Gilead Sciences, Inc. · NASDAQ:GILD
Gilead Sciences — 26th Annual JPMorgan Healthcare Conference 2008
30 slides from Gilead Sciences's conference presentation, Jan 7, 2008
Slide 1: 26th Annual JPMorgan Healthcare Conference
John C. Martin, Ph.D. President and Chief Executive Officer 26th 26 th Annual Annual JPMorgan JPMorgan Healthcare Healthcare Conference Conference January January 7, 7, 2008 2008
Slide 2: Forward-looking Statement and GAAP Reconciliation
Forward-looking Statement and GAAP Reconciliation Forward-looking Statement Statements 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-loo
Slide 3: Achievements in 2007 Strengthen Foundation for Growth in 2008 and Beyond
Achievements in 2007 Strengthen Foundation for Growth in 2008 and Beyond ♦ Research & Development ; Received approval of Letairis in U.S. ; Received approval of Atripla in EU ; Filed marketing application for Viread for HBV in the U.S. and EU ; Filed marketing application for aztreonam lysine for CF
Slide 4: Products Contributing to Revenue Stream Through Direct Sales or Partner Promotion
11 Products Contributing to Revenue Stream Through Direct Sales or Partner Promotion Primary Pulmonary HIV/AIDS HIV/AIDS Hypertension Japan Tobacco (Japan) Japan Tobacco (Japan) Gilead GSK (US) Founded HIV/AIDS Gilead Bristol-Myers Squibb (US) and (EU) HIV/AIDS IPO Japan Tobacco (Japan) Merck (Devel
Slide 5: Expanding Pipeline of Product Candidates Filed or in Clinical Development
Expanding Pipeline of Product Candidates Filed or in Clinical Development I Phase Product/Candidate File New Drug I II III Application Viread® (Tenofovir DF) HBV U.S. sNDA and EU Type II MAA Submitted Aztreonam Lysine Cystic Fibrosis (CF) U.S. NDA Submitted Darusentan Resistant Hypertension Elvitegr
Slide 6: Broad Platforms Across Three Business Units
Broad Platforms Across Three Business Units Antiviral Cardiovascular Respiratory HIV/AIDS PAH Influenza Atripla Letairis Tamiflu Truvada Flolan Viread Emtriva Elvitegravir (Ph II) Resistant Hypertension CF GS 9131 (Ph I) Darusentan (Ph III) Aztreonam Lysine (NDA submitted) GS 9310 / 11 (Ph I) HBV He
Slide 7: Strategy for Continued Growth
Strategy for Continued Growth ♦ Support of Current Products – Continued commercial operational excellence – Emphasis on disease awareness – Support policy initiatives to ensure coverage for patients in need – Build on market leadership position through Phase IV programs ♦ Internal Research & Develop
Slide 8: Antivirals: HIV
Antivirals HIV – Foster City
Slide 9: Favorable Profile of Gilead's HIV Products Driving Franchise Growth
Favorable Profile of Gilead’s HIV Products Driving Franchise Growth 53.6% 53.6% 55% 50% Total NRTI Prescription 45% Atripla Market Share (%) 40% 35% 27.1% 27.1% 30% 25% Truvada 20% 15% 10% Emtriva 5% Viread 0% 8/6/2004 10/23/2004 1/9/2005 3/28/2005 6/14/2005 8/31/2005 11/17/2005 2/3/2006 4/22/2006 7
Slide 10: Current U.S. Share of Treatment-Naïve Market
Current U.S. Share of Treatment-Naïve Market Gilead is Capturing ~ 81% of HIV-infected Patients New to Therapy Truvada 25% Non- Gilead 19% Atripla 55% Viread 1% Based on Synovate Healthcare HIV Monitor of all patients initiating therapy in Q3 2007
Slide 11: U.S. HIV Market Dynamics
U.S. HIV Market Dynamics Only half of HIV-infected individuals are currently on antiretroviral therapy 1,400 U.S. HIV Market 1,000 – 1,2001 1,200 Patients in 000s 1,000 750 – 9001 Up 9% 800 Y/Y ~75% 600 5142 400 ~57% 3302 200 ~64% 0 HIV Infected Diagnosed On Antiretroviral On Tenofovir Treatment (At
Slide 12: Progress on Increasing HIV Testing and Implementing Earlier Treatment
Progress on Increasing HIV Testing and Implementing Earlier Treatment ♦ In 2006, the CDC recommended voluntary opt-out HIV screening as part of routine medical care in all health care settings – Eight states have reduced legislative and regulatory barriers to routine screening ♦ As a result of incre
Slide 13: EU Big 5 HIV Market Dynamics
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 ~5241 Patients in 000s 400 ~3261 ~62% ~2532 200 ~78% ~1272 ~50% 0 HIV Infected Diagnosed On Antiretroviral On Tenofovir Treatment (Truvada or Vire
Slide 14: Momentum in Europe Mirroring the U.S.
Momentum in Europe Mirroring the U.S. ♦ European AIDS Clinical Society issued new treatment guidelines (October 2007) – Treatment now “recommended” for patients with a CD4 count under 350 cells/mm3 rather than “to be considered” – Patients with CD4 counts under 200 cells/mm3 should start treatment “
Slide 15: Atripla Approved for Marketing in the European Union
Atripla Approved for Marketing in the European Union Announced on December 17, 2007 ♦ Approved in 27 European Union countries ♦ Indicated for the treatment of HIV-1 infections in adults – Patients with a viral load <50 copies/mL on current combination antiretroviral therapy ♦ Product launch underway
Slide 16: Elvitegravir for HIV: Phase III Trial Design
Elvitegravir (integrase inhibitor) for HIV: Phase III Trial Design Anticipate Enrollment to Begin Q2 08 Two Phase III double-blinded, multi-center, active control Trial Designs non-inferiority studies versus raltegravir 125 U.S. sites and 125 international sites to enroll up to 1,560 total patients
Slide 17: Antivirals: Hepatitis
Antivirals Hepatitis – Durham
Slide 18: U.S. HBV Market Dynamics
U.S. HBV Market Dynamics 1,400 ~1,200 1,200 Patients in 000s 1,000 800 600 400 ~260 200 ~21% ~17% ~43 0 HBV Chronically Infected Diagnosed On Oral Antiviral Treatment *CDC 2005 and Kaiser Family Foundation
Slide 19: Treatment Dynamics for Hepatitis B
Treatment Dynamics for Hepatitis B ♦ Chronic hepatitis B is a viral infection of the liver that can result in cirrhosis (scarring) of the liver, liver cancer, liver failure and death ♦ Increased diagnosis and treatment are key to reducing the associated morbidity and mortality – Referred to as a “si
Slide 20: Hepsera and Tenofovir DF (Viread) for the Treatment of Hepatitis B
Hepsera and Tenofovir DF (Viread) for the Treatment of Hepatitis B ♦ Hepsera has solid long-term safety, efficacy and resistance data to support its leading position in the market – Remains the current #1 treatment for HBV in the U.S.* and #2 in the five major EU countries** ♦ Viread sNDA filed (PDU
Slide 21: Efforts in Hepatitis C
Efforts in Hepatitis C ♦ In-house and Collaborative Research Efforts – Internal efforts focused on protease and polymerase inhibitors – Achillion focused on NS4A antagonist compounds – Genelabs focused on nucleoside polymerase inhibitors ♦ GS 9190 - Non-nucleoside Polymerase Inhibitor – Phase I data
Slide 22: GS 9450 (caspase inhibitor) for Fibrotic Diseases
GS 9450 (caspase inhibitor) for Fibrotic Diseases ♦ Liver fibrosis occurs after chronic injury from viral infection, alcoholism or non-alcoholic steatohepatitis (NASH) – ~3 million chronically infected HCV patients with fibrosis/cirrhosis • Current HCV treatment results in only a 50% response rate –
Slide 23: Cardiovascular
Cardiovascular Westminster
Slide 24: Letairis for Pulmonary Arterial Hypertension
Letairis for Pulmonary Arterial Hypertension ♦ U.S. field sales team focused on large PAH centers, cardiologists, pulmonologists and rheumatologists ♦ Strong label - efficacy, safety (LFT elevations), drug-drug interactions and once daily dosing ♦ Parity pricing to Tracleer has helped with reimburse
Slide 25: Respiratory
Respiratory Seattle
Slide 26: Aztreonam Lysine for Inhalation for Cystic Fibrosis
Aztreonam Lysine for Inhalation for Cystic Fibrosis ♦ Patients with cystic fibrosis are predisposed to life-shortening chronic pseudomonas airway infections − TOBI®, the only inhaled anti-infective, approved in 1997 − 30,000 CF patients in U.S. and EU each − Concentrated market, with 115 U.S. treatm
Slide 27: Tamiflu for Influenza
Tamiflu for Influenza ♦ Seasonal Status – Influenza season mild to date in the U.S., EU and Japan – To date, post-marketing, clinical and preclinical studies do not support any causal relationship between Tamiflu use and neuropsychiatric events ♦ Pandemic Update – Bird flu (H5N1) human infections wo
Slide 28: Financial Highlights
Financial Highlights (US$ millions, except per share amounts) 99 Mos Mos 07 07 99 Mos Mos 06 06 % % Change Change Net Revenue $3,135 $2,127 +47% +47% Product Sales 2,707 1,820 +49% +49% Royalty, Contract and Other 428 307 +40% +40% Costs and Expenses R&D* 350 234 +50% +50% SG&A* 439 375 +17% +17% Ne
Slide 29: Upcoming Major Milestones for 2008
Upcoming Major Milestones for 2008 Antiviral Franchise ♦ Launch Atripla throughout the EU 2008 ♦ Go/No-go decision for GS 9190 for HCV Q1 08 ♦ Commence Phase III program for elvitegravir for HIV Q2 08 ♦ Commence Phase I/II program for GS 9131 for HIV 1H 08 ♦ Anticipate EU and U.S. marketing approval
Slide 30: 26th Annual JPMorgan Healthcare Conference
John C. Martin, Ph.D. President and Chief Executive Officer 26th 26 th Annual Annual JPMorgan JPMorgan Healthcare Healthcare Conference Conference January January 7, 7, 2008 2008
Gilead Sciences — 26th Annual JPMorgan Healthcare Conference 2008 on 6ix