Year-end Report January - December 2007
THE YEAR IN BRIEF
-Net revenues decreased to MSEK 76.8 (132.0)
-The loss after tax was MSEK 172.6 (loss 33.0)
-Earnings per share amounted to a loss of SEK 11.42 (loss 2.46)
-Orexo reported positive results in completed comparative Phase III profile of the SublinoxTM (OX22) study
-Orexo signed a distribution agreement with Hospira in Asia for pain product Rapinyl™
-Orexo acquired Biolipox AB in November, forming an innovative specialty pharma company
-The acquisition of Inflazymes research and development assets for treatment of COPD, Chronic Obstructive Pulmonary Disease, and asthma was completed
-Torbjörn Bjerke new President and CEO of Orexo AB as of November 23
-Endo announced favorable results from the interim analysis of the Rapinyl ™ phase III clinical trial
FOURTH QUARTER 2007
-Net revenues increased to MSEK 55.1 (51.7)
-The loss after tax was MSEK 44,1 (loss 12.4)
-Earnings per share amounted to a loss of SEK 2.47 (loss: 0.91)
KEY EVENTS AFTER THE YEAR-END
-Orexo is reducing operating expenses, partly through capitalizing on cost synergies in conjunction with the acquisition of Biolipox and partly through optimizing the product portfolio by focusing on commercialization of prioritized projects.
-A so-called pre-NDA meeting with the US Food and Drug Administration (FDA) for Sublinox™ (OX22) was carried out. The meeting affirmed Orexo’s registration strategy. Preparations for filing a registration application in the first quarter of 2008 are proceeding according to plan.
-A pharmacokinetic study on OX19, involving healthy test subjects was completed. Analysis of the data is under way. The results are to provide a basis for outlicensing.
-For OX17, a pharmacodynamic study involving patients with reflux disease, was finalized. Analysis of the data is under way.
-For OX-NLA, a tolerability study of a final formulation in patients with rhinitis (hay fever) was completed. Analysis of the data is under way.
CEO COMMENTS – "COMMERCIAL COLLABORATIONS IN FOCUS FOR NEW AND STRONGER OREXO"
A strong company with an attractive portfolio – and with potential to strengthen its position within pain and inflammation, areas with great medical needs. That’s the new Orexo after the Biolipox acquisition during fall 2007. Our combined portfolio makes us an interesting partner to the large, international pharmaceutical companies – and increases our potential to become a long-term profitable and successful company.
In 2008, Orexo’s primary objective will be to promote our existing collaborations and sign new license and development agreements. Accordingly, Orexo is optimizing its combined project portfolio and prioritizing projects deemed to have the best commercial potential. The actions we are now taking strengthen the company’s financial sustainability and conditions to achieve commercial successes through entering into license and development agreements.
Torbjörn Bjerke, President and CEO
For Year-end report in full format, see enclosed link to pdf.