MECHELEN, BELGIUM--(Marketwire - Mar 8, 2013) - This is a correction of the announcement
from 07:30 08.03.2013 CET. Reason for
the correction is replacement of language version:
· Group revenues EUR153 M (+36%) versus guidance of EUR150 M
· Group operating loss before exceptional items EUR2.1 M due
to EUR10 M
pulled-forward investment on '634, while total budget for external spending
on
this program remains unchanged
· Year-end cash EUR94.7 M, excluding EUR20.7 M in milestone
receivables for
2012 revenues and EUR25 M guaranteed and due under the CIR program of the
French
government
· Service division external revenues +10% to EUR65.8 M,
segment profit for
running business EUR9.1 M, in line with 2011
· 2012 AbbVie partnering deal for GLPG0634, total value of up
to $1.35 B
plus double digit royalties
· Three Phase 2 and multiple Phase 1 programs in promising
clinical
pipeline by end 2013
· 2013 guidance for Group revenues of EUR160 M
Live audio webcast presentation at 10.00 CET, call number +32-2290-1608,
www.glpg.com
Galapagos NV (Euronext: GLPG) presents audited
financial results, highlights the key events for the full year 2012 and
provides
an outlook for 2013.
"In 2012, Galapagos claimed leadership in the JAK1 inflammatory space," CEO
Onno
van de Stolpe commented. "The global collaboration agreement with
AbbVie on
GLPG0634 and the in-licensing of another JAK1 molecule by GSK
provide two
opportunities towards success with Galapagos-discovered selective
molecules in
three inflammation indications with high medical need. The R&D
division
continues to deliver milestones in its alliances with pharma companies,
while
achieving progress in our cystic fibrosis and other proprietary programs.
The
service division realized a solid 2012, with external revenues
growth and
profitability in line with 2011. By the end of 2013, Galapagos will have
three
Phase 2 programs in four indications, multiple Phase 1 studies, and
pre-clinical candidates in the alliances and our internal programs,
highlighting a broad and
maturing pipeline."
"Galapagos' business model generates considerable revenues from
licensing,
alliances, and fee-for-service activities. Group revenues were fuelled by
EUR37.2
million in revenue recognition of the $150 million upfront payment received
from
AbbVie. R&D productivity was reflected further by EUR50.2 million in
alliance and
other R&D revenues. BioFocus and Argenta both showed good
performances in
2012. The service division achieved 10% organic growth of external
revenues,
making strides toward independence from internal revenues and helping to
fund
our R&D pipeline. Taken together, these factors resulted in the Group
reporting
record revenues. Our liquid assets position shows EUR115.4 million, and
reflects
a EUR10 million pulled-forward investment in 2012 for the Phase 2b
studies with
GLPG0634, while the total budget for external spending on this program
remains
unchanged at EUR70 million. Furthermore, Galapagos holds
unrestricted and
unconditional receivables from the French government (CIR) of EUR25
million, for
which the first tranche will be payable in early 2014," said Guillaume
Jetten,
CFO of Galapagos.
Key figures (consolidated)
(EUR millions, except basic result per share)
|Continuing Operations|Continuing Operations
| 31 Dec 2012 | 31 Dec 2011¹
| |
-------------------------------+---------------------+---------------------
Revenues | 153.0 | 112.9
-------------------------------+---------------------+---------------------
Services cost of sales | -48.2 | -39.1
-------------------------------+---------------------+---------------------
R&D expenditure | -80.3 | -84.5
-------------------------------+---------------------+---------------------
General & administrative | -24.5 | -22.1
-------------------------------+---------------------+---------------------
Sales & marketing | -2.1 | -2.3
-------------------------------+---------------------+---------------------
Operating result before | -2.1 | -35.1
exceptional items | |
-------------------------------+---------------------+---------------------
Restructuring & integration | -2.5 | -
-------------------------------+---------------------+---------------------
Result on divestment | -2.0 | 5.2
-------------------------------+---------------------+---------------------
Operating result | -6.6 | -29.9
-------------------------------+---------------------+---------------------
Net result for the period | -5.7 | -30.1
-------------------------------+---------------------+---------------------
Basic result per share (EUR) | -0.22 | -1.13
-------------------------------+---------------------+---------------------
Cash and cash | |
equivalents²/³ | 94.7 | 32.6
Notes:
1) 2011 figures are for continuing operations, with minimal
differences for
accounting comparison to 2012
2) Cash on 31 December 2012 did not include EUR20.7 million in
receivables for
revenues recognized in 2012
3) Liquid assets position includes cash and milestone receivables
Details of the financial results
Revenues
Galapagos' revenues for the full year 2012 amounted to EUR153 million, an
increase
of 36% compared to 2011. The service division focused efforts on growing
their
external business in 2012, with external revenues of EUR65.8 million
growing +10%
over 2011, despite closure of BioFocus' Basel operations and the
resulting
transfer of the high-throughput screening activities to Chesterford Park.
The
R&D division reported total revenues of EUR87.2 million, reflecting
considerable
milestone achievements in the alliances and EUR37.2 million in revenue
recognition
from the $150 million AbbVie payment.
Result
The Group incurred a net loss for the full year 2012 of EUR5.7 million,
or EUR0.22
loss per share, compared to a loss of EUR30.1 million, or EUR1.13 loss per
share in
2011.
The R&D division incurred a segment loss of EUR3.5 million in 2012,
compared to
EUR40.5 million last year. R&D expenses were EUR80.3 million, compared
to EUR84.5
million last year.
The BioFocus and Argenta Service division reported a gross margin of 33.7%
('11:
31.7%) on external revenues and a segment result of EUR8.2 million,
compared to
EUR9.0 million last year. Included in the reported segment result for
2012 were
one-off investments to build up the high-throughput screening business
in the
UK, following the transfer from Basel. Corrected for these
factors, the
profitability of the running business in 2012 was in line with 2011.
General and administrative costs from continuing operations increased to
EUR24.5
million, reflecting expenses related to the now-completed implementation
of a
company-wide ERP system to achieve better cost control and
purchasing
efficiencies of scale and one-off payroll expenses related to closing the
AbbVie
deal. General and administrative expenses as a share of group
revenues
decreased to 16.0% compared to 19.6% in 2011
Restructuring and integration expenses of EUR2.5 million relate to the
closure of
Basel and reorganization costs. Result on divestment of EUR2 million is
the net
of the liquidation costs of dormant legal entities and an earnout
payment
received from Evotec connected with the sale of Compound Focus in 2011.
Liquid assets position
Cash on balance was EUR94.7 million on 31 December 2012. The Company's
liquid
asset position of EUR115.4 million at year end 2012 (EUR48.5 million at
year end
2011) included EUR20.7 million in alliance related receivables for which
revenues
were recorded in 2012 and payment is expected in Q1 2013. The liquid
asset
position was negatively impacted by pulled-forward preparations for the
Phase
2b study with GLPG0634, amounting to EUR10 million spending earlier than
planned
in 2012, while total external spend expected for the Phase 2
studies in
rheumatoid arthritis remains unchanged. In addition, Galapagos' balance
sheet
holds an unconditional and unrestricted receivable from the French
government
(Crédit d'Impôt Recherche)[1] amounting to EUR25 million,
payable in three yearly
tranches starting in early 2014. A significant portion of this receivable
could
be transferred into cash if needed.
Operational highlights
On 29 February 2012, Galapagos and Abbott (now AbbVie) announced a
global
collaboration to develop and commercialize GLPG0634 to treat
autoimmune
diseases. Under the terms of the agreement, AbbVie made an upfront
payment of
$150 million for rights related to the global collaboration. This
upfront
payment will be recognized over 30 months and will contribute to
Galapagos'
revenues over the coming three years. Upon successful completion
of the
rheumatoid arthritis Phase 2 studies by Galapagos, AbbVie will
license the
program for a one-time fee of $200 million. AbbVie will assume
sole
responsibility for Phase 3 clinical development and will have
global
manufacturing rights. Pending achievement of certain developmental,
regulatory,
commercial and sales-based milestones, Galapagos will be eligible to
receive
additional milestone payments from AbbVie, potentially amounting to $1
billion,
in addition to tiered double-digit royalties on net sales
upon
commercialization. Furthermore, Galapagos retains co-promotion rights
in the
Benelux.
R&D operations
Galapagos increased the momentum of its R&D pipeline by the end of 2012,
ending
the year with 4 clinical, 6 pre-clinical, and more than 30 discovery
programs.
Galapagos is on track to have a mature pipeline of three programs in
Phase 2
studies and multiple Phase 1 programs by end 2013.
* In the field of inflammation:
* reported confirmation of the efficacy and safety profile of
GLPG0634 in
a multi-center, dose-range finding clinical study in 90 rheumatoid
arthritis patients
* opened an IND for GLPG0634 in the United States
* GSK exercised in February 2012 the exclusive option to license
GLPG0555
and GLPG0778 and recently announced the initiation of Phase 2
studies
with GLPG0778 in psoriasis and lupus
* reported excellent pharmacokinetics and up to 90% inhibition of a
biomarker in the Phase 1 First-In-Human clinical study with
GLPG0974
* initiated a second, multiple ascending dose Phase 1 study with
GLPG0974
* delivered a drug candidate in the osteoarthritis alliance with
Servier,
two drug candidates in the alliance with Janssen Pharmaceutica, and
a
fifth candidate in the alliance with GSK
* In the field of oncology:
* completed a Phase 1b clinical study including cancer patients for
metastasis candidate drug GLPG0187
* In the field of anti-infectives:
* nominated a pre-clinical candidate against Methicillin-Resistant
Staphylococcus Aureus
* In orphan diseases:
* discovered a potentiator in the cystic fibrosis program
* In other areas:
* terminated GLPG0492 in cachexia
* progressed 30 discovery programs, including antibody programs with
MorphoSys
* received from the Flemish government agency IWT a three-year grant
to
discover new antibiotic treatments and a 2.5-year grant to identify
new
therapeutic compounds for future treatment of Inflammatory Bowel
Disease
patients
Service operations
* BioFocus
* Drug discovery collaboration between Argenta, BioFocus and
AstraZeneca
in respiratory and inflammatory disease
* Target discovery agreement with Ono Pharma in the field of allergic
disease
* Drug discovery agreement with Ono Pharma in the field of CNS
disorders
* Milestone achievement in its drug discovery collaboration with UCB
* Argenta
* Collaboration with the University of Cambridge to seek novel
treatments
for pain
* Drug discovery agreement with ANTABIO in anti-infectives
Corporate
* Average daily trading volumes and values in 2012 were 79,815
shares/EUR1.4
million
* Galapagos won the European Mediscience Awards for CEO and for
Transaction of
the Year
Outlook 2013
The Phase 2b clinical study for GLPG0634 will start in the second
quarter of
2013, on track to delivering the full Phase 2 package to Abbott in late
2014.
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 three Phase 2 and multiple Phase 1
programs
by end 2013. Management guides for EUR160 million in Group revenues in
2013.
Annual Financial Report 2012
Galapagos is currently finalizing its financial statements for the year
ended
31 December 2012. 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 2012 on or around 29
March
2013.
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
27 March 2013 R&D Update in New York, USA
30 April 2013 Annual General Meeting of Shareholders in Mechelen
17 May 2013 First Quarter 2013 Business Update
9 Augustus 2013 First Half 2013 Results
15 November 2013 Third Quarter 2013 Business Update
7 March 2014 Full Year 2013 Results
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel
modes-of-action,
with a large pipeline of four clinical, six pre-clinical, and 30
discovery
small-molecule and antibody programs in cystic fibrosis,
inflammation,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the
treatment
of rheumatoid arthritis and potentially other inflammatory diseases,
about to
enter Phase 2b studies. AbbVie and Galapagos signed a worldwide
license
agreement whereby AbbVie will be responsible for further
development and
commercialization after Phase 2b. Galapagos has another selective
JAK1
inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly
GLPG0778,
in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin
receptor
antagonist currently in a Phase 1b patient study in metastasis. GLPG0974
is the
first inhibitor of GPR43 to be evaluated clinically for the treatment of
IBD;
this program will start a Proof of Concept Phase 2 study in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus,
Argenta and
Fidelta, has over 800 employees and operates facilities in five countries,
with
global headquarters in Mechelen, Belgium. Further information at:
www.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
Financial tables 2012:
http://hugin.info/133350/R/1683950/551253.pdf
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Source: Galapagos NV via Thomson Reuters ONE
[HUG#1683950]