Gen-Probe Reports Strong Financial Results for Third Quarter 2007, Raises Full-Year Guidance for Earnings Per Share and Total Revenues
- Company Establishes New Quarterly Records for Product Sales ($97.4 Million,
SAN DIEGO, Oct. 30 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today reported strong financial results for the third quarter of 2007 and raised its full-year guidance for earnings per share (EPS) and total revenues.
"Gen-Probe posted very good financial results in the third quarter of 2007, as both our clinical diagnostics and blood screening businesses again established new sales records," said Henry L. Nordhoff, the Company's chairman, president and chief executive officer.
In the third quarter of 2007, net income was $17.3 million, compared to $14.8 million in the prior year period, an increase of 17%. EPS in the third quarter of 2007 were $0.31, compared to $0.28 in the prior year period, an increase of 11%. In this press release, all per share amounts are calculated on a fully diluted basis, and all results are presented on a GAAP basis.
Product sales in the third quarter of 2007 were $97.4 million, compared to $83.5 million in the prior year period, an increase of 17%. Total revenues for the third quarter of 2007 were $101.7 million, compared to $92.2 million in the prior year period, an increase of 10%.
For the first nine months of 2007, net income was $65.7 million, compared to $42.4 million in the prior year period, an increase of 55%. EPS in the first nine months of 2007 were $1.21, compared to $0.80 in the prior year period, an increase of 51%. Product sales for the first nine months of 2007 were $278.5 million, compared to $239.8 million in the prior year period, an increase of 16%. Total revenues for the first nine months of 2007 were $304.1 million, compared to $263.7 million in the prior year period, an increase of 15%.
Gen-Probe's net income and EPS in the third quarter of 2007 benefited from a reduction in income tax expense of approximately $0.9 million ($0.02 per share) associated with the completion of the Company's 2006 federal tax return. In addition, the Company's net income and EPS for the first nine months of 2007 benefited from a reduction in income tax expense of approximately $8.7 million ($0.16 per share), which was recorded in the second quarter. As previously disclosed, this benefit resulted from the completion in April of an Internal Revenue Service audit of the Company's 2003 and 2004 federal income tax returns. Based on the results of this audit, the Company released reserves primarily associated with federal research and development tax credits generated from 1999 to 2004.
Gen-Probe's clinical diagnostics sales in the third quarter of 2007 were again led by the APTIMA Combo 2(R) assay, an amplified nucleic acid test (NAT) for simultaneously detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Sales of this assay continued to grow strongly, driven by market share gains on both the Company's semi-automated instrument platform and on the high-throughput, fully automated TIGRIS(R) system. Clinical diagnostics sales in the third quarter also benefited from increased sales of instrumentation to current and new customers. Revenue from the PACE(R) product line, the Company's non-amplified tests for Chlamydia and gonorrhea, declined in the third quarter compared to the prior year period, in line with Gen-Probe's expectations.
In blood screening, product sales in the third quarter of 2007 benefited from continued international expansion, and from higher pricing associated with U.S. commercial sales of the PROCLEIX(R) WNV (West Nile virus) assay on the TIGRIS system. Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics. Gen-Probe's blood screening sales in the third quarter of 2007 also benefited from favorable assay ordering patterns, primarily associated with the Company's WNV assay, and from increased sales of TIGRIS instruments to Novartis.
Product sales were, in millions: Three Months Ended Sept. 30, Nine Months Ended Sept. 30, 2007 2006 Increase 2007 2006 Increase Clinical diagnostics $51.8 $43.3 20 % $149.5 $125.8 19 % Blood screening $45.6 $40.2 13 % $129.0 $114.0 13 % Total product sales $97.4 $83.5 17 % $278.5 $239.8 16 %
Collaborative research revenues in the third quarter of 2007 were $3.1 million, compared to $1.5 million in the prior year period, an increase of 107% that resulted primarily from higher reimbursement from Novartis of shared expenses in the companies' blood screening collaboration. For the first nine months of 2007, collaborative research revenues were $11.2 million, compared to $14.7 million in the prior year period, a decrease of 24% that resulted primarily from the reclassification of revenue associated with investigational use of the PROCLEIX WNV assay. Beginning in the third quarter of 2006, the Company began recording all revenue associated with this assay in product sales, rather than in collaborative research revenues. The assay was approved by the US Food and Drug Administration (FDA) for use on Gen-Probe's enhanced semi-automated instrument system (eSAS) in December of 2005, and for use on the TIGRIS system in March of 2006.
Royalty and license revenues for the third quarter of 2007 were $1.2 million, compared to $7.3 million in the prior year period. In the third quarter of 2006, royalty and license revenues were high due to $5.0 million of revenue associated with the first payment arising from the successful settlement of Gen-Probe's patent infringement claims against Bayer HealthCare (now Siemens Medical Solutions Diagnostics). Gen-Probe also earned $1.0 million of license revenue in the prior year period under a 2004 agreement with Tosoh Corporation. For the first nine months of 2007, royalty and license revenues were $14.4 million, compared to $9.2 million in the prior year period. This 57% increase resulted primarily from $10.3 million of royalty revenue that was recorded in the first quarter of 2007 associated with the second payment arising from the Bayer patent litigation.
Gross margin on product sales in the third quarter of 2007 was 67.3%, compared to 70.9% in the prior year period. This decrease resulted primarily from an unfavorable product sales mix, namely increased sales of low-margin instrumentation to clinical diagnostics and blood screening customers. For the first nine months of 2007, gross margin on product sales was 67.3%, compared to 68.2% in the prior year period.
Research and development (R&D) expenses in the third quarter of 2007 were $27.6 million, compared to $24.2 million in the prior year period, an increase of 14%. This increase, which was expected, resulted primarily from the purchase of human papillomavirus (HPV) oligonucleotides from Roche. For the first nine months of 2007, R&D expenses were $72.8 million, compared to $63.8 million in the prior year period, an increase of 14%.
Marketing and sales expenses in the third quarter of 2007 were $9.7 million, compared to $9.5 million in the prior year period, an increase of 2%. For the first nine months of 2007, marketing and sales expenses were $28.6 million, compared to $27.5 million in the prior year period, an increase of 4%.
General and administrative (G&A) expenses in the third quarter of 2007 were $11.4 million, compared to $12.7 million in the prior year period, a decrease of 10%. In the third quarter of 2006, the Company paid its outside litigation counsel $2.0 million in connection with the Company's successful settlement of the Bayer patent litigation. For the first nine months of 2007, G&A expenses were $34.7 million, compared to $34.1 million in the prior year period, an increase of 2%.
Gen-Probe continues to have a strong balance sheet. As of September 30, 2007, the Company had $395.1 million of cash, cash equivalents and short-term investments, and no debt. In the first nine months of 2007, Gen-Probe generated net cash of $71.2 million from its operating activities, higher than the Company's year-to-date net income of $65.7 million.
Updated 2007 Financial Guidance
"Based on our strong performance in the third quarter, we are raising our full-year 2007 revenue and EPS guidance," said Herm Rosenman, the Company's senior vice president of finance and chief financial officer.
For the full year 2007, Gen-Probe now expects:
A live webcast of Gen-Probe's third quarter 2007 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) 947-6450 for domestic callers and (203) 369-3539 for international callers.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 24 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 1,000 people. For more information, go to http://www.gen-probe.com.
APTIMA, APTIMA COMBO 2, PACE and TIGRIS are trademarks of Gen-Probe. ULTRIO and PROCLEIX are trademarks of Novartis. All other trademarks are the property of their owners.
Caution Regarding Forward-Looking Statements
Any statements in this press release about our expectations, beliefs, plans, objectives, assumptions or future events or performance, including those under the heading "Updated 2007 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, updated financial guidance, regulatory approvals, future milestone payments, growth opportunities, and plans and objectives 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 2007 growth, revenue, earnings or other financial targets, (ii) the risk that we may not earn or receive milestone payments from our collaborators, including Novartis and 3M, (iii) the possibility that the market for the sale of our new products, such as our TIGRIS system, APTIMA Combo 2 assay, PROCLEIX ULTRIO assay and PROGENSA PCA3 assay, may not develop as expected, (iv) the enhancement of existing products and the development of new products, including products, if any, to be developed under our recent industrial collaborations, may not proceed as planned, (v) the risk that new products or indications, such as the HBV screening claim for our PROCLEIX ULTRIO assay in the United States, may not be approved by regulatory authorities or commercially available in the time frame we anticipate, or at all, (vi) we may not be able to compete effectively, (vii) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, (viii) we are dependent on Novartis, Siemens (as assignee of Bayer) and other third parties for the distribution of some of our products, (ix) we are dependent 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 of our products, (xi) changes in government regulation affecting our diagnostic products could harm our sales and increase our development costs, (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. The foregoing list sets forth 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.
Contact: Michael Watts Sr. director, investor relations and corporate communications 858-410-8673 Gen-Probe Incorporated Consolidated Balance Sheets (In thousands, except share and per share data) September 30, December 31, 2007 2006 (Unaudited) Assets Current assets: Cash and cash equivalents $66,888 $87,905 Short-term investments 328,185 202,008 Trade accounts receivable, net of allowance for doubtful accounts of $750 and $670 at September 30, 2007 and December 31, 2006, respectively 38,235 25,880 Accounts receivable - other 5,166 1,646 Inventories 49,186 52,056 Deferred income tax - short term 6,673 7,247 Prepaid income tax 16,229 - Prepaid expenses 17,874 11,362 Other current assets 5,374 2,583 Total current assets 533,810 390,687 Property, plant and equipment, net 131,245 134,614 Capitalized software 16,552 18,437 Goodwill 18,621 18,621 Deferred income tax - long term 2,064 2,064 License, manufacturing access fees and other assets 58,947 59,416 Total assets $761,239 $623,839 Liabilities and stockholders' equity Current liabilities: Accounts payable $14,696 $13,586 Accrued salaries and employee benefits 23,055 16,723 Other accrued expenses 8,683 3,320 Income tax payable 732 14,075 Deferred income tax - short term 103 - Deferred revenue 1,623 921 Total current liabilities 48,892 48,625 Non-current income tax payable 4,766 - Deferred income tax - long term 360 - Deferred revenue 3,167 3,667 Deferred rent 40 128 Deferred compensation plan liabilities 1,755 1,211 Commitments and contingencies Stockholders' equity: Preferred stock, $.0001 par value per share, 20,000,000 shares authorized, none issued and outstanding - - Common stock, $.0001 par value per share; 200,000,000 shares authorized, 53,718,400 and 52,233,656 shares issued and outstanding at September 30, 2007 and December 31, 2006, respectively 5 5 Additional paid-in capital 400,883 334,184 Accumulated other comprehensive income (loss) 581 (5) Retained earnings 300,790 236,024 Total stockholders' equity 702,259 570,208 Total liabilities and stockholders' equity $761,239 $623,839 Gen-Probe Incorporated Consolidated Statements of Income (In thousands, except per share data) (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2007 2006 2007 2006 Revenues: Product sales $97,402 $83,470 $278,451 $239,811 Collaborative research revenue 3,118 1,470 11,239 14,743 Royalty and license revenue 1,213 7,287 14,375 9,151 Total revenues 101,733 92,227 304,065 263,705 Operating expenses: Cost of product sales 31,810 24,298 91,148 76,207 Research and development 27,582 24,178 72,813 63,833 Marketing and sales 9,651 9,526 28,580 27,533 General and administrative 11,380 12,748 34,742 34,104 Total operating expenses 80,423 70,750 227,283 201,677 Income from operations 21,310 21,477 76,782 62,028 Total other income, net 3,333 1,921 8,610 5,081 Income before income tax 24,643 23,398 85,392 67,109 Income tax expense 7,392 8,587 19,664 24,745 Net income $17,251 $14,811 $65,728 $42,364 Net income per share: Basic $0.32 $0.29 $1.25 $0.82 Diluted $0.31 $0.28 $1.21 $0.80 Weighted average shares outstanding: Basic 53,221 51,638 52,661 51,407 Diluted 54,857 53,180 54,210 53,001 Gen-Probe Incorporated Consolidated Statements of Cash Flows (In thousands) (Unaudited) Nine Months Ended September 30, 2007 2006 Operating activities: Net income $65,728 $42,364 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 25,518 19,752 Stock-based compensation charges 14,487 17,755 Stock option income tax benefits 2,031 111 Excess tax benefit from employee stock options (13,055) (8,232) Loss on disposal of property and equipment 202 4 Changes in assets and liabilities: Accounts receivable (15,861) 7,550 Inventories 2,660 (5,338) Prepaid expenses (6,538) (682) Other current assets (2,756) 507 Other long term assets (930) (1,305) Accounts payable 1,116 (3,103) Accrued salaries and employee benefits 6,328 2,821 Other accrued expenses 5,343 624 Income tax payable (14,544) 2,037 Deferred revenue 202 (3,975) Deferred income tax 794 645 Deferred rent (88) (87) Deferred compensation plan liabilities 544 593 Net cash provided by operating activities 71,181 72,041 Investing activities: Proceeds from sales and maturities of short-term investments 57,391 83,641 Purchases of short-term investments (182,449) (104,163) Purchases of property, plant and equipment (17,674) (40,126) Capitalization of intangible assets, including license and manufacturing access fees (2,127) (2,245) Cash paid for investment in Qualigen - (6,993) Other assets (334) (223) Net cash used in investing activities (145,193) (70,109) Financing activities: Repurchase and retirement of restricted stock for payment of taxes (1,020) - Excess tax benefit from employee stock options 13,055 8,232 Proceeds from issuance of common stock 40,677 19,089 Net cash provided by financing activities 52,712 27,321 Effect of exchange rate changes on cash and cash equivalents 283 485 Net (decrease)/increase in cash and cash equivalents (21,017) 29,738 Cash and cash equivalents at the beginning of period 87,905 32,328 Cash and cash equivalents at the end of period $66,888 $62,066
SOURCE Gen-Probe Incorporated