How Gilead is redefining
the ‘S’ in ESG
In Partnership with
2 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
INTRODUCTION
Environmental, Social and Governance (ESG) issues have
become increasingly important to investors in the last decade,
as investors realized that factors from climate change to
access to healthcare and executive compensation could have a
material impact on the sustainability of businesses.
Over the past couple of years, ESG has been in a state of flux,
particularly in the U.S., where it has become increasingly
politicized, with significant pushback from some politicians.
Reuters reported in April 2023 that 99 anti-ESG bills had been
$3.1T
proposed across 13 states since the start of the year, compared Total in ESG funds
to 39 in the whole of 2022. We have seen a growing divide over
the last several years as ESG's true purpose has been diverted under management
from its initial aim as a risk management investing tool.
Despite this, many investors continue to value ESG analysis to
help them better understand company priorities, augment their
long-term planning, and allocate funds accordingly. Morgan
Stanley reported that there was $3.1 trillion in ESG classified
funds under management at the end of June 2023 and its
Sustainable (a term typically synonymous with ESG) funds
outperformed its traditional funds during the first half of 2023.
3 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
ESG DEMONSTRATES ITS VALUE
There are two main narratives around ESG – one says it is
part of prudent risk management, and the other says that it
reduces returns for investors in favor of pursing broader social
or environmental ambitions. For companies and investors,
there is also a geographic divergence occurring. Whereas the
U.S. has historically positioned ESG as a voluntary approach to
improve the scope and transparency of company disclosures
in order to help investors allocate funds, the European Union
(EU) has embedded ESG disclosures in regulatory filings,
increasing the importance of these topics and disclosures by
codifying them into regional and national policies.
“AT GILEAD, WE'RE CREATING
For example, the EU’s Corporate Sustainability Reporting POSSIBLE AT THE INTERSECTION
Directive (CSRD) will require large companies, including
virtually all multinational corporations, to report on OF INNOVATION, ACCESS AND
their material ESG and climate risks. To prepare for and HEALTH EQUITY. PRIORITIES LIKE
implement these changes, PwC announced in 2021 that it CLINICAL TRIAL DIVERSITY ARE
was planning to hire 100,000 employees focused on ESG. WHAT'S DRIVING OUR SUCCESS
In the U.S., mandatory ESG related disclosures, including AND ALLOWING US TO REDEFINE
a proposed climate disclosure rule, are being assessed THE "S" IN ESG. BY GOING
by the Securities and Exchange Commission (SEC). More
BEYOND THE MEDICINES, WE'RE
recently, the state of California approved two climate-
related reporting statutes, SB 253 and SB 261. The first will ONE STEP CLOSER TO CREATING
require certain public and private entities doing business in A HEALTHIER WORLD FOR
California to make public disclosures of their scope 1, 2 and EVERYONE”
3 greenhouse gas emissions. The second will require certain
public and private entities doing business in California to - Deb Telman, EVP, Corporate Affairs and General
publicly report their climate-related risks and efforts to Counsel
address them. These statutes go beyond the current SEC
proposed disclosure standards and could affect more than •
More than 30 million patients reached globally through
8,000 companies, according to law firm Dentons. voluntary licensing agreements, across COVID-19, HIV,
Despite the views of ESG detractors and the complex and hepatitis C therapies.
regulatory environment both within and outside the U.S., All of these programs exist because, for Gilead, ESG is not a
more companies are applying ESG considerations to better nice-to-have or a political statement. It is something that is
inform their company’s strategy. And some investors and embedded into its value chain and core business operations,
businesses have been doing so for decades, since before the and it drives value for the company and the communities it
term ESG existed. serves.
Pharmaceutical company Gilead Sciences is a great example Companies with a clear purpose and mission are often
– it has integrated ESG throughout its value chain, as among those that see the most benefit from ESG analysis.
illustrated by: Gilead’s vison is to create a healthier world for all people,
•
$5 billion annual R&D expense exclusively dedicated to and it believes that ESG advances its strategic priorities,
meeting unmet needs in underserved populations. which are to scientifically innovate to address unmet medical
needs and to promote health equity and partnerships in
•
$300M in 2022 corporate philanthropy funding communities it serves.
4 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
Pulse of Perseverance, Gilead Foundation grantee
IMPROVING ACCESS
TO HEALTHCARE
For the pharmaceutical sector, access to healthcare is the
most important aspect of ESG, and Gilead’s voluntary “GILEAD'S RESOURCE-INTENSIVE
licensing program is a leading example. A voluntary license INVESTMENT IN GLOBAL
enables select generic manufacturers to manufacture a Gilead SUPPLY CHAINS OPTIMIZES FOR
branded product for distribution in certain resource limited
countries. Gilead provides education and technical training.
UNINTERRUPTED RESPONSE TO
This arrangement facilitates competition among generic GLOBAL PATIENT DEMAND AND
manufacturers to create high quality and low-cost products. “It PROTECTS PATIENT ACCESS”
is a more sustainable model than simply donating medicines,
we are instead providing the blueprint,” says Andrew Spiegel, - Hemal Shah, Director Public Policy
Director of ESG Strategy at Gilead. “It’s like teaching someone
to fish rather than just giving them fish.”
advance. Ultimately, various regulatory authorities did approve
Access is made possible by a proactive investment in the medicine for patients hospitalized with COVID-19. Gilead
manufacturing capabilities, supply chain logistics and strategic went from having 5,000 doses in storage to producing over 1
partnerships in voluntary licensing agreements. At the onset million doses by the end of 2020. This ramp-up came despite
of the COVID-19 pandemic, Gilead did not yet know how widespread shortages of active pharmaceutical ingredients
safe and effective its investigational medicine was in treating (APIs) and constrained working conditions. In addition to
COVID-19, yet still invested $1B to rapidly scale production its own manufacturing efforts, Gilead’s voluntary licensing
while awaiting regulatory approval. Gilead knew that if the agreements have played a key role in enabling more than 13
drug was approved, it would not have sufficient supplies to million patients around the world to receive the medication to
meet the demand unless it rapidly scaled manufacturing in date.
5 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
ADDRESSING UNMET NEEDS
Often, for communicable diseases, a treatment exists but may
not be reaching the people who need it because of a lack of “GILEAD WAS INSTRUMENTAL IN
awareness and a stigma about the disease, which reduces CHANGING HIV REGIMENS FROM
the number of people who come forward for testing. The
World Health Organization estimates that up to 300 million
MULTI-PILL ‘COCKTAILS’ TO A
people around the world are living with chronic viral hepatitis, SINGLE TABLET OR ONCE DAILY
and another 37 million are living with HIV. “The scientific TREATMENTS. GILEAD CONTINUES
community has done miraculous work in their effort to meet TO BE AT THE FOREFRONT OF HIV
these needs. Much of the remaining work lies in educating
INNOVATION.”
communities about testing, which therapies are appropriate,
and finally access to those therapies,” Spiegel explains. - Jared Baeten, VP Clinical Development
Gilead focuses on scientifically innovating for unmet needs,
and also on disease prevention and awareness. “HIV and affect high-income people or those that mostly affect those on
cancer … these are massive unmet needs, particularly when lower incomes,” she points out. “For the good of the world, we
there are available therapies to greatly improve the lives of should be spending more money on diseases that affect a lot
people with these conditions,” he adds. of people who are not rich.”
Addressing unmet needs is a conscious choice for Gilead has always been committed to addressing the social
pharmaceutical companies, says Sherry Glied, Dean of New determinants of health and overcoming barriers to care.
York University’s Robert F. Wagner Graduate School of Public Through its many global and local partnerships, it strives to
Service. “Companies can choose to target diseases that most advance health equity, diversity in clinical trials and access to
6 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
medicines to reduce disparities, advance education among
healthcare professionals and support the local communities in
which it operates.
There are three aspects to unmet needs, which sometimes
overlap. These are:
•
difficult to treat diseases
•
medical conditions that disproportionately impact
underserved communities
•
disease areas where front line therapies are either
insufficient or burdensome therapy regimens
HIV, for example, was once a disease that met all three of
these criteria. The HIV epidemic has moved from a mysterious
public health crisis in the 1980s to a disease that the CDC
officially aims to eliminate as a public health threat by 2030.
Gilead has played an integral role in mitigating its devastation,
through significant investment in R&D, ground-breaking
scientific work (including several drugs that were designated
by the FDA as breakthrough therapies) and a dedication to
partnering with communities to reduce the stigma of the
disease and overcome barriers to care.
“FOR THE GOOD OF THE WORLD, WE
SHOULD BE SPENDING MORE MONEY
ON DISEASES THAT AFFECT A LOT OF
PEOPLE WHO ARE NOT RICH”
-S
herry Glied, Dean of New York University’s Robert
F. Wagner Graduate School of Public Service
Gilead Employees – Month of Service campaign
Gilead sees great potential in tackling the issue of hard-
real-world effects for people at risk of acquiring HIV and could
to-follow therapy regimens with another breakthrough
ultimately pave the way for tens of millions of people to live
treatment, this time for heavily treatment experienced
healthier lives.
patients with multi-drug resistant HIV. These patients often
develop resistance to other HIV therapies after years or Tackling unmet needs is a long-term, ongoing process that
decades of existing HIV treatment. begins long before starting to think about access to medicines.
It starts with decisions about what pharmaceutical companies
The backbone molecule of this treatment is also being studied
want to put their research and development dollars into – and
as the next generation in HIV prevention dosing regimens. In
whether those investments will just produce an economic
the 1990s, HIV patients had to take numerous pills each day.
return on investment or also make real world impacts
Today, once daily medications are available that can either
lessening disease burdens in underserved populations.
prevent an individual from acquiring HIV or keep their levels
of HIV so low as to be undetectable. Gilead’s newest HIV Meeting unmet needs is thus a conscious strategic decision
treatment is now being evaluated as an investigational twice- that must be made by boards, management teams, investors
yearly injection to prevent the acquisition of HIV. If approved, and other stakeholders dedicated to making a healthier world
this is the type of innovation that has the potential to have for all people.
7 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
ADVANCING
HEALTH EQUITY
Related to the issue of unmet needs, but not the same, is the
concept of health equity. It is not enough to invest in therapies
for unmet needs. There must also be a commitment to health
equity. It is worth pointing out that equity is not the same as
equality – with equality, everyone gets the same regardless
of whether it is what they need, or the treatment is right for
them. With a focus on equity, everyone gets what they need,
considering an individual’s circumstances, the barriers they
must overcome and the conditions they face in their daily lives.
It is important to understand that different groups have
different needs. For example, 42% of new U.S. HIV diagnoses
are among Black people, even though they make up only 13%
of the population. In oncology, the mortality rate for multiple Bridget Ndagaano Jjuuko, Executive Director, ACTS 101 Uganda
myeloma in the U.S. is double for Black individuals compared Yvette Raphael, Executive Director of Advocacy for the Prevention of HIV
with white people, while Hispanic people in the U.S. have and AIDS in South Africa
nearly double the incidence of liver, stomach and cervical
cancers compared to white people. Gilead then began to focus on cancers that primarily affect
populations with an unmet medical need, including Triple
Negative Breast Cancer (TNBC), a type of cancer that
“GILEAD WAS A PIONEER IN predominantly affects women of color, as well as HR+/HER2-
CLINICAL TRIAL DIVERSITY Breast Cancer. Black women have a breast cancer mortality
rate 40% higher than other women. Gilead’s innovations in
AND WE CONTINUE TO LEAD cancer therapy include a medicine that can be used to treat
THE WAY. THE PURPOSE 1 & 2 advanced stages of both of these breast cancers, potentially
TRIALS FOR HIV PREVENTION helping these underserved populations. Gilead is investing in
ARE SPECIFICALLY DESIGNED research to determine whether it will be effective in treating
other types of cancer.
TO ENSURE UNDERREPRESENTED
COMMUNITIES ARE PART OF But to ensure health equity, the industry must also commit
resources and education to make sure that underserved
THE CLINICAL PROCESS”
populations can access the treatments they need. One way to
-R
ashad Burgess, VP Advancing Health & Black ensure this is to expand the diversity of clinical trials. Gilead
Equity was the first company to intentionally include pregnant
and lactating people, as well as adolescents, in Phase 3 HIV
prevention (PrEP) clinical trials and the first to intentionally
Gilead’s acquisition of Kite Pharma in 2017 transformed them include transgender men and gender nonbinary individuals.
into market leaders within hematological malignancy, or “Historically, drug trials have targeted white men. Now there
blood cancer, where it focused on treatments for those with is an increased focus on women and different ethnicities. Sex
no or limited options. Kite’s focus on cell therapy requires differences are probably more important than ethnicity, but
a patients T-cells to be removed, re-engineered in the lab, age is the most important aspect of all,” says Stefano Bertozzi,
and reinfused as treatment. “This approach may sound like professor of health policy and management at the University
science fiction, but it is the key to helping these patients with of California - Berkeley. “In the past, people under 18 have
no or limited treatment options,” Spiegel says. been ignored until really late in the process.”
8 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
PARTNERING WITH
COMMUNITIES
Gilead has a central role in the history of access to innovative
medicines in the U.S. and around the world. In employing
innovative pricing and access models, Gilead has built
meaningful and enduring partnerships with patients,
healthcare professionals, NGO’s and communities.
This also means working with communities as a partner, above
and beyond advocating for Gilead’s own products. Gilead
funds scholarships, schools, and community programs, as well
as promoting de-stigma campaigns so that people living with
HIV can live in communities without being defined by their
diagnosis.
Healthcare systems are increasingly complex, and treatments
can be, too. Patients often struggle to find healthcare
providers, access insurance coverage and adhere to therapy
regimens, all of which can affect their ability to achieve
beneficial health outcomes. To improve access and outcomes,
there must be a full understanding of how people interact
with the complex healthcare system whose mechanics vary by
country. Gilead has taken a holistic, people-centric approach Power Institute
to strengthening health systems and outcomes. COMPASS grantees™
(Photo courtesy of Emory University)
Gilead devotes tens of millions of dollars to testing programs Gilead facilitates partnerships with a range of organizations
so that people are aware of their conditions. It also provides throughout the U.S, working with local health departments,
robust outreach and access programs to help people navigate hospitals and clinics and the staff that try to reach these
the processes of health insurance and co pays. In some populations.”
cases, it offsets the cost of therapies. “Gilead is a leader on
prevention and treatment medications, but its commitment Another way to make therapy regimens more manageable is
goes beyond just producing medications,” says Guillermo to develop treatment options with different dosing regimens.
Chacón, President of the Latino Commission on AIDS and the This is something that has happened in HIV care, where
founder of the Hispanic Health Network. “It has a fantastic multiple pills a day have become one pill, and Gilead’s clinical
track record of supporting community-based organizations development program aims to reduce the requirement to an
and programs to address prevention and cure disparities.” injection twice a year.
Hispanics are the second-most affected group by HIV, but And access to health goes far beyond delivering the drugs
prevention is a difficult topic, he adds. “Young gay men and that patients need. There are so many aspects of health
transgender individuals are very marginalized and lack access that are related to environmental and social factors, and
to both prevention services and care. In many places, these pharmaceutical companies can help to address these by
populations are in great need, but no one is reaching them. working together with communities and patients.
9 HOW GILEAD IS REDEFINING THE ‘S’ IN ESG
VOLUNTARY
LICENSING
Gilead recognizes the need to make accessible and affordable
treatments for all. Voluntary licensing is one of several
components of Gilead’s access strategy in resource-limited
countries. Gilead looks for trusted partners that can produce
the relevant drug at scale and high quality.
“Voluntary licensing involves building capacity in low-income
countries, rather than leaving them dependent on high-
income manufacturers,” says Glied. “The social benefit is
increased if those countries learn how to manufacture drugs
more generally because they are then able to take over more
drug production locally.”
Intellectual property rights enable voluntary licensing and
effective technology transfer. Such collaborative approaches
enable therapies to be distributed in countries with significant
barriers to healthcare access, which allows underserved
populations to live healthier lives. It is also a process that
creates more resilient supply chains and wider distribution of
manufacturing capabilities. “On HIV, Gilead instituted more
aggressive licensing and deals with low- and middle-income
countries compared to the rest of the industry,” says Bertozzi.
And by working on a partnership basis, rather than simply mothers2mothers
Zeroing In grantee
donating medicines, it creates a knowledge base for producing
medicines while enabling the companies that invest billions Bringing a new drug to market can entail testing many
of dollars in research and development to discover the thousands of molecules before finding the right one. Gilead’s
formulations for new therapies to preserve their intellectual newest HIV treatment, for example, emerged from the testing
property. “It is in Gilead’s interests for a local manufacturer to of more than 4,000 molecules. Once the right molecule has
be producing the drug and knowing that it is a high-quality been found, it can take up to a decade of clinical trials before
product rather than a counterfeit,” Bertozzi says. the drug is approved.
LOOKING AHEAD
With over twenty clinical trials expecting readouts in will face ongoing expectations to demonstrate how their ESG
2024, including five Phase 3 trials, Gilead enters the year investments reflect their stated mission and vision.
demonstrating their commitment to addressing unmet
needs across key therapy areas including HIV, Oncology By centering their efforts in the “S” of ESG, Gilead can
and COVID-19. demonstrate how the promise of scientific innovation,
coupled with person-centric decision making across
As the ESG landscape continues to evolve, companies like the value chain, will result in the broad availability of
Gilead, whose vision is to “create a healthier world for all”, transformative therapies to create a healthier world for all.