Newark, Delaware
February 27, 2003
Strategic Diagnostics Inc.
(Nasdaq:SDIX) - a leading provider of antibody products and
analytical test kits for the food safety and water quality
markets, today reported financial results for the fourth quarter
and year ended December 31, 2002.
Revenue for the fourth quarter of 2002 was $6.3 million,
compared with $6.6 million in the fourth quarter of 2001. The
net loss in the fourth quarter totaled $113,000, or $0.01 per
share, compared to a net loss of $763,000, or $0.04 per share,
in the prior year quarter. For the year ended December 31, 2002,
revenues were $23.8 million, versus $29.4 million in the prior
year. Net loss for the year totaled $912,000, or $0.05 per
share, down from net income of $1.1 million, or $0.06 per
diluted share in the
prior year.
Revenues for the water quality category increased in 2002,
primarily due to increasing sales of the Microtox(R) toxicity
screening systems. More than 50 North American water systems,
most of which serve more than 100,000 households, currently
utilize the system for drinking water. The Company continues to
work with customers as they assess their vulnerability to
threats of intentional contamination as currently required under
U.S. law and is expanding its efforts to market its Microtox(R)
test systems to potential customers in the food and beverage
industry. The increase in Microtox(R) sales has been somewhat
offset by a decrease in sales of tests in the remediation
market. Sales in this category during 2002 were slower due to
weak general economic conditions and harsh weather experienced
during the winter. The Company expects water quality revenues to
grow in
2003, particularly due to increased demand for Microtox(R) and
its attendant consumables as water processors and users have a
heightened awareness of the potential threat of chemical
contamination, intentional or otherwise.
The Company was recently awarded a 2002 Business Achievement
Award from Environmental Business Journal (EBJ) for its work in
developing Microtox(R) Technology into an effective Homeland
Security technology. In its announcement of the award, EBJ
stated it was awarding the Company its 2002 Homeland Security
Award "...for rapidly deploying the Microtox(R) technology it
acquired from AZUR Environmental in 2001 to water quality
security applications. Used predominantly for wastewater and
research prior to 9/11, SDI developed additional protocols and
application notes and as of the end of 2002 Microtox(R) is being
used by more than 50 major drinking water utilities across the
country." Also recently, American Water Company adopted the
Company's Microtox(R) toxicity testing technology for drinking
water as an emergency response to detect intentional
contamination of drinking water supplies. American Water is the
largest private drinking water utility in the United States,
providing drinking water services to more than 15 million
customers in 27 states and Canada. The company's quality control
and research laboratory located in Belleville, Illinois
conducted a thorough technical analysis of the operation and
detection capabilities of Microtox(R) technology. Based on the
positive results of that study, AW has selected Microtox(R)
technology for implementation as a rapid response analytical
technology for use throughout their service areas.
Additionally, a manufacturer and processor of prepared meat
products and a supplier of meat products to many major consumer
brand companies has adopted Microtox(R) to test the water that
is used in and on all of their products. They selected the
Microtox(R) system due to its ease of use and the ease of
incorporating the system into their normal food safety
analytical program. Their customers have commented how pleased
they are that the company is taking this action to protect the
products supplied to them and, in doing so, protecting their
brands.
"We are very pleased that American Water Company and food
processors have selected Microtox(R) Technology as part of their
comprehensive counter-terrorism drinking water monitoring
program," commented Richard C. Birkmeyer, President and CEO. "We
are also pleased that our work in making Microtox(R) available
to serve as an early warning technology for drinking water
systems has been recognized by Environmental Business Journal, a
leading environmental and water industry publication.
Microtox(R) technology is currently serving as a crucial part of
the drinking water security monitoring programs of many major
drinking water utilities across the country. Microtox(R)
provides the best means available for rapid detection of the
actual chemical impact and increase in toxicity from an
intentional contamination of drinking water. We are pleased that
Microtox(R) systems can serve in this important application to
help deter the threat of terrorism and we will continue to work
with more and
more major drinking water utilities, as well as food and
beverage companies, to maximize the utilization of this
important application of Microtox(R) technology."
Food safety revenues decreased in 2002,
primarily due to the significant decline in sales of
StarLink(TM) test kits from record sales levels in 2001, as the
removal of StarLink(TM) corn from the nation's grain supply
commenced late in 2000. StarLink(TM), which has been approved
only for non-food uses, was discovered in food products in 2000
and resulted in the need for growers, handlers, processors,
shippers and exporters to test corn for the presence of
StarLink(TM). The Company believes that reliance on genetically
modified organism (GMO) technology continues to grow both in the
U.S. and abroad, and that as a result, demand for the Company's
GMO testing products, other than tests for StarLink(TM), will
increase as well. Sales of Company's GMO tests for cottonseed
increased during 2002 and the Company believes it now supplies
every major cottonseed company (in terms of seed sales) in the
U.S. Many countries outside the U.S. and Canada have adopted
labeling regulations relating to GMO content that could
stimulate demand for the Company's GMO tests as food
manufacturers develop protocols to comply with these
regulations.
Since the July 2002 launch of the RapidChek(R) lateral flow test
for E. coli O157, several field evaluations have been performed
by major independent laboratories. The results from these
evaluations have prompted a globally recognized food safety
laboratory corporation to begin a nationwide implementation of
the RapidChek(R) E. coli O157 test method into its testing
protocols. This corporation expects its implementation to be
complete by the end of March 2003. Also, a leading global
foodservice provider has completed an in-depth study of the
RapidChek(R) E. coli O157 test method. According to statements
made by the foodservice provider, the findings of this study
revealed that laboratories performing the RapidChek(R) test
found a 65% reduction in overall false positives when compared
to a well-recognized competitive test, and that RapidChek(R)
showed greater sensitivity and was easier to use than the
competitive brand. This foodservice provider has endorsed the
use of RapidChek(R) tests for E. coli O157 testing by its meat
suppliers. Several of these meat suppliers initiated use of
RapidChek(R) in January 2003. Another significant evaluation
performed by a U.S. regulatory agency has shown that the
RapidChek(R) E. coli O157 growing media performs better
than other leading brands in either 8-hour or 24-hour methods.
Based on the foregoing, the Company expects to attract a
meaningful share of the worldwide E. coli testing market.
In January 2003, the Company conducted the commercial launch of
its newest food pathogen test to detect salmonella in food.
Salmonella is the most common food pathogen and is found in a
wide variety of foods including meats, dairy and processed
foods. The Company's new test has several advantages over
competitive methods including a simplified preparation process
that makes the test easier to perform versus competitive brands.
The product's performance standard meets all necessary
regulatory requirements. The Company has submitted the
salmonella test for third party validation by the AOAC Research
Institute and key evaluations are currently underway with major
food companies and laboratories. The Company expects to complete
a licensing agreement of a lateral flow reading instrument
to read and record test results from its food pathogen lateral
flow strip tests, including the strip test used to detect
salmonella.
In another development, the Company announced the release of its
screening test for the detection of meat and bone meal in animal
feed, which is linked to the transmission of BSE, commonly known
as mad cow disease. This test, known as FeedCheck, was designed
in a lateral flow format to be more sensitive and easier to use
than other rapid, on-site methods. Compared to certain
competitive products, this test does not require weighing or
boiling of samples. By eliminating these steps, the FeedCheck
test is faster, easier to use and will not require equipment
such as scales and heating devices. The method for animal feed
has been designed with multiple tests per strip to address the
various analytical requirements throughout the world. SDI's
product has been shown to detect as little as 0.1% bovine
meat-and-bone meal in feed. These product features are important
to comply with
customer specifications and governmental regulations throughout
the U.S., Europe and Japan. The test was developed in
collaboration with Molecular Circuitry, Inc. and sponsored by
McDonald's. Additionally, the Company's research and product
development efforts are continuing toward the completion of new
products, including tests for the food pathogen listeria.
Antibody segment revenues declined slightly in 2002 as the
Company completed the consolidation of its San Diego,
California, operations into a single site at its Maine location
during 2002. Several new or expanded relationships were
established during 2002 as customers and prospects had the
opportunity to validate manufacturing and quality procedures at
the expanded manufacturing facilities in Maine. The Company
believes that these relationships are designed to develop into
increasing sales, as the antibody division earns additional
projects under these relationships. The Company's project to
develop a point-of-treatment diagnostic test for Bayer's new
product Repinotan(TM) is continuing with Bayer's Phase III
clinical trials expected to be completed during 2003.
Fourth quarter manufacturing expenses were $3.6 million in the
fourth quarter of 2002 compared to $4.3 million in the prior
year fourth quarter. For the year, these expenses totaled $12.3
million in 2002 down from $14.5 million in 2001. The decrease
for the quarter and year is primarily attributable to lower
StarLink(TM)-related sales volume in 2002. For the year, gross
profits (total revenues less manufacturing costs) decreased $3.4
million or 23% to $11.4 million and gross margins declined to
48.1% in 2002 from 50.6% in 2001. The decline in gross margins
is primarily attributable to the fact that the Company's
utilization of its manufacturing capacity was reduced as
compared to 2001, a result of lower sales volume during 2002,
resulting primarily from reduced StarLink(TM)-related sales. The
Company instituted several initiatives late in the fourth
quarter 2002 and early in the first quarter 2003 to leverage its
manufacturing capacity and improve its production yields. One
such effort is the elimination of separate test kit and antibody
business units, resulting in a single manufacturing
organization.
Research and development expenses increased slightly to $850,000
in the fourth quarter of 2002 compared to $812,000 in the prior
year fourth quarter. For the year these expenses totaled $3.3
million in 2002 versus $3.0 million in 2001. These increases are
primarily due to continued investment in the animal feed test
and the lateral flow food pathogen tests.
Selling, general and administrative expenses decreased to $2.3
million in the fourth quarter of 2002 from $3.0 million in the
prior year fourth quarter primarily due to the Company's efforts
to lower its expenses, including the consolidation of its
antibody facilities in Maine. For the year, these expenses were
essentially flat at $10.3 million. These expenses are expected
to decline in 2003 as the Company has stepped-up its efforts to
streamline its operations, including creating a single sales and
marketing organization, which had previously been organized in
three distinct teams in the water quality, food safety and
antibody product categories. The Company believes that its new
sales organization structure is more efficient and will be more
effective in addressing all of the Company's market
opportunities.
Commenting on the recent product introductions and market
opportunities, Mr. Birkmeyer said, "We continue to build on our
reputation for quality products. We expect these new food safety
products to complement the growth of our sales in our water and
antibody products and together drive increase in 2003 revenues.
The recent organizational changes allow us to leverage our staff
and position us to meet the growth in revenues with improved
profitability."
In another development, the Company reported that its commercial
bank waived the loan covenant covering the required level of
EBITDA for the fourth quarter of 2002 and has amended the loan
covenants to a minimum quick ratio of 2.25 and a minimum
tangible net worth of $22.5 million for the first three quarters
of 2003. Beginning with the fourth quarter of 2003, the original
provisions of the loan agreement regarding financial covenants
will be operative, namely a ratio of EBITDA to current
maturities of debt plus interest and cash paid for taxes and a
ratio of funded debt to EBITDA. The Company reported cash and
working capital of $2.1 million and $12.5 million respectively
at December 31, 2002.
SDI is a leading provider of
biotechnology-based diagnostic tests for a broad range of
agricultural, industrial, and water treatment applications.
Through its antibody business, Strategic BioSolutions, Strategic
Diagnostics also provides antibody and immunoreagent research
and development services. SDI's test kits are produced in a
variety of formats suitable for field and laboratory use,
offering advantages of accuracy, cost-effectiveness,
portability, and rapid response. Trait Check(TM), GMO
QuickCheck(TM), and GMO Check(TM) are pending trademarks for
SDI.
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