06.05.2008 20:05:00
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Conceptus Reports First Quarter Net Sales Up 53%
Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure®
procedure, the first and only non-incisional permanent birth control
method available, today reported financial results for the three months
ended March 31, 2008.
Net sales for the first quarter of 2008 were $21.1 million, up 53% over
net sales of $13.8 million for the first quarter of 2007 and up 14% over
net sales of $18.6 million for the fourth quarter of 2007. These results
are within the Company’s guidance of $21.0
million to $22.0 million issued on February 19, 2008. The net loss for
the first quarter of 2008 was $6.4 million, or $0.21 per share. This
compares with the net loss for the first quarter of 2007 of $4.1
million, or $0.14 per share, and the net loss for the fourth quarter of
2007 of $2.8 million, or $0.09 per share. The net loss for the 2008
first quarter exceeded the Company’s guidance
for a net loss of $4.4 million to $5.3 million, largely due to a
higher-than-expected one-time inventory adjustment in connection with
the Company’s acquisition of Conceptus SAS,
its principal European distributor.
Net sales growth during the 2008 first quarter was due to higher
commercial sales of the Essure system worldwide. Domestic
sales of the Essure system for the first quarter of 2008 of $16.4
million increased 31% over the first quarter of 2007. International
sales of $4.7 million increased 285% over the first quarter of 2007,
largely as a result of the acquisition in January 2008 of Conceptus SAS,
and the recognition of international sales at end-user pricing. During
the first quarter of 2008, the Company entered 484 physicians into
preceptorship, certified 442 physicians and transitioned 472 physicians
to performing procedures in the office setting. Domestic in-office
procedures represented 46% of net sales for the first quarter of 2008,
compared with 46% in the fourth quarter of 2007 and 36% in the first
quarter of 2007.
"During the first quarter our physicians in
the U.S. were impacted by reduced patient requests for all gynecological
procedures, due to insurance deductibles re-setting and the overall
economic uncertainty,” commented Mark
Sieczkarek, president and chief executive officer of Conceptus. "Despite
this, we were able to execute on plan and grow our overall business. We
remain very positive about the growth potential of our business as we
believe we will continue to achieve our key goals for physicians
entering preceptorship and becoming certified to perform the Essure
procedure, as well as transitioning their cases into the higher
utilization office setting.”
Gross profit for the first quarter of 2008 was $15.7 million, or 74% of
net sales. This compares with gross margin for first quarter of 2007 of
73% of net sales and with gross margin for the fourth quarter of 2007 of
76% of net sales. Gross profit was negatively impacted in the first
quarter by $1.2 million due to the write-up of inventory balances
required under purchase accounting for the acquisition of Conceptus SAS
in January 2008, which reduced gross margin by approximately 600 basis
points, Although the Company had anticipated this one-time write-up in
its guidance, the amount was greater than expected due to higher
inventories and to a larger per-unit write-up due to higher European
average selling prices.
Research and development expenses were $1.9 million for the first
quarter of 2008, up from $1.6 million for the first quarter of 2007 and
$1.7 million for the fourth quarter of 2007. R&D expenses reflect
product development, clinical and manufacturing engineering
expenditures, which are substantially related to the ongoing development
of improvements to the Essure device.
Selling, general and administrative expenses were $20.1 million for the
first quarter of 2008, up from $13.0 million for the first quarter of
2007 and $16.0 million for the fourth quarter of 2007. The increase in
SG&A expenses was due primarily to $3.5 million in expenses for the
direct-to-consumer advertising campaign that the Company launched in
full during the first quarter of 2008.
Other income and expense was essentially breakeven, compared with net
income of $0.5 million in the first quarter of 2007 and net income of
$0.7 million in the fourth quarter of 2007. Interest income was lower in
the current quarter due to both lower interest rates and lower invested
cash balances. In addition, the Company was subject to foreign currency
exposure upon the acquisition of Conceptus SAS and as a result recorded
a charge of $0.3 million in other expense related to the combined
effects of an unfavorable hedge obligation and exchange rate gains in
the first quarter of 2008.
Cash, cash equivalents and short-term investments were $18.2 million as
of March 31, 2008, a decrease of $27.0 million from December 31, 2007.
The Company used $24.3 million of cash for the acquisition of Conceptus
SAS in January 2008.
"Although our first quarter net loss was
greater than we had anticipated, this was largely the result of a
one-time acquisition-related adjustment. With gross margins expected to
increase to 79% to 80% in the second quarter, we expect to resume our
improving financial performance,” added Mark
Sieczkarek. "Importantly, we are very
encouraged by the early indicators in the direct-to-consumer advertising
campaign, such as calls to the call center, hits to our website and
referrals to physicians, and continue to expect to drive consumer demand
for the product over the coming 12 to 18 months in the DTC cities.” Financial Guidance
The Company also announced financial guidance for the second quarter of
2008, and re-affirmed full-year 2008 net sales and net income guidance,
as follows:
The Company expects net sales in the second quarter to be $25.0
million to $26.0 million, and affirms guidance for net sales for the
full year to be in the range of $102.0 million to $105.0 million.
The Company expects gross margin to be between 79% and 80% for the
second quarter and for the remainder of the year.
The Company expects operating expenses to be $21.0 million to $22.0
million for the second quarter of 2008 and $76.0 million to $77.0
million for the full-year 2008. Guidance issued in January 2008 and
updated in February 2008 was for full-year operating expenses of
approximately $80.0 million.
The Company expects a net loss for the second quarter of 2008 of $0.5
to $1.5 million. This net loss guidance includes stock-based
compensation expense, which the Company expects to be approximately
$1.6 million. The Company affirms expectations for net income to be in
the range of $3.0 million to $5.5 million for the full year of 2008,
including equity-based compensation expense of approximately $6.3
million.
"We are maintaining our original net income
guidance for the full year and intend to adjust operating expenses in
the remainder of the year to offset the lower-than-anticipated gross
profit and other income for the first quarter,”
concluded Mr. Sieczkarek. "We still expect to
be profitable in the second half of the year and to achieve that
important milestone.”
These statements are only effective as of the date of this press release
and Conceptus undertakes no duty to publicly revise or update these
forward-looking statements, whether as a result of new information,
future developments or otherwise.
Conference Call
Management will host an investment-community conference call beginning
at 4:30 p.m. Eastern time today to discuss these results and to answer
questions. To participate in the live call by telephone, please dial
(888) 803-8296 from the U.S., or (706) 634-1250, from outside the
U.S. Individuals interested in listening to the live conference call via
the Internet may do so by logging on to the Company’s
website, www.conceptus.com. A
replay will be available on the website for 14 days.
A telephone replay will be available from 6:30 p.m. Eastern time May 6,
2008 through 11:59 p.m. Eastern time on May 8, 2008 by dialing (800)
642-1687 (domestic) or (706) 645-9291 (international) and entering
conference ID number 44245855
About the Essure Procedure
The Essure procedure, approved by the FDA in 2002, is a permanent
birth control procedure that replaces tubal ligation for women. In the
comfort of a physician’s office and in about
10 minutes, the soft micro-inserts are placed into the Fallopian tubes
through the cervix eliminating the need for incisions. Once in place,
the device is designed to elicit tissue growth in and around the
micro-insert to form an occlusion or blockage in the Fallopian tubes.
The Essure confirmation test is performed three months after the
procedure to confirm that the micro-inserts are in the correct location,
the tubes are blocked and that the woman can discontinue temporary birth
control. The Essure procedure is 99.80% effective and is the
first and only FDA approved female sterilization procedure to have zero
pregnancies in clinical trials.
About Conceptus
Conceptus, Inc. manufactures and markets the Essure Permanent
Birth Control system, an innovative medical device and procedure
designed to provide a non-incisional alternative to tubal ligation,
which is currently the leading form of birth control worldwide. The
availability of the Essure procedure in the United States is
expected to open up a market currently occupied by incisional tubal
ligation and vasectomy, which combined account for over 1 million
procedures annually.
Additional information about the Essure procedure is available at www.essure.com
or by calling the Essure Information Center at 1-877-ESSURE1.
Additional information about Conceptus is available at www.conceptus.com
or by calling 1-877-ESSURE2.
Except for the historical information contained herein, the matters
discussed in this press release are forward-looking statements, the
accuracy of which is necessarily subject to risks and uncertainties.
Discussions regarding growth in net sales, gross margin, earnings
guidance, physician utilization, the results of the direct-to-consumer
campaign, and the performance of Essure in the office setting, and other
matters discussed in this release, may differ significantly from the
discussion of such matters in the forward-looking statements. Such
differences may be based upon factors such as strategic planning
decisions by management, re-allocation of internal resources, decisions
by insurance companies, scientific advances by third parties, and
introduction of competitive products, 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. Conceptus, Inc.
Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts)
Three Months Ended March 31,
2008
2007
Net sales
$
21,127
$
13,780
Cost of goods sold
5,445
3,705
Gross profit
15,682
10,075
Operating expenses:
Research and development
1,931
1,642
Selling, general and administrative
20,102
13,009
Total operating expenses
22,033
14,651
Operating loss
(6,351
)
(4,576
)
Interest and other income (loss), net
(28
)
476
Net loss
$
(6,379
)
$
(4,100
)
Basic and diluted net loss per share
$
(0.21
)
$
(0.14
)
Shares used in computing basic and diluted
net loss per share
29,935
29,260
Conceptus, Inc.
Condensed Consolidated Balance Sheets (Unaudited) (In thousands)
March 31, December 31,
2008
2007
Cash, cash equivalents and short-term investments
$
18,183
$
45,150
Accounts receivable, net
13,082
11,903
Inventories, net
3,738
2,418
Other current assets
5,129
3,271
Total current assets
40,132
62,742
Property and equipment, net
6,392
5,312
Intangible assets, net
8,471
3,719
Long-term investments
46,103
48,800
Goodwill
15,672
-
Other assets
157
102
Total assets
$ 116,927
$ 120,675
Total liabilities
100,971
98,748
Common stock and additional paid in capital
259,874
257,176
Other comprehensive income (loss)
(2,290
)
-
Accumulated deficit
(241,628
)
(235,249
)
Total stockholders' equity
15,956
21,927
Total liabilities and stockholders' equity
$ 116,927
$ 120,675
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