Mechelen,
Belgium; November 10, 2005 - Galapagos NV (Euronext
& LSE: GLPG) today announced its financial results for
the first nine months of 2005.
Total revenue for the first nine months of 2005 amounted
to € 3.3 million, compared to € 3.6 million in
the first nine months of 2004, due to a decrease in custom
adenovirus orders delivered in this period. The net loss
for the first half of 2005 increased to € 5.7 million
from € 4.3 million in the same period last year, reflecting
stepped up R&D program investment. Cash and cash equivalents
amounted to € 25.1 million on September 30, 2005.
"We have had an exciting quarter with the acquisition
of BioFocus. We also have seen good service revenues but
a slower custom adenovirus business. With our order portfolio,
we expect to recoup some of these sales in the fourth quarter.
We are optimistic on closing further deals this quarter,
especially as we now have a joint sales offering with BioFocus.
Consolidating their activities, we can give revenue guidance
of € 7.7 million for the last quarter of 2005. We have
taken adequate cost control measures in order to offset
the slower-than-expected third quarter sales; consequently,
we remain on track to meet our full year 2005 cash burn
guidance of € 7 million," said Onno van de Stolpe,
Galapagos' CEO. "Having seen the first very promising
in vivo data from our rheumatoid arthritis program, we are
excited about the progress in our drug discovery programs
and expect to move forward rapidly toward demonstrating
our first in vivo proof of concept."
Key figures for first nine months 2005
(€ thousand, except net loss per share)
Details of financial results for first nine months
2005
Note:
Consolidation of BioFocus results will start on October
12, 2005, to be published in Galapagos’ Full Year
2005 Results on March 3, 2006.
Revenue
Galapagos' revenues for the first nine months of 2005 amounted
to € 3.3 million, a decrease of 8% on the € 3.6
million recorded in the same period of 2004.
Galadeno service division revenues amounted to € 1.7
million for the first nine months compared to € 1.9
million for the same period in 2004.
Government grants in the period were € 1.6 million
compared to € 1.7 million in the same period last year.
The decrease in service division revenues compared to last
year is the result of fewer deliveries in the custom adenovirus
business. Deliveries are expected to increase in the fourth
quarter, allowing us to recoup some of these revenues. Following
the BioFocus acquisition, we have decided to review the
merits of pursuing medicinal chemistry work on the Alzheimer
program in-house, thereby increasing the value of these
targets. We have therefore decided to delay the out-licensing
of the Alzheimer program, which is likely to decrease our
fourth quarter 2005 contract revenues compared to the same
period last year. Guidance for consolidated revenues for
fourth quarter 2005 is € 7.7 million.
Results
The net loss for the first nine months of 2005 was €
5.7 million, or € 0.75 per share, an increase of €
1.4 million from the € 4.3 million, or € 0.73
per share for the first nine months of 2004.
Total
research and development expenses in the first nine months
of 2005 were € 4.8 million, compared to € 3.9
million in the same period 2004. The additional investment
in R&D programs includes additional chemistry on our
product development, including stepped up outsourcing.
Selling,
general and administrative expenses increased slightly to
€ 3.2 million in the first nine months of 2005 when
compared to the € 3.0 million in the same period of
2004.
Cash flow and cash position
A net increase of € 14.8 million in cash and cash equivalents
was recorded during the first nine months of 2005 (€
25.1 million compared to € 10.3 million at the end
of 2004). Cash used in operations was € 5.1 million,
on track for this year's projected cash burn of € 7.0
million. Furthermore, total lease payments made and investments
in equipment amounted to € 0.8 million. Galapagos raised
€ 22.4 million in a public offering priced at €
7 per share, amounting to a net cash contribution of €
20.7 million.
Galapagos'
cash and cash equivalents amounted to € 25.1 million
on September 30, 2005.
Corporate highlights
•
Acquisition of BioFocus plc completed
• Listing on the AiM London
• Management further strengthened
• US patent protecting target discovery platform
• Boston sales office opened
In September
2005, Galapagos announced an all share offer for BioFocus
plc in the UK. The strategic rationale for the offer was
that BioFocus’ expertise in chemistry, lead discovery
and lead optimization will greatly accelerate the progress
of Galapagos’ programs and assist in Galapagos’
transition to a fully integrated drug development biopharmaceutical
company. Additionally, the Enlarged Group would be well
positioned to provide a suite of complementary biology and
chemistry services to a broad base of customers, offering
turnkey projects from target discovery to lead delivery.
Galapagos’
offer for BioFocus became wholly unconditional on October
17, 2005. Galapagos shares were admitted to trading on the
London Stock Exchange’s Alternative Investment Market
(AiM) on October 20, 2005. On October 27, 2005, Galapagos
announced that acceptances had been received for over 92%
of the BioFocus shares, and the offer for BioFocus was closed.
Following
the completion of the acquisition of BioFocus, a number
of appointments were made. Chris Newton, previous Chief
Operating Officer of BioFocus, and David Phillips, previous
Chief Business Officer of BioFocus, have joined the Executive
Committee of Galapagos as Senior VP BioFocus and Senior
VP Sales & Marketing, respectively. Also as a result
of the acquisition, Galapagos' Board of Directors will be
strengthened by Geoff McMillan, previous CEO of BioFocus
and David Stone, previous Chairman of BioFocus, as non-executive
Directors.
David
Smith was appointed as Chief Financial Officer of Galapagos
and will fulfill his role starting February 1, 2006. David
joins from AstraZeneca Netherlands, where he was Chief Financial
Officer.
Galapagos
announced that its IP position was strengthened further
by receiving its third U.S. patent for its target discovery
platform. This patent protects the Company’s adenoviral
gene knock-down (SilenceSelect®) and gene knock-in (FLeXSelect®)
collections, the core of multiple target discovery deals
with pharmaceutical and biotech companies as well as patient
organizations.
Additionally,
Galapagos has opened a sales office in Boston, US, as of
November 1, to support its sales and marketing activities.
This office is headed by Nathalie Joly, BioFocus’
Director Business Development, North America.
Operational highlights
Partnering
activities
•
Chemical library supply and medicinal chemistry services
deal with Serono (Switzerland) (signed in fourth quarter)
• Target discovery alliance with High Q Foundation
(US) for Huntington disease
• Research collaboration with Novartis Pharmaceuticals
(UK)
• Research collaboration with Amsterdam Molecular
Therapeutics, Netherlands Institute for Brain Research and
Vrije Universiteit Amsterdam
• BioFocus product offering broadened with two new
compound libraries and increased ion channel screening capabilities.
Galapagos
is optimistic regarding the opportunities to close further
partnering deals and library sales in the remaining period
of the year.
Integration
With
the acquisition of BioFocus, the integration with Galapagos’
partnering unit Galadeno is underway, and the integrated
services unit now operates under the BioFocus brand name.
BioFocus provides reagents and gene-to-preclinical drug
discovery services to a broad base of customers throughout
the global pharmaceutical and biotechnology industries.
Several deal synergies and cross selling opportunities to
our complementary client bases were identified and are being
pursued actively.
Galapagos drug discovery
•
First in vivo results in proprietary rheumatoid arthritis
program – proprietary target validated
• Drug discovery collaboration with ZoBio, Pyxis and
Leiden University, supported by Dutch government grant of
€ 1.2 million
• Alzheimer targets move into proof of principle studies
Galapagos
focuses on bone and joint diseases to build a pipeline of
new chemical entities to treat these diseases. The company’s
most advanced drug discovery program is in the area of rheumatoid
arthritis and focuses on proprietary targets whose modulation
significantly diminishes joint destruction and where the
medicine has a clear benefit over existing therapies. The
market for autoimmune diseases, including rheumatoid arthritis,
currently exceeds € 7 billion and is expected to grow
to € 14 billion in the next few years. Galapagos started
its drug discovery program 14 months ago. The in vivo proof
of concept study currently underway investigates how a compound
developed against one of Galapagos’ proprietary targets
reduces paw swelling in a well-established mouse arthritis
model. Our results today show a significant and important
reduction in disease causing cytokines such as TNFa, providing
the first in vivo validation of a Galapagos target for rheumatoid
arthritis.
The
collaboration with ZoBio, Pyxis Discovery and Leiden University,
which was announced in August 2005 has enabled Galapagos
to take advantage of cutting-edge drug discovery technology
in the progression of one of its proprietary targets in
arthritis. As part of the € 1.2 million government
grant for the collaboration, Galapagos receives € 550k
in support of this program.
As further
support to out-licensing efforts, we will combine the required
expertise of BioFocus in medicinal chemistry with our proprietary
Alzheimer targets, thereby creating additional value for
these targets.
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, and will be available
for replay a few minutes after the live version airs.
About
Galapagos
Galapagos is a publicly traded, genomics-based drug discovery
company (Euronext Brussels: GLPG; Euronext Amsterdam: GLPGA,
London AiM: GLPG) that has drug discovery programs based
on proprietary, novel targets in the bone and joint diseases
- osteoarthritis, osteoporosis and rheumatoid arthritis.
Galapagos offers a full suite of target-to-drug discovery
products and services to pharmaceutical and biotech companies
through its division BioFocus, encompassing target discovery
and validation, and drug discovery services through to delivery
of pre-clinical candidates. In addition, BioFocus provides
adenoviral reagents for rapid identification and validation
of novel drug targets and compound libraries for screening.
Galapagos currently employs 193 people, including 74 PhDs,
and occupies facilities in Mechelen, Belgium, Saffron Walden,
UK and Leiden, The Netherlands. The partners of Galapagos
include Amgen, AstraZeneca, Bayer, Boehringer Ingelheim,
Celgene, GlaxoSmithKline, Novartis, Organon, Serono, Vertex,
and Wyeth. More information about Galapagos and BioFocus
can be found at www.glpg.com.
Contact
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir@galapagos.be