• Financial results of the first nine months:
o Group revenues €47.2 M
o Group net loss €61.4 M, reflecting planned increase in pipeline investment
o End of third quarter cash €374.4 M, including €7.9 M in restricted cash
• Filgotinib 24 week DARWIN Phase 2B studies successful
o Confirmed promising efficacy and differentiated safety profile
o Galapagos regained full rights, in discussions with multiple potential partners
o Preparations underway for Phase 3 program in rheumatoid arthritis
o Phase 2 FITZROY 10 week topline readout expected in Crohn’s disease before year-end
• Nomination of cystic fibrosis candidate GLPG2665 completes discovery phase of triple combination therapy.
Clinical trial initiations expected before year-end
Mechelen, Belgium; 12 November 2015 - Galapagos NV (Euronext & NASDAQ: GLPG) announces its non-audited third quarter results, which are further detailed in an online Q3 2015 report published on the Galapagos website, www.glpg.com.
“After confirming the best-in-class potential of filgotinib in our DARWIN studies, we regained the full rights, thereby accelerating our transformation into a Phase 3 company and opening up discussions with potential new partners for this novel autoimmune disease therapy. We are preparing for Phase 3 studies in rheumatoid arthritis, in time for our planned start in the first half of 2016. We expect the topline 10 week results from the FITZROY Phase 2 study with filgotinib in Crohn’s disease before year-end,” said Onno van de Stolpe, CEO. “Early in the current quarter, we announced the nomination of GLPG2665 as our second corrector candidate, which is expected to work with our first corrector candidate and potentiator in a triple combination therapy to address the needs of the largest group of CF patients.”
“Galapagos ended the third quarter of 2015 with a solid cash balance, putting us in a position of strength to further develop filgotinib, without needing to compromise on plans for further development of our other promising candidate drugs,” said Bart Filius, CFO. “Despite the expense of preparing this Phase 3 program in RA for filgotinib, we are able to remain within guidance for full year operational cash burn of between €110 - 130 million.”
Key figures Q3 2015
(€ millions, except basic income/loss per share)
| 30 Sept 2015 Group Total | 30 Sept 2014 Group Total | |
| Revenues | 47.2 | 62.7 |
| R&D expenditure | -96.9 | -77.2 |
| G&A and S&M expenses | -13.6 | -10.8 |
| Operating result before exceptional items | -63.3 | -25.3 |
| Restructuring & integration costs | -0.6 | |
| Operating result | -63.3 | -25.9 |
| Net financial result | 0.4 | 0.7 |
| Taxes | 1.4 | -1.8 |
| Net result from continuing operations | -61.4 | -27.0 |
| Net result from discontinued operations1 | 70.5 | |
| Net result | -61.4 | 43.5 |
| Basic income/loss per share (€) | -1.78 | 1.44 |
| Cash, Cash equivalents and Restricted cash | 374.4³ | 216.62 |
Notes:
1) Galapagos sold its service operations to Charles River Laboratories Inc. on 1 April 2014. As a result of this sale, the service operations are reported as discontinued operations.
2) including €10.7 million of restricted cash
3) including €7.9 million of restricted cash
Q3 Report 2015
The Galapagos’ Q3 Report for 2015 is available at http://www.glpg.com/financial-reports. Printed versions of the report can be requested via ir@glpg.com.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public tomorrow (13 November 2015) at 14:00 Central European Time (CET), which will also be webcast. To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:
CODE: 2724028
USA: +1 646 254 3365
UK: +44 20 3427 1906
Netherlands: +31 20 721 9158
France: +33 1 70 48 01 66
Belgium: +32 2 404 0660
A question and answer session will follow the presentation of the results. Go to www.glpg.com to access the live audio webcast. The archived webcast will also be available for replay shortly after the close of the call.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, with a pipeline comprising three Phase 2 programs, two Phase 1 trials, five pre-clinical studies, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. Filgotinib is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases. Galapagos has reported good activity and a favorable safety profile in both the DARWIN 1 and 2 trials in RA. Galapagos is preparing to enter Phase 3 studies in RA and to report Phase 2 topline results with filgotinib in Phase 2 in Crohn’s disease. In the field of cystic fibrosis, AbbVie and Galapagos collaborate to develop and commercialize molecules that address mutations in the CFTR gene. Further clinical trial initiations are expected in the CF program before end 2015. GLPG1205, a first-in-class inhibitor of GPR84 and fully-owned by Galapagos, will report topline results in Q4 2015 from a Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690, a fully proprietary, first-in-class inhibitor of autotaxin, has shown favorable safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic pulmonary fibrosis. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. More info at www.glpg.com.
