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 June 30,
2021.
“This quarter, OraSure once again demonstrated
strong financial performance highlighted by a recovery in our core
business as the Company began to return to pre-pandemic revenue
levels. Importantly, we have now received three EUAs for our
InteliSwab™ COVID-19 Rapid Tests, signed up two major distributors,
and established a significant pipeline of sales inquiries. This
represents a significant achievement as we continue to demonstrate
the ability of the Company to develop and launch new products,”
said Stephen Tang, Ph.D., President and CEO of OraSure
Technologies.
Dr. Tang continued, “As we look to the second
half of the year we believe the business is well positioned for
year-over-year growth given the commercial launch of InteliSwab™.
We are responding to strong global customer interest for
InteliSwab™ tests and anticipate exiting the year at a significant
revenue run rate. Newer areas such as our microbiome kits and
services business are becoming increasingly important to our growth
story and achieved record revenue in the second quarter. Overall,
we are highly focused on spurring innovation, strengthening our
product pipeline, and deploying capital through strategically sound
acquisitions that leverage our commercial infrastructure to drive
long-term sustained growth and value for our stockholders.”
Financial Highlights
- Net revenues for the second quarter
of 2021 were $57.6 million, a 97% increase from the second
quarter of 2020. Excluding COVID-19 product revenues, revenues for
the quarter increased 122% YoY and 48% sequentially as the company
began to return to pre-pandemic revenue levels.
- Total revenues from the Company’s
Diagnostic business unit were $19.3 million during the second
quarter of 2021 and grew 85% relative to the same period last year.
Revenue growth was driven predominantly by higher global OraQuick®
HIV and OraQuick® HCV sales as clinics returned to testing for
these critical diseases, along with higher risk assessment testing
due to an increase in workplace testing.
- Total product and service revenues
for the Company’s Molecular Solutions business unit were $38.3
million during the second quarter of 2021, an increase of 103%
from the second quarter of 2020. The increase was driven by
strengthening demand for genomic collection kits from commercial
and academic customers, growth in microbiome collection kits and
services, and modestly higher COVID-19 collection kit sales.
- Gross margin percentage in the
second quarter was 53.2% compared to 59.0% 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 as
well as the higher mix of HIV testing revenue from international
markets which carries a lower gross margin than the corporate
average. We also saw an impact from increased labor and material
costs.
- Operating income in the second
quarter was $1.8 million compared to a loss of ($9.4) million in
the second quarter of last year. Improved operating profit was
driven by higher revenues and expense control with total operating
expenses only increasing 8% year-over-year despite the 97% overall
revenue growth.
- Net loss for the second quarter of
2021 was ($1.4) million, or ($0.02) per share on a
fully-diluted basis, compared to a net loss of ($10.5)
million, or ($0.16) per share on a fully-diluted basis,
for the second quarter of 2020.
- Cash flow used in operations in the
quarter was ($3.4) million. Cash and investments
totaled $229.4 million at June 30, 2021.
Recent Business Highlights
COVID-19 Testing
- OraSure received three Emergency
Use Authorizations (EUA) from the U.S. Food and Drug Administration
(FDA) for its InteliSwab™ COVID-19 Rapid Tests. The FDA has
authorized these tests 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 the InteliSwab™ COVID-19 Rapid Test Rx
for Prescription Home Use. The OTC and POC tests can be used for
those with or without symptoms, when tested twice over two to three
days, with 24-36 hours between tests.
- As anticipated, due to the timing
of EUA for InteliSwab™ and the time required for product
relabeling, OraSure did not recognize InteliSwab™ sales in the
second quarter of 2021. OraSure signed distribution agreements for
this product with two major U.S. distributors for US clinical and
physician office channels. Additionally, we currently have
significant customer inquiries, including inquiries from over 15
different countries that will accept FDA EUA product with
appropriate country specific documents and labeling.
- Following discussions with the FDA
and their de-prioritization of antibody testing in the U.S.,
OraSure has decided to no longer pursue EUAs for its oral fluid
COVID-19 antibody test. The Company will continue to offer the
product for research use only and has several labs interested in
COVID antibody surveillance and research applications.
Infectious Disease and Risk Assessment
Testing
- Global OraQuick® HIV sales in the
second quarter were $10.9 million versus $7.1 million in the prior
year period. Sales increased due to improved domestic HIV sales
along with continued strong double-digit international test volume
growth.
- OraSure Technologies was selected
by the Centers for Disease Control and Prevention (CDC) to
distribute 100,000 HIV self-test kits to individuals who request
them. The program sent out OraQuick® In-Home HIV Tests, which
allow an individual to detect antibodies to both HIV-1 and HIV-2
with an oral test, and provide results in 20 minutes, at home.
- Global OraQuick® HCV sales grew
208% to $4.3 million in the second quarter compared to $1.4 million
in the second quarter of 2020 as professional testing was
reinstated in many countries.
- Risk assessment testing revenue
grew 71% in the second quarter to $2.6 million based primarily upon
increased workplace drugs-of-abuse testing as economic conditions
and hiring have improved.
Molecular Solutions
- Genomics collection kit revenue of
$19.6 million for the second quarter of 2021 grew 203% YoY. The
growth was driven predominantly by growth in the key markets of
consumer genomics, disease risk management, companion animal and
research.
- Sales of OraSure’s sample
collection devices for molecular/PCR COVID-19 testing increased
year-over-year to $11.5 million in the second quarter of 2021
compared to $8.5 million in the prior year period. However, on a
sequential basis total sales declined by $15.9 million as total
U.S. PCR based test volumes for COVID-19 declined meaningfully from
the March 2021 quarter to the June 2021 quarter.
- A new study was published in
Gynecologic Oncology where the data indicated the ability of
Colli-Pee®, OraSure’s proprietary urine sample collection
technology, to facilitate test results for human papilloma virus
(HPV) using first-void urine samples from patients. In the study of
approximately 500 women, the accuracy of testing utilizing Abbott’s
RealTime High Risk HPV assay was statistically equivalent
using Colli-Pee® first-void urine-based samples as compared to
clinician collected cervical tissue cell samples.
- Total microbiome revenue, including
kits and services, was $6.0 million in the quarter and grew 94%
relative to the second quarter of last year. OraSure’s Diversigen
business now supports over 50 commercial customers including over
30 biopharmaceutical customers with 20 ongoing clinical
trials.
Third Quarter 2021 Guidance
The Company expects third quarter 2021 net
revenues to range from $45 million to $50 million.
The Company has also provided guidance for
InteliSwab™ for the full year stating that in now anticipates total
InteliSwab™ sales through December 2021 of approximately $30
million with the preponderance of revenue coming in the fourth
quarter of calendar year 2021.
The Company expects fiscal year 2021 total
revenue of approximately $230 million.
Financial Data (Unaudited)
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Results of Operations |
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
57,607 |
|
|
$ |
29,259 |
|
|
$ |
116,189 |
|
|
$ |
60,855 |
|
Cost of
products and services sold |
|
|
26,934 |
|
|
|
11,995 |
|
|
|
47,190 |
|
|
|
27,460 |
|
Gross profit |
|
|
30,673 |
|
|
|
17,264 |
|
|
|
68,999 |
|
|
|
33,395 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
7,682 |
|
|
|
6,924 |
|
|
|
16,674 |
|
|
|
12,568 |
|
Sales and marketing |
|
|
10,420 |
|
|
|
10,121 |
|
|
|
19,950 |
|
|
|
17,490 |
|
General and administrative |
|
|
10,993 |
|
|
|
10,280 |
|
|
|
21,181 |
|
|
|
20,334 |
|
Change in fair value of acquisition-related contingent
consideration |
|
|
(220 |
) |
|
|
(660 |
) |
|
|
(1,026 |
) |
|
|
450 |
|
Total operating expenses |
|
|
28,875 |
|
|
|
26,665 |
|
|
|
56,779 |
|
|
|
50,842 |
|
Operating income (loss) |
|
|
1,798 |
|
|
|
(9,401 |
) |
|
|
12,220 |
|
|
|
(17,447 |
) |
Other
income |
|
|
448 |
|
|
|
216 |
|
|
|
329 |
|
|
|
1,646 |
|
Income
(loss) before income taxes |
|
|
2,246 |
|
|
|
(9,185 |
) |
|
|
12,549 |
|
|
|
(15,801 |
) |
Income tax
expense |
|
|
3,610 |
|
|
|
1,309 |
|
|
|
10,139 |
|
|
|
2,021 |
|
Net income
(loss) |
|
$ |
(1,364 |
) |
|
$ |
(10,494 |
) |
|
$ |
2,410 |
|
|
$ |
(17,822 |
) |
Earnings
(loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.02 |
) |
|
$ |
(0.16 |
) |
|
$ |
0.03 |
|
|
$ |
(0.28 |
) |
Diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.16 |
) |
|
$ |
0.03 |
|
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
71,983 |
|
|
|
64,745 |
|
|
|
71,931 |
|
|
|
63,335 |
|
Diluted |
|
|
71,983 |
|
|
|
64,745 |
|
|
|
72,683 |
|
|
|
63,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
2021 |
|
2020 |
|
% Change |
|
2021 |
|
2020 |
|
% Change |
|
DIAGNOSTICS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious Disease Testing Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
|
$ |
4,135 |
|
|
$ |
3,197 |
|
|
29 |
|
% |
$ |
9,050 |
|
|
$ |
7,414 |
|
|
22 |
|
% |
International HIV |
|
|
6,809 |
|
|
|
3,883 |
|
|
75 |
|
|
|
10,672 |
|
|
|
10,832 |
|
|
(1 |
) |
|
Net HIV revenues |
|
|
10,944 |
|
|
|
7,080 |
|
|
55 |
|
|
|
19,722 |
|
|
|
18,246 |
|
|
8 |
|
|
Domestic HCV |
|
|
2,571 |
|
|
|
757 |
|
|
240 |
|
|
|
3,754 |
|
|
|
2,251 |
|
|
67 |
|
|
International HCV |
|
|
1,729 |
|
|
|
641 |
|
|
170 |
|
|
|
2,914 |
|
|
|
1,738 |
|
|
68 |
|
|
Net HCV revenues |
|
|
4,300 |
|
|
|
1,398 |
|
|
208 |
|
|
|
6,668 |
|
|
|
3,989 |
|
|
67 |
|
|
Net OraQuick® revenues |
|
|
15,244 |
|
|
|
8,478 |
|
|
80 |
|
|
|
26,390 |
|
|
|
22,235 |
|
|
19 |
|
|
Other infectious disease revenues |
|
|
379 |
|
|
|
259 |
|
|
46 |
|
|
|
604 |
|
|
|
1,165 |
|
|
(48 |
) |
|
Total Infectious Disease |
|
|
15,623 |
|
|
|
8,737 |
|
|
79 |
|
|
|
26,994 |
|
|
|
23,400 |
|
|
15 |
|
|
Risk Assessment |
|
|
2,629 |
|
|
|
1,533 |
|
|
71 |
|
|
|
4,591 |
|
|
|
4,533 |
|
|
1 |
|
|
Other non-product revenues |
|
|
1,059 |
|
|
|
157 |
|
|
575 |
|
|
|
2,272 |
|
|
|
286 |
|
|
694 |
|
|
TOTAL DIAGNOSTIC NET REVENUE |
|
$ |
19,311 |
|
|
$ |
10,427 |
|
|
85 |
|
% |
$ |
33,857 |
|
|
$ |
28,219 |
|
|
20 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MOLECULAR SOLUTIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
|
$ |
19,582 |
|
|
$ |
6,471 |
|
|
203 |
|
% |
$ |
30,646 |
|
|
$ |
14,863 |
|
|
106 |
|
|
Microbiome |
|
|
2,853 |
|
|
|
853 |
|
|
234 |
|
|
|
4,941 |
|
|
|
2,430 |
|
|
103 |
|
|
COVID-19 |
|
|
11,491 |
|
|
|
8,472 |
|
|
36 |
|
|
|
38,880 |
|
|
|
8,866 |
|
|
339 |
|
|
Laboratory services |
|
|
3,114 |
|
|
|
2,222 |
|
|
40 |
|
|
|
5,611 |
|
|
|
5,053 |
|
|
11 |
|
|
Other product and services revenues |
|
|
449 |
|
|
|
49 |
|
|
816 |
|
|
|
657 |
|
|
|
78 |
|
|
742 |
|
|
Net product and service revenues |
|
|
37,489 |
|
|
|
18,067 |
|
|
107 |
|
|
|
80,735 |
|
|
|
31,290 |
|
|
158 |
|
|
Other non-product and service revenues |
|
|
807 |
|
|
|
765 |
|
|
5 |
|
|
|
1,597 |
|
|
|
1,346 |
|
|
19 |
|
|
TOTAL MOLECULAR SOLUTIONS NET REVENUE |
|
$ |
38,296 |
|
|
$ |
18,832 |
|
|
103 |
|
% |
$ |
82,332 |
|
|
$ |
32,636 |
|
|
152 |
|
|
TOTAL NET REVENUES |
|
$ |
57,607 |
|
|
$ |
29,259 |
|
|
97 |
|
% |
$ |
116,189 |
|
|
$ |
60,855 |
|
|
91 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited) |
|
|
|
|
June 30, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
158,120 |
|
|
$ |
160,802 |
|
Short-term
investments |
|
|
35,185 |
|
|
|
48,599 |
|
Accounts
receivable, net |
|
|
35,259 |
|
|
|
38,835 |
|
Inventories |
|
|
48,170 |
|
|
|
31,863 |
|
Other
current assets |
|
|
8,316 |
|
|
|
8,794 |
|
Property,
plant and equipment, net |
|
|
72,034 |
|
|
|
51,860 |
|
Intangible
assets, net |
|
|
16,241 |
|
|
|
17,904 |
|
Goodwill |
|
|
40,810 |
|
|
|
40,351 |
|
Long-term
investments |
|
|
36,131 |
|
|
|
47,718 |
|
Other
non-current assets |
|
|
14,783 |
|
|
|
7,746 |
|
Total assets |
|
$ |
465,049 |
|
|
$ |
454,472 |
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Accounts
payable |
|
$ |
22,119 |
|
|
$ |
17,407 |
|
Deferred
revenue |
|
|
4,240 |
|
|
|
4,811 |
|
Contingent
consideration obligation |
|
|
219 |
|
|
|
402 |
|
Other
current liabilities |
|
|
19,994 |
|
|
|
23,869 |
|
Non-current
contingent consideration obligation |
|
|
800 |
|
|
|
2,049 |
|
Other
non-current liabilities |
|
|
12,861 |
|
|
|
7,363 |
|
Stockholders’ equity |
|
|
404,816 |
|
|
|
398,571 |
|
Total liabilities and stockholders’ equity |
|
$ |
465,049 |
|
|
$ |
454,472 |
|
|
|
|
|
|
|
|
|
Additional Financial Date (Unaudited) |
|
Six Months Ended |
|
|
June 30, |
|
|
2021 |
|
2020 |
Capital expenditures |
|
$ |
22,929 |
|
|
$ |
6,037 |
|
Depreciation
and amortization |
|
$ |
5,524 |
|
|
$ |
4,600 |
|
Stock-based
compensation |
|
$ |
2,937 |
|
|
$ |
4,048 |
|
Cash used in
operating activities |
|
$ |
3,472 |
|
|
$ |
2,184 |
|
|
|
|
|
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
second 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 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 (888) 771-4371 (Domestic) or (847) 585-4405
(International) and reference Conference ID # 50205303 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, August 17, 2021, by dialing 855-859-2056
(Domestic) or 404-537-3406 (International) and entering the
Conference ID # 50205303.
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
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 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, 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: |
Scott Gleason |
Amy Koch |
SVP Investor Relations & Corporate Communications |
Sr. Mgr. Corporate Communications |
484-425-0588 |
484-523-1815 |
sgleason@orasure.com |
media@orasure.com |
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
Storico
Da Lug 2023 a Lug 2024