Hologic to Remove Adiana Permanent
Contraception System From the Market
2012 Financial Guidance
Updated
MOUNTAIN VIEW, Calif., April 30, 2012 (GLOBE NEWSWIRE) --
Conceptus, Inc. (Nasdaq:CPTS), developer of the
Essure® procedure, the leading non-surgical permanent birth control
method, today announced that it has reached an agreement with
Hologic, Inc. (Nasdaq:HOLX) to settle the ongoing patent
infringement litigation related to Hologic's Adiana Permanent
Contraception System. The settlement agreement resolves all
outstanding litigation between Conceptus and Hologic.
Under the terms of the settlement agreement, Hologic has agreed
to remove its Adiana system from the worldwide permanent birth
control market by May 18, 2012. In addition, Conceptus has relieved
Hologic of the $18.8 million payment for monetary damages awarded
to Conceptus as part of the October 17, 2011 jury
verdict. Both companies have agreed to withdraw their
respective appeals. In February, Conceptus had filed an appeal to
overturn the court's ruling denying its motion for permanent
injunction against the sale of Hologic's Adiana system, and Hologic
had filed an appeal of the jury's finding of patent validity and
infringement. Hologic has also agreed to withdraw its False
Patent Marking claims filed in 2009 in the United States District
Court for Massachusetts. Furthermore, both parties will file
with the United States District Court for Northern California
appropriate motions seeking a consent judgment to the voluntary
injunction of Hologic's sale of the Adiana product within the next
30 days. Lastly, Conceptus will receive non-exclusive
licensing rights to the technology related to Hologic's Adiana
system, limited to use in the field of permanent birth
control. While Conceptus has been granted these rights, it
does not intend to market the Adiana system.
"We are pleased to reach this settlement agreement with Hologic,
which we believe is in the best interests of Conceptus, its
employees and shareholders, as well as the market and its
physicians and patients," said D. Keith Grossman, president and
chief executive officer of Conceptus. "Essure is the leading
hysteroscopic permanent birth control procedure, allowing women to
achieve highly reliable permanent birth control without the risks
and recovery time associated with surgical tubal ligation. We
believe that the settlement with Hologic will allow us to expand
our distribution and increase the overall availability and usage of
Essure. This is an important and significant achievement for our
company as we advance our vision of making Essure the standard of
care in permanent birth control for women and position Conceptus
for long-term growth."
Update on Financial Guidance
As a result of this agreement, Conceptus now expects 2012 net
sales to be in the range of $140 million to $144 million, or an
increase of $5 million compared to previously announced
expectations of 2012 net sales of $135 million to $139
million. The Company expects 2012 adjusted EBITDA to be in the
range of $26 million to $28 million, or an increase of $3 million
compared to previously announced expectations of 2012 adjusted
EBITDA of $23 million to $25 million.
"We will be reaching out immediately to service the needs of all
of those customers who have been using or trialing the Adiana
product. However, given the lack of transparency as to the
utilization intentions of those customers, and their current Adiana
inventory, we want to be cautious in setting sales expectations for
this year," stated Mr. Grossman. "Once we get beyond the initial
evaluation period, we will be in a better position to evaluate the
impact upon our business, but we believe that this development will
improve our growth rates extending into 2013."
Use of Non-GAAP Financial Measures
The Company has supplemented its GAAP net income/loss with a
non-GAAP measure of adjusted EBITDA. Management believes that this
non-GAAP financial measure provides useful supplemental information
to management and investors regarding the performance of the
Company, facilitates a more meaningful comparison of results for
current periods with previous operating results, and assists
management in analyzing future trends, making strategic and
business decisions and establishing internal budgets and forecasts.
A reconciliation of non-GAAP adjusted EBITDA to GAAP net
income/loss in the most directly comparable GAAP measure is
provided in the schedule below.
There are limitations in using this non-GAAP financial measure
because it is not prepared in accordance with GAAP and may be
different from non-GAAP financial measures used by other
companies. This non-GAAP financial measure should not be
considered in isolation or as a substitute for GAAP financial
measures. Investors and potential investors should consider
non-GAAP financial measures only in conjunction with the Company's
consolidated financial statements prepared in accordance with GAAP
and the reconciliations of the non-GAAP financial measure provided
in the schedule below.
About the Essure® Procedure
The Essure procedure, FDA approved since 2002, is the first
permanent birth control method that can be performed in the comfort
of a physician's office in less than 10 minutes (average
hysteroscopic time) without hormones, cutting, burning or the risks
associated with general anesthesia or tubal ligation. Soft,
flexible inserts are placed in a woman's fallopian tubes through
the cervix without incisions. Over the next three months, the body
forms a natural barrier around and through the inserts to prevent
sperm from reaching the egg. Three months after the Essure
procedure, a doctor is able to perform an Essure Confirmation Test
to confirm that the inserts are properly placed and that the
fallopian tubes are fully blocked, allowing the patient to rely
upon Essure for permanent birth control.
The Essure procedure is 99.83% effective based on five years of
follow up with zero pregnancies reported in clinical trials, making
it the most effective form of permanent birth control on the
market. Essure's 10-year commercial data tracks closely with
its five-year clinical results, and Essure has been proven and
trusted by physicians since 2002. The Essure procedure is
covered in the U.S. by most public and private insurance plans and
more than 625,000 women worldwide have undergone the
procedure.
About Conceptus®, Inc.
Conceptus, Inc. is a leader in the design, development and
marketing of innovative solutions in women's healthcare. The
Company manufactures and markets the Essure procedure. The
Essure procedure is available in the United States, Europe,
Australia, New Zealand, Canada, Mexico, Central and South America
and the Middle East.
Please visit www.essure.com for more information on the Essure
procedure. Patients may call the Essure Information Center at
1-877-ESSURE-1 with questions or to find a physician in their
area.
The Conceptus, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, the accuracy of which is subject to known and unknown
risks and uncertainties. These forward-looking statements include,
without limitation, discussions regarding projected net sales and
adjusted earnings before interest, taxes, depreciation,
amortization and stock-based compensation ("adjusted EBITDA") for
the full year 2012, and our ability to successfully expand the
distribution and increase the overall availability of the Essure
procedure as a result our settlement agreement with Hologic Inc.
These discussions and other forward-looking statements included
herein may differ significantly from actual results. Such
differences may be based upon factors such as changes in strategic
planning decisions by management, re-allocation of internal
resources, changes in the impact of domestic and global
macroeconomic pressures, reimbursement decisions by insurance
companies and domestic and foreign governments, scientific advances
by third parties, litigation risks, and attempts to amend or repeal
all or part of the Patient Protection and Affordable Care Act of
2010 as amended, as well as those factors set forth in the
Company's most recent Annual Report on Form 10-K and most recent
Quarterly Report on Form 10-Q, and other filings with the
Securities and Exchange Commission. These forward-looking
statements speak only as to the date on which the statements were
made. The Company undertakes no obligation to update or revise
publicly any forward-looking statements, whether as a result of new
information, future events, or otherwise.
|
Conceptus,
Inc. |
Reconciliation of
Forward-Looking Guidance For Non-GAAP Financial
Measures |
To Projected GAAP Net
Income |
(Unaudited) |
|
|
|
|
Twelve Months
Ending |
|
December 31,
2012 |
|
From |
To |
|
|
|
Net Income Guidance |
$ 3,032 |
$ 4,125 |
|
|
|
Adjustments to net
income: |
|
|
Interest and other
income (expense), net (a) |
4,440 |
4,440 |
Provision for income
taxes |
2,469 |
3,376 |
Amortization of
intangibles (b) |
3,631 |
3,631 |
Stock-based
compensation (c) |
6,925 |
6,925 |
Depreciation expense
(d) |
5,503 |
5,503 |
Adjustments to net
income |
22,968 |
23,875 |
|
|
|
Adjusted EBITDA |
$ 26,000 |
$ 28,000 |
|
|
|
(a) Consists of interest
from available-for-sale securities, interest expense associated
with our |
convertible debt
and foreign exchange currency transactions |
(b) Consists of
amortization of intangible assets, primarily licenses and customer
relationships |
(c) Consists of
stock-based compensation in accordance with ASC 718 |
(d) Consists of
depreciation, primarily on property, plant and
equipment |
© 2012 Conceptus, Inc. – All rights reserved.
CONTACT: Investor and Public Relations Contact:
Cindy Klimstra
(650) 962-4032
cindy_klimstra@conceptus.com
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