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Gen-Probe Reports Financial Results for the Second Quarter of 2011
Date:7/28/2011

SAN DIEGO, July 28, 2011 /PRNewswire/ -- Gen-Probe Incorporated (NASDAQ: GPRO) today reported financial results for the second quarter of 2011, with total revenues of $135.9 million and non-GAAP earnings per share (EPS) of $0.51.  

"Gen-Probe posted record sales of APTIMA women's health products in the second quarter of 2011, while supply chain fluctuations caused blood screening revenue to decline compared to strong sales a year ago," said Carl Hull, the Company's president and chief executive officer.  "In addition, we are off to a good start with the first of several new product launches in the United States, and with our PANTHER® introduction in Europe."

Key financial results for the second quarter of 2011 were ($ in millions, except EPS):Non-GAAPGAAP2011

2010

Change2011

2010

ChangeProduct sales

$132.9

$132.7

--$132.9

$132.7

--Total revenues

$135.9

$138.6

-2%$135.9

$138.6

-2%Operating profit

$34.1

$37.2

-8%$29.8

$34.2

-13%Net income

$25.3

$26.0

-3%$22.3

$28.1

-21%EPS

$0.51

$0.52

-2%$0.45

$0.57

-21%Revenue DetailIn the second quarter of 2011, clinical diagnostics product sales grew by 18% 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 GTI product sales, which were not part of Gen-Probe in the prior year period.  Foreign currency fluctuations increased clinical diagnostics sales by an estimated $1.3 million compared to the prior year period.

In blood screening, sales declined compared to the second quarter of 2010, as expected, due to lower shipments of assays and instruments to Novartis, the Company's blood screening partner.  Although total blood screening assay revenue for the joint business increased compared to the prior year period, Gen-Probe's assay shipments to Novartis decreased by nearly $6 million, instrument shipments declined by nearly $5 million, and additional supply chain fluctuations reduced sales by approximately $3 million.

"We believe the decrease in blood screening sales resulted mainly from reductions in our partner's inventory levels and lower instrument revenues," said Hull.  "The underlying fundamentals of our blood screening business remain healthy, evidenced by the solid donation volumes, market share and profitability we experienced in the second quarter."

The percentage decline in blood screening sales in the second quarter of 2011 was magnified when compared to strong sales in the prior year period, which were more than $5 million higher than in any other quarter last year.  Finally, foreign currency fluctuations increased blood screening sales by an estimated $1.1 million compared to the prior year period.  

Sales of research products and services in the second quarter of 2011 were $2.3 million, down 28% compared to the prior year period due to continued market weakness affecting contract research organizations.  Foreign currency fluctuations increased sales of research products and services by an estimated $0.2 million compared to the prior year period.

Second quarter product sales were ($ in millions):Three Months Ended June 30,Change2011

2010As
Reported

Constant CurrencyClinical Diagnostics

$87.5

$73.9+18%

+17%Blood Screening

$43.2

$55.7-22%

-24%Research Products  and Services

$2.3

$3.2-28%

-34%Total Product Sales

$132.9

$132.7--

-2%Collaborative research revenues in the second quarter of 2011 were $1.6 million, compared to $4.1 million in the prior year period, a decrease of 61% 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.

Royalty and license revenues in the second quarter of 2011 were $1.4 million, compared to $1.8 million in the prior year period.  

GAAP Income Statement DetailsGross margin on product sales was 70.3% in the second quarter of 2011, compared to 66.6% in the prior year period.  This increase resulted mainly from a favorable product sales mix, namely higher sales of APTIMA products and lower sales of instrumentation to Novartis.  

Acquisition-related amortization expenses were $2.7 million in the second quarter of 2011, compared to $2.2 million in the prior year period, an increase of 23% that resulted mainly from the acquisition of GTI in December of 2010.

Research and development (R&D) expenses were $27.7 million in the second quarter of 2011, compared to $27.1 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 $17.5 million in the second quarter of 2011, compared to $15.8 million in the prior year period, an increase of 11% that resulted primarily from the addition of GTI's cost structure, and ongoing European commercial expansion.  

General and administrative (G&A) expenses were $18.7 million in the second quarter of 2011, compared to $15.0 million in the prior year period, an increase of 25% that resulted from the addition of GTI's cost structure, increased legal expenses, and higher stock-based compensation.  

Total other income, net, was $3.8 million in the second quarter of 2011, compared to $6.9 million in the prior year period, a decrease of 45% that resulted primarily from a non-cash gain in the prior year period related to a change in the fair value of contingent consideration in connection with the acquisition of PRODESSE.  

Income tax expense was $11.2 million in the second quarter of 2011, leading to a tax rate of 33%.  

Non-GAAP Income Statement DetailsExcluding $0.1 million of acquisition-related depreciation expense, gross margin on product sales was 70.4% in the second quarter of 2011, compared to 66.7% in the prior year period.

Excluding transaction-related and restructuring costs, G&A expenses were $17.3 million in the second quarter of 2011, compared to $14.3 million in the prior year period.

Income tax expense was $12.5 million in the second quarter of 2011, leading to a tax rate of 33%.

Cash Flows and Balance SheetIn the second quarter of 2011, Gen-Probe generated net cash of $45.4 million from operating activities, more than double GAAP net income of $22.3 million.  The Company spent $12.5 million on property, plant and equipment in the quarter, leading to free cash flow of $32.9 million.  

Gen-Probe continues to have a strong balance sheet.  As of June 30, 2011, the Company had $529.4 million of cash, cash equivalents and marketable securities, and $248 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 0.2%.  

Updated 2011 Financial Guidance"We are tightening our 2011 revenue guidance based on our first-half performance," said Herm Rosenman, the Company's senior vice president, finance, and chief financial officer.  "We also are adjusting our EPS guidance based on the higher share count and stock compensation expense resulting from the recent increase in our share price, the effects of which are partially offset by higher gross margins."  Gen-Probe's updated 2011 financial guidance is provided below:Current

Guidance

(non-GAAP)

Previous

Guidance

(non-GAAP)

Current

Guidance

(GAAP)

Previous

Guidance

(GAAP)Total revenues

$575 to $590 million

$570 to $595 million

$575 to $590 million

$570 to $595 millionProduct gross margins

69% to 70%

68% to 69.5%

69% to 70%

68% to 69.5%Acquisition-related amortization and other transaction expense

N/A

N/A

$15 million

$13 to $14 millionOperating margin

27% to 29%

27% to 29%

24.5% to 26.5%

25% to 27%Tax rate

32% to 33%

32% to 33%

32% to 33%

32% to 33%Diluted shares

49 million

48 to 49 million

49 million

48 to 49 millionEPS

$2.28 to $2.37

$2.28 to $2.40

$2.06 to $2.15

$2.06 to $2.20Notes on PresentationIn this news release, all per share amounts are calculated on a fully 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 second quarter of 2010.

About Non-GAAP Financial MeasuresGen-Probe's management believes that 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.  To supplement the Company's financial results for the second 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 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.

Webcast Conference CallA live webcast of Gen-Probe's second 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 866-415-2341 (domestic) or 203-369-0686 (international).  

About Gen-ProbeGen-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.

TrademarksAPTIMA, APTIMA COMBO 2, PANTHER and PRODESSE are trademarks of Gen-Probe.  All other trademarks are the property of their owners.

Caution Regarding Forward-Looking StatementsAny 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 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 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 instrument 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.

Contact:
Michael Watts
Vice president, investor relations and
corporate communications
858-410-8673

Gen-Probe IncorporatedConsolidated Balance Sheets – GAAP(In thousands, except share and per share data)June 30,December 31,20112010(Unaudited)AssetsCurrent assets:Cash and cash equivalents

$  176,719$  59,690Marketable securities

212,499170,648Trade accounts receivable, net of allowance for doubtful accounts of $414 and $355 at June 30, 2011 and December 31, 2010, respectively

52,74254,739Accounts receivable — other

3,5695,493Inventories

70,66666,416Deferred income tax

13,16913,634Prepaid income tax

2932,993Prepaid expenses

15,93611,672Other current assets

5,1245,148Total current assets

550,717390,433Marketable securities, net of current portion

140,227259,317Property, plant and equipment, net

169,262160,863Capitalized software, net

15,02013,981Patents, net

12,11512,450Goodwill

150,830150,308Purchased intangibles, net

116,006120,270License, manufacturing access fees and other assets, net

65,56360,175Total assets

$  1,219,740$1,167,797Liabilities and stockholders' equityCurrent liabilities:Accounts payable

$  11,358$  14,614Accrued salaries and employee benefits

22,94726,825Other accrued expenses

13,93913,935Income tax payable

5,470634Short-term borrowings

248,000240,000Deferred income tax

97-Deferred revenue

1,3871,166Total current liabilities

303,198297,174Non-current income tax payable

9,0418,315Deferred income tax

27,95529,775Deferred revenue, net of current portion

2,2692,500Other long-term liabilities

7,4606,654Commitments and contingenciesStockholders' equity:Preferred stock, $0.0001 par value per share; 20,000,000 shares authorized, none issued and outstanding

——Common stock, $0.0001 par value per share; 200,000,000 shares authorized, 48,170,514 and 47,966,156 shares issued and outstanding at June 30, 2011 and December 31, 2010, respectively

55Additional paid-in capital

204,786195,820Accumulated other comprehensive (loss) income

(7,471)678Retained earnings

672,497626,876Total stockholders' equity

869,817823,379Total liabilities and stockholders' equity

$  1,219,740$  1,167,797Gen-Probe IncorporatedConsolidated Statements of Income – GAAP(In thousands, except per share data)

(Unaudited)Three Months EndedSix Months EndedJune 30,June 30,2011201020112010Revenues:Product sales

$132,921$132,734$271,033$  263,303Collaborative research revenue

1,6174,1415,1857,405Royalty and license revenue

1,3601,7742,7183,360Total revenues

135,898138,649278,936274,068Operating expenses:Cost of product sales (excluding acquisition-related intangible amortization)

39,43144,31181,37486,972Acquisition-related intangible amortization

2,7292,1995,5344,415Research and development

27,71327,10456,67656,785Marketing and sales

17,51015,82434,03230,605General and administrative

18,70315,01836,85629,697Total operating expenses

106,086104,456214,472208,474Income from operations

29,81234,19364,46465,594Other income (expense):Investment and interest income

2,9373,2693,6727,167Interest expense

(497)(549)(1,000)(1,095)Gain on contingent consideration

—4,337—6,082Other income (expense), net

1,315(190)1,492(349)Total other income, net

3,7556,8674,16411,805Income before income tax

33,56741,06068,62877,399Income tax expense

11,22312,95023,00725,096Net income

$  22,344$  28,110$  45,621$  52,303Net income per share:Basic

$  0.47$  0.57$  0.95$  1.06Diluted

$  0.45$  0.57$  0.93$  1.05Weighted average shares outstanding:Basic

47,88448,90247,87349,066Diluted

49,33849,36649,19649,549Gen-Probe IncorporatedConsolidated Statements of Income – Non-GAAP Reconciliations(In thousands, except per share data)

(Unaudited)Three Months EndedThree Months EndedJune 30, 2011June 30, 2010Non—GAAPAdjustmentsGAAPNon—GAAPAdjustmentsGAAPRevenues:Product sales

$132,921

$  —

$132,921$132,734

$  —

$132,734Collaborative research revenue

1,617

1,6174,141

4,141Royalty and license revenue

1,360

1,3601,774

1,774Total revenues

135,898

135,898138,649

138,649Operating expenses:Cost of product sales (excluding acquisition-related intangible amortization)

39,329

102

39,43144,221

90

44,311Acquisition-related intangible amortization

2,729

2,729—

2,199

2,199Research and development

27,696

17

27,71327,104

27,104Marketing and sales

17,504

6

17,51015,824

15,824General and administrative

17,308

1,395

18,70314,349

669

15,018Total operating expenses

101,837

4,249

106,086101,498

2,958

104,456Income from operations

34,061

(4,249)

29,81237,151

(2,958)

34,193Other income (expense):Investment and interest income

2,937

2,9373,269

3,269Interest expense

(497)

(497)(549)

(549)Gain on contingent consideration

——

4,337

4,337Other income (expense), net

1,315

1,315(190)

(190)Total other income, net

3,755

3,7552,530

4,337

6,867Income before income tax

37,816

(4,249)

33,56739,681

1,379

41,060Income tax expense

12,521

(1,298)

11,22313,720

(770)

12,950Net income

$  25,295

$(2,951)

$  22,344$  25,961

$2,149

$  28,110Net income per share:Basic

$  0.53

$  (0.06)

$  0.47$  0.53

$  0.04

$  0.57Diluted

$  0.51

$  (0.06)

$  0.45$  0.52

$  0.05

$  0.57Weighted average shares outstanding:Basic

47,884

47,88448,902

48,902Diluted

49,338

49,33849,366

49,366Gen-Probe IncorporatedConsolidated Statements of Income – Non-GAAP Reconciliations(In thousands, except per share data)

(Unaudited)Six Months EndedSix Months EndedJune 30, 2011June 30, 2010Non-GAAPAdjustmentsGAAPNon-GAAPAdjustmentsGAAPRevenues:Product sales

$271,033

$  —

$271,033$263,303

$  —

$263,303Collaborative research revenue

5,185

5,1857,405

7,405Royalty and license revenue

2,718

2,7183,360

3,360Total revenues

278,936

278,936274,068

274,068Operating expenses:Cost of product sales (excluding acquisition-related intangible amortization)

81,181

193

81,37486,791

181

86,972Acquisition-related intangible amortization

5,534

5,534—

4,415

4,415Research and development

56,659

17

56,67656,785

56,785Marketing and sales

34,026

6

34,03230,605

30,605General and administrative

34,108

2,748

36,85629,001

696

29,697Total operating expenses

205,974

8,498

214,472203,182

5,292

208,474Income from operations

72,962

(8,498)

64,46470,886

(5,292)

65,594Other income (expense):Investment and interest income

3,672

3,6727,167

7,167Interest expense

(1,000)

(1,000)(1,095)

(1,095)Gain on contingent consideration

——

6,082

6,082Other income (expense), net

1,492

1,492(349)

(349)Total other income, net

4,164

4,1645,723

6,082

11,805Income before income tax

77,126

(8,498)

68,62876,609

790

77,399Income tax expense

25,277

(2,270)

23,00726,677

(1,581)

25,096Net income

$51,849

$(6,228)

$  45,621$  49,932

$2,371

$  52,303Net income per share:Basic

$  1.08

$  (0.13)

$  0.95$  1.01

$  0.05

$  1.06Diluted

$  1.05

$  (0.12)

$  0.93$  1.00

$  0.05

$  1.05Weighted average shares outstanding:Basic

47,873

47,87349,066

49,066Diluted

49,196

49,19649,549

49,549Gen-Probe IncorporatedConsolidated Statements of Cash Flows – GAAP(In thousands)

(Unaudited)Six Months EndedJune 30, 20112010Operating activities:Net income

$  45,621$  52,303Adjustments to reconcile net income to net cash provided by
operating activities:Depreciation and amortization

22,88622,628Amortization of premiums on investments, net of
accretion of discounts

5,2094,523Stock-based compensation

12,85912,338Excess tax benefit from employee stock-based compensation

(3,916)(919)Deferred revenue

12(1,241)Deferred income tax

(1,632)(1,930)Gain on contingent consideration

—(6,082)Loss on disposal of property and equipment

207143Changes in assets and liabilities:Trade and other accounts receivable

4,290(1,494)Inventories

(540)2,998Prepaid expenses

(4,205)1,907Other current assets

44918Other long-term assets

(453)390Accounts payable

(3,417)(7,082)Accrued salaries and employee benefits

(3,999)(4,336)Other accrued expenses

342(1,086)Income tax payable

11,4378,530Other long-term liabilities

769(684)Net cash provided by operating activities

85,51481,824Investing activities:Proceeds from sales and maturities of marketable securities

223,439281,958Purchases of marketable securities

(162,258)(168,395)Purchases of property, plant and equipment

(23,245)(14,567)Purchases of capitalized software

(2,547)(1,457)Purchases of intangible assets, including licenses and manufacturing access fees

(4,424)(1,865)Cash paid for investment in Pacific Biosciences

—(50,000)Cash paid for investment in Roka Bioscience

(3,980)—Other

(348)(1,967)Net cash provided by investing activities

26,63743,707Financing activities:Repurchase and retirement of common stock

(47,972)(52,299)Proceeds from issuance of common stock and employee stock purchase plan

40,72720,062Repurchase and retirement of restricted stock for payment of taxes

(363)(43)Excess tax benefit from employee stock-based compensation

3,916919Borrowings, net

8,000—Net cash provided by (used in) financing activities

4,308(31,361)Effect of exchange rate changes on cash and cash equivalents

570(1,864)Net increase in cash and cash equivalents

117,02992,306Cash and cash equivalents at the beginning of period

59,69082,616Cash and cash equivalents at the end of period

$  176,719$  174,922
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SOURCE Gen-Probe Incorporated
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