OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests and specimen collection devices,
today announced its financial results for the full year and fourth
quarter of 2018.
Financial Highlights
- Net revenues for the year ended
December 31, 2018 were $181.7 million, a 9% increase from
2017. Net product revenues were $165.4 million, representing
2% growth over 2017.
- Net revenues for the fourth quarter
of 2018 were $50.2 million, a 3% decrease from the fourth quarter
of 2017. Net product revenues were $44.8 million, representing an
11% decrease from the fourth quarter of 2017.
- Molecular collection systems net
revenues for the full year 2018, including royalty income from a
litigation settlement, were $96.1 million, up 28% from 2017.
Molecular collection systems net revenues including royalty income
were $30.2 million during the fourth quarter of 2018, up 2% from
the fourth quarter of 2017. Molecular collection systems net
product revenues during the year ended December 31, 2018 were $86.5
million, a 15% increase from the comparable period of 2017.
Molecular collection systems net product revenues were $25.4
million during the fourth quarter of 2018, which represents a 15%
decrease from the fourth quarter of 2017.
- For the full year of 2018,
international sales of the Company’s OraQuick® HIV products were
$21.8 million, an increase of 93% compared to 2017.
International sales of the Company’s OraQuick® HIV products of $4.4
million in the fourth quarter of 2018 increased 23% compared to the
fourth quarter of 2017. The increases in both periods were
primarily the result of higher sales of the Company’s OraQuick® HIV
Self-Test.
- Full year 2018 international sales
of the Company’s OraQuick® HCV product of $4.9 million decreased
71% from 2017. International sales of the Company’s OraQuick® HCV
product of $1.6 million increased 40% for the fourth quarter of
2018 compared to the fourth quarter of 2017. The decline for
the full year was primarily the result of the non-renewal of a
foreign government supply contract in support of a countrywide HCV
eradication program at the end of 2017. This program
contributed $11.8 million in sales during the full year of 2017 and
$270,000 during the fourth quarter of 2017. The increase in
the fourth quarter was due to continued growth in Asia and
Africa.
- Net income for the year ended
December 31, 2018 was $20.4 million, or $0.33 per share on a fully
diluted basis, which compares to net income of $30.9 million, or
$0.51 per share on a fully diluted basis, for 2017. Net income for
2018 included $1.2 million of pre-tax transaction costs associated
with two recent acquisitions that closed in early January 2019 and
$9.6 million of pre-tax transition costs associated with the
retirement of the Company’s former Chief Executive Officer and
Chief Financial Officer and the hiring of their successors. The
transaction costs were $0.02 per share and the transition costs
were $0.15 per share for the year ended December 31, 2018.
The transition costs primarily consisted of non-cash stock
compensation charges. Net income for the year ended December 31,
2017 included a $12.5 million gain related to the settlement of
litigation against Ancestry.com DNA and its contract
manufacturer. This gain was accounted for as a reduction of
operating expenses and amounted to $0.15 per share on a fully
diluted after-tax basis in that period.
- Net income for the fourth quarter
of 2018 was $10.3 million, or $0.16 per share on a fully diluted
basis, which compares to net income of $7.3 million, or $0.12 per
share on a fully diluted basis, for the fourth quarter of 2017. Net
income for the fourth quarter of 2018 included $1.2 million of
pre-tax transaction costs related to the recent acquisitions and
$974,000 of pre-tax transition costs associated with the Company’s
executive management changes. The transaction and transition
costs together were $0.04 per share for the fourth quarter of 2018.
The transition costs in the fourth quarter consisted of non-cash
stock compensation charges.
- Cash and investments totaled $201.3
million at December 31, 2018.
“With the highest annual revenues in our history
and strong profitability, 2018 was another financially successful
year for OraSure. Our OraQuick® international HIV business
and our Molecular business continued to drive performance with
double-digit growth from 2017 to 2018. Our 2018 microbiome
revenues nearly doubled when compared to 2017,” said OraSure
President and Chief Executive Officer, Dr. Stephen S. Tang.
“2018 was also a pivotal year strategically. The acquisitions
we announced in January were the first outcomes of our robust
innovation-driven growth strategy. I am confident we have the
right strategy and talent in place to deliver against our strategic
objectives. We begin 2019 poised to leverage our strengths,
grow our product portfolio and expand into new markets.”
Financial ResultsNet product
revenues for the year ended December 31, 2018 increased 2% over
2017, primarily as a result of higher sales of the Company’s
molecular collection systems products and higher international
sales of the OraQuick® HIV Self-Test, partially offset by lower
sales of the Company’s HCV product, lower domestic sales of the
professional OraQuick® HIV test and lower sales of the Company’s
cryosurgical systems products.
Net product revenues for the fourth quarter of
2018 decreased 11% from the comparable period of 2017, primarily as
a result of lower sales of the Company’s molecular collections
products and lower domestic sales of the Company’s HIV and HCV
tests, partially offset by higher international sales of the
OraQuick® HIV Self-Test and OraQuick® HCV test.
Sales of the OraQuick® HIV Self-Test for the
year and three months ended December 31, 2018 included $4.4 million
and $855,000, respectively, of support payments under the Company’s
charitable support agreement with the Bill & Melinda Gates
Foundation (“Gates Foundation”), while the year and three months
ended December 31, 2017 included $1.0 million and $589,000,
respectively, of such payments.
Royalty income from a litigation settlement
associated with a molecular collection device was $9.7 million for
the full year and $4.8 million for the fourth quarter of 2018.
There were no such royalties in 2017. Other revenues were
$6.7 million and $5.1 million for the full year of 2018 and 2017,
respectively. Other revenues were $578,000 and $1.8 million for the
fourth quarter of 2018 and 2017, respectively. Other revenues
in the full year of 2018 increased due to higher Ebola and
Zika-related funding received from the U.S. Biomedical Advanced
Research Development Authority (“BARDA”) and increased cost
reimbursement from the Gates Foundation. Other revenues
decreased in the fourth quarter of 2018 largely due to lower BARDA
funding and lower cost reimbursement under the Company’s charitable
support agreement with the Gates Foundation.
Gross profit percentage was 63% and 69% for the
year and three months ended December 31, 2018, respectively,
compared to 59% and 55% and for the year and three months ended
December 31, 2017, respectively. Gross profit percentage in the
full year of 2018 benefited from improved product mix associated
with an increase in higher gross profit percentage product sales,
lower manufacturing costs associated with the Company’s Oragene®
product, increased royalty income and other revenues, lower scrap
and spoilage costs and lower royalty expense. Gross profit
percentage in the current quarter benefited from improved product
mix associated with an increase in higher profit percentage product
sales, increased royalty income, lower manufacturing costs
associated with the Company’s Oragene® product, lower scrap and
spoilage costs and lower royalty expense partially offset by a
decrease in other revenues.
For the year ended December 31, 2018, operating
expenses were $85.2 million, an increase of $26.5 million from the
$58.7 million reported for the year ended December 31, 2017.
The increase for the full year period was largely due to the
inclusion of $9.6 million of transition costs associated with
executive management changes, $1.2 million of transaction costs
associated with the Company’s recent acquisitions and higher
spending on research and development and sales and marketing during
the period and by the absence of the $12.5 million litigation gain
associated with the settlement of litigation against Ancestry.com
DNA and its contract manufacturer that was included in 2017.
There was no similar gain recorded during 2018.
Operating expenses increased to $22.2 million
during the fourth quarter of 2018 compared to $18.4 million in the
fourth quarter of 2017. The fourth quarter increase was largely due
to the inclusion of $1.2 million of transaction costs associated
with the recent acquisitions, $973,000 of additional transition
costs associated with the management changes, and higher
commissions, consulting costs and other staffing costs, partially
offset by the absence of a cost write-off in the fourth quarter of
2017 resulting from the non-renewal of a large HCV supply
contact. A similar write-off did not recur in the fourth
quarter of 2018.
Operating income for the year end December 31,
2018 was $28.4 million compared $40.2 million for the year ended
December 31, 2017. The Company reported operating income of
$12.5 million in the fourth quarter of 2018, compared to operating
income of $10.2 million in the fourth quarter of 2017.
For the year ended December 31, 2018, other
income increased to $3.3 million from $794,000 in the comparable
period of 2017. Other income increased to $1.6 million during
the fourth quarter of 2018 compared to $118,000 in the fourth
quarter of 2017. The increase in other income for the full year
2018 is largely due to increased foreign currency gains associated
with the strengthening of the Canadian dollar and higher interest
income, partially offset by an increase in investment losses
associated with the Company’s deferred compensation plan. The
increase in other income in the fourth quarter of 2018 is also
largely due to increased foreign currency gains and higher interest
income earned on the Company’s investment balances.
Income tax expense was $11.3 million during the
full year of 2018 compared to $10.1 million during the full-year of
2017. Income tax expense was $3.8 million during the fourth
quarter of 2018 compared to $3.0 million recorded in the fourth
quarter of 2017. Income tax expense in 2018 reflects the
higher pre-tax income generated by the Company’s Canadian
subsidiary. Income tax expense in 2017 included the
additional taxes due as a result of the $12.5 million
litigation settlement gain.
The Company’s cash and investment balance
totaled $201.3 million atDecember 31, 2018, compared to $176.6
million atDecember 31, 2017. For the year ended December 31,
2018, the Company generated $39.1 million in cash from
operations.
First Quarter 2019 Outlook
The Company expects net revenues to range from
$29.0 million to $30.5 million and is projecting a net
loss of $0.06 to $0.07 per share for the first quarter of 2019. The
foregoing guidance includes the expected revenue contribution from
the two acquisitions that closed in early January 2019 and
transaction costs approximating $0.01 per share, but does not
account for any additional transaction and integration costs of
those or any other completed transactions, which cannot be
reasonably estimated at this time.
“We believe that revenues for the second half of
2019 will be materially greater than in the first half of the year,
as we have experienced in the past. Additionally, we expect
that performance by our core businesses combined with additional
acquisitions will support our growth in future periods,” Dr. Tang
said.
Financial Data
|
Condensed Consolidated Financial
Data |
(In thousands, except per-share
data) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Year Ended |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
2018 |
|
|
2017 |
|
Results of
Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
50,246 |
|
|
$ |
52,028 |
|
|
|
$ |
181,743 |
|
|
$ |
167,064 |
|
Cost of products
sold |
|
|
15,540 |
|
|
|
23,503 |
|
|
|
|
68,130 |
|
|
|
68,108 |
|
Gross
profit |
|
|
34,706 |
|
|
|
28,525 |
|
|
|
|
113,613 |
|
|
|
98,956 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
4,059 |
|
|
|
3,829 |
|
|
|
|
16,250 |
|
|
|
13,365 |
|
Sales and
marketing |
|
|
8,377 |
|
|
|
6,991 |
|
|
|
|
30,609 |
|
|
|
28,532 |
|
General
and administrative |
|
|
9,758 |
|
|
|
7,544 |
|
|
|
|
38,325 |
|
|
|
29,321 |
|
Gain on
litigation settlement |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
(12,500 |
) |
Total
operating expenses |
|
|
22,194 |
|
|
|
18,364 |
|
|
|
|
85,184 |
|
|
|
58,718 |
|
Operating
income |
|
|
12,512 |
|
|
|
10,161 |
|
|
|
|
28,429 |
|
|
|
40,238 |
|
Other income |
|
|
1,629 |
|
|
|
118 |
|
|
|
|
3,287 |
|
|
|
794 |
|
Income before income
taxes |
|
|
14,141 |
|
|
|
10,279 |
|
|
|
|
31,716 |
|
|
|
41,032 |
|
Income tax expense |
|
|
3,843 |
|
|
|
2,963 |
|
|
|
|
11,320 |
|
|
|
10,084 |
|
Net income |
|
$ |
10,298 |
|
|
$ |
7,316 |
|
|
|
$ |
20,396 |
|
|
$ |
30,948 |
|
Earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.17 |
|
|
$ |
0.12 |
|
|
|
$ |
0.33 |
|
|
$ |
0.52 |
|
Diluted |
|
$ |
0.16 |
|
|
$ |
0.12 |
|
|
|
$ |
0.33 |
|
|
$ |
0.51 |
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
61,268 |
|
|
|
60,652 |
|
|
|
|
61,112 |
|
|
|
59,050 |
|
Diluted |
|
|
62,511 |
|
|
|
62,371 |
|
|
|
|
62,532 |
|
|
|
61,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary of Net
Revenues by Market and Product Line (Unaudited)
|
|
Three Months Ended
December 31, |
|
|
|
|
Dollars |
|
|
|
|
|
|
Percentage of Total Net Revenues |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
|
2017 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease
testing |
|
$ |
13,643 |
|
|
$ |
14,129 |
|
|
(3 |
) |
% |
|
27 |
|
% |
|
27 |
|
% |
Risk assessment
testing |
|
|
2,898 |
|
|
|
3,141 |
|
|
(8 |
) |
|
|
6 |
|
|
|
6 |
|
|
Cryosurgical
systems |
|
|
2,894 |
|
|
|
3,163 |
|
|
(9 |
) |
|
|
6 |
|
|
|
6 |
|
|
Molecular collection
systems |
|
|
25,407 |
|
|
|
29,784 |
|
|
(15 |
) |
|
|
50 |
|
|
|
58 |
|
|
Net
product revenues |
|
|
44,842 |
|
|
|
50,217 |
|
|
(11 |
) |
|
|
89 |
|
|
|
97 |
|
|
Royalty income |
|
|
4,826 |
|
|
|
- |
|
|
N/A |
|
|
|
10 |
|
|
|
- |
|
|
Other |
|
|
578 |
|
|
|
1,811 |
|
|
(68 |
) |
|
|
1 |
|
|
|
3 |
|
|
Net
revenues |
|
$ |
50,246 |
|
|
$ |
52,028 |
|
|
(3 |
) |
% |
|
100 |
|
% |
|
100 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31, |
|
|
|
|
Dollars |
|
|
|
|
|
|
Percentage of Total Net Revenues |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
|
2017 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease
testing |
|
$ |
56,148 |
|
|
$ |
61,951 |
|
|
(9 |
) |
% |
|
31 |
|
% |
|
37 |
|
% |
Risk assessment
testing |
|
|
12,058 |
|
|
|
12,659 |
|
|
(5 |
) |
|
|
7 |
|
|
|
8 |
|
|
Cryosurgical
systems |
|
|
10,767 |
|
|
|
12,279 |
|
|
(12 |
) |
|
|
6 |
|
|
|
7 |
|
|
Molecular collection
systems |
|
|
86,455 |
|
|
|
75,099 |
|
|
15 |
|
|
|
47 |
|
|
|
45 |
|
|
Net
product revenues |
|
|
165,428 |
|
|
|
161,988 |
|
|
2 |
|
|
|
91 |
|
|
|
97 |
|
|
Royalty income |
|
|
9,653 |
|
|
|
- |
|
|
N/A |
|
|
|
5 |
|
|
|
- |
|
|
Other |
|
|
6,662 |
|
|
|
5,076 |
|
|
31 |
|
|
|
4 |
|
|
|
3 |
|
|
Net
revenues |
|
$ |
181,743 |
|
|
$ |
167,064 |
|
|
9 |
|
% |
|
100 |
|
% |
|
100 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Year Ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
OraQuick®
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
4,974 |
|
|
$ |
6,494 |
|
|
(23 |
) |
% |
|
$ |
19,663 |
|
|
$ |
23,847 |
|
|
(18 |
) |
% |
International HIV |
|
|
4,399 |
|
|
|
3,563 |
|
|
23 |
|
|
|
|
21,794 |
|
|
|
11,301 |
|
|
93 |
|
|
Net HIV
revenues |
|
|
9,373 |
|
|
|
10,057 |
|
|
(7 |
) |
|
|
|
41,457 |
|
|
|
35,148 |
|
|
18 |
|
|
Domestic HCV |
|
|
2,066 |
|
|
|
2,468 |
|
|
(16 |
) |
|
|
|
7,490 |
|
|
|
8,448 |
|
|
(11 |
) |
|
International HCV |
|
|
1,598 |
|
|
|
1,144 |
|
|
40 |
|
|
|
|
4,904 |
|
|
|
16,961 |
|
|
(71 |
) |
|
Net HCV
revenues |
|
|
3,664 |
|
|
|
3,612 |
|
|
1 |
|
|
|
|
12,394 |
|
|
|
25,409 |
|
|
(51 |
) |
|
Net
product revenues |
|
$ |
13,037 |
|
|
$ |
13,669 |
|
|
(5 |
) |
% |
|
$ |
53,851 |
|
|
$ |
60,557 |
|
|
(11 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Year Ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Molecular
Collection Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
|
$ |
23,505 |
|
|
$ |
28,679 |
|
|
(18 |
) |
% |
|
$ |
79,765 |
|
|
$ |
71,611 |
|
|
11 |
|
% |
Microbiome |
|
|
1,902 |
|
|
|
1,105 |
|
|
72 |
|
|
|
|
6,690 |
|
|
|
3,488 |
|
|
92 |
|
|
Net
product revenues |
|
$ |
25,407 |
|
|
$ |
29,784 |
|
|
(15 |
) |
% |
|
$ |
86,455 |
|
|
$ |
75,099 |
|
|
15 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
December 31,
2018 |
|
|
December 31,
2017 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
88,438 |
|
|
$ |
72,869 |
|
Short-term
investments |
|
|
68,134 |
|
|
|
83,028 |
|
Accounts receivable,
net |
|
|
34,842 |
|
|
|
42,521 |
|
Inventories |
|
|
22,888 |
|
|
|
19,343 |
|
Other current
assets |
|
|
5,010 |
|
|
|
4,144 |
|
Property and equipment,
net |
|
|
24,299 |
|
|
|
21,372 |
|
Intangible assets,
net |
|
|
5,137 |
|
|
|
8,223 |
|
Goodwill |
|
|
18,521 |
|
|
|
20,083 |
|
Long-term
investments |
|
|
44,752 |
|
|
|
20,690 |
|
Other non-current
assets |
|
|
3,550 |
|
|
|
3,928 |
|
Total
assets |
|
$ |
315,571 |
|
|
$ |
296,201 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
10,598 |
|
|
$ |
10,228 |
|
Deferred revenue |
|
|
3,521 |
|
|
|
1,314 |
|
Other current
liabilities |
|
|
13,861 |
|
|
|
20,695 |
|
Other non-current
liabilities |
|
|
901 |
|
|
|
3,932 |
|
Deferred income
taxes |
|
|
3,312 |
|
|
|
1,951 |
|
Stockholders’
equity |
|
|
283,378 |
|
|
|
258,081 |
|
Total
liabilities and stockholders’ equity |
|
$ |
315,571 |
|
|
$ |
296,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December 31, |
|
Additional
Financial Data (Unaudited) |
|
2018 |
|
|
2017 |
|
Capital
expenditures |
|
$ |
6,344 |
|
|
$ |
4,337 |
|
Depreciation and
amortization |
|
$ |
7,222 |
|
|
$ |
6,402 |
|
Stock-based
compensation |
|
$ |
15,237 |
|
|
$ |
6,973 |
|
Cash provided by
operating activities |
|
$ |
39,090 |
|
|
$ |
28,156 |
|
|
|
|
|
|
|
|
|
|
Conference CallThe Company will
host a conference call and audio webcast for analysts and investors
to discuss the Company’s 2018 fourth quarter and full year
financial results, certain business developments and financial
guidance for the first quarter of 2019, beginning today at 5:00
p.m. Eastern Time (2:00 p.m. Pacific Time). On the call will be Dr.
Stephen S. Tang, President and Chief Executive Officer, and Roberto
Cuca, Chief Financial 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 844-831-3030 (Domestic) or 315-625-6887
(International) and reference Conference ID #2986827 or go to
OraSure Technologies’ web site, www.orasure.com, and click on the
Investor Relations page. Please click on the webcast link and
follow the prompts for registration and access 10 minutes prior to
the call. 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 midnight, February 13, 2019, by dialing 855-859-2056
(Domestic) or 404-537-3406 (International) and entering the
Conference ID #2986827.
About OraSure
TechnologiesOraSure Technologies is a leader in the
development, manufacture and distribution of point-of-care
diagnostic and collection devices and other technologies designed
to detect or diagnose critical medical conditions. Its
first-to-market, innovative products include rapid tests for the
detection of antibodies to HIV and HCV on the OraQuick® platform,
oral fluid sample collection, stabilization and preparation
products for molecular diagnostic applications, and oral fluid
laboratory tests for detecting various drugs of abuse. OraSure’s
portfolio of products is sold globally to various clinical
laboratories, hospitals, clinics, community-based organizations and
other public health organizations, research and academic
institutions, distributors, government agencies, physicians’
offices, commercial and industrial entities and consumers. The
Company’s products enable healthcare providers to deliver critical
information to patients, empowering them to make decisions to
improve and protect their health.
Important InformationThis press
release contains certain forward-looking statements, including with
respect to expected revenues and earnings/loss per share.
Forward-looking statements are not guarantees of future performance
or results. Known and unknown factors that could cause actual
performance or results to be materially different from those
expressed or implied in these statements include, but are not
limited to: successfully managing and integrating acquisitions of
other companies in a manner that complements or leverages our
existing business, or otherwise expands or enhances our portfolio
of products and our end-to-end service offerings, and the diversion
of management’s attention from our ongoing business and regular
business responsibilities to effect such integration; the expected
economic benefits of acquisitions (and increased returns for our
stockholders), including that the anticipated synergies, revenue
enhancement strategies and other benefits from the acquisitions may
not be fully realized or may take longer to realize than expected
and our actual integration costs may exceed our estimates; ability
to market and sell products, whether through our internal, direct
sales force or third parties; ability to manufacture products in
accordance with applicable specifications, performance standards
and quality requirements; 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; ability to
effectively resolve warning letters, audit observations and other
findings or comments from the U.S. Food and Drug Administration
(“FDA”) or other regulators; changes in relationships, including
disputes or disagreements, with strategic partners or other parties
and reliance on strategic partners for the performance of critical
activities under collaborative arrangements; ability to meet
increased demand for the Company’s products; impact of significant
customer concentration in the genomics business; impact of
increased reliance on U.S. government contracts; failure of
distributors or other customers to meet purchase forecasts,
historic purchase levels or minimum purchase requirements for our
products; impact of replacing distributors; inventory levels at
distributors and other customers; ability of the Company to achieve
its financial and strategic objectives and continue to increase its
revenues, including the ability to expand international sales;
ability to identify, complete, integrate and realize the full
benefits of future acquisitions; impact of competitors, competing
products and technology changes; impact of negative economic
conditions; reduction or deferral of public funding available to
customers; competition from new or better technology or lower cost
products; ability to develop, commercialize and market new
products; market acceptance of oral fluid or urine testing,
collection or other products; market acceptance and uptake of
microbiome informatics, microbial genetics technology and related
analytics services; changes in market acceptance of products based
on product performance or other factors, including changes in
testing guidelines, algorithms or other recommendations by the
Centers for Disease Control and Prevention (“CDC”) or other
agencies; 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 products and components; availability of
related products produced by third parties or products required for
use of our products; ability to maintain sustained profitability;
ability to utilize net operating loss carry forwards 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 the impact of changes in international
funding sources and testing algorithms; adverse movements in
foreign currency exchange rates; loss or impairment of sources of
capital; ability to meet financial covenants in credit agreements;
ability to attract and retain qualified personnel; exposure to
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; and general political,
business and economic conditions. These and other factors that
could affect our results are discussed more fully in the Company’s
Securities and Exchange Commission (“SEC”) filings, including our
registration statements, Annual Report on Form 10-K for the year
ended December 31, 2017, Quarterly Reports on Form 10-Q, and
other filings with the SEC. Although forward-looking statements
help to provide 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.
Company Contact:
Roberto Cuca |
Jeanne Mell |
Chief Financial
Officer610-882-1820 |
VP Corporate
Communications484-353-1575 |
Investorinfo@orasure.com |
media@orasure.com |
www.orasure.com |
www.orasure.com |
OraSure Technologies (NASDAQ:OSUR)
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OraSure Technologies (NASDAQ:OSUR)
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