Maturing pipeline supported by very strong balance
sheet
- Group revenues €160 M (+4% over
'12), equal to guidance
- Group net loss €8.1 M ('12: €5.7
M)
- Year-end cash €141.5 M, excluding €6.0
M in milestone receivables for 2013 revenues and also excluding €33
M under the CIR program of the French government
- Expansions of GLPG0634 franchise with AbbVie for Phase
2 studies in RA & Crohn's disease
- Major collaboration with AbbVie signed in cystic
fibrosis, nomination of candidate potentiator
GLPG1837
- Three Phase 2 patient study readouts expected this
year: topline 12 week Phase 2B data with GLPG0634 in rheumatoid
arthritis in H2, psoriasis data from GSK2856184 and GLPG0974 data
in ulcerative colitis in H1
- Service division H2 '13 external revenues €34.1 M (+5%
over normalized H2 '12)
- Service division full year external revenues
€63.2 M (+2% over normalized
'12)
- Management guidance for 2014 Group revenues of
€180 M (+12.5% over '13)
Live audio webcast presentation at 10.00 CET, call
number + 32-2290-1608, www.glpg.com
MECHELEN, Belgium, March 7, 2014 (GLOBE
NEWSWIRE) -- Galapagos NV (Euronext: GLPG) presents
audited financial results and highlights the key events for the
full year 2013.
"In 2013, Galapagos delivered further validation
of its strategy and scientific approach, both in the clinic and on
the deal-making front. Galapagos' pipeline has matured further and
is supported by the strongest balance sheet ever. The Company
expects readouts from four patient studies between now and the end
of 2015, with additional novel target based programs moving into
pre-clinical and clinical stages in that period as well," CEO Onno
van de Stolpe commented. "Galapagos is well-positioned to
capitalize on its considerable R&D assets."
"Financially, 2013 was a very good year for the
Company. We grew Group revenues 4% to €160 million, fully in
line with our guidance. We limited our operating and net
loss, notwithstanding the planned substantial increase in spending
on Phase 2 clinical programs. The service division rallied in
the second half of the year, delivering 5% external revenues growth
in H2 2013 compared to H2 2012, normalized for the discontinuation
of BioFocus' Basel operations. Despite the weak first half of
2013, the service division ended the full year with 2% external
sales growth on a normalized basis. Galapagos' liquid assets
position is solid with cash reserves of €141.5 million on 31
December 2013 plus €6.0 million in 2013 milestone receivables,"
said Guillaume Jetten, CFO of Galapagos.
Key figures (consolidated) (€ millions, except
basic result per share)
|
31 Dec 2013 |
31 Dec 2012 |
Revenues1/2 |
159.5 |
153.0 |
Services cost of
sales |
-41.3 |
-48.2 |
R&D expenditure |
-99.4 |
-80.3 |
General &
administrative |
-26.4 |
-24.5 |
Sales & marketing |
-2.4 |
-2.1 |
Operating result
before exceptional items |
-10.0 |
-2.1 |
Restructuring &
integration |
-1.1 |
-2.5 |
Result on divestment |
- |
-2.0 |
Operating
result |
-11.0 |
-6.6 |
Net result
for the period |
-8.1 |
-5.7 |
Basic result
per share (€) |
-0.28 |
-0.22 |
Cash and cash
equivalents³ |
141.5 |
94.7 |
Notes: 1) '13 Group revenues
comprise R&D revenues of €96.4 M and Services revenues of €63.2
M. 2) '12 Group revenues comprise R&D
revenues of €87.3 M, normalized Services revenues of €61.9 M and
Basel revenues of €3.8 M. 3) Cash on 31 December
2013 did not include €6.0 million in receivables for revenues
recognized in 2013 and also does not include €33 million in French
CIR receivables.
Details of the financial
results
Revenues
Galapagos' revenues for 2013 amounted to €159.5
million, an increase of 4% compared to 2012 and equal to management
guidance. The R&D division reported total revenues of
€96.4 million, reflecting milestone achievements in the R&D
alliances, €45 million in revenue recognition from the $150 million
upfront and the $20 million extension AbbVie payments for GLPG0634,
and €6.8 million in revenue recognition from the $45 million
upfront from AbbVie for cystic fibrosis. After a weak H1, the
service division turned around performance to increase total
external revenues in H2 by €5.0 million to €34.1 million, a 17%
improvement over H1, and a 5% improvement over H2 2012 on a
normalized basis. For the full year, the service division
reported total external revenues of €63.2 million, an increase of
2% compared to €61.9 million last year on a normalized basis.
Result
The Group incurred a net loss in 2013 of €8.1
million, or €0.28 loss per share, compared to a net loss of €5.7
million, or €0.22 loss per share in 2012.
The R&D division incurred a segment loss of
€12.9 million in 2013, compared to a segment loss of €3.5 million
last year. R&D expenses were €99.4 million, compared to
€80.3 million last year. This planned increase was driven by
the Phase 2B program and Phase 2 Crohn's disease study for
GLPG0634, together with other clinical studies to support the
pipeline.
The Service division reported a gross margin of
35.4% compared to 35.9% in 2012 on a normalized basis and a segment
profit of €8.9 million, compared to €9.1 million on a normalized
basis in 2012.
General and administrative costs for the Group
increased to €26.4 million, compared to €24.5 million in 2012.
General and administrative expenses as a share of group revenues
increased to 16.6% compared to 16.0% in 2012.
Liquid assets position
Cash balance was €141.5 million
on 31 December 2013, the highest year end cash balance the
Company has ever had. Including €6.0 million
in alliance related receivables for which revenues were
recorded in 2013 and for which payment is expected in Q1 2014, the
Company's liquid asset position was €147.5 million
at year end 2013, compared to €115.4 million at
year end 2012. In addition, Galapagos' balance sheet holds a
receivable from the French government (Crédit d'Impôt
Recherche)[1] amounting to €33
million, payable in four yearly tranches starting
mid-2014. Payment of €8.6 million of this is expected in
2014, with equal tranches expected annually subsequent to that for
three more years.
Operational highlights
R&D operations
- In the field of inflammation:
- expanded scope of Phase 2B program with GLPG0634 in
rheumatoid arthritis
- started Phase 2B program with GLPG0634 in patients with
moderate to severe RA who do not respond to methotrexate
(MTX). DARWIN 1: dose-range finding in up to 595 patients on
background treatment with MTX. DARWIN 2: dose-range finding
in up to 280 patients without MTX. Both studies are placebo
controlled for first 12 weeks, plus 12 more weeks' treatment for
longer term safety data. DARWIN 3: long term extension
study. DARWIN 1 remains on track to deliver topline 12 week
safety and efficacy data by end 2014
- extended GLPG0634 collaboration with AbbVie to include Crohn's
disease
- started Phase 2 Crohn's study with GLPG0634
- started Proof of Concept study with GLPG0974 in ulcerative
colitis
- reported positive Phase 1 results for GLPG1205 as part of its
alliance with Janssen Pharmaceuticals NV
- GSK moved GSK2586184 JAK1 molecule into multiple Phase 2
patient studies in 2013. GSK has since completed the
psoriasis study with topline results expected in H1 2014, stopped
the lupus study recently due to a lack of efficacy, and put
the ulcerative colitis study on hold
- In orphan diseases:
- announced co-development of cystic fibrosis therapies with
AbbVie
- selected GLPG1837 as a pre-clinical candidate for cystic
fibrosis
- In the field of oncology:
- discovered novel candidate drug GLPG1790 to treat breast
cancer
- In osteoarthritis:
- delivered novel osteoarthritis molecules in the alliance with
Servier
- ended work on the pre-clinical candidate in the Servier
osteoarthritis alliance due to toxicity findings of the
molecule
- Grants for research:
Service operations
- BioFocus
- extended collaboration with and received Rapid Response
Innovation Award from the Michael J. Fox Foundation
- signed agreement with Biogen Idec in scleroderma
- signed collaboration with Boehringer Ingelheim
- Argenta
- signed collaboration with Boehringer Ingelheim in respiratory
diseases
- signed collaboration with Pcovery for the
identification of novel anti-fungal agents
- announced fourth extension of drug discovery collaboration with
Genentech
Corporate
- Average daily trading volumes and value were 80,179 shares/€1.3
million
- Private placement and warrant exercises raised €56 million
- NYSE Liffe listed options in Galapagos shares (ticker:
GLS)
- David Smith appointed as CEO Services
- Katrine Bosley joined the Galapagos Supervisory Board
Outlook 2014
The Phase 2B clinical program for GLPG0634 is on
track to deliver the 12 week topline efficacy and safety data for
DARWIN 1 in late 2014. Further topline results are expected
from GSK's Phase 2 psoriasis study with GSK2586184 as well as
Galapagos' Phase 2 Proof-of-Concept study with GLPG0974 in
ulcerative colitis. 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 2014. Management guides
for €180 million in Group revenues in 2014, representing a 12.5%
increase over 2013.
Annual Financial Report
2013
Galapagos is currently finalizing its financial
statements for the year ended 31 December 2013. 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 2013 on or around 28
March 2014.
Conference call and webcast presentation
Galapagos will conduct a conference call open to
the public today at 10:00 Central European Time (CET), which will
also be webcast. To participate in the conference call,
please call +32-2290-1608 ten minutes prior to commencement.
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
29 April
2014
Annual General Meeting of Shareholders in Mechelen 16 May 2014
First Quarter 2014 Business
Update 8 Augustus
2014
First Half 2014
Results
14 November 2014
Third Quarter 2014 Business
Update 6 March
2015
Full Year 2014
Results
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is
specialized in novel modes-of-action, with a large pipeline
comprising of six Phase 2 studies (three led by GSK), one Phase 1
study, six pre-clinical, and 20 discovery small-molecule and
antibody programs in cystic fibrosis, inflammation, antibiotics,
metabolic disease, and other indications. In the field of
inflammation, AbbVie and Galapagos signed a worldwide license
agreement whereby AbbVie will be responsible for further
development and commercialization of GLPG0634 after Phase 2B.
GLPG0634 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. Galapagos has another selective
JAK1 inhibitor in Phase 2 in ulcerative colitis and psoriasis,
GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in
2012). GLPG0974 is the first inhibitor of FFA2 to be
evaluated clinically for the treatment of IBD; this program is
currently in a Proof-of-Concept Phase 2 study. GLPG1205 is a
first-in-class molecule that targets inflammatory disorders and has
completed Phase 1. AbbVie and Galapagos signed an agreement
in CF where they work collaboratively to develop and commercialize
oral drugs that address two mutations in the CFTR gene, the G551D
and F508del mutation. Potentiator GLPG1837 is at the
pre-clinical candidate stage. The Galapagos Group, including
fee-for-service companies BioFocus, Argenta and Fidelta, has around
800 employees and operates facilities in five countries, with
global headquarters in Mechelen, Belgium. Further information
at: www.glpg.com
CONTACT
Elizabeth Goodwin, Head of Corporate
Communications & Investor Relations Tel: +31 6 2291 6240
ir@glpg.com
This release may contain forward-looking
statements, including, without limitation, statements containing
the words "believes," "anticipates," "expects," "intends," "plans,"
"seeks," "estimates," "may," "will," "could," "stands to," and
"continues," 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. 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. [1] Crédit
d'Impôt Recherche refers to an innovation incentive system
underwritten by the French government
2013 financial tables
http://hugin.info/133350/R/1767054/600212.PDF
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