- Product Sales of $8.2 billion -
- Non-GAAP EPS of $3.22 per share -
- Revised 2015 Net Product Sales Guidance -
Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of
operations for the third quarter ended September 30, 2015. The financial
results that follow represent a year-over-year comparison of third
quarter 2015 to the third quarter 2014. Total revenues were $8.3 billion
in 2015 compared to $6.0 billion in 2014. Net income was $4.6 billion or
$3.06 per diluted share in 2015 compared to $2.7 billion or $1.67 per
diluted share in 2014. Non-GAAP net income, which excludes amounts
related to acquisition, restructuring, stock-based compensation and
other, was $4.8 billion or $3.22 per diluted share in 2015 compared to
$3.0 billion or $1.84 per diluted share in 2014.
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
(In millions, except per share amounts)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Product sales
|
|
$
|
8,211
|
|
|
$
|
5,968
|
|
|
$
|
23,742
|
|
|
$
|
17,252
|
Royalty, contract and other revenues
|
|
84
|
|
|
74
|
|
|
391
|
|
|
324
|
Total revenues
|
|
$
|
8,295
|
|
|
$
|
6,042
|
|
|
$
|
24,133
|
|
|
$
|
17,576
|
|
|
|
|
|
|
|
|
|
Net income attributable to Gilead
|
|
$
|
4,600
|
|
|
$
|
2,731
|
|
|
$
|
13,425
|
|
|
$
|
8,614
|
Non-GAAP net income attributable to Gilead
|
|
$
|
4,836
|
|
|
$
|
3,014
|
|
|
$
|
14,285
|
|
|
$
|
9,431
|
|
|
|
|
|
|
|
|
|
Diluted EPS
|
|
$
|
3.06
|
|
|
$
|
1.67
|
|
|
$
|
8.73
|
|
|
$
|
5.18
|
Non-GAAP diluted EPS
|
|
$
|
3.22
|
|
|
$
|
1.84
|
|
|
$
|
9.29
|
|
|
$
|
5.68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Sales
Total product sales for the third quarter of 2015 were $8.2 billion
compared to $6.0 billion for the third quarter of 2014. Product sales in
the U.S. were $5.6 billion compared to $4.2 billion for the third
quarter of 2014. In Europe, product sales were $1.7 billion compared to
$1.4 billion for the same period in 2014. Sales in other international
locations increased to $1.0 billion compared to $327 million in the
third quarter of 2014 primarily as a result of the launch of our HCV
products in Japan.
Antiviral Product Sales
Antiviral product sales were $7.7 billion for the third quarter of 2015,
compared to $5.5 billion for the third quarter of 2014 primarily due to
sales of Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), which was
approved in the U.S. and Europe in the fourth quarter of 2014, partially
offset by a decrease in sales of Sovaldi® (sofosbuvir 400 mg) due
primarily to the uptake in Harvoni.
Other Product Sales
Other product sales, which include Letairis® (ambrisentan),
Ranexa® (ranolazine) and AmBisome® (amphotericin B
liposome for injection), were $509 million for the third quarter of 2015
compared to $424 million for the third quarter of 2014.
Operating Expenses
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
(In millions)
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Non-GAAP research and development expenses (R&D)
|
|
$
|
713
|
|
|
$
|
586
|
|
|
$
|
2,066
|
|
|
$
|
1,686
|
Non-GAAP selling, general and administrative expenses (SG&A)
|
|
$
|
850
|
|
|
$
|
888
|
|
|
$
|
2,211
|
|
|
$
|
1,958
|
Note: Non-GAAP R&D and SG&A expenses exclude amounts related
to acquisition, restructuring, stock-based compensation and other.
During the third quarter of 2015, compared to the same period in 2014:
-
Non-GAAP research and development expenses increased primarily due to
the progression of Gilead's clinical studies.
-
Non-GAAP selling, general and administrative expenses decreased
primarily due to a cumulative catch-up of the branded prescription
drug fee recorded in the same period in 2014, partially offset by
higher costs to support Gilead's growth and the geographic expansion
in its business.
Cash, Cash Equivalents and Marketable Securities
As of September 30, 2015, Gilead had $25.1 billion of cash, cash
equivalents and marketable securities compared to $14.7 billion as of
June 30, 2015. This increase was primarily due to the issuance of senior
unsecured notes in September 2015 for a total aggregate principal amount
of $10.0 billion. During the third quarter of 2015, Gilead generated
$4.1 billion in operating cash flow, utilized $3.1 billion to repurchase
28 million shares and paid a cash dividend of $627 million, or $0.43 per
share.
Revised 2015 Full Year Guidance
Gilead updated its full year 2015 guidance as follows:
(In millions, except percentages and per share amounts)
|
|
Initially Provided February 3, 2015
|
|
|
Updated April 30, 2015
|
|
|
Updated July 28, 2015
|
|
|
Updated October 27, 2015
|
Net Product Sales
|
|
$26,000 - $27,000
|
|
|
$28,000 - $29,000
|
|
|
$29,000 - $30,000
|
|
|
$30,000 - $31,000
|
Non-GAAP*
|
|
|
|
|
|
|
|
|
|
|
|
Product Gross Margin
|
|
87% - 90%
|
|
|
87% - 90%
|
|
|
88% - 90%
|
|
|
88% - 90%
|
R&D expenses
|
|
$3,000 - $3,300
|
|
|
$3,000 - $3,300
|
|
|
$2,800 - $3,000
|
|
|
$2,800 - $3,000
|
SG&A expenses
|
|
$3,000 - $3,300
|
|
|
$3,000 - $3,300
|
|
|
$3,000 - $3,200
|
|
|
$3,000 - $3,200
|
Effective Tax Rate
|
|
18.0% - 20.0%
|
|
|
18.0% - 20.0%
|
|
|
17.0% - 18.0%
|
|
|
17.0% - 18.0%
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS Impact of Acquisition-Related, Restructuring,
Stock-Based Compensation Expenses and Other
|
|
$0.82 - $0.87
|
|
|
$0.82 - $0.87
|
|
|
$0.82 - $0.87
|
|
|
$0.82 - $0.87
|
|
|
|
|
* Non-GAAP product gross margin, R&D and SG&A expenses and effective
tax rate exclude amounts related to acquisition, restructuring,
stock-based compensation and other.
|
|
Product & Pipeline Updates Announced by Gilead
During the Third Quarter of 2015 Include:
Antiviral Program
-
Announced positive topline results from four international Phase 3
clinical studies (ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4)
evaluating a once-daily, fixed-dose combination of sofosbuvir (SOF)
with velpatasvir (VEL), an investigational pangenotypic NS5A
inhibitor, for the treatment of genotype 1-6 HCV infection. In the
ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, patients with genotype 1-6
HCV infection received 12 weeks of SOF/VEL. Among these patients, 21
percent had compensated cirrhosis and 28 percent had failed prior
treatments. In the ASTRAL-4 study, patients with decompensated
cirrhosis (Child-Pugh class B) received 12 weeks of SOF/VEL with or
without ribavirin, or 24 weeks of SOF/VEL.
-
Announced that the Japanese Ministry of Health, Labour and Welfare
approved Harvoni, the first once-daily single tablet regimen (STR) for
the treatment of chronic hepatitis C genotype 1 infection in adults.
In Japan, Harvoni is indicated for the suppression of viremia in
patients with genotype 1 HCV infection with or without compensated
cirrhosis, with a treatment duration of 12 weeks.
-
Announced that the company submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for an investigational,
once-daily STR that combines Gilead’s emtricitabine 200 mg and
tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF)
from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, for the treatment of HIV-1 infection
in adult and pediatric patients 12 years of age and older. The data
submitted in the NDA support the use of R/F/TAF among patients who are
HIV treatment-naïve or who are virologically suppressed and want to
replace their current antiretroviral treatment regimen.
-
Announced that the company’s Marketing Authorization Application (MAA)
for R/F/TAF was fully validated and under evaluation by the European
Medicines Agency (EMA). The data included in the application support
the use of R/F/TAF for the treatment of HIV-1 infection in adults and
pediatric patients 12 years and older.
-
Announced that the Committee for Medicinal Products for Human Use, the
scientific committee of the EMA, adopted a positive opinion on the
company’s MAA for E/C/F/TAF on September 25, 2015.
-
Announced a Phase 3 study of F/TAF for the treatment of HIV-1
infection met its primary objective. The ongoing study was designed to
explore the efficacy and safety of F/TAF-based regimens among
virologically suppressed adult patients switching from HIV treatment
regimens containing emtricitabine/tenofovir disoproxil fumarate. At
week 48, the F/TAF-based regimens and the TDF-based regimens achieved
similar rates of virologic suppression based on the proportion of
patients with HIV RNA levels (viral load) of less than 50 copies/mL.
-
Announced positive results from a Phase 3 clinical study of E/C/F/TAF
among virologically suppressed adult patients switching from
TDF-containing regimens. The study met its primary endpoint by
demonstrating non-inferiority of E/C/F/TAF to the TDF-based regimens
at week 48. The study also demonstrated statistical superiority among
patients with HIV-1 RNA levels less than 50 copies/mL at week 48 and
statistically significant improvements in bone and renal laboratory
parameters. These data were presented at the 8th IAS Conference on HIV
Pathogenesis, Treatment & Prevention.
Conference Call
At 4:30 p.m. Eastern Time today, Gilead's management will host a
conference call and a simultaneous webcast to discuss results from its
third quarter 2015 as well as provide a general business update. The
live webcast of the call can be accessed at the company's Investors page
at www.gilead.com/investors.
Please connect to the company's website at least 15 minutes prior to the
start of the call to ensure adequate time for any software download that
may be required to listen to the webcast. Alternatively, please call
1-877-359-9508 (U.S.) or 1-224-357-2393 (international) and dial the
conference ID 52441979 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, 2015. To access the phone replay,
please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international) and
dial the conference ID 52441979.
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. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
Non-GAAP Financial Information
Gilead has presented certain financial information in accordance with
U.S. generally accepted accounting principles (GAAP) and also on a
non-GAAP basis. Management believes this non-GAAP information is useful
for investors, when considered in conjunction with Gilead's GAAP
financial statements, because management uses such information
internally for its operating, budgeting and financial planning purposes.
Non-GAAP information is not prepared under a comprehensive set of
accounting rules and should only be used to supplement an understanding
of Gilead's operating results as reported under GAAP. A reconciliation
between GAAP and non-GAAP financial information is provided in the
tables on pages 7 and 8.
Forward-looking Statements
Statements included in this press release that are not historical in
nature are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Gilead cautions readers that
forward-looking statements are subject to certain risks and
uncertainties that could cause actual results to differ materially.
These risks and uncertainties include: Gilead's ability to achieve its
anticipated full year 2015 financial results; Gilead's ability to
sustain growth in revenues for its antiviral and other programs;
availability of funding for state AIDS Drug Assistance Programs (ADAPs);
continued fluctuations in ADAP purchases driven by federal and state
grant cycles which may not mirror patient demand and may cause
fluctuations in Gilead's earnings; the possibility of unfavorable
results from clinical trials involving sofosbuvir-containing products,
including fixed dose combination of SOF/VEL; Gilead's ability to
initiate clinical trials in its currently anticipated timeframes; 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; Gilead's ability to receive regulatory approvals in a
timely manner or at all, for new and current products, including
E/C/F/TAF, F/TAF and R/F/TAF; Gilead's ability to successfully
commercialize its products; the risk that physicians and patients may
not see advantages of these products over other therapies and may
therefore be reluctant to prescribe the products; the risk that
estimates of patients with HCV or anticipated patient demand may not be
accurate; the risk that private and public payers may be reluctant to
provide, or continue to provide, coverage or reimbursement for new
products, including Sovaldi and Harvoni; Gilead's ability to
successfully develop its oncology, inflammation, cardiovascular and
respiratory programs; safety and efficacy data from clinical studies may
not warrant further development of Gilead's product candidates,
including the fixed dose regimen of SOF/VEL; the potential for
additional austerity measures in European countries that may increase
the amount of discount required on Gilead's products; Gilead's ability
to complete its share repurchase program due to changes in its stock
price, corporate or other market conditions; Gilead’s ability to pay
dividends under its dividend program and the risk that its Board of
Directors may reduce the amount of the dividend; fluctuations in the
foreign exchange rate of the U.S. dollar that may cause an unfavorable
foreign currency exchange impact on Gilead's future revenues and pre-tax
earnings; and other risks identified from time to time in Gilead's
reports filed with the U.S. Securities and Exchange Commission (SEC). In
addition, Gilead makes estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses and related
disclosures. Gilead bases its estimates on historical experience and on
various other market specific and other relevant assumptions that it
believes to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets
and liabilities that are not readily apparent from other sources. Actual
results may differ significantly from these estimates. You are urged to
consider statements that include the words may, will, would, could,
should, might, believes, estimates, projects, potential, expects, plans,
anticipates, intends, continues, forecast, designed, goal, or the
negative of those words or other comparable words to be uncertain and
forward-looking. Gilead directs readers to its press releases, Quarterly
Report on Form 10-Q for the quarter ended June 30, 2015 and other
subsequent disclosure documents filed with the SEC. Gilead claims the
protection of the Safe Harbor contained in the Private Securities
Litigation Reform Act of 1995 for forward-looking statements.
All forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation to update any such
forward-looking statements.
Gilead owns or has rights to various trademarks, copyrights and trade
names used in our business, including the following: GILEAD®,
GILEAD SCIENCES®, HARVONI®, SOVALDI®,
TRUVADA®, STRIBILD®, COMPLERA®, EVIPLERA®,
VIREAD®, LETAIRIS®, RANEXA®, AMBISOME®,
ZYDELIG®, EMTRIVA®, TYBOST®, HEPSERA®,
VITEKTA®, CAYSTON®, VOLIBRIS®, and
RAPISCAN®.
ATRIPLA® is a registered trademark belonging to Bristol-Myers
Squibb & Gilead Sciences, LLC. LEXISCAN® is a
registered trademark belonging to Astellas U.S. LLC. MACUGEN®
is a registered trademark belonging to Eyetech, Inc. SUSTIVA®
is a registered trademark of Bristol-Myers Squibb Pharma Company. TAMIFLU®
is a registered trademark belonging to Hoffmann-La Roche 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).
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in millions, except per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
8,211
|
|
|
$
|
5,968
|
|
|
$
|
23,742
|
|
|
$
|
17,252
|
|
Royalty, contract and other revenues
|
|
84
|
|
|
74
|
|
|
391
|
|
|
324
|
|
Total revenues
|
|
8,295
|
|
|
6,042
|
|
|
24,133
|
|
|
17,576
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
1,064
|
|
|
987
|
|
|
2,944
|
|
|
2,725
|
|
Research and development expenses
|
|
743
|
|
|
630
|
|
|
2,257
|
|
|
1,809
|
|
Selling, general and administrative expenses
|
|
903
|
|
|
945
|
|
|
2,360
|
|
|
2,107
|
|
Total costs and expenses
|
|
2,710
|
|
|
2,562
|
|
|
7,561
|
|
|
6,641
|
|
Income from operations
|
|
5,585
|
|
|
3,480
|
|
|
16,572
|
|
|
10,935
|
|
Interest expense
|
|
(165
|
)
|
|
(104
|
)
|
|
(458
|
)
|
|
(282
|
)
|
Other income (expense), net
|
|
52
|
|
|
(5
|
)
|
|
108
|
|
|
(27
|
)
|
Income before provision for income taxes
|
|
5,472
|
|
|
3,371
|
|
|
16,222
|
|
|
10,626
|
|
Provision for income taxes
|
|
880
|
|
|
647
|
|
|
2,801
|
|
|
2,029
|
|
Net income
|
|
4,592
|
|
|
2,724
|
|
|
13,421
|
|
|
8,597
|
|
Net loss attributable to noncontrolling interest
|
|
(8
|
)
|
|
(7
|
)
|
|
(4
|
)
|
|
(17
|
)
|
Net income attributable to Gilead
|
|
$
|
4,600
|
|
|
$
|
2,731
|
|
|
$
|
13,425
|
|
|
$
|
8,614
|
|
Net income per share attributable to Gilead common stockholders -
basic
|
|
$
|
3.14
|
|
|
$
|
1.80
|
|
|
$
|
9.11
|
|
|
$
|
5.64
|
|
Shares used in per share calculation - basic
|
|
1,463
|
|
|
1,514
|
|
|
1,474
|
|
|
1,528
|
|
Net income per share attributable to Gilead common stockholders -
diluted
|
|
$
|
3.06
|
|
|
$
|
1.67
|
|
|
$
|
8.73
|
|
|
$
|
5.18
|
|
Shares used in per share calculation - diluted
|
|
1,503
|
|
|
1,637
|
|
|
1,538
|
|
|
1,662
|
|
Cash dividends declared per share
|
|
$
|
0.43
|
|
|
$
|
—
|
|
|
$
|
0.86
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(unaudited)
(in millions, except percentages and per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
Cost of goods sold reconciliation:
|
|
|
|
|
|
|
|
|
GAAP cost of goods sold
|
|
$
|
1,064
|
|
|
$
|
987
|
|
|
$
|
2,944
|
|
|
$
|
2,725
|
|
Stock-based compensation expenses
|
|
(3
|
)
|
|
(3
|
)
|
|
(9
|
)
|
|
(8
|
)
|
Acquisition related-amortization of purchased intangibles
|
|
(207
|
)
|
|
(201
|
)
|
|
(620
|
)
|
|
(600
|
)
|
Other(1)
|
|
2
|
|
|
—
|
|
|
3
|
|
|
—
|
|
Non-GAAP cost of goods sold
|
|
$
|
856
|
|
|
$
|
783
|
|
|
$
|
2,318
|
|
|
$
|
2,117
|
|
|
|
|
|
|
|
|
|
|
Product gross margin reconciliation:
|
|
|
|
|
|
|
|
|
GAAP product gross margin
|
|
87.0
|
%
|
|
83.5
|
%
|
|
87.6
|
%
|
|
84.2
|
%
|
Acquisition related-amortization of purchased intangibles
|
|
2.5
|
%
|
|
3.4
|
%
|
|
2.6
|
%
|
|
3.5
|
%
|
Non-GAAP product gross margin(2)
|
|
89.6
|
%
|
|
86.9
|
%
|
|
90.2
|
%
|
|
87.7
|
%
|
|
|
|
|
|
|
|
|
|
Research and development expenses reconciliation:
|
|
|
|
|
|
|
|
|
GAAP research and development expenses
|
|
$
|
743
|
|
|
$
|
630
|
|
|
$
|
2,257
|
|
|
$
|
1,809
|
|
Stock-based compensation expenses
|
|
(44
|
)
|
|
(40
|
)
|
|
(128
|
)
|
|
(111
|
)
|
Acquisition related expenses
|
|
—
|
|
|
—
|
|
|
(66
|
)
|
|
—
|
|
Other(1)
|
|
14
|
|
|
(4
|
)
|
|
3
|
|
|
(12
|
)
|
Non-GAAP research and development expenses
|
|
$
|
713
|
|
|
$
|
586
|
|
|
$
|
2,066
|
|
|
$
|
1,686
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses reconciliation:
|
|
|
|
|
|
|
|
|
GAAP selling, general and administrative expenses
|
|
$
|
903
|
|
|
$
|
945
|
|
|
$
|
2,360
|
|
|
$
|
2,107
|
|
Stock-based compensation expenses
|
|
(50
|
)
|
|
(56
|
)
|
|
(148
|
)
|
|
(146
|
)
|
Restructuring expenses
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
Acquisition related-amortization of purchased intangibles
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
(3
|
)
|
Other(1)
|
|
(3
|
)
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
Non-GAAP selling, general and administrative expenses
|
|
$
|
850
|
|
|
$
|
888
|
|
|
$
|
2,211
|
|
|
$
|
1,958
|
|
|
|
|
|
|
|
|
|
|
Operating margin reconciliation:
|
|
|
|
|
|
|
|
|
GAAP operating margin
|
|
67.3
|
%
|
|
57.6
|
%
|
|
68.7
|
%
|
|
62.2
|
%
|
Stock-based compensation expenses
|
|
1.2
|
%
|
|
1.6
|
%
|
|
1.2
|
%
|
|
1.5
|
%
|
Acquisition related expenses
|
|
—
|
%
|
|
—
|
%
|
|
0.3
|
%
|
|
—
|
%
|
Acquisition related-amortization of purchased intangibles
|
|
2.5
|
%
|
|
3.3
|
%
|
|
2.6
|
%
|
|
3.4
|
%
|
Other(1)
|
|
(0.2
|
)%
|
|
0.1
|
%
|
|
—
|
%
|
|
0.1
|
%
|
Non-GAAP operating margin(2)
|
|
70.8
|
%
|
|
62.6
|
%
|
|
72.7
|
%
|
|
67.2
|
%
|
|
|
|
|
|
|
|
|
|
Other income (expense) reconciliation:
|
|
|
|
|
|
|
|
|
GAAP other income (expense), net
|
|
$
|
52
|
|
|
$
|
(5
|
)
|
|
$
|
108
|
|
|
$
|
(27
|
)
|
Other(1)
|
|
1
|
|
|
—
|
|
|
1
|
|
|
(2
|
)
|
Non-GAAP other income (expense), net
|
|
$
|
53
|
|
|
$
|
(5
|
)
|
|
$
|
109
|
|
|
$
|
(29
|
)
|
|
|
|
|
|
|
|
|
|
Notes:
|
|
|
|
|
|
|
|
|
(1) Amounts related to consolidation of a contract
manufacturer, contingent consideration and/or other individually
insignificant amounts
|
(2) Amounts may not sum due to rounding
|
|
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION -
(Continued)
(unaudited)
(in millions, except percentages and per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
Effective tax rate reconciliation:
|
|
|
|
|
|
|
|
|
GAAP effective tax rate
|
|
16.1
|
%
|
|
19.2
|
%
|
|
17.3
|
%
|
|
19.1
|
%
|
Stock-based compensation expenses
|
|
0.4
|
%
|
|
—
|
%
|
|
0.1
|
%
|
|
—
|
%
|
Acquisition related-amortization of purchased intangibles
|
|
(0.2
|
)%
|
|
(1.0
|
)%
|
|
(0.4
|
)%
|
|
(0.9
|
)%
|
Non-GAAP effective tax rate(1)
|
|
16.3
|
%
|
|
18.2
|
%
|
|
17.0
|
%
|
|
18.2
|
%
|
|
|
|
|
|
|
|
|
|
Net income attributable to Gilead reconciliation:
|
|
|
|
|
|
|
|
|
GAAP net income attributable to Gilead
|
|
$
|
4,600
|
|
|
$
|
2,731
|
|
|
$
|
13,425
|
|
|
$
|
8,614
|
|
Stock-based compensation expenses
|
|
44
|
|
|
81
|
|
|
184
|
|
|
217
|
|
Restructuring expenses
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|
—
|
|
Acquisition related expenses
|
|
—
|
|
|
—
|
|
|
66
|
|
|
—
|
|
Acquisition related-amortization of purchased intangibles
|
|
202
|
|
|
198
|
|
|
605
|
|
|
589
|
|
Other(2)
|
|
(10
|
)
|
|
4
|
|
|
7
|
|
|
11
|
|
Non-GAAP net income attributable to Gilead
|
|
$
|
4,836
|
|
|
$
|
3,014
|
|
|
$
|
14,285
|
|
|
$
|
9,431
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share reconciliation:
|
|
|
|
|
|
|
|
|
GAAP diluted earnings per share
|
|
$
|
3.06
|
|
|
$
|
1.67
|
|
|
$
|
8.73
|
|
|
$
|
5.18
|
|
Stock-based compensation expenses
|
|
0.03
|
|
|
0.05
|
|
|
0.12
|
|
|
0.13
|
|
Acquisition related expenses
|
|
—
|
|
|
—
|
|
|
0.04
|
|
|
—
|
|
Acquisition related-amortization of purchased intangibles
|
|
0.13
|
|
|
0.12
|
|
|
0.39
|
|
|
0.35
|
|
Other(2)
|
|
(0.01
|
)
|
|
—
|
|
|
0.01
|
|
|
0.01
|
|
Non-GAAP diluted earnings per share(1)
|
|
$
|
3.22
|
|
|
$
|
1.84
|
|
|
$
|
9.29
|
|
|
$
|
5.68
|
|
|
|
|
|
|
|
|
|
|
Shares used in per share calculation (diluted) reconciliation:
|
|
|
|
|
|
|
|
|
GAAP shares used in per share calculation (diluted)
|
|
1,503
|
|
|
1,637
|
|
|
1,538
|
|
|
1,662
|
|
Share impact of current stock-based compensation rules
|
|
(1
|
)
|
|
(1
|
)
|
|
(1
|
)
|
|
(1
|
)
|
Non-GAAP shares used in per share calculation (diluted)
|
|
1,502
|
|
|
1,636
|
|
|
1,537
|
|
|
1,661
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustment summary:
|
|
|
|
|
|
|
|
|
Cost of goods sold adjustments
|
|
$
|
208
|
|
|
$
|
204
|
|
|
$
|
626
|
|
|
$
|
608
|
|
Research and development expenses adjustments
|
|
30
|
|
|
44
|
|
|
191
|
|
|
123
|
|
Selling, general and administrative expenses adjustments
|
|
53
|
|
|
57
|
|
|
149
|
|
|
149
|
|
Other income (expense) adjustments
|
|
1
|
|
|
—
|
|
|
1
|
|
|
(2
|
)
|
Total non-GAAP adjustments before tax
|
|
292
|
|
|
305
|
|
|
967
|
|
|
878
|
|
Income tax effect
|
|
(58
|
)
|
|
(23
|
)
|
|
(116
|
)
|
|
(61
|
)
|
Other(2)
|
|
2
|
|
|
—
|
|
|
9
|
|
|
—
|
|
Total non-GAAP adjustments after tax attributable to Gilead
|
|
$
|
236
|
|
|
$
|
282
|
|
|
$
|
860
|
|
|
$
|
817
|
|
|
|
|
|
|
|
|
|
|
Notes:
|
|
|
|
|
|
|
|
|
(1) Amounts may not sum due to rounding
|
(2) Amounts related to consolidation of a contract
manufacturer, contingent consideration and/or other individually
insignificant amounts
|
|
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in millions)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2015
|
|
2014(1)
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
25,114
|
|
|
$
|
11,726
|
|
Accounts receivable, net
|
|
6,105
|
|
|
4,635
|
|
Inventories
|
|
1,988
|
|
|
1,386
|
|
Property, plant and equipment, net
|
|
2,143
|
|
|
1,674
|
|
Intangible assets, net
|
|
10,454
|
|
|
11,073
|
|
Goodwill
|
|
1,172
|
|
|
1,172
|
|
Other assets
|
|
3,661
|
|
|
2,998
|
|
Total assets
|
|
$
|
50,637
|
|
|
$
|
34,664
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
9,360
|
|
|
$
|
5,761
|
|
Long-term liabilities
|
|
23,329
|
|
|
13,069
|
|
Equity component of currently redeemable convertible notes
|
|
4
|
|
|
15
|
|
Stockholders’ equity(2)
|
|
17,944
|
|
|
15,819
|
|
Total liabilities and stockholders’ equity
|
|
$
|
50,637
|
|
|
$
|
34,664
|
|
|
|
|
|
|
Notes:
|
|
|
|
|
(1) Derived from the audited consolidated financial
statements as of December 31, 2014.
|
(2) As of September 30, 2015, there were 1,449 million
shares of common stock issued and outstanding.
|
|
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY
(unaudited)
(in millions)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Antiviral products:
|
|
|
|
|
|
|
|
|
Harvoni – U.S.
|
|
$
|
2,541
|
|
|
$
|
—
|
|
|
$
|
8,383
|
|
|
$
|
—
|
Harvoni – Europe
|
|
532
|
|
|
20
|
|
|
1,632
|
|
|
20
|
Harvoni – Other International
|
|
259
|
|
|
—
|
|
|
504
|
|
|
—
|
|
|
3,332
|
|
|
20
|
|
|
10,519
|
|
|
20
|
|
|
|
|
|
|
|
|
|
Sovaldi – U.S.
|
|
692
|
|
|
2,200
|
|
|
1,728
|
|
|
7,329
|
Sovaldi – Europe
|
|
337
|
|
|
523
|
|
|
1,342
|
|
|
1,087
|
Sovaldi – Other International
|
|
437
|
|
|
73
|
|
|
659
|
|
|
135
|
|
|
1,466
|
|
|
2,796
|
|
|
3,729
|
|
|
8,551
|
|
|
|
|
|
|
|
|
|
Truvada – U.S.
|
|
561
|
|
|
472
|
|
|
1,470
|
|
|
1,239
|
Truvada – Europe
|
|
268
|
|
|
327
|
|
|
846
|
|
|
988
|
Truvada – Other International
|
|
74
|
|
|
78
|
|
|
207
|
|
|
216
|
|
|
903
|
|
|
877
|
|
|
2,523
|
|
|
2,443
|
|
|
|
|
|
|
|
|
|
Atripla – U.S.
|
|
597
|
|
|
621
|
|
|
1,640
|
|
|
1,689
|
Atripla – Europe
|
|
161
|
|
|
223
|
|
|
533
|
|
|
694
|
Atripla – Other International
|
|
60
|
|
|
51
|
|
|
161
|
|
|
162
|
|
|
818
|
|
|
895
|
|
|
2,334
|
|
|
2,545
|
|
|
|
|
|
|
|
|
|
Stribild – U.S.
|
|
422
|
|
|
278
|
|
|
1,068
|
|
|
695
|
Stribild – Europe
|
|
73
|
|
|
38
|
|
|
199
|
|
|
93
|
Stribild – Other International
|
|
16
|
|
|
11
|
|
|
47
|
|
|
24
|
|
|
511
|
|
|
327
|
|
|
1,314
|
|
|
812
|
|
|
|
|
|
|
|
|
|
Complera / Eviplera – U.S.
|
|
210
|
|
|
183
|
|
|
580
|
|
|
467
|
Complera / Eviplera – Europe
|
|
137
|
|
|
134
|
|
|
427
|
|
|
375
|
Complera / Eviplera – Other International
|
|
13
|
|
|
13
|
|
|
40
|
|
|
38
|
|
|
360
|
|
|
330
|
|
|
1,047
|
|
|
880
|
|
|
|
|
|
|
|
|
|
Viread – U.S.
|
|
151
|
|
|
122
|
|
|
385
|
|
|
320
|
Viread – Europe
|
|
76
|
|
|
87
|
|
|
233
|
|
|
259
|
Viread – Other International
|
|
70
|
|
|
66
|
|
|
184
|
|
|
168
|
|
|
297
|
|
|
275
|
|
|
802
|
|
|
747
|
|
|
|
|
|
|
|
|
|
Other Antiviral – U.S.
|
|
8
|
|
|
14
|
|
|
30
|
|
|
34
|
Other Antiviral – Europe
|
|
6
|
|
|
9
|
|
|
20
|
|
|
28
|
Other Antiviral – Other International
|
|
1
|
|
|
1
|
|
|
3
|
|
|
5
|
|
|
15
|
|
|
24
|
|
|
53
|
|
|
67
|
|
|
|
|
|
|
|
|
|
Total antiviral products – U.S.
|
|
5,182
|
|
|
3,890
|
|
|
15,284
|
|
|
11,773
|
Total antiviral products – Europe
|
|
1,590
|
|
|
1,361
|
|
|
5,232
|
|
|
3,544
|
Total antiviral products – Other International
|
|
930
|
|
|
293
|
|
|
1,805
|
|
|
748
|
|
|
7,702
|
|
|
5,544
|
|
|
22,321
|
|
|
16,065
|
Other products:
|
|
|
|
|
|
|
|
|
Letairis
|
|
181
|
|
|
146
|
|
|
508
|
|
|
414
|
Ranexa
|
|
161
|
|
|
132
|
|
|
419
|
|
|
366
|
AmBisome
|
|
88
|
|
|
98
|
|
|
276
|
|
|
284
|
Zydelig
|
|
36
|
|
|
6
|
|
|
92
|
|
|
6
|
Other
|
|
43
|
|
|
42
|
|
|
126
|
|
|
117
|
|
|
509
|
|
|
424
|
|
|
1,421
|
|
|
1,187
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
$
|
8,211
|
|
|
$
|
5,968
|
|
|
$
|
23,742
|
|
|
$
|
17,252
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20151027006687/en/
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