Upload
earningreport-earningreport
View
697
Download
1
Tags:
Embed Size (px)
Citation preview
1
April 21, 2009April 21, 2009
Q1 2009 Earnings ResultsConference Call and Webcast
2
Forward-looking Statement and GAAP Reconciliation
Forward-looking StatementStatements included in this presentation 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, 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 ReconciliationThis 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.
3
Q1 2009 Earnings Call Agenda
♦ Corporate HighlightsJohn Martin, PhD, Chairman and CEO
♦ Financial PerformanceRobin Washington, SVP and CFO
♦ Commercial UpdateKevin Young, EVP of Commercial Operations
♦ R&D UpdateNorbert Bischofberger, PhD, EVP of R&D and CSO
♦Upcoming Growth DriversJohn Milligan, PhD, President and COO
♦ Q&A
4
Corporate HighlightsJohn Martin, PhD, Chairman and CEO
April 21, 2009April 21, 2009
5
Gilead Completes Acquisition of CV Therapeutics on April 17, 2009
♦ Ranexa for chronic angina with new, stronger US label– Specialty sales force detailing cardiologists
♦ Lexiscan opportunity in EU♦ Proven development and regulatory organization
– Improved opportunity for Letairis and darusentan♦ Pipeline of cardiovascular products♦ Improved future earnings profile and growth rate
Vision for CV Therapeutics: Bolsters Gilead’s Presence in the
Cardiovascular Space
6
Strong Geographical Presence Around the World
Australia/New Zealand
IrelandU.K.
Portugal
Germany
Switzerland
Austria
ItalyGreece
TurkeyDurham, NC
Westminster, CO
San Dimas, CA
Foster City, CAPalo Alto, CA
Edmonton, Albertaand Mississauga, ON
Seattle, WA
LEGEND
Respiratory Research
Antiviral Research
Cardiovascular Research
Manufacturing Operations
Sales and Marketing Operations
HQ, Manufacturing Operations, Antiviral Research *Includes Field Employees
China
France
Spain
Belgium
Sweden
Denmark
Norway
FinlandThe Netherlands
Gilead Locations
7
Research and DevelopmentNorbert Bischofberger, PhD,
EVP of R&D and CSO
April 21, 2009April 21, 2009
8
Gilead’s Platform Spans Four Therapeutic Areas
AtriplaAtriplaTruvadaTruvadaVireadViread
EmtrivaEmtrivaElvitegravir Elvitegravir (Ph III)(Ph III)
Integrase FDRIntegrase FDR (Ph II)(Ph II)GS 9350 GS 9350 (Ph I)(Ph I)
Ranexa Ranexa -- AnginaAngina
Letairis Letairis -- PAHPAHCicletanineCicletanine -- PAH (Ph II)PAH (Ph II)
Lexiscan Lexiscan -- MPIMPI
DarusentanDarusentan-- Resistant Resistant
HypertensionHypertension(Ph III)(Ph III)
AdentriAdentri-- Acute Heart Failure Acute Heart Failure
(Ph III)(Ph III)
Tecadenoson Tecadenoson -- Atrial Fibrillation (Ph II)Atrial Fibrillation (Ph II)
CVT3619CVT3619-- Diabetes (Ph I)Diabetes (Ph I)
Tamiflu Tamiflu -- InfluenzaInfluenza
Aztreonam Lysine Aztreonam Lysine -- CF (Ph III)CF (Ph III)
-- BronchiestasisBronchiestasis (Ph II)(Ph II)
GS 9310 / 11 GS 9310 / 11 -- CF (Ph II)CF (Ph II)GS 9411 GS 9411 -- CF (Ph I)CF (Ph I)
Ambrisentan Ambrisentan -- IPF (Ph III) IPF (Ph III)
CVTCVT--68836883-- Pulmonary DiseasesPulmonary Diseases
(Ph I)(Ph I)
Hepsera Hepsera -- HBVHBVViread Viread -- HBVHBV
GS 9450 GS 9450 -- HCV (Ph II) HCV (Ph II) GS 9190 GS 9190 -- HCV (Ph II)HCV (Ph II)
GS 9450 GS 9450 -- NASH (Ph II)NASH (Ph II)
HIV/AIDSHIV/AIDS CardiovascularCardiovascular/ Metabolic/ MetabolicRespiratoryRespiratoryLiver DiseaseLiver Disease
9
Darusentan for Resistant Hypertension
♦ 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
– 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
Reductions in mean trough sitting DBP from baseline
5.3 mmHg 10.1 mmHg 9.9 mmHg 10.7 mmHg
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%
Serum aminotransferase concentrations (>3x upper limit of normal range)
1 patient 0 1 patient 1patient
♦ 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
– n=770; 90% enrolled, data early 2010* As of April 2, 2009
10
Financial PerformanceRobin Washington, SVP and CFO
April 21, 2009April 21, 2009
11
Financial Highlights: A Snapshot of Q1 2009
♦ Total revenues were up 22 percent over Q1 2008
♦ Net income attributable to Gilead per diluted share of $0.63; Non-GAAP net income attributable to Gilead per diluted share of $0.66*
♦ $3.6 billion in cash, cash equivalents and marketable securities as of March 31, 2009
♦ Cash flow from operations of $641.3 million
* Excludes after-tax stock-based compensation expense
12
$0.46$0.53
$0.66
$0.00
$0.25
$0.50
$0.75
Q1
200720082009
♦ Q1 2009 increase of 24% over Q1 2008
Note: Non-GAAP EPS for all periods exclude after-tax stock-based compensation expenseOn 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.
+24%
+16%
Financial Highlights:Non-GAAP EPS
13
Financial Highlights:Total Revenues
♦ Q1 2009 increase of 22% over Q1 2008
$1,028
$1,258
$1,530
$0
$400
$800
$1,200
$1,600
Q1
200720082009
$ In Millions +22%
+22%
14
$840
$1,141
$1,448
$0
$250
$500
$750
$1,000
$1,250
$1,500
Q1
200720082009
$ In Millions +27%
+36%
Financial Highlights:Total Product Sales
♦ Q1 2009 increase of 27% over Q1 2008
15
$484
$606$641
$0
$250
$500
$750
Q1
200720082009
$ In Millions
+6%+25%
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.
Financial Highlights: Operating Cash Flows
16
Product Sales: Antiviral FranchiseProduct Product ($ in Millions)($ in Millions)
Q1 2009
Q12008 %▲
Antiviral Franchise♦ U.S.♦ Europe♦ Other International
$1,340.8754.0509.877.0
$1,047.7643.2349.355.2
28%
Truvada®
♦ U.S.♦ Europe♦ Other International
$590.4281.0278.430.9
$479.4238.5218.422.5
23%
57%
5%
Hepsera®
♦ U.S.♦ Europe♦ Other International
$72.725.738.98.1
$83.031.348.53.3
-12%
-14%Emtriva®
♦ U.S.♦ Europe♦ Other International
$7.23.62.41.3
$8.43.82.62.0
Atripla®
♦ U.S.♦ Europe♦ Other International
$509.9374.1124.811.0
$324.2306.514.23.5
Viread®
♦ U.S.♦ Europe♦ Other International
$160.669.665.325.7
$152.763.165.723.9
Note: Amounts may not sum due to rounding
17
Other Product Sales
Product Product ($ in Millions)($ in Millions)
Q1 2009
Q1 2008 %▲
AmBisome® $64.3 $71.0 -10%
95%Letairis® $39.6 $20.3
18
Royalty, Contract and Other Revenues
♦ Lower royalty, contract and other revenues are primarily due to:
– Lower Q1 2009 Tamiflu royalties of $33.2 million, down 64% from Q1 2008, partially offset by the recognition of $23.7 million of previously deferred collaboration payments from a corporate partner as we no longer have substantive ongoing performance obligations
($ in Millions)($ in Millions)Q1
2009Q1
2008 %▲
-29%Total Royalty, Contract & Other Revenues
$82.9 $116.8
19
79.9% 79.1% 77.6%
0%
20%
40%
60%
80%
100%
Q1
2007 2008 2009
♦ Q1 2009 decrease from Q1 2008 driven primarily by:
– Higher proportion of Atripla sales which includes the efavirenz component at zero gross margin
Note: Non-GAAP product gross margin for all periods exclude stock-based compensation expense
Non-GAAP Product Gross Margin
20
Non-GAAP R&D Expenses
♦ Higher non-GAAP R&D expenses in Q1 2009 were primarily due to:
– Increased headcount
– Increased clinical study activity
($ in Millions)($ in Millions)Q1
2009Q1
2008 %▲
24%Non-GAAP R&D Expenses*
$171.8 $138.4
* Excludes stock-based compensation expense
21
Non-GAAP SG&A Expenses
♦ Higher non-GAAP SG&A expenses in Q1 2009 were primarily due to:
– Increased headcount
($ in Millions)($ in Millions)Q1
2009Q1
2008 %▲
3%Non-GAAP SG&A Expenses*
$183.1 $177.4
* Excludes stock-based compensation expense
22
Other Selected Financial InformationMar. 31,
2009Dec. 31,
2008
Cash, Cash Equivalents & Marketable Securities ($ in Millions)
$3,608.9 $3,239.6
Days Sales Outstanding (Accounts Receivable) 63 65
Common Shares Repurchased During the Quarter ($ in Millions)*
$230.0 $753.5
Diluted Shares Used in Per Share Calculation for the Quarter (GAAP) (In thousands)
942,479 942,837
Inventories ($ in Millions) $936.7 $927.9
* 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.
23
Effective Tax Rate
♦ Q1 2009 effective tax rate decreased over Q1 2008 primarily due to:
– Extension of federal R&D tax credit
– Increased earnings in lower tax rate jurisdictions
Q12009
Q12008
Effective Tax Rate 26.3% 27.9%
24
Commercial UpdateKevin Young, EVP of Commercial Operations
April 21, 2009April 21, 2009
25
HIV/AIDS Japan Tobacco (Japan)
Severe Fungal InfectionsAstellas (US and Canada)Sumitomo (Japan)
CMV Retinitis/AIDS
Influenza A & B Roche (Worldwide)
HIV/AIDS Japan Tobacco (Japan)
Age-related Macular DegenerationOSI (US) / Pfizer (OUS)
Chronic Hepatitis BGSK (Asia, Latin America)
HIV/AIDS Japan Tobacco (Japan)Chronic Hepatitis B
12 Products Contributing to Revenue Stream Through Direct Sales or Partner Promotion
HIV/AIDS Bristol-Myers Squibb (US and EU) Merck (Developing Countries)
Pulmonary Arterial HypertensionGSK (EU)
Chronic AnginaMenarini (EU)
Myocardial Perfusion ImagingAstellas (US and Canada)
26
HIV Franchise Highlights
U.S.♦ >70% of all treated patients received Gilead HIV products♦ >80% of treatment naïve patients started therapy on a Gilead
product♦ Atripla was the most prescribed regimen in HIV
(31% of all patients)♦ Truvada remained the most prescribed product in HIV
(35% of all patients)EU♦ Atripla is reimbursed in 15 countries, including all of the Big 5♦ Truvada continued to build on its solid base as the #1 brand in all
Big 5 markets♦ >70% of all patients initiating therapy received a Tenofovir-
containing regimenU.S. data from Synovate Healthcare U.S. HIV Monitor Q4 2008EU data from IMS/GERS & Synovate Q4 2008* Including developing world
Around the World, More than One Million Individuals Received One of Gilead’s Four HIV Medications*
27
U.S. HIV Market Dynamics
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
0
200
400
600
800
1,000
1,200
1,400
HIV Infected* Diagnosed* On AntiretroviralTreatment**
On Atripla, Truvadaor Viread**
Patie
nts
in 0
00s
1,056 – 1,156
835 – 915
565
409
Significant Opportunity Remains to Grow Market by Increasing Diagnosis and Bringing Patients onto Therapy
Significant Opportunity Remains to Grow Market by Increasing Diagnosis and Bringing Patients onto Therapy
~79%
~62%~72%
Up 7%
^ Growth rate calculated as MAT (moving annual total)
^
28
0
200
400
600
HIV Infected* Diagnosed* On AntiretroviralTreatment**
On Atripla, Truvadaor Viread**
Patie
nts
in 0
00s
Sources:* National Surveillance Units per country & ECDC Q4 2008** IMS/GERS & Synovate Q4 2008
557
377
273
166
Similar Dynamics as Seen in the U.S. with Strong Support in the EU for Increased Testing Initiatives and Early Treatment
EU Big 5 HIV Market DynamicsSimilar Dynamics as Seen in the U.S. with
Strong Support in the EU for Increased Testing Initiatives and Early Treatment
~68%
~72%
~61%
Up 7%^
^ Growth rate calculated as MAT (moving annual total)
29
Viread for Hepatitis B: Rapidly Gaining Market Share in the U.S.
Weekly Gilead HBV Franchise NRx Market Share Has Grown from 43% to 51% Since Launch of Viread*
Source:Weekly Wolters Kluwer Health (WKH) Prescriber data*Gilead Proprietary Method of estimating Viread market share
0%
5%
10%
15%
20%
25%
30%
35%
40%
7/4/08
7/18/0
88/1
/088/1
5/08
8/29/0
89/1
2/08
9/26/0
810
/10/08
10/24
/0811
/7/08
11/21
/0812
/5/08
12/19
/081/2
/091/1
6/09
1/30/0
92/1
3/09
2/27/0
93/1
3/09
3/27/0
9
Hepsera 25%
Baraclude 33%
Viread* 26%
Epivir 14%
Tyzeka 3%
30
0
500
1,000
1,500
2,000
HBV Chronically Infected* Diagnosed** On Oral AntiviralTreatment**
Patie
nts
in 0
00s
2,000
30062
~15%~21%
U.S. HBV Market Dynamics
Sources:*CDC 12/4/08 Institute of Medicine presentation ** Based on Gilead estimates as of Q1 2009
Approximately 1 in 10 Asian Americans is Living with Chronic Hepatitis B
Approximately 1 in 10 Asian Americans is Living with Chronic Hepatitis B
Up 13% Y/Y
31
Viread for HBV Launch Update
1H081H08 2H082H08 20092009
TurkeyCanada
UK
Denmark, Finland, Norway and Sweden
Netherlands
ItalyFrance
PortugalGreece
New ZealandUnited StatesGermany
AustraliaSpainAustria
EU Approval on April 25, 2008 U.S. Approval on August 11, 2008
EU Approval on April 25, 2008 U.S. Approval on August 11, 2008
As of March 31, 2009
BelgiumPoland
32
♦ PAH afflicts ~200K patients worldwide, ~75 - 90K in the U.S.– ~5K newly diagnosed per year in the U.S.
♦ Marketed in the U.S. by Gilead; in EU by GSK as Volibris®
♦ Approximately 1out of every 3 U.S. patients receiving an ERA received Letairis at the end of Q1 09
♦ ~30% of all U.S. patients taking Letairis had switched from bosentan
♦ Physician prescribing base nearly doubled over past 12 months♦ Phase IV trial ongoing along with 17 investigator initiated studies
Source:Gilead conducted physician survey as of March 31, 2009
Letairis for Pulmonary Arterial Hypertension
33
Upcoming Growth DriversJohn Milligan, PhD, President and COO
April 21, 2009April 21, 2009
34
Anticipated Pipeline Milestones in 2009HIV/AIDSHIV/AIDS
Q1 09 Present PK data from both GS 9350 and integrase FDR at CROI
Q2 09 Initiate Ph II in treatment-naïve HIV patients
GS 9450 Q2 09 Initiate Ph IIb in HCV
GS 9350/ Elvitegravir/ Truvada
GS 9350 Q2 09 Initiate Ph II as a pharmacokinetic enhancer in a PI based regimen
Liver DiseaseLiver Disease
Q4 09 Complete Ph IIa in NASH
RespiratoryRespiratoryQ2 09 Complete Ph IGS 9411
Ambrisentan Q2 09 Initiate Ph III study in pulmonary hypertension associated with IPFPresent ARIES-3 data at ATS meeting
Darusentan Q2 09 Complete and release data from DAR 311 Ph III study in resistanthypertension (presentation at ASH)
Q4 09 Complete DAR 312 Ph III study in resistant hypertension
Cicletanine Q1 09 Initiate Ph II in PAHCardiovascularCardiovascular
35
Gilead’s Strengths to Drive Growth
♦ Significant growth drivers for antiviral franchise♦ Research and development strength, with cardiovascular
efforts augmented with the acquisition of CV Therapeutics♦ Numerous presentations at upcoming scientific
conferences♦ Demonstrated track record bringing forward “best-in-class”
compounds♦ Unique organizational structure♦ Strong balance sheet
36
Q&A
April 21, 2009April 21, 2009