Attached files

file filename
8-K - CURRENT REPORT ON FORM 8-K - GILEAD SCIENCES INCd8k.htm

 

Exhibit 99.1

 

LOGO

 

CONTACTS:    Investors    Media
   Robin Washington    Amy Flood
   (650) 522-5688    (650) 522-5643
   Susan Hubbard   
   (650) 522-5715   

For Immediate Release

GILEAD SCIENCES ANNOUNCES THIRD QUARTER 2010 FINANCIAL RESULTS

- Total Revenues of $1.94 Billion, Up 8 Percent over Third Quarter 2009 -

- Record Product Sales of $1.87 Billion, Up 13 Percent over Third Quarter 2009 -

- Third Quarter Non-GAAP EPS of $0.90 per Share, Up 15 Percent over Third Quarter 2009 -

Foster City, CA, October 19, 2010 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share. Non-GAAP net income for the third quarter of 2010, which excludes after-tax acquisition-related expenses, restructuring expenses and stock-based compensation expenses, was $759.7 million, or $0.90 per diluted share. Non-GAAP net income for the third quarter of 2009, which excludes after-tax acquisition-related expenses, restructuring expenses and stock-based compensation expenses, was $730.3 million, or $0.78 per diluted share.

Product Sales

Product sales increased 13 percent to $1.87 billion for the third quarter of 2010, compared to $1.65 billion in the third quarter of 2009.

Antiviral Franchise

Antiviral product sales increased 12 percent to $1.65 billion in the third quarter of 2010, up from $1.47 billion for the same quarter of 2009.

 

 

Atripla

Sales of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV infection increased 23 percent to $742.7 million for the third quarter of 2010, up from $605.3 million in the third quarter of 2009, driven primarily by sales volume growth in the United States and Europe.

 

 

Truvada

Sales of Truvada® (emtricitabine/tenofovir disoproxil fumarate) for the treatment of HIV infection increased 8 percent to $668.7 million for the third quarter of 2010, up from $620.6 million in the third quarter of 2009, driven primarily by sales volume growth in the United States and Europe.

 

 

Viread

Sales of Viread® (tenofovir disoproxil fumarate) for the treatment of HIV infection and chronic hepatitis B increased 9 percent to $184.3 million for the third quarter of 2010, up from $169.7 million in the third quarter of 2009, driven primarily by sales volume growth in the United States, Europe and 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   


 

October 19, 2010

 

  Page 2

 

Letairis

Sales of Letairis® (ambrisentan) for the treatment of pulmonary arterial hypertension increased 26 percent to $60.4 million for the third quarter of 2010, up from $48.1 million for the third quarter of 2009, driven primarily by sales volume growth in the United States.

Ranexa

Sales of Ranexa® (ranolazine) for the treatment of chronic angina increased 23 percent to $60.3 million for the third quarter of 2010, up from $49.0 million for the third quarter of 2009, driven primarily by sales volume growth in the United States.

Other Products

Sales of other products were $149.1 million for the third quarter of 2010 compared to $156.3 million for the third quarter of 2009 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). Sales of Cayston were $14.7 million for the third quarter of 2010.

Royalty, Contract and Other Revenues

Royalty, contract and other revenues resulting primarily from collaborations with corporate partners were $72.1 million in the third quarter of 2010, down from $152.4 million in the third quarter of 2009. This decrease was due primarily to lower Tamiflu® (oseltamivir phosphate) royalties from F. Hoffmann-La Roche Ltd of $34.5 million in the third quarter of 2010, compared to Tamiflu royalties of $113.5 million in the third quarter of 2009.

Research and Development

Research and development (R&D) expenses in the third quarter of 2010 were $230.4 million, compared to $269.9 million for the third quarter of 2009. Non-GAAP R&D expenses for the third quarter of 2010, which exclude restructuring and stock-based compensation expenses, were $203.2 million, compared to $242.2 million for the third quarter of 2009. The decrease in non-GAAP R&D expenses was due primarily to lower R&D expense reimbursement related to Gilead’s collaboration with Tibotec Pharmaceuticals (Tibotec).

Selling, General and Administrative

Selling, general and administrative (SG&A) expenses in the third quarter of 2010 were $250.6 million, compared to $227.4 million for the third quarter of 2009. Non-GAAP SG&A expenses for the third quarter of 2010, which exclude acquisition-related, restructuring and stock-based compensation expenses, were $220.6 million, compared to $200.3 million for the third quarter in 2009. The increase in non-GAAP SG&A expenses was driven primarily by higher headcount and expenses to support Gilead’s expanding commercial activities.

Net Foreign Currency Exchange Impact

The net foreign currency exchange impact on third quarter 2010 revenues and pre-tax earnings, which includes revenues and expenses generated from outside the United States, was an unfavorable $44.2 million and $37.4 million, respectively, compared to the third quarter of 2009, and an unfavorable $7.0 million and $1.7 million, respectively, compared to the second quarter of 2010.

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2010, Gilead had cash, cash equivalents and marketable securities of $5.05 billion compared to $3.90 billion as of December 31, 2009. Gilead generated $2.11 billion of operating cash flow for the first nine months of 2010 including $739.5 million in the third quarter of 2010.

 

- more -


 

October 19, 2010

 

  Page 3

 

Corporate Highlights

Under the company’s previously announced $5.0 billion stock repurchase program authorized by its Board of Directors in May 2010, Gilead has repurchased approximately $2.41 billion in common stock through September 30, 2010. In conjunction with the company’s announcement of its convertible debt offering on July 26, 2010, Gilead has since acquired approximately $1.18 billion of shares repurchased at an average price of $33.84 per share. Total purchase activity was $1.55 billion in common stock for the third quarter of 2010. Total purchase activity for the year to date was $3.41 billion in common stock, representing 93.6 million repurchased shares or approximately 10% of Gilead’s total common shares outstanding at December 31, 2009.

Product and Pipeline Update

Antiviral Franchise

In September, Gilead announced that it had submitted a Marketing Authorization Application to the European Medicines Agency for marketing approval of the fixed-dose combination of Truvada and Tibotec’s investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine) for the treatment of HIV-1 infection in adults.

Also in September, Gilead released positive 48-week results from two of its ongoing Phase II clinical studies in HIV-infected patients. The first were from the study of its investigational fixed-dose, single-tablet “Quad” regimen of elvitegravir, cobicistat and Truvada versus Atripla. The second were from the study of cobicistat-boosted atazanavir plus Truvada compared to ritonavir-boosted atazanavir plus Truvada. Results from both studies were presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in Boston.

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 third quarter 2010 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 1-866-770-7051 (U.S.) or 1-617-213-8064 (international) and dial the participant passcode 16880218 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 October 22, 2010. To access the phone replay, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international) and dial the participant passcode 60311851.

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 Australia.

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 nine months ended September 30, 2010 and 2009. 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.

 

- more -


 

October 19, 2010

 

  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 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; Gilead’s ability to submit NDAs for new product candidates, including the fixed-dose combination of Truvada and TMC278, 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 its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, cobicistat (formerly GS 9350) and Truvada and the fixed-dose combination of Truvada and TMC278, both for the treatment of HIV infection; Gilead’s ability to successfully commercialize its products, including Cayston as a treatment for the improvement of respiratory symptoms in cystic fibrosis patients with P. aeruginosa; Gilead’s ability to successfully develop its respiratory and cardiovascular franchises; safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates, including the Quad and the fixed-dose combination of Truvada and TMC278; initiating and completing clinical trials may take longer or cost more than expected, including in the clinical studies evaluating the Quad for the treatment of HIV infection; fluctuations in the foreign exchange rate of the U.S. dollar that may reduce or eliminate the favorable foreign currency exchange impact on Gilead’s future revenues and pre-tax earnings; Gilead’s ability to consummate the $5.0 billion share repurchase program due to changes in its stock price, corporate or other market conditions; risks and uncertainties related to Gilead’s ability to successfully advance CGI Pharmaceuticals, Inc.’s pipeline programs; whether the FDA or other international regulatory authorities will agree that steps taken or to be taken by Gilead to correct matters described in the Warning Letter received from the FDA on September 24, 2010, with respect to Gilead’s manufacturing and distribution center in San Dimas, California, are adequate; Gilead’s ability to resolve any continuing concerns that may be expressed by the FDA or other international regulatory authorities in a timely manner and whether the FDA or other international regulatory authorities decide to take further corrective or disciplinary actions against Gilead, including, without limitation, withholding permission to export AmBisome to certain countries outside the United States and Europe; 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 Quarterly Reports on Form 10-Q for the first and second quarters and other publicly filed disclosure documents filed with the Securities and Exchange Commission and subsequent 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.

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).


 

October 19, 2010

 

  Page 5

 

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(unaudited)

(in thousands, except per share amounts)

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2010     2009     2010     2009  

Revenues:

        

Product sales

   $ 1,865,559      $ 1,648,955      $ 5,459,683      $ 4,664,913   

Royalty, contract and other revenues

     72,097        152,434        491,050        314,091   
                                

Total revenues

     1,937,656        1,801,389        5,950,733        4,979,004   

Costs and expenses:

        

Cost of goods sold

     477,584        409,700        1,373,539        1,122,159   

Research and development

     230,440        269,856        680,170        700,273   

Selling, general and administrative

     250,559        227,427        764,183        692,789   
                                

Total costs and expenses

     958,583        906,983        2,817,892        2,515,221   
                                

Income from operations

     979,073        894,406        3,132,841        2,463,783   

Interest and other income, net

     15,593        14,017        49,523        31,098   

Interest expense

     (33,620     (17,217     (68,339     (52,372
                                

Income before provision for income taxes

     961,046        891,206        3,114,025        2,442,509   

Provision for income taxes

     258,883        220,728        850,641        616,310   
                                

Net income

     702,163        670,478        2,263,384        1,826,199   

Net loss attributable to noncontrolling interest

     2,713        2,555        8,454        7,344   
                                

Net income attributable to Gilead

   $ 704,876      $ 673,033      $ 2,271,838      $ 1,833,543   
                                

Net income per share attributable to Gilead common stockholders - basic

   $ 0.85      $ 0.75      $ 2.61      $ 2.02   
                                

Net income per share attributable to Gilead common stockholders - diluted

   $ 0.83      $ 0.72      $ 2.55      $ 1.96   
                                

Shares used in per share calculation - basic

     833,006        903,319        871,887        906,213   
                                

Shares used in per share calculation - diluted

     847,228        932,424        890,216        936,530   
                                


 

October 19, 2010

 

  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
September 30,
    Nine Months Ended
September 30,
 
     2010     2009     2010     2009  

Cost of goods sold reconciliation:

        

GAAP cost of goods sold

   $ 477,584      $ 409,700      $ 1,373,539      $ 1,122,159   

Acquisition-related amortization of inventory mark-up

     —          (4,922     (7,020     (8,633

Acquisition-related amortization of purchased intangibles

     (14,981     (14,585     (44,946     (26,651

Stock-based compensation expenses

     (2,728     (2,461     (8,548     (8,486
                                

Non-GAAP cost of goods sold

   $ 459,875      $ 387,732      $ 1,313,025      $ 1,078,389   
                                

Product gross margin reconciliation:

        

GAAP product gross margin

     74.4     75.2     74.9     76.0

Acquisition-related amortization of inventory mark-up

     —          0.3     0.1     0.2

Acquisition-related amortization of purchased intangibles

     0.8     0.9     0.8     0.6

Stock-based compensation expenses

     0.1     0.1     0.2     0.2
                                

Non-GAAP product gross margin (1)

     75.4     76.5     76.0     77.0
                                

Research and development expenses reconciliation:

        

GAAP research and development expenses

   $ 230,440      $ 269,856      $ 680,170      $ 700,273   

Restructuring expenses

     (6,315     (5,780     (10,545     (17,031

Stock-based compensation expenses

     (20,946     (21,916     (62,536     (63,192
                                

Non-GAAP research and development expenses

   $ 203,179      $ 242,160      $ 607,089      $ 620,050   
                                

Selling, general and administrative expenses reconciliation:

        

GAAP selling, general and administrative expenses

   $ 250,559      $ 227,427      $ 764,183      $ 692,789   

Acquisition-related transaction costs

     (387     (239     (387     (8,404

Restructuring expenses

     (1,413     (2,623     (14,903     (15,478

Stock-based compensation expenses

     (28,128     (24,230     (75,606     (72,255
                                

Non-GAAP selling, general and administrative expenses

   $ 220,631      $ 200,335      $ 673,287      $ 596,652   
                                

Operating margin reconciliation:

        

GAAP operating margin

     50.5     49.7     52.6     49.5

Acquisition-related transaction costs

     0.0     0.0     0.0     0.2

Acquisition-related amortization of inventory mark-up

     —          0.3     0.1     0.2

Acquisition-related amortization of purchased intangibles

     0.8     0.8     0.8     0.5

Restructuring expenses

     0.4     0.5     0.4     0.7

Stock-based compensation expenses

     2.7     2.7     2.5     2.9
                                

Non-GAAP operating margin (1)

     54.4     53.9     56.4     53.9
                                

Net income attributable to Gilead reconciliation:

        

GAAP net income attributable to Gilead

   $ 704,876      $ 673,033      $ 2,271,838      $ 1,833,543   

Acquisition-related transaction costs

     388        239        388        8,404   

Acquisition-related amortization of inventory mark-up

     —          3,667        5,090        6,326   

Acquisition-related amortization of purchased intangibles

     10,951        10,866        32,680        19,775   

Restructuring expenses

     5,639        6,260        18,488        24,052   

Stock-based compensation expenses

     37,812        36,218        106,620        106,467   
                                

Non-GAAP net income attributable to Gilead

   $ 759,666      $ 730,283      $ 2,435,104      $ 1,998,567   
                                

Diluted earnings per share reconciliation:

        

GAAP diluted earnings per share

   $ 0.83      $ 0.72      $ 2.55      $ 1.96   

Acquisition-related transaction costs

     0.00        0.00        0.00        0.01   

Acquisition-related amortization of inventory mark-up

     —          0.00        0.01        0.01   

Acquisition-related amortization of purchased intangibles

     0.01        0.01        0.04        0.02   

Restructuring expenses

     0.01        0.01        0.02        0.03   

Stock-based compensation expenses

     0.04        0.04        0.12        0.11   
                                

Non-GAAP diluted earnings per share (1)

   $ 0.90      $ 0.78      $ 2.74      $ 2.13   
                                

Shares used in per share calculation (diluted) reconciliation:

        

GAAP shares used in per share calculation (diluted)

     847,228        932,424        890,216        936,530   

Share impact of current stock-based compensation guidance

     (2,208     (119     (1,621     245   
                                

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

     845,020        932,305        888,595        936,775   
                                

Non-GAAP adjustment summary:

        

Cost of goods sold adjustments

   $ 17,709      $ 21,968      $ 60,514      $ 43,770   

Research and development expenses adjustments

     27,261        27,696        73,081        80,223   

Selling, general and administrative expenses adjustments

     29,928        27,092        90,896        96,137   
                                

Total non-GAAP adjustments before tax

     74,898        76,756        224,491        220,130   

Income tax effect

     (20,108     (19,506     (61,225     (55,106
                                

Total non-GAAP adjustments after tax

   $ 54,790      $ 57,250      $ 163,266      $ 165,024   
                                

Note:

 

(1) Amounts may not sum due to rounding


 

October 19, 2010

 

  Page 7

 

GILEAD SCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     September 30,
2010
     December 31,
2009
 
     (unaudited)      (Note 1)  

Cash, cash equivalents and marketable securities

   $ 5,051,681       $ 3,904,846   

Accounts receivable, net

     1,670,405         1,389,534   

Inventories

     1,273,389         1,051,771   

Property, plant and equipment, net

     692,032         699,970   

Intangible assets

     1,576,573         1,524,777   

Other assets

     1,191,511         1,127,661   
                 

Total assets

   $ 11,455,591       $ 9,698,559   
                 

Current liabilities

   $ 2,590,108       $ 1,871,631   

Long-term liabilities

     2,986,711         1,321,770   

Stockholders’ equity (Note 2)

     5,878,772         6,505,158   
                 

Total liabilities and stockholders’ equity

   $ 11,455,591       $ 9,698,559   
                 

Notes:

 

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

 

(2) As of September 30, 2010, there were 815,474 shares of common stock issued and outstanding.


 

October 19, 2010

 

  Page 8

 

GILEAD SCIENCES, INC.

PRODUCT SALES SUMMARY

(unaudited)

(in thousands)

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2010      2009      2010      2009  

Antiviral products:

           

Atripla – U.S.

   $ 491,645       $ 407,896       $ 1,414,365       $ 1,180,072   

Atripla – Europe

     222,727         182,222         661,424         461,836   

Atripla – Other International

     28,320         15,181         75,579         42,416   
                                   
     742,692         605,299         2,151,368         1,684,324   
                                   

Truvada – U.S.

     325,545         292,918         969,884         859,603   

Truvada – Europe

     292,028         292,819         867,929         859,036   

Truvada – Other International

     51,168         34,827         130,409         100,357   
                                   
     668,741         620,564         1,968,222         1,818,996   
                                   

Viread – U.S.

     82,431         74,675         239,225         212,122   

Viread – Europe

     72,489         67,989         216,636         199,329   

Viread – Other International

     29,343         27,047         85,260         77,790   
                                   
     184,263         169,711         541,121         489,241   
                                   

Hepsera – U.S.

     19,055         25,795         60,090         74,218   

Hepsera – Europe

     25,095         38,123         87,021         117,837   

Hepsera – Other International

     3,369         4,010         9,866         15,661   
                                   
     47,519         67,928         156,977         207,716   
                                   

Emtriva – U.S.

     3,966         3,865         12,345         11,211   

Emtriva – Europe

     1,657         1,863         5,216         6,369   

Emtriva – Other International

     1,073         1,001         3,036         3,421   
                                   
     6,696         6,729         20,597         21,001   
                                   

Total Antiviral products – U.S.

     922,642         805,149         2,695,909         2,337,226   

Total Antiviral products – Europe

     613,996         583,016         1,838,226         1,644,407   

Total Antiviral products – Other International

     113,273         82,066         304,150         239,645   
                                   
     1,649,911         1,470,231         4,838,285         4,221,278   
                                   

AmBisome

     75,132         77,064         230,355         214,645   

Letairis

     60,446         48,073         176,293         131,781   

Ranexa

     60,312         49,005         172,015         85,070   

Other products

     19,758         4,582         42,735         12,139   
                                   
     215,648         178,724         621,398         443,635   
                                   

Total product sales

   $ 1,865,559       $ 1,648,955       $ 5,459,683       $ 4,664,913