OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care and home diagnostic tests, specimen collection
devices, and microbiome laboratory and analytical services, today
announced its financial results for the three months ended
September 30, 2021.
“OraSure demonstrated strong revenue growth and
laid the foundation to dramatically scale the size of the Company
in fiscal year 2022. Importantly, we signed three major contracts
this quarter with the U.S. government: $205 million for InteliSwab™
COVID-19 Rapid Test procurement, $109 million for InteliSwab™
manufacturing capacity build out, and $13.6 million to pursue full
FDA 510(k) clearance for InteliSwab™. These contracts position
OraSure as an important part of the government’s global pandemic
response and will lower our cost per product and broaden our
customer reach.”
Dr. Tang continued, “We continue to view
InteliSwab™ as an integral part of our long-term growth strategy,
as an entrance into the respiratory rapid test market--the largest
point-of-care testing market in the world. This provides an
unprecedented opportunity to strategically transform our company
and improve our long-term growth profile. Given the strong growth
we anticipate in 2022, we are highly focused on execution and
ramping our manufacturing production to meet demand. We are also
actively working to bolster innovation both through internal
research and development and external M&A which we believe will
drive long-term sustained growth and value for our
stockholders.”
Financial Highlights
- Net revenues for the third quarter
of 2021 were $53.9 million, a 12% increase from the third
quarter of 2020. Excluding COVID-19 product revenues, revenues for
the quarter increased 37% year-over-year representing a continued
recovery in the Company’s core business.
- Total revenues from the Company’s
Diagnostic business unit were $23.5 million during the third
quarter of 2021 and grew 44% relative to the same period last year.
Revenue growth was driven predominantly by the addition of
InteliSwab™ along with higher global HCV and risk assessment
revenues.
- Total product and service revenues
for the Company’s Molecular Solutions business unit were $30.4
million during the third quarter of 2021, a decline of 4% from
the third quarter of 2020. The decline was driven primarily by
lower sales of the Company’s COVID-19 molecular collection kits.
Excluding these COVID-19 revenues, the molecular solutions business
grew 87% year-over-year.
- Gross margin percentage in the
third quarter was 39.8% compared to 63.1% in the prior year. Gross
margins were negatively impacted by the build out of manufacturing
capacity to support the InteliSwab™ COVID-19 Rapid Test launch,
along with production inefficiencies and higher scrap rates as the
Company worked through the scale-up process. Additionally, gross
margins were negatively impacted by the expiration of the Bill and
Melinda Gates Foundation subsidy for international OraQuick® HIV
self-tests and a less favorable product mix.
- Operating loss in the third quarter
was ($13.0) million compared to operating income of $4.4 million in
the third quarter of last year. OraSure’s operating loss in the
quarter was driven by a ramp in investments to support the
InteliSwab™ launch and higher sales projected for 2022, along with
lower gross margins as described above.
- Net loss for the third quarter of
2021 was ($15.0) million, or ($0.21) per share on a
fully-diluted basis, compared to a net income of $1.0 million,
or $0.01 per share on a fully-diluted basis, for the
third quarter of 2020.
- Cash flow used in operations in the
quarter was ($22.6) million. Cash and investments
totaled $202.3 million at September 30, 2021.
Recent Business Highlights
InteliSwab™ COVID-19
Testing
- Awarded a procurement contract from
the Defense Logistics Agency (DLA) for the Company’s InteliSwab™
COVID-19 Rapid Test for over-the-counter use, which the DLA
estimated to have a value of $205 million. Under the terms of the
contract, OraSure will provide its InteliSwab™ COVID-19 Rapid Test
to up to 25,000 sites throughout the United States with the test
purchases funded by the U.S. government. The contract will run from
October 2021 through September 2022.
- Awarded a $109 million contract
from the U.S. Department of Defense (DOD), in coordination with the
Department of Health and Human Services, to build additional
manufacturing capacity in the United States for InteliSwab™
COVID-19 rapid tests as part of the nation’s pandemic preparedness
plan. The federal funding will be used to expand OraSure’s
production capacity by 100 million tests annually, by March
2024.
- Announced that the Biomedical
Advanced Research Development Authority (BARDA), part of the office
of the Assistant Secretary for Preparedness and Response at the
U.S. Department of Health and Human Services, will provide up to
$13.6 million in funding for the Company to obtain 510(k) clearance
and Clinical Laboratory Improvement Amendments (CLIA) waiver for
the InteliSwab™ COVID-19 Rapid Test from the U.S. Food and Drug
Administration (FDA). These authorizations will help ensure the
continued availability of InteliSwab™ products long after the
pandemic is declared over.
- OraSure has been scaling its weekly
manufacturing production for InteliSwab™ and the Company believes
it has isolated the scale-up challenges to variability in certain
incoming raw materials and processing steps. We are currently
working with vendors and third-party experts to work toward
resolution. Importantly, as we look to January of next year, we
believe we are on track to scale to approximately four million
tests a month, our current installed capacity, assuming resolution
of our manufacturing process.
- Received U.S. FDA authorization to
amend the over-the-counter InteliSwab™ emergency use authorization
to revise the indication for use such that those with symptoms only
need to test once and serial testing is only required for those
without symptoms and to create a new single-test over-the-counter
product with this new indication.
- Submitted data from
pediatric-specific usability and clinical studies to the U.S. FDA
to expand the age range enabling use of InteliSwab™ with
individuals two and older, and to revise our instructions to
include the new InteliSwab™ Connect application for reporting of
results.
- Confirmed that InteliSwab™ detects
all variants of concern, including the Delta variant, via testing
in third party laboratories with live virus.
Infectious Disease and Risk Assessment
Testing
- Global OraQuick® HIV sales in the
third quarter were $10.0 million versus $10.8 million in the prior
year period. Despite global test volume growth, revenue declined
year-over year due to the expected expiration of the Bill and
Melinda Gates Foundation test subsidy when the Company’s four year
contract with the Foundation ended in the second quarter of 2021,
as well as order timing changes between the second and third
quarters.
- InteliSwab™ revenue in the third
quarter was $7.7 million, limited by supply as production is
scaling up.
- Global OraQuick® HCV sales grew 22%
to $2.7 million in the third quarter compared to $2.2 million in
the third quarter of 2020 as a result of the recovery in testing
programs following the pandemic and new marketing initiatives.
- Risk assessment testing revenue
grew 19% in the third quarter to $2.7 million compared to $2.3
million in 2020 primarily due to increased workplace drugs-of-abuse
testing and insurance testing as economic conditions and hiring
have improved.
Molecular Solutions
- Genomics collection kit revenue of
$19.0 million for the third quarter of 2021 grew 125%
year-over-year. The growth was driven predominantly by higher sales
in the key markets of consumer genomics, disease risk management,
companion animal and research as well as accelerated ordering
patterns of certain consumer facing customers anticipating strong
holiday sales.
- Sales of OraSure’s sample
collection devices for molecular/PCR COVID-19 testing decreased
year-over-year to $6.3 million in the third quarter of 2021
compared to $18.8 million in the prior year period. The decline in
revenue is attributable to lower testing volumes with core
customers, as high vaccination rates and the increasing
availability of rapid antigen tests impact lab-based PCR workplace
and back to school testing programs.
- Total microbiome revenue, including
kits and services, was $4.1 million in the quarter and grew 8%
relative to the third quarter of last year. OraSure’s Diversigen
business now supports over 50 commercial customers including over
30 biopharmaceutical customers with 20 ongoing clinical
trials.
- Announced plans to launch a new gut
metatranscriptome collection kit and metatranscriptome service
offering to our microbiome customers through our Diversigen
subsidiary by the first quarter of fiscal year 2022.
- The Company has developed and
submitted for FDA approval a new collection kit for gut microbiome
which the company plans to launch commercially in the first half of
fiscal year 2022.
Fiscal Year 2021 and Fourth Quarter 2021
Guidance
The Company is increasing its financial guidance
range for 2021 and is now calling for revenues of $230 to $233
million compared to previous guidance which called for total
revenues of approximately $230 million. For the fourth quarter of
2021, this translates to total revenue of $60 to $63 million. The
Company continues to expect total InteliSwab™ revenue of
approximately $30 million for the fiscal year.
Financial Data (Unaudited)
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September
30, |
|
September
30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Results of Operations |
|
|
|
|
|
|
|
|
Net
revenues |
|
$ |
53,917 |
|
|
$ |
48,011 |
|
|
$ |
170,106 |
|
|
$ |
108,866 |
|
Cost of
products and services sold |
|
|
32,449 |
|
|
|
17,722 |
|
|
|
79,639 |
|
|
|
45,182 |
|
Gross profit |
|
|
21,468 |
|
|
|
30,289 |
|
|
|
90,467 |
|
|
|
63,684 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
8,596 |
|
|
|
8,007 |
|
|
|
25,270 |
|
|
|
20,575 |
|
Sales and marketing |
|
|
13,886 |
|
|
|
7,849 |
|
|
|
33,836 |
|
|
|
25,339 |
|
General and administrative |
|
|
12,499 |
|
|
|
10,108 |
|
|
|
33,680 |
|
|
|
30,442 |
|
Change in fair value of acquisition-related contingent
consideration |
|
|
(500 |
) |
|
|
(60 |
) |
|
|
(1,526 |
) |
|
|
390 |
|
Total operating expenses |
|
|
34,481 |
|
|
|
25,904 |
|
|
|
91,260 |
|
|
|
76,746 |
|
Operating income (loss) |
|
|
(13,013 |
) |
|
|
4,385 |
|
|
|
(793 |
) |
|
|
(13,062 |
) |
Other
income |
|
|
100 |
|
|
|
314 |
|
|
|
429 |
|
|
|
1,960 |
|
Income
(loss) before income taxes |
|
|
(12,913 |
) |
|
|
4,699 |
|
|
|
(364 |
) |
|
|
(11,102 |
) |
Income tax
expense |
|
|
2,102 |
|
|
|
3,659 |
|
|
|
12,241 |
|
|
|
5,680 |
|
Net income
(loss) |
|
$ |
(15,015 |
) |
|
$ |
1,040 |
|
|
$ |
(12,605 |
) |
|
$ |
(16,782 |
) |
Earnings
(loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.21 |
) |
|
$ |
0.01 |
|
|
$ |
(0.18 |
) |
|
$ |
(0.25 |
) |
Diluted |
|
$ |
(0.21 |
) |
|
$ |
0.01 |
|
|
$ |
(0.18 |
) |
|
$ |
(0.25 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
72,023 |
|
|
|
71,537 |
|
|
|
71,962 |
|
|
|
66,088 |
|
Diluted |
|
|
72,023 |
|
|
|
72,662 |
|
|
|
71,962 |
|
|
|
66,088 |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Nine Months
Ended |
|
|
|
|
September 30, |
|
|
September 30, |
|
|
|
|
|
2021 |
|
|
2020 |
|
% Change |
|
|
|
2021 |
|
|
2020 |
|
% Change |
|
|
DIAGNOSTICS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious Disease Testing
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
3,440 |
|
$ |
3,909 |
|
(12 |
) |
% |
$ |
12,490 |
|
$ |
11,323 |
|
10 |
|
% |
|
International HIV |
|
|
6,582 |
|
|
6,865 |
|
(4 |
) |
|
|
|
17,255 |
|
|
17,697 |
|
(2 |
) |
|
|
Net HIV revenues |
|
|
10,022 |
|
|
10,774 |
|
(7 |
) |
|
|
|
29,745 |
|
|
29,020 |
|
2 |
|
|
|
Domestic HCV |
|
|
1,827 |
|
|
1,186 |
|
54 |
|
|
|
|
5,580 |
|
|
3,437 |
|
62 |
|
|
|
International HCV |
|
|
888 |
|
|
1,033 |
|
(14 |
) |
|
|
|
3,802 |
|
|
2,772 |
|
37 |
|
|
|
Net HCV revenues |
|
|
2,715 |
|
|
2,219 |
|
22 |
|
|
|
|
9,382 |
|
|
6,209 |
|
51 |
|
|
|
Net
OraQuick revenues |
|
|
12,737 |
|
|
12,993 |
|
(2 |
) |
|
|
|
39,127 |
|
|
35,229 |
|
11 |
|
|
|
COVID-19 |
|
|
7,675 |
|
|
63 |
|
NM |
|
|
|
|
7,938 |
|
|
63 |
|
NM |
|
|
|
Other infectious disease
revenues |
|
|
195 |
|
|
231 |
|
(16 |
) |
|
|
|
537 |
|
|
1,396 |
|
(62 |
) |
|
|
Total Infectious Disease |
|
|
20,607 |
|
|
13,287 |
|
55 |
|
|
|
|
47,602 |
|
|
36,688 |
|
30 |
|
|
|
Risk Assessment |
|
|
2,674 |
|
|
2,253 |
|
19 |
|
|
|
|
7,265 |
|
|
6,786 |
|
7 |
|
|
|
Other non-product revenues |
|
|
230 |
|
|
774 |
|
(70 |
) |
|
|
|
2,501 |
|
|
1,060 |
|
136 |
|
|
|
TOTAL DIAGNOSTIC NET REVENUE |
|
|
23,511 |
|
|
16,314 |
|
44 |
|
|
|
|
57,368 |
|
|
44,534 |
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MOLECULAR SOLUTIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
|
$ |
19,018 |
|
$ |
8,454 |
|
125 |
|
|
|
$ |
49,333 |
|
$ |
23,224 |
|
112 |
|
|
|
Microbiome |
|
|
1,693 |
|
|
1,530 |
|
11 |
|
|
|
|
5,888 |
|
|
3,869 |
|
52 |
|
|
|
COVID-19 |
|
|
6,255 |
|
|
18,804 |
|
(67 |
) |
|
|
|
46,209 |
|
|
27,855 |
|
66 |
|
|
|
Laboratory services |
|
|
2,406 |
|
|
2,280 |
|
6 |
|
|
|
|
8,017 |
|
|
6,798 |
|
18 |
|
|
|
Other product and services
revenues |
|
|
576 |
|
|
141 |
|
309 |
|
|
|
|
1,235 |
|
|
752 |
|
64 |
|
|
|
Net product and service revenues |
|
|
29,948 |
|
|
31,209 |
|
(4 |
) |
|
|
|
110,682 |
|
|
62,498 |
|
77 |
|
|
|
Other non-product and service
revenues |
|
|
458 |
|
|
488 |
|
(6 |
) |
|
|
|
2,056 |
|
|
1,834 |
|
12 |
|
|
|
TOTAL MOLECULAR SOLUTIONS NET REVENUE |
|
|
30,406 |
|
|
31,697 |
|
(4 |
) |
|
|
|
112,738 |
|
|
64,332 |
|
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NET REVENUES |
|
$ |
53,917 |
|
$ |
48,011 |
|
12 |
|
% |
$ |
170,106 |
|
$ |
108,866 |
|
56 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited) |
|
|
|
|
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
134,962 |
|
|
$ |
160,802 |
|
Short-term
investments |
|
|
50,065 |
|
|
|
48,599 |
|
Accounts
receivable, net |
|
|
40,075 |
|
|
|
38,835 |
|
Inventories |
|
|
53,583 |
|
|
|
31,863 |
|
Other
current assets |
|
|
10,542 |
|
|
|
8,794 |
|
Property,
plant and equipment, net |
|
|
77,586 |
|
|
|
51,860 |
|
Intangible
assets, net |
|
|
15,221 |
|
|
|
17,904 |
|
Goodwill |
|
|
40,264 |
|
|
|
40,351 |
|
Long-term
investments |
|
|
17,271 |
|
|
|
47,718 |
|
Other
non-current assets |
|
|
16,188 |
|
|
|
7,746 |
|
Total assets |
|
$ |
455,757 |
|
|
$ |
454,472 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
Accounts
payable |
|
$ |
23,778 |
|
|
$ |
17,407 |
|
Deferred
revenue |
|
|
3,488 |
|
|
|
4,811 |
|
Contingent
consideration obligation |
|
|
201 |
|
|
|
402 |
|
Other
current liabilities |
|
|
26,700 |
|
|
|
23,869 |
|
Non-current
contingent consideration obligation |
|
|
318 |
|
|
|
2,049 |
|
Other
non-current liabilities |
|
|
13,452 |
|
|
|
7,363 |
|
Stockholders
equity |
|
|
387,820 |
|
|
|
398,571 |
|
Total liabilities and stockholders equity |
|
$ |
455,757 |
|
|
$ |
454,472 |
|
|
|
|
|
|
|
|
Additional Financial Date (Unaudited) |
|
Nine Months
Ended |
|
|
|
September 30, |
|
|
|
|
2021 |
|
|
|
2020 |
|
Capital
expenditures |
|
$ |
27,508 |
|
|
$ |
11,234 |
|
Depreciation
and amortization |
|
$ |
8,479 |
|
|
$ |
6,880 |
|
Stock-based
compensation |
|
$ |
5,155 |
|
|
$ |
5,913 |
|
Cash (used
in) provided by operating activities |
|
$ |
(22,598 |
) |
|
$ |
2,196 |
|
|
|
|
|
|
|
|
|
|
|
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
third quarter 2021 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 Scott Gleason, Interim 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 (888) 771-4371 (Domestic) or (847) 585-4405
(International) and reference Conference ID # 50214426 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 14 days. A replay of the call can also be accessed
until midnight, November 17, 2021, by dialing 855-859-2056
(Domestic) or 404-537-3406 (International) and entering the
Conference ID # 50214426.
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.
Multiple government agencies, including the DOD and HHS are
working to address COVID-19 testing needs. Development of the
InteliSwab™ COVID-19 Rapid Test has been funded in whole or in part
with federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority,
Division of Research, Innovation and Ventures under contract number
75A50120C00061, utilizing Health Care Enhancement Act (HCEA)
funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the
manufacturing expansion effort for the InteliSwab™ COVID-19 rapid
test in coordination with the Department of the Air Force’s
Acquisition COVID-19 Task Force (DAF ACT). This effort was funded
through the American Rescue Plan Act (ARPA) to enable and support
domestic industrial base expansion for critical medical
resources.
About InteliSwab™OraSure has received Emergency
Use Authorizations (EUA) from the U.S. Food and Drug Administration
(FDA) for its InteliSwab™ COVID-19 rapid tests. The FDA has
authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter
(OTC) use without a prescription. FDA has also authorized the
InteliSwab™ COVID-19 Rapid Test Pro for professional use in point
of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid
Test Rx for Prescription Home Use. These remarkably simple COVID-19
lateral flow tests use samples self-collected from the lower
nostrils. InteliSwab™’s unique design incorporates a built-in swab
fully integrated into the test stick. After users swab their lower
nostrils, the test stick is swirled in a pre-measured buffer
solution, and the result appears right on the test stick within 30
minutes, with no instruments, batteries, smartphone or laboratory
analysis needed to see the result. With less than one minute of
“hands-on time,” it is as simple as Swab, Swirl, and See.
This product has not been FDA cleared or approved; but
authorized by the FDA under an EUA; This product has been
authorized only for the detection of proteins from SARS-CoV-2, not
for any other viruses or pathogens; and, This product is only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21
U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
About OraSure TechnologiesOraSure Technologies
empowers the global community to improve health and wellness by
providing access to accurate, essential information. OraSure,
together with its wholly-owned subsidiaries, DNA Genotek,
Diversigen, and Novosanis, 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 document 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 of the Company
to manufacture sufficient quantities of the InteliSwab COVID-19
rapid test and resolve manufacturing challenges and the expected
timeframe for doing so; 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 collection products 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 Securities and Exchange Commission (“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 call and we undertake no duty to update
these statements.
Investor
Contact: |
Media
Contact: |
Scott Gleason |
Amy Koch |
Interim CFO SVP Investor Relations & Corp.
Communications |
Sr. Mgr. Corporate Communications |
484-425-0588 |
484-523-1815 |
sgleason@orasure.com |
media@orasure.com |
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