25.10.2007 20:05:00
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Conceptus Reports Third Quarter Net Sales of $16.4 Million
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 and
nine months ended September 30, 2007.
Net sales for the third quarter of 2007 were $16.4 million, up 49%
compared with net sales of $11.0 million for the third quarter of 2006
and up 5% compared with net sales of $15.7 million for the second
quarter of 2007. These results exceeded the Company’s
2007 third quarter net sales guidance of $15.7 million to $16.1 million.
The net loss for the third quarter of 2007 was $2.6 million, or $0.09
per share, compared with the net loss for the third quarter of 2006 of
$3.4 million, or $0.12 per share. Included in the net loss for the third
quarter of 2007 and 2006 are non-cash stock-based compensation expenses
of $1.7 million and $1.5 million, respectively.
Net sales growth during the 2007 third quarter was due to higher
commercial sales of the Essure system worldwide, and reflects
record numbers of physicians entering and completing training and record
numbers of certified physicians performing the Essure procedure
in-office, the highest utilization setting. Domestic sales of the
Essure system increased 51% and international sales increased 25%,
both compared with the comparable prior-year period.
"We are back on plan with hiring of sales
representatives, which in turn helped us to deliver a net sales
performance that was above guidance, and business metrics that continue
to move forward very solidly. Physician interest in the Essure system
was at record levels in the third quarter with 611 physicians entering
preceptorship and 366 physicians becoming certified,”
commented Mark Sieczkarek, president and chief executive officer of
Conceptus. "In addition, we moved another 208
physicians into the office setting, so overall 26% of our physicians are
performing the Essure procedure in the office, including more
than 500 physicians who have started their training in the office
setting.”
Gross profit for the third quarter of 2007 was $12.1 million, or 74% of
net sales. This compares favorably with gross margin for the third
quarter of 2006 of 68% and is a slight improvement over the 73% gross
margin for the second quarter of 2007. The year-over-year increase in
gross margin is related to lower manufacturing costs associated with
higher unit volume, decreased unit costs of the Company’s
next-generation Essure system and to a domestic price increase
implemented during the first quarter of 2007. The gross margin in the
third quarter of 2007 was negatively impacted by approximately 100 basis
points due to certain transition costs associated with the market launch
of the third-generation Essure system.
Research and development expenses were $1.5 million for the third
quarter of 2007, compared with $1.0 million for the third quarter of
2006 and $1.1 million for the second quarter of 2007. R&D expenses
reflect product development and clinical expenditures, which are
substantially related to the ongoing development and associated
regulatory approvals of our technology.
Selling, general and administrative expenses were $13.9 million for the
third quarter of 2007, compared with $10.3 million for the third quarter
of 2006 and $13.2 million for the second quarter of 2007. The Company
continues to increase the number of sales personnel, and is funding a
variety of marketing and field programs in an effort to broaden patient
awareness and refine physician skills in delivering the Essure
procedure in-office with minimal anesthesia.
Cash, cash equivalents and short-term investments were $94.3 million as
of September 30, 2007, a reduction of $1.3 million from June 30, 2007.
This net cash usage compares with a $0.2 million net cash increase in
the third quarter of 2006, which included a $1.7 million increase from
the exercise of stock awards, compared with $0.3 million generated in
the third quarter of 2007 from the exercise of stock awards. Also
included in net cash usage for the third quarter of 2007 was the first
interest payment of $1.0 million on the company’s
convertible debt offering completed earlier in 2007. Net cash usage of
$1.3 million in the third quarter of 2007 compares favorably with net
cash usage of $1.6 million in the second quarter of 2007.
For the nine months ended September 30, 2007, Conceptus reported net
sales of $45.9 million, up 58% compared with net sales of $29.0 million
for the first nine months of 2006. The net loss for the first nine
months of 2007 of $8.9 million, or $0.30 per share, compares favorably
with the net loss of $14.6 million, or $0.50 per share, for the first
nine months of 2006. Included in the net loss for the first nine months
of 2007 and 2006 are non-cash stock-based compensation expenses of $4.7
million and $4.5 million, respectively.
Financial Guidance
Conceptus issued fourth quarter guidance and revised full-year 2007
guidance, as follows:
For the fourth quarter of 2007 the Company expects net sales to be in
the range of $17.5 million to $18.5 million, and net loss to be in the
range of $0.2 million to $1.2 million, or $0.01 to $0.04 per share.
For 2007 the Company expects net sales for the year to be in the range
of $63.4 million to $64.4 million, and net loss to be in the range of
$9.1 million to $10.1 million, or $0.31 to $0.34 per share. The Company’s
previous guidance was for 2007 net sales of $62 million to $65 million
and a net loss of $7.6 million to $10.0 million.
"The record level of new physician interest
combined with the momentum toward the in-office procedure bodes well for
continued high growth and continued movement towards our profitability
targets,” continued Mr. Sieczkarek. "We
expect a solid conclusion to another great year and are preparing
ourselves for the opportunities that lay ahead.”
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 onto 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 October
25, 2007 through 11:59 p.m. Eastern time October 27, 2007 by dialing
(800) 642-1687 (domestic) or (706) 645-9291 (international) and entering
conference ID number 19966336.
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 U.S. 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 and the sales force, physician
utilization 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 Nine Months Ended September 30, September 30,
2007
2006
2007
2006
Net sales
$
16,430
$
11,013
$
45,879
$
28,978
Cost of goods sold
4,317
3,486
12,260
10,020
Gross profit
12,113
7,527
33,619
18,958
Operating expenses:
Research and development
1,513
1,030
4,216
3,299
Selling, general and administrative
13,917
10,265
40,098
31,200
Total operating expenses
15,430
11,295
44,314
34,499
Operating loss
(3,317
)
(3,768
)
(10,695
)
(15,541
)
Interest and other income
682
329
1,820
985
Net loss
$
(2,635
)
$
(3,439
)
$
(8,875
)
$
(14,556
)
Basic and diluted net loss per share
$
(0.09
)
$
(0.12
)
$
(0.30
)
$
(0.50
)
Shares used in computing basic and diluted net loss per share
29,525
29,034
29,405
28,938
Conceptus, Inc.
Condensed Consolidated Balance Sheets (In thousands, Unaudited)
September 30, December 31,
2007
2006
Cash, cash equivalents, and short-term investments
$
94,343
$
25,838
Accounts receivable, net
11,295
6,976
Inventories
2,272
610
Other current assets
1,719
1,064
Total current assets
109,629
34,488
Property and equipment, net
3,687
2,917
Intangible assets, net
3,925
1,350
Other assets
322
996
Total assets
$ 117,563
$ 39,751
Total liabilities
96,399
8,737
Common stock and additional paid in capital
253,656
254,631
Accumulated deficit
(232,492
)
(223,617
)
Total stockholders' equity
21,164
31,014
Total liabilities and stockholders' equity
$ 117,563
$ 39,751
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