Empresas y finanzas

Gilead Sciences Announces Third Quarter 2007 Financial Results



    Gilead Sciences, Inc. (Nasdaq:GILD) announced today its results of
    operations for the quarter ended September 30, 2007. Total revenues
    for the third quarter of 2007 were $1.06 billion, up 41 percent
    compared to total revenues of $748.7 million for the third quarter of
    2006. Net income for the third quarter of 2007 was $398.3 million, or
    $0.42 per diluted share, including after-tax stock-based compensation
    expense of $31.8 million. Excluding after-tax stock-based compensation
    expense, non-GAAP net income for the third quarter of 2007 was $430.1
    million, or $0.45 per diluted share, compared to non-GAAP net income
    of $329.0 million, or $0.34 per diluted share, for the third quarter
    of 2006, which excluded after-tax stock-based compensation expense of
    $25.6 million and purchased in-process research and development
    (IPR&D) of $355.6 million.

    Product Sales

    Product sales were a record $961.9 million for the third quarter
    of 2007, compared to $670.1 million in the third quarter of 2006, a 44
    percent increase. This growth was driven primarily by Gilead's HIV
    product franchise, including the continued strong uptake of Atripla(R)
    (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate
    300 mg) in the United States as well as the strong growth of
    Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) in
    Europe. Hepsera(R) (adefovir dipivoxil) and AmBisome(R) (amphotericin
    B) liposome for injection also experienced solid sales growth compared
    to the same quarter last year.

    HIV Franchise

    HIV product sales were $805.8 million in the third quarter of
    2007, a 45 percent increase from $557.3 million for the same period in
    2006, driven primarily by the sales volume growth in Truvada and
    Atripla.

    -- Truvada

    Truvada sales were $409.1 million for the third quarter of 2007,
    an increase of 32 percent from $309.0 million in the third quarter of
    2006. Truvada sales accounted for approximately 51 percent of our
    total HIV product sales and approximately 43 percent of Gilead's total
    product sales in the third quarter of 2007.

    -- Atripla

    Atripla sales were $241.1 million in the third quarter of 2007, an
    increase of 14 percent from $212.4 million in the second quarter of
    2007 and more than triple the $68.4 million recorded in the third
    quarter of 2006, when sales of Atripla first commenced in the United
    States.

    -- Viread

    Sales of Viread(R) (tenofovir disoproxil fumarate) were $149.1
    million in the third quarter of 2007, a 13 percent decrease from
    $170.6 million in the third quarter of 2006.

    -- Emtriva

    Emtriva(R) (emtricitabine) sales were $6.5 million for the third
    quarter of 2007, a decrease of 30 percent from $9.3 million in the
    third quarter of 2006.

    Hepsera for Chronic Hepatitis B

    Hepsera sales were $79.3 million for the third quarter of 2007, a
    44 percent increase from $55.1 million in the third quarter of 2006,
    driven primarily by sales volume growth in the United States and
    Europe.

    AmBisome for Severe Fungal Infections

    Sales of AmBisome for the third quarter of 2007 were $68.5
    million, an increase of 24 percent from $55.3 million for the third
    quarter of 2006, driven primarily by sales volume growth across
    European territories and Australia as well as a favorable foreign
    currency exchange impact.

    Royalty, Contract and Other Revenues

    For the third quarter of 2007, royalty, contract and other
    revenues resulting primarily from collaborations with corporate
    partners were $96.9 million, an increase of 23 percent from $78.7
    million in the third quarter of 2006. The increase was driven
    primarily by the recognition of Tamiflu(R) (oseltamivir phosphate)
    royalties from F. Hoffmann-La Roche Ltd (Roche) of $77.4 million,
    compared to Tamiflu royalties of $62.7 million recognized in the third
    quarter of 2006, due to the higher Tamiflu sales recorded by Roche
    during the second quarter of 2007 compared to the same period in 2006.

    Research and Development

    Research and development (R&D) expenses in the third quarter of
    2007 were $140.4 million compared to $93.3 million for the same
    quarter in 2006. Non-GAAP R&D expenses, which exclude stock-based
    compensation expense, for the third quarter of 2007 were $122.0
    million, compared to $80.0 million for the same quarter in 2006.
    Non-GAAP R&D expenses for the third quarter of 2007 were higher
    primarily as a result of increased compensation and benefits related
    to higher headcount, as well as increased clinical study expenses
    related to Gilead's respiratory and cardiovascular franchises, which
    were acquired in the latter part of 2006.

    Selling, General and Administrative

    Selling, general and administrative (SG&A) expenses in the third
    quarter of 2007 were $173.0 million compared to $132.5 million for the
    same quarter in 2006. Non-GAAP SG&A expenses, which exclude
    stock-based compensation expense, for the third quarter of 2007 were
    $148.4 million, compared to $116.6 million for the same quarter in
    2006. Non-GAAP SG&A expenses for the third quarter of 2007 were higher
    primarily as a result of increased compensation and benefits related
    to increased headcount, increased marketing and promotional expenses
    as well as other consulting and support services expenses related to
    our cardiovascular franchise.

    Net Foreign Exchange Impact on Pre-Tax Earnings

    The net foreign exchange impact on third quarter 2007 pre-tax
    earnings, including revenues and expenses generated from outside the
    United States and impact of our hedging activities, was a favorable
    $17.4 million compared to the same quarter in 2006, due primarily to
    the stronger Euro relative to the U.S. dollar.

    Cash, Cash Equivalents and Marketable Securities

    As of September 30, 2007, Gilead had cash, cash equivalents and
    marketable securities of $2.22 billion compared to $1.39 billion as of
    December 31, 2006. The increase in cash, cash equivalents and
    marketable securities was primarily attributable to $1.25 billion of
    operating cash flows generated during the first nine months of 2007,
    partially offset by the Gilead's repurchase of $454.9 million of its
    common stock under its stock repurchase program during the second
    quarter of 2007.

    Product and Pipeline Highlights

    Antiviral Franchise

    In July 2007, Gilead announced the presentation of 144-week data
    from an ongoing clinical trial, Study 934, comparing a once-daily
    regimen of Truvada and Sustiva(R) (efavirenz) to a twice-daily regimen
    of Combivir(R) (lamivudine/zidovudine) with Sustiva once daily in
    treatment-naive adults with HIV. These data were presented in July
    2007 at the 4th International AIDS Society Conference on HIV
    Pathogenesis, Treatment and Prevention in Sydney, Australia by Jose
    Arribas, MD, of the University Hospital La Paz, Madrid, Spain (Poster
    #WEPEB029).

    Cardiovascular Franchise

    In September 2007, Gilead announced that data from a Phase IIb
    study (DAR-201) of darusentan, an investigational treatment for
    resistant hypertension, were published in the October 2007 edition of
    the Journal of Clinical Hypertension. In this study, darusentan was
    evaluated as an add-on antihypertensive treatment in patients who had
    not achieved goal blood pressure while being treated with full doses
    of three or more antihypertensive medications, including a diuretic.
    Preliminary data from this study were previously presented at the 55th
    Annual Scientific Session of the American College of Cardiology
    Conference in Atlanta, Georgia.

    Respiratory Franchise

    In August 2007, Gilead entered into an exclusive licensing and
    co-development agreement for P-680, an epithelial sodium channel
    (ENaC) inhibitor discovered by privately-held Parion Sciences, Inc.
    The agreement grants Gilead worldwide commercialization rights to
    P-680 for the treatment of pulmonary diseases, including cystic
    fibrosis (CF), chronic obstructive pulmonary disease and non-CF
    bronchiectasis. In addition, under the agreement, the companies will
    collaborate on a research program to identify other promising ENaC
    blocker-based drug candidates utilizing Parion's proprietary
    ENaC-based chemistry platform.

    Conference Call

    At 4:30 p.m. Eastern Time today, Gilead will host a conference
    call with a simultaneous webcast to discuss the results of its third
    quarter of 2007. During this call/webcast, Gilead's management will be
    discussing the company's third quarter 2007 results and providing a
    general business update. The webcast will be available live via the
    internet by accessing Gilead's website at www.gilead.com. To access
    the webcast, please connect to the company's website at least 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 1-800-435-1398 (U.S.) or 1-617-614-4078
    (international) and dial the participant passcode 63822863 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 21, 2007. To access the phone
    replay, please call 1-888-286-8010 (U.S.) or 1-617-801-6888
    (international) and dial the participant passcode 65873786.

    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 Australia.

    Non-GAAP Financial Information

    Non-GAAP net income, net income per diluted share, R&D expenses
    and SG&A expenses for the 2007 periods are presented excluding the
    impact of stock-based compensation expense and the related methodology
    for deriving dilutive securities. Non-GAAP net income, net income per
    diluted share, R&D expenses and SG&A expenses for the 2006 periods are
    presented excluding the impact of stock-based compensation expense and
    the related methodology for deriving dilutive securities, as well as
    the impact of the IPR&D charge incurred in connection with the
    acquisition of Corus Pharma, Inc. 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 the company's operating results as
    reported under United States generally accepted accounting principles.

    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 HIV franchise, Hepsera and
    AmBisome; unpredictable variability of Tamiflu royalties and the
    strong relationship between this royalty revenue and global pandemic
    planning and supply; Gilead's ability to receive regulatory approvals
    in a timely manner or at all, for new and current products; Gilead's
    ability to successfully develop its respiratory and cardiovascular
    franchises; initiating and completing clinical trials may take longer
    or cost more than expected; and other risks identified from time to
    time in Gilead's reports filed with the U.S. Securities and Exchange
    Commission. 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, 2006, its Quarterly Reports on Form 10-Q for
    the first and second quarters of 2007 and its subsequent current
    reports on Form 8-K. 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.

    Viread, Emtriva, Truvada, AmBisome and Hepsera are registered
    trademarks of Gilead Sciences, Inc.

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

    Sustiva is a registered trademark of Bristol-Myers Squibb Pharma
    Company.

    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).

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    GILEAD SCIENCES, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (unaudited)
    (in thousands, except per share amounts)

    Three Months Ended Nine Months Ended
    September 30, September 30,
    --------------------- -----------------------
    2007 2006 2007 2006
    ----------- --------- ----------- -----------
    Revenues:
    Product sales $ 961,931 $670,060 $2,707,214 $1,820,104
    Royalty, contract
    and other revenues 96,872 78,673 428,108 306,809
    ----------- --------- ----------- -----------
    Total revenues 1,058,803 748,733 3,135,322 2,126,913
    ----------- --------- ----------- -----------

    Costs and expenses:
    Cost of goods sold
    (1) 198,460 109,791 553,229 278,031
    Research and
    development (1) 140,357 93,305 406,378 272,241
    Selling, general and
    administrative (1) 172,956 132,529 525,693 426,567
    Purchased in-process
    research and
    development (2) - 355,568 - 355,568
    -------------------------------- --------- ----------- -----------
    Total costs and expenses 511,773 691,193 1,485,300 1,332,407
    ----------- --------- ----------- -----------

    Income from operations 547,030 57,540 1,650,022 794,506

    Interest and other
    income, net 29,502 36,197 80,295 102,082
    Interest expense (2,989) (6,081) (10,243) (15,012)
    Minority interest in
    joint venture 2,478 1,640 7,032 3,878
    ----------- --------- ----------- -----------
    Income before provision
    for income taxes 576,021 89,296 1,727,106 885,454
    Provision for income
    taxes (1) 177,702 141,460 513,450 409,764
    ----------- --------- ----------- -----------
    Net income (loss) $ 398,319 $(52,164) $1,213,656 $ 475,690
    =========== ========= =========== ===========

    Net income (loss) per
    share - basic $ 0.43 $ (0.06) $ 1.31 $ 0.52
    =========== ========= =========== ===========

    Net income (loss) per
    share - diluted $ 0.42 $ (0.06) $ 1.26 $ 0.49
    =========== ========= =========== ===========

    Shares used in per share
    calculation - basic 926,963 914,866 928,519 917,546
    =========== ========= =========== ===========

    Shares used in per share
    calculation - diluted 959,043 914,866 962,804 956,202
    =========== ========= =========== ===========

    ----
    Notes:
    (1) The following is the stock-based compensation expense included in
    the respective captions of the condensed consolidated statements
    of operations above:

    Three Months Ended Nine Months Ended
    September 30, September 30,
    --------------------- -----------------------
    2007 2006 2007 2006
    ----------- --------- ----------- -----------

    Stock-based
    compensation
    expense:
    Cost of goods
    sold $ 3,138 $ 2,524 $ 8,350 $ 8,236
    Research and
    development 18,360 13,267 56,129 38,108
    Selling, general
    and
    administrative 24,563 15,954 86,683 51,800
    Income tax effect (14,284) (6,165) (44,939) (21,340)
    ----------- --------- ----------- -----------
    Total stock-
    based
    compensation
    expense, net
    of tax $ 31,777 $ 25,580 $ 106,223 $ 76,804
    =========== ========= =========== ===========

    (2) For the three and nine months ended September 30, 2006, Gilead
    incurred $355.6 million of purchased in-process research and
    development as a result of the acquisition of Corus Pharma, Inc.
    in August 2006.
    *T

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    GILEAD SCIENCES, INC.
    RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
    (unaudited)
    (in thousands, except per share amounts)

    Below is a reconciliation of Gilead's GAAP operating results and
    diluted per share amounts as reported in the attached press release.
    Non-GAAP net income and net income per diluted share for the 2007
    periods are presented excluding the impact of stock-based
    compensation expense and the related methodology for deriving
    dilutive securities. Non-GAAP net income and net income per diluted
    share for the 2006 periods are presented excluding the impact of
    stock-based compensation expense and the related methodology for
    deriving dilutive securities, as well as the impact of the purchased
    in-process research and development charge incurred in connection
    with the acquisition of Corus Pharma, Inc. 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 the company's operating results as
    reported under GAAP.

    Three Months Ended Nine Months Ended
    September 30, September 30,
    ------------------- --------------------
    2007 2006 2007 2006
    -------- --------- ---------- --------

    Net income (loss) (GAAP) $398,319 $(52,164) $1,213,656 $475,690
    Purchased in-process research
    and development - 355,568 - 355,568
    Stock-based compensation
    expense, net of tax 31,777 25,580 106,223 76,804
    -------- --------- ---------- --------
    Net income (Non-GAAP) $430,096 $328,984 $1,319,879 $908,062
    ======== ========= ========== ========

    Shares used in per share
    calculation - diluted (GAAP) 959,043 914,866 962,804 956,202
    Dilutive securities 1,780 38,780 2,108 1,335
    -------- --------- ---------- --------
    Shares used in per share
    calculation - diluted (Non-
    GAAP) 960,823 953,646 964,912 957,537
    ======== ========= ========== ========

    Net income (loss) per share -
    diluted (GAAP) $ 0.42 $ (0.06) $ 1.26 $ 0.49
    ======== ========= ========== ========
    Net income per share -
    diluted (Non-GAAP) $ 0.45 $ 0.34 $ 1.37 $ 0.95
    ======== ========= ========== ========
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    GILEAD SCIENCES, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands)

    September 30, December 31,
    2007 2006
    ------------- ------------
    (unaudited) (Note 1)

    Cash, cash equivalents and marketable
    securities $ 2,218,051 $ 1,389,566
    Other current assets 1,778,278 1,492,355
    Property, plant and equipment, net 441,797 361,299
    Other noncurrent assets 879,449 842,761
    ------------- ------------
    Total assets $ 5,317,575 $ 4,085,981
    ============= ============

    Current liabilities $ 691,439 $ 764,276
    Long-term liabilities and minority
    interest 1,644,291 1,505,987
    Stockholders' equity 2,981,845 1,815,718
    ------------- ------------
    Total liabilities and stockholders'
    equity $ 5,317,575 $ 4,085,981
    ============= ============

    Note:
    (1) Derived from audited consolidated financial statements at that
    date.
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    GILEAD SCIENCES, INC.
    PRODUCT SALES SUMMARY
    (unaudited)
    (in thousands)

    Three Months Ended Nine Months Ended
    September 30, September 30,
    ------------------ ---------------------
    2007 2006 2007 2006
    --------- -------- ---------- ----------
    HIV products:
    Truvada - U.S. $ 206,681 $201,482 $ 579,725 $ 589,010
    Truvada - Europe 183,523 100,544 502,154 253,633
    Truvada - Other
    International 18,880 7,007 58,503 14,592
    --------- -------- ---------- ----------
    409,084 309,033 1,140,382 857,235
    ========= ======== ========== ==========

    Atripla - U.S. 240,217 68,373 641,706 68,373
    Atripla - Europe - - - -
    Atripla - Other
    International 884 - 1,962 -
    --------- -------- ---------- ----------
    241,101 68,373 643,668 68,373
    ========= ======== ========== ==========

    Viread - U.S. 63,488 71,795 194,841 222,439
    Viread - Europe 62,944 71,931 199,892 240,251
    Viread - Other International 22,676 26,898 69,950 67,151
    --------- -------- ---------- ----------
    149,108 170,624 464,683 529,841
    ========= ======== ========== ==========

    Emtriva - U.S. 3,315 5,064 10,213 13,384
    Emtriva - Europe 2,408 3,347 9,014 12,601
    Emtriva - Other
    International 738 861 5,161 1,914
    --------- -------- ---------- ----------
    6,461 9,272 24,388 27,899
    ========= ======== ========== ==========

    Total HIV products - U.S. 513,701 346,714 1,426,485 893,206
    Total HIV products - Europe 248,875 175,822 711,060 506,485
    Total HIV products - Other
    International 43,178 34,766 135,576 83,657
    --------- -------- ---------- ----------
    805,754 557,302 2,273,121 1,483,348
    ========= ======== ========== ==========

    Hepsera - U.S. 32,387 23,426 94,647 69,615
    Hepsera - Europe 36,087 25,012 103,004 77,242
    Hepsera - Other International 10,799 6,675 28,139 17,755
    --------- -------- ---------- ----------
    79,273 55,113 225,790 164,612
    ========= ======== ========== ==========

    AmBisome 68,508 55,313 194,764 164,740
    Other products 8,396 2,332 13,539 7,404
    --------- -------- ---------- ----------
    76,904 57,645 208,303 172,144
    ========= ======== ========== ==========

    Total product sales $ 961,931 $670,060 $2,707,214 $1,820,104
    ========= ======== ========== ==========
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