OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests and specimen collection devices,
today announced its financial results for the three and nine months
ended September 30, 2018.
Financial Highlights
- Net revenues for the third quarter of 2018 were $45.9 million,
an 8% increase from the third quarter of 2017. Net product revenues
were $43.5 million, representing a 6% increase from the third
quarter of 2017.
- Net revenues for the nine months ended September 30, 2018
were $131.5 million, a 14% increase from the comparable period of
2017. Net product revenues for the first nine months of 2018
were $120.6 million, representing an 8% increase over the first
nine months of 2017.
- Net molecular collection systems revenues were $25.5 million
during the third quarter of 2018, which represents a 37% increase
over the third quarter of 2017. Net molecular collection
systems revenues during the nine months ended September 30,
2018 were $61.0 million, a 35% increase from the comparable period
of 2017.
- International sales of the Company’s OraQuick® HIV products of
$4.3 million increased 41% compared to the third quarter of 2017.
For the first nine months of 2018, international sales of the
Company’s OraQuick® HIV products of $17.4 million increased 125%
compared to the first nine months of 2017. The increases in
both periods were primarily the result of higher sales of the
Company’s OraQuick® HIV Self-Test.
- International sales of the Company’s OraQuick® HCV product of
$1.2 million decreased 81% for the third quarter of 2018 compared
to the third quarter of 2017. International sales of the
Company’s OraQuick® HCV product of $3.3 million for the first nine
months of 2018 decreased 79% from the comparable period of
2017. These declines were 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 $4.7 million of sales during the third quarter
of 2017 and $11.6 million during the first nine months of
2017.
- Net income for the third quarter of 2018 was $8.1 million, or
$0.13 per share on a fully diluted basis, which compares to net
income of $5.8 million, or $0.09 per share on a fully diluted
basis, for the third quarter of 2017. Net income for the nine
months ended September 30, 2018 was $10.1 million, or $0.16
per share on a fully diluted basis, which compares to net income of
$23.6 million, or $0.39 per share on a fully diluted basis, for the
comparable period of 2017. Net income for the year-to-date
period included $8.6 million of transition costs associated with
the retirement of the Company’s former Chief Executive Officer and
Chief Financial Officer and the hiring of their successors.
These transition costs approximated $0.14 per share for the nine
month period ended September 30, 2018 and primarily consisted of
non-cash stock compensation charges. Net income for the nine months
ended September 30, 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 approximated $0.15 per share on
a fully diluted after-tax basis in that period.
- Cash and investments totaled $192.1 million at
September 30, 2018.
“Our solid third quarter performance was driven
by strong growth in our molecular collections and international HIV
Self-Test businesses,” said Dr. Stephen S. Tang, President and
Chief Executive Officer of OraSure Technologies. “An abundance of
opportunity remains in the growth drivers for our business and
capitalizing on these opportunities will remain a priority for our
management team. In addition, as we execute against our
strategic goals, we continue to actively explore ways to leverage
our strong balance sheet to further enhance our growth. We are very
well positioned to compete in our key markets and expect to deliver
a strong end to the year.”
Financial Results
Net product revenues for the third quarter of
2018 increased 6% from the comparable period of 2017, primarily as
a result of higher sales of the Company’s molecular collections
products and higher international sales of the OraQuick® HIV
Self-Test, partially offset by lower international sales of the
Company’s OraQuick® HCV test and lower domestic sales of the
professional OraQuick® HIV test.
Net product revenues for the first nine months
of 2018 increased 8% over the comparable period of 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.
Sales of the OraQuick® HIV Self-Test for the
three and nine months ended September 30, 2018 included $840,000
and $3.6 million, respectively, of support payments under the
Company’s charitable support agreement with the Bill &
Melinda Gates Foundation (“Gates Foundation”).
Other revenues were $2.4 million and $1.2
million for the third quarter of 2018 and 2017, respectively. Other
revenues were $10.9 million and $3.3 million for the first nine
months of 2018 and 2017, respectively. Other revenues in the
third quarter of 2018 included royalty income of $1.1 million
associated with a litigation settlement agreement, Ebola and
Zika-related funding received from the U.S. Biomedical Advanced
Research Development Authority (“BARDA”) of $1.1 million and cost
reimbursement under the Company’s charitable support agreement with
the Gates Foundation of $220,000, which is separate from the
support payments mentioned above. Other revenues in the first nine
months of 2018 included royalty income associated with the
litigation settlement of $4.8 million, BARDA funding of $4.5
million, and cost reimbursement from the Gates Foundation of $1.5
million. Other revenues in the third quarter of 2017 included
$939,000 of BARDA funding and $218,000 of cost reimbursement.
Revenues in the first nine months of 2017 consisted of $3.0 million
of BARDA funding and $218,000 of cost reimbursement.
Gross profit percentage was 62% and 60% for the
three and nine months ended September 30, 2018, respectively,
and 58% and 61% for the three and nine months ended
September 30, 2017, respectively. Gross profit percentage in
the current quarter benefited from lower manufacturing costs
associated with the Company’s Oragene® product, lower royalty
expense, and the increase in other revenues. The decline in
gross profit percentage for the first nine months of 2018 was
primarily due to an increase in lower profit percentage product
sales partially offset by the increase in other revenues.
Operating expenses increased modestly to $17.7
million during the third quarter of 2018 compared to $17.3 million
in the third quarter of 2017. For the nine months ended
September 30, 2018, operating expenses were $63.0 million, an
increase of $22.6 million from the $40.4 million reported for the
nine months ended September 30, 2017. The third quarter
increase was largely due to higher research and development
spending and higher commissions and consulting costs, partially
offset by lower staffing expenses. The increase for the
nine-month period was largely due to the inclusion of $8.6 million
of management transition costs 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 the first nine months of
2017. There was no similar gain recorded during the first
nine months of 2018.
The Company reported operating income of $10.9
million in the third quarter of 2018, compared to operating income
of $7.3 million in the third quarter of 2017. Operating income for
the nine months ended September 30, 2018 was $15.9 million
compared $30.1 million for the nine months ended September 30,
2017.
Income tax expense was $3.3 million during the
third quarter of 2018 compared to $1.7 million recorded in the
third quarter of 2017. Income tax expense was $7.5 million during
the first nine months of 2018 compared to $7.1 million during the
first nine months of 2017. Income tax expense in 2018
reflects the higher pre-tax income generated by the Company’s
Canadian subsidiary. Income tax expense in the first nine
months of 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 $192.1 million at September 30, 2018, compared to
$176.6 million at December 31, 2017. For the nine months ended
September 30, 2018, the Company generated $24.8 million in
cash from operations.
Fourth Quarter 2018 Outlook
The Company expects net revenues to range from
$46.5 million to $48.0 million - which implies full year
2018 revenue growth of 7% over 2017 - and is projecting net income
of $0.09 to $0.11 per share for the fourth quarter of
2018.
Financial Data
|
Condensed Consolidated
Financial Data |
(In thousands, except
per-share data) |
|
Unaudited |
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
September 30, |
|
September 30, |
|
|
2018 |
|
|
2017 |
|
2018 |
|
|
2017 |
|
Results of Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
$ |
45,885 |
|
|
$ |
42,314 |
|
$ |
131,497 |
|
|
$ |
115,036 |
|
Cost of products sold |
|
17,340 |
|
|
|
17,670 |
|
|
52,590 |
|
|
|
44,605 |
|
Gross profit |
|
28,545 |
|
|
|
24,644 |
|
|
78,907 |
|
|
|
70,431 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,855 |
|
|
|
3,228 |
|
|
12,191 |
|
|
|
9,536 |
|
Sales and marketing |
|
7,304 |
|
|
|
7,162 |
|
|
22,232 |
|
|
|
21,541 |
|
General and administrative |
|
6,529 |
|
|
|
6,935 |
|
|
28,567 |
|
|
|
21,777 |
|
Gain on litigation settlement |
|
— |
|
|
|
— |
|
|
— |
|
|
|
(12,500 |
) |
Total operating expenses |
|
17,688 |
|
|
|
17,325 |
|
|
62,990 |
|
|
|
40,354 |
|
Operating income |
|
10,857 |
|
|
|
7,319 |
|
|
15,917 |
|
|
|
30,077 |
|
Other income |
|
510 |
|
|
|
113 |
|
|
1,658 |
|
|
|
676 |
|
Income before income taxes |
|
11,367 |
|
|
|
7,432 |
|
|
17,575 |
|
|
|
30,753 |
|
Income tax expense |
|
3,271 |
|
|
|
1,669 |
|
|
7,477 |
|
|
|
7,121 |
|
Net income |
$ |
8,096 |
|
|
$ |
5,763 |
|
$ |
10,098 |
|
|
$ |
23,632 |
|
Earnings per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.13 |
|
|
$ |
0.10 |
|
$ |
0.17 |
|
|
$ |
0.40 |
|
Diluted |
$ |
0.13 |
|
|
$ |
0.09 |
|
$ |
0.16 |
|
|
$ |
0.39 |
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
61,208 |
|
|
|
60,090 |
|
|
61,059 |
|
|
|
58,511 |
|
Diluted |
|
62,606 |
|
|
|
62,172 |
|
|
62,539 |
|
|
|
60,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary of Net Revenues by Market and Product
(Unaudited)
|
|
Three Months Ended
September 30, |
|
|
|
Dollars |
|
|
|
|
|
|
|
Percentage of Total Net
Revenues |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
|
2017 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
$ |
12,417 |
|
|
$ |
16,577 |
|
|
|
(25 |
) |
% |
|
|
27 |
|
% |
|
|
39 |
|
% |
Risk assessment testing |
|
2,842 |
|
|
|
3,149 |
|
|
|
(10 |
) |
|
|
|
6 |
|
|
|
|
7 |
|
|
Cryosurgical systems |
|
2,696 |
|
|
|
2,879 |
|
|
|
(6 |
) |
|
|
|
6 |
|
|
|
|
7 |
|
|
Molecular collection systems |
|
25,495 |
|
|
|
18,552 |
|
|
|
37 |
|
|
|
|
56 |
|
|
|
|
44 |
|
|
Net product revenues |
|
43,450 |
|
|
|
41,157 |
|
|
|
6 |
|
|
|
|
95 |
|
|
|
|
97 |
|
|
Other |
|
2,435 |
|
|
|
1,157 |
|
|
|
110 |
|
|
|
|
5 |
|
|
|
|
3 |
|
|
Net revenues |
$ |
45,885 |
|
|
$ |
42,314 |
|
|
|
8 |
|
% |
|
|
100 |
|
% |
|
|
100 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30, |
|
|
|
|
Dollars |
|
|
|
|
|
|
|
Percentage of Total Net
Revenues |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
|
2017 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ |
42,506 |
|
|
$ |
47,822 |
|
|
|
(11 |
) |
% |
|
|
33 |
|
% |
|
|
42 |
|
% |
Risk assessment testing |
|
|
9,159 |
|
|
|
9,517 |
|
|
|
(4 |
) |
|
|
|
7 |
|
|
|
|
8 |
|
|
Cryosurgical systems |
|
|
7,874 |
|
|
|
9,116 |
|
|
|
(14 |
) |
|
|
|
6 |
|
|
|
|
8 |
|
|
Molecular collection systems |
|
|
61,047 |
|
|
|
45,316 |
|
|
|
35 |
|
|
|
|
46 |
|
|
|
|
39 |
|
|
Net product revenues |
|
|
120,586 |
|
|
|
111,771 |
|
|
|
8 |
|
|
|
|
92 |
|
|
|
|
97 |
|
|
Other |
|
|
10,911 |
|
|
|
3,265 |
|
|
|
234 |
|
|
|
|
8 |
|
|
|
|
3 |
|
|
Net revenues |
|
$ |
131,497 |
|
|
$ |
115,036 |
|
|
|
14 |
|
% |
|
|
100 |
|
% |
|
|
100 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
Nine Months
Ended |
|
|
|
|
September 30, |
|
|
|
September 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
OraQuick®
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
2,749 |
|
|
$ |
3,622 |
|
|
|
(24 |
) |
% |
|
$ |
10,043 |
|
|
$ |
12,401 |
|
|
|
(19 |
) |
% |
International HIV |
|
|
4,328 |
|
|
|
3,069 |
|
|
|
41 |
|
|
|
|
17,395 |
|
|
|
7,738 |
|
|
|
125 |
|
|
Domestic OTC HIV |
|
|
1,706 |
|
|
|
1,515 |
|
|
|
13 |
|
|
|
|
4,646 |
|
|
|
4,951 |
|
|
|
(6 |
) |
|
Net HIV revenues |
|
|
8,783 |
|
|
|
8,206 |
|
|
|
7 |
|
|
|
|
32,084 |
|
|
|
25,090 |
|
|
|
28 |
|
|
Domestic HCV |
|
|
2,066 |
|
|
|
1,889 |
|
|
|
9 |
|
|
|
|
5,424 |
|
|
|
5,980 |
|
|
|
(9 |
) |
|
International HCV |
|
|
1,168 |
|
|
|
6,154 |
|
|
|
(81 |
) |
|
|
|
3,306 |
|
|
|
15,817 |
|
|
|
(79 |
) |
|
Net HCV revenues |
|
|
3,234 |
|
|
|
8,043 |
|
|
|
(60 |
) |
|
|
|
8,730 |
|
|
|
21,797 |
|
|
|
(60 |
) |
|
Net product revenues |
|
$ |
12,017 |
|
|
$ |
16,249 |
|
|
|
(26 |
) |
% |
|
$ |
40,814 |
|
|
$ |
46,887 |
|
|
|
(13 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
Nine Months
Ended |
|
|
|
|
September 30, |
|
|
|
September 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Cryosurgical Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic professional |
|
$ |
1,349 |
|
|
$ |
1,426 |
|
|
|
(5 |
) |
% |
|
$ |
3,292 |
|
|
$ |
4,368 |
|
|
|
(25 |
) |
% |
International professional |
|
|
220 |
|
|
|
179 |
|
|
|
23 |
|
|
|
|
633 |
|
|
|
552 |
|
|
|
15 |
|
|
Domestic OTC |
|
|
333 |
|
|
|
325 |
|
|
|
2 |
|
|
|
|
917 |
|
|
|
957 |
|
|
|
(4 |
) |
|
International OTC |
|
|
794 |
|
|
|
949 |
|
|
|
(16 |
) |
|
|
|
3,032 |
|
|
|
3,239 |
|
|
|
(6 |
) |
|
Net product revenues |
|
$ |
2,696 |
|
|
$ |
2,879 |
|
|
|
(6 |
) |
% |
|
$ |
7,874 |
|
|
$ |
9,116 |
|
|
|
(14 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
Nine Months
Ended |
|
|
|
|
September 30, |
|
|
|
September 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Molecular Collection Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial Genomics |
|
$ |
21,505 |
|
|
$ |
14,544 |
|
|
|
48 |
|
% |
|
$ |
48,024 |
|
|
$ |
34,615 |
|
|
|
39 |
|
% |
Academic Genomics |
|
|
2,299 |
|
|
|
3,232 |
|
|
|
(29 |
) |
|
|
|
8,236 |
|
|
|
8,316 |
|
|
|
(1 |
) |
|
Microbiome |
|
|
1,691 |
|
|
|
776 |
|
|
|
118 |
|
|
|
|
4,787 |
|
|
|
2,385 |
|
|
|
101 |
|
|
Net product revenues |
|
$ |
25,495 |
|
|
$ |
18,552 |
|
|
|
37 |
|
% |
|
$ |
61,047 |
|
|
$ |
45,316 |
|
|
|
35 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
|
Nine Months
Ended |
|
|
|
|
September 30, |
|
|
|
September 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Other Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty income |
|
$ |
1,132 |
|
|
$ |
— |
|
|
N/A |
|
|
|
$ |
4,827 |
|
|
$ |
— |
|
|
N/A |
|
|
BARDA funding |
|
|
1,083 |
|
|
|
939 |
|
|
15 |
|
% |
|
|
4,540 |
|
|
|
3,047 |
|
|
|
49 |
|
% |
Charitable support reimbursement |
|
|
220 |
|
|
|
218 |
|
|
1 |
|
|
|
|
1,544 |
|
|
|
218 |
|
|
|
608 |
|
|
Other revenues |
|
$ |
2,435 |
|
|
$ |
1,157 |
|
|
110 |
|
% |
|
$ |
10,911 |
|
|
$ |
3,265 |
|
|
|
234 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
September 30,
2018 |
|
|
December 31,
2017 |
|
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
78,146 |
|
|
$ |
72,869 |
|
Short-term investments |
|
72,192 |
|
|
|
83,028 |
|
Accounts receivable, net |
|
33,284 |
|
|
|
42,521 |
|
Inventories |
|
19,899 |
|
|
|
19,343 |
|
Other current assets |
|
4,376 |
|
|
|
4,144 |
|
Property and equipment, net |
|
24,395 |
|
|
|
21,372 |
|
Intangible assets, net |
|
6,053 |
|
|
|
8,223 |
|
Goodwill |
|
19,568 |
|
|
|
20,083 |
|
Long-term investments |
|
41,788 |
|
|
|
20,690 |
|
Other non-current assets |
|
4,606 |
|
|
|
3,928 |
|
Total assets |
$ |
304,307 |
|
|
$ |
296,201 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Accounts payable |
$ |
8,064 |
|
|
$ |
10,228 |
|
Deferred revenue |
|
3,106 |
|
|
|
1,314 |
|
Other current liabilities |
|
10,250 |
|
|
|
20,695 |
|
Other non-current liabilities |
|
4,649 |
|
|
|
3,932 |
|
Deferred income taxes |
|
1,484 |
|
|
|
1,951 |
|
Stockholders’ equity |
|
276,754 |
|
|
|
258,081 |
|
Total liabilities and stockholders’ equity |
$ |
304,307 |
|
|
$ |
296,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
Ended |
|
|
September 30, |
|
Additional Financial Data (Unaudited) |
2018 |
|
|
2017 |
|
Capital expenditures |
$ |
5,938 |
|
|
$ |
3,462 |
|
Depreciation and amortization |
$ |
5,588 |
|
|
$ |
4,589 |
|
Stock-based compensation |
$ |
12,526 |
|
|
$ |
5,213 |
|
Cash provided by operating activities |
$ |
24,807 |
|
|
$ |
30,361 |
|
|
|
|
|
|
|
|
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
2018 third quarter financial results, certain business developments
and financial guidance for the fourth quarter of 2018, 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 #8850417 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, November 14, 2018, by dialing 855-859-2056
(Domestic) or 404-537-3406 (International) and entering the
Conference ID #8850417.
About OraSure Technologies
OraSure 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 Information
This 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: 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 or other 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 testing,
collection or other products; 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 |
Chief Financial Officer610-882-1820 |
Investorinfo@orasure.com |
www.orasure.com |
OraSure Technologies (NASDAQ:OSUR)
過去 株価チャート
から 6 2024 まで 7 2024
OraSure Technologies (NASDAQ:OSUR)
過去 株価チャート
から 7 2023 まで 7 2024