Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health,
announced today that it has signed a definitive agreement to acquire
Focal Therapeutics, a privately-held company, for $125 million in cash.
In conjunction with Hologic’s recent acquisition of Faxitron Bioptics,
Focal strengthens the Company’s position in the rapidly growing market
for breast conserving surgery.
The transaction adds Focal’s innovative BioZorb marker to the Company’s
Breast Health product portfolio. BioZorb is an implantable
three-dimensional marker that helps clinicians overcome challenges in
breast conserving surgery, or lumpectomy. The marker, placed by the
surgeon, is used to mark the tumor excision site for monitoring and
future treatments, and its unique open design allows for tissue
in-growth during the healing process.
“Focal Therapeutics has commercialized an innovative marker that
improves the standard of care for breast cancer patients by creating a
permanent, three-dimensional indicator of the surgical site,” said Pete
Valenti, Hologic’s Division President, Breast and Skeletal Health
Solutions. “Coupled with our recent acquisition of Faxitron, BioZorb
further expands our ability to help women diagnosed with breast cancer
from screening through surgery.”
“Acquiring Focal Therapeutics strengthens our position in an attractive,
adjacent breast health market, and is consistent with our capital
deployment goals,” said Steve MacMillan, Hologic’s Chairman, President
and Chief Executive Officer. “The transaction is accretive to our
revenue growth rate and gross margin, broadens our recurring revenue
base, and provides attractive return on invested capital.”
Focal generated approximately $16 million of revenue in the last 12
months. The acquisition, which is expected to close in early October, is
estimated to be neutral to Hologic’s non-GAAP earnings per share in
fiscal 2019, and accretive thereafter.
“We are very excited to become part of Hologic,” said Dr. Gail Lebovic,
Focal’s co-founder and Chief Medical Officer. “Hologic’s long-standing
commitment to early cancer detection is key for success in breast
conserving surgery. Hologic is the perfect fit for our company.”
About Hologic, Inc.
Hologic, Inc. is an innovative medical technology company primarily
focused on improving women's health and well-being through early
detection and treatment. For more information on Hologic, visit www.hologic.com.
Hologic is a trademark and/or registered trademark of Hologic, Inc.
and/or its subsidiaries in the United States and/or other countries.
About Focal Therapeutics
Focal Therapeutics, Inc. is a medical device company based in Sunnyvale,
Calif. The company’s BioZorb marker is a proprietary, bio-absorbable
device that provides radiographic marking of soft tissue sites. The
BioZorb device is placed at the time of surgical removal of tissue, such
as during breast surgery, and the device’s three-dimensional array of
marker clips has unique clinical utility for patient imaging. BioZorb
has received 510(k) clearance from the U.S. Food and Drug
Administration. The device is available in a range of sizes to
accommodate a variety of clinical situations.
Non-GAAP Financial Measures
This press release discusses non-GAAP diluted EPS, which is a non-GAAP
financial measure. The Company's definition of non-GAAP diluted EPS may
differ from similarly titled measures used by others. The Company
defines its non-GAAP EPS presented in this press release to primarily
exclude the amortization of intangible assets, acquisition- and
integration-related charges, and income taxes related to such adjustment.
Non-GAAP diluted EPS adjusts for specified items that may be non-cash,
or can be highly variable or difficult to predict. In the context of
forward-looking statements, the non-GAAP financial measures facilitate
period-to-period comparisons by excluding the effects of events that
have occurred in the past or may occur in the future and have accounting
consequences that can mask underlying operational trends, such as
acquisitions, restructurings, debt extinguishment and impairments.
This non-GAAP financial measure should be considered supplemental to,
and not a substitute for, financial information prepared in accordance
with GAAP. Because non-GAAP financial measures exclude the effect of
items that will increase or decrease the Company's reported results of
operations, management encourages investors to review the Company's
consolidated financial statements and publicly filed reports in their
entirety.
Future GAAP EPS may be affected by changes in ongoing assumptions and
judgments, and may also be affected by non-recurring, unusual or
unanticipated charges, expenses or gains, which are excluded in the
calculation of the Company's non-GAAP EPS as described in this press
release.
When Hologic provides its expectations for non-GAAP EPS on a
forward-looking basis, a reconciliation of the differences between these
non-GAAP expectations and the corresponding GAAP measures are not
available without unreasonable effort because Hologic has not estimated
the fair value of the assets and liabilities expected to be acquired in
the transaction. Nor has the Company determined the fair value of
acquired intangible assets and related annual amortization expense that
would be required in order to provide the corresponding GAAP measure.
The variability of the items that have not yet been determined may have
a significant, and potentially unpredictable, impact on Hologic’s future
GAAP results.
Forward-Looking Statements
This news release contains forward-looking information that involves
risks and uncertainties, including statements about each company’s
plans, objectives, expectations and intentions. Such statements include,
without limitation: financial or other information based upon or
otherwise incorporating judgments or estimates relating to future
performance, events or expectations; each company’s strategies,
positioning, resources, capabilities, and expectations for future
performance; and each company’s outlook and financial and other
guidance. These forward-looking statements are based upon assumptions
made as of this date and are subject to known and unknown risks and
uncertainties that could cause actual results to differ materially from
those anticipated.
Risks and uncertainties that could adversely affect either company’s
business and prospects, and otherwise cause actual results to differ
materially from those anticipated, include without limitation: the risk
that the transaction will not close in the expected time period, or at
all; the possibility that the anticipated benefits from the proposed
transaction cannot be fully realized or may take longer to realize than
expected; the possibility that costs or difficulties related to the
integration of Focal Therapeutics’s operations with those of Hologic
will be greater than expected; the ability of Hologic and Focal
Therapeutics to retain and hire key personnel; the coverage and
reimbursement decisions of third-party payers and the guidelines,
recommendations, and studies published by various organizations relating
to the use of products and treatments; the uncertainty of the impact of
cost containment efforts and federal healthcare reform legislation on
each company’s business and results of operations; the ability to
successfully manage ongoing organizational and strategic changes,
including Hologic’s ability to attract, motivate and retain key
employees; the impact and anticipated benefits of completed acquisitions
and acquisitions Hologic may complete in the future; the ability to
consolidate certain of Hologic’s manufacturing and other operations on a
timely basis and within budget, without disrupting Hologic’s business
and to achieve anticipated cost synergies related to such actions; the
development of new competitive technologies and products; regulatory
approvals and clearances for products; production schedules for
products; the anticipated development of markets in which products are
sold into and the success of products in these markets; the anticipated
performance and benefits of products; estimated asset and liability
values; anticipated trends relating to Hologic’s financial condition or
results of operations; and Hologic’s capital resources and the adequacy
thereof.
The risks included above are not exhaustive. Other factors that could
adversely affect each company’s business and prospects are described in
the filings made by the applicable company with the SEC. Hologic and
Focal Therapeutics expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any such statements
presented herein to reflect any change in expectations or any change in
events, conditions or circumstances on which any such statements are
based.
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