Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results
of operations for the quarter ended September 30, 2011. Total
revenues for the third quarter of 2011 were $2.12 billion, up 9
percent compared to total revenues of $1.94 billion for the third
quarter of 2010. Net income for the third quarter of 2011 was
$741.1 million, or $0.95 per diluted share, compared to net income
for the third quarter of 2010 of $704.9 million, or $0.83 per
diluted share. Non-GAAP net income for the third quarter of 2011,
which excludes after-tax acquisition-related, restructuring and
stock-based compensation expenses, was $795.2 million, or $1.02 per
diluted share, compared to non-GAAP net income for the third
quarter of 2010 of $759.7 million, or $0.90 per diluted share.
Product Sales
Product sales increased 11 percent to $2.07 billion for the
third quarter of 2011, compared to $1.87 billion in the third
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 9 percent to $1.79 billion in
the third quarter of 2011, up from $1.65 billion for the same
quarter of 2010.
Sales of Atripla for the treatment of HIV infection increased 7
percent to $794.7 million for the third quarter of 2011, up from
$742.7 million in the third quarter of 2010, driven primarily by
sales volume growth in Europe and the United States.
Sales of Truvada for the treatment of HIV infection increased 11
percent to $744.7 million for the third quarter of 2011, up from
$668.7 million in the third quarter of 2010, driven primarily by
sales volume growth in Europe and the United States.
Sales of Viread® (tenofovir disoproxil fumarate) for the
treatment of HIV infection and chronic hepatitis B increased 5
percent to $192.9 million for the third quarter of 2011, up from
$184.3 million in the third quarter of 2010. Sales increases in
Europe and the United States were partially offset by lower sales
in Latin America.
Sales of our newest product, Complera® (emtricitabine 200
mg/rilpilvirine 25 mg/tenofovir disoproxil fumarate 300 mg) for the
treatment of HIV infection, were $19.0 million for the third
quarter of 2011. On August 10, 2011, the U.S. Food and Drug
Administration (FDA) approved Complera, a new once-daily, complete
single-tablet HIV treatment regimen for treatment-naïve adults.
Letairis
Sales of Letairis® (ambrisentan) for the treatment of pulmonary
arterial hypertension increased 31 percent to $79.0 million for the
third quarter of 2011, up from $60.4 million for the third quarter
of 2010, driven primarily by sales volume growth.
Ranexa
Sales of Ranexa® (ranolazine) for the treatment of chronic
angina increased 36 percent to $82.0 million for the third quarter
of 2011, up from $60.3 million for the third quarter of 2010,
driven primarily by sales volume growth.
Other Products
Sales of other products were $153.6 million for the third
quarter of 2011 compared to $149.1 million for the third 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). Sales of Cayston were $23.6 million for
the third quarter of 2011, up from $14.7 million in the same
quarter of 2010 driven by sales volume growth in the United
States.
Royalty, Contract and Other
Revenues
Royalty, contract and other revenues from collaborations were
$55.8 million in the third quarter of 2011, down 23 percent from
$72.1 million in the third quarter of 2010. This decrease was due
to an 89 percent decrease in Tamiflu royalties from F. Hoffmann-La
Roche Ltd to $3.7 million in the third quarter of 2011 from $34.5
million in the third quarter of 2010, as pandemic planning
initiatives worldwide have declined.
Research and Development
Research and development (R&D) expenses in the third quarter
of 2011 were $290.1 million, compared to $230.4 million for the
third quarter of 2010. Non-GAAP R&D expenses for the third
quarter of 2011, which exclude acquisition-related, restructuring
and stock-based compensation expenses, were $269.3 million,
compared to $203.2 million for the third quarter of 2010. The
increase in non-GAAP R&D expenses was due primarily to
increased clinical activities and expenses associated with
acquisitions and collaborations.
Selling, General and
Administrative
Selling, general and administrative (SG&A) expenses in the
third quarter of 2011 were $295.9 million, compared to $250.6
million for the third quarter of 2010. Non-GAAP SG&A expenses
for the third quarter of 2011, which exclude acquisition-related,
restructuring and stock-based compensation expenses, were $265.1
million, compared to $220.6 million for the third 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, expansion of commercial activities and legal
expenses.
Net Foreign Currency Exchange
Impact
The net foreign currency exchange impact on third quarter 2011
revenues and pre-tax earnings, which includes revenues and expenses
generated from outside the United States, was a favorable $19.9
million and $2.6 million, respectively, compared to the third
quarter of 2010.
Cash, Cash Equivalents and Marketable
Securities
As of September 30, 2011, Gilead had cash, cash equivalents and
marketable securities of $5.48 billion compared to $5.32 billion as
of December 31, 2010. Gilead generated $2.66 billion of operating
cash flow during the first nine months of 2011 including $897.1
million generated in the third quarter of 2011.
Share Repurchase Update
During the quarter, Gilead repurchased and retired a total of
$883.6 million or 22.4 million shares of common stock. The company
has completed its May 2010 $5.00 billion share repurchase program,
which retired a total of 135.5 million common shares at an average
price of $36.89 per share, and commenced its January 2011
three-year $5.00 billion share repurchase program. Since January
2010, Gilead repurchased and retired $6.18 billion or 164.2 million
common shares or 18 percent of the company’s common stock
outstanding at December 31, 2009.
Corporate Highlights
In July, Gilead announced an expansion of its access initiatives
for its antiretrovirals in resource-limited countries. The company
established new licensing terms with four India-based drug
manufacturers – Hetero Drugs Ltd., Matrix Laboratories Ltd.,
Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. – for three of
its late-stage HIV pipeline products. In addition, Gilead became
the first pharmaceutical company to enter a licensing agreement
with the Medicines Patent Pool Foundation.
In August, Gilead announced the purchase of a clinical biologics
manufacturing facility and certain process development assets
located in Oceanside, California from Genentech, a member of the
Roche Group. This transaction was completed in September 2011.
Initially, Gilead will use the facility for the process development
and manufacture of its investigational monoclonal antibody
candidates.
Also in August, Gilead announced that it had resolved all
outstanding issues raised in a Warning Letter issued by the U.S.
FDA in September 2010 related to its San Dimas, California
manufacturing facility.
Product and Pipeline
Update
Antiviral Franchise
In July, Gilead announced Phase 3 clinical trial results from
the pivotal Study 145 showing that its investigational
antiretroviral elvitegravir, a novel oral integrase inhibitor being
evaluated for the treatment of HIV-1 infection, was non-inferior to
the integrase inhibitor raltegravir after 48 weeks of therapy in
treatment-experienced patients. The data were presented at the 6th
International AIDS Society Conference on HIV Pathogenesis,
Treatment and Prevention (IAS 2011) in Rome, Italy.
In August, Gilead announced that the FDA had approved Complera,
a complete single-tablet regimen for the treatment of HIV-1
infection in treatment-naïve adults.
Also in August, Gilead announced that a Phase 3 clinical trial
(Study 102) of its investigational fixed-dose, single-tablet “Quad”
regimen of elvitegravir, cobicistat, emtricitabine and tenofovir
disoproxil fumarate, being evaluated for HIV-1 infection in
treatment-naïve patients, met its primary objective of
non-inferiority at week 48 as compared to Atripla.
In September, Gilead announced that the second pivotal Phase 3
clinical trial (Study 103) of the “Quad” in treatment-naïve HIV-1
infected patients met its primary objective of non-inferiority at
week 48 as compared to ritonavir-boosted atazanavir plus Truvada.
Upon this announcement, Gilead updated its timelines for filing for
U.S. regulatory approval to take place prior to the end of this
year.
Also in September, Gilead announced that the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee
of the European Medicines Agency, had adopted a positive opinion on
the company’s Marketing Authorisation Application for the
once-daily single-tablet regimen, Eviplera®, launched first as
Complera in the United States and is a combination of Gilead’s
Truvada and Tibotec Pharmaceuticals’ non-nucleoside reverse
transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride))
for the treatment of HIV-1 infection in antiretroviral-naïve adults
with a viral load less than or equal to 100,000 HIV-1 RNA
copies/mL.
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 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
1-866-730-5765 (U.S.) or 1-857-350-1589 (international) and dial
the participant passcode 52967950 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 30,
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
50031971.
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 third quarter of
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
7.
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 AIDS Drug Assistance Programs (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 New Drug Applications for new product
candidates in the timelines currently anticipated, including for
elvitegravir and cobicistat; Gilead’s ability to receive regulatory
approvals in a timely manner or at all, for new and current
products, including the Quad; Gilead’s ability to successfully
commercialize its products, including the risk that physicians may
not see advantages of Complera over other therapies and may
therefore be reluctant to prescribe the product; 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;
initiating and completing clinical trials may take longer or cost
more than expected; 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 $5.00 billion share
repurchase program due to changes in its stock price, corporate or
other market conditions; 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 Report on Form 10-Q for the quarter ended June 30, 2011
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, Complera, 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).
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED
STATEMENTS OF INCOME (unaudited) (in thousands, except per
share amounts)
Three Months Ended Nine Months Ended September 30, September 30,
2011 2010 2011 2010 Revenues: Product sales $ 2,065,859 $ 1,865,559
$ 5,969,025 $ 5,459,683 Royalty, contract and other revenues
55,801 72,097 215,982
491,050 Total revenues 2,121,660
1,937,656 6,185,007 5,950,733
Costs and expenses: Cost of goods sold 531,989 477,584 1,539,963
1,373,539 Research and development 290,066 230,440 826,915 680,170
Selling, general and administrative 295,927
250,559 895,764 764,183 Total
costs and expenses 1,117,982 958,583
3,262,642 2,817,892 Income from
operations 1,003,678 979,073 2,922,365 3,132,841 Interest and other
income, net 14,406 15,593 40,216 49,523 Interest expense
(43,097 ) (33,620 ) (130,420 ) (68,339 )
Income before provision for income taxes 974,987 961,046 2,832,161
3,114,025 Provision for income taxes 237,449
258,883 704,861 850,641 Net
income 737,538 702,163 2,127,300 2,263,384 Net loss attributable to
noncontrolling interest 3,586 2,713
11,192 8,454 Net income attributable to
Gilead $ 741,124 $ 704,876 $ 2,138,492 $
2,271,838
Net income per share attributable to
Gilead common stockholders - basic
$ 0.97 $ 0.85 $ 2.72 $ 2.61
Net income per share attributable to
Gilead common stockholders - diluted
$ 0.95 $ 0.83 $ 2.66 $ 2.55 Shares used
in per share calculation - basic 767,033
833,006 787,272 871,887 Shares
used in per share calculation - diluted 781,312
847,228 802,762 890,216
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, 2011 2010 2011 2010
Cost of goods
sold reconciliation: GAAP cost of goods sold $ 531,989 $
477,584 $ 1,539,963 $ 1,373,539 Acquisition-related amortization of
inventory mark-up - - - (7,020 ) Acquisition-related amortization
of purchased intangibles (17,407 ) (14,981 ) (52,222 ) (44,946 )
Stock-based compensation expenses (2,234 ) (2,728 )
(7,765 ) (8,548 ) Non-GAAP cost of goods sold $
512,348 $ 459,875 $ 1,479,976 $ 1,313,025
Product gross margin reconciliation: GAAP
product gross margin 74.3 %
74.4 % 74.3 % 74.9 % Acquisition-related amortization of inventory
mark-up - - - 0.1 % Acquisition-related amortization of purchased
intangibles 0.8 % 0.8 % 0.9 % 0.8 % Stock-based compensation
expenses 0.1 % 0.1 % 0.1 % 0.2 %
Non-GAAP product gross margin (1) 75.3 %
75.4 % 75.3 % 76.0 %
Research and
development expenses reconciliation: GAAP research and
development expenses $ 290,066 $ 230,440 $ 826,915 $ 680,170
Acquisition-related transaction costs - - (446 ) -
Acquisition-related remeasurement of contingent consideration
(1,616 ) - (1,198 ) - Restructuring expenses (806 ) (6,315 ) (1,360
) (10,545 ) Stock-based compensation expenses (18,389 )
(20,946 ) (54,529 ) (62,536 ) Non-GAAP
research and development expenses $ 269,255 $ 203,179
$ 769,382 $ 607,089
Selling, general and
administrative expenses reconciliation: GAAP selling, general
and administrative expenses $ 295,927 $ 250,559 $ 895,764 $ 764,183
Acquisition-related transaction costs (535 ) (387 ) (1,278 ) (387 )
Restructuring expenses (4,388 ) (1,413 ) (6,054 ) (14,903 )
Stock-based compensation expenses (25,897 ) (28,128 )
(83,821 ) (75,606 ) Non-GAAP selling, general and
administrative expenses $ 265,107 $ 220,631 $ 804,611
$ 673,287
Operating margin
reconciliation: GAAP operating margin 47.3 % 50.5 % 47.2 % 52.6
% Acquisition-related transaction costs 0.0 % 0.0 % 0.0 % 0.0 %
Acquisition-related amortization of inventory mark-up - - - 0.1 %
Acquisition-related amortization of purchased intangibles 0.8 % 0.8
% 0.8 % 0.8 % Acquisition-related remeasurement of contingent
consideration 0.1 % - 0.0 % - Restructuring expenses 0.2 % 0.4 %
0.1 % 0.4 % Stock-based compensation expenses 2.2 %
2.7 % 2.4 % 2.5 % Non-GAAP operating margin (1)
50.7 % 54.4 % 50.6 % 56.4 %
Net income attributable to Gilead reconciliation: GAAP net
income attributable to Gilead $ 741,124 $ 704,876 $ 2,138,492 $
2,271,838 Acquisition-related transaction costs 535 388 1,724 388
Acquisition-related amortization of inventory mark-up - - - 5,090
Acquisition-related amortization of purchased intangibles 13,172
10,951 39,225 32,680 Acquisition-related remeasurement of
contingent consideration 1,213 - 900 - Restructuring expenses 3,908
5,639 5,569 18,488 Stock-based compensation expenses 35,221
37,812 109,750 106,620
Non-GAAP net income attributable to Gilead $ 795,173
$ 759,666 $ 2,295,660 $ 2,435,104
Diluted earnings per share reconciliation: GAAP diluted
earnings per share $ 0.95 $ 0.83 $ 2.66 $ 2.55 Acquisition-related
transaction costs 0.00 0.00 0.00 0.00 Acquisition-related
amortization of inventory mark-up - - - 0.01 Acquisition-related
amortization of purchased intangibles 0.02 0.01 0.05 0.04
Acquisition-related remeasurement of contingent consideration 0.00
- 0.00 - Restructuring expenses 0.01 0.01 0.01 0.02 Stock-based
compensation expenses 0.05 0.04
0.14 0.12 Non-GAAP diluted earnings per share
(1) $ 1.02 $ 0.90 $ 2.87 $ 2.74
Shares used in per share calculation (diluted)
reconciliation: GAAP shares used in per share calculation
(diluted) 781,312 847,228 802,762 890,216 Share impact of current
stock-based compensation guidance (2,096 ) (2,208 )
(2,007 ) (1,621 ) Non-GAAP shares used in per share
calculation (diluted) 779,216 845,020
800,755 888,595
Non-GAAP
adjustment summary: Cost of goods sold adjustments $ 19,641 $
17,709 $ 59,987 $ 60,514 Research and development expenses
adjustments 20,811 27,261 57,533 73,081 Selling, general and
administrative expenses adjustments 30,820
29,928 91,153 90,896 Total
non-GAAP adjustments before tax 71,272 74,898 208,673 224,491
Income tax effect (17,223 ) (20,108 ) (51,505
) (61,225 ) Total non-GAAP adjustments after tax $ 54,049
$ 54,790 $ 157,168 $ 163,266
Note: (1) Amounts may not sum due to rounding
GILEAD
SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in
thousands) September 30, December 31, 2011
2010 (unaudited) (Note 1) Cash, cash equivalents and
marketable securities $ 5,482,116 $ 5,318,071 Accounts receivable,
net 1,867,092 1,621,966 Inventories 1,337,751 1,203,809 Property,
plant and equipment, net 761,190 701,235 Intangible assets
2,111,003 1,425,592 Other assets 1,080,746 1,321,957
Total assets $ 12,639,898 $ 11,592,630 Current liabilities $
2,224,431 $ 2,464,950 Long-term liabilities 4,182,261 3,005,843
Stockholders’ equity (Note 2) 6,233,206 6,121,837
Total liabilities and stockholders’ equity $ 12,639,898 $
11,592,630 Notes: (1) Derived from audited
consolidated financial statements at that date. (2) As of
September 30, 2011, there were 756,094 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, 2011 2010 2011 2010 Antiviral
products: Atripla – U.S. $ 501,576 $ 491,645 $ 1,474,580 $
1,414,365 Atripla – Europe 254,957 222,727 775,167 661,424 Atripla
– Other International 38,166 28,320 111,456
75,579 794,699 742,692 2,361,203
2,151,368 Truvada – U.S. 357,660 325,545 1,011,837 969,884
Truvada – Europe 319,149 292,028 940,312 867,929 Truvada – Other
International 67,918 51,168 176,990
130,409 744,727 668,741 2,129,139
1,968,222 Viread – U.S. 87,712 82,431 240,420 239,225 Viread
– Europe 82,927 72,489 245,062 216,636 Viread – Other International
22,248 29,343 61,517 85,260
192,887 184,263 546,999 541,121 Hepsera
– U.S. 14,170 19,055 42,809 60,090 Hepsera – Europe 18,223 25,095
60,293 87,021 Hepsera – Other International 3,238
3,369 9,281 9,866 35,631 47,519
112,383 156,977 Complera - U.S. 19,044 - 19,044 -
Complera - Europe - - - - Complera - Other - -
- - 19,044 - 19,044 -
Emtriva – U.S. 4,666 3,966 12,482 12,345 Emtriva – Europe 1,772
1,657 5,162 5,216 Emtriva – Other International 1,229
1,073 3,331 3,036 7,667 6,696
20,975 20,597 Total Antiviral products – U.S. 984,828
922,642 2,801,172 2,695,909 Total Antiviral products – Europe
677,028 613,996 2,025,996 1,838,226 Total Antiviral products –
Other International 132,799 113,273 362,575
304,150 1,794,655 1,649,911 5,189,743
4,838,285 AmBisome 82,241 75,132 249,372 230,355
Letairis 78,954 60,446 214,765 176,293 Ranexa 81,983 60,312 236,353
172,015 Other products 28,026 19,758 78,792
42,735 271,204 215,648 779,282
621,398 Total product sales $ 2,065,859 $ 1,865,559 $
5,969,025 $ 5,459,683
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