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- and nine-month periods ended
September 30, 2020.
“We achieved strong top-line results in the
third quarter driven by the performance of our Molecular Solutions
business unit, which marked its highest quarter ever, with $31.7
million in total revenue. The Company’s ability to quickly respond
to the need for increased COVID-19 testing resulted in $18.4
million in sales of sample collection devices for molecular testing
in the third quarter, which is more than double the COVID-19
related revenue achieved in the first half of the year,” said
Stephen S. Tang, Ph.D., President and Chief Executive Officer. “We
are confident in our ability to meet the massive and persistent
need for COVID-19 testing and sample collection. We recently
submitted an application for Emergency Use Authorization (EUA) to
the U.S. Food and Drug Administration (FDA) for our
laboratory-based oral fluid SARS-CoV-2 Antibody test. To date there
are no oral fluid antibody tests for COVID-19 authorized for sale
in the U.S. We continue to make progress on our rapid antigen
self-test and have completed studies to confirm the assay’s
proprietary chemistry. Additionally, we were pleased to see growth
in the quarter from our international HIV business.”
Third Quarter
Financial Highlights
- Net revenues for the third quarter
of 2020 were $48.0 million, a 33% increase from the third
quarter of 2019. Net product and services revenues were $46.7
million, a 32% increase from the third quarter of 2019.
- Total product and service revenues
for the Company’s Molecular Solutions business unit were $31.2
million during the third quarter of 2020, an increase of 79%
from the third quarter of 2019. This increase included $18.4
million in sales of oral fluid sample collection devices for
COVID-19 molecular testing, which was partially offset by a
decrease in genomics sales.
- International sales of the
Company’s OraQuick® HIV Self-Test increased 17% compared to the
third quarter of 2019.
- Net income for the third quarter of
2020 was $1.0 million, or $0.01 per share on a
fully-diluted basis, compared to net income of $13.1 million,
or $0.21 per share on a fully-diluted basis, for the
third quarter of 2019.
- Cash and investments
totaled $263.7 million at September 30, 2020.
COVID-19 Update
Molecular/PCR:
- In the third quarter,
sales of oral fluid collection devices
for molecular/PCR COVID-19
testing grew
substantially, two of
the Company’s collection
devices received Emergency Use
Authorization (EUA),
and the Company’s collection devices are
expected to be part of future customer
EUAs.
- COVID-19 testing revenue grew to
$18.4 million in the third quarter, up 118% from the second quarter
of 2020. About half of these sales were to customers not currently
holding EUAs.
- The OMNIgene®·ORAL (OM-505,
OME-505) and the ORAcollect®·RNA (OR-100, ORE-100) collection
devices were granted EUAs by the FDA for the collection,
stabilization and transport of saliva specimens suspected of
containing SARS-CoV-2 RNA. The authorizations also allow the
products to be used as a component of an authorized or cleared
self-collection kit for unsupervised home-use. This means the
devices can be part of a kit that is authorized under its own EUA
for use by an individual to collect saliva specimens at home.1 Both
devices also have CE marking for in vitro diagnostic use in the
European Union.
- The Company’s molecular collection
kits have also been included in six EUAs granted by the FDA to DNA
Genotek customers for COVID-19 testing.
- Costco is selling COVID-19 saliva
collection kits in conjunction with P23 Labs, which received an FDA
EUA for the laboratory test workflow with its PCR test for
COVID-19. The workflow includes OMNIgene·ORAL as the saliva
collection device.
Antibody:
- OraSure
recently submitted
an EUA
application to
the FDA for
its laboratory-based oral
fluid SARS-CoV-2 Antibody ELISA
test. To date, there are
no oral fluid antibody tests for COVID-19 authorized for sale in
the U.S.
- The Company plans to commercialize
the laboratory-based test in the fourth quarter, subject to receipt
of the EUA.
- The OraSure SARS-CoV-2 Antibody
ELISA is intended for qualitative detection of total antibodies
(including IgM/IgA/IgG) to SARS-CoV-2 in human oral fluid specimens
collected with the OraSure Oral Antibody Collection Device.
- Oral sample collection is quick,
painless, non-invasive and requires less human contact than a blood
draw, minimizing the need for personal protective equipment and
reducing exposure to potentially infected patients.
- With this test, individuals would
use a collection pad to self-collect an oral fluid sample under the
observation of a healthcare professional. The sample would then be
placed into the OraSure Oral Antibody Collection Device buffer for
storage and transport, and then later dispensed onto the OraSure
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 recent or prior infection.
- Antibody tests are well suited for
community surveillance and seroprevalence studies to identify
people in a population or community who have antibodies against an
infectious disease such as COVID-19.
Antigen:
- The Company
continues to make progress on its
OraQuick® Coronavirus Rapid Antigen Self-Test
and expects to apply for
its first EUA in the first
quarter of 2021.
To date, there are no self-tests
authorized in the U.S. to detect
active COVID-19 infection that enable
individuals to test themselves and read the
results at the point of collection with no
instrumentation needed.
- Between now and the filing of the
EUA application OraSure will finalize the device design and
complete the EUA studies necessary to demonstrate achievement of
the high performance standards the FDA demands of a self-test.
- Subject to receipt of an EUA, this
product would test for active COVID-19 infection using nasal
samples self-collected from the lower nostril. Results would be
available at the point of collection, with no instrumentation or
laboratory analysis needed to interpret results.
- Subject to regulatory approvals,
the Company intends to sequentially introduce its antigen test to
the market for three different uses:
- Professional Test
for use at drive-through sites, physician offices, public health
testing sites, and employer/university health centers. In this
instance, a physician would prescribe the test and the patient
would conduct a self-swab in the presence of a healthcare provider
who would then interpret the results.
- 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. In this instance, a physician would prescribe the test and
the patient would conduct a self-swab at home, or in any location,
where they would then interpret their own results.
- OTC Self-Test for
use by consumers who would purchase online or at retail without
prescription, and conduct the test and receive the results
themselves anytime, anywhere.
- OraSure expects to file for the
Professional Test EUA in Q1 2021, with the Prescription Self-Test
and OTC Self-Test EUAs to follow as soon as possible thereafter.
Although the timing of the EUA receipt is subject to FDA review,
the Company will be prepared to launch the test, subject to
authorization, without delay.
Manufacturing:
- OraSure’s plans to increase
manufacturing capacity to meet demand for COVID-19 sample
collection kits and tests continue on
schedule.
Financial Results for
the Three Months Ended September 30,
2020
Net revenues for the third quarter of 2020 of
$48.0 million increased 33% from the comparable period of 2019,
primarily as a result of strong sales of molecular sample
collection kits for COVID-19 testing, an increase in international
sales of the Company’s HIV Self-Test and in laboratory service
revenues. These increases were partially offset by lower sales of
the Company’s genomics, risk assessment, HCV, and domestic HIV
products.
Gross profit percentage was 63% and 60% for the
three months ended September 30, 2020 and 2019,
respectively. Gross profit percentage in the third quarter of 2020
benefited from an improved product mix associated with higher gross
profit percentage product sales.
For the three months ended September 30,
2020, operating expenses were $25.9 million, an increase
of $17.3 million from the $8.6 million reported
for the three months ended September 30, 2019. This increase
was due primarily to increased spend associated with COVID-19
product development and the inclusion of expenses incurred by the
Company’s newly acquired subsidiaries, UrSure and Diversigen, whose
results were not included in the third quarter of 2019. In
addition, operating expenses in the third quarter of 2019 were
reduced by a gain on the sale of the Company’s cryosurgical
business of $10.1 million and a $2.4 million decrease in the change
in the fair value of contingent acquisition consideration.
The Company generated operating income
of $4.4 million in the third quarter of 2020 compared to
operating income of $13.1 million in the third quarter of
2019.
During the third quarters of 2020 and 2019, the
Company recorded income tax expense of $3.7 million and $1.2
million, respectively. Income tax expense in both periods largely
consisted of foreign taxes due.
Fourth Quarter 2020
Guidance
The Company expects fourth quarter 2020 net
revenues to range from $55 million to $60 million.
Financial Data
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September
30, |
|
September
30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Results of Operations |
|
|
|
|
|
|
|
Net revenues |
$ |
48,011 |
|
|
$ |
35,989 |
|
|
$ |
108,866 |
|
|
$ |
104,937 |
|
Cost of products and services sold |
|
17,722 |
|
|
|
14,343 |
|
|
|
45,182 |
|
|
|
40,193 |
|
Gross profit |
|
30,289 |
|
|
|
21,646 |
|
|
|
63,684 |
|
|
|
64,744 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
8,007 |
|
|
|
4,619 |
|
|
|
20,575 |
|
|
|
13,525 |
|
Sales and marketing |
|
7,849 |
|
|
|
8,955 |
|
|
|
25,339 |
|
|
|
23,937 |
|
General and administrative |
|
10,108 |
|
|
|
7,556 |
|
|
|
30,442 |
|
|
|
23,748 |
|
Change in fair value of acquisition-related contingent
consideration |
|
(60 |
) |
|
|
(2,387 |
) |
|
|
390 |
|
|
|
(843 |
) |
Gain on sale of business |
|
— |
|
|
|
(10,149 |
) |
|
|
— |
|
|
|
(10,149 |
) |
Total operating expenses |
|
25,904 |
|
|
|
8,594 |
|
|
|
76,746 |
|
|
|
50,218 |
|
Operating income (loss) |
|
4,385 |
|
|
|
13,052 |
|
|
|
(13,062 |
) |
|
|
14,526 |
|
Other income |
|
314 |
|
|
|
1,195 |
|
|
|
1,960 |
|
|
|
2,243 |
|
Income (loss) before income taxes |
|
4,699 |
|
|
|
14,247 |
|
|
|
(11,102 |
) |
|
|
16,769 |
|
Income tax expense |
|
3,659 |
|
|
|
1,169 |
|
|
|
5,680 |
|
|
|
2,551 |
|
Net income (loss) |
$ |
1,040 |
|
|
$ |
13,078 |
|
|
$ |
(16,782 |
) |
|
$ |
14,218 |
|
Income (loss) per share: |
|
|
|
|
|
|
|
Basic |
$ |
0.01 |
|
|
$ |
0.21 |
|
|
$ |
(0.25 |
) |
|
$ |
0.23 |
|
Diluted |
$ |
0.01 |
|
|
$ |
0.21 |
|
|
$ |
(0.25 |
) |
|
$ |
0.23 |
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
71,537 |
|
|
|
61,726 |
|
|
|
66,088 |
|
|
|
61,656 |
|
Diluted |
|
72,662 |
|
|
|
62,143 |
|
|
|
66,088 |
|
|
|
62,172 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Dollars |
|
|
|
|
Percentage of Total Net Revenues |
|
|
|
2020 |
|
|
2019 |
|
|
% Change |
|
|
2020 |
|
|
2019 |
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
$ |
13,224 |
|
$ |
13,588 |
|
|
(3 |
) |
% |
|
28 |
% |
|
38 |
% |
Risk
assessment testing |
|
2,316 |
|
|
3,312 |
|
|
(30 |
) |
|
|
5 |
|
|
9 |
|
Cryosurgical
systems |
— |
|
|
961 |
|
|
(100 |
) |
|
|
— |
|
|
3 |
|
Molecular
collection systems |
|
31,209 |
|
|
17,438 |
|
|
79 |
|
|
|
65 |
|
|
48 |
|
Net product and service revenues |
|
46,749 |
|
|
35,299 |
|
|
32 |
|
|
|
98 |
|
|
98 |
|
Royalty
income |
|
450 |
|
|
758 |
|
|
(41 |
) |
|
|
1 |
|
|
2 |
|
Other |
|
812 |
|
|
(68 |
) |
|
— |
|
|
|
1 |
|
|
— |
|
Net revenues |
$ |
48,011 |
|
$ |
35,989 |
|
|
33 |
|
% |
|
100 |
% |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Dollars |
|
|
|
|
Percentage of Total Net Revenues |
|
|
|
2020 |
|
|
2019 |
|
% Change |
|
|
2020 |
|
|
2019 |
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
$ |
36,625 |
|
$ |
39,273 |
|
(7 |
) |
% |
|
34 |
% |
|
37 |
% |
Risk
assessment testing |
|
6,848 |
|
|
9,246 |
|
(26 |
) |
|
|
6 |
|
|
9 |
|
Cryosurgical
systems |
— |
|
|
7,054 |
|
(100 |
) |
|
|
— |
|
|
7 |
|
Molecular
collection systems |
|
62,499 |
|
|
45,325 |
|
38 |
|
|
|
58 |
|
|
43 |
|
Net product and service revenues |
|
105,972 |
|
|
100,898 |
|
5 |
|
|
|
98 |
|
|
96 |
|
Royalty
income |
|
1,623 |
|
|
2,956 |
|
(45 |
) |
|
|
1 |
|
|
3 |
|
Other |
|
1,271 |
|
|
1,083 |
|
17 |
|
|
|
1 |
|
|
1 |
|
Net revenues |
$ |
108,866 |
|
$ |
104,937 |
|
4 |
|
% |
|
100 |
% |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September 30, |
|
September 30, |
|
|
|
2020 |
|
|
2019 |
|
% Change |
|
|
2020 |
|
|
2019 |
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OraQuick® Revenues |
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
$ |
3,909 |
|
$ |
4,259 |
|
(8 |
) |
% |
$ |
11,323 |
|
$ |
13,024 |
|
(13 |
) |
% |
International HIV |
|
6,865 |
|
|
5,891 |
|
17 |
|
|
|
17,697 |
|
|
15,313 |
|
16 |
|
|
Net HIV revenues |
|
10,774 |
|
|
10,150 |
|
6 |
|
|
|
29,020 |
|
|
28,337 |
|
— |
|
|
Domestic
HCV |
|
1,186 |
|
|
1,977 |
|
(40 |
) |
|
|
3,437 |
|
|
5,907 |
|
(42 |
) |
|
International HCV |
|
1,033 |
|
|
1,129 |
|
(9 |
) |
|
|
2,772 |
|
|
3,569 |
|
(22 |
) |
|
Net HCV revenues |
|
2,219 |
|
|
3,106 |
|
(29 |
) |
|
|
6,209 |
|
|
9,476 |
|
(34 |
) |
|
Net product revenues |
$ |
12,993 |
|
$ |
13,256 |
|
(2 |
) |
% |
$ |
35,229 |
|
$ |
37,813 |
|
(7 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Nine Months
Ended |
|
|
September 30, |
|
|
September 30, |
|
|
|
2020 |
|
|
2019 |
|
% Change |
|
|
|
2020 |
|
|
2019 |
|
% Change |
|
Molecular Collection Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
$ |
8,519 |
|
$ |
13,647 |
|
(38 |
) |
% |
|
$ |
23,381 |
|
$ |
35,449 |
|
(34 |
) |
% |
Microbiome |
|
1,828 |
|
|
1,878 |
|
(3 |
) |
|
|
|
4,259 |
|
|
5,325 |
|
(20 |
) |
|
COVID-19 |
|
18,441 |
|
— |
|
N/A |
|
|
|
|
27,307 |
|
— |
|
N/A |
|
|
Laboratory
services |
|
2,418 |
|
|
1,618 |
|
49 |
|
|
|
|
7,472 |
|
|
3,947 |
|
89 |
|
|
Other
product revenues |
|
3 |
|
|
295 |
|
(99 |
) |
|
|
|
80 |
|
|
604 |
|
(87 |
) |
|
Net product and service revenues |
|
31,209 |
|
|
17,438 |
|
79 |
|
|
|
|
62,499 |
|
|
45,325 |
|
38 |
|
|
Other |
|
488 |
|
|
821 |
|
(41 |
) |
|
|
|
1,834 |
|
|
3,277 |
|
(44 |
) |
|
Net product and service revenues |
$ |
31,697 |
|
$ |
18,259 |
|
74 |
|
% |
|
$ |
64,333 |
|
$ |
48,602 |
|
32 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited) |
|
|
|
September 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
162,859 |
|
$ |
75,715 |
Short-term
investments |
|
72,961 |
|
|
80,623 |
Accounts
receivable, net |
|
30,638 |
|
|
36,948 |
Inventories |
|
30,488 |
|
|
23,155 |
Other
current assets |
|
6,031 |
|
|
8,109 |
Property,
plant and equipment, net |
|
39,056 |
|
|
30,339 |
Intangible
assets, net |
|
18,111 |
|
|
14,674 |
Goodwill |
|
39,480 |
|
|
36,201 |
Long-term
investments |
|
27,841 |
|
|
33,420 |
Other
non-current assets |
|
8,945 |
|
|
10,111 |
Total assets |
$ |
436,410 |
|
$ |
349,295 |
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Accounts
payable |
$ |
14,377 |
|
$ |
9,567 |
Deferred
revenue |
|
5,311 |
|
|
3,713 |
Contingent
consideration obligation |
|
764 |
|
|
3,500 |
Other
current liabilities |
|
16,775 |
|
|
15,933 |
Non-current
contingent consideration obligation |
|
3,176 |
|
|
112 |
Other
non-current liabilities |
|
8,115 |
|
|
9,325 |
Stockholders' equity |
|
387,892 |
|
|
307,145 |
Total liabilities and stockholders' equity |
$ |
436,410 |
|
$ |
349,295 |
|
|
|
|
Additional Financial Data (Unaudited) |
Nine Months
Ended |
September 30, |
|
|
2020 |
|
|
2019 |
Capital
expenditures |
$ |
11,234 |
|
$ |
7,961 |
Depreciation
and amortization |
$ |
7,051 |
|
$ |
5,532 |
Stock-based
compensation |
$ |
5,913 |
|
$ |
3,283 |
Cash
provided by operating activities |
$ |
2,196 |
|
$ |
10,838 |
|
|
|
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
2020 third 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 #9459222 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 18, 2020, 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, CoreBiome (now operating
under the Diversigen brand), UrSure 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 InformationThis 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, 2019, 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.
1 The ORAcollect·RNA and OMNIgene·ORAL sample collection devices
have not been FDA cleared or approved; the devices have been
authorized by FDA under an EUA. The ORAcollect·RNA and
OMNIgene·ORAL sample collection devices have been authorized only
to collect, stabilize, and maintain during transport, saliva
specimens suspected of containing SARS-CoV-2 ribonucleic acid
(RNA), not for any other viruses or pathogens; andthe
ORAcollect·RNA and OMNIgene·ORAL sample collection devices are only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in medical
devices during the COVID-19 outbreak under Section564(b)(1) of the
Federal Food, Drug, and Cosmetic Act,21U.S.C.
§360bbb-3(b)(1),unless the authorization is terminated or revoked
sooner.
Investor contact: |
Media contact: |
Sam Martin |
Jeanne Mell |
Argot Partners |
VP Corporate Communications |
212-600-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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