EXHIBIT 99.1
| |
|
|
COMPANY CONTACT:
|
|
INVESTOR CONTACTS: |
Mark Fischer-Colbrie
|
|
Jody Cain (jcain@lhai.com) |
Chief Financial Officer
|
|
Bruce Voss (bvoss@lhai.com) |
Adeza Biomedical Corporation
|
|
Lippert/Heilshorn & Associates, Inc. |
(408) 745-0975 ext 520
|
|
(310) 691-7100 |
ir@adeza.com |
|
|
ADEZA ANNOUNCES 2006 SECOND QUARTER FINANCIAL RESULTS
Achieves
16th Consecutive Quarter of Profitability on Record Product Sales
Company Affirms 2006 Revenue Guidance
Conference Call to Begin at 4:30 p.m. Eastern Time Today
SUNNYVALE, Calif. (August 3, 2006) — Adeza (NASDAQ: ADZA) today announced financial results for
the second quarter ended June 30, 2006.
Adeza reported record product sales of $13.0 million for the second quarter of 2006, an increase of
23% from product sales of $10.6 million for the second quarter of 2005. This increase was due to
higher sales volume of FullTerm™, The Fetal Fibronectin Test.
Net income for the second quarter of 2006 was $537,000, or diluted earnings per share of $0.03,
which included charges of $931,000 for stock-based compensation expense. Net income for the second
quarter of 2005 was $1.8 million, or diluted earnings per share of $0.10, which included no
stock-based compensation expense related to SFAS 123R and a 5% tax rate.
Gross profit for the second quarter of 2006 was $11.1 million, or 85.4%, and included stock-based
compensation expense of $48,000. This compares with gross profit of $9.2 million, or 86.6%, for
the second quarter of 2005.
Sales and marketing expenses for the second quarter of 2006 were $7.4 million, including
stock-based compensation expense of $457,000, compared with $4.8 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 second quarter of 2006 were $2.2 million, including
stock-based compensation expense of $352,000, compared with $1.9 million in the comparable quarter
of the prior year. Research and development expenses were $1.6 million for the second quarter of
2006, including stock-based compensation expense of $75,000, compared with $1.2 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 half of 2006 totaled $23.8 million, an increase of 18% from $20.2
million for the first half of 2005. For the six months ended June 30, 2006 Adeza reported net
income of $543,000, or diluted earnings per share of $0.03, which included $1.8 million for
stock-based compensation expense due to the adoption of SFAS 123R. This compares with net income
of $3.3 million, or diluted earnings per share of $0.18, for the
six months ended June 30, 2005, which included no employee
stock-based compensation expense related to SFAS 123R and a 5% tax
rate.
As of June 30, 2006 Adeza had cash and cash equivalents of $93.4 million, an increase of $2.8
million from $90.5 million of cash and cash equivalents as of March 31, 2006 and an increase of
$3.6 million since December 31, 2005. Stockholders’ equity was $100.2 million and working capital
was $99.5 million as of June 30, 2006.
“We see significant opportunity for growth in the ‘signs-and-symptoms’ market, while continuing
marketing programs aimed at expanding FullTerm, The Fetal Fibronectin Test to women who are at risk
for preterm birth,” said Emory V. Anderson, president and chief executive officer.
“We are pleased with the regulatory progress of Gestiva, our drug candidate for the prevention of
preterm birth in women with a history of preterm delivery,” he continued. “Since announcing the submission of the Gestiva New Drug Application
(NDA) in early May, the U.S. Food and Drug Administration (FDA) has accepted the NDA filing and
assigned a date of August 29 for an advisory committee meeting. The FDA has also granted the NDA
Priority Review designation, setting a goal to complete its review or otherwise respond to the
Gestiva NDA by October 20. If approved, Gestiva will have a favorable impact on our 2007 product
sales.”
2006 Financial Guidance
Adeza today affirmed guidance for 2006 revenue to be in the range of $54 million to $57 million.
It also affirmed that gross margin for 2006 is expected to exceed
80%, and has revised the full-year tax
rate to a range of 48% to 52%, which is higher than the statutory tax rate 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 3584280.
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 U.S. Food and Drug
Administration (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. Adeza’s NDA
submission includes data from a clinical study conducted by the National Institutes of Health. In
June 2006, the NDA for Gestiva was granted Priority Review status. 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, projections about Adeza’s anticipated expenses and
financial performance and statements related to
Gestiva’s regulatory status and medical potential. 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 the
anticipated regulatory or commercial path for its product candidates. Further information about
these and other risks is included 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.
[Tables to follow]