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,
2022.
“This quarter we delivered strong revenue growth
driven by InteliSwab® which helped offset headwinds in our core
business. We have commenced our strategic transformation with a
three-part approach intended to strengthen our foundation, elevate
our existing lines of business and accelerate growth. Our team also
made significant progress in cost productivity and manufacturing
efficiency priorities which we believe will lead to positive cash
flow later this calendar year,” said OraSure President and CEO
Carrie Eglinton Manner.
She continued, “Our teams are committed to
innovating and operating with disciplined execution and
accountability across the organization. We see an important
strategic niche for OraSure as a Company leveraging our strengths
in the face of current shifts in healthcare delivery. We are
dedicated to facilitating testing and sample collection for
patients at the point of care. In further evolving our
organization’s strategic plan, we will provide updates on our
progress. We are committed to driving sustained profitable growth
over the long-term and to unlocking shareholder value.”
Financial Highlights
- Net revenues for the second quarter
of 2022 were $80.2 million, a 39% increase from the second
quarter of 2021 and a new record for the Company.
- Total revenues from the Company’s
Diagnostic business unit were $60.4 million during the second
quarter of 2022 and grew 213% relative to the same period last
year. Revenue growth was driven by InteliSwab® which grew 95%
sequentially and offset a 10% decline in the base Diagnostic
business.
- Total product and service revenues
for the Company’s Molecular Solutions business unit were $19.8
million during the second quarter of 2022, an increase of 1%
sequentially and a decline of 48% from the second quarter of 2021.
The reduction from 2Q21 was driven predominantly by changes in
COVID-19 laboratory testing and the associated drop in the
Company’s COVID-19 molecular collection kits.
- GAAP gross margins in the quarter
were 34.4% compared to 53.2% in the second quarter of last year. On
a non-GAAP basis, gross margins this quarter improved 250 basis
points sequentially to 40.1% based predominantly on improvements in
InteliSwab® manufacturing which offset the impact of product mix
changes.
- GAAP operating loss in the second
quarter of 2022 was $21.3 million compared to operating income of
$1.8 million in the second quarter of last year and GAAP operating
loss of $16.0 million in the first quarter of 2022. The Company’s
GAAP operating loss included the impact of the $3.8 million
inventory reserve and $10.5 million in expenses tied to goodwill
impairment and long-lived asset impairment. On a non-GAAP basis,
the Company’s operating income improved by $5.2 million
sequentially to a $1.4 million loss reflecting the significant
improvements in InteliSwab® gross margins and expense control.
- Cash flow used in operations in the
quarter was $9.7 million due mostly to working capital changes
associated with the InteliSwab® scale-up. Cash and investments
totaled $95.8 million as of June 30, 2022.
Recent Business Highlights
InteliSwab® COVID-19
Testing
- InteliSwab® revenue in the quarter grew to $43.1 million
representing over 95% sequential growth relative to the first
quarter.
- Production volumes of InteliSwab®
scaled dramatically during the second quarter, and the Company has
current capacity to produce approximately 1.6 million tests per
week. The Company expects this capacity to nearly double by early
2023 given the opening of a new facility, hiring of new employees,
and validation of additional production equipment.
- Weekly production output for
InteliSwab® has increased approximately 14X since launch based upon
dozens of processing step enhancements which have dramatically
improved yield. Gross margins for InteliSwab® improved by over
2,000 basis points in the quarter based upon these manufacturing
efficiencies and better overhead absorption.
- OraSure has now received more than
$400 million in delivery orders from the US Defense Logistics
Agency (DLA) under the Company’s procurement contract supporting
the U.S. Department of Health and Human Services (HHS). The Company
has been informed that HHS/DLA can continue to provide shipping
instructions against these Delivery Orders past the contract
expiration date of September 13, 2022.
Diagnostics Business Results (excluding
InteliSwab®)
- Excluding InteliSwab® revenue,
Diagnostics base business revenue was $17.3 million in the quarter
and declined 10% compared to the prior year quarter. Year-to-date
Diagnostics base business revenue was relatively flat.
- International Diagnostics revenue
was $7.8M in Q2, a 9% decline compared to the prior year period.
Over half of the international revenue decline was due to the
one-time restock in Q2 2021 of HCV professional tests in Asia as
COVID-19 receded. In addition, the expiration of the Bill and
Melinda Gates Foundation subsidy for HIV self-tests occurred in the
second quarter of last year. Excluding this subsidy international
revenue declined 5% in the quarter.
- U.S. Diagnostics revenue, excluding
InteliSwab®, declined 10% year-over-year due to the lapping of
revenue associated with the Center for Disease Control’s, “Let’s
Stop HIV Together,” home testing program in Q2 2021. This program
procured our OraQuick® HIV OTC tests and sent them to consumer’s
homes in Q1 and Q2 of 2021.
Molecular Solutions
- Core collection kits declined 21%
in the quarter on a year-over-year basis, as expected following
timing shifts which positively impacted Q1 results. YTD core
collection kits were relatively flat and grew 1% sequentially
relative to the first quarter.
- Sales of OraSure’s sample
collection devices for molecular/PCR COVID-19 testing decreased
significantly year-over-year to $0.3 million in the second quarter
of 2022 compared to $12.0 million in the prior year period. The
decline is due to the continued transition to COVID-19 point of
care solutions and decreases in laboratory testing following
reimbursement changes.
- Total microbiome revenue, including
kits and services, was $3.0 million in the quarter and declined 45%
relative to the second quarter of last year. During the quarter,
kits and services revenue was negatively impacted by the timing of
customer clinical trials, shifts in research funding and the market
exit of a key customer.
- Launched the new OMNIgene® GUT
RNA/DNA collection kits. This Research Use Only product, based on
the OMNIgene® Gut DNA kit, incorporates a newly developed &
validated reagent to stabilize microbial DNA and RNA from human
fecal samples.
Financial Guidance
The Company is guiding toward 3Q22 revenue of
$90 to $95 million representing 67% to 76% growth relative to the
third quarter of last year. The Company also anticipates continued
improvements in gross margins, and improved cash flow from
operations in the third quarter. As such, the Company is guiding to
having positive cash flow from operations beginning in the fourth
quarter of this fiscal year.
New Chief Financial Officer
OraSure has appointed Kenneth J. McGrath as the
Company’s new Chief Financial Officer, effective August 8,
2022. Mr. McGrath replaces Scott Gleason, who has served as
the interim Chief Financial Officer and will continue in his role
leading Investor Relations and Corporate Communications going
forward. Mr. McGrath joined Quest Diagnostics in February 2014 and
most recently served as Vice President in Finance, where he led an
organization responsible for over $7 billion in revenue. He
helped build Quest’s Advanced Diagnostics business accelerating
growth while improving profitability with expanded capabilities and
new innovation. His expertise also includes value creation
via partnerships and successfully assessing and integrating
multiple acquisitions. Mr. McGrath’s finance operating
responsibility also spanned information technology, R&D and
medical functions, as well as commercial regions amongst other
responsibilities. Prior to his time at Quest, Mr. McGrath
held various leadership positions in finance operating roles at
Johnson & Johnson Inc. He began his career at Ford Motor
Company, received an M.B.A from the University of Michigan and a
B.S from the University of Notre Dame, and is a CFA
Charterholder.
Changes to Board of
Directors
- As part of OraSure’s strategic
transformation, we are also announcing important changes to our
Board of Directors. On August 8, 2022, each of Michael Celano,
Chairman of the Board, Ronny Lancaster, and Eamonn Hobbs resigned
from the Board, to be effective November 8, 2022. Upon the
effectiveness of such resignations, we will reduce our Board size
from 10 to 7. We thank Mr. Celano, Mr. Lancaster, and Mr. Hobbs for
their many committed years of service.
- In addition, effective November 8,
2022, Mara G. Aspinall will be appointed as Chair of the Board. Ms.
Mara G. Aspinall, MBA, is a diagnostic industry leader and pioneer.
Ms. Aspinall is Managing Director of Health Catalysts Group and
BlueStone Venture Partners following her 30-year operating career
in diagnostics where she served in many executive roles, including
Chief Executive of Ventana Medical Systems, now Roche Tissue
Diagnostics, as well as Genzyme Genetics. An author and frequent
speaker, Ms. Aspinall co-founded the Biomedical Diagnostics Master
Degree program at Arizona State University.
Inducement Awards
On August 8, 2022, OraSure granted Ken McGrath,
OraSure’s newly appointed Chief Financial Officer, an inducement
award of 131,883 shares of restricted stock. The restricted stock
granted to Mr. McGrath will vest in three equal annual
installments, on the first, second and third anniversaries of the
grant date, subject in each case to Mr. McGrath’s continued
employment through the relevant vesting date.
In addition, on August 8, 2022, OraSure granted
Zachary Wert, the Company’s newly appointed Senior Vice President,
Global Operations, an inducement award of 49,456 shares of
restricted stock. The restricted stock granted to Mr. Wert will
vest in full on August 8, 2023, subject to Mr. Wert’s continued
employment through that date.
The inducement awards for each of Mr. McGrath
and Mr. Wert were approved by OraSure’s Board of Directors, and
were granted pursuant to Nasdaq Listing Rule 5635(c)(4), as an
inducement material their acceptance of employment with
OraSure.
Financial Data (Unaudited)
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Results of Operations |
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
80,231 |
|
|
$ |
57,607 |
|
|
$ |
147,938 |
|
|
$ |
116,189 |
|
Cost of
products and services sold |
|
|
52,647 |
|
|
|
26,934 |
|
|
|
96,082 |
|
|
|
47,190 |
|
Gross profit |
|
|
27,584 |
|
|
|
30,673 |
|
|
|
51,856 |
|
|
|
68,999 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
9,068 |
|
|
|
7,682 |
|
|
|
17,481 |
|
|
|
16,674 |
|
Sales and marketing |
|
|
11,684 |
|
|
|
10,420 |
|
|
|
24,401 |
|
|
|
19,950 |
|
General and administrative |
|
|
17,579 |
|
|
|
10,993 |
|
|
|
36,735 |
|
|
|
21,181 |
|
Goodwill and long-lived assets impairment charges |
|
|
10,542 |
|
|
|
- |
|
|
|
10,542 |
|
|
|
- |
|
Change in fair value of acquisition-related contingent
consideration |
|
|
- |
|
|
|
(220 |
) |
|
|
(36 |
) |
|
|
(1,026 |
) |
Total operating expenses |
|
|
48,873 |
|
|
|
28,875 |
|
|
|
89,123 |
|
|
|
56,779 |
|
Operating income (loss) |
|
|
(21,289 |
) |
|
|
1,798 |
|
|
|
(37,267 |
) |
|
|
12,220 |
|
Other
income |
|
|
1,318 |
|
|
|
448 |
|
|
|
1,265 |
|
|
|
329 |
|
Income
(loss) before income taxes |
|
|
(19,971 |
) |
|
|
2,246 |
|
|
|
(36,002 |
) |
|
|
12,549 |
|
Income tax
expense |
|
|
(1,169 |
) |
|
|
3,610 |
|
|
|
2,767 |
|
|
|
10,139 |
|
Net income
(loss) |
|
$ |
(18,802 |
) |
|
$ |
(1,364 |
) |
|
$ |
(38,769 |
) |
|
$ |
2,410 |
|
Earnings
(loss) per share: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.26 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.54 |
) |
|
$ |
0.03 |
|
Diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.54 |
) |
|
$ |
0.03 |
|
Weighted
average shares: |
|
|
|
|
|
|
|
|
Basic |
|
|
72,496 |
|
|
|
71,983 |
|
|
|
72,361 |
|
|
|
71,931 |
|
Diluted |
|
|
72,496 |
|
|
|
71,983 |
|
|
|
72,361 |
|
|
|
72,683 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2022 |
|
2021 |
|
%Change |
|
|
2022 |
|
2021 |
|
%Change |
|
DIAGNOSTICS |
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious Disease Testing Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic HIV |
$ |
3,741 |
|
|
$ |
4,135 |
|
|
(10 |
) |
% |
|
$ |
7,506 |
|
|
$ |
9,050 |
|
|
(17 |
) |
% |
International HIV |
|
6,616 |
|
|
|
6,809 |
|
|
(3 |
) |
|
|
|
11,017 |
|
|
|
10,672 |
|
|
3 |
|
|
Net HIV revenues |
|
10,357 |
|
|
|
10,944 |
|
|
(5 |
) |
|
|
|
18,523 |
|
|
|
19,722 |
|
|
(6 |
) |
|
Domestic HCV |
|
2,537 |
|
|
|
2,571 |
|
|
(1 |
) |
|
|
|
4,574 |
|
|
|
3,754 |
|
|
22 |
|
|
International HCV |
|
1,154 |
|
|
|
1,729 |
|
|
(33 |
) |
|
|
|
2,374 |
|
|
|
2,914 |
|
|
(19 |
) |
|
Net HCV revenues |
|
3,691 |
|
|
|
4,300 |
|
|
(14 |
) |
|
|
|
6,948 |
|
|
|
6,668 |
|
|
4 |
|
|
Net OraQuick® revenues |
|
14,048 |
|
|
|
15,244 |
|
|
(8 |
) |
|
|
|
25,471 |
|
|
|
26,390 |
|
|
(3 |
) |
|
COVID-19 |
|
43,114 |
|
|
|
89 |
|
|
NM |
|
|
|
|
65,250 |
|
|
|
262 |
|
|
NM |
|
|
Other infectious disease revenues |
|
184 |
|
|
|
290 |
|
|
(37 |
) |
|
|
|
460 |
|
|
|
342 |
|
|
35 |
|
|
Total Infectious Disease |
|
57,346 |
|
|
|
15,623 |
|
|
267 |
|
|
|
|
91,181 |
|
|
|
26,994 |
|
|
238 |
|
|
Risk Assessment |
|
2,630 |
|
|
|
2,629 |
|
|
— |
|
|
|
|
5,191 |
|
|
|
4,591 |
|
|
13 |
|
|
Other non-product revenues |
|
479 |
|
|
|
1,059 |
|
|
(55 |
) |
|
|
|
2,393 |
|
|
|
2,272 |
|
|
5 |
|
|
TOTAL DIAGNOSTIC NET REVENUE |
|
60,455 |
|
|
|
19,311 |
|
|
213 |
|
|
|
|
98,765 |
|
|
|
33,857 |
|
|
192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MOLECULAR SOLUTIONS |
|
|
|
|
|
|
|
|
|
|
|
|
|
Genomics |
$ |
15,486 |
|
|
$ |
19,498 |
|
|
(21 |
) |
|
|
$ |
30,578 |
|
|
$ |
30,316 |
|
|
1 |
|
|
Microbiome |
|
1,832 |
|
|
|
2,447 |
|
|
(25 |
) |
|
|
|
3,822 |
|
|
|
4,198 |
|
|
(9 |
) |
|
COVID-19 |
|
264 |
|
|
|
11,981 |
|
|
(98 |
) |
|
|
|
9,161 |
|
|
|
39,953 |
|
|
(77 |
) |
|
Laboratory services |
|
1,204 |
|
|
|
3,114 |
|
|
(61 |
) |
|
|
|
2,938 |
|
|
|
5,611 |
|
|
(48 |
) |
|
Other product and services revenues |
|
405 |
|
|
|
449 |
|
|
(10 |
) |
|
|
|
1,532 |
|
|
|
657 |
|
|
133 |
|
|
Net product and service revenues |
|
19,191 |
|
|
|
37,489 |
|
|
(49 |
) |
|
|
|
48,031 |
|
|
|
80,735 |
|
|
(41 |
) |
|
Other non-product and service revenues |
|
585 |
|
|
|
807 |
|
|
(28 |
) |
|
|
|
1,142 |
|
|
|
1,597 |
|
|
(28 |
) |
|
TOTAL MOLECULAR SOLUTIONS NET REVENUE |
|
19,776 |
|
|
|
38,296 |
|
|
(48 |
) |
|
|
|
49,173 |
|
|
|
82,332 |
|
|
(40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NET REVENUES |
$ |
80,231 |
|
|
$ |
57,607 |
|
|
39 |
|
% |
|
$ |
147,938 |
|
|
$ |
116,189 |
|
|
27 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited) |
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
66,159 |
|
|
$ |
116,762 |
|
Short-term
investments |
|
|
29,625 |
|
|
|
36,279 |
|
Accounts
receivable, net |
|
|
62,886 |
|
|
|
45,323 |
|
Inventories |
|
|
71,304 |
|
|
|
53,138 |
|
Other
current assets |
|
|
37,332 |
|
|
|
36,929 |
|
Property,
plant and equipment, net |
|
|
93,697 |
|
|
|
88,164 |
|
Intangible
assets, net |
|
|
12,851 |
|
|
|
14,343 |
|
Goodwill |
|
|
36,038 |
|
|
|
40,279 |
|
Long-term
investments |
|
|
- |
|
|
|
17,009 |
|
Other
noncurrent assets |
|
|
19,362 |
|
|
|
12,764 |
|
Total assets |
|
$ |
429,254 |
|
|
$ |
460,990 |
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
Accounts
payable |
|
$ |
36,226 |
|
|
$ |
28,024 |
|
Deferred
revenue |
|
|
2,660 |
|
|
|
2,936 |
|
Other
current liabilities |
|
|
26,600 |
|
|
|
37,104 |
|
Other
non-current liabilities |
|
|
19,576 |
|
|
|
12,393 |
|
Stockholders’ equity |
|
|
344,192 |
|
|
|
380,533 |
|
Total liabilities and stockholders’ equity |
|
$ |
429,254 |
|
|
$ |
460,990 |
|
|
|
|
|
|
|
|
|
Additional Financial Data (Unaudited) |
|
Six Months Ended |
|
|
June 30, |
|
|
2022 |
|
2021 |
Capital expenditures |
|
$ |
25,281 |
|
|
$ |
22,929 |
|
Depreciation
and amortization |
|
$ |
7,777 |
|
|
$ |
5,524 |
|
Stock-based
compensation |
|
$ |
6,804 |
|
|
$ |
2,937 |
|
Cash used in
operating activities |
|
$ |
45,489 |
|
|
$ |
3,472 |
|
|
|
|
|
|
Conference Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
second quarter 2022 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 Carrie Eglinton
Manner, President and Chief Executive Officer, Lisa
Nibauer, President Diagnostics, Kathleen Weber, President Molecular
Solutions, Ken McGrath, Chief Financial Officer, and Scott Gleason,
SVP Investor Relations and Corporate Communications. The call will
include prepared remarks by management and a question and answer
session.
In order to listen to the conference call,
please dial (866) 374-5140 and reference Conference ID #11565698 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. It is recommended to dial-in 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 InteliSwab®OraSure has received Emergency
Use Authorizations (EUA) from the 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. The 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.
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 it has
been authorized by the FDA under an EUA. The emergency use of this
product has been authorized only for the detection of proteins from
SARS-CoV-2, not for any other viruses or pathogens. 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.
Multiple government agencies, including the U.S. Department of
Defense (DoD) and Department of Health and Human Services (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 HHS; the Administration for
Strategic Preparedness and Response; Biomedical Advanced Research
and Development Authority, under contract numbers 75A50120C00061
and 75A50121C00078, 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). The manufacturing effort
was funded through the American Rescue Plan Act (ARPA) to enable
and support domestic industrial base expansion for critical medical
resources.
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 press
release contains certain forward-looking statements, including with
respect to products, product development activities, regulatory
submissions and authorizations, revenue growth, cost savings, cash
flow, increasing margins 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: our ability to
satisfy customer demand; ability to reduce our spending rate,
capitalize on manufacturing efficiencies and drive profitable
growth; 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 the Company's business, supply chain,
labor force, 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, and demand for our COVID-19 testing
products; 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 and the ability to continue
to reduce costs; 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, civil unrest,
hostilities and war; and general political, business and economic
conditions, including inflationary pressures. 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, 2021, 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.
Statement Regarding Use of Non-GAAP Financial
Measures
In this press release, the company’s financial results and
financial guidance are provided in accordance with accounting
principles generally accepted in the United States (GAAP) and using
certain non-GAAP financial measures, including non-GAAP gross
margin, non-GAAP operating loss, and non-GAAP earnings (loss) per
share. Management believes that presentation of operating results
using these non-GAAP financial measures provides useful
supplemental information to investors and facilitates the analysis
of the company’s core operating results and comparison of operating
results across reporting periods, while excluding certain expenses
that may not be indicative of the Company’s recurring core business
operating results. In addition, management believes these non-GAAP
financial measures are useful to investors both because they (1)
allow for greater transparency with respect to key metrics used by
management in its financial and operational decision-making and (2)
are used by OraSure’s institutional investors and the analysis
community to help them analyze the health of OraSure’s business.
Management also uses non-GAAP financial measures to establish
budgets and to manage the company’s business. A reconciliation of
the GAAP financial results to non-GAAP financial results is
included in the schedules below and a description of the
adjustments made to the GAAP financial measures is included at the
end of the schedules.
The company encourages investors to carefully consider its
results under GAAP, as well as its supplemental non-GAAP
information and the reconciliation between these presentations, to
more fully understand its business. Non-GAAP financial results are
reported in addition to, and not as a substitute for, or superior
to, financial measures calculated in accordance with GAAP. Further,
non-GAAP financial measures, even if similarly titled, may not be
calculated in the same manner by all companies, and therefore
should not be compared.
|
OraSure
Technologies GAAP to Non-GAAP Reconciliation ($ in
000's) |
|
Three Months Ended |
|
Three Months Ended |
|
Three Months Ended |
|
Three Months Ended |
|
Mar 31, |
|
June 30, |
|
Mar 31, |
|
June 30, |
|
2022 |
|
2022 |
|
2021 |
|
2021 |
|
|
|
|
|
|
|
|
Revenue |
$ |
67,707 |
|
|
$ |
80,231 |
|
|
$ |
58,582 |
|
|
$ |
57,607 |
|
GAAP Cost of
Goods Sold |
|
43,435 |
|
|
|
52,647 |
|
|
|
20,256 |
|
|
|
26,934 |
|
GAAP Gross
Margin |
|
36 |
% |
|
|
34 |
% |
|
|
65 |
% |
|
|
53 |
% |
Stock compensation |
|
150 |
|
|
|
155 |
|
|
|
62 |
|
|
|
72 |
|
Amortization of acquisition-related intangible assets |
|
132 |
|
|
|
132 |
|
|
|
132 |
|
|
|
132 |
|
Transformation related expenses |
|
371 |
|
|
|
544 |
|
|
|
- |
|
|
|
- |
|
Inventory reserve for excess levels |
|
575 |
|
|
|
3,794 |
|
|
|
- |
|
|
|
- |
|
Non-GAAP
Cost of Goods Sold |
|
42,207 |
|
|
|
48,022 |
|
|
|
20,062 |
|
|
|
26,730 |
|
Non-GAAP
Gross Margin |
|
38 |
% |
|
|
40 |
% |
|
|
66 |
% |
|
|
54 |
% |
|
|
|
|
|
|
|
|
GAAP
Operating Income (Loss) |
|
(15,978 |
) |
|
|
(21,289 |
) |
|
|
10,422 |
|
|
|
1,798 |
|
Stock compensation |
|
2,062 |
|
|
|
2,447 |
|
|
|
1,464 |
|
|
|
1,474 |
|
Amortization of acquisition-related intangible assets |
|
501 |
|
|
|
501 |
|
|
|
705 |
|
|
|
718 |
|
Inventory reserve for excess levels |
|
575 |
|
|
|
3,794 |
|
|
|
- |
|
|
|
- |
|
Goodwill and long-lived assets impairment charges |
|
- |
|
|
|
10,542 |
|
|
|
- |
|
|
|
- |
|
Transformation related expenses |
|
4,153 |
|
|
|
902 |
|
|
|
- |
|
|
|
- |
|
Severance expense |
|
1,461 |
|
|
|
1,531 |
|
|
|
- |
|
|
|
- |
|
Strategic alternative costs |
|
651 |
|
|
|
197 |
|
|
|
- |
|
|
|
- |
|
Change in fair value of acquisition-related contingent
consideration |
|
(36 |
) |
|
|
- |
|
|
|
(806 |
) |
|
|
(220 |
) |
Non-GAAP
Operating Income (Loss) |
|
(6,611 |
) |
|
|
(1,375 |
) |
|
|
11,785 |
|
|
|
3,770 |
|
|
|
|
|
|
|
|
|
GAAP Net
Income (Loss) |
|
(19,967 |
) |
|
|
(18,802 |
) |
|
|
3,774 |
|
|
|
(1,364 |
) |
Stock compensation |
|
2,062 |
|
|
|
2,447 |
|
|
|
1,464 |
|
|
|
1,474 |
|
Amortization of acquisition-related intangible assets |
|
501 |
|
|
|
501 |
|
|
|
705 |
|
|
|
718 |
|
Inventory reserve for excess levels |
|
575 |
|
|
|
3,794 |
|
|
|
- |
|
|
|
- |
|
Goodwill and long-lived assets impairment charges |
|
- |
|
|
|
10,542 |
|
|
|
- |
|
|
|
- |
|
Transformation related expenses |
|
4,153 |
|
|
|
902 |
|
|
|
- |
|
|
|
- |
|
Severance expense |
|
1,461 |
|
|
|
1,531 |
|
|
|
- |
|
|
|
- |
|
Strategic alternative costs |
|
651 |
|
|
|
197 |
|
|
|
- |
|
|
|
- |
|
Change in fair value of acquisition-related contingent
consideration |
|
(36 |
) |
|
|
- |
|
|
|
(806 |
) |
|
|
(220 |
) |
Tax effect of Non-GAAP adjustments |
|
(89 |
) |
|
|
(1,156 |
) |
|
|
(80 |
) |
|
|
21 |
|
Non-GAAP Net
Income (Loss) |
$ |
(10,689 |
) |
|
$ |
(44 |
) |
|
$ |
5,057 |
|
|
$ |
629 |
|
|
|
|
|
|
|
|
|
GAAP
Earnings (Loss) Per Share: |
($0.28 |
) |
|
($0.26 |
) |
|
$0.05 |
|
|
($0.02 |
) |
Non-GAAP
Earnings (Loss) Per Share: |
($0.15 |
) |
|
($0.00 |
) |
|
$0.07 |
|
|
$0.01 |
|
Diluted Shares Outstanding |
|
72,194 |
|
|
|
72,496 |
|
|
|
72,766 |
|
|
|
71,983 |
|
|
|
|
|
|
|
|
|
Following is a description of the adjustments made to GAAP
financial measures:
- Stock Compensation:
non-cash equity-based compensation provided to OraSure employees
and directors, excluding accelerated stock compensation as required
under former employees’ employment agreements.
- Amortization of
acquisition-related intangible assets: represents recurring
amortization charges resulting from the acquisition of intangible
assets associated with our business combinations.
- Inventory reserve
for excess levels: reserves recorded for inventory balances that
are deemed excess based on current forecasts and expirations
dates.
- Transformation
related expenses: transitory costs such as consulting and
professional fees related to transformation initiatives.
- Goodwill and
long-live assets impairment charge: charges related to the write
down of company assets including PP&E and Goodwill
- Strategic
alternative costs: one-time expenses such as legal and banking fees
tied to the company’s strategic alternative process
- Severance
expenses: one-time expenses tied to executive severance agreements
including accelerated stock compensation
- Change in fair value of acquisition-related contingent
consideration: changes in the fair value of contingent
consideration liability associated with estimate changes in
reaching contingent consideration metrics.
- Tax impact
associated with non-GAAP adjustments – tax expense/(benefit) due to
non-GAAP adjustments
|
|
Investor Contact: |
Media Contact: |
Scott Gleason |
Amy Koch |
SVP Investor Relations & Corp. Communications |
Sr. Mgr. Corporate Communications |
484-425-0588 |
484-523-1815 |
sgleason@orasure.com |
media@orasure.com |
|
|
OraSure Technologies (NASDAQ:OSUR)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
OraSure Technologies (NASDAQ:OSUR)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024