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 six months ended June 30, 2020.
“In the second quarter, our work to leverage our scientific and
technological expertise against the COVID-19 pandemic has already
generated meaningful revenue. Our sample collection devices are
being used for the collection, both in at-home and professional
settings, and transport of samples for COVID-19 molecular testing.
We are also developing a COVID-19 rapid antigen in-home self-test
and an ELISA-based oral fluid COVID-19 antibody test, both of which
we now expect to launch in the fourth quarter,” said Stephen S.
Tang, Ph.D., President and Chief Executive Officer. “We are
confident, given our ongoing initiative to scale up our production
capacity, that OraSure will be able to deliver substantially
increased volumes of collection and testing products, while
ensuring that they meet the highest quality standards as we
contribute to the fight against this global crisis. At the same
time, we have continued to serve our existing customers across our
business lines and to identify opportunities for business
development that will contribute to longer-term sustainable
growth.”
“We further strengthened our balance sheet in June with the
completion of an equity offering that included investments from top
institutional healthcare investors, bringing us to $265.8 million
in cash and investments as of June 30, 2020, with no debt,” said
Roberto Cuca, Chief Financial Officer. “Although we are not
providing formal guidance for the remainder of 2020 due to the
uncertainty of the effect of the pandemic on our operations, we
continue to anticipate that sales of our existing and new products
for COVID-19 testing will offset the negative impact of the
pandemic on our non-COVID-19 business.”
Second Quarter Financial Highlights
- Net revenues for the second quarter of 2020 were $29.3
million, a 25% decrease from the second quarter of 2019. Net
product and services revenues were $28.3 million, a 24%
decrease from the second quarter of 2019. Excluding cryosurgical
revenues, the line of business the Company divested in August
2019, and revenues from the Diversigen subsidiary, which the
Company acquired in November 2019, net revenues and product
and services revenues declined 21% and 20%, respectively, from the
second quarter of 2019.
- Other revenue highlights: - Total product and service
revenues for the Company’s molecular business unit were $18.1
million during the second quarter of 2020, an increase of 4%
from the second quarter of 2019. This increase included $8.5
million in sales of oral fluid collection devices for COVID-19
molecular testing.- International sales of the Company’s
OraQuick® HIV products decreased 28% compared to the second
quarter of 2019. This decrease was due to delays of shipments which
moved from the end of the second quarter into the early third
quarter.- Total laboratory service revenues in the second
quarter of 2020 were $2.2 million compared to $1.2
million in the second quarter of 2019. Laboratory services in
2020 include the revenues generated by both of the Company’s
laboratory service subsidiaries, which are now operating under the
Diversigen brand.
- Net loss for the second quarter of 2020 was $10.5 million,
or $0.16 per share on a fully-diluted basis, compared to net
income of $4.4 million, or $0.07 per share on a
fully-diluted basis, for the second quarter of 2019. Net loss for
the second quarter of 2020 included a $660,000 non-cash
pre-tax benefit associated with the change in fair value of
acquisition-related contingent consideration and $195,000 of
acquisition-related transaction costs. Net income in the second
quarter of 2019 included a $249,000 non-cash pre-tax
charge associated with the change in the fair value of
acquisition-related contingent consideration. The impact of these
items were negligible to earnings per share in both periods.
- Cash and investments totaled $265.8
million at June 30, 2020, including $95 million in
proceeds from an equity offering completed in June.
COVID-19 Program Update
OraSure is well positioned to support multiple modes for
COVID-19 testing, including PCR/Molecular, Antigen, and Antibody
testing. To support capacity building for the Company’s existing
products and anticipated new product launches, the Company is
executing on a series of capital investments intended to ensure
scaled-up capacity to meet both current and anticipated substantial
COVID-19-related demand.
- Use of existing oral fluid collection devices in
molecular COVID-19 testing generated $8.5M in revenue in the second
quarter. In the second quarter, devices from OraSure’s DNA
Genotek subsidiary, including the ORAcollect RNA collection kit,
OMNIgene ORAL saliva collection device, and Oragene®•Dx device,
were included in U.S. Food and Drug
Administration (FDA) Emergency Use Authorizations (EUAs)
granted to four customers. The EUAs granted to Clinical Reference
Laboratory (CRL), Biocerna, P23 Labs and Phosphorous enable the
Company’s devices to be used for supervised and unsupervised
COVID-19 sample collection with their EUA assays for the detection
of SARS-CoV-2. OraSure’s devices are also currently being used as
part of several back-to-school and back-to-work programs across the
country. The Company expects one or more of its products to be
included in several additional EUAs to be granted in the near
future.
- OraQuick Coronavirus Rapid Antigen Self-Test on track
for EUA submission and subsequent launch in the fourth
quarter. OraSure is developing a rapid antigen self-test,
designed to produce a result for active COVID-19 infection within
minutes, with no instrumentation needed to interpret the results
and no need to transport samples to a lab for processing, enabling
the detection of COVID-19 infection anytime, anywhere. The
development of the test is supported by $710,310 of funding from
the Biomedical Advanced Research and Development
Authority (BARDA), part of the U.S. Department of Health
and Human Services (HHS). The test is currently in human
clinical testing. Although originally intended for use with oral
fluid, this test has been modified to employ an easily and
comfortably self-collected lower nostril sample in order to achieve
the best possible accuracy. The Company fully expects to meet or
exceed applicable FDA performance requirements, with EUA filing and
subsequent commercial launch in the fourth quarter, pending
regulatory approvals. To date, there are no COVID-19 tests for
active infection which provide a result at the point of collection
with no need for a diagnostic instrument to interpret the
result.
- OraSure SARS-CoV-2 Antibody test anticipated to launch
in the fourth quarter. The Company is also developing an
Enzyme-Linked Immunosorbent Assay (ELISA) using oral fluid to
detect human anti-SARS-CoV-2 antibodies that would enable specimen
collection in any location, promoting social distancing. The test
would utilize the Company’s existing OraSure® oral fluid specimen
collection device. To date, there are no commercially
available anti-SARS-CoV-2 antibody tests using oral fluid samples
with automated assays. In June, OraSure received $629,217 in
funding from BARDA to support the development of this test. OraSure
has completed the final product design and this test is currently
in human clinical testing. The Company fully expects to meet or
exceed applicable FDA performance requirements for this product,
file for EUA, and launch in the fourth quarter, pending regulatory
approvals.The pan-SARS-coronavirus antigen rapid in-home self-test
project 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, under Contract No.
75A50120C00061. The SARS-CoV-2 antibody 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, under Contract No. 75A50120C00122.
Additional Second Quarter Business
Highlights
- Continued progress in executing on innovation-driven
growth strategy with purchase of UrSure, Inc., strengthening
OraSure’s global leadership in the HIV testing field. In
May, the Company announced that it had entered into a definitive
agreement to acquire privately-owned UrSure, Inc., a company
developing and commercializing products that measure adherence to
HIV medications that prevent (Pre-Exposure Prophylaxis or PrEP) and
treat HIV. This cash transaction, which approximated $3.1 million,
closed in July and supports OraSure’s strategy of expanding its
core offerings to include additional diagnostic products,
particularly point-of-care tests that complement its current
infectious disease portfolio and pipeline. OraSure will be able to
offer a full HIV portfolio that covers the spectrum from screening
to treatment adherence, two pillars of the federal government’s
“Ending the HIV Epidemic: A Plan for America” initiative.
- Continued expansion of sample collection products to
meet the needs of research and academic institutions. In
June, the Company, through its DNA Genotek subsidiary, introduced
the OMNImet™·GUT (ME-200) device for metabolomics, the first and
only commercially available research use only device for in-home,
self-collection of fecal samples for metabolomics. This product
augments the Company’s portfolio of multiomic sample collection
products.
Financial Results for the Three Months
Ended June 30, 2020
Net product and service revenues for the second quarter of 2020
decreased 24% from the comparable period of 2019, primarily as a
result of lower sales of the Company’s genomics products due to the
timing of orders placed by one of the Company’s largest genomics
customers and due to the impact of the COVID-19 pandemic. The
decline is also a result of lower sales of the Company’s OraQuick®
HIV, OraQuick® HCV, and risk assessment products due to reduced
research and testing as a result of the COVID-19 pandemic, and the
absence of cryosurgical systems revenues, partially offset by the
inclusion of product sales related to COVID-19 and higher
laboratory services revenues.
Royalty income from a litigation settlement associated with a
molecular collection device was $727,000 and $1.1
million for the second quarters of 2020 and 2019,
respectively. Other revenues
were $195,000 and $445,000 for the second
quarter of 2020 and 2019 respectively.
Gross profit percentage was 59% and 64% for the three months
ended June 30, 2020 and 2019, respectively. Gross profit
percentage in the second quarter of 2020 was negatively affected by
lower labor utilization as the Company increased its manufacturing
headcount with full-time and temporary employees to prepare for
expected production expansion later in the year, a less favorable
overall product mix as a result of higher sales of lower gross
profit products and services, and the decline in other revenues
which contribute 100% to the Company’s gross profit percentage.
For the three months ended June 30, 2020, operating
expenses were $26.7 million, an increase of $6.9
million from the $19.7 million reported for the
three months ended June 30, 2019. This increase was due
primarily to increased spending associated with COVID-19 product
development, increased staffing costs, higher bad debt associated
with uncollectible customer accounts, higher legal fees, and the
inclusion of Diversigen operating expenses, all partially offset by
lower spending on market studies, tradeshows and travel.
The Company generated an operating loss of $9.4
million in the second quarter of 2020 compared to operating
income of $5.3 million in the second quarter of 2019.
During the second quarter of 2020 and 2019, the Company recorded
income tax expense of $1.3 million and $1.4 million,
respectively. Income tax expense in both periods largely consists
of foreign taxes due.
Financial Results for the Six Months Ended June 30,
2020
Net product and service revenues for the six months ended June
30, 2020 decreased 10% from the comparable period of 2019,
primarily as a result of lower sales of the Company’s genomics
products due to the timing of orders placed by one of the Company’s
largest genomics customer and due to the impact of the COVID-19
pandemic. The decline is also a result of lower sales of the
Company’s domestic OraQuick® HIV, OraQuick® HCV, risk assessment,
and microbiome products due to reduced research and testing as a
result of the COVID-19 pandemic, and the absence of cryosurgical
sales, partially offset by the inclusion of product revenues
associated with COVID-19 testing, higher laboratory services
revenues and increased international sales of the Company’s
OraQuick® HIV Self-Test.
For the six months ended June 30, 2020, royalty income from a
litigation settlement associated with a molecular collection device
was $1.2 million compared to $2.2 million for the six months ended
June 30, 2019. Other revenues were $460,000 and $1.2 million for
the first six months of 2020 and 2019, respectively.
Gross profit percentage was 55% and 63% for the six months ended
June 30, 2020 and 2019, respectively. Gross profit percentage
in the first six months of 2020 was negatively affected by a less
favorable product mix as a result of higher sales of lower gross
profit products and services, lower labor utilization rates,
increased international freight costs, the decline in other
revenues which contribute 100% to the Company’s gross profit
percentage, and higher scrap and spoilage expense.
For the six months ended June 30, 2020, operating expenses were
$50.8 million, an increase of $9.2 million from the $41.6 million
reported for the six months ended June 30, 2019. This increase was
due primarily to increased spending associated with COVID-19
product development, increased staffing costs, higher bad debt
expense associated with uncollectible customer accounts, higher
legal fees, and the inclusion of Diversigen operating expenses, all
partially offset by lower spending on market studies, tradeshows
and travel.
The Company generated an operating loss of $17.4 million in the
first six months of 2020 compared to operating income of $1.5
million in the first six months of 2019.
During the first half of 2020, the Company recorded income tax
expense of $2.0 million compared to income tax expense of $1.4
million recorded in the first six months of 2019. This tax increase
largely reflects the higher pre-tax income generated by the
Company’s Canadian subsidiary.
For the six months ended June 30, 2020, the Company used $2.2
million in cash from operations compared with $4.7 million
generated in the same period of 2019. The Company’s cash and
investment balance totaled $265.8 million at June
30, 2020, compared to $189.8
million at December 31, 2019.
Full-Year 2020 Guidance
As announced last quarter, the Company has withdrawn its
full-year 2020 financial guidance due to the unpredictable impact –
both positive and negative – of the ongoing COVID-19 global
pandemic on its results of operations, and the Company will not be
reinstating financial guidance at this time.
Financial Data
Consolidated Financial
Data(in thousands, except per-share
data)Unaudited
|
|
Three Months
Ended |
|
Six Months
Ended |
|
|
June 30, |
|
June 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Results of Operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
revenues |
|
$ |
29,259 |
|
|
$ |
38,826 |
|
|
$ |
60,855 |
|
|
$ |
68,948 |
|
Cost of
products and services sold |
|
|
11,995 |
|
|
|
13,808 |
|
|
|
27,460 |
|
|
|
25,850 |
|
Gross profit |
|
|
17,264 |
|
|
|
25,018 |
|
|
|
33,395 |
|
|
|
43,098 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,924 |
|
|
|
4,535 |
|
|
|
12,568 |
|
|
|
8,906 |
|
Sales and marketing |
|
|
10,121 |
|
|
|
7,687 |
|
|
|
17,490 |
|
|
|
14,982 |
|
General and administrative |
|
|
10,280 |
|
|
|
7,262 |
|
|
|
20,334 |
|
|
|
16,192 |
|
Change in fair value of acquisition-related contingent
consideration |
|
|
(660 |
) |
|
|
249 |
|
|
|
450 |
|
|
|
1,544 |
|
Total operating expenses |
|
|
26,665 |
|
|
|
19,733 |
|
|
|
50,842 |
|
|
|
41,624 |
|
Operating income (loss) |
|
|
(9,401 |
) |
|
|
5,285 |
|
|
|
(17,447 |
) |
|
|
1,474 |
|
Other
income |
|
|
216 |
|
|
|
524 |
|
|
|
1,646 |
|
|
|
1,048 |
|
Income
(loss) before income taxes |
|
|
(9,185 |
) |
|
|
5,809 |
|
|
|
(15,801 |
) |
|
|
2,522 |
|
Income tax
expense |
|
|
1,309 |
|
|
|
1,411 |
|
|
|
2,021 |
|
|
|
1,382 |
|
Net income
(loss) |
|
$ |
(10,494 |
) |
|
$ |
4,398 |
|
|
$ |
(17,822 |
) |
|
$ |
1,140 |
|
Income
(loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.16 |
) |
|
$ |
0.07 |
|
|
$ |
(0.28 |
) |
|
$ |
0.02 |
|
Diluted |
|
$ |
(0.16 |
) |
|
$ |
0.07 |
|
|
$ |
(0.28 |
) |
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
64,745 |
|
|
|
61,709 |
|
|
|
63,335 |
|
|
|
61,621 |
|
Diluted |
|
|
64,745 |
|
|
|
62,128 |
|
|
|
63,335 |
|
|
|
62,191 |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
Dollars |
|
|
|
|
Percentage of Total NetRevenues |
|
|
|
2020 |
|
2019 |
|
%Change |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ |
8,737 |
|
|
$ |
13,348 |
|
|
(35 |
) |
% |
|
30 |
% |
|
34 |
% |
Risk
assessment testing |
|
|
1,533 |
|
|
|
3,097 |
|
|
(51 |
) |
|
|
5 |
|
|
8 |
|
Cryosurgical
systems |
|
|
— |
|
|
|
3,518 |
|
|
(100 |
) |
|
|
— |
|
|
9 |
|
Molecular
collection systems |
|
|
18,067 |
|
|
|
17,304 |
|
|
4 |
|
|
|
63 |
|
|
45 |
|
Net product and service revenues |
|
|
28,337 |
|
|
|
37,267 |
|
|
(24 |
) |
|
|
98 |
|
|
96 |
|
Royalty
income |
|
|
727 |
|
|
|
1,114 |
|
|
(35 |
) |
|
|
1 |
|
|
3 |
|
Other |
|
|
195 |
|
|
|
445 |
|
|
(56 |
) |
|
|
1 |
|
|
1 |
|
Net revenues |
|
$ |
29,259 |
|
|
$ |
38,826 |
|
|
(25 |
) |
% |
|
100 |
% |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
Dollars |
|
|
|
|
Percentage of Total NetRevenues |
|
|
|
2020 |
|
2019 |
|
%Change |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Market |
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious disease testing |
|
$ |
23,400 |
|
|
$ |
25,686 |
|
|
(9 |
) |
% |
|
38 |
% |
|
37 |
% |
Risk
assessment testing |
|
|
4,533 |
|
|
|
5,934 |
|
|
(24 |
) |
|
|
7 |
|
|
9 |
|
Cryosurgical
systems |
|
|
— |
|
|
|
6,093 |
|
|
(100 |
) |
|
|
— |
|
|
9 |
|
Molecular
collection systems |
|
|
31,290 |
|
|
|
27,886 |
|
|
12 |
|
|
|
52 |
|
|
40 |
|
Net product and service revenues |
|
|
59,223 |
|
|
|
65,599 |
|
|
(10 |
) |
|
|
97 |
|
|
95 |
|
Royalty
income |
|
|
1,172 |
|
|
|
2,198 |
|
|
(47 |
) |
|
|
2 |
|
|
3 |
|
Other |
|
|
460 |
|
|
|
1,151 |
|
|
(60 |
) |
|
|
1 |
|
|
2 |
|
Net revenues |
|
$ |
60,855 |
|
|
$ |
68,948 |
|
|
(12 |
) |
% |
|
100 |
% |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Six Months
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2020 |
|
2019 |
|
%Change |
|
|
2020 |
|
2019 |
|
%Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OraQuick®
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
3,197 |
|
|
$ |
4,460 |
|
|
(28 |
) |
% |
|
$ |
7,414 |
|
|
$ |
8,765 |
|
|
(15 |
) |
% |
International HIV |
|
|
3,883 |
|
|
|
5,422 |
|
|
(28 |
) |
|
|
|
10,832 |
|
|
|
9,423 |
|
|
15 |
|
|
Net HIV revenues |
|
|
7,080 |
|
|
|
9,882 |
|
|
(28 |
) |
|
|
|
18,246 |
|
|
|
18,188 |
|
|
— |
|
|
Domestic
HCV |
|
|
757 |
|
|
|
2,102 |
|
|
(64 |
) |
|
|
|
2,251 |
|
|
|
3,930 |
|
|
(43 |
) |
|
International HCV |
|
|
641 |
|
|
|
983 |
|
|
(35 |
) |
|
|
|
1,738 |
|
|
|
2,440 |
|
|
(29 |
) |
|
Net HCV revenues |
|
|
1,398 |
|
|
|
3,085 |
|
|
(55 |
) |
|
|
|
3,989 |
|
|
|
6,370 |
|
|
(37 |
) |
|
Net product revenues |
|
$ |
8,478 |
|
|
$ |
12,967 |
|
|
(35 |
) |
% |
|
$ |
22,235 |
|
|
$ |
24,558 |
|
|
(9 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Six Months
Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2020 |
|
2019 |
|
%Change |
|
|
2020 |
|
2019 |
|
%Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Molecular Collection Systems Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
|
$ |
6,471 |
|
|
$ |
13,943 |
|
|
(54 |
) |
% |
|
$ |
14,863 |
|
|
$ |
21,791 |
|
|
(32 |
) |
% |
Microbiome |
|
|
853 |
|
|
|
2,057 |
|
|
(59 |
) |
|
|
|
2,430 |
|
|
|
3,446 |
|
|
(29 |
) |
|
COVID-19 |
|
|
8,472 |
|
|
|
— |
|
|
N/A |
|
|
|
|
8,866 |
|
|
|
— |
|
|
N/A |
|
|
Laboratory
services |
|
|
2,222 |
|
|
|
1,196 |
|
|
86 |
|
|
|
|
5,053 |
|
|
|
2,332 |
|
|
117 |
|
|
Other
product revenues |
|
|
49 |
|
|
|
108 |
|
|
(55 |
) |
|
|
|
78 |
|
|
|
317 |
|
|
(75 |
) |
|
Net molecular product and service revenues |
|
|
18,067 |
|
|
|
17,304 |
|
|
4 |
|
|
|
|
31,290 |
|
|
|
27,886 |
|
|
12 |
|
|
Other |
|
|
765 |
|
|
|
1,150 |
|
|
(33 |
) |
|
|
|
1,346 |
|
|
|
2,457 |
|
|
(45 |
) |
|
Net molecular product and service revenues |
|
$ |
18,832 |
|
|
$ |
18,454 |
|
|
2 |
|
% |
|
$ |
32,636 |
|
|
$ |
30,343 |
|
|
8 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited) |
|
|
June 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
173,874 |
|
|
$ |
75,715 |
|
Short-term
investments |
|
|
82,666 |
|
|
|
80,623 |
|
Accounts
receivable, net |
|
|
25,918 |
|
|
|
36,948 |
|
Inventories |
|
|
27,707 |
|
|
|
23,155 |
|
Other
current assets |
|
|
7,799 |
|
|
|
8,109 |
|
Property,
plant and equipment, net |
|
|
33,763 |
|
|
|
30,339 |
|
Intangible
assets, net |
|
|
15,221 |
|
|
|
14,674 |
|
Goodwill |
|
|
35,244 |
|
|
|
36,201 |
|
Long-term
investments |
|
|
9,222 |
|
|
|
33,420 |
|
Other
non-current assets |
|
|
9,413 |
|
|
|
10,111 |
|
Total assets |
|
$ |
420,827 |
|
|
$ |
349,295 |
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Accounts
payable |
|
$ |
9,057 |
|
|
$ |
9,567 |
|
Deferred
revenue |
|
|
4,917 |
|
|
|
3,713 |
|
Contingent
consideration obligation |
|
|
560 |
|
|
|
3,500 |
|
Other
current liabilities |
|
|
16,054 |
|
|
|
15,933 |
|
Other
non-current liabilities |
|
|
8,482 |
|
|
|
9,437 |
|
Stockholders’ equity |
|
|
381,757 |
|
|
|
307,145 |
|
Total liabilities and stockholders’ equity |
|
$ |
420,827 |
|
|
$ |
349,295 |
|
|
|
|
|
|
Additional Financial Data (Unaudited) |
|
Six Months
Ended |
|
|
June 30, |
|
|
2020 |
|
2019 |
|
|
|
|
|
|
Capital expenditures |
|
$ |
6,037 |
|
|
$ |
5,513 |
|
Depreciation
and amortization |
|
$ |
4,600 |
|
|
$ |
3,610 |
|
Stock-based
compensation |
|
$ |
4,048 |
|
|
$ |
1,848 |
|
Cash
provided by (used in) operating activities |
|
$ |
(2,184 |
) |
|
$ |
4,661 |
|
|
|
|
|
|
|
|
|
Conference Call
The Company will host a conference call and audio webcast for
analysts and investors to discuss the Company’s 2020 second 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 #3276612 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
12, 2020, by dialing 855-859-2056 (Domestic) or 404-537-3406
(International) and entering the Conference ID #3276612.
Given the circumstances globally, 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 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 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 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 Report on Form
10-Q for the quarter ended March 31, 2020, 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 |
VP Corporate Communications |
212-600-1902 |
484-353-1575 |
orasure@argotpartners.com |
media@orasure.com |
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