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Gilead Sciences Announces Third Quarter 2013 Financial Results
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- Total Revenues of $2.78 billion, Up 15 percent over Third Quarter 2012 -
- Revised Full Year 2013 Guidance -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 29, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended September 30, 2013. Total revenues for the third quarter of 2013 increased 15 percent to $2.78 billion, from $2.43 billion for the third quarter of 2012. Product sales increased 15 percent to $2.71 billion for the third quarter of 2013 compared to $2.36 billion for the third quarter of 2012. Net income for the third quarter of 2013 was $788.6 million, or $0.47 per diluted share compared to $675.5 million, or $0.43 per diluted share for the third quarter of 2012. Non-GAAP net income for the third quarter of 2013, which excludes acquisition-related, restructuring and stock-based compensation expenses, was $879.1 million, or $0.52 per diluted share compared to $788.9 million, or $0.50 per diluted share for the third quarter of 2012.

  Three Months Ended   Nine Months Ended
September 30, September 30,
(In thousands, except per share amounts)   2013   2012 2013   2012
Product sales $ 2,709,652 $ 2,357,978 $ 7,760,505 $ 6,887,560
Royalty, contract and other revenues 73,181   68,619   321,357   226,672
Total revenues $ 2,782,833   $ 2,426,597   $ 8,081,862   $ 7,114,232
 
Net income attributable to Gilead $ 788,606 $ 675,505 $ 2,283,397 $ 1,829,025
Non-GAAP net income attributable to Gilead $ 879,081 $ 788,940 $ 2,520,749 $ 2,260,606
 
Diluted EPS $ 0.47 $ 0.43 $ 1.35 $ 1.17
Non-GAAP diluted EPS $ 0.52 $ 0.50 $ 1.49 $ 1.44
 

Product Sales

Product sales were driven primarily by growth in Gilead's antiviral franchise during the third quarter of 2013. Significantly contributing to the increase were sales of Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) which launched in the third quarter of 2012 and sales of Complera®/Eviplera® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg). Product sales for the third quarter increased 20 percent in the U.S. and 5 percent in Europe compared to the third quarter of 2012.

Antiviral Product Sales

Antiviral product sales increased 14 percent to $2.33 billion for the third quarter of 2013, up from $2.04 billion for the third quarter of 2012, reflecting sales growth of 19 percent in the U.S. and 6 percent in Europe. The increase reflects strong underlying demand for our new single tablet regimen products, specifically Stribild and Complera/Eviplera.

  Three Months Ended     Nine Months Ended  
September 30, September 30,
(In thousands, except percentages) 2013   2012 % Change 2013   2012 % Change
Antiviral product sales $ 2,326,727 $ 2,035,833 14 % $ 6,700,052 $ 5,973,922 12 %
Atripla 899,669 865,378 4 % 2,714,850 2,656,997 2 %
Truvada 813,652 804,190 1 % 2,321,673 2,348,386 (1 )%
Viread 231,555 214,909 8 % 692,075 622,016 11 %
Complera/Eviplera 210,736 99,297 112 % 547,608 224,386 144 %
Stribild 143,953 17,511 722 % 335,495 17,511 1,816 %
 

Cardiovascular Product Sales

Cardiovascular product sales increased 25 percent to $250.9 million for the third quarter of 2013.

  Three Months Ended     Nine Months Ended  
September 30, September 30,
(In thousands, except percentages) 2013   2012 % Change 2013   2012 % Change
Cardiovascular product sales $ 250,887 $ 200,120 25 % $ 700,134 $ 567,798 23 %
Letairis 135,072 105,054 29 % 381,436 293,976 30 %
Ranexa 115,815 95,066 22 % 318,698 273,822 16 %
 

Operating Expenses and Other

Non-GAAP research and development (R&D) expenses increased due to the progression of Gilead's clinical studies, particularly in oncology and HIV. Non-GAAP selling, general and administrative (SG&A) expenses increased primarily due to the ongoing growth and expansion of Gilead's business in preparation for the anticipated launch of sofosbuvir.

Interest expense decreased primarily due to the maturity of the May 2013 convertible senior notes and the repayment of $850.0 million in bank debt issued in connection with the acquisition of Pharmasset Inc.

  Three Months Ended   Nine Months Ended
September 30, September 30,
(In thousands, except percentages) 2013   2012 2013   2012
Non-GAAP research and development expenses $ 488,535 $ 383,553 $ 1,436,282 $ 1,086,289
Non-GAAP selling, general and administrative expenses $ 376,841 $ 287,205 $ 1,086,241 $ 893,677
 
Non-GAAP Interest expense $ (73,949 ) $ (89,322 ) $ (233,744 ) $ (267,677 )

Note: Non-GAAP R&D, SG&A and interest expenses exclude the impact of acquisition-related, restructuring and stock-based compensation expenses where applicable.

Net Foreign Currency Exchange Impact

The net foreign currency exchange impact on third quarter 2013 product sales and pre-tax earnings was an unfavorable $17.5 million and $15.9 million, respectively, compared to the third quarter of 2012.

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2013, Gilead had $2.76 billion of cash, cash equivalents and marketable securities compared to $2.58 billion as of December 31, 2012. During the first nine months of 2013, Gilead generated $2.38 billion in operating cash flow.

Full Year 2013 Guidance

Gilead revised its full year 2013 guidance, which it initially provided on February 4, 2013 and reiterated on July 25, 2013:

(In millions, except percentages and per share amounts)   Initially provided February 4, 2013;

Reiterated July 25, 2013

  Updated

October 29, 2013

Net Product Sales $10,000 - $10,200 $10,300 - $10,400
Non-GAAP*
Product Gross Margin 74% - 76% 74% - 76%
R&D $1,800 - $1,900 $1,950 - $2,000
SG&A $1,550 - $1,650 $1,500 - $1,550
Effective Tax Rate 26% - 28% 26% - 27%
 
Diluted EPS Impact of Acquisition-Related, Restructuring and Stock-Based Compensation Expenses $0.21 - $0.24 $0.21 - $0.24

* Non-GAAP product gross margin, expense and effective tax rate exclude the impact of acquisition-related, restructuring and stock-based compensation expenses, where applicable.

Product & Pipeline Updates Announced by Gilead During the Third Quarter of 2013 Include:

Antiviral Program

  • Results from a Phase 2 study (Study 102) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection. At 48 weeks, a regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg was found to be similar to Stribild based on the percentage of patients with HIV RNA levels less than 50 copies/mL, and was associated with more favorable renal and bone safety markers. These results were presented at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy in Denver.
  • Granting of marketing authorization by the European Commission for once-daily Tybost®, a pharmacokinetic enhancer that boosts blood levels of certain HIV medicines. Tybost is indicated as a boosting agent for the HIV protease inhibitors atazanavir 300 mg once daily and darunavir 800 mg once daily as part of antiretroviral combination therapy in adults with HIV-1 infection. This approval allows for the marketing of Tybost in all 28 countries of the European Union.

Oncology Program

  • Submission of a New Drug Application to the U.S. Food and Drug Administration for marketing approval to support the use of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin’s lymphoma (iNHL) for patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.

Conference Call

At 4:30 p.m. Eastern Time today, Gilead's management will host a conference call and a simultaneous webcast to discuss results from its third quarter 2013 as well as provide a general business update. To access the webcast live via the internet, please connect to the company's website at www.gilead.com 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call 1-866-825-3209 (U.S.) or 1-617-213-8061 (international) and dial the participant passcode 95755257 to access the call.

A replay of the webcast will be archived on the company's website for one year, and a phone replay will be available approximately two hours following the call through November 1, 2013. To access the phone replay, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international) and dial the participant passcode 81078378.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia-Pacific.

Non-GAAP Financial Information

Gilead has presented certain financial information in accordance with U.S. generally accepted accounting principles (GAAP) and also on a non-GAAP basis. Management believes this non-GAAP information is useful for investors, when considered in conjunction with Gilead's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead's operating results as reported under GAAP. A reconciliation between GAAP and non-GAAP financial information is provided in the table on pages 7 and 8.

Forward-looking Statements

Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2013 financial results; Gilead's ability to sustain growth in revenues for its antiviral, cardiovascular and respiratory programs; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; the possibility of unfavorable results from clinical trials involving sofosbuvir, the fixed-dose combination of sofosbuvir/ledipasvir, TAF and idelalisib; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Gilead's ability to submit NDAs for new product candidates in the timelines currently anticipated, including the fixed-dose combination of sofosbuvir/ledipasvir for the treatment of HCV; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including sofosbuvir for the treatment of HCV and idelalisib for iNHL; Gilead's ability to successfully commercialize its products, including Stribild and Tybost; Gilead's ability to successfully develop its respiratory, cardiovascular and oncology/inflammation programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including sofosbuvir, the fixed-dose combination of sofosbuvir/ledipasvir, TAF and idelalisib; the potential for additional austerity measures in European countries that may increase the amount of discount required on Gilead's products; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (SEC). In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market-specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. You are urged to consider statements that include the words may, will, would, could, should, might, believes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal, or the negative of those words or other comparable words to be uncertain and forward-looking. Gilead directs readers to its press releases, Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead owns or has rights to various trademarks, copyrights and trade names used in our business, including the following:
GILEAD®, GILEAD SCIENCES®, STRIBILD®, COMPLERA®, EVIPLERA®, TRUVADA®, VIREAD®, TYBOST®, HEPSERA®, EMTRIVA®, LETAIRIS®, RANEXA®, AMBISOME®, CAYSTON® and VISTIDE®.

ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC.

For more information on Gilead Sciences, Inc., please visit www.gilead.com or
call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).

 

                 

 

 
GILEAD SCIENCES, INC.
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share amounts)
 
Three Months Ended Nine Months Ended
September 30, September 30,
  2013     2012     2013     2012  
Revenues:
Product sales $ 2,709,652 $ 2,357,978 $ 7,760,505 $ 6,887,560
Royalty, contract and other revenues   73,181     68,619     321,357     226,672  
Total revenues   2,782,833     2,426,597     8,081,862     7,114,232  
Costs and expenses:
Cost of goods sold 681,868 597,269 2,000,979 1,795,545
Research and development 546,244 465,831 1,567,778 1,320,286
Selling, general and administrative   406,860     319,583     1,186,147     1,095,209  
Total costs and expenses   1,634,972     1,382,683     4,754,904     4,211,040  
Income from operations 1,147,861 1,043,914 3,326,958 2,903,192
Interest expense (73,949 ) (89,322 ) (233,744 ) (275,010 )
Other income (expense), net   5,777     (3,505 )   2,222     (38,665 )
Income before provision for income taxes 1,079,689 951,087 3,095,436 2,589,517
Provision for income taxes   294,473     280,052     824,892     774,877  
Net income 785,216 671,035 2,270,544 1,814,640
Net loss attributable to noncontrolling interest   3,390     4,470     12,853     14,385  
Net income attributable to Gilead $ 788,606   $ 675,505   $ 2,283,397   $ 1,829,025  
Net income per share attributable to Gilead common stockholders

- basic

$ 0.51   $ 0.45   $ 1.50   $ 1.21  
Net income per share attributable to Gilead common stockholders

- diluted

$ 0.47   $ 0.43   $ 1.35   $ 1.17  
Shares used in per share calculation - basic   1,532,105     1,514,770     1,526,847     1,514,064  
Shares used in per share calculation - diluted   1,691,898     1,584,608     1,689,647     1,567,648  
 
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(unaudited)
(in thousands, except percentages and per share amounts)
                   
Three Months Ended Nine Months Ended
September 30, September 30,
  2013     2012     2013     2012  
Cost of goods sold reconciliation:
GAAP cost of goods sold $ 681,868 $ 597,269 $ 2,000,979 $ 1,795,545
Stock-based compensation expenses (1,823 ) (1,864 ) (6,296 ) (6,084 )
Acquisition related-amortization of purchased intangibles   (21,264 )   (15,837 )   (63,792 )   (47,509 )
Non-GAAP cost of goods sold $ 658,781   $ 579,568   $ 1,930,891   $ 1,741,952  
 
Product gross margin reconciliation:
GAAP product gross margin 74.8 % 74.7 % 74.2 % 74.0 %
Stock-based compensation expenses 0.1 % 0.1 % 0.1 % 0.1 %
Acquisition related-amortization of purchased intangibles   0.8 %   0.7 %   0.8 %   0.7 %
Non-GAAP product gross margin(1)   75.7 %   75.5 %   75.1 %   74.8 %
 
Research and development expenses reconciliation:
GAAP research and development expenses $ 546,244 $ 465,831 $ 1,567,778 $ 1,320,286
Stock-based compensation expenses (27,740 ) (23,236 ) (79,261 ) (162,214 )
Restructuring expenses 31 (232 ) (4,793 ) (7,322 )
Acquisition related-transaction costs (345 )
Acquisition related-contingent consideration remeasurement   (30,000 )   (58,810 )   (47,442 )   (64,116 )
Non-GAAP research and development expenses $ 488,535   $ 383,553   $ 1,436,282   $ 1,086,289  
 
Selling, general and administrative expenses reconciliation:
GAAP selling, general and administrative expenses $ 406,860 $ 319,583 $ 1,186,147 $ 1,095,209
Stock-based compensation expenses (33,010 ) (29,364 ) (94,736 ) (177,237 )
Restructuring expenses 2,972 (2,792 ) 2,534 (13,199 )
Acquisition related-transaction costs 300 (222 ) (6,860 ) (11,096 )
Acquisition related-amortization of purchased intangibles   (281 )       (844 )    
Non-GAAP selling, general and administrative expenses $ 376,841   $ 287,205   $ 1,086,241   $ 893,677  
 
Operating margin reconciliation:
GAAP operating margin 41.2 % 43.0 % 41.2 % 40.8 %
Stock-based compensation expenses 2.2 % 2.2 % 2.2 % 4.9 %
Restructuring expenses (0.1 )% 0.1 % 0.0 % 0.3 %
Acquisition related-transaction costs 0.0 % 0.0 % 0.1 % 0.2 %
Acquisition related-amortization of purchased intangibles 0.8 % 0.7 % 0.8 % 0.7 %
Acquisition related-contingent consideration remeasurement   1.1 %   2.4 %   0.6 %   0.9 %
Non-GAAP operating margin(1)   45.2 %   48.5 %   44.9 %   47.7 %
 
Interest expense reconciliation:
GAAP interest expense $ (73,949 ) $ (89,322 ) $ (233,744 ) $ (275,010 )
Acquisition related-transaction costs               7,333  
Non-GAAP interest expense $ (73,949 ) $ (89,322 ) $ (233,744 ) $ (267,677 )
 
Net income attributable to Gilead reconciliation:
GAAP net income attributable to Gilead, net of tax $ 788,606 $ 675,505 $ 2,283,397 $ 1,829,025
Stock-based compensation expenses 46,576 39,442 132,335 304,282
Restructuring expenses (2,076 ) 2,165 3,048 14,937
Acquisition related-transaction costs (300 ) 123 6,860 13,665
Acquisition related-amortization of purchased intangibles 16,275 11,462 47,667 34,581
Acquisition related-contingent consideration remeasurement   30,000     60,243     47,442     64,116  
Non-GAAP net income attributable to Gilead, net of tax $ 879,081   $ 788,940   $ 2,520,749   $ 2,260,606  
 
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)
(unaudited)
(in thousands, except percentages and per share amounts)
                   
Three Months Ended Nine Months Ended
September 30, September 30,
  2013     2012     2013     2012  
Diluted earnings per share reconciliation:
GAAP diluted earnings per share $ 0.47 $ 0.43 $ 1.35 $ 1.17
Stock-based compensation expenses 0.03 0.02 0.08 0.19
Restructuring expenses (0.00 ) 0.00 0.00 0.01
Acquisition related-transaction costs (0.00 ) 0.00 0.00 0.01
Acquisition related-amortization of purchased intangibles 0.01 0.01 0.03 0.02
Acquisition related-contingent consideration remeasurement   0.02     0.04     0.03     0.04  
Non-GAAP diluted earnings per share(1) $ 0.52   $ 0.50   $ 1.49   $ 1.44  
 
Shares used in per share calculation (diluted) reconciliation:
GAAP shares used in per share calculation (diluted) 1,691,898 1,584,608 1,689,647 1,567,648
Share impact of current stock-based compensation rules   (1,139 )   (2,620 )   (1,281 )   (2,854 )
Non-GAAP shares used in per share calculation (diluted)   1,690,759     1,581,988     1,688,366     1,564,794  
 
Non-GAAP adjustment summary:
Cost of goods sold adjustments $ 23,087 $ 17,701 $ 70,088 $ 53,593
Research and development expenses adjustments 57,709 82,278 131,496 233,997
Selling, general and administrative expenses adjustments 30,019 32,378 99,906 201,532
Interest expense adjustments               7,333  
Total non-GAAP adjustments before tax 110,815 132,357 301,490 496,455
Income tax effect   (20,340 )   (18,922 )   (64,138 )   (64,874 )
Total non-GAAP adjustments after tax $ 90,475   $ 113,435   $ 237,352   $ 431,581  
 
(1) Amounts may not sum due to rounding.
 
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
           
September 30, December 31,
  2013   2012(1)
(unaudited)
Cash, cash equivalents and marketable securities $ 2,755,557 $ 2,582,086
Accounts receivable, net 1,971,926 1,751,388
Inventories 1,946,048 1,744,982
Property, plant and equipment, net 1,133,032 1,100,259
Intangible assets, net 12,034,457 11,736,393
Goodwill 1,188,157 1,060,919
Other assets   1,439,251   1,263,811
Total assets $ 22,468,428 $ 21,239,838
 
Current liabilities $ 4,895,124 $ 4,270,020
Long-term liabilities 6,380,831 7,418,949
Stockholders’ equity(2)   11,192,473   9,550,869
Total liabilities and stockholders’ equity $ 22,468,428 $ 21,239,838
 
(1) Derived from the audited consolidated financial statements as of December 31, 2012.
(2) As of September 30, 2013, there were 1,534,028 shares of common stock issued and outstanding.
 
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY
(unaudited)
(in thousands)
                   
Three Months Ended Nine Months Ended
September 30, September 30,
  2013   2012   2013   2012
Antiviral products:
Atripla – U.S. $ 575,533 $ 539,797 $ 1,740,689 $ 1,672,676
Atripla – Europe 256,853 270,273 805,848 821,094
Atripla – Other International   67,283   55,308   168,313   163,227
  899,669   865,378   2,714,850   2,656,997
 
Truvada – U.S. 430,173 414,452 1,153,575 1,180,791
Truvada – Europe 313,963 329,936 970,982 980,626
Truvada – Other International   69,516   59,802   197,116   186,969
  813,652   804,190   2,321,673   2,348,386
 
Viread – U.S. 108,718 98,969 305,311 282,737
Viread – Europe 86,177 81,962 262,425 250,955
Viread – Other International   36,660   33,978   124,339   88,324
  231,555   214,909   692,075   622,016
 
Complera / Eviplera – U.S. 126,888 82,099 350,372 195,742
Complera / Eviplera – Europe 74,025 14,306 172,288 24,771
Complera / Eviplera – Other   9,823   2,892   24,948   3,873
  210,736   99,297   547,608   224,386
 
Stribild – U.S. 134,700 17,511 323,639 17,511
Stribild – Europe 7,911 9,759
Stribild – Other International   1,342     2,097  
  143,953   17,511   335,495   17,511
 
Hepsera – U.S. 8,578 12,615 31,399 33,596
Hepsera – Europe 9,760 11,999 30,251 41,384
Hepsera – Other International   1,978   2,705   6,545   7,827
  20,316   27,319   68,195   82,807
 
Emtriva – U.S. 5,127 4,717 14,424 13,580
Emtriva – Europe 1,560 1,617 4,895 5,169
Emtriva – Other International   159   895   837   3,070
  6,846   7,229   20,156   21,819
 
Total Antiviral products – U.S. 1,389,717 1,170,160 3,919,409 3,396,633
Total Antiviral products – Europe 750,249 710,093 2,256,448 2,123,999
Total Antiviral products – Other International   186,761   155,580   524,195   453,290
  2,326,727   2,035,833   6,700,052   5,973,922
 
Letairis 135,072 105,054 381,436 293,976
Ranexa 115,815 95,066 318,698 273,822
AmBisome 97,812 87,448 258,224 255,865
Other products   34,226   34,577   102,095   89,975
  382,925   322,145   1,060,453   913,638
 
Total product sales $ 2,709,652 $ 2,357,978 $ 7,760,505 $ 6,887,560

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Investors
Robin Washington, 650-522-5688
Patrick O'Brien, 650-522-1936
or
Media
Cara Miller, 650-522-1616

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