Full Press Release Details
information 5 August 2015, 22.00 CET
Galapagos on track to deliver on pipeline in second half 2015
Half-year financial results 2015
? Filgotinib shows promising efficacy and potentially differentiated safety profile in DARWIN 1 and 2 Phase 2B studies
? Phase 2 readouts expected with filgotinib: DARWIN 2 24 weeks in rheumatoid arthritis and
FITZROY in Crohn s disease
? Nomination of second corrector candidate this quarter in cystic fibrosis. Initiation of Phase 1 study with GLPG2222 and Phase 2 study with GLPG1837 in Class III mutation patients
expected before end 2015
? First half year financials:
o Group revenues 36.9 M
o Group net loss 34.2 M,reflecting planned increase in pipeline investment
o Half year cash of 404.6 M, including 7.2 M in restricted cash
? Full year operational cash burn guidance reiterated: 110 130 M, excluding alliance
milestones or income from filgotinib
webcast presentation tomorrow, 6 August 2015, at 14.00 CET, www.glpg.com, call numbers:
New York: +1-646-254-3366
Toll free USA: +1-877-280-2342
Toll free Netherlands: 0800 020 2576
Brussels: +32(0)2 404 0660
Toll free phone Belgium: 0800 58032
Mechelen, Belgium; 5 August 2015 Galapagos NV (Euronext & NASDAQ: GLPG)
announces its non-audited half year results and reiterates guidance for the full year
This has been a phenomenal year for Galapagos so far. Galapagos announced promising efficacy and the potential for a differentiated safety profile of filgotinib in rheumatoid
arthritis in the DARWIN 1 and 2 studies. We look forward to completing the data package for AbbVie s licensing decision on filgotinib, said Galapagos CEO Onno van de Stolpe. We remain on track to deliver a triple combination therapy
to Class II patients in cystic fibrosis, with our second corrector to be nominated as a candidate this quarter. We anticipate starting our first patient study in CF in the Class III mutation with GLPG1837 later this year.
Building on the positive 12 week data with filgotinib and newsflow outlook with our maturing pipeline of novel mode
of action therapies, Galapagos attracted capital in a successful global offering and concurrent listing on NASDAQ. As a result, Galapagos ended the first half of 2015
solid cash balance to support further development of candidate drugs said Bart Filius, CFO
We retain our initial guidance for full year operational cash burn of between 110
130 million, and our first half was in line with this expectation.
Key figures half year 2015
( millions, except basic income/loss per share)
Group Total 30 June 2014
Services cost of sales
R&D expenditure -63.3
G&A and S&M expenses -9.2 -7.4
Operating result before exceptional items
Restructuring & integration costs -0.6
Operating result -35.6 -15.7
Net financial result
Result on divestment
Net result from continuing operations
Net result from discontinued operations1
Net result -34.2 55.9
Basic income/loss per share
Cash, Cash equivalents and
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 7.2 million of restricted cash
Details of the financial results
Group revenues and other income for the
first half of 2015 amounted to 36.9 million compared to 45.1 million in the same period of 2014. Revenues ( 26.7 million vs 35.5 million last year) were lower due to reduced milestone payments, reflecting the
increasing proprietary nature of our pipeline programs. Other income ( 10.3 million vs 9.6 million last year) increased in H1 15, driven mainly by R&D incentives in Belgium and France.
The Group realized a net loss for the first half of 2015 of 34.2 million, compared to a net loss of
14.6 million in the first six months of 2014 for continuing operations.
the sale of the service operations, the Group reported a net profit from discontinued operations of 70.5 million in the first half of 2014. Galapagos recorded a result on divestment of 67.5 million.
R&D expenses for the Group in the first half of 2015 were 63.3 million compared to 52.8 million
in 2014. This planned increase is mainly due to increased efforts on the filgotinib and cystic fibrosis programs.
G&A and S&M expenses of the Group were 9.2 million in the first half of 2015, compared to 7.4
million in the first half of 2014.
Finally, for one subsidiary, a deferred tax asset was set up for an amount of 1.8 million on 30
June 2015, of which 1.5 million was additionally recognized in the first six months of 2015.
Liquid assets position
Cash, cash equivalents and
restricted cash totaled 404.6 million on 30 June 2015, which is the
highest cash balance the
Company has ever reported.
A net increase of 209.8 million in cash and cash equivalents was
recorded during the first half of
2015, compared to an increase of 82.6 million during the same
period last year. Net cash flows from financing activities generated 261.0 million through a recent global offering and concurrent
listing on NASDAQ, as well as 10.2 million from warrant exercises. Furthermore, the Company
continued to intensify its R&D investments, with a net cash outflow of 62.2 million from operating
activities in the first six months of 2015.
Restricted cash amounted to 10.7 million at the end of December 2014, and decreased to 7.2 million
for the half year ended 30 June 2015. This decrease is related to (i) the release of the 3 million bank guarantee issued in 2013 for the rental of the new premises in France which expired on 30 June 2015 following the move
to the new offices, and (ii) the payment of a claim to Charles River by decrease of the escrow account. Restricted cash on 30 June 2015 is related to 0.3 million bank guarantee on real estate lease obligations in Belgium, and to
6.9 million escrow account containing part of the proceeds from the sale of the service division in 2014 for which the release will be possible after final agreement between the parties on the exposure regarding one outstanding claim. An
amount of 0.3 million has been accrued in March 2015 based on a preliminary estimate of the exposure.
Furthermore, Galapagos balance sheet holds an unconditional and unrestricted receivable from the French government
(Cr dit d Imp t Recherche)1 now amounting to 35.6 million, payable in
tranches. Galapagos balance sheet also holds a receivable from the Belgian Government for R&D incentives now amounting to 22.4 million, payable as from 2016 in 5.5 yearly tranches.
Operational overview
o Rheumatoid arthritis
o Galapagos reported promising efficacy, a rapid onset of action, and a potentially differentiated safety profile in its
topline week 12 results for DARWIN 1 (594 rheumatoid arthritis patients, methotrexate add-on) and DARWIN 2 (283 RA patients, monotherapy) with filgotinib in April 2015
2015, Galapagos announced that at week 24, patients treated with the selective JAK1 inhibitor filgotinib showed further improvement in signs and symptoms of rheumatoid arthritis activity, as demonstrated by improved ACR responses, DAS28(CRP), and
other scores, compared to week 12 in the DARWIN 1 Phase 2B methotrexate add-on study.
o Topline 24 week data
for DARWIN 2 are expected later this month, with a licensing decision by AbbVie expected following this
Inflammatory bowel disease
o We expect to report 10 week, primary endpoint topline results before end 2015
the FITZROY Phase 2 study with filgotinib: a 20 week, 175 patient study in Crohn s
o Galapagos completed recruitment for ORIGIN, a Phase 2 Proof-of-Concept study with GLPG1205, a selective inhibitor of GPR84, in 60 ulcerative colitis patients. We expect to announce
topline results from ORIGIN in Q1 2016
o AbbVie presented novel assays used by Galapagos and AbbVie to screen for novel
corrector-potentiator combinations at ECFS 2015
o Nomination of a second corrector as a pre-clinical candidate is expected later this quarter, thereby completing the discovery phase of our potential triple combination therapy for Class
II patients in cystic fibrosis
o Topline safety and tolerability results of the Phase 1 with potentiator