CoreBiome leverages OraSure’s leadership position in microbiome
sample collection with end-to-end laboratory services for sample
processing, sequencing, and bioinformatics
OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point
of care diagnostic tests and specimen collection and stabilization
devices, today announced that it has entered into definitive
agreements to acquire two companies. The transactions are expected
to close within the next week. OraSure also reaffirmed its
fourth quarter 2018 financial guidance.
“These acquisitions clearly demonstrate our
commitment to our innovation-driven growth strategy,” said Dr.
Stephen S. Tang, Ph.D., President and CEO of OraSure Technologies.
“The acquisitions of Novosanis and CoreBiome, both innovators in
their respective markets, add differentiated products and services
that we expect will enhance our Molecular business, our longer-term
corporate growth profile, and returns for our stockholders. Both
transactions will leverage the sales and marketing resources of our
wholly-owned subsidiary DNA Genotek to cultivate commercial
customers, key opinion leaders and academic collaborators.”
CoreBiome CoreBiome is a
privately-held, Minnesota-based early-stage microbiome services
provider that accelerates discovery for customers in the
pharmaceutical, agricultural, and research communities. CoreBiome’s
technology provides information-rich characterization of microbial
diversity and function, paired with machine learning and expert
analytics. CoreBiome’s proprietary genomics pipeline and optimal
algorithms deliver speed and scalability in the lab as well as
highly precise analytics. CoreBiome was co-founded in 2016 by Dr.
Dan Knights, a globally recognized expert in microbiome
informatics who has developed leading methods for analyzing
microbiome data, along with Dr. Daryl Gohl and Dr. Kenny Beckman,
domain experts in genomics methods and clinical lab operations.
“The global microbiome market is expected to
grow by double digits, from approximately $325 million in 2017 to
$725 million or more in 2022,” said Dr. Tang. “Expanding our
services through the CoreBiome acquisition will allow OraSure to
optimally address future microbiome research needs, capture new
segments and expand our leadership position in this dynamic
market.”
“The microbiome is transforming how people do
research in human health and agriculture. Companies are
increasingly looking to understand how the complex behavior of the
microbiome affects their product development, and this requires big
data,” said Dr. Knights, CEO of CoreBiome. “CoreBiome’s highly
scalable and reproducible BoosterShot™ platform allows researchers
to efficiently run high-resolution DNA sequencing on thousands of
microbiome samples. This means investigators can now measure
important changes often missed in under-powered studies.
CoreBiome’s bioinformatics platform uses machine learning and
advanced data visualization to help customers leverage that big
data and to make world-class microbiome expertise available
on-demand.”
The CoreBiome acquisition positions OraSure to
become a leading, end-to-end solution provider for researchers,
therapeutic and diagnostic development customers, and
Direct-to-Consumer companies,” said Dr. Tang. “We look forward to
accelerating the adoption of CoreBiome’s cutting-edge microbial
genomics technology and analytics expertise into DNA Genotek’s
customer network. We’re excited about the synergies that will come
from combining DNA Genotek’s proprietary sampling and stabilization
technology with CoreBiome’s platform across the many industries
that will be impacted by the microbiome.”
Novosanis Novosanis is a
privately-held, Belgian company founded as a spinoff company from
the University of Antwerp, Belgium, in 2013. Novosanis is an early
commercial-stage producer and distributor of urine sample
collection devices targeted primarily at the liquid biopsy,
Sexually Transmitted Infection (STI) screening, and urological
cancer markets.
Novosanis’ primary product technology is
Colli-Pee, an easy-to-use device designed for the standardized
collection of first-void urine in the privacy of the user’s home or
at a clinic. The initial commercial application is as a collection
device for liquid biopsy tests in the prostate and bladder cancer
markets. Additionally, product validation and clinical trials are
underway with industry-leading STI test manufacturers.
Colli-Pee is the only product specifically designed to collect a
first-void sample and offers significant advantages to urinary
testing companies, including superior test performance, ease-of-use
for both collection and in the lab, and flexible customization
options based on specific need.
“The Novosanis acquisition represents a clear
fit in our stated ‘core growth strategy’ for our Molecular business
– to grow our portfolio of collection products beyond oral samples
by leveraging expertise in collection and stabilization tools and
technologies – all of which can be used at home or in the clinic,”
said Dr. Tang. “The Colli-Pee urine collection device has utility
in high-growth markets, including liquid biopsy and STI diagnostics
where OraSure can leverage its existing intellectual property,
brand, and market expertise to deliver even more value to existing,
and new, Molecular customers.”
Dr. Tang continued: “We believe there is a
significant opportunity for an easy-to-use, differentiated product
that combines our existing stabilization technology with Novosanis’
first-void sample and volumetric capabilities. The Colli-Pee
product is the perfect answer for this unmet market need. DNA
Genotek built its business on establishing DNA from saliva as a
proven and trusted sample type for molecular analysis. We believe a
key enabler for similar development of the urine market will be an
improved collection experience with Colli-Pee, combined with
ambient temperature stabilization of the sample.”
Dr. Vanessa Vankerckhoven, co-founder and CEO of
Novosanis, added, “The Novosanis team is excited to become part of
the OraSure family. The Colli-Pee device is complementary to
OraSure’s existing portfolio of non-invasive sample collection
devices. The acquisition will allow us to ensure further growth and
expansion of our Colli-Pee device globally.”
“With our growing customer base, we’ve been
rapidly expanding our manufacturing capacity in recent months,”
Koen Beyers, Novosanis co-founder and Chief Technology Officer
explained. “I’m looking forward to building scale and diversity of
our innovation with OraSure and DNA Genotek.”
CoreBiome and Novosanis Acquisitions –
Financial Considerations
The transactions are structured with an upfront
payment and potential additional payments based on future
performance. The Company expects that the acquisitions will
together contribute from $4 million to $7 million in net revenues
in 2019, with $0.03 to $0.05 per share of dilution to non-GAAP
earnings excluding transaction costs and required acquisition
accounting adjustments.
Fourth Quarter 2018
Guidance
The Company continues to expect net revenue to
range from $46.5 million to $48.0 million – representing full year
revenue growth of 7% over 2017 – and net income of $0.09 to $0.11
per share for the three months ended December 31, 2018.
Investor Conference Call
The Company will host a conference call to
discuss the foregoing transactions on Friday, January 4, 2019 at
8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). On the call will
be Stephen S. Tang, Ph.D., President and Chief Executive Officer,
and Roberto Cuca, Chief Financial Officer. The call will include
prepared remarks by management and a question and answer
session.
In order to listen to the conference call, dial
(844) 831-3030 (domestic) or (315) 625-6887 (international) and
reference Conference ID# 3783126.
About OraSure
Technologies
OraSure Technologies is a leader in the
development, manufacture and distribution of point-of-care
diagnostic and collection devices and other technologies designed
to detect or diagnose critical medical conditions. Its
first-to-market, innovative products include rapid tests for the
detection of antibodies to HIV and HCV on the OraQuick® platform,
oral fluid sample collection, stabilization and preparation
products for molecular diagnostic applications, and oral fluid
laboratory tests for detecting various drugs of abuse. OraSure’s
portfolio of products is sold globally to various clinical
laboratories, hospitals, clinics, community-based organizations and
other public health organizations, research and academic
institutions, distributors, government agencies, physicians’
offices, commercial and industrial entities and consumers. The
Company’s products enable healthcare providers to deliver critical
information to patients, empowering them to make decisions to
improve and protect their health.
Important Information
This press release contains certain
forward-looking statements, including with respect to the
acquisitions of CoreBiome and Novosanis, and the expected benefits
thereof, and with respect to expected revenues and earnings/loss
per share. Forward-looking statements are not guarantees of future
performance or results. Known and unknown factors that could cause
actual performance or results to be materially different from those
expressed or implied in these statements include, but are not
limited to: ability to successfully manage and integrate the
acquisitions in a manner that complements or leverages our existing
business, or otherwise expands or enhances our portfolio of
products and our end-to-end service offerings, and the diversion of
management's attention from our ongoing business and regular
business responsibilities to effect such integration; failure to
realize the expected economic benefits of the acquisitions (and
increased returns for our stockholders), including that the
anticipated synergies, revenue enhancement strategies and other
benefits from the acquisitions may not be fully realized or may
take longer to realize than expected or that our actual integration
costs may exceed our estimates; ability to market and sell
products, whether through our internal, direct sales force or third
parties; ability to manufacture products in accordance with
applicable specifications, performance standards and quality
requirements; ability to obtain, and timing and cost of obtaining,
necessary regulatory approvals for new products or new indications
or applications for existing products; ability to comply with
applicable regulatory requirements; ability to effectively resolve
warning letters, audit observations and other findings or comments
from the U.S. Food and Drug Administration (“FDA”) or
other regulators; changes in relationships, including disputes or
disagreements, with strategic partners or other parties and
reliance on strategic partners for the performance of critical
activities under collaborative arrangements; ability to meet
increased demand for the Company’s products; impact of significant
customer concentration in the genomics business; impact of
increased reliance on U.S. government contracts; failure of
distributors or other customers to meet purchase forecasts,
historic purchase levels or minimum purchase requirements for our
products; impact of replacing distributors; inventory levels at
distributors and other customers; ability of the Company to achieve
its financial and strategic objectives and continue to increase its
revenues, including the ability to expand international sales;
ability to identify, complete, integrate and realize the full
benefits of future acquisitions; impact of competitors, competing
products and technology changes; impact of negative economic
conditions; reduction or deferral of public or other funding
available to customers; competition from new or better technology
or lower cost products; ability to develop, commercialize and
market new products; market acceptance of oral fluid or urine
testing, collection or other products; market acceptance and uptake
of microbiome informatics, microbial genetics technology and
related analytics services; changes in market acceptance of
products based on product performance or other factors, including
changes in testing guidelines, algorithms or other recommendations
by the Centers for Disease Control and Prevention (“CDC”) or
other agencies; ability to fund research and development and other
products and operations; ability to obtain and maintain new or
existing product distribution channels; reliance on sole supply
sources for critical products and components; availability of
related products produced by third parties or products required for
use of our products; ability to maintain sustained profitability;
ability to utilize net operating loss carry forwards or other
deferred tax assets; volatility of the Company’s stock price;
uncertainty relating to patent protection and potential patent
infringement claims; uncertainty and costs of litigation relating
to patents and other intellectual property; availability of
licenses to patents or other technology; ability to enter into
international manufacturing agreements; obstacles to international
marketing and manufacturing of products; ability to sell products
internationally, including the impact of changes in international
funding sources and testing algorithms; adverse movements in
foreign currency exchange rates; loss or impairment of sources of
capital; ability to meet financial covenants in credit agreements;
ability to attract and retain qualified personnel; exposure to
product liability and other types of litigation; changes in
international, federal or state laws and regulations; customer
consolidations and inventory practices; equipment failures and
ability to obtain needed raw materials and components; the impact
of terrorist attacks and civil unrest; and general political,
business and economic conditions. These and other factors that
could affect our results are discussed more fully in the
Company’s Securities and Exchange Commission (“SEC”)
filings, including our registration statements, Annual Report on
Form 10-K for the year ended December 31, 2017, Quarterly
Reports on Form 10-Q, and other filings with the SEC. Although
forward-looking statements help to provide information about future
prospects, readers should keep in mind that forward-looking
statements may not be reliable. The forward-looking statements are
made as of the date of this press release and OraSure
Technologies undertakes no duty to update these
statements.
Company contact:
Roberto
Cuca |
Jeanne
Mell |
Chief
Financial Officer |
VP
Corporate Communications |
610-882-1820 |
484-353-1575 |
Investorinfo@orasure.com |
media@orasure.com |
www.orasure.com |
www.orasure.com |
OraSure Technologies (NASDAQ:OSUR)
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