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

2

Access Operations & Emerging Markets Geography

Gilead medicines reach patients in more than 125 countries supplied by 20 regional business partners

Access Guiding Principles

PartnershipCollaborate with public

sector and other companies

AdaptabilityHeed lessons learned;

continually innovate

SustainabilityDesign access efforts for

the long term

ResponsibilityFocus where needs

are greatest

Gilead’s Access Operations & Emerging Markets business unit works to improve treatment access in resource-limited countries

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

Gilead Access Medicines

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’s developing world programs enable access to eight medicines and generic versions of their chemical compounds

Gilead Approach to Treatment Expansion

Tiered PricingBased on a country’s disease burden, development status, and healthcare

infrastructure

Generic LicensingPartnering with multiple generic drug

manufacturers encouraging marketplace competition to lower prices

Partnerships & Health Systems Strengthening

Agreements with non-profit service providers and on the ground medical education and

training

Product DonationsTargeted donations enabling treatment

initiation for key underserved populations

Relevant DataBroad clinical trials across broad patient

populations; local clinical trials where appropriate; key demonstration projects

Drug RegistrationSubmission of individual regulatory dossiers

on a country by country basis

Generic Licensing

Innovative Use of Intellectual Property

Medicines Patent Pool• UN-supported initiative to enhance drug access

through sharing of patents

• Gilead first innovator company to join (2011)

• 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

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

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Gilead Medicine Truvada Complera Stribild Viread for HIV Viread for HBV Sovaldi

DevelopingWorld

Registrations109 21 7 109 65 1

Critical Support Activities: Medical Education

Medical education events and materials increase knowledge of available therapies and standards of care

Patient education aid for low-literacy populations in Chad

Gilead-supported HIV medical education event in Myanmar, 2013

Gilead works with regional business partners and local health agencies to ensure that medical education materials are culturally appropriate

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

35 million people living with HIV

worldwide

Leading cause of liver failure and

liver cancer

Second deadliest parasitic disease

after malaria

HIV/AIDS Viral HepatitisVisceral

Leishmaniasis

HIV/AIDS Treatment Expansion Milestones

20062006 20112011 2014201420032003

Gilead HIV medicines are reaching 6 million patients in the developing world

Gilead launches its HIV Access Program to provide access to TDF in nearly 60 developing countries

Gilead establishes licensing agreements with 11 Indian generic manufacturers, reaching a total of 94 countries; Gilead develops a network of regional distributors

Gilead becomes the first HIV manufacturer to sign a licensing agreement with the Medicines Patent Pool

More than 50% of patients on antiretroviral therapy in the developing world are receiving Gilead medicines

Increasing Patient Reach

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

1UNAIDS Country Profile. Accessed April 17, 20142UNGASS, 2011 Zambia Country Progress Report*Gilead interview with Zambian Health Ministry, October 2013

20072007 20092009 20112011 2013201320052005

More than 70K people die of AIDS in Zambia

“In 2007, we made the most dramatic change in our guidelines, when we opted for tenofovir-based regimens.”

– Dr. Albert MwangoNational ARV CoordinatorZambia Ministry of Health

“In 2007, we made the most dramatic change in our guidelines, when we opted for tenofovir-based regimens.”

– Dr. Albert MwangoNational ARV CoordinatorZambia Ministry of Health

AIDS deaths fall to 37K

Zambia introduces generic Atripla® as first-line therapy

90% of treatment-eligible adults in Zambia are receiving HIV therapy

AIDS deaths fall to 30K

Special Initiatives

Myanmar

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

Chronic hepatitis B (HBV) is estimated to affect nearly 350 million people worldwide

More than 185 million people around the world have been infected with the hepatitis C virus (HCV)

HBV Prevalence HCV Prevalence

≥ 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

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

Chronic Hepatitis C

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

Generic Licensing

• 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.

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

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

• 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

Tiered Pricing

Looking Ahead

2015

• New HCV access agreements with Ministries of Health and international NGOs

• Development of pan-genotypic regimen for chronic HCV

• Further expansion of HIV partnerships

• Roll out TAF treatment expansion for HIV and HBV

• Continued collaboration with WHO, NGOs on VL

2014 (Q2) HIV Dashboard Gilead Access Operations & Emerging Markets

Growth in Patients Reached*Low and Low-Middle Income Countries

Gilead’s access efforts reach 58% of people in developing countries receiving HIV treatment

Over 130 Access Countries

Access countries are home to 95%of people with HIV in developing countries

ProductsMedicine Lowest Price Registrations

Viread 109

Truvada 109

Complera 22

Branded Generic

FDA/WHO generic approvals: 34

17.00

4.00

26.25

5.29

* TDF-containing regimens from tech transfer recipients, branded sales, direct and MPP licensees

Thank you