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Regeneron Pharmaceuticals

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FY2020 Annual Report · Regeneron Pharmaceuticals
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THE ANSWERS

2020 Annual Report

antibody cocktail treatment for COVID-19 in 
record time — just 10 months from program 
inception through an emergency use 
authorization (EUA) from the U.S. Food and 
Drug Administration (FDA). To date, tens of 
thousands of patients have received REGEN-
COV, and we are now working in partnership 
with the U.S. government, healthcare providers 
and advocacy groups to ensure all appropriate 
patients can access it. 

Unlike vaccines, which trigger the body’s own 
immune response to protect against infection, 
REGEN-COV provides virus-neutralizing 
antibodies directly to the patient. In the pivotal 
Phase 3 treatment trial, REGEN-COV reduced 
hospitalization or death by 70 percent in 
high-risk outpatients and reduced symptom 
duration. As we do our part to bring this 
pandemic to an end, we continue to evaluate 
REGEN-COV in additional patient populations, 
at lower dose levels and for prevention 
purposes. To that end, results from the Phase 

3 prevention trial showed that REGEN-COV 
administered as a subcutaneous injection 
reduced the risk of symptomatic SARS-CoV-2 
infections by 81 percent among household 
contacts of infected patients. As of April 2021, 
more than 25,000 people have participated in 
clinical trials of REGEN-COV, and we thank all 
the individuals, investigators and collaborators.

Our financial position remained strong this 
year, with top-line growth of 30 percent and 
bottom-line growth of 28 percent1 through  
an increasingly diversified set of revenue  
and earnings streams. Total revenues for  
2020 increased to $8.5 billion, compared  
to $6.6 billion for the full year 2019.

EYLEA® (aflibercept) Injection continues 
to reach more patients in competitive eye 
disease markets, with its efficacy, safety and 
convenience setting a high bar for current 
and potential future entries. We are confident 
in the durability and continued growth of this 
important medicine for years to come. Annual 

EYLEA global net product sales reached 
nearly $8 billion in 2020 (net product sales 
outside the U.S. recorded by our collaborator 
Bayer), and $4.9 billion in the U.S., still without 
a single price increase in its history. 

Looking to the rest of our growing portfolio, 
more than 80 percent of our top-line growth in 
2020 came from products and revenues other 
than EYLEA. Dupixent® (dupilumab) global 
net product sales in 2020 (recorded by our 
collaborator Sanofi) were more than $4 billion, 
reflecting growth of 75 percent versus 2019. 
This “pipeline in a product” continues to reach 
more patients in need with an expanded FDA 
indication for atopic dermatitis in patients 
ages 6 to 11 and an FDA acceptance of 
our supplemental application as an add-on 
treatment for children aged 6 to 11 years with 
uncontrolled moderate-to-severe asthma, 
with even more room to grow as it meets its 
potential to transform the treatment of certain 
type 2 inflammatory diseases. We also made 

DEAR FELLOW SHAREHOLDERS,

When we wrote to you this time last year, the 
novel coronavirus, SARS-CoV-2, had recently 
been declared a global pandemic. Our team 
had quickly identified ways Regeneron could 
help and had already begun isolating novel 
antibodies to combat the disease, but no 
one recognized the epic, world-changing 
challenges COVID-19 and 2020 would bring. 
The numbers have been sobering — nearly 
100 million people infected globally, several 
million dead, and almost everyone impacted 
in some significant way. The Regeneron team 
has been deeply impacted as well, from 
an early outbreak near our headquarters in 
Westchester, New York, to the personal loss  
of loved ones. 

Despite this unprecedented public health 
crisis, 2020 was an inspiring year in many  
ways, demonstrating the power of science  
and the resilience of our team. We discovered, 
developed and manufactured our novel 
REGEN-COV™ (casirivimab with imdevimab) 

1 Bottom-line growth represented by non-GAAP net income per share — diluted, 
which is not a measure calculated in accordance with U.S. Generally Accepted 
Accounting Principles (“GAAP”). See “Forward-Looking Statements and Non-
GAAP Financial Measures” on pages 35 and 37 for a definition of this measure 
and a reconciliation of this measure to the most directly comparable GAAP 
financial measure.

2

Dupixent treatment more convenient with the 
FDA approval of a single-dose, 300mg pre-
filled syringe.

As the foundation of our oncology portfolio, 
our PD-1 inhibitor Libtayo® (cemiplimab-rwlc) 
is achieving significant and steady growth 
with FDA approvals in two new indications, 
non-small cell lung cancer and basal cell 
carcinoma, in early 2021. Global net product 
sales for Libtayo were $348 million in 2020, 
representing 80 percent year-over-year 
growth. We are making progress in other 
cancers as well, including in March 2021 when 
positive results in overall survival prompted us 
to stop our cervical cancer trial early, with the 
data forming the basis of upcoming regulatory 
submissions. With 11 investigational 
therapeutics in clinic for a wide range of 
cancers, including eight bispecific antibodies, 
we continue to diversify our approach to 
oncology and are positioned to lead the next 
wave of innovation in immuno-oncology. 

Our COVID-19 program and other important 
progress this year was made possible by 
decades of investment in our foundational 
VelociSuite® antibody discovery and 
development technologies, as well as in 
world-class manufacturing enterprise. Thanks 
to these investments and the hard work of 
our colleagues, in 2020 and early 2021 we 
achieved two new FDA-approvals of novel, 
Regeneron-discovered antibody medicines: 
the multi-antibody cocktail Inmazeb™ 
(atoltivimab, maftivimab, and odesivimab-
ebgn) for Ebola, and the ANGPTL3 inhibiting 
antibody Evkeeza™ (evinacumab-dgnb) for  
a rare form of inherited high cholesterol. 

Regeneron is known for our science-driven 
approach, and as such our pipeline and 
research efforts continue to expand. We 
continue to reinvest a significant portion of 
our growing revenue into our R&D efforts to 
fuel the remarkable innovation and curiosity 
of our world-class team. Our early pipeline 

is increasingly powered by genetics, thanks 
to significant insights from the Regeneron 
Genetics Center ®, which reveals new targets 
for exploration as well as enriching current 
clinical programs. Our genetics medicine 
efforts also include important collaborations 
with Intellia Therapeutics, Inc. and Alnylam 
Pharmaceuticals, Inc., which pair Regeneron’s 
biologic and antibody capabilities with cutting-
edge technologies like CRISPR gene editing 
and RNA silencing. Both of these partnerships 
advanced candidates into clinical development 
for the first time in the past year.

While 2020 tested us in new ways, we 
are proud to say that the Regeneron team 
successfully advanced our mission of using 
the power of science to bring new medicines 
to people in need. We came together as  
never before. Watching our employees rally  
to support each other was awe-inspiring, 
as was the strong spirit of collaboration and 
pride in our collective purpose. We head into 

Regeneron Annual Report 2020
Regeneron Annual Report 2020

this next year with the confidence that we will 
continue to tackle some of the world’s biggest 
health and scientific challenges.

SINCERELY, 
ROY, LEN AND GEORGE

P. ROY VAGELOS, M.D.
Chairman of the Board

LEONARD S. SCHLEIFER, M.D., PH.D.
President and Chief Executive Officer

GEORGE D. YANCOPOULOS, M.D., PH.D.
President and Chief Scientific Officer

3

2020 BY THE NUMBERS

30 investigational 
medicines in 
clinical development

115 global and U.S. patient 
advocacy and professional 
societies engaged across 
25 disease states

41 countries where we 
conducted clinical trials

6 U.S. marketing 
applications for  
new products or  
new indications for  
existing products

$3.9 million raised from  
employee donations and  
company matches — nearly  
four times previous years

179 manuscripts published 
in peer-reviewed journals

100+ Regeneron Genetics 
Center collaborations in 
21 countries

Provided STEM 
experiences to 
524,000 students

4

TABLE OF 
CONTENTS

06
SCIENTIFIC BREADTH AND DEPTH
	| FDA-Approved Medicines
	| Clinical Pipeline
	|  Notable Peer-Reviewed Publications
	| Infectious Diseases
	| Ophthalmology
	| Immunology and Inflammation
	| Oncology
	| Non-Oncology Hematology
	| Cardiovascular Diseases
	| Rare Diseases

24
ADVANCES IN TECHNOLOGY
27
STRATEGIC BUSINESS APPROACHES
28
STRENGTHENING OUR CULTURE 
DURING A PANDEMIC
29
RESPONSIBLE REGENERON

5

FDA-APPROVED
MEDICINES

1 

2

3

4

2

2

1 Marketed by Kiniksa Pharmaceuticals.
2  In collaboration with Sanofi. For Praluent, in collaboration with Sanofi prior to  
April 2020; effective April 2020, Regeneron is solely responsible for the U.S.  
development and commercialization and Sanofi is solely responsible for the 
ex-U.S. development and commercialization of Praluent.

3 In collaboration with Bayer outside of U.S.

4 Marketed by Sanofi.
5  In collaboration with Roche outside of U.S. REGEN-COV has not been approved, 
but has been authorized for emergency use by the FDA. This use is authorized  
only for the duration of the declaration that circumstances exist justifying the  
authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C.  
§ 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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

6

2EMERGENCY USE AUTHORIZATION ONLY5CLINICAL PIPELINE

Our pipeline continues to grow and advance 
across a wide variety of diseases.

Cardiovascular/ 
Metabolic Diseases

Immunology & 
Inflammatory Diseases

General Medicine

Infectious Diseases

Hematology

Oncology

Ophthalmology

Pain/Neurology

Rare Diseases

PHASE 1

PHASE 2

PHASE 3

REGN3767
LAG-3 Antibody
Solid tumors, advanced hematologic 
malignancies

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

REGN5381
NPR1 Agonist Antibody
Heart failure

AFLIBERCEPT3 
VEGF-Trap
High-dose (8mg) for wet age-related 
macular degeneration (AMD)

DUPILUMAB1
IL-4R Antibody
Peanut allergy, grass allergy

POZELIMAB
C5 Antibody
CD-55 deficient protein-losing 
enterotherapy

AFLIBERCEPT3 
VEGF-Trap
Retinopathy of prematurity (ROP), high-
dose formulation (8mg) for wet AMD 
and diabetic macular edema (DME)

REGN5713-5714-5715
Bet v 1 Multi-Antibody Therapy
Birch allergy

REGN6569
GITR Antibody
Solid tumors

ODRONEXTAMAB
CD20 X CD3 Antibody
B-cell malignancies  
(on FDA partial clinical hold)

REGN4018
MUC16 X CD3 Antibody
Platinum-resistant ovarian cancer

REGN5459
BCMA X CD3 Antibody
Multiple myeloma

REGN5678
PSMA X CD28 Antibody
Prostate cancer

Pipeline Collaborator Key
1 Sanofi 

2 Teva and Mitsubishi Tanabe 

REGN5668
MUC16 X CD28 Antibody
Ovarian cancer

REGN7257
IL-2Rg Antibody
Aplastic anemia

POZELIMAB + CEMDISIRAN5
C5 Antibody X C5 siRNA 
Therapeutic
Paroxysmal nocturnal hemoglobinuria 
(PNH)

NTLA-20014
CRISPR/Cas9
Hereditary transthyretin amyloidosis 
with polyneuropathy

REGN7075
EGFR X CD28 Antibody
Solid tumors

REGN6490
IL-36R Antibody
Palmo-plantar pustulosis

ALN-HSD5
HSD17B13 RNAi Therapeutic
Nonalcoholic steatohepatitis

CASIRIVIMAB with IMDEVIMAB
SARS-CoV-2 Virus Multi-
Antibody Therapy 
Multi-dose safety study in 
healthy volunteers 

CEMIPLIMAB1 
PD-1 Antibody
Basal cell carcinoma (BCC), metastatic 
or locally advanced cutaneous 
squamous cell carcinoma (CSCC), 
neoadjuvant CSCC

ODRONEXTAMAB
CD20 X CD3 Antibody
B-cell non-Hodgkin lymphoma  
(on FDA partial clinical hold)

REGN5458
BCMA X CD3 Antibody
Multiple myeloma

SARILUMAB1
IL-6R Antibody
Polyarticular-course juvenile idiopathic 
arthritis, systemic juvenile idiopathic 
arthritis

REGN1908-1909
Fel d 1 Multi-Antibody Therapy
Cat allergy

CEMDISIRAN5
C5 siRNA Therapeutic
Immunoglobulin A nephropathy

CASIRIVIMAB with IMDEVIMAB
SARS-CoV-2 Virus Multi-
Antibody Therapy
Dose-ranging virology study in non-
hospitalized patients

EVINACUMAB
ANGPTL3 Antibody
Severe hypertriglyceridemia

REGN4461
LEPR Agonist Antibody
Generalized lipodystrophy

CEMIPLIMAB1 
PD-1 Antibody
Non-small cell lung cancer (NSCLC), 
cervical cancer, adjuvant cutaneous 
squamous cell carcinoma (CSCC)

GARETOSMAB
Activin-A Antibody
Fibrodysplasia Ossificans Progressiva 
(FOP) 

CASIRIVIMAB with IMDEVIMAB
SARS-CoV-2 Virus Multi-
Antibody Therapy
Treatment for certain hospitalized 
and non-hospitalized patients with 
COVID-19; prevention of COVID-19 
in household contacts of diagnosed 
patients

DUPILUMAB1
IL-4R Antibody
Atopic dermatitis in pediatric patients  
6 mo.–5 y.o., hand and foot atopic 
dermatitis, asthma in pediatric patients 
6–11 y.o., eosinophilic esophagitis in 
patients 6 and older, chronic obstructive 
pulmonary disease (COPD), bullous 
pemphigoid, prurigo nodularis, 
chronic spontaneous urticaria, allergic 
bronchopulmonary aspergillosis, 
chronic inducible urticaria, chronic 
sinusitis without nasal polyposis, allergic 
fungal rhinosinusitis

ALIROCUMAB
PCSK9 Antibody 
Heterozygous familial 
hypercholesterolemia (HeFH) in 
pediatrics

FASINUMAB2 
NGF Antibody 
Chronic pain from osteoarthritis  
of the knee or hip

ITEPEKIMAB1
IL-33 Antibody
COPD

3 Bayer 

4 Intellia 

5 Alnylam 

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.

7

NOTABLE PEER-REVIEWED 
PUBLICATIONS

POSITIVE INITIAL ANTIBODY COCKTAIL RESULTS IN 
NON-HOSPITALIZED PATIENTS WITH COVID-19

POSITIVE PHASE 3 EVINACUMAB RESULTS IN PATIENTS 
WITH SEVERE INHERITED FORM OF HIGH CHOLESTEROL

CANCER TREATMENT ENHANCED BY COMBINING 
NOVEL COSTIMULATORY BISPECIFIC ANTIBODIES 
WITH LIBTAYO 

EFFICACY AND SAFETY OF DUPILUMAB WITH 
CONCOMITANT TOPICAL CORTICOSTEROIDS IN 
CHILDREN 6 TO 11 YEARS OLD WITH SEVERE ATOPIC 
DERMATITIS: A RANDOMIZED, DOUBLE-BLINDED, 
PLACEBO-CONTROLLED PHASE 3 TRIAL

ANTIBODY COCKTAIL TO SARS-COV-2 SPIKE PROTEIN 
PREVENTS RAPID MUTATIONAL ESCAPE SEEN WITH 
INDIVIDUAL ANTIBODIES

POSITIVE PIVOTAL (PHASE 3) LIBTAYO RESULTS IN 
ADVANCED NON-SMALL CELL LUNG CANCER WITH 
≥50% PD-L1 EXPRESSION

STUDIES IN HUMANIZED MICE AND CONVALESCENT 
HUMANS YIELD A SARS-COV-2 ANTIBODY COCKTAIL

8

Photo taken prior to COVID-19 pandemic.

INFECTIOUS 
DISEASES

TAKING QUICK ACTION TO 
HELP ADDRESS DEADLY 
INFECTIOUS DISEASES

Our innovative work in infectious diseases 
took center stage over the past year in a way 
we never imagined. Regeneron’s proprietary 
VelociSuite technologies were applied in our 
“rapid response” efforts, enabling us to break 
records by accelerating drug discovery and 
development for novel COVID-19 and Ebola 
antibody cocktail treatments. 

INMAZEB™ (ATOLTIVIMAB, MAFTIVIMAB, 
AND ODESIVIMAB-EBGN)1

In October 2020, the FDA approved the first 
treatment for the infection caused by Zaire 
ebolavirus in adult and pediatric patients, 
including newborns of mothers who have tested 
positive for the infection. Inmazeb’s (previously 
known as REGN-EB3) development started in 
2014 during the Ebola outbreak in West Africa, 

when our scientists first considered applying 
our antibody technologies to respond to a 
potential viral epidemic. This program laid the 
groundwork for our subsequent efforts against 
Middle East Respiratory Syndrome (MERS) and 
SARS-CoV-2. 

The FDA approval of Inmazeb was the result 
of a long collaborative effort with government, 
academic and non-profit organizations that 
helped coordinate and conduct the PALM 
clinical trial in the Democratic Republic of 
the Congo during the 2019 outbreak. The 
collaboration continues as we recently 
worked with the World Health Organization 
(WHO); the Biomedical Advanced Research 
and Development Authority (BARDA), part of 
the U.S. Department of Health and Human 
Services, Office of the Assistant Secretary for 
Preparedness and Response; and the FDA to 
ship dozens of doses of Inmazeb to Guinea, 
which unfortunately began experiencing its 
own outbreak in early 2021. Additional supply 
is ready to ship, if necessary, and we are also 
working to ensure that bordering countries  
can gain access to Inmazeb quickly if the 
outbreak spreads. With the combined impact  

1  Inmazeb was developed in collaboration and with federal funds from BAR-
DA under ongoing USG Contract Nos. HHSO100201700016C and HH-
SO100201500013C. 

9

INFECTIOUS DISEASES

THANKS TO DECADES OF 
FOUNDATIONAL RESEARCH, 
BY EARLY JANUARY 2020, 
REGENERON WAS ALREADY BUSY 
IN THE LABS INVESTIGATING  
A POTENTIAL TREATMENT  
FOR COVID-19.

of dedicated healthcare workers and safe  
and effective vaccines and treatments, we 
hope that the global health community can 
stand ready to quickly end new outbreaks  
as they occur. 

Inmazeb is a prime example of our work at 
Regeneron — a medicine we hoped would 
never have to be used broadly, but one that 
we knew from the start could change lives. 

REGEN-COV has not been approved, but has been authorized for emergency  
use by the FDA. This use is authorized only for the duration of the declaration  
that circumstances exist justifying the authorization of the emergency use under  
section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization  
is terminated or revoked sooner. 

REGEN-COV™ (CASIRIVIMAB WITH 
IMDEVIMAB), COVID-19 ANTIBODY 
COCKTAIL THERAPY1

Thanks to our prior experiences with Ebola 
and MERS, by early January 2020, Regeneron 
was already busy in the labs investigating a 
potential treatment and preventative approach 
to COVID-19. Knowing the nature of viral 
mutation, we once again planned a multi-
antibody “cocktail” approach. This way, if the 
virus mutated to evade one antibody, the other 
would still be potent in blocking the virus’ 
ability to infect healthy cells. We screened 
thousands of neutralizing antibodies and 
selected two — casirivimab and imdevimab —  
to form our first clinical-stage combination.  

We fast-tracked this novel anti-viral antibody 
cocktail, now known as REGEN-COV in the 
U.S., even further by kicking off the large-scale 
manufacturing process before clinical trials had 
even begun. We were able to initiate our clinical 
program in early June 2020. In September and 
October 2020, we announced data from the trial 
of non-hospitalized COVID-19 patients, which 
showed REGEN-COV significantly reduced viral 
load and the need for medical visits in mild to 
moderate COVID-19 patients. In November 
2020, REGEN-COV received EUA from the 
FDA for recently diagnosed, mild to moderate 
COVID-19 in high-risk patients. Most recently, 

1  REGEN-COV’s development and manufacturing have been funded in part with 
federal funds from BARDA, part of the U.S. Department of Health and Human 
Services, Office of the Assistant Secretary for Preparedness and Response, 
under OT number: HHSO100201700020C.

10

 
INFECTIOUS DISEASES

in April 2021, the National Institutes of Health 
updated their COVID-19 treatment guidelines 
to strongly recommend use of REGEN-COV in 
outpatients at high risk of clinical progression. 
In April 2021, we shared data from two Phase 3 
trials using subcutaneous administration — the 
first showed the potential for REGEN-COV as 
a preventative tool with 81 percent reduction 
in risk for symptomatic SARS-CoV-2 infections 
and the second trial demonstrated significantly 
reduced progression to symptomatic COVID-19 
for recently infected asymptomatic patients.

We knew that global need for REGEN-COV 
would be great, even as effective vaccines 
became available, so over the summer of 

2020, we moved most of our commercial 
medicine manufacturing to our Irish facility in 
order to produce as much REGEN-COV as 
possible at our New York site. We also signed 
a strategic partnership with Roche to increase 
supply of the antibody therapy by more than 
threefold, and to ensure access in other 
geographies around the world, including  
low- and middle-income countries. 

The development and manufacturing of 
REGEN-COV was funded in part with federal 
funds from BARDA. We also established 
supply agreements with the U.S. government, 
including one in January 2021 to purchase 
all finished doses of the cocktail supplied 

by June 30, 2021, up to 1.25 million doses, 
as well as a previous agreement to supply 
doses to treat approximately 300,000 people, 
bringing the total potential purchase to over 
1.5 million doses.

We have been working closely with the  
U.S. government to raise public awareness, 
support physician education and reduce 
barriers to treatment in order to ensure all 
qualified patients have access to this  
important medicine. 

5
MONTHS

Our team took just 5 
months from beginning 
our COVID-19 research to 
having an investigational 
medicine ready for human 
clinical trials.

11

STORIES FROM 2020

LEAVING NO STONE UNTURNED

Since SARS-CoV-2 was first identified, 
researchers have conducted a thorough 
examination of whether existing medicines 
could be used successfully against the 
novel coronavirus. One early idea, based 
on research out of China, was that an 
IL-6 inhibitor, like Regeneron and Sanofi’s 
Kevzara® (sarilumab), might lessen the 
extreme immune reaction a severe  
COVID-19 infection sometimes caused. 

“We knew we had to work quickly to replicate 
these early, unverified findings in a rigorous 
setting,” said David Weinreich, M.D., Executive 
Vice President, Global Clinical Development.

Global Development and Industrial Operations 
and Product Supply (IOPS) colleagues worked 
around the clock to start the trial — the first 
placebo-controlled trial in the U.S. testing the 
effect of an IL-6 inhibitor in COVID-19 patients.

“Just five days after the U.S. declared a 
national emergency on March 18, the Kevzara 

trial enrolled its first patient,” said David.  
“We ran processes typically done step- 
by-step in parallel, shifted colleagues from 
other teams and built an electronic database  
in record time — over a weekend instead of 
over a few months.” 

Ultimately, the controlled study results 
did not show a benefit. “The pursuit of 
Kevzara as a COVID-19 treatment option 
demonstrates our ethos and science-driven 
culture. Despite the early unknowns, we  
did not hesitate to initiate a robust clinical 
trial,” said David. 

12

OPHTHALMOLOGY

EYLEA 2020 
REGULATORY 
HIGHLIGHTS

	|  EU approval of the 
EYLEA pre-filled 
syringe

	|  Japan approval 

for the treatment 
of neovascular 
glaucoma

HELPING PRESERVE EYESIGHT FOR A 
DECADE: EYLEA® (AFLIBERCEPT)

For nearly a decade, EYLEA® (aflibercept) 
Injection has helped protect the eyesight 
of millions of patients with serious retinal 
diseases. Physicians and patients rely on 
the anti-vascular endothelial growth factor 
(VEGF) medicine for its efficacy, safety and 
convenience, making it the global standard of 
care for certain serious retinal diseases. 

During the pandemic, we worked closely to 
respond to changing patient needs. The pre-
filled EYLEA syringe introduced in late 2019 
helped create efficiency of care, as did the 
ability to extend dosing up to 12 weeks in 
appropriate patients. In addition, we helped 
support patients with tools to monitor vision 
at home and a more comprehensive patient 
assistance program.

Trust in EYLEA led to robust commercial 
performance and an increase in 2020 full year 
global net product sales of 5 percent to nearly 
$8 billion versus 2019, while full year 2020 U.S. 
net sales increased 7 percent versus 2019. 
Bayer records net product sales of EYLEA 
outside the U.S. 

Diabetic eye diseases remains a significant and 
expanding part of our business. Positive two-
year results from the Phase 3 PANORAMA trial 
evaluating EYLEA in patients with moderately 
severe to severe non-proliferative diabetic 
retinopathy (NPDR) showed it reduced the 
likelihood of developing vision-threatening 
events by at least 75 percent. 

13

OPHTHALMOLOGY

TRUST IN EYLEA LED TO ROBUST 
COMMERCIAL PERFORMANCE AND 
AN INCREASE IN ANNUAL GLOBAL 
NET PRODUCT SALES OF 5% TO 
NEARLY $8 BILLION.

We have a Phase 3 trial ongoing in retinopathy 
of prematurity (ROP), and we also initiated 
Phase 3 studies exploring less frequent dosing 
intervals by using a high-dose formulation in 
neovascular age-related macular degeneration 
(wet AMD) and diabetic macular edema (DME).

Beyond EYLEA, we are exploring other cutting-
edge technologies that might be the basis for 
new agents to preserve vision. Our preclinical 
pipeline includes monoclonal antibodies, 
RNA interference and gene therapy for many 
other serious ophthalmic diseases, including 
glaucoma, uveitis, corneal dystrophies, dry eye 
and inherited retinal disease.

14

IMMUNOLOGY &
INFLAMMATION

DUPIXENT 2020 
REGULATORY 
HIGHLIGHTS

	|  U.S. approval of 

single-dose, 300mg 
pre-filled syringe

	|  U.S. and EU 

approval in pediatric 
atopic dermatitis  
(6–11 years of age)

	|  China approval 
for adults with 
moderate-to-severe 
atopic dermatitis

	|  Japan approval for 

chronic rhinosinusitis 
with nasal polyposis 
(CRSwNP)

UNLOCKING THE KEYS TO  
THE TYPE 2 INFLAMMATORY 
PATHWAY: DUPIXENT®  
(DUPILUMAB)

Dupixent is a “pipeline-in-a-product” with 
enormous potential to transform treatment 
of a spectrum of diseases that involve the 
type 2 inflammatory pathway. As a result of 
our steady expansion to additional diseases 
and age groups, Dupixent growth continued 
to increase significantly, with 2020 total 
annual global net product sales of more than 
$4 billion, representing year-over-year growth 
of 75 percent versus 2019.1 We maintained 
robust growth even during the pandemic, with 
new options like a single-dose, 300mg pre-filled 
syringe, which the FDA approved in 2020.

In 2020, Dupixent became the first biologic 
medicine approved for U.S. and EU children 
aged 6 to 11 years with atopic dermatitis. 
In addition, our Phase 3 trial for asthma in 
children aged 6 to 11 years met its primary and 

secondary endpoints, and we filed regulatory 
submissions for the new indication in the U.S. 
in late 2020 and in the EU in early 2021. 

Another encouraging research area with 
Dupixent is eosinophilic esophagitis (EoE), 
a chronic type 2 inflammatory disease that 
damages the esophagus and causes serious 
trouble swallowing. We presented positive 
results from the first part of our Phase 3 
program and were given Breakthrough 
Therapy designation by the FDA for adults 
and adolescents. Following those results, we 
initiated a Phase 3 study for pediatric patients 
who are 1 to 11 years of age.

We are also conducting Phase 3 studies of 
Dupixent in chronic obstructive pulmonary 
disease (COPD), as well as other diseases 
where type 2 inflammation may play an 
important role, such as hand and foot 
atopic dermatitis, bullous pemphigoid, 
prurigo nodularis, chronic spontaneous 
urticaria, chronic inducible urticaria, allergic 
bronchopulmonary aspergillosis, chronic 
sinusitis without nasal polyposis and allergic 
fungal rhinosinusitis. 

1 Global product sales are reported by Sanofi.

15

APPROVED

PHASE 3

PHASE 2

ATOPIC DERMATITIS
ASTHMA
CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS (CRSwNP)
ATOPIC DERMATITIS (6MO–5YR)
HAND AND FOOT ATOPIC DERMATITIS
ASTHMA (6–11YR)
EOSINOPHILIC ESOPHAGITIS (EOE)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
BULLOUS PEMPHIGOID
PRURIGO NODULARIS
CHRONIC SPONTANEOUS URTICARIA
ALLERGIC BRONCHOPULMONARY ASPERGILLOSIS
CHRONIC INDUCIBLE URTICARIA
CHRONIC SINUSITIS WITHOUT NASAL POLYPOSIS
ALLERGIC FUNGAL RHINOSINUSITIS
PEANUT ALLERGY
GRASS ALLERGY

DUPIXENT® 
(DUPILUMAB)

PIPELINE IN 
A PRODUCT

With regulatory approvals in atopic dermatitis, 
asthma and chronic rhinosinusitis with 
nasal polyposis (CRSwNP) and a late-stage 
development program across nine additional 
disease types, Dupixent has the potential to 
transform the treatment of type 2 inflammatory 
diseases.

Dupixent is currently in Phase 3 trials for 
atopic dermatitis (6mo–5yr), hand and 
foot atopic dermatitis, asthma (6–11yr), 
eosinophilic esophagitis (EoE), chronic 
obstructive pulmonary disease (COPD), 
bullous pemphigoid, prurigo nodularis, 
chronic spontaneous urticaria, allergic 
bronchopulmonary aspergillosis, chronic 
inducible urticaria, chronic sinusitis 
without nasal polyposis and allergic fungal 
rhinosinusitis. Dupixent is currently in  
Phase 2 trials for peanut allergy and  
grass allergy.

16

IMMUNOLOGY & INFLAMMATION

PIPELINE IMMUNOLOGY & INFLAMMATION 
PRODUCTS

Given the interconnected nature of immune 
conditions, we have an ever-deepening 
clinical portfolio exploring new options for 
the treatment of allergic and autoimmune 
diseases. For example, we are investigating 
REGN3500, our IL-33 antibody, for COPD with 
data from our Phase 2 proof-of-concept trial 
expected to be published soon. Additionally, 
two Phase 3 studies are currently underway  
in COPD.

CAT AND 
BIRCH ALLERGIES

We are undertaking groundbreaking approaches to allergy with 
the first antibody-based therapeutics directed to allergens. 
These antibodies can directly bind and neutralize the allergens. 
We have clinical stage research in the major allergens of  
cat (Fel d 1; REGN1908-1909) and birch allergy (Bet v 1; 
REGN5713-5714-5715), which can trigger reactions such  
as allergic rhinitis and asthma. After presenting positive Phase 
2 data for REGN1908-1909 in February 2021, we plan to 
present other data from proof-of-concept studies at upcoming 
meetings with the goal of demonstrating that these anti-
allergen antibodies may provide important new  
hope for allergy sufferers.

17

ONCOLOGY

MAKING SUBSTANTIAL 
PROGRESS AGAINST CANCER

Our oncology portfolio is built around 
two foundational approaches — our PD-1 
inhibitor Libtayo® (cemiplimab-rwlc) and  
our bispecific antibodies, which are being 
investigated as monotherapies or rationally 
combined with each other and emerging 
therapeutic modalities. These include immune-
modulating antibodies, CD3 bispecifics, 
CD28 costimulatory bispecifics and tumor-
specific bispecifics, among others. Together, 
they provide us with unique “combinatorial 
flexibility” to develop customized treatments 
for both solid tumors and blood cancers.

LIBTAYO IS THE #1 MOST-PRESCRIBED 
SYSTEMIC THERAPY BY ONCOLOGISTS FOR 
PATIENTS WITH ADVANCED CUTANEOUS 
SQUAMOUS CELL CARCINOMA (CSCC).

18ONCOLOGY

LIBTAYO® (CEMIPLIMAB-RWLC)

We have recently expanded the reach of 
Libtayo into advanced non-small cell lung 
cancer (NSCLC) and an additional form of 
advanced skin cancer, basal cell carcinoma 
(BCC). Libtayo was approved under Priority 
Review by the FDA for these cancers in 
early 2021. We have also submitted similar 
applications in the EU with regulatory decisions 
expected in mid-2021. Our pivotal trials in 
these cancers have strengthened the evidence 
supporting Libtayo as a potent PD-1 inhibitor. 

Our Phase 3 trial of Libtayo as monotherapy 
in first-line NSCLC for high-PD-L1 (>/=50%) 
was stopped early after demonstrating highly 
significant improvement in overall survival, and 
our Phase 2 trial in advanced BCC following 
treatment with a hedgehog inhibitor led to 
the first clinically meaningful results observed 
for any medicine in this patient population. In 
March 2021, positive results on overall survival 
also prompted our Phase 3 trial in cervical 
cancer to be stopped early, and the data will 
form the basis for regulatory submissions.

Libtayo is also approved as monotherapy 
treatment for advanced cutaneous squamous 

cell carcinoma (CSCC), where it has become 
the standard of care and #1 prescribed 
therapy for these patients. As our pivotal 
data in advanced CSCC mature, Libtayo has 
continued to demonstrate its value — results 
that were added to its U.S. label in 2020.

In 2020, global net product sales for Libtayo 
totaled $348 million, representing year-over-
year growth of 80 percent. Sanofi records 
net product sales of Libtayo outside the U.S. 
We continue to explore it in combination with 
numerous other investigational therapies.

19

ONCOLOGY

OUR BISPECIFICS ARE DESIGNED TO 
BIND TO TWO DIFFERENT TARGETS, 
CREATING AN ARRAY OF POSSIBILITIES 
FOR TARGETING AND KILLING CANCER.

BISPECIFICS

Our bispecific antibodies are another promising 
way to target cancer cells. Created with our 
VelocImmune® and Veloci-Bi® technologies, 
our bispecifics are designed to bind to two 
different targets (one on a cancer cell and 
one on a cancer-killing T-cell), creating an 
array of possibilities for targeting and killing 
cancer — and can be combined with each 
other, our PD-1 immunotherapy Libtayo and 
other standard treatments.

One of our most advanced classes of 
bispecifics is our CD3 bispecific antibodies. 
In 2021, we are planning to initiate 

multiple potentially registrational trials for 
odronextamab (formerly REGN1979), a 
CD20 X CD3 bispecific,1 which has already 
demonstrated positive early results in 
relapsed/refractory B-cell non-Hodgkin 
lymphomas. Our other late-stage CD3 
bispecific candidate, REGN5458 (BCMA 
X CD3), continues to show promising data 
for multiple myeloma, with early, deep and 
durable anti-tumor activity in these patients.

A second class of bispecifics that began 
entering the clinic in 2019 were our CD28 
costimulatory bispecifics. We are investigating 
our potentially first-in-class CD28 costimulatory 
bispecific (REGN5678, PSMA X CD28) in 

combination with Libtayo in prostate cancer, 
and we have started enrolling patients in 
clinical trials investigating two additional 
candidates — REGN5668 (MUC16 X CD28)  
and REGN7075 (EGFR X CD28). 

We also applied our Veloci-Bi technology 
to generate a third class of potential drug 
candidates called tumor-specific bispecifics 
that bind specifically to proteins on the cancer 
cell and induce their internalization, known as 
a VelociNator™ mechanism. Our first tumor-
specific bispecific in the clinic, REGN5093 
(MET X MET), targets two different proteins 
on the MET receptor to disrupt cell survival 
signaling pathways.

1 Currently on FDA partial clinical hold.

20NON-ONCOLOGY  
HEMATOLOGY

ADVANCING THERAPIES  
FOR BLOOD DISORDERS

We have multiple hematology candidates 
in clinical trials and nearly a dozen in the 
preclinical phase, representing about one-
quarter of our pipeline and demonstrating  
our continued diversification into new disease 
areas with unmet need. In 2020, we established 
a dedicated hematology therapeutic area with  
a rapidly expanding team representing some  
of the best in the field.

Our preclinical and clinical research includes 
partnered explorations in gene editing using 
CRISPR and gene knockout technologies with 
Intellia, and in RNA interference (RNAi) and 
antibody-based medicines with Alnylam —  
both of which have the potential to deplete 
abnormal proteins or block disease-causing 
cellular signaling. To this end, we were pleased 

to have new investigational medicines enter 
Phase 1 clinical trials late in 2020: NTLA-2001 
(a CRISPR/Cas9 therapeutic), the combination 
of pozelimab and cemdisiran (C5 antibody 
X C5 siRNA therapeutic) and ALN-HSD 
(HSD17B13 RNAi therapeutic). 

We also initiated a Phase 2 study of 
pozelimab  in the ultra-rare disease CD55-
deficient protein-losing enteropathy, a genetic 
disorder of the immune system that can be 
life-threatening. 

21CARDIOVASCULAR 
DISEASES

ADVANCING MEDICINE FOR 
PEOPLE WITH RARE GENETIC 
HEART DISEASE

EVKEEZA™ (EVINACUMAB-DGNB)

PRALUENT® (ALIROCUMAB)

In the past year, we added an additional 
indication for Praluent, which we gained sole 
U.S. rights to in April 2020 after completion 
of our restructured agreement with Sanofi. 
With a more efficient sales and marketing 
organization committed to bringing this 
medicine to patients, we turned we turned 
Praluent into a profitable product in 2020. 

In February 2021, the FDA approved 
Evkeeza™ (evinacumab-dgnb) — our first-
in-class angiopoietin-like 3 (ANGPTL3) 
antibody — for treatment of patients with 
homozygous familial hypercholesterolemia 
(HoFH), a rare, severe, inherited form of 
high cholesterol. Patients with HoFH face 
limited choices in reducing their low-density 
lipoprotein (LDL) cholesterol. We also expect 
action from the EU on a similar application  
in 2021.

Our Phase 3 trial results, published in The  
New England Journal of Medicine on Evkeeza 
for HoFH, showed positive results: adding it 
to other lipid-lowering therapies that cut bad 
cholesterol levels in half in these patients, 
including the most difficult-to-treat patients who 
had nearly non-existent LDL-receptor activity.

22RARE DISEASES

GARETOSMAB (REGN2477)

For more than 20 years, we have worked 
to address the unmet need for people with 
fibrodysplasia ossificans progressiva (FOP), 
a devastating orphan disease in which 
muscles, tendons and ligaments are 
progressively replaced by bone. We 
remain passionate about our research 
of FOP and believe in our hypothesis 
that Activin A drives its progression. We 
completed a Phase 2 trial and are evaluating 
the results.

REGN4461

REGN4461, our agonist antibody to leptin 
receptor (LEPR), is in ongoing Phase 2  
trials for generalized lipodystrophy, a 
rare metabolic disorder characterized by 
decreases in the quantity and distribution 
of body fat. The disease is often associated 
with low levels of a hormone called leptin, 
which can lead to extreme hunger, disrupt 
the body’s metabolism and cause fatty 
tissue to accumulate in muscles and organs 
such as the liver. REGN4461 stimulates 

the leptin receptor to replace the deficient 
hormone, and our trials are designed to 
evaluate if this therapy improves the health  
of people with this rare disease.

OUR RARE DISEASE RESEARCH:  
DRIVING SCIENCE FORWARD 
FOR SMALL POPULATIONS

Our work in rare disease includes 
numerous therapeutic areas as we 
continue to use our cutting-edge 
research tools and unique resources, 
such as the Regeneron Genetics 
Center (RGC), to further understand  
diseases that affect small  
populations. Our passion  
for science and  
commitment to  
patients drives us  
to help in rare  
and ultra-rare  
conditions.

23ADVANCES IN 
TECHNOLOGY

Regeneron’s VelociSuite technologies have 
been decades in the making and instrumental 
in our ability to discover and develop targeted 
antibody medicines. We bring this commitment 
to technological innovation to other facets of 
Regeneron as well. For example, with the new 
Imaging Center that we opened in Tarrytown 
in 2020. The 27,000-square-foot space greatly 
expands our in vivo imaging capabilities and 
establishes new histology and microscopy 
core services in collaboration with 
therapeutic research teams.

Cross-company collaboration is key to 
ensuring everyone benefits from advances 
in technology. Key examples in 2020 include 
innovations from the Automation Core 
Technologies (ACT) team, which launched a 
new automated biobanking network across 
Regeneron and opened the Viral Production 
Core to support an Adeno Associated Virus 
(AAV) manufacturing platform used for multiple 
research programs, such as our work with 
Intellia and Decibel.

In 2020, we completed the installation of 
our in-house facility for cryogenic electron 
microscopy, or cryo-EM. This Nobel prize-
winning structural biology technique allows 
us to view the interactions of our 

investigational antibodies with their target 
proteins at a very high resolution. We have 
applied this new knowledge in our preclinical 
research efforts across therapeutic areas, 
giving us critical information about the binding 
epitopes of our antibodies as well as any 
changes induced in the target protein upon 
antibody binding. With cryo-EM structures in 
hand, we can have more confidence that a 
combination of antibodies would not interfere 
with one another for binding on the surface 
of the protein, or that a mutation or natural 
variation in the sequence of the target protein 
will not interfere with antibody binding. Thanks 
to Regeneron’s extensive efforts in utilizing 
cloud computing, we are able to provide 
cryo-EM structures rapidly, informing which 
candidates will advance to the clinic.

VelociHum® is our mouse platform that allows 
for human immune system reconstitution 
and can be used to accurately test human 
therapeutics against human immune cells 
and to study human tumor models. Through 
genetic humanizations, VelociHum mice 
have been optimized to allow for better 
development of human immune cells in vivo. 
The technique also allows for engraftment of 
primary patient-derived tumors that do not 
take in other commercially available mice.

24Photo taken prior to COVID-19 pandemic.ADVANCES IN TECHNOLOGY

IOPS: PRIORITIZING QUALITY, EXCELLENCE 
AND CONTINUOUS IMPROVEMENT

Our IOPS team is an integral part of our 
success every year, but especially in 2020. 
Throughout the pandemic, the team has gone 
above and beyond to ensure supply of our 
life-saving medicines, while maintaining our 
commitment to the highest quality standards. 

Importantly, the team worked quickly to 
ensure maximum supply of our investigational 

antibody cocktail for COVID-19, moving 
production for many of our existing commercial 
products from the U.S. to our site in Limerick, 
Ireland, to make room for rapidly scaling up 
REGEN-COV. As a point of comparison, it 
typically takes months to transfer a cell line 
from Preclinical Manufacturing and Product 
Development to Manufacturing vial thaw, 
but for REGEN-COV, our team condensed 
this process to just a few weeks. To support 
these efforts, we announced 400 new jobs 
at our Irish facility, bringing the team there 

to more than 1,400 people, all of whom are 
fully focused on delivering the highest quality 
product for patients.

In addition, the team transitioned to conducting 
remote, paper-based document reviews with 
regulatory authorities and accelerated the 
advancement of certain validated automated 
technologies to continue our work during  
the pandemic.

25

ADVANCES IN TECHNOLOGY

THE RGC HAS DEVELOPED  
ONE OF THE LARGEST AND 
MOST ANCESTRALLY DIVERSE 
DATASETS IN THE WORLD.

REGENERON GENETICS CENTER 

The Regeneron Genetics Center (RGC) has 
long embodied Regeneron’s entrepreneurial 
and curious spirit, and has become a core 
contributor to our early-stage clinical and 
future pipeline. By understanding the genetic 
variations that may protect someone from 
a disease, or make them more susceptible, 
we can discover the root causes of diseases 
and identify potential therapies. To further 
our collective understanding of how diseases 

impact different people, the RGC has used 
world-class automation and analytics 
to develop one of the largest and most 
ancestrally diverse datasets in the world. 
The RGC continues to build collaborations 
and expand our work globally, now with more 
than 100 unique partnerships in 21 countries 
and more than 1.4 million patient volunteers 
sequenced since its inception.

The work of the RGC is not just impressive 
numbers and reams of data — this effort has a 
tangible impact on patient lives and the future 

of medicine. Genetics is already informing 
the development of our late-stage pipeline, 
as seen with Evkeeza, and fueling discovery 
and development with critical insights that will 
lead to potential medicines for the future. We 
currently have nine genetics targets brought 
forward by the RGC and our therapeutic focus 
area partners, across 13 different preclinical and 
clinical programs — and we expect our program 
to grow in 2021. 

26STRATEGIC BUSINESS 
APPROACHES

STRONG FINANCIAL MANAGEMENT  
FOR SUSTAINABLE LONG-TERM GROWTH

Our disciplined financial management is 
focused on ensuring sustainable long-term 
growth while delivering continued innovation for 
patients. Our financial position remained strong 
in 2020, with top-line growth of 30 percent and 
bottom-line growth of 28 percent,1 achieved 
through an increasingly diversified set of 
revenue and earnings streams. Total revenues 
for 2020 increased to $8.5 billion, compared to 
$6.6 billion for the full year 2019, and more than 
80 percent of our top-line growth in 2020 came 
from products and revenues other than our 
flagship retinal therapy EYLEA. 

In 2020, we completed a secondary offering 
of the approximately 13.0 million shares of 
our common stock held by Sanofi. Regeneron 
purchased approximately 9.8 million shares 
directly from Sanofi for an aggregate purchase 
price of $5 billion. This important transaction 
reflected our conviction in our business 
fundamentals, future prospects and valuation 

and delivered immediate accretion, while 
leveraging our strong balance sheet. We also 
issued and sold $1.250 billion aggregate 
principal amount of 1.750 percent senior 
unsecured notes due 2030 and $750 million 
aggregate principal amount of 2.800 percent 
senior unsecured notes due 2050, which were 
used in part to repay the $1.5 billion bridge loan 
facility in connection with Regeneron’s purchase 
of the common stock held by Sanofi.

As part of Regeneron’s strategic capital 
allocation strategy, we continued to prioritize 
R&D innovation, investing more than 30 percent 
of our revenues in 2020 ($2.7 billion dollars) 
into our research efforts. That’s well above the 
industry average of approximately 20 percent. 
We also continued to opportunistically buy 
back shares as part of a share repurchase 
program that commenced in 2019. In addition, 
we continued to make strategic investments 
in innovative biotech partnerships that are 
complementary to our in-house efforts.

1  Bottom-line growth represented by non-GAAP net income per share — diluted, which is not a measure calculated in accordance with U.S. Generally Accepted Accounting 
Principles (“GAAP”). See “Forward-Looking Statements and Non-GAAP Financial Measures” on pages 35 and 37 for a definition of this measure and a reconciliation of 
this measure to the most directly comparable GAAP financial measure.

27Photo taken prior to COVID-19 pandemic.  
STRENGTHENING OUR 
CULTURE DURING 
A PANDEMIC

Despite the challenges of the pandemic, 
which limited our ability to be onsite together, 
Regeneron employees were more engaged 
than ever. Our team continued to grow — in 
fact, 16 percent of our colleagues joined us 
since the beginning of the pandemic — and we 
found new ways to collaborate and support 
each other, whether in the office or from 
home. We were proud and honored to once 
again be ranked by Science magazine as 
the top biopharma employer, making us the 
magazine’s most highly ranked company of  
the past decade.

During the pandemic, we found ourselves 
in the early epicenter of the virus, with more 
than 3,000 “essential” employees working 
onsite at our New York State research and 
manufacturing locations and many more 
contributing to our critical projects from 
home. Our Facilities, Environmental Health & 
Safety and Human Resources colleagues led 
the charge to find ways to ensure a low-risk 
environment for our onsite colleagues and to 
provide support for those who were suddenly 
working remotely. These included alternating 
shift schedules to reduce density onsite, 
a mask requirement on campus, provision 
of masks and other personal protective 

equipment, health monitoring for onsite 
colleagues, and physical modifications to 
office and lab spaces. 

This past year also renewed our focus on 
diversity, equity and inclusion (DE&I), including 
hiring our new Chief DE&I Officer. We strongly 
believe diversity allows us to foster innovation 
and deliver on our mission to help patients. 
However, as with many institutions in 2020, we 
have had deeper discussions on how we can 
do more, faster. We are accelerating our efforts 
with a prioritized strategy to foster inclusion, 
increase diverse representation and build 
equity in our communities. Concrete actions 
like mandatory leadership training and more 
development and mentoring opportunities for 
underrepresented groups will help us further 
advance equality in our workplace.

WE STRONGLY BELIEVE DIVERSITY 
ALLOWS US TO FOSTER INNOVATION 
AND DELIVER ON OUR MISSION TO 
HELP PATIENTS.

28RESPONSIBLE 
REGENERON 

In keeping with our “doing well by doing good” 
ethos, we weave corporate responsibility 
into every aspect of our business. Our 
responsibility strategy focuses on three  
areas that reflect our dedication to our 
patients, our team, our communities and  
our environment:

In 2020, even as we prioritized and organized 
our business to address the COVID-19 
pandemic, we continued to make progress 
across these three responsibility focus areas:

	|  IMPROVE THE LIVES OF PEOPLE WITH 

SERIOUS DISEASES

	|  IMPROVE THE LIVES OF PEOPLE  

WITH SERIOUS DISEASES

	|  FOSTER A CULTURE OF INTEGRITY  

AND EXCELLENCE

	| BUILD SUSTAINABLE COMMUNITIES

We are committed to operating responsibly, 
communicating transparently about our 
impacts and engaging all stakeholders in our 
mission. In 2021, we published on our website 
our first report on climate-related risks and 
opportunities, aligned to the recommendations 
of the Task Force on Climate-related Financial 
Disclosures (TCFD). In addition, our 2020 
Responsibility Report continues to align with 
the framework of the Sustainability Accounting 
Standards Board (SASB). You can view our 
2020 Responsibility Report online for more 
details on our responsibility efforts and results.

As a science-focused company, we are 
dedicated to turning rigorous scientific 
research into important new medicines. Our 
support for patients extends beyond the labs 
to include disease education and awareness 
efforts, product support services and our 
commitment to drug access and responsible 
pricing. After all, our lifesaving advancements 
only matter if patients can obtain them. 

Since 2018, we have worked with the WHO, 
FDA and other global organizations to 
offer Inmazeb under a compassionate use 
protocol in response to Ebola outbreaks in 
affected African countries. We are actively 
working with public health organizations, 
governmental agencies and others in our 
industry to ensure continued access to 
Inmazeb in low- and middle-income countries.

29Photo taken prior to COVID-19 pandemic.RESPONSIBLE REGENERON

Similarly, we are committed to providing 
access to REGEN-COV to patients around 
the world. We are collaborating with Roche 
to increase global supply of this important 
treatment. Both companies will support access 
in low- and lower-middle income countries 
through drug donations to be made in 
partnership with public health organizations.

	|  FOSTER A CULTURE OF INTEGRITY 

AND EXCELLENCE

Our longstanding commitment to ethical, 
responsible business standards is the 
foundation of our company. We uphold our 
commitment through the policies, practices 
and initiatives that encompass areas such as 
compliance, responsible sales and marketing, 
ethical clinical trials, responsible supply chain 
and product quality and safety.

In 2020, as with other companies, our 
responsibility to our people took center 
stage. In addition to our focus on the safety 
of our employees on- and off-site, we took 
important steps to accelerate and advance our 
diversity, equity and inclusion efforts (DE&I). 
And, we continued to invest in attracting and 
developing talent with the skills and expertise 
needed to drive our business. As noted earlier, 
we sought to strengthen our culture through 
employee-focused initiatives that supported 
their different work environments and family life.

30

RESPONSIBLE REGENERON

WE DOUBLED COMPANY 
MATCHING FOR EMPLOYEE  
CASH DONATIONS — TO 
GIVE EXTRA SUPPORT TO  
NONPROFITS FOCUSED ON 
THE PANDEMIC AND SOCIAL 
JUSTICE ISSUES.

	| BUILD SUSTAINABLE COMMUNITIES

2020 presented hardships for people globally. 
While working hard in our labs to develop 
potential solutions to COVID-19, we also 
maintained our focus on supporting our 
communities — including protecting and 
restoring our planet. Through our commitment 
to our world and its people, we made strides  
in advancing our environmental targets and 
raised critical funds and mobilized resources  
to support those in need. 

2020 was our first year as title sponsor of the 
International Science and Engineering Fair, 
the world’s largest pre-college science and 
engineering competition. We also continued 
sponsorship of the Regeneron Science 
Talent Search, the nation’s most prestigious 
pre-college science and math competition. 
Although the pandemic created challenges 
for both events, we committed to continuing 
both, finding a way to host virtual events that 
still celebrated and recognized the students’ 
achievements. 

In addition, we helped our employees 
give back to causes they cared about and 
maximize their impact through double-
matching gift campaigns and volunteer 
opportunities.

31STORIES FROM 2020

DOING WELL BY DOING GOOD: 
PANDEMIC EDITION

A foundational aspect of Regeneron’s culture  
is giving back to our local communities — it’s 
part of our DNA. 

As soon as COVID-19 hit, we engaged 
colleagues through the Regeneron COVID-19 
matching gift campaign, raising $750,000 for 
nonprofits focused on relief efforts. Later in 
the year, we added an additional $750,000 
employee matching gift program specific to 
furthering causes that promote social justice 
and diversity and equity efforts. Approximately 
2,200 Regeneron colleagues participated in 
the programs, with more than 1,600 charities 
benefiting from nearly $2.2 million in donations 
from the company and our employees.

In October, we held our annual global Day 
for Doing Good (D4DG), an employee-led 
event focused on volunteering and creating 
positive change in our communities. To allow 
colleagues more flexibility to participate, we 
held our 2020 D4DG virtually and extended 
activities over a full week. “We had colleagues 
support education equity projects, like 

assembling learning supply kits for student at-
home learning, and others who made masks 
for the homeless,” said Potoula Stavropoulos, 
Director, Social Impact. “Some even hosted 
interactive student science lectures from home. 

“It was heartening — but not surprising — to 
see how quickly our employees came together 
to positively impact society’s most pressing 
issues,” said Potoula. “Through our giving and 
volunteer programs, we provide meaningful 
community engagement opportunities that are 
responsive to both our employees’ interests 
and our communities’ unmet needs.”

Regeneron colleagues found other ways 
to volunteer this year, as well. Our IOPS 
Rensselaer “Quaranteam” reimagined our 
annual food drive to include contactless drop-
offs at designated times, donating a whopping 
12 tons of food to the Regional Food Bank 
of Northeastern New York. In addition, the 
team donated 500 meals to “Meals to Heal,” 
a program that provides meals to healthcare 
workers at local hospitals.

32CONTINUED 
OPERATIONAL GROWTH

TOTAL REVENUES

$8,497.1B

TOTAL EMPLOYEES

9,100

RESEARCH AND 
DEVELOPMENT 
INVESTMENTS

$6,557.6B

$5,145.6B

$4,257.5B

$3,630.6B

8,100

7,300

6,200

5,300

$2.7B 
(32% OF REVENUE) 

6
1
0
2

7
1
0
2

8
1
0
2

9
1
0
2

0
2
0
2

6
1
0
2

7
1
0
2

8
1
0
2

9
1
0
2

0
2
0
2

332020 AWARDS

TOP EMPLOYER, 2020

CHANGE THE WORLD, 2020

JUST 100, 2020

AMERICA’S MOST RESPONSIBLE 
COMPANIES, 2020

MOST COMMUNITY-MINDED COMPANIES IN 
THE NATION, 2020

BEST COMPANIES TO WORK FOR®,  2020

DOW JONES SUSTAINABILITY WORLD 
INDEX, 2020

BEST WORKPLACES FOR INNOVATORS, 2020

WORLD’S 25 GREATEST LEADERS: HEROES 
OF THE PANDEMIC: GEORGE YANCOPOULOS

DOW JONES SUSTAINABILITY NORTH 
AMERICAN INDEX, 2020

BEST WORKPLACE IN IRELAND, 2020

34

FORWARD-LOOKING 
STATEMENTS AND 
NON-GAAP FINANCIAL 
MEASURES

This Annual 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, and 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 or otherwise commercialized 

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 product 
candidates being developed by Regeneron 
and/or its collaborators (collectively, 
“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), Inmazeb™ 
(atoltivimab, maftivimab, and odesivimab-
ebgn), Evkeeza™ (evinacumab), REGEN-
COV™ (casirivimab with imdevimab), 
fasinumab, garetosmab, Regeneron’s 
and its collaborators’ other oncology 
programs (including odronextamab (formerly 
REGN1979) and REGN5458), Regeneron’s 
and its collaborators’ other hematology 
programs (including pozelimab (REGN3918)), 
Regeneron’s and its collaborators’ 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; safety issues resulting from the 
administration of Regeneron’s Products and 
Regeneron’s Product Candidates in patients, 
including serious complications or side effects 
in connection with the use of Regeneron’s 
Products and Regeneron’s Product Candidates 
in clinical trials; the likelihood, timing, and 
scope 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 and/or 
its collaborators may be replicated in other 
studies and/or lead to advancement of product 
candidates to clinical trials, therapeutic 
applications, or regulatory approval; ongoing 
regulatory obligations and oversight impacting 
Regeneron’s Products (such as EYLEA, 
Dupixent, Libtayo, Praluent, Kevzara, Inmazeb, 
and Evkeeza), 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 

35

FORWARD-LOOKING 
STATEMENTS AND 
NON-GAAP FINANCIAL 
MEASURES

to continue to develop or commercialize 
Regeneron’s Products and Regeneron’s 
Product Candidates; competing drugs and 
product candidates that may be superior 
to Regeneron’s Products and Regeneron’s 
Product Candidates; uncertainty of market 
acceptance and commercial success of 
Regeneron’s Products and Regeneron’s 
Product Candidates and the impact of studies 
(whether conducted by Regeneron or others 
and whether mandated or voluntary) on the 
commercial success of Regeneron’s Products 
and Regeneron’s 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 Regeneron’s 
Product Candidates; the availability and 
extent of reimbursement of Regeneron’s 
Products from third-party payors, including 
private payor healthcare and insurance 
programs, health maintenance organizations, 
pharmacy benefit management companies, 
and government programs such as Medicare 
and Medicaid; coverage and reimbursement 
determinations by such payors and new 
policies and procedures adopted by such 
payors; unanticipated expenses; the costs of 
developing, producing, and selling products; 
the ability of Regeneron to meet any of 
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), as well as Regeneron’s agreement 
with Roche relating to REGEN-COV, to be 
canceled or terminated; and risks associated 
with intellectual property of other parties and 
pending or future litigation relating thereto 
(including without limitation the patent litigation 
and other related proceedings relating to 
EYLEA, Dupixent, Praluent, and REGEN-
COV), 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 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, 2020, 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 or otherwise) 
any forward-looking statement, whether as a 
result of new information, future events, 
or otherwise.

This Annual Report uses non-GAAP net 
income and non-GAAP net income per share, 
which are financial measures that are not 
calculated in accordance with U.S. Generally 
Accepted Accounting Principles (“GAAP”). 

These non-GAAP financial measures are 
computed by excluding certain non-cash and 
other items from the related GAAP financial 
measure. Non-GAAP adjustments also 
include the estimated income tax effect of 
reconciling items. The Company makes such 
adjustments for items the Company does 
not view as useful in evaluating its operating 
performance. For example, adjustments may 
be made for items that fluctuate from period to 
period based on factors that are not within the 
Company’s control (such as the Company’s 
stock price on the dates share-based grants 
are issued) or items that are not associated 
with normal, recurring operations (such as 
changes in applicable laws and regulations). 
Management uses these non-GAAP measures 
for planning, budgeting, forecasting, 
assessing historical performance, and making 
financial and operational decisions, and also 
provides forecasts to investors on this basis. 
Additionally, such non-GAAP measures provide 
investors with an enhanced understanding of 
the financial performance of the Company’s 
core business operations. However, there are 
limitations in the use of these and other non-
GAAP financial measures as they exclude 
certain expenses that are recurring in nature. 
Furthermore, the Company’s non-GAAP 
financial measures may not be comparable 
with non-GAAP information provided by other 
companies. Any non-GAAP financial measure 
presented by Regeneron should be considered 
supplemental to, and not a substitute for, 
measures of financial performance prepared 
in accordance with GAAP. A reconciliation of 
the Company’s historical GAAP to non-GAAP 
results is included below.

36

FORWARD-LOOKING 
STATEMENTS AND 
NON-GAAP FINANCIAL 
MEASURES

RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME
(Unaudited)  (In millions, except per share data) 

YEAR ENDED DECEMBER 31

2020

GAAP R&D 

R&D: Non-cash share-based compensation expense
R&D:  Up-front payments related to license 
and collaboration agreements

Non-GAAP R&D

GAAP SG&A

SG&A: Non-cash share-based compensation expense
SG&A: Litigation contingencies
SG&A: Restructuring-related expenses
Non-GAAP SG&A

GAAP COGS

COGS: Non-cash share-based compensation expense
COGS: Other
Non-GAAP COGS

GAAP other income (expense), net

Other income/expense: Gains on investments
Interest expense: Other 
Non-GAAP other income (expense), net

$2,735.0

238.6

85.0
$2,411.4 

$1,346.0

153.0
(95.0)
8.1 
$1,279.9 

$491.9

40.4
0.9 
$450.6 

$233.8

(221.6)
12.7 
$24.9 

2019

$2,450.0

250.4

430.0
$1,769.6

$1,341.9

167.7
70.0
35.2
$1,069.0

$362.3

46.2
—
$316.1

$219.3

(118.3)
—
$101.0

YEAR ENDED DECEMBER 31

2020

2019

GAAP net income

$3,513.2

$2,115.8

Total of GAAP to non-GAAP reconciling items above
Income tax effect of GAAP to non-GAAP reconciling items
Income tax expense:  Impact of sale of assets between  

foreign subsidiaries

222.1
(38.9)

(30.0)

881.2
(169.9)

—

Non-GAAP net income

$3,666.4

$2,827.1

Non-GAAP net income per share — basic

$34.07

Non-GAAP net income per share — diluted

$31.47

Shares used in calculating:

GAAP net income per share — basic

GAAP net income per share — diluted

Non-GAAP net income per share — basic

107.6

115.1

107.6

Non-GAAP net income per share — diluted

116.5

$25.89

$24.67

109.2

114.6

109.2

114.6

37

 
 
 
 
CORPORATE
INFORMATION

COMMON STOCK AND RELATED MATTERS

SHAREHOLDERS’ INQUIRIES

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 13, 2021, there were 163 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 $477.04. We have never paid cash dividends and do 
not anticipate paying any in the foreseeable future. 

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.

SEC FORM 10-K

ANNUAL MEETING

A copy of our 2020 Annual Report on Form 10-K filed with the 
Securities and Exchange Commission (which forms part of this 
2020 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.

The Annual Meeting will be held virtually via the Internet 
at www virtualshareholdermeeting com/REGN2021 on  
June 11, 2021 at 10:30 a.m., Eastern Time.

Due to continuing concerns regarding the COVID-19 
pandemic and to assist in protecting the health and well-

being of our shareholders, directors, and employees, the 
Annual Meeting will be held virtually via the Internet at www 
virtualshareholdermeeting com/REGN2021. We have designed 
the format of the Annual Meeting to ensure that shareholders are 
afforded similar rights and opportunities to participate as they 
would at an in-person meeting. Under New York law, the legal 
requirement to include an in-person option has been waived by 
relevant governmental action. If this waiver is no longer in effect 
for the Annual Meeting, shareholders will have the option to 
attend the Annual Meeting in person at the Westchester Marriott 
Hotel, 670 White Plains Road, Tarrytown, New York (or at another 
location if required by the circumstances). In any such case, we 
would notify our shareholders in advance on our website and by 
issuing a press release and filing it as additional proxy material 
with the United States Securities and Exchange Commission.

CORPORATE OFFICE

777 Old Saw Mill River Road  
Tarrytown, New York 10591-6707 
(914) 847-7000

TRANSFER AGENT AND REGISTRAR

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

INDEPENDENT REGISTERED PUBLIC 
ACCOUNTING FIRM 

PricewaterhouseCoopers LLP

REGENERON®, SCIENCE TO MEDICINE®, REGENERON 
GENETICS CENTER® and the following are trademarks of 
Regeneron Pharmaceuticals, Inc.: ARCALYST®, EVKEEZA™, 
EYLEA®, INMAZEB™, LIBTAYO® (in the United States), 
PRALUENT® (in the United States), REGEN-COV™, Veloci-Bi®, 
VelociGene®, VelociHum®, VelocImmune®, VelociMab®, 
VelociMouse®, VelociSuite®, VelociT™ and ZALTRAP®. 
Dupixent® and Kevzara® are registered trademarks of Sanofi.

38

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•  2020 ANNUAL REPORT