Gilead Sciences, Inc. · NASDAQ:GILD
Gilead Sciences — 35th Annual J.P. Morgan Healthcare Conference (January 2017)
33 slides from Gilead Sciences's conference presentation, Jan 9, 2017
Slide 1: 35th Annual J.P. Morgan Healthcare Conference
John Milligan, PhD President & Chief Executive Officer 35th Annual J.P. Morgan Healthcare Conference January 9, 2017
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 t
Slide 3: 2016 Successes
2016 Successes • Launched Four New Products – Descovy and Odefsey for HIV – Epclusa for HCV – Vemlidy for HBV • Progressed Pipeline – NDA/MAA filed for SOF/VEL/VOX for HCV – Bictegravir/F/TAF STR Phase 3 studies enrolled – Filgotinib Phase 3 studies initiated in RA, UC and Crohn’s disease – Selonser
Slide 4: As We Begin 2017…
As We Begin 2017… • Market Leaders in HIV and HCV – Growing TAF-based regimens in U.S. and Europe – Three SOF-based regimens that simplify therapy for HCV patients • Operationally and Financially Efficient (Results through September 2016) – Generated revenue of $23.1 billion – $13.2 billion in opera
Slide 5: HIV
HIV
Slide 6: History & Future of HIV Treatment and Prevention
History & Future of HIV Treatment and Prevention 2001-2014 2015 Beginning of TDF-Era TAF-Era • Truvada • Genvoya TDF-Based • Atripla TAF-Based • Odefsey Regimens • Complera Regimens • Descovy • Stribild Non-Boosted Integrase • B/F/TAF Inhibitor 6
Slide 7: Tenofovir Alafenamide (TAF): Key Component of Next Generation STRs
Tenofovir Alafenamide (TAF): Key Component of Next Generation STRs • Highly active and potent nucleotide HIV polymerase inhibitor • Improved renal and bone safety compared to Viread (TDF) • In both DHHS and IAS – USA guidelines, TAF is already recommended as a preferred treatment option • New STRs u
Slide 8: Genvoya has Surpassed Atripla in its First Year of Launch in the U.S.
Genvoya has Surpassed Atripla in its First Year of Launch in the U.S.* Launched Aligned Monthly TRx 50,000 Atripla 40,000 TRx / Month 30,000 Triumeq (ViiV) 20,000 Stribild 10,000 0 0 1 2 3 4 5 6 7 8 9 10 11 Months Post-Launch Source: Based on data derived from IMS NPA Monthly. *As measured 12-months
Slide 9: Bictegravir (B)/F/TAF
Bictegravir (B)/F/TAF • Bictegravir is a novel integrase inhibitor – In development with FTC and TAF as the single-tablet regimen B/F/TAF • Target profile: – High barrier to resistance – Efficacy against INSTI-associated resistance – Once-daily dosing – Excellent tolerability and safety – Minimal dr
Slide 10: Pre-Exposure Prophylaxis (PrEP): Truvada & Descovy
Pre-Exposure Prophylaxis (PrEP): Truvada & Descovy • Prevention is gaining traction globally to lower the rate of new HIV infections • Truvada is the only drug that is indicated for the prevention of HIV – In the U.S., an estimated 80–90k people are using Truvada for PrEP – U.S. field team focused o
Slide 11: Vision and Strategy for the Future of HIV Treatment and Prevention
Vision and Strategy for the Future of HIV Treatment and Prevention 2001-2014 2015 Beginning The Future TDF-Era of TAF-Era Highly TE Patients • Truvada • Genvoya TDF-Based • Atripla TAF-Based • Descovy Long Regimens • Complera Regimens • Odefsey Acting • Stribild • B/F/TAF Injectables HIV Cure 11
Slide 12: Hepatitis C (HCV)
Hepatitis C (HCV)
Slide 13: Gilead HCV Regimens
Gilead HCV Regimens Backbone of HCV therapy NDA/MAA Submitted • ~1.2 million patients treated worldwide with Gilead regimens since December 2013* • Real world data shows 96% cure rates with Harvoni 8-week regimen** * Through September 2016. **Sundaram V, AASLD 2016. 13
Slide 14: Ongoing Activities to Test and Treat HCV Patients
Ongoing Activities to Test and Treat HCV Patients 14
Slide 15: Changing Dynamics Anticipated within the HCV Market
Changing Dynamics Anticipated within the HCV Market 2014 2015 2016 & Beyond • Warehoused pool of patients • Lower patient starts cued-up and ready for therapy • High percentage of patients with • Higher percentage of patients with advanced disease (F3/F4) earlier-stage disease (F0-F2) and less urg
Slide 16: Liver Disease
Liver Disease Non-Alcoholic Steatohepatitis (NASH) with Fibrosis
Slide 17: Approach to NASH: Compounds with Distinct Mechanisms of Action
Approach to NASH: Compounds with Distinct Mechanisms of Action Hepatocyte Fibrogenesis/Matrix Dysfunction Remodeling GS-0976 Lipotoxicity Cell Signaling (ACC) GS-9674 NASH (FXR) Selonsertib (GS-4997, ASK1) ACC, acetyl CoA carboxylase; ASK1, apoptosis signal-regulating kinase 1; FXR, farnesoid X rece
Slide 18: NASH in the U.S.
NASH in the U.S. Non-Alcoholic Fatty Liver NAFLD ~75 Million Disease Spectrum Non-Alcoholic Steatohepatitis ~12 Million NASH NASH with Fibrosis ~3 Million 18
Slide 19: Rationale for Focusing on NASH Patients with F3/F4
Rationale for Focusing on NASH Patients with F3/F4 F0 Cum Survival (%) F1 F2 F3 F4 Follow-up (years) • Less than 1% of NASH patients have confirmed diagnosis • 25% of diagnosed patients have F3/F4 • F4: More clinical events, but higher efficacy bar to demonstrate benefit 19
Slide 20: Positive Phase 2 Results for Selonsertib (GS-4997) in NASH: Fibrosis Response
Positive Phase 2 Results for Selonsertib (GS-4997) in NASH: Fibrosis Response* Selonsertib Selonsertib Percent of Subjects 13/30 8/27 2/10 2/27 2/10 1/30 Fibrosis Improvement Progression to Cirrhosis * Loomba R, et al, AASLD 2016. 20
Slide 21: NASH: Clinical Programs
NASH: Clinical Programs 2016 2017 2018 Selonsertib (GS-4997) Separate studies for F3 Phase 3 Oral ASK1 Inhibitor and F4 patients GS-0976 Phase 2 Oral ACC Inhibitor GS-9674 Phase 2 Oral FXR Agonist Phase 2 Dual Combinations 21
Slide 22: Oncology
Oncology
Slide 23: Six Late Stage Oncology Programs
Six Late Stage Oncology Programs: GS-5745 in Phase 3 and Five Phase 2 Studies Phase I Phase 2 Phase 3 GS-5745 (MMP9) for Gastric Cancer (GC) Futility analysis in Q3 2017 GS-5745 + nivolumab for GC Entospletinib for AML Entospletinib + R-CHOP for DLBCL GS-4059 (BTK)/entospletinib for CLL Idelalisib/G
Slide 24: GS-5745 (MMP9): Clinical Data from a Phase 1b Study
GS-5745 (MMP9): Clinical Data from a Phase 1b Study Gastric Cancer GS-5745 800 mg q2wk + mFOLFOX6 Patients with Measurable Disease at Baseline n=30 Median PFS: 13.9 months (historical control: 5-6 months) Note: All patient data through August 31, 2016. SLD, sum of longest diameter, IRC assessed. Dat
Slide 25: Entospletinib (Syk inhibitor) for Treatment of AML
Entospletinib (Syk inhibitor) for Treatment of AML Complete Remission Monotherapy Lead-in Cycle 1 Cycle ≥2 Overall Phase Induction Induction Rate Chemo backbone1 200 mg 3/3 0 1 2 BID (100%) Entospletinib 400 mg 7/7 1 6 0 BID (100%) Epigenetic2 200 mg 2/3 0 1 1 BID (67%) Entospletinib 400 mg 2/3 0 2
Slide 26: Inflammation
Inflammation
Slide 27: Filgotinib
Filgotinib • Selective JAK-1 inhibitor with 900 patient years clinical trial experience • Once-daily dosing • Only JAK inhibitor with activity in RA and Crohn’s disease in Phase 2 • Safety profile thus far: – Well tolerated – No change in laboratory parameters (including hemoglobin and lipids) – Low
Slide 28: Filgotinib: Phase 3 Studies Initiated in RA, UC, and Crohn's Disease
Filgotinib: Phase 3 Studies Initiated in RA, UC, and Crohn’s Disease Methotrexate-Naïve n = 1,200 RA Methotrexate-Inadequate Responder n = 1,650 Biologic-Inadequate Responder n = 423 UC Biologic Experienced and Naïve (Induction) Maintenance n = 1,300 CD Biologic Experienced and Naïve (Induction) Mai
Slide 29: Reaching Patients
Reaching Patients
Slide 30: Positively Impacting Global Health
Positively Impacting Global Heath We’ve treated more 10 million than 1.2 million people with HCV HIV patients since approval of reached daily by Sovaldi in 2013 Gilead and generic partners Truvada for PrEP approved in 34 countries in 2016 Nubia, infant born with Ebola who received GS- 5734, celebrat
Slide 31: Thoughts on 2017
Thoughts on 2017
Slide 32: Our Focus in 2017 and Beyond
Our Focus in 2017 and Beyond • Extend and grow our leadership position in HIV • Maximize the HCV opportunity by focusing on patients and access • Build out emerging therapeutic areas – Internal programs, M&A, and partnerships • Maintain our strong operating and financial discipline – Expense control
Slide 33: 35th Annual J.P. Morgan Healthcare Conference
John Milligan, PhD President & Chief Executive Officer 35th Annual J.P. Morgan Healthcare Conference January 9, 2017
Gilead Sciences — 35th Annual J.P. Morgan Healthcare Conference (January 2017) on 6ix