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Exhibit 99.1

LOGO

 

CONTACTS:   Investors    Media
 

Robin Washington

(650) 522-5688

  

Amy Flood

(650) 522-5643

 

Susan Hubbard

(650) 522-5715

  

For Immediate Release

GILEAD SCIENCES ANNOUNCES SECOND QUARTER 2011 FINANCIAL RESULTS

- Product Sales Surpass $2.00 Billion Mark -

- Total Revenues Achieve New Record of $2.14 Billion -

- Second Quarter Non-GAAP EPS of $1.00 -

Foster City, CA, July 26, 2011 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended June 30, 2011. Total revenues for the second quarter of 2011 were $2.14 billion, up 11 percent compared to total revenues of $1.93 billion for the second quarter of 2010. Net income for the second quarter of 2011 was $746.2 million, or $0.93 per diluted share, compared to net income for the second quarter of 2010 of $712.1 million, or $0.79 per diluted share. Non-GAAP net income for the second quarter of 2011, which excludes after-tax acquisition-related, restructuring and stock-based compensation expenses, was $797.7 million, or $1.00 per diluted share, compared to non-GAAP net income for the second quarter of 2010 of $760.7 million, or $0.85 per diluted share.

Product Sales

Product sales increased 13 percent to $2.04 billion for the second quarter of 2011, compared to $1.81 billion in the second quarter of 2010. This increase in sales was driven primarily by Gilead’s antiviral franchise, due to strong growth in sales of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) and Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).

Antiviral Franchise

Antiviral product sales increased 11 percent to $1.76 billion in the second quarter of 2011, up from $1.59 billion for the same quarter of 2010.

 

 

Atripla

Sales of Atripla for the treatment of HIV infection increased 15 percent to $822.0 million for the second quarter of 2011, up from $715.8 million in the second quarter of 2010, driven primarily by sales volume growth in the United States and Europe.

 

 

Truvada

Sales of Truvada for the treatment of HIV infection increased 11 percent to $711.3 million for the second quarter of 2011, up from $641.7 million in the second quarter of 2010, driven primarily by sales volume growth in Europe and the United States.

 

 

Viread

Sales of Viread® (tenofovir disoproxil fumarate) for the treatment of HIV infection and chronic hepatitis B increased 5 percent to $185.7 million for the second quarter of 2011, up from $176.2 million in the second quarter of 2010, due primarily to sales volume growth in Europe and the United States partially offset by lower sales in Latin America.

- more -

 

Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 USA    www.gilead.com
phone 650 574 3000 facsimile 650 578 9264   


July 26, 2011    Page 2

 

Letairis

Sales of Letairis® (ambrisentan) for the treatment of pulmonary arterial hypertension increased 22 percent to $73.6 million for the second quarter of 2011, up from $60.3 million for the second quarter of 2010, driven primarily by sales volume growth.

Ranexa

Sales of Ranexa® (ranolazine) for the treatment of chronic angina increased 42 percent to $86.1 million for the second quarter of 2011, up from $60.5 million for the second quarter of 2010, driven primarily by sales volume growth.

Other Products

Sales of other products were $160.9 million for the second quarter of 2011 compared to $151.6 million for the second quarter of 2010 and included AmBisome® (amphotericin B) liposome for injection for the treatment of severe fungal infections, Hepsera® (adefovir dipivoxil) for the treatment of chronic hepatitis B, Emtriva® (emtricitabine) for the treatment of HIV infection and Cayston® (aztreonam for inhalation solution) for the improvement of respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa (P. aeruginosa). The increase in sales of other products was due primarily to sales volume growth of AmBisome in Europe and Latin America and Cayston in the United States. Sales of Cayston were $21.5 million for the second quarter of 2011, up from $10.5 million in the same quarter of 2010.

Royalty, Contract and Other Revenues

Royalty, contract and other revenues from collaborations were $97.7 million in the second quarter of 2011, down 19 percent from $121.2 million in the second quarter of 2010. This decrease was due to lower Tamiflu royalties from F. Hoffmann-La Roche Ltd of $50.6 million in the second quarter of 2011, compared to Tamiflu royalties of $83.8 million in the second quarter of 2010 as pandemic planning initiatives worldwide have declined.

Research and Development

Research and development (R&D) expenses in the second quarter of 2011 were $282.4 million, compared to $231.1 million for the second quarter of 2010. Non-GAAP R&D expenses for the second quarter of 2011, which exclude acquisition-related, restructuring and stock-based compensation expenses, were $262.6 million, compared to $207.4 million for the second quarter of 2010. The increase in non-GAAP R&D expenses was due primarily to increased clinical activities and expenses associated with acquisitions, collaborations and the ongoing growth of Gilead’s business.

Selling, General and Administrative

Selling, general and administrative (SG&A) expenses in the second quarter of 2011 were $304.3 million, compared to $248.0 million for the second quarter of 2010. Non-GAAP SG&A expenses for the second quarter of 2011, which exclude acquisition-related, restructuring and stock-based compensation expenses, were $276.4 million, compared to $223.5 million for the second quarter of 2010. The increase in non-GAAP SG&A expenses was driven primarily by the impact of the pharmaceutical excise tax resulting from U.S. healthcare reform and increased expenses associated with the ongoing growth of Gilead’s business.

Net Foreign Currency Exchange Impact

The net foreign currency exchange impact on second quarter 2011 revenues and pre-tax earnings, which includes revenues and expenses generated from outside the United States, was a favorable $27.3 million and $9.7 million, respectively, compared to the second quarter of 2010.

Cash, Cash Equivalents and Marketable Securities

As of June 30, 2011, Gilead had cash, cash equivalents and marketable securities of $5.50 billion compared to $5.32 billion as of December 31, 2010. Gilead generated $1.76 billion of operating cash flow for the first six months of 2011 including $943.3 million in the second quarter of 2011.

Corporate Highlights

In April, Gilead announced the appointment of Muzammil M. Mansuri, PhD, to Senior Vice President, Research and Development Strategy and Corporate Development.

 

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July 26, 2011    Page 3

 

In May, Gilead announced that it had extended its funding support for the Gilead Sciences Research Centre at the Institute of Organic Chemistry and Biochemistry (IOCB) of the Academy of Sciences of the Czech Republic for an additional five years. Gilead will provide a $1.15 million annual donation to IOCB in order to continue to fund the Research Centre’s operations and ongoing research efforts. Gilead has the first option to license inventions that result from the Research Centre’s scientific programs and drug discovery efforts.

Under the company’s $5.00 billion stock repurchase program authorized in May 2010, Gilead has repurchased approximately $4.29 billion in common stock through June 30, 2011. Total purchase activity was $723.9 million in common stock for the second quarter of 2011.

Product and Pipeline Update

Antiviral Franchise

In June, Gilead announced that it had entered into a license agreement with Tibotec Pharmaceuticals (Tibotec) for the development and commercialization of a new fixed-dose antiretroviral combination product containing Gilead’s investigational agent cobicistat and Tibotec’s protease inhibitor Prezista® (darunavir). In addition, the companies are also negotiating terms for the development and commercialization of a future single-tablet regimen (STR) combining Prezista with Emtriva and the investigational agents GS 7340 and cobicistat. The agreement to develop the fixed-dose combination of cobicistat and Prezista is contingent upon the signing of the agreement to develop the Emtriva, GS 7340, cobicistat and Prezista STR.

Respiratory Franchise

In April, Gilead and MicroDose Therapeutx (MicroDose) announced that the companies had entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of MDT-637, MicroDose’s inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus.

Conference Call

At 5:00 p.m. Eastern Time today, Gilead’s management will host a conference call and a simultaneous webcast to discuss results from its second quarter 2011 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 1-800-299-7089 (U.S.) or 1-617-801-9714 (international) and dial the participant passcode 36874698 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 July 29, 2011. To access the phone replay, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international) and dial the participant passcode 45716316.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead’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 GAAP and also on a non-GAAP basis for the three and six months ended June 30, 2011 and 2010. Management believes this non-GAAP information is useful for investors, taken 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 U.S. GAAP. A reconciliation between GAAP and non-GAAP financial information is provided in the table on page 6.

 

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July 26, 2011    Page 4

 

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 2011 financial results, including the possibility that its full year 2011 guidance may be revised at a later date; Gilead’s ability to sustain growth in revenues for its antiviral, cardiovascular and respiratory franchises; unpredictable variability of Tamiflu royalties and the strong relationship between this royalty revenue and global pandemic planning and supply; the availability of funding for state ADAPs and their ability to purchase at levels to support the number of patients that rely on ADAPs; 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; Gilead’s ability to receive regulatory approvals in a timely manner or at all, for new and current products, including cobicistat and GS 7340; Gilead’s ability to successfully commercialize its products; Gilead’s ability to successfully develop its respiratory, cardiovascular and oncology franchises; safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates, including the clinical studies evaluating cobicistat and GS 7340; initiating and completing clinical trials may take longer or cost more than expected, including the clinical studies evaluating cobicistat and GS 7340; 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; Gilead’s ability to complete the current $5.00 billion share repurchase program and commence purchases under the additional $5.00 billion share repurchase program due to changes in its stock price, corporate or other market conditions; risks that the funding of the Gilead Sciences Research Center at IOCB will not lead to the discovery of any potential product candidates; risks that Gilead will not sign an agreement to develop the Emtriva, GS 7340, cobicistat and Prezista STR and as a result, the parties will not develop the fixed-dose combination of cobicistat and Prezista; risks that the development and commercialization of cobicistat and Prezista will not be successful; risks that the collaboration with MicroDose will not lead to the commercialization of MDT-637; and other risks identified from time to time in Gilead’s reports filed with the U.S. Securities and Exchange Commission. 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 Annual Report on Form 10-K for the year ended December 31, 2010 and other subsequent disclosure documents filed with the Securities and Exchange Commission and press releases. 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.

# # #

Truvada, Viread, Hepsera, Emtriva, AmBisome, Letairis, Cayston and Ranexa are

registered trademarks of Gilead Sciences, Inc.

Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

Tamiflu is a registered trademark of F. Hoffmann-La Roche Ltd.

Prezista is a registered trademark of Tibotec, Inc.

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).

 


July 26, 2011    Page 5

 

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(unaudited)

(in thousands, except per share amounts)

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2011      2010      2011      2010  

Revenues:

           

Product sales

     $     2,039,588           $     1,806,061           $     3,903,166           $     3,594,124     

Royalty, contract and other revenues

     97,665           121,163           160,181           418,953     
                                   

Total revenues

     2,137,253           1,927,224           4,063,347           4,013,077     
                                   

Costs and expenses:

           

Cost of goods sold

     533,863           455,525           1,007,974           895,955     

Research and development

     282,403           231,066           536,849           449,730     

Selling, general and administrative

     304,269           248,006           599,837           513,624     
                                   

Total costs and expenses

     1,120,535           934,597           2,144,660           1,859,309     
                                   

Income from operations

     1,016,718           992,627           1,918,687           2,153,768     

Interest and other income, net

     11,978           18,285           25,810           33,930     

Interest expense

     (46,107)          (17,764)          (87,323)          (34,719)    
                                   

Income before provision for income taxes

     982,589           993,148           1,857,174           2,152,979     

Provision for income taxes

     240,130           284,021           467,412           591,758     
                                   

Net income

     742,459           709,127           1,389,762           1,561,221     

Net loss attributable to noncontrolling interest

     3,768           2,934           7,606           5,741     
                                   

Net income attributable to Gilead

     $ 746,227           $ 712,061           $ 1,397,368           $ 1,566,962     
                                   

Net income per share attributable to Gilead
common stockholders - basic

     $ 0.95           $ 0.81           $ 1.77           $ 1.76     
                                   

Net income per share attributable to Gilead
common stockholders - diluted

     $ 0.93           $ 0.79           $ 1.73           $ 1.71     
                                   

Shares used in per share calculation - basic

     784,807           881,802           790,430           891,649     
                                   

Shares used in per share calculation - diluted

     800,800           898,753           806,462           913,819     
                                   

 


July 26, 2011    Page 6

 

GILEAD SCIENCES, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

(unaudited)

(in thousands, except percentages and per share amounts)

 

    Three Months Ended
June 30,
    Six Months Ended
June 30,
 
    2011     2010     2011     2010  

Cost of goods sold reconciliation:

       

GAAP cost of goods sold

    $     533,863          $     455,525          $ 1,007,974          $ 895,955     

Acquisition-related amortization of inventory mark-up

    -              (2,042)         -              (7,020)    

Acquisition-related amortization of purchased intangibles

    (17,408)         (14,981)         (34,815)         (29,965)    

Stock-based compensation expenses

    (2,887)         (2,967)         (5,531)         (5,820)    
                               

Non-GAAP cost of goods sold

    $ 513,568          $ 435,535          $ 967,628          $ 853,150     
                               

Product gross margin reconciliation:

       

GAAP product gross margin

    73.9%         74.8%         74.2%         75.1%    

Acquisition-related amortization of inventory mark-up

    -              0.1%         -              0.2%    

Acquisition-related amortization of purchased intangibles

    0.9%         0.8%         0.9%         0.8%    

Stock-based compensation expenses

    0.1%         0.2%         0.1%         0.2%    
                               

Non-GAAP product gross margin (1)

    74.9%         75.9%         75.3%         76.3%    
                               

Research and development expenses reconciliation:

       

GAAP research and development expenses

    $ 282,403          $ 231,066          $ 536,849          $ 449,730     

Acquisition-related transaction costs

    -              -              (446)         -         

Acquisition-related remeasurement of contingent consideration

    418          -              418          -         

Restructuring expenses

    (767)         (2,130)         (554)         (4,230)    

Stock-based compensation expenses

    (19,420)         (21,521)         (36,140)         (41,590)    
                               

Non-GAAP research and development expenses

    $ 262,634          $ 207,415          $ 500,127          $ 403,910     
                               

Selling, general and administrative expenses reconciliation:

       

GAAP selling, general and administrative expenses

    $ 304,269          $ 248,006          $ 599,837          $ 513,624     

Acquisition-related transaction costs

    (365)         -              (743)         -         

Restructuring expenses

    353          (906)         (1,666)         (13,490)    

Stock-based compensation expenses

    (27,818)         (23,559)         (57,924)         (47,478)    
                               

Non-GAAP selling, general and administrative expenses

    $ 276,439          $ 223,541          $ 539,504          $ 452,656     
                               

Operating margin reconciliation:

       

GAAP operating margin

    47.6%         51.5%         47.2%         53.7%     

Acquisition-related transaction costs

    0.0%         -              0.0%         -         

Acquisition-related amortization of inventory mark-up

    -              0.1%         -              0.2%    

Acquisition-related amortization of purchased intangibles

    0.8%         0.8%         0.9%         0.7%    

Acquisition-related remeasurement of contingent consideration

    0.0%         0.0%         0.0%         -         

Restructuring expenses

    0.0%         0.2%         0.1%         0.4%    

Stock-based compensation expenses

    2.3%         2.5%         2.5%         2.4%    
                               

Non-GAAP operating margin (1)

    50.7%         55.0%         50.6%         57.4%    
                               

Net income attributable to Gilead reconciliation:

       

GAAP net income attributable to Gilead

    $ 746,227          $ 712,061          $     1,397,368          $     1,566,962     

Acquisition-related transaction costs

    365          -              1,189          -         

Acquisition-related amortization of inventory mark-up

    -              1,433          -              5,090     

Acquisition-related amortization of purchased intangibles

    13,170          10,721          26,053          21,729     

Acquisition-related remeasurement of contingent consideration

    (313)         -              (313)         -         

Restructuring expenses

    324          2,061          1,661          12,849     

Stock-based compensation expenses

    37,915          34,395          74,529          68,808     
                               

Non-GAAP net income attributable to Gilead

    $ 797,688          $ 760,671          $ 1,500,487          $ 1,675,438     
                               

Diluted earnings per share reconciliation:

       

GAAP diluted earnings per share

    $ 0.93          $ 0.79          $ 1.73          $ 1.71     

Acquisition-related transaction costs

    0.00          -              0.00          -         

Acquisition-related amortization of inventory mark-up

    -              0.00          -              0.01     

Acquisition-related amortization of purchased intangibles

    0.02          0.01          0.03          0.02     

Acquisition-related remeasurement of contingent consideration

    (0.00)         -              (0.00)         -         

Restructuring expenses

    0.00          0.00          0.00          0.01     

Stock-based compensation expenses

    0.05          0.04          0.09          0.08     
                               

Non-GAAP diluted earnings per share (1)

    $ 1.00          $ 0.85          $ 1.87          $ 1.84     
                               

Shares used in per share calculation (diluted) reconciliation:

       

GAAP shares used in per share calculation (diluted)

    800,800          898,753          806,462          913,819     

Share impact of current stock-based compensation guidance

    (2,010)         (1,555)         (1,993)         (1,262)    
                               

Non-GAAP shares used in per share calculation (diluted)

    798,790          897,198          804,469          912,557     
                               

Non-GAAP adjustment summary:

       

Cost of goods sold adjustments

    $ 20,295          $ 19,990          $ 40,346          $ 42,805     

Research and development expenses adjustments

    19,769          23,651          36,722          45,820     

Selling, general and administrative expenses adjustments

    27,830          24,465          60,333          60,968     
                               

Total non-GAAP adjustments before tax

    67,894          68,106          137,401          149,593     

Income tax effect

    (16,433)         (19,496)         (34,282)         (41,117)    
                               

Total non-GAAP adjustments after tax

    $ 51,461          $ 48,610          $ 103,119          $ 108,476     
                               

Note:

(1) Amounts may not sum due to rounding

 


July 26, 2011    Page 7

 

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     June 30,
2011
     December 31,
2010
 
     (unaudited)      (Note 1)  

Cash, cash equivalents and marketable securities

     $ 5,499,312          $ 5,318,071    

Accounts receivable, net

     1,938,645          1,621,966    

Inventories

     1,321,615          1,203,809    

Property, plant and equipment, net

     721,884          701,235    

Intangible assets

     2,128,410          1,425,592    

Other assets

     1,084,274          1,321,957    
                 

Total assets

     $     12,694,140          $     11,592,630    
                 

Current liabilities

     $ 2,310,841          $ 2,464,950    

Long-term liabilities

     4,171,968          3,005,843    

Stockholders’ equity (Note 2)

     6,211,331          6,121,837    
                 

Total liabilities and stockholders’ equity

     $ 12,694,140          $ 11,592,630    
                 

 

Notes:

     

 

(1)      Derived from audited consolidated financial statements at that date.

 

(2)      As of June 30, 2011, there were 776,405 shares of common stock issued and outstanding.

 


July 26, 2011    Page 8

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY

(unaudited)

(in thousands)

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2011      2010      2011      2010  

Antiviral products:

           

Atripla – U.S.

    $ 510,237         $ 466,819         $ 973,004         $ 922,720    

Atripla – Europe

     267,153          221,149          520,210          438,697    

Atripla – Other International

     44,602          27,836          73,290          47,259    
                                   
     821,992          715,804          1,566,504          1,408,676    
                                   

Truvada – U.S.

     334,064          317,522          654,177          644,339    

Truvada – Europe

     322,007          278,373          621,163          575,901    

Truvada – Other International

     55,230          45,787          109,072          79,241    
                                   
     711,301          641,682          1,384,412          1,299,481    
                                   

Viread – U.S.

     80,228          78,787          152,708          156,794    

Viread – Europe

     86,123          71,004          162,135          144,147    

Viread – Other International

     19,366          26,381          39,269          55,917    
                                   
     185,717          176,172          354,112          356,858    
                                   

Hepsera – U.S.

     14,765          19,470          28,639          41,035    

Hepsera – Europe

     20,582          28,551          42,070          61,926    

Hepsera – Other International

     3,309          3,313          6,043          6,497    
                                   
     38,656          51,334          76,752          109,458    
                                   

Emtriva – U.S.

     3,914          4,135          7,816          8,379    

Emtriva – Europe

     1,705          1,684          3,390          3,559    

Emtriva – Other International

     1,113          926          2,102          1,963    
                                   
     6,732          6,745          13,308          13,901    
                                   

Total Antiviral products – U.S.

     943,208          886,733          1,816,344          1,773,267    

Total Antiviral products – Europe

     697,570          600,761          1,348,968          1,224,230    

Total Antiviral products – Other International

     123,620          104,243          229,776          190,877    
                                   
     1,764,398          1,591,737          3,395,088          3,188,374    
                                   

AmBisome

     88,625          78,174          167,131          155,223    

Letairis

     73,637          60,348          135,811          115,847    

Ranexa

     86,077          60,460          154,370          111,703    

Other products

     26,851          15,342          50,766          22,977    
                                   
     275,190          214,324          508,078          405,750    
                                   

Total product sales

    $     2,039,588         $     1,806,061         $     3,903,166         $     3,594,124