Robust clinical
programs in inflammation and cystic fibrosis supported by a strong
financial position
Key 2014 results:
-
Group revenues €108m, including
€18m from discontinued operations
-
Group net profit €33m resulting from divestment of service
operations
-
Year-end
cash €198m, including €11m in restricted cash
-
Filgotinib: recruitment
completed for phase 2B studies DARWIN 1 and 2; 98% of eligible
patients enrolled in long term extension DARWIN 3
-
Cystic fibrosis program in
the clinic
-
GLPG1205 in Phase 2A study
for ulcerative colitis
Management guidance for
2015:
-
All Phase 2B studies with
filgotinib in RA completed, AbbVie licensing decision expected
following DARWIN 24-week readouts
-
Cystic fibrosis program in
Phase 2; all molecules of a triple-combo therapy in development by
end of H1
-
Cash burn €110 -
€130m, excluding cash income from milestones and
licenses
-
Cash reserves expected to yield
runway until end 2016
Live audio
webcast presentation at 14.00 CET, www.glpg.com, call numbers:
Local Belgium, also outside
Belgium: |
+32(0)2 402 3092 |
Toll free in Belgium: |
0800 58033 |
Local Netherlands, also outside
Netherlands: |
+31(0)20 716 8295 |
Toll free in the
Netherlands: |
0800 020 2576 |
Mechelen,
Belgium; 6 March 2015 - Galapagos NV (Euronext: GLPG) presents
financial results and highlights the key events for the full year
2014.
"With the sale last year of
BioFocus and Argenta to Charles River Laboratories, Galapagos made
the transition from a hybrid service and pipeline company into a
clinical stage R&D biotech that develops drugs with novel modes
of action for high unmet medical needs. Our priority is to
execute on our current clinical programs, and use our unique target
discovery platform to deliver new innovative programs in the
future. In 2014 we greatly expanded our clinical pipeline",
CEO Onno van de Stolpe commented. Galapagos completed
recruitment for the global DARWIN Phase 2B program with filgotinib
in rheumatoid arthritis; we expect to report topline results for 12
weeks of treatment in DARWIN 1 (mid-April) and DARWIN 2
(early-May). Our cystic fibrosis program entered the clinic,
and we are close to candidate nomination for our third molecule to
complement our triple combination therapy for the main cystic
fibrosis mutation. In addition to filgotinib and cystic
fibrosis, the Company has '1205 (ulcerative colitis) and '1690
(pulmonary disease) in clinical development and 25 programs in
earlier stages. Management expects 2015 to exceed 2014 in the
number and breadth of clinical readouts, while also delivering
Phase 1 and novel pre-clinical candidates."
"Galapagos exceeded guidance for
full year revenues, achieving €108 million including €18 million in
services revenues from the first quarter. The Company is
well-positioned to create significant value from its R&D
assets, with nearly €200 million in cash on the balance sheet, the
largest year end cash position ever for Galapagos" said Bart
Filius, CFO of Galapagos. "Management will put
considerable R&D investments to work to progress the Company's
mid stage clinical and other programs and deliver extensive news
flow in 2015. Guidance for cash burn is therefore between
€110 - 130 million for 2015, excluding cash from milestones and
licensing. Excluding income from a $200 million license of
filgotinib by AbbVie, we have a runway until the end of 2016."
Key figures
(consolidated)
(€ millions, except basic income/loss per share)
|
31
Dec 2014 Continuing Operations |
31
Dec 2013
Continuing Operations |
31
Dec 2014 Group Total1 |
31
Dec 2013
Group Total1 |
Revenues |
90.0 |
96.6 |
108.2 |
159.5 |
Services cost of sales |
|
|
-11.3 |
-41.3 |
R&D expenditure |
-111.1 |
-99.4 |
-111.1 |
-99.4 |
G&A and S&M expenses |
-14.9 |
-13.8 |
-18.9 |
-28.8 |
Operating result
before exceptional items |
-36.0 |
-16.6 |
-33.1 |
-10.0 |
Restructuring & integration
costs |
-0.7 |
-0.3 |
-0.7 |
-1.1 |
Result on divestment |
|
|
67.5 |
- |
Operating
result |
-36.6 |
-16.9 |
33.7 |
-11.0 |
|
|
|
|
|
Net result for the
period |
-37.3 |
-16.8 |
33.2 |
-8.1 |
Basic income / Loss
(-) per share (€) |
-1.24 |
-0.58 |
1.10 |
-0.28 |
Cash, Cash
equivalents and Restricted cash³ at
year-end |
NA |
NA |
198.4² |
141.5³ |
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. Group results include both continuing and
discontinued operations.
2) including €10.7 million of restricted
cash
3) including €3.3 million of restricted
cash
Details of the
financial results
Revenues
Galapagos' revenues for 2014 amounted to €108.2 million, which
includes €18.2 million of revenues from discontinued service
operations, sold to Charles River Laboratories on 1 April
2014. Revenues from continuing operations of €90.0 million
represent a decrease of 7% compared to 2013, reflecting lower
recognition of deferred revenues from upfront payments, as a result
of the longer duration of the filgotinib program. Income from
milestones, grants and R&D incentives was in line with
2013.
Result
The Group realized a net profit in 2014 of €33.2 million, or €1.10
income per share, compared to a net loss of €8.1 million, or €0.28
loss per share in 2013.
Net loss from continuing
operations amounted to €37.3 million. Operating expenses from
continuing operations at €126.6 million were 11.6% (€13.2 million)
higher than in 2013. This increase is principally the result
of higher investments in the development of our mid-stage product
candidates filgotinib, GLPG1205, and GLPG1690, and increased
spending to accelerate the cystic fibrosis program with
AbbVie. This planned increase was driven by the maturing
R&D pipeline and the resulting costs of clinical trials.
Cash
position
Cash, cash equivalents and restricted cash totaled €198.4 million
on 31 December 2014, which is the highest year-end cash balance the
Company has ever reported. Restricted cash of €10.7 million
includes a bank guarantee on real estate lease obligations and an
escrow account connected to the sale of the service
operations. €10.4 million of this restricted cash is expected
to be released by mid-2015. Net cash proceeds from the sale
of the service operations amounted to €130.8 million. In
addition, Galapagos' balance sheet holds R&D incentives
receivables from the French and Belgian governments amounting to
€51.3 million, of which €7.4 million will be collected in 2015.
Operational
highlights
R&D
operations
Service
operations
Corporate
-
Average daily trading volumes and value were 69k
shares / €1.0 million
-
Warrant exercises raised €4.4 million
-
Bart Filius joined as CFO
-
Vicki Sato resigned from the Galapagos Board of
Directors
Outlook
2015
The Phase 2B clinical program for filgotinib in RA is expected to
deliver the 12-week topline efficacy and safety data for DARWIN 1
by mid-April, with 12 week topline results for DARWIN 2 in early
May. 24-week results from both studies are expected in
July. The 10-week results from filgotinib in Crohn's disease
(FITZROY) are expected in the second half of 2015. Subsequent
to DARWIN 24-week results becoming available, a licensing decision
by AbbVie is expected.
In cystic fibrosis, Galapagos
expects to nominate a second corrector in the first half of
2015. Galapagos will report topline Phase 1 results with
GLPG1837 and initiate a Phase 2 study in class III cystic fibrosis
patients in the second half of 2015.
The Company expects to make
significant progress in both partnered and non-partnered R&D
programs as the pipeline continues to mature across a broad range
of therapeutic areas, resulting in multiple additional clinical and
pre-clinical stage programs by end 2015.
The Company expects an operational
use of cash of €110 - 130 million during 2015, excluding milestone
payments and a potential $200 million license fee from our partner
AbbVie for filgotinib. Excluding income from a license of
filgotinib by AbbVie, Galapagos has a runway until the end of
2016.
Annual Financial
Report 2014
Galapagos is currently finalizing its financial statements for the
year ended 31 December 2014. The auditor has confirmed that
his audit procedures, which are substantially completed, have not
revealed any material corrections required to be made to the
financial information included in this press release. Should
any material changes arise during the audit finalization, an
additional press release will be issued. Galapagos expects to
be able to publish its fully audited Annual Financial Report for
the full year 2014 on or around 27 March 2015.
Conference call and webcast presentation
Galapagos will conduct a
conference call open to the public today 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:
Local Belgium, also outside Belgium: |
+32(0)2 402 3092 |
Toll free in Belgium: |
0800 58033 |
Local Netherlands, also outside Netherlands: |
+31(0)20 716 8295 |
Toll free in the Netherlands: |
0800 020 2576 |
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.
Financial
calendar
28 April 2015
Annual General Meeting of Shareholders in Mechelen
7 August 2015
First Half 2015
Results
About
Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) 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 25 discovery small-molecule and
antibody programs in cystic fibrosis, inflammation, and other
indications. In the field of inflammation, AbbVie and
Galapagos signed a collaboration agreement for the development and
commercialization of filgotinib. Filgotinib is an
orally-available, selective inhibitor of JAK1 for the treatment of
rheumatoid arthritis and potentially other inflammatory diseases,
currently in Phase 2B studies in RA and in Phase 2 in Crohn's
disease. GLPG1205, a first-in-class inhibitor of GPR84, is
currently being tested in a Phase 2 proof-of-concept trial in
ulcerative colitis patients. GLPG1690 is a compound that
targets pulmonary diseases and is currently in a Phase 1
trial. AbbVie and Galapagos also signed a collaboration
agreement in cystic fibrosis to develop and commercialize molecules
that address mutations in the CFTR gene. Potentiator GLPG1837
is currently in a Phase 1 trial, and corrector GLPG2222 is at the
pre-clinical candidate stage. 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. Further
information at: www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications &
IR
Tel: +31 6 2291 6240
ir@glpg.com
Galapagos forward-looking
statements
This release may contain forward-looking
statements, including, without limitation, statements concerning
the safety and efficacy of filgotinib and the expected timing of
the release of topline 12-week results from the DARWIN 1 and 2
trials and the expected timing and announcement of topline 24-week
results from the DARWIN 1 and 2 trials, expectations regarding the
commercial potential of our product candidates generally, all of
which involve certain risks and uncertainties. These statements are
often, but are not always, made through the use of words or phrases
such as "believes," "anticipates," "expects," "intends," "plans,"
"seeks," "estimates," "may," "will," "could," "stands to,"
"continues," "we believe," "we intend," as well as similar
expressions. Such forward-looking statements may involve
known and unknown risks, uncertainties and other factors which
might cause the actual results, financial condition, performance or
achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial
conditions, performance or achievements expressed or implied by
such forward-looking statements. Among the factors that may
result in differences are the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities, regulatory approval requirements and
estimating the commercial potential of our product
candidates. 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,
unless required by law or regulation.
Financial tables 2014
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
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