Mechelen, Belgium; 16 November 2012 – Galapagos NV (Euronext: GLPG) announces today that third quarter 2012 operational and financial results were in line with management expectations. Management confirms the 2012 financial guidance given earlier this year:group revenues of €150 million, sustained operational and net profitability, and a year-end cash position of at least €130 million by the end of 2012.
GLPG0634 Phase 2a results
Galapagos announced that a second Phase 2A clinical trial with GLPG0634 repeated the excellent safety of the drug, as well as the significant clinical improvements to rheumatoid arthritis (RA) patients within 4 weeks. Statistically significant improvements were seen for DAS28, HAQ-DI, ACR and CRP for the 300mg dose. The results enable Galapagos to move rapidly into Phase 2B clinical studies in early 2013. GLPG0634 is the first selective JAK1 inhibitor to potentially treat multiple autoimmune diseases, such as RA. In February 2012, Galapagos and Abbott announced a global collaboration for GLPG0634 to treat RA and other autoimmune diseases.
Tax ruling on Abbott collaboration
Galapagos received a positive ruling from the Belgian tax authorities on the collaboration agreement with Abbott. Galapagos may exempt 80% of qualifying income, based on the Galapagos patents covering JAK1 inhibitor GLPG0634, from Belgian corporate income tax. This will result in an effective income tax rate of under 5% for Galapagos for this income.
Initiation of Phase I study with GLPG0974
In October, Galapagos started its second Phase I clinical study with GLPG0974, a GPR43 inhibitor being developed to treat chronic neutrophil-driven inflammatory conditions such as inflammatory bowel disease (IBD). In this clinical study, the safety and tolerability of GLPG0974 will be evaluated for 2 weeks in 32 healthy volunteers. Aim of the study is also to confirm the strong biomarker signal and the once-daily (QD) dosing of the compound after 14 days. Results of the study are expected to be reported early next year.
The Capital Group Companies gave notification of a holding of 1,554,436 Galapagos shares, which represents 5.8% of Galapagos’ shares outstanding today. Johnson & Johnson notified that it indirectly held 2,350,061 Galapagos shares through Tibotec-Virco and Crucell, which represents 8.8% of Galapagos’ shares outstanding today. .
Management reiterates the full-year 2012 guidance given earlier in the year: The service operations are expected to increase further their cash and profit contribution in 2012. Management guides for at least €150 million in revenues, sustained operational and net profitability, and a year-end cash position of at least €130 million by the end of 2012.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size clinical stage biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing its JAK1 inhibitor GLPG0634, as well as one of the largest pipelines in biotech, with four programs in development and over 30 discovery programs. The Galapagos Group has over 800 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
This release may contain forward-looking statements, including, without limitation, statements containing the words “believes,” “anticipates,” “expects,” “intends,” “plans,” “seeks,” “estimates,” “may,” “will,” “could,” “stands to,” and “continues,” as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.