Focus on filgotinib and cystic fibrosis
July 28 2016 - 4:20PM
- First half-year financial results:
- Revenues €48.8 M, an increase of €11.9 M
compared to H1 2015
- Operating loss €24.3 M, an improvement of €
11.3 M compared to H1 2015
- Cash on 30 June 2016 of €968.5 M
- Ruling for reduced tax rate on filgotinib income
- Solid execution of R&D programs
- Successful conclusion of regulatory discussions for
filgotinib in rheumatoid arthritis Phase 3 program
- Expansion of cystic fibrosis collaboration with
AbbVie
- Favorable topline Phase 1 results in cystic fibrosis and
osteoarthritis
- Nomination of two fully proprietary pre-clinical candidates
in inflammation
Webcast presentation tomorrow 29 July at 14.00
CET/8 AM ET, www.glpg.com, +32 2 404 0659, code
4067587
MECHELEN, Belgium, July 28, 2016 (GLOBE
NEWSWIRE) -- Galapagos NV (Euronext &
NASDAQ: GLPG) announces its unaudited
first half-year results, which are further detailed in an online H1
2016 report published on the Galapagos website,
www.glpg.com.
Galapagos reported financial results in line
with expectations and solid progress in its R&D programs. The
filgotinib FINCH Phase 3 program in rheumatoid arthritis (RA) is
expected to start shortly and preparations for the Phase 3 program
in Crohn's disease and the Phase 2/3 program in ulcerative colitis
are underway for a start later this year as well. At its annual
R&D update Galapagos announced substantial progress in its
cystic fibrosis programs with AbbVie, conducting several Phase 1
and 2 clinical studies. Finally, the rest of the pipeline made
encouraging progress with the start of the FLORA Phase 2a study
with GLPG1690 in idiopathic pulmonary fibrosis, the start of a
Phase 1 study with novel monoclonal antibody MOR106, encouraging
osteoarthritis biomarker data for GLPG1972 in Phase 1 and the
nomination of two fully proprietary pre-clinical candidates in
idiopathic pulmonary fibrosis and atopic dermatitis. With regard to
the Gilead filgotinib collaboration, Galapagos received a
confirmation ruling from the Belgian Ministry of Finance that the
collaboration agreement benefits from the Belgian patent income
deduction, which allows Galapagos to deduct 80% of patent-related
income from its taxable income. The ruling is valid for five years
and an extension can be requested thereafter.
"I am pleased with the results over the first
six months, both financially as well as in our R&D," said Onno
van de Stolpe, CEO. "The main focus of the investors has been on
our cystic fibrosis and filgotinib programs. We are pleased with
the successful outcome of the RA discussions between Gilead and the
regulatory authorities. We expect to have filgotinib in two Phase 3
studies and one Phase 2/3 study before year end, which is a
hallmark for Galapagos. In cystic fibrosis we are on track to
nominate the triple combo therapy with the aim to start treating
class II patients in clinical trials in 2017."
"In the first half of 2016 Galapagos was
selected for inclusion in the AEX and the BEL20, the primary
indices in Amsterdam and Brussels, respectively. This confirms the
strong progress Galapagos has been making over the past years,"
said Bart Filius, CFO. "Our revenues in the first half of 2016 have
gone up by 32%, and the cash generating part of revenues has nearly
tripled compared to the same period last year[1]. With a cash
position of close to €1 billion, we are well positioned to execute
on our promising pipeline. We confirm our cash burn guidance for
the full year within the range of €100 - 120 million, excluding
payments from Gilead for filgotinib."
Key figures First Half-year Report 2016
(unaudited) (€ millions, except basic income/loss per
share)
|
30 June 2016 Group Total |
30 June 2015 Group Total |
Revenues |
48.8 |
36.9 |
R&D expenditure |
(62.4) |
(63.3) |
G&A and S&M expenses |
(10.7) |
(9.2) |
Operating loss |
(24.3) |
(35.6) |
Fair value re-measurement of share subscription agreement1 |
57.5 |
|
Other net financial result |
(0.9) |
(0.1) |
Taxes |
- |
1.5 |
Net result |
32.2 |
(34.2) |
Basic income/loss (-) per share (€) |
0.71 |
(1.06) |
Diluted income/loss (-) per share (€) |
0.69 |
(1.06) |
Cash, Cash equivalents and Restricted cash |
968.53 |
404.62 |
Notes: 1) reflects non-cash financial
asset adjustment resulting from the Gilead subscription agreement,
which offsets the negative €30.6 million non-cash adjustment booked
in Q4 2015 2) including €7.2 million of restricted cash
3) including €8.0 million of restricted cash
First Half-year Report 2016 A detailed First Half-year
Report for 2016 is available at 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 (29 July
2016) 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: 4067587
USA: |
+1 719 457 2086 |
UK: |
+44 203 043 2003 |
Netherlands: |
+31 20 721 9251 |
France: |
+33 1 7677 2274 |
Belgium: |
+32 2 404 0659 |
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. Our pipeline comprises Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications. We
have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world. Galapagos
is focused on the development and commercialization of novel
medicines that will improve people's lives. The Galapagos group,
including fee-for-service subsidiary Fidelta, has approximately 460
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contacts
Investors: |
Media: |
Elizabeth Goodwin |
Evelyn
Fox |
VP IR
& Corporate Communications |
Director
Communications |
+1 781
460 1784 Paul van der Horst Director Business Development
& IR +31 6 53 725 199 |
+31 6 53 591 999
communications@glpg.com |
ir@glpg.com |
|
Forward-looking statements This release may contain
forward-looking statements, including, among other things,
statements regarding the guidance from management (including
guidance regarding the expected cash burn during financial year
2016), financial results, timing of clinical trials, and
interaction with regulators. Galapagos cautions the reader that
forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown
risks, uncertainties and other factors which might cause the actual
results, financial condition and liquidity, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial conditions
and liquidity, performance or achievements expressed or implied by
such forward-looking statements. In addition, even if Galapagos'
results, performance, financial condition and liquidity, and the
development of the industry in which it operates are consistent
with such forward-looking statements, they may not be predictive of
results or developments in future periods. Among the factors that
may result in differences are that Galapagos' expectations
regarding its 2016 revenues and financial results and 2016
operating expenses may be incorrect (including because one or more
of its assumptions underlying its revenue or expense expectations
may not be realized), Galapagos' expectations regarding its
development programs may be incorrect, the inherent uncertainties
associated with competitive developments, clinical trial and
product development activities and regulatory approval requirements
(including that data from Galapagos' ongoing clinical research
programs may not support registration or further development of its
product candidates due to safety, efficacy or other reasons),
Galapagos' reliance on collaborations with third parties, and
estimating the commercial potential of its development programs. A
further list and description of these risks, uncertainties and
other risks can be found in Galapagos' Securities and Exchange
Commission (SEC) filings and reports, including in Galapagos' most
recent annual report on form 20-F filed with the SEC and other
filings and reports filed by Galapagos with the SEC. 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 or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements,
unless specifically required by law or regulation.
(1) Increase in cash income includes $20 M in milestones
from AbbVie for the cystic fibrosis program in H1 '16
HUG#2031535
Galapagos (EU:GLPG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Galapagos (EU:GLPG)
Historical Stock Chart
From Jul 2023 to Jul 2024