Gilead Sciences Inc.

Performance

Falls 5 places to 13th due to a comparatively poor performance in governance and compliance. It maintains a strong performance in some areas, for example, in its licensing strategy and its application of equitable pricing strategies across a high proportion of its products. 

Opportunities

Expand access plans across pipeline. Gilead has an opportunity to develop a pipeline-wide approach to planning for access. For example, Gilead's access planning process currently focuses on HIV/AIDS and hepatitis B and C. The company can also expand such planning to R&D projects for projects targeting communicable diseases, including presatovir for the treatment of RSV, and non-communicable diseases, including three late-stage oral anti-cancer agents.

Strengthen transparency, policies and procedures to ensure compliance. Gilead falls behind peers due to overall lack of transparency across the Market Influence and Compliance Technical Area. Gilead can publicly disclose which stakeholder groups (e.g., patient groups in countries in scope) the company participates in and whether it provides financial support to such groups. The company can also publicly disclose whether political contributions have been made in low- and middle-income countries. The company can improve its internal control framework to ensure compliance through the implementation of a fraud-specific risk assessment, and procedures to segregate duties. It can also help improve responsible sales practices by decoupling sales incentives from sales targets.

Expand access further by maximising effectiveness of licensing approach. Gilead consistently applies inter- and intra-country equitable pricing strategies and licensing approaches across its portfolio. Gilead can maximise the effectiveness of its licensing-based approach by reviewing generic company activity in countries within the scope of agreed licences where Gilead does not have sales.  In cases where generic company activity is absent/limited, Gilead can consider proactively registering and pricing equitably within these countries to facilitate competition and access, or by identifying mechanisms within licences to incentivise generic market entry. Gilead commits to filing its newest products in scope for registration in countries in scope within 12 months of first market approval.

Change since 2016

• Developed a comprehensive process to develop access plans for all R&D projects targeting HIV/AIDS, viral hepatitis B and C and leishmaniasis during development.
• Launched the Gilead Public Health Award: Viral Hepatitis Program in 2017 to provide research grants to researchers in low- and middle-income countries focused on viral hepatitis care and treatment.
• Joined the MenStar Coalition that was launched in 2018 and aims to improve diagnosis and treatment of HIV in men, particularly in sub-Saharan Africa.
• Expanded its HIV licences signed with the MPP to include three additional countries with the inclusion of Malaysia and Ukraine as middle-income countries within the scope of the Index.
• Received FDA approval for the first pangenotypic hepatitis C treatment, sofosbuvir/velpatasvir (Epclusa®) in June 2016, followed by FDA approval for the second, sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) in July 2017

Pipeline​ and Portfolio

for diseases and countries in scope

Business context

One business unit: Human Therapeutics, which has five therapeutic areas (HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases and cardiovascular diseases).

M&A news: 2017 acquisition of Kite Therapeutics, specialising in cancer immunotherapy products; acquisition of Cell Design labs, Inc., specialising in cell-based therapies for cancer and other diseases. 

Presence in emerging markets: In 2018, Gilead reports sales in 32 countries in scope.

* Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
** See Appendix IV for definition.