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Incyte

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FY2010 Annual Report · Incyte
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Incyte Corporation
Experimental Station
Route 141 & Henry Clay Road / Building E336
Wilmington, Delaware 19880
302.498.6700

www.incyte.com

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THE DRIVE TO DISCOVER.  THE EXPERIENCE TO DELIVER.

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Incyte developed  ruxolitinib internally,

advanced  the compound through the clinic, 

and is prepared to make a difference 

in the lives of patients who suffer from myelofibrosis.

BOARD  OF   
DIRECTORS

EXECUTIVE   
MANA GEMEN T

STOCKHOLDER   
IN FORMATION

Market Information
Incyte’s Common Stock trades 
on The Nasdaq Global Market 
under the symbol INCY.

Investor Relations
You can obtain recent press 
releases and other publicly 
available information on  
Incyte by visiting our web site 
at www.incyte.com.

Contact
Pamela Murphy 
Vice President,  
Investor Relations and  
Corporate Communications
Email: pmurphy@incyte.com

Corporate Headquarters
Incyte Corporation
Experimental Station
Route 141 & Henry Clay Road
Building E336
Wilmington, Delaware 19880
302.498.6700

© 2011 Incyte Corporation.  
All rights reserved.

Transfer Agent and Registrar
BNY Mellon  
Shareowner Services 
PO Box 358015 
Pittsburgh, PA 15252-8015
or 
480 Washington Boulevard 
Jersey City, NJ 07310-1900 
Phone: 800.851.9677

TDD for Hearing Impaired: 
800.231.5469

Foreign Shareowners: 
201.680.6578

TDD Foreign Shareowners: 
201.680.6610

www.bnymellon.com/ 
   shareowner/equityaccess

Annual Meeting
The Annual Meeting of 
Stockholders will be held 
May 20, 2011, at 10:00 a.m., 
Eastern Daylight Time, at 
the Hotel du Pont, 11th and 
Market Streets, Wilmington, 
Delaware 19801.

Outside Counsel
Pillsbury Winthrop Shaw  
Pittman LLP

Independent Registered  
Public Accounting Firm
Ernst & Young LLP

Richard U. De Schutter
Chairman of the Board 
Formerly Chairman and  
Chief Executive Officer 
DuPont Pharmaceuticals 
Company

Paul A. Friedman, M.D.
President and  
Chief Executive Officer 
Incyte Corporation

Barry M. Ariko
Formerly President, Chief  
Executive Officer and Chairman 
Mirapoint, Inc.

Julian C. Baker
Managing Member 
Baker Bros. Advisors, LLC

Paul A. Friedman, M.D.
President and  
Chief Executive Officer

Patricia S. Andrews
Executive Vice President and 
Chief Commercial Officer

David C. Hastings
Executive Vice President and 
Chief Financial Officer

Reid M. Huber, Ph.D.
Senior Vice President,  
Discovery Biology 

Richard S. Levy, M.D.
Executive Vice President and 
Chief Drug Development and 
Medical Officer

Paul A. Brooke
Founder and Managing Director 
venBio LLC

Brian W. Metcalf, Ph.D.
Executive Vice President and 
Chief Drug Discovery Scientist

Patricia A. Schreck
Executive Vice President and 
General Counsel

Paula J. Swain
Executive Vice President,  
Human Resources

Wenqing Yao, Ph.D.
Senior Vice President,  
Discovery Chemistry

Wendy L. Dixon, Ph.D.
Formerly Chief Marketing  
Officer and President,  
Global Marketing  
Bristol-Myers Squibb Company

John F. Niblack, Ph.D.
Formerly Vice Chairman and 
President of Global Research 
and Development 
Pfizer Inc. 

Roy A. Whitfield
Formerly Chairman of the Board 
and Chief Executive Officer 
Incyte Corporation

FORWARD-LOOKING STATEMENTS

Except  for  the  historical  information  set  forth  herein,  the  matters  set  forth  in  this  annual  report,  including  statements  regarding  our  planned 
NDA submission and potential commercialization of ruxolitinib, anticipated future success in drug discovery and development, plans and expected 
timelines for advancing our drug candidates through clinical trials, NDA submission and potential commercialization, including our objectives and 
agenda for 2011, and potential therapeutic and commercial value, including attributes and indications of our drug candidates, contain predictions, 
estimates and other forward-looking statements.

These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risk that 
results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, the high degree of risk and uncertainty associated 
with drug development and clinical trials, the uncertainty associated with the regulatory approval processes, risks related to the timing of and 
patient enrollment in clinical trials, unanticipated developments in and risks related to the efficacy or safety of our compounds in clinical trials, the 
results of further research and development, risks associated with our dependence on our relationships with our collaboration partners, risks related 
to market competition, and the other risks detailed from time to time in our reports filed with the Securities and Exchange Commission, including 
our Form 10-K for the year ended December 31, 2010. Incyte disclaims any intent or obligation to update these forward-looking statements.

 
 
To Our Stockholders:

The achievement of key clinical and financial goals in 2010 has positioned us for a 

very promising and eventful 2011. We are preparing a New Drug Application (NDA) 

for  ruxolitinib  (INCB18424)  for  myelofibrosis  (MF)  and  look  to  our  first  potential 

launch in the United States later this year. This NDA could result in the approval of 

the first JAK inhibitor drug to treat MF, which makes our discovery of this compound 

even more satisfying. An approval would also represent an important and significant 

event for the MF community as this disease is life-shortening and can be profoundly 

disabling, placing a tremendous burden on the patients.

SUBSTANTIAL PROGRESS

a  variety  of  sales  and  marketing  approaches 

The  success  we  expect  in  2011  is  supported 

to  reach  the  hematologists  and  oncologists 

by the substantial progress we achieved in the 

who  treat  MF  in  the  United  States  as  rapidly, 

clinic.  Last  December  we  reported  statistically 

effectively and efficiently as possible.

significant results for ruxolitinib versus placebo 

in  our  Phase  III  COMFORT-I  trial.  Then,  in  

March  of  this  year,  we  announced  that  the 

second Phase III trial, COMFORT-II, conducted 

in Europe by our collaborator, Novartis, achieved 

statistically  significant  results  for  ruxolitinib 

versus  best  available  therapy.  These  findings 

were  consistent  with  the  results  from  our 

previous clinical studies and will now form the 

basis for the planned regulatory submissions in 

As  a  potent,  selective  inhibitor  of  the  janus 

kinase (JAK) cell pathway, ruxolitinib may have 

applications  in  the  treatment  of  several  other 

cancers, which we are now exploring or planning 

to explore in clinical studies. In October, we and 

Novartis launched the global Phase III RESPONSE 

trial with ruxolitinib in patients with advanced 

polycythemia  vera,  another  myeloproliferative 

neoplasm related to MF.

the United States and the European Union. 

We  plan  to  initiate  a  Phase  II  trial  this  year  in 

SUBSTANTIAL EXPERIENCE

patients  with  pancreatic  cancer  to  build  on 

encouraging results from our preclinical studies. 

Our  commercial  team  has  substantial  experience 

We also have plans to study the drug in cancers 

with  oncology,  hematology  and  specialty 

such as lymphoma and solid tumors where the 

products  and  with  the  launch,  marketing  and 

disease may be resistant or poorly responsive to  

reimbursement of new drugs. They plan to use 

current therapies.

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“Our  achievements  reflect  the  

productivity of our R&D team  

and  the  continuing  success  

of  our  drug  development 

programs and collaborations.”

Although  ruxolitinib  is  our  most  advanced 

STRENGTHENED FINANCIAL POSITION

product candidate, it is not the only promising JAK 

inhibitor in our pipeline. We have an exclusive 

worldwide license and collaboration agreement 

with Eli Lilly for the development of LY3009104 

(INCB28050),  our  second  JAK  compound,  for 

inflammatory  and  autoimmune  diseases.  Last 

year  Lilly  advanced  this  compound  to  Phase 

Importantly,  we  continue  to  be  rewarded  for  

our  clinical  successes  and  last  year  we  earned 

more than $100 million in milestone payments 

from  our  collaborators,  which  strengthened  

our  financial  position  and  helped  us  advance 

our pipeline. 

IIb  development  in  patients  with  rheumatoid 

DRUG DISCOVERY CONTINUES TO BEAR FRUIT

arthritis based upon impressive 6-month results 

from  our  Phase  IIa  study.  We  exercised  our  

co-development  rights  for  this  compound  in 

2010 and are now responsible for funding thirty 

percent  of  the  associated  global  development 

costs in rheumatoid arthritis through regulatory 

approval  in  exchange  for  tiered  royalty  rates 

ranging  up  to  the  high  twenties  on  potential 

future  global  sales.  We  believe  JAK  inhibition 

represents  an  important  new  approach  to 

inflammatory  and  autoimmune  diseases  and  

we  look  forward  to  seeing  this  compound 

progress,  initially  in  rheumatoid  arthritis  and 

potentially in other conditions. 

Our commitment to investing in drug discovery 

continues  to  bear  fruit.  We  recently  began 

a  new  clinical  program  in  oncology  with 

INCB24360, a selective, orally available inhibitor 

of  indoleamine  2,  3-dioxygenase  (IDO),  an 

immune regulatory enzyme. Preclinical studies 

have  shown  that  inhibition  of  this  enzyme 

increases the anti-tumor immune response and 

dramatically  increases  the  efficacy  of  various 

chemotherapeutic agents in controlling tumor 

growth.  We  are  currently  conducting  a  dose-

escalation  study  of  this  compound  in  patients 

with solid tumors.

Discovery: 

Development: 

Commercialization: 

Our pharmaceutically 
experienced biologists 
and chemists utilize an 
integrated approach 
with the development 
teams to generate high 
quality proprietary 
compounds to build and 
sustain our pipeline.

Our drug development 
team carefully plans and 
conscientiously executes 
the clinical programs. 
Our studies are designed 
with a focus on patient 
safety and clinically 
meaningful endpoints.

Based upon a deep 
understanding of 
market dynamics, our 
commercial team creates 
the strategies and 
materials to support the 
launch of a new product 
and sustain its growth.

Our achievements reflect the productivity of our 

team  and  the  continuing  success  of  our  drug 

··>  Completing  the  initial  studies  for  our 
c-MET  inhibitor  in  solid  tumors  and  then 

development programs and collaborations. 

transferring the program to Novartis; and 

LOOKING AHEAD

This year, we plan to focus our resources on:

··>  Obtaining FDA approval of ruxolitinib;

··>  Initiating Phase I testing of a novel oncology 
compound that we have not yet disclosed. 

This is an ambitious agenda and one that I am 

confident  we  have  the  talent  and  resources  to 

··>  Successfully  launching  the  drug  in  the 

accomplish this year. 

United States; 

··>  Completing enrollment in the global Phase 
III RESPONSE clinical study of ruxolitinib in 

polycythemia vera; 

In closing, I thank our employees for their hard 

work  and  disciplined  efforts.  I  also  want  to 

recognize and thank the physicians and patients 

who have participated in our clinical programs 

··>  Initiating  new  studies  of  ruxolitinib  in 

and aided us in the development of ruxolitinib. 

lymphoma and pancreatic cancer;

Sincerely,

··>  Determining  future  clinical  plans  for  the 
development  of  our  Sheddase  inhibitor, 

INCB7839, in breast cancer; 

··>  Completing  the  Phase  I  study  of  our  IDO 
inhibitor,  INCB24360,  and  selecting  doses 

for Phase II testing; 

Paul A. Friedman, M.D. 
President and Chief Executive Officer 
March 31, 2011

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Our Pipeline

Incyte’s pipeline is focused in oncology and inflammation 

and  includes  multiple  programs  in  various  stages  of 

development. We have established several collaborations 

with  major  pharmaceutical  companies  to  advance  the 

clinical  development  and  global  commercialization  of  

our compounds. This year, we plan to submit a new drug 

application for our lead compound in myelofibrosis and 

look to the potential U.S. approval of ruxolitinib. 

Discovery/
Preclinical

Phase I

Phase II

Phase III

Market

Myelofibrosis  ruxolitinib1,4 – JAK

Polycythemia vera  ruxolitinib1,4 – JAK

Essential thrombocythemia  ruxolitinib1,4 – JAK

Breast cancer  INCB7839 – Sheddase

Solid/hematologic tumors  ruxolitinib1,4 – JAK

Solid tumors  INCB28060 2 – c-MET

Solid tumors  INCB24360 – IDO

Other programs

Rheumatoid arthritis  LY30091043,5 – JAK

Psoriasis  INCB18424 – JAK (topical)

Other programs

ONCOLOGY

INFLAMMATION

1  Incyte: U.S. rights;  
  Novartis: ex U.S. rights
2  Novartis: worldwide rights

3  Lilly: worldwide rights
4  Formerly INCB18424
5  Formerly INCB28050

Incyte developed  ruxolitinib internally,

advanced  the compound through the clinic, 

and is prepared to make a difference 

in the lives of patients who suffer from myelofibrosis.

BOARD  OF   
DIRECTORS

EXECUTIVE   
MANA GEMEN T

STOCKHOLDER   
IN FORMATION

Market Information
Incyte’s Common Stock trades 
on The Nasdaq Global Market 
under the symbol INCY.

Investor Relations
You can obtain recent press 
releases and other publicly 
available information on  
Incyte by visiting our web site 
at www.incyte.com.

Contact
Pamela Murphy 
Vice President,  
Investor Relations and  
Corporate Communications
Email: pmurphy@incyte.com

Corporate Headquarters
Incyte Corporation
Experimental Station
Route 141 & Henry Clay Road
Building E336
Wilmington, Delaware 19880
302.498.6700

© 2011 Incyte Corporation.  
All rights reserved.

Transfer Agent and Registrar
BNY Mellon  
Shareowner Services 
PO Box 358015 
Pittsburgh, PA 15252-8015
or 
480 Washington Boulevard 
Jersey City, NJ 07310-1900 
Phone: 800.851.9677

TDD for Hearing Impaired: 
800.231.5469

Foreign Shareowners: 
201.680.6578

TDD Foreign Shareowners: 
201.680.6610

www.bnymellon.com/ 
   shareowner/equityaccess

Annual Meeting
The Annual Meeting of 
Stockholders will be held 
May 20, 2011, at 10:00 a.m., 
Eastern Daylight Time, at 
the Hotel du Pont, 11th and 
Market Streets, Wilmington, 
Delaware 19801.

Outside Counsel
Pillsbury Winthrop Shaw  
Pittman LLP

Independent Registered  
Public Accounting Firm
Ernst & Young LLP

Richard U. De Schutter
Chairman of the Board 
Formerly Chairman and  
Chief Executive Officer 
DuPont Pharmaceuticals 
Company

Paul A. Friedman, M.D.
President and  
Chief Executive Officer 
Incyte Corporation

Barry M. Ariko
Formerly President, Chief  
Executive Officer and Chairman 
Mirapoint, Inc.

Julian C. Baker
Managing Member 
Baker Bros. Advisors, LLC

Paul A. Friedman, M.D.
President and  
Chief Executive Officer

Patricia S. Andrews
Executive Vice President and 
Chief Commercial Officer

David C. Hastings
Executive Vice President and 
Chief Financial Officer

Reid M. Huber, Ph.D.
Senior Vice President,  
Discovery Biology 

Richard S. Levy, M.D.
Executive Vice President and 
Chief Drug Development and 
Medical Officer

Paul A. Brooke
Founder and Managing Director 
venBio LLC

Brian W. Metcalf, Ph.D.
Executive Vice President and 
Chief Drug Discovery Scientist

Patricia A. Schreck
Executive Vice President and 
General Counsel

Paula J. Swain
Executive Vice President,  
Human Resources

Wenqing Yao, Ph.D.
Senior Vice President,  
Discovery Chemistry

Wendy L. Dixon, Ph.D.
Formerly Chief Marketing  
Officer and President,  
Global Marketing  
Bristol-Myers Squibb Company

John F. Niblack, Ph.D.
Formerly Vice Chairman and 
President of Global Research 
and Development 
Pfizer Inc. 

Roy A. Whitfield
Formerly Chairman of the Board 
and Chief Executive Officer 
Incyte Corporation

FORWARD-LOOKING STATEMENTS

Except  for  the  historical  information  set  forth  herein,  the  matters  set  forth  in  this  annual  report,  including  statements  regarding  our  planned 
NDA submission and potential commercialization of ruxolitinib, anticipated future success in drug discovery and development, plans and expected 
timelines for advancing our drug candidates through clinical trials, NDA submission and potential commercialization, including our objectives and 
agenda for 2011, and potential therapeutic and commercial value, including attributes and indications of our drug candidates, contain predictions, 
estimates and other forward-looking statements.

These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risk that 
results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, the high degree of risk and uncertainty associated 
with drug development and clinical trials, the uncertainty associated with the regulatory approval processes, risks related to the timing of and 
patient enrollment in clinical trials, unanticipated developments in and risks related to the efficacy or safety of our compounds in clinical trials, the 
results of further research and development, risks associated with our dependence on our relationships with our collaboration partners, risks related 
to market competition, and the other risks detailed from time to time in our reports filed with the Securities and Exchange Commission, including 
our Form 10-K for the year ended December 31, 2010. Incyte disclaims any intent or obligation to update these forward-looking statements.

 
 
Incyte Corporation
Experimental Station
Route 141 & Henry Clay Road / Building E336
Wilmington, Delaware 19880
302.498.6700

www.incyte.com

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THE DRIVE TO DISCOVER.  THE EXPERIENCE TO DELIVER.

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