UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): October 30, 2007
OraSure Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-16537 | 36-4370966 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
| 220 East First Street Bethlehem, Pennsylvania |
18015-1360 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: 610-882-1820
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 – Results of Operations and Financial Condition.
On October 30, 2007, OraSure Technologies, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2007 and providing an update on financial guidance for the full year 2007. A copy of the press release is attached as Exhibit 99 to this Form 8-K and is incorporated herein by reference.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits
| Exhibit |
Description | |
| 99 |
Press Release, dated October 30, 2007, announcing financial results of OraSure Technologies, Inc. for the quarter ended September 30, 2007 and providing an update on financial guidance for the full year 2007. |
Signatures
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| ORASURE TECHNOLOGIES, INC. | ||||
| Date: October 30, 2007 | By: | /s/ Jack E. Jerrett | ||
| Jack E. Jerrett | ||||
| Senior Vice President, General Counsel and Secretary | ||||
Index to Exhibits
| Exhibit No. |
Description | |
| 99 |
Press Release, dated October 30, 2007, announcing financial results of OraSure Technologies, Inc. for the quarter ended September 30, 2007 and providing an update on financial guidance for the full year 2007. |
Exhibit 99
Company Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
www.orasure.com
OraSure Technologies Announces Third Quarter Financial Results
- Quarterly Revenues Increase 21% Over 2006 -
BETHLEHEM, PA – October 30, 2007 – (BW HealthWire) – OraSure Technologies, Inc. (NASDAQ: OSUR), a market leader in oral fluid diagnostics, today announced quarterly revenues of $21.4 million for the three months ended September 30, 2007, a 21% increase over the $17.6 million in revenues recorded for the three months ended September 30, 2006. Increased sales of the Company’s OraQuick ADVANCE® rapid HIV-1/2 antibody test and over-the-counter (“OTC”) cryosurgery products, together with an increase in funded research and development related to the Company’s rapid Hepatitis C (“HCV”) test, contributed to the increase in total revenues during the third quarter.
The Company’s net income was $4,000 representing break-even earnings per share on a fully-diluted basis for the third quarter of 2007, compared to net income of $2.1 million, or $0.05 per share on a fully-diluted basis for the third quarter of 2006. This decrease is the result of higher operating expenses during the current quarter, primarily research and development costs associated with the product development and clinical work for an OraQuick ADVANCE® HIV-1/2 test for home use and an OraQuick® HCV test for professional use, along with higher staffing-related expenses and higher legal expenses.
For the nine months ended September 30, 2007, the Company recorded revenues of $62.9 million, an increase of 25% over the $50.4 million in revenues recorded for the nine months ended September 30, 2006. The Company recorded net income of $2.4 million, or $0.05 per share on a fully-diluted basis, for the nine months ended September 30, 2007, compared to net income of $4.2 million, or $0.09 per share on a fully-diluted basis, during the nine months ended September 30, 2006. Net income for the nine months ended September 30, 2007 included a $1.4 million pre-tax gain on sale of investment in a privately-held nonaffiliated company.
Gross margin for the quarter ended September 30, 2007 was 60%, compared to 64% for the same period in 2006. Gross margin for the first nine months of 2007 was 62% compared to 63% in 2006. The decrease in gross margin for the three month period was due to an increase in scrap expense, higher product support costs and a less favorable product mix.
Operating expenses for the third quarter of 2007 increased to $13.7 million from $8.8 million in the third quarter of 2006. Operating expenses for the nine months ended September 30, 2007 were $38.5 million, compared to $27.2 million for the comparable period in 2006.
“We are pleased with the Company’s top line performance in the third quarter and that overall financial results are in line with expectations,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “We are particularly happy with the strong performance of our infectious disease testing and international OTC cryosurgical businesses. We continue to make good progress toward the achievement of our long-term strategic initiatives and look forward to closing out a successful 2007.”
Cash flow from operations for the nine months ended September 30, 2007 was $7.8 million, compared to $14.1 million for the comparable period in 2006. The decrease of $6.3 million was primarily the result of lower net income and increases in accounts receivable and inventories, offset by an increase in accounts payable and accrued expenses during the current nine-month period.
Cash, cash equivalents and short-term investments totaled $92.3 million and working capital was $105.5 million at September 30, 2007, compared to $91.0 million and $96.0 million, respectively, at December 31, 2006.
2007 Financial Guidance
The Company expects revenues of $19.5 to $20.0 million in the fourth quarter and continues to expect approximately $83.0 million for the full-year 2007. Fully diluted earnings per share are expected to be breakeven in the fourth quarter and to be approximately $0.05 per share for the full year.
Condensed Financial Data
(In thousands, except per-share data and percentages)
Unaudited
| Three months ended September 30, |
Nine months ended September 30, | ||||||||||||
| 2007 | 2006 | 2007 | 2006 | ||||||||||
| Results of Operations |
|||||||||||||
| Revenues |
$ | 21,415 | $ | 17,639 | $ | 62,877 | $ | 50,421 | |||||
| Cost of products sold |
8,647 | 6,365 | 24,122 | 18,516 | |||||||||
| Gross profit |
12,768 | 11,274 | 38,755 | 31,905 | |||||||||
| Operating expenses: |
|||||||||||||
| Research and development |
3,672 | 1,753 | 9,896 | 5,150 | |||||||||
| Acquired in-process technology |
— | — | — | 600 | |||||||||
| Sales and marketing |
4,979 | 3,632 | 14,999 | 11,977 | |||||||||
| General and administrative |
5,074 | 3,410 | 13,637 | 9,510 | |||||||||
| Total operating expenses |
13,725 | 8,795 | 38,532 | 27,237 | |||||||||
| Operating income (loss) |
(957 | ) | 2,479 | 223 | 4,668 | ||||||||
| Other income, net |
1,085 | 920 | 4,443 | 2,607 | |||||||||
| Income tax provision |
124 | 1,264 | 2,221 | 3,033 | |||||||||
| Net income |
$ | 4 | $ | 2,135 | $ | 2,445 | $ | 4,242 | |||||
| Earnings per share: |
|||||||||||||
| Basic |
$ | — | $ | 0.05 | $ | 0.05 | $ | 0.09 | |||||
| Diluted |
$ | — | $ | 0.05 | $ | 0.05 | $ | 0.09 | |||||
| Weighted average shares: |
|||||||||||||
| Basic |
46,341 | 45,922 | 46,393 | 45,888 | |||||||||
| Diluted |
46,988 | 47,247 | 46,893 | 47,712 | |||||||||
| Three months ended September 30, | |||||||||||||||
| Dollars | % Change |
Percentage of Total Revenues |
|||||||||||||
| 2007 | 2006 | 2007 | 2006 | ||||||||||||
| Market Revenues |
|||||||||||||||
| Infectious disease testing |
$ | 8,233 | $ | 7,536 | 9 | % | 38 | % | 42 | % | |||||
| Substance abuse testing |
4,070 | 4,213 | (3 | ) | 19 | 24 | |||||||||
| Cryosurgical systems |
6,738 | 4,025 | 67 | 31 | 23 | ||||||||||
| Insurance risk assessment |
1,620 | 1,734 | (7 | ) | 8 | 10 | |||||||||
| Product revenues |
20,661 | 17,508 | 18 | 96 | 99 | ||||||||||
| Licensing and product development |
754 | 131 | 476 | 4 | 1 | ||||||||||
| Total revenues |
$ | 21,415 | $ | 17,639 | 21 | % | 100 | % | 100 | % | |||||
| Nine months ended September 30, | |||||||||||||||
| Dollars | % Change |
Percentage of Total Revenues |
|||||||||||||
| 2007 | 2006 | 2007 | 2006 | ||||||||||||
| Market Revenues |
|||||||||||||||
| Infectious disease testing |
$ | 26,350 | $ | 21,239 | 24 | % | 42 | % | 42 | % | |||||
| Substance abuse testing |
12,396 | 11,694 | 6 | 20 | 23 | ||||||||||
| Cryosurgical systems |
18,190 | 13,063 | 39 | 29 | 26 | ||||||||||
| Insurance risk assessment |
3,859 | 4,128 | (7 | ) | 6 | 8 | |||||||||
| Product revenues |
60,795 | 50,124 | 21 | 97 | 99 | ||||||||||
| Licensing and product development |
2,082 | 297 | 601 | 3 | 1 | ||||||||||
| Total revenues |
$ | 62,877 | $ | 50,421 | 25 | % | 100 | % | 100 | % | |||||
| Three months ended September 30, |
% Change |
Nine months ended September 30, |
% Change |
|||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||||
| OraQuick® Revenues |
||||||||||||||||||
| Direct to U.S. Public Health |
$ | 4,492 | $ | 3,837 | 17 | % | $ | 14,339 | $ | 10,794 | 33 | % | ||||||
| Abbott |
2,159 | 1,651 | 31 | 6,087 | 5,224 | 17 | ||||||||||||
| SAMHSA |
5 | — | N/A | 339 | 256 | 32 | ||||||||||||
| CDC |
25 | 748 | (97 | ) | 1,125 | 1,009 | 11 | |||||||||||
| International |
850 | 394 | 116 | 2,110 | 1,185 | 78 | ||||||||||||
| Total OraQuick® revenues |
$ | 7,531 | $ | 6,630 | 14 | % | $ | 24,000 | $ | 18,468 | 30 | % | ||||||
| Three months ended September 30, |
% Change |
Nine months ended September 30, |
% Change |
|||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||||
| Intercept® Revenues |
||||||||||||||||||
| Workplace testing |
$ | 1,804 | $ | 1,679 | 7 | % | $ | 5,288 | $ | 4,675 | 13 | % | ||||||
| Criminal Justice |
613 | 640 | (4 | ) | 1,881 | 1,428 | 32 | |||||||||||
| International |
482 | 599 | (20 | ) | 1,598 | 1,615 | (1 | ) | ||||||||||
| Direct |
273 | 175 | 56 | 739 | 528 | 40 | ||||||||||||
| Total Intercept® revenues |
$ | 3,172 | $ | 3,093 | 3 | % | $ | 9,506 | $ | 8,246 | 15 | % | ||||||
| Three months ended September 30, |
% Change |
Nine months ended September 30, |
% Change |
|||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||||
| Cryosurgical Systems Revenues |
||||||||||||||||||
| Professional domestic |
$ | 1,028 | $ | 1,755 | (41 | )% | $ | 3,441 | $ | 4,156 | (17 | )% | ||||||
| Professional international |
574 | 576 | 0 | 1,551 | 1,496 | 4 | ||||||||||||
| OTC domestic |
2,453 | — | N/A | 5,587 | 3,956 | 41 | ||||||||||||
| OTC international |
2,683 | 1,694 | 58 | 7,611 | 3,455 | 120 | ||||||||||||
| Total Cryosurgical revenues |
$ | 6,738 | $ | 4,025 | 67 | % | $ | 18,190 | $ | 13,063 | 39 | % | ||||||
| Unaudited | ||||||
| September 30, 2007 | December 31, 2006 | |||||
| Balance Sheets |
||||||
| Assets | ||||||
| Cash, cash equivalents and short-term investments |
$ | 92,335 | $ | 91,001 | ||
| Accounts receivable, net |
12,014 | 10,357 | ||||
| Inventories |
7,768 | 5,535 | ||||
| Current deferred income taxes |
6,430 | 3,676 | ||||
| Other current assets |
1,468 | 1,989 | ||||
| Property and equipment, net |
20,218 | 17,375 | ||||
| Deferred income taxes |
15,565 | 19,846 | ||||
| Other non-current assets |
5,656 | 6,786 | ||||
| Total assets |
$ | 161,454 | $ | 156,565 | ||
| Liabilities and Stockholders’ Equity | ||||||
| Current portion of long-term debt |
$ | 557 | $ | 609 | ||
| Accounts payable |
4,395 | 3,312 | ||||
| Accrued expenses |
9,552 | 12,659 | ||||
| Long-term debt |
9,332 | 10,030 | ||||
| Other liabilities |
380 | 451 | ||||
| Stockholders’ equity |
137,238 | 129,504 | ||||
| Total liabilities and stockholders’ equity |
$ | 161,454 | $ | 156,565 | ||
| Nine months ended September 30, | ||||||
| 2007 | 2006 | |||||
| Additional Financial Data |
||||||
| Capital expenditures |
$ | 4,281 | $ | 11,552 | ||
| Depreciation and amortization |
$ | 1,997 | $ | 1,440 | ||
| Accounts receivable – days sales outstanding |
52 days | 53 days | ||||
Conference Call
The Company will host a conference call and audio webcast today to discuss the Company’s 2007 third quarter financial results, business developments and the Company’s 2007 outlook, beginning 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 Operating Officer and Chief Financial Officer. The call will include remarks by management and a question and answer session.
In order to listen to the conference call, please dial 888-742-2024 (Domestic) or 706-643-0033 (International) and reference 21207217 or go to OraSure Technologies’ web site, www.orasure.com, and click on the Investor Info link. 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 5, 2007, by dialing 800-642-1687 (Domestic) or 706-645-9291 (International) and entering the Conference ID #21207217.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and other diagnostic products using its proprietary technologies, including immunoassays and other in vitro diagnostic tests and other medical devices. These products are sold in the United States and certain foreign countries to clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. For more information on the Company, please visit www.orasure.com.
Important Information
This press release contains certain forward-looking statements, including with respect to revenues, net income and products. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; changes in relationships, including disputes or disagreements, with strategic partners 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 competitors, competing products and technology changes; 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; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; 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 product components; availability of related products produced by third parties or products required for use of our products; 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; history of losses and ability to achieve sustained profitability; volatility of our stock price; uncertainty relating to patent protection; 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; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to patent infringement, 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; ability to complete consolidation or restructuring activities; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission (“SEC”) filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2006, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Although forward-looking statements help to provide complete 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.
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