Opportunities & Challenges: Expanding Access to Hepatitis C Treatment

1. Opportunities & Challenges:Expanding Access to Hepatitis C Treatment Gregg Alton Executive Vice President, Corporate & Medical Affairs Gilead Sciences 24th July, 2014

2. Gilead Sciences Discover, develop and deliver innovative medicines in areas of unmet medical need • 6,400 employees in 28 countries on 5 continents • 18 marketed medicines (US) and more than 250ongoing and planned clinical studies Focus on patient needs • All people should have access to our medicines, regardless of where they live or their economic status • Gilead also supports medical education and training, together with local health system improvement 2

3. Research & Development HCV • Recently filed for approval of Sofosbuvir/Ledipasvir FDC in the US for treatment-naïve and treatment-experienced GT 1 patients (8 or 12 weeks of therapy) • Sofosbuvir/GS-5816 FDC pan-genotypic treatment in development HBV • Conducting early-stage research to find a cure for HBV • Collaborating with GlobeImmune to explore an investigational therapeutic vaccine (in Phase 2 studies) • Evaluating toll-like receptor 7 (TLR7) agonist (Phase 1 studies) HIV • Investigational STR (single tablet regimen) containing low-dose ARV tenofoviralafenamide (TAF) in Phase 3 studies to address medical needs in several key populations • Also trials for treatment of hepatitis B • Evolving HIV eradication program focused on two compounds – the HDAC inhibitor romidepsin and a toll-like receptor TLR-7 agonist All treatments described above are investigational only and have not received regulatory approval

4. Gilead Approach to Treatment Expansion Tiered Pricing Based on a country’s disease burden, development status, and healthcare infrastructure Generic Licensing Partnering with multiple generic drug manufacturers encouraging marketplace competition to lower prices Product Donations Targeted donations enabling treatment initiation for key underserved populations Relevant Data Broad clinical trials across broad patient populations; local clinical trials where appropriate; key demonstration projects Drug Registration Submission of individual regulatory dossiers on a country by country basis Partnerships & Health Systems Strengthening Agreements with non-profit service providers and on the ground medical education and training 3

5. Gilead HIV Treatment Expansion • 5.4 million people on Gilead based ARVs today • Viread: $17 per month (low-income) • Truvada: $26 per month (low-income) • Over 240 HIV drug registrations • 17 generic licensing partnerships • First company signed to MPP • 80% price reduction in TDF-based Gilead ARVs over 8 years • Generic TDF: $4 per month

6. HCV Treatment Expansion • Appropriate drugs and diagnostics • Registration • Affordability • Education and awareness • Distribution and infrastructure  With opportunities come challenges… …..what is Gilead doing?

7. Simple drug regimens • Gilead’s ultimate goal is to create a simple, short-course oral cure for all HCV patients (pan genotypic, IFN, RBV free) LDV/SOF and SOF/GS-5816 are investigational combinations only and have not received regulatory approval

8. Optimal data sets for registration • Submitting individual regulatory dossiers on a country by country basis takes time. Clinical trials needed in certain countries in order for drugs to be approved • Gilead country clinical trials underway where necessary (China, India, Taiwan, Korea, Egypt, Japan,Vietnam, Russia) • Broad data sets needed for infected population • Gilead studies in co-infection, Decompensated liver disease, Hemophilia, Sickle cell anemia, Acute infection

9. Affordability • Need to reach low-income patients in middle-income countries • Tiered pricing based on burden of disease and economic means • Allowing generic manufacturing encouraging generic competition • Working with Ministries of Health to encourage treatment scale up • Working with NGOs to undertake demonstration projects • Exploring innovative partnerships with other multinationals • Insurance companies • Islamic development Bank • Working with global donors to encourage initial funding • PEPFAR • Global Fund

10. Education & Awareness • Health system strengthening activity • Ongoing medical and education training needs • Strengthening local health systems and local knowledge • Prevention messages • Working with Health Ministries on medical education and knowledge exchange programs • Working with Community Groups on awareness programs and policy change • Working with public health providers, policy makers, and NGOs on awareness / education programs

11. Distribution & Infrastructure • On the ground distribution and logistics so the medicines get to the right patients at the right time • Appropriate anti-diversion measures • Medicines need to go those patients for which its intended • In-country pharmaco-vigilance • Supporting ongoing data gathering • Feedback mechanisms

12. Thank you