- Domestic physician penetration metrics
solid
- Updates 2011 financial guidance
Conceptus, Inc. (Nasdaq:CPTS),developer of the
Essure® procedure, the most effective non-surgical permanent birth
control method available, today reported financial results for the
three months ended September 30, 2011.
Net sales for the third quarter of 2011 were $33.1 million,
compared with net sales of $33.9 million for the third quarter of
2010 and net sales of $33.8 million for the second quarter of
2011.
Net loss for the third quarter of 2011 was $2.9 million, or
($0.09) per diluted share. Excluding an income tax provision
of $2.7 million, the net loss before provision for income taxes for
the third quarter of 2011 was $0.2 million. This compares with
net income for the third quarter of 2010 of $1.0 million, or $0.03
per diluted share, and net income for the second quarter of 2011 of
$0.5 million, or $0.01 per diluted share.
Adjusted earnings before interest, taxes, depreciation,
amortization and stock-based compensation ("adjusted EBITDA") for
the third quarter of 2011 were $5.4 million. This compares
with adjusted EBITDA for the third quarter of 2010 of $6.6 million
and adjusted EBITDA for the second quarter of 2011 of $5.8
million.
"Macroeconomic and insurance factors remain an overhang to our
business, but there is evidence that the trends are turning
positive. In addition, we believe the growth drivers we are
employing are taking hold and we expect to be back on track to
growth in the near future," said Mark Sieczkarek, president and
chief executive officer of Conceptus. "We are working at all
levels to increase adoption of Essure, expand the market and drive
long-term growth, as you would expect from the market leader with a
truly differentiated product. We consider our business to be
a growth story, and we will continue to selectively invest in our
business to capture that growth."
"Over the past year, we have been keenly focused on blunting the
impact of competitive trialing, and were especially gratified with
the recent jury verdict in a patent infringement case that found in
favor of Conceptus. We believe that we have stabilized the
competitive threat in the market, and that the jury verdict will
further support those efforts," said Sieczkarek.
Third Quarter of 2011 Highlights
Domestic sales were $25.8 million for the third quarter of 2011,
compared with $27.3 million for the third quarter of 2010 and $24.8
million for the second quarter of 2011. The year-over-year
reduction of $1.5 million reflected net sales in the prior year
period associated with the company's former direct-to-consumer
advertising campaign that was not repeated this year, and
continuing macroeconomic pressures that have contributed to
patients delaying non-urgent procedures such as Essure. The
quarter-to-quarter increase of $1.0 million reflects success of the
Company's growth initiatives, including an expanded field sales
presence and success in reducing competitive trialing, as well as
an increase in physician office visits for the quarter.
Typical seasonality would mean some insured families may have
met their annual deductibles for the year during the third
quarter.
In the third quarter of 2011 in the U.S., the Company expanded
physician penetration by entering approximately 465 new physicians
into preceptorship, certifying approximately 453 physicians and
transitioning approximately 151 physicians to performing procedures
in the office setting. To date, approximately 14,018 U.S.
physicians have performed the Essure procedure.
International sales were $7.3 million for the third quarter of
2011, a growth of 11.5% when compared with $6.6 million for the
third quarter of 2010. International sales in the second
quarter of 2011 were $9.0 million. Year-over-year sales
increased primarily from favorable currency exchange and higher
average selling prices due to channel mix. The
quarter-to-quarter sales decrease was due to typical seasonality
across Europe.
"Our Essure physician penetration metrics were strong again this
quarter, and we gained more first-time cases of physicians trialing
GYNECARE THERMACHOICE® III endometrial ablation system in the
office setting," said Sieczkarek. "In September we launched a
national direct-to-consumer advertising campaign, which
successfully reached our target consumer audience multiple times
through print and digital media channels. Our collective marketing
initiatives, which are designed to increase awareness of Essure
among patients and physicians, have continued to gain
momentum."
Gross profit was $27.3 million or 82.6% of net sales for the
third quarter of 2011, compared with $27.3 million or 80.6% of net
sales for the third quarter of 2010 and $27.7 million or 81.9% of
net sales for the second quarter of 2011. The year-over-year and
quarter-over-quarter increases in gross profit margin were
primarily due to continued reductions in product
manufacturing cost.
Total operating expenses were $25.9 million for the third
quarter of 2011, compared with $24.6 million for the third quarter
of 2010 and $25.8 million for the second quarter of 2011. The
year-over-year increase primarily reflected higher selling,
marketing, and research and development expenses, offset by lower
general and administrative expenses.
In the third quarter of 2011, the Company recorded a net income
tax expense of $2.7 million. The income tax expense recorded
for the nine months ended September 30, 2011 reflects the Company's
current annual effective tax rate assumption of approximately
5%.
Cash, cash equivalents and investments were $99.8 million as of
September 30, 2011, an increase of $4.1 million from June 30,
2011. The Company has generated $14.4 million in cash from
operations in 2011, including $5.9 million during the third quarter
of 2011.
As a result of the Company's net loss for the quarter, due in
part to increased litigation costs associated with the patent
infringement trial, the Company was not in compliance with the
minimum profitability covenant under its credit facility at the end
of the third quarter of 2011. The lender under the credit facility
has agreed to grant the Company a one-time waiver with respect to
this covenant for the third quarter of 2011. As a result, the
Company will continue to have the ability to draw down under the
credit facility subject to its compliance with the credit
facility's other covenants. As of today, there are no amounts
outstanding under the facility.
Financial Guidance
Conceptus updated full year 2011 financial guidance as
follows:
- Net sales: the Company expects 2011 net sales to be in the
range of $132 million to $136 million, compared with 2010 net sales
of $141 million and previous guidance for 2011 of $135 million to
$140 million.
- Adjusted EBITDA: the Company expects 2011 adjusted EBITDA
to be in the range of $20 million to $22 million, compared with
2010 adjusted EBITDA of $25 million and previous guidance for 2011
of $23 million to $26 million.
"We see some very positive trends developing in our business and
our implemented growth drivers are just starting to gain
traction. Physician office visits are up, penetration rates
remain strong, and new accounts for GYNECARE THERMACHOICE®III are
accelerating. Our direct-to-consumer advertising campaign that
launched in September is expected to generate significant
incremental sales in the fourth quarter, as have previous
campaigns. While the outlook appears promising, we believe it
prudent to reduce the lower end of our net sales guidance range
without having greater certainty of the magnitude of contribution
from these drivers and improving macro-factors. We are also
lowering the adjusted EBITDA guidance range to account for both
lower gross profit on the revised net sales guidance range and
higher legal fees than expected as a result of the patent
infringement trial we won," said Sieczkarek.
Conference Call
Conceptus will host an investment community conference call
beginning at 4:30 p.m. Eastern time today to discuss results and
answer questions. In addition to the conference call, there
will be accompanying slides accessible on the Company's website at
www.conceptus.com in the "Events and Presentations" portion of the
"Investors" section.
Conference call dial-in information is as follows:
- U.S. callers: (888) 803-8296
- International callers: (706) 634-1250
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 telephone replay will be available from 7:30 p.m. Eastern time
on October 25, 2011, through 11:59 p.m. Eastern time on October 27,
2011. Replay dial-in information is as follows:
- U.S. callers: (855) 859-2056 (domestic)
- International callers: (404) 537-3406 (international)
- Conference ID number (U.S. and international): 15954494
- The replay will also be available at www.conceptus.com
Use of Non-GAAP Financial Measures
The Company has supplemented its GAAP net income / (loss) with a
non-GAAP measure of adjusted earnings before interest, taxes,
depreciation, amortization and stock-based compensation ("adjusted
EBITDA"). Management believes that this non-GAAP financial measure
provides useful supplemental information to management and
investors regarding the performance of the Company's business
operations, facilitates a better comparison of results for current
periods with the Company's 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 micro-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 99.95% effective based on one year of
follow up with zero pregnancies reported in clinical trials, making
it the most effective form of permanent birth control on the
market. The procedure is covered by most insurance plans, and when
it is performed in a doctor's office the cost to the patient may be
as low as a simple co-pay. Essure has been proven and trusted by
physicians since 2002, with more than 570,000 women worldwide
having undergone the Essure 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. The Company also promotes the GYNECARE
THERMACHOICE® Uterine Balloon Therapy System by ETHICON™ Women's
Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN
physician offices.
The Conceptus, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7961
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.
Forward Looking Statements
Except for the historical information contained herein, the
matters discussed in this press release include forward-looking
statements, 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 2011, the expected impact of ongoing macroeconomic
and insurance pressures on our growth in 2011, our continued
success in defending our physician accounts against competitive
trialing, our ability to expand physician market penetration, our
ability to improve sales force productivity, our ability to
increase utilization of Essure through the promotion of a
compatible endometrial ablation product, our ability to market
effectively to physicians and prospective patients, our
ability to secure government reimbursement in foreign countries,
the potential impact on our financial statements due to favorable
litigation results and potential subsequent motions and appeals,
discussions with our bank lender regarding potential changes to our
credit facility, and the expected attainment of strategic
initiatives intended to grow the business and make the Essure
procedure the standard of care in permanent birth
control. 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, attempts to repeal all or part
of the Patient Protection and Affordable Care Act of 2010, and the
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. These forward-looking
statements speak only as to the date on which the statements were
made. We undertake no obligation to update or revise publicly
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
Conceptus,
Inc. |
Condensed Consolidated
Statements of Operations |
(Unaudited) |
(In thousands, except
per share amounts) |
|
|
|
|
|
|
Three Months
Ended |
Nine Months
Ended |
|
September
30, |
September
30, |
|
2011 |
2010 |
2011 |
2010 |
|
|
|
|
|
Net sales |
$ 33,093 |
$ 33,882 |
$ 93,468 |
$ 104,087 |
Cost of goods sold |
5,748 |
6,562 |
17,063 |
20,238 |
Gross profit |
27,345 |
27,320 |
76,405 |
83,849 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and
development |
2,144 |
1,610 |
5,574 |
5,171 |
Selling, general and
administrative |
23,723 |
22,968 |
71,122 |
75,277 |
Total operating
expenses |
25,867 |
24,578 |
76,696 |
80,448 |
|
|
|
|
|
Operating income (loss) |
1,478 |
2,742 |
(291) |
3,401 |
Interest and other income (expense),
net |
(1,660) |
(1,561) |
(4,833) |
(4,605) |
Income (loss) before provision for
income taxes |
(182) |
1,181 |
(5,124) |
(1,204) |
|
|
|
|
|
Provision for income
taxes |
2,720 |
205 |
251 |
461 |
|
|
|
|
|
Net income (loss) |
$ (2,902) |
$ 976 |
$ (5,375) |
$ (1,665) |
|
|
|
|
|
Basic income (loss) per
share |
$ (0.09) |
$ 0.03 |
$ (0.17) |
$ (0.05) |
Shares used in computing basic net
income (loss) |
31,239 |
31,072 |
31,177 |
31,012 |
|
|
|
|
|
Diluted income (loss) per
share |
$ (0.09) |
$ 0.03 |
$ (0.17) |
$ (0.05) |
Shares used in computing diluted net
income (loss) |
31,239 |
31,413 |
31,177 |
31,012 |
|
|
Conceptus,
Inc. |
Condensed Consolidated
Balance Sheets |
(Unaudited) |
(In
thousands) |
|
|
|
|
September 30, |
December 31, |
|
2011 |
2010 |
|
|
|
Cash and cash
equivalents |
$ 24,537 |
$ 18,383 |
Short-term
investments |
60,508 |
59,398 |
Accounts receivable,
net |
18,900 |
20,451 |
Inventories, net |
3,817 |
2,915 |
Short-term deferred tax
asset |
5,061 |
5,058 |
Other current assets |
6,296 |
7,003 |
Total current assets |
119,119 |
113,208 |
|
|
|
Property and equipment,
net |
9,948 |
10,062 |
Intangible assets, net |
21,791 |
24,145 |
Long-term investments |
14,734 |
13,104 |
Goodwill |
16,428 |
16,013 |
Long-term deferred tax
asset |
74,009 |
73,696 |
Other assets |
345 |
518 |
Total assets |
$ 256,374 |
$ 250,746 |
|
|
|
Total liabilities |
104,232 |
99,160 |
Common stock and additional paid in
capital |
311,955 |
306,276 |
Other comprehensive
loss |
(2,089) |
(2,341) |
Accumulated deficit |
(157,724) |
(152,349) |
Total stockholders'
equity |
152,142 |
151,586 |
Total liabilities and stockholders'
equity |
$ 256,374 |
$ 250,746 |
|
|
Conceptus,
Inc. |
Reconciliation of Net
Income (loss) to Adjusted Earnings Before Interest, Taxes,
Depreciation, Amortization and Stock-Based Compensation (Adjusted
EBITDA) |
(Unaudited) |
(In
thousands) |
|
|
|
|
|
|
Three Months
Ended |
Nine Months
Ended |
|
September
30, |
September
30, |
|
2011 |
2010 |
2011 |
2010 |
|
|
|
|
|
Net Income (Loss), as
reported |
$ (2,902) |
$ 976 |
$ (5,375) |
$ (1,665) |
|
|
|
|
|
Adjustments to net income
(loss): |
|
|
|
|
Interest and other
income (expense), net (a) |
1,660 |
1,561 |
4,833 |
4,605 |
Provision for income
taxes |
2,720 |
205 |
251 |
461 |
Amortization of
intangibles (b) |
816 |
810 |
2,448 |
2,437 |
Stock-based
compensation (c) |
1,811 |
1,881 |
5,233 |
5,412 |
Depreciation expense
(d) |
1,335 |
1,177 |
3,965 |
3,418 |
|
|
|
|
|
Adjustments to net
income (loss) |
8,342 |
5,634 |
16,730 |
16,333 |
|
|
|
|
|
Adjusted EBITDA |
$ 5,440 |
$ 6,610 |
$ 11,355 |
$ 14,668 |
|
|
|
|
|
|
|
|
|
|
(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 |
|
|
|
Conceptus,
Inc. |
Reconciliation of
Forward-Looking Guidance For Non-GAAP Financial
Measures |
To Projected GAAP Net
Loss |
(Unaudited) |
|
|
|
|
Twelve Months
Ending |
|
December
31, 2011 |
|
From |
To |
|
|
|
Net Loss Guidance |
$ (1,697) |
$ (572) |
|
|
|
Estimated Non-GAAP
Guidance |
|
|
Interest and other
income (expense), net (a) |
6,480 |
6,480 |
Provision (benefit) for
income taxes |
(495) |
380 |
Amortization of
intangibles (b) |
3,263 |
3,263 |
Stock-based
compensation (c) |
7,084 |
7,084 |
Depreciation expense
(d) |
5,365 |
5,365 |
Adjustments to net
income |
$ 21,697 |
$ 22,572 |
|
|
|
Adjusted EBITDA |
$ 20,000 |
$ 22,000 |
|
|
|
|
|
|
(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
© 2011 Conceptus, Inc.—All rights reserved. Conceptus and Essure
are trademarks or registered trademarks of Conceptus, Inc.
CC-2932 25OCT11F
|
CONTACT: Investor Relations and Public Relations Contact:
Cindy Klimstra
(650) 962-4032
cindy_klimstra@conceptus.com
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