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
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 of Biosite Incorporated, +1-858-805-2820,
npadilla@biosite.com
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