Focus on filgotinib and cystic fibrosis
(Thomson Reuters ONE) -
* 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; 28 July 2016, 22.00 CET - 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| 57.5 | |
|agreement(1) | | |
+----------------------------+------------------------+------------------------+
|Other net financial result | (0.9) | (0.1) |
+----------------------------+------------------------+------------------------+
|Taxes | - | 1.5 |
+----------------------------+------------------------+------------------------+
|Net result | 32.2 | (34.2) |
+----------------------------+------------------------+------------------------+
|Basic income/loss (-) per| 0.71 | (1.06) |
|share (?) | | |
+----------------------------+------------------------+------------------------+
|Diluted income/loss (-) per| 0.69 | (1.06) |
|share (?) | | |
+----------------------------+------------------------+------------------------+
|Cash, Cash equivalents and| 968.5(3) | 404.6(2) |
|Restricted cash | | |
+----------------------------+------------------------+------------------------+
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(at)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 +31 6 53 591 999
communications(at)glpg.com
Paul van der Horst
Director Business Development & IR
+31 6 53 725 199
ir(at)glpg.com
Forward-looking statements
This release may contain forward-looking statements, including, among other
things, statements regarding theguidance 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 thatGalapagos'
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
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
[HUG#2031535]
Unternehmensinformation / Kurzprofil:
Datum: 28.07.2016 - 22:00 Uhr
Sprache: Deutsch
News-ID 486216
Anzahl Zeichen: 13623
contact information:
Town:
Mechelen
Kategorie:
Business News
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