Company Provides Financial Guidance and Outlines R&D Objectives
SAN DIEGO, Oct. 25 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today reported results for the third quarter of 2005. The
Company also updated certain research and development milestones for 2006
aimed at expanding Biosite's portfolio of innovative diagnostic products.
Financial Results
In the third quarter of 2005, total revenues were $69.7 million, a
14 percent increase from $61.2 million in the comparable period of 2004. The
Company reported net income of $12.6 million for the quarter, a 21 percent
increase over the third quarter of 2004. Diluted earnings per share were
$0.68, compared with $0.60 in the third quarter of 2004, a 13 percent
increase.
Biosite generated positive cash flow in the third quarter while continuing
to invest in its new corporate facility, which is near completion. At
September 30, 2005, cash and marketable securities totaled $128.8 million, up
78 percent from $72.4 million at the end of 2004.
The Company tightened its 2005 annual growth target for revenues to a
range of 17 to 19 percent from 16 to 20 percent. Biosite also narrowed its
current 2005 annual growth target range for diluted earnings per share to 18
to 20 percent, compared with its previous target range of 15 to 21 percent.
Looking forward to 2006, Biosite management stated that it expects
year-over-year annual growth in total revenues of approximately 10 percent,
annual growth in net income of approximately 10 percent and annual growth in
diluted earnings per share of approximately 7 percent.
Biosite's expectations for 2006 exclude the effects of FAS 123R,
Share-Based Payment, which is related to expensing of share-based
compensation, such as stock options. FAS 123R is expected to be adopted for
2006.
"Our market research indicates that Biosite continues to lead the BNP
testing market with a 67 percent share of volume, and the market continues to
grow," said Kim Blickenstaff, Biosite's chairman and chief executive officer.
"In 2006 we expect our overall Triage BNP Test product growth rates will slow,
compared to recent years, as a result of both market saturation for diagnostic
applications in the hospital, and increased competition. However, we continue
to believe that increased utilization of BNP for risk assessment and physician
office testing have the potential to expand the BNP market in the future. In
the face of this market evolution, we feel our financial objectives for 2006
are reasonable.
"Also for 2006, we have determined that our primary research and
development objectives will be:
* U.S. regulatory approval of the Triage(R) Stroke Panel(TM).
* U.S. launch of the Triage Profiler with MPO (myloperoxidase) and the
Triage MPO Test, for evaluation of chest pain, in the first quarter of
2006 following regulatory submission in the fourth quarter of 2005.
* Launch of the Triage Profiler with MPO and with Biosite's proprietary
MultiMarker Index TM in Europe in the first half of 2006.
* Regulatory submissions for our planned sepsis and abdominal pain
tests.
* Completing pre-clinical development of a diagnostic test for acute
kidney injury.
"We believe these objectives, if successfully completed, have the
potential for restoring the growth rates we achieved during our pioneering
launch of the Triage BNP Test."
Following are financial highlights for the quarter ended September 30,
2005:
($ in 000's, except per share data and margins)
Three months ended Nine months ended
9/30/05 9/30/04 Chg. 9/30/05 9/30/04 Chg.
Triage(R) BNP Test
sales $43,892 $38,936 13% $142,721 $118,518 20%
Total product sales 68,888 60,392 14% 211,282 175,851 20%
Total revenues 69,668 61,183 14% 215,278 178,722 20%
Net income 12,569 10,381 21% 40,333 29,302 38%
Diluted earnings per
share $0.68 $0.60 13% $2.19 $1.74 26%
Shares used in
calculating diluted
per share amounts 18,596 17,311 7% 18,394 16,864 9%
Gross margin on product
sales 70% 69% 70% 67%
Operating margin 28% 28% 29% 27%
September 30, 2005 December 31, 2004 Chg.
Cash and marketable
securities balance $128,846 $72,410 78%
Research and Development Update
As previously reported, in the third quarter of 2005 the U.S. Food and
Drug Administration (FDA) granted a CLIA waiver for the Triage BNP Test,
substantially expanding healthcare professionals' access to the 15-minute
blood test to aid in the diagnosis and assessment of patients with symptoms of
heart failure. Biosite currently has the only CLIA-waived natriuretic peptide
test that can be used by any healthcare professional.
Additionally, in September Biosite reported that the FDA cleared a new
indication for the Triage BNP Test enabling it to be used to help physicians
assess the risk of mortality or re-hospitalization in heart failure patients.
Biosite also reported that earlier this month the FDA agreed to Biosite's
request for an extension for the Premarket Approval Application (PMA) for the
Triage Stroke Panel, which is on hold pending submission of additional
information. Biosite plans to submit additional information prior to the end
of the first quarter of 2006. The Triage Stroke Panel was launched in several
European countries during the third quarter of 2005.
In October, Biosite conducted its second annual R&D Day for investors.
The Company reported pre-clinical proof of principle sufficient to support
continued development activities for diagnostic panels aimed at acute coronary
syndromes and sepsis. Biosite also indicated that it has initiated research
projects for potential panels for acute kidney injury, respiratory infections
and cancer.
About Biosite(R) 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 more than 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,
October 25, 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, 9802947.
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
and 2006 fiscal years, such as anticipated growth in revenues, net income and
earnings per share and anticipated growth in the Company's target markets; the
Company's ability to launch new products, such as MPO tests and panels, the
Company's ability to define panels of biomarkers for sepsis and abdominal pain
to file FDA submissions for both panels in 2006; the Company's ability to
complete development of a diagnostic test for renal injury; the Company's
ability to restore historical growth rates by achieving its objectives; 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 and complete clinical trials as currently planned for a
sepsis panel and a panel for use in evaluating one or more causes of abdominal
pain; 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. 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 Nine Months Ended
September 30, September 30,
% %
2005 2004 Change 2005 2004 Change
Total revenues:
Product sales $68,888 $60,392 14% $211,282 $175,851 20%
Contract revenue 780 791 (1%) 3,996 2,871 39%
Total revenues 69,668 61,183 14% 215,278 178,722 20%
Gross margin on
product sales 70% 69% 70% 67%
Operating expenses:
Cost of product
sales 20,900 18,583 12% 64,155 57,920 11%
Selling, general and
administrative 17,858 16,108 11% 54,930 47,664 15%
Research and
development 10,549 9,588 10% 31,509 25,412 24%
License and patent
disputes 788 -- 1,340 --
Total operating
expenses 50,095 44,279 13% 151,934 130,996 16%
Operating income 19,573 16,904 16% 63,344 47,726 33%
Operating income as
% of total revenue 28% 28% 29% 27%
Interest and other
income, net 1,095 119 820% 1,669 499 234%
Income before provision
for income taxes 20,668 17,023 21% 65,013 48,225 35%
Provision for income
taxes (8,099) (6,642) 22% (24,680) (18,923) 30%
Net income $12,569 $10,381 21% $40,333 $29,302 38%
Diluted net income
per share $0.68 $0.60 13% $2.19 $1.74 26%
Diluted shares used in
calculating per share
amounts 18,596 17,311 18,394 16,864
Biosite Incorporated
Unaudited Balance Sheet Data
(in thousands)
September 30, 2005 December 31, 2004
Unaudited
Assets
Cash, cash equivalents
& marketable securities $128,846 $72,410
Accounts receivable 26,875 36,867
Inventories 31,949 37,077
Other current assets 12,192 14,513
Total current assets 199,862 160,867
Property, equipment and leasehold
improvements, net 142,344 111,135
Patents and license rights, net 4,529 5,484
Other assets 6,730 6,029
Total assets $353,465 $283,515
Liabilities and Stockholders' Equity
Current liabilities $45,701 $46,073
Long-term liabilities 14,849 17,105
Stockholders' equity 292,915 220,337
Total liabilities and
stockholders' equity $353,465 $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 of Biosite Incorporated, +1-858-805-2820,
npadilla@biosite.com
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