Myriad Acquires Sividon Diagnostics
May 31 2016 - 4:05PM
Strengthens Market Leading Oncology Product
Portfolio with Breast Cancer Prognostic Test EndoPredict®
SALT LAKE CITY, May 31, 2016 (GLOBE NEWSWIRE)
-- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that it has
acquired Sividon Diagnostics, a leading breast cancer prognostic
company, for €35 million upfront with the potential for €15 million
in additional performance-based milestones. The transaction closed
on May 31, 2016. Myriad expects the deal to be neutral to both
revenue and earnings in fiscal year 2017. A discussion on the
details and strategy underlying the transaction will be provided on
a conference call today at 4:30 pm EDT.
"Sividon brings to Myriad the best-in-class breast
cancer prognostic test and strengthens our market leading oncology
portfolio of high value personalized medicine products," said Mark
C. Capone, president and CEO, Myriad Genetic Laboratories. "The
EndoPredict® test
will be the foundational product of our newly initiated kit-based
strategy and allow Myriad to leverage its global oncology
distribution to bring this important test to patients
worldwide."
"We are excited to be integrated with the global
leader and pioneer in personalized medicine," said Christoph Petry,
CEO of Sividon Diagnostics. "Myriad has the reimbursement,
regulatory, and commercial expertise to make this product very
successful, especially as we seek distribution in the United States
and broader reimbursement coverage in Europe."
Sividon Diagnostics was spun out of Siemens
Healthcare Diagnostics in 2010 as part of a management buyout.
Their core EndoPredict product is a kit-based RNA expression test
that evaluates 12 genes to assess the aggressiveness of breast
cancer on a molecular level. The test is currently CE Marked on the
Siemens Versant instrument, however, Myriad is transitioning the
product to the Thermo Fisher QuantStudio platform as a key step in
the international kit strategy. EndoPredict has been evaluated in 5
major studies incorporating more than 4,000 patients, utilized on a
clinical basis in over 13,000 patients worldwide, and is
extensively referenced in clinical guidelines across the globe. In
a head-to-head study, it has been shown to outperform the
prognostic ability of the leading first generation test while
providing definitive answers with no intermediate
results.
Benefits of the Transaction
-
Synergistic Product
Within the 4in6 Strategy: EndoPredict evaluates the
aggressiveness of breast cancer to help patients decide whether to
safely forgo chemotherapy and will be added into our existing
oncology commercial channel, creating significant opportunities for
operating leverage.
-
Substantial Market
Opportunity: Myriad believes the global market opportunity
for EndoPredict is greater than $600 million with the majority of
that market existing in major European countries, Canada, and the
United States. We estimate that this market is less than 25 percent
penetrated on a global basis and EndoPredict should benefit from a
significant expansion in reimbursement in the coming years.
-
Best-in-Class
Product: EndoPredict has been studied in approximately
4,000 patients and utilized in over 13,000 patients, and has
consistently demonstrated the best ability to predict which
patients are at low risk for distant metastases in both node
negative and node positive patients. Additionally, the kit-based
format provides unique advantages in the marketplace and
EndoPredict will be the foundational product in Myriad's global
kit-based strategy.
-
Broadens Comprehensive
Product Offering in Oncology: Myriad currently sells
market leading tests in oncology for hereditary cancer and
companion diagnostics. EndoPredict answers another important
clinical question for breast cancer patients by identifying which
can safely forgo chemotherapy. Oncology customers can
increasingly rely on Myriad as a single source trusted advisor
answering questions across the entire continuum of care with
unmatched quality.
Financing
Myriad intends to fund the transaction entirely through cash on
hand. At the end of the fiscal third quarter Myriad had cash and
cash equivalents of $286 million on hand.
Conference Call and
Webcast
A conference call will be held today, Tuesday, May 31, 2016, at
4:30 p.m. EDT to discuss Myriad's acquisition of Sividon
Diagnostics. The dial-in number for domestic callers is
1-888-224-7964. International callers may dial
1-303-223-4373. All callers will be asked to reference
reservation number 21812274. An archived replay of the call
will be available for seven days by dialing 1-800-633-8284 and
entering the reservation number above. The conference call
along with a slide presentation will also will be available through
a live webcast at www.myriad.com.
About Myriad
Genetics
Myriad Genetics Inc., is a leading personalized medicine company
dedicated to being a trusted advisor transforming patient lives
worldwide with pioneering molecular diagnostics. Myriad
discovers and commercializes molecular diagnostic tests that:
determine the risk of developing disease, accurately diagnose
disease, assess the risk of disease progression, and guide
treatment decisions across six major medical specialties where
molecular diagnostics can significantly improve patient care and
lower healthcare costs. Myriad is focused on three strategic
imperatives: transitioning and expanding its hereditary
cancer testing markets, diversifying its product portfolio through
the introduction of new products and increasing the revenue
contribution from international markets. For more information
on how Myriad is making a difference, please visit the Company's
website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad
myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis
CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra and Prolaris are
trademarks or registered trademarks of Myriad Genetics, Inc. or its
wholly owned subsidiaries in the United States and foreign
countries. MYGN-F, MYGN-G
Safe Harbor
Statement
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to the acquisition of Sividon
Diagnostics for €35 million upfront with the potential for €15
million in additional performance-based milestones; the
Company's expectation that the deal to be neutral to both revenue
and earnings in fiscal year 2017; the EndoPredict test being the
foundational product of the Company's newly initiated kit-based
strategy and allowing the Company to leverage its global oncology
distribution to bring this important test to patients worldwide;
the transitioning of the EndoPredict test to the Thermo Fisher
QuantStudio platform as a key step in the international kit
strategy; the EndoPredict test's outperformance in its prognostic
ability in a head-to-head study; the Company's estimate that the
EndoPredict test market is less than 25 percent penetrated on a
global basis and the EndoPredict test should benefit from a
significant expansion in reimbursement in the coming years; the
EndoPredict test being the foundational product in Myriad's global
kit-based strategy; and the Company's strategic directives under
the caption "About Myriad Genetics." These "forward-looking
statements" are based on management's current expectations of
future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those described or implied in the
forward-looking statements. These risks include, but are not
limited to: the risk that sales and profit margins of our existing
molecular diagnostic tests and pharmaceutical and clinical services
may decline or will not continue to increase at historical rates;
risks related to our ability to transition from our existing
product portfolio to our new tests; risks related to changes in the
governmental or private insurers' reimbursement levels for our
tests or our ability to obtain reimbursement for our new tests at
comparable levels to our existing tests; risks related to increased
competition and the development of new competing tests and
services; the risk that we may be unable to develop or achieve
commercial success for additional molecular diagnostic tests and
pharmaceutical and clinical services in a timely manner, or at all;
the risk that we may not successfully develop new markets for our
molecular diagnostic tests and pharmaceutical and clinical
services, including our ability to successfully generate revenue
outside the United States; the risk that licenses to the technology
underlying our molecular diagnostic tests and pharmaceutical and
clinical services tests and any future tests are terminated or
cannot be maintained on satisfactory terms; risks related to delays
or other problems with operating our laboratory testing facilities;
risks related to public concern over our genetic testing in general
or our tests in particular; risks related to regulatory
requirements or enforcement in the United States and foreign
countries and changes in the structure of the healthcare system or
healthcare payment systems; risks related to our ability to obtain
new corporate collaborations or licenses and acquire new
technologies or businesses on satisfactory terms, if at all; risks
related to our ability to successfully integrate and derive
benefits from any technologies or businesses that we license or
acquire, including but not limited to our acquisition of a
healthcare clinic in Germany; risks related to our projections
about the potential market opportunity for our products; the risk
that we or our licensors may be unable to protect or that third
parties will infringe the proprietary technologies underlying our
tests; the risk of patent-infringement claims or challenges to the
validity of our patents; risks related to changes in intellectual
property laws covering our molecular diagnostic tests and
pharmaceutical and clinical services and patents or enforcement in
the United States and foreign countries, such as the Supreme Court
decision in the lawsuit brought against us by the Association for
Molecular Pathology et al; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; and other factors discussed under the heading
"Risk Factors" contained in Item 1A of our Annual report on Form
10-K for the fiscal year ended June 30, 2016, which has been filed
with the Securities and Exchange Commission, as well as any updates
to those risk factors filed from time to time in our Quarterly
Reports on Form 10-Q or Current Reports on Form 8-K.
Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Myriad Genetics, Inc. via Globenewswire
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