Treatment Expansion in Access & Emerging Markets Cristin Lis Vice President, Government Affairs October 22, 2014

Gilead Sciences Mission: Discover, develop and deliver innovative medicines in areas of unmet medical need 7,000 employees in 28 countries on 5 continents 17 marketed medicines (US) and more than 250 ongoing 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 local health system improvement

Access Operations & Emerging Markets Geography Gilead medicines reach patients in more than 125 countries supplied by 20 regional business partners

Access Guiding Principles Gilead’s Access Operations & Emerging Markets business unit works to improve treatment access in resource-limited countries Sustainability Design access efforts for the long term Partnership Collaborate with public sector and other companies Adaptability Heed lessons learned; continually innovate   Responsibility Focus where needs are greatest

Gilead Access Medicines Gilead’s developing world programs enable access to eight medicines and generic versions of their chemical compounds Viread® (TDF) tenofovir disoproxil fumarate 300 mg Truvada® (TDF/FTC) emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg Complera® (RVP/TDF/FTC) emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg Tybost® cobicistat 150mg Vitekta® elvitegravir 150mg Stribild® (EVG/COBI/TDF/FTC) elvitegravir 150 mg/cobicistat 150 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg Sovaldi® sofosbuvir 400 mg AmBisome® 1 amphotericin b liposome for injection 50 mg/vial 1 AmBisome is not available in generic form. Gilead provides AmBisome to public sector agencies at no-profit prices and donates the medicine to WHO for use in high-burden countries.

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

Innovative Use of Intellectual Property Generic Licensing HIV, HBV and HCV Treatment scale:up in resource poor settings Indian, Chinese and African licensees Full technology transfer Small royalty to ensure sustainability of programs Medicines Patent Pool UN-supported initiative to enhance drug access through sharing of patents Gilead first innovator company to join (2011)

Critical Support Activities Together with our partners, we conduct a number of support activities to help ensure effective and appropriate use of Gilead medicines and strengthen health systems in developing countries Product Registration Medical Education & Training Logistics & Supply Management Collaborative Research

Critical Support Activities: Product Registration Regional business partners help register medicines with national regulatory authorities, ensuring that documents conform to national requirements and are processed efficiently Gilead Medicine Truvada Complera Stribild Viread for HIV Viread for HBV Sovaldi Developing World Registrations 109 21 7 65 1

Critical Support Activities: Medical Education Medical education events and materials increase knowledge of available therapies and standards of care Gilead works with regional business partners and local health agencies to ensure that medical education materials are culturally appropriate Gilead-supported HIV medical education event in Myanmar, 2013 Patient education aid for low-literacy populations in Chad

Critical Support Activities: Supply Management A reliable supply chain is essential to treatment expansion Proprietary information tools track orders and inventory across regions and avoid supply stock-outs   Partnerships with organizations such as the Clinton Health Access Initiative help coordinate large-scale purchasing of medicines

Critical Support Activities: Collaborative Research Gilead supports clinical research to determine optimal use of its medicines in Africa, Asia and Latin America Studies address: How to reach more patients by streamlining clinical procedures The potential benefits of early treatment initiation The safety and efficacy of treatment for children and adolescents

Recognition of Gilead’s Access Efforts Access to Medicine Index #1 ranking in product pricing #1 ranking in use of patents to expand access Patents for Humanity Innovative use of IP recognized by U.S. Patent and Trademark Office's “Patents for Humanity” award

Therapeutic Area Focus Visceral Leishmaniasis HIV/AIDS Viral Hepatitis 35 million people living with HIV worldwide Leading cause of liver failure and liver cancer Second deadliest parasitic disease after malaria

HIV/AIDS Treatment Expansion Milestones Gilead launches its HIV Access Program to provide access to TDF in nearly 60 developing countries Gilead becomes the first HIV manufacturer to sign a licensing agreement with the Medicines Patent Pool 2003 2006 2011 2014 Gilead establishes licensing agreements with 11 Indian generic manufacturers, reaching a total of 94 countries; Gilead develops a network of regional distributors Gilead HIV medicines are reaching 6 million patients in the developing world

Increasing Patient Reach More than 50% of patients on antiretroviral therapy in the developing world are receiving Gilead medicines Generic drug manufacturers account for 99% of Gilead HIV medicines prescribed in developing countries

Increased Competition Lowers Drug Prices 17 generic partners are licensed to manufacture and sell Gilead HIV therapies; market competition has helped reduce the cost of TDF by 80% since 2006 2006 2007 2008 2009 2010 2011 2012 2013 $25 $20 $15 $10 $5 TDF/FTC TDF

Case Study: Zambia “In 2007, we made the most dramatic change in our guidelines, when we opted for tenofovir-based regimens.” – Dr. Albert Mwango National ARV Coordinator Zambia Ministry of Health Zambia introduces generic Atripla® as first-line therapy 2005 2007 2009 2011 2013 More than 70K people die of AIDS in Zambia AIDS deaths fall to 37K AIDS deaths fall to 30K 90% of treatment-eligible adults in Zambia are receiving HIV therapy 1UNAIDS Country Profile. Accessed April 17, 2014 2UNGASS, 2011 Zambia Country Progress Report *Gilead interview with Zambian Health Ministry, October 2013

Special Initiatives Myanmar Ethiopia and Uganda Tanzania In October 2013, signed agreement with National AIDS Program to donate generic Atripla® for 2,000 patients at government hospitals Ethiopia and Uganda In early 2013, supported HiV-Link pilot, which connects rural Ethiopian and Ugandan healthcare providers with U.S. and UK treatment experts via text Tanzania In early 2014, with the Holy See’s Good Samaritan Foundation, launched an HIV “test- and-treat” demonstration project to screen 120,000 patients and provide ARVs to 20,000

Viral Hepatitis Viral hepatitis is far more common than HIV; it is estimated that more than 500 million people are affected by viral hepatitis HBV Prevalence HCV Prevalence More than 185 million people around the world have been infected with the hepatitis C virus (HCV) Chronic hepatitis B (HBV) is estimated to affect nearly 350 million people worldwide ≥ 8% 5-7% 2-4% < 2% No Data > 4% 2-4% 1-1.9% < 1% No Data

Viral Hepatitis Treatment Expansion Hepatitis B Viread for hepatitis B is available in same 125+ countries and at same prices as for HIV Viread for HBV is now registered in over 60 countries and has been filed for approval or is pending submission in more than 50 additional countries Hepatitis C WHO HCV treatment guidelines recommend treatment with Sovaldi for genotypes 1-4 Three tiered pricing bands for Gilead branded medicines Generic licenses to produce low cost SOF and SOF/LDV NGO / Gov’t partnerships Standardize, images of viread and sovaldi—do a quick search search on cheap websites, or let it go if not quickly available. Lisa to send product shots.

Chronic Hepatitis C Gilead’s strategy is to invest in long-term partnerships with governments and NGOs to implement public health plans, and engage regulatory and funding agencies to support national treatment strategies Tiered pricing of Gilead branded medicines for low-, lower-middle and upper-middle income countries Licensed generic SOF and LDV/SOF for distribution in 91 developing countries Over 20 regional business partnerships to manage supply chains and distribute branded Sovaldi in developing countries Registrations focusing initially on the highest-burden countries & greatest needs Medical education to train health care providers in hepatitis C diagnosis and care Try Key Access strategies as a table try making round logo huge and crop off page

Generic Licensing 15th September 2014: Gilead Sciences signed non-exclusive license agreements with seven generic pharmaceutical manufacturers to expand access to hepatitis C medicines in developing countries Companies granted rights to manufacture sofosbuvir and single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries The countries account for more than 100 million people living with hepatitis C globally – 54% of the total global infected population Companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible Licensees required to manufacture to local Indian DCGI quality standards Licensees set their own prices for the product they produce, paying a royalty on sales to Gilead to support product registrations, medical education/training, safety monitoring and other business essential activities Large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries.

Indian Generic Licensees Cadila Healthcare Ltd Cipla Ltd Hetero Labs Ltd Mylan Laboratories Ltd Ranbaxy Laboratories Ltd Strides Arcolab Ltd Sequent Scientific Ltd More than 100 million people living with hepatitis C 91 countries included 54% of the estimated HCV infected global population 75% of countries designated low-middle Income 90% of people living in low-middle income countries

Tiered Pricing Three basic tiered pricing bands that serve as the starting point for negotiations with national governments Countries are categorized within the bands according to gross national income (GNI) per capita (a reflection of the average income of a country’s citizens) and hepatitis C prevalence. The tiers follow World Bank nomenclature of (i) Low-income; (ii) Lower-middle-income; (iii) Upper-middle-income Gilead classifies more countries as low- and lower-middle- income than the World Bank does As disease prevalence is considered, some countries classified as lower-middle-income by the World Bank are included in Gilead’s lowest tier Final prices are determined on a country-by-country basis

Looking Ahead New HCV access agreements with Ministries of Health and international NGOs Development of pan-genotypic regimen for chronic HCV 2015 Further expansion of HIV partnerships Roll out TAF treatment expansion for HIV and HBV Continued collaboration with WHO, NGOs on VL

Growth in Patients Reached* Low and Low-Middle Income Countries 2014 (Q2) HIV Dashboard Gilead Access Operations & Emerging Markets Growth in Patients Reached* Low and Low-Middle Income Countries Over 130 Access Countries Access countries are home to 95% of people with HIV in developing countries Products Medicine Lowest Price Registrations Viread 109 Truvada Complera 22 17.00 4.00 n Branded n Generic 26.25 5.29 Gilead’s access efforts reach 58% of people in developing countries receiving HIV treatment FDA/WHO generic approvals: 34 * TDF-containing regimens from tech transfer recipients, branded sales, direct and MPP licensees

Thank you