II dose-finding trial with IMVAMUNE™ in 165 healthy volunteers.
Bavarian Nordic began a Phase I study comparing IMVAMUNE™ with DryVax® in 90 healthy volunteers.
Bavarian Nordic started a Phase I study with IMVAMUNE™ in 60 subjects, including persons with atopic disorders (such as eczema).
Milestones – Production in 2004
The industrial scale MVA-BN® manufacturing process was optimized.
Test-runs on the MVA-BN® manufacturing process have shown that the Kvistgård facility will be able to produce approximately 40-60 million doses of IMVAMUNE™ per year.
Bavarian Nordic received environmental approval of the Kvistgård site from Danish authorities. The re-construction project continues on-schedule and on-budget. The quality control laboratory has been approved and is in operation. Installation and qualification of equipment is underway.
The Berlin site fully-implemented the MVA-BN® manufacturing technology and applied for manufacturing authorization which was granted in 2005.
Milestones - HIV Vaccine Programmes in 2004
The company reported positive results from a Phase I/II study with MVA nef in 14 HIV-infected patients. Five out of 14 patients continue to remain off HAART therapy after 34 months.
A Phase II study with MVA nef in 75 HIV-infected patients was approved and patients screened.
Milestones - Research & Development in 2004
The MVA-BN® platform was expanded to investigate its potential in the development of vaccines against childhood infectious diseases. An Immunology group was established for this purpose.
Milestones – Other Business Activities in 2004
Bavarian Nordic’s management group was strengthened with the appointment of Hans Christian Teisen as Executive Vice President of Finance and Commercial Affairs.
The Bavarian Nordic organisation nearly doubled in size and moved to new offices in Denmark and Germany.
Events After the Close of the Fiscal Year
The company presented data showing that IMVAMUNE™ is expected to be effective in protecting against smallpox infection three days after just one vaccination compared to traditional replicating vaccines that only show protection after 10-14 days and have an increased risk for severe complications.
The company announced that it will start three new Phase ll trials before the end of the year that will result in vaccination of 2000 persons with IMVAMUNE™.
To-date, the company has completed 12 out of 20 test-runs on the robustness of the commercial MVA-BN® manufacturing process. The industrial scale MVA-BN® manufacturing process in terms of vaccine yield, production output and process control is ready for commercial production.
The company started a Phase ll study with MVA nef in 75 HIV-infected patients with CD4 counts down to 250 (patients in AIDS disease state). Fifty patients will receive the MVA nef vaccine and 25 patients will receive IMVAMUNE™ as a control arm for the study.
The company announced that three studies with the MVA-BN® polytope vaccine are planned for 2005. The two Bavarian Nordic studies are a Phase l trial in healthy volunteers and a Phase l/ll trial in HIV-infected patients. The third study is in conjunction with Epimmune and financially supported by the National Institute of Allergy and Infectious Diseases (NIAID).
The company announced that the MVA-BN® multiantigen vaccine has been cloned and transferred to the Berlin facility for production of vaccine for clinical trials.
The Berlin facility was granted manufacturing authorisation. The company is now able to produce its own clinical trial materials, the first priority being clinical materials for the company’s HIV programmes.
Bavarian Nordic resumed its activities in the field of cancer immunotherapy with the establishment of BN ImmunoTherapeutics Inc. in the USA to conduct research and development on MVA-BN®-based vaccines against breast, prostate and colon cancer.
The company announced that the first project for BN ImmunoTherapeutics will be an MVA-BN®-based vaccine against breast cancer. The vaccine has already been constructed and is ready for clinical production.
BN ImmunoTherapeutics has today entered into an agreement with Pharmexa A/S that gives the company the global rights to HER-2/DNA Autovac™MVA-BN®-based cancer vaccines.
The company announced that it will initiate a public offering, with pre-emptive rights for existing shareholders, to generate DKK 300 million in new equity. The public offering is expected to be carried out during the early summer of 2005.
Expectations for 2005
Excluding the effect of Bavarian Nordic’s share of the expected order from the US government for up to 60 million doses of safe smallpox vaccine (IMVAMUNE™), the company projects a revenue of approximately DKK 450-500 million in 2005. As a result of the planned increase in activities, the company does not project that the expected revenue for the year will be realised in the bottom line, which is expected to be a result of DKK 0 for 2005.
Bavarian Nordic expects a negative development in liquidity of DKK 110-130 million in 2005. This amount does not include Bavarian Nordic’s share of the expected order from the US Government on their purchase of up to 60 million doses of safe smallpox vaccine (IMVAMUNE™). The budget for 2005 includes increased investments in the Kvistgård production facilities as well as an acceleration of clinical development programmes against smallpox, HIV and cancer in the USA and Europe.
The company also plans to invest an additional DKK 115 million in a vaccine filling and packing line to ensure security of supply of product for its governmental customers. These investments will be financed through a public offering, with pre-emptive rights for existing shareholders to generate DKK 300 million in new equity. The public offering is expected to be carried out during the early summer of 2005.
Bavarian Nordic expects revenue in 2005 to come from the sales of remaining stocks of Elstree-BN and revenue from the ongoing US government contracts (awarded under RFP-l and RFP-ll). Two-thirds of the revenue is expected to come from RFP-l/ll spread over the year and the remaining third from the sale of Elstree-BN expected in the second-half of 2005.
Bavarian Nordic is optimistic in its position to win a contract as a result of the expected RFP-lll from the US Government which will describe the government’s purchase of up to 60 million doses of MVA-based smallpox vaccine.
The company projects sales of IMVAMUNE™ to other governments, in addition to the USA.
The company projects that costs will increase in 2005 due to the start-up of production, the acceleration of clinical development activities, and an increase in the organizational headcount to achieve the goals set.
The company expects to receive manufacturing authorisation from Danish authorities so that the Kvistgård plant is in operation in the summer of 2005. In addition, the company plans to build a vaccine filling and packing line at the site to secure the supply of product to its governmental customers.
The company expects to have enough clinical data on IMVAMUNE™ at the end of the year to submit an application to the US FDA (under the criteria for Emergency Use Authorization) allowing for the vaccination with IMVAMUNE™ for risk populations.
The company will accelerate its HIV programmes by starting a number of Phase l, Phase l/ll and Phase ll trials in 2005.
The company expects BN ImmunoTherapeutics to be in full operation with an MVA-BN®-based vaccine against breast cancer with the goal of filing an Investigational New Drug (IND) application on its first vaccine candidate in 2006.
The company will investigate the potential of MVA-BN® in the development of vaccines against measles and respiratory syncytial virus (RSV) infections, both of which are the cause of a large number of infant deaths
The company intends to broaden its technological platform in 2005 with other technologies that complement and/or supplement its MVA-BN® technology.
Enclosed with this announcement are:
Group Key Figures 2000-2004
Management Report for 2004
Financial Review for 2004
Income statements (1 January to 31 December 2004)
Balance Sheet as of 31 December 2004 – Assets
Balance Sheet as of 31 December 2004 – Liabilities
