OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care and home diagnostic tests, sample management
solutions, and microbiome laboratory and analytical services, today
announced its financial results for the three months ended December
31, 2023.
“We made meaningful progress on our
transformation journey in 2023. We generated significant positive
operating cash flow with margin expansion, driven by our
enterprise-wide focus on innovating and operating with disciplined
execution. We expect to deliver additional productivity gains
across our organization, and we are on track to achieve our target
of break-even in cash flow from operations for the core business by
the end of 2024,” said OraSure President and CEO Carrie Eglinton
Manner.
She continued, “We are focused on elevating our
core growth as volumes under our COVID-19 contracts taper down in
2024 and expect that the trajectory in our key segments will begin
to improve later in the year. We are investing in our innovation
roadmap, organically and inorganically. Our recent investment and
agreement with Sapphiros expands our product pipeline potential,
and we continue to increase the breadth of our portfolio through
additional partnerships, like with Diagnostics Direct. Overall, we
believe the progress we are making positions OraSure to drive
profitable growth and create additional shareholder value.”
Financial Highlights
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
% Change |
|
|
2023 |
|
|
|
2022 |
|
|
% Change |
Core Business 1 |
$ |
34,217 |
|
|
$ |
34,084 |
|
|
— |
|
% |
|
$ |
147,693 |
|
|
$ |
144,154 |
|
|
2 |
|
% |
COVID-19 |
|
41,664 |
|
|
|
88,994 |
|
|
(53 |
) |
|
|
|
257,779 |
|
|
|
243,325 |
|
|
6 |
|
|
Total Net Revenue |
$ |
75,881 |
|
|
$ |
123,078 |
|
|
(38 |
) |
% |
|
$ |
405,472 |
|
|
$ |
387,479 |
|
|
5 |
|
% |
(1) Includes diagnostics, molecular sample management solutions
and molecular services, other products and services revenue, and
non-product and services revenue.
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
2023 |
|
2022 |
|
% Change |
|
2023 |
|
2022 |
|
% Change |
Net revenues |
$ |
75,881 |
|
|
|
$ |
123,078 |
|
|
|
(38 |
) |
% |
|
$ |
405,472 |
|
|
|
$ |
387,479 |
|
|
|
5 |
|
% |
Gross profit |
|
35,126 |
|
|
|
|
49,828 |
|
|
|
(30 |
) |
|
|
|
171,652 |
|
|
|
|
148,438 |
|
|
|
16 |
|
|
Gross margin |
|
46.3 |
|
% |
|
|
40.5 |
|
% |
|
|
|
|
|
|
42.3 |
|
% |
|
|
38.3 |
|
% |
|
|
|
|
Non-GAAP gross profit |
|
37,737 |
|
|
|
|
50,365 |
|
|
|
(25 |
) |
|
|
|
184,489 |
|
|
|
|
155,265 |
|
|
|
19 |
|
|
Non-GAAP gross margin |
|
49.7 |
|
% |
|
|
40.9 |
|
% |
|
|
|
|
|
|
45.5 |
|
% |
|
|
40.1 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
3,898 |
|
|
|
|
14,621 |
|
|
|
(73 |
) |
|
|
|
32,684 |
|
|
|
|
(22,156 |
) |
|
|
NM |
|
|
Operating margin |
|
5.1 |
|
% |
|
|
11.9 |
|
% |
|
|
|
|
|
|
8.1 |
|
% |
|
|
(5.7 |
) |
% |
|
|
|
|
Non-GAAP operating income
(loss) |
|
13,624 |
|
|
|
|
18,580 |
|
|
|
(27 |
) |
|
|
|
73,576 |
|
|
|
|
22,528 |
|
|
|
227 |
|
|
Non-GAAP operating margin |
|
18.0 |
|
% |
|
|
15.1 |
|
% |
|
|
|
|
|
|
18.1 |
|
% |
|
|
5.8 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
20,073 |
|
|
|
|
15,801 |
|
|
|
27 |
|
|
|
|
53,655 |
|
|
|
|
(17,133 |
) |
|
|
NM |
|
|
Non-GAAP net income
(loss) |
|
16,479 |
|
|
|
|
26,282 |
|
|
|
(37 |
) |
|
|
|
77,585 |
|
|
|
|
25,789 |
|
|
|
201 |
|
|
GAAP EPS |
$ |
0.27 |
|
|
|
$ |
0.22 |
|
|
|
23 |
|
|
|
$ |
0.72 |
|
|
|
$ |
(0.24 |
) |
|
|
NM |
|
|
Non-GAAP EPS |
$ |
0.22 |
|
|
|
$ |
0.36 |
|
|
|
(39 |
) |
|
|
$ |
1.04 |
|
|
|
$ |
0.36 |
|
|
|
193 |
|
|
NM – not meaningful
- Total net revenues
for the fourth quarter of 2023 decreased 38% to $75.9 million from
$123.1 million in the fourth quarter of 2022.
- Core revenue (all revenue excluding
COVID-19 revenue) of $34.2 million in the fourth quarter increased
0.4% year-over-year. Core revenue growth was driven by strong HIV
sales in the U.S. and international markets, which were partially
offset by a decline in non-product revenue.
- COVID-19 revenue of $41.7 million
in the fourth quarter decreased 53% year-over-year.
- GAAP gross margin percentage was
46.3% in the fourth quarter of 2023 compared to 40.5% in the fourth
quarter of 2022. Non-GAAP gross margins in the fourth quarter of
2023 were 49.7% compared to 40.9% in the fourth quarter of 20221.
Gross margins benefited from production efficiencies, cost
reduction initiatives, and changes to InteliSwab® packaging that
were implemented during the first quarter of 2023.
- GAAP operating income in the fourth
quarter of 2023 was $3.9 million compared to $14.6 million in the
fourth quarter of 2022. Non-GAAP operating income was $13.6 million
in the fourth quarter of 2023 compared to $18.6 million in the
fourth quarter of 2022.
- Cash, cash equivalents, and
short-term investments increased to $290.4 million as of
December 31, 2023. The $65.5 million increase in our cash
balance during the fourth quarter of 2023 was primarily driven by
our improved operational performance. In addition, during the
fourth quarter, we received $24.4 million from the U.S. government
related to our manufacturing expansion contract.
Recent Business Highlights
- In January, entered into a
strategic distribution relationship and investment in Sapphiros, a
next generation consumer diagnostics company. Through this
strategic partnership, OraSure expects to be able to offer a more
comprehensive range of low-cost diagnostic tests and sample
management solutions to our customers globally. OraSure has secured
exclusive distribution rights to key products in Sapphiros’
development pipeline that align with and enhance OraSure’s existing
areas of expertise, including self-collected blood samples and
diagnostic tests for sexually transmitted infections, respiratory
conditions, and other diseases.
- In February, signed a strategic
agreement with Diagnostics Direct to distribute Syphilis Health
Check, the first CLIA-waived treponemal test, which delivers point
of care results in 10 minutes.
- Established new distribution
relationships to expand our product offerings in sample management
solutions and substance abuse testing.
- Consolidated one of our
distribution facilities into our Opus Way facility in order to
drive additional operating efficiencies and cost savings.
- Remain on track to achieve
operating cash flow break-even for the core business by the end of
2024.
Financial Guidance
The Company is guiding to Q1 2024 revenue of $50
to $54 million, which includes core revenue of $29 to $31 million
and InteliSwab® revenue of $21 to $23 million.
______________________________1 For additional
information on non-GAAP financial measures and a reconciliation of
the GAAP financial results to non-GAAP financial results, see the
schedules below. A description of the adjustments made to the GAAP
financial measures is included at the end of the schedules.
Financial Data (Unaudited)
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Results of
Operations |
|
|
|
|
|
|
|
Net revenues |
$ |
75,881 |
|
|
$ |
123,078 |
|
|
$ |
405,472 |
|
|
$ |
387,479 |
|
Cost of products and services
sold |
|
40,755 |
|
|
|
73,250 |
|
|
|
233,820 |
|
|
|
239,041 |
|
Gross profit |
|
35,126 |
|
|
|
49,828 |
|
|
|
171,652 |
|
|
|
148,438 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
6,991 |
|
|
|
8,052 |
|
|
|
33,728 |
|
|
|
36,237 |
|
Sales and marketing |
|
6,906 |
|
|
|
11,363 |
|
|
|
36,319 |
|
|
|
49,238 |
|
General and administrative |
|
14,005 |
|
|
|
15,944 |
|
|
|
58,191 |
|
|
|
68,206 |
|
Loss on impairment |
|
3,326 |
|
|
|
— |
|
|
|
10,829 |
|
|
|
17,101 |
|
Change in fair value of acquisition-related contingent
consideration |
|
— |
|
|
|
(152 |
) |
|
|
(99 |
) |
|
|
(188 |
) |
Total operating expenses |
|
31,228 |
|
|
|
35,207 |
|
|
|
138,968 |
|
|
|
170,594 |
|
Operating income (loss) |
|
3,898 |
|
|
|
14,621 |
|
|
|
32,684 |
|
|
|
(22,156 |
) |
Other income |
|
16,822 |
|
|
|
1,014 |
|
|
|
23,574 |
|
|
|
6,481 |
|
Income (loss) before income
taxes |
|
20,720 |
|
|
|
15,635 |
|
|
|
56,258 |
|
|
|
(15,675 |
) |
Income tax expense
(benefit) |
|
647 |
|
|
|
(166 |
) |
|
|
2,603 |
|
|
|
1,458 |
|
Net income (loss) |
$ |
20,073 |
|
|
$ |
15,801 |
|
|
$ |
53,655 |
|
|
$ |
(17,133 |
) |
Earnings (loss) per
share: |
|
|
|
|
|
|
|
Basic |
$ |
0.27 |
|
|
$ |
0.22 |
|
|
$ |
0.73 |
|
|
$ |
(0.24 |
) |
Diluted |
$ |
0.27 |
|
|
$ |
0.22 |
|
|
$ |
0.72 |
|
|
$ |
(0.24 |
) |
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
73,499 |
|
|
|
72,734 |
|
|
|
73,348 |
|
|
|
72,505 |
|
Diluted |
|
75,013 |
|
|
|
73,248 |
|
|
|
74,389 |
|
|
|
72,505 |
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
% Change |
|
|
2023 |
|
|
|
2022 |
|
|
% Change |
COVID-19 Diagnostics |
$ |
41,617 |
|
|
$ |
88,857 |
|
|
(53 |
) |
% |
|
$ |
257,493 |
|
|
$ |
233,666 |
|
|
10 |
|
% |
Diagnostics |
|
17,219 |
|
|
|
14,422 |
|
|
19 |
|
|
|
|
73,694 |
|
|
|
52,181 |
|
|
41 |
|
|
Molecular Sample Management
Solutions |
|
13,044 |
|
|
|
11,998 |
|
|
9 |
|
|
|
|
54,274 |
|
|
|
63,342 |
|
|
(14 |
) |
|
Other products and
services |
|
2,722 |
|
|
|
3,008 |
|
|
(10 |
) |
|
|
|
12,001 |
|
|
|
11,903 |
|
|
1 |
|
|
Molecular Services |
|
907 |
|
|
|
2,401 |
|
|
(62 |
) |
|
|
|
4,474 |
|
|
|
7,296 |
|
|
(39 |
) |
|
COVID-19 Molecular
Products |
|
47 |
|
|
|
137 |
|
|
(66 |
) |
|
|
|
286 |
|
|
|
9,659 |
|
|
(97 |
) |
|
Net product and services revenues |
|
75,556 |
|
|
|
120,823 |
|
|
(37 |
) |
|
|
|
402,222 |
|
|
|
378,047 |
|
|
6 |
|
|
Non-product and services revenues |
|
325 |
|
|
|
2,255 |
|
|
(86 |
) |
|
|
|
3,250 |
|
|
|
9,432 |
|
|
(66 |
) |
|
Net revenues |
$ |
75,881 |
|
|
$ |
123,078 |
|
|
(38 |
) |
% |
|
$ |
405,472 |
|
|
$ |
387,479 |
|
|
5 |
|
% |
Condensed Consolidated Balance Sheets
(Unaudited)
|
December 31, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
290,407 |
|
|
$ |
83,980 |
|
Short-term investments |
|
— |
|
|
|
26,867 |
|
Accounts receivable, net |
|
40,171 |
|
|
|
70,797 |
|
Inventories |
|
47,614 |
|
|
|
95,704 |
|
Other current assets |
|
8,267 |
|
|
|
47,842 |
|
Property, plant and equipment,
net |
|
45,420 |
|
|
|
59,413 |
|
Intangible assets, net |
|
1,206 |
|
|
|
11,694 |
|
Goodwill |
|
35,696 |
|
|
|
35,104 |
|
Other noncurrent assets |
|
14,064 |
|
|
|
12,779 |
|
Total assets |
$ |
482,845 |
|
|
$ |
444,180 |
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
13,151 |
|
|
$ |
38,020 |
|
Deferred revenue |
|
1,559 |
|
|
|
2,273 |
|
Other current liabilities |
|
24,826 |
|
|
|
28,770 |
|
Other non-current
liabilities |
|
12,638 |
|
|
|
10,692 |
|
Stockholders’ equity |
|
430,671 |
|
|
|
364,425 |
|
Total liabilities and stockholders’ equity |
$ |
482,845 |
|
|
$ |
444,180 |
|
Additional Financial Data (Unaudited)
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
Capital expenditures |
$ |
10,303 |
|
|
$ |
63,909 |
|
Proceeds from funding under
government contract(1) |
$ |
48,669 |
|
|
$ |
60,331 |
|
Depreciation and
amortization |
$ |
20,936 |
|
|
$ |
15,308 |
|
Stock-based compensation |
$ |
10,729 |
|
|
$ |
11,622 |
|
Cash provided by (used in)
operating activities |
$ |
141,583 |
|
|
$ |
(47,202 |
) |
(1) Proceeds represent reimbursements for
capital expenditures, engineering consulting costs, guaranteed
profit to cover project management costs, and the excess of the
contract value over the Company’s final cash outlay.
Consolidated Statement of Cash Flows
(Unaudited)
|
Years Ended December 31, |
|
|
2023 |
|
|
|
2022 |
|
OPERATING ACTIVITIES: |
|
|
|
Net income (loss) |
$ |
53,655 |
|
|
$ |
(17,133 |
) |
Adjustments to reconcile net income (loss) to net cash provided by
(used in) operating activities: |
|
|
|
Stock-based compensation |
|
10,729 |
|
|
|
11,622 |
|
Depreciation and amortization |
|
20,936 |
|
|
|
15,308 |
|
Loss on impairments |
|
10,829 |
|
|
|
17,101 |
|
Other non-cash amortization |
|
3 |
|
|
|
228 |
|
Provision for credit losses |
|
(462 |
) |
|
|
(1,032 |
) |
Unrealized foreign currency gain |
|
103 |
|
|
|
(161 |
) |
Interest expense on finance leases |
|
51 |
|
|
|
94 |
|
Deferred income taxes |
|
102 |
|
|
|
(1,651 |
) |
Loss on sale of fixed assets |
|
— |
|
|
|
729 |
|
Change in the estimated fair value of acquisition-related
contingent consideration |
|
(99 |
) |
|
|
(188 |
) |
Payment of acquisition-related contingent consideration |
|
(19 |
) |
|
|
— |
|
Changes in assets and liabilities: |
|
|
|
Accounts receivable |
|
31,116 |
|
|
|
(25,162 |
) |
Inventories |
|
48,228 |
|
|
|
(43,274 |
) |
Prepaid expenses and other assets |
|
(2,499 |
) |
|
|
(7,091 |
) |
Accounts payable |
|
(26,976 |
) |
|
|
2,634 |
|
Deferred revenue |
|
(730 |
) |
|
|
(596 |
) |
Accrued expenses and other liabilities |
|
(3,384 |
) |
|
|
1,370 |
|
Net cash provided by (used in) operating activities |
|
141,583 |
|
|
|
(47,202 |
) |
INVESTING ACTIVITIES: |
|
|
|
Purchases of short-term investments |
|
(74,652 |
) |
|
|
(22,873 |
) |
Proceeds from maturities and redemptions of short-term
investments |
|
102,440 |
|
|
|
47,415 |
|
Proceeds from sale of assets |
|
— |
|
|
|
121 |
|
Purchases of property and equipment |
|
(5,802 |
) |
|
|
(6,774 |
) |
Purchase of property and equipment under government contracts |
|
(4,501 |
) |
|
|
(57,135 |
) |
Proceeds from funding under government contract(1) |
|
48,669 |
|
|
|
60,331 |
|
Net cash provided by investing activities |
|
66,154 |
|
|
|
21,085 |
|
FINANCING ACTIVITIES: |
|
|
|
Cash payments for lease liabilities |
|
(1,345 |
) |
|
|
(1,381 |
) |
Proceeds from exercise of stock options |
|
269 |
|
|
|
15 |
|
Payment of acquisition-related contingent consideration |
|
(46 |
) |
|
|
(208 |
) |
Repurchase of common stock |
|
(1,901 |
) |
|
|
(2,254 |
) |
Net cash used in financing activities |
|
(3,023 |
) |
|
|
(3,828 |
) |
EFFECT OF FOREIGN EXCHANGE
RATE CHANGES ON CASH |
|
1,713 |
|
|
|
(2,837 |
) |
NET INCREASE (DECREASE) IN
CASH AND CASH EQUIVALENTS |
|
206,427 |
|
|
|
(32,782 |
) |
CASH AND CASH EQUIVALENTS,
BEGINNING OF PERIOD |
|
83,980 |
|
|
|
116,762 |
|
CASH AND CASH EQUIVALENTS, END
OF PERIOD |
$ |
290,407 |
|
|
$ |
83,980 |
|
(1) Proceeds represent reimbursements for
capital expenditures, engineering consulting costs, guaranteed
profit to cover project management costs, and the excess of the
contract value over the Company’s final cash outlay.
Conference Call
The Company will host a conference call and
audio webcast to discuss the Company’s fourth quarter 2023 results
and certain business developments, beginning today at 5 p.m. ET. On
the call will be Carrie Eglinton Manner, President and Chief
Executive Officer, and Ken McGrath, Chief Financial Officer. The
call will include prepared remarks by management and a question and
answer session.
A webcast of the conference call will be
available on the investor relations page of OraSure’s website at
https://orasure.gcs-web.com/events-and-presentations. Please click
on the webcast link and follow the prompts for registration and
access at least 10 minutes prior to the call. The webcast will be
archived on OraSure’s website shortly after the call has ended and
will be available for approximately 90 days. If a participant will
be listen-only, they are encouraged to listen via the webcast.
To participate in the live conference call,
please follow the link below to pre-register. After registering,
you will be provided with your access details via email. It is
recommended to dial in at least 15 minutes prior to the call start
time.
https://register.vevent.com/register/BI02fb7bbb6778405db15374b4d472fd84
About InteliSwab®
OraSure has received Emergency Use
Authorizations (EUA) from the FDA for its InteliSwab® COVID-19
rapid tests. The U.S. Food and Drug Administration (“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. The InteliSwab® test’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.
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; 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 Technologies
OraSure Technologies (the “Company”) transforms
health through actionable insight and powers the shift that
connects people to healthcare wherever they are. The Company
improves access, quality, and value of healthcare with innovation
in effortless tests, sample management solutions, and services.
OraSure, together with its wholly-owned subsidiaries, DNA Genotek,
Diversigen, and Novosanis, provides its customers with end-to-end
solutions that encompass diagnostics, tools, and services. 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, pharmaceutical companies,
commercial entities, and direct to consumers. For more information
on OraSure Technologies, please visit www.orasure.com
Forward Looking Statements
This press release contains certain
forward-looking statements, including with respect to products,
product development and manufacturing activities, regulatory
submissions and authorizations, revenue growth and guidance,
expected revenue from government orders, 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: Sapphiros’ and its
related entities’ ability to seek and obtain regulatory approval
for products in development; our ability to satisfy customer
demand; ability to reduce our spending rate, capitalize on
manufacturing efficiencies and drive profitable growth; ability to
achieve the anticipated cost savings as a result of our business
restructuring; 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 or have
manufactured 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 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, such as Sapphiros, 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 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; cybersecurity breaches or other attacks involving our
systems or those of our third-party contractors and IT service
providers; the impact of terrorist attacks, civil unrest,
hostilities and war ; and general political, business and economic
conditions, including inflationary pressures and banking stability.
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, 2022, 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 income (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 December 31, |
|
Years Ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue |
$ |
75,881 |
|
|
|
$ |
123,078 |
|
|
|
$ |
405,472 |
|
|
|
$ |
387,479 |
|
|
GAAP Cost of products and
services sold |
|
40,755 |
|
|
|
|
73,250 |
|
|
|
|
233,820 |
|
|
|
|
239,041 |
|
|
GAAP Gross Margin |
|
46.3 |
|
% |
|
|
40.5 |
|
% |
|
|
42.3 |
|
% |
|
|
38.3 |
|
% |
Stock compensation |
|
138 |
|
|
|
|
140 |
|
|
|
|
564 |
|
|
|
|
331 |
|
|
Amortization of acquisition-related intangible assets |
|
— |
|
|
|
|
132 |
|
|
|
|
396 |
|
|
|
|
528 |
|
|
Reduction in workforce severance |
|
— |
|
|
|
|
— |
|
|
|
|
369 |
|
|
|
|
— |
|
|
Transformation related expenses |
|
— |
|
|
|
|
265 |
|
|
|
|
281 |
|
|
|
|
1,599 |
|
|
Accelerated depreciation |
|
516 |
|
|
|
|
— |
|
|
|
|
7,466 |
|
|
|
|
— |
|
|
Inventory reserve for excess levels |
|
1,957 |
|
|
|
|
— |
|
|
|
|
3,761 |
|
|
|
|
4,369 |
|
|
Non-GAAP Cost of Goods Sold |
|
38,144 |
|
|
|
|
72,713 |
|
|
|
|
220,983 |
|
|
|
|
232,214 |
|
|
Non-GAAP Gross Margin |
|
49.7 |
|
% |
|
|
40.9 |
|
% |
|
|
45.5 |
|
% |
|
|
40.1 |
|
% |
|
|
|
|
|
|
|
|
GAAP Operating Income (Loss) |
|
3,898 |
|
|
|
|
14,621 |
|
|
|
|
32,684 |
|
|
|
|
(22,156 |
) |
|
Stock compensation |
|
3,127 |
|
|
|
|
2,349 |
|
|
|
|
10,729 |
|
|
|
|
9,154 |
|
|
Amortization of acquisition-related intangible assets |
|
150 |
|
|
|
|
467 |
|
|
|
|
1,549 |
|
|
|
|
1,937 |
|
|
Reduction in workforce severance |
|
— |
|
|
|
|
— |
|
|
|
|
3,264 |
|
|
|
|
— |
|
|
Accelerated depreciation |
|
516 |
|
|
|
|
— |
|
|
|
|
7,466 |
|
|
|
|
— |
|
|
Inventory reserve for excess levels |
|
1,957 |
|
|
|
|
— |
|
|
|
|
3,761 |
|
|
|
|
4,369 |
|
|
Loss on impairment |
|
3,326 |
|
|
|
|
— |
|
|
|
|
10,829 |
|
|
|
|
17,101 |
|
|
Transformation related expenses |
|
— |
|
|
|
|
520 |
|
|
|
|
707 |
|
|
|
|
6,191 |
|
|
Executive severance expense |
|
— |
|
|
|
|
300 |
|
|
|
|
— |
|
|
|
|
3,850 |
|
|
Strategic alternative costs |
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
848 |
|
|
Transaction costs |
|
650 |
|
|
|
|
— |
|
|
|
|
650 |
|
|
|
|
— |
|
|
Government grant accounting |
|
— |
|
|
|
|
475 |
|
|
|
|
2,036 |
|
|
|
|
1,422 |
|
|
Change in fair value of acquisition-related contingent
consideration |
|
— |
|
|
|
|
(152 |
) |
|
|
|
(99 |
) |
|
|
|
(188 |
) |
|
Non-GAAP Operating Income |
|
13,624 |
|
|
|
|
18,580 |
|
|
|
|
73,576 |
|
|
|
|
22,528 |
|
|
|
|
|
|
|
|
|
|
GAAP Net Income (Loss) |
|
20,073 |
|
|
|
|
15,801 |
|
|
|
$ |
53,655 |
|
|
|
|
(17,133 |
) |
|
Stock compensation |
|
3,127 |
|
|
|
|
2,349 |
|
|
|
|
10,729 |
|
|
|
|
9,154 |
|
|
Amortization of acquisition-related intangible assets |
|
150 |
|
|
|
|
467 |
|
|
|
|
1,549 |
|
|
|
|
1,937 |
|
|
Reduction in workforce severance |
|
— |
|
|
|
|
— |
|
|
|
|
3,264 |
|
|
|
|
— |
|
|
Accelerated depreciation |
|
516 |
|
|
|
|
— |
|
|
|
|
7,466 |
|
|
|
|
— |
|
|
Inventory reserve for excess levels |
|
1,957 |
|
|
|
|
— |
|
|
|
|
3,761 |
|
|
|
|
4,369 |
|
|
Loss on impairment |
|
3,326 |
|
|
|
|
— |
|
|
|
|
10,829 |
|
|
|
|
17,101 |
|
|
Transformation related expenses |
|
— |
|
|
|
|
520 |
|
|
|
|
707 |
|
|
|
|
6,191 |
|
|
Executive severance expense |
|
— |
|
|
|
|
300 |
|
|
|
|
— |
|
|
|
|
3,850 |
|
|
Strategic alternative costs |
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
848 |
|
|
Transaction costs |
|
650 |
|
|
|
|
— |
|
|
|
|
650 |
|
|
|
|
— |
|
|
Change in fair value of acquisition-related contingent
consideration |
|
— |
|
|
|
|
(152 |
) |
|
|
|
(99 |
) |
|
|
|
(188 |
) |
|
Additional profit from government contract |
|
(12,802 |
) |
|
|
|
— |
|
|
|
|
(12,802 |
) |
|
|
|
— |
|
|
Tax effect of Non-GAAP adjustments |
|
(518 |
) |
|
|
|
6,997 |
|
|
|
|
(2,124 |
) |
|
|
|
(340 |
) |
|
Non-GAAP Net Income (Loss) |
$ |
16,479 |
|
|
|
$ |
26,282 |
|
|
|
$ |
77,585 |
|
|
|
$ |
25,789 |
|
|
|
|
|
|
|
|
|
|
GAAP Earnings (Loss) Per
Share: |
$ |
0.27 |
|
|
|
$ |
0.22 |
|
|
|
$ |
0.72 |
|
|
|
$ |
(0.24 |
) |
|
Non-GAAP Earnings (Loss) Per
Share: |
$ |
0.22 |
|
|
|
$ |
0.36 |
|
|
|
$ |
1.04 |
|
|
|
$ |
0.36 |
|
|
Diluted Shares Outstanding |
|
75,013 |
|
|
|
|
73,248 |
|
|
|
|
74,389 |
|
|
|
|
72,505 |
|
|
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
- Reduction in workforce severance: one-time termination benefits
associated with the Company’s workforce reduction
- Inventory reserve for excess levels: reserves recorded for
inventory balances that are deemed excess based on current
forecasts and expirations dates
- Loss on impairment: charges related to the write down of
Company’s PP&E, goodwill and intangible assets
- Transaction costs: costs related to mergers and acquisition
transactions or strategic investments
- Transformation related expenses: transitory costs such as
consulting and professional fees related to transformation
initiatives
- Accelerated depreciation: reduction in the useful life of
certain assets to fully depreciate those assets which were
identified as having no future use beyond the period presented due
to a manufacturing site closure
- Strategic alternative costs: one-time expenses such as legal
and banking fees tied to the Company’s strategic alternative
process
- Executive severance expenses: expenses tied to executive
severance agreements including accelerated stock compensation
- Government contract accounting: As required under International
Accounting Standard Board IAS 20, Accounting for Government
Contracts and Disclosure of Government Assistance, our operating
expenses associated with the Department of Defense expansion
contract are reflected in operating expenses with offsetting
reimbursement reflected in other income
- 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
- Additional profit from government contracts: income earned
under a fixed-firm contract as a result of spending below the
original budgeted amount expected under the contract
- Tax impact associated with non-GAAP adjustments – tax
expense/(benefit) due to non-GAAP adjustments
A reconciliation of our non-GAAP measures to their most directly
comparable GAAP measures can also be found at:
https://orasure.gcs-web.com/gaap-non-gaap-reconciliation
Investor Contact: |
Media Contact: |
Jason Plagman |
Amy Koch |
VP, Investor Relations |
Director, Corporate Communications |
investorinfo@orasure.com |
media@orasure.com |
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
Storico
Da Gen 2024 a Gen 2025