Gilead Sciences 2015 Annual Report Download - page 2

Gilead achieved record total revenue of $32.6 billion in 2015, with marked
progress across our portfolio of products and pipeline. The company
returned about three-quarters of free cash flow to investors as it issued
its first-ever quarterly cash dividend and increased the stock buy-back
program. The company also expanded its global reach and today more
than 8,000 employees across six continents are working together and
with Gilead’s partners to help millions of patients around the world.
Working Toward the Next Generation of HIV Care
For more than 25 years, Gilead has led the development of antiviral therapy
for HIV/AIDS, helping to transform HIV infection from a fatal and debilitating
disease into a chronic, manageable condition. The availability of HIV
therapies has helped avert an estimated 7.8 million AIDS deaths since 2000.
In 2015, Gilead’s HIV products were prescribed for more than 70 percent
of newly-diagnosed HIV patients in the United States. In Europe, 7 out of 10
patients started on a regimen with a Truvada® backbone.
While exceptional progress has been made in the field of HIV, there is
still a growing need for new treatment options to improve the health of
people as they age with the disease. To help provide this much needed
new option, Gilead has been studying an innovative nucleotide called
tenofovir alafenamide (TAF) as an alternative to tenofovir disoproxil
fumarate (TDF)—the active ingredient in Viread® and a component of
Truvada, Atripla® , Complera® and Stribild® . TAF has demonstrated high
antiviral efficacy and improved laboratory markers of renal and bone
safety compared to TDF in clinical trials in combination with other
antiretroviral agents.
In November, Genvoya® , the company’s first TAF-based single tablet
regimen (STR) for the treatment of HIV-1 infection, was approved by the
U.S. Food and Drug Administration (FDA) and the European Commission.
Odefsey® , Gilead’s second TAF-based STR, received FDA approval in
March 2016 and has been submitted for regulatory review in the
European Union. Odefsey combines emtricitabine and TAF (F/TAF) plus
Janssen’s rilpivirine, and is the smallest STR for the treatment of HIV.
Three other TAF-based HIV treatments are in development including
F/TAF—a potential new HIV treatment backbone to be used in
combination with other antiretroviral medicines—submitted for
regulatory review in the United States and the European Union in
2015. Janssen is also developing D/C/F/TAF, which contains Janssen’s
darunavir and may be the first STR containing a protease inhibitor.
Finally, Gilead initiated a Phase 3 program for GS-9883, the company’s
proprietary integrase inhibitor, combined in an STR with F/TAF.
Public health officials, HIV advocates and the medical community have
turned their attention to methods to prevent HIV transmission more
effectively, including PrEP or pre-exposure prophylaxis. Recently, the
World Health Organization issued new guidelines that will significantly
increase the number of people who are eligible to receive Truvada for PrEP,
an approach that involves the use of Gilead’s antiretroviral medication in
combination with safer sex practices to reduce the chance of acquiring
HIV-1 infection in HIV-1 negative individuals at high risk. More than
80,000 people in the United States have received Truvada for PrEP since
2012. The company continues to work to make Truvada for PrEP available
in more countries, receiving approval in South Africa and Kenya in 2015,
approval in Canada in 2016 and filing for marketing authorization in
Europe earlier this year. We continue to work across multiple fronts to
help ensure that Truvada for PrEP is used safely and appropriately as part
of a comprehensive strategy to prevent HIV transmission.
Changing the Course of Liver Disease
Gilead helped revolutionize the treatment of viral hepatitis, which affects
approximately half a billion people worldwide, by providing medicines
that cure chronic hepatitis C infection and manage chronic hepatitis B
infection more effectively.
More than 770,000 hepatitis C patients around the world have initiated
treatment with a Gilead product since the company introduced its first
treatment in late 2013. Today, Sovaldi® is approved in 65 countries and
Harvoni® , the first once-daily STR treatment of chronic hepatitis C virus
(HCV) infection in genotype 1 patients, is approved in 50 countries.
In 2015 and early 2016, several supplemental new drug applications were
approved for Harvoni, expanding its use to include HCV/HIV co-infected
patients, patients with genotypes 4-6, patients with advanced liver
disease and post-liver transplant recipients. Harvoni and Sovaldi
continue to perform well in real-world settings, with safety, tolerability
and cure rates comparing favorably to those observed in clinical studies.
In the United States, Gilead provides public and private payers
substantial discounts and maintains a dedicated patient assistance
program to help ensure patients receive the treatments they need.
Outside the United States, Gilead works with governments to secure
country-by-country reimbursement as quickly as possible. The high cure
rates, low incidence of side effects and substantial discounts in place
for various public and private payers have allowed the company to have
productive discussions about the value of Sovaldi and Harvoni with
payers around the world.
Gilead remains focused on advancing care for people with HCV. In 2015,
the company submitted for regulatory review in the United States
and Europe a fixed-dose combination of sofosbuvir and velpatasvir,
an investigational pan-genotypic NS5A inhibitor, for the treatment of
patients with all six genotypes (1–6) of HCV. This is the company’s third
filing of a new HCV medicine in three years. If approved, SOF/VEL will
complement Gilead’s current HCV portfolio of Sovaldi and Harvoni,
offering high cure rates with 12 weeks of therapy and the potential to
simplify treatment and eliminate the need for HCV genotype testing.
The advances with Sovaldi and Harvoni over the past two years have
allowed Gilead to work with governments and public health experts on
HCV elimination strategies among specific populations and geographies.
Programs, such as those ongoing in Georgia and Iceland, could serve as
examples for other governments around the world seeking to eliminate HCV.
Chronic hepatitis B virus (HBV) infection is the leading cause of liver
cancer. An estimated 350 million people are infected with chronic HBV
worldwide, and an estimated 786,000 deaths are linked to chronic HBV
every year. Approved for chronic HBV in 2008, Viread continues to be the
most prescribed therapy for the disease in the United States and Europe.
TAF is also being evaluated as a single agent to treat HBV patients. Phase
3 study results reflect high efficacy and improved renal and bone safety
laboratory parameters when compared to Viread and similar to those
Left to right, top to bottom: Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs; John McHutchison, MD, Executive Vice President, Clinical Research;
John F. Milligan, PhD, President and Chief Executive Offi cer; Robin L. Washington, Executive Vice President and Chief Financial Offi cer; Taiyin Yang, PhD, Executive Vice
President, Pharmaceutical Development and Manufacturing; John C. Martin, PhD, Executive Chairman; William A. Lee, PhD, Executive Vice President, Research;
Katie L. Watson, Executive Vice President, Human Resources; Brett Pletcher, Executive Vice President and General Counsel; Norbert W. Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientifi c Offi cer; Andrew Cheng, MD, PhD, Executive Vice President, Clinical Research and Development Operations;
Paul R. Carter, Executive Vice President, Commercial Operations.
TO OUR
STOCKHOLDERS,
EMPLOYEES
& FRIENDS:
We aspire to transform and
simplify care for people with
life-threatening illnesses.
These efforts extend across
the continuum of care—
from the laboratory to the
clinic to access to medicine
in all corners of the world.
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