Bavarian Nordic Reports First Half 2011 Financial Results
Kvistgaard, Denmark, August 31, 2011 - Bavarian Nordic A/S (OMX: BAVA) today announced its half year 2011 results. Revenue generated for the six months ended June 30, 2011 were DKK 58 million, compared to DKK 175 million for the six months ended June 30, 2010.
For the six months ended June 30, 2011, the Company reported a loss before tax of DKK 275 million compared to a net loss before tax of DKK 179 million, for the six months ended June 30, 2010. The half year 2011 results were in line with expectations.
As of 30 June 2011 the cash preparedness was DKK 800 million, including credit lines of DKK 120 million.
The company maintains its full-year expectations with revenues of approximately DKK 500 million, and a pre-tax loss estimate of DKK 350 million. The cash preparedness at year-end is expected to be in the level of DKK 525 million.
Highlights from the first half
- Successfully raised DKK 654 million in rights issue In May, Bavarian Nordic successfully completed an offering, generating net proceeds of DKK 654 million, allowing the company to pursue the development of PROSTVAC® which is scheduled to start the pivotal Phase 3 trial in the second half of 2011.
- U.S. Government expands development contract for freeze-dried IMVAMUNE® In April, the U.S. Government increased the value of the existing contract to develop a freeze-dried version of IMVAMUNE® smallpox vaccine from USD 40 million to USD 94 million. The increased funding will support additional studies and manufacturing activities to further advance the development of the freeze-dried version of IMVAMUNE® by the end of the contract period.
- Submitted a marketing authorization application for IMVAMUNE® in Canada In March, Bavarian Nordic submitted a marketing authorization application (MAA) in Canada for IMVAMUNE® for active immunization against smallpox in the general population of 18 years and older.
- Signed two new delivery contracts for IMVAMUNE® In June, Bavarian Nordic signed a contract with the Danish Defence and second contract with European NATO country for the delivery of IMVAMUNE®.
- Initiated an NCI sponsored Phase 2 combination study with PROSTVAC® and chemotherapy In February, a new multicenter, randomized Phase 2 study of 144 patients with metastatic castration-resistant prostate cancer (mCRPC) was initiated. The study will compare PROSTVAC®followed by docetaxel (chemotherapy) versus docetaxel alone.
- Presented PROSTVAC® data in early stage prostate cancer at the 2011 ASCO Annual Meeting In June at the 2011 ASCO Annual Meeting in Chicago, investigators from the National Cancer Institute (NCI) presented data from a study with PROSTVAC® in patients with locally recurrent prostate cancer. The data indicates that PROSTVAC® is active in stages of prostate cancer as early as locally recurrent disease.
- Successfully defended patent position on MVA-BN® In April, the ICC International Court of Arbitration rendered its decision in favor of Bavarian Nordic in the arbitration that had been pending against Helmholtz Zentrum München since 2009. Helmholtz Zentrum München's claims of rights to royalties on Bavarian Nordic's MVA-BN® based vaccines, including IMVAMUNE®, were found to be baseless on all grounds.
Important events after the first half
- IMVAMUNE® Phase 3 expanded; still awaiting final regulatory guidelines from the FDA The FDA has recently announced a public workshop in September to discuss the regulatory pathway for next generation smallpox vaccines, e.g. IMVAMUNE®, for which licensure under the animal rule will be sought. Although this novel regulatory path has delayed the initiation of the pivotal non-clinical studies, the Phase 3 clinical study design has essentially been agreed with the FDA, and planning of the trial will be initiated already this year, although recruitment will only commence in the second half of 2012. The deliveries of IMVAMUNE® under the RFP-3 base contract will not be affected by the planning and subsequent initiation of the Phase 3 trial. As the Phase 3 design agreed with the FDA is larger and requires additional subjects than initially proposed by Bavarian Nordic, the company has requested the U.S. government to cover the added costs under a stipulation in the RFP-3 contract prior to the initiation of the study.
Anders Hedegaard, President & CEO commented on the interim report: "During first half of 2011, we accomplished a number of significant events, supporting the continued progress of our business. With the successful completion of a rights issue in May, we have secured a timely launch of the pivotal Phase 3 trial of PROSTVAC® later this year. We also successfully scaled up the production of IMVAMUNE® and are on track to deliver the 4 million doses by the end of 2011. Additionally, the expansion of the contract for freeze-dried IMVAMUNE® further strengthens our ties with the U.S. Government, leading to potential future contracts. Our strong cash position and secured contracts protect us well against the current turmoil in the global markets."
Selected, upcoming milestones
- Initiation of Phase 3 study of PROSTVAC® in patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (H2, 2011)
- Complete enrolment of patients and report initial immune data for MVA-BN® HER2 in breast cancer (H2, 2011)
- Report final Phase 1/2 data for MVA-BN® PRO in prostate cancer (H1, 2012)
- Initiate Phase 3 study of IMVAMUNE® (H2, 2012)
- Approval of MAA in Canada for IMVAMUNE® (2012)
- Initiate Phase 1 study of MVA-BN® Anthrax (H1, 2012)
- Initiate Phase 1 study of MVA-BN® RSV (H1, 2012)
Conference call The company will host a conference call today, Wednesday, August 31 at 2 p. m. CET. President and CEO, Anders Hedegaard will present the interim results followed by a Q&A session with additional attendance of Ole Larsen, CFO and Rolf Sass Sørensen, Vice President Investor Relations and Communications. Dial-in numbers for the conference call are: Denmark: +45 3271 4607, UK: +44 (0)20 7162 0077, US: +1 334 323 6201. The accompanying presentation is available on the company's website: www.bavarian-nordic.com/q2.