WIPO Global Challenges Seminar Innovation and Access: A Case Study for HIV/AIDS and Hepatitis C Gregg Alton, Executive Vice President, Corporate and Medical Affairs December 5, 2014

Gilead Sciences’ Commitment to Innovation and Access Mission: Discover, develop and deliver innovative medicines in areas of unmet medical need The active ingredient in Gilead’s HIV medicines is the most widely prescribed molecule (TDF) for HIV therapy worldwide. Gilead improves HIV care by developing single tablet regimens. New hepatitis C (HCV) regimens provide a simple, safe and highly effective cure. An all-oral regimen to treat all HCV patients (pangenotypic) is in development. Focus on patient needs All people should have access to our medicines, regardless of where they live or their economic status. As part of a comprehensive access approach, Gilead has entered into licensing agreements with generic pharmaceutical manufacturers to create a sustainable, market-based model for broadening access to HIV, hepatitis B (HBV) and HCV medicines in the developing world. Our partnership model for HIV now reaches more than 6.7 million patients in developing countries. 2

The HIV Partnership Model: Creating Demand, Reducing Prices and Increasing Access $5.6B Donor support of the Gilead partnership model created demand for generic competition, resulting in prices falling 80% since We are now reaching 6.7 million people, 52 percent of those receiving HIV treatment globally. $20.7B 3

Benefits from the Licensing Model Technology transfer of the pharmaceutical manufacturing process Shortens regulatory approval process Ensures safety, quality and efficacy standards Reduces the length of time to scale up production and reach patients Partners have received a combined 34 U.S. FDA tentative approvals and WHO pre- qualifications Allows licensees to compete for high-volume business through national tenders and multilateral treatment programs Indian manufacturers are responsible for more than 80 percent of sales of TDF- containing medicines to developing countries through this partnership Economic growth in India: high-wage jobs for scientists, engineers, doctors and global managers Long-term capital investment in manufacturing for high-value medical products 4

Epidemiology of Hepatitis C Viral hepatitis is far more common than HIV; it is estimated that 185 million people are infected with HCV 5

From Innovation to Access Research and development Develop HCV treatments with high cure rates and shortened duration of therapy, including single tablet, pangenotypic regimens Clinical development Support high-quality medical research conducted in countries where HCV is most prevalent Regulatory approvals Submit country dossiers for regulatory approvals Manufacturing and distribution Develop tiered-pricing structure, negotiate generic licenses and build regional partnerships to enable access 6

Evolution of HCV Treatment Duration of Therapy (months) 3 IFN IFN/RBV Peg-IFN SVR Rate (%) Peg- IFN/RBV PI/Peg- IFN/RBV SOF/Peg- IFN/RBV LDV/SOF

Gilead's Waves of HCV Drug Development SOF, sofosbuvir, HCV NS5B nucleotide inhibitor; LDV, ledipasvir HCV NS5A inhibitor; STR, single tablet regimen All-oral therapy for GT 2/3: SOF+RBV Simple, short duration for GT-1: SOF+Peg-IFNα+RBV STR: SOF/LDV FDA approval October 2014 (GT-1); EMA approval (GT 1/4) November 2014 Pangenotypic STR: SOF/GS-5816 Key in the developing world where epidemiological data and access to genotyping diagnostics limited Pangenotypic STR: Shortened treatment duration Wave Wave Wave Wave

JapanKoreaTaiwanChinaVietnamIndiaRussiaEgypt HCV Genotypes HCV Prevalence Estimate* 1-1.9%1.29%4.4%1-1.9%2-2.9%1-1.9%1-2.5%14.9% Wave 1 (SOF) Complete MoH IND Review Enrolling Complete Wave 2 (LDV/SOF) Complete MoH IND Review NAPlanned MoH IND Review IND Filing Oct 2014 Wave 3 (5816/SOF) NA Planned NA Combined HCV Pool Estimate 45 – 72 M 1a 1b 2a2b2a/c 3a/b 46 Many Countries Require Local Clinical Trials Studies Planned, Ongoing and Completed *Cornberg M, et al. Liver Int Jul; 31 Suppl 2: Sievert W, et al Liver Int Jul; 31 Suppl 2 :

Regulatory Submissions 10

Generic Licensing: New HCV Agreements Biocon Limited Cadila Healthcare Ltd Cipla Ltd Hetero Labs Ltd Mylan Laboratories Ltd Ranbaxy Laboratories Ltd Sequent Scientific Ltd Strides Arcolab Ltd Potential to supply therapy to more than 100 million people living with hepatitis C Gilead first company to announce generic licensing for HCV treatments 91 countries included 54 middle-income countries 54% of the estimated HCV-infected global population, including: Low income (70 million patients) Lower middle-income (29 million patients) Upper middle-income (1 million patients) 11

Tiered pricing Gilead considers gross national income (GNI) per capita and hepatitis C prevalence 50 countries in tiers lower than their World Bank classifications Three pricing bands are starting points for negotiations Generic licensing Direct and through the Medicines Patent Pool Countries outside the licensing territory, including poor populations in middle-income countries Gilead works with governments and NGOs to ensure access to HIV and viral hepatitis treatment The Comprehensive Approach to Access 12

Expanding Hepatitis C Treatment Access in Egypt Increasing access in Egypt is a high priority, given the enormous national burden of HCV −12 million Egyptians infected; 15% of total pop. Gilead and Egypt’s Ministry of Health signed an agreement in July 2014 −Sovaldi ® priced at $300/bottle – our lowest available pricing, given national HCV burden −Distributed through Government-run treatment centers −Gilead to provide medical education and training initiatives Egyptian Government strongly committed to scaling up HCV treatment in the country −Goal of treating 1 million patients in 4 years 13

Country-level clinical and policy leadership National guidelines Country strategic plans (i.e., awareness, screening, care and treatment) Healthcare system capacity Country-level funding International donor funding Increases demand and enables global forecasting, which increases competition and lowers prices Regulatory harmonization Accelerates distribution and patient access Licensing and technology transfer partnerships Ensures licensing partner program quality control through technology transfer Protects partner investments in scale and manufacturing The Foundation for Access to Medicines 14

Thank you

BACK-UP SLIDES

HCV Tiered Pricing Structure 8

8 Because Gilead’s tiered pricing structure takes disease burden into account, some countries fall into a lower income tier than their World Bank classification (upper-middle  lower-middle, lower-middle  low)

HCV Demonstration Projects 8 Indonesia: Gilead partners with PKNI and the Ministry of Health to expand HCV testing and treatment among injection drug users Mongolia: With Gilead support, the Onom Foundation works to eradicate HCV through prevention, early diagnosis and treatment