QIAGEN Acquires DxS Ltd - Creating Leadership i...
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In addition, QIAGEN unveils for the first time its companion
diagnostic pipeline, which the Company believes is unmatched in terms
of depth and profile
VENLO, The Netherlands, September 22, 2009 - QIAGEN N.V. (NASDAQ:
QGEN; Frankfurt, Prime Standard: QIA) today announced that it has
acquired DxS Ltd (DxS), a privately-held developer and manufacturer
of companion diagnostic products headquartered in Manchester, United
Kingdom. The transaction is valued at approximately US$ 95 million in
cash (subject to customary purchase price adjustments), plus up to an
additional US$ 35 million if specified commercial and other
milestones are met.
With this acquisition, QIAGEN has taken a strong leadership position
in the new era of personalized healthcare (PHC). The Company believes
it offers all the required elements to help drive and shape this
rapidly emerging trend in healthcare.
In addition, QIAGEN unveiled for the first time that the combined
company is currently active in over 15 collaborations with
pharmaceutical companies to market and / or develop companion
diagnostic products. The programs span genetic, expression,
epigenetic and other markers. QIAGEN believes that this pipeline is
the deepest such portfolio in the pivotal field of molecular
diagnostics for personalized healthcare.
Acquisition of DxS
The acquisition of DxS brings to QIAGEN a portfolio of molecular
diagnostic assays and intellectual property, as well as a deep
pipeline of active or planned companion diagnostic partnerships in
oncology with many of the leading pharmaceutical companies, including
seven of the largest drug makers in this field. These assets
complement QIAGEN's existing strong portfolio of personalized
healthcare diagnostic solutions and are very synergistic with
QIAGEN's sample and assay technologies.
DxS has developed a set of molecular diagnostic assays which allow
physicians in oncology to predict patients' responses to certain
treatments in order to make cancer therapies more effective and
safer. The currently marketed portfolio spans seven real-time PCR
tests including a test for the mutation status of the oncogene K-RAS,
which is indicative for successful treatment of patients suffering
from metastatic colorectal cancer (mCRC) with EGFR inhibitors. In
addition, three assays are in the near-term pipeline and further
assays are in the medium-term pipeline. DxS' portfolio of assays,
both marketed and in its pipeline, is strongly suitable for use with
QIAGEN's existing suite of platform instruments, including
QIAsymphony and Rotor-Gene Q.
DxS is one of the pioneers which have brought molecular companion
diagnostics to market. The TheraScreen: K-RAS Mutation Kit® developed
by DxS has already been CE-marked. In the United States, the test is
expected to be submitted to the FDA for regulatory approval (PMA) in
2010. It is estimated that in the future the market for overall K-RAS
testing could reach up to US$ 100 million. DxS' current portfolio and
near-term pipeline includes ten unique and proprietary assays. The
company has accumulated a significant intellectual property portfolio
for its current and planned diagnostic content.
"The acquisition of DxS is strategically a highly important
transaction for QIAGEN. It combines two leadership positions to
create a very powerful leader in a transformational area of
healthcare: personalized healthcare. This transaction is a key
element of our strategy to lead in molecular diagnostic-based
prevention, profiling and personalized healthcare. These three
elements are expected to significantly shape and contribute to future
improvements in healthcare and have the potential to provide
significant benefits to patients as well as exceptional value for
payers, providers, and the pharmaceutical industry", said Peer M.
Schatz, CEO of QIAGEN.
"QIAGEN is the ideal partner for DxS to globally roll out our assays,
to take our partnerships to the next level and to take a leadership
position in companion diagnostics", said Stephen Little, founder and
CEO of DxS. "Unlike any other company, we believe that QIAGEN
addresses the broadest range of companion diagnostic options for
pharmaceutical and large biotech companies - starting from an
independent sales reach over broad technology, R&D and manufacturing
capabilities up to expertise in regulatory affairs and access
creation to physicians and laboratories."
"This combination has the potential to create a classical win-win
situation for everyone involved", said Peer Schatz. "We believe that
QIAGEN can use its enhanced strategic position to leverage the
opportunities in personalized healthcare: pharma customers can
benefit from a stronger, independent and focused partner to better
serve their special development needs, employees can benefit from
enhanced career opportunities, physicians can benefit from faster
access to better tools for diagnosis and treatment, and healthcare
systems can benefit from the potential for increases in effective and
efficient treatments. But most importantly, patients who suffer from
serious diseases, such as cancer, stand to benefit significantly from
these new trends in personalized healthcare, which can lead to the
avoidance of unnecessary or even harmful treatments and therefore to
an increase in the quality of their lives."
DxS' senior management will join QIAGEN in leading roles in the
Company's rapidly expanding personalized healthcare focus area,
facilitating rapid integration and focus on the further expansion of
this key segment. For that purpose, QIAGEN intends to establish DxS'
headquarters in Manchester as a Center of Excellence in Pharma
Partnering. Given the high level of synergies, QIAGEN expects to grow
the Manchester location.
Transaction Highlights
* QIAGEN believes it has taken a leadership position in molecular
diagnostics for personalized healthcare, positioned to help drive
and shape this rapidly emerging trend.
* QIAGEN unveils for the first time the depth of its partnered
companion diagnostics pipeline and is now active in over 15
partnerships. This is believed to be one of the deepest such
pipelines in the industry.
* QIAGEN expands leadership in personalized healthcare, a key
pillar in the Company's strategy to focus on molecular
diagnostic-based prevention, profiling, and personalized
healthcare.
* QIAGEN creates a leading portfolio in companion diagnostics:
* DxS adds seven PCR assays targeting biomarkers including
K-RAS and EGFR29, which may be useful in identifying
patients' response to certain cancer treatments (e.g. colon,
lung cancer).
* QIAGEN's existing portfolio already included
pyrosequencing-based K-RAS, BRAF and methylation assays
targeting biomarkers, as well as large numbers of gene
expression and miRNA assays for discovery of future
biomarkers and instrument platforms to automate these tests.
* Accretion to adjusted EPS beyond the year 2010.
* Very synergistic; minimal overlap and seamless integration
expected. DxS' senior management will continue to assume leading
positions in expanding QIAGEN's partnerships with pharma and
biotech in companion diagnostics.
Financial Details
Under the terms of the agreement, QIAGEN acquired the entire
outstanding share capital in DxS. QIAGEN expects to incur one-time
charges of approximately US$ 0.02 in EPS in the third quarter 2009 in
connection with this acquisition. These charges primarily relate to
consulting and advisory fees incurred in connection with the
acquisition and the write-off of certain assets. In addition, based
on preliminary analyses and following the streamlining of the
portfolio, QIAGEN expects this transaction to contribute
approximately US$ 6 million in sales in the remainder of 2009 and
approximately US$ 30 million in sales in 2010. On an adjusted basis
excluding one-time charges, integration and restructuring costs, and
amortization of acquisition related intangible assets, the
acquisition is expected to be neutral to EPS in the remainder of 2009
and to be dilutive by US$ 0.02 in 2010. Beyond 2010, it is expected
that the acquisition will be accretive to adjusted EPS. Jefferies
acted as exclusive financial advisors in this transaction.
About QIAGEN in Molecular Diagnostics
With a run-rate over US$ 450 million in sales and rapid growth in
this segment, QIAGEN believes it is a leader in molecular
diagnostics, excluding viral load testing and blood screening.
QIAGEN has defined three segments in laboratory-based molecular
diagnostics it is focusing on:
1) Prevention: This segment covers markers tested for in asymptomatic
patients for the purpose of early disease or risk detection and in
regular intervals. These assays are typically performed by
laboratories in high volumes. QIAGEN's portfolio in HPV testing and,
in addition, the panel of assays in development (including tests for
chlamydia and gonorrhea) address the most attractive and fastest
growing segments in Prevention. These assays can be performed on
current systems and on QIAGEN's QIAensemble platform. This platform
is expected to be launched in late 2010 in Europe and in mid 2012 in
the United States and is expected to set a new standard in molecular
diagnostic screening in terms of throughput and utility.
2) Profiling: This segment covers tests performed on symptomatic
patients to create or confirm a diagnosis. The assays are mostly
performed at lower throughputs, but are often of higher value per
test. QIAGEN's portfolio of molecular diagnostic assays (>80) for
pathogens is considered one of the broadest in the world and is used
to detect and profile pathogens. This segment also includes a number
of genetic and other assays.
3) Personalized Healthcare: QIAGEN believes that this is the most
transformative area of molecular diagnostics. These assays are used
to guide therapy for pre-diagnosed symptomatic patients. They are
typically higher value, lower volume assays. QIAGEN today sells
approximately 20 assays in personalized healthcare.
In Personalized Healthcare and Profiling throughput requirements are
lower than in the segment of Prevention, but the bandwidth
requirements (sample types, etc.) are much higher. The random access,
continuous load QIAsymphony platform (sample to result, of which the
first modules have been very successfully launched) was designed for
these segments.
About QIAGEN in Personalized Healthcare
QIAGEN believes it brings a special value proposition to
pharmaceutical companies for companion diagnostics development
projects. The Company is considered a key partner as it is:
* The largest molecular diagnostics company based on revenues,
technology and portfolio breadths, outside blood screening/viral
load testing.
* A significant supplier to pharmaceutical discovery and
development already today.
* Owner of a broad technology portfolio in molecular sample & assay
technologies.
* Independent: not owned by a pharmaceutical company.
* A company with strong regulatory presence, sales channel strength
and global reach.
About Companion Diagnostics and Personalized Healthcare
Companion diagnostics are expected to become a key contributor to the
transformational trend towards personalized healthcare (PHC). In
addition to the increasing awareness of the significant benefits of
PHC to key players in healthcare (payers, physicians, regulators,
patients), new possibilities in molecular diagnostics and in
particular very recent regulatory and payer decisions, most notably
around products where DxS' portfolio plays a key role, have
accelerated the trend towards a more integrated use of diagnostic
information to guide therapy.
While most current companion diagnostics are "retrofitted"
diagnostics, i.e. diagnostics that were retroactively added to
approved drugs to improve outcomes, the new generation of companion
diagnostics is being developed together with drugs to predict
responses of patient populations to the drug treatment and increase
its efficacy and safety. By testing for specific genetic variations
related to certain biomarkers, health professionals can customize
their therapies and avoid unnecessary or harmful treatments. The
concept of personalized healthcare plays an increasingly important
role in treatment decisions in clinical areas such as cardiovascular
and neurological diseases and - most prominently - in cancer. There
are 28 companion diagnostic tests for valid genomic biomarkers
identified by the FDA in the context of FDA-approved drug labels.
According to industry reports, the market for personalized healthcare
grew annually at 24% over the last decade, amounting to US$ 13
billion in 2008.
About QIAGEN:
QIAGEN N.V., a Netherlands holding company, is the
leading global provider of sample and assay technologies. Sample
technologies are used to isolate and process DNA, RNA and proteins
from biological samples such as blood or tissue. Assay technologies
are used to make such isolated biomolecules visible. QIAGEN has
developed and markets more than 500 sample and assay products as well
as automated solutions for such consumables. The company provides its
products to molecular diagnostics laboratories, academic researchers,
pharmaceutical and biotechnology companies, and applied
testing customers for purposes such as forensics, animal or food
testing and pharmaceutical process control. QIAGEN's assay
technologies include one of the broadest panels of molecular
diagnostic tests available worldwide. This panel includes the digene
HPV Test, which is regarded as a "gold standard" in testing for
high-risk types of human papillomavirus (HPV), the primary cause of
cervical cancer, as well as a broad suite of solutions for infectious
disease testing and companion diagnostics. QIAGEN employs more than
3,200 people in over 30 locations worldwide. Further information
about QIAGEN can be found at
http://www.qiagen.com/.
About DxS:
DxS is a personalized healthcare company providing molecular
diagnostics to aid doctors and drug companies in selecting safe and
effective therapies for patients based on their molecular profiles
(Companion diagnostics). Headquartered in Manchester, UK, the company
employs approximately 80 employees in two countries, most of them in
the UK. More information about DxS can be found at
www.DxSdiagnostics.com.
SAFE HARBOR STATEMENT
Statements contained in this release that are not historical facts
are forward-looking statements, including statements about our
products, markets, strategy and operating results. Such statements
are based on current expectations that involve risks and
uncertainties including, but not limited to, those associated with:
management of growth and international operations (including currency
fluctuations and logistics), variability of our operating results,
commercial development of our markets (including applied testing,
clinical and academic research, proteomics, women's health/HPV
testing, molecular diagnostics, personalized healthcare and companion
diagnostics), our relationships with customers, suppliers and
strategic partners, competition, changes in technology, fluctuations
in demand, regulatory requirements, identifying, developing and
producing integrated products differentiated from our competitors'
products, market acceptance of our products, and integration of
acquired technologies and businesses. For further information, refer
to our filings with the SEC, including our latest Form 20-F.
Information in this release is as of the date of the release, and we
undertake no duty to update this information unless required by law.
# # #
Contacts:
Dr. Solveigh Mähler Dr. Thomas Theuringer
Director Investor Relations Associate Director Public
QIAGEN N.V. Relations
+49 2103 29 11710 QIAGEN GmbH
e-mail: +49 2103 29 11826
solveigh.maehler@qiagen.com email:
thomas.theuringer@qiagen.com
Albert F. Fleury
Director Corporate Finance and Investor
Relations North America
QIAGEN N.V.
+1 301 944 7028
e-mail: albert.fleury@qiagen.com
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Qiagen N.V.
Spoorstraat 50 KJ Venlo Netherlands
WKN: 901626; ISIN:
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