Bavarian Nordic - The sky is the limit (Seite 207)
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ISIN: DK0015998017 · WKN: 917165 · Symbol: BV3
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Weitere Einschätzung (meine Meinung): Wir sollten in den nächsten Monaten die 65 DKK mal weichschiessen, das ist ein ziemlicher Widerstand (schon letztes Jahr) und spätestens nächstes Jahr wieder dreistellige DKK Kurse haben. PROSTVAC soll bis Ende 2013 die Patientenaufnahme abgeschlossen haben. Ergebnisse dann wohl 2015/2016. Zulassung im Gut-Fall dann 2016/2017 möglich.
Die Firma hat ein wahrscheinlich gut funktionierendes off the shelf Prostatakrebs Vaccine in der späten Pipeline. Wir wissen, dass Provenge v.a. deswegen nicht wie erwartet läuft, weil es nicht off the shelf ist, zudem sind die Margen durch das komplizierte Fertigungs- und Logistikverfahren bei extrem hohen Preisen so gering, dass die erst ab 400Mio USD Umsatz im Jahr überhaupt in die Gewinnzone kommen. Das sähe bei BAVA dann ganz anders aus. Zudem sehe ich Provenge und PROSTVAC nicht als Konkurreten, eine mehrfache Vaccinierung mit unterschiedliche Vaccinen ist gut denkbar.
Desweiteren haben wir ein Vaccine gegen Brustkrebs in der Pipe, das einen Proof of Concept bereits geleistet hat. Die lizensierte Technologie ist breit und aussichtsreich.
Dazu geschenkt gibt es die eigentliche Vaccine Division mit den Smallpox Vaccines, welche aktuell hochprofitabel ist und auf weitere Indikationen ausgeweitet wird. Die bestehende Indikation erhält zudem weitere Aufträge und bald hoffentlich auch Zulassungen in EU und Kanada, was weitere Märkte außerhalb US Gov erschliessen würde.
Haltet mich nicht für verrückt, aber sollte PROSTVAC ein Erfolg werden halte ich mit der anderen Pipe im Hintergrund binnen 5 Jahren Kurse um 400 DKK je Aktie locker für möglich - entspräche bei moderater Verwässerung ca. 2Mrd USD Marktkapitalisierung.
Die Firma hat ein wahrscheinlich gut funktionierendes off the shelf Prostatakrebs Vaccine in der späten Pipeline. Wir wissen, dass Provenge v.a. deswegen nicht wie erwartet läuft, weil es nicht off the shelf ist, zudem sind die Margen durch das komplizierte Fertigungs- und Logistikverfahren bei extrem hohen Preisen so gering, dass die erst ab 400Mio USD Umsatz im Jahr überhaupt in die Gewinnzone kommen. Das sähe bei BAVA dann ganz anders aus. Zudem sehe ich Provenge und PROSTVAC nicht als Konkurreten, eine mehrfache Vaccinierung mit unterschiedliche Vaccinen ist gut denkbar.
Desweiteren haben wir ein Vaccine gegen Brustkrebs in der Pipe, das einen Proof of Concept bereits geleistet hat. Die lizensierte Technologie ist breit und aussichtsreich.
Dazu geschenkt gibt es die eigentliche Vaccine Division mit den Smallpox Vaccines, welche aktuell hochprofitabel ist und auf weitere Indikationen ausgeweitet wird. Die bestehende Indikation erhält zudem weitere Aufträge und bald hoffentlich auch Zulassungen in EU und Kanada, was weitere Märkte außerhalb US Gov erschliessen würde.
Haltet mich nicht für verrückt, aber sollte PROSTVAC ein Erfolg werden halte ich mit der anderen Pipe im Hintergrund binnen 5 Jahren Kurse um 400 DKK je Aktie locker für möglich - entspräche bei moderater Verwässerung ca. 2Mrd USD Marktkapitalisierung.
Du bist nicht alleine!! Du hast mich hereingeführt und nun bleibe ich mit Dir zusammen Bavarian Nordic auch treu!! 
Danke nochmal für den Tip
Danke nochmal für den Tip
Antwort auf Beitrag Nr.: 44.240.376 von Ville7 am 12.03.13 09:33:41DKK 64,50 RT = +17,3% an der NASDAQ OMX
Scheint so als bin ich inzwischen alleine hier.
Scheint so als bin ich inzwischen alleine hier.
Antwort auf Beitrag Nr.: 44.051.110 von GuHu1 am 22.01.13 21:00:53NASDAQ OMX heute +10% nach Zahlen und Ausblick - Break Even Fieber.
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Bavarian Nordic Announces 2012 Full Year Results
KVISTGAARD, Denmark, March 12, 2013 - Bavarian Nordic A/S (OMX: BAVA) today published its 2012 Annual Report. Revenue was DKK 1,017 million (DKK 524 million in 2011). The Group recorded a loss before tax of DKK 49 million (DKK 296 million loss in 2011). Revenue and results were significantly improved, compared to original expectations for the year. This was primarily due to the successful optimization of the production of smallpox vaccine which allowed for more doses to be delivered than anticipated, combined with lower production costs. A total of 8.3 million doses of IMVAMUNE® were delivered to the U.S. in 2012. Following the optimization and the increased deliveries, the infectious disease division became profitable with an EBIT of DKK 282 million (DKK 52 million loss in 2011).
At year-end 2012, the cash preparedness was DKK 670 million (DKK 704 million as of 31 December 2011), and this was also significantly improved compared to the original guidance.
For 2013, Bavarian Nordic expects revenue at the level of DKK 1,100 million and a break-even result before tax. The revenue will primarily be generated from deliveries of IMVAMUNE® to the U.S. Strategic National Stockpile. The cash preparedness at year-end is expected to be roughly DKK 600 million.
Group key figures are found at the end of this announcement. The full financial statements for 2012 are available in the annual report which can be downloaded from the Company's website: www.bavarian-nordic.com
Anders Hedegaard, President & CEO of Bavarian Nordic said: "Our financial results for 2012 were most satisfactory and reflect the progress we have achieved in our production and deliveries of smallpox vaccine for the U.S. Government. This part of our business is now profitable and will also contribute to our expected strong financial results in 2013 as we expect a new contract from the U.S. Government to be awarded soon for continued delivery of IMVAMUNE®. We also saw progress in our Phase 3 trial of PROSTVAC®, which is now active in 10 countries and will soon be initiated in all remaining planned countries."
Significant achievements in 2012 and up to the reporting date
The PROSPECT Phase 3 trial of PROSTVAC® in prostate cancer began enrollment in Europe and is now active in 10 countries
Promising Phase 2 data for CV-301 in breast cancer were presented at the European Society of Medical Oncology 2012 congress
Productivity of IMVAMUNE® manufacturing significantly improved over the year, resulting in more deliveries to the U.S. Additionally, the Infectious Diseases division became profitable
We delivered 8.3 million doses of IMVAMUNE® to the U.S. Strategic National Stockpile
The U.S. Government expanded the population eligible to receive IMVAMUNE® in an emergency, which significantly increased the vaccine's future business potential
A marketing application for IMVANEX® (IMVAMUNE®) was submitted to the European Medicines Agency. A decision on European approval is anticipated in 2013, and also from the Canadian health authorities for the application that was submitted in 2011
Additional USD 55 million was awarded in funding by the U.S. Government to support the IMVAMUNE® Phase 3 trial, as well as new research and development to expand the use of the MVA-BN® vaccine platform technology into other diseases
A new order contract for IMVAMUNE® was received from Canada to replenish its existing stockpile
In January 2013, Bavarian Nordic announced that it will transform its manufacturing facility in Kvistgaard into a multipurpose facility to accommodate the production of clinical trial material as well as the future commercial production of PROSTVAC®
In February 2013, James B. Breitmeyer was appointed new President of the Cancer Vaccine division. He has also joined the Bavarian Nordic executive management
Selected upcoming milestones
Obtain new IMVAMUNE® delivery contract with the U.S. Government
Deliver 7 million doses of IMVAMUNE® to the U.S. Strategic National Stockpile in 2013
Complete enrolment in the IMVAMUNE® Phase 3 lot consistency trial
Initiate Phase 3 non-inferiority trial of IMVAMUNE®
Obtain marketing authorization for IMVAMUNE® in Canada
Obtain marketing authorization for IMVANEX® (IMVAMUNE®) in the EU
Initiate Phase 2 study with the freeze-dried version of IMVAMUNE® to support emergency use
Report data from NCI-sponsored clinical trials of PROSTVAC®
Report data from NCI-sponsored clinical trials of CV-301 and determine development strategy
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Bavarian Nordic Announces 2012 Full Year Results
KVISTGAARD, Denmark, March 12, 2013 - Bavarian Nordic A/S (OMX: BAVA) today published its 2012 Annual Report. Revenue was DKK 1,017 million (DKK 524 million in 2011). The Group recorded a loss before tax of DKK 49 million (DKK 296 million loss in 2011). Revenue and results were significantly improved, compared to original expectations for the year. This was primarily due to the successful optimization of the production of smallpox vaccine which allowed for more doses to be delivered than anticipated, combined with lower production costs. A total of 8.3 million doses of IMVAMUNE® were delivered to the U.S. in 2012. Following the optimization and the increased deliveries, the infectious disease division became profitable with an EBIT of DKK 282 million (DKK 52 million loss in 2011).
At year-end 2012, the cash preparedness was DKK 670 million (DKK 704 million as of 31 December 2011), and this was also significantly improved compared to the original guidance.
For 2013, Bavarian Nordic expects revenue at the level of DKK 1,100 million and a break-even result before tax. The revenue will primarily be generated from deliveries of IMVAMUNE® to the U.S. Strategic National Stockpile. The cash preparedness at year-end is expected to be roughly DKK 600 million.
Group key figures are found at the end of this announcement. The full financial statements for 2012 are available in the annual report which can be downloaded from the Company's website: www.bavarian-nordic.com
Anders Hedegaard, President & CEO of Bavarian Nordic said: "Our financial results for 2012 were most satisfactory and reflect the progress we have achieved in our production and deliveries of smallpox vaccine for the U.S. Government. This part of our business is now profitable and will also contribute to our expected strong financial results in 2013 as we expect a new contract from the U.S. Government to be awarded soon for continued delivery of IMVAMUNE®. We also saw progress in our Phase 3 trial of PROSTVAC®, which is now active in 10 countries and will soon be initiated in all remaining planned countries."
Significant achievements in 2012 and up to the reporting date
The PROSPECT Phase 3 trial of PROSTVAC® in prostate cancer began enrollment in Europe and is now active in 10 countries
Promising Phase 2 data for CV-301 in breast cancer were presented at the European Society of Medical Oncology 2012 congress
Productivity of IMVAMUNE® manufacturing significantly improved over the year, resulting in more deliveries to the U.S. Additionally, the Infectious Diseases division became profitable
We delivered 8.3 million doses of IMVAMUNE® to the U.S. Strategic National Stockpile
The U.S. Government expanded the population eligible to receive IMVAMUNE® in an emergency, which significantly increased the vaccine's future business potential
A marketing application for IMVANEX® (IMVAMUNE®) was submitted to the European Medicines Agency. A decision on European approval is anticipated in 2013, and also from the Canadian health authorities for the application that was submitted in 2011
Additional USD 55 million was awarded in funding by the U.S. Government to support the IMVAMUNE® Phase 3 trial, as well as new research and development to expand the use of the MVA-BN® vaccine platform technology into other diseases
A new order contract for IMVAMUNE® was received from Canada to replenish its existing stockpile
In January 2013, Bavarian Nordic announced that it will transform its manufacturing facility in Kvistgaard into a multipurpose facility to accommodate the production of clinical trial material as well as the future commercial production of PROSTVAC®
In February 2013, James B. Breitmeyer was appointed new President of the Cancer Vaccine division. He has also joined the Bavarian Nordic executive management
Selected upcoming milestones
Obtain new IMVAMUNE® delivery contract with the U.S. Government
Deliver 7 million doses of IMVAMUNE® to the U.S. Strategic National Stockpile in 2013
Complete enrolment in the IMVAMUNE® Phase 3 lot consistency trial
Initiate Phase 3 non-inferiority trial of IMVAMUNE®
Obtain marketing authorization for IMVAMUNE® in Canada
Obtain marketing authorization for IMVANEX® (IMVAMUNE®) in the EU
Initiate Phase 2 study with the freeze-dried version of IMVAMUNE® to support emergency use
Report data from NCI-sponsored clinical trials of PROSTVAC®
Report data from NCI-sponsored clinical trials of CV-301 and determine development strategy
Antwort auf Beitrag Nr.: 44.046.934 von Ville7 am 22.01.13 06:25:42da bin ich jetzt auch mal gespannt......
Trading Spotlight
Mal sehen, wie der Kurs sich heute verhält, nachdem gestern der extrem überaschende Abgang von Rainer Laus vermeldet wurde. Laus war die "Mutter" von PROSTVAC. Hoffentlich hat das keine fundamentalen Gründe. Abkassiert hat er ja ziemlich....
Bavarian Nordic At Risk As U.S. Weighs Smallpox Order
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http://www.bloomberg.com/news/2012-08-21/bavarian-nordic-at-…
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http://www.bloomberg.com/news/2012-08-21/bavarian-nordic-at-…
Antwort auf Beitrag Nr.: 42.937.456 von Der.Eroberer am 21.03.12 19:17:07hat sich ganz schön wieder erholt! 
Bavarian Nordic May Seek Government Funding for Anthrax Vaccine
Bavarian Nordic A/S (BAVA), the Danish company that’s developing a prostate-cancer treatment, may seek government funding to help develop its anthrax vaccine, said Chief Executive Officer Anders Hedegaard.
Bavarian Nordic, based in Kvistgaard, may ask governments, starting with the U.S., to fund its MVA-BN anthrax vaccine should pre-clinical data justify further testing, Hedegaard said in an interview at a conference in Stockholm today.
The company is using its MVA-BN technology to combine vaccines for anthrax and smallpox and offer protection against two major biological threats. The U.S. National Institutes of Health funded studies of Bavarian Nordic’s Imvamune smallpox vaccine, already supplied to the U.S. government, which stockpiles it for emergency use.
The company is also developing its Prostvac therapeutic vaccine for prostate cancer and is enrolling patients for a late-stage clinical trial.
While the company is seeking a partner for Prostvac, there is “not as much time pressure” after the company raised 650 million kroner ($115 million) last year in a share sale to fund the trial, Hedegaard said. Still, he remains optimistic about securing a licensing agreement.
“There’s no doubt there is interest in immunotherapy,” Hedegaard said.
Sales of U.S. drugmaker Dendreon Corp. (DNDN)’s Provenge prostate- cancer therapy, part of a new class of drugs that trigger the body’s immune system to attack cancer cells as if they were a virus, more than tripled in the fourth quarter, the Seattle- based company said Jan. 5.
“Provenge will pave the way for clinicians who will adopt immunotherapy,” Hedegaard said.
Prostvac will be available as an “off-the-shelf, ready-to- use” treatment, offering more convenience for doctors compared with Provenge, Hedegaard said. The two drugs may also complement each other, and Prostvac has also been shown to slow disease progression in combination with hormone therapy in mid-stage trials, he said.
Editors: Robert Valpuesta, Phil Serafino.
http://www.bloomberg.com/news/2012-03-21/bavarian-nordic-may…
Bavarian Nordic A/S (BAVA), the Danish company that’s developing a prostate-cancer treatment, may seek government funding to help develop its anthrax vaccine, said Chief Executive Officer Anders Hedegaard.
Bavarian Nordic, based in Kvistgaard, may ask governments, starting with the U.S., to fund its MVA-BN anthrax vaccine should pre-clinical data justify further testing, Hedegaard said in an interview at a conference in Stockholm today.
The company is using its MVA-BN technology to combine vaccines for anthrax and smallpox and offer protection against two major biological threats. The U.S. National Institutes of Health funded studies of Bavarian Nordic’s Imvamune smallpox vaccine, already supplied to the U.S. government, which stockpiles it for emergency use.
The company is also developing its Prostvac therapeutic vaccine for prostate cancer and is enrolling patients for a late-stage clinical trial.
While the company is seeking a partner for Prostvac, there is “not as much time pressure” after the company raised 650 million kroner ($115 million) last year in a share sale to fund the trial, Hedegaard said. Still, he remains optimistic about securing a licensing agreement.
“There’s no doubt there is interest in immunotherapy,” Hedegaard said.
Sales of U.S. drugmaker Dendreon Corp. (DNDN)’s Provenge prostate- cancer therapy, part of a new class of drugs that trigger the body’s immune system to attack cancer cells as if they were a virus, more than tripled in the fourth quarter, the Seattle- based company said Jan. 5.
“Provenge will pave the way for clinicians who will adopt immunotherapy,” Hedegaard said.
Prostvac will be available as an “off-the-shelf, ready-to- use” treatment, offering more convenience for doctors compared with Provenge, Hedegaard said. The two drugs may also complement each other, and Prostvac has also been shown to slow disease progression in combination with hormone therapy in mid-stage trials, he said.
Editors: Robert Valpuesta, Phil Serafino.
http://www.bloomberg.com/news/2012-03-21/bavarian-nordic-may…
Bavarian Nordic Announces 2011 Full Year Results
KVISTGAARD, Denmark, March 8, 2012 - Bavarian Nordic A/S (OMX: BAVA) today published its 2011 Annual Report. The 2011 financial statements show improved revenue, result before tax and year-end cash preparedness compared to the announced outlook for the year. Revenue was DKK 524 million, compared with a guidance of DKK 500 million. The revenue was primarily generated from the deliveries of four million doses of IMVAMUNE® to the US health authorities. The Group recorded a loss before tax of DKK 296 million, compared with a guided loss of DKK 350 million. The improved financial result was due to costs that were lower than anticipated, mainly related to a slight delay in the initiation of the PROSTVAC® Phase 3 trial, as well as ordinary cost-saving initiatives. At year-end 2011, the cash preparedness was DKK 704 million, compared with the latest upgraded guidance of DKK 650 million.
For 2012, Bavarian Nordic expects revenue at the level of DKK 850 million and a pre-tax loss at the level of DKK 200 million. The revenue will primarily be generated from deliveries of seven million doses IMVAMUNE® to the US Strategic National Stockpile. The cash preparedness at year-end is expected to be roughly DKK 350 million.
Group key figures are found at the end of this announcement. The full financial statements for 2011 are available in the annual report which can be downloaded from the Company's website: www.bavarian-nordic.com
Anders Hedegaard, President & CEO of Bavarian Nordic said: "2011 was a year of substantial achievements, making it among the best operational years in our history. We met our two major objectives for the year: initiating Phase 3 trials with PROSTVAC® and delivering four million doses of IMVAMUNE® smallpox vaccines to the USA after a successful scale-up of production. The year, however also presented us with the challenge to fund the Phase 3 development of PROSTVAC®."
Significant achievements in 2011 and up to the reporting date
Initiated the pivotal Phase 3 trial of PROSTVAC® in metastatic prostate cancer
Delivered four million doses IMVAMUNE® to the US Strategic National Stockpile
Received a USD 25 million milestone payment under the US government contract after a successful scale-up of production
Phase 3 protocol for IMVAMUNE® agreed with the FDA
Extended the contract for development of freeze-dried IMVAMUNE® to a total value of USD 94 million
IMVAMUNE® delivery contracts signed with Denmark and an another European NATO country
Raised nearly DKK 700 million in a rights issue through the placement of new shares with both existing shareholders as well as new, international healthcare specialist investors
Expanded the cancer pipeline through expanded collaboration with the National Cancer Institute (NCI) which included rights to new cancer vaccine product candidates (CV-301) for multiple cancer indications
Marketing authorization application for IMVAMUNE® submitted to the Canadian health authorities
Marketing authorization application for IMVANEX® (IMVAMUNE®) submitted to the European health authorities in February 2012
Selected, upcoming milestones
Deliver seven million doses IMVAMUNE® to the US Strategic National Stockpile (2012)
Phase 2 data for CV-301 in breast cancer (H2, 2012)
Initiate Phase 3 trial of IMVAMUNE® (H2, 2012)
Initiate Phase 2 study for the freeze-dried IMVAMUNE® (H1, 2013)
Approval of MAA in Canada for IMVAMUNE® (2012)
Changes to financial calendar for 2012
The company has moved its reporting date for the first quarterly results 2012 to 22 May 2012.
http://www.bavarian-nordic.com/investor/announcements/2012-0…
KVISTGAARD, Denmark, March 8, 2012 - Bavarian Nordic A/S (OMX: BAVA) today published its 2011 Annual Report. The 2011 financial statements show improved revenue, result before tax and year-end cash preparedness compared to the announced outlook for the year. Revenue was DKK 524 million, compared with a guidance of DKK 500 million. The revenue was primarily generated from the deliveries of four million doses of IMVAMUNE® to the US health authorities. The Group recorded a loss before tax of DKK 296 million, compared with a guided loss of DKK 350 million. The improved financial result was due to costs that were lower than anticipated, mainly related to a slight delay in the initiation of the PROSTVAC® Phase 3 trial, as well as ordinary cost-saving initiatives. At year-end 2011, the cash preparedness was DKK 704 million, compared with the latest upgraded guidance of DKK 650 million.
For 2012, Bavarian Nordic expects revenue at the level of DKK 850 million and a pre-tax loss at the level of DKK 200 million. The revenue will primarily be generated from deliveries of seven million doses IMVAMUNE® to the US Strategic National Stockpile. The cash preparedness at year-end is expected to be roughly DKK 350 million.
Group key figures are found at the end of this announcement. The full financial statements for 2011 are available in the annual report which can be downloaded from the Company's website: www.bavarian-nordic.com
Anders Hedegaard, President & CEO of Bavarian Nordic said: "2011 was a year of substantial achievements, making it among the best operational years in our history. We met our two major objectives for the year: initiating Phase 3 trials with PROSTVAC® and delivering four million doses of IMVAMUNE® smallpox vaccines to the USA after a successful scale-up of production. The year, however also presented us with the challenge to fund the Phase 3 development of PROSTVAC®."
Significant achievements in 2011 and up to the reporting date
Initiated the pivotal Phase 3 trial of PROSTVAC® in metastatic prostate cancer
Delivered four million doses IMVAMUNE® to the US Strategic National Stockpile
Received a USD 25 million milestone payment under the US government contract after a successful scale-up of production
Phase 3 protocol for IMVAMUNE® agreed with the FDA
Extended the contract for development of freeze-dried IMVAMUNE® to a total value of USD 94 million
IMVAMUNE® delivery contracts signed with Denmark and an another European NATO country
Raised nearly DKK 700 million in a rights issue through the placement of new shares with both existing shareholders as well as new, international healthcare specialist investors
Expanded the cancer pipeline through expanded collaboration with the National Cancer Institute (NCI) which included rights to new cancer vaccine product candidates (CV-301) for multiple cancer indications
Marketing authorization application for IMVAMUNE® submitted to the Canadian health authorities
Marketing authorization application for IMVANEX® (IMVAMUNE®) submitted to the European health authorities in February 2012
Selected, upcoming milestones
Deliver seven million doses IMVAMUNE® to the US Strategic National Stockpile (2012)
Phase 2 data for CV-301 in breast cancer (H2, 2012)
Initiate Phase 3 trial of IMVAMUNE® (H2, 2012)
Initiate Phase 2 study for the freeze-dried IMVAMUNE® (H1, 2013)
Approval of MAA in Canada for IMVAMUNE® (2012)
Changes to financial calendar for 2012
The company has moved its reporting date for the first quarterly results 2012 to 22 May 2012.
http://www.bavarian-nordic.com/investor/announcements/2012-0…
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