Company Reports Delay in Triage(R) Stroke Panel Review
SAN DIEGO, April 21 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today reported that its total revenues grew 25 percent to
$71.8 million, from $57.7 million in the comparable period of 2004. The
Company's net income was $13.8 million for the first quarter of 2005, a
54 percent increase over the $8.9 million reported in the first quarter of
2004. First quarter earnings per diluted share were $.76, compared with
$.55 in the first quarter of 2004, a 38 percent increase.
The Company also reported that it has received a letter from the U.S. Food
and Drug Administration (FDA) indicating that the Premarket Approval
Application (PMA) submitted in 2004 for Biosite's Triage Stroke Panel is on
hold pending submission of additional information. The letter further states
that the issues raised need to be resolved before the FDA can complete their
review, otherwise the PMA in its current form would be considered not
approvable.
"With a 31 percent operating margin in the first quarter, the year 2005 is
off to a great start from a financial perspective," said Kim Blickenstaff,
Biosite chairman and chief executive officer. "On the development side, we
believe in the potential of the Triage Stroke Panel and will continue to work
with the FDA to respond to the questions they have raised." The Company
intends to provide a revised timeline after further discussions with the
agency.
As a result of its performance and trends in the first quarter, the
Company raised its 2005 annual growth targets for total revenues and diluted
earnings per share to 15 to 20 percent and 10 to 20 percent, respectively.
The Company's previous growth targets for total revenues and diluted earnings
per share were 10 to 15 percent and five to 15 percent, respectively.
Following are financial highlights for the quarter ending March 31, 2005:
($ in 000's, except per share data and margins)
Three months ended
3/31/2005 3/31/2004 Change
Triage(R) BNP Test products
sales $49,771 $39,152 27%
Total product sales 70,496 56,698 24%
Total revenue 71,846 57,677 25%
Net income 13,792 8,945 54%
Diluted earnings per share $.76 $.55 38%
Gross margin on product sales 71% 65%
Operating margin 31% 25%
March 31, December 31,
2005 2004
Cash and marketable
securities $95,854 $72,410
"We saw sound performance this quarter in several areas," said
Blickenstaff. "Our Triage(R) BNP Test products led sales, posting 27 percent
year-over-year growth. In total, our other cardiovascular products grew
35 percent annually, while our Triage Drugs of Abuse and TOX Drug Screen
products grew 10 percent. We also launched the Triage D-Dimer Test to a solid
market reception. In the international markets, we achieved a 55 percent
increase in sales for the quarter."
"We believe three factors largely affected market demand for Triage BNP
Test products in the first quarter: changes in the number of hospitals using
the test, changes in the clinical uses for BNP and a seasonal trend," said Tom
Watlington, Biosite executive vice president and chief operating officer.
"Favorable trends in all of these areas have heightened our confidence in
maintaining leadership in the BNP market, thereby driving our positive outlook
for the year."
Research and Development Update
Biosite also provided the additional research and development updates:
During the first quarter, Biosite identified a new six-marker panel of
biomarkers intended to aid in the early evaluation of acute coronary
syndromes. Preliminary data have shown that the new panel has very high
overall diagnostic accuracy for acute coronary syndromes and heart attack.
The Company is continuing to study marker combinations and plans to initiate
clinical studies for the product as early as the second quarter of 2005.
Acute coronary syndromes are defined by a spectrum of clinical conditions
ranging from unstable angina, coronary heart disease-related chest pain at
rest, to non-Q wave and Q-wave acute myocardial infarction (i.e., heart
attack). They are among the most common disorders seen in the emergency
department and are often missed in many older patients who present with chest
pain. It is estimated that there are more than 1 million episodes of acute
coronary syndromes per year in persons aged 65 years and older and that up to
33 percent of acute heart attacks are clinically unrecognized in the older
population. In the United States, persons aged 65 years and older account for
more than 60 percent of acute heart attacks and for more than 80 percent of
heart attack deaths.
Biosite also reported that it continues to advance development of
potential multimarker panels for sepsis. Discovery work aimed at identifying
optimal panels of markers to aid in the diagnosis and risk assessment of
sepsis patients is progressing. Biosite is targeting the second half of 2005
for the commencement of clinical studies.
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.
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, April
21, 2005, at 1:30 p.m. PDT. A live web cast 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
5418856.
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 sales, net income and earnings
per share; the Company's ability to maintain a leadership position in the BNP
market; the Company's ability to resolve FDA concerns and address issues
related to its pending PMA submission for the Triage Stroke Panel; the
benefits of a six-marker panel of biomarkers in the early evaluation of acute
coronary syndromes patients and the Company's intention of commencing clinical
studies for such a product as early as the second quarter of 2005; the
Company's ability to identify an optimal panel of biomarkers for the risk
assessment of sepsis patients and to commence clinical studies for such a
product 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.
Biosite Incorporated
Unaudited Statements of Income Data
(in thousands, except per share data)
Three months ended
March 31,
2005 2004 %Change
Total revenues:
Product sales $70,496 $56,698 24%
Contract revenue 1,350 979 38%
Total revenues 71,846 57,677 25%
Gross margin on product sales 71% 65%
Operating expenses:
Cost of product sales 20,240 19,742 3%
Selling, general and
administrative 18,557 15,883 17%
Research and development 10,768 7,488 44%
License and patent disputes 209 0 100%
Total operating expenses 49,774 43,113 15%
Operating income 22,072 14,564 52%
Operating income as % of
total revenue 31% 25%
Interest and other income, net 59 194 (70%)
Income before provision
for income taxes 22,131 14,758 50%
Provision for income taxes (8,339) (5,813) 43%
Net income $13,792 $8,945 54%
Diluted net income per share $0.76 $0.55 38%
Diluted shares used in
calculating per share
amounts 18,226 16,366
Biosite Incorporated
Balance Sheet Data
(in thousands)
March 31, 2005 December 31, 2004
Unaudited
Assets
Cash, cash equivalents & marketable
securities $95,854 $72,410
Accounts receivable 31,052 36,867
Inventories 36,402 37,077
Other current assets 13,367 14,513
Total current assets 176,675 160,867
Property, equipment and leasehold
improvements, net 123,067 111,135
Patents and license rights, net 5,261 5,484
Other assets 6,658 6,029
Total assets $311,661 $283,515
Liabilities and Stockholders' Equity
Current liabilities $46,869 $46,073
Long-term liabilities 17,513 17,105
Stockholders' equity 247,279 220,337
Total liabilities and stockholders'
equity $311,661 $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:
Nadine Padilla, VP, Corporate & Investor
Relations, ext. 3187, npadilla@biosite.com, or Media, Nicole
Beckstrand, ext. 3686, nbeckstrand@biosite.com, both of Biosite
Incorporated, +1-858-455-4808
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