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 first quarter ended
March 31, 2015.
Financial Highlights
- Consolidated net revenues for the first quarter of 2015 were
$27.1 million, a 15% increase from the comparable period of 2014.
- Net product revenues for the Company's OraQuick® rapid HCV test
were $2.2 million for the first quarter of 2015, representing a 39%
increase over the first quarter of 2014. Total HCV-related
revenues, including exclusivity payments recognized under the HCV
co-promotion agreement with AbbVie, were $5.5 million for the first
quarter of 2015, $3.9 million higher than the same period last
year.
- Net revenues generated by the Company's molecular collection
systems subsidiary, DNA Genotek ("DNAG"), were $6.7 million during
the first quarter of 2015, representing a 17% increase over the
first quarter of 2014.
- Consolidated net income for the first quarter of 2015 was
$113,000, or $0.00 per share, which compares to a net loss of $5.6
million, or $0.10 per share, for the first quarter of
2014. This improvement was primarily the result of the AbbVie
exclusivity revenues of $3.3 million and lower sales and marketing
expenses.
- Cash and short term investments totaled $89.5 million and
working capital amounted to $105.6 million at March 31, 2015.
"We are pleased with our financial performance for the first
quarter," said Douglas A. Michels, President and CEO of OraSure
Technologies, Inc. "Increased HCV-related revenues and higher
sales from our molecular collections systems business were the
primary reasons for this performance and will set the stage for a
successful year."
Financial Results
Consolidated net product revenues for the first quarter of 2015
increased 1% from the comparable period of 2014, primarily as a
result of higher sales of the Company's molecular collection
systems, OraQuick® HCV and Intercept® products. These
increases were partially offset by lower sales of the Company's
cryosurgical systems, OraQuick® professional HIV and OraQuick®
In-Home HIV products.
Consolidated net revenues for the first quarter of 2015 also
included $3.3 million of exclusivity payments recognized under the
Company's HCV co-promotion agreement with AbbVie.
Consolidated gross margin for the three months ended March 31,
2015 was 63% compared to 59% for the three months ended March 31,
2014. Gross margin for the current quarter improved largely as
a result of the $3.3 million in AbbVie revenues.
Consolidated operating expenses decreased to $17.3 million
during the first quarter of 2015 compared to $19.5 million in the
comparable period of 2014. This decrease was primarily due to lower
promotional expenses associated with the Company's OraQuick®
In-Home HIV test, partially offset by higher research and
development costs and legal fees. Promotional expenses for the
OraQuick® In-Home HIV test were $432,000 and $4.6 million for the
first quarters of 2015 and 2014, respectively.
The Company's cash and short-term investment balance totaled
$89.5 million at March 31, 2015 compared to $97.9 million at
December 31, 2014. Working capital was $105.6 million at March
31, 2015 compared to $104.8 million at December 31, 2014. For
the three months ended March 31, 2015, the Company used $6.6
million to fund operations.
Second Quarter 2015
Outlook
The Company expects consolidated net revenues to range from
$29.0 to $29.5 million and is projecting consolidated net income of
approximately $0.00 to $0.01 per share for the second quarter of
2015.
Financial Data
Condensed Consolidated
Financial Data |
(In thousands, except
per-share data) |
|
|
|
Unaudited |
|
|
|
|
Three months
ended |
|
March
31, |
|
2015 |
2014 |
Results of Operations |
|
|
Net revenues |
$ 27,088 |
$ 23,537 |
Cost of products sold |
10,090 |
9,610 |
Gross profit |
16,998 |
13,927 |
Operating expenses: |
|
|
Research and development |
3,440 |
2,481 |
Sales and marketing |
7,884 |
11,340 |
General and administrative |
5,965 |
5,724 |
Total operating expenses |
17,289 |
19,545 |
Operating loss |
(291) |
(5,618) |
Other income |
409 |
118 |
Income (loss) before income taxes |
118 |
(5,500) |
Income tax expense |
5 |
131 |
Net income (loss) |
$ 113 |
$ (5,631) |
Earnings (loss) per share: |
|
|
Basic and Diluted |
$ 0.00 |
$ (0.10) |
|
|
|
Weighted average shares: |
|
|
Basic |
56,343 |
55,762 |
Diluted |
57,173 |
55,762 |
Summary of Net Revenues by Market and Product
(Unaudited)
|
Three Months
Ended March 31, |
|
Dollars |
|
Percentage of
Total Net Revenues |
Market |
2015 |
2014 |
% Change |
2015 |
2014 |
|
|
|
|
|
|
Infectious disease testing |
$ 11,495 |
$ 11,064 |
4% |
43% |
47% |
Substance abuse testing |
2,102 |
1,830 |
15 |
8 |
8 |
Cryosurgical systems |
2,545 |
3,967 |
(36) |
9 |
17 |
Molecular collection systems |
6,717 |
5,759 |
17 |
25 |
24 |
Insurance risk assessment |
906 |
917 |
(1) |
3 |
4 |
Net product revenues |
23,765 |
23,537 |
1 |
88 |
100 |
Other |
3,323 |
-- |
100 |
12 |
-- |
Net revenues |
$ 27,088 |
$ 23,537 |
15% |
100% |
100% |
|
|
|
Three Months
Ended |
|
March
31, |
HIV Revenues |
2015 |
2014 |
% Change |
|
|
|
|
Domestic |
$ 6,007 |
$ 6,618 |
(9)% |
International |
948 |
558 |
70 |
Domestic OTC |
1,561 |
1,953 |
(20) |
Net product revenues |
$ 8,516 |
$ 9,129 |
(7)% |
|
|
|
Three Months
Ended |
|
March
31, |
HCV Revenues |
2015 |
2014 |
% Change |
|
|
|
|
Domestic |
$ 1,197 |
$ 663 |
81% |
International |
972 |
896 |
8 |
Net product revenues |
2,169 |
1,559 |
39 |
Amortization of exclusivity
payments |
3,323 |
-- |
100 |
Net HCV-related revenues |
$ 5,492 |
$ 1,559 |
252% |
|
|
|
Three Months
Ended |
|
March
31, |
Intercept® Revenues |
2015 |
2014 |
% Change |
|
|
|
|
Net Intercept® revenues |
$ 1,575 |
$ 1,290 |
22 |
|
|
|
Three Months
Ended |
|
March
31, |
Cryosurgical Systems
Revenues |
2015 |
2014 |
% Change |
|
|
|
|
Domestic professional |
$ 661 |
$ 1,542 |
(57)% |
International professional |
357 |
310 |
15 |
Domestic over-the-counter |
55 |
-- |
100 |
International over-the-counter |
1,472 |
2,115 |
(30) |
Net cryosurgical systems revenues |
$ 2,545 |
$ 3,967 |
(36)% |
|
Condensed Consolidated
Balance Sheets (Unaudited) |
|
|
March 31, 2015 |
December 31,
2014 |
Assets |
|
|
|
$ 85,547 |
$ 92,867 |
Cash |
|
|
Short-term investments |
3,942 |
5,000 |
Accounts receivable, net |
16,367 |
16,138 |
Inventories |
15,619 |
15,763 |
Other current assets |
1,708 |
1,446 |
Property and equipment, net |
17,645 |
17,934 |
Intangible assets, net |
15,581 |
17,505 |
Goodwill |
19,913 |
21,734 |
Other non-current assets |
1,320 |
1,246 |
Total assets |
$ 177,642 |
$ 189,633 |
|
|
|
Liabilities and Stockholders' Equity |
|
|
Accounts payable |
$ 5,037 |
$ 7,148 |
Deferred revenue |
5,492 |
8,043 |
Accrued expenses |
7,005 |
11,271 |
Other non-current liabilities |
1,311 |
1,234 |
Deferred income taxes |
2,970 |
3,236 |
Stockholders' equity |
155,827 |
158,701 |
Total liabilities and stockholders'
equity |
$ 177,642 |
$ 189,633 |
|
|
|
Three months
ended |
|
March
31, |
Additional Financial
Data (Unaudited) |
2015 |
2014 |
|
|
|
Capital expenditures |
$ 437 |
$ 647 |
Depreciation and amortization |
$ 1,409 |
$ 1,539 |
Stock based compensation |
$ 1,475 |
$ 1,406 |
Cash used in operating activities |
$ 6,591 |
$ 7,668 |
Conference Call
The Company will host a conference call and audio webcast to
discuss the Company's 2015 first quarter financial results, certain
business developments and financial guidance for the second quarter
of 2015, 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 #19423338 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 May 13, 2015, by
dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and
entering the Conference ID #19423338.
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 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; our ability to achieve financial and performance
objectives under the HCV co-promotion agreement with AbbVie;
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
DNA Genotek to achieve its financial and strategic objectives and
continue to increase its revenues; 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 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, including the OraQuick® In-Home HIV test;
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 CDC or other testing
guidelines, algorithms or other recommendations; 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 OraSure's stock price; uncertainty relating
to patent protection and potential patent infringement claims;
uncertainty and costs of litigation relating to patents and other
intellectual property; availability of licenses to patents or other
technology; ability to enter into international manufacturing
agreements; obstacles to international marketing and manufacturing
of products; ability to sell products internationally, including
the impact of changes in international funding sources and testing
algorithms; adverse movements in foreign currency exchange rates;
loss or impairment of sources of capital; ability to attract
and retain qualified personnel; exposure to product liability and
other types of litigation; changes in international, federal or
state laws and regulations; customer consolidations and inventory
practices; equipment failures and ability to obtain needed raw
materials and components; the impact of terrorist attacks and civil
unrest; and general political, business and economic
conditions. These and other factors are discussed more
fully in the Company's Securities and Exchange Commission
filings, including its registration statements, Annual Report on
Form 10-K for the year ended December 31, 2014, 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.
CONTACT: Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
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