OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care
diagnostic tests and specimen collection devices, today announced
its consolidated financial results for the three and nine months
ended September 30, 2017.
Financial Highlights
- Consolidated net revenues for the third quarter of 2017 were
$42.3 million, a 31% increase from the third quarter of 2016.
Consolidated net product revenues were $41.2 million, representing
a 62% increase over the third quarter of 2016.
- Consolidated net revenues for the nine months ended September
30, 2017 were $115.0 million, a 24% increase from the comparable
period of 2016. Consolidated net product revenues were $111.8
million, representing a 43% increase over the first nine months of
2016.
- Net molecular collection systems revenues were $18.6 million
during the third quarter of 2017, which represents a 123% increase
over the third quarter of 2016. Net molecular collection systems
revenues during the nine months ended September 30, 2017 were $45.3
million, a 92% increase from the comparable period in
2016.
- Total OraQuick® HCV sales of $8.0 million for the third quarter
of 2017 increased 185% compared to the third quarter of 2016 and
included a 376% increase in international sales of the product from
the prior year quarter. OraQuick® HCV sales were $21.8 million in
the first nine months of 2017, a 144% increase over the first nine
months of 2016 and included a 325% increase in international sales
of the product from the prior year period.
- Net revenues from international sales of the Company’s
OraQuick® HIV products of $3.1 million increased 176% compared to
the third quarter of 2016. Total international OraQuick® HIV sales
for the nine months ended September 30, 2017 were $7.7 million, a
97% increase over the first nine months of 2016.
- Consolidated net income for the third quarter of 2017 was $5.8
million, or $0.09 per share on a fully diluted basis, which
compares to consolidated net income of $6.2 million, or $0.11 per
share on a fully diluted basis, for the third quarter of
2016. Consolidated net income for the nine months ended
September 30, 2017 was $23.6 million, or $0.39 per share on a
fully-diluted basis, which compares to consolidated net income of
$12.5 million, or $0.22 per share, for the comparable period of
2016. Results for the first nine months of 2017 included a
$12.5 million pre-tax gain related to a litigation settlement that
was accounted for as a reduction of operating expenses.
- Cash and investments totaled $180.3 million and working capital
amounted to $182.7 million at September 30, 2017.
“We are very pleased with the Company’s third
quarter financial results,” said Douglas A. Michels, President and
Chief Executive Officer of OraSure Technologies. “Sales of
our molecular collections products during the quarter were
particularly strong and our infectious disease business experienced
strong growth compared to the prior year quarter. We continue
to deliver on our strategic growth priorities and we expect our
strong performance to continue into the fourth quarter.”
Financial Results
Consolidated net product revenues for the third
quarter of 2017 increased 62% over the comparable period of
2016. Consolidated net product revenues for the first nine
months of 2017 increased 43% over the comparable period of 2016.
These increases were primarily the result of higher sales of the
Company’s molecular collections and OraQuick® HCV products and
higher international sales of the OraQuick® HIV self-test,
partially offset by lower domestic sales of the Company’s
professional OraQuick® HIV product and lower cryosurgical product
sales. Product revenues associated with the 2017 sales of the
OraQuick® HIV self-test include $458,000 of support payments
associated with the charitable support agreement with the Bill and
Melinda Gates Foundation (“Gates Foundation”).
Consolidated other revenues for the third
quarter and first nine months of 2017 were $1.2 million and $3.3
million, respectively. This compares to consolidated other revenues
for the third quarter and first nine months of 2016 of $6.8 million
and $14.4 million, respectively. Other revenues in the third
quarter of 2017 included $939,000 of funding received from the U.S.
Biomedical Advanced Research Development Authority (“BARDA”) and
$218,000 in cost reimbursement under the Company’s charitable
support agreement with the Gates Foundation. Other revenues
in the third quarter of 2016 included $676,000 of BARDA funding and
$6.1 million of exclusivity revenues recognized under the Company’s
HCV co-promotion agreement with AbbVie, which terminated on
December 31, 2016. Other revenues in the first nine months of
2017 included $3.1 million of BARDA funding and $218,000 of cost
reimbursement under the Gates Foundation agreement. Other
revenues in the first nine months of 2016 included $1.6 million of
BARDA funding and $12.8 million of AbbVie exclusivity revenues.
Consolidated gross margin was 58% and 61% for
the three and nine months ended September 30, 2017, respectively.
Consolidated gross margin for the three and nine months ended
September 30, 2016 was 70% and 69%, respectively. Gross
margin for the current quarter and the first nine months of 2017
decreased primarily due to the absence of AbbVie exclusivity
revenues during these periods, an increase in lower margin product
sales, and higher scrap and spoilage costs.
Consolidated operating expenses increased to
$17.3 million during the third quarter of 2017 compared to $16.5
million in the third quarter of 2016. For the nine months
ended September 30, 2017, consolidated operating expenses were
$40.4 million, a $10.5 million decrease from the $50.9 million
reported for the nine months ended September 30, 2016. The
quarterly increase was largely due to higher sales and marketing
expenses resulting from higher staffing costs, higher external
commissions to be paid to certain international distributors, and
an increase in our allowance for doubtful accounts related to a
genomics customer. The reduction in the nine-month period was
primarily due to a $12.5 million gain on a litigation settlement
reported earlier this year, the absence of costs associated with
the AbbVie HCV co-promotion agreement, and lower legal fees
partially offset by higher staffing costs.
Operating income increased 19% to $7.3 million
in the third quarter of 2017 compared to $6.1 million in the third
quarter of 2016. Operating income for the nine months ended
September 30, 2017 was $30.1 million, a 128% increase over the
comparable period in 2016.
The Company’s cash and investment balance
totaled $180.3 million at September 30, 2017, compared to $120.9
million at December 31, 2016. Working capital was $182.7
million at September 30, 2017, compared to $139.1 million at
December 31, 2016. For the nine months ended September 30,
2017, the Company generated $30.4 million in cash from
operations.
Fourth Quarter 2017
Outlook
The Company expects consolidated net revenues to
range from $45 million to $46 million and is projecting
consolidated net income of $0.08 to $0.09 per share for the fourth
quarter of 2017.
Financial Data
Condensed Consolidated Financial
Data |
(In thousands, except per-share
data) |
|
|
|
|
|
|
|
|
|
|
Unaudited |
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
September 30, |
|
|
September 30, |
|
|
2017 |
|
2016 |
|
|
2017 |
|
2016 |
Results of
Operations |
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
42,314 |
|
$ |
32,251 |
|
|
$ |
115,036 |
|
|
$ |
92,699 |
|
Cost of products
sold |
|
|
17,670 |
|
|
9,576 |
|
|
|
44,605 |
|
|
|
28,626 |
|
Gross
profit |
|
|
24,644 |
|
|
22,675 |
|
|
|
70,431 |
|
|
|
64,073 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,228 |
|
|
3,196 |
|
|
|
9,536 |
|
|
|
8,547 |
|
Sales and marketing |
|
|
7,162 |
|
|
6,428 |
|
|
|
21,541 |
|
|
|
22,531 |
|
General and administrative |
|
|
6,935 |
|
|
6,907 |
|
|
|
21,777 |
|
|
|
19,803 |
|
Gain on litigation settlement |
|
|
- |
|
|
- |
|
|
|
(12,500 |
) |
|
|
- |
|
Total operating
expenses |
|
|
17,325 |
|
|
16,531 |
|
|
|
40,354 |
|
|
|
50,881 |
|
Operating income |
|
|
7,319 |
|
|
6,144 |
|
|
|
30,077 |
|
|
|
13,192 |
|
Other income
(expense) |
|
|
113 |
|
|
498 |
|
|
|
676 |
|
|
|
(34 |
) |
Income before income
taxes |
|
|
7,432 |
|
|
6,642 |
|
|
|
30,753 |
|
|
|
13,158 |
|
Income tax expense |
|
|
1,669 |
|
|
400 |
|
|
|
7,121 |
|
|
|
634 |
|
Net income |
|
$ |
5,763 |
|
$ |
6,242 |
|
|
$ |
23,632 |
|
|
$ |
12,524 |
|
Earnings per
share: |
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.10 |
|
$ |
0.11 |
|
|
$ |
0.40 |
|
|
$ |
0.23 |
|
Diluted |
|
$ |
0.09 |
|
$ |
0.11 |
|
|
$ |
0.39 |
|
|
$ |
0.22 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares: |
|
|
|
|
|
|
|
|
|
Basic |
|
|
60,090 |
|
|
55,653 |
|
|
|
58,511 |
|
|
|
55,549 |
|
Diluted |
|
|
62,172 |
|
|
56,530 |
|
|
|
60,569 |
|
|
|
56,273 |
|
Summary of Net Revenues by Market and Product
(Unaudited)
|
|
Three Months Ended September 30, |
|
|
|
Dollars |
|
|
|
|
Percentage of Total Net Revenues |
Market |
2017 |
|
2016 |
|
% Change |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious
disease testing |
$ |
16,577 |
|
$ |
10,412 |
|
59 |
|
% |
39 |
% |
32 |
% |
Risk
assessment testing |
|
3,149 |
|
|
3,481 |
|
(10 |
) |
|
|
7 |
|
|
11 |
|
Cryosurgical systems |
|
2,879 |
|
|
3,240 |
|
(11 |
) |
|
|
7 |
|
|
10 |
|
Molecular
collection systems |
|
18,552 |
|
|
8,327 |
|
123 |
|
|
|
44 |
|
|
26 |
|
|
Net product
revenues |
|
41,157 |
|
|
25,460 |
|
62 |
|
|
|
97 |
|
|
79 |
|
Other |
|
|
1,157 |
|
|
6,791 |
|
(83 |
) |
|
|
3 |
|
|
21 |
|
|
Net revenues |
$ |
42,314 |
|
$ |
32,251 |
|
31 |
|
% |
|
100 |
% |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
Dollars |
|
|
|
|
Percentage of Total Net Revenues |
Market |
2017 |
|
2016 |
|
% Change |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infectious
disease testing |
$ |
47,822 |
|
$ |
34,729 |
|
38 |
|
% |
42 |
% |
37 |
% |
Risk
assessment testing |
|
9,517 |
|
|
9,746 |
|
(2 |
) |
|
|
8 |
|
|
10 |
|
Cryosurgical systems |
|
9,116 |
|
|
10,162 |
|
(10 |
) |
|
|
8 |
|
|
11 |
|
Molecular
collection systems |
|
45,316 |
|
|
23,649 |
|
92 |
|
|
|
39 |
|
|
26 |
|
|
Net product
revenues |
|
111,771 |
|
|
78,286 |
|
43 |
|
|
|
97 |
|
|
84 |
|
Other |
|
|
3,265 |
|
|
14,413 |
|
(77 |
) |
|
|
3 |
|
|
16 |
|
|
Net revenues |
$ |
115,036 |
|
$ |
92,699 |
|
24 |
|
% |
|
100 |
% |
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
HIV
Revenues |
2017 |
|
2016 |
|
% Change |
|
2017 |
|
2016 |
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
$ |
3,622 |
|
$ |
4,858 |
|
(25 |
) |
% |
|
$ |
12,401 |
|
$ |
16,446 |
|
(25 |
) |
% |
International |
|
3,069 |
|
|
1,110 |
|
176 |
|
|
|
|
7,738 |
|
|
3,934 |
|
97 |
|
|
Domestic OTC |
|
1,515 |
|
|
1,311 |
|
16 |
|
|
|
|
4,951 |
|
|
4,574 |
|
8 |
|
|
|
Net
product revenues |
$ |
8,206 |
|
$ |
7,279 |
|
13 |
|
% |
|
$ |
25,090 |
|
$ |
24,954 |
|
1 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
HCV
Revenues |
2017 |
|
2016 |
|
% Change |
|
2017 |
|
2016 |
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic |
$ |
1,889 |
|
$ |
1,529 |
|
24 |
|
% |
|
$ |
5,980 |
|
$ |
5,218 |
|
15 |
|
% |
International |
|
6,154 |
|
|
1,293 |
|
376 |
|
|
|
|
15,817 |
|
|
3,722 |
|
325 |
|
|
|
Net
product revenues |
|
8,043 |
|
|
2,822 |
|
185 |
|
|
|
|
21,797 |
|
|
8,940 |
|
144 |
|
|
Amortization of exclusivity payments |
|
- |
|
|
6,114 |
|
(100 |
) |
|
|
|
- |
|
|
12,837 |
|
(100 |
) |
|
|
Net
HCV-related revenues |
$ |
8,043 |
|
$ |
8,936 |
|
(10 |
) |
% |
|
$ |
21,797 |
|
$ |
21,777 |
|
0 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
Cryosurgical Systems Revenues |
2017 |
|
2016 |
|
% Change |
|
2017 |
|
2016 |
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
professional |
$ |
1,426 |
|
$ |
1,456 |
|
(2 |
) |
% |
|
$ |
4,368 |
|
$ |
4,155 |
|
5 |
|
% |
International professional |
|
179 |
|
|
162 |
|
10 |
|
|
|
|
552 |
|
|
607 |
|
(9 |
) |
|
Domestic
OTC |
|
325 |
|
|
339 |
|
(4 |
) |
|
|
|
957 |
|
|
1,062 |
|
(10 |
) |
|
International OTC |
|
949 |
|
|
1,283 |
|
(26 |
) |
|
|
|
3,239 |
|
|
4,338 |
|
(25 |
) |
|
|
Net
product revenues |
$ |
2,879 |
|
$ |
3,240 |
|
(11 |
) |
% |
|
$ |
9,116 |
|
$ |
10,162 |
|
(10 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets
(Unaudited) |
|
|
|
September 30, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
$ |
78,610 |
|
$ |
109,790 |
Cash and cash
equivalents |
Short-term
investments |
|
83,372 |
|
|
11,160 |
Accounts receivable,
net |
|
28,099 |
|
|
19,827 |
Inventories |
|
16,859 |
|
|
11,799 |
Other current
assets |
|
2,395 |
|
|
3,865 |
Property and equipment,
net |
|
21,496 |
|
|
20,033 |
Intangible assets,
net |
|
8,972 |
|
|
10,337 |
Goodwill |
|
20,257 |
|
|
18,793 |
Long-term
investments |
|
18,290 |
|
|
- |
Other non-current
assets |
|
3,909 |
|
|
2,331 |
Total assets |
$ |
282,259 |
|
$ |
207,935 |
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
Accounts payable |
$ |
9,624 |
|
$ |
4,633 |
Deferred revenue |
|
1,186 |
|
|
1,388 |
Other current
liabilities |
|
15,813 |
|
|
11,314 |
Other non-current
liabilities |
|
3,928 |
|
|
2,304 |
Deferred income
taxes |
|
2,194 |
|
|
2,446 |
Stockholders’
equity |
|
249,514 |
|
|
185,850 |
Total liabilities and stockholders’ equity |
$ |
282,259 |
|
$ |
207,935 |
|
Nine Months Ended |
September 30, |
Additional
Financial Data (Unaudited) |
2017 |
|
2016 |
|
|
|
|
Capital
expenditures |
$ |
3,462 |
|
$ |
3,512 |
Depreciation and
amortization |
$ |
4,589 |
|
$ |
4,152 |
Stock-based
compensation |
$ |
5,213 |
|
$ |
4,438 |
Cash provided by
operating activities |
$ |
30,361 |
|
$ |
25,180 |
Conference
Call
The Company will host a conference call and
audio webcast for analysts and investors to discuss the Company’s
2017 third quarter financial results, certain business developments
and financial guidance for the fourth quarter of 2017, beginning
today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). On the
call will be Douglas A. Michels, President and Chief Executive
Officer, and Ronald H. Spair, Chief Financial Officer and Chief
Operating Officer. The call will include prepared remarks by
management and a question and answer session.
In order to listen to the conference call,
please either dial 844-831-3030 (Domestic) or 315-625-6887
(International) and reference Conference ID #90105011 or go to
OraSure Technologies' web site, www.orasure.com, and click on the
Investor Relations page. Please click on the webcast link and
follow the prompts for registration and access 10 minutes prior to
the call. A replay of the call will be archived on OraSure
Technologies' web site shortly after the call has ended and will be
available for seven days. A replay of the call can also be accessed
until November 8, 2017, by dialing 855-859-2056 (Domestic) or
404-537-3406 (International) and entering the Conference ID
#90105011.
About OraSure
Technologies
OraSure Technologies is a leader in the
development, manufacture and distribution of point-of-care
diagnostic and collection devices and other technologies designed
to detect or diagnose critical medical conditions. Its
first-to-market, innovative products include rapid tests for the
detection of antibodies to HIV and HCV on the OraQuick® platform,
oral fluid sample collection, stabilization and preparation
products for molecular diagnostic applications, and oral fluid
laboratory tests for detecting various drugs of abuse. OraSure's
portfolio of products is sold globally to various clinical
laboratories, hospitals, clinics, community-based organizations and
other public health organizations, research and academic
institutions, distributors, government agencies, physicians'
offices, commercial and industrial entities and consumers. The
Company's products enable healthcare providers to deliver critical
information to patients, empowering them to make decisions to
improve and protect their health.
Important
Information
This press release contains certain
forward-looking statements, including with respect to expected
revenues and earnings/loss per share. Forward-looking statements
are not guarantees of future performance or results. Known and
unknown factors that could cause actual performance or results to
be materially different from those expressed or implied in these
statements include, but are not limited to: ability to market
and sell products, whether through our internal, direct sales force
or third parties; 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; 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 increased
reliance on U.S. government contracts; failure of distributors or
other customers to meet purchase forecasts, historic purchase
levels or minimum purchase requirements for our products; impact of
replacing distributors; inventory levels at distributors and other
customers; ability of the Company to achieve its financial and
strategic objectives and continue to increase its revenues,
including the ability to expand international sales; ability to
identify, complete, integrate and realize the full benefits of
future acquisitions; impact of competitors, competing products and
technology changes; impact of negative economic conditions, high
unemployment levels and poor credit conditions; 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 testing or other products; 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; history of
losses and ability to achieve 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; ability to successfully renew contracts or enter into
new contracts with existing customers; adverse movements in foreign
currency exchange rates; loss or impairment of sources of
capital; ability to meet financial covenants in credit
agreements; ability to attract and retain qualified personnel;
exposure to product liability and other types of litigation;
changes in international, federal or state laws and regulations;
customer consolidations and inventory practices; equipment failures
and ability to obtain needed raw materials and components; the
impact of terrorist attacks and civil unrest; and general
political, business and economic conditions. These and other
factors are discussed more fully in the Company’s Securities
and Exchange Commission (“SEC”) filings, including our registration
statements, Annual Report on Form 10-K for the year ended December
31, 2016, 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. The
forward-looking statements are made as of the date of this press
release and OraSure Technologies undertakes no duty to update these
statements.
Company Contact:
Ronald H. SpairChief Financial
Officer610-882-1820Investorinfo@orasure.comwww.orasure.com
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
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Da Set 2024 a Ott 2024
Grafico Azioni OraSure Technologies (NASDAQ:OSUR)
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Da Ott 2023 a Ott 2024