Gilead Sciences 2012 Annual Report Download - page 8

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Roberto Tascione, General Manager, Italy, Gilead Sciences
EU MARKETING APPROVAL SUBMITTED
STRIBILD® (ELVITEGRAVIR 150MG/COBICISTAT 150MG/
EMTRICITABINE 200MG/TENOFOVIR DISOPROXIL
FUMARATE 300MG)
POTENTIAL INDICATION: HIV/AIDS
U.S. AND EU MARKETING APPROVALS SUBMITTED
COBICISTAT (PHARMACOKINETIC ENHANCER)
POTENTIAL INDICATION: HIV/AIDS
ELVITEGRAVIR (INTEGRASE INHIBITOR)
POTENTIAL INDICATION: HIV/AIDS
PHASE 3
SINGLE TABLET REGIMEN OF ELVITEGRAVIR/COBICISTAT/
EMTRICITABINE/TENOFOVIR ALAFENAMIDE
POTENTIAL INDICATION: HIV/AIDS
PHASE 2
SINGLE TABLET REGIMEN OF DARUNAVIR/COBICISTAT/
EMTRICITABINE/TENOFOVIR ALAFENAMIDE
POTENTIAL INDICATION: HIV/AIDS
Gilead is working to develop the next generation of HIV
single tablet regimens that are effective, tolerable and
convenient and that may provide certain advantages
over existing treatment options. This is particularly
important as more individuals with HIV are diagnosed
and brought into care, because life-long treatment is
required to control the virus.
We are conducting clinical trials of tenofovir alafen-
amide (TAF; GS-7340); TAF may be able to exhibit greater
antiviral efficacy than Viread® at a dose that is 10 times
lower, which may improve the tolerability of HIV therapy.
Phase 3 studies will examine a once-daily single tablet
regimen of TAF, Emtriva,
® the integrase inhibitor
elvitegravir and the boosting agent cobicistat, compared
to Stribild® among patients new to HIV therapy.
While HIV medicines reduce the level of virus in the
blood to undetectable levels, the ultimate goal is to
develop a cure. Gilead scientists are engaged in early-
stage research to identify novel therapeutic agents that
may help eradicate HIV infection.
FOCUS AREA
HIV/AIDS
FINANCIAL
HIGHLIGHTS
* The earnings per share calculations for all
periods presented reflect the two-for-one stock
split effective on January 25, 2013.
Non-GAAP diluted earnings per share for 2010
exclude the impact of after-tax acquisition-
related expenses of $0.08, restructuring
expenses of $0.02 and stock-based
compensation expenses of $0.08.
Non-GAAP diluted earnings per share for 2011
exclude after-tax acquisition-related expenses
of $0.05 and stock-based compensation
expenses of $0.09.
Non-GAAP diluted earnings per share for 2012
exclude after-tax acquisition-related expenses
of $0.08, restructuring expenses of $0.01 and
stock-based compensation expenses of $0.22.
EARNINGS PER SHARE
10 11 12
GAAP DILUTED
EARNINGS PER SHARE
NON-GAAP DILUTED
EARNINGS PER SHARE
*
$
2.00 –
$
1.75–
$
1.50–
$
1.25 –
$
1.00 –
$
.75 –
$
.50 –
$
.25 –
$
0 –
PRODUCT SALES
($ IN MILLIONS)
10 11 12
$1
0,000 –
$ 9,000 –
$ 8,000 –
$ 7, 000 –
$ 6,000 –
$ 5,000 –
$ 4,000 –
$ 3,000 –
$ 2,000 –
$ 1,000 –
$ 0 –
OTHER
AMBISOME
RANEXA
LETAIRIS
ANTIVIRAL
FRANCHISE
TOTAL REVENUES
($ IN MILLIONS)
10 11 12
$1
0,000 –
$ 9,000 –
$ 8,000 –
$ 7, 000 –
$ 6,000 –
$ 5,000 –
$ 4,000 –
$ 3,000 –
$ 2,000 –
$ 1,000 –
$ 0 –
OPERATING CASH FLOW
($ IN MILLIONS)
$
4,000 –
$
3,500 –
$
3,000 –
$
2,500 –
$
2,000 –
$
1,500 –
$
1,000 –
$
500 –
$
0 –
10 11 12
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