Bavarian Nordic A/S – Interim Report for the period 1 January to 30 September 2011
Solid performance in both divisions; on track for major 2011 goals with deliveries of 4 million doses of IMVAMUNE® to the U.S. and recent initiation of PROSTVAC® Phase 3 trial.
Revenue generated for the nine months ended September 30, 2011 were DKK 155 million, compared to DKK 219 million for the nine months ended September 30, 2010. For the nine months ended September 30, 2011, the Company reported a pre-tax loss of DKK 333 million compared to a pre-tax loss of DKK 386 million for the nine months ended September 30, 2010. The results are in line with expectations. As of 30 September 2011 the cash preparedness was DKK 632 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. As announced on 28 October 2011, the expectations for the cash preparedness at year-end were raised from approximately DKK 525 million to DKK 650 million after receiving a performance-based milestone payment of USD 25 million under the RFP-3 contract.
Significant achievements in 2011
- PROSTVAC® Phase 3 trial opened at first site in the U.S.
- Successful scale up of IMVAMUNE® production to four batches per week to maintain the planned delivery schedule
- All doses planned for delivery to the Strategic National Stockpile in 2011 have been produced and have either been delivered or are awaiting final release and shipment during 2011.
- Performance-based milestone of USD 25 million received under U.S. Government contract
- RFP-3 contract modifications increases total contract value with up to USD 8 million
- Expanded collaboration with the National Cancer Institute (NCI) on immunotherapies for multiple cancers
- Pipeline expanded with the inlicensing of new cancer immunotherapy Phase 2 candidate, CV-301
Anders Hedegaard, President & CEO commented on the interim report: "Following our successful scale-up of IMVAMUNE®production earlier this year and with the recent initiation of the Phase 3 trial with PROSTVAC®, we are well on track to accomplish our major goals for 2011, marking a great year for Bavarian Nordic. Beyond these achievements we have also succeeded in expanding our activities in both business divisions. Most recently we expanded our collaboration with the NCI and obtained the rights to develop vaccines for multiple cancers on the same technology platform, that PROSTVAC® builds on. And the work in our infectious disease division was acknowledged with the recent obtaining of a performance-based milestone payment, which reinforced our capital preparedness."
Selected, upcoming milestones
- Delivery of two million doses IMVAMUNE® (Q4. 2011)
- Phase 2 data update for CV-301 in breast cancer (H1, 2012)
- Report final Phase 1/2 data for MVA-BN® PRO in prostate cancer (H1, 2012)
- Initiate Phase 3 study of IMVAMUNE® (H2, 2012)
- Initiate Phase 2 study for the freeze-dried IMVAMUNE® (H2, 2012)
- Approval of MAA in Canada for IMVAMUNE® (2012)
- Further results from ongoing NCI-sponsored PROSTVAC® Phase 1 and Phase 2 studies (2012)
Highlights from the third quarter For highlights throughout 2011, please refer to the list of selected company announcements on page 9
- IMVAMUNE® production successfully scaled up In August, Bavarian Nordic scaled up its production of IMVAMUNE® from three to four batches per week at the commercial manufacturing plant in Denmark. At the current rate, the company expects to deliver a total of 4 million doses in 2011 and 14 million doses in 2012 and 2013, thus completing the deliveries under the existing contract with the U.S. Government.
- RFP-3 contract modification adds to the total contract value In September, the RFP-3 contract was modified increasing the total value of the contract by up to USD 8 million to USD 513 million to cover incurred costs associated with certain regulatory delays and additional work requested by the U.S. Government. Approximately, USD 6 million will be invoiced this year, while the remaining approximately USD 2 million will be recognised over the remaining period of the contract.
- IMVAMUNE® Phase 3 clinical protocol approved by FDA The Phase 3 clinical protocol has been accepted by the FDA and will be a randomized, placebo controlled, double blinded lot consistency study in 4,000 healthy volunteers. Selection of the CRO is ongoing and is expected to be finalized in 2011, while enrolment is planned for the second half 2012 in the U.S. and Europe. The approved study design will require the U.S. Government to exercise one of the options of the RFP-3 base contract, to cover the additional costs associated with the inclusion of more subjects than originally planned. The design of the pivotal non-clinical studies is still pending feedback from the FDA.
Important events after the third quarter
- PROSTVAC® Phase 3 trial initiated In November, enrolment was initiated in the pivotal Phase 3 trial of PROSTVAC® for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer The trial is being conducted under a Special Protocol Assessment agreement with the FDA and is expected to enrol about 1,200 patients at about 300 clinical trial centers in more than 20 countries.
- New collaboration with the National Cancer Institute; includes rights to new vaccine candidates In October, Bavarian Nordic entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI). Through this expanded collaboration, Bavarian Nordic obtained an exclusive license for CV-301 - an off-the-shelf product candidate for the treatment of multiple cancers. CV-301 is currently the subject of an NCI-sponsored, randomized Phase 2 study of docetaxel (chemotherapy) alone or in combination with CV-301 in metastatic breast cancer with data update expected in the first half of 2012.
- USD 25 million milestone payment received after successfully scaling up production of IMVAMUNE® In October, Bavarian Nordic received a performance-based milestone payment of USD 25 million under its contract with the U.S. Government. The milestone payment relates to the recent successful scale-up of production from three to four batches per week.
Conference call The company will host a conference call today, Wednesday, November 16 at 2 pm CET (8 am ET). 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/q3. A replay and transcript of the conference call will be available within 48 hours of the conference call.