Adeza (NASDAQ:ADZA) today announced financial results for the
quarter ended September 30, 2006 and updated 2006 financial
guidance. Adeza reported record product sales of $13.5 million for
the third quarter of 2006, an increase of 18% from product sales of
$11.4 million for the third quarter of 2005. This increase was due
primarily to higher sales volume of FullTerm�, The Fetal
Fibronectin Test. Net income for the third quarter of 2006 was
$751,000, or diluted earnings per share of $0.04, which included
charges of $825,000 for stock-based compensation expense related to
SFAS 123R and a tax rate of 59.5%. Net income for the third quarter
of 2005 was $2.2 million, or diluted earnings per share of $0.12,
which included no stock-based compensation expense related to SFAS
123R and a 5.9% tax rate. Gross profit for the third quarter of
2006 was $11.5 million, or 85.4%, which included stock-based
compensation expense related to SFAS 123R of $39,000. This compares
with gross profit of $9.7 million, or 85.1%, for the third quarter
of 2005. Sales and marketing expenses for the third quarter of 2006
were $6.6 million, including stock-based compensation expense
related to SFAS 123R of $418,000, compared with $4.6 million for
the same quarter in 2005. This increase reflects expansion of the
company�s direct sales force and marketing programs. General and
administrative expenses for the third quarter of 2006 were $1.8
million, including stock-based compensation expense related to SFAS
123R of $309,000, compared with $2.0 million in the comparable
quarter of the prior year. Research and development expenses were
$2.5 million for the third quarter of 2006, including stock-based
compensation expense related to SFAS 123R of $59,000, compared with
$1.6 million in the same quarter of the prior year. This increase
was mainly due to product development efforts, including costs
related to Gestiva�, Adeza�s drug candidate for the prevention of
preterm birth in women with a history of preterm delivery. Product
sales for the first nine months of 2006 totaled $37.3 million, an
increase of 18% from $31.7 million for the first nine months of
2005. For the nine months ended September 30, 2006, Adeza reported
net income of $1.3 million, or diluted earnings per share of $0.07,
which included $2.7 million for stock-based compensation expense
due to the adoption of SFAS 123R and a tax rate of 56.0%. This
compares with net income of $5.4 million, or diluted earnings per
share of $0.31, for the nine months ended September 30, 2005, which
included no employee stock-based compensation expense related to
SFAS 123R and a 5.5% tax rate. As of September 30, 2006, Adeza had
cash and cash equivalents of $94.2 million, an increase of $4.5
million since December 31, 2005. Stockholders� equity was $102.0
million and working capital was $101.3 million as of September 30,
2006. �We see significant market opportunity for FullTerm, the
Fetal Fibronectin Test and have initiatives underway to drive
growth in both the �high risk� and �signs-and-symptoms� market,�
said Emory V. Anderson, president and chief executive officer.
�With respect to Gestiva, following the receipt of our approvable
letter, we have requested a meeting with the U.S. Food and Drug
Administration (FDA) to review the requirements outlined in the
letter.� 2006 Financial Guidance Adeza today updated its guidance
for 2006. The company expects revenue to be in the range of $51
million to $53 million. Previous 2006 revenue guidance was in the
range of $54 million to $57 million. Adeza is reaffirming its
financial guidance that gross margin for 2006 is expected to exceed
80%. The tax rate through September 30, 2006 of 56.0% is expected
to remain above the previously announced 48% to 52% guidance range,
primarily as a result of accounting for stock-based compensation
expense under SFAS 123R. Conference Call Adeza�s management will
host an investment-community conference call today beginning at
4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss these
results and to answer questions. Individuals interested in
participating in the conference call may do so by dialing (888)
463-4383 for domestic callers, or (706) 634-5615 for international
callers. A telephone replay will be available for 48 hours
following the conclusion of the call by dialing (800) 642-1687 for
domestic callers, or (706) 645-9291 for international callers, and
entering reservation code 9490938. The live call also will be
available via the Internet on the Investor Relations section of the
company�s Web site at www.adeza.com. A webcast replay of the call
will be available following the conclusion of the call. About Adeza
Adeza designs, manufactures and markets innovative products for
women's health. Adeza's initial focus is on reproductive healthcare
using its proprietary technologies to predict preterm birth and
assess infertility. Adeza's principal product is a patented
diagnostic test, FullTerm, The Fetal Fibronectin Test, which
utilizes a single-use, disposable cassette and is analyzed on
Adeza's patented TLiIQ� System. This product is approved by the FDA
for use in assessing the risk of preterm birth. Adeza also markets
and sells the E-tegrity� Test, an infertility-related test to
assess receptivity of the uterus to embryo implantation in women
with unexplained infertility. In May 2006, Adeza announced the
submission of its New Drug Application (NDA) to the FDA for
Gestiva, a long-acting form of a naturally occurring progesterone
to prevent preterm birth in women with a history of preterm
delivery. On October 23, 2006 Adeza announced that it received an
approvable letter from the FDA, subject to the completion of
certain animal studies and other conditions. More information is
available at www.adeza.com. Adeza cautions you that statements
included in this press release that are not a description of
historical facts are forward-looking statements, including for
example, statements about forecasts of future revenue and the bases
for revenue growth, and the uses of Adeza�s products and potential
regulatory approvals. The inclusion of forward-looking statements
should not be regarded as a representation by Adeza that any of its
plans will be achieved. Actual results may differ materially from
those set forth in this release due to the risks and uncertainties
inherent in Adeza's business including, without limitation, risks
related to fluctuations in our business and market acceptance of
our products, and risks related to obtaining and maintaining
government approvals of our products. Further information about
these and other risks is included in Adeza�s Annual Report on Form
10-K and other periodic and current reports filed by Adeza with the
Securities Exchange Commission, which are available from the SEC's
Web site (www.sec.gov), and also available on the Investor
Relations section of Adeza�s Web site. All forward-looking
statements are qualified in their entirety by this cautionary
statement and Adeza undertakes no obligation to revise or update
this news release to reflect events or circumstances after the date
hereof. ADEZA BIOMEDICAL CORPORATION CONDENSED STATEMENTS OF INCOME
(In thousands, except per share amounts) (Unaudited) � Three Months
Nine Months Ended Ended September 30, September 30, 2006� 2005�
2006� 2005� � � Product sales $ 13,471� $11,419� $ 37,293� $31,663�
Cost of product sales 1,961� 1,703� 5,623� 4,559� � Gross profit
11,510� 9,716� 31,670� 27,104� � Operating costs and expenses:
Sales and marketing 6,581� 4,566� 20,042� 14,078� General and
administrative 1,840� 1,959� 6,302� 5,363� Research and development
2,490� 1,634� 5,763� 3,711� � Total operating costs and expenses
10,911� 8,159� 32,107� 23,152� � Income (loss) from operations 599�
1,557� (437) 3,952� Interest income 1,256� 729� 3,378� 1,802� �
Income before provision for income taxes 1,855� 2,286� 2,941�
5,754� Provision for income taxes 1,104� 136� 1,647� 319� � Net
income $ 751� $ 2,150� $ 1,294� $ 5,435� � � Net income per share:
Basic $ 0.04� $ 0.13� $ 0.07� $ 0.32� Diluted $ 0.04� $ 0.12� $
0.07� $ 0.31� � Shares used to compute net income per share: Basic
17,494� 16,991� 17,459� 16,803� Diluted 18,156� 17,931� 18,174�
17,798� ADEZA BIOMEDICAL CORPORATION CONDENSED BALANCE SHEETS (In
thousands, except par value) � September 30, December 31, 2006�
2005� (unaudited) (1) Assets � Current assets: Cash and cash
equivalents $ 94,199� $ 89,722� Accounts receivable, net 9,470�
9,182� Inventories 1,030� 849� Prepaid expenses and other current
assets 410� 292� Current deferred tax asset 4,929� 4,929� Total
current assets 110,038� 104,974� � Property and equipment, net 419�
348� Noncurrent deferred tax asset 193� 193� Intangible assets, net
92� 128� � Total assets $ 110,742� $ 105,643� � � Liabilities and
Stockholders' Equity � Current liabilities: Accounts payable 1,971�
$ 1,994� Accrued compensation 2,061� 2,216� Accrued royalties 807�
1,427� Other accrued liabilities 1,827� 1,246� Taxes payable 2,008�
1,322� Deferred revenue 82� 33� Total current liabilities 8,756�
8,238� � � Stockholders' equity: Common stock, $0.001 par value;
100,000 shares authorized; 17,504 and 17,376 shares issued and
outstanding at September 30, 2006 and December 31, 2005,
respectively. � 17� 17� Additional paid-in-capital 133,114�
132,432� Deferred compensation -� (2,604) Accumulated other
comprehensive income 1� -� Accumulated deficit (31,146) (32,440)
Total stockholders' equity 101,986� 97,405� � Total liabilities and
stockholders' equity $ 110,742� $ 105,643� � � (1) - Derived from
the December 31, 2005 audited financial statements included in the
Annual Report on Form 10-K of Adeza Biomedical Corporation for
fiscal year 2005. Adeza (NASDAQ:ADZA) today announced financial
results for the quarter ended September 30, 2006 and updated 2006
financial guidance. Adeza reported record product sales of $13.5
million for the third quarter of 2006, an increase of 18% from
product sales of $11.4 million for the third quarter of 2005. This
increase was due primarily to higher sales volume of FullTerm(TM),
The Fetal Fibronectin Test. Net income for the third quarter of
2006 was $751,000, or diluted earnings per share of $0.04, which
included charges of $825,000 for stock-based compensation expense
related to SFAS 123R and a tax rate of 59.5%. Net income for the
third quarter of 2005 was $2.2 million, or diluted earnings per
share of $0.12, which included no stock-based compensation expense
related to SFAS 123R and a 5.9% tax rate. Gross profit for the
third quarter of 2006 was $11.5 million, or 85.4%, which included
stock-based compensation expense related to SFAS 123R of $39,000.
This compares with gross profit of $9.7 million, or 85.1%, for the
third quarter of 2005. Sales and marketing expenses for the third
quarter of 2006 were $6.6 million, including stock-based
compensation expense related to SFAS 123R of $418,000, compared
with $4.6 million for the same quarter in 2005. This increase
reflects expansion of the company's direct sales force and
marketing programs. General and administrative expenses for the
third quarter of 2006 were $1.8 million, including stock-based
compensation expense related to SFAS 123R of $309,000, compared
with $2.0 million in the comparable quarter of the prior year.
Research and development expenses were $2.5 million for the third
quarter of 2006, including stock-based compensation expense related
to SFAS 123R of $59,000, compared with $1.6 million in the same
quarter of the prior year. This increase was mainly due to product
development efforts, including costs related to Gestiva(TM),
Adeza's drug candidate for the prevention of preterm birth in women
with a history of preterm delivery. Product sales for the first
nine months of 2006 totaled $37.3 million, an increase of 18% from
$31.7 million for the first nine months of 2005. For the nine
months ended September 30, 2006, Adeza reported net income of $1.3
million, or diluted earnings per share of $0.07, which included
$2.7 million for stock-based compensation expense due to the
adoption of SFAS 123R and a tax rate of 56.0%. This compares with
net income of $5.4 million, or diluted earnings per share of $0.31,
for the nine months ended September 30, 2005, which included no
employee stock-based compensation expense related to SFAS 123R and
a 5.5% tax rate. As of September 30, 2006, Adeza had cash and cash
equivalents of $94.2 million, an increase of $4.5 million since
December 31, 2005. Stockholders' equity was $102.0 million and
working capital was $101.3 million as of September 30, 2006. "We
see significant market opportunity for FullTerm, the Fetal
Fibronectin Test and have initiatives underway to drive growth in
both the 'high risk' and 'signs-and-symptoms' market," said Emory
V. Anderson, president and chief executive officer. "With respect
to Gestiva, following the receipt of our approvable letter, we have
requested a meeting with the U.S. Food and Drug Administration
(FDA) to review the requirements outlined in the letter." 2006
Financial Guidance Adeza today updated its guidance for 2006. The
company expects revenue to be in the range of $51 million to $53
million. Previous 2006 revenue guidance was in the range of $54
million to $57 million. Adeza is reaffirming its financial guidance
that gross margin for 2006 is expected to exceed 80%. The tax rate
through September 30, 2006 of 56.0% is expected to remain above the
previously announced 48% to 52% guidance range, primarily as a
result of accounting for stock-based compensation expense under
SFAS 123R. Conference Call Adeza's management will host an
investment-community conference call today beginning at 4:30 p.m.
Eastern time (1:30 p.m. Pacific time) to discuss these results and
to answer questions. Individuals interested in participating in the
conference call may do so by dialing (888) 463-4383 for domestic
callers, or (706) 634-5615 for international callers. A telephone
replay will be available for 48 hours following the conclusion of
the call by dialing (800) 642-1687 for domestic callers, or (706)
645-9291 for international callers, and entering reservation code
9490938. The live call also will be available via the Internet on
the Investor Relations section of the company's Web site at
www.adeza.com. A webcast replay of the call will be available
following the conclusion of the call. About Adeza Adeza designs,
manufactures and markets innovative products for women's health.
Adeza's initial focus is on reproductive healthcare using its
proprietary technologies to predict preterm birth and assess
infertility. Adeza's principal product is a patented diagnostic
test, FullTerm, The Fetal Fibronectin Test, which utilizes a
single-use, disposable cassette and is analyzed on Adeza's patented
TLiIQ(R) System. This product is approved by the FDA for use in
assessing the risk of preterm birth. Adeza also markets and sells
the E-tegrity(R) Test, an infertility-related test to assess
receptivity of the uterus to embryo implantation in women with
unexplained infertility. In May 2006, Adeza announced the
submission of its New Drug Application (NDA) to the FDA for
Gestiva, a long-acting form of a naturally occurring progesterone
to prevent preterm birth in women with a history of preterm
delivery. On October 23, 2006 Adeza announced that it received an
approvable letter from the FDA, subject to the completion of
certain animal studies and other conditions. More information is
available at www.adeza.com. Adeza cautions you that statements
included in this press release that are not a description of
historical facts are forward-looking statements, including for
example, statements about forecasts of future revenue and the bases
for revenue growth, and the uses of Adeza's products and potential
regulatory approvals. The inclusion of forward-looking statements
should not be regarded as a representation by Adeza that any of its
plans will be achieved. Actual results may differ materially from
those set forth in this release due to the risks and uncertainties
inherent in Adeza's business including, without limitation, risks
related to fluctuations in our business and market acceptance of
our products, and risks related to obtaining and maintaining
government approvals of our products. Further information about
these and other risks is included in Adeza's Annual Report on Form
10-K and other periodic and current reports filed by Adeza with the
Securities Exchange Commission, which are available from the SEC's
Web site (www.sec.gov), and also available on the Investor
Relations section of Adeza's Web site. All forward-looking
statements are qualified in their entirety by this cautionary
statement and Adeza undertakes no obligation to revise or update
this news release to reflect events or circumstances after the date
hereof. -0- *T ADEZA BIOMEDICAL CORPORATION CONDENSED STATEMENTS OF
INCOME (In thousands, except per share amounts) (Unaudited) Three
Months Nine Months Ended Ended September 30, September 30,
----------------- ----------------- 2006 2005 2006 2005 --------
-------- -------- -------- Product sales $13,471 $11,419 $37,293
$31,663 Cost of product sales 1,961 1,703 5,623 4,559 --------
-------- -------- -------- Gross profit 11,510 9,716 31,670 27,104
Operating costs and expenses: Sales and marketing 6,581 4,566
20,042 14,078 General and administrative 1,840 1,959 6,302 5,363
Research and development 2,490 1,634 5,763 3,711 -------- --------
-------- -------- Total operating costs and expenses 10,911 8,159
32,107 23,152 -------- -------- -------- -------- Income (loss)
from operations 599 1,557 (437) 3,952 Interest income 1,256 729
3,378 1,802 -------- -------- -------- -------- Income before
provision for income taxes 1,855 2,286 2,941 5,754 Provision for
income taxes 1,104 136 1,647 319 -------- -------- --------
-------- Net income $751 $2,150 $1,294 $5,435 ======== ========
======== ======== Net income per share: Basic $0.04 $0.13 $0.07
$0.32 ======== ======== ======== ======== Diluted $0.04 $0.12 $0.07
$0.31 ======== ======== ======== ======== Shares used to compute
net income per share: Basic 17,494 16,991 17,459 16,803 ========
======== ======== ======== Diluted 18,156 17,931 18,174 17,798
======== ======== ======== ======== *T -0- *T ADEZA BIOMEDICAL
CORPORATION CONDENSED BALANCE SHEETS (In thousands, except par
value) September 30, December 31, 2006 2005 -------------
------------ (unaudited) (1) Assets Current assets: Cash and cash
equivalents $94,199 $89,722 Accounts receivable, net 9,470 9,182
Inventories 1,030 849 Prepaid expenses and other current assets 410
292 Current deferred tax asset 4,929 4,929 -------------
------------ Total current assets 110,038 104,974 Property and
equipment, net 419 348 Noncurrent deferred tax asset 193 193
Intangible assets, net 92 128 ------------- ------------ Total
assets $110,742 $105,643 ============= ============ Liabilities and
Stockholders' Equity Current liabilities: Accounts payable 1,971
$1,994 Accrued compensation 2,061 2,216 Accrued royalties 807 1,427
Other accrued liabilities 1,827 1,246 Taxes payable 2,008 1,322
Deferred revenue 82 33 ------------- ------------ Total current
liabilities 8,756 8,238 Stockholders' equity: Common stock, $0.001
par value; 100,000 shares authorized; 17,504 and 17,376 shares
issued and outstanding at September 30, 2006 and December 31, 2005,
respectively. 17 17 Additional paid-in-capital 133,114 132,432
Deferred compensation - (2,604) Accumulated other comprehensive
income 1 - Accumulated deficit (31,146) (32,440) -------------
------------ Total stockholders' equity 101,986 97,405
------------- ------------ Total liabilities and stockholders'
equity $110,742 $105,643 ============= ============ (1) - Derived
from the December 31, 2005 audited financial statements included in
the Annual Report on Form 10-K of Adeza Biomedical Corporation for
fiscal year 2005. *T
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