SAN DIEGO, Jan. 30 /PRNewswire-FirstCall/ -- Biosite Incorporated
(NASDAQ:BSTE) today reported financial results for the fourth
quarter and full year 2006 and discussed its revenue and earnings
per share guidance for 2007. The Company also provided an update on
clinical trials for several potential new products. Key Financial
Results * Revenues for the fourth quarter of 2006 totaled $76.9
million, a 6 percent increase from $72.4 million in the comparable
period of 2005. Year-over-year sales of Triage(R) BNP Test
products, which represented 63 percent of total product sales,
increased 2 percent in the quarter. Sales of Biosite's other
cardiovascular products increased 31 percent. Combined sales from
physician office and international markets increased 29 percent
over the fourth quarter of 2005. * For the fourth quarter of 2006,
GAAP diluted earnings per share was $0.60 and Non-GAAP diluted
earnings per share was $0.85. By comparison, in the fourth quarter
of 2005 the Company's diluted earnings per share was $0.73.
Non-GAAP results exclude the impact of FAS 123R, Share-Based
Payment, which relates to the expensing of non-cash stock-based
compensation, such as stock options and the Company's Employee
Stock Purchase Program awards. 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. The Company also noted
that 2006 fourth quarter earnings were favorably affected by the
resolution of certain tax contingencies amounting to $0.06 per
diluted share following the recent completion of a California
Franchise Tax Board audit of certain of the Company's prior years'
returns. * GAAP operating income for the fourth quarter of 2006 was
$15.0 million and Non-GAAP operating income was $21.1 million. In
the comparable period of 2005, operating income was $20.3 million.
* Cash generated from operations was $8.3 million in the fourth
quarter of 2006 and $75.1 million for the year. * For the year
ended December 31, 2006, total revenues were $308.6 million, a 7
percent increase from $287.7 million in 2005. GAAP diluted earnings
per share was $2.20 for the year and Non-GAAP diluted earnings per
share was $3.21, compared with diluted earnings per share of $2.92
in 2005. * As a result of the Company's previously announced $100
million accelerated stock buyback program, the Company repurchased
and retired 1.9 million of its outstanding shares of common stock
in the fourth quarter. For the year ended December 31, 2006,
Biosite repurchased and retired approximately 2.5 million shares of
common stock at a cost of $130 million. As of December 31, 2006,
the Company's cash balance was approximately $64.2 million.
Following are financial highlights pertaining to revenues and cash
flow for the three and 12 months ended December 31, 2006 and 2005:
($ in 000's) Three months ended Twelve months ended 12/31/06
12/31/05 Change 12/31/06 12/31/05 Change Triage BNP Test sales
$47,620 $46,893 2% $196,393 $189,614 4% Other cardiovascular
product sales 15,226 11,598 31% 54,877 39,559 39% Other product
sales 12,775 12,999 (2%) 51,991 53,599 (3%) Total product sales
75,621 71,490 6% 303,261 282,772 7% Total revenues 76,851 72,421 6%
308,592 287,699 7% Cash flow from operations $8,280 $12,202 (32%)
$75,089 $91,543 (18%) Cash used for stock repurchases $100,000 --
$130,000 -- 12/31/06 12/31/05 Change Cash and marketable securities
balance $64,229 $132,412 (51%) "We exited 2006 with a strong
cardiovascular franchise and healthy margins that we will work to
maintain in 2007," said Kim Blickenstaff, Biosite's chairman and
chief executive officer. "Additionally, our investments in the
physician office and international markets are producing results
and we will continue to expand with the aim of increasing our
presence in both of these areas in 2007." Financial Guidance Update
Commenting on expectations for 2007, Biosite management maintained
its 2007 total revenue target of $326 million, a 6 percent increase
over 2006. The Company also said its 2007 GAAP diluted earnings per
share target is $2.33, a 6 percent increase over 2006. The 2007
diluted earnings per share target includes an estimated $20.0
million of stock-based compensation expense and $6.0 million of tax
benefits associated with the compensation expense, compared to
$24.9 million and $7.2 million, respectively in 2006. See the
Biosite Incorporated Guidance Data table included at the end of
this release for additional details regarding the Company's
financial guidance data. Research and Development In the area of
research and development, Biosite announced that it has received
clearance from the U.S. Food and Drug Administration (FDA) for its
Protein C test. As reported last year, the Company expects this
test to be used in a clinical trial undertaken by Eli Lilly and
Company that will employ a tailored therapy strategy for Lilly's
sepsis drug Xigris(R). Biosite also reported that it will allow its
pending Premarket Notification 510(k) FDA submission for its
myeloperoxidase (MPO) test to expire. The Company filed the
submission in December of 2005 and has been attempting to resolve
questions concerning data poolability among four clinical sample
banks previously collected that were used in support of the
submission. "At this time, we believe that continuing to pursue the
current 510(k) submission using data from past studies is not in
the best interest of the Company," said Ken Buechler, Ph.D.,
Biosite's president and chief scientific officer. "We are already
well underway with studies aimed at providing data intended to
support a submission and expect to file a new Premarket
Notification 510(k) submission for the prognostic use of MPO within
the next several months." The Company also reported commencement of
the MIDAS (Myeloperoxidase and Multimarkers in the Diagnosis of
ACS) trial in the fourth quarter of 2006. The MIDAS trial is, in
part, intended to generate data to support regulatory submissions
for an MPO test and for the Triage CardioProfilER(R) Panel with MPO
featuring the MultiMarker Index(TM) Value. During the fourth
quarter of 2006, Biosite completed product design and optimization
of the Triage Sepsis Panel. The product combines three biomarkers,
which Biosite's discovery program has shown to be potentially
useful in the prognosis of sepsis, and will be evaluated in a
validation clinical study, called MINDSET (MultiMarker Index for
the Risk Assessment of Sepsis in the Emergency Department), which
is aimed at generating data in support of an FDA submission. This
multi-center study is expected to commence in the spring of 2007.
Commenting on its kidney injury program, Biosite reported that it
intends to perform additional investigational studies, beginning in
the first quarter of 2007, prior to starting the KINGPIN (Kidney
Injury Assessment Using NGAL in Cardiopulmonary Bypass Patients)
validation trial. The KINGPIN trial, which is expected to commence
once these investigational studies have been completed, is intended
to generate data to support the use of the biomarker neutrophil
gelatinase-associated lipocalin (NGAL) as a predictor of kidney
injury following cardiovascular surgery in adults. Early data on
NGAL from children suggest that the biomarker may be useful in
evaluating the risk of kidney injury and the resulting loss of
kidney function. 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. The Biosite(R) Triage(R) rapid diagnostic tests 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,
January 30, 2007, at 1:30 p.m. Pacific. A live webcast of the call
can be accessed via the Internet at http://www.biosite.com/. The
phone number for U.S. callers is (866) 713-8562 and international
callers is (617) 597-5310. The conference call code for the live
call is 20195944. 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 88652592. About Non-GAAP Financial
Measures This press release contains financial results that exclude
the effects of FAS 123R, Share-Based Payment, which relates to
stock-based compensation, and 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 has used this Non- GAAP measure for 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 from or as a substitute for the Company's
financial results 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.
Forward Looking Statements 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 2007 fiscal year, such as anticipated revenues,
operating margins and earnings per share, the Company's ability to
achieve growth targets in the international and physician office
markets, the Company's ability to maintain market share for
cardiovascular testing, the Company's plans to initiate the
proposed MINDSET and KINGPIN validation studies when expected, the
Company's plans to complete new studies intended to support
regulatory filings relating to MPO and Triage CardioProfilER with
MPO, as well as the Company's plan to file a new Premarket
Notification 510(k) for those potential new products when expected.
Risks and uncertainties include risks associated with Biosite's
ability to commence and complete clinical trials as currently
planned, Biosite's ability to obtain regulatory approvals and
complete other pre-market activities needed to launch new products
as currently planned, Biosite's ability to manufacture new products
on a commercial scale and in accordance with acceptable quality
standards, 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, the
Company's ability to effectively expand sales activities outside
the United States, and other risks associated with changing market
conditions and the effect of competition from companies with
greater capital and resources, including the impact on market
pricing for BNP testing generally. Other risks that should be
considered are detailed in the Company's most recent Annual Report
on Form 10-K and subsequent 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 website.
Biosite(R), Cardio Profiler(R), Triage(R) and New Dimensions in
Diagnosis(R) are registered trademarks of Biosite Incorporated.
MultiMarker Index(TM) is a trademark of Biosite Incorporated.
Xigris(R) is a registered trademark of Eli Lilly and Company.
Biosite Incorporated Unaudited Statements of Income Data - GAAP (in
thousands, except per share data and margins) Three months ended
Year ended December 31, December 31, 2006 2005 %Change 2006 2005
%Change Total revenues: Product sales $75,621 $71,490 6% $303,261
$282,772 7% Contract revenue 1,230 931 32% 5,331 4,927 8% Total
revenues 76,851 72,421 6% 308,592 287,699 7% Gross margin on
product sales 68% 71% 69% 70% Operating expenses: Cost of product
sales 23,992 20,953 15% 94,228 85,108 11% Selling, general and
administrative 24,189 19,828 22% 97,098 74,758 30% Research and
development 13,689 10,706 28% 53,043 42,215 26% License and patent
disputes -- 637 (100%) 3,142 1,977 59% Total operating expenses
61,870 52,124 19% 247,511 204,058 21% Operating income 14,981
20,297 (26%) 61,081 83,641 (27%) Operating income as % of total
revenue 19% 28% 20% 29% Interest and other income, net 690 1,053
(34%) 4,244 2,722 56% Income before provision for income taxes
15,671 21,350 (27%) 65,325 86,363 (24%) Provision for income taxes
(5,197) (7,654) (32%) (25,331) (32,334) (22%) Net income $10,474
$13,696 (24%) $39,994 $54,029 (26%) Diluted earnings per share
$0.60 $0.73 (18%) $2.20 $2.92 (25%) Diluted shares used in
calculating per share amounts 17,571 18,773 18,186 18,505
Share-based compensation expense for stock options and the employee
stock purchase plan recorded in accordance with FAS 123R for
continuing operations: Cost of product sales $858 $-- $2,728 $--
Selling, general and administrative 3,577 -- 15,100 -- Research and
development 1,732 -- 7,031 -- Subtotal $6,167 $-- $24,859 $-- Tax
benefit (1,934) -- (7,217) -- Total $4,233 $-- $17,642 $-- Biosite
Incorporated Unaudited Statement 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
Year ended December 31, December 31, 2006 2005 %Change 2006 2005
%Change Total revenues: Product sales $75,621 $71,490 6% $303,261
$282,772 7% Contract revenue 1,230 931 32% 5,331 4,927 8% Total
revenues 76,851 72,421 6% 308,592 287,699 7% Gross margin on
product sales 69% 71% 70% 70% Operating expenses: Cost of product
sales 23,134 20,953 10% 91,500 85,108 8% Selling, general and
administrative 20,612 19,828 4% 81,998 74,758 10% Research and
development 11,957 10,706 12% 46,012 42,215 9% License and patent
disputes -- 637 (100%) 3,142 1,977 59% Total operating expenses
55,703 52,124 7% 222,652 204,058 9% Operating income 21,148 20,297
4% 85,940 83,641 3% Operating income as % of total revenue 28% 28%
28% 29% Interest and other income, net 690 1,053 (34%) 4,244 2,722
56% Income before provision for income taxes 21,838 21,350 2%
90,184 86,363 4% Provision for income taxes (7,131) (7,654) (7%)
(32,548) (32,334) 1% Net income $14,707 $13,696 7% $57,636 $54,029
7% Diluted earnings per share $0.85 $0.73 16% $3.21 $2.92 10%
Diluted shares used in calculating per share amounts 17,271 18,773
17,936 18,505 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 December
31, 2006 December 31, 2005 Non-GAAP Adjmts GAAP Non-GAAP Adjmts
GAAP Total revenues: Product sales $75,621 $-- $75,621 $71,490 $--
$71,490 Contract revenue 1,230 -- 1,230 931 -- 931 Total revenues
76,851 -- 76,851 72,421 -- 72,421 Gross margin on product sales 69%
(1%) 68% 71% 0% 71% Operating expenses: Cost of product sales
23,134 858[a] 23,992 20,953 -- 20,953 Selling, general and
administrative 20,612 3,577[a] 24,189 19,828 -- 19,828 Research and
development 11,957 1,732[a] 13,689 10,706 -- 10,706 License and
patent disputes -- -- -- 637 -- 637 Total operating expenses 55,703
6,167 61,870 52,124 -- 52,124 Operating income 21,148 (6,167)
14,981 20,297 -- 20,297 Operating income as % of total revenue 28%
(9%) 19% 28% 0% 28% Interest and other income, net 690 -- 690 1,053
-- 1,053 Income before provision for income taxes 21,838 (6,167)
15,671 21,350 -- 21,350 Provision for income taxes (7,131) 1,934[a]
(5,197) (7,654) -- (7,654) Net income $14,707 $(4,233) $10,474
$13,696 $-- $13,696 Diluted earnings per share $0.85 $(0.25) $0.60
$0.73 $-- $0.73 Diluted shares used in calculating per share
amounts 17,271 300 17,571 18,773 -- 18,773 [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
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) Year ended
Year ended December 31, 2006 December 31, 2005 Non-GAAP Adjmts GAAP
Non-GAAP Adjmts GAAP Total revenues: Product sales $303,261 $--
$303,261 $282,772 $-- $282,772 Contract revenue 5,331 -- 5,331
4,927 -- 4,927 Total revenues 308,592 -- 308,592 287,699 -- 287,699
Gross margin on product sales 70% (1%) 69% 70% 0% 70% Operating
expenses: Cost of product sales 91,500 2,728[a] 94,228 85,108 --
85,108 Selling, general and administrative 81,998 15,100[a] 97,098
74,758 -- 74,758 Research and development 46,012 7,031[a] 53,043
42,215 -- 42,215 License and patent disputes 3,142 -- 3,142 1,977
-- 1,977 Total operating expenses 222,652 24,859 247,511 204,058 --
204,058 Operating income 85,940 (24,859) 61,081 83,641 -- 83,641
Operating income as % of total revenue 28% (8%) 20% 229 0% 29%
Interest and other income, net 4,244 -- 4,244 2,722 -- 2,722 Income
before provision for income taxes 90,184 (24,859) 65,325 86,363 --
86,363 Provision for income taxes (32,548) 7,217[a] (25,331)
(32,334) -- (32,334) Net income $57,636 $(17,642) $39,994 $54,029
$-- $54,029 Diluted earnings per share $3.21 $(1.01) $2.20 $2.92
$-- $2.92 Diluted shares used in calculating per share amounts
17,936 250 18,186 18,505 -- 18,505 [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 Incorporated Selected
Product Data (in thousands, except margins and %'s) Sales by
Product: Q1 2005 Q2 2005 Q3 2005 Q4 2005 Triage(R) Drugs of Abuse
Products $10,283 $11,341 $12,408 $11,018 Triage Cardiac Panel 5,985
6,439 7,142 6,629 Triage BNP Tests 49,771 49,058 43,892 46,893
Triage Profiler Products 1,946 2,226 2,852 3,465 Triage D-Dimer
Test 131 481 757 1,489 Triage Parasite Panel 255 283 355 269 Triage
C. difficile Panel 1,349 1,377 942 988 Triage Meters 776 693 538
724 Triage Stroke Panel (EU) -- -- 2 15 Total Product Sales $70,496
$71,898 $68,888 $71,490 International Sales: Q1 2005 Q2 2005 Q3
2005 Q4 2005 International Sales as % of Product Sales 13% 12% 12%
13% BNP International Sales as % of BNP Total Sales 10% 9% 9% 10%
Margin by Product Type (a), (b): Q1 2005 Q2 2005 Q3 2005 Q4 2005
Triage Drugs of Abuse Product Line 82% 78% 82% 81% Triage
Cardiovascular Product Line (incl. BNP) 72% 69% 69% 70% Sales by
Product: Q1 2006 Q2 2006 Q3 2006 Q4 2006 Triage(R) Drugs of Abuse
Products $11,547 $10,464 $11,444 $10,836 Triage Cardiac Panel 6,616
7,188 6,902 7,606 Triage BNP Tests 52,564 50,678 45,531 47,620
Triage Profiler Products 4,036 4,598 5,735 5,743 Triage D-Dimer
Test 1,417 1,450 1,616 1,852 Triage Parasite Panel 286 337 377 360
Triage C. difficile Panel 1,029 1,088 1,022 977 Triage Meters 625
539 458 602 Triage Stroke Panel (EU) 37 30 26 25 Total Product
Sales $78,157 $76,372 $73,111 $75,621 International Sales: Q1 2006
Q2 2006 Q3 2006 Q4 2006 International Sales as % of Product Sales
14% 15% 14% 16% BNP International Sales as % of BNP Total Sales 11%
11% 10% 13% Margin by Product Type (a), (b): Q1 2006 Q2 2006 Q3
2006 Q4 2006 Triage Drugs of Abuse Product Line 79% 77% 73% 78%
Triage Cardiovascular Product Line (incl. BNP) 71% 70% 68% 69% (a)
These margins do not include all products. The Triage Meters,
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 Biosite Incorporated Unaudited Balance Sheet Data - GAAP
(in thousands) December 31, 2006 December 31, 2005 Unaudited Assets
Cash, cash equivalents & marketable securities $64,229 $132,412
Accounts receivable 33,613 30,303 Inventories 33,154 32,627 Other
current assets 14,603 9,422 Total current assets 145,599 204,764
Property, equipment and leasehold improvements, net 157,945 151,018
Patents and license rights, net 9,399 4,764 Other assets 13,644
7,380 Total assets $326,587 $367,926 Liabilities and Stockholders'
Equity Current liabilities $34,669 $39,104 Long-term liabilities
11,763 13,457 Stockholders' equity 280,155 315,365 Total
liabilities and stockholders' equity $326,587 $367,926 Biosite
Incorporated Guidance Data -- GAAP (in thousands, except per share
data, margins and %'s) The financial guidance provided below is an
estimate based on information available as of January 30, 2007. 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. Year ended December 31,
2007 Guidance 2006 %Change BNP product sales $200,500 $196,393 2.1%
Total product sales $321,000 $303,261 5.8% Total revenues $326,000
$308,592 5.6% International sales % of total product sales 18.0%
14.7% 3.3%(a) Gross margin on product sales 68.5% 68.9% (0.4%)(a)
Operating expenses (excl. Cost of sales) % of revenues 49.5% 49.7%
(0.2%)(a) Operating income as % of total revenues 19.5% 19.8%
(0.3%)(a) Diluted earnings per share $2.33 $2.20 5.9% Income tax
rate 40.5% 38.8% 1.7%(a) Cash flow from operations $80,000 $75,089
6.5% (a) Percentage point change DATASOURCE: Biosite Incorporated
CONTACT: Nadine Padilla, VP, Corporate & Investor Relations of
Biosite Incorporated, +1-858-805-2820, Web site:
http://www.biosite.com/ Company News On-Call:
http://www.prnewswire.com/comp/116737.html
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