Company Says Triage(R) Stroke Panel(TM) Now Available in Europe
SAN DIEGO, July 26 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today reported results for the second quarter of 2005.
Additionally, the Company announced commercialization of its Triage(R) Stroke
Panel(TM) in the European Union, with registration pending in other
international markets.
Financial Results
In the second quarter of 2005, total revenues grew 23 percent, rising to
$73.8 million from $59.9 million in the comparable period of 2004. The
Company reported net income of $14.0 million for the quarter, a 40 percent
increase over the second quarter of 2004. Diluted earnings per share were
$0.76, compared with $0.59 in the second quarter of 2004, a 29 percent
increase.
Based on its second quarter results, the Company raised its 2005 annual
growth target for diluted earnings per share to 15 to 21 percent from 10 to 20
percent. The Company narrowed its 2005 annual growth target range for
revenues to 16 to 20 percent from 15 to 20 percent.
"In the second quarter of 2005, we maintained strong year-over-year sales
growth despite increasing competition," said Kim Blickenstaff, Biosite
chairman and chief executive officer. "We also scaled-up new products, such
as the Triage D-Dimer Test and Triage Profiler Tests. Development of our
international operations continued, with sales growing 46 percent year-over-
year in the second quarter.
"We are pleased with our earnings growth, which resulted, in part, from
lower than expected expenses. While we will incur some of these expenses in
future quarters, overall expense management has been good."
Following are financial highlights for the quarter ending June 30, 2005:
($ in 000's, except per share data and margins)
Three months ended Six months ended
6/30/05 6/30/04 Chg. 6/30/05 6/30/04 Chg.
Triage(R) BNP
sales $49,058 $40,430 21% $98,829 79,582 24%
Total product
sales 71,898 58,761 22% 142,394 115,459 23%
Total revenues 73,764 59,862 23% 145,610 117,539 24%
Net income 13,972 9,976 40% 27,764 18,921 47%
Earnings per
share (Diluted) $.76 $.59 29% $1.52 1.14 34%
Gross margin on
product sales 68% 67% 70% 66%
Operating margin 29% 27% 30% 26%
June 30, 2005 December 31, 2004 Chg.
Cash and marketable
securities balance $119,463 $72,410 65%
"We have recently commenced the move into our new corporate facilities,
with expanded research and manufacturing capacity," said Blickenstaff. "It is
exciting to begin a new chapter in our story, backed by a solid base of
business, excellent operating fundamentals, a strong balance sheet and an
exciting product pipeline."
Triage Stroke Panel
The CE Marked Triage Stroke Panel is a rapid immunoassay intended to aid
in the assessment and diagnosis of stroke. The test uses a small sample of
blood to simultaneously measure four biomarkers, brain natriuretic peptide
(BNP), D-dimer, MMP-9, and S100(beta). It is the first commercialized Biosite
test to incorporate the Company's proprietary MultiMarker Index(TM) feature,
which analyzes information from multiple biomarkers and presents a single
composite index result.
The Triage Stroke Panel is now being sold in the European Union. The test
is currently not approved for sale in the United States.
"With the European launch of the Triage Stroke Panel, Biosite takes an
important step forward in providing the European medical community with a
diagnostic tool to help physicians identify patients who should be on the
stroke care pathway," said Blickenstaff. "The incidence of stroke is on the
rise and the lack of readily available diagnostic tools is evident. This test
is designed to add important objective information to the physician's
assessment of a patient presenting with symptoms of stroke."
Research and Development Update
In the area of research and development, Biosite reported that in the
second quarter of 2005 it advanced its study of potential biomarkers for
sepsis. The Company, which is seeking to identify panels of biomarkers for
use in the diagnosis and risk assessment of sepsis, has now measured 56
biomarkers and has observed favorable results with preliminary panels.
Biosite intends to continue its research and is targeting the second half of
2005 for the commencement of clinical studies.
During the quarter, the Company also continued research associated with a
potential panel of biomarkers for use in evaluating one or more common causes
of acute abdominal pain, such as acute pancreatitis, appendicitis and ischemic
bowel disease. Sample collection related to early stage development of a
potential abdominal pain panel is underway, and the Company is aiming to
define a panel of biomarkers in the second half of 2005.
About Biosite Incorporated
Biosite Incorporated is a leading bio-medical company commercializing
proteomics discoveries for the advancement of medical diagnosis. The
Company's products contribute to improvements in medical care by aiding
physicians in the diagnosis of critical diseases and health conditions.
Biosite's Triage(R) rapid diagnostics are used in approximately 50 percent of
U.S. hospitals and in over 50 international markets. Information on Biosite
can be found at http://www.biosite.com.
For information on ordering the Triage Stroke Panel in Europe, please call
+33 1 39 20 21 00 or visit http://www.biosite.com.
Investor Conference Call
Biosite will host an investor conference call to discuss financial results
and research and development progress. The call will take place today, July
26, 2005, at 1:30 p.m. PDT. A live webcast of the call can be accessed via
the Internet at http://www.biosite.com. The phone number for U.S. and international
callers is (706)634-7088. The call will be archived on the Biosite website
for at least 21 days. The phone replay number is (800)642-1687.
International callers, please dial (706)645-9291. Please reference the
conference call code, 7772745.
Except for the historical information presented herein, matters discussed
in this press release are forward-looking statements that involve risks and
uncertainties that could cause actual results to differ materially from any
future results, performance or achievements expressed or implied by such
statements. Examples of forward-looking statements are financial targets and
growth objectives and also include but are not limited to statements that are
preceded by, followed by, or that include the words "will"; "believes";
"should"; "intend"; "anticipates"; "plans"; "expects"; "estimates"; or similar
statements. Forward-looking statements in this press release include
statements: regarding the Company's expected financial performance for the
2005 fiscal year, such as anticipated growth in revenues and earnings per
share; the Company's ability to scale-up new products, such as the Triage D-
Dimer Test; the benefits of the Triage Stroke Panel in the assessment of
patients presenting with symptoms of stroke; the Company's ability to identify
an optimal panel of biomarkers for the diagnosis and risk assessment of sepsis
patients and to commence clinical studies for such a product in the second
half of 2005; the Company's ability to define a panel of biomarkers for use in
evaluating one or more causes of abdominal pain in the second half of 2005;
and the Company's ability to access potential markers of disease, identify
proteins with high diagnostic utility, and develop and commercialize products
and educate the medical community on new diagnostic approaches. Risks and
uncertainties include risks associated with Biosite's ability to obtain
regulatory approvals and complete other clinical and pre-market activities
needed to launch new products as currently planned, including the Triage
Stroke Panel; Biosite's ability to effectively promote and market acceptance
of the Triage Stroke Panel; the continued growth of the BNP market; Biosite's
ability to commence clinical trials as currently planned for a sepsis panel
and a six-marker panel for acute coronary syndromes; the implementation of
automated and semi-automated manufacturing methods that maintain or improve
product quality and manufacturing efficiency; costs and expenses that the
Company may incur in transitioning from a distributor sales model to a direct
sales model in selected international markets; Biosite's ability to
effectively promote the Triage BNP Tests, either directly or through
distributors, and acceptance of the Triage BNP Test in the physician office
market; and Biosite's ability to obtain a CLIA waiver for the rapid Triage BNP
Test. Biosite also faces risks associated with pending litigation between the
company and Roche Diagnostics Corporation and certain of its affiliates
(collectively "Roche"), including whether Biosite will be able to successfully
assert its claims against Roche, whether Biosite will be able to successfully
defend against the claims that Roche is asserting against the Company, as well
as whether the litigation will result in a significant diversion of effort by
Biosite's management and scientific personnel and/or the expenditure of funds
that exceed the Company's current estimates. Other risks that should be
considered include risks associated with changing market conditions, sales,
profitability, and the extent to which products under development are
successfully developed and gain market acceptance, risks associated with the
introduction of competitive products from companies with greater capital and
resources, and risks and expenses associated with litigation, contract
disputes, patent conflicts, product recalls, manufacturing constraints,
backlog, delays or inefficiencies, shipment problems, seasonal customer
demand, the timing of significant orders, changes in reimbursement policies,
regulatory changes, competitive pressures on average selling prices, changes
in the mix of products sold, and the other risks detailed in the Company's
most recent Annual Report on Form 10-K, as amended, and other SEC filings. The
Company disclaims, however, any intent or obligation to update these forward-
looking statements. Copies of the Company's SEC filings are available from the
Investor Relations department.
Biosite(R), Triage(R) and New Dimensions in Diagnosis(R) are registered
trademarks of Biosite Incorporated. MultiMarker Index(TM) and Stroke Panel(TM)
are trademarks of Biosite Incorporated.
Biosite Incorporated
Unaudited Statements of Income Data
(in thousands, except per share data)
Three months ended Six Months Ended
June 30, June 30,
% %
2005 2004 Change 2005 2004 Change
Total revenues:
Product sales $71,898 $58,761 22% $142,394 $115,459 23%
Contract revenue 1,866 1,101 69% 3,216 2,080 55%
Total revenues 73,764 59,862 23% 145,610 117,539 24%
Gross margin on
product sales 68% 67% 70% 66%
Operating expenses:
Cost of product
sales 23,015 19,595 17% 43,255 39,337 10%
Selling, general
and
administrative 18,515 15,673 18% 37,072 31,556 17%
Research and
development 10,192 8,336 22% 20,960 15,824 32%
License and
patent disputes 343 -- 552 --
Total operating
expenses 52,065 43,604 19% 101,839 86,717 17%
Operating income 21,699 16,258 33% 43,771 30,822 42%
Operating income
as % of total
revenue 29% 27% 30% 26%
Interest and other
income, net 515 186 177% 574 380 51%
Income before
provision for
income taxes 22,214 16,444 35% 44,345 31,202 42%
Provision for
income taxes (8,242) (6,468) 27% (16,581) (12,281) 35%
Net income $13,972 $9,976 40% $27,764 $18,921 47%
Diluted net
income per share $0.76 $0.59 29% $1.52 $1.14 34%
Diluted shares
used in
calculating per
share amounts 18,343 16,880 18,282 16,635
Biosite Incorporated
Unaudited Balance Sheet Data
(in thousands)
June 30, 2005 December 31,
Unaudited 2004
Assets
Cash, cash equivalents &
marketable securities $119,463 $72,410
Accounts receivable 26,579 36,867
Inventories 33,807 37,077
Other current assets 11,472 14,513
Total current assets 191,321 160,867
Property, equipment and leasehold
improvements, net 132,953 111,135
Patents and license rights, net 5,040 5,484
Other assets 6,749 6,029
Total assets $336,063 $283,515
Liabilities and Stockholders' Equity
Current liabilities $44,087 $46,073
Long-term liabilities 16,090 17,105
Stockholders' equity 275,886 220,337
Total liabilities and
stockholders' equity $336,063 $283,515
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
Company News On-Call:
http://www.prnewswire.com/comp/116737.html
CONTACT:
Investors-Media, Nadine Padilla, VP Corporate
and Investor Relations, +1-858-805-2820, npadilla@biosite.com, or
U.S. Trade Media, Nicole Beckstrand, +1-858-805-2803,
nbeckstrand@biosite.com, both of Biosite Incorporated; or
International Trade Media, Claire Eldridge of Fleishman Hillard
UK, +44-207-395-7111, eldridgc@fleishmaneurope.com, for Biosite
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