OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care diagnostic tests, specimen collection devices, and
microbiome laboratory and analytical services, today announced its
financial results for the three months and year ended December 31,
2020.
“OraSure continues to successfully navigate the
pandemic, with a record-breaking fourth quarter and double-digit
full-year revenue growth driven by a strong sequential quarterly
increase in sales of our molecular sample collection kits for
COVID-19 testing. We expect this strong sustained performance to
persist as testing continues to be a key strategy to combat the
ongoing pandemic. Our base business was resilient, with
demonstrated strength in international HIV testing,” said Stephen
S. Tang, Ph.D., President and Chief Executive Officer.
Dr. Tang continued, “Importantly, we have made
substantial progress on our COVID-19 Rapid Antigen Self-Test and
oral fluid antibody test. We expect that OraSure’s COVID-19
activities will continue to accelerate the Company’s growth and
significantly outweigh any negative impact of the pandemic on other
parts of our business. We have locked the proprietary assay
chemistry and completed development and clinical testing of our
rapid antigen test for COVID-19. We accelerated the Prescription
Self-Test trials and now plan to submit for both the Professional
and Prescription Self-Test for Emergency Use Authorization (EUA) by
the end of this month. We are also planning to resubmit two
separate EUAs for our lab-based oral fluid antibody test, including
additional analytical study data, as requested by the FDA, and look
forward to bringing this important product to market as soon as
possible.”
Financial Highlights
- Net revenues for the fourth quarter
of 2020 were $62.9 million, a 27% increase from the fourth
quarter of 2019. Net product and services revenues were $60.4
million, a 28% increase from the fourth quarter of 2019.
- Net revenues for the full year 2020
were $171.7 million, an 11% increase over 2019.
- Total product and service revenues
for the Company’s molecular business unit were $40.3
million during the fourth quarter of 2020, an increase of 58%
from the fourth quarter of 2019. This increase included $22.5
million in sales of sample collection devices for COVID-19
molecular testing.
- Total product and service revenues
for the Company’s molecular business unit were $102.8 million for
the full year 2020, an increase of 45% from the full year 2019. The
increase included $49.8 million in sales of sample collection
devices for COVID-19 molecular testing.
- Full year 2020 international sales
of the Company’s HIV products grew 16% over the prior year driven
by a 21% increase in HIV Self-Test sales in Africa. For the fourth
quarter, HIV international revenue was $11.3 million, a 16%
increase from the fourth quarter of 2019. This was a record quarter
and year for sales of OraSure’s HIV self-tests
internationally.
- Net income for the fourth quarter
of 2020 was $1.9 million, or $0.03 per share on a
fully-diluted basis, compared to net income of $2.4 million,
or $0.04 per share on a fully-diluted basis, for the
fourth quarter of 2019.
- Cash and investments
totaled $257.1 million at December 31, 2020.
COVID-19 Update
Molecular/PCR:
- Sales of sample collection
devices for molecular/PCR COVID-19 testing in the fourth quarter
showed sequential quarterly growth and persistence of commercial
opportunity; the Company’s sample collection kits continued to be
included in Emergency Use Authorizations (EUAs) granted to
customers.
- Use of DNA Genotek molecular sample
collection kits continued to grow in back-to-work settings,
back-to-school programs, laboratory testing and direct-to-consumer
offerings. OraSure continues to build its customer base, with
high-volume repeat orders from existing customers and demand from
new customers.
- The Company’s molecular collection
kits are now included in eight EUAs granted by the U.S. Food and
Drug Administration (FDA) to DNA Genotek customers for COVID-19
testing.
- The Company’s ORAcollect® •RNA
saliva collection device has been used in the more than one million
COVID-19 tests administered by State University of New York
campuses since the start of the 2020-2021 academic year. These
tests were developed by DNA Genotek customer Quadrant
Biosciences.
- The Company’s OMNIgene·ORAL and
ORAcollect® •RNA saliva collection devices have received interim
authorization for use in COVID-19 testing from Health Canada.
- Through OraSure’s customer
Chronomics, the OMNIgene·ORAL is being utilized as a collection
device for the UK Government’s “Test to Release for International
Travel” COVID-19 testing program.
Antigen:
- OraSure has finalized all
product development and completed clinical studies
for its COVID-19 Rapid Antigen Self-Test and now
plans FDA EUA submission for both
Professional and Prescription Self-Test in the first
quarter.
- OraSure has locked the proprietary
assay chemistry and completed development of its COVID-19 Rapid
Antigen Self-Test and has collected all clinical study data to now
submit both the Professional version and Prescription Self-Test
version for EUA in the first quarter of 2021.
- Subject to receipt of EUA, this
product would test for active COVID-19 infection using nasal
samples self-collected from the lower nostrils. The COVID-19 Rapid
Antigen Self-Test is designed to be performed anytime, anywhere,
with no instrumentation, batteries or laboratory analysis needed to
interpret results.
- Subject to regulatory approvals,
the Company intends to market its Prescription
Self-Test for use by individual consumers (with
prescription) at home, or in any location by employers/universities
on- or off-site, or by physicians, or public health via remote
testing, and its Professional Test for use at
drive-through sites, physician offices, public health testing
sites, and employer/university health centers.
- After the Company submits the
Professional Test and Prescription Self-Test for EUA, it intends to
continue plans to pursue an OTC claim.
- The Company will be manufacturing
at risk and intends to launch the tests without delay, subject to
authorization.
Antibody:
- OraSure is working with the
FDA to secure Emergency Use Authorization for its lab-based OraSure
SARS-CoV-2 Antibody ELISA. Currently no COVID-19 antibody tests
that use oral fluid samples have received Emergency Use
Authorization. OraSure’s test could be the first. Oral fluid
samples minimize healthcare professionals’ need for personal
protective equipment and reduces their exposure to potentially
infected patients as compared to blood draws; the test could aid
health officials in community surveillance efforts and
seroprevalence studies.
- With this test, individuals would
use the OraSure Oral Antibody Collection Device to self-collect an
oral fluid sample under the observation of a healthcare
professional. The sample would then be placed into the buffer vial
for storage and transport, and then later dispensed onto the
OraSure SARS-CoV-2 ELISA microplate for testing in a laboratory.
This lab-based antibody test can aid in identifying individuals
with an adaptive immune response to SARS-CoV-2, indicating prior
infection.
- At the request of the FDA, the
Company plans to resubmit two separate EUAs for the test, one
covering the oral fluid specimen collector and one for the
microplate assay. In addition, the FDA has requested that
additional analytical studies be conducted on sample collection and
stability.
- OraSure continues to sell its
antibody test for research use only, which has led to interest from
several companies and labs regarding seroprevalence studies in
cities or university populations.
Manufacturing:
- OraSure’s initiative to
increase manufacturing capacity to meet demand for COVID-19 sample
collection kits and tests continues on schedule.
Additional expansion planned to support Rapid Antigen
Self-Test.
- Previously the Company had disclosed that it was expanding
manufacturing capacity for the Rapid Antigen Self-Test to 70
million tests per year in the third quarter of 2021 (including
tests for HIV, HCV and Ebola).
- OraSure now plans additional expansion of 50 million Rapid
Antigen Self-Tests, bringing capacity to 120 million tests per year
(including tests for HIV, HCV and Ebola) by the second quarter of
2022. The Company expects this additional capacity to support sales
outside of the U.S.
- As previously disclosed, the Company is expanding capacity of
its molecular sample collection devices to a rate of approximately
75 million units annually in the second quarter of 2021 and further
to 80 million units in the third quarter, including non-COVID
kits.
- Also as previously disclosed, installation of new lines for the
oral-fluid antibody test will bring total capacity to 20 million
units per year by the fourth quarter, including existing
products.
Financial Results for
the Three Months Ended December 31, 2020
Net revenues for the fourth quarter of 2020 of
$62.9 million increased 27% from the comparable period of 2019,
primarily as a result of strong sales of molecular sample
collection kits for COVID-19 testing and increased international
sales of the Company’s HIV Self-Test partially offset by declines
in revenues of our other product lines largely due to the impact of
COVID-19.
Gross profit percentage was 61% for the three
months ended December 31, 2020 compared to 60% for the
three months ended December 31, 2019. Gross profit in the current
quarter benefited from an improved product mix associated with
higher gross profit percentage product sales.
For the three months ended December 31,
2020, operating expenses were $30.3 million, an increase
of $4.1 million from the $25.8 million reported
for the three months ended December 31, 2019, largely due to
increased investment in the development of the Company’s COVID
products.
The Company generated operating income
of $7.9 million in the fourth quarter of 2020 compared to
operating income of $4.1 million in the fourth quarter of
2019.
During the fourth quarters of 2020 and 2019, the
Company recorded income tax expense of $5.7 million and $2.1
million, respectively. Income tax expense in both periods largely
consisted of foreign taxes due related to our Canadian
subsidiary.
First Quarter 2021 Guidance
The Company expects first quarter 2021 net
revenues to range from $55.0 million to $60.0 million.
Financial Data (Unaudited)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Results of Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
62,855 |
|
|
$ |
49,668 |
|
|
$ |
171,721 |
|
|
$ |
154,605 |
|
Cost of products and services
sold |
|
|
24,671 |
|
|
|
19,829 |
|
|
|
69,853 |
|
|
|
60,022 |
|
Gross profit |
|
|
38,184 |
|
|
|
29,839 |
|
|
|
101,868 |
|
|
|
94,583 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,457 |
|
|
|
6,104 |
|
|
|
31,032 |
|
|
|
19,629 |
|
Sales and marketing |
|
|
9,120 |
|
|
|
7,932 |
|
|
|
34,459 |
|
|
|
31,869 |
|
General and administrative |
|
|
12,211 |
|
|
|
11,539 |
|
|
|
42,653 |
|
|
|
35,287 |
|
Change in fair value of acquisition-related contingent
consideration |
|
|
(1,489 |
) |
|
|
179 |
|
|
|
(1,099 |
) |
|
|
(664 |
) |
Gain on sale of business |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(10,149 |
) |
Total operating expenses |
|
|
30,299 |
|
|
|
25,754 |
|
|
|
107,045 |
|
|
|
75,972 |
|
Operating income (loss) |
|
|
7,885 |
|
|
|
4,085 |
|
|
|
(5,177 |
) |
|
|
18,611 |
|
Other income (expense) |
|
|
(307 |
) |
|
|
477 |
|
|
|
1,653 |
|
|
|
2,720 |
|
Income (loss) before income
taxes |
|
|
7,578 |
|
|
|
4,562 |
|
|
|
(3,524 |
) |
|
|
21,331 |
|
Income tax expense |
|
|
5,718 |
|
|
|
2,124 |
|
|
|
11,398 |
|
|
|
4,675 |
|
Net income (loss) |
|
$ |
1,860 |
|
|
$ |
2,438 |
|
|
$ |
(14,922 |
) |
|
$ |
16,656 |
|
Earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.03 |
|
|
$ |
0.04 |
|
|
$ |
(0.22 |
) |
|
$ |
0.27 |
|
Diluted |
|
$ |
0.03 |
|
|
$ |
0.04 |
|
|
$ |
(0.22 |
) |
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
71,723 |
|
|
|
61,729 |
|
|
|
67,505 |
|
|
|
61,675 |
|
Diluted |
|
|
72,817 |
|
|
|
62,199 |
|
|
|
67,505 |
|
|
|
62,170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
|
Dollars |
|
|
|
|
|
|
|
Percentage of Total Net Revenues |
|
|
|
|
2020 |
|
|
2019 |
|
|
%Change |
|
|
|
2020 |
|
|
|
2019 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ |
17,602 |
|
|
$ |
18,743 |
|
|
|
(6 |
) |
% |
|
|
28 |
|
% |
|
|
38 |
|
% |
Risk assessment testing |
|
|
2,526 |
|
|
|
2,944 |
|
|
|
(14 |
) |
|
|
|
4 |
|
|
|
|
6 |
|
|
Molecular solutions |
|
|
40,281 |
|
|
|
25,487 |
|
|
|
58 |
|
|
|
|
64 |
|
|
|
|
51 |
|
|
Net product and service revenues |
|
|
60,409 |
|
|
|
47,174 |
|
|
|
28 |
|
|
|
|
96 |
|
|
|
|
95 |
|
|
Royalty income |
|
|
1,809 |
|
|
|
2,160 |
|
|
|
(16 |
) |
|
|
|
3 |
|
|
|
|
4 |
|
|
Other |
|
|
637 |
|
|
|
334 |
|
|
|
91 |
|
|
|
|
1 |
|
|
|
|
1 |
|
|
Net revenues |
|
$ |
62,855 |
|
|
$ |
49,668 |
|
|
|
27 |
|
% |
|
|
100 |
|
% |
|
|
100 |
|
% |
|
|
Year Ended December 31, |
|
|
|
|
Dollars |
|
|
|
|
|
|
|
Percentage of Total Net Revenues |
|
|
|
|
2020 |
|
|
2019 |
|
|
%Change |
|
|
|
2020 |
|
|
|
2019 |
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ |
54,227 |
|
|
$ |
58,016 |
|
|
|
(7 |
) |
% |
|
|
32 |
|
% |
|
|
38 |
|
% |
Risk assessment testing |
|
|
9,374 |
|
|
|
12,189 |
|
|
|
(23 |
) |
|
|
|
5 |
|
|
|
|
8 |
|
|
Cryosurgical systems |
|
|
— |
|
|
|
7,054 |
|
|
|
(100 |
) |
|
|
|
— |
|
|
|
|
5 |
|
|
Molecular solutions |
|
|
102,780 |
|
|
|
70,814 |
|
|
|
45 |
|
|
|
|
60 |
|
|
|
|
45 |
|
|
Net product and service revenues |
|
|
166,381 |
|
|
|
148,073 |
|
|
|
12 |
|
|
|
|
97 |
|
|
|
|
96 |
|
|
Royalty income |
|
|
3,432 |
|
|
|
5,116 |
|
|
|
(33 |
) |
|
|
|
2 |
|
|
|
|
3 |
|
|
Other |
|
|
1,908 |
|
|
|
1,416 |
|
|
|
35 |
|
|
|
|
1 |
|
|
|
|
1 |
|
|
Net revenues |
|
$ |
171,721 |
|
|
$ |
154,605 |
|
|
|
11 |
|
% |
|
|
100 |
|
% |
|
|
100 |
|
% |
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
|
2020 |
|
|
2019 |
|
|
%Change |
|
|
2020 |
|
|
2019 |
|
|
%Change |
|
|
OraQuick®
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
3,861 |
|
|
$ |
4,960 |
|
|
|
(22 |
) |
% |
$ |
15,184 |
|
|
$ |
17,984 |
|
|
|
(16 |
) |
% |
International HIV |
|
|
11,343 |
|
|
|
9,795 |
|
|
|
16 |
|
|
|
29,040 |
|
|
|
25,108 |
|
|
|
16 |
|
|
Net HIV revenues |
|
|
15,204 |
|
|
|
14,755 |
|
|
|
3 |
|
|
|
44,224 |
|
|
|
43,092 |
|
|
|
3 |
|
|
Domestic HCV |
|
|
1,356 |
|
|
|
2,202 |
|
|
|
(38 |
) |
|
|
4,793 |
|
|
|
8,108 |
|
|
|
(41 |
) |
|
International HCV |
|
|
884 |
|
|
|
1,295 |
|
|
|
(32 |
) |
|
|
3,655 |
|
|
|
4,864 |
|
|
|
(25 |
) |
|
Net HCV revenues |
|
|
2,240 |
|
|
|
3,497 |
|
|
|
(36 |
) |
|
|
8,448 |
|
|
|
12,972 |
|
|
|
(35 |
) |
|
Net product revenues |
|
$ |
17,444 |
|
|
$ |
18,252 |
|
|
|
(4 |
) |
% |
$ |
52,672 |
|
|
$ |
56,064 |
|
|
|
(6 |
) |
% |
|
|
Three Months Ended |
|
|
|
Year Ended |
|
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
|
2020 |
|
|
2019 |
|
|
%Change |
|
|
|
2020 |
|
|
2019 |
|
|
%Change |
|
|
Molecular Solutions Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
|
$ |
13,760 |
|
|
$ |
20,761 |
|
|
|
(34 |
) |
% |
|
$ |
37,141 |
|
|
$ |
56,212 |
|
|
|
(34 |
) |
% |
Microbiome |
|
|
1,898 |
|
|
|
1,847 |
|
|
|
3 |
|
|
|
|
6,156 |
|
|
|
7,172 |
|
|
|
(14 |
) |
|
COVID-19 |
|
|
22,494 |
|
|
|
— |
|
|
N/A |
|
|
|
|
49,802 |
|
|
|
— |
|
|
N/A |
|
|
Laboratory services |
|
|
2,093 |
|
|
|
2,820 |
|
|
|
(26 |
) |
|
|
|
9,564 |
|
|
|
6,767 |
|
|
|
41 |
|
|
Other product revenues |
|
|
36 |
|
|
|
59 |
|
|
|
(39 |
) |
|
|
|
117 |
|
|
|
663 |
|
|
|
(82 |
) |
|
Net product and service revenues |
|
|
40,281 |
|
|
|
25,487 |
|
|
|
58 |
|
|
|
|
102,780 |
|
|
|
70,814 |
|
|
|
45 |
|
|
Other |
|
|
1,866 |
|
|
|
2,289 |
|
|
|
(18 |
) |
|
|
|
3,701 |
|
|
|
5,566 |
|
|
|
(34 |
) |
|
Net revenues |
|
$ |
42,147 |
|
|
$ |
27,776 |
|
|
|
52 |
|
% |
|
$ |
106,481 |
|
|
$ |
76,380 |
|
|
|
39 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
December 31, 2020 |
|
|
December 31, 2019 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
160,802 |
|
|
$ |
75,715 |
|
Short-term investments |
|
|
48,599 |
|
|
|
80,623 |
|
Accounts receivable, net |
|
|
38,835 |
|
|
|
36,948 |
|
Inventories |
|
|
31,863 |
|
|
|
23,155 |
|
Other current assets |
|
|
8,794 |
|
|
|
8,109 |
|
Property, plant and equipment,
net |
|
|
51,860 |
|
|
|
30,339 |
|
Intangible assets, net |
|
|
17,904 |
|
|
|
14,674 |
|
Goodwill |
|
|
40,351 |
|
|
|
36,201 |
|
Long-term investments |
|
|
47,718 |
|
|
|
33,420 |
|
Other non-current assets |
|
|
7,746 |
|
|
|
10,111 |
|
Total assets |
|
$ |
454,472 |
|
|
$ |
349,295 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
17,407 |
|
|
$ |
9,567 |
|
Deferred revenue |
|
|
4,811 |
|
|
|
3,713 |
|
Contingent consideration
obligation |
|
|
402 |
|
|
|
3,500 |
|
Other current liabilities |
|
|
23,869 |
|
|
|
15,933 |
|
Non-current contingent
consideration obligation |
|
|
2,049 |
|
|
|
112 |
|
Other non-current
liabilities |
|
|
7,363 |
|
|
|
9,325 |
|
Stockholders’ equity |
|
|
398,571 |
|
|
|
307,145 |
|
Total liabilities and stockholders’ equity |
|
$ |
454,472 |
|
|
$ |
349,295 |
|
Additional Financial Data
(Unaudited)
|
|
Year Ended |
|
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Capital expenditures |
|
$ |
26,674 |
|
|
$ |
9,314 |
|
Depreciation and
amortization |
|
$ |
9,714 |
|
|
$ |
7,730 |
|
Stock-based compensation |
|
$ |
7,139 |
|
|
$ |
4,057 |
|
Cash provided by operating
activities |
|
$ |
5,807 |
|
|
$ |
9,804 |
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
2020 full year and fourth quarter results and certain business
developments, 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 dial 844-831-3030 (Domestic) or 315-625-6887 (International)
and reference Conference ID # 8168847 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, March 15, 2021, by dialing 855-859-2056
(Domestic) or (404) 537-3406 (International) and entering the
Conference ID #9459222.
It is recommended to dial-in at most 15 to 20
minutes prior to the call start to reduce waiting times. If a
participant will be listen-only, they are encouraged to listen via
the webcast on OraSure’s Investor Relations page.
About OraSure Technologies
OraSure Technologies empowers the global
community to improve health and wellness by providing access to
accurate, essential information. Together with its wholly-owned
subsidiaries, DNA Genotek, Diversigen and Novosanis, OraSure
provides its customers with end-to-end solutions that encompass
tools, services and diagnostics. The OraSure family of companies is
a leader in the development, manufacture, and distribution of rapid
diagnostic tests, sample collection and stabilization devices, and
molecular services solutions designed to discover and detect
critical medical conditions. OraSure’s portfolio of products is
sold globally to clinical laboratories, hospitals, physician’s
offices, clinics, public health and community-based organizations,
research institutions, government agencies, pharma, commercial
entities and direct to consumers. For more information on OraSure
Technologies, please visit www.orasure.com.
Important Information
This press release contains certain
forward-looking statements, including with respect to expected
revenues, products, product development activities, regulatory
submissions and authorizations and other matters. 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
successfully manage and integrate 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; impact
of increased or different risks arising from the acquisition of
companies located in foreign countries; ability to market and sell
products, whether through our internal, direct sales force or third
parties; impact of significant customer concentration in the
genomics business; failure of distributors or other customers to
meet purchase forecasts, historic purchase levels or minimum
purchase requirements for our products; 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; the impact of the novel
coronavirus (“COVID-19”) pandemic on our business and our ability
to successfully develop new products, validate the expanded use of
existing collector products, receive necessary regulatory approvals
and authorizations and commercialize such products for COVID-19
testing; 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 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; 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; impact of contracting with the U.S.
government; impact of negative economic conditions; 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 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 our SEC filings, including our registration statements,
Annual Report on Form 10-K for the year ended December 31, 2020,
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. Readers are
cautioned not to place undue reliance on the forward-looking
statements. The forward-looking statements are made as of the date
of this press release and OraSure Technologies undertakes no duty
to update these statements.
Investor
contact: |
Media
contact: |
Sam Martin |
Jeanne Mell |
Argot Partners |
OraSure Technologies |
212-600-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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