SAN DIEGO, Feb. 18 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated today reported financial results for the fourth quarter of 2009, with record product sales and total revenues driving non-GAAP earnings per share (EPS) of $0.52 and GAAP EPS of $0.48.
"Gen-Probe posted strong financial results in the fourth quarter of 2009 based on balanced performance across our key product areas: women's health, infectious diseases, blood screening and transplant diagnostics," said Carl Hull, the Company's president and chief executive officer.
In 2008, Gen-Probe's total revenues, net income, EPS and free cash flow benefited from a number of non-recurring items. The two most significant benefits were:
In 2009, the Company's product sales, total revenues, net income, EPS and free cash flow benefited from $8.2 million of one-time revenue ($0.10 of EPS) recorded in the first quarter associated with the renegotiation of the Company's collaboration agreement with Novartis.
Revenue Detail
In the fourth quarter of 2009, clinical diagnostics sales growth was driven by transplant diagnostics and influenza products, and the APTIMA Combo 2(R) assay for detecting Chlamydia and gonorrhea. Compared to the prior year period, clinical diagnostics sales also benefited from the weaker US dollar, which added an estimated $0.8 million, or 1%, to growth.(3)
In blood screening, fourth quarter sales growth was driven mainly by higher sales of TIGRIS instruments to Novartis, which generally are a precursor to future assay sales. Compared to the prior year period, blood screening sales also benefited from the weaker US dollar, which added an estimated $1.2 million, or 2%, to growth.
Sales of research products and services in the fourth quarter of 2009 were $4.4 million. These sales, resulting from the Tepnel acquisition, were not included in Gen-Probe's prior year results.
For the full year 2009, clinical diagnostics sales were negatively affected by the stronger US dollar, which reduced growth by an estimated $2.9 million, or 1%, compared to the prior year. In blood screening, full year 2009 sales also were negatively affected by the stronger US dollar, which reduced growth by an estimated $6.1 million, or 3%, compared to the prior year.
Collaborative research revenues in the fourth quarter of 2009 were $2.0 million, compared to $2.1 million in the prior year period. For the full year 2009, collaborative research revenues were $7.9 million, compared to $20.6 million in the prior year. As discussed, this decrease resulted primarily from the $10.0 million milestone earned from Novartis in 2008 based on the full FDA approval of the PROCLEIX ULTRIO assay on the TIGRIS system.
Royalty and license revenues for the fourth quarter of 2009 were $1.4 million, compared to $1.3 million in the prior year period. For the full year 2009, royalty and license revenues were $6.6 million, compared to $22.9 million in the prior year. As discussed, this decrease resulted primarily from $16.4 million of revenue that was recorded in 2008 associated with the settlement of patent infringement litigation against Bayer.
Expense Detail
Gross margin on product sales in the fourth quarter of 2009 was 67.3% on a non-GAAP basis that excludes $0.1 million of acquisition-related depreciation expense, compared to 69.6% in the prior year period. This decrease resulted mainly from increased sales of low-margin TIGRIS instruments to Novartis. For the full year 2009, gross margin on product sales was 68.6% on a non-GAAP basis that excludes $0.3 million of acquisition-related depreciation expense, compared to 70.2% in the prior year. On a GAAP basis, gross margin on product sales was 67.2% in the fourth quarter of 2009, and 68.5% for the full year.
Acquisition-related amortization expenses were $1.9 million in the fourth quarter of 2009 and $4.1 million for the full year, compared to $0 in the comparable periods of the prior year.
Research and development (R&D) expenses in the fourth quarter of 2009 were $27.4 million, compared to $24.2 million in the prior year period, an increase of 13% that resulted primarily from expenses associated with clinical trials of the Company's HPV, PCA3 and trichomonas assays, and from the addition of Tepnel's R&D activities. For the full year 2009, R&D expenses were $106.0 million, compared to $101.1 million in the prior year, an increase of 5%. R&D expenses represented 21.3% of total revenues in 2009, and 21.4% of total revenues in 2008.
Marketing and sales expenses in the fourth quarter of 2009 were $15.2 million on a non-GAAP basis that excludes $0.1 million of acquisition-related expense, compared to $11.8 million in the prior year period, an increase of 29% that resulted primarily from the addition of Tepnel's cost structure, and European sales force expansion and market development efforts. For the full year 2009, marketing and sales expenses were $53.8 million on a non-GAAP basis that excludes $0.1 million of acquisition-related expense, compared to $45.9 million in the prior year, an increase of 17%. On a GAAP basis, marketing and sales expenses were $15.3 million in the fourth quarter of 2009, and $53.9 million for the full year.
General and administrative (G&A) expenses in the fourth quarter of 2009 were $14.5 million on a non-GAAP basis that excludes $0.4 million of transaction-related expense, compared to $13.8 million in the prior year period. This increase of 5% resulted primarily from the addition of Tepnel's cost structure. For the full year 2009, G&A expenses were $55.5 million on a non-GAAP basis that excludes $6.3 million of transaction-related expense, compared to $52.3 million in the prior year, an increase of 6%. On a GAAP basis, G&A expenses were $14.9 million in the fourth quarter of 2009, and $61.8 million for the full year.
Total other income in the fourth quarter of 2009 was $2.3 million, compared to $3.8 million in the prior year period. This decrease of 39% resulted primarily from lower yields on the Company's municipal bond portfolio, and lower investment balances following the completion of the Company's $250 million share repurchase program and the acquisitions of Tepnel and Prodesse. For the full year 2009, total other income was $19.7 million, compared to $15.5 million in the prior year, an increase of 27% that resulted primarily from realized investment gains.
In the fourth quarter of 2009, Gen-Probe generated net cash of $39.6 million from operating activities, substantially higher than GAAP net income of $24.0 million. The Company spent $10.1 million on property, plant and equipment in the quarter, leading to free cash flow of $29.5 million.
Gen-Probe continues to have a strong balance sheet. As of December 31, 2009, the Company had $501.1 million of cash, cash equivalents and marketable securities, and $240.8 million of short-term debt. The Company pays interest on substantially all this debt at a rate 0.6% above the one-month London Interbank Offered Rate (LIBOR), which was recently below 0.3%.
2010 Financial Guidance
"Based on the midpoints of our non-GAAP 2010 guidance, we expect to show solid, double-digit growth on both the top and bottom lines, as well as improved operating profit and very strong free cash flow," said Herm Rosenman, Gen-Probe's senior vice president - finance, and chief financial officer.
Webcast Conference Call
A live webcast of Gen-Probe's fourth quarter 2009 conference call for investors can be accessed at http://www.gen-probe.com beginning at 4:30 p.m. Eastern Time today. The webcast will be archived for at least 90 days. A telephone replay of the call also will be available for approximately 24 hours. The replay number is 800-509-8621 for domestic callers and 203-369-3807 for international callers.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe has approximately 27 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,300 people. For more information, go to www.gen-probe.com.
About Non-GAAP Financial Measures
To supplement Gen-Probe's financial results for the fourth quarter of 2009 and its 2010 financial guidance, in each case presented in accordance with GAAP, Gen-Probe uses the following financial measures defined as non-GAAP by the SEC: non-GAAP net income, non-GAAP gross margin, non-GAAP marketing and sales expenses, non-GAAP G&A expenses, non-GAAP operating margin, non-GAAP income tax rate, and non-GAAP EPS. Gen-Probe's management does not, nor does it suggest that investors should, consider such non-GAAP financial measures in isolation from, or as a substitute for, financial information prepared and presented in accordance with GAAP. Gen-Probe's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance by excluding certain expenses that may not be indicative of core business results. Gen-Probe believes that both management and investors benefit from referring to these non-GAAP financial measures in assessing Gen-Probe's performance and when planning, forecasting and analyzing future periods. These non-GAAP financial measures also facilitate management's internal comparisons to Gen-Probe's historical performance and our competitors' operating results. Gen-Probe believes these non-GAAP financial measures are useful to investors in allowing for greater transparency with respect to supplemental information used by management in its financial and operational decision making. Further, our reconciliations of non-GAAP to GAAP operating results, which are included on the attached tables, are presented in the format of consolidated statements of income solely to assist a reader in understanding the impact of the various adjustments to our GAAP operating results, individually and in the aggregate, and are not intended to place any undue prominence on our non-GAAP operating results.
Trademarks
APTIMA, APTIMA COMBO 2 and TIGRIS are trademarks of Gen-Probe. PROCLEIX and ULTRIO are trademarks of Novartis. All other trademarks are the property of their owners.
Caution Regarding Forward-Looking Statements
Any statements in this news release about our expectations, beliefs, plans, objectives, assumptions or future events or performance, including those under the heading "2010 Financial Guidance," are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning Gen-Probe's financial condition, possible or expected results of operations, regulatory approvals, future milestones, growth opportunities, and plans of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied. Some of these risks, uncertainties and assumptions include but are not limited to: (i) the risk that we may not achieve our expected 2010 financial targets, (ii) the risk that we may not integrate acquisitions, such as Tepnel and Prodesse, successfully, (iii) the possibility that the market for the sale of our new products, such as our PANTHER system and PROGENSA PCA3, APTIMA HPV and APTIMA trichomonas assays, may not develop as expected, (iv) the enhancement of existing products and the development of new products may not proceed as planned, (v) the risk that investigational products, including those now in US clinical trials, may not be approved by regulatory authorities or become commercially available in the time frame we anticipate, or at all, (vi) the risk that we may not be able to compete effectively, (vii) the risk that we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, (viii) our dependence on Novartis and other third parties for the distribution of some of our products, (ix) our dependence on a small number of customers, contract manufacturers and single source suppliers of raw materials, (x) changes in third-party reimbursement policies regarding our products could adversely affect sales, (xi) changes in government regulation or tax policy affecting our diagnostic products could harm our sales, increase our development costs or increase our taxes, (xii) the risk that our intellectual property may be infringed by third parties or invalidated, and (xiii) our involvement in patent and other intellectual property and commercial litigation could be expensive and could divert management's attention. This list includes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update forward-looking statements to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
(1) In this press release, all per share amounts are calculated on a fully diluted basis. Non-GAAP EPS for the fourth quarter of 2009 excludes $2.5 million of pre-tax expenses ($0.04 per share) related mainly to the Company's acquisitions of Tepnel and Prodesse. Some totals may not foot due to rounding.
(2) Cash from operations less purchases of property, plant and equipment.
(3) In this press release, all estimates of "constant currency" growth exclude foreign currency fluctuations associated with revenues from acquired companies, which were not part of Gen-Probe in 2008.
CONTACT: Michael Watts, Vice president, investor relations and corporate
communications of Gen-Probe Incorporated, +1-858-410-8673
Web site: http://www.gen-probe.com/
