Q4 2015 Earnings Results
February 2, 2016
Forward-looking Statements
2
The projected financial results presented in the following slides represent management's estimates of Gilead’s future financial results. 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 2016 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 investigational compounds, including GS-5734 and filgotinib; 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 F/TAF, R/F/TAF and SOF/VEL; Gilead's ability to successfully commercialize its products, including Genvoya;
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; the potential for pricing pressure from additional competitive HCV launches or austerity measures in
European countries and Japan 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 September 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.
This presentation includes GAAP and non-GAAP financial measures, a complete reconciliation between these two measures is available on the
Company’s website at www.gilead.com within the investor section. 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 U.S. GAAP.
Q4 2015 Earnings Call Agenda
Introduction Patrick O’Brien, VP, Investor Relations
Commentary
Q&A
John Martin, Chairman and CEO
John Milligan, President and COO
Paul Carter, EVP, Commercial Operations
Robin Washington, EVP and CFO
Also:
Norbert Bischofberger, EVP, R&D and CSO
3
Table of Contents
Discussion Slide #
John Martin, Chairman and CEO
John Milligan, President and COO
Key Accomplishments, Pipeline and Milestones 6 – 11
HIV 12 – 14
HBV 15 – 16
HCV 17 – 18
Paul Carter, EVP, Commercial Operations
Product Performance 20 – 23
HCV Performance 24 – 30
HIV Performance 31 – 39
Robin Washington, EVP and CFO
Income Statement Performance 40 – 46
Cash Flows and Return of Capital to Shareholders 47 – 50
2016 Guidance 51 – 52
Appendix 53 – 65
4
John F. Milligan, Ph.D.
President and COO
Key Accomplishments in 2015
HIV
─ Genvoya approved in the U.S. and EU and added to the DHHS treatment guidelines
─ U.S. and EU regulatory submissions for R/F/TAF and F/TAF
─ Initiated Phase 3 program for GS-9883/F/TAF
HCV
─ More than 770k patients treated worldwide with sofosbuvir-containing regimens from
Dec 2013 through Dec 2015
─ Harvoni and Sovaldi approved and launched in Japan
─ U.S. and EU regulatory submissions for the pan-genotypic regimen of SOF/VEL (U.S.
Priority Review granted, PDUFA June 28, 2016)
Corporate
─ Record revenue and EPS
─ Initiated quarterly dividend program
─ Significant shareholder return
o Announced new $15 billion repurchase program
o Repurchased ~$10.0 billion of stock (~95 million shares)
o Completed early retirement of 46 million warrants for $3.9 billion 6
HIVF/TAF (emtricitabine/tenofovir alafenamide) U.S. and EU Regulatory Submission
STR of rilpivirine/FTC/TAF U.S. and EU Regulatory Submission
GS-9883 (non-boosted integrase inhibitor)/FTC/TAF
GS-9620 (TLR-7 agonist)
Liver DiseasesHCV
STR of SOF/VEL* (pan-genotypic NS5B/NS5A inhibitors) U.S. and EU Regulatory Submission
SOF/VEL/GS-9857 (pan-genotypic NS3 protease inhibitor)
HBV
TAF (nucleotide reverse transcriptase inhibitor) U.S. Regulatory Submission
GS-4774 (Tarmogen T cell immunity stimulator)
GS-9620 (TLR-7 agonist)
NASH/Other Liver Diseases
Simtuzumab (monoclonal antibody) - Primary Sclerosing Cholangitis
Simtuzumab (monoclonal antibody) - NASH
GS-4997 (ASK-1 inhibitor) - NASH
GS-4997 + Simtuzumab - NASH
GS-9674 (FXR Agonist) - NASH
CardiovascularEleclazine** (late sodium current inhibitor) - LQT-3 Syndrome
GS-4997 (ASK-1 inhibitor) - PAH
Eleclazine (late sodium current inhibitor) - Hypertrophic Cardiomyopathy
Eleclazine (late sodium current inhibitor) - Ventricular Tachycardia/Ventricular Fibrillation
*Velpatasvir is abbreviated VEL and was formerly called GS-5816.
**Formerly called GS-6615.
1 2 3
Regulatory
Submissions
Phase
Pipeline Product Candidates
7
Pipeline Product Candidates (continued)
8
Hematology/Oncology
Idelalisib (PI3K delta inhibitor) - Frontline and Relapsed Refractory CLL
Idelalisib (PI3K delta inhibitor) - Relapsed Refractory iNHL
Momelotinib (JAK inhibitor) - Myelofibrosis
Momelotinib (JAK inhibitor) - Pancreatic Cancer
GS-5745 (MMP9 mAb inhibitor) - Gastric Cancer
Idelalisib (PI3K delta inhibitor) - Frontline iNHL
Entospletinib (Syk inhibitor) - Hematological Malignancies
GS-4059 (BTK inhibitor) - B-cell Malignancies
GS-5745 (MMP9 mAb inhibitor) - Solid Tumors
GS-5829 (BET inhibitor) - Solid Tumors
Inflammation/Respiratory
GS-5745 (MMP9 mAb inhibitor) - Ulcerative Colitis
Presatovir* (fusion inhibitor) - Respiratory Syncytial Virus
Filgotinib (JAK1 inhibitor) - Rheumatoid Arthritis
Filgotinib (JAK1 inhibitor) - Crohn's Disease
GS-5745 (MMP9 mAb inhibitor) - Crohn's Disease
GS-5745 (MMP9 mAb inhibitor) - COPD
GS-5745 (MMP9 mAb inhibitor) - Rheumatoid Arthritis
GS-9876 (Syk inhibitor) - Rheumatoid Arthritis
Other
GS-4997 (ASK-1 inhibitor) - Diabetic Nephropathy
GS-5734 (Nuc inhibitior) - Ebola
Phase Regulatory
Submissions1 2 3
*Formerly called GS-5806.
HIV
TAF
Q4 15
Q1 16
Q2 16
Q3 16
U.S. FDA and European Commission approval of E/C/F/TAF
Approval of R/F/TAF in the U.S. (PDUFA March 1)
Approval of F/TAF in the U.S. (PDUFA April 7) and in the EU
Approval of R/F/TAF in the EU
GS-9883/F/TAF 1H 17 Achieve 48-week endpoint in Phase 3 studies in treatment-naïve
and switch patients
GS-9620 1H 16 Complete Phase 1 study in HIV cure
9
Significant Pipeline Milestones Anticipated in 2016 - 2017
Cardiovascular
GS-4997 Q3 16 Complete 24-week period of Phase 2 study in PAH
Eleclazine
Q2 16
2H 16
1H 17
1H 17
Complete enrollment of Phase 2 studies in VT/VF and HCM
Complete enrollment of Phase 3 study in LQT-3 syndrome
Complete Phase 2 studies in VT/VF and HCM
Complete Phase 3 study in LQT-3 syndrome
Other
GS-4997 Q4 16 Complete Phase 2 study in diabetic kidney disease
10
Significant Pipeline Milestones Anticipated in 2016 - 2017 (Continued)
HBV
TAF
Q4 15
Q1 16
Q1 16
Top line data from Phase 3 studies
Submitted U.S. NDA
Submit EU MAA
GS-9620
Q4 15
Q1 16
Q4 16
Initiate Phase 2 study in treatment-naïve patients
Complete Phase 2 study in virally suppressed patients
Complete Phase 2 study in treatment-naïve patients
NASH
Simtuzumab Q4 16 Complete Phase 2 study
GS-4997 Q3 16 Complete Phase 2 study
GS-9674 Q1 16 Initiate Phase 1 study
HCV
LDV/SOF Q1 16 Label update for decompensated cirrhotics and post-transplant
patients (PDUFA February 26)
SOF/VEL/GS-9857 Q4 16 Complete Phase 3 studies (initiated in Q4 2015)
SOF/VEL
Q4 15
Q2 16
Q3 16
Submit U.S. NDA and EU MAA
Approval in the U.S. (PDUFA June 28)
Approval in the EU
11
Hematology/Oncology
Idelalisib
Q2 16
Q2 16
Q4 16
Interim data from Phase 3 study for previously treated iNHL w/bendamustine
+ rituximab
Submit sNDA for combination use with bendamustine + rituximab in previously
treated CLL patients
Interim data from Phase 3 study for CLL frontline w/bendamustine + rituximab
Momelotinib
Q2 16
1H 17
Complete enrollment in Phase 3 studies vs ruxolitinib and best available
treatment for myelofibrosis
Interim data from Phase 3 study for previously untreated pancreatic cancer
w/gemcitabine + Abraxane
GS-5745 1H 17 Interim data from Phase 3 study for gastric cancer
Significant Pipeline Milestones Anticipated in 2016 - 2017 (Continued)
Inflammation/Respiratory
Filgotinib 2H 16 Initiate Phase 3 studies in RA and Crohn’s Disease
GS-5745
Q2 16
Q3 16
Q4 16
Q4 16
Complete enrollment in Phase 2 study for Crohn’s Disease
Initiate Phase 2 studies in RA, CF, and COPD
Complete enrollment in Phase 2/3 study for ulcerative colitis
Complete Phase 2 study for Crohn’s Disease
Presatovir (formerly GS-5806)
Q4 16 Complete RSV Phase 2 studies in adults with infection in upper or lower
respiratory tracts
GS-9876 2H 16 Initiate Phase 2 study in RA
Entospletinib 1H 16 Initiate Phase 2 study in GVHD
HIV
GS-9883
─ A novel once daily unboosted integrase inhibitor (50mg), combined
with F/TAF represents the smallest HIV STR pill size
─ Phase 3 studies for GS-9883/F/TAF initiated in Q4 2015
13
Innovation in HIV Continues with GS-9883
Adult Switch from
ABC/DTG/3TC
(n = 520)
Adult Switch from
Boosted PI (DRV or ATV)
(n = 520)
Adult Tx-Naïve
GS-9883/F/TAF vs ABC/DTG/3TC
(n=600)
Adult Tx-Naïve
GS-9883/F/TAF vs DTG + F/TAF
(n=600)
F/TAF
─ U.S. PDUFA date April 7, 2016
─ EU MAA submitted in April 2015
R/F/TAF
─ U.S. PDUFA date March 1, 2016
─ EU MAA submitted in July 2015
D/C/F/TAF (darunavir/cobicistat/F/TAF) will be developed and
commercialized by Janssen
─ First STR containing a protease inhibitor
14
Additional TAF-Based Regimens Pending Approval
and Under Development
HBV
TAF is non-inferior to Viread
─ Study 108 (HBeAg-negative patients): 94.0% of TAF patients compared to 92.9% of Viread patients
─ Study 110 (HBeAg-positive patients): 63.9% of TAF patients compared to 66.8% of Viread patients
Higher rates of ALT normalization
The median change in estimated glomerular filtration rate (eGFR) from
baseline to week 48 favored TAF in both studies (p<0.01)
Statistically significant smaller mean percentage decrease from baseline in
hip and spine bone mineral density compared to Viread patients
U.S. NDA submitted on January 12, 2016 and EU MAA submission
planned for Q1 2016
16
TAF for HBV Top Line Results from Phase 3 Studies
HCV
SOF/VEL (sofosbuvir/velpatasvir)
─ Once-daily pan-genotypic single tablet regimen
─ Four Phase 3 studies
─ U.S. NDA filed in October 2015 (Priority Review, PDUFA June 28, 2016)
and EU MAA validated in December, 2015 (Accelerated Assessment)
ASTRAL-2 ASTRAL-1
18
Genotype
1, 2, 4-6
ASTRAL-3
Genotype 3
SVR12
95%
Genotype 2
SVR12
99%
Gilead's Evolving HCV Portfolio
SVR12
99%
ASTRAL-4
Genotype 1-6
w/Child-Pugh
class B
SVR12
94%*
*When taken with ribavirin.
Paul Carter
EVP, Commercial Operations
$7,222 $7,405
$8,126 $8,211 $8,409
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000
$9,000
$10,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Mil
lio
ns
)
Total Product Sales
20
Q4 2015 up 16% from Q4 2014
Q4 2015: $8,409 (16% YoY Growth)
21 Note: Amounts may not sum due to rounding.
Europe: $1,680
(20% of Total)
(22% YoY Growth)
U.S.: $4,792
(57% of Total)
(-12% YoY Growth)
Other International
(including Japan): $1,937
(23% of Total)
(419% YoY Growth)
Product Sales by Geography (in millions, except percentages)
FX impact to European revenues was unfavorable $34 million
QoQ and unfavorable $150 million YoY
22
Q4 2015 up 22% (32% excluding FX) from Q4 2014
European Product Sales
Q4'15 Q4'14 YoY Excl FX
Atripla $161 $194 (17%) (10%)
Eviplera $149 $138 8% 19%
Stribild $83 $52 60% 76%
Truvada $272 $287 (5%) 3%
Viread $77 $77 0% 10%
Sovaldi $259 $459 (44%) (38%)
Harvoni $587 $83 NM NM
AmBisome $58 $67 (13%) (6%)
Other $34 $24 42% 54%
Total $1,680 $1,381 22% 32%
$5
,08
6
$4
,89
9
$5
,20
3
$5
,18
2
$4
,36
9
$1
,29
7
$1
,74
8
$1
,89
4
$1
,59
0
$1
,59
5
$343 $341
$534 $930 $1,922
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000
$9,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(in
Mil
lio
ns
)
U.S. Europe Other International
Key Metrics
U.S.:
● Inventory levels for HIV
products at the Big-3
wholesalers ended at the
high-end of the inventory
management agreement
range
Europe:
● Sequentially flat primarily
driven by stabilization of
patient demand in earlier
launch markets
Other International:
● Sequential growth driven by
HCV uptake in Japan ($1.4
billion in sales in Q4 15)
Antiviral Product Sales
23
$6,726
Q4 2015 up 17% from Q4 2014
Note: Q4 14 EU Antiviral products sales were negatively impacted by new tax legislation in France
associated with HCV and Italian spending rebates.
$6,988
$7,631 $7,702 $7,886
HCV
$1
,73
2
$9
72
$1
,29
1
$1
,46
6
$1
,54
7
$2
,10
7
$3
,57
9
$3
,60
8
$3
,33
2
$3
,34
5$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(in
Mil
lio
ns
)
Sovaldi Harvoni
Key Metrics
● Increase in Sovaldi sales
from Q3 15 driven primarily
by uptake in Japan
(launched May 25th)
● Harvoni launched in Japan
in Q3 15 (September 1st)
● In Q4 15, approximately
47,000, 28,000 and 35,000
patient starts with a Gilead
HCV regimen in the U.S.,
Europe and Japan,
respectively
Total HCV Product Sales
25
$3,839
Q4 2015 up 27% from Q4 2014
$4,551
$4,899 $4,798 $4,892
Q4 2015: $4,892 (27% YoY Growth)
26 Note: Amounts may not sum due to rounding.
Europe: $846
(17% of Total)
(56% YoY Growth)
U.S.: $2,367
(48% of Total)
(-26% YoY Growth)
Other International
(including Japan): $1,679
(34% of Total)
Total HCV Sales by Geography (in millions, except percentages)
The Number of Patients Receiving a Sofosbuvir-Based Regimen Increased Significantly in 2015
27
Patients Treated with a SOF-based Regimen (in thousands)
Note: Graph illustrates the estimated number of patients treated with a Gilead HCV drug for each year. Patient numbers are subject to adjustments. Rest of
World is comprised primarily of Egypt and Pakistan.
Sovaldi was approved in the U.S in December 2013 and in the EU in January 2014. Harvoni was approved in the U.S. in October 2014 and in the EU in
November 2014. In Japan, Sovaldi launched in May 2015 and Harvoni launched in September 2015.
142
236
32
113
49
15
185
2
189
583
2013 2014 2015
Rest of World
Japan
Europe
U.S.
HCV Prevalence
Global Prevalence of HCV Estimated to Be 185 Million(1)
Sources: 1) WHO Guidelines for the Screening, Care, and Treatment of Persons with Hepatitis C Infection, April 2014 2) Gilead Forecast (2011
prevalence estimate). 3) Cornberg, Sievert, and Kershenobich, et al. 2011. Country populations from 2009 World Bank estimates.
Core Markets(2) Emerging Markets(3)
Region US Europe
Big-5
Japan Europe
Other
Asia
Other
Latin
America
All Genotypes
(Millions)
4.0 2.6 1.1 6.7 70.8 5.4
Genotype 1 (%) 79% 63% 67% 65% 39% 68%
<1%
1-1.9%
2-2.9%
>3%
Not tested
HCV Prevalence
28
F0-F2, 50%
F3-F4, 50%
GT 1, 80%
GT 2, 12%
GT 3, 7%
Profile of U.S. HCV Patients that are Intended for Treatment with a Sofosbuvir-based Regimen (October – Dec 2015*)
29
Genotype Fibrosis Score
Patient Type
Treatment
Naïve,
85%
Treatment
Experienced,
15%
Note:
Fibrosis score is based on the METAVIR scoring system.
‘Intended for treatment’ is based on scripts written, not scripts filled.
*Data Source: Gilead market research Oct 1 – Dec 6, 2015.
Other,
1%
30
Simplifying and Advancing the Treatment for HCV Cures
®
$5.3 billion in worldwide sales in 2015
─ $2.4 billion in sales in the U.S.
─ $1.6 billion in sales in Europe
─ $878 million in sales in Japan
$13.9 billion in worldwide sales in 2015
─ $10.1 billion in sales in the U.S.
─ $2.2 billion in sales in Europe
─ $1.0 billion in sales in Japan
sNDA approved in the U.S. for GT-4, 5 & 6 and
co-infected HIV patients. 12-week usage with
ribavirin can be considered for treatment-
experienced GT-1 patients with cirrhosis Note: Japan: Sovaldi is approved for GT-2 and Harvoni for GT-1 patients.
EU: Harvoni is approved for GT-1-2 , 3 (certain subgroups) , 4-6 patients.
HIV
U.S. HIV Market Dynamics
0
200
400
600
800
1,000
1,200
1,400
HIV Infected Diagnosed On Antiretroviral
Treatment
On a Gilead HIV
Product
(Es
tim
ate
d P
ati
en
ts i
n 0
00
's) ~1,218
~1,062
~757
~584
Up 5%^
~87%
~71%
~77%
Sources:
• CDC and Ipsos Healthcare U.S. HIV Monitor Q3 2015.
• ^Growth rate calculated as MAT (moving annual total).
32
Gilead U.S. Share in HIV Treatment Naïve Patients
Base: All initiations within each quarter.
Source: Ipsos Healthcare HIV U.S. Scope Q3 2015.
33
Top Prescribed HIV Regimens
34
Rank Naïve All Patients
1 Stribild Atripla
2 Other STR Stribild
3 Complera Complera
4 Atripla Other STR
5 Truvada + other 3rd
Agent
Truvada + other 3rd
Agent
Gilead STR
U.S. Europe Big-5
Rank Naïve All Patients
1 Eviplera Atripla
2 Stribild Eviplera
3 Other STR Stribild
4 Truvada + other 3rd
Agent
Truvada + other 3rd
Agent
5 Atripla Other STR
EU Naïve Source: Ipsos Healthcare HIV EU Scope Q3 2015.
EU All Patient Source: Ipsos Healthcare HIV EU Monitor Q3 2015.
US Naïve Source: Ipsos Healthcare HIV U.S. Scope Q3 2015.
US All Patient Source: Ipsos Healthcare HIV U.S. Monitor Q3 2015.
35
U.S.
Approved by the FDA on November 5, 2015
Added to the “Recommended” category in
the DHHS guidelines 13 days post-approval
$44 million in sales in Q4 2015
Genvoya: The First TAF-Containing HIV Single Tablet Regimen
Europe
Approved by the European Commission on
November 23, 2015
Preferred in the guidelines of Spain, Italy, and
Denmark prior to reimbursement
Pricing and reimbursement process is ongoing
and could take up to 12 months to complete
$3
19
$2
82
$3
64
$4
22
$4
08
$5
2
$6
1
$6
5
$7
3
$8
3$0
$100
$200
$300
$400
$500
$600
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Millio
ns)
U.S. Europe Other International
Key Metrics*
U.S.:
● Captured 30% of naïve HIV
patient share
● Number two most prescribed
HIV regimen across all
treated patients
Europe:
● Captured 18% of naïve HIV
patient share in Big-5
● Number two most prescribed
HIV regimen in naïve patients
● Launched in Big-5 as well as
eighteen additional countries
*Sources:
U.S. data from Ipsos Healthcare HIV U.S. Therapy Monitor
Q3 2015 & Ipsos Healthcare HIV U.S. Scope Q3 2015.
EU data from Ipsos Healthcare HIV EU Scope Q3 2015.
Note: Stribild is indicated for the treatment of HIV-1
infection in antiretroviral treatment naïve patients.
36
Stribild Product Sales
$385
Q4 2015 up 33% from Q4 2014
$356
$447
$511 $511
$1
96
$1
63
$2
07
$2
10
$2
16
$1
38
$1
45
$1
45
$1
37
$1
49
$0
$100
$200
$300
$400
$500
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Millio
ns)
U.S. Europe Other International
Key Metrics*
U.S. (Complera):
● Captured 17% of naïve HIV
patient share
● Third most prescribed HIV
regimen across all patients
Europe (Eviplera):
● Captured 19% of naïve HIV
patient share in Big-5
● Preferred status in Big-5
*Sources:
U.S. data from Ipsos Healthcare HIV U.S. Therapy Monitor
Q3 2015 & Ipsos Healthcare HIV U.S. Scope Q3 2015.
EU data from Ipsos Healthcare HIV EU Scope Q3 2015.
Note: In Spain, Eviplera is preferred in patients with a
baseline viral load <100,000 copies/mL.
Complera/Eviplera Product Sales
37
$348
Q4 2015 up 9% from Q4 2014
$320
$367 $360 $380
$5
48
$4
09
$5
00
$5
61
$5
87
$2
87
$3
01 $
27
7 $2
68
$2
72
$0
$250
$500
$750
$1,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Millio
ns)
U.S. Europe Other International
Key Metrics*
U.S.:
● Used by 27% of all
treated HIV patients
● Used by 16% of naïve
HIV patient share
Europe:
● Most prescribed HIV
product with 29% of all
treated patients
● Captured 28% of naïve
HIV patient share
*Sources:
U.S. data from Ipsos Healthcare HIV U.S. Therapy Monitor
Q3 2015 & Ipsos Healthcare HIV U.S. Scope Q3 2015.
EU data from Ipsos Healthcare HIV EU Therapy Monitor
Q3 2015 & Ipsos Healthcare HIV EU Scope Q3 2015.
38
Truvada Product Sales
$897
Q4 2015 up 4% from Q4 2014
$771
$849
$903 $936
$6
68
$4
94
$5
49
$5
97
$5
82
$1
94
$1
94
$1
78
$1
61
$1
61
$0
$250
$500
$750
$1,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Millio
ns)
U.S. Europe Other International
Atripla Product Sales
Key Metrics*
U.S.:
● Most prescribed HIV regimen
with 20% of all treated
patients
● Captured 8% of naïve HIV
patient share
Europe:
● Most prescribed HIV regimen
with 16% of all treated
patients
● Captured 9% of naïve HIV
patient share**
*Sources:
U.S. data from Ipsos Healthcare HIV U.S. Therapy Monitor
Q3 2015 & Ipsos Healthcare HIV U.S. Scope Q3 2015.
EU data from Ipsos Healthcare HIV EU Therapy Monitor Q3
2015 & Ipsos Healthcare HIV EU Scope Q3 2015.
**Note: In the EU Atripla does not have an indication for the
treatment of naïve patients and there is no Atripla
promotion concerning treatment naïve patients.
Note: Efavirenz (the active pharmaceutical component in Atripla purchased
from Bristol-Myers Squibb) accounted for approximately 37% of Atripla sales
in Q4 2015 which represented $295 million to be paid to BMS. 39
$925
Q4 2015 down 14% from Q4 2014 (Downgraded in DHHS guidelines)
$734
$782 $818 $800
Robin Washington
EVP and Chief Financial Officer
Financial Highlights: Q4 2015 (in millions, except percentages and per share amounts)
* Other Products comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan.
**Non-GAAP costs and expenses, net income and diluted EPS exclude amounts related to acquisition, stock-based compensation and other.
***Q4 14 includes $265 million of one-time items for collaboration related expenses and purchase of a FDA Priority Review Voucher.
41
Q4 2014 Q4 2015 % Change
Net Product Sales $7,222 $8,409 16%
Antiviral Products 6,726 7,886 17%
HCV 3,839 4,892 27%
HIV and Other Antiviral 2,887 2,994 4%
Other Products* 496 523 5%
Non-GAAP Costs and Expenses** $2,545 $2,649 4%
COGS 847 857 1%
Product Gross Margin 88% 90%
R&D*** 899 779 (13%)
SG&A 799 1,013 27%
Operating Margin 65% 69%
Non-GAAP Net Income** $3,883 $4,889 26%
Non-GAAP Diluted EPS** $2.43 $3.32 37%
Financial Highlights: Fiscal Year (in millions, except percentages and per share amounts)
* Other Products comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan.
**Non-GAAP costs and expenses, net income and diluted EPS exclude amounts related to acquisition, stock-based compensation and other.
42
FY 2014 FY 2015 % Change
Net Product Sales $24,474 $32,151 31%
Antiviral Products 22,791 30,207 33%
HCV 12,410 19,140 54%
HIV and Other Antiviral 10,381 11,067 7%
Other Products* 1,683 1,944 16%
Non-GAAP Costs and Expenses** $8,306 $9,244 11%
COGS 2,964 3,175 7%
Product Gross Margin 88% 90%
R&D 2,585 2,845 10%
SG&A 2,757 3,224 17%
Operating Margin 67% 72%
Non-GAAP Net Income** $13,314 $19,174 44%
Non-GAAP Diluted EPS** $8.09 $12.61 56%
$2.43
$2.94
$3.15$3.22
$3.32
$0.00
$0.50
$1.00
$1.50
$2.00
$2.50
$3.00
$3.50
$4.00
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
Non-GAAP Diluted EPS
43
Note: Non-GAAP diluted EPS excludes amounts related to acquisition, stock-based compensation and other.
Q4 2015 up 37% from Q4 2014
$702 $713
$779
$0
$100
$200
$300
$400
$500
$600
$700
$800
$900
$1,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Mil
lio
ns
)
R&D One-time items
Non-GAAP R&D Expenses
Note: Non-GAAP R&D expenses exclude amounts related to acquisition, stock-based
compensation and other.
Key Metrics
● Higher R&D expenses in
Q4 15 over Q4 14
(excluding one-time items)
primarily driven by the
continued progression of
clinical studies
44
$899
Q4 2015 up 23% from Q4 2014
(excluding one-time items)
$265 *
* One-time items of $265 million for collaboration related expenses and purchase of a FDA
Priority Review Voucher.
$651
$761
$850
$1,013
$0
$100
$200
$300
$400
$500
$600
$700
$800
$900
$1,000
$1,100
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Millio
ns)
45
Non-GAAP SG&A Expenses
Note: Non-GAAP SG&A expenses exclude amounts related to acquisition, stock-based
compensation and other.
Q4 2015 up 27% from Q4 2014
* Q1 15 is favorably impacted by prior year adjustments of $101 million following receipt of
2015 IRS invoice.
Key Metrics
● Higher SG&A expenses in
Q4 15 compared to Q4 14
primarily due to higher
costs to support growth and
the geographic expansion
of the business
● P&L impact of the
estimated Branded
Prescription Drug (BPD)
fee:
$600
$799
*
$M
2014 BPD Fee $587
2015 BPD Fee $414
2016 BPD Range $550-650
Non-GAAP Effective Tax Rate
46
Note: Non-GAAP Effective Tax Rate excludes amounts related to acquisition, stock-based
compensation and other.
• The decrease from Q3 2015 is primarily due to the Q4 2015 cumulative catch-up
for the permanent extension of the Federal research tax credit and the increase in
HCV product revenue.
Q1 2015 Q2 2015 Q3 2015 Q4 2015 FY 2015
Non-GAAP Effective
Tax Rate 16.9% 17.7% 16.3% 13.9% 16.2%
$3,021
$5,701 $5,658
$4,097
$4,874
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Millio
ns)
Operating Cash Flows
47
Key Drivers
● Increase primarily due to
collections partly offset by
the timing of cash payments
related to current liabilities
Return of Capital to Shareholders - 2015
Cash dividend program
- Paid quarterly dividend in Q4 2015 of $0.43 per share
- Declared Q1 2016 quarterly dividend of $0.43 per share, payable on March 30,
2016 to stockholders of record as of the close of business on March 16, 2016
Share repurchase program
- Repurchased $3.1 billion of stock (29.3 million shares) at an average price of
$103.94 during the fourth quarter
- $8 billion of the January 2015 share repurchase program ($15 billion
authorization) remaining as of December 31, 2015
Warrants repurchase
- In Q2 2015, paid $3.9 billion for early redemption of 46 million warrants related to
the 2016 convertible bonds at an average stock price of $113.96
- The transaction reduced fully diluted shares outstanding by 32 million shares
(inclusive of the 7 million and 25 million share reduction in Q2 and Q3 2015
respectively)
- Approximately 9 million warrants outstanding as of December 31, 2015
48
49 * Excludes commissions
** Based on average warrant strike price of $29.93
2015 Share Activity
~77% of free cash flow was returned (inclusive of dividend and warrant settlements)
during the period from January 2010 through December 2015
• As of March 31, 2015, we completed the $5 billion share repurchase plan authorized in May 2014. Under the program, we repurchased 48.8
million shares with an average purchase price of $102.36 per share.
• $15 billion share repurchase program was authorized in January 2015 and commenced in April 2015. Under this program, we repurchased 65.7
million shares with an average purchase price of $106.50 per share. The remaining authorization is $8.0 billion as of December 31, 2015.
• As of June 30, 2015, we completed an early retirement of 46 million warrants (related to the 2016 convertible bonds) at an average stock price of
$113.96 per warrant for approximately $3.9 billion. The repurchased warrants were not part of the January 2015 share repurchase authorization.
There are approximately 9 million 2016 warrants outstanding as of December 31, 2015 and maturing in Q3 2016.
Type of Activity Dollar Amount
(In Millions)
Shares /
Warrants
Average
Purchase Price
Q1 2015 Open Market
Share Repurchase* $3,000 29,593,030 $101.38
Q2 2015 Open Market
Share Repurchase* $900 8,811,676 $102.14
Q2 2015 Warrant Repurchase** $3,865 46,000,000 $113.96
Q3 2015 Open Market
Share Repurchase* $3,050 27,570,455 $110.63
Q4 2015 Open Market
Share Repurchase* $3,050 29,343,991 $103.94
2015 Total Open Market
Share Repurchase* $10,000 95,319,152 $104.91
Update to Capital Allocation Plan - 2016
Cash dividend program
- Quarterly dividend increase of 10% from $0.43 to $0.47 per share
- Beginning in the second quarter of 2016, subject to declaration by the Board
of Directors
$12 billion share repurchase program authorized
- To be utilized upon completion of the $15 billion January 2015 repurchase
program which had $8 billion remaining as of December 31, 2015
- Intend to utilize a portion of the remaining January 2015 program to enter
into a $5 billion accelerated share repurchase (ASR) program in the near
term and expect to complete the ASR in approximately three months
50
Provided 2/2/2016
Net Product Sales* $ 30,000 – $ 31,000
Non-GAAP**
Product Gross Margin 88% – 90%
R&D Expenses $ 3,200 – $ 3,500
SG&A Expenses $ 3,300 – $ 3,600
Effective Tax Rate 18.0% – 20.0%
Diluted EPS Impact of
Acquisition-Related and
Stock-Based Compensation
Expenses
$ 1.10 – $ 1.16
*This guidance is subject to a number of uncertainties, including, but not limited to, inaccuracy in our estimates of HCV patient starts, a larger than anticipated shift
in payer mix to more highly discounted payer segments – such as PHS, FSS, Medicaid and the VA, the potential adoption in Europe and other countries of
additional pricing measures to reduce HCV spending, the pricing and acceptance of competing products and the potential for continued volatility in foreign currency
exchange rates.
**Non-GAAP product gross margin, expenses and effective tax rate exclude amounts related to acquisition, stock-based compensation and other.
Full Year 2016 Guidance (in millions, except percentages and per share amounts)
51
Projected product gross margin GAAP to non-GAAP reconciliation:
GAAP projected product gross margin
Acquisition related-expenses
Non-GAAP projected product gross margin*
Projected research and development expenses GAAP to non-GAAP reconciliation:
GAAP projected research and development expenses
Acquisition related / upfront collaboration expenses
Stock-based compensation expenses
Non-GAAP projected research and development expenses
Projected selling, general and administrative expenses GAAP to non-GAAP
reconciliation:
GAAP projected selling, general and administrative expenses
Acquisition related-expenses
Stock-based compensation expenses
Non-GAAP projected selling, general and administrative expenses
Projected diluted EPS impact of acquisition-related, stock-based compensation and
other:
Acquisition related / upfront collaboration expenses
Stock-based compensation expense
Projected diluted EPS impact of acquisition-related, stock-based compensation and other
Provided on 2/2/2016
(in millions, except percentages and per share amounts)
GAAP to Non-GAAP Reconciliation of Full Year 2016 Guidance
85% - 87%
3% - 3%
88% - 90%
$3,530 - $3,840
-
(230) - (240)
$3,300 - $3,600
$0.88 - $0.92
0.22 - 0.24
$1.10 - $1.16
$3,837 - $4,182
(447) - (477)
(190) - (205)
$3,200 - $3,500
*Stock-based compensation expenses have a less than one percent impact on non-GAAP projected product gross margin 52
Appendix Slides
Gilead's Efforts to Increase Global Access
HIV and HCV Generic Licensing
─ Entered into licensing agreements for HIV with eight India-based generic
manufacturers in 2006
─ Announced non-exclusive licensing agreements for HCV with eleven India-
based generic manufacturers in 2014 and 2015
o Includes Sovaldi and Harvoni
o For distribution in 101 developing countries, where more than 100 million
people estimated living with HCV
Medicines Patent Pool (MPP)
─ Announced new agreement with MPP to expand access to the investigational
drug TAF for HIV and HBV, contingent on U.S. regulatory approval
─ MPP can sub-license TAF to generic drug companies who may manufacture
and distribute in 112 developing countries
Gilead’s Access Operations & Emerging Markets
─ Combined access efforts reached ~8 million HIV patients in low and middle-
income countries
54
$7,314$7,594
$8,244 $8,295 $8,506
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000
$9,000
$10,000
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Mil
lio
ns
)
Total Revenues
55
Q4 2015 up 16% from Q4 2014
Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 FY 2015
%
Change
from
Q4 2014
Viread $311 $234 $271 $297 $306 $1,108 (2)%
Letairis $181 $151 $176 $181 $192 $700 6%
Ranexa $144 $117 $141 $161 $169 $588 17%
AmBisome $104 $85 $103 $88 $74 $350 (29%)
Genvoya - - - - $45 $45 NM
Zydelig $17 $26 $30 $36 $40 $132 135%
Other* $50 $38 $45 $43 $48 $174 (4)%
56
Select Product Sales (in millions)
*Other comprised primarily of Cayston and Lexiscan.
FY 2015: $19,140 (54% YoY Growth)
57 Note: Amounts may not sum due to rounding.
Europe: $3,820
(20% of Total)
(132% YoY Growth) U.S.: $12,478
(65% of Total)
(19% YoY Growth)
Other International
(including Japan): $2,842
(15% of Total)
Total HCV Sales by Geography (in millions, except percentages)
$18
$116
$60
$9$26
$74
$73
$58
$75
$71
$0
$25
$50
$75
$100
$125
$150
$175
$200
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
(In
Mil
lio
ns
)
Tamiflu Other
Total Royalty, Contract and Other Revenues
58
$92
Q4 2015 up 5% from Q4 2014
$189
$118
$84
$97
88.3%90.9% 90.3% 89.6% 89.8%
0%
25%
50%
75%
100%
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
Non-GAAP Product Gross Margin
Note: Non-GAAP product gross margin excludes amounts related to acquisition,
stock-based compensation and other.
59
Key Metrics
● Higher Non-GAAP
Product Gross Margin
Q4 15 over Q4 14
driven primarily by
favorable product mix
65.2%
74.7% 72.7% 70.8% 68.9%
0%
25%
50%
75%
100%
Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
Non-GAAP Operating Margin
Note: Non-GAAP operating margin excludes amounts related to acquisition,
stock-based compensation and other.
60
Key Metrics
● Higher Non-GAAP
Operating Margin in
Q4 15 over Q4 14 driven
primarily by:
- Higher gross margin from
favorable product mix
- Lower operating expense
growth than revenue
growth
GAAP to Non-GAAP
Diluted Earnings Per Share Reconciliation
Q1 2015 Q2 2015 Q3 2015 Q4 2015 FY 2015
GAAP Diluted EPS $2.76 $2.92 $3.06 $3.18 $11.91
All Acquisition-Related
Expenses $0.13 $0.18 $0.13 $0.14 $0.57
Stock-Based
Compensation Expenses $0.04 $0.05 $0.03 $0.05 $0.17
Other* $0.00 $0.00 ($0.01) ($0.04) ($0.04)
Non-GAAP Diluted EPS $2.94 $3.15 $3.22 $3.32 $12.61
61
* Amounts related to consolidation of a contract manufacturer, contingent consideration and/or other individually insignificant amounts.
Note: Amounts may not sum due to rounding.
Outstanding Debt
*Debt amount shown at face value.
Total interest expense and amortization from all issued debt is expected to be approximately $216 million per
quarter and $864 million for full year 2016.
62
(in billions)
Mar. 31,
2015
Jun. 30,
2015
Sep. 30,
2015
Dec. 31,
2015
Senior Unsecured Notes $11.95 $11.95 $21.95 $21.95
Convertible Notes $0.45 $0.36 $0.34 $0.29
Total Debt* $12.40 $12.31 $22.29 $22.24
Debt to GAAP EBITDA ~0.66x ~0.62x ~1.01x ~0.95x
63
Dilution from Outstanding Convertible Notes
2016
Notes
Total
Dilution
Average share price
Q4 2015 $104.05; FY 2015 $106.53
Convertible Notes(1) (Current Outstanding)
$285M
Conversion Price (2) $22.44
Q4 2015 Share Dilution 11.2M 11.2M
YTD Share Dilution 13.6M 13.6M
Warrants (3)
(Current Outstanding) 9.1M
Warrant Exercise Price (2) $28.76
Q4 2015 Share Dilution 6.5M 6.5M
YTD Share Dilution 20.7M 20.7M
Total Q4 2015 Dilution from
Convertible Notes and Warrants(4) 17.7M
(1) At issuance, the amount outstanding on the 2016 convertible notes was $1.25 billion.
(2) Conversion and warrants exercise price post-dividend are $22.44 (convertible notes) and $28.76 (warrants); pre-dividend prices were $22.53 (convertible notes) and
$29.19 (warrants), respectively.
(3) At issuance, there were 55 million warrants outstanding. During Q2 2015, 46 million warrants were redeemed early (55 million – 46 million = 9 million warrants).
(4) Represents 1.2% diluted non-GAAP shares outstanding.
Other Selected Financial Information (in millions, except days sales outstanding)
Sep. 30,
2015
Dec. 31,
2015
Cash, Cash Equivalents & Marketable Securities $25,114 $26,208
Inventories $1,988 $1,955
Days Sales Outstanding (Accounts Receivable) 48 50
Share Repurchases During the Quarter* $3,050 $3,050
Interest Expense and
Other Income (Expense), net ($113) ($184)
Diluted Shares Used in Per Share Calculation for the Quarter
(Non-GAAP) 1,502 1,472
Diluted Shares Used in Per Share Calculation for the Quarter
(GAAP) 1,503 1,472
Basic Shares Outstanding 1,463 1,436
64
*Excludes commissions. The Q4 15 repurchases were executed under the January 2015 share repurchase authorization. The remaining
authorization is $8.0 billion as of 12/31/2015.
Q4 2015 Earnings Results
February 2, 2016