Full Press Release Details
Chief Financial Officer
OraSure Announces 2013 Third Quarter Financial Results
Quarterly Revenues Reach Record High
BETHLEHEM, PA November 6, 2013 (Globe Newswire) OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid
diagnostics, today announced its consolidated financial results for the third quarter and nine months ended September 30, 2013.
We are pleased with the Company s record revenue performance for the third quarter, said Douglas A. Michels, President and CEO of OraSure
Technologies. Our molecular collection systems business continues to deliver strong growth and we are encouraged by the higher sales of our OraQuick HCV test. We have also launched a
new targeted promotional campaign for the OraQuick In-Home HIV test in an effort to accelerate growth of that important product line.
Consolidated net product revenues for
the third quarter and nine month periods of 2013 increased 13% and 9%, respectively, primarily as a result of higher sales of the Company s infectious disease testing and molecular collection systems products. These increases were partially
offset by lower sales of the Company s substance abuse testing, cryosurgical systems and insurance risk assessment products.
Consolidated licensing
and product development revenues for the third quarter of 2013 decreased to $147,000 from $386,000 for the third quarter of 2012 as a result of the expiration of certain patents licensed to a third party. Consolidated licensing and product
development revenues for the nine months ended September 30, 2013 decreased to $623,000 from $1.9 million in the comparable period of the prior year, primarily due to the absence of a $1.0 million milestone payment received in the first quarter
of 2012 under the Company s HCV collaboration agreement with Merck. No similar payment was received during 2013 because the collaboration agreement with Merck was terminated in November 2012.
Consolidated gross margin for the three and nine months ended September 30, 2013 was 61% and 59%, respectively. Consolidated gross margin for the three
and nine months ended September 30, 2012 was 63% and 64%, respectively. The current quarter gross margin was negatively impacted by higher royalties paid on sales of the Company s
OraQuick HIV products and an unfavorable change in product mix partially offset by an improvement in overhead absorption and a
decline in scrap and spoilage costs. Gross margin for the current nine month period was negatively impacted by the higher royalties, the change in product mix and the absence of the $1.0 million
HCV milestone payment, partially offset by the improvement in overhead absorption.
Consolidated operating expenses remained relatively flat at $17.0
million during the third quarter of 2013 compared to $16.8 million in the comparable period of 2012. For the nine months ended September 30, 2013, consolidated operating expenses were $59.7 million, an increase over the $52.4 million reported
for the nine months ended September 30, 2012. The increase for the first nine months of 2013 was primarily the result of higher promotional and advertising expenses associated with the Company s OraQuick In-Home HIV test. The current quarter and nine month period expenses included $1.9 million and $14.2 million of promotional and advertising costs related to this product, compared to $1.8 million
and $4.7 million spent in the third quarter and first nine months of 2012, respectively.
For the three and nine months ended September 30, 2013, the
Company recorded a Canadian income tax benefit of $127,000 and $786,000, respectively, associated with the loss before income taxes and certain Canadian research and development and investment tax credits at DNAG.
The Company s cash balance totaled $82.6 million at September 30, 2013 compared to $87.9 million at December 31, 2012. Working capital was
$92.1 million at September 30, 2013 compared to $103.5 million at December 31, 2012. For the nine months ended September 30, 2013, the Company used $3.1 million to fund operations, including the advertising and promotional activities
related to the OraQuick In-Home HIV test. Cash generated by operations in the third quarter of 2013 was $6.1 million.
Fourth Quarter 2013 Outlook
consolidated net revenues to range from $27.5 to $28.0 million and is projecting a consolidated net loss of approximately $0.07 - $0.08 per share for the fourth quarter of 2013.
Condensed Consolidated Financial Data
(In thousands, except per-share data)
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Results of Operations | ||||||||||||||||
| Net revenues | $ | 24,671 | $ | 22,115 | $ | 70,172 | $ | 65,675 | ||||||||
| Cost of products sold | 9,738 | 8,227 | 28,711 | 23,356 | ||||||||||||
| Gross profit | 14,933 | 13,888 | 41,461 | 42,319 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,670 | 2,994 | 8,720 | 9,551 | ||||||||||||
| Sales and marketing | 8,981 | 8,602 | 35,224 | 25,490 | ||||||||||||
| General and administrative | 5,342 | 5,220 | 15,742 | 17,398 | ||||||||||||
| Total operating expenses | 16,993 | 16,816 | 59,686 | 52,439 | ||||||||||||
| Operating loss | (2,060 | ) | (2,928 | ) | (18,225 | ) | (10,120 | ) | ||||||||
| Other income (expense) | 41 | (34 | ) | 36 | (267 | ) | ||||||||||
| Loss before income taxes | (2,019 | ) | (2,962 | ) | (18,189 | ) | (10,387 | ) | ||||||||
| Income tax benefit | (127 | ) | (527 | ) | (786 | ) | (1,138 | ) | ||||||||
| Net loss | $ | (1,892 | ) | $ | (2,435 | ) | $ | (17,403 | ) | $ | (9,249 | ) | ||||
| Loss per share: | ||||||||||||||||
| Basic and Diluted | $ | (0.03 | ) | $ | (0.04 | ) | $ | (0.31 | ) | $ | (0.18 | ) | ||||
| Weighted average shares: | ||||||||||||||||
| Basic and Diluted | 55,592 | 54,441 | 55,534 | 50,177 |
Summary of Revenues by Market and Product (Unaudited)
| Three Months Ended September 30, | ||||||||||||||||||||
| Dollars | Percentage of Total Net Revenues | |||||||||||||||||||
| Market | 2013 | 2012 | % Change | 2013 | 2012 | |||||||||||||||
| Infectious disease testing | $ | 12,873 | $ | 10,718 | 20 | % | 52 | % | 48 | % | ||||||||||
| Substance abuse testing | 2,092 | 2,331 | (10 | ) | 8 | 11 | ||||||||||||||
| Cryosurgical systems | 3,649 | 4,199 | (13 | ) | 15 | 19 | ||||||||||||||
| Molecular collection systems | 4,964 | 3,353 | 48 | 20 | 15 | |||||||||||||||
| Insurance risk assessment | 946 | 1,128 | (16 | ) | 4 | 5 | ||||||||||||||
| Net product revenues | 24,524 | 21,729 | 13 | 99 | 98 | |||||||||||||||
| Licensing and product development | 147 | 386 | (62 | ) | 1 | 2 | ||||||||||||||
| Net revenues | $ | 24,671 | $ | 22,115 | 12 | % | 100 | % | 100 | % | ||||||||||
| Nine Months Ended September 30, | ||||||||||||||||||||
| Dollars | Percentage of Total Net Revenues | |||||||||||||||||||
| Market | 2013 | 2012 | % Change | 2013 | 2012 | |||||||||||||||
| Infectious disease testing | $ | 35,526 | $ | 30,880 | 15 | % | 51 | % | 47 | % | ||||||||||
| Substance abuse testing | 6,455 | 7,305 | (12 | ) | 9 | 11 | ||||||||||||||
| Cryosurgical systems | 10,910 | 12,181 | (10 | ) | 16 | 19 | ||||||||||||||
| Molecular collection systems | 13,550 | 9,992 | 36 | 19 | 15 | |||||||||||||||
| Insurance risk assessment | 3,108 | 3,448 | (10 | ) | 4 | 5 | ||||||||||||||
| Net product revenues | 69,549 | 63,806 | 9 | 99 | 97 | |||||||||||||||
| Licensing and product development | 623 | 1,869 | (67 | ) | 1 | 3 | ||||||||||||||
| Net revenues | $ | 70,172 | $ | 65,675 | 7 | % | 100 | % | 100 | % |
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
| September 30 , | September 30, | |||||||||||||||||||||||
| OraQuick Revenues | 2013 | 2012 | % Change | 2013 | 2012 | % Change | ||||||||||||||||||
| Domestic HIV | $ | 8,093 | $ | 8,527 | (5 | )% | $ | 23,854 | $ | 25,106 | (5 | )% | ||||||||||||
| International HIV | 1,157 | 884 | 31 | 2,457 | 2,287 | 7 | ||||||||||||||||||
| Domestic HIV OTC | 1,762 | N/A | 5,196 | N/A | ||||||||||||||||||||
| Domestic HCV | 653 | 678 | (4 | ) | 1,772 | 1,958 | (9 | ) | ||||||||||||||||
| International HCV | 924 | 241 | 283 | 1,409 | 734 | 92 | ||||||||||||||||||
| Net OraQuick revenues | $ | 12,589 | $ | 10,330 | 22 | % | $ | 34,688 | $ | 30,085 | 15 | % | ||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||||||
| Intercept Revenues | 2013 | 2012 | % Change | 2013 | 2012 | % Change | ||||||||||||||||||
| Domestic | $ | 1,495 | $ | 1,499 | 0 | % | $ | 4,240 | $ | 4,981 | (15 | )% | ||||||||||||
| International | 29 | 279 | (90 | ) | 385 | 616 | (38 | ) | ||||||||||||||||
| Net Intercept revenues | $ | 1,524 | $ | 1,778 | (14 | )% | $ | 4,625 | $ | 5,597 | (17 | )% | ||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||||||||||
| September 30, | September 30, | |||||||||||||||||||||||
| Cryosurgical Systems Revenues | 2013 | 2012 | % Change | 2013 | 2012 | % Change | ||||||||||||||||||
| Professional domestic | $ | 1,803 | $ | 2,025 | (11 | )% | $ | 4,192 | $ | 5,342 | (22 | )% | ||||||||||||
| Professional international | 435 | 453 | (4 | ) | 1,039 | 1,110 | (6 | ) | ||||||||||||||||
| Over-the-Counter | 1,411 | 1,721 | (18 | ) | 5,679 | 5,729 | (1 | ) | ||||||||||||||||
| Net cryosurgical systems revenues | $ | 3,649 | $ | 4,199 | (13 | )% | $ | 10,910 | $ | 12,181 | (10 | )% |
| Condensed Consolidated Balance Sheets (Unaudited) | September 30, 2013 | December 31, 2012 | ||||||
| Assets | ||||||||
| Cash | $ | 82,590 | $ | 87,888 | ||||
| Accounts receivable, net | 14,292 | 17,545 | ||||||
| Inventories | 12,000 | 12,758 | ||||||
| Other current assets | 2,516 | 2,212 | ||||||
| Property and equipment, net | 17,989 | 18,546 | ||||||
| Intangible assets, net | 23,701 | 27,207 | ||||||
| Goodwill | 24,510 | 25,445 | ||||||
| Other non-current assets | 614 | 124 | ||||||
| Total assets | $ | 178,212 | $ | 191,725 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Accounts payable | $ | 3,859 | $ | 3,380 | ||||
| Deferred revenue | 4,472 | 5,580 | ||||||
| Accrued expenses | 10,995 | 7,960 | ||||||
| Other non-current liabilities | 539 | 89 | ||||||
| Deferred income taxes | 3,456 | 4,401 | ||||||
| Stockholders equity | 154,891 | 170,315 | ||||||
| Total liabilities and stockholders equity | $ | 178,212 | $ | 191,725 |
| Nine months ended | ||||||||
| September 30, | ||||||||
| Additional Financial Data (Unaudited) | 2013 | 2012 | ||||||
| Capital expenditures | $ | 1,696 | $ | 1,402 | ||||
| Depreciation and amortization | $ | 4,846 | $ | 5,455 | ||||
| Stock based compensation | $ | 4,187 | $ | 3,845 | ||||
| Cash used in operating activities | $ | 3,142 | $ | 4,006 |
Company will host a conference call and audio webcast to discuss the Company s 2013 third quarter financial results, business developments and financial guidance for the fourth quarter of 2013, 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, Ronald H. Spair, Chief Financial Officer and Chief Operating Officer, and Kathleen Weber, Senior Vice President and General Manager, Consumer
Products. 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 877-348-9357 (Domestic) or 970-315-0488 (International) and reference Conference ID #87563319 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 13, 2013, by
dialing 855-859-2056 (Domestic) or 404-537-3406 (International) and entering the Conference ID #87563319.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies
designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In July 2012, the
Company received approval from the U.S. Food and Drug Administration to sell its OraQuick In-Home HIV Test directly to consumers in the over-the-counter (OTC) market making it the
first and only rapid OTC HIV test approved in the U.S. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. 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, and
commercial and industrial entities. The Company s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. For more information on OraSure
Technologies, please visit www.orasure.com.
Important Information
This press release contains certain forward-looking statements, including with respect to 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; 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; failure of distributors or other customers to meet purchase forecasts or minimum
purchase requirements for the Company s products; impact of replacing distributors; inventory levels at distributors and other customers; ability to integrate and realize the full benefits of the Company s acquisition of DNA Genotek;
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 and high unemployment; 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; 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 our 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 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, 2012, 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.