Robust progress in Q3 2016
(Thomson Reuters ONE) -
* Financial results of the first nine months:
* Group revenues increased by ?17.8 M to ?65.0 M
* Operating loss reduced by ?14.8 M to ?48.5 M
* End of third quarter cash ?938.8 M
* Progress in R&D:
* Start FINCH Phase 3 program with filgotinib in rheumatoid arthritis (RA)
* Successful completion of regulatory consultations for filgotinib in
inflammatory bowel disease (IBD)
* Endoscopic improvements with filgotinib consistent with clinical
remission rates in Crohn's disease (CD)
* Improvements in FEV1 with GLPG1837 in cystic fibrosis (CF) patients
(S1251N, SAPHIRA 2)
* MorphoSys and Galapagos start first-in-patient dosing of IL-17C antibody
MOR106 in atopic dermatitis
Webcast presentation tomorrow 28 October at 14.00 CET/8 AM ET,
www.glpg.com, +32 2 400 6926, code 2352766
Mechelen, Belgium; 27 October 2016, Galapagos NV (Euronext & NASDAQ: GLPG)
announces significant progress in R&D in the first nine months while reporting
financial results in line with management guidance. These unaudited results of
the first nine months are further detailed in an online Q3 2016 Report published
on the Galapagos website, www.glpg.com.
"This quarter, we are again encouraged by the progress made in our R&D programs.
The FINCH Phase 3 program in RA is recruiting. By year end, Gilead is expected
to have in total three major late stage clinical programs dosing patients with
filgotinib, with more Phase 2 studies targeting other inflammatory diseases
expected in 2017. The endoscopy and histopathology data reported from the
FITZROY study with filgotinib in Crohn's disease at UEG Week set a high bar for
Crohn's clinical research going forward. We are excited about the progress made
in our cystic fibrosis program, keeping us on track to potentially have a triple
combination therapy in Class II patient studies by mid-year 2017," said Onno van
de Stolpe, CEO. "In the background, our research teams continue to discover new
targets and molecules, propelling them forward toward patients, as we go for our
ambitious goal of delivering three novel target based Proofs-of-Concept in
patients every year."
"The financial results for the first nine months of 2016 were fully in line with
our expectations, leaving us with a solid cash position of ?939 million on 30
September. Our revenues increased by 38% compared to the same period in 2015. We
reiterate our cash burn guidance for the full year within the range of ?100-120
million, excluding payments from Gilead for filgotinib," said Bart Filius, CFO.
Key figures Q3 Report 2016 (unaudited)
(? millions, except basic income/loss per share)
+----------------------------+------------------------+------------------------+
| |30 September 2016 Group |30 September 2015 Group |
| | Total | Total |
+----------------------------+------------------------+------------------------+
|Revenues | 65.0 | 47.2 |
+----------------------------+------------------------+------------------------+
|R&D expenditure | (96.7) | (96.9) |
+----------------------------+------------------------+------------------------+
|G&A and S&M expenses | (16.8) | (13.6) |
+----------------------------+------------------------+------------------------+
|Operating loss | (48.5) | (63.3) |
+----------------------------+------------------------+------------------------+
|Fair value re-measurement of| | |
|share subscription| 57.5 | |
|agreement(1) | | |
+----------------------------+------------------------+------------------------+
|Other net financial result | (0.9) | 0.4 |
+----------------------------+------------------------+------------------------+
|Taxes | (0.1) | 1.4 |
+----------------------------+------------------------+------------------------+
|Net result | 8.1 | (61.4) |
+----------------------------+------------------------+------------------------+
|Basic income/loss (-) per| 0.18 | (1.78) |
|share (?) | | |
+----------------------------+------------------------+------------------------+
|Diluted income/loss (-) per| 0.17 | (1.78) |
|share (?) | | |
+----------------------------+------------------------+------------------------+
|Cash, Cash equivalents and| 938.8(3) | 374.4(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 ?7.9 million of restricted cash
3) including ?8.0 million of restricted cash
Q3 Report 2016
A detailed Q3 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 (28 October
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: 2352766
USA: +1 719 325 2213
UK: +44 20 7026 5967
Netherlands: +31 20 703 8261
France: +33 1 76 77 22 57
Belgium: +32 2 400 6926
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 3, 2, 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 480 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 Director Communications
Communications +31 6 53 591 999
+1 781 460 1784 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 the guidance from management (including guidance
regarding the expected cash burn during financial year 2016), financial results,
timing and/or results 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.
Galapagos Q3 results 2016:
http://hugin.info/133350/R/2052203/768011.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 27.10.2016 - 22:00 Uhr
Sprache: Deutsch
News-ID 503444
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contact information:
Town:
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