GPRO GoPro Inc

SAN DIEGO, Nov. 2, 2011 /PRNewswire/ -- Gen-Probe Incorporated (NASDAQ: GPRO) today reported financial results for the third quarter of 2011, with total revenues of $139.1 million and non-GAAP earnings per share (EPS) of $0.57.

"Gen-Probe's non-GAAP financial results in the third quarter of 2011 were in line with our expectations," said Carl Hull, the Company's president and chief executive officer.  "In addition, we are pleased with the progress of our two ongoing new product introductions, and excited that we are already launching our APTIMA HPV assay, which was just approved by the FDA."

On a GAAP basis, Gen-Probe reported a loss of ($0.33) per share in the third quarter, caused by a $39.5 million other-than-temporary impairment loss in the value of the Company's equity investment in Pacific Biosciences of California, Inc.  Gen-Probe recognized this loss because the trading price of Pacific Biosciences' stock may remain below the Company's cost basis for an extended period of time.  In June 2010, Gen-Probe made a $50 million investment in Pacific Biosciences and the firms began working together to develop third-generation sequencing systems for the diagnostics market.  That collaboration remains active.

Key financial results for the third quarter of 2011 were ($ in millions, except EPS):

Revenue Detail

In the third quarter of 2011, clinical diagnostics product sales grew by 16% compared to the prior year period.  This increase was driven primarily by domestic and international growth of the APTIMA Combo 2® assay for detecting Chlamydia and gonorrhea, and by the inclusion of product sales by GTI Diagnostics (GTI), which was not part of Gen-Probe in the prior year period.  Foreign currency fluctuations increased clinical diagnostics sales by an estimated $0.7 million compared to the prior year period.

In blood screening, sales declined by 6% compared to the prior year period, as expected, mainly due to lower shipments of instruments to Novartis, the Company's blood screening partner.  Foreign currency fluctuations increased blood screening sales by an estimated $1.7 million compared to the prior year period.  

Sales of research products and services in the third quarter of 2011 were $2.4 million, down 23% compared to the prior year period.  

Third quarter product sales were ($ in millions):

Collaborative research revenues in the third quarter of 2011 were $1.1 million, compared to $3.4 million in the prior year period, a decrease of 68% that resulted primarily from an expected decrease in funding from Novartis associated with the development of the fully automated PANTHER instrument for the blood screening market.  The PANTHER system remains on track to be launched into international blood screening markets next year.

Royalty and license revenues in the third quarter of 2011 were $1.6 million, compared to $0.8 million in the prior year period, an increase of 100% that resulted mainly from increased royalties received from Novartis related to the plasma testing market.  

GAAP Income Statement Details

Gross margin on product sales was 70.3% in the third quarter of 2011, compared to 67.2% in the prior year period.  This increase resulted mainly from a favorable product sales mix, with higher sales of APTIMA products and lower sales of instrumentation to Novartis.  

Acquisition-related amortization expenses were $2.8 million in the third quarter of 2011, compared to $2.2 million in the prior year period, an increase of 27% that resulted mainly from the acquisition of GTI in December of 2010.

Research and development (R&D) expenses were $27.9 million in the third quarter of 2011, compared to $27.4 million in the prior year period, an increase of 2% that resulted primarily from the addition of GTI's R&D programs.  

Marketing and sales expenses were $17.3 million in the third quarter of 2011, compared to $13.9 million in the prior year period, an increase of 24% that resulted primarily from the addition of GTI's cost structure and ongoing European commercial expansion.  

General and administrative (G&A) expenses were $18.3 million in the third quarter of 2011, compared to $11.5 million in the prior year period, an increase of 59% that resulted mainly from increased legal expenses, the addition of GTI's cost structure, and higher stock-based compensation charges.  G&A expenses also were unusually low in the prior year period due to the receipt of a $2.9 million arbitration award from Qiagen, which was recorded as a credit to G&A expense.  

Total other expense, net, was $37.7 million in the third quarter of 2011, compared to other income, net, of $4.4 million in the prior year period.  As previously discussed, in the third quarter of 2011 the Company recognized a $39.5 million loss related to its investment in Pacific Biosciences.  In addition, in the prior year period, the Company recorded a $1.5 million non-cash gain on a change in the fair value of contingent consideration in connection with the acquisition of PRODESSE.  

Income tax expense was $10.0 million in the third quarter of 2011, as the other-than-temporary impairment loss was not tax-deductible.  

Non-GAAP Income Statement Details

In the third quarter of 2011, non-GAAP gross margin on product sales, R&D expenses, and marketing and sales expenses were similar to the corresponding GAAP results.

Excluding transaction-related expenses, restructuring costs and non-recurring legal fees, non-GAAP G&A expenses were $16.5 million in the third quarter of 2011, compared to $10.8 million in the prior year period, an increase of 53%.

Total other income, net, was $1.8 million in the third quarter of 2011, compared to total other income, net, of $2.9 million in the prior year period, a decrease of 38%.  

Non-GAAP income tax expense was $11.5 million in the third quarter of 2011, leading to an effective tax rate of 30%.

Cash Flows and Balance Sheet

In the third quarter of 2011, Gen-Probe generated net cash of $42.3 million from operating activities, and spent $11.2 million on property, plant and equipment, leading to free cash flow of $31.1 million.  

Gen-Probe continues to have a strong balance sheet.  As of September 30, 2011, the Company had $426.3 million of cash, cash equivalents and marketable securities, and $248.0 million of short-term debt.  The Company pays interest on this debt at a rate 0.6% above the one-month London Interbank Offered Rate (LIBOR), which was recently below 0.3%.  

During the third quarter of 2011, Gen-Probe repurchased more than 1.7 million shares of Company stock for $102 million, at an average purchase price of $58.49 per share.  This completed the $150 million repurchase plan that was authorized by Gen-Probe's board of directors in February of 2011.

New Stock Repurchase Plan

Gen-Probe's board of directors has authorized the repurchase of up to an additional $100 million of the Company's stock through June of 2012.  Repurchases may occur from time to time and at the Company's discretion, depending on market conditions and other factors.  Shares may be purchased on the open market or through private transactions, pursuant to Rule 10b5-1 trading plans or other available means.

Updated 2011 Financial Guidance

Gen-Probe's updated 2011 financial guidance is provided below:

About Non-GAAP Financial Measures

Gen-Probe's management believes that non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance by excluding certain expenses and other items that may not be indicative of core business results.  To supplement the Company's financial results for the third quarter of 2011 and its updated 2011 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 research and development expense, non-GAAP marketing and sales expenses, non-GAAP G&A expenses, non-GAAP operating profit, 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 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.

Notes on Presentation

In this news release, all per share amounts are calculated on a diluted basis.  Some totals may not foot due to rounding.  Certain prior year amounts have been reclassified to conform to the current year presentation.  Estimates of constant currency results exclude currency fluctuations associated with revenue from GTI, which was not part of Gen-Probe in the third quarter of 2010.

Webcast Conference Call

A live webcast of Gen-Probe's third quarter 2011 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.  Call 866-346-2384 (domestic) or 203-369-0005 (international).  

About Gen-Probe

Gen-Probe 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 is headquartered in San Diego and employs approximately 1,400 people. For more information, go to www.gen-probe.com.

Trademarks

APTIMA, APTIMA COMBO 2, PANTHER and PRODESSE are trademarks of Gen-Probe.  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 "Updated 2011 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, the development and commercialization of new products, regulatory approvals, future milestones, growth opportunities, market trends, and management plans are 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 2011 financial targets, (ii) the risk that we may not integrate acquisitions, such as Tepnel, PRODESSE and GTI, 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 or enter into new ones, (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 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 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

Vice president, investor relations and

corporate communications

858-410-8673

SOURCE Gen-Probe Incorporated