OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests and specimen collection devices,
today announced its consolidated financial results for the three
and six months ended June 30, 2018.
Financial Highlights
- Consolidated net revenues for the
second quarter of 2018 were $43.6 million, a 9% increase from the
second quarter of 2017. Consolidated net product revenues were
$38.8 million, representing a 1% decrease from the second quarter
of 2017.
- Consolidated net revenues for the
six months ended June 30, 2018 were $85.6 million, an 18% increase
from the comparable period of 2017. Consolidated net product
revenues for the first six months of 2018 were $77.1 million,
representing a 9% increase over the first half of 2017.
- Net molecular collection systems
revenues were $17.2 million during the second quarter of 2018,
which represents a 7% increase over the second quarter of
2017. Net molecular collection systems revenues during the
six months ended June 30, 2018 were $35.6 million, a 33% increase
from the comparable period of 2017.
- International sales of the
Company’s OraQuick® HIV products of $7.4 million increased 265%
compared to the second quarter of 2017. International sales of the
Company’s OraQuick® HIV products of $13.1 million increased 180%
compared to the first six 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 $1.5 million decreased 72% for
the second quarter of 2018 compared to the second quarter of
2017. International sales of the Company’s OraQuick® HCV
product of $2.1 million for the first six months of 2018 decreased
78% from the comparable period of 2017. These declines were a
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 $4.1 million of sales during
the second quarter of 2017 and $6.9 million during the first six
months of 2017.
- Consolidated net income for the
second quarter of 2018 was $4.1 million, or $0.07 per share on a
fully diluted basis, which compares to consolidated net income of
$5.4 million, or $0.09 per share on a fully diluted basis, for the
second quarter of 2017. Consolidated net income for the six months
ended June 30, 2018 was $2.0 million, or $0.03 per share on a fully
diluted basis, which compares to consolidated net income of $17.9
million, or $0.30 per share on a fully diluted basis, for the
comparable period of 2017. Consolidated net income for the
current quarter and year to date period included $2.2 million and
$8.6 million, respectively, of transition costs associated with the
retirement of the Company’s Chief Executive Officer and Chief
Financial Officer and the hiring of their successors. These
transition costs approximated $0.04 and $0.14 per share,
respectively, for the three and six month periods ended June 30,
2018, and primarily consisted of non-cash stock compensation
charges. Consolidated net income for the six months ended June 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 $0.16 per share on a fully
diluted after-tax basis in that period.
- Cash and investments totaled $181.2
million at June 30, 2018.
“Our financial results for the second quarter of
2018 exceeded expectations and continued the solid performance
started in Q1,” said Dr. Stephen S. Tang, President and CEO of
OraSure Technologies. “Continued strong international sales
of our HIV Self-Test and another strong quarter by our molecular
collections business were the primary drivers of this
performance. We expect that our HIV Self-Test and molecular
businesses will continue to be key growth contributors for the rest
of 2018.”
Financial Results
Consolidated net product revenues for the second
quarter of 2018 decreased 1% from the comparable period of 2017,
primarily as a result of lower sales of the Company’s OraQuick® HCV
and cryosurgical systems products and lower domestic sales of the
professional OraQuick® HIV test, partially offset by higher
international sales of the OraQuick® HIV Self-Test and higher sales
of the Company’s molecular collections products.
Consolidated net product revenues for the first
six months of 2018 increased 9% 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 six months ended June 30, 2018 included $1.7 million and
$2.7 million, respectively, of support payments under the Company’s
charitable support agreement with the Bill & Melinda Gates
Foundation (“Gates Foundation”).
Consolidated other revenues were $4.8 million
and $1.0 million for the second quarter of 2018 and 2017,
respectively. Consolidated other revenues were $8.5 million and
$2.1 million for the first six months of 2018 and 2017,
respectively. Other revenues in the second quarter of 2018
included royalty income of $2.1 million associated with a
litigation settlement agreement, Ebola and Zika-related funding
received from the U.S. Biomedical Advanced Research Development
Authority (“BARDA”) of $1.9 million and cost reimbursement under
the Company’s charitable support agreement with the Gates
Foundation of $795,000, which is separate from the support payments
mentioned above. Other revenues in the first six months of 2018
included royalty income from the litigation settlement of $3.7
million, BARDA funding of $3.5 million, and cost reimbursement from
the Gates Foundation of $1.3 million. Other revenues in the second
quarter and first six months of 2017 consisted only of BARDA
funding.
Consolidated gross profit percentage was 59% for
the three and six months ended June 30, 2018 and 63% for the three
and six months ended June 30, 2017. Gross profit percentage
declined in both periods primarily due to an increase in lower
profit percentage product sales partially offset by an increase in
other revenues.
Consolidated operating expenses increased to
$20.3 million during the second quarter of 2018 compared to $18.6
million in the second quarter of 2017. For the six months ended
June 30, 2018, consolidated operating expenses were $45.3 million,
an increase of $22.3 million from the $23.0 million reported for
the six months ended June 30, 2017. The quarter increase was
largely due to the inclusion of $2.2 million of retirement-related
transition costs as discussed above and increased spending in
research and development, partially offset by lower staffing
costs. The increase for the year to date period was largely
due to the inclusion of $8.6 million of transition costs and higher
spending on research and development and sales and marketing,
partially offset 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 half of 2017. There was no similar gain recorded
during the first half of 2018.
The Company reported operating income of $5.6
million in the second quarter of 2018, compared to operating income
of $6.9 million in the second quarter of 2017. Operating income for
the six months ended June 30, 2018 was $5.1 million compared $22.8
million for the six months ended June 30, 2017.
Income tax expense was $2.2 million during the
second quarter of 2018 compared to $1.6 million recorded in the
second quarter of 2017. Income tax expense was $4.2 million during
the first six months of 2018 compared to $5.5 million during the
first six 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 six 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 $181.2 million at June 30, 2018, compared to $176.6
million at December 31, 2017. For the six months ended
June 30, 2018, the Company generated $13.9 million in cash
from operations.
Third Quarter 2018 Outlook
The Company expects consolidated net revenues to
range from $44.0 million to $45.5 million and is
projecting consolidated net income of $0.10 to $0.12 per share for
the third quarter of 2018.
Financial Data
Condensed Consolidated Financial
Data(In thousands, except per-share
data)
Unaudited
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
|
2018 |
|
|
2017 |
|
Results of
Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
43,625 |
|
|
$ |
40,176 |
|
|
|
$ |
85,612 |
|
|
$ |
72,722 |
|
Cost of products
sold |
|
|
17,730 |
|
|
|
14,699 |
|
|
|
|
35,250 |
|
|
|
26,935 |
|
Gross
profit |
|
|
25,895 |
|
|
|
25,477 |
|
|
|
|
50,362 |
|
|
|
45,787 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
4,261 |
|
|
|
3,338 |
|
|
|
|
8,336 |
|
|
|
6,308 |
|
Sales and
marketing |
|
|
7,429 |
|
|
|
7,502 |
|
|
|
|
14,928 |
|
|
|
14,379 |
|
General
and administrative |
|
|
8,647 |
|
|
|
7,750 |
|
|
|
|
22,038 |
|
|
|
14,842 |
|
Gain on
litigation settlement |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
(12,500 |
) |
Total
operating expenses |
|
|
20,337 |
|
|
|
18,590 |
|
|
|
|
45,302 |
|
|
|
23,029 |
|
Operating
income |
|
|
5,558 |
|
|
|
6,887 |
|
|
|
|
5,060 |
|
|
|
22,758 |
|
Other income |
|
|
736 |
|
|
|
96 |
|
|
|
|
1,148 |
|
|
|
563 |
|
Income before income
taxes |
|
|
6,294 |
|
|
|
6,983 |
|
|
|
|
6,208 |
|
|
|
23,321 |
|
Income tax expense |
|
|
2,173 |
|
|
|
1,555 |
|
|
|
|
4,206 |
|
|
|
5,452 |
|
Net income |
|
$ |
4,121 |
|
|
$ |
5,428 |
|
|
|
$ |
2,002 |
|
|
$ |
17,869 |
|
Earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.07 |
|
|
$ |
0.09 |
|
|
|
$ |
0.03 |
|
|
$ |
0.31 |
|
Diluted |
|
$ |
0.07 |
|
|
$ |
0.09 |
|
|
|
$ |
0.03 |
|
|
$ |
0.30 |
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
61,100 |
|
|
|
58,478 |
|
|
|
|
60,983 |
|
|
|
57,708 |
|
Diluted |
|
|
62,244 |
|
|
|
60,728 |
|
|
|
|
62,379 |
|
|
|
59,755 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary of Net Revenues by Market and Product
(Unaudited)
|
|
Three Months Ended
June 30, |
|
|
|
|
Dollars |
|
|
|
|
|
|
|
Percentage of TotalNet Revenues |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
|
2017 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease
testing |
|
$ |
15,919 |
|
|
$ |
16,663 |
|
|
|
(4 |
) |
% |
|
|
36 |
|
% |
|
|
41 |
|
% |
Risk assessment
testing |
|
|
3,315 |
|
|
|
3,238 |
|
|
|
2 |
|
|
|
|
8 |
|
|
|
|
8 |
|
|
Cryosurgical
systems |
|
|
2,392 |
|
|
|
3,174 |
|
|
|
(25 |
) |
|
|
|
6 |
|
|
|
|
8 |
|
|
Molecular collection
systems |
|
|
17,192 |
|
|
|
16,057 |
|
|
|
7 |
|
|
|
|
39 |
|
|
|
|
40 |
|
|
Net
product revenues |
|
|
38,818 |
|
|
|
39,132 |
|
|
|
(1 |
) |
|
|
|
89 |
|
|
|
|
97 |
|
|
Other |
|
|
4,807 |
|
|
|
1,044 |
|
|
|
360 |
|
|
|
|
11 |
|
|
|
|
3 |
|
|
Net
revenues |
|
$ |
43,625 |
|
|
$ |
40,176 |
|
|
|
9 |
|
% |
|
|
100 |
|
% |
|
|
100 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30, |
|
|
|
|
Dollars |
|
|
|
|
|
|
|
Percentage of TotalNet Revenues |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
|
2017 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease
testing |
|
$ |
30,090 |
|
|
$ |
31,245 |
|
|
|
(4 |
) |
% |
|
|
35 |
|
% |
|
|
43 |
|
% |
Risk assessment
testing |
|
|
6,316 |
|
|
|
6,368 |
|
|
|
(1 |
) |
|
|
|
7 |
|
|
|
|
9 |
|
|
Cryosurgical
systems |
|
|
5,177 |
|
|
|
6,237 |
|
|
|
(17 |
) |
|
|
|
6 |
|
|
|
|
8 |
|
|
Molecular collection
systems |
|
|
35,553 |
|
|
|
26,764 |
|
|
|
33 |
|
|
|
|
42 |
|
|
|
|
37 |
|
|
Net
product revenues |
|
|
77,136 |
|
|
|
70,614 |
|
|
|
9 |
|
|
|
|
90 |
|
|
|
|
97 |
|
|
Other |
|
|
8,476 |
|
|
|
2,108 |
|
|
|
302 |
|
|
|
|
10 |
|
|
|
|
3 |
|
|
Net
revenues |
|
$ |
85,612 |
|
|
$ |
72,722 |
|
|
|
18 |
|
% |
|
|
100 |
|
% |
|
|
100 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
|
June 30, |
|
|
|
June 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
OraQuick®
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
3,881 |
|
|
$ |
4,965 |
|
|
|
(22 |
) |
% |
|
$ |
7,293 |
|
|
$ |
8,779 |
|
|
|
(17 |
) |
% |
International HIV |
|
|
7,397 |
|
|
|
2,025 |
|
|
|
265 |
|
|
|
|
13,067 |
|
|
|
4,669 |
|
|
|
180 |
|
|
Domestic OTC HIV |
|
|
1,308 |
|
|
|
1,894 |
|
|
|
(31 |
) |
|
|
|
2,941 |
|
|
|
3,436 |
|
|
|
(14 |
) |
|
Net HIV
revenues |
|
|
12,586 |
|
|
|
8,884 |
|
|
|
42 |
|
|
|
|
23,301 |
|
|
|
16,884 |
|
|
|
38 |
|
|
Domestic HCV |
|
|
1,730 |
|
|
|
2,382 |
|
|
|
(27 |
) |
|
|
|
3,358 |
|
|
|
4,091 |
|
|
|
(18 |
) |
|
International HCV |
|
|
1,473 |
|
|
|
5,261 |
|
|
|
(72 |
) |
|
|
|
2,138 |
|
|
|
9,664 |
|
|
|
(78 |
) |
|
Net HCV
revenues |
|
|
3,203 |
|
|
|
7,643 |
|
|
|
(58 |
) |
|
|
|
5,496 |
|
|
|
13,755 |
|
|
|
(60 |
) |
|
Net
product revenues |
|
$ |
15,789 |
|
|
$ |
16,527 |
|
|
|
(4 |
) |
% |
|
$ |
28,797 |
|
|
$ |
30,639 |
|
|
|
(6 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
|
June 30, |
|
|
|
June 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Cryosurgical
Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
professional |
|
$ |
1,068 |
|
|
$ |
1,445 |
|
|
|
(26 |
) |
% |
|
$ |
1,943 |
|
|
$ |
2,941 |
|
|
|
(34 |
) |
% |
International
professional |
|
|
264 |
|
|
|
243 |
|
|
|
9 |
|
|
|
|
413 |
|
|
|
373 |
|
|
|
11 |
|
|
Domestic OTC |
|
|
295 |
|
|
|
347 |
|
|
|
(15 |
) |
|
|
|
584 |
|
|
|
632 |
|
|
|
(8 |
) |
|
International OTC |
|
|
765 |
|
|
|
1,139 |
|
|
|
(33 |
) |
|
|
|
2,237 |
|
|
|
2,291 |
|
|
|
(2 |
) |
|
Net
product revenues |
|
$ |
2,392 |
|
|
$ |
3,174 |
|
|
|
(25 |
) |
% |
|
$ |
5,177 |
|
|
$ |
6,237 |
|
|
|
(17 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
|
June 30, |
|
|
|
June 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Molecular
Collection Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial
Genomics |
|
$ |
12,263 |
|
|
$ |
12,815 |
|
|
|
(4 |
) |
% |
|
$ |
26,519 |
|
|
$ |
20,072 |
|
|
|
32 |
|
% |
Academic Genomics |
|
|
3,105 |
|
|
|
2,399 |
|
|
|
29 |
|
|
|
|
5,937 |
|
|
|
5,083 |
|
|
|
17 |
|
|
Microbiome |
|
|
1,824 |
|
|
|
843 |
|
|
|
116 |
|
|
|
|
3,097 |
|
|
|
1,609 |
|
|
|
92 |
|
|
Net
product revenues |
|
$ |
17,192 |
|
|
$ |
16,057 |
|
|
|
7 |
|
% |
|
$ |
35,553 |
|
|
$ |
26,764 |
|
|
|
33 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|
|
|
June 30, |
|
|
|
June 30, |
|
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
|
2018 |
|
|
2017 |
|
|
%Change |
|
|
Other
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty income |
|
$ |
2,092 |
|
|
$ |
— |
|
|
N/A |
|
|
|
$ |
3,694 |
|
|
$ |
— |
|
|
N/A |
|
|
BARDA funding |
|
|
1,920 |
|
|
|
1,044 |
|
|
|
84 |
|
% |
|
|
3,458 |
|
|
|
2,108 |
|
|
|
64 |
|
% |
Charitable support
reimbursement |
|
|
795 |
|
|
|
— |
|
|
N/A |
|
|
|
|
1,324 |
|
|
|
— |
|
|
N/A |
|
|
Other
revenues |
|
$ |
4,807 |
|
|
$ |
1,044 |
|
|
|
360 |
|
% |
|
$ |
8,476 |
|
|
$ |
2,108 |
|
|
|
302 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
June 30,
2018 |
|
|
December 31,
2017 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
71,069 |
|
|
$ |
72,869 |
|
Short-term
investments |
|
|
74,269 |
|
|
|
83,028 |
|
Accounts receivable,
net |
|
|
31,648 |
|
|
|
42,521 |
|
Inventories |
|
|
20,599 |
|
|
|
19,343 |
|
Other current
assets |
|
|
4,637 |
|
|
|
4,144 |
|
Property and equipment,
net |
|
|
23,946 |
|
|
|
21,372 |
|
Intangible assets,
net |
|
|
6,622 |
|
|
|
8,223 |
|
Goodwill |
|
|
19,231 |
|
|
|
20,083 |
|
Long-term
investments |
|
|
35,828 |
|
|
|
20,690 |
|
Other non-current
assets |
|
|
4,513 |
|
|
|
3,928 |
|
Total
assets |
|
$ |
292,362 |
|
|
$ |
296,201 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,659 |
|
|
$ |
10,228 |
|
Deferred revenue |
|
|
1,621 |
|
|
|
1,314 |
|
Other current
liabilities |
|
|
9,837 |
|
|
|
20,695 |
|
Other non-current
liabilities |
|
|
4,474 |
|
|
|
3,932 |
|
Deferred income
taxes |
|
|
1,600 |
|
|
|
1,951 |
|
Stockholders’
equity |
|
|
265,171 |
|
|
|
258,081 |
|
Total
liabilities and stockholders’ equity |
|
$ |
292,362 |
|
|
$ |
296,201 |
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
Additional
Financial Data (Unaudited) |
|
2018 |
|
|
2017 |
|
Capital
expenditures |
|
$ |
4,484 |
|
|
$ |
1,567 |
|
Depreciation and
amortization |
|
$ |
3,746 |
|
|
$ |
2,891 |
|
Stock-based
compensation |
|
$ |
11,262 |
|
|
$ |
3,631 |
|
Cash provided by
operating activities |
|
$ |
13,928 |
|
|
$ |
21,704 |
|
|
|
|
|
|
|
|
|
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
2018 second quarter financial results, certain business
developments and financial guidance for the third 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 #4795505 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, August 15, 2018, by dialing 855-859-2056 (Domestic)
or 404-537-3406 (International) and entering the Conference ID
#4795505.
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 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 CucaChief Financial
Officer610-882-1820Investorinfo@orasure.comwww.orasure.com
OraSure Technologies (NASDAQ:OSUR)
過去 株価チャート
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OraSure Technologies (NASDAQ:OSUR)
過去 株価チャート
から 7 2023 まで 7 2024