Sharp
revenue increase and strong progress in research programs for Galapagos
in the first half-year 2007
•
Revenues increase 140% to €26.3 M
• R&D programs accelerate toward the clinic on R&D
investment of €15.7 M
• Expansion of turn-key osteoarthritis alliance with GSK
• Integration of sites and rationalization of operations to
reduce fixed costs
• Group net loss of €16.7 M includes €2.7 M restructuring
and other one-off costs
• Cash position of €37.1 M on 30 June 2007
• Expected milestone payments from all alliances now exceed
€300 M
Webcast
audio conference presentation 9.30 CET today at www.glpg.com
Mechelen,
Belgium; 8 August 2007 – Galapagos NV (Euronext & LSE:
GLPG), an integrated drug discovery company, announces its half
year results and reiterates guidance for the second half of 2007.
Galapagos’
operational and strategic highlights for first half of 2007 include:
• Drug Discovery division reached striking results in its
proprietary therapeutic programs; new and strong data in animal
tests in the arthritis programs bode well for initiating phase I
clinical studies in 2008
• Rodent studies showed that the SARM1
and OARA2 compounds against osteoporosis increase
bone strength to a higher level than bisphosphonates, the drugs
currently marketed for treatment of osteoporosis
• In the alliance with GlaxoSmithKline in osteoarthritis,
Galapagos achieved three milestones and expanded the alliance to
include drug discovery programs based on GSK targets. GSK also made
an equity investment of €4.4 M in Galapagos
• The BioFocus DPI service division almost doubled its revenues
to €22.5 M, representing an overall growth of 95% and an organic
growth of 12% compared to the first six months of 2006. A high level
of fixed costs has led to a loss for the division of €2.6 M.
Synergies and savings will become apparent as our cost saving measures
take effect throughout the rest of 2007 and 2008
• Headcount increased to 460 people, including 177 PhD’s
Key figures half year 2007
(€ millions, except net loss per share)
Note: The drug discovery operations of Discovery Partners International
Inc were acquired 5 July 2006. Inpharmatica Ltd was acquired on
5 December 2006, and ProSkelia SASU on 22 December 2006.

“Galapagos has strongly accelerated its R&D activities,
in line with our strategy to deliver a clinical portfolio in bone
& joint disease next year. Not only have we advanced our own
programs as planned, but we also have delivered on milestone-bearing
alliances with our R&D partners and expanded our turnkey alliance
with GSK,” stated Onno van de Stolpe, CEO of Galapagos. “Following
the acquisitions last year, BioFocus DPI will be optimizing performance
further as it also grows revenues. We expect that the powerful service
division we created last year will be capable of generating significant
cash flows in future years, thereby reducing the Company’s
need for external funding for internal drug discovery programs.”
“Increases in service division revenues and milestone payments
led to growth in Group revenues of 140% in the first half of 2007,”
said Leo Steenbergen, Galapagos’ CFO. “We remain on
track to deliver full year revenue growth in line with our guidance,
and we will consolidate further the operations acquired last year,
reducing our cost base going forward.”
Operational
overview
Acceleration of therapeutic programs
Drug Discovery is showing exciting results and the programs are
progressing toward the clinic across all three therapeutic areas.
The division delivered a total of €4.6 M in milestone revenues
in the first half of 2007. Lead compounds in the rheumatoid arthritis
program show significant disease-modifying properties in the industry
gold standard animal model, including protection against bone loss
and reduction in joint swelling. In the osteoarthritis program,
Proof of Principle was demonstrated in an animal model through an
increase in cartilage and bone. In the anti-catabolic approach for
osteoarthritis, the proprietary lead compounds show prevention of
cartilage degradation. In the osteoporosis programs, Galapagos announced
in June that Wyeth licensed three proprietary bone anabolic drug
targets from the 2003 research agreement, resulting in a €1.05
M milestone payment. In rodent studies the SARM and OARA compounds
against osteoporosis show an increase in bone strength to higher
levels than bisphosphonates, the drugs currently marketed for treatment
of osteoporosis. The strong results in all three core bone &
joint disease programs encourage the Company to retain its focus
of bringing proprietary drugs towards and into the clinic. With
the help of Clinquest Inc., acting Chief Medical Officer Cees Wortel
is building the clinical infrastructure necessary to initiate phase
I studies in Galapagos’ bone & joint programs in 2008.
Estrogen
glucoside
Given the success and quality of the internal drug discovery programs,
the Company has decided to focus all of its internal resources on
these programs and only pursue the estrogen glucoside program in
the event a commercial partner is found. Galapagos obtained a license
option for estrogen glucoside through the acquisition of ProSkelia
in December 2006. Preliminary discussions have been initiated with
several parties interested in this program.
Expansion
of Galapagos’ alliance with GSK in osteoarthritis
In June 2006, Galapagos and GlaxoSmithKline entered into a broad
alliance to discover and develop novel drugs in osteoarthritis.
In this multi-year, multi-program alliance, Galapagos is developing
molecules based on proprietary targets and taking these through
to clinical Proof of Concept (Phase IIA), with the option for GSK
to further develop and market the resulting drugs. Three milestones
have been achieved in the first half of 2007, resulting in payments
of €3.6 M from GSK. In June 2007, the scope of the alliance
was expanded to include up to two drug discovery programs on selected
GSK drug targets. Under the expanded agreement, Galapagos could
obtain up to €186 M in total milestones and up to double digit
royalties on worldwide sales of two marketed products. With this
alliance expansion, the total downstream milestones of all alliances
could result in payments to Galapagos in excess of €300 M.
Growth
and performance of the service division
BioFocus DPI showed a year-on-year growth of 95% compared to the
first six months of 2006, which was due for a large part to the
acquisition of the activities of Discovery Partners International
and Inpharmatica in 2006. These acquisitions expanded the products
and services of BioFocus DPI, propelling the service division into
a top tier position in drug discovery worldwide. BioFocus DPI achieved
an organic growth of 12% in the first half of 2007, slightly below
the Company’s target growth for full year 2007 of 15%. BioFocus
DPI announced deals with existing partners such as Amgen, AstraZeneca,
Ono Pharmaceuticals, Johnson & Johnson and Cancer Research Technology,
as well as with new customers such as the US Environmental Protection
Agency and the University of Bristol and University of Rochester.
BioFocus DPI also announced a milestone payment for progress in
the target discovery collaboration with Boehringer Ingelheim.
The
segment loss for BioFocus DPI over the first six months of the year
was €2.6 M. Synergies and savings will become apparent as cost
saving measures work through the rest of 2007 and 2008. This should
lead to a well integrated, efficient and cost effective service
organization. The target discovery operations were relocated to
state-of the-art facilities in Leiden. The efficiency and profitability
of the high-throughput screening and natural products businesses
will improve by merging the Heidelberg operations into the Basel
operations later this year. Additionally, in November the activities
in Cambridge (UK) will be relocated to BioFocus DPI headquarters
in Saffron Walden, facilitating easy interaction between the medicinal
chemistry and ADMET teams. Galapagos expects that these initiatives
will generate cost savings, towards profitability of BioFocus DPI
in the years to come.
Details of the financial results
Revenue
Galapagos’ revenues for the first half of 2007 amounted to
€25.0 M compared to €10.2 M recorded in the same period
of 2006. Total revenues including other income amounted to €26.3
M compared to €11.0 M in the first half of 2006. This growth
is attributable to organic growth of BioFocus DPI as well as the
acquisitions of the Discovery Partners International operations
in July 2006, and of Inpharmatica and ProSkelia in December 2006.
The revenues from acquired operations are fully reflected in the
first half of 2007, but not in the consolidated results of the first
half of 2006.
Results
The net loss for the first half-year of 2007 was €16.7 M, including
restructuring and other one-off costs of €2.7 M, compared to
the loss of €5.5 M for the first six months of 2006.
Total
research and development expenses in the first half-year of 2007
were €15.7 M compared to €4.0 M in the same period of
2006.
General
and administrative expenses were €11.7 M in the first half
of 2007, including €2.7 M restructuring and other one-off costs,
compared to €5.3 M in the first six months of 2006. Again,
this is directly attributable to the acquisitions in 2006 and therefore
is fully reflected in the first half of 2007, but not in the consolidated
results of the first half of 2006. Excluding restructuring and other
one-off costs, the Company has reduced G&A to 34% of total revenues,
as compared to 49% in 1H 2006.
Cash
flow and cash position
A net decrease of €14.5 M in cash and cash equivalents was
recorded during the first half of 2007. The cash used in operations
was €19.3 M, as compared to €1.5 M during the same period
in 2006; this is a result of the planned increase in r&d costs,
the BioFocus DPI segment result, and restructuring and other one-off
costs. Proceeds of the capital increase related to the GSK alliance
amounted to €4.4 M. Galapagos’ cash and cash equivalents
amounted to €37.1 M on 30 June 2007.
Outlook
2007
Based on the visibility in revenue streams, the Company reiterates
its full-year 2007 revenue guidance of €54 to €58 million,
a 150 - 165% increase in annual consolidated sales of 2006. Furthermore,
the Company maintains guidance for R&D expenditure of €33
million and, based on the contracts in the pipeline, a maximum cash
burn of €20 million, expecting to result in a 2007 year end
cash position exceeding €31 million.
The
Company continues to move forward on the strategic objectives for
2007:
• Delivery of pre-clinical candidates in RA and OP
• Continued growth of the BioFocus DPI service division
• Increased revenues from milestone payments to offset r&d
costs
• Partnering our r&d programs with big pharma for long
term value creation
Interim Report 2007
The electronic version of Galapagos’ Interim Report for half
year 2007 is now available online at www.glpg.com/investor/financial_reports.htm.
Printed versions of the report can be requested by e-mailing ir@glpg.com.
Conference call and webcast presentation
Galapagos will conduct a conference call open to the public today
at 09.30 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. The live audio webcast
can be accessed via Galapagos’ website at www.glpg.com.
The archived webcast also will be available for replay shortly after
the close of the call.
About
Galapagos
Galapagos (Euronext Brussels, GLPG; Euronext Amsterdam, GLPGA; London
AiM: GLPG) is a drug discovery company with pre-clinical programs
in bone and joint diseases and cachexia. Its division BioFocus DPI
offers a full suite of target-to-drug discovery products and services
to pharmaceutical and biotech companies, encompassing target discovery
and validation, screening and drug discovery through to delivery
of pre-clinical candidates. BioFocus DPI also provides adenoviral
reagents for rapid identification and validation of novel drug targets,
compound libraries for drug screening as well as chemogenomics and
ADMET database products to select targets and compounds. Galapagos
currently employs 460 people and operates facilities in seven countries,
with global headquarters in Mechelen, Belgium. More information
about Galapagos and BioFocus DPI can be found at www.glpg.com
and www.biofocusdpi.com.
CONTACT
Galapagos
NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
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
Selective androgen receptor modulator
2 Osteoclast adhesion receptor antagonist
3
Includes “Other Income”
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