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Regeneron Pharmaceuticals

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FY2018 Annual Report · Regeneron Pharmaceuticals
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LIMITLESS

POSSIBILITIES

2018 ANNUAL REPORT

CONTENTS

3

REGENERON  
AT A GLANCE

4

SHAREHOLDER  
LETTER

7

MARKETED  
PRODUCTS AND  
LATE-STAGE PIPELINE

17

OUR GROWING  
PIPELINE

25

WHAT MAKES 
REGENERON  
DIFFERENT

31

FORWARD-LOOKING 
STATEMENTS &  
NON-GAAP  
FINANCIAL  
MEASURES¹

33

CORPORATE  
INFORMATION

1. See pages 31 and 32 for important information regarding forward-looking statements and financial measures 
not calculated in accordance with U.S. Generally Accepted Accounting Principles mentioned in this report.

REGENERON 2018 ANNUAL REPORT  |  2

REGENERON AT A GLANCE

7

FDA-approved  
products 

2

major FDA approvals  
in 2018 

20

candidates in  
clinical development 

7.5M+

doses of our medicines manufactured  
by our Industrial Operations and  
Product Supply (IOPS) team in 2018

#1

top-ranked Biopharma Employer  
in Science global survey  
for 6th time

7,300+

employees from  
100+ countries in 7 locations 

4,000+

employees participated in 2nd annual  
Day for Doing Good, logging more  
than 14,000 hours of service

98%

of our waste diverted  
from landfill,  
surpassing our goal

REGENERON 2018 ANNUAL REPORT  |  3

DEAR FELLOW 
SHAREHOLDERS

2018 was a milestone year that marked 30 years since Regeneron’s 
founding. During these three decades, we stayed true to our mission of  
harnessing the power of science to bring important new medicines  
to people with serious diseases. Our long-term commitment to science 
and technology has resulted in seven approved medicines, a clinical 
product pipeline of 20 candidates across therapeutic areas, and a strong  
engine for future discovery and innovation.

REGENERON 2018 ANNUAL REPORT  |  4

We continue to receive important new regulatory approvals for our 
products. This included the September 2018 U.S. Food and Drug 
Administration (FDA) approval for our first immuno-oncology therapy, 
the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for advanced cutaneous 
squamous cell carcinoma. In  October 2018, we received FDA approval for 
Dupixent® (dupilumab) in asthma, which followed its 2017 approval for 
adults with atopic dermatitis. In March 2019, Dupixent was also approved 
for adolescents with atopic dermatitis. In addition, in August 2018, we 
received FDA approval on a new dosing regimen for EYLEA® (aflibercept) 
Injection in wet age-related macular degeneration (AMD).

Together with our ex-U.S. collaborator Bayer, we continued to bring EYLEA 
to more patients, achieving a record $6.75 billion in global net product 
sales for 2018. EYLEA continues to have opportunities to help more 
patients in need. In 2018, we reported positive Phase 3 results in patients 
with diabetic retinopathy and are expecting FDA action on our submission 
for this indication in May 2019.

Dupixent achieved $922 million in 2018 global net product sales, as 
recorded by our collaborator Sanofi, and has the potential to be a ‘pipe-
line-in-a-product’ as it targets Type 2 inflammation, which underlies many 
allergic diseases. In 2019, the FDA accepted for Priority Review our submis-
sion for a third Type 2 disease, chronic rhinosinusitis with nasal polyps, 
which has a target action date of June 26, 2019. We are studying Dupixent 
in a broad development program in other Type 2 allergic conditions, 
including eosinophilic esophagitis and peanut and grass  allergies.

Our robust immuno-oncology portfolio, anchored by Libtayo, is beginning 
to show important potential. Libtayo is being studied as a monotherapy 
as well as in combination across various types of cancer. We are also 
encouraged by our broad bispecific development program, including 
 clinical-stage CD3 bispecifics and our new class of costimulatory bispe-
cifics. At the most recent American Society of Hematology meeting, 

$6.7 billion

in total revenue (14 percent increase from 2017) 

we reported promising results from early clinical trials of our CD20xCD3 bispecific in certain 
advanced lymphoma patients. We believe these approaches may be able to extend the benefits 
of immunotherapy to more patients in need.

These are just a few highlights from our innovative, growing pipeline that spans therapeutic 
areas with high unmet need including eye diseases, allergic and inflammatory diseases, cancer, 
cardiovascular and metabolic diseases, musculoskeletal diseases, infectious diseases and 
rare diseases.

Developing innovative technology and pursuing basic biological research that drives the drug 
development process continues to be a priority. In 2019, we will be celebrating the fifth anniver-
sary of the Regeneron Genetics Center® (RGC), one of the world’s largest research efforts on the 
genetic causes of health and disease. As of January 2019, the RGC had sequenced exomes from 
more than 500,000 volunteers and paired that data with deidentified health records, enabled 
through collaborations with health record pioneers like the Geisinger Health System and the UK 
Biobank. In March 2019, we were proud to share some of this valuable work with the world when 
the first batch of sequencing data from the UK Biobank initiative was made publicly available to 
the global research community.

We believe that our commitment to long-term science and innovation brings value to patients and 
shareholders alike, and we are committed to reinvesting a significant share of our revenues to this 
effort. In 2018, total revenues increased 14 percent from 2017 to $6.7 billion, and we were able to 
reinvest 33 percent¹ of our revenues back into our R&D efforts. Revenue was driven by continued  
EYLEA growth, the launch of our new products and collaboration revenues. GAAP net income 

1. 2018 research and development expenses as a percentage of 2018 total revenues.

REGENERON 2018 ANNUAL REPORT  |  5

for 2018 was $2.4 billion, or $21.29 per diluted share, compared to GAAP 
net income for 2017 of $1.2 billion, or $10.34 per diluted share. In 2018, our 
non-GAAP net income increased 38 percent from 2017 to $2.6 billion, or 
$22.84 per diluted share.¹ Our balance sheet remains strong, and we ended 
the year with $4.6 billion in cash and marketable securities.

The Regeneron team continues to expand, and we now have more than 
7,300 colleagues across seven sites. We are expanding our presence in 
Rensselaer, NY, and in Ireland, where we have our Industrial Operations and 
Product Supply (IOPS) teams, and we opened a new office in the United 
Kingdom to support our global regulatory and clinical needs.

As part of our long-standing commitment to operating as a responsible 
corporate citizen, we continue to foster the next generation of scientific 
innovators, support sustainable communities and run our business with 
the highest standards of ethics and integrity. We are a leader in supporting 
STEM (Science, Technology, Engineering and Math) initiatives that reward 
and inspire promising young minds, including providing $100 million over 
ten years to support the Regeneron Science Talent Search, the nation’s 
oldest and most prestigious high school science competition. To learn 
more about our commitment to corporate citizenship, please review our 
second annual Responsibility Report.

We are proud of the work we do every day to find new solutions for people 
with serious diseases but know there is much more work to do. We are 
confident that if we continue delivering important advances through 
innovative science and technology, we will achieve a diverse portfolio of 
medicines and sustainable, long-term growth.

Sincerely,

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

Founder, President and 
Chief Executive Officer

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

Founding Scientist,  
President and  
Chief Scientific Officer

P. ROY VAGELOS  
M.D.

Chairman of the Board

1. Non-GAAP net income and non-GAAP net income per share are not measures calculated in accordance with U.S. 
Generally Accepted  Accounting Principles (“GAAP”). See “Note Regarding Forward-Looking Statements and Non-
GAAP Financial Measures” on pages 31 and 32 for a definition of these measures and a reconciliation of each of these 
measures to the most directly comparable GAAP financial measure.

REGENERON 2018 ANNUAL REPORT  |  6

EYLEA® 8

Dupixent® 9

Libtayo® and our  
Immuno-Oncology Platform 11

Praluent® 15

Kevzara® 15

MARKETED 
PRODUCTS AND 
LATE-STAGE 
PIPELINE

REGENERON 2018 ANNUAL REPORT  |  7

EYLEA® (AFLIBERCEPT) INJECTION

In 2018, EYLEA® (aflibercept) Injection, our market-leading anti-vascular endothelial 
growth factor (VEGF) treatment, continued to reach more patients with  blindness- 
causing retinal conditions, including wet age-related macular degeneration 
(AMD) and diabetic macular edema (DME). In its seventh year on the market, 
2018 annual net product sales of EYLEA increased by 10 percent to $4.08 billion 
in the U.S., and global net product sales increased by 14 percent to $6.75 billion¹ 
versus full-year 2017. EYLEA currently has approximately 70 percent of the overall 
branded U.S. anti-VEGF market for serious retinal disease. 

In August 2018, the FDA approved our supplemental Biologics Licensing Application (sBLA) for 
a dosing option of every 12 weeks following one year of effective therapy in patients with wet 
AMD — a new option available for patients who require a less frequent dosing regimen. For more 
details, see our Prescribing Information.

WE CONTINUE TO FOCUS ON ADVANCING RETINAL DISEASE TREATMENT, INCLUDING:

Diabetic retinopathy: In 2018, we reported positive EYLEA Phase 3 data in diabetic 
retinopathy (DR) and are expecting FDA action on our sBLA by May 13, 2019. The  
Phase 3 PANORAMA trial evaluating EYLEA in patients with moderately severe and  
severe non-proliferative DR met its primary endpoint of improving diabetic  retinopathy 
as well as key secondary endpoints. The results of the PANORAMA study have the 
opportunity to change the treatment paradigm for people with DR, as they revealed  
that more than 40 percent of untreated patients developed vision-threatening 
 complications within one year and that treatment with EYLEA reduced these events  
by approximately 75 percent.

1. Bayer records net product sales of 
EYLEA outside the United States.

3.5+ M

WITH DIABETIC RETINOPATHY
Of the 3.5 million people in the U.S. with diabetic retinopathy 
without diabetic macular edema, approximately 1 million 
individuals have moderately severe to severe disease and 
are at greater risk of developing severe vision loss.2, 3 

2. NHANES 2005–2008, projected to 2012 U.S. population; 

American Diabetes Association.

3.  BioTrends Research Group, Treatment Trends®: Diabetic 

Retinopathy / Diabetic Macular Edema (U.S.) 2013. 

New, simpler administration option: In October 2018, the FDA issued a Complete 
Response Letter regarding the Chemistry, Manufacturing, and Controls Prior-Approval 
Supplement (PAS) for the EYLEA pre-filled syringe. Resubmission is in the first half 
of 2019.

Continued retinal disease innovation: We continue to advance new innovations for 
people with retinal diseases. To that end, we plan to advance a high-dose formulation 
of EYLEA into the clinic in 2019.

REGENERON 2018 ANNUAL REPORT  |  8

DUPIXENT ® (DUPILUMAB)

Dupixent® (dupilumab), our IL-4/IL-13 antibody, entered its second year on the market for atopic dermatitis (AD) in adults. In October 2018, 
Dupixent received U.S. approval for moderate-to-severe asthma in patients 12 and older. Dupixent has been welcomed by patients and physicians 
and has generated strong growth with $922 million global net product sales in 2018, largely driven by adult AD.¹

Dupixent targets the IL-4/IL-13 signaling 
pathway, which is a major driver of Type 2 
allergic inflammation.

We are extending Dupixent’s benefit to 
the treatment of younger patients with 
AD. Most recently, the FDA approved 
Dupixent in adolescents (ages 12–17) 
with moderate-to-severe AD. This sBLA 
was supported by positive Phase 3 data 
announced in 2018. Phase 3 studies for 
pediatric (6 months to 5 years and 6 to 
11 years of age) atopic dermatitis patients 
are ongoing.

In asthma, the FDA approval was 
based on positive results from three  
late-stage clinical trials. Results from  
two of these studies were published in 
The New England Journal of Medicine 
in May 2018. Dupixent was also approved 
for asthma in adults and adolescents in 
Japan, and the European Commission is 
currently reviewing the regulatory filing. In 
addition, we are working to extend avail-
ability of Dupixent to younger patients 
suffering from asthma, with Phase 3 
studies in pediatric (6 to 11 years of age) 
asthma ongoing.

WE ARE INVESTIGATING DUPIXENT IN A BROAD ARRAY OF  
TYPE 2 INFLAMMATORY DISEASES, INCLUDING:

Chronic rhinosinusitis with nasal polyps: 
In October 2018, we reported positive topline 
results from two pivotal Phase 3 trials of 
Dupixent in adults with chronic rhinosinusitis 
with nasal polyps. The FDA has accepted 
for Priority Review our submission with an 
action date of June 26, 2019.

Eosinophilic esophagitis: We are continuing 
to study Dupixent in a potentially pivotal 
Phase 2/3 study in patients with eosinophilic 
esophagitis.

Allergies: We have Phase 2 studies 
underway for grass allergy and 
peanut allergy.

Other areas of interest: A Phase 3 trial is 
planned for chronic obstructive pulmonary 
disease (COPD) this year. Dupixent is also 
being studied for atopic dermatitis and 
asthma in combination with REGN3500, 
an antibody which targets IL-33 and is 
supported by human genetics data from 
our Regeneron Genetics Center.

1. In collaboration with Sanofi. Sanofi records global net product sales of Dupixent.

REGENERON 2018 ANNUAL REPORT  |  9

Patient Perspective:
NEW PERSPECTIVE AND MORE CLARITY 

Three decades suffering from uncontrolled, severe atopic dermatitis (AD) has had 
a dramatic impact on Sirish’s life. “I’d scratch myself bloody,” he says, referring 
to what doctors call the “itch-scratch cycle,” when itching further breaks down 
the skin barrier and allows germs, viruses and allergens to enter the body, 
triggering more immune signals to scratch. Always one with a deep interest in 
biology and health, Sirish was pursuing a medical degree but had to take multiple 
leaves of absence from medical school due to the severity of his disease.

Fortunately, with treatment, Sirish’s AD is now under control. He reflected, “The 
new perspective I have gained for what is possible has provided me with more 
clarity. It is surprising what is possible when human ingenuity is put to good use.”

Sirish hopes to put his personal experience and medical knowledge to use working 
with patients and doctors to understand the impact of AD and seek options for 
people suffering from the disease.

REGENERON 2018 ANNUAL REPORT  |  10

SirishLIBTAYO® (CEMIPLIMAB-RWLC)

Libtayo® (cemiplimab-rwlc),¹ our PD-1 inhibitor and the backbone for many 
combination approaches being investigated in our immuno-oncology pipeline, 
was approved by the FDA in September 2018 for advanced cutaneous squamous 
cell carcinoma (CSCC). Libtayo was the first therapy approved for these 
patients. Our Marketing Authorization Application (MAA) for this indication is 
under review by the European Commission with a decision expected in the first 
half of 2019. In June 2018, pivotal data from two trials evaluating Libtayo in 
advanced CSCC were published in The New England Journal of Medicine. With an 
October 1, 2018 U.S. launch, Libtayo achieved net product sales of $14.8 million 
in the United States during the fourth quarter 2018.

WE CONTINUE TO INVESTIGATE LIBTAYO AS MONOTHERAPY AND IN  
COMBINATION FOR A RANGE OF CANCERS:

Skin cancer: We have ongoing studies in 
basal cell carcinoma and we are planning 
Phase 3 adjuvant trials in CSCC.

Additional  indications: We initiated Phase 
1/2 trials of Libtayo in pediatric glioblas-
toma, and are investigating Libtayo in 
colorectal cancer and prostate cancer.

Non-small cell lung cancer (NSCLC): 
An ongoing pivotal program for Libtayo in 
first-line NSCLC is underway. At the 2018 
American Society of Clinical Oncology 
meeting, we shared positive interim results 
from a Phase 1 study in advanced NSCLC.

Combinations: We are also exploring 
Libtayo in combination with various other 
therapies, including immune modulators, 
vaccines, cell therapies, kinase inhibitors, 
chemotherapy and bispecific antibodies.

HPV-positive cancers: A Phase 3 trial of 
Libtayo in cervical cancer is ongoing.

1. In collaboration with Sanofi.

REGENERON 2018 ANNUAL REPORT  |  11

Patient Perspective:
KEEP LOOKING FORWARD

Bob’s skin cancer experience began in May 2002 with a dry patch of skin on 
his cheek. After years of surgeries, radiation and chemotherapy, he was told he’d 
run out of treatment options.

Then, in 2015, Bob’s doctor suggested he enter a Regeneron and Sanofi-
sponsored clinical trial for advanced cutaneous squamous cell carcinoma 
(CSCC), which helped shrink Bob’s tumors. Today, Bob enjoys playing with his 
granddaughter and enhancing students’ lives as a school superintendent.

“If you’re going through this, just keep looking forward. Keep your eyes on 
the windshield, not the rearview mirror,” said Bob. Because of his cancer 
battle, he continues to deal with complications, like poor function of his limbs 
after numerous operations. Nevertheless, Bob’s positive attitude keeps him 
looking forward.

REGENERON 2018 ANNUAL REPORT  |  12

BobBUILDING OUR IMMUNO-ONCOLOGY PORTFOLIO

Our immuno-oncology program, including Libtayo, a PD-1 antibody, continues to expand rapidly. 
In January 2019, we announced a restructuring of our Immuno-Oncology Collaboration with 
Sanofi whereby we will continue to collaborate with Sanofi on Libtayo, REGN4018 (MUC16xCD3 
bispecific antibody) and REGN5458 (BCMAxCD3 bispecific antibody). We retain full rights 
to all of our other investigational immuno-oncology programs. Sanofi paid $462 million 
for the  termination of the original Immuno-oncology Discovery and Development Agreement, 
the prepayment of certain discovery and development activities regarding REGN4018 and 
REGN5458, and the reimbursement of costs incurred under the original Immuno-oncology 
Discovery and Development Agreement during the fourth quarter of 2018.

REGN1979, our CD20xCD3 bispecific antibody, demonstrated positive data in relapsed or 
refractory B-cell non-Hodgkin lymphoma (NHL), including promising clinical results in follicular 
lymphoma and diffuse large B-cell lymphoma (DLBCL), which are the two most common types 
of NHL. We plan to initiate a potentially registrational Phase 2 trial in relapsed or refractory 
follicular lymphoma and a separate study in DLBCL in 2019. Our other investigational bispecific 
antibodies in clinical stage include REGN4018 for ovarian cancer and REGN5458 for multiple 
myeloma. In 2019, we expect to start clinical trials of our costimulatory bispecifics, a new class 
of bispecific antibodies that are designed to activate cellular immunity to cancer in novel ways; 
these include two distinct CD28 bispecific antibodies.

WHAT IS A
BISPECIFIC?

A bispecific is a type of engineered antibody 
that can simultaneously bind to two different 
molecular targets, allowing for diverse 
approaches to targeting and killing cancer cells.

WHAT IS A  
COSTIM?

“Costim” is short for “costimulatory” and 
describes using one bispecific antibody to 
activate a T-cell by stimulating two receptors 
or “signals” on the cell’s surface. Some cancers 
can be addressed with just one signal, but 
sometimes applying two T-cell stimulatory 
signals at once is more effective. This “costim” 
approach has the potential to synergistically 
amplify antigen-specific T-cell signals.

REGENERON 2018 ANNUAL REPORT  |  13

ISRAEL LOWY, M.D., Ph.D.

SENIOR VICE PRESIDENT,  
TRANSLATIONAL SCIENCES AND ONCOLOGY

Scientist Perspective:

BREAKOUT YEAR FOR 
IMMUNO-ONCOLOGY

“2018 was a breakout year for the immuno- 
oncology effort at Regeneron, and 
was the consequence of a sustained 
 multidisciplinary commitment throughout 
Regeneron over multiple years,” said 
Israel (Izzy) Lowy, M.D., Ph.D., Senior 
Vice President, Translational Sciences 
and Oncology. “Our immuno- oncology 
strategy is built on a deep foundation 
of science and technology. Successful 
cancer immunotherapies will require 
combination approaches. We started with 
a focus on Libtayo as a core foundational 
element to facilitate novel combinations. 

Building on promising early clinical 
results for REGN1979, in 2019, we plan to 
initiate trials with a new type of bispecific 
antibody. These costim bispecifics activate 
a patient’s T lymphocytes via a novel 
 mechanism, and that may be combined 
with CD3 bispecific antibodies and/or 
with Libtayo. We have developed multiple, 
complementary individual pieces that may 
fit together into a cohesive whole, to bring 
the most potent  therapies forward for 
patients with cancer. We are excited to see 
what 2019 will bring.”

REGENERON 2018 ANNUAL REPORT  |  14

PRALUENT® (ALIROCUMAB)

KEVZARA® (SARILUMAB)

Praluent® (alirocumab), our PCSK9 inhibitor, had approximately $306.8 million 
in global net product sales for 2018.¹ We continue our efforts to increase access 
to this important medicine for people in need. In February 2019, we announced 
with Sanofi a new reduced U.S. list price of $5,850 annually, a 60 percent reduction 
from the original list price. This follows an earlier announcement in March 2018, 
when we committed to lowering the U.S. net price for payers in return for helping to 
reduce burdensome access barriers for appropriate patients.

Positive data from the 18,924-patient ODYSSEY OUTCOMES trial were announced in the first 
quarter of 2018 and published in The New England Journal of Medicine in November 2018, showing 
that Praluent helps prevent heart attack, stroke and other major adverse cardiovascular events. 
Based on these data, the European Commission approved new labeling for Praluent in March 2019, 
and the FDA has accepted our sBLA for cardiovascular risk reduction, with a target action date of 
April 28, 2019.

In 2018, the FDA approved an update to the Praluent Prescribing Information to include clinical 
 information regarding its use in patients with heterozygous familial hypercholesterolemia (HeFH) 
who require additional lowering of LDL-C along with diet and maximally-tolerated statin therapy 
and who are undergoing apheresis treatment. We also initiated a Phase 3 study of pediatric patients 
with homozygous hypercholesterolemia (HoFH).

In February 2019, a jury from the U.S. District Court for the District of Delaware upheld the validity 
of three of the five asserted claims of two Amgen U.S. patents covering antibodies targeting 
PCSK9. The jury agreed with Regeneron and Sanofi on two of the five asserted claims, finding 
they were invalid based on lack of written description. The verdict does not impact U.S. physicians’ 
and patients’ access to Praluent. The judge will review the verdict and may decide the case on 
purely legal grounds or may order a new trial. An appeal will almost certainly follow in any event.

Kevzara® (sarilumab), our IL-6R antibody for adults with rheumatoid 
arthritis (RA), generated $96.6 million in global net product sales in 
2018.² The FDA approved our pre-filled pen for use in moderately to 
severely active RA, enabling button-free, ergonomic and overall easier 
 administration for Kevzara patients. We initiated two separate Phase 3 
studies in new indications in 2018: one in polymyalgia rheumatica, an 
inflammatory disorder in older adults, and another in giant cell arteritis, 
an inflammatory disease of blood vessels.

1. In collaboration with Sanofi. Sanofi records global net 

product sales of Praluent.

2. In collaboration with Sanofi. Sanofi records global  

net product sales of Kevzara.

REGENERON 2018 ANNUAL REPORT  |  15

Patient Perspective:
THE SMALL THINGS MEAN THE WORLD TO ME

When Beth was diagnosed in 2005 with moderate RA, she had known something 
was not right. Her shoulders were very sore, and she had swelling and “intense” 
stiffness all over her body. But she knew she couldn’t suffer in silence and 
immediately started working with her healthcare team to find a treatment that 
would work for her.

After years of trying different treatment approaches, she found one treatment 
that makes a difference for her. Now, she’s able to enjoy the small things that 
matter most: “My friend has a baby, and this past weekend I was able to hold 
her and not worry about dropping her. For me to be able to do that, it was such 
a special moment. It meant the world to me.”

Through her years suffering from this debilitating condition, she found it helpful 
to develop a strong relationship with her rheumatologist and rheumatologist’s 
nurse, and she encourages other people living with RA to do the same. Beth 
also credits her family, and especially her husband, for helping her through the 
difficult days, and she believes staying active and keeping a positive attitude 
are very important.

REGENERON 2018 ANNUAL REPORT  |  16

BethOur Growing Pipeline 18

Diverse Approach to Early Research 21

The Regeneron Genetics Center 23

OUR  
GROWING  
PIPELINE

REGENERON 2018 ANNUAL REPORT  |  17

OUR GROWING PIPELINE
Regeneron has 20 investigational compounds in clinical development, all of which were developed  
in our own laboratories, most using our proprietary VelociGene® and VelocImmune® technologies.

Phase 

1

CEMIPLIMAB¹ 
PD-1 Antibody 
Cancer

REGN1979 
CD20xCD3 Antibody 
Cancer

CEMIPLIMAB + REGN1979 
PD-1 Antibody +  
CD20xCD3 Antibody 
Cancer

REGN3767 
LAG-3 Antibody 
Cancer

CEMIPLIMAB + REGN3767 
PD-1 Antibody + LAG-3 
Antibody 
Cancer

REGN5458¹ 
BCMAxCD3 Antibody 
Cancer

REGN4018¹ 
MUC16xCD3 Antibody 
Cancer

CEMIPLIMAB +  
REGN4018¹ 
PD-1 Antibody + 
MUC16xCD3 Antibody 
Cancer

REGN4659 
CTLA4 Antibody 
Cancer

REGN1908-1909 
Feld1 Antibody 
Cat allergy

REGN-EB3 (REGN3470-
3471-3479) 
Ebola Virus Antibody 
Ebola virus infection

REGN3048-3051 
Middle Eastern Respiratory 
Coronavirus Antibody 
MERS-CoV infection

POZELIMAB 
C5 Antibody 
Paroxysmal nocturnal  
hemoglobinuria

REGN4461 
LEPR Antibody 
Lipodystrophy and obesity

REGN5069 
GFRα3 Antibody 
Pain

Phase

2

CEMIPLIMAB¹ 
PD-1 Antibody 
Basal cell carcinoma

DUPILUMAB¹ 
IL-4R Antibody 
Grass allergy, peanut allergy

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

EVINACUMAB 
ANGPTL3 Antibody 
Refractory 
hypercholesterolemia (both 
HeFH and non-FH), severe 
hypertriglyceridemia

GARETOSMAB 
Activin A Antibody 
Fibrodysplasia Ossificans 
Progressiva (FOP)

REGN3500¹ 
IL-33 Antibody 
Asthma, chronic obstructive 
pulmonary disease (COPD), 
atopic dermatitis

Phase

3

AFLIBERCEPT 
VEGF-Trap 
Non-proliferative diabetic 
retinopathy (NPDR) without 
DME

ALIROCUMAB¹ 
PCSK9 Antibody 
Homozygous familial 
hypercholesterolemia (HoFH) 
in adults and pediatrics, 
heterozygous familial 
hypercholesterolemia in 
pediatrics

CEMIPLIMAB¹ 
PD-1 Antibody 
Non-small cell lung cancer, 
cervical cancer

DUPILUMAB¹ 
IL-4R Antibody 
Atopic dermatitis in 
pediatrics and adolescents, 
asthma in pediatrics, 
chronic rhinosinusitis with 
nasal polyps (CRSwNP), 
eosinophilic esophagitis

SARILUMAB¹ 
IL-6R Antibody 
Polymyalgia rheumatica,  
giant cell arteritis

EVINACUMAB 
ANGPTL-3 Antibody 
Homozygous familial 
hypercholesterolemia (HoFH)

FASINUMAB² 
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.

1. In collaboration with Sanofi.    2. In collaboration with Teva and Mitsubishi Tanabe.

REGENERON 2018 ANNUAL REPORT  |  18

SELECT CLINICAL PROGRAMS

Evinacumab

An ANGPTL3 antibody for severe forms 
of dyslipidemia, evinacumab is in a 
Phase 3 study for patients with homo-
zygous familial hypercholesterolemia. 
We also initiated a Phase 2 study in 
severe hypertriglyceridemia in 2018.

REGN3500

In addition to being evaluated in combi-
nation with Dupixent, REGN3500, our 
IL-33 antibody, is also being studied 
as a potential monotherapy for atopic 
 dermatitis, asthma and COPD. We 
initiated Phase 2 trials in each of these 
diseases in 2018.

Fasinumab

Our nerve growth factor (NGF) antibody, fasinumab, continues to 
advance in clinical studies in collaboration with Teva and Mitsubishi-
Tanabe. In August 2018, it demonstrated positive topline results in a 
Phase 3 study in patients with chronic pain from osteoarthritis of the 
knee or hip. The need for new treatments has only increased with our 
nation’s continuing opioid crisis. Our Phase 3 long-term safety and 
efficacy studies are ongoing.

Garetosmab

We have fully enrolled a potentially pivotal Phase 2 study of 
 garetosmab, our Activin A antibody for the treatment of the rare 
disease fibrodysplasia ossificans progressiva (FOP). We are eager 
to make progress for patients in this particularly devastating and 
heartbreaking disease.

REGN-EB3

REGN-EB3 (formerly called REGN3470-3471-3479), our triple monoclonal antibody 
combination treatment, is being investigated for the treatment of Ebola. It is 
currently being administered as part of a World Health Organization (WHO)-
sponsored Controlled Randomized Trial to patients suffering from the most 
recent Ebola outbreak in the Democratic Republic of the Congo (DRC). Working 
closely with the WHO, Biomedical Advanced Research and Development 
Authority (BARDA), FDA and others, we were able to successfully and very 
quickly export the drug to the DRC. Healthcare providers on the ground initially 
administered REGN-EB3 under Monitored Emergency Use of Unregistered 
Interventions (MEURI) protocols, and now as part of the randomized trial testing 
four investigational therapies. We are hopeful that our treatment is helping sick 
patients. The data collected may potentially support future regulatory filings. 
Meanwhile, we continue Phase 1 and additional preclinical research of the 
antibody cocktail.

Additional Clinical Highlights

Among our investigational products in Phase 1 development, we also have 
REGN1908-1909, our Feld1 antibody for cat allergy, and pozelimab, our C5 antibody 
for the rare disease paroxysmal nocturnal hemoglobinuria. In December 2018 at 
the American Society of Hematology annual meeting, we reported data from a 
Phase 1 study of pozelimab in healthy volunteers. We plan to initiate an additional 
study in 2019.

REGENERON 2018 ANNUAL REPORT  |  19

Scientist Perspective:

COLLABORATION TO 
ADDRESS DEVASTATING 
INFECTIOUS DISEASE

SUMATHI SIVAPALASINGAM, M.D.

SENIOR DIRECTOR,  
EARLY CLINICAL DEVELOPMENT AND EXPERIMENTAL SCIENCES

While finding new treatments for any disease 
is challenging, addressing evolving infectious 
diseases in hard-to-access  geographies can be 
an even more intense and urgent quest. When 
Ebola broke out in the Democratic Republic 
of the Congo (DRC) in 2014, killing more than 
11,300 people, we leveraged our VelociGene®, 
VelocImmune® and VelociMab® antibody 
discovery and production technologies to 
develop REGN-EB3. In 2018, with support 
from BARDA, the World Health Organization 
and DRC health authorities, we were able to 
deliver this new therapeutic candidate for use 
in patients during the most recent outbreak 
under both compassionate use guidelines 
and as part of a randomized controlled trial. 
Despite the ongoing conflict in the region,  
we are continuing to try and help people 
impacted by Ebola.

“Such a quick turnaround required 
seamless collaboration across multiple 
teams. For my part, when it came to getting 
this investigational drug to people in the 
DRC, it involved calling the World Health 
Organization at four in the morning to 
get regular updates from the ground and 
provide guidance on preparing and infusing 
REGN-EB3 to patients with Ebola infection,” 
said Sumathi Sivapalasingam, M.D., Senior 
Director, Early Clinical Development and 
Experimental Sciences, who was  intimately 
involved developing REGN-EB3 and making 
it available for outbreaks. “Motivated by 
our commitment to do the right thing and 
armed with the speed and precision of our 
Regeneron technologies, we strive every 
day to make a difference.”

REGENERON 2018 ANNUAL REPORT  |  20

DIVERSE APPROACH TO EARLY RESEARCH

Our VelociSuite® continues to grow and evolve, with the 
VelocImmune NEXT team working on ways to improve our 
current VelocImmune® mice. We are using immuno-PET 
(Positron Emission Tomography) technology in novel ways 
to probe the immune environment of tumors with a goal of 
accelerating our oncology programs. A cross-functional 
team is isolating and evaluating PiG (“Peptide in Groove”) 
antibodies, which could enable targeting of intracellular 
tumor antigens.

We are applying VelociBi™, our proprietary bispecifics platform, to make minimally-engineered bispecifics that 
behave like normal human antibodies. This is in contrast to other bispecific approaches, which tend to be more 
 synthetic-looking to the body, resulting in the potential for immunogenicity, side effects, higher dosing needs 
and longer manufacturing timelines and waste. For each of our Regeneron bispecifics, we engineer mice to express 
the human targets so we can study the cell biology in vivo to confirm we are achieving the desired effects.

Another way we are putting our VelociSuite platform to use is through collaborations with other companies to 
identify and develop potential therapeutic targets. One such example is bluebird bio, with which we announced a 
collaboration in August 2018 to pursue new cell therapies for cancer that will tap into our expertise and technologies 
related to  antibodies and T-cell receptors and bluebird’s expertise in gene transfer and cell therapy.

REGENERON 2018 ANNUAL REPORT  |  21

LYNN MACDONALD, Ph.D.

VICE PRESIDENT, RESEARCH,  
 VELOCIMMUNE NEXT, NEUROSCIENCE, MOLECULAR PROFILING,  
BIOINFORMATIC CORE, DNA CORE & AUTOMATION

Scientist Perspective:

CONSTANTLY EVOLVING 
OUR FOUNDATIONAL 
TECHNOLOGIES

Lynn Macdonald, Ph.D., Vice President, 
Research, VelocImmune NEXT, 
Neuroscience, Molecular Profiling, 
Bioinformatic Core, DNA Core & 
Automation, marks her 20-year anniversary 
with Regeneron this year. Over the past 
two decades, one of Lynn’s roles has 
been to help advance the VelociSuite 
technologies, finding new ways to apply 
our in-house expertise and curiosity 
to speeding up the drug discovery and 
development process.

“Our in-house technologies are key to 
our research. In order to accelerate drug 
discovery, we tap into a powerhouse 
 combination of deep understanding of 
biology, our proprietary technologies 
and an unwavering drive to pursue big 
ideas,” said Lynn. “VelociBi, our proprietary 
platform for developing bispecific 
antibodies, and VelociT, our unique 
technology for producing fully human 
therapeutic T-cell receptors against 
tumor and viral antigens, are the next 
iteration of this approach and the future 
of our VelociSuite technologies.”

REGENERON 2018 ANNUAL REPORT  |  22

THE REGENERON GENETICS CENTER

Nearing five years since its inception, the Regeneron Genetics Center (RGC) has 
now sequenced the exomes of more than 500,000 consented individuals. The RGC is 
accelerating our drug development pipeline through target validation and discovery, 
while also allowing our collaborators to return validated results back to patients. 

2018 was an exciting year for the RGC. In early 2018, we developed an innovative 
pre-competitive consortium to fund the sequencing of DNA samples from the UK 
Biobank resource. This enables us along with our collaborators AbbVie, Alnylam, 
AstraZeneca, Biogen, Bristol-Myers Squibb, Takeda and Pfizer, to deliver a rich data 
resource to the broader global research community, following a short period of 
data exclusivity. The first batch of sequencing data on 50,000 exomes was released 
via the UK Biobank in March 2019 and is now accessible to scientists around the 
world. In addition to the UK Biobank effort and foundational collaboration with 
Geisinger Health System, the RGC has secured over 60 other research collaborations 
to ensure a continued pool of diverse genetic samples. One unique example is our 
collaboration with Alnylam to identify RNAi therapeutics for the chronic liver disease 
nonalcoholic steatohepatitis (NASH) and potentially other related diseases. The 
discovery collaboration is based on our publication in The New England Journal of 
Medicine identifying for the first time a variant in the HSD17B13 gene that is associated 
with reduced risk of chronic liver diseases, which we discovered based on data 
generated by the RGC. Work in the RGC has also contributed to our understanding 
of evinacumab, an ANGPTL3 antibody now in Phase 3 studies, and REGN3500, 
our IL-33 antibody currently in Phase 2 studies.

REGENERON 2018 ANNUAL REPORT  |  23

Scientist Perspective:

GENES ACCELERATE 
OUR DRUG DISCOVERY 
AND DEVELOPMENT

Launched in 2014, the RGC has always had ambitious 
goals —  and thus far has exceeded them. Whether it is 
the quantity or quality of the collaborations, the number 
of exomes sequenced or the number of new targets 
discovered, the RGC team is continually striving to 
provide more and better actionable findings to the rest 
of the Regeneron team. Aris Baras, M.D., Senior Vice 
President and Head of the RGC, believes it has to do 
with the key motivator: making a difference for patients, 

both in the short-term as our collaborators return 
 validated results and in the long-term by  accelerating 
drug discovery and development.

“At the RGC, we’ve been focusing on identifying the 
best drug targets and using genomics to advance our 
existing pipeline,” said Aris. “We’ve made big bets in 
genomics and we’re going all in. The possibilities are 
really endless.”

ARIS BARAS, M.D.

SENIOR VICE PRESIDENT AND  
HEAD OF THE REGENERON GENETICS CENTER

REGENERON 2018 ANNUAL REPORT  |  24

The Regeneron Way 26

An Award-Winning Culture 27

Being a Responsible Corporate Citizen 28

Continued Operational Growth 30

WHAT MAKES 
REGENERON 
DIFFERENT

REGENERON 2018 ANNUAL REPORT  |  25

THE REGENERON WAY

As we continue to grow as a company, we 
want to sustain the unique culture that 
drives team members to do their best. 
Our company values, The Regeneron Way, 
reflect this mindset:

REGENERON 2018 ANNUAL REPORT  |  26

MAKE IT  HAPPENDO WHAT’S  RIGHTLEAD WITH SCIENCETAKE ON  BIG IDEASBE GREAT  TOGETHERAN AWARD-WINNING CULTURE

Science Magazine
#1 Top Employer 
in global survey of 
biopharmaceutical 
industry

Forbes
One of the world’s 
Most Innovative 
Companies

“The Civic 50”
One of the most 
community-minded 
companies in the U.S.

Fortune
Ranked among  
100 Best Companies  
to Work For

Great Places to Work
Included on the Best 
Large Workplaces  
in Ireland

Shingo Prize
Rensselaer Industrial Operations and  
Product Supply (IOPS) honored for continuous 
improvement and manufacturing excellence

IDA Ireland
Won “Grand Prix”  
and “Excellence in 
Regional Investment” 
awards

REGENERON 2018 ANNUAL REPORT  |  27

BEING A RESPONSIBLE CORPORATE CITIZEN

Regeneron’s mission is to use the power of science to repeatedly bring new medicines to patients. 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.

In 2017, we conducted a review of our approach to Environmental, Social and Governance (ESG) issues.  
We have used these insights to identify three focus areas for our responsibility strategy:

 1. Improve the lives of people with serious disease
2. Foster a culture of integrity and operational excellence
3. Build a better future

In 2018, we began the process of setting strategic goals, which 
we plan to share in our 2019 Responsibility Report. As part 
of this process, we conducted a responsibility materiality¹ 
assessment to prioritize the ESG issues that matter most to our 
business and stakeholders. The outcomes of our materiality 
assessment have been disclosed in our Responsibility Report 
and will inform our responsibility strategy and reporting.

We also formalized our responsibility operational structure in 
2018. We established a Responsibility Committee comprised 
of cross-functional business leaders. We also amended the 
charter of the board’s Corporate Governance and Compliance 
Committee to expressly delegate board oversight of corporate 
 responsibility to the committee.

100+

U.S. and global patient advocacy 
group relationships

89%

of employees said 
Regeneron is a great 
place to work in our 
annual employee 
engagement survey

30%

reduction in our green-
house gas emissions  
per full-time employee  
over past five years, 
achieving our goal

$10.4M

in 2018 to support the Regeneron Science Talent 
Search as well as national outreach and equity 
programs in science education

1. In this section, we use the terms “material” and “materiality” to refer to topics that reflect Regeneron’s meaningful economic, environmental, and social impacts or that influence the assessments and decisions of stakeholders, or what sustainability 
organizations and standards commonly define as “material aspects.” The use of such terms shall not be deemed to constitute an admission as to the materiality of any information in this Annual Report for purposes of applicable securities laws or 
any other laws of the United States, nor are we using them as they are used in the context of financial statements and financial reporting.

REGENERON 2018 ANNUAL REPORT  |  28

OUR THREE RESPONSIBILITY PILLARS

1

   Improve the lives of people  
with serious disease

Our business model is founded on scientific innovation. At  
Regeneron, we deliver growth by inventing therapies that  
address serious medical conditions and have a life- transforming  
impact on patients’ health. To date, we have brought to 
market seven FDA-approved treatments and have 20 product 
candidates in development, all of which were homegrown in  
our laboratories. 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 operational excellence

We are committed to being a top biotechnology employer that 
attracts and retains highly talented and motivated people,  
and facilitates a diverse and inclusive workforce where people  
feel safe, engaged and supported. At the end of 2018, 
48 percent of our employees, and 37 percent of those in  
leadership positions, were women.

We believe that creating life-transforming medicines should 
go hand-in-hand with a healthy living environment. In 2013, we 
created ambitious, five-year environmental sustainability goals 
for four major focus areas: carbon, waste, hazardous chemical 
waste and electricity.

When setting these environmental sustainability goals, we 
chose targets that we would have to stretch to achieve. 
We are proud to have achieved our carbon reduction and 
waste  diversion goals. Although we attained notable reduc-
tions in our electricity and hazardous chemical waste, we had 
not fully achieved the initial goals in these areas by 2018. This 
was largely due to our substantial growth over this five-year 
period; since 2013, the Company has added one new site in the 
United States and three others in Europe. This expansion of our 
infrastructure resulted in our electricity reduction rate coming 
just under target. Similarly, we increased our lab space to 
accommodate our significant R&D investments, which resulted 
in a corresponding increase in the lab equipment that gener-
ates hazardous chemical waste. Much of this added equipment 
runs autonomously, contributing to a lower reduction in 
hazardous chemical waste per lab employee than targeted.

In 2018, we conducted a comprehensive review of our envi-
ronment programs to better understand the strengths and 
opportunities across our operations. This work will inform our  
next generation of responsibility goals, which we began to 
develop in 2018 and on which we will begin reporting in our 
2019 Responsibility Report.

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 compliance, anti-bribery and 
corruption, responsible sales and marketing, ethical clinical 
trials, and product quality and safety.

  Build a better future

3

We are a long-standing supporter of science education and 
make major philanthropic investment to inspire future inno-
vators, including our 10-year, $100-million commitment to the 
Regeneron Science Talent Search, the nation’s most prestigious 
pre-college science and mathematics competition. Science, 
technology, engineering and math (STEM) education represents 
more than 93 percent of our corporate philanthropy grants 
made in 2018, not including medical grants and matched funds.

In 2018, we also held our second annual Day for Doing Good, 
a company-wide day of service that had 55 percent employee 
participation. We are proud to be recognized for the second 
consecutive year as one of the 2018 Civic 50 by the non-profit 
organization Points of Light, distinguishing us as one of the 
50 most community-minded companies in the United States.

For more information about our responsibility efforts and 
results, please refer to the 2018 Responsibility Report available 
on our website.

REGENERON 2018 ANNUAL REPORT  |  29

CONTINUED OPERATIONAL GROWTH

As of end of year 2018, Regeneron had 7,383 employees, and we are 
proud to maintain employee turnover rates well below the industry 
average. Our team is growing thoughtfully, with one new salesforce for 
Libtayo, expanded Dupixent and EYLEA salesforces to support new 
indications, and continual bolstering of our research and development 
teams to reflect our deepening pipeline. We opened our first office in 
the United Kingdom in Uxbridge in 2018, where we now have more than 
30 employees.

Our Industrial Operations and Product Supply (IOPS) organization, headquartered in Rensselaer, New York, continues to 
be industry-leading. IOPS hired almost 800 employees globally and produced more drug supply in 2018 than any prior year. 
IOPS completed multiple global successful inspections in 2018, including a pre-approval FDA inspection for Libtayo and 
two partner audits in Rensselaer. An additional partner audit in Raheen was successfully completed in the fourth quarter of 
2018. The global IOPS team successfully shipped product within one business day of the FDA approval of Libtayo and also 
successfully support the launch of the asthma indication for Dupixent. In September 2018, New York Governor Andrew 
Cuomo announced Regeneron’s plan to add 1,500 new jobs and invest $800 million in our facilities in the Capital Region 
over the next seven years, in turn providing us with performance-based incentives and tax credits worth $140 million.

REVENUE

FULL-TIME EMPLOYEES

R&D INVESTMENT

$6.711B
2018

$5.872B
2017

$4.860B
2016

$4.104B
2015

7,300
2018

6,200
2017

5,300
2016

4,300
2015

14% INCREASE FROM 2017–2018

17% INCREASE FROM 2017–2018

33%
We reinvested  
33 percent of our revenues 
back into our R&D efforts¹

1. 2018 research and development expenses as a percentage  

of 2018 total revenues.

REGENERON 2018 ANNUAL REPORT  |  30

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 perfor-
mance  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  iden-
tify 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 nature, timing, and 
possible success and therapeutic applications 
of  Regeneron’s  products,  product  candidates, 
and  research  and  clinical  programs  now 
underway or planned, including without limita-
tion  EYLEA®  (aflibercept)  Injection,  Dupixent® 
(dupilumab),  Praluent®  (alirocumab),  Kevzara® 
(sarilumab), Libtayo® (cemiplimab), fasinumab, 
and  evinacumab;  the  likelihood  and  timing 
of  achieving  any  of  Regeneron’s  anticipated 
clinical  development  milestones;  unforeseen 

safety issues resulting from the administration 
of products and product candidates in patients, 
including serious complications or side effects 
in  connection  with  the  use  of  Regeneron’s 
product  candidates  in  clinical  trials;  the  likeli-
hood and timing of possible regulatory approval 
and  commercial  launch  of  Regeneron’s  late-
stage product candidates and new indications 
for  marketed  products,  including  without 
limitation EYLEA, Dupixent, Praluent, Kevzara, 
Libtayo, fasinumab, and evinacumab; the extent 
to which the results from the research and devel-
opment  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  marketed  products 
(such  as  EYLEA,  Dupixent,  Praluent,  Kevzara, 
and  Libtayo),  research  and  clinical  programs, 
and business, including those relating to patient 
privacy; determinations by regulatory and admin-
istrative  governmental  authorities  which  may 
delay or restrict Regeneron’s ability to continue 
to develop or commercialize Regeneron’s prod-
ucts and product candidates; competing drugs 
and product candidates that may be superior to 

Regeneron’s products and product candidates; 
uncertainty of market acceptance and commer-
cial  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  prod-
ucts;  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), 
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  EYLEA, 
Dupixent, and Praluent, the ultimate outcome of 
any such proceedings, and the impact any of the 
foregoing may have on Regeneron’s business, 
prospects, operating results, and financial condi-
tion. 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, 2018, 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.

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 

REGENERON 2018 ANNUAL REPORT  |  31

FORWARD-LOOKING STATEMENTS AND NON-GAAP FINANCIAL MEASURES (CONT.)

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  perfor-
mance  prepared  in  accordance  with  GAAP.  A 
reconciliation of the Company’s historical GAAP 
to non-GAAP results is included below.

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  oper-
ational 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 

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

GAAP net income

Adjustments:

Year Ended December 31,
  2017

  2018  

$ 2,444.4  

$ 1,198.5

R&D: Non-cash share-based compensation expense

  229.0  

  271.9

R&D: Up-front payments related to license and collaboration agreements  

 —

25.0

SG&A: Non-cash share-based compensation expense

  169.2  

  208.4

SG&A: Litigation contingencies

COGS and COCM: Non-cash share-based compensation expense

Other income/expense: Loss on extinguishment of debt

Other income/expense: Gains and losses on investments in equity 

securities¹

Income tax effect of reconciling items above

Income tax (benefit) expense: Impact of sale of assets between 

foreign subsidiaries

Income tax (benefit) expense: (Adjustment) charge related to enactment 

of U.S. Tax Reform Act

Non-GAAP net income

Non-GAAP net income per share — basic

Non-GAAP net income per share — diluted

Shares used in calculating:

Non-GAAP net income per share — basic

Non-GAAP net income per share — diluted

30.0  

29.2  

 —

41.9  

(92.1)  

—

27.0

30.1

—

  (186.0)

  (162.1)  

—

(68.0)  

$ 2,621.5  

$  24.30  

$  22.84  

  326.2

$ 1,901.1

$  17.88

$  16.32

  107.9  

  114.8  

  106.3

  116.5

1. Prior to the quarter ended March 31, 2018, unrealized gains and losses on equity securities were recorded in Other 

comprehensive income (loss). In connection with the adoption of Accounting Standards Update 2016-01, unrealized gains 
and losses on equity securities during the year ended December 31, 2018 were recorded in Other income (expense), net.

REGENERON 2018 ANNUAL REPORT  |  32

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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.

SEC Form 10-K
A copy of our 2018 Annual Report on 
Form 10-K filed with the Securities and 
Exchange Commission (which forms part 
of this 2018 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.

As of April 17, 2019, there were 183 shareholders of record of our  
Common Stock and 18 shareholders of record of our Class A Stock.  
The closing sales price for the Common Stock on that date was $342.97. 

We have never paid cash dividends and do not anticipate  
paying any in the foreseeable future.

Shareholders’ Inquiries
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 avail-
able 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.

Annual Meeting
The Annual Meeting will 
be held on June 14, 2019 at 
10:30 a.m., Eastern Time, 
at the Westchester Marriott 
Hotel, 670 White Plains Road, 
Tarrytown, New York 10591.

Corporate Office
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

REGENERON®, Science to Medicine®, Regeneron Genetics Center® and the following are registered trademarks of Regeneron Pharmaceuticals, Inc.: ARCALYST®, EYLEA®, Libtayo®  
(in the United States), VelociGene®, VelocImmune®, VelociBi™, VelociMab®, VelociMouse®, VelociSuite® and ZALTRAP®. Praluent®, Dupixent® and Kevzara® are registered trademarks of Sanofi.

REGENERON 2018 ANNUAL REPORT  |  33