SAN DIEGO, Jan. 26 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE), a leading research-based provider of novel, rapid medical
diagnostic tests, today reported a 44 percent year-over-year growth in
revenues in the fourth quarter spurred by growth in sales of its Triage(R) BNP
Test products. Operating margins increased to 25 percent for the quarter and
26 percent for the full year.
Biosite said its fourth quarter earnings were $12.1 million, or $.68 per
diluted share, compared with $5.2 million, or $.32 per diluted share in 2003.
Product sales for the quarter were $64.8 million, driven by a 50 percent
year-over-year increase in sales of its Triage BNP Test products. The Company
noted that the fourth quarter earnings were favorably affected by a decrease
in its effective income tax rate amounting to $.09 per diluted share.
The Company set its 2005 annual growth targets for total revenues at 10 to
15 percent and net income at 10 to 20 percent.
Following are financial highlights for the quarter and year ending
December 31, 2004:
($ in 000's, except per share data and margins)
Three months ended Twelve months ended
12/31/04 12/31/03 Chg. 12/31/04 12/31/03 Chg.
Triage(R) BNP
sales $43,494 $28,910 50% $162,012 $103,224 57%
Total product
sales 64,756 45,015 44% 240,607 169,298 42%
Total revenues 66,220 45,955 44% 244,942 173,364 41%
Net income 12,146 5,152 136% 41,448 24,763 67%
Earnings per
share (Diluted) $.68 $.32 114% $2.42 $1.50 62%
Gross margin on
product sales 67% 63% 67% 65%
Operating margin 25% 17% 26% 22%
December 31, 2004 December 31, 2003 Chg.
Cash and
marketable
securities
balance $72,410 $53,934 34%
"With sound fundamentals in our U.S. BNP franchise, we think the prospects
for continuing growth in 2005 are positive," said Kim Blickenstaff, chairman
and chief executive officer. "As we enter 2005, we are focused on maintaining
our market position, expanding our presence through multiple product lines,
building up our physician office and point-of-care businesses and preparing
for the launch of our new MultiMarker Index products."
Blickenstaff noted that the success of the Triage BNP Test, since its U.S.
Food and Drug Administration (FDA) clearance in November 2000, has enabled
Biosite to build significant market presence, which the Company aims to
leverage across other product lines. Biosite's Triage BNP Tests are used in
2,806 U.S. hospitals and 392 physician office labs as of December 31, 2004.
Research and Development Update
In addition to announcing quarterly and annual results, Biosite also
provided the following research and development updates:
-- During the fourth quarter of 2004, Biosite filed a premarket 510(k)
notification with the FDA seeking clearance to add acetaminophen to
the Triage TOX Drug Screen, a rapid test panel for the detection of
commonly abused drugs. Currently, the product tests for amphetamines,
methamphetamines, barbiturates, benzodiazepines, cocaine, opiates,
phencyclidine, marijuana and tricyclic antidepressants in urine.
Acetaminophen is estimated to represent five percent of all toxic
exposures annually (275,000 out of 5.2 million), and nearly 10 percent
of all toxic pharmaceutical exposures annually (275,000 out of
2.9 million).
-- As previously announced, Biosite filed a Premarket Approval
Application (PMA) at the end of 2004 for the Triage Stroke Panel. The
test is a rapid immunoassay intended for use in conjunction with
neurological imaging (e.g. CT scans) as an aid in the assessment and
diagnosis of cerebral ischemia (stroke). Currently, there are no
rapid, in vitro diagnostic tests that aid in the diagnosis of stroke,
utilizing protein markers from a blood sample, on the market in the
United States.
-- Biosite also reported that in the fourth quarter the FDA requested
that the Company file a PMA for the Triage Profiler CP Panel. As
reported in October 2004, Biosite had submitted a premarket 510(k)
notification to the FDA seeking clearance to market the addition of a
novel, proprietary MultiMarker Index(TM) algorithm that analyzes
information from all four markers on the currently marketed product
and presents a single composite result. The product is intended to
aid in the diagnosis of acute coronary syndromes including heart
attack.
"We understand the FDA's decision to seek a more comprehensive review
of the Triage Profiler CP Panel and, more specifically, the
MultiMarker Index, which is a new concept for interpreting blood
levels of multiple proteins," said Ken Buechler, Ph.D., president and
chief scientific officer. "We are already working with the FDA to
build upon the clinical data previously submitted and will seek
opportunities to expedite the approval process, if possible. We
believe this cooperative approach to understanding the function of our
MultiMarker Index will also facilitate the FDA's review and
understanding of our Triage Stroke Panel, which is currently under
review at the agency."
-- Biosite further confirmed that the Company remains on track to
commence the commercial launch in the first quarter of 2005 of the
Triage D-Dimer Test as an aid in the assessment and evaluation of
patients suspected of having thromboembolic events, including
pulmonary embolism.
About Biosite
A leader in the drive to advance diagnosis, Biosite(R) Incorporated is a
research-based company dedicated to the discovery and development of novel
protein-based diagnostic tests that improve a physician's ability to diagnose
debilitating and life-threatening diseases. Through combined expertise in
diagnostic discovery and commercialization, the Company is able to access
potential markers of disease, identify proteins with high diagnostic utility,
develop and commercialize products and educate the medical community on new
diagnostic approaches, thereby benefiting patients. Biosite's Triage(R) rapid
diagnostics are used in approximately 50 percent of U.S. hospitals and in over
50 international markets for toxicology screening and diagnosis of infectious
and cardiovascular disease. 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,
January 26, 2005, at 1:30 p.m. (Pacific). 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 706-643-1834. 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 3254959.
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 and net income; the
Company's ability to build its physician office and point-of-care businesses;
the Company's ability to achieve FDA approval of its pending PMA submission
for the Triage Stroke Panel; the Company's ability to submit a PMA for the
Triage Profiler CP Panel and to achieve FDA approval of that PMA on an
expedited basis; the benefits of the MultiMarker Index algorithm incorporated
in the Triage Profiler CP Panel; the Company's ability to commence commercial
shipments of the Triage D-Dimer Test during the first quarter of 2005; the
Company's ability to achieve FDA clearance of its 510(k) submission to add
acetaminophen to the Triage TOX Drug Screen; 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 stroke diagnostic product, Triage Profiler CP
Panel and Triage D-Dimer Test; the continued growth of the BNP market; 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,
Quarterly Report on Form 10-Q 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) and Triage(R) and New Dimensions in Diagnosis(R) are registered
trademarks of Biosite Incorporated. MultiMarker Index(TM) is a trademark of
Biosite Incorporated.
Biosite Incorporated
Unaudited Statements of Income Data
(in thousands, except per share data)
Three months ended Year ended
December 31, December 31,
% %
2004 2003 Change 2004 2003 Change
Total revenues:
Product sales $64,756 $45,015 44% $240,607 $169,298 42%
Contract revenue 1,464 940 56% 4,335 4,066 7%
Total revenues 66,220 45,955 44% 244,942 173,364 41%
Gross margin on product
sales 67% 63% 67% 65%
Operating expenses:
Cost of product sales 21,468 16,602 29% 79,388 58,567 36%
Selling, general and
administrative 17,730 14,506 22% 65,394 51,944 26%
Research and
development 10,282 6,975 47% 35,694 24,474 46%
License and patent
disputes 178 0 100% 178 0 100%
Total operating
expenses 49,658 38,083 30% 180,654 134,985 34%
Operating income 16,562 7,872 110% 64,288 38,379 68%
Operating income as % of
total revenue 25% 17% 26% 22%
Interest and other
income, net 814 274 197% 1,313 1,436 (9%)
Income before provision
for income taxes 17,376 8,146 113% 65,601 39,815 65%
Provision for income
taxes (5,230) (2,994) 75% (24,153) (15,052) 60%
Net income $12,146 $5,152 136% $41,448 $24,763 67%
Diluted net income per
share $0.68 $0.32 114% $2.42 $1.50 62%
Diluted shares used in
calculating per share
amounts 17,824 16,191 17,097 16,497
Biosite Incorporated
Balance Sheet Data
(in thousands)
December 31, 2004 December 31, 2003
(Unaudited)
Assets
Cash, cash equivalents &
marketable
securities $72,410 $53,934
Accounts receivable 36,867 23,755
Inventories 37,077 27,780
Other current assets 14,513 9,534
Total current assets 160,867 115,003
Property, equipment and leasehold
improvements, net 111,135 71,408
Patents and license rights, net 5,484 6,771
Other assets 6,029 1,442
Total assets $283,515 $194,624
Liabilities and Stockholders' Equity
Current liabilities $46,073 $24,128
Long-term liabilities 17,105 17,593
Stockholders' equity 220,337 152,903
Total liabilities and
stockholders' equity $283,515 $194,624
SOURCE Biosite Incorporated
 back to top
Related links:
http://www.biosite.com
Company News On-Call:
http://www.prnewswire.com/comp/116737.html
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations of Biosite Incorporated, +1-858-455-4808, ext. 3187,
npadilla@biosite.com
|
