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. FINANCIAL HEARINGS - FEBRUARY 15 AT 12.00 (CET) You are welcome to follow CEO Torbjörn Bjerke´s presentation of the Year End Report 2007 on Friday, February 15 at 12.00 CET (in English) at Operaterrassen, Stockholm Moderator: Björn Andersson, Redeye Visit or follow the presentation: In Stockholm, at Operaterrassen Register at www.financialhearings.com, or via e-mail hearings@financialhearings.com alt. by phone +46(0)8-411 43 80 Live telephone conference: +44 20 88 17 93 01, alt + 46(0)8-505 202 70, Confirmation code 644 2430 Webcast http://www.financialhearings.com/hearing/financia1.nsf/(recordednew)/36A4ADC8FEA 67F01C12573D2002C386A?OpenDocument FOR MORE INFORMATION, PLEASE CONTACT Torbjörn Bjerke, President and CEO, Orexo AB Tel: +46 (0)708-66 19 90 E-mail: torbjorn.bjerke@orexo.com Claes Wenthzel, Executive Vice President and Chief Financial Officer, Orexo AB Tel: +46 (0)18 - 780 88 44 Email: claes.wenthzel@orexo.com TO THE EDITORS About Orexo Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of new treatments for respiratory and inflammatory diseases. Orexo has a broad and competitive late-stage product portfolio, including two marketed products, five products in clinical phase and two undergoing registration. To date, Orexo have out-licensed the market rights for Rapinyl for the US, the EU and Japan markets, and signed a research collaboration with Boehringer Ingelheim regarding the development of a new class of drugs to treat pain and inflammation. Also, Orexo has established a Nordic sales force by entering into a joint venture with ProStrakan. Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange Stockholm, Small Cap (ticker: ORX). www.orexo.com
Year-end Report January - December 2007
| Source: Orexo AB