Quarterlytics / Healthcare / Biotechnology / Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

regn · NASDAQ Healthcare
Claim this profile
Ticker regn
Exchange NASDAQ
Sector Healthcare
Industry Biotechnology
Employees 5001-10,000
← All annual reports
FY2019 Annual Report · Regeneron Pharmaceuticals
Sign in to download
Loading PDF…
MORE SCIENCE,  
MORE IMPACT

2019
ANNUAL REPORT

As 2020 began, the world was presented 
with a major crisis as the SARS-CoV-2 
(COVID-19) pandemic spread across 
the globe. Regeneron mobilized quickly, 
realizing that we were uniquely suited 
to bring forward potential solutions. We 
are extremely proud of how our talented 
team is responding to this public health 
challenge. Given our more than 30 years 
of investment in core technologies 
that improve the drug discovery and 
development process, and our track 

record of success with infectious 
diseases like Ebola, we are optimistic 
that we can make a meaningful and 
timely impact. We have two important 
COVID-19 research and development 
efforts ongoing: a global clinical trial of 
our IL-6 inhibitor Kevzara® (sarilumab) 
in hospitalized patients with severe or 
critical COVID-19; and the development 
of a novel antibody cocktail specifically 
designed to prevent or treat COVID-19 
infection. We will be sharing updates on 

these programs as quickly as possible 
over the coming weeks and months.   

Now, more than ever, we must remain 
focused on our mission to repeatedly 
bring important new medicines to 
patients with serious diseases. In 2019 
we had a year of strong performance 
and delivery on this mission. We reached 
more and more patients through newly 
approved indications and record 
growth for our blockbuster treatments 

02

DEAR FELLOW SHAREHOLDERS,Regeneron / Annual Report 2019OUR BUSINESS IS SOLID,  
AND 2019 WAS A YEAR  
OF TREMENDOUS PROGRESS  
FOR REGENERON

EYLEA® (aflibercept) Injection and 
Dupixent® (dupilumab), made significant 
advancements throughout our preclinical 
and clinical pipelines, and delivered 
a public health breakthrough with an 
effective treatment for Ebola which is 
currently under review by the U.S. Food 
and Drug Administration (FDA).

Total revenues for 2019 were $7.9 billion, 
a 17 percent increase over 2018, which 
included U.S. EYLEA net product sales 
of $4.6 billion. Our collaborator Bayer 
recorded net product sales for EYLEA 

outside the U.S. of $2.9 billion, bringing 
EYLEA’s total global net product sales 
to $7.5 billion, a 12 percent increase 
compared to 2018. These figures show 
the continuing strength of this important 
treatment that has had double-digit sales 
growth for seven years without a single 
price increase. We remain confident in 
EYLEA’s ability to help even more patients 
as we expand our leadership position in 
wet age-related macular degeneration and 
diabetic eye diseases. Dupixent 2019 global 
net product sales, which are recorded by 
Sanofi, were $2.3 billion, an increase of 
151 percent over the previous year. We 
have just begun to tap the potential of this 
first-in-class treatment option for several 
Type 2 inflammatory diseases, with many 
more studies underway. 

In part due to Dupixent’s strong sales, 
our antibody collaboration with Sanofi 

became profitable for the first time in 2019,  
and we took important additional steps 
to strengthen Regeneron’s financial 
position. In the second quarter of 2020 we 
restructured our antibody collaboration 
with Sanofi to enhance profitability 
further and to simplify the commercial 
strategy for Praluent® (alirocumab). We 
will continue to collaborate with Sanofi 
on studying Kevzara for COVID-19, 
with Regeneron leading U.S.-based 
development and Sanofi leading 
development outside of the U.S. 

Meanwhile, our research and 
development productivity continues,  
with notable progress in our growing 
immuno-oncology portfolio and 
diversification across the pipeline as 
a whole. We expanded our clinical 
program with Libtayo® (cemiplimab-
rwlc), a PD-1 inhibitor, and moved 

0303

Regeneron / Annual Report 2019multiple bispecific antibodies into the 
clinic, including the first in a whole new 
class of co-stimulatory bispecifics, which 
position us to become a leader in this 
emerging field. We continue to explore 
Dupixent in a variety of additional  
Type 2 inflammatory conditions, with 
late-stage trials underway in eosinophilic 
esophagitis, chronic obstructive 
pulmonary disease, prurigo nodularis 
and chronic spontaneous urticaria,  
as well as earlier studies in grass and 
food allergies. 

From a public health perspective, we 
made a breakthrough in the fight against 
the devastating Ebola outbreak in the 
Democratic Republic of the Congo (DRC) 
with REGN-EB3’s impressive reduction in 
mortality compared to the prior standard-
of-care in the PALM clinical trial. We are 
applying the same technologies against 

the novel coronavirus and hope for 
similar success. 

All of this important research and 
groundbreaking medicine is built on 
three decades of investment in our 
VelociSuite® technologies. These 
proprietary end-to-end drug discovery 
and development tools allow us to 
quickly identify multiple antibody 
candidates against diseases—from 
Ebola to cancer to asthma to rare 
diseases, such as fibrodysplasia 
ossificans progressiva. Paired with 
our excellent clinical development 
and manufacturing capabilities, the 
possibilities are truly endless, and we 
feel that we are just at the beginning 
of what we can do using the power of 
science and technology. 

20+

approved and  
investigational medicines 
built using the power  
of VelociSuite

Our commitment to continually advancing 
research through sophisticated and 
broadly applicable technology propelled 
our Regeneron Genetics Center® team 
to the major milestone of sequencing the 
exomes of over one million people as of 

0404

Regeneron / Annual Report 20192019 was a busy and successful year for 
Regeneron, and we believe 2020 will be 
even more impactful. We will innovate 
against COVID-19 and the other serious 
diseases that continue to impact lives, 
even during a time of pandemic. We have 
our sights firmly set on the future as we 
expand the types of ailments we can treat 
and number of people we can help. The 
world needs us and the power of science, 
more than ever.  

Sincerely, 
Roy, Len, George

February 2020. We are also applying our 
genetics and biology expertise to explore 
new modalities that are complementary 
to our world-class therapeutic antibodies. 
Key examples include our preclinical 
work in viral vector and gene therapy 
technologies, as well as ongoing 
collaborations with organizations who 
bring unique expertise in areas like gene 
silencing, gene editing and CAR-Ts. 

In 2020 and beyond, we will continue 
to reinvest a significant portion of our 
growing revenue into our R&D efforts as 
we believe our scientific innovation and 
talent are our greatest differentiators. As 
we look toward the future of Regeneron 
we have begun to evaluate ex-U.S. 
commercialization opportunities, starting 
with exercising our co-commercialization 
rights for Dupixent in certain countries 
outside the U.S.

P. ROY VAGELOS
M.D.

Chairman of the Board

LEONARD S. SCHLEIFER
M.D., Ph.D.

Co-Founder, President 
and Chief Executive 
Officer

GEORGE D. YANCOPOULOS
M.D., Ph.D.

Co-Founder, President 
and Chief Scientific 
Officer

0505

Regeneron / Annual Report 20192019
BY THE NUMBERS

13

U.S. and European 
regulatory 
approvals

30M

doses of EYLEA 
administered from launch 
through early 2020

20+

investigational 
medicines in clinical 
development

80

patient advocacy and professional 
societies engaged across 
20 disease states

8,400+

patients enrolled in  
clinical trials

53

countries in which we 
conducted trials

1M

people sequenced by 
the Regeneron Genetics 
Center (as of  
February 2020) 

27,800+

colleague  
volunteer hours 

1 of 4

biotechs included 
on Dow Jones 
Sustainability World 
Index

0606

Regeneron / Annual Report 2019TABLE OF CONTENTS

08

25

SCIENTIFIC BREADTH 
AND DEPTH

CUTTING-EDGE RESEARCH 
AND TECHNOLOGY

30

SCIENCE-ENABLING 
BUSINESS STRATEGIES  

33

RESPONSIBLE 
REGENERON

Our Approved Medicines

Robust Clinical Pipeline

Recent Publication Highlights

Excellence in Retinal Diseases

Broad Development in Inflammation  
and Allergic Diseases

Diverse and Flexible  
Immuno-oncology Approach  

Rapid Response Approach in  
Infectious Diseases 

Rare Disease and Pain Programs

09

10

11

13

15

18

21

24

SCIENTIFIC BREADTH 
AND DEPTH

7 REGENERON-DISCOVERED, FDA-APPROVED MEDICINES

1

2

Please refer  
to Regeneron.com  
for more information  
on our marketed  
medicines, including  
full safety  
information.

1.  Commercialized by Bayer ex-U.S.
2.  Developed and commercialized under 

global collaboration with Sanofi
3.  Commercialized by Sanofi ex-U.S., 

effective April 1, 2020

4.  Commercialized exclusively by Sanofi

3

4

2

09

Regeneron / Annual Report 2019ROBUST CLINICAL PIPELINE

Over 20 investigational medicines in clinical development, all of which 
were discovered and developed in our own laboratories using our 
proprietary VelociSuite® technologies.

PHASE 1

CEMIPLIMAB*
PD-1 Antibody
Cancer

REGN3767 
LAG-3 Antibody 
Solid tumors, hematologic 
malignancies

REGN1979
CD20 X CD3 Antibody  
B-cell malignancies

REGN4018*
MUC16 X CD3 Antibody  
Platinum-resistant  
ovarian cancer

REGN5458*
BCMA X CD3 Antibody
Multiple myeloma

REGN5459*
BCMA X CD3 Antibody
Multiple myeloma

REGN5678
PSMA X CD28 Antibody
Prostate cancer

REGN5093
MET X MET Antibody
MET-altered advanced 
non-small cell lung cancer 
(NSCLC)

REGN5713-5714-5715
Bet v 1 Antibodies 
Birch allergy

PHASE 2

AFLIBERCEPT 
VEGF-Trap 
8mg for wet age-related 
macular degeneration (AMD)

CEMIPLIMAB* 
PD-1 Antibody 
Basal cell carcinoma (BCC), 
cutaneous squamous cell 
carcinoma (CSCC)

REGN1979
CD20 X CD3 Antibody  
Relapsed/refractory 
follicular lymphoma, 
non-Hodgkin lymphomas, 
diffuse large B-cell 
lymphoma

DUPILUMAB* 
IL-4R Antibody
Grass allergy, peanut 
allergy

Immunology & 
Inflammatory Diseases

Cardiovascular/ 
Metabolic diseases

Oncology

Rare Diseases

Infectious Diseases

Ophthalmology

Pain

PHASE 3

SARILUMAB*
IL-6R Antibody  
Polyarticular-course 
juvenile idiopathic arthritis, 
systemic juvenile idiopathic 
arthritis

REGN1908-1909
Fel d 1 Antibodies  
Cat allergy

REGN3500* 
IL-33 Antibody 
Asthma, chronic obstructive 
pulmonary disease (COPD)

REGN5069
GFRα3 Antibody  
Osteoarthritis knee pain

GARETOSMAB
Activin A Antibody 
Fibrodysplasia Ossificans 
Progressiva (FOP)

AFLIBERCEPT 
VEGF-Trap
Retinopathy of prematurity 
(ROP)

EVINACUMAB
ANGPTL-3 Antibody
Refractory 
hypercholesterolemia (both 
HeFH and non-FH), severe 
hypertriglyceridemia

POZELIMAB
C5 Antibody
Paroxysmal nocturnal 
hemoglobinuria, CD55-
deficient protein-losing 
enteropathy

REGN4461
LEPR Antibody
Generalized lipodystrophy

ALIROCUMAB
PCSK9 Antibody  
Homozygous familial 
hypercholesterolemia 
(HoFH) in adults 
and pediatrics, 
heterozygous familial 
hypercholesterolemia in 
pediatrics

EVINACUMAB
ANGPTL-3 Antibody
Homozygous familial 
hypercholesterolemia 
(HoFH)

CEMIPLIMAB*
PD-1 Antibody 
NSCLC, cervical cancer; 
CSCC (adjuvant)

DUPILUMAB* 
IL-4R Antibody  
Atopic dermatitis in 
pediatric patients 
6 mo.–11 y.o., asthma in 
pediatric patients 6–11 y.o., 
eosinophilic esophagitis, 
chronic obstructive 
pulmonary disease (COPD), 
prurigo nodularis, chronic 
spontaneous urticaria

SARILUMAB* 
IL-6R Antibody 
Severe and critical 
COVID-19, polymyalgia 
rheumatica, giant cell 
arteritis

REGN-EB3
Ebola Virus Antibodies 
Ebola virus infection

FASINUMAB† 
NGF Antibody 
Chronic pain from 
osteoarthritis of the  
knee or hip

This graphic displays pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy  
of these drug candidates have not been fully evaluated by any regulatory authorities for the indications described in this section.

*In collaboration with Sanofi
† In collaboration with Teva and Mitsubishi Tanabe

10

Regeneron / Annual Report 2019EFFICACY AND SAFETY OF DUPILUMAB 
IN PATIENTS WITH SEVERE CHRONIC 
RHINOSINUSITIS WITH NASAL POLYPS

A RANDOMIZED, CONTROLLED TRIAL OF 
EBOLA VIRUS DISEASE THERAPEUTICS

DUAL BLOCKADE OF IL-4 AND IL-13 WITH 
DUPILUMAB, AN IL-4Rα± ANTIBODY,  
IS REQUIRED TO BROADLY INHIBIT TYPE 2 
INFLAMMATION

200+

peer-reviewed 
scientific publications 
in 2019

~90

citations of data 
generated from the 
Regeneron  
Genetics Center

Regeneron / Annual Report 2019

11

PUBLICATIONS HIGHLIGHTSA CLASS OF COSTIMULATORY CD28-
BISPECIFIC ANTIBODIES THAT  
ENHANCE THE ANTITUMOR ACTIVITY  
OF CD3-BISPECIFIC ANTIBODIES

A NOVEL BISPECIFIC ANTIBODY PLATFORM 
TO DIRECT COMPLEMENT ACTIVITY  
FOR EFFICIENT LYSIS OF TARGET CELLS  
OF CD3-BISPECIFIC ANTIBODIES

KAPPA-ON-HEAVY (KOH) BODIES ARE 
A DISTINCT CLASS OF FULLY-HUMAN 
ANTIBODY-LIKE THERAPEUTIC AGENTS 
WITH ANTIGEN-BINDING PROPERTIES

A MUCIN 16 BISPECIFIC T CELL-ENGAGING 
ANTIBODY FOR THE TREATMENT OF 
OVARIAN CANCER

PATIENTS WITH HIGH GENOME-WIDE 
POLYGENIC RISK SCORES FOR CORONARY 
ARTERY DISEASE MAY RECEIVE  
GREATER CLINICAL BENEFIT FROM 
ALIROCUMAB TREATMENT IN THE  
ODYSSEY OUTCOMES TRIAL

12

Regeneron / Annual Report 2019EYLEA 2019 REGULATORY 
HIGHLIGHTS

•  FDA approval for diabetic retinopathy

•  FDA approval and launch of pre-filled syringe

in diabetic retinopathy, a major milestone that extends 
the benefits of EYLEA to many additional patients.

The initial uptake of EYLEA for diabetic retinopathy 
has been strong, with positive feedback from 
ophthalmologists. Yet tremendous unmet need 
remains. Too often, diabetic retinopathy is undiagnosed 
and untreated due to a lack of visual symptoms in early 
stages, putting patients’ vision at risk. In the Phase 3 
PANORAMA trial, EYLEA was shown to reduce 
the risk of vision threatening complications from 
Proliferative Diabetic Retinopathy or Anterior Segment 
Neovascularization, as well as center-involved  
Diabetic Macular Edema, compared to placebo, 
findings that underscore our efforts to advocate for  
proactive treatment and increased diabetic  
retinopathy screenings.

Through our clinical research, we are also preparing for 
our next chapter in ophthalmology innovation with  
an ongoing Phase 3 trial in retinopathy of prematurity. 
In addition, we expect to start two Phase 3 trials of 
high-dose EYLEA to evaluate 12-week or longer dosing 
intervals in wet AMD (PULSAR, sponsored by Bayer) 
and DME (PHOTON, sponsored by Regeneron). 

EXCELLENCE IN 
RETINAL DISEASE

EYLEA® (AFLIBERCEPT)

Help people protect and regain their vision. That was our 
goal when EYLEA was first approved, and it continues to 
drive our work nine years later. In 2019, EYLEA continued 
its run as the number one prescribed FDA-approved  
anti-VEGF treatment across its approved indications in 
the U.S. and finished the year with a total of $7.5 billion 
in annual global net product sales.1

Our focus on continually enhancing the value of EYLEA, 
for both physicians and patients, underpins its growth 
and is reflected in the multiple FDA approvals we 
received in 2019.2 Among them were the approval and 
launch of the EYLEA pre-filled syringe, which gives 
physicians a more convenient and efficient way to 
administer EYLEA to patients, and the approval of EYLEA 

1.  Bayer records net product sales of EYLEA outside the U.S.
2.  Sanofi records global net product sales of Dupixent

13

Regeneron / Annual Report 2019THE PEOPLE WHO INSPIRE US

OUR HARD-WORKING IOPS TEAM

The pre-filled syringe for EYLEA was an eye-opening project for the Industrial 
Operations and Product Supply (IOPS) team.

“It was important for us to get EYLEA in a pre-
filled syringe on the market so that doctors 
could dose patients more efficiently with fewer 
preparatory steps,” said Amy Walsh, Senior 
Director, Drug Product Manufacturing & Project 
Management in IOPS. “We also recognized that 
this pre-filled syringe could become the standard 
way EYLEA is administered to patients, so we 
challenged ourselves to examine closely each 
step of the manufacturing process to be able to 
deliver the safest and highest-quality device.”  

For example, “after much research and 
discussion with the FDA around sterilization 
requirements, we opted to use vaporized 

hydrogen peroxide for our sterilization—even 
though we’d have to build our sterilization 
process from scratch. We believed the gentler 
approach may be a better fit than the more 
common ethylene oxide approach.”

Developing this new process meant finding 
new solutions and building equipment and 
methods that didn’t exist before. This included 
working with vendors to develop and source 
new machines, as well as coordinating across 
numerous internal and external teams to 
implement this process. After much hard work, 
the pre-filled syringe was approved by the FDA 
in August 2019. “It’s rewarding that all of our 

effort has made it simpler for doctors to treat 
their patients,” said Amy. “When we first learned 
it was approved, my reaction was happiness 
and pride in our team. We are proud that we 
developed this product form and of the impact 
it can have on clinical care. I’m thankful to work 
with such a great group of people!”

14

Regeneron / Annual Report 2019BROAD 
DEVELOPMENT IN 
INFLAMMATION 
AND ALLERGIC 
DISEASES

DUPIXENT® (DUPILUMAB)

The unique ability of Dupixent to reduce excessive Type 
2 inflammation continues to transform the treatment 
paradigms of several allergic and inflammatory diseases. 
With hundreds of thousands of patients now receiving 
treatment, Dupixent has generated impressive year-
over-year growth, achieving total annual global net 

product sales of $2.3 billion in 2019. Yet even with 
approvals for several conditions and age groups, we 
are just beginning to realize the full potential of this 
innovative medicine. 

In 2019, we added several new indications to 
Dupixent’s label, securing approvals in adolescents 
with moderate-to-severe atopic dermatitis (AD) and  
adults with chronic rhinosinusitis with nasal polyposis  
(CRSwNP) in the U.S., European Union (EU) and 
other countries around the world. We also worked 
diligently to extend the benefits of Dupixent to even 
more children suffering from asthma and atopic 
dermatitis. In August, we shared positive topline 
results from a Phase 3 trial in children aged six 
through 11 with severe AD. These data formed the 
basis for our regulatory applications in the U.S.  
and EU, with an FDA priority review expected by  
May 2020 and a European Commission (EC) 
decision by the end of 2020. In addition, our Phase 3 
trial in children aged six through 11 with asthma  
is progressing forward, with a regulatory submission 
to the FDA targeted by 2021.

Finally, we continue to broaden the scope of our 
Dupixent development program. In late 2019,  
we initiated new late-stage trials in prurigo nodularis 
and chronic spontaneous urticaria. These add to 
our ongoing clinical trials in chronic obstructive 
pulmonary disease (COPD), peanut allergy and grass 
allergy, as well as in eosinophilic esophagitis.

DUPIXENT 2019 REGULATORY 
HIGHLIGHTS

•  FDA and EC approvals for adolescents (ages 12-17) 

with moderate-to-severe AD 

•  Supplemental Biologics License Application (sBLA) 
and Marketing Authorization Application (MAA) 
submitted for 300 mg pre-filled pen; EC approval 
for 200 mg and 300 mg pre-filled pen (response 
to FDA complete response letter for 200 mg in 
progress)

•  FDA and EC approval for CRSwNP (via Priority 

Review)

•  EC approval for adults and adolescents with severe 

asthma 

•  Submitted sBLA for children ≥6 to <12 years with 

moderate-to-severe AD

15

Regeneron / Annual Report 2019THE PEOPLE WHO INSPIRE US

PATIENTS AND THEIR FAMILIES

Jake, an 18-year-old from San Diego, CA, was diagnosed with severe atopic 
dermatitis (AD) when he was just six-months old.

During his childhood, symptoms of the disease 
covered up to 80 percent of his body, resulting in 
bloody arms and scars from constant scratching. 
Despite trying natural and prescription standard-
of-care therapies, Jake’s AD persisted as he 
grew older, impacting his daily life. As he put 
it, “My AD kept me from feeling like a ‘normal’ 
kid my age.” Jake, who loves to play lacrosse, 
run and surf, gave up many of his hobbies and 
opted to wear long-sleeved shirts and long pants 
despite the California sun. 

“There are many common misconceptions 
about AD,” said Jake. “People don’t think that 

my AD is a serious disease, but it is. Some 
people think that it’s related to poor hygiene or 
it’s contagious – and it’s neither of those things. 
It’s an inflammatory disease caused in part by 
a hypersensitive immune system. Even when I 
don’t have a visible rash, the inflammation is still 
active under my skin.”

Determined not to let AD take control of their 
son’s life, Jake’s parents, Jen and Tom, found 
a pediatric dermatologist who was enrolling 
patients in a clinical trial for an investigational 
biologic aimed at treating the underlying causes 
of AD. During the trial, Jake noticed his skin 

“became clear and the wounds turned to scars.” 
Today, Jake’s AD is under control, and he is 
feeling more confident. He is attending college 
in California and even chronicled his experience 
with AD in his college application essays.

16

Regeneron / Annual Report 2019Building on the expertise established with Dupixent, we have made significant strides in 
investigating the potential of new approaches to treating allergic and inflammatory diseases:

REGN3500

REGN1908-1909

REGN5713-5714-5715

REGN3500 is an IL-33 antibody in Phase 2 trials for 
asthma and COPD. In June 2019, we announced, 
with our collaborator Sanofi, that our Phase 2 proof-
of-concept trial in asthma had met its primary and 
secondary endpoints, improving loss of asthma control 
and lung function compared to placebo. Although the 
Phase 2 trial in COPD patients did not meet its primary 
endpoint, the company and Sanofi are reviewing the data 
further to determine who may yet benefit from this new 
potential drug.

Cat allergy is a major source of indoor allergies and 
a main risk factor for asthma. With limited treatments 
available, an estimated 500,000 Americans pursue 
laborious allergy desensitization, which can be difficult 
to tolerate and can take years to achieve significant 
effects. Our ongoing Phase 2 trial of REGN1908-1909, 
a Fel d 1 antibody, aims to provide relief, specifically to 
people who experience cat allergen-triggered asthma. 
In early studies, the investigational compound has been 
shown to markedly improve symptoms, with responses 
to treatment lasting at least one month.

Our Bet v 1 combination therapy, also known as 
REGN5713-5714-5715, is our latest investigational 
medicine to enter the clinic and is currently being studied 
in a Phase 1 trial for birch allergy.

17

Regeneron / Annual Report 2019LIBTAYO 2019 REGULATORY 
HIGHLIGHTS

•  Conditional EC approval for advanced CSCC 

DIVERSE AND 
FLEXIBLE 
IMMUNO-
ONCOLOGY 
APPROACH  

LIBTAYO®  
(CEMIPLIMAB-RWLC)

In 2019, our PD-1 inhibitor Libtayo became the standard of  
care for advanced cutaneous squamous cell carcinoma 
(CSCC) generating global net product sales of $194 million.1 
The rapid transformation of this treatment paradigm 
occurred in less than a year, underscoring the significant 
unmet need in advanced CSCC that Libtayo is addressing.

Our pivotal Phase 2 trial in advanced CSCC continues to 
show meaningful and durable clinical outcomes year after 
year. We are now exploring the ability of Libtayo to help 
patients with earlier stages of the disease, starting with a  
Phase 3 trial in adjuvant CSCC initiated in late 2019. 
In addition, our ongoing potentially registrational trials 
investigating Libtayo in cervical cancer, basal cell cancer 
(BCC) and non-small cell cancer (NSCLC) have made 
significant progress. Specifically, interim data from our 
Phase 3 trial in NSCLC showed positive early objective 
response rate results and our BCC trial is expected to  
report topline data in 2020.

Libtayo also continues to serve as the backbone for multiple 
investigational combination therapies both internally and 
with external collaborators. At the end of 2019, we had 
signed clinical collaborations and drug supply agreements 
with 10 companies, pairing Libtayo with a diverse range 
of novel cancer approaches that include oncolytic viruses, 
vaccines and gene therapies, among others. 

Regeneron / Annual Report 2019

1.  Sanofi records net product sales of Libtayo outside the U.S.

18

THE PEOPLE WHO INSPIRE US

PATIENTS AND THEIR FAMILIES

Unfortunately, Cathy was no stranger to skin cancer. Over the course of several 
decades, she had undergone multiple surgeries to remove growths of cutaneous 
squamous cell carcinoma (CSCC) on her head and upper body.

But when one of the growths of CSCC on her 
scalp penetrated her skull and the lining of her 
brain and aggressively returned despite major 
surgery, Cathy began to lose hope. Her doctor 
recommended a course of radiation over several 
weeks. However, being highly claustrophobic, 
Cathy did not think she could endure the 
confinement required for treatment, especially 
since the doctor did not think it would be 
curative. “I was ready to give up,” recalls Cathy. 
“I couldn’t bear the idea of radiation and there 
were just no other options. My husband and I 
decided to call our children to break the news. It 
was one of the hardest things I’ve ever done.”

One of her children, Lorah, happened to be 
a Regeneron Ph.D. scientist, and when she 
received the call, she told her mother there 
was actually one other option to consider: a 
FDA-approved immunotherapy medicine from 
Regeneron. “After reading the clinical trial results, 
I felt it was a good option for my mom given  
the situation,” Lorah said. Following a broader 
family conversation, Cathy discussed further with 
her doctor, and they decided to move forward. 

“It was a new experience for everyone,” said 
Cathy. “I was the first person my doctor  
had ever treated with this medicine and also the  

first patient with metastatic CSCC to receive  
an immunotherapy at his hospital. So the day  
the doctor confirmed that my metastatic 
CSCC was no longer visible in my scan was 
momentous for everybody—it seemed like 
the whole hospital celebrated with me.” Since 
then, Cathy has also become a mentor to 
other patients with advanced CSCC through a 
program run by Regeneron and Sanofi.

19

Regeneron / Annual Report 2019BISPECIFIC ANTIBODIES

Following the successful launch of Libtayo, we have 
continued to advance multiple investigational candidates 
from our bispecific antibody platform. Designed to 
closely resemble natural human antibodies, all of 
Regeneron bispecifics can bind to two different targets, 
opening up a diverse array of possibilities for targeting 
and killing cancer.

Regeneron currently has six bispecific antibodies in the 
clinic that fall into three categories. Our CD3-targeted 
bispecifics are designed to bridge cancer cells to the 
CD3 stimulatory receptors on T-cells, thus activating 
T-cell killing of cancer cells at the tumor site. Similarly, 
our CD28 costimulatory bispecifics also bridge cancer 
cells to T-cells. Designed to synergize with PD-1 
inhibitors and/or CD-3 bispecifics, they costimulate 
T-cells via their CD28 receptors and thereby provide a 
signal needed to activate T cells more completely. In 
contrast, our third category of tumor-targeted bispecifics 
bind to proteins only on the cancer cell. In this way, they 
may affect various signaling pathways to hamper the 
cancer cells’ ability to survive and proliferate.

In 2019, we saw progress across all three categories 
of Regeneron bispecifics. Our first CD3 bispecific to 
enter the clinic, REGN1979 (CD20xCD3) continued 
to show positive results in patients with late-stage 
lymphomas, including in patients whose tumors did not 
respond to CAR-T therapy. In addition, we shared the 
first encouraging data from a second CD3 bispecific 
REGN5458 (BCMAxCD3) in multiple myeloma. We 
also initiated Phase 1/2 clinical trials for our first CD28 
costimulatory bispecific, REGN5678 (PSMAxCD28), in 
prostate cancer and our first tumor-targeted bispecific, 
REGN5093 (METxMET), in MET-altered non-small cell 
lung cancer.

20

Regeneron / Annual Report 2019RAPID RESPONSE 
IN INFECTIOUS 
DISEASES

REGN-EB3 FOR EBOLA

REGN-EB3 LED TO A NEARLY  
90 PERCENT SURVIVAL RATE IN  
EBOLA PATIENTS WHO RECEIVED  
THE TREATMENT EARLY

One of our proudest moments of 2019 was learning 
that our investigational Ebola therapy, REGN-EB3, 
was so effective in preventing death compared to 
the prior antibody standard of care that the PALM 
clinical trial was halted early. The results, later 
published in The New England Journal of Medicine, 
found that REGN-EB3 demonstrated superior 
efficacy compared to the ZMapp control arm across 
multiple measures, including the primary endpoint 
of mortality at day 28 and secondary endpoint of 
reduction of number of days until the Ebola virus  
was no longer detected in the bloodstream. Given 
these groundbreaking results, we are working 
with the FDA to gain regulatory approval and with 
U.S. and global health authorities to determine 
appropriate stockpiling of REGN-EB3.

A cocktail of three antibodies, REGN-EB3 is a prime 
example of the power of Regeneron’s novel and 
proprietary VelocImmune® platform and associated 
VelociSuite technologies to generate and identify 
potential treatments rapidly, condensing a process 
that normally takes years into less than 12 months.

REGN-EB3 2019 REGULATORY 
HIGHLIGHTS

•  Breakthrough Therapy designation granted by FDA 

•  BLA for Ebola under review with October 25, 2020 

action deadline

21

Regeneron / Annual Report 2019THE PEOPLE WHO INSPIRE US

HEALTHCARE PROVIDERS ON THE GROUND 

While the city of Goma bustled around them, 
Drs. Patrice Kabongo and Ian Crozier sat quietly 
and intently focused on an infant in a small 
Ebola virus disease (EVD) treatment center in the 
Democratic Republic of Congo (DRC). Dressed 
head-to-toe in personal protective equipment, 
Crozier, an infectious diseases clinician deployed 
to North Kivu by the World Health Organization 
(WHO), held the infant, stabilizing an intravenous 
site tethered to an infusion bag containing 
Regeneron’s investigational antibody treatment. 
Kabongo, a physician with the DRC Ministry 
of Health, periodically monitored and recorded 
the infant’s vital signs, frequently reassuring the 
baby’s mother who watched anxiously nearby. 
She too was newly diagnosed with EVD and 
would soon be the second patient in Goma to 
receive similar treatment under an emergency 
use protocol enabled by the DRC and WHO. 
Her husband, the baby’s father, had arrived with 

severe illness too late to receive effective care and 
had died the night before; this hung heavy over 
the small team of healthcare workers determined 
the wife and infant would not meet the same fate. 

“I have a particular experience of the suffering 
associated with this disease, much of it 
unfortunately at the bedsides of many patients 
in Western Africa who were not able to access 
effective supportive care and therapeutics,” said 
Crozier, who previously worked in Sierra Leone 
and has been on ground for much of the current 
outbreak in DRC. “While the suffering continues 
here, there is a new will and capacity to provide 
patients what they need: that bundle of care now 
includes specific therapeutics for EVD, and we 
need every tool we can get. These therapeutics 
were made available for compassionate use  
by companies like Regeneron, and global 
collaboration importantly enabled identification of 

the most effective treatments in the historic Pamoja 
Tulinde Maisha (PALM) randomized controlled trial.”

Among those benefiting under the team’s care 
were the baby and mother, who were both able 
to leave the Ebola Treatment Unit days later—a 
moment Crozier described as “truly gratifying.”

The entire Regeneron team is humbled by the 
dedication of healthcare workers on the frontline 
in fighting Ebola. Amidst risk of harm from violence  
and the virus, heath care workers in DRC have 
administered high-quality medical care that also 
supported a landmark clinical trial, setting an 
important model for future outbreaks and inspiring 
hope in the ongoing fight against COVID-19.

22

Regeneron / Annual Report 2019NOVEL ANTIBODIES FOR COVID-19

With the emergence of the novel coronavirus SARS-
CoV-2 in late 2019 and early 2020, the Regeneron team 
again responded with urgency, applying our core ‘rapid 
response’ technologies to identify hundreds of virus-
neutralizing antibodies and selecting the most potent to 
move forward in therapeutic development. These novel 
antibodies are currently being scaled up for preclinical- 
and clinical-scale testing, with the goal of entering human 
clinical trials in June 2020. This therapeutic could be  
used to treat patients already infected with COVID-19 or 
to protect people not yet infected by the virus. 

We are also investigating the potential of Kevzara, our  
FDA-approved medicine for moderate-to-severe 
rheumatoid arthritis, in hospitalized patients with severe 
or critical COVID-19. We are awaiting data from a 
Phase 2/3 clinical trial that is enrolling patients around 
the U.S. A separate global study is being led by our 
collaborator Sanofi. Kevzara is an IL-6 antibody and, 
based on promising data seen in China with another  
IL-6 inhibitor, we believe it may have efficacy in 
addressing the lung inflammation associated with 
COVID-19.  

Based in large part on our experience with REGN-EB3,  
we are collaborating with the U.S. Department of 
Health and Human Services (HHS) and the Biomedical 
Advanced Research and Development Authority  
on both of these COVID-19 efforts under our existing 
collaboration agreement.  

23

Regeneron / Annual Report 2019RARE DISEASE AND PAIN PROGRAMS

EVINACUMAB

POZELIMAB

GARETOSMAB

FASINUMAB

In mid-2019, we announced that our 
Phase 3 trial investigating evinacumab, an 
angiopoietin-like 3 (ANGPTL3) antibody, 
in patients with homozygous familial 
hypercholesterolemia (HoFH) met its 
primary endpoint. In the trial, adding 
evinacumab to other lipid-lowering 
therapies, including statins and PCSK9 
inhibitors, decreased low-density lipoprotein 
(LDL) cholesterol by nearly 50 percent 
compared to lipid-lowering therapies alone. 
Currently, people living with HoFH, a severe, 
inherited form of high cholesterol, must 
often choose from treatment choices that 
can be time consuming or associated  
with potential side effects. With our positive 
Phase 3 data an FDA Breakthrough Therapy 
designation, we hope to offer patients a new 
option. We have begun a rolling BLA for 
evinacumab in the U.S. and plan to submit  
a regulatory filing in the EU in 2020.

In patients with the ultra-rare condition 
of paroxysmal nocturnal hemoglobinuria 
(PNH), genetic mutations cause the 
abnormal destruction of red blood cells in a 
process known as hemolysis. Left untreated 
or inadequately controlled, PNH can result 
in a range of chronic, sometimes life-
threatening symptoms that include fatigue, 
shortness of breath and blood clots. Current 
treatments require intravenous infusion and 
may not adequately control the disease in 
approximately 50 percent of patients. With 
pozelimab, an antibody designed to block 
complement factor C5, our aim is to offer an 
effective and more convenient option. We 
saw positive initial early data from a Phase 2 
trial presented in late 2019 and expect data 
from additional patients in 2020.  

Fibrodysplasia ossificans progressive (FOP) 
is an extremely rare genetic disease that 
progressively replaces muscles, tendons 
and ligaments with bone, effectively 
locking patients into their own skeleton. 
After two decades of dedicated research 
into FOP, we reached a major milestone 
with the announcement of encouraging 
data from our first-in-human Phase 2 trial 
of garetosmab, an Activin A antibody. 
In the trial, treated patients experienced 
a reduction in new lesions compared 
to those given a placebo. These results 
validate our hypothesis that Activin A  
is responsible for the progression of FOP 
and informed discussions with regulatory 
authorities on potential submissions,  
the first of which is planned for 2020.  
Plans for a pediatric trial for this ultra-rare 
disease are also underway.

As the opioid crisis continues and the 
need for alternative chronic pain solutions 
remains, we are making progress with 
fasinumab, our nerve growth factor (NGF) 
antibody, for osteoarthritis pain. In 2019, 
we completed enrollment in our Phase 3 
efficacy and safety studies. We expect to 
share a data update in 2020.

2424

Regeneron / Annual Report 2019Veloci-Bi®

Viral Vector and Gene Therapy 
Technologies

Gene Silencing and siRNA

Regeneron Genetics Center

Industrial Operations and  
Product Supply

26

26

26

28

29

CUTTING-EDGE 
RESEARCH AND 
TECHNOLOGY

VIRAL VECTOR AND  
GENE THERAPY TECHNOLOGIES

GENE SILENCING AND siRNA

Veloci-Bi allows us to create bispecific antibodies 
with no linkers or artificial sequences. As 
a result, our bispecifics are able to closely 
resemble natural human antibodies and have 
similar pharmacokinetics. As of early 2020, six 
investigational candidates developed with Veloci-
Bi technology are in clinical trials for a diverse 
range of solid tumors and blood cancers.

Regeneron’s expertise in viral vector engineering, 
gene editing and DNA repair biology synergizes 
with our antibody technologies and gives us 
the ability to correct the abnormal function of 
genes at the heart of many genetic diseases. 
We have achieved proof of concept with adeno-
associated virus (AAV) gene delivery of an 
antibody-guided enzyme-replacement therapy 
to potentially treat Pompe disease. We have 
also partnered with Decibel Therapeutics, Inc. 
to explore two other AAV-gene therapies, one 
designed to correct severe balance impairment 
and one intended to correct otoferlin deficiency, 
a cause of congenital deafness. Additionally, 
we are collaborating with Intellia Therapeutics, 
Inc. to tap the power of their high-efficiency 
CRISPR/Cas9 gene editing platform and have 
achieved proof of concept for several programs, 
including a Factor 9 gene insertion program in 
hemophilia B.

The underlying cause of many diseases can 
be traced back to the faulty functioning of one 
or more genes. Through our collaboration with 
Alnylam Pharmaceuticals, Inc., we are exploring 
innovative approaches to turn off, or silence, such 
genes using short interfering RNA (siRNA).

26

Regeneron / Annual Report 2019THE PEOPLE WHO INSPIRE US

OUR SCIENCE-FOCUSED COLLABORATORS 

What happens when two like-minded and innovation-focused companies bring 
their expertise together on a novel challenge? Beautiful science that we hope 
will lead to life-changing medicine.

In April 2019, we announced a broad new 
collaboration with Alnylam to explore RNA 
interference in ocular, central nervous system 
and liver diseases. Regeneron and Alnylam 
share complementary R&D strength and 
entrepreneurial spirits, making us well-suited  
to push beyond the core capabilities of  
either organization alone.

“We have a similar mindset when it comes to 
learning and understanding the science. Both 
teams love to ask lots of questions, challenge 
others to think differently, and dive deep into  

the details, which help us uncover ideas that 
might otherwise be obscured. Most importantly, 
we all try our best to do the right thing,” said 
Yi Zhang, Director of Clinical Pharmacology at 
Regeneron and the Clinical Pharmacology  
lead for the C5 complement-mediated diseases 
team with Alnylam.

Mangala Soundar, Senior Scientist, who works 
on the joint CNS programs and serves as the 
preclinical lead for Huntington disease research 
at Alnylam, agreed. “Working with Regeneron  
has opened doors to phenomenal capabilities 

and allowed us to expand our reach. We 
complement each other in a lot of ways and 
together make a stronger team,” she said.  

Regeneron is bringing our industry-leading 
capabilities in human genetics and expertise in 
various other areas such as disease modeling 
technologies together with Alnylam’s pioneering 
work in gene silencing. Let’s see what we can 
do, together.

27

Regeneron / Annual Report 2019REGENERON GENETICS CENTER

In 2019 and early 2020, our Regeneron Genetics Center 
celebrated two major achievements as they worked to 
further our understanding of the genetic underpinnings 
of disease and thus advance the future of medicine. 

First, in mid-2019, the RGC team made the first tranche 
of genomic data from the UK Biobank cohort available 
to the global scientific research community. The 
batch of sequences from the first 50,000 UK Biobank 
participants has the potential to drive new discoveries 
and invites researchers from all over the world to join 
in this important effort. The team expects to complete 
sequencing for all of the 500,000 total participants by 
the end of 2020. 

Second, as of February 2020, the RGC had sequenced 
the exomes of one million people, all with associated 
health record information. This makes the RGC the 
largest such genetics database in the world. From 
this unprecedented database, the team is generating 
important and actionable findings. 

For example, using genetic analysis, our researchers 
identified a patient subgroup that may receive 
greater benefit from PSCK9 treatments in terms of 
cardiovascular events risk reduction. This finding 
was validated by real-world evidence in a long-
running cardiovascular outcomes study. Similarly, 
the team used genetic evidence to help select COPD 
as a potential target for Regeneron’s IL-33 antibody. 
A variant in the HSD17B13 gene associated with 
reduced risk of or protection from certain chronic 
liver disease was first identified by RGC and Alnylam 
collaborators in 2018. The target is now a lead program 
for therapeutic intervention, with a potential RNAi 
therapeutic expected to enter the clinic this year. 

The RGC continues to be an important and uniquely 
Regeneron asset, as our scientists discover new 
targets, inform our preclinical and clinical work and 
contribute to important genetic research efforts  
around the globe. 

28

Regeneron / Annual Report 20192019  
SHINGO PRIZE

received by IOPS 
Rensselaer team

INDUSTRIAL OPERATIONS  
AND PRODUCT SUPPLY

Our IOPS teams in Rensselaer, New York, and Raheen, 
Ireland, continue to maintain and advance industry-
leading manufacturing, quality and supply chain 
practices for our clinical and commercial medicines. 
In 2019, the team completed seven successful global 
inspections and partner audits, including with the FDA 
and the U.S. Department of Agriculture. Our IOPS facility 
in Raheen became fully operational in 2019 and is now 
the largest biotech facility in Ireland. In recognition of 
their exceptional culture and commitment to continuous 
improvement, our IOPS Rensselaer team won the 
prestigious 2019 Shingo Prize for operational excellence.

In 2020, our IOPS team is demonstrating remarkable 
resiliency and flexibility as they enable rapidly shifting 
priorities and increased need for multiple products 
during the ongoing COVID-19 pandemic.

29

Regeneron / Annual Report 2019Investing in Regeneron’s Future

Sanofi Collaboration Restructurings

31

32

SCIENCE-ENABLING 
BUSINESS 
STRATEGIES  

INVESTING IN 
REGENERON’S FUTURE

As we strengthen Regeneron for the future, we are not only 
diversifying our portfolio through the science we pursue but 
also through the strategic investments we make. 

Central to this approach is continuing to prioritize our 
investment in internal R&D capabilities. While the industry 
average R&D investment as a percentage of revenue hovers 
at approximately 20 percent, we routinely reinvest around 
30 percent or more of our revenue into R&D. Our investment 
provides our researchers with the resources they need to gain 
critical insights into the underlying biology and mechanisms of 
diverse diseases, which fuel smarter, science-driven decisions 
throughout the preclinical and clinical research phases. 

However, we recognize that not every area of scientific interest 
can be fully explored through our R&D capabilities alone.  
We continue to invest in collaborations with other innovative, 
science-minded companies in our industry. In April 2019, 

we announced that Alnylam and Regeneron will be working 
on a broad research initiative that covers the discovery, 
development and commercialization of RNAi therapies 
primarily in ocular and central nervous system disorders. A 
second collaboration, with Vyriad, Inc., was announced in 
November 2019, centered on jointly designing and validating 
novel Vesicular Stomatitis Virus (VSV)-based oncolytic 
virus treatments for diverse cancers using our VelociSuite 
technology. Although different in scope, these and other 
ongoing collaborations allow us to enhance our core 
capabilities, amplify our collective expertise and quickly branch 
into new technologies that may transform medicine.  

In 2019, we also announced the initiation of a $1.0 billion share 
repurchase program as part of our strategic and diversified 
approach to capital allocation. 

~30%

of annual revenue 
routinely reinvested 
into R&D

31

Regeneron / Annual Report 2019SANOFI COLLABORATION 
RESTRUCTURINGS

We have collaborated with Sanofi for more than a 
decade, with our highly productive partnership evolving 
in step with our companies’ growth and development. 

In January 2019, we announced the restructuring of our 
global Immuno-oncology Discovery and Development 
Agreement for new immuno-oncology cancer 
treatments. The revised agreement refocuses our 
ongoing collaboration to Libtayo and the clinical-stage 
BCMAxCD3 and MUC16xCD3 bispecific programs. 
The revised agreement allows Regeneron to retain all 
rights to its other immuno-oncology discovery and 
development programs and provides Sanofi increased 
flexibility to advance its early-stage immuno-oncology 
pipeline independently.

In addition, in the second quarter of 2020, we  
simplified our antibody collaboration for Praluent  
by restructuring into a royalty-based agreement.  
Sanofi gained sole ex-U.S. rights to Praluent while 
Regeneron gained sole U.S. rights to Praluent. Each 
company is now solely responsible for funding 
development and commercialization expenses in  
their respective territories. This restructuring  
does not impact Dupixent, and the companies will 
continue to collaborate on the potential use of  
Kevzara in COVID-19. Together with Sanofi, we  
agree these changes will help both companies  
increase efficiency and streamline operations. 

32

Regeneron / Annual Report 2019Being a Responsible Corporate Citizen

2025 Global Responsibility Goals

New Environmental Targets to Help 
Protect and Restore the Planet

34

37

38

RESPONSIBLE 
REGENERON

BEING A RESPONSIBLE 
CORPORATE CITIZEN

Regeneron’s mission is to use the power of 
science to bring new medicines to patients, 
over and over again. We are committed 
to operating responsibly, communicating 
transparently about our impacts and engaging 
all stakeholders in our mission. We strive 
to “do well by doing good” and have been 
publicly disclosing information about significant 
corporate responsibility matters since 2014. 

For more details about our responsibility  
efforts and results, please refer to the  
2019 Responsibility Report. 

SELECT 2019 HONORS

•  RobecoSAM and S&P Dow Jones Indices: Dow 

Jones Sustainability World Index

•  Science: Top Employer

•  Harvard Business Review: Best Performing CEOs

•  Fast Company: Best Workplaces for Innovators

•  IDEA Pharma: Pharmaceutical Invention Index

•  Shingo Institute: The Shingo Prize

•  Great Places to Work: Best Workplace in Ireland

•  Civic 50: Most Community-Minded Companies  

in the U.S.

34

Regeneron / Annual Report 2019Our responsibility strategy centers on three focus areas:

1. Improve the lives of people with serious diseases. As 
a science-focused company, we operate Regeneron with 
the long-term outlook required to turn rigorous scientific 
research into important new medicines. All seven of 
our approved medicines and all product candidates 
in our clinical pipeline are homegrown – discovered in 
Regeneron’s labs using our industry-leading, proprietary 
technologies. Our support for patients extends beyond the 
labs to disease education and awareness efforts, product 
support services and our commitment to drug access and 
responsible pricing.

2. Foster a culture of integrity and excellence. 

Regeneron’s culture is special and unique. Our culture 
includes our science-led mindset, our high ethical 
standards and our unbridled focus on solving big, 
complex problems. As we continue to grow, we remain 
committed to making significant investments to attract 
and retain top talent and facilitate the diverse and 
inclusive workforce we require to bring new medicines to 
people in need.  

We are equally committed to conducting our business 
responsibly and ethically. This is demonstrated through 

the range of policies, practices and initiatives 
we have implemented, encompassing areas 
such as compliance, responsible sales and 
marketing, ethical clinical trials, responsible 
supply chain and product quality and safety. 

3. Build sustainable communities. We believe 
that our role in creating a healthier world 
extends beyond creating life-transforming 
medicines to building a healthy living 
environment. In 2020, we announced a 
set of 2025 global responsibility goals and 
accompanying environmental targets, as 
shown on the subsequent two pages. We plan 
to begin reporting on our progress toward 
these goals in the 2020 Responsibility Report.  

We also strengthen our communities through 
strategic philanthropic investments, product 
donations and the power of our employees’ 
talents and time. We are a long-standing 
supporter of science, technology, engineering 
and math (STEM) education, and make major 
philanthropic investments to inspire and 
celebrate future scientific innovators. These 
include our 10-year, $100-million commitment 

35

Regeneron / Annual Report 2019 
 
to the Regeneron Science Talent Search, the nation’s 
most prestigious pre-college science and mathematics 
competition, and our new five-year, $24-million 
commitment to the Regeneron International Science and 
Engineering Fair, the world’s largest pre-college science 
and engineering competition. In 2019, we also launched 
the Regeneron DNA Learning Center, a program of  
Cold Spring Harbor Laboratory. Our investments in STEM 
education represented approximately 86 percent of our 
2019 corporate philanthropy grants, excluding medical 
grants and matched funds. 

Also in 2019, 59 percent of Regeneron worldwide 
employees donated more than 27,800 hours to local non-
profit organizations through our volunteer programs. This 
is in the top-quartile of corporate volunteer participation 
rates, and well above the 33 percent corporate average 
rate, according to a benchmarking study published in 
2019 by Chief Executives for Corporate Purpose. Among 
our volunteer activities, we held our third annual Day  
for Doing Good, a company-wide day of service that had 
a record-high 57 percent employee participation.

IN 2019, 59 PERCENT OF 
REGENERON WORLDWIDE 
EMPLOYEES DONATED  
MORE THAN 27,800 HOURS  
OF THEIR TIME 

36

Regeneron / Annual Report 2019 
REGENERON’S 
2025 
RESPONSIBILITY 
GOALS

In 2019, we set global 
2025 responsibility 
goals, which span 
across these three 
focus areas and 
the environmental 
and social issues 
that we believe are 
most significant to 
our business and 
stakeholders. 

IMPROVE THE LIVES OF PEOPLE 
WITH SERIOUS DISEASES

Use the power of science to discover 
and advance important new 
medicines while continuing to make 
substantial investments into R&D.

Identify genetic insights that will 
support the discovery and 
advancement of tomorrow’s 
medicines through our Regeneron 
Genetics Center®.

Set fair, value-based prices for our 
medicines and break down barriers to 
patient access.

Support organizations that offer 
disease prevention, diagnosis 
and treatment for people 
touched by serious 
diseases.

FOSTER A CULTURE OF INTEGRITY 
AND EXCELLENCE

Cultivate a leading workplace 
experience that is rooted in our unique 
science-driven culture.

Increase representation of qualified 
diverse individuals in leadership and 
foster inclusion across our organization.

Be vigilant in ensuring integrity remains 
at the core of how we operate.

Implement continuous improvements 
to uphold our high-quality, safe and 
reliable product supply.

Make Regeneron the safest 
part of people’s day by 
focusing on prevention in 
our drive towards zero 
incidents.

BUILD SUSTAINABLE 
COMMUNITIES

Achieve our environmental targets to 
help protect and restore the planet.*

Foster the next generation of scientific 
innovators by providing STEM 
experiences to 2.5 million students.

Drive employee volunteer levels above 
national standards.

*See next page for specific  
  environment targets.

37

Regeneron / Annual Report 2019NEW ENVIRONMENTAL TARGETS TO HELP PROTECT AND RESTORE THE PLANET

WATER

WASTE

ENERGY & 
EMISSIONS

By 2021, achieve zero waste to 
landfill status at all Regeneron 
sites.**

By 2021, compost food waste 
at all sites with more than 
2,000 employees. 

By 2021, engage our top 30 
suppliers, representing more 
than 50% of spend, to gather 
and report relevant Scope 3 
greenhouse gas (GHG) 
emissions data.

By 2025, improve water efficiencies by implementing global water 
mapping strategy and water stewardship program.

By 2025, develop and implement waste management plans to further 
increase our plastic recycling and reduce hazardous waste generation.

By 2023, set global 
science-based targets for 
Scope 1 and 2 GHG emissions. 

By 2025, match 50% of our electricity consumption with electricity from 
certified renewable energy sources.

By 2025, invest in the production of renewable power to meet our 
long-term electricity needs.

By 2025, reduce combined Scope 1 & 2 (market-based) GHG emissions 
per square meter by 30% based on 2016 peak baseline. 

By 2035, match 
100% of our 
electricity 
consumption 
with electricity 
from certified 
renewable 
energy sources.

2021

2023

2025

2035

**Excludes construction and demolition waste

38

Regeneron / Annual Report 2019CONTINUED OPERATIONAL GROWTH

REVENUE*

FULL-TIME EMPLOYEES

R&D INVESTMENT*

$7.863B

$6.711B

$5.872B

8,100

7,300

6,200

$3.037B

$2.075B

$2.186B 

2017

2018

2019

2017

2018

2019

2017

2018

2019

* As reported in Regeneron’s Annual Report on Form 10-K for the year ended December 31, 2019. In the second quarter of 2020, Regeneron announced that it had implemented changes in the presentation 
of its consolidated financial statements relating to certain reimbursements and other payments for products developed and commercialized with collaborators. These changes were made effective January 
1, 2020 and have also been applied retrospectively. After giving effect to these changes, Regeneron’s revenue for fiscal 2017, 2018 and 2019 would have been $4.258 billion, $5.146 billion and $6.558 
billion, respectively; and Regeneron’s R&D expense for fiscal 2017, 2018 and 2019 would have been $1.181 billion, $1.469 billion and $2.450 billion, respectively. There is no impact from these changes to 
net income or net income per share.

Regeneron / Annual Report 2019

39

FORWARD LOOKING STATEMENTS

This report includes forward-looking statements that 
involve risks and uncertainties relating to future events and 
the future performance of Regeneron Pharmaceuticals, 
Inc. (where applicable, together with its subsidiaries, 
“Regeneron” or the “Company”), and actual events or 
results may differ materially from these forward-looking 
statements.  Words such as “anticipate,” “expect,” 
“intend,” “plan,” “believe,” “seek,” “estimate,” variations 
of such words, and similar expressions are intended to 
identify such forward-looking statements, although not 
all forward-looking statements contain these identifying 
words. These statements concern, and these risks 
and uncertainties include, among others, the impact of 
SARS-CoV-2 (the virus that has caused the COVID-19 
pandemic) on Regeneron’s business and its employees, 
collaborators, suppliers, and other third parties on which 
Regeneron relies, Regeneron’s and its collaborators’ ability 
to continue to conduct research and clinical programs, 
Regeneron’s ability to manage its supply chain, net 
product sales of products marketed by Regeneron and/
or its collaborators (collectively, “Regeneron’s Products”), 
and the global economy; the nature, timing, and possible 
success and therapeutic applications of Regeneron’s 

Products and Regeneron’s product candidates and 
research and clinical programs now underway or 
planned, including without limitation EYLEA® (aflibercept) 
Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), 
Praluent® (alirocumab), Kevzara® (sarilumab), fasinumab, 
evinacumab, REGN-EB3, garetosmab, pozelimab, 
Regeneron’s immuno-oncology programs (including its 
costimulatory bispecific portfolio), Regeneron’s COVID-19 
antibody program and other earlier-stage programs, 
and the use of human genetics in Regeneron’s research 
programs; the likelihood and timing of achieving any of 
Regeneron’s anticipated development and production 
milestones; unforeseen safety issues resulting from the 
administration of Regeneron’s Products and product 
candidates in patients, including serious complications 
or side effects in connection with the use of Regeneron’s 
Products and product candidates in clinical trials; the 
likelihood and timing of possible regulatory approval and 
commercial launch of Regeneron’s product candidates 
and new indications for Regeneron’s Products; the extent 
to which the results from the research and development 
programs conducted by Regeneron or its collaborators 
may be replicated in other studies and lead to therapeutic 

applications; ongoing regulatory obligations and oversight 
impacting Regeneron’s Products (such as EYLEA, 
Dupixent, Libtayo, Praluent, and Kevzara), research and 
clinical programs, and business, including those relating 
to patient privacy; determinations by regulatory and 
administrative governmental authorities which may delay 
or restrict Regeneron’s ability to continue to develop 
or commercialize Regeneron’s Products and product 
candidates; competing drugs and product candidates that 
may be superior to Regeneron’s Products and product 
candidates; uncertainty of market acceptance and 
commercial success of Regeneron’s Products and product 
candidates; the ability of Regeneron to manufacture and 
manage supply chains for multiple products and product 
candidates; the ability of Regeneron’s collaborators, 
suppliers, or other third parties (as applicable) to perform 
manufacturing, filling, finishing, packaging, labeling, 
distribution, and other steps related to Regeneron’s 
Products and product candidates; coverage and 
reimbursement determinations by third-party payers, 
including Medicare and Medicaid; unanticipated 
expenses; the costs of developing, producing, and 
selling products; the ability of Regeneron to meet any of 

40

Regeneron / Annual Report 2019FORWARD LOOKING STATEMENTS (Continued)

and other material risks can be found in 
Regeneron’s filings with the U.S. Securities 
and Exchange Commission, including 
its Form 10-K for the fiscal year ended 
December 31, 2019, including in the section 
thereof captioned “Item 1A. Risk Factors.” 
Any forward-looking statements are made 
based on management’s current beliefs and 
judgment, and the reader is cautioned not 
to rely on any forward-looking statements 
made by Regeneron. Regeneron does not 
undertake any obligation to update publicly 
any forward-looking statement, whether  
as a result of new information, future events, 
or otherwise.

its financial projections or guidance, and 
changes to the assumptions underlying 
those projections or guidance; the potential 
for any license or collaboration agreement, 
including Regeneron’s agreements with 
Sanofi, Bayer, and Teva Pharmaceutical 
Industries Ltd. (or their respective affiliated 
companies, as applicable), to be cancelled 
or terminated without any further product 
success; and risks associated with 
intellectual property of others and pending 
or future litigation relating thereto (including 
without limitation the patent litigation 
and other related proceedings relating to 
Dupixent and Praluent), other litigation 
and other proceedings and government 
investigations relating to the Company and/
or its operations, the ultimate outcome of 
any such proceedings and investigations, 
and the impact any of the foregoing may 
have on Regeneron’s business, prospects, 
operating results, and financial condition. 
A more complete description of these 

41

Regeneron / Annual Report 2019CORPORATE INFORMATION

Common Stock and Related Matters

Our Common Stock is traded on The 
NASDAQ Global Select Market under  
the symbol “REGN.” Our Class A Stock  
is not publicly quoted or traded.

As of April 14, 2020, there were 170 shareholders of record of our Common Stock and 16 shareholders of record of our Class A Stock.  
The closing sales price for the Common Stock on that date was $524.84. We have never paid cash dividends and do not anticipate  
paying any in the foreseeable future.

SEC Form 10-K

Shareholders’ Inquiries

Annual Meeting

Corporate Office

A copy of our 2019 Annual Report on 
Form 10-K filed with the Securities and 
Exchange Commission (which forms 
part of this 2019 Annual Report to 
Shareholders and is incorporated herein 
by reference) is available without  
charge from the Regeneron Investor 
Relations Department, reachable via  
invest@regeneron.com.

Inquiries relating to stock transfer or 
lost certificates and notices of changes 
of address should be directed to our 
Transfer Agent, American Stock Transfer 
& Trust Co., 6201 15th Avenue, Brooklyn, 
New York 11219, (800) 937-5449, www.
amstock.com/main. General information 
regarding the Company, recent press 
releases, and SEC filings are available  
on our website at www.regeneron.com,  
or can be obtained by contacting our 
Investor Relations Department at  
(914) 847-7741 or invest@regeneron.com.

The 2020 Annual Meeting of Shareholders will be 
held on June 12, 2020 at 10:30 a.m., Eastern Time, 
virtually via www.virtualshareholdermeeting.com/
REGN2020 and at the Westchester Marriott Hotel,  
670 White Plains Road, Tarrytown, New York 10591. 
Due to the COVID-19 outbreak, we may change 
the venue for the in-person meeting or hold the 
Annual Meeting as a virtual-only event to the extent 
permitted under New York law. Please visit  
investor.regeneron.com for the most up-to-date  
information on the 2020 Annual Meeting, any 
procedures and limitations concerning in-person  
attendees, and information regarding any 
government-imposed limits on public gatherings 
applicable to the Annual Meeting that may be in 
effect at that time.

777 Old Saw Mill River Road  
Tarrytown, New York 10591-6707  
(914) 847-7400

Transfer Agent and Registrar

American Stock Transfer & Trust Co.  
6201 15th Avenue  
Brooklyn, New York 11219

Independent Registered 
Public Accounting Firm 

PricewaterhouseCoopers LLP

42

Regeneron / Annual Report 2019REGENERON®, Science to Medicine®, Regeneron Genetics Center® and the following  
are registered trademarks of Regeneron Pharmaceuticals, Inc.: ARCALYST®,  
EYLEA®, Libtayo® (in the U.S.), VelociGene®, VelocImmune®, Veloci-Bi®, VelociMab®, 
VelociMouse®, VelociSuite® and ZALTRAP®. Praluent®, Dupixent® and Kevzara®  
are registered trademarks of Sanofi.

m
o
c
.
n
o
s
d
d
a

i

y
b
n
g
s
e
D

i