Resources Connection Inc. Annual Report 2007

FY2007 Annual Report · Resources Connection Inc.

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WORKING

Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
regeneron.com

Regeneron Annual Report 2007

Regeneron was founded on the principle
that strong science and innovative tech-
nology could accelerate the development
of new medicines. From the beginning, we
assembled teams of talented scientists and
challenged them to thoroughly understand
the biology of diseases, develop new
technology platforms, and discover and
develop potential therapeutic candidates.

Forward-looking Statements and Risk Factors: This news release discusses historical information and in-
cludes forward-looking statements about Regeneron and its products, development programs, finances, and
business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical
and clinical development of Regeneron’s drug candidates, determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commer-
cialize its product and drug candidates, competing drugs that are superior to Regeneron’s product and drug
candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated
expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the
potential for any collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group
and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with
third party intellectual property, and other material risks. A more complete description of these and other
material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commis-
sion (SEC), including its Form 10-K for the year ended December 31, 2007. Regeneron does not undertake
any obligation to update publicly any forward-looking statement, whether as a result of new information,
future events, or otherwise unless required by law.

Corporate Directory

Directors

P. Roy Vagelos, M.D.

Chairman of the Board

Senior Management Team

Leonard S. Schleifer, M.D., Ph.D.

President and Chief Executive Officer

Leonard S. Schleifer, M.D., Ph.D.

George D. Yancopoulos, M.D., Ph.D.

President and Chief Executive Officer

Executive Vice President,

Charles A. Baker

Retired Chairman of the Board,

President and Chief Executive Officer

of The Liposome Company, Inc.

Michael S. Brown, M.D.

Regental Professor,

Department of Molecular Genetics,

The University of Texas

Chief Scientific Officer and President,

Regeneron Research Laboratories

Murray A. Goldberg

Senior Vice President,

Finance and Administration,

Chief Financial Officer, Treasurer

and Assistant Secretary

Stuart Kolinski

Southwestern Medical Center at Dallas

Senior Vice President,

General Counsel and Secretary

Peter Powchik, M.D.

Senior Vice President,

Clinical Development

Neil Stahl, Ph.D.

Senior Vice President,

Research and Developmental Sciences

Robert J. Terifay

Senior Vice President,

Commercial

Daniel Van Plew

Senior Vice President

and General Manager,

Industrial Operations and Product Supply

Alfred G. Gilman, M.D., Ph.D.

Provost and Executive Vice President

for Academic Affairs,

The University of Texas

Dean, Southwestern Medical School

Joseph L. Goldstein, M.D.

Regental Professor and Chairman,

Department of Molecular Genetics,

The University of Texas

Southwestern Medical Center at Dallas

Arthur F. Ryan

Chairman of the Board

and Retired Chief Executive Officer,

Prudential Financial, Inc.

Eric M. Shooter, Ph.D.

Professor Emeritus,

Department of Neurobiology,

Stanford University School of Medicine

George L. Sing

Chief Executive Officer, Stemnion, Inc.

Managing Director, Lancet Capital

George D. Yancopoulos, M.D., Ph.D.

Executive Vice President,

Chief Scientific Officer and President,

Regeneron Research Laboratories

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WORKING

Targeting serious medical conditions, we built a fully integrated
biopharmaceutical company, with capabilities spanning all key
competencies – research, development, manufacturing, and
commercialization.

During the last 12 months, Regeneron’s vision resulted

in exciting breakthroughs on several fronts:

The FDA approved our ﬁ rst drug, ARCALYST™ (rilonacept) Injection for Subcutaneous

Use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including

Familial Cold Auto-inﬂ ammatory Syndrome (FCAS) and Muckle-Wells Syndrome

(MWS) in adults and children 12 and older. ARCALYST was designed, via our pro-

prietary Trap platform, to be a speciﬁ c blocker of an endogenous pro-inﬂ ammatory

agent known as interleukin-1.

We entered into an unprecedented new global collaboration with sanoﬁ -aventis that

will enable us to more fully exploit the potential of our research capabilities and the

VelociSuite of technologies – VelociGene, ® VelociMouse,™ VelocImmune® and

VelociMab™ – to discover, develop, manufacture, and commercialize fully human

therapeutic antibodies.

The ﬁ rst antibody from this collaboration, REGN88, a fully human monoclonal antibody

to the interleukin-6 receptor, generated via VelocImmune technology, entered clinical

development in patients with rheumatoid arthritis.

Aﬂ ibercept, our VEGF Trap product candidate for oncology (designed to potently

block VEGF via the Trap technology platform also used to generate ARCALYST),

moved into Phase 3 trials in four different types of cancer.

Our VEGF Trap-Eye ophthalmology product candidate advanced into Phase 3

studies in the neovascular form of Age-related Macular Degeneration (wet AMD).

These major milestones are not the result of happenstance. Instead,
they represent the ongoing realization of a corporate vision to focus
on innovative medical research that has guided our company since
its inception and will continue to guide us as we strive to discover,
develop, and commercialize new medicines.

REGENERON AR 2007

We could use our Trap technology platform to create
an effective inhibitor of interleukin -1 (IL-1)
to treat speciﬁ c inﬂ ammatory diseases.

Pioneering new technologies could streamline target
discovery and validation, and create a robust pipeline
of fully human therapeutic antibodies.

WORKING

During the last 12 months, Regeneron’s vision resulted

in exciting breakthroughs on several fronts:

The FDA approved our ﬁ rst drug, ARCALYST™ (rilonacept) Injection for Subcutaneous

Use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including

Familial Cold Auto-inﬂ ammatory Syndrome (FCAS) and Muckle-Wells Syndrome

(MWS) in adults and children 12 and older. ARCALYST was designed, via our pro-

prietary Trap platform, to be a speciﬁ c blocker of an endogenous pro-inﬂ ammatory

agent known as interleukin-1.

We entered into an unprecedented new global collaboration with sanoﬁ -aventis that

will enable us to more fully exploit the potential of our research capabilities and the

VelociSuite of technologies – VelociGene, ® VelociMouse,™ VelocImmune® and

VelociMab™ – to discover, develop, manufacture, and commercialize fully human

therapeutic antibodies.

The ﬁ rst antibody from this collaboration, REGN88, a fully human monoclonal antibody

to the interleukin-6 receptor, generated via VelocImmune technology, entered clinical

development in patients with rheumatoid arthritis.

Aﬂ ibercept, our VEGF Trap product candidate for oncology (designed to potently

block VEGF via the Trap technology platform also used to generate ARCALYST),

moved into Phase 3 trials in four different types of cancer.

Our VEGF Trap-Eye ophthalmology product candidate advanced into Phase 3

studies in the neovascular form of Age-related Macular Degeneration (wet AMD).

REGENERON AR 2007

We could use our Trap technology platform to create
an effective inhibitor of interleukin -1 (IL-1)
to treat speciﬁ c inﬂ ammatory diseases.

Pioneering new technologies could streamline target
discovery and validation, and create a robust pipeline
of fully human therapeutic antibodies.

ARCALYST ™ (rilonacept): A Breakthrough Medication

Steven Weinstein M.D., Ph.D.
Clinical Development

Mierette Stocker
Regulatory Affairs

Claudia Howard
Program Management

“Following the initiation of our

“I was the regulatory liaison to

“As program manager for

ARCALYST clinical program in

the FDA for the CAPS program.

ARCALYST, I coordinated

CAPS by our Translational Medi-

I’ve been working on this program

Regeneron’s cross-functional

cine group, I served as medical

since its inception in 2000, and

effort to support the Biologics

lead for late-stage ARCALYST

when news of its approval came

License Application. Although

clinical development. It was inspir-

through I literally jumped for joy.

the CAPS patient population is

ing to see so many groups and in-

This is why we’re here – to develop

very small, the process of ﬁ ling

dividuals working together to bring

and commercialize medicines for

a BLA is just as complex as for

this new drug to market. But the

patients who need them. Now

a much larger indication. I’m so

most exciting aspect for me has

we’ve demonstrated that we have

proud of what we accomplished.

been hearing patient responses

the resources, technology, and

With ARCALYST, we proved we

to the drug. It is gratifying to see

capabilities to do it.”

could bring a product from our

the impact that our drug can have

on the health and quality of life of

patients suffering from this rare

disease.”

research laboratories all the way

through clinical development

and to market.”

“CAPS is my body’s response to changes in
temperature. My ﬂ are-ups include hives that
cover my entire body, headaches, tiredness,
joint pain, and disabling eye pain.”

– Patient from pivotal CAPS study of ARCALYST™ (rilonacept)
Marina, White Plains, NY

Targeting a

How ARCALYST works.

Working with patients.

heartbreaking disease.

CAPS are generally caused by

Regeneron is committed to helping

Cryopyrin-Associated Periodic

mutations in the NLRP-3 gene

patients suffering from CAPS gain

Syndromes, or CAPS, is a group

that controls the production of

access to ARCALYST treatment.

of rare, inherited, auto-inﬂ amma-

interleukin-1 (IL-1), a soluble

We have developed a variety of

tory diseases, including Familial

protein secreted by certain cells

assistance programs called the

Cold Auto-inﬂ ammatory Syndrome

in the body. In excess, IL-1 can be

Regeneron ARC (ARCALYST

(FCAS) and Muckle-Wells Syn-

harmful and has been linked to a

Resource Center). As part of the

drome (MWS).

variety of inﬂ ammatory diseases.

ARC program, we help patients

Patients with CAPS experience

chronic, life-long symptoms

(including rash, fever and chills,

joint pain, eye redness and pain,

and fatigue), punctuated by inter-

mittent, disruptive exacerbations

or ﬂ ares which can be triggered

at any time by exposure to cooling

temperatures, stress, exercise,

or other unknown stimuli. To avoid

triggers that cause ﬂ ares, patients

often resort to a compromised

lifestyle with limitations on

everyday activities.

ARCALYST is an IL-1 inhibitor gen-

ﬁ nd appropriate medical care from

erated via our Trap technology and

healthcare providers and work with

therefore initially called the IL-1

physicians to help them diag-

Trap. It attaches to and neutralizes

nose and treat this rare disease.

IL-1 before it can attach to cell-

Through the ARC Program, we

surface receptors and generate

also provide assistance to CAPS

signals that can trigger inﬂ amma-

patients in working with insurers

tion in body tissue. Once attached

and various patient assistance

to ARCALYST, IL-1 cannot bind

programs to facilitate access

to the cell surface receptors and

to therapy.

is eventually eliminated from the

body. ARCALYST is delivered by

weekly injection.

“Sometimes I have to just close my eyes and
lie down, unable to continue with my day.”

REGENERON AR 2007

ARCALYST™ A BREAKTHROUGH MEDICATION

REGENERON AR 2007

ARCALYST™ A BREAKTHROUGH MEDICATION

WORKING

On February 27, 2008, the FDA approved ARCALYST ™
(rilonacept) Injection for Subcutaneous Use for the treatment
of Cryopyrin-Associated Periodic Syndromes (CAPS),
a group of rare, but serious, life-long diseases.

CAPS may be just the beginning for ARCALYST.

milestone for the company: we invented the Trap

Regeneron is evaluating the potential use of

technology in our laboratories, applied it to IL-1

ARCALYST in other conditions in which interleukin -1

inhibition, and developed and commercialized our

may play a major role. In 2007, we initiated a Phase

ﬁ rst drug product. It also provides validation that

2 safety and efﬁ cacy study of ARCALYST for the

our novel Trap technology, also used to generate

prevention of gout ﬂ ares.

the VEGF Trap and the VEGF Trap-Eye, can pro-

With the approval of ARCALYST for CAPS, Regeneron

duce effective biologic therapies.

has become a fully integrated biopharmaceutical

Pictured:

company. The approval represents a signiﬁ cant

Patient from pivotal CAPS study of ARCALYST

Marina, White Plains, NY

ARCALYST ™ (rilonacept): A Breakthrough Medication

Steven Weinstein M.D., Ph.D.
Clinical Development

Mierette Stocker
Regulatory Affairs

Claudia Howard
Program Management

“Following the initiation of our

“I was the regulatory liaison to

“As program manager for

ARCALYST clinical program in

the FDA for the CAPS program.

ARCALYST, I coordinated

CAPS by our Translational Medi-

I’ve been working on this program

Regeneron’s cross-functional

cine group, I served as medical

since its inception in 2000, and

effort to support the Biologics

lead for late-stage ARCALYST

when news of its approval came

License Application. Although

clinical development. It was inspir-

through I literally jumped for joy.

the CAPS patient population is

ing to see so many groups and in-

This is why we’re here – to develop

very small, the process of ﬁ ling

dividuals working together to bring

and commercialize medicines for

a BLA is just as complex as for

this new drug to market. But the

patients who need them. Now

a much larger indication. I’m so

most exciting aspect for me has

we’ve demonstrated that we have

proud of what we accomplished.

been hearing patient responses

the resources, technology, and

With ARCALYST, we proved we

to the drug. It is gratifying to see

capabilities to do it.”

could bring a product from our

the impact that our drug can have

on the health and quality of life of

patients suffering from this rare

disease.”

research laboratories all the way

through clinical development

and to market.”

“CAPS is my body’s response to changes in
temperature. My ﬂ are-ups include hives that
cover my entire body, headaches, tiredness,
joint pain, and disabling eye pain.”

– Patient from pivotal CAPS study of ARCALYST™ (rilonacept)
Marina, White Plains, NY

Targeting a

How ARCALYST works.

Working with patients.

heartbreaking disease.

CAPS are generally caused by

Regeneron is committed to helping

Cryopyrin-Associated Periodic

mutations in the NLRP-3 gene

patients suffering from CAPS gain

Syndromes, or CAPS, is a group

that controls the production of

access to ARCALYST treatment.

of rare, inherited, auto-inﬂ amma-

interleukin-1 (IL-1), a soluble

We have developed a variety of

tory diseases, including Familial

protein secreted by certain cells

assistance programs called the

Cold Auto-inﬂ ammatory Syndrome

in the body. In excess, IL-1 can be

Regeneron ARC (ARCALYST

(FCAS) and Muckle-Wells Syn-

harmful and has been linked to a

Resource Center). As part of the

drome (MWS).

variety of inﬂ ammatory diseases.

ARC program, we help patients

Patients with CAPS experience

chronic, life-long symptoms

(including rash, fever and chills,

joint pain, eye redness and pain,

and fatigue), punctuated by inter-

mittent, disruptive exacerbations

or ﬂ ares which can be triggered

at any time by exposure to cooling

temperatures, stress, exercise,

or other unknown stimuli. To avoid

triggers that cause ﬂ ares, patients

often resort to a compromised

lifestyle with limitations on

everyday activities.

ARCALYST is an IL-1 inhibitor gen-

ﬁ nd appropriate medical care from

erated via our Trap technology and

healthcare providers and work with

therefore initially called the IL-1

physicians to help them diag-

Trap. It attaches to and neutralizes

nose and treat this rare disease.

IL-1 before it can attach to cell-

Through the ARC Program, we

surface receptors and generate

also provide assistance to CAPS

signals that can trigger inﬂ amma-

patients in working with insurers

tion in body tissue. Once attached

and various patient assistance

to ARCALYST, IL-1 cannot bind

programs to facilitate access

to the cell surface receptors and

to therapy.

is eventually eliminated from the

body. ARCALYST is delivered by

weekly injection.

“Sometimes I have to just close my eyes and
lie down, unable to continue with my day.”

REGENERON AR 2007

ARCALYST™ A BREAKTHROUGH MEDICATION

REGENERON AR 2007

ARCALYST™ A BREAKTHROUGH MEDICATION

WORKING

CAPS may be just the beginning for ARCALYST.

milestone for the company: we invented the Trap

Regeneron is evaluating the potential use of

technology in our laboratories, applied it to IL-1

ARCALYST in other conditions in which interleukin -1

inhibition, and developed and commercialized our

may play a major role. In 2007, we initiated a Phase

ﬁ rst drug product. It also provides validation that

2 safety and efﬁ cacy study of ARCALYST for the

our novel Trap technology, also used to generate

prevention of gout ﬂ ares.

the VEGF Trap and the VEGF Trap-Eye, can pro-

With the approval of ARCALYST for CAPS, Regeneron

duce effective biologic therapies.

has become a fully integrated biopharmaceutical

Pictured:

company. The approval represents a signiﬁ cant

Patient from pivotal CAPS study of ARCALYST

Marina, White Plains, NY

WORKING

CAPS may be just the beginning for ARCALYST.

milestone for the company: we invented the Trap

Regeneron is evaluating the potential use of

technology in our laboratories, applied it to IL-1

ARCALYST in other conditions in which interleukin -1

inhibition, and developed and commercialized our

may play a major role. In 2007, we initiated a Phase

ﬁ rst drug product. It also provides validation that

2 safety and efﬁ cacy study of ARCALYST for the

our novel Trap technology, also used to generate

prevention of gout ﬂ ares.

the VEGF Trap and the VEGF Trap-Eye, can pro-

With the approval of ARCALYST for CAPS, Regeneron

duce effective biologic therapies.

has become a fully integrated biopharmaceutical

Pictured:

company. The approval represents a signiﬁ cant

Patient from pivotal CAPS study of ARCALYST

Marina, White Plains, NY

Pioneering new technologies could streamline target
discovery and validation, and create a robust pipeline
of fully human therapeutic antibodies.

WORKING

The ﬁ rst fully human antibody generated by the VelociSuite
of technologies (including VelociGene®, VelociMouse™, VelocImmune®
and VelociMab™) entered clinical trials in 2007.

Our VelociSuite of technologies improves our ability

the most desirable characteristics and generate high-

to determine the best targets for therapeutic inter-

producing cell lines to manufacture these antibodies.

vention, and then rapidly generates high-quality fully

human antibodies as drug candidates addressing

these targets. VelociGene® and VelociMouse™ are

new high-throughput approaches for generating

thousands of knockout and transgenic mouse models,

which can be used to evaluate each gene of interest

as a potential drug target. Once a gene has been vali-

dated for therapeutic intervention, our scientists use

In 2007, vision became reality with the initiation of

clinical trials in rheumatoid arthritis of an antibody to

the interleukin-6 receptor (IL-6R). A second antibody

against a novel angiogenesis target (Dll4) is slated to

enter clinical development in mid-2008. These anti-

bodies are being developed with sanoﬁ -aventis

as part of our global collaboration.

VelocImmune® and VelociMab™ to rapidly generate

Our goal is to bring two to three new antibodies

high-quality, fully human antibody candidates. Using

into clinical development each year.

VelociMab, scientists screen for the antibodies with

Blocking angiogenesis through VEGF inhibition
could starve tumors of the blood supply needed for them
to grow, and provide a mechanism for treating cancer.

WORKING

Four Phase 3 trials are underway evaluating aﬂ ibercept
(VEGF Trap) in multiple cancer indications.

Tumor growth requires the development of new

Together with sanoﬁ -aventis, we are conducting piv-

blood vessels, or angiogenesis, to provide oxygen

otal Phase 3 trials that combine aﬂ ibercept with stan-

and nutrients. Blocking Vascular Endothelial Growth

dard chemotherapy regimens in second-line metastat-

Factor (VEGF) is the best validated anti-angiogen-

ic colorectal cancer, ﬁ rst-line metastatic pancreatic

esis approach in cancer, and was recognized at an

cancer, ﬁ rst-line metastatic androgen independent

early stage by the Regeneron oncology team as an

prostate cancer, and second-line metastatic non-small

important target for therapeutic intervention in solid

cell lung cancer. A Phase 2 trial is studying aﬂ ibercept

tumors. Using our proprietary Trap technology (which

for the treatment of symptomatic malignant ascites in

we also used to develop ARCALYST™ (rilonacept),

women with ovarian cancer. In addition, the National

initially termed IL-1 Trap), Regeneron developed

Cancer Institute is sponsoring more than 15 studies

aﬂ ibercept (VEGF Trap), an anti-angiogenesis agent

evaluating aﬂ ibercept as a single agent or in combi-

that is designed to bind and neutralize VEGF, thereby

nation with chemotherapy regimens in a variety of

inhibiting the growth of blood vessels in tumors in

cancer indications.

numerous types of cancers.

Inhibiting blood vessel growth and abnormal vessel
leakage in the eye could help restore vision in patients
with certain serious eye disorders.

WORKING

The large Phase 3 program of VEGF Trap-Eye is enrolling
patients with the neovascular form of Age-related
Macular Degeneration (wet AMD).

Blocking the activity of Vascular Endothelial Growth

Regeneron is conducting a 1,200 patient Phase 3

Factor (VEGF) in the eye can prevent abnormal blood

clinical trial of VEGF Trap-Eye in wet AMD in North

vessel growth and vascular leakage associated with

America. Bayer HealthCare is initiating a Phase 3

eye diseases such as wet AMD, the leading cause of

wet AMD trial that will enroll 1,200 patients outside

blindness for people over the age of 65 in the U.S.

North America. Both trials are comparing treatment

and Europe. The VEGF Trap-Eye is a form of aﬂ iber-

with VEGF Trap-Eye at various dose regimens to

cept that has been formulated for use by direct injec-

treatment with ranibizumab, the current standard

tion into the eye. We are developing VEGF Trap-Eye

of care.

in collaboration with Bayer HealthCare.

Envisioning the Future

Over the past twelve months, we received FDA
approval to market our ﬁ rst product, advanced our
lead product candidates into late-stage development,
and initiated a sweeping new antibody collaboration.
Yet what excites us most is the future:

Full commercialization of ARCALYST™ (rilon-

acept) for patients who suffer from CAPS

Expanding the global Phase 3 VEGF Trap-Eye

ophthalmology program to patients in North

America, Europe, Asia, and Latin America

Continued clinical evaluation of rilonacept

in inﬂ ammatory diseases, including gout

Discovering and validating genes as drug

targets, and then using VelocImmune®

to generate antibodies to these targets

Enrollment of thousands of new patients

in our late-stage aﬂ ibercept oncology trials

Advancing 2 to 3 new fully human monoclonal

antibodies into clinical development each year

With an innovative new product on the market and a robust pipeline that includes two late-stage

product candidates addressing large markets, we are looking forward to continued progress that

will help us meet our goal of commercializing important new medicines for patients suffering

from serious diseases.

REGENERON AR 2007

REGENERON CLINICAL DEVELOPMENT

Phase 1

Phase 2

Phase 3

Marketed

ARCALYST ™ (rilonacept)

CAPS

Gout

VEGF Trap-Eye

Wet age-related
macular degeneration

Aﬂ ibercept (VEGF Trap)

Metastatic
prostate cancer

Metastatic non-
small cell lung cancer

Metastatic
colorectal cancer

Metastatic
pancreatic cancer

Other indications

REGN88 (IL-6R antibody)

Rheumatoid arthritis

REGENERON AR 2007

Research

Since its inception, Regeneron has been committed to the

principle that strong science coupled with empowering new

technology platforms could accelerate the effort to develop

a large, diverse, and risk-balanced, development pipeline.

Our VelociSuite of technologies (including VelociGene®,

VelociMouse™, VelocImmune,® and VelociMab™) greatly

increases the efﬁ ciency of progressing from early discovery

through drug candidate generation. Our scientists use these

technologies to evaluate hundreds of new targets each year,

and generate fully human therapeutic antibody candidates,

resulting in a robust antibody pipeline.

Development

Regeneron has put in place an organizational structure

to manage our growing pipeline. A translational medicine

group was established to rapidly assess the potential of

new product candidates and design and initiate ﬁ rst-in-

human clinical trials. Other groups in our clinical development

department oversee the next stages of drug development

through registration. These groups have additional support

from our regulatory group, responsible for coordinating inter-

actions with the U.S. Food and Drug Administration and other

regulatory agencies. Our Medical Affairs group acts as

a liaison between Regeneron and external constituencies

of physicians, clinicians, and patients.

REGENERON AR 2007

Manufacturing

Our large-scale biologics manufacturing operations are

located in Rensselaer, New York. With over 300,000

square feet of space, the Rensselaer site houses our

Industrial Operations and Product Supply (IOPS) function

and our clinical and commercial scale bioreactors (up to

10,000 liters). Operating under current Good Manufacturing

Practice (cGMP) conditions, IOPS manufactures ARCALYST™

(rilonacept), our ﬁ rst FDA approved drug, and product

for our growing clinical development program. To date,

this facility has manufactured investigational drugs used

by several thousand patients in clinical trials.

Commercialization

With the FDA approval of ARCALYST, Regeneron has

moved into an exciting new chapter in our corporate his-

tory. We are now focused on bringing ARCALYST to CAPS

patients who suffer from this debilitating disease. Our

expanded commercial group is implementing our commer-

cialization strategy, including disease awareness, marketing,

patient advocacy, and customer service activities. The

commercial group also provides input into the decision-

making process on target and disease selection for our

clinical development programs.

REGENERON AR 2007

Leonard S. Schleifer, M.D., Ph.D.
President and Chief Executive Ofﬁ cer

P. Roy Vagelos, M.D.
Chairman of the Board

George Yancopoulos, M.D., Ph.D.
Executive Vice President, Chief Scientiﬁ c Ofﬁ cer
and President, Regeneron Research Laboratories

REGENERON AR 2007

Dear Shareholders,
For Regeneron, the past twelve months
have been among the most eventful, exciting,
and productive in our history.

Recently, we received FDA approval for ARCALYST™

ingenuity that went into discovering and developing

(rilonacept), our ﬁ rst marketed product, which was

this unique medicine. Joy, because of the relief our

designed using our proprietary Trap technology

medicine can bring to CAPS patients who have

platform to speciﬁ cally block interleukin-1 (IL-1), and

suffered life-long, debilitating symptoms that inter-

was thus initially called the IL-1 Trap. We established

fere with their ability to participate in everyday work,

a groundbreaking collaboration with sanoﬁ -aventis

family, and social activities.

that will help us exploit the immense potential of our

drug discovery and therapeutic antibody develop-

ment capabilities, which include our proprietary

new technology platform for generating fully human

antibodies, termed VelocImmune.® Jump-starting this

important new collaboration, we recently initiated our

ﬁ rst clinical program testing a fully human antibody

generated via VelocImmune technology. In our oncol-

ogy collaboration with sanoﬁ -aventis, we advanced

aﬂ ibercept (VEGF Trap) into four Phase 3 clinical

trials, and in our ophthalmology collaboration with

Bayer HealthCare, we advanced VEGF Trap-Eye into

Phase 3 clinical trials. Any one of these events on its

own would have made this an outstanding year for our

company. Together, they represent a signiﬁ cant leap

forward, establishing a stronger and higher founda-

tion on which to build a successful and sustainable

biopharmaceutical company.

For patients, the approval of ARCALYST is particularly

welcome because it is the only therapy approved

for CAPS, a group of rare, inherited, auto-inﬂ amma-

tory diseases characterized by life-long, recurrent

symptoms of rash, fever and chills, joint pain, eye

redness and pain, and fatigue. Intermittent, disruptive

exacerbations or ﬂ ares can be triggered at any time

by exposure to cooling temperatures, stress, exercise,

or other stimuli. We have had the opportunity to meet

patients diagnosed with CAPS, and their stories paint

a clear picture of how this disease can affect their

lives – and how ARCALYST can provide relief. During

clinical trials, patients treated with ARCALYST

experienced a signiﬁ cant improvement in their overall

disease symptom scores. These improvements were

sustained over time with continued ARCALYST treat-

ment. The most commonly reported adverse react-

ions reported with ARCALYST were injection site

Let’s begin with ARCALYST. On February 27th of

reaction and upper respiratory tract infection. Full

this year, the FDA granted marketing approval for

product and safety information is available at

ARCALYST™ (rilonacept) Injection for Subcutaneous

www.ARCALYST.com.

Use for the treatment of Cyropyrin-Associated Peri-

odic Syndromes (CAPS), including Familial Cold Auto-

inﬂ ammatory Syndrome (FCAS) and Muckle-Wells

Syndrome (MWS) in adults and children 12 and older.

This was very exciting news for us and for patients

suffering from CAPS. We wish each of our sharehold-

ers could have been at our ofﬁ ces that afternoon.

Pride and joy were evident on the face of every one of

our colleagues: Pride, because of the hard work and

The launch of ARCALYST represents validation of

our ability to discover, develop, manufacture, and

commercialize novel therapeutics that meet unmet

medical needs. What’s more, although CAPS is a

very rare orphan disease that is estimated to affect

only several hundred people in the United States,

Regeneron continues to evaluate the potential use

of rilonacept in other indications in which interleukin-1

is believed to play a key role, such as gout.

REGENERON AR 2007

A groundbreaking collaboration

We began reaping the beneﬁ ts of this collaboration

involving VelocImmune.®

right out of the gate. At the end of last year, we initi-

Another exciting event for our company was the

ated our ﬁ rst clinical trial of a therapeutic antibody:

November 2007 global collaboration with sanoﬁ -

REGN88, a fully human antibody to the interleukin-6

aventis to discover, develop, and commercialize fully

receptor (IL-6R) that is being evaluated in patients

human monoclonal antibodies. This groundbreaking

with rheumatoid arthritis. The second antibody sched-

collaboration validates the potential of our research

uled to enter clinical trials under the collaboration is

capabilities and innovative technologies to add sig-

a fully human antibody to Delta-like ligand-4 (Dll4), a

niﬁ cantly to the future development pipelines of both

novel anti-angiogenesis agent that currently is slated

companies. Sanoﬁ -aventis’ funding and expertise will

to start clinical development in mid-2008. We and

help us translate our research efforts into antibody

sanoﬁ -aventis plan to advance two to three antibody

product candidates on a much broader scale than

product candidates into clinical trials each year

we could ever do alone. We’ve long believed that our

beginning this year.

strong research capabilities and VelociSuite of tech-

nologies (which include VelociGene,® VelociMouse,™

and VelociMab™ in addition to VelocImmune®) had the

potential to transform Regeneron – and, potentially,

the health and healthcare of millions of people world-

wide. Now we have the resources to begin to make

this happen.

Thus, the collaboration with sanoﬁ -aventis will en-

able us to bring promising new candidates into and

through our pipeline at an accelerated pace. It also

relieves us of much of the ﬁ nancial obligations in-

curred by biopharmaceutical companies with multiple

drug candidates in development. As with our ﬁ rst drug

approval, we wish each of our shareholders could visit

To understand the sweeping signiﬁ cance of this col-

our facilities and sense the spirit of enthusiasm and

laboration for Regeneron, it’s important to understand

commitment that pervades our labs, manufacturing

its key components. As part of the collaboration,

plant, and ofﬁ ces as we begin this important collabo-

sanoﬁ -aventis made an $85 million upfront payment

ration. Our people are excited by the opportunity to

to Regeneron and agreed to fund up to $475 million

apply their creative talents and collaborate with their

of research and preclinical development over the next

counterparts at sanoﬁ -aventis to build a new pipeline

ﬁ ve years. Sanoﬁ -aventis has the exclusive option to

of drug candidates for important diseases and disor-

co-develop with Regeneron each antibody candidate

ders with unmet medical needs.

that emerges from the collaboration. If sanoﬁ -aventis

chooses to co-develop the antibody with us, they will

fund all development costs up front through the ﬁ rst

successful Phase 3 trial. Following commercialization,

Regeneron and sanoﬁ -aventis will share future proﬁ ts

from sales of collaboration antibodies. At that time,

we will reimburse sanoﬁ -aventis for half of the devel-

opment costs that they funded from our share

of the proﬁ ts. If sanoﬁ -aventis elects not to co-devel-

op an antibody with us, we retain exclusive rights to

develop and commercialize the antibody and will pay

sanoﬁ -aventis a single digit royalty on sales of such an

VelocImmune® Licenses.

In 2007, Regeneron entered into non-exclusive

license agreements with AstraZeneca and Astellas

to allow those companies to utilize the VelocImmune

technology in their internal research programs to

discover human monoclonal antibody products.

The licensing agreements highlight the acceptance

of the VelocImmune technology as an emerging new

standard for the development of fully human antibod-

ies. Regeneron is also considering exploring additional

license agreements.

antibody.

Oncology and ophthalmology.

Clearly, this is a very important strategic collaboration

for both companies. It is particularly important today

because antibodies are playing a growing and increas-

ingly important role in pharmaceutical development.

The 23 antibody-based therapies currently on the

market generated an estimated $32 billion of sales

in the U.S. in 2007.

The excitement surrounding ARCALYST™ (rilonacept)

and the sanoﬁ -aventis antibody collaboration should

not obscure the great progress we made in 2007 with

our two lead development candidates. In 2007, we

achieved our goal of accelerating the progress of our

oncology program. We now have more than 20 clinical

trials underway of aﬂ ibercept, our VEGF (Vascular

Endothelial Growth Factor) inhibitor, including four

REGENERON AR 2007

Phase 3 clinical trials in patients with metastatic

Looking ahead.

hormone-resistant prostate cancer, metastatic

We fully expect 2008 to be another important year

non-small cell lung cancer, metastatic colorectal

for Regeneron as we record progress in all areas of

cancer, and metastatic pancreatic cancer. These four

the company. With the initiation of research under the

trials are expected to enroll a total of almost 4,000

sanoﬁ -aventis antibody collaboration, the progress

patients, and additional trials are being planned. We

in enrolling patients in each of our ongoing late stage

and sanoﬁ -aventis also have on-going Phase 1 and

clinical programs, and the commercial launch of

Phase 2 trials in a variety of solid tumors plus a trial in

ARCALYST™ (rilonacept), Regeneron has already

symptomatic malignant ascites in women with ovarian

made great headway in the ﬁ rst half of 2008. We

cancer. In addition, the National Cancer Institute (NCI)

expect this momentum to continue as our colleagues

is sponsoring more than ﬁ fteen studies with aﬂ iber-

here at Regeneron apply their collective talents and

cept. In total, more than 1,000 patients have already

enthusiasm to build upon this strong foundation and

participated in clinical trials with aﬂ ibercept, and

remain focused on bringing important new therapeu-

many more will soon join them.

tics to patients.

Our VEGF Trap-Eye ophthalmology program, which

is being conducted in collaboration with Bayer

HealthCare, also made signiﬁ cant progress over

the past year. Our pre-clinical and Phase 2 clinical

data suggest that our VEGF Trap-Eye may offer an

efﬁ cacy advantage or require less frequent dosing

compared with the current standard of care for the

treatment of the neovascular form of Age-related

Macular Degeneration (wet AMD). The VEGF Trap-Eye

currently is in Phase 3 clinical development for wet

AMD. The ﬁ rst Phase 3 study, which we are conduct-

ing, is enrolling 1,200 patients in more than 200

sites in North America. Bayer HealthCare is initiating

a second Phase 3 wet AMD trial. This study will enroll

approximately 1,200 patients in up to 200 centers in

Europe, Asia, and Latin America. Regeneron retains

exclusive rights to the VEGF Trap-Eye in the United

States and will share proﬁ ts with Bayer HealthCare

from the commercialization of VEGF Trap-Eye

outside the United States.

Financial strength.

We move forward from a very strong ﬁ nancial posi-

tion. At year-end 2007, we had nearly $850 million in

cash and securities. Moreover, with almost 100 per-

cent of our oncology and antibody programs funded

by sanoﬁ -aventis, almost 50 percent of our ophthal-

mology program funded by Bayer HealthCare, and

annual fees from our VelocImmune® licenses, we will

be able to signiﬁ cantly leverage our own investment

in our research and development programs without

a corresponding increase in our net cash usage.

REGENERON AR 2007

Corporate Information

Common Stock and Related Matters

SEC Form 10-K

Our Common Stock is quoted on The Nasdaq Stock

A copy of our annual report to the Securities and

Market under the symbol “REGN.” Our Class A Stock,

Exchange Commission on Form 10-K is available

par value $.001 per share, is not publicly quoted

without charge from the Regeneron Investor

or traded.

Relations Department.

The following table sets forth, for the periods

Annual Meeting

indicated, the range of high and low sales prices

The Annual Meeting will be held on Friday, June 13,

for the Common Stock as reported by The Nasdaq

2008 at 10:30 a.m. at the Westchester Marriott

Stock Market.

Hotel, 670 White Plains Road, Tarrytown, NY 10591.

2006

First Quarter

Second Quarter

Third Quarter

Fourth Quarter

2007

First Quarter

Second Quarter

Third Quarter

Fourth Quarter

High

$18.00

16.69

17.00

24.85

$22.84

28.74

21.78

24.90

Low

$14.35

10.97

10.88

15.27

$17.87

17.55

13.55

16.77

Shareholders’ Inquiries

Inquiries relating to stock transfer or lost certiﬁ cates

and notices of changes of address should be directed

to our Transfer Agent, American Stock Transfer &

Trust Co., 59 Maiden Lane, Plaza Level, New York,

NY 10038, (800) 937-5449. General information

regarding the Company, recent press releases, and

SEC ﬁ lings are available on our Worldwide Web Home

Page at www.regn.com, or can be obtained by con-

tacting our Investor Relations Department at

(914) 345-7741.

Transfer Agent and Registrar

American Stock Transfer & Trust Co.

As of April 15, 2008, there were 511 shareholders

of record of our Common Stock and 42 shareholders

of record of our Class A Stock. The closing bid price

59 Maiden Lane

Plaza Level

New York, NY 10038

for the Common Stock on that date was $18.23.

Independent Registered Public Accounting Firm

We have never paid cash dividends and do not

PricewaterhouseCoopers LLP

anticipate paying any in the foreseeable future.

REGENERON® is a registered trademark

Corporate Ofﬁ ce

777 Old Saw Mill River Road

Tarrytown, NY 10591-6707

(914) 345-7400

of Regeneron Pharmaceuticals, Inc.

REGENERON AR 2007

FINANCIAL REVIEW

Corporate Directory

Directors

P. Roy Vagelos, M.D.

Chairman of the Board

Senior Management Team

Leonard S. Schleifer, M.D., Ph.D.

President and Chief Executive Officer

Leonard S. Schleifer, M.D., Ph.D.

George D. Yancopoulos, M.D., Ph.D.

President and Chief Executive Officer

Executive Vice President,

Charles A. Baker

Retired Chairman of the Board,

President and Chief Executive Officer

of The Liposome Company, Inc.

Michael S. Brown, M.D.

Regental Professor,

Department of Molecular Genetics,

The University of Texas

Chief Scientific Officer and President,

Regeneron Research Laboratories

Murray A. Goldberg

Senior Vice President,

Finance and Administration,

Chief Financial Officer, Treasurer

and Assistant Secretary

Stuart Kolinski

Southwestern Medical Center at Dallas

Senior Vice President,

General Counsel and Secretary

Peter Powchik, M.D.

Senior Vice President,

Clinical Development

Neil Stahl, Ph.D.

Senior Vice President,

Research and Developmental Sciences

Robert J. Terifay

Senior Vice President,

Commercial

Daniel Van Plew

Senior Vice President

and General Manager,

Industrial Operations and Product Supply

Alfred G. Gilman, M.D., Ph.D.

Provost and Executive Vice President

for Academic Affairs,

The University of Texas

Dean, Southwestern Medical School

Joseph L. Goldstein, M.D.

Regental Professor and Chairman,

Department of Molecular Genetics,

The University of Texas

Southwestern Medical Center at Dallas

Arthur F. Ryan

Chairman of the Board

and Retired Chief Executive Officer,

Prudential Financial, Inc.

Eric M. Shooter, Ph.D.

Professor Emeritus,

Department of Neurobiology,

Stanford University School of Medicine

George L. Sing

Chief Executive Officer, Stemnion, Inc.

Managing Director, Lancet Capital

George D. Yancopoulos, M.D., Ph.D.

Executive Vice President,

Chief Scientific Officer and President,

Regeneron Research Laboratories

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WORKING

Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
regeneron.com

Regeneron Annual Report 2007