Incyte Corporation
(Nasdaq:INCY) today announced its third
quarter 2008 financial results and reported continued progress in
multiple clinical programs.
Paul Friedman, M.D., President and CEO of Incyte, stated, "Recently
presented clinical data for our lead JAK inhibitor, INCB18424, continue
to support its broad therapeutic potential as a treatment for
myelofibrosis, rheumatoid arthritis and psoriasis. With additional Phase
II trial results expected in 2009 from several other clinical programs,
including 11beta-HSD1 and HM74A and the potential start of our
registration trials in myelofibrosis patients, we’re
confident we can continue to strengthen the pipeline and create
sustainable value.”
Below is a summary of recent achievements and clinical activities:
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Janus Kinase (JAK) Inhibitor
Program
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INCB18424: Myelofibrosis (MF), a life-threatening
myeloproliferative disease
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-- On September 5, the U.S. Food and Drug Administration (FDA)
granted orphan drug designation for INCB18424 for the treatment of
patients with myelofibrosis.
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-- On September 11, the Committee for Orphan Medicinal Products
adopted a positive opinion for INCB18424 for the treatment of
chronic idiopathic myelofibrosis.
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-- We continued to enroll MF patients in a Phase II trial to confirm
an optimal dosing regimen and to select, in addition to spleen
reduction, a co-primary endpoint for registration trials. Currently,
over 135 MF patients have been enrolled in the trial.
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-- Results from the ongoing Phase II trial were presented at the
European Society of Hematology meeting in Athens, Greece
demonstrating that INCB18424 provided:
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-- unprecedented reductions in splenomegaly which affects the
majority of MF patients; and
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-- clinically meaningful improvements in the constitutional symptoms
of MF, including reductions in fatigue, night sweats, pruritus,
abdominal discomfort, poor appetite and cachexia.
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-- Reversible thrombocytopenia seen in this trial has been
effectively managed by dose reduction and/or interruption of therapy.
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INCB18424: Additional Myeloproliferative Diseases: Polycythemia
Vera (PV) and Essential Thrombocythemia (ET)
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-- Ongoing enrollment and site initiation of an open-label
multiple-dose Phase II trial to determine the safety and efficacy of
INCB18424 in patients with advanced PV and ET. This trial includes
clinical sites in the U.S. and Europe and is expected to enroll over
100 patients. We plan to present top-line results from this trial in
mid-2009.
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INCB18424: Rheumatoid Arthritis (RA)
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-- Full results from a 28-day Phase IIa trial were presented at the
2008 American College of Rheumatology Annual Scientific Meeting in
October.
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-- Results from the 50-patient placebo-controlled trial demonstrated
that three of the four doses of INCB18424 evaluated (15 mg BID, 25
mg BID and 50 mg QD) produced impressive clinical benefits and all
of the doses were well tolerated.
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-- ACR 20/50/70/90 response rates ranged from 50% to 83%, 40% to
50%, 25% to 30%, 10% to 17% respectively, and were achieved in one
month, with responses seen as early as one week.
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-- Although there have been no head-to-head comparator trials, ACR
20/50/70 response rates with existing injectable biologic agents in
larger studies typically average 60%/40%/20%, respectively, after 3
to 6 months of therapy.
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-- Two six-month Phase IIb trials are expected to begin in the
fourth quarter of 2008.
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INCB18424: Psoriasis (topical formulation)
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-- Results from the completed 28-day Phase IIa trial and preliminary
results from an ongoing 28-day sub-total inunction trial were
presented as a poster at the European Academy of Dermatology and
Venereology meeting in September 2008.
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-- Results from these trials demonstrated that topical INCB18424 in
mild to moderate psoriasis patients was well tolerated at all doses
tested thus far and significantly improved overall total lesion
score and each component of the total lesion score (thickness,
erythema and scaling).
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-- In addition to the safety and efficacy results, transcriptional
profiling data from the sub-total inunction trial demonstrated that
topical INCB18424 inhibits two key pathways, Th1 and Th17, which
play important roles in the pathogenesis of psoriasis.
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-- A three-month multiple-dose Phase IIb trial involving
approximately 300 psoriasis patients with mild to moderate disease
is currently underway with results expected in the second half of
2009.
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INCB28050: Follow-on compound for inflammation
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-- Results from the single- and multiple-dose Phase I trial in
healthy volunteers confirmed that INCB28050 was well tolerated and
demonstrated appropriate pharmacokinetic and pharmacodynamic
properties to warrant further development. We intend to begin a
Phase IIb trial in RA patients in the first half of 2009.
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11beta-HSD1 Inhibitor Program
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INCB13739: Type 2 Diabetes
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-- INCB13739 is being studied in a randomized, double-blind,
placebo-controlled, dose-ranging Phase IIb clinical trial in
patients with type 2 diabetes. This is a multi-national trial
designed to evaluate the safety and efficacy of multiple once-daily
dose regimens of INCB13739 when added to failing metformin
monotherapy. The primary endpoint of the trial is the change from
baseline to week 12 in hemoglobin A1c. Top-line results from this
trial are expected in mid-2009.
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HM74a Agonist Program
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INCB19602: Type 2 Diabetes
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-- INCB19602 is being evaluated in a 28-day dose-ranging Phase IIa
trial involving 120 type 2 diabetes patients. This trial is expected
to provide top-line proof-of-concept data early next year.
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Sheddase Inhibitor Program
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INCB7839: Breast Cancer
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-- We continued to enroll breast cancer patients in a Phase II trial
in combination with Herceptin(R) with top-line results expected
later this year or early in 2009.
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Third Quarter Financial Results
Cash Position
As of September 30, 2008, cash, short-term and long-term marketable
securities totaled $249.9 million, compared to $257.3 million as of
December 31, 2007.
During the nine months ended September 30, 2008, we used $109.1 million
in cash and marketable securities. This figure does not include proceeds
of $101.7 million, net of the underwriting discount and offering
expenses, received from the follow on equity financing completed in the
third quarter of 2008. Cash use guidance of $132 to $142 million for
2008 remains unchanged.
Revenues
Total revenues for the quarter ended September 30, 2008 were $1.1
million as compared to $6.7 million for the same period in 2007.
Revenues for the nine months ended September 30, 2008 were $3.0 million,
as compared to $24.7 million for the same period in 2007. The decrease
was primarily the result of revenues recognized in 2007 under our
collaborative research and license agreement with Pfizer.
Net Loss
The net loss for the quarter ended September 30, 2008 was $44.8 million,
or $0.48 per share, as compared to $24.5 million, or $0.29 per share,
for the same period in 2007.
The net loss for the nine months ended September 30, 2008 was $130.5
million or $1.50 per share, as compared to $65.1 million or $0.77 per
share, for the same period in 2007.
The increase in net loss for the quarter and nine-months ended September
30, 2008 from the same periods in 2007 is primarily the result of the
growth and advancement of our clinical pipeline. Included in the net
loss for the quarter and the nine months ended September 30, 2008 was
$3.9 million and $11.1 million, respectively, of non-cash expense
related to the impact of expensing share-based payments, including
employee stock options, as compared to $2.6 million and $7.4 million,
respectively, for the same periods in 2007.
Operating Expenses
Research and development expenses for the quarter ended September 30,
2008 were $36.9 million as compared to $25.0 million for the same period
last year. Research and development expenses for the nine months ended
September 30, 2008 were $108.0 million, as compared to $72.3 million for
the same period last year. The increase in research and development
expenses resulted from the growth and advancement of our clinical
pipeline. We expect our research and development expenses to vary from
quarter to quarter, primarily due to the timing of our clinical
development activities.
Included in the research and development expenses for the quarter and
the nine months ended September 30, 2008 was $2.8 million and $8.1
million, respectively, of non-cash expense related to the impact of
expensing share-based payments, including employee stock options, as
compared to $1.8 million and $5.1 million, respectively, for the same
periods in 2007.
Selling, general and administrative expenses for the quarter and the
nine months ended September 30, 2008 were $4.0 million and $12.5
million, respectively, as compared to $3.6 million and $10.8 million,
respectively, for the same periods in 2007.
Included in the selling, general and administrative expenses for the
quarter and the nine months ended September 30, 2008 was $1.1 million
and $3.0 million, respectively, of non-cash expense related to the
impact of expensing share-based payments, including employee stock
options, as compared to $0.8 million and $2.3 million, respectively, for
the same periods in 2007.
Interest Income (Expense)
Interest income for the quarter and the nine months ended September 30,
2008 was $1.3 million and $4.7 million, respectively, as compared to
$2.9 million and $10.7 million, respectively, for the same periods in
2007.
Interest expense for the quarter and the nine months ended September 30,
2008 was $6.3 million and $18.6 million, respectively, as compared to
$6.0 million and $17.9 million, respectively, for the same periods in
2007. Included in interest expense for the quarter and the nine months
ended September 30, 2008, was $2.2 million and $6.5 million,
respectively, of non-cash charges to amortize the original issue
discount of our 3 1/2% Convertible Senior Notes.
Conference Call Information
Incyte will hold its third quarter 2008 financial results conference
call this morning at 8:30 a.m. ET Thursday, November 6, 2008. To access
the conference call, please dial 877-407-8037 for domestic callers or
201-689-8037 for international callers. When prompted, provide the
passcode, which is 300368.
If you are unable to participate, a replay of the conference call, when
made available, will be available for thirty days. The replay dial-in
number for the U.S. is 877-660-6853 and dial-in number for international
callers is 201-612-7415. To access the replay you will need the
conference account number 278 and the ID number 300368.
The conference call will also be webcast live on CCBN and can be
accessed at www.incyte.com
under Investor Relations, Events and Webcasts. When available, the
conference call replay can also be accessed at www.incyte.com
under Investor Relations, Events and Webcasts.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based drug discovery and
development company focused on developing proprietary small molecule
drugs to treat serious unmet medical needs. Incyte's pipeline includes
multiple compounds in clinical development for oncology, inflammation
and diabetes. For additional information on Incyte, visit the Company's
web site at www.incyte.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set
forth in this press release, including statements with respect to the
broad therapeutic potential of our lead JAK inhibitor, INCB18424, as a
treatment for myelofibrosis, rheumatoid arthritis and psoriasis,
expectations regarding continuing to strengthen the pipeline and create
sustainable value, expectation regarding results from several other
clinical programs expected in 2009, including 11beta-HSD1 and HM74A and
the potential start of registration trials in myelofibrosis patients,
the continued enrollment of patients in a Phase II trial to confirm an
optimal dosing regimen and to select the co-primary endpoint to use for
the INCB18424 registration trials in myelofibrosis, plans to present
results from a Phase II trial of INCB18424 in PV and ET in mid-2009 and
expectations regarding trial size of the Phase II trial for INCB18424 in
PV and ET, expectations of top-line results later this year, plans to
initiate two six-month Phase IIb trials of INCB18424 in RA in the fourth
quarter, expectations that results from a three month Phase IIb trial of
INCB18424 in mild to moderate psoriatic patients are expected in the
second half of 2009, plans to initiate a Phase IIb trial with INCB28050
in RA patients in the first half of 2009, expectations that a Phase IIb
trial in type 2 diabetes for our 11beta-HSD1 inhibitor INCB13739 will
provide top-line results in mid-2009, expectations that a Phase IIa
trial in type 2 diabetes for our HM74a agonist INCB19602 will provide
top-line proof-of-concept data early next year, the continued enrollment
in a Phase II trial with our sheddase inhibitor INCB7839, expectations
that top line results for the Phase II trial of INCB7839 will be
provided late this year or early in 2009, and financial guidance about
expected cash use, are all forward-looking statements within the meaning
of the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are subject to
risks and uncertainties that may cause actual results to differ
materially, including the high degree of risk associated with drug
development and clinical trials, the uncertainty of the FDA approval
process, results of further research and development, the impact of
competition and of technological advances and the ability of Incyte to
compete against parties with greater financial or other resources,
Incyte's ability to enroll a sufficient number of patients for its
clinical trials, and other risks detailed from time to time in Incyte's
filings with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2008.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
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INCYTE CORPORATION
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Condensed Consolidated Statements of Operations
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(in thousands, except per share amounts)
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2008
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2007
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2008
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2007
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Revenues:
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Contract revenues
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$
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15
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$
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5,909
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$
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659
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$
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20,916
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License and royalty revenues
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1,046
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781
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2,322
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3,772
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Total revenues
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1,061
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6,690
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2,981
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24,688
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Costs and expenses:
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Research and development
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36,949
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25,044
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108,036
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72,251
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Selling, general and administrative
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4,005
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3,587
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12,462
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10,814
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Other expenses
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(100
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)
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(566
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)
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(895
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)
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(532
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Total costs and expenses
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40,854
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28,065
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119,603
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82,533
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Loss from operations
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(39,793
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)
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(21,375
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)
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(116,622
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)
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(57,845
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)
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Interest and other income, net
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1,253
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2,883
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4,746
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10,663
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Interest expense
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(6,254
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)
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(6,002
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)
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(18,639
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)
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(17,898
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)
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Net loss
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$
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(44,794
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$
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(24,494
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)
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$
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(130,515
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)
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$
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(65,080
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)
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Basic and diluted net loss per share
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$
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(0.48
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)
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$
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(0.29
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)
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$
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(1.50
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)
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$
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(0.77
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)
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Shares used in computing basic and diluted net loss per share
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92,385
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84,213
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87,286
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84,111
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INCYTE CORPORATION
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Condensed Consolidated Balance Sheet Data
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(in thousands)
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September 30,
2008
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December 31,
2007
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Cash, cash equivalents, and short-term and long-term marketable
securities
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$
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249,893
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$
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257,327
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Total assets
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264,718
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275,695
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Convertible senior notes
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128,714
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122,180
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Convertible subordinated notes
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264,988
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264,376
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Total stockholders’ deficit
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(177,377
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)
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(159,517
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)
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