SAN DIEGO, April 24 /PRNewswire-FirstCall/ -- Biosite(R) Incorporated
(Nasdaq: BSTE) today reported financial results for the first quarter of
2006. The Company also provided updates on several research and development
projects and announced that its board of directors has authorized a new
stock repurchase of up to $50 million of common stock.
Key Financial Results
* Revenues for the first quarter of 2006 totaled $79.3 million, a
10 percent increase from $71.8 million in the comparable period of
2005. The Company benefited from diversified product sales growth
among its BNP, and other cardiovascular and drug screening product
lines. International sales also increased 19 percent over the first
quarter of 2005.
* GAAP diluted earnings per share were $0.68, and Non-GAAP diluted
earnings per share were $0.92. By comparison, in the first quarter of
2005 the Company's diluted earnings per share were $0.76. The Company
noted that its first quarter earnings in 2006 were favorably affected
by the resolution of certain tax contingencies following the recent
completion of an IRS audit of certain prior years amounting to $0.05
per diluted share.
Non-GAAP results in the first quarter of 2006 exclude the impact of FAS
123R, Share-Based Payment, which relates to the expensing of non-cash
stock-based compensation, such as stock options. The Company adopted
FAS 123R as of January 1, 2006 on a modified prospective basis. See
the tables included at the end of this release for a reconciliation of
Non-GAAP financial results to GAAP financial results. See also "About
Non-GAAP Financial Measures" below.
* GAAP operating income for the first quarter of 2006 was $18.5 million.
On a Non-GAAP basis, operating income in the first quarter was
$24.6 million. In the comparable period of 2005, operating income was
$22.1 million.
* Biosite also announced that in the quarter it completed the repurchase
of approximately 576,000 shares of its outstanding common stock for
$30 million. After taking into account the cash used to complete those
repurchases, Biosite's cash and marketable securities totaled
$131.2 million at March 31, 2006, compared with $132.4 million at
December 31, 2005. In the first quarter of 2006, cash flow from
operations was $31.0 million.
In addition, Biosite announced its board of directors has approved a
program for the repurchase of up to an additional $50 million of
Biosite common stock over the next 12 months. The timing of
repurchases and the exact number of shares of common stock to be
purchased will depend upon prevailing market conditions, the Company's
balances of cash resources and other factors. Repurchases under this
program will be made using the Company's own cash resources and may be
made in the open market, in privately negotiated transactions, or
through the use of derivative securities and similar arrangements.
Following are financial highlights pertaining to revenues and cash flow
for the quarters ended March 31, 2006 and 2005:
($ in 000's)
Three months ended
3/31/06 3/31/05 Change
Triage(R) BNP Test sales $52,564 $49,771 6%
Other cardiovascular products 12,106 8,062 50%
Other products 13,487 12,663 7%
Total product sales 78,157 70,496 11%
Total revenues 79,332 71,846 10%
Cash flow from operations $30,996 $31,642 (2%)
Cash used for stock repurchases 30,000 --
3/31/06 12/31/05 Change
Cash and marketable
securities balance $131,165 $132,412 (1%)
"The year has started on a solid note, with growth in all of our major
product lines and strong gross margins and operating margins," said Kim
Blickenstaff, Biosite's chairman and chief executive officer. "In the first
quarter, we continued to successfully defend our BNP franchise and realized
growth resulting from a combination of increases in utilization and new
account adoptions. In the high-volume segment of the market we experienced
strong sales and placement growth with our Triage BNP Test for the Beckman
Coulter Immunoassay Systems."
Financial Guidance Update
Commenting on expectations for 2006, Biosite management reiterated its
previous 2006 total revenue target of approximately $318.0 million. The
Company raised its Non-GAAP diluted earnings per share target from $3.12 to
approximately $3.34, and its GAAP diluted earnings per share target
increased from $2.14 to approximately $2.30.
See the Biosite Incorporated Guidance Data table included at the end of
this release for additional details regarding the Company's financial
guidance data, a reconciliation of Non-GAAP financial guidance to GAAP
financial guidance and a description of certain factors that could affect
the Company's actual financial results. See also "About Non-GAAP Financial
Measures" below.
In addition to providing financial results, the Company offered the
following research, regulatory and litigation updates:
Research and Development Update
* Biosite continued to advance development of a panel for sepsis in the
first quarter of 2006. The Company has identified several promising
markers that could be used on its panel in order to potentially improve
performance and continues internal research to define the composition
of a final version of the panel. Biosite has targeted the second half
of 2006 for the initiation of prospective clinical studies for
regulatory filings.
* As previously reported, in the first quarter of 2006, Biosite entered
into an agreement with Eli Lilly & Co to develop a Protein-C test that
will be used in connection with a clinical trial employing a tailored
therapy strategy for Lilly's severe sepsis drug, Xigris(R) (drotrecogin
alfa [activated]). The clinical trial is expected to begin in the
fourth quarter of 2006.
Regulatory Update
* During the first quarter Biosite engaged in conversations with the U.S.
Food and Drug Administration (FDA) regarding its anticipated submission
of additional information related to the Company's ongoing Premarket
Approval (PMA) application for the Triage(R) Stroke Panel, which
remains on hold pending submission of additional information. The
Company is continuing to analyze the additional clinical data that it
collected subsequent to its initial PMA filing and is compiling other
information responsive to questions from the FDA. The Triage Stroke
Panel was launched in several European countries during the third
quarter of 2005.
* Reporting on progress of the 510(k) Premarket Notification submission
for its myeloperoxidase (MPO) assays, Biosite reported that it has
received initial comments from the FDA and is working with the agency
to submit responsive information during the second quarter of 2006.
Biosite is targeting mid-2006 for U.S. and European launches of the
Triage MPO Test and a second generation Triage Cardio Profiler(R) Panel
that will include MPO, a biomarker of inflammation in the vascular
system.
* In the first quarter of 2006, the Company filed a 510(k) Premarket
Notification for a new Triage TOX Drug Screen Panel that includes
methadone. The enhanced Triage TOX Drug Screen Panel will enable an
emergency department physician to test for the presence of 10 commonly
overdosed or abused drugs in approximately 15 minutes.
Litigation Update
* The Company's ongoing patent litigation with Roche Diagnostics and
several of its affiliated entities, both in the United States District
Courts of the Southern District of California and the Southern District
of Indiana, remain subject to a previously announced stay through the
end of April 2006. If the parties are unable to reach a mutually
acceptable resolution, it is likely that the litigation in both courts
will resume. As of March 2006, one of the two patents that Roche is
asserting against Biosite, U.S. Patent 4,816,224, has expired.
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 more than 50 percent of
U.S. hospitals and in more than 60 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 24, 2006, 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 (617) 614-4076. The conference call code for the
live call is 91493864. The call will be archived on the Biosite website for
at least 21 days. The phone replay number is (888) 286-8010. International
callers, please dial (617) 801-6888. Please reference the conference call
code 34509395.
About Non-GAAP Financial Measures
This press release contains financial results and guidance that
excludes the effects of FAS 123R, Share-Based Payment, which relates to
stock-based compensation, is not in accordance with U.S. generally accepted
accounting principles (GAAP). The Company believes that this non-GAAP
financial measure provides meaningful supplemental information to both
management and investors that is indicative of the Company's core operating
results and facilitates comparison of operating results across reporting
periods. The Company uses this non-GAAP measure when evaluating its
financial results as well as for internal resource management, planning and
forecasting purposes. This non- GAAP measure should not be viewed in
isolation to or as a substitute for the Company's financial results or
guidance in accordance with GAAP. Assumptions regarding the valuation of
stock-based compensation and the timing of events, such as the issuance of
new stock-based compensation awards and the realization of tax benefits,
may differ from actual results. For more information, please see the
guidance table included at the end of this release.
This press release contains 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 2006 fiscal year, such as anticipated
revenues and earnings per share; the Company's plans to submit additional
information to the FDA concerning the Triage Stroke Panel and MPO tests and
panels; the Company's ability to launch new products when expected; the
Company's ability to define panels of biomarkers for sepsis and to commence
clinical trials for a potential sepsis panel in 2006; and the Company's
ability to complete development of a diagnostic test for renal injury.
There are also other forward-looking statements in this release regarding
the pending stay of litigation between Biosite and Roche Diagnostics. The
discussions between Biosite and Roche may not lead to a settlement of
either pending case and any such settlement, if reached, may not be on
favorable terms. Risks and uncertainties include risks associated with
Biosite's ability to commence and complete clinical trials as currently
planned; Biosite's ability to adequately respond to the FDA's questions
regarding the pending PMA filing for the Triage Stroke Panel in the time
permitted; Biosite's ability to complete the development of a satisfactory
Protein C test; Biosite's ability to obtain regulatory approvals and
complete other pre-market activities needed to launch new products as
currently planned, including the Triage Stroke Panel, MPO test and panel,
the Triage TOX Drug Screen plus MTD Panel and a Protein C test; Biosite's
ability to effectively promote and market acceptance of any new products;
the continued growth of the BNP market generally, including the physician
office market; and other risks associated with changing market conditions
and the effect of competition from companies with greater capital and
resources. 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 are detailed in the
Company's most recent Annual Report on Form 10-K 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 or from the Company's web
site.
Biosite(R), Cardio Profiler(R), Triage(R) and New Dimensions in
Diagnosis(R) are registered trademarks of Biosite Incorporated.
Biosite Incorporated
Unaudited Statements of Income Data - GAAP
(in thousands, except per share data and margins)
Three months ended
March 31,
2006 2005 % Change
Total revenues:
Product sales $78,157 $70,496 11%
Contract revenue 1,175 1,350 (13%)
Total revenues 79,332 71,846 10%
Gross margin on
product sales 70% 71%
Operating expenses:
Cost of product
sales 23,105 20,240 14%
Selling, general
and administrative 23,966 18,557 29%
Research and
development 13,698 10,768 27%
License and patent
disputes 41 209 (80%)
Total operating
expenses 60,810 49,774 22%
Operating income 18,522 22,072 (16%)
Operating income as
% of total revenue 23% 31%
Interest and other
income, net 1,248 59 2015%
Income before
provision for income
taxes 19,770 22,131 (11%)
Provision for income
taxes (7,213) (8,339) (14%)
Net income $12,557 $13,792 (9%)
Diluted earnings per
share $0.68 $0.76 (11%)
Diluted shares used
in calculating per
share amounts 18,601 18,226
Share-based compensation expense for stock
options and Employee Stock Purchase Plan
recorded in accordance with FAS 123R for
continuing operations:
Cost of product sales $222 $--
Selling, general and
administrative 4,022 --
Research and
development 1,810 --
Subtotal $6,054 $--
Tax (Benefit)/Provision (1,639) --
Total $4,415 $--
Biosite Incorporated
Unaudited Statements of Income Data - Non-GAAP
(in thousands, except per share data and margins)
NOTE: Non-GAAP results exclude the impact of FAS 123R, which relates to
the expensing of non-cash stock-based compensation
Three months ended
March 31,
2006 2005 % Change
Total revenues:
Product sales $78,157 $70,496 11%
Contract revenue 1,175 1,350 (13%)
Total revenues 79,332 71,846 10%
Gross margin on
product sales 71% 71%
Operating expenses:
Cost of product
sales 22,883 20,240 13%
Selling, general
and administrative 19,944 18,557 7%
Research and
development 11,888 10,768 10%
License and patent
disputes 41 209 (80%)
Total operating
expenses 54,756 49,774 10%
Operating income 24,576 22,072 11%
Operating income as
% of total revenue 31% 31%
Interest and other
income, net 1,248 59 2015%
Income before
provision for income
taxes 25,824 22,131 17%
Provision for income
taxes (8,852) (8,339) 6%
Net income $16,972 $13,792 23%
Diluted earnings per
share $0.92 $0.76 21%
Diluted shares used in
calculating per share
amounts 18,493 18,226
Biosite Incorporated
Unaudited Reconciliation of Consolidated Statements of Income Data - Non-GAAP
to Consolidated Statements of Income Data - GAAP
(in thousands, except per share data and margins)
Three months ended Three months ended
March 31, 2006 March 31, 2005
Non-GAAP Adjmts GAAP Non-GAAP Adjmts GAAP
Total revenues:
Product sales $78,157 $-- $78,157 $70,496 $-- $70,496
Contract
revenue 1,175 -- 1,175 1,350 -- 1,350
Total
revenues 79,332 -- 79,332 71,846 -- 71,846
Gross margin on
product sales 71% (1%) 70% 71% 0% 71%
Operating expenses:
Cost of product
sales 22,883 222 [a] 23,105 20,240 -- 20,240
Selling,
general and
administrative 19,944 4,022 [a] 23,966 18,557 -- 18,557
Research and
development 11,888 1,810 [a] 13,698 10,768 -- 10,768
License and
patent
disputes 41 -- 41 209 -- 209
Total
operating
expenses 54,756 6,054 60,810 49,774 -- 49,774
Operating income 24,576 (6,054) 18,522 22,072 -- 22,072
Operating income as
% of total revenue 31% (8%) 23% 31% 0% 31%
Interest and other
income, net 1,248 -- 1,248 59 -- 59
Income before
provision
for income taxes 25,824 (6,054) 19,770 22,131 -- 22,131
Provision for
income taxes (8,852) 1,639 [a] (7,213) (8,339) -- (8,339)
Net income $16,972 $(4,415) $12,557 $13,792 $-- $13,792
Diluted earnings
per share $0.92 $(0.24) $0.68 $0.76 $-- $0.76
Diluted shares
used in
calculating per
share amounts 18,493 108 18,601 18,226 -- 18,226
[a] - Adjustments to exclude from Non-GAAP financial measures the impact
of FAS 123R, which relates to the expensing of non-cash stock-based
compensation, beginning the first quarter of 2006
Biosite Incorporates
Unaudited Balance Sheet Data
(in thousands)
March 31, 2006 December 31, 2005
Unaudited
Assets
Cash, cash equivalents &
marketable securities $131,165 $132,412
Accounts receivable 31,070 30,303
Inventories 33,089 32,627
Other current assets 8,173 9,422
Total current assets 203,497 204,764
Property, equipment and
leasehold improvements, net 153,304 151,018
Patents and license rights, net 4,422 4,764
Other assets 8,863 7,380
Total assets $370,086 $367,926
Liabilities and Stockholders' Equity
Current liabilities $46,974 $39,104
Long-term liabilities 12,139 13,457
Stockholders' equity 310,973 315,365
Total liabilities and
stockholders' equity $370,086 $367,926
Biosite Incorporated
Guidance Data
(in thousands, except per share data, margins and %'s)
The financial guidance provided below is an estimate based on
information available as of April 24, 2006. The Company's future
performance and financial results are subject to risks and uncertainties,
and actual results could differ materially from the guidance set forth
below. Some of the factors that could affect the Company's actual financial
results are stated above in the section entitled "Forward-looking
Statements" and in the Company's filings with the SEC. The Company assumes
no obligation to update the guidance set forth below.
Three months ended June 30, 2006
Non-GAAP GAAP
Estimate Adjustments(a) Estimate
BNP product sales $50,000 -- $50,000
Total product sales $76,000 -- $76,000
Total revenues $77,500 -- $77,500
International sales % of total
sales 14.5% -- 14.5%
Gross margin on product sales 70.0% (1.0%)(b) 69.0%
Operating expenses (excl. Cost
of sales) % of Revenue 40.5% 8.5% (b) 49.0%
Operating income as % of total
revenues 29.0% (9.5%)(b) 19.5%
Diluted earnings per share $0.80 $(0.28)(b) $0.52
Income tax rate 37.8% 4.0% (b) 41.8%
Cash flow from operations $20,000 -- $20,000
Year ended December 31, 2006
Non-GAAP GAAP
Estimate Adjustments(a) Estimate
BNP product sales $201,000 -- $201,000
Total product sales $313,000 -- $313,000
Total revenues $318,000 -- $318,000
International sales % of total
sales 14.5% -- 14.5%
Gross margin on product sales 69.5% (1.0%)(b) 68.5%
Operating expenses (excl. Cost
of sales) % of Revenue 40.0% 8.0% (b) 48.0%
Operating income as % of total
revenues 29.0% (9.0%)(b) 20.0%
Diluted earnings per share $3.34 $(1.04)(b) $2.30
Income tax rate 37.0% 3.0% (b) 40.0%
Cash flow from operations $85,000 -- $85,000
(a) These adjustments reconcile the Company's non-GAAP financial guidance
to its GAAP financial guidance for the next quarter and full year
2006. See the section entitled "About Non-GAAP Financial Measures"
above.
(b) Reflects the estimated non-cash compensation expense attributable to
stock-based compensation awards including stock options and employee
stock purchase plan shares and their estimated impact on income taxes
and diluted shares used in calculating EPS.
Biosite Incorporated
Selected Product Data
(in thousands, except margins and %'s)
Sales by Product:
Q1 2005 Q2 2005 Q3 2005 Q4 2005 Q1 2006
Triage(R) Drugs of Abuse
Products $10,283 $11,341 $12,408 $11,018 $11,547
Triage Cardiac Panel 5,985 6,439 7,142 6,629 6,616
Triage BNP Tests 49,771 49,058 43,892 46,893 52,564
Triage Profiler Products 1,946 2,226 2,852 3,465 4,036
Triage D-Dimer Test 131 481 757 1,489 1,417
Triage Parasite Panel 255 283 355 269 286
Triage C. difficile Panel 1,349 1,377 942 988 1,029
Triage Meter 776 693 538 724 625
Triage Stroke Panel (EU) -- -- 2 15 37
Total Product Sales $70,496 $71,898 $68,888 $71,490 $78,157
International Sales:
Q1 2005 Q2 2005 Q3 2005 Q4 2005 Q1 2006
International Sales as % of
Total Sales 13% 12% 12% 13% 14%
BNP International Sales as
% of BNP Total Sales 10% 9% 9% 10% 11%
Margin by Product Type (a),
(b):
Q1 2005 Q2 2005 Q3 2005 Q4 2005 Q1 2006
Triage Drugs of Abuse
Product Line 82% 78% 82% 81% 79%
Triage Cardiovascular
Product Line (incl. BNP) 72% 69% 69% 70% 71%
(a) These margins do not include all products. The Triage Meter, Triage
Micro Product Line and Triage Stroke Panel are not included.
(b) Includes the impact of FAS 123R, which relates to the expensing of
non-cash stock-based compensation, beginning the first quarter of 2006
SOURCE Biosite Incorporated
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Related links:
http://www.biosite.com
http://www.prnewswire.com/comp/116737.html /
CONTACT:
Nadine Padilla, VP, Corporate & Investor
Relations, +1-858-805-2820, npadilla@biosite.com, or Nicole
Beckstrand, Manager, Public Relations, +1-858-805-2803,
nbeckstrand@biosite.com, both of Biosite Incorporated
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