Myriad Acquires Sividon Diagnostics
May 31 2016 - 4:05PM
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 WebcastA 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 GeneticsMyriad 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 StatementThis 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
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