OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in
point-of-care and home diagnostic tests and sample management
solutions, today announced its financial results for the three
months ended September 30, 2024.
“Our Q3 results were consistent with our
expectations, and we continue to make progress on our strategic
transformation. Core revenue improved sequentially in the third
quarter and our key end markets are showing signs of gradual
recovery. Our sustained focus on operational efficiency is
delivering consistent productivity gains, and we generated positive
cash flow from operations for the core business in Q3,” said
OraSure President and CEO Carrie Eglinton Manner.
She added, “We are winding down our Risk
Assessment testing business to focus on opportunities that align
with our strengths in Diagnostics and Sample Management and elevate
profitable growth in our core. As we position OraSure for a return
to growth, our strong balance sheet provides flexibility as we
invest in our innovation roadmap, including internal development,
partnerships, and potential acquisition opportunities that leverage
our existing capabilities.”
Financial Highlights
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
|
2023 |
|
|
% Change |
Core Business (1) |
$ |
37,751 |
|
|
$ |
38,154 |
|
|
(1 |
) |
% |
|
$ |
102,468 |
|
|
$ |
109,909 |
|
|
(7 |
) |
% |
Molecular Services |
|
9 |
|
|
|
834 |
|
|
(99 |
) |
|
|
|
1,692 |
|
|
|
3,567 |
|
|
(53 |
) |
|
COVID-19 |
|
2,155 |
|
|
|
50,199 |
|
|
(96 |
) |
|
|
|
44,222 |
|
|
|
216,115 |
|
|
(80 |
) |
|
Total Net Revenues |
$ |
39,915 |
|
|
$ |
89,187 |
|
|
(55 |
) |
% |
|
$ |
148,382 |
|
|
$ |
329,591 |
|
|
(55 |
) |
% |
|
(1) Includes Diagnostics, Molecular Sample Management Solutions,
other products and services revenues, and non-product and services
revenues. |
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
Net revenues |
$ |
39,915 |
|
|
|
$ |
89,187 |
|
|
|
(55 |
) |
% |
|
$ |
148,382 |
|
|
|
$ |
329,591 |
|
|
|
(55 |
) |
% |
Gross profit |
|
17,070 |
|
|
|
|
44,340 |
|
|
|
(62 |
) |
|
|
|
65,824 |
|
|
|
|
136,526 |
|
|
|
(52 |
) |
|
Gross margin |
|
42.8 |
|
% |
|
|
49.7 |
|
% |
|
|
|
|
|
|
44.4 |
|
% |
|
|
41.4 |
|
% |
|
|
|
|
Non-GAAP gross profit |
|
17,272 |
|
|
|
|
44,609 |
|
|
|
(61 |
) |
|
|
|
67,490 |
|
|
|
|
137,998 |
|
|
|
(51 |
) |
|
Non-GAAP gross margin |
|
43.3 |
|
% |
|
|
50.0 |
|
% |
|
|
|
|
|
|
45.5 |
|
% |
|
|
41.9 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
(5,999 |
) |
|
|
|
10,894 |
|
|
|
NM |
|
|
|
|
(15,832 |
) |
|
|
|
28,786 |
|
|
|
NM |
|
|
Operating margin |
(15.0 |
) |
% |
|
|
12.2 |
|
% |
|
|
|
|
|
(10.7 |
) |
% |
|
|
8.7 |
|
% |
|
|
|
|
Non-GAAP operating income
(loss) |
|
(2,698 |
) |
|
|
|
20,568 |
|
|
|
NM |
|
|
|
|
323 |
|
|
|
|
51,198 |
|
|
|
(99 |
) |
|
Non-GAAP operating margin |
(6.8 |
) |
% |
|
|
23.1 |
|
% |
|
|
|
|
|
|
0.2 |
|
% |
|
|
15.5 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
(4,507 |
) |
|
|
|
11,159 |
|
|
|
NM |
|
|
|
|
(8,706 |
) |
|
|
|
33,582 |
|
|
|
NM |
|
|
Non-GAAP net income
(loss) |
|
(688 |
) |
|
|
|
20,034 |
|
|
|
NM |
|
|
|
|
8,173 |
|
|
|
|
52,790 |
|
|
|
(85 |
) |
|
Diluted GAAP EPS |
$ |
(0.06 |
) |
|
|
$ |
0.15 |
|
|
|
NM |
|
|
|
$ |
(0.12 |
) |
|
|
$ |
0.45 |
|
|
|
NM |
|
|
Diluted Non-GAAP EPS |
$ |
(0.01 |
) |
|
|
$ |
0.27 |
|
|
|
NM |
|
|
|
$ |
0.11 |
|
|
|
$ |
0.71 |
|
|
|
(85 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NM – not meaningful |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- Total net revenues
for the third quarter of 2024 decreased 55% to $39.9 million from
$89.2 million in the third quarter of 2023.
- Core revenues (all
revenues excluding COVID-19 and Molecular Services revenues) of
$37.8 million in the third quarter decreased 1% year-over-year.
Diagnostics revenues in the third quarter increased 13%
year-over-year to $22.0 million and Molecular Sample Management
revenues decreased 16% to $12.8 million. The year-over-year decline
in Core revenues was impacted by a decrease in revenues from the
Risk Assessment testing business that we are exiting.
- COVID-19 revenues
of $2.2 million in the third quarter decreased 96%
year-over-year primarily due to the completion of our largest
government contract earlier in 2024.
- GAAP gross margin
percentage was 42.8% in the third quarter of 2024 compared to 49.7%
in the third quarter of 2023. Non-GAAP gross margin percentage in
the third quarter of 2024 was 43.3% compared to 50.0% in the third
quarter of 20231. On a year-over-year basis, gross margin was
impacted by the decline in COVID-19 revenues and the higher mix of
International revenues.
- GAAP operating loss
in the third quarter of 2024 was $6.0 million compared to operating
income of $10.9 million in the third quarter of 2023. Non-GAAP
operating loss was $2.7 million in the third quarter of 2024
compared to non-GAAP operating income of $20.6 million in the
third quarter of 2023.
- Cash and cash
equivalents were $279 million as of September 30, 2024. Cash
flow from operations in the third quarter of 2024 was $12.7
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.
Recent Business
Developments
- Received initial
international orders for our OraQuick® HCV Self-test following
receipt of WHO pre-qualification status in July. The OraQuick® HCV
Self-test is the first Hepatitis C self-test to earn this
designation, and we are actively working with the global health
community to bring this test to populations in need.
- Expanding our
sample management portfolio with the planned launch of a new
solution targeting the blood proteomics market in the second half
of 2025. Blood proteomics is a large and rapidly growing market,
and there is a need for collection devices that effectively
stabilize blood proteins in an easy-to-use format.
- Initiated steps to
exit our Risk Assessment testing business by the end of 2024 to
focus on markets that offer attractive growth opportunities. Risk
Assessment testing products generated revenues of $1.9 million
during the third quarter and $6.3 million during the first
nine months of 2024, which was a decline from $2.6 million during
the third quarter of 2023 and $7.5 million during the first nine
months of 2023.
- Generated $12.7
million of operating cash flow in the third quarter, driven by
positive cash flow generation in our Core business and collections
of accounts receivable related to InteliSwab®.
Financial Guidance
The Company is guiding to Q4 2024 revenues of
$36 to $38 million. The Company anticipates Core revenues in Q4
2024 of $35 to $37 million, which includes $1 to $2 million of Risk
Assessment testing revenues. The Company anticipates COVID-19
revenues in Q4 2024 of approximately $1 million.
Conference Call
The Company will host a conference call and
audio webcast to discuss the Company’s third quarter 2024 results
and certain business developments, beginning today at 5 p.m.
Eastern Time. 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.
For participants interested in asking a question during the
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/BIbe76f335a1d54f62abf8377abec292b4
OraSure intends to use the Investor Relations
Section of its website as a means of disclosing material non-public
information (MNPI) and for complying with its disclosure
obligations under Regulation FD. Accordingly, investors should
monitor OraSure’s website in addition to following its press
releases, SEC filings, public conference calls, presentations, and
webcasts.
Financial Data (Unaudited)
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Results of
Operations |
|
|
|
|
|
|
|
Net revenues |
$ |
39,915 |
|
|
$ |
89,187 |
|
|
$ |
148,382 |
|
|
$ |
329,591 |
|
Cost of products and services
sold |
|
22,845 |
|
|
|
44,847 |
|
|
|
82,558 |
|
|
|
193,065 |
|
Gross profit |
|
17,070 |
|
|
|
44,340 |
|
|
|
65,824 |
|
|
|
136,526 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
5,623 |
|
|
|
8,516 |
|
|
|
19,960 |
|
|
|
26,737 |
|
Sales and marketing |
|
7,615 |
|
|
|
8,736 |
|
|
|
23,994 |
|
|
|
29,413 |
|
General and administrative |
|
9,831 |
|
|
|
10,051 |
|
|
|
33,310 |
|
|
|
44,186 |
|
Loss on impairments |
|
— |
|
|
|
6,183 |
|
|
|
4,392 |
|
|
|
7,503 |
|
Change in the estimated fair value of acquisition-related
contingent consideration |
|
— |
|
|
|
(40 |
) |
|
|
— |
|
|
|
(99 |
) |
Total operating expenses |
|
23,069 |
|
|
|
33,446 |
|
|
|
81,656 |
|
|
|
107,740 |
|
Operating income (loss) |
|
(5,999 |
) |
|
|
10,894 |
|
|
|
(15,832 |
) |
|
|
28,786 |
|
Other income |
|
2,781 |
|
|
|
2,612 |
|
|
|
9,338 |
|
|
|
6,752 |
|
Income (loss) before income
taxes |
|
(3,218 |
) |
|
|
13,506 |
|
|
|
(6,494 |
) |
|
|
35,538 |
|
Income tax expense |
|
678 |
|
|
|
2,347 |
|
|
|
1,041 |
|
|
|
1,956 |
|
Loss on equity investment |
|
(611 |
) |
|
|
— |
|
|
|
(1,171 |
) |
|
|
— |
|
Net income (loss) |
$ |
(4,507 |
) |
|
$ |
11,159 |
|
|
$ |
(8,706 |
) |
|
$ |
33,582 |
|
Income (loss) per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.06 |
) |
|
$ |
0.15 |
|
|
$ |
(0.12 |
) |
|
$ |
0.46 |
|
Diluted |
$ |
(0.06 |
) |
|
$ |
0.15 |
|
|
$ |
(0.12 |
) |
|
$ |
0.45 |
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
Basic |
|
74,583 |
|
|
|
73,453 |
|
|
|
74,330 |
|
|
|
73,298 |
|
Diluted |
|
74,583 |
|
|
|
74,349 |
|
|
|
74,330 |
|
|
|
74,197 |
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
|
2023 |
|
|
% Change |
Consolidated Net
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COVID-19 Diagnostics |
$ |
2,155 |
|
|
$ |
50,145 |
|
|
(96 |
) |
% |
|
$ |
44,186 |
|
|
$ |
215,876 |
|
|
(80 |
) |
% |
Diagnostics |
|
22,023 |
|
|
|
19,551 |
|
|
13 |
|
|
|
|
57,162 |
|
|
|
56,475 |
|
|
1 |
|
|
Molecular Sample Management
Solutions |
|
12,806 |
|
|
|
15,238 |
|
|
(16 |
) |
|
|
|
36,237 |
|
|
|
41,230 |
|
|
(12 |
) |
|
Risk Assessment Testing |
|
1,911 |
|
|
|
2,554 |
|
|
(25 |
) |
|
|
|
6,265 |
|
|
|
7,540 |
|
|
(17 |
) |
|
Other products and
services |
|
748 |
|
|
|
638 |
|
|
17 |
|
|
|
|
1,802 |
|
|
|
1,739 |
|
|
4 |
|
|
Molecular Services |
|
9 |
|
|
|
834 |
|
|
(99 |
) |
|
|
|
1,692 |
|
|
|
3,567 |
|
|
(53 |
) |
|
COVID-19 Molecular
Products |
|
— |
|
|
|
54 |
|
|
(100 |
) |
|
|
|
36 |
|
|
|
239 |
|
|
(85 |
) |
|
Net product and services revenues |
|
39,652 |
|
|
|
89,014 |
|
|
(55 |
) |
|
|
|
147,380 |
|
|
|
326,666 |
|
|
(55 |
) |
|
Non-product and services revenues |
|
263 |
|
|
|
173 |
|
|
52 |
|
|
|
|
1,002 |
|
|
|
2,925 |
|
|
(66 |
) |
|
Net revenues |
$ |
39,915 |
|
|
$ |
89,187 |
|
|
(55 |
) |
% |
|
$ |
148,382 |
|
|
$ |
329,591 |
|
|
(55 |
) |
% |
Condensed Consolidated Balance Sheets
(Unaudited)
|
September 30, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
Cash and cash equivalents |
$ |
278,571 |
|
|
$ |
290,407 |
|
Accounts receivable, net |
|
26,954 |
|
|
|
40,171 |
|
Inventories |
|
38,870 |
|
|
|
47,614 |
|
Other current assets |
|
5,756 |
|
|
|
8,267 |
|
Property, plant and equipment,
net |
|
38,143 |
|
|
|
45,420 |
|
Intangible assets, net |
|
665 |
|
|
|
1,206 |
|
Goodwill |
|
35,287 |
|
|
|
35,696 |
|
Investment in equity method
investee |
|
28,829 |
|
|
|
— |
|
Other noncurrent assets |
|
11,010 |
|
|
|
14,064 |
|
Total assets |
$ |
464,085 |
|
|
$ |
482,845 |
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
9,581 |
|
|
$ |
13,151 |
|
Deferred revenue |
|
1,619 |
|
|
|
1,559 |
|
Other current liabilities |
|
16,584 |
|
|
|
24,826 |
|
Other noncurrent
liabilities |
|
10,736 |
|
|
|
12,638 |
|
Stockholders’ equity |
|
425,565 |
|
|
|
430,671 |
|
Total liabilities and stockholders’ equity |
$ |
464,085 |
|
|
$ |
482,845 |
|
Additional Financial Data (Unaudited)
|
For the Nine Months Ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
Capital expenditures |
$ |
3,341 |
|
|
$ |
9,018 |
|
Proceeds from funding under
government contract (1) |
|
— |
|
|
|
24,290 |
|
Depreciation and
amortization |
|
8,380 |
|
|
|
17,372 |
|
Stock-based compensation |
|
9,178 |
|
|
|
7,602 |
|
Cash provided by operating
activities |
$ |
27,265 |
|
|
$ |
100,217 |
|
|
|
|
|
|
|
|
|
(1) Proceeds represent reimbursement for capital expenditures,
engineering consulting costs, and guaranteed profit to cover
project management costs. |
Consolidated Statement of Cash Flows
(Unaudited)
|
For the Nine Months Ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
OPERATING ACTIVITIES: |
|
|
|
Net (loss) income |
$ |
(8,706 |
) |
|
$ |
33,582 |
|
Adjustments to reconcile net (loss) income to net cash provided by
operating activities: |
|
|
|
Stock-based compensation |
|
9,178 |
|
|
|
7,602 |
|
Depreciation and amortization |
|
8,380 |
|
|
|
17,372 |
|
Loss on impairments |
|
4,392 |
|
|
|
7,503 |
|
Other non-cash amortization |
|
(569 |
) |
|
|
3 |
|
Provision for credit losses |
|
521 |
|
|
|
(75 |
) |
Unrealized foreign currency gain |
|
(154 |
) |
|
|
(66 |
) |
Interest expense on finance leases |
|
20 |
|
|
|
42 |
|
Loss on equity investment |
|
1,171 |
|
|
|
— |
|
Deferred income taxes |
|
165 |
|
|
|
(490 |
) |
Loss on sale of fixed assets |
|
(121 |
) |
|
|
— |
|
Change in the estimated fair value of acquisition-related
contingent consideration |
|
— |
|
|
|
(99 |
) |
Payment of acquisition-related contingent consideration |
|
— |
|
|
|
(19 |
) |
Changes in assets and liabilities: |
|
|
|
Accounts receivable |
|
12,658 |
|
|
|
17,468 |
|
Inventories |
|
8,659 |
|
|
|
36,425 |
|
Prepaid expenses and other assets |
|
2,622 |
|
|
|
10,530 |
|
Accounts payable |
|
(3,431 |
) |
|
|
(25,122 |
) |
Deferred revenue |
|
66 |
|
|
|
(449 |
) |
Accrued expenses and other liabilities |
|
(7,586 |
) |
|
|
(3,990 |
) |
Net cash provided by operating activities |
|
27,265 |
|
|
|
100,217 |
|
INVESTING ACTIVITIES: |
|
|
|
Purchases of short-term investments |
|
(53,244 |
) |
|
|
(74,652 |
) |
Investment in equity method investee |
|
(30,000 |
) |
|
|
— |
|
Proceeds from maturities and redemptions of short-term
investments |
|
53,052 |
|
|
|
94,980 |
|
Purchases of property and equipment |
|
(3,341 |
) |
|
|
(4,517 |
) |
Purchase of property and equipment under government contracts |
|
— |
|
|
|
(4,501 |
) |
Proceeds from funding under government contract (1) |
|
— |
|
|
|
24,290 |
|
Net cash (used in) provided by investing activities |
|
(33,533 |
) |
|
|
35,600 |
|
FINANCING ACTIVITIES: |
|
|
|
Cash payments for lease liabilities |
|
(746 |
) |
|
|
(835 |
) |
Proceeds from exercise of stock options |
|
214 |
|
|
|
76 |
|
Payment of acquisition-related contingent consideration |
|
— |
|
|
|
(46 |
) |
Repurchase of common stock |
|
(3,533 |
) |
|
|
(1,863 |
) |
Net cash used in financing activities |
|
(4,065 |
) |
|
|
(2,668 |
) |
EFFECT OF FOREIGN EXCHANGE
RATE CHANGES ON CASH |
|
(1,503 |
) |
|
|
404 |
|
NET INCREASE (DECREASE) IN
CASH AND CASH EQUIVALENTS |
|
(11,836 |
) |
|
|
133,553 |
|
CASH AND CASH EQUIVALENTS,
BEGINNING OF PERIOD |
|
290,407 |
|
|
|
83,980 |
|
CASH AND CASH EQUIVALENTS, END
OF PERIOD |
$ |
278,571 |
|
|
$ |
217,533 |
|
About OraSure Technologies
OraSure Technologies, Inc. (“OraSure”)
transforms health through actionable insight and powers the shift
that connects people to healthcare wherever they are. OraSure
improves access, quality, and value of healthcare with innovation
in effortless tests and sample management solutions. OraSure,
together with its wholly-owned subsidiary, DNA Genotek Inc., is a
leader in the development, manufacture, and distribution of rapid
diagnostic tests and sample collection and stabilization devices
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, and direct to
consumers. For more information on OraSure Technologies, please
visit www.orasure.com
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.
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: 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, including from insourcing third party manufacturing
and exiting microbiome services; 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 or other public health crises 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; 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 achieve and 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,
suppliers and customers; 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, 2023, 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 gross profit, non-GAAP net income
(loss), 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)
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Revenue |
$ |
39,915 |
|
|
$ |
89,187 |
|
|
$ |
148,382 |
|
|
$ |
329,591 |
|
GAAP Cost of products and
services sold |
|
22,845 |
|
|
|
44,847 |
|
|
|
82,558 |
|
|
|
193,065 |
|
GAAP Gross Margin |
|
42.8 |
% |
|
|
49.7 |
% |
|
|
44.4 |
% |
|
|
41.4 |
% |
Stock compensation |
|
195 |
|
|
|
137 |
|
|
|
539 |
|
|
|
426 |
|
Amortization of acquisition-related intangible assets |
|
— |
|
|
|
132 |
|
|
|
— |
|
|
|
396 |
|
Reduction in workforce severance |
|
7 |
|
|
|
— |
|
|
|
1,127 |
|
|
|
369 |
|
Transformation related expenses |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
281 |
|
Non-GAAP Cost of Goods
Sold |
|
22,643 |
|
|
|
44,578 |
|
|
|
80,892 |
|
|
|
191,593 |
|
Non-GAAP Gross Margin |
|
43.3 |
% |
|
|
50.0 |
% |
|
|
45.5 |
% |
|
|
41.9 |
% |
|
|
|
|
|
|
|
|
GAAP Operating Income
(Loss) |
|
(5,999 |
) |
|
|
10,894 |
|
|
|
(15,832 |
) |
|
|
28,786 |
|
Stock compensation |
|
2,889 |
|
|
|
2,590 |
|
|
|
9,178 |
|
|
|
7,602 |
|
Amortization of acquisition-related intangible assets |
|
59 |
|
|
|
467 |
|
|
|
176 |
|
|
|
1,399 |
|
Reduction in workforce severance |
|
353 |
|
|
|
— |
|
|
|
2,409 |
|
|
|
3,264 |
|
Loss on impairment |
|
— |
|
|
|
6,183 |
|
|
|
4,392 |
|
|
|
7,503 |
|
Transformation related expenses |
|
— |
|
|
|
26 |
|
|
|
— |
|
|
|
707 |
|
Government grant accounting |
|
— |
|
|
|
448 |
|
|
|
— |
|
|
|
2,036 |
|
Change in fair value of acquisition-related contingent
consideration |
|
— |
|
|
|
(40 |
) |
|
|
— |
|
|
|
(99 |
) |
Non-GAAP Operating Income
(Loss) |
|
(2,698 |
) |
|
|
20,568 |
|
|
|
323 |
|
|
|
51,198 |
|
|
|
|
|
|
|
|
|
GAAP Net Income (Loss) |
|
(4,507 |
) |
|
|
11,159 |
|
|
$ |
(8,706 |
) |
|
|
33,582 |
|
Stock compensation |
|
2,889 |
|
|
|
2,590 |
|
|
|
9,178 |
|
|
|
7,602 |
|
Amortization of acquisition-related intangible assets |
|
59 |
|
|
|
467 |
|
|
|
176 |
|
|
|
1,399 |
|
Reduction in workforce severance |
|
353 |
|
|
|
— |
|
|
|
2,409 |
|
|
|
3,264 |
|
Loss on impairment |
|
— |
|
|
|
6,183 |
|
|
|
4,392 |
|
|
|
7,503 |
|
Transformation related expenses |
|
— |
|
|
|
26 |
|
|
|
— |
|
|
|
707 |
|
Change in fair value of acquisition-related contingent
consideration |
|
— |
|
|
|
(40 |
) |
|
|
— |
|
|
|
(99 |
) |
Loss on equity investment |
|
611 |
|
|
|
— |
|
|
|
1,171 |
|
|
|
— |
|
Tax effect of Non-GAAP adjustments |
|
(93 |
) |
|
|
(351 |
) |
|
|
(447 |
) |
|
|
(1,168 |
) |
Non-GAAP Net Income
(Loss) |
$ |
(688 |
) |
|
$ |
20,034 |
|
|
$ |
8,173 |
|
|
$ |
52,790 |
|
|
|
|
|
|
|
|
|
GAAP Earnings (Loss) Per
Share: |
$ |
(0.06 |
) |
|
$ |
0.15 |
|
|
$ |
(0.12 |
) |
|
$ |
0.45 |
|
Non-GAAP Earnings (Loss) Per
Share: |
$ |
(0.01 |
) |
|
$ |
0.27 |
|
|
$ |
0.11 |
|
|
$ |
0.71 |
|
Diluted Shares Outstanding |
|
74,583 |
|
|
|
74,349 |
|
|
|
74,330 |
|
|
|
74,197 |
|
Diluted Shares Outstanding Used For Computing Non-GAAP Earnings
(Loss) Per Share |
|
74,583 |
|
|
|
74,349 |
|
|
|
75,328 |
|
|
|
74,197 |
|
The 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
- 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: termination benefits
associated with the Company’s workforce reduction associated with
certain business events
- Loss on impairment: charges related to the write down of
Company’s intangibles, PP&E, or leased assets
- Transformation related expenses: transitory costs such as
consulting and professional fees related to transformation
initiatives
- 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
- Loss on equity investment: we have excluded our proportionate
share of our equity method investee’s net loss as we do not have
direct control over the investee’s operations or resulting revenue
and expenses
- 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 |
OraSure Technologies (NASDAQ:OSUR)
過去 株価チャート
から 11 2024 まで 12 2024
OraSure Technologies (NASDAQ:OSUR)
過去 株価チャート
から 12 2023 まで 12 2024