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FY2018 Annual Report · Incyte
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2018 Annual Report

TA B L E   O F   C O N T E N T S

  3  Letter to Stockholders  

  9  Financial Strength  

 14  Key Programs in Oncology  

  GVHD (ruxolitinib & itacitinib)

  Pemigatinib 

  Parsaclisib 

INCMGA0012

 20 Inflammation and 

  Autoimmunity (IAI)    
  Ruxolitinib Cream 

INCB54707 

  Parsaclisib

23 Partnered Products  

  Olumiant® (baricitinib) 

  Capmatinib 

25 Optionality in Discovery  

  Early Stage Portfolio

  Multiple Discovery Platforms

Incyte Research Institute

27 Corporate Responsibility  

  Patients 

  Employees 

  Community 

  Environment  

  Compliance & Transparency

37  Company Information  

  History

  Leadership Team

  Corporate Information

2

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEW 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
L E T T E R   T O 
S T O C K H O L D E R S

3
3

2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWL E T T E R   T O   S T O C K H O L D E R S

Hervé Hoppenot
Chairman and CEO

DEAR FELLOW STOCKHOL DERS, 

At Incyte, our belief is that science drives success, and specifically 
that our efforts to discover and develop novel medicines will create 
value for patients, society and stockholders. 2018 was another year 
of significant progress as we seek to build Incyte into a diversified, 
fast-growing and global biopharmaceutical company. It was also 
a year where we were reminded of the importance of having a 
diversified portfolio of products with the potential to improve the 
lives of patients with cancer and other diseases.

Before highlighting our achievements, an important—although 
disappointing—event in 2018 was the result of ECHO-301, our 
Phase 3 trial together with Merck evaluating epacadostat in 
combination with pembrolizumab, Merck’s PD-1 antagonist, for 
the first-line treatment of patients with advanced or metastatic 
melanoma. Expectations internally and within the medical 
community were high, and we were disappointed that the 
combination did not show a benefit in progression-free survival 
(PFS) over pembrolizumab monotherapy. We continue to learn 
as much as we can from the results, but this event reinforced our 
belief in the importance of having a robust portfolio of development 
projects. I’d like to now move on to our 2018 achievements. 

CONTINUING TO  DRIVE M OM EN T U M 

2018 was a year of financial strength and continued revenue growth, 
with total revenues reaching $1.9B, an increase of over 20 percent 
versus 2017. GAAP Net Income grew to a profit of $110M for 2018 
as compared to a GAAP Net Loss of $313M in 2017. 

Sales of Jakafi® (ruxolitinib) were strong in 2018, driven by demand 
in both myelofibrosis (MF) and polycythemia vera (PV).1 Iclusig® 
(ponatinib)2 continues to grow, and the royalties we receive from 
Jakavi® (ruxolitinib, from Novartis)3 and Olumiant® (baricitinib, from 
Lilly)4 are contributing more to our top-line growth each year.

4

The stories of the patients we treat inspire us to do 
better, and we are committed to maintaining our leadership 
position in the treatment of patients with myeloproliferative 
neoplasms (MPNs). We are pursuing three key strategies that aim 
to improve the outcomes of MPN patients: improved formulations 
of ruxolitinib, developing ruxolitinib-based combination therapies 
and pursuing new targets beyond JAK inhibition. I look forward to 
reporting on these initiatives next year.

Overall, we are very pleased with our progress in 2018 and are 
increasingly confident in our potential to drive additional top-line 
growth in the near- and medium-term.

We have a broad and diversified selection of clinical 
candidates in our growing portfolio of medicines in both 
oncology and within inflammation and autoimmunity.

O PP ORTU N ITIES   FOR NEA R-TE RM  GROWT H

We are proud to have a growing portfolio in both oncology and 
within inflammation and autoimmunity. This includes multiple 
late-stage projects that we believe have significant potential on a 
standalone basis and, collectively, have the potential to transform 
Incyte into a company with multiple approved products in the U.S., 
Europe and Japan, driving significant revenue growth over the 
next several years.

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWL E T T E R   T O   S T O C K H O L D E R S

GRAFT-V ERSU S-HOST D ISEAS E  ( GVH D )

INF LAM MATI ON AND  AUTO IMM UNIT Y  (I AI)

Ruxolitinib (JAK1/JAK2) is currently being reviewed by the U.S. 
Food and Drug Administration (FDA) for use in steroid-refractory 
acute GVHD and, in collaboration with Novartis, is currently being 
evaluated in two global Phase 3 trials in steroid-refractory acute 
and chronic GVHD.

Itacitinib (JAK1) is in Phase 3 trials in patients with treatment-naïve 
acute and treatment-naïve chronic GVHD. Itacitinib represents a 
significant opportunity for Incyte, as it is being studied in the first-line 
setting where approximately 15,000 new patients are diagnosed 
each year in the U.S., Europe and Japan.

TARGETED THER APIES

Pemigatinib (FGFR1/2/3) has shown promise in certain cancers 
with activating FGF/FGFR alterations. Registration-directed trials in 
patients with cholangiocarcinoma, bladder cancer and 8p11 MPN 
are all ongoing. We expect to file a New Drug Application (NDA) with 
the FDA in cholangiocarcinoma this year.

Phase 2 trials of parsaclisib (PI3Kδ) for the treatment of patients 
with follicular lymphoma, marginal zone lymphoma and mantle cell 
lymphoma are all ongoing. Data are expected to be available in 2020.

IMMUNO-ONCOLO GY

INCMGA0012 (PD-1) is being developed in collaboration with 
MacroGenics and is currently in registration-directed trials in patients 
with MSI-high endometrial cancer, Merkel cell carcinoma and anal 
cancer. Initial data are expected in 2020.

We see multiple opportunities in inflammation and autoimmunity (IAI) 
and are advancing a number of clinical programs. Our most advanced 
IAI program is for ruxolitinib cream, which is being evaluated in a 
Phase 3 trial in patients with mild-to-moderate atopic dermatitis (AD) 
as well as a Phase 2 trial in patients with vitiligo.

PART NE RE D  P ROJECTS

We have two partnered product candidates, baricitinib (JAK1/JAK2, 
Lilly) and capmatinib (MET, Novartis)5. In June, we, along with Eli 
Lilly, announced that the FDA approved Olumiant (baricitinib) for 
the treatment of rheumatoid arthritis (RA). Baricitinib is also being 
developed in several other indications. Earlier in 2019, the readouts 
of the first two Phase 3 trials of baricitinib in patients with AD were 
announced and showed that the trials achieved their primary 
endpoints. Additionally, data from capmatinib in patients with non-
small cell lung cancer (NSCLC) with MET exon 14 skipping mutations 
were presented at the European Society for Medical Oncology 
(ESMO) 2018 Congress, and Novartis has stated that it plans to 
submit an NDA in this indication this year.

AN T ICIPATED   REGU LATO RY  AC TI ONS

We are anticipating the decision from the FDA for potential approval 
of Jakafi in steroid-refractory acute GVHD in the coming months, 
which, if approved, would make it the first and only approved 
treatment for patients with acute GVHD that have had an inadequate 
response to steroids. In the next 6-18 months, we are also expecting 
to submit NDAs to the FDA for pemigatinib and itacitinib, and we are 
expecting Novartis to submit the NDA for capmatinib. Should these 
drug candidates achieve FDA approval, a total of five molecules 
discovered by Incyte scientists will have been approved and available 
to patients, which would be a fitting testament to the expertise of 
our world-class biologists and chemists.

5

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWIn closing, 2018 represented another year of marked financial, 
research and organizational progress. Together, we will continue 
to strive to make a meaningful difference for those living with 
cancer and other diseases, and in doing so, we aim to create 
long-term and sustainable value for you, our stockholders.

I thank you for your continued support and look forward to 
keeping you updated on our progress and achievements.

Sincerely,

Hervé Hoppenot 
Chairman and CEO

L E T T E R   T O   S T O C K H O L D E R S

INVESTING IN OUR PEO PLE A ND  M A I NTAI N IN G 
OUR CULTURE 

In 2018, Incyte grew to a company of over 1,300 employees, 
including more than 600 world-class medicinal scientists. We also 
had the opportunity to strengthen our executive management 
team with three new members. First, we welcomed Maria 
Pasquale, J.D., as our General Counsel in April. Ms. Pasquale 
has nearly 20 years of legal and compliance experience in the 
biopharmaceutical industry and most recently held the position 
of Global Chief Compliance Officer at Celgene Corporation. We 
were excited to also welcome Dashyant Dhanak, M.D., to the 
team as our Chief Scientific Officer in December. Dr. Dhanak 
joined us from Janssen Research & Development, where he most 
recently served as Global Head, Discovery Sciences. In February 
2019, we welcomed Christiana Stamoulis as our new Chief 
Financial Officer. Ms. Stamoulis has over 20 years of experience 
in the biopharmaceutical industry, 15 in investment banking and 
management consulting and thereafter in executive positions 
at Vertex Pharmaceuticals and most recently serving as the 
President and CFO of Unum Therapeutics. We believe their diverse 
backgrounds and proven leadership will be great assets for Incyte 
as we embark on our next stage of growth.

We are committed to maintaining a culture that is driven by a 
passion for innovative science and where patients are at the 
forefront of everything we do.

The collective experience and passion of our talented colleagues 
is foundational to our success, and as our organization continues 
to grow, we are committed to maintaining a culture that is driven 
by a passion for innovative science and where patients are at 
the forefront of everything we do. As such, we were proud to 
be recognized in October as the number two employer in the 
biopharma industry by Science magazine.

Forward-looking statements: Safe Harbor rules govern any forward-looking statements made in this Annual Report; for more information, please visit page 41.

6

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEW 
CAM  &  JAN E ON LIFE WITH 
POLYCYTHEMIA VERA (PV)

For Cam and Jane, navigating life together is an important concept. Married for more 
than 43 years, they’ve raised four children and watched nine grandchildren enter the 
world. Together, they are dedicated to carrying on the legacy of Cam’s fifth-generation 
family farm and recycling business. Mornings start early, with Jane feeding animals and 
Cam operating machinery or working in the fields to prepare the season’s harvest. Each 
day requires a high level of activity and brings a new challenge, but despite the long and 
hard days, they always make time for family. And, whenever they have the chance, they 
pursue passions such as riding Cam’s motorcycle or taking a weekend trip in their RV. 

Unfortunately, Cam and Jane have navigated a few complicated health journeys, 
including Cam’s diagnosis of a rare blood cancer called polycythemia vera (PV) –  
a disease that is part of a group of blood cancers known as myeloproliferative 
neoplasms (MPNs) – which causes blood to thicken, resulting in a variety of impacts 
on the body. 

“I was diagnosed with PV because I noticed impacts on my hearing, extreme itchiness 
after getting out of the shower and also had intense night sweats,” said Cam.

Over the next eight years, with the guidance of his doctor, Cam’s PV was treated with 
phlebotomies – a procedure to draw blood from the body – and then hydroxyurea, 
a chemotherapy agent and common treatment option for PV. Unfortunately, these 
treatments weren’t working.

“It was hard to see Cam lacking energy – it really had an impact on his daily life. 
He didn’t have any interest in doing the things around the farm and with family that  
have always made him happy,” said Jane. 

With Jane at his side and the continued support of his MPN specialist, Cam was 
ultimately prescribed Jakafi to treat his PV.

Over time, Cam got back to doing the things that he loves.

“Though he never stopped working, he really was a different person. I’m thankful that 
today he is feeling better,” said Jane.

Cam’s tenacity and Jane’s unwavering support of him throughout 
this journey are an inspiration for all of us at Incyte. They are also a reminder of 
why every day we remain committed to following the science to discover and  
deliver novel medicines that may improve the lives of patients. 

7

2 0 1 8   Y E A R   I N   R E V I E W

I N C Y T E   2 0 1 8   A N N U A L   R E P O R T

O B J E C T I V E S   B E F O R E   E N D   O F   2 0 1 9
2019 newsflow for key development projects

PLANNED REGULATORY 
UPDATES

PL ANNED PIVOTAL   
CLINICAL UPDATES

P LAN NE D   PI VOTAL 
TRI AL   IN ITIATION S

ruxolitinib 
(JAK1/JAK2) 

Achieve FDA approval 
for steroid-refractory 
acute GVHD (REACH1)6

baricitinib 
(JAK1/JAK2)

Phase 3 atopic 
dermatitis results to be 
reported by Lilly

ruxolitinib 
cream 
(JAK1/JAK2)

Atopic dermatitis  
(TRuE-AD1, TRuE-AD2)

pemigatinib 
(FGFR1/2/3)

Submit NDA for 
cholangiocarcinoma 
(FIGHT-202)7

itacitinib 
(JAK1)

Phase 3 treatment-naïve 
acute GVHD results 
(GRAVITAS-301)

itacitinib  
(JAK1)

Treatment-naïve chronic 
GVHD (GRAVITAS-309)

capmatinib 
(MET)

NDA for NSCLC to be 
submitted by Novartis

ruxolitinib 
(JAK1/JAK2)

Phase 3 steroid-refractory 
acute GVHD results 
(REACH2)

pemigatinib 
(FGFR1/2/3)

1L cholangiocarcinoma 
(FIGHT-302)

ruxolitinib 
(JAK1/JAK2)

Phase 3 steroid-refractory 
chronic GVHD results 
(REACH3)

ruxolitinib 
cream 
(JAK1/JAK2)

Vitiligo, if Phase 2 
is positive

pemigatinib 
(FGFR1/2/3)

Phase 2 cholangiocarcinoma 
data (FIGHT-202)

pemigatinib 
(FGFR1/2/3)

1L bladder cancer

pemigatinib 
(FGFR1/2/3)

Phase 2 bladder cancer 
to complete recruitment 
(continuous dosing cohort, 
FIGHT-201)

pemigatinib 
(FGFR1/2/3)

Solid tumors with driver 
activations of FGF/FGFR

Milestones that have 
been achieved as of 
March 25, 2019.

8

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWF I N A N C I A L   S T R E N G T H

9

2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEW 23%

TOP LINE GROWTH

3 

CONTINENTS

 13

COUNTRIES

#7 

MOST INNOVATIVE 
COMPANY

>1,300

EMPLOYEES

6

ASSETS IN 
LATE-STAGE 
DEVELOPMENT

$1.9B 

TOTAL REVENUE

#2 

MAGAZINE
TOP EMPLOYER 
IN BIOPHARMA

4 

SOURCES 
OF REVENUE

 $1.4B

IN CASH, CASH 
EQUIVALENTS 
& MARKETABLE  
SECURITIES

 17 

YEARS OF DRUG 
DISCOVERY & 
DEVELOPMENT

10

INCYTE AT A GLANCEINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWF I N A N C I A L   S T R E N G T H

SIGNIFICANT TOP-LINE MOMENTUM FROM FOUR SOURCES OF REVENUE

REVENUE GROWTH IN 2018

+22%

+19%

ROYALTY GROWTH IN 2018

+28%

+340%

JA KAFI (RUXOLIT INIB)

Patient demand for Jakafi (JAK1/JAK2 inhibitor) for the treatment of MF and PV remains strong as it enters its seventh full year 
on the market, with net product revenues totaling $1.39B in 2018. The total number of patients on therapy grew to over 13,000 
patients at the end of 2018—an increase of nearly 2,000 patients from the end of 2017. 

11

FY 2015Product-Related Revenue (U.S. $M)2,0001,5001,000500FY 2014FY 2016FY 2017FY 20180Olumiant royaltiesJakavi royaltiesIclusigJakafiProduct-related revenue excludes milestone revenue. Jakavi (ruxolitinib) licensed to Novartis ex-U.S., Olumiant (baricitinib) licensed to Lilly worldwide; these brands are registered trademarks of Novartis (Jakavi) and Lilly (Olumiant), respectively. Iclusig is a registered trademark of ARIAD Pharmaceuticals. INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWF I N A N C I A L   S T R E N G T H

M AI NTAINING OUR 
LEA DERSHIP IN MPNs
We are committed to the treatment of patients with MPNs. 
As such, we are continuing our work toward discovering 
and developing therapeutic options with a goal to improve 
the outcomes for this group of patients in three ways:

1

IMPROVED  FORMULATIONS

Ruxolitinib is the first JAK inhibitor approved for the treatment 
of MF, but its efficacy can often be associated with cytopenia. 
It is possible that the severity of cytopenia is in part driven by 
the peak concentration of ruxolitinib immediately following a 
dose. Some evidence8 suggests that an extended-release 
formulation of ruxolitinib may decrease cytopenia and therefore 
improve the side-effect profile for some patients. To that end, 
we are currently working to develop an extended-release 
formulation of ruxolitinib.

PHASE 2 INVESTIGATOR-INITIATED TRIAL EVALUATING AN  
EXTENDED-RELEASE FORMULATION OF RUXOLITINIB SHOWED LOWER MEAN  
PEAK TO TROUGH PLASMA CONCENTRATIONS IN PATIENTS WITH MF

Verstovsek et al, Hematological Oncology 2018

12

2

3

R U XOL ITI NI B- BASE D CO MBINATION  T H ER APY

Ruxolitinib
+
PI3Kδ-1

In pivotal trials, ruxolitinib has been shown to reduce spleen size 
and improve symptoms in intermediate- or high-risk MF patients. 
However, there are some patients who have only suboptimal responses or declining 
activity over time. We have three ongoing clinical initiatives evaluating ruxolitinib- 
based combinations to improve responses or to drive patients back into response 
once they’ve begun to fail. Activation of the PI3K pathway has been reported in 
patients with MF.9,10 Preliminary data of ruxolitinib in combination with parsaclisib 
(PI3Kδ) were presented at the 60th American Society of Hematology (ASH) Annual 
Meeting in 2018. These data suggested that the addition of PI3Kδ inhibition to 
ruxolitinib has the potential to improve outcomes in heavily pre-treated and refractory 
MF. The preliminary data showed reductions in spleen volume at weeks 12 and 24 
in these patients, and additional dosing work is underway. We expect data from 
additional cohorts of patients later this year. Initial data from ruxolitinib in combination 
with our PIM inhibitor (INCB53914) and with our JAK1 selective inhibitor (itacitinib) 
are also expected to be available in 2019 or early 2020.

SPLEEN VOLUME REDUCTION IN PHASE 2 TRIAL OF RUXOLITINIB 
PLUS PARSACLISIB IN REFRACTORY MF PATIENTS

Daver et al, ASH 2018

N EW  TAR GETS

Early target discovery work is underway internally as well as through collaborative 
initiatives with academia and industry, including Syros Pharmaceuticals, Vanderbilt 
University and The Moffitt Cancer Center, that may uncover new targets to better 
help patients with MPNs over the longer term.

1,000Concentration, nMHours Postdose100100369Patients, nSR 25 mg QDIR 5 mg BID3733SR 25 mg QDIR 5 mg BID37373737373722222222Week 12 (n = 27)*• Patients with reduced spleen volume: 56% (15/27) • Median (range) reduction: –10.9% (–26.6% to –1.29%)Week 24 (n = 19)†• Patients with reduced spleen volume: 63% (12/19)• Median (range) reduction: –8.8% (–41.5% to –0.55%)Percent Change from Baseline Percent Change from Baseline –25–5002550–25–500255012 patients are not shown; 4 patients did not have spleen volume measurements due to treatment discontinuation, 8 patients had not reached the response assessment at the time of the data cutoff date. † patients not shown; all did not have spleen volume   measurements due to treatment discontinuation. *INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWF I N A N C I A L   S T R E N G T H

ICLUSIG  (PONATINIB)

Sales of Iclusig, a potent BCR-ABL inhibitor designed to address mutation-driven resistance in patients with 
treatment-resistant chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic 
leukemia (Ph+ ALL), have grown nicely and increased 19 percent in 2018 versus 2017. Over 20 percent of patients 
with BCR-ABL-mutated CML have the T315I mutation, which has been associated with resistance to treatment and 
poor outcomes. Iclusig is the only drug currently approved in Europe with activity against T315I.

ROYALTIES FROM JAKAVI (RU XOL ITI NIB )  AN D   
OLUMIANT (BARICITINIB ) 

Jakavi royalties have grown strongly, and royalties from Olumiant (JAK1/JAK2), which is now approved 
in multiple territories globally for the treatment of certain patients with moderate to severe RA, are 
growing each quarter. Olumiant was launched in the U.S. during 2018. 

STR ONG BALANCE SHEET

Financially, we are in a strong position, reporting a total of $1.4B in 
cash, cash equivalents and marketable securities at the end of 2018. 

13

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWK E Y   P R O G R A M S   
I N   O N C O L O G Y

14
14

2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWK E Y   P R O G R A M S   I N   O N C O L O G Y

GR AFT-VERSUS-HOST  DISEAS E  (GV H D)

We believe that JAK inhibition has significant potential as a treatment 
for GVHD, and we have two pivotal programs that span several 
aspects of this devastating and often fatal disease. 

In February 2019, the FDA extended the review period by three 
months for the sNDA of ruxolitinib for use in patients with acute 
GVHD who have had an inadequate response to corticosteroids.6 
REACH1 data provided the basis for this application, and these data 
were highlighted in an oral presentation at the 60th Annual ASH 
Meeting in December.

Results from two global Phase 3 trials in collaboration with Novartis –
REACH2 and REACH3, evaluating ruxolitinib in steroid-refractory 
acute GVHD and steroid-refractory chronic GVHD, respectively – 
are expected to be available this year. 

PIVOTAL REACH1 DATA OF RUXOLITINIB IN 
STEROID-REFRACTORY ACUTE GVHD PATIENTS 

Median time to first response was 7 days. Median duration of response was 345 days.

Day 28 responders

Other responders

s
r
e
d
n
o
p
s
e
R

CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
CR
VGPR
PR
CR
CR
CR
CR
VGPR
CR
CR
VGPR
CR
CR
PR
CR
CR
VGPR
CR
PR
CR
CR
CR
CR
CR
PR
CR
PR
VGPR
PR

First Response
Progressive Disease
Death
New anti-aGVHD therapy started
Censored
Last dose of ruxolitinib for patients
that have ended treatment

0

28

56

84

112

140

168

196

224

252

280

308

336

364

392

420

448

476

Day

15

Jagasia et al, ASH 2018

PHASE 1 PROOF-OF-CONCEPT TRIAL OF 
ITACITINIB IN PATIENTS WITH GVHD

ITACITINIB (200mg and 300mg dose groups, combined)

RESPONSE  
N (%)* 

FIRST-LINE  
(N = 12)

STEROID-REFRACTORY  
(N = 17)

Complete response (CR)

8 (66.7)

Very Good Partial Response (VGPR)

0

Partial Response (PR)

2 (16.7)

3 (17.6)

1 (5.9)

7 (41.2)

OVERALL RESPONSE** 

10 (83.3)

11 (64.7)

* Last response data available on or before Day 28. 
** Patients with complete response, very good partial response, or partial response.
Responses were graded according to CIBMTR (Center for International Blood and Marrow Transplant Research) 
response criteria. The treatment population was limited to patients who received study treatment. 
Schroeder et al, ASH 2016

We believe itacitinib has significant potential as a first-line 
treatment for GVHD, as approximately 15,000 new GVHD patients 
are diagnosed each year in the U.S., Europe and Japan. In the 
initial proof-of-concept trial, itacitinib showed an overall response 
rate of over 80 percent in patients with acute GVHD who had not 
yet been treated with steroids. We look forward to sharing 
the results of GRAVITAS-301, a Phase 3 trial evaluating itacitinib in 
steroid-naïve acute GVHD, later this year. The GRAVITAS-309 trial 
was initiated in January 2019 and will evaluate itacitinib as a 
first-line treatment in patients with chronic GVHD.

We are hopeful that the Phase 3 trials of itacitinib and ruxolitinib 
will support our hypothesis that these compounds may provide 
significant therapeutic benefit for patients suffering from GVHD.

FINANCIAL STRENGTHINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWK E Y   P R O G R A M S   I N   O N C O L O G Y

PEMIGATINIB

Pemigatinib is a potent and selective FGFR1/2/3 inhibitor, which 
is currently in development for patients with cholangiocarcinoma, 
bladder cancer and 8p11 MPN. At ESMO 2018 in October, preliminary 
data were presented from FIGHT-201 (bladder cancer) and FIGHT-202 
(cholangiocarcinoma). Data from FIGHT-203 (8p11 MPN) were 
presented at ASH 2018. Safety data from all three trials suggest that 
pemigatinib has a manageable safety profile. Pending additional data 
that would support an NDA filing, we are hopeful that second-line 
cholangiocarcinoma may be the first FDA-approved indication for 
pemigatinib, potentially followed by bladder cancer and 8p11 MPN. 
We are also preparing a development program focusing on a tumor-
agnostic, FGFR-altered, disease indication in the future, and we 
expect that program to be initiated this year.

C HO LANG IOCAR CINOM A

We are studying pemigatinib as a first- and second-line therapy for 
patients with FGFR2 translocated cholangiocarcinoma through the 
FIGHT-302 and FIGHT-202 studies, respectively.

Recruitment into the FIGHT-202 trial in patients with cholangio-
carcinoma is complete, and we are now waiting for the data from 
the trial to mature. Data presented from the Phase 2 FIGHT-202 
trial at ESMO 2018 showed an overall response rate of 40 percent 
and a median PFS of greater than nine months. Importantly,  all 
tumor response data were assessed by independent review  
per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

FIGHT-202 PHASE 2 DATA OF PEMIGATINIB IN PATIENTS 
WITH CHOLANGIOCARCINOMA (COHORT A)

16

 Hollebecque et al, ESMO 2018

6040*200-20-100-40-80-60Best Percent Change from Baseline in Target Lesion SizeIntermittent dosing: ORR 40%, DCR 85%N = 44: excludes 3 patients (n = 1 NE, patient died before the first assessment, n = 2 SD, no target lesions)* Patient had a response of SD, and a best percentage change from baseline of 0.0%= PD= SD= PR= NEINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWK E Y   P R O G R A M S   I N   O N C O L O G Y

CHOLANGIOCAR CINOMA  CONT INU ED

If the data continue to evolve as we expect, we intend to submit 
an NDA seeking approval of pemigatinib in second-line FGFR2 
translocated cholangiocarcinoma this year. We were happy to 
announce in February 2019 that the FDA granted pemigatinib 
Breakthrough Therapy designation for the treatment of previously 
treated, advanced/metastatic or unresectable FGFR2 translocated 
cholangiocarcinoma. Breakthrough Therapy designation is utilized 
to expedite the development and review of drugs for serious 
conditions that have shown encouraging early clinical results and 
may demonstrate substantial improvements over available medicines. 
We plan to expand this program with FIGHT-302, a Phase 3 trial 
in first-line cholangiocarcinoma.

BLADD ER CA NCER

Encouraging data from the ongoing trial in bladder cancer, FIGHT-201, 
were also presented at ESMO 2018. It is important to note that 
the data were from the cohort receiving intermittent dosing. The 
FIGHT-201 protocol has since been amended to allow continuous 
pemigatinib dosing, which we anticipate may further improve 
response rates. This cohort is expected to complete recruitment later 
this year. If these data are positive, they could form the basis for a 
regulatory submission seeking approval of this second indication in 
the U.S. We are also planning to initiate a pivotal program in first-line 
bladder cancer later this year.

FIGHT-201 PHASE 2 DATA OF PEMIGATINIB IN PATIENTS 
WITH BLADDER CANCER (INTERMITTENT DOSING)

Hollebecque et al, ESMO 2018

8P11  M PN

At ASH 2018, data were presented from the FIGHT-203 study of 
pemigatinib in patients with 8p11 MPN, an ultra-orphan cancer. Of 
the 13 evaluable patients in the trial, 11 (85 percent) achieved clinical 
response, including clinical and cytogenetic responses.

FIGHT-203 PHASE 2 DATA OF PEMIGATINIB 
IN PATIENTS WITH 8P11 MPN

BEST RESPONSES

ORR

CR (N)

PR (N)

CLINICAL RESPONSESa

85%

CYTOGENETIC RESPONSESb

77%

7

6

4

4

a  CR, bone marrow with <5% blasts and normal cellularity, normal CBC, complete resolution of EMD; 
PR, same as CR except 50% reduction of bone marrow blasts (and blast equivalents), but with <5% 
remaining fibrosis and dysplasia. 

b  CCyR, 0% abnormal metaphases; PCyR, decrease of ≥50% of abnormal metaphases. 

Verstovsek et al, ASH 2018

17

80604020-20-40-60-800Percent Change from Baseline in Target Lesion SizeOrange bars = partial response.       * FGFR3 fusions.******INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWCITADEL PHASE 2 DATA OF PARSACLISIB IN NHLS

K E Y   P R O G R A M S   I N   O N C O L O G Y

PA RSACLISIB 

PI3Kδ inhibition is a potent therapeutic mechanism with the 
potential for broad application across multiple diseases. At our 
2018 Investor & Analyst Event in June, we touched on multiple 
areas where our investigational novel oral inhibitor of PI3Kδ inhibitor, 
parsaclisib, could provide benefit to patients both as monotherapy 
and in combination with other agents.

The CITADEL program for oncology indications is currently 
evaluating parsaclisib in several ongoing Phase 2 trials as a 
monotherapy for non-Hodgkin lymphomas: follicular (FL), marginal 
zone (MZL) and mantle cell lymphomas (MCL). In Phase 1, we were 
encouraged to see responses in these three diseases, but we also 
saw some immune-related and likely on-target toxicities after several 
months on therapy. The dosing regimen has since been adjusted, 
and data presented at ASH 2017 suggested this adjustment may 
enable patients to remain on therapy and hence potentially continue 
to benefit from the potent activity of the molecule. We look forward 
to sharing these evolving data as they become available, and we 
expect that we will start to see additional data in 2020. Each of 
these trials is designed to support a registration in the U.S. if they 
are successful. 

CITADEL PHASE 2 DATA OF PARSACLISIB IN NHLS

FL
MZL
MCL
MCL patients who received prior ibrutinib treatment

IB

100

50

0

-50

-75

e
n

i
l

e
s
a
B
m
o
r
f
e
g
n
a
h
C

t
n
e
c
r
e
P

e
z
i
S
n
o
i
s
e
L
t
e
g
r
a
T
n

i

-100

Forero-Torres et al, ASH 2017

18

Forero-Torres et al, ASH 2017

024681012141618202224Duration of Treatment, MonthsIBFLMZLMCLSwitch to QW dosingPDTreatment ongoingDiscontinued treatment due to AEPrior ibrutinibAEPatientsINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEW 
 
 
 
 
 
 
K E Y   P R O G R A M S   I N   O N C O L O G Y

INCMGA0012

INCMGA0012 is a PD-1 antagonist that we are developing in 
collaboration with MacroGenics. 

Last year, we declared our intent to run three registration-directed 
development efforts for INCMGA0012 monotherapy. These 
initial studies are being conducted in patients with microsatellite 
instability-high (MSI-high) endometrial cancer, Merkel cell carcinoma 
and anal cancer. We expect to report initial data in 2020.

Harnessing our own portfolio, we are also planning studies 
using INCMGA0012 in combination with both small molecules and 
monoclonal antibodies. We expect that having an in-house PD-1 
antagonist will speed our decision making and could obviate the 
need to either buy supply from a third party and/or to unnecessarily 
share any plans or data with third parties.

PD1 Clinical Program in Multiple Malignancies

Anne Guntz, Senior Director, Human Resources

“It’s all about the patients. For people that are in my position and not 

directly working on drug development, it could be easy to lose sight of why 

you’re there. I love our Town Hall meetings as there are often presentations 
given by patients, and I’m reminded why I do what I do. It’s inspiring to think that 

my colleagues could invent the next life-saving drug.”

19

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWI N F L A M M AT I O N 
A N D   A U T O I M M U N I T Y

20
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2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWI N F L A M M AT I O N   A N D   A U T O I M M U N I T Y   ( I A I )
Capitalizing on our drug discovery and immunology expertise, we have established 
a specialty-focused effort in inflammation and autoimmunity.

R UXOLITINIB CREAM 

The most advanced IAI project is with our cream formulation 
of ruxolitinib, which has shown promise in AD and vitiligo. 

Phase 2 data of ruxolitinib cream in patients with mild-to-moderate 
AD were presented in September at the European Academy of 
Dermatology and Venerology Annual Meeting (EADV) in Paris. 
The data showed rapid improvements in itch for patients on 
ruxolitinib cream versus both placebo and steroid cream, which 
were seen as early as two days after the first usage, as seen in 
the chart below. These responses, as well as the main efficacy 

endpoints based on Eczema Area and Severity Index 
(EASI) and Investigator’s Global Assessment (IGA), were 
statistically and clinically meaningfully superior to vehicle 
cream, and the treatment was not associated with any 
notable safety or tolerability findings.

As a result of these promising data, we have already initiated 
a Phase 3 program in patients with mild-to-moderate AD. 
We expect the results of this program to be available in 2020.

PHASE 2 DATA OF RUXOLITINIB CREAM IN PATIENTS 
WITH MILD-TO-MODERATE ATOPIC DERMATITIS

Kim et al, EADV 2018

21

Mean Change from Baseline in Daily Itch NRS ScoreStudy DayPHASE 2 DATA OF RUXOLITINIB CREAM IN PATIENTS WITH MILD-TO-MODERATE ATOPIC DERMATITISVehicle BIDRUX 0.15% QDTAC 0.1% BIDRUX 0.5% QDRUX 1.5% QDRUX 1.5% BIDB0-0.5-1-1.5-2-2.5-3-3.5-4-4.5-52345678910111213141516171819202122232425262728INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWI N F L A M M AT I O N   A N D   A U T O I M M U N I T Y   ( I A I )

R UXOLITINIB CREAM  CO NT INUE D 

INCB547 07 

Ruxolitinib cream also has potential as a treatment for patients 
with vitiligo, which is a skin disorder characterized by patchy 
depigmentation of skin, in particular the face, neck and scalp. 
It is estimated to affect 2-3 million patients in the U.S., but only 
about 150,000 patients are currently seeking treatment, which 
is likely due to the fact that there are no approved therapies. 

A small, investigator-initiated proof-of-concept trial of ruxolitinib 
cream showed promising results, with a 23 percent improvement 
in the mean vitiligo area scoring index (VASI) score across the 11 
patients participating. Importantly, four of these patients had a 
76 percent improvement in the facial area severity score. As this 
disease can be cosmetically disfiguring with associated quality-
of-life changes, including depression and anxiety, these results 
encouraged us to launch a randomized, double-blind, vehicle-
controlled Phase 2 study of ruxolitinib cream in patients with 
vitiligo. The trial is ongoing, and we expect to announce initial 
data this year. If the study results are positive, we expect to 
move ahead into a Phase 3 program in this condition.

INDEPENDENT PROOF-OF-CONCEPT TRIAL OF 
RUXOLITINIB CREAM IN PATIENTS WITH VITILIGO

BAS E L INE

W E EK  8

WEEK  2 0

INCB54707 is a differentiated JAK1 inhibitor due to its selectivity 
as well as its longer half-life compared to ruxolitinib or itacitinib. 
We have initially chosen to study INCB54707 in hidradenitis 
suppurativa, which is an inflammatory skin disease characterized 
by lesions in the axilla, in the groin and under the breast area as a 
result of inflammation and infection of the sweat glands. A Phase 2 
trial is now underway.

PARSACLISIB

We are beginning to study PI3Kδ inhibition across a variety of 
B-cell mediated and antibody-driven diseases beyond oncology. 
We believe that there’s potential to differentiate from anti-CD20 
antibodies based upon the mechanisms of action and the ability 
for reversible suppression versus long-lasting depletion. 

The first indication is autoimmune hemolytic anemia, which occurs 
when the immune system makes antibodies that attack red blood 
cells. Symptoms include weakness and fatigue with tachycardia 
and breathing difficulties, jaundice, dark urine and/or splenomegaly. 
We will also be studying PI3Kδ inhibition in Sjögren’s syndrome, a 
disease characterized by extreme dryness as a result of destruction 
of the lacrimal and salivary glands, which can result in debilitating 
symptoms such as difficulty swallowing. 

Rothstein et al, J AmAcad Dermatol 2017

22

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWPA R T N E R E D   P R O D U C T S

23
23

2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWPA R T N E R E D   P R O D U C T S

OLUMIANT (BARICITINIB )

Baricitinib (JAK1/JAK2) was licensed to Eli Lilly in 2009 and is now approved in multiple territories globally as Olumiant for certain patients with moderate to 
severe RA. Lilly is actively developing baricitinib in other autoimmune diseases and is currently running late-stage trials in moderate-to-severe AD, systemic 
lupus erythematosus (SLE) and severe alopecia areata. Lilly announced that the first two Phase 3 trials of baricitinib in patients with AD achieved their 
primary endpoints. The additional three trials in the pivotal program are expected to read out later in 2019. Data from the trials in lupus and alopecia are 
expected in 2020 and 2021, respectively.

CA PMATINIB

Capmatinib is an oral, reversible inhibitor of the MET receptor 
tyrosine kinase, and it has shown both high selectivity for 
MET and is extremely potent against MET exon 14 skipping 
mutations compared to all other MET inhibitors in development. 
Capmatinib was licensed globally to Novartis under our 2009 
license agreement and has the potential to be the first MET-
selective inhibitor to be approved, given the promising data 
presented at ESMO 2018.

These data were from the GEOMETRY mono-1 study, being 
run by Novartis, in patients with NSCLC with MET exon 14 
skipping mutations, which occur in up to four percent of patients 
with NSCLC. The response rates seen in this 94-patient trial 
were clinically meaningful, with an overall response rate 
in second- and third-line patients of 39 percent and in first-
line the response rate was 72 percent. All data were centrally 
reviewed, and capmatinib showed a manageable safety profile 
in this challenging patient population. 

Novartis is expected to submit an NDA to the FDA for capmatinib 
in 2019, and we are proud that another Incyte-invented molecule 
appears to be on a path to potential registration.

24

GEOMETRY MONO-1 PHASE 2 DATA OF CAPMATINIB IN NSCLC 
PATIENTS WITH MET EXON 14 SKIPPING MUTATIONS

Wolf et al, ESMO 2018; waterfall plot represents 1st line patients; 2nd/3rd line patient data not shown

= PR5025n = 24+/25Confirmed ORR by blinded independent review committee (BIRC) is 72%; deep responses were observed in almost all patientsBest Percent Change in Tumor Size from Baseline* Patients still on treatment+  Number of patients with measurable disease at baseline and ≥1 post-baseline assessment0-25-50-100-75= SD***********INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWO P T I O N A L I T Y   
I N   D I S C O V E R Y

25
25

2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWO P T I O N A L I T Y   I N   D I S C O V E R Y
Incyte was founded on its expertise in biology and small molecule drug discovery, and this continues to be 
the heartbeat of the company. Indeed, the majority of the clinical candidates in our portfolio are the product of 
Incyte’s internal discovery unit. Capitalizing on this success, we have continued to increase capacity and add new 
capabilities to sustain a robust and diverse early clinical portfolio. 

EARLY STAGE PORTFOLIO

Beyond our six key late-stage projects, we have multiple candidates 
under evaluation in human proof-of-concept studies. Additionally, 
earlier in 2019, we were excited to announce two new clinical 
candidates, one of which is already being tested in cancer patients. 

INCB86550 is a first-in-class oral, small molecule PD-L1 inhibitor.  
Its preclinical efficacy profile appears comparable to anti-PD-L1 
antagonist antibodies but it also has a novel mechanism of action 
that leads to internalization of cell surface PD-L1 on cancer and 
immune cells. This may support inhibition of PD-1 and PD-L1 axis 
signaling. We believe this is an important molecule as its profile 
may allow for rapid dose titration in patients and offers the potential 
to develop all-oral combinations with other targeted agents. We 
initiated clinical testing in December of 2018.

In January 2019, Merus announced the clearance of an IND 
application for MCLA-145, a first-in-class PD-L1 x CD137 bispecific 
antibody, which is being co-developed by Merus and Incyte. The 
new agent is expected to enter the clinic in the second quarter of 
this year. Incyte holds ex-U.S. commercialization rights to MCLA-145.

M ULTIPLE DISCOVERY PLATFOR MS 

We have now established three core drug discovery platforms: 
small molecules, monoclonal antibodies and bispecific antibodies. 
We believe this multi-faceted approach in discovery allows us to 
pursue a diverse spectrum of the most promising therapeutic targets. 

To supplement our small molecule discovery capabilities, we initiated 
monoclonal antibody discovery efforts in 2015 through a discovery 

26

Incyte
Research
Institute

alliance with Agenus. This partnership was productive and has since 
yielded four clinical candidates. Incyte’s discovery team has also 
progressed its monoclonal antibodies platform internally to develop 
molecules independent of any collaborations.

We strongly believe bispecific antibodies have the potential to 
play an important role in the future of biotherapeutics and were 
excited to enter into a long-term research collaboration with 
Merus to discover and develop novel bispecific antibodies, 
including and beyond the collaboration mentioned in the 
section above. This further expands our monoclonal antibody 
discovery capabilities, which we believe will create additional 
opportunities for drug discovery over the coming years.

INCYTE  RES E ARCH IN STI TUT E

A core belief of Incyte is that close integration of both our research 
and development organizations at a single campus helps to fuel 
success. To underscore this philosophy, on January 1, 2018, we 
launched the Incyte Research Institute (IRI) located at the Wilmington, 
Delaware campus. The IRI encompasses our biology and chemistry 
discovery organizations, research laboratories and intellectual 
property teams. 

Creation of the IRI recognizes the critical role of collaborative 
scientific research in the discovery of innovative medicines at Incyte. 
We are confident the IRI will continue to be internally and externally 
recognized as an exceptionally productive discovery organization.

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E 
R E S P O N S I B I L I T Y

27
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2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y
At Incyte, in addition to our commitment to innovation and the pursuit of research and development 
excellence, we are also committed to enhancing the communities in which we operate, improving the 
treatment and experience of patients, supporting our colleagues and operating our business in a way 
that protects the environment. To learn more about Our Commitment, click here.

PATIENTS

At Incyte, we believe in the power of research to advance scientific 
innovation and improve patient health and outcomes. Every day 
we are driven to discover and deliver medicines that will positively 
impact the lives of people with cancer and other serious diseases. 
We support our patients through commitments in four key areas: 
Safety, Scientific Excellence, Access to Medicine and Education 
and Awareness.

SAFETY

Patient safety is at the forefront of all our activities. We are 
committed to adhering to the applicable laws and regulations in all 
territories in which we operate clinical trials, and to conducting 

those clinical trials in an ethical manner. We are also committed 
to the supervision of all ongoing trials through an institutional 
review board, an ethics committee and/or a research ethics 
board in an effort to protect the safety of trial participants 
before, during and after patients are treated.

our focus on data transparency from applicable trials 
through presentations of both positive and negative data 
at appropriate medical meetings and in peer-reviewed 
journals. Publication of these data is scientifically responsible 
and may serve to benefit both patients as well as the entire 
scientific community as we collectively seek to improve the 
treatment of cancer and other diseases.

The effort to bring transformative treatments to patients with 
cancer is a significant undertaking, and we are committed to 
partnering with companies, universities and research institutions 
to share knowledge, resources and ideas that may best benefit 
patients. We may also provide investigational products and/
or financial support for research by third parties related to our 
products that address therapeutic areas of interest to us. We are 
committed to ensuring that these investigator-initiated research 
trials are submitted, reviewed and, if approved, conducted and 
funded in a standardized, consistent and transparent manner.

SCIEN TIFIC EXCELLENCE 

AC C ES S TO M E DICINE

We hold our clinical research to the highest standards of 
scientific and ethical rigor, and we strive to implement programs 
and initiatives to allow for broad access to our medicines for 
appropriate patients. We execute on this commitment through 
our rigorous discovery process, our adherence to clinical trial 
standards set by the FDA and other global regulatory bodies and 

Incyte is committed to ensuring that eligible patients have access 
to applicable clinical trials by providing them with information and 
resources to support their treatment journey. 

28

FINANCIAL STRENGTHINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y

We may also choose to provide individual patients with access 
to unapproved or investigational products through Incyte’s 

compassionate use program. 

Our IncyteCARES (Connecting to Access, 

Reimbursement, Education and Support) program 
supports eligible patients in the U.S. before 
and during applicable treatment by providing 

ongoing education, resources as well as a dedicated 

nursing support program. For more information, 

please click here.

Since February 2017, Incyte has partnered with The Max 

Foundation in its drug donation program to assist patients with 
cancer in Central Asia and Eastern Europe who are unable to 

access treatment with Iclusig.

ED UCATION  AND  AWAR E NESS

Incyte is committed to providing patients with resources 
to support their treatment journey. Voices of MPN is 
a website created by Incyte to help connect MPN 

patients to information, educational programs and 

community activities as well as to provide a forum 
where people can share stories and promote 

disease awareness.

Each year, in partnership with CURE Magazine, 
Incyte sponsors the MPN Heroes® Recognition 
Program, which honors and celebrates 
individuals and organizations for their 
contributions in caregiving, community 
leadership or scientific advances in the MPN 
community. To learn more about our efforts, 
please click here.

In 2018, Incyte launched CML Life, a patient 
support program for patients in Europe suffering 
from chronic myeloid leukemia (CML), regardless 
of their treatment or their stage of disease. CML Life 
seeks to help patients, caregivers and heath care professionals 
better understand and manage CML from diagnosis to 
treatment, with the goal of facilitating treatment engagement 
and adherence. This program has been co-created and co-
developed with the patients that may eventually be using 
it, as well as the health care professionals who may also be 
supporting its use. For more information, please click here. 

Musa Nsereko, Executive Director, Biostatistical Programming

“I volunteer with Serviam Girls Academy to help them identify opportunities 
to introduce underserved young girls and teens to STEM (Science Technology 
Engineering Math) subjects. We identify opportunities for scientists and science-based 
companies to meet with the girls to learn more about possible careers, and recently, Incyte 
hosted the group here. Seeing how involved Incyte is in the community here in Delaware 
has inspired me to become more involved as well.”

29

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y

EMPLOYEES

Incyte is committed to ensuring our colleagues are happy and 
healthy. We promote an inclusive company culture grounded in 
scientific excellence and foster a collaborative, innovative and 
respectful work environment in which everyone can contribute to 

their fullest potential. We appreciate, celebrate and thrive on one 
another’s differences and strengths and are proud to be an 

Equal Opportunity Employer. 

In 2018, Incyte was proud to be recognized as the 

number two employer in the biopharma industry by 
Science magazine. The Science and Science Careers’ 

2018 annual Top Employers Survey polled employees 
in biotechnology, pharmaceutical and related industries to 
determine the 20 best employers in these industries as well 

as their driving characteristics. Respondents were asked to 

evaluate companies based on 23 different characteristics, including 

financial strength, easy adaptation to change and a research-driven 
environment. Incyte was specifically recognized by its team members 
for its innovation, work culture and respect for employees.

At Incyte, we support our colleagues in their professional 
development. Opportunities for growth are offered through 
challenging job assignments, performance management, training 
and tuition reimbursement. These opportunities enhance career 
aspirations, job satisfaction as well as personal enrichment.

Over the years, we have added numerous benefits to support our 
colleagues in their professional as well as personal endeavors. 
A competitive benefits package is offered, as well as many 
complimentary tools for health, such as on-site flu shots and a 
webinar series on the importance of sleep. A patient support program 
is another one of many complimentary benefits provided by Incyte, 
which offers broad assistance with a variety of healthcare and 
insurance-related issues to help colleagues make more informed 
healthcare decisions. 

30

Furthermore, our cafeterias provide nutrition-conscious 
meal options, helping to ensure our colleagues can make 
more informed dietary choices while at work. The addition of 
standing-desks has also helped to promote healthy living.

Incyte was specifically recognized by its team members 
for its innovation, work culture and respect for employees.

Learning seminars are often offered on-site, including nutrition and 
financial planning seminars. Additionally, Incyte offers office-based 
group fitness classes at work as well as healthy competitions, such 
as the 6-week Walking Challenge.

At the heart of Incyte’s business is the value we place on improving 
the world’s health, and a high level of environmental, health and 
safety performance is simply another expression of this value. 
A strong safety culture is a fundamental part of how we work, and 
our philosophy is that everyone at Incyte has a responsibility to 
create and maintain a safe and healthy workplace with a goal to 
reduce risk and prevent injuries. Our management team recognizes 
this responsibility and is committed to providing the resources 
necessary to achieve this goal. 

WIDTH OF BUBBLE = WORK CULTURE VALUES ALIGNED

T
C
E
P
S
E
R

100

90

80

70

NOVO-
ZYMES

MERCK 
KGAA

Regeneron

Incyte

NOVO
NORDISK

VERTEX

GENENTECH

ABBVIE

BIOCON

MODERNA

80

85

90

95

100

Reprinted with permission from American Association for the Advancement of Science (AAAS)

INNOVATION

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y

COMMUNITY

Incyte is committed to being an active participant in improving 
the communities in which we live and work. Incyte Involved is a 
program comprised of three initiatives focused on philanthropy 
as well as employee and community engagement. These include 
the Incyte Charitable Giving Foundation, the Community Service 
Program and the Matching Gifts Program. 

In 2018 alone, Incyte donated over $620,000 to more than 20 
organizations through the Incyte Charitable Giving Foundation. 

Through the Foundation, we also launched the Incyte Cancer Care 
Assistance Fund for Delaware, which provides emergency financial 
assistance for cancer patients, their caregivers and family members 
living in Delaware. This Fund was launched in collaboration with 
Cancer Support Community Delaware, which independently 
processes applications and determines the need. Since its launch 
in February 2018, 72 individuals have received emergency funding 
to cover bills such as rent, mortgage, car insurance and the cost 
of groceries. Most of these people have lost their jobs or are on 
disability due to their cancer and unfortunately had to face the 
choice of either paying these bills or treating their cancer. We 
are proud to be able to help so many patients and their families, 
not only with providing treatment options but with emotional and 
financial support. 

Our Community Service Program provides our colleagues with 
paid time off to volunteer in their communities. In 2018, Incyte 
colleagues donated over 1,200 hours of time working with 
organizations, including the Food Bank of Delaware, MANNA and 
Salvation Army. This is a remarkable increase of nearly 60 percent 
since 2017 and almost triple the number of hours since 2016. 

31

We also support our colleagues’ charitable interests through 
our Matching Gifts Program, which matches 100 percent of 
their donations up to a predetermined cap. In 2018, we matched 
more than $120,000 given by our colleagues to their charities 
of choice.

Learn more about Incyte Involved.

Beyond these formal programs, we also enjoy being involved 
in many other charitable events and drives. During the 2018 U.S. 
Business National Meeting, over 200 Incyte employees from 
across the country volunteered for either the Houston Food Bank, 
which provides meals and support for those in need, or B.I.G. 
Love Cancer Care, which offers support for children with cancer 
and their families.

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y

COMMUNITY  CONTI NUED

Other philanthropic events included our ninth year of participating 
in the Light the Night Walk, which benefits the Leukemia & 
Lymphoma Society, and our first annual Kind to Kids Back to School 
Drive in which we collected book bags, boxes of school supplies 
and cash donations.

We feel it is especially important to support those who are 
less fortunate during the holiday season. Every year we 
have an annual food drive to collect food and cash 
donations for the Food Bank of Delaware and an 
annual Salvation Army Angel Tree Program, in 

which Delaware-based employees can buy toys 

for one or more local children in need. Last year, 
Incyte collectively donated over 600 pounds of 
food for the Food Bank of Delaware and donated 

over 600 gifts to families in Delaware. In Europe, 
our Christmas Food Donation Program helps provide 

meals to Swiss families in need.

By participating in charitable activities, we deliver a 
positive impact on the greater communities in which 

we live and work.

32

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWLeft: Paula Swain, Incyte 
Right: Nicole Pickles, Cancer Support Community Delaware

ABOUT CANCER SUPPO RT COMMU NITY  DELAWA RE

Cancer Support Community Delaware is a statewide nonprofit 
organization whose mission is to ensure that all people impacted 
by cancer are empowered by knowledge, strengthened by action 
and sustained by community. Support groups and programs are 
professionally led and are provided at no cost to help participants 
and caregivers cope with the emotional and life changing aspects 
of cancer. Learn more at cancersupportdelaware.org.

33

2 0 1 8   Y E A R   I N   R E V I E W

MAKIN G  A DIFFE RE NCE   IN  D EL AWAR E

Making a difference in the lives of patients and giving back to our local 
communities is an integral part of the Incyte culture and who we are as a company. 

In 2017, we proudly announced the establishment of the Incyte Cancer Care 
Assistance Fund for Delaware with our partners, the Cancer Support Community 
Delaware (CSCDE). The fund provides emergency financial assistance for cancer 
patients, their caregivers and family members living in Delaware. 

Nicole Pickles, Executive Director of CSCDE, reflects on what Incyte 
and CSCDE have been able to accomplish through the Fund in its 
first two years of giving, and what it means for Delaware to have 
this type of support from Incyte. 

“The Incyte Cancer Care Assistance Fund for Delaware 
is a critical resource for our local community. 

The people we’re helping through the Fund have emergent 
needs as they navigate their disease and its impact across all 
aspects of their lives. Many of these individuals have lost their 
jobs, are on disability or their income has been substantially reduced 
because of their cancer. In addition to trying to process what is often an 
overwhelming diagnosis, they are having difficulty coping on a daily basis. 

In 2018, we exceeded our expectations for the Fund – we paid bills for 72 people, 
including rent, mortgage, utilities, medical bills, car insurance and food. The 
response we’ve received has been heartwarming, with recipients noting they are 
‘truly grateful for the help,’ and that the support allowed them to have ‘one less thing 
to worry about at this time.’

Through the Fund, we are reaching people living with cancer in Delaware that we 
would never have been able to reach. Applications for funding have come from all 
three of our counties, including Kent and Western Sussex County, which are home 
to medically and socioeconomically underserved communities. The Fund is uniquely 
positioned to meet the needs of local individuals living with cancer because Incyte 
partnered closely with CSCDE to learn about Delaware and what our communities 
truly needed.

We value Incyte’s consistent and unwavering dedication to those touched by 
cancer. Through its support for the Fund and in many other ways, Incyte is an 
anchor to CSCDE – helping us to provide greater knowledge and understanding of 
the important resources available to cancer patients from prevention to education, 
social and emotional support, patient care and advocacy.”

INCYTE 2018 ANNUAL REPORTIn addition, we now only use paper made from recycled 
material for all printed pieces. Throughout our offices, there are 
sorting bins to separate waste from recycling both in public areas 
and at each individual’s work station. In the cafeteria at our newly-
expanded U.S. headquarters, reusable plates, silverware and 
trays are used to limit the amount of landfill waste. Incyte has also 
moved to the use of paper straws and has set up frequent and 
accessible recycling stations throughout the Wilmington campus. 
Incyte also incentivizes the purchase of electric cars by employees 
by providing electric car charging units in our parking lots for 
complimentary use during the workday.

C O R P O R AT E   R E S P O N S I B I L I T Y

E NVIRONMENT

At Incyte, we seek to operate in a way that reduces our environmental 
impact. This includes programs for data collection and analysis in 
order to measure and reduce hazardous air emissions, greenhouse 
gases and water use. In 2019, Incyte launched Greencyte, which is 
a cross-functional and global team dedicated to seeking ways to 
minimize our impact on the environment.

UNITED  STATES

Incyte’s Environmental Health and Safety (EHS) team works closely 
with our hazardous waste vendor and researchers to identify waste 
minimization and pollution prevention. Their initiatives allow the 

Hazardous Waste Team to divert materials for recycling, 
recovery or reuse. We encourage researchers to work 
with the EHS team to identify additional efforts to 

reduce our waste and improve our environmental 

stewardship goals.

We manage all hazardous waste in 
compliance with EPA regulations, and all 
hazardous waste is recycled, reused, fuel-
blended or disposed of at an EPA approved 

disposal facility. 

As Incyte expands, so must our facilities. As we 
construct new buildings, our team makes sure to 

keep environmental responsibility as a priority. When building the 
expanded headquarters in Wilmington, for example, the team removed 
approximately 160 trees and then planted over 400 new trees, 
more than doubling the original number of trees on-site.

Beyond these broader business initiatives, employees take an active 
role in our commitment to environmental sustainability. For example, 
the commercial operations team uses only Forest Stewardship Council® 
(FSC)-certified printers for Incyte’s marketing materials. 

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INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y

E NVIRONMENT  CONTI NUE D 

EUROPE

In Europe, our first production site is under construction in Yverdon-
les-Bains, Switzerland. The building and its construction is following 
strict Swiss regulations regarding environment protection and energy 
consumption. At the construction site, waste is carefully managed. 
Additionally, the concrete is produced on-site, which reduces the 
number of trucks required from an average of 15 daily down to only four, 
thus reducing pollution as well as positively impacting our neighbors. 
Water for concrete production is reused, and nothing is released into 
nature. Additionally, a study was conducted to optimize the future 
energy consumption of the building itself. The energy produced from 
the heating and cooling equipment will be partially recovered using heat 
exchangers, and solar panels will be used on the roof. 

Our new and consolidated European headquarters to be opened 
in Morges, Switzerland, is currently being constructed through the 
renovation of an industrial site. The renovation, as at the site in Yverdon-
les-Bains, will be completed according to the latest Swiss construction 
norms, which favor lower energy consumption and minimize 
environmental impact. Solar panels have already been added to the 
roof, the thermal insulation will be beyond what is required by Swiss 
regulation and the roof will retain rain water through “vegetalized” 
areas which will also reduce the need for cooling. The selection of 
Morges as the location of our European headquarters was made in 
part due to its close proximity to the railway station (and connections 
to Lausanne and Geneva), with the intent of reducing the need for 
employees to commute by car.

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INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O R P O R AT E   R E S P O N S I B I L I T Y

COMPLIANCE & TRANSPAREN CY

We aim to make a difference – for patients, medical professionals, 
organizations, the broader healthcare community and all our 
global stakeholders. To achieve these goals, we are committed 
to conducting business ethically. We hold ourselves accountable 
to the highest standards to ensure that all of our interactions are 
conducted appropriately. We regularly review and amend our 
practices according to current laws and regulations, as well as 
both our own standards and the standards required of us by the 
communities in which we live and work.

All new team members are required to read and acknowledge their 
commitment to comply with Incyte’s Code of Business Conduct and 
Ethics, which serves as our roadmap for acting ethically whenever 
and wherever we conduct business. It provides, among other 
things, that:

•  We foster a respectful and safe workplace
•  We conduct business ethically
•  We operate honestly and transparently
•  We act as a good corporate citizen

For more details, please visit our  
Compliance & Transparency page. 

HO NESTY & 
TRANSPARENCY

ETH ICS

RESPECT
& SAF ETY

GOOD 
COR PORATE 
CITIZ EN S

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INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O M PA N Y   
I N F O R M AT I O N

37
37

2018 Annual ReportINCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWPIVOTAL MOMENTS THAT DE FI NE  IN CYT E’ S   H ISTO RY

Quibus eaqui que velitem et vendigenda quas alis et la volupti orectate dolessus 

cupta comnihillaut min peri doluptate pre, corepe earcitium adit odi offic tem con 

cus sum sit quis deles mi, incim quae prae comnime

C O M PA N Y   I N F O R M AT I O N

PIVOTAL MOMENTS 
THAT DEFINE 
INCYT E’S HISTO RY

Joined S&P 500 index

Opened operations  
in Tokyo 

Expanded global 
headquarters and campus 
in Wilmington, DE

Olumiant (baricitinib)
marketing approvals 
received in Europe (Feb.), 
Japan (July)

Established first office 
outside of the U.S.

2016

2017

2018

Olumiant 
marketing 
approval in  
U.S. (June)

FDA approved 
Jakafi (ruxolitinib)
as first treatment for 
myelofibrosis

2015

2014

Drug discovery  
efforts founded

2005

2011

FDA approved Jakafi 
as first treatment for 
polycythemia vera

Incyte Europe expanded; 
European commercialization 
rights to Iclusig (ponatinib)
gained through acquisition 
of ARIAD Pharmaceuticals’ 
European operations

Surpassed $1B in revenue

2002

JAK2 mutation in 
myeloproliferative 
neoplasms (MPNs) 
discovered

38

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O M PA N Y   I N F O R M AT I O N

LEA DERSHIP TEAM 
LEFT TO RIGHT

STEVEN H. STEIN, M D
Chief Medical Officer 

WENQING YAO, P HD
Head of Discovery Chemistry

VIJAY IYENGAR, M D
Head of Global Strategy 
& Corporate Development

MARIA E. PASQUALE
General Counsel

39

JO NAT HAN  E .  D ICK IN SO N
General Manager, Europe 

HERVÉ  HO PP EN OT
Chairman, Chief Executive Officer 

C HR ISTI AN A  STA MO UL IS
Chief Financial Officer

LOT HAR   H.   FIN KE,   M D,   P HD
General Manager & Head of 
Development, Japan

MICH AE L  MO RRI SSE Y
Head of Global Technical Operations

PAULA   J.  S WAIN
Head of Human Resources

DAS HYA NT DH A NA K,  P HD
Chief Scientific Officer

BA RRY  P.  FLANNE LLY, 
PH A RMD, MB A
General Manager, U.S.

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O M PA N Y   I N F O R M AT I O N

CORPORATE

Incyte Corporation 
1801 Augustine Cut-Off  
Wilmington, DE 19803  
855.446.2983

Transfer Agent and Registrar Computershare 
PO Box 43078  
Providence, RI 02940-3078  
or  
250 Royall Street  
Canton, MA 02021  
877.272.1536  
http://www.computershare.com/investor

TDD for Hearing Impaired 
800.231.5469

Foreign Stockholders 
201.680.6578

TDD Foreign Stockholders 
201.680.6610

Outside Counsel 
Pillsbury Winthrop Shaw Pittman LLP

40

Independent Registered Public Accounting Firm
Ernst & Young LLP

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

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

Contact 
Michael Booth, DPhil  
Vice President, Investor Relations  
mbooth@incyte.com

Lauren Kwiecinski, MBA  
Senior Director, Investor Relations  
lkwiecinski@incyte.com

Annual Meeting 
The Annual Meeting of Stockholders will be held April 26, 2019,  
at 1:00 p.m., Eastern Daylight Time, at Incyte Corporation,  
1801 Augustine Cut-Off, Wilmington, DE 19803.

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O M PA N Y   I N F O R M AT I O N

FO RWARD-LOOKING  STATEMEN TS

Except for the historical information set forth herein, the matters set forth 

These forward-looking statements are based on our current expectations 

in this annual report contain predictions, estimates and other forward-

and are subject to risks and uncertainties that may cause actual results to 

looking statements, including without limitation statements regarding: 

differ materially, including unanticipated developments in and risks related 

our confidence in our potential to drive additional top-line growth in the 

to: delays in obtaining results from clinical trials or in drug development 

near-and medium-term; our belief that our multiple late-stage projects 

generally; the ability to enroll sufficient numbers of subjects for clinical 

have significant potential on a standalone basis and, collectively, have the 

trials; further research and development and the results of clinical trials; 

potential to drive significant revenue growth over the next several years; our 

the efficacy or safety of our products and product candidates and the 

expectations to file an NDA for pemigatinib in cholangiocarcinoma in 2019 

products and product candidates of our collaboration partners; the effects 

and for NDAs for pemigatinib in cholangiocarcinoma, itacitinib in GVHD and 

of market competition; clinical trials, including pivotal trials, possibly being 

capmatinib to be submitted in the next 6 to 18 months; our expectations 

unsuccessful or insufficient to meet applicable regulatory standards for 

for the availability of data from the clinical trials of parsaclisib, itacitinib, 

clinical advancement or approval or warrant continued development; other 

ruxolitinib in GVHD, pemigatinib, INCMGA0012, ruxolitinib in combination 

market, economic or strategic factors and technological advances; our 

therapies and ruxolitinib cream; our expectations regarding planned pivotal 

dependence on our relationships with our collaboration partners; and other 

trial initiations for pemigatinib in first line cholangiocarcinoma, first line 

risks detailed from time to time in our reports filed with the Securities and 

bladder cancer and solid tumors and for ruxolitinib cream in vitiligo; our 

Exchange Commission, including our Annual Report on Form 10-K for the 

expectation to initiate a development program with pemigatinib focusing on 

year ended December 31, 2018. We disclaim any intent or obligation to 

a tumor-agnostic, FGFR-altered, disease indication in 2019; our expectation 

update these forward-looking statements. 

that having an in-house PD-1 antagonist will speed our decision-making 

and could obviate the need to either buy supply from a third party and/

or to unnecessarily share any plans or data with third parties; plans and 

expectations regarding development activities of our collaboration partners, 

including the expectation that an NDA will be submitted for capmatinib 

in 2019 and expectations for data from clinical trials of baricitinib; and 

whether our collaboration with Merus will create additional opportunities 

for drug discovery over the coming years; and the potential therapeutic and 

commercial value of our drug candidates.

41

INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEWC O M PA N Y   I N F O R M AT I O N

E NDNOTES 

1.  Jakafi (ruxolitinib) is approved in intermediate or high-risk 
myelofibrosis (MF), including primary myelofibrosis, post-
polycythemia vera myelofibrosis and post-essential thrombo-
cythemia myelofibrosis, and in patients with polycythemia vera 
(PV) who have had an inadequate response to or are intolerant 
of hydroxyurea. 

2.  Iclusig is marketed by ARIAD Pharmaceuticals, Inc in the U.S. 

and by Incyte in the European Union and select countries. In the 
European Union, Iclusig is indicated for adult patients with CP-, 
AP-, or BP-CML who are resistant to dasatinib or nilotinib; who 
are intolerant to dasatinib or nilotinib and for whom subsequent 
treatment with imatinib is not clinically appropriate; or who have 
the T315I mutation, and adult patients with Ph+ ALL who are 
resistant to dasatinib; who are intolerant to dasatinib and for whom 
subsequent treatment with imatinib is not clinically appropriate; 
or who have the T315I mutation.

3.  Ex-U.S. rights to ruxolitinib license to Novartis; commercialized 

by Novartis as Jakavi. 

4.  Worldwide rights to baricitinib licensed to Eli Lilly; Olumiant 

(baricitinib) is approved for the treatment of mild to moderate 
rheumatoid arthritis in patients with inadequate response to 
standard-of-care therapies.

5.  Worldwide rights to capmatinib licensed to Novartis. 

6.  Development of ruxolitinib in GVHD in collaboration with Novartis. 

7.  FIGHT-201 and FIGHT-202 have the potential to enable 

registration. 

8.  Verstovsek et al (2018) Hematological Oncology 36:701–708. 

9. Grimwade L, et al. Br J Haematol. 2009;147:495–506. 

10. Oku S, et al. Br J Haematol. 2010;150:334–44.

INCYTE, the INCYTE logo, JAKAFI, and the MPN Heroes logo are registered trademarks of Incyte.  |  ICLUSIG is a registered trademark of ARIAD 
Pharmaceuticals, Inc.  |  JAKAVI is a trademark of Novartis.  |  OLUMIANT is a trademark of Eli Lilly.  |  MPN Heroes, the MPN Heroes logo, Voices of MPN, 
and the Voices of MPN logo are registered trademarks of Incyte.  |  The Moffitt Cancer Center logo is a registered trademark of Moffitt Cancer Center.  |  
The Syros logo is a trademark of Syros Pharmaceuticals, Inc.  |  The Vanderbilt logo is a registered trademark of The Vanderbilt University.

© 2019 Incyte Corporation

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INCYTE 2018 ANNUAL REPORT2018 YEAR IN REVIEW