1. Q1 2009 Earnings Results
Conference Call and Webcast
April 21, 2009
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2. Forward-looking Statement and
GAAP Reconciliation
Forward-looking Statement
Statements included in this presentation that are not historical in nature
are āforward-looking statementsā 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,
which could cause actual results to differ materially. Gilead directs readers
to its Annual Report on Form 10-K for the year ended December 31, 2008
and its subsequent current reports on Form 8-K. Gilead claims the
protection of the Safe Harbor contained in the Private Securities Litigation
Reform Act of 1995 for forward-looking statements. All forward-looking
statements are based on information currently available to Gilead, and
Gilead assumes no obligation to update any such forward-looking
statements.
GAAP Reconciliation
This presentation contains references to financial measures for Gilead that
are on a non-GAAP basis. Gilead provides a reconciliation between
GAAP and non-GAAP in our press releases which are available on our
website at www.gilead.com.
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3. Q1 2009 Earnings Call Agenda
ā¦ Corporate Highlights
John Martin, PhD, Chairman and CEO
ā¦ Financial Performance
Robin Washington, SVP and CFO
ā¦ Commercial Update
Kevin Young, EVP of Commercial Operations
ā¦ R&D Update
Norbert Bischofberger, PhD, EVP of R&D and CSO
ā¦Upcoming Growth Drivers
John Milligan, PhD, President and COO
ā¦ Q&A
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5. Gilead Completes Acquisition of
CV Therapeutics on April 17, 2009
Vision for CV Therapeutics:
Bolsters Gileadās Presence in the
Cardiovascular Space
ā¦ Ranexa for chronic angina with new, stronger US label
ā Specialty sales force detailing cardiologists
ā¦ Lexiscan opportunity in EU
ā¦ Proven development and regulatory organization
ā Improved opportunity for Letairis and darusentan
ā¦ Pipeline of cardiovascular products
ā¦ Improved future earnings profile and growth rate
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6. Strong Geographical Presence Around the World
Sweden
Norway The Netherlands
Edmonton, Alberta
Ireland
and Mississauga, ON Finland
Germany
U.K.
Austria
Belgium Denmark
Durham, NC France Turkey
Italy
Westminster, CO Greece
Portugal China
San Dimas, CA Switzerland
Spain
Foster City, CA
Palo Alto, CA
Australia/New Zealand
Seattle, WA
LEGEND
Gilead Locations HQ, Manufacturing Operations, Antiviral Research *Includes Field Employees
Respiratory Research Sales and Marketing Operations
Manufacturing Operations
Antiviral Research
Cardiovascular Research 6
9. Darusentan for
Resistant Hypertension
ā¦ Positive DAR 311 top-line results announced on 4/2/09, full data to be
presented at ASH on 5/8/09 in San Francisco, CA
ā Met co-primary efficacy endpoints of change from baseline to week 14 in trough
sitting systolic blood pressure (SBP) and trough sitting diastolic blood pressure (DBP)
(p<0.001 for all darusentan groups)
Placebo 50 mg 100 mg 300 mg
SBP from baseline 8.6 mmHg 16.5 mmHg 18.1 mm Hg 18.1 mm Hg
5.3 mmHg 10.1 mmHg 9.9 mmHg 10.7 mmHg
Reductions in mean trough
sitting DBP from baseline
Peripheral edema 17% 32% 36% 29%
Discontinued due to edema 0% 1.2% 4.9% 5.9%
Decreases in hemoglobin 0.19 g/dL 0.92 g/dL 0.93 g/dL 1.08 g/dL
Decreases in hematocrit 0.89% 2.89% 2.54% 2.88%
1 patient 0 1 patient
Serum aminotransferase 1patient
concentrations (>3x upper limit
of normal range)
ā¦ DAR 312* double-blinded, 14-week, placebo and active comparator (guanfacine)
study in patients taking full doses of three or more antihypertensive agents,
including a diuretic
ā n=770; 90% enrolled, data early 2010
* As of April 2, 2009 9
11. Financial Highlights:
A Snapshot of Q1 2009
ā¦ Total revenues were up 22 percent over Q1 2008
ā¦ Net income attributable to Gilead per diluted share of $0.63;
Non-GAAP net income attributable to Gilead per diluted share
of $0.66*
ā¦ $3.6 billion in cash, cash equivalents and marketable
securities as of March 31, 2009
ā¦ Cash flow from operations of $641.3 million
* Excludes after-tax stock-based compensation expense
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12. Financial Highlights:
Non-GAAP EPS
ā¦ Q1 2009 increase of 24% over Q1 2008
+24%
$0.75
$0.66
+16%
$0.53
2007
$0.46
$0.50 2008
2009
$0.25
$0.00
Q1
Note: Non-GAAP EPS for all periods exclude after-tax stock-based compensation expense
On January 1, 2009, Gilead adopted FSP APB 14-1 on a retrospective basis for its convertible senior
notes. GAAP and non-GAAP net income attributable to Gilead and the per share amounts have been
adjusted from that which was previously reported to reflect additional after-tax interest expense.
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13. Financial Highlights:
Total Revenues
ā¦ Q1 2009 increase of 22% over Q1 2008
+22%
$ In Millions
$1,530
$1,600
+22%
$1,258
$1,200
$1,028 2007
2008
2009
$800
$400
$0
Q1
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14. Financial Highlights:
Total Product Sales
ā¦ Q1 2009 increase of 27% over Q1 2008
+27%
$ In Millions
$1,448
$1,500
+36%
$1,250 $1,141
2007
$1,000
$840 2008
2009
$750
$500
$250
$0
Q1
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15. Financial Highlights:
Operating Cash Flows
$ In Millions
$750 +6%
+25% $641
$606
$484 2007
$500
2008
2009
$250
$0
Q1
Note: On January 1, 2009, Gilead adopted SFAS 160 on a retrospective basis for its noncontrolling interest.
Accordingly, the operating cash flow amounts have been adjusted from that which was previously
reported to reflect the impact.
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16. Product Sales: Antiviral Franchise
Q1 Q1
Product
%ā²
2009 2008
($ in Millions)
$1,340.8 $1,047.7
Antiviral Franchise
28%
U.S. 754.0 643.2
ā¦
Europe 509.8 349.3
ā¦
Other International 77.0 55.2
ā¦
$590.4 $479.4
TruvadaĀ®
U.S. 281.0 238.5
ā¦
23%
Europe 278.4 218.4
ā¦
Other International 30.9 22.5
ā¦
$509.9 $324.2
AtriplaĀ®
U.S. 374.1 306.5
ā¦
57%
Europe 124.8 14.2
ā¦
Other International 11.0 3.5
ā¦
$160.6 $152.7
VireadĀ®
5%
U.S. 69.6 63.1
ā¦
Europe 65.3 65.7
ā¦
Other International 25.7 23.9
ā¦
$72.7 $83.0
HepseraĀ®
U.S. 25.7 31.3
ā¦
-12%
Europe 38.9 48.5
ā¦
Other International 8.1 3.3
ā¦
$7.2 $8.4
EmtrivaĀ®
U.S. 3.6 3.8
ā¦
-14%
Europe 2.4 2.6
ā¦
Other International 1.3 2.0
ā¦
Note: Amounts may not sum due to rounding 16
18. Royalty, Contract and Other Revenues
Q1 Q1
($ in Millions) 2009 2008 %ā²
Total Royalty,
$82.9 $116.8 -29%
Contract & Other
Revenues
ā¦ Lower royalty, contract and other revenues are
primarily due to:
ā Lower Q1 2009 Tamiflu royalties of $33.2 million,
down 64% from Q1 2008, partially offset by the recognition
of $23.7 million of previously deferred collaboration
payments from a corporate partner as we no longer have
substantive ongoing performance obligations
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19. Non-GAAP Product Gross Margin
100%
ā¦ Q1 2009 decrease from
79.9% 79.1%
Q1 2008 driven primarily by:
77.6%
80%
ā Higher proportion of
60%
Atripla sales which
includes the efavirenz
40%
component at zero gross
20%
margin
0%
Q1
2007 2008 2009
Note: Non-GAAP product gross margin for all periods exclude stock-based compensation expense
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20. Non-GAAP R&D Expenses
Q1 Q1
($ in Millions) 2009 2008 %ā²
Non-GAAP $171.8 $138.4 24%
R&D Expenses*
ā¦ Higher non-GAAP R&D expenses in Q1 2009 were
primarily due to:
ā Increased headcount
ā Increased clinical study activity
* Excludes stock-based compensation expense
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21. Non-GAAP SG&A Expenses
Q1 Q1
($ in Millions) 2009 2008 %ā²
Non-GAAP $183.1 $177.4 3%
SG&A Expenses*
ā¦ Higher non-GAAP SG&A expenses in Q1 2009 were
primarily due to:
ā Increased headcount
* Excludes stock-based compensation expense
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22. Other Selected Financial Information
Mar. 31, Dec. 31,
2009 2008
Cash, Cash Equivalents & Marketable
$3,608.9 $3,239.6
Securities ($ in Millions)
Inventories ($ in Millions) $936.7 $927.9
Days Sales Outstanding
63 65
(Accounts Receivable)
Common Shares Repurchased During
$230.0 $753.5
the Quarter ($ in Millions)*
Diluted Shares Used in Per Share Calculation
942,479 942,837
for the Quarter (GAAP) (In thousands)
* As of March 31, 2009, the remaining authorized amount of share repurchases that may be made
under the current share repurchase program that expires in December 2010 was $768 million.
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23. Effective Tax Rate
Q1 Q1
2008
2009
Effective Tax Rate 26.3% 27.9%
ā¦ Q1 2009 effective tax rate decreased over Q1 2008
primarily due to:
ā Extension of federal R&D tax credit
ā Increased earnings in lower tax rate jurisdictions
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25. 12 Products Contributing to Revenue Stream
Through Direct Sales or Partner Promotion
HIV/AIDS HIV/AIDS
HIV/AIDS Japan Tobacco (Japan) Japan Tobacco (Japan)
Bristol-Myers Squibb (US and EU) Chronic Hepatitis B
Merck (Developing Countries)
Pulmonary Arterial
Hypertension
HIV/AIDS Chronic Hepatitis B
GSK (EU)
Japan Tobacco (Japan) GSK (Asia, Latin America)
Age-related
Macular Degeneration
Influenza A & B
Severe Fungal Infections
Roche (Worldwide) OSI (US) / Pfizer (OUS)
Astellas (US and Canada)
Sumitomo (Japan)
Myocardial Perfusion Imaging
Chronic Angina
CMV Retinitis/AIDS Astellas (US and Canada)
Menarini (EU)
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26. HIV Franchise Highlights
Around the World, More than One Million Individuals
Received One of Gileadās Four HIV Medications*
U.S.
ā¦ >70% of all treated patients received Gilead HIV products
ā¦ >80% of treatment naĆÆve patients started therapy on a Gilead
product
ā¦ Atripla was the most prescribed regimen in HIV
(31% of all patients)
ā¦ Truvada remained the most prescribed product in HIV
(35% of all patients)
EU
ā¦ Atripla is reimbursed in 15 countries, including all of the Big 5
ā¦ Truvada continued to build on its solid base as the #1 brand in all
Big 5 markets
ā¦ >70% of all patients initiating therapy received a Tenofovir-
containing regimen
U.S. data from Synovate Healthcare U.S. HIV Monitor Q4 2008
EU data from IMS/GERS & Synovate Q4 2008
* Including developing world 26
27. U.S. HIV Market Dynamics
Significant Opportunity Remains to Grow Market by
Increasing Diagnosis and Bringing Patients onto Therapy
1,400
1,056 ā 1,156
1,200
835 ā 915
Patients in 000s
1,000
Up 7%^
~79%
800
565
600
409
~62%
400
~72%
200
0
HIV Infected* Diagnosed* On Antiretroviral On Atripla, Truvada
Treatment** or Viread**
Sources:
* October, 2008 CDC estimates as of the end of 2006
** Synovate Healthcare U.S. HIV Monitor Q4 2008 growth rate calculated as moving annual total
^ Growth rate calculated as MAT (moving annual total)
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28. EU Big 5 HIV Market Dynamics
Similar Dynamics as Seen in the U.S. with
Strong Support in the EU for Increased
Testing Initiatives and Early Treatment
600
557
Up 7%^
Patients in 000s
377
400
~68%
273
~72%
166
200
~61%
0
HIV Infected* Diagnosed* On Antiretroviral On Atripla, Truvada
Treatment** or Viread**
Sources:
* National Surveillance Units per country & ECDC Q4 2008
** IMS/GERS & Synovate Q4 2008
^ Growth rate calculated as MAT (moving annual total)
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30. U.S. HBV Market Dynamics
Approximately 1 in 10 Asian Americans is
Living with Chronic Hepatitis B
2,000
2,000
Patients in 000s
1,500
1,000
Up 13%
Y/Y
500
300
~15%
~21% 62
0
HBV Chronically Infected* Diagnosed** On Oral Antiviral
Treatment**
Sources:
*CDC 12/4/08 Institute of Medicine presentation
** Based on Gilead estimates as of Q1 2009
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31. Viread for HBV Launch Update
EU Approval on April 25, 2008
U.S. Approval on August 11, 2008
1H08 2H08 2009
Austria Spain Australia
Germany United States New Zealand
Belgium
Greece Portugal
Poland
France Italy
Netherlands Denmark, Finland, Norway and
Sweden
UK
Canada
Turkey
As of March 31, 2009
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32. Letairis for
Pulmonary Arterial Hypertension
ā¦ PAH afflicts ~200K patients worldwide, ~75 - 90K in the U.S.
ā ~5K newly diagnosed per year in the U.S.
ā¦ Marketed in the U.S. by Gilead; in EU by GSK as VolibrisĀ®
ā¦ Approximately 1out of every 3 U.S. patients receiving
an ERA received Letairis at the end of Q1 09
ā¦ ~30% of all U.S. patients taking Letairis had switched from
bosentan
ā¦ Physician prescribing base nearly doubled over past 12 months
ā¦ Phase IV trial ongoing along with 17 investigator initiated studies
Source:
Gilead conducted physician survey as of March 31, 2009
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34. Anticipated Pipeline Milestones in 2009
HIV/AIDS
GS 9350/ Present PK data from both GS 9350 and integrase FDR at CROI
Q1 09
Elvitegravir/
Truvada Initiate Ph II in treatment-naĆÆve HIV patients
Q2 09
GS 9350 Initiate Ph II as a pharmacokinetic enhancer in a PI based regimen
Q2 09
Liver Disease
GS 9450 Initiate Ph IIb in HCV
Q2 09
Complete Ph IIa in NASH
Q4 09
Respiratory
Q2 09
GS 9411 Complete Ph I
Cardiovascular
Q1 09
Cicletanine Initiate Ph II in PAH
Q2 09
Ambrisentan Initiate Ph III study in pulmonary hypertension associated with IPF
Present ARIES-3 data at ATS meeting
Q2 09
Darusentan Complete and release data from DAR 311 Ph III study in resistant
hypertension (presentation at ASH)
Q4 09 Complete DAR 312 Ph III study in resistant hypertension
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35. Gileadās Strengths to Drive Growth
ā¦ Significant growth drivers for antiviral franchise
ā¦ Research and development strength, with cardiovascular
efforts augmented with the acquisition of CV Therapeutics
ā¦ Numerous presentations at upcoming scientific
conferences
ā¦ Demonstrated track record bringing forward ābest-in-classā
compounds
ā¦ Unique organizational structure
ā¦ Strong balance sheet
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