OraSure Technologies, Inc. (NASDAQ:OSUR), a market leader in oral fluid
diagnostics, today announced revenues of $71.1 million and $17.2 million
for the year and quarter ended December 31, 2008, respectively. This
compares to revenues of $82.7 million and $19.8 million for the year and
quarter ended December 31, 2007, respectively.
The Company recorded a net loss of $31.3 million or $0.67 per share, and
$29.3 million or $0.64 per share, on a GAAP1 basis, for the
year and quarter ended December 31, 2008, respectively. The net loss for
these periods includes a non-cash charge of $26.0 million reflected in
the income tax provision, which resulted from establishing a full
valuation allowance against the Company’s net deferred tax asset.
Excluding the impact of this non-cash charge, the Company’s net loss on
a non-GAAP basis would have been $5.3 million, or $0.11 per share, and
$3.3 million, or $0.07 per share, for the year and quarter ended
December 31, 2008, respectively. These results compare to net income of
$2.5 million, or $0.05 per fully-diluted share for the year ended
December 31, 2007, and net income of $27,000, or break-even earnings per
share for the fourth quarter of 2007.
“We have recorded a full valuation allowance against our net deferred
tax asset, in accordance with GAAP, as a result of the continued
unprecedented volatility in the global economy and our expectation of a
loss for 2009,” said Ronald H. Spair, OraSure Technologies Inc.’s Chief
Financial Officer. “Establishing this valuation allowance, however, does
not change our view of the Company’s long-term financial outlook or the
expected utilization of our net operating loss carryforwards or other
deferred tax assets in the future upon returning to profitability. In
addition, we finished 2008 with strong liquidity as we had $82.5 million
of cash, cash equivalents and short-term investments and $91.0 million
of working capital at year end.”
For the year ended December 31, 2008, increased sales of the Company’s
OraQuick ADVANCE® rapid HIV-1/2 antibody test, coupled with
increased sales in the insurance risk assessment market and higher
licensing and product development revenues, were offset by an expected
decline in sales of the Company’s cryosurgical wart removal and
substance abuse testing products.
For the quarter ended December 31, 2008, increased sales of the
Company’s Intercept® oral fluid drug testing products and higher
licensing and product development revenues, were offset by lower sales
of the OraQuick ADVANCE® HIV-1/2 test to Abbott Laboratories, in
anticipation of the transition of the U.S. hospital business to a direct
sales model in 2009, coupled with the expected decline in sales of the
Company’s cryosurgical wart removal products.
“Despite the challenges we faced during 2008 and the current uncertain
economic climate, we are starting the new year on a positive note,” said
Douglas A. Michels, President and Chief Executive Officer of OraSure
Technologies. “Our newly expanded sales force is now selling OraQuick ADVANCE®
directly into the U.S. hospital market, our sales and marketing group
has been realigned and strengthened, and we recently received FDA
approval of a twelve-month shelf life for OraQuick ADVANCE®. We
have also made significant progress on our strategic initiatives by
filing for FDA approval of our OraQuick® HCV test and advancing the
clinical development of our OraQuick® HIV OTC test and the fully
automated oral fluid substance abuse assays.”
The Company’s gross margins were 58% and 56% for the year and quarter
ended December 31, 2008, respectively. Gross margins decreased from 61%
for the full year 2007 and from 58% for the quarter ended December 31,
2007. The decrease in gross margin for both the year and fourth quarter
was largely due to a less favorable product mix, driven primarily by
significant declines in cryosurgical product revenues, and increases in
manufacturing scrap and spoilage expense. Although scrap and
spoilage for the full year exceeded 2007 levels, OraQuick® scrap and
spoilage was down sequentially in each quarter of 2008. The majority of
scrap and spoilage charges in the fourth quarter were related to
products other than OraQuick® and are not expected to recur. Scrap and
spoilage charges for 2009 are expected to be significantly lower than
2008 levels.
For the full year 2008, operating expenses increased to $57.5 million
from $51.5 million in 2007. Operating expenses for the quarter ended
December 31, 2008 were $15.8 million, compared to $13.0 million for the
fourth quarter of 2007. These increases were primarily attributable to
higher research and development costs and higher sales and marketing
expenses.
Research and development costs increased in both the year and the
quarter ended December 31, 2008 as a result of planned incremental costs
incurred for the Company’s OraQuick® HIV-OTC and OraQuick® HCV clinical
development programs. In addition, during the fourth quarter of 2008,
the Company recorded a $1.0 million charge related to a patent license
milestone payment required upon filing of the Company’s OraQuick® HCV
pre-market approval application with the U.S. Food and Drug
Administration.
Sales and marketing expenses also increased for both the year and the
quarter ended December 31, 2008. The net increases experienced in these
periods were primarily due to higher staffing related costs, driven by
an increase in the Company’s direct sales force for the hospital market,
as well as by recent organizational changes, partially offset by a
decline in reimbursable cryosurgical distributor advertising and
promotional costs.
General and administrative expenses for the full year 2008 decreased as
a result of lower compensation costs, bank charges, consulting fees and
legal expenses. Fourth quarter 2008 general and administrative expenses
increased as a result of an accrual for costs associated with the
termination of the Company’s OraQuick® distribution agreement with
Abbott Laboratories, coupled with an increase in legal fees associated
with the patent infringement lawsuit filed against the Company by
Inverness Medical and Church & Dwight. By contrast, fourth quarter 2007
legal expenses reflected the award of certain legal fees to the Company
in connection with the Company’s arbitration with Prestige Brands.
Cash, cash equivalents and short-term investments totaled $82.5 million
and working capital was $91.0 million at December 31, 2008, compared to
$95.6 million and $105.6 million, respectively, at December 31, 2007.
First Quarter 2009 Outlook
The Company expects total revenues for the first quarter of 2009 to
range from approximately $16.5 to $17.0 million. The Company is
currently projecting a loss per share for the first quarter of 2009 of
approximately $0.07.
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Condensed Financial Data
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(In thousands, except per-share
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data and percentages)
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Unaudited
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Three months ended
December 31,
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Year ended
December 31,
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2008
|
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2007
|
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2008
|
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2007
|
|
Results of Operations
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|
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Revenues
|
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$
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17,209
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|
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$
|
19,809
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|
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$
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71,104
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$
|
82,686
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Cost of products sold
|
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7,583
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8,281
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29,976
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|
|
|
32,403
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Gross profit
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9,626
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11,528
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41,128
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50,283
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Operating expenses:
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Research and development
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5,392
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4,240
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20,255
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14,136
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Sales and marketing
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5,411
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5,063
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20,917
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20,062
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General and administrative
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4,994
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3,668
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16,287
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17,304
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Total operating expenses
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15,797
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12,971
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57,459
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51,502
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Operating loss
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(6,171
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)
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(1,443
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)
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(16,331
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)
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(1,219
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)
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Other income, net
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506
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1,070
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7,583
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5,513
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Pre-tax income (loss)
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(5,665
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)
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(373
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)
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(8,748
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)
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4,294
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Income tax provision (benefit)
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23,607
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(400
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)
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22,527
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1,821
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Net income (loss)
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$
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(29,272
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)
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$
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27
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$
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(31,275
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)
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$
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2,473
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Earnings (loss) per share
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Basic and Diluted
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$
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(0.64
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)
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$
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—
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$
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(0.67
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)
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$
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0.05
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Weighted average shares:
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Basic
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45,882
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46,625
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46,550
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|
|
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46,325
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Diluted
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45,882
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|
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47,336
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|
|
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46,550
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|
|
|
46,878
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Non-GAAP Financial Measures
The Company’s management considers the use of non-GAAP financial
measures helpful in assessing the Company’s current periods’ financial
performance, especially in comparison to the same periods of the prior
year. As such, the Company has presented non-GAAP net income (loss) and
non-GAAP basic and diluted earnings (loss) per share in the table below.
While the Company believes that disclosing the following non-GAAP
financial measures allows for greater transparency in the review of its
underlying financial performance, it does not consider such measures to
be substitutes for, or superior to, net income (loss) or basic and
diluted earnings (loss) per share as determined in accordance with GAAP.
For purposes of calculating the non-GAAP net loss and non-GAAP basic and
diluted loss per share for the current periods, the Company excluded the
$26.0 million increase to the income tax provision related to
establishing a full valuation allowance against the Company’s deferred
tax asset, since such a significant adjustment is not expected to recur
on a quarterly or annual basis.
The following table reconciles the GAAP net income (loss) and GAAP basic
and diluted earnings (loss) per share to the non-GAAP net income (loss)
and non-GAAP basic and diluted earnings (loss) per share for the periods
indicated.
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Three months ended
December 31,
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Year ended
December 31,
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2008
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|
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2007
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|
2008
|
|
2007
|
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Net income (loss), as reported under GAAP
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$
|
(29,272
|
)
|
|
$
|
27
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$
|
(31,275
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)
|
|
$
|
2,473
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Tax adjustment
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|
25,978
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−
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25,978
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−
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Net income (loss), non-GAAP
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$
|
(3,294
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)
|
|
$
|
27
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|
$
|
(5,297
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)
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$
|
2,473
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|
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|
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Earnings (loss) per share:
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Basic and Diluted, as reported under GAAP
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$
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(0.64
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)
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$
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−
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$
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(0.67
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)
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$
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0.05
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Tax adjustment
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0.57
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−
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0.56
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−
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Basic and Diluted, non-GAAP
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$
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(0.07
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)
|
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$
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−
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$
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(0.11
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)
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$
|
0.05
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|
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Weighted average shares:
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Basic
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45,882
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46,625
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46,550
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46,325
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Diluted
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45,882
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47,336
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46,550
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46,878
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Three months ended December 31,
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Percentage of
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Dollars
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%
|
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Total Revenues
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Market Revenues
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2008
|
|
2007
|
|
Change
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2008
|
|
2007
|
|
|
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|
|
|
|
|
|
|
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Infectious disease testing
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$
|
8,837
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|
$
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9,444
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(6
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)%
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|
51
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%
|
|
48
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%
|
|
Substance abuse testing
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3,452
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|
3,390
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2
|
|
|
20
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|
|
17
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|
Cryosurgical systems
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|
2,928
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|
|
5,343
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(45
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)
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17
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27
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|
|
Insurance risk assessment
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|
1,690
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|
1,605
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|
5
|
|
|
10
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|
|
8
|
|
|
Product revenues
|
|
|
16,907
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|
|
19,782
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|
(15
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)
|
|
98
|
|
|
100
|
|
|
Licensing and product development
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|
|
302
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|
|
27
|
|
1,019
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|
2
|
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—
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Total revenues
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|
$
|
17,209
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|
$
|
19,809
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(13
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)%
|
|
100
|
%
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
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|
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Year ended December 31,
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|
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|
|
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Percentage of
|
|
|
|
Dollars
|
|
%
|
|
Total Revenues
|
|
Market Revenues
|
|
2008
|
|
2007
|
|
Change
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing
|
|
$
|
38,096
|
|
$
|
35,791
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|
6
|
%
|
|
54
|
%
|
|
43
|
%
|
|
Substance abuse testing
|
|
|
14,006
|
|
|
15,789
|
|
(11
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)
|
|
20
|
|
|
19
|
|
|
Cryosurgical systems
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|
|
10,655
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|
|
23,533
|
|
(55
|
)
|
|
15
|
|
|
28
|
|
|
Insurance risk assessment
|
|
|
6,085
|
|
|
5,464
|
|
11
|
|
|
8
|
|
|
7
|
|
|
Product revenues
|
|
|
68,842
|
|
|
80,577
|
|
(15
|
)
|
|
97
|
|
|
97
|
|
|
Licensing and product development
|
|
|
2,262
|
|
|
2,109
|
|
7
|
|
|
3
|
|
|
3
|
|
|
Total revenues
|
|
$
|
71,104
|
|
$
|
82,686
|
|
(14
|
)%
|
|
100
|
%
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
|
Year ended
|
|
|
|
|
|
December 31,
|
|
%
|
|
December 31,
|
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%
|
|
OraQuick® Revenues
|
|
2008
|
|
2007
|
|
Change
|
|
2008
|
|
2007
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Direct to U.S. Public Health
|
|
$
|
6,177
|
|
$
|
5,460
|
|
13
|
%
|
|
$
|
25,438
|
|
$
|
19,799
|
|
28
|
%
|
|
Abbott
|
|
|
1,137
|
|
|
2,018
|
|
(44
|
)
|
|
|
6,625
|
|
|
8,102
|
|
(18
|
)
|
|
International
|
|
|
930
|
|
|
1,181
|
|
(21
|
)
|
|
|
3,234
|
|
|
3,291
|
|
(2
|
)
|
|
SAMHSA/ CDC
|
|
|
—
|
|
|
—
|
|
—
|
|
|
|
12
|
|
|
1,464
|
|
(99
|
)
|
|
Total OraQuick® revenues
|
|
$
|
8,244
|
|
$
|
8,659
|
|
(5
|
)%
|
|
$
|
35,309
|
|
$
|
32,656
|
|
8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
|
Year ended
|
|
|
|
|
|
December 31,
|
|
%
|
|
December 31,
|
|
%
|
|
Intercept® Revenues
|
|
2008
|
|
2007
|
|
Change
|
|
2008
|
|
2007
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Workplace testing
|
|
$
|
1,270
|
|
$
|
1,282
|
|
(1
|
)%
|
|
$
|
4,750
|
|
$
|
6,650
|
|
(29
|
)%
|
|
Criminal justice
|
|
|
698
|
|
|
622
|
|
12
|
|
|
|
2,663
|
|
|
2,570
|
|
4
|
|
|
International
|
|
|
598
|
|
|
431
|
|
39
|
|
|
|
2,168
|
|
|
2,188
|
|
(1
|
)
|
|
Direct
|
|
|
299
|
|
|
264
|
|
13
|
|
|
|
1,204
|
|
|
1,003
|
|
20
|
|
|
Total Intercept® revenues
|
|
$
|
2,865
|
|
$
|
2,599
|
|
10
|
%
|
|
$
|
10,785
|
|
$
|
12,411
|
|
(13
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
|
Year ended
|
|
|
|
|
|
December 31,
|
|
%
|
|
December 31,
|
|
%
|
|
Cryosurgery Revenues
|
|
2008
|
|
2007
|
|
Change
|
|
2008
|
|
2007
|
|
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional domestic
|
|
$
|
970
|
|
$
|
1,806
|
|
(46
|
)%
|
|
$
|
3,911
|
|
$
|
5,247
|
|
(25
|
)%
|
|
Professional international
|
|
|
725
|
|
|
798
|
|
(9
|
)
|
|
|
2,529
|
|
|
2,349
|
|
8
|
|
|
OTC domestic
|
|
|
—
|
|
|
650
|
|
(100
|
)
|
|
|
—
|
|
|
6,237
|
|
(100
|
)
|
|
OTC international
|
|
|
1,233
|
|
|
2,089
|
|
(41
|
)
|
|
|
4,215
|
|
|
9,700
|
|
(57
|
)
|
|
Total cryosurgery revenues
|
|
$
|
2,928
|
|
$
|
5,343
|
|
(45
|
)%
|
|
$
|
10,655
|
|
$
|
23,533
|
|
(55
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheets
|
|
December 31, 2008
|
|
December 31, 2007
|
|
Assets
|
|
|
|
|
|
Cash, cash equivalents and short-term
investments
|
|
$
|
82,523
|
|
$
|
95,566
|
|
Accounts receivable, net
|
|
|
11,571
|
|
|
11,296
|
|
Inventories
|
|
|
10,704
|
|
|
9,410
|
|
Current deferred income taxes
|
|
|
−
|
|
|
5,061
|
|
Other current assets
|
|
|
1,418
|
|
|
2,455
|
|
Property and equipment, net
|
|
|
21,235
|
|
|
20,911
|
|
Deferred income taxes
|
|
|
−
|
|
|
17,266
|
|
Other non-current assets
|
|
|
4,467
|
|
|
5,387
|
|
Total assets
|
|
$
|
131,918
|
|
$
|
167,352
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
Current portion of long-term debt
|
|
$
|
558
|
|
$
|
557
|
|
Accounts payable
|
|
|
3,926
|
|
|
5,616
|
|
Accrued expenses
|
|
|
10,796
|
|
|
11,996
|
|
Long-term debt
|
|
|
8,301
|
|
|
8,818
|
|
Other liabilities
|
|
|
12
|
|
|
311
|
|
Stockholders’ equity
|
|
|
108,325
|
|
|
140,054
|
|
Total liabilities and stockholders’ equity
|
|
$
|
131,918
|
|
$
|
167,352
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31,
|
|
Additional Financial Data
|
|
2008
|
|
2007
|
|
|
|
|
|
|
|
Capital expenditures
|
|
$
|
2,643
|
|
|
$
|
5,504
|
|
Depreciation and amortization
|
|
$
|
3,177
|
|
|
$
|
2,736
|
|
Purchase and retirement of common stock
|
|
$
|
5,121
|
|
|
|
−
|
|
Cash flows from operating activities
|
|
$
|
(2,670
|
)
|
|
$
|
11,584
|
|
Accounts receivable – days sales outstanding
|
|
60 days
|
|
50 days
|
|
|
|
|
|
|
Conference Call
The Company will host a conference call and audio webcast to discuss the
Company’s 2008 fourth quarter and full-year financial results, business
developments and first quarter 2009 financial guidance, beginning today
at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be
Douglas A. Michels, President and Chief Executive Officer, and Ronald H.
Spair, Chief Financial Officer and Chief Operating Officer. The call
will include prepared remarks by management and a question and answer
session.
In order to listen to the conference call, please either dial
888-742-2024 (Domestic) or 706-643-0033 (International) and reference
Conference ID #83800004, or go to OraSure Technologies' web site, www.orasure.com,
and click on the Investor Info link. A replay of the call will be
archived on OraSure Technologies' web site shortly after the call has
ended and will be available for seven days. A replay of the call can
also be accessed until February 16, 2009, by dialing 800-642-1687
(Domestic) or 706-645-9291 (International) and entering the Conference
ID #83800004.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid
specimen collection devices and tests and other diagnostic products
using proprietary technologies, including immunoassays and other in
vitro diagnostic tests and other medical devices. These products are
sold in the United States and certain foreign countries to clinical
laboratories, hospitals, clinics, community-based organizations and
other public health organizations, distributors, government agencies,
physicians' offices, and commercial and industrial entities. For more
information on the Company, please visit www.orasure.com.
Important Information
This press release contains certain forward-looking statements,
including with respect to revenues, expenses, net income, earnings/loss
per share and products. Actual results could be significantly different.
Factors that could affect results include the ability to market and sell
products, whether through an internal, direct sales force or third
parties; changes in relationships, including disputes or disagreements,
with strategic partners and reliance on strategic partners for the
performance of critical activities under collaborative arrangements;
failure of distributors or other customers to meet purchase forecasts or
minimum purchase requirements for the Company’s products; impact of
replacing distributors and success of direct sales efforts; inventory
levels at distributors and other customers; impact of competitors,
competing products and technology changes; ability to develop,
commercialize and market new products; market acceptance of oral fluid
testing or other products; changes in market acceptance of products
based on product performance and extended shelf life; continued bulk
purchases by customers, including governmental agencies, and the ability
to fully deploy those purchases in a timely manner; ability to fund
research and development and other products and operations; ability to
obtain and maintain new or existing product distribution channels;
reliance on sole supply sources for critical product components;
availability of related products produced by third parties or products
required for use of our products; ability to obtain, and timing and cost
of obtaining, necessary regulatory approvals for new products or new
indications or applications for existing products; ability to comply
with applicable regulatory requirements; history of losses and ability
to achieve sustained profitability and ability to utilize net operating
loss carryforwards or other deferred tax assets; volatility of the
Company’s stock price; uncertainty relating to patent protection and
potential patent infringement claims; uncertainty and costs of
litigation relating to patents and other intellectual property;
availability of licenses to patents or other technology; ability to
enter into international manufacturing agreements; obstacles to
international marketing and manufacturing of products; ability to sell
products internationally, including changes in international funding
sources; loss or impairment of sources of capital; ability to meet
financial covenants in agreements with financial institutions; ability
to retain qualified personnel; exposure to patent infringement, product
liability, and other types of litigation; changes in international,
federal or state laws and regulations; customer consolidations and
inventory practices; equipment failures and ability to obtain needed raw
materials and components; the impact of terrorist attacks and civil
unrest; ability to identify, complete and realize the full benefits of
potential acquisitions; and general political, business and economic
conditions. These and other factors are discussed more fully in the
Securities and Exchange Commission (“SEC”) filings of OraSure
Technologies, including its registration statements, its Annual Report
on Form 10-K for the year ended December 31, 2007, its Quarterly Reports
on Form 10-Q, and its other filings with the SEC. Although
forward-looking statements help to provide complete information about
future prospects, readers should keep in mind that forward-looking
statements may not be reliable. The forward-looking statements are made
as of the date of this press release and OraSure Technologies undertakes
no duty to update these statements.
1 GAAP is defined as U.S. Generally Accepted Accounting
Principles
OraSure Technologies, Inc.
Ronald H. Spair
Chief
Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
