Conference Call Scheduled Today at 8:30 a.m. ET
Incyte Corporation (Nasdaq:INCY) today reported second quarter 2009
financial results and provided an update on its highest priority
clinical programs.
"With the Phase III registration trials for our lead JAK1/JAK2
inhibitor, INCB18424, now underway in both the U.S. and Europe; the
launch of a six-month Phase II trial for our second JAK1/JAK2 inhibitor,
INCB28050, in rheumatoid arthritis; the release of positive Phase IIb
results for our 11beta-HSD1 inhibitor for type 2 diabetes; and the
expected release of Phase IIb results for topical INCB18424 in psoriasis
later this summer, we have made substantial progress building our
pipeline. I believe we are in a strong position to create and capture
value from these programs both on our own and through strategic
partnerships," stated Paul A. Friedman, M.D., Incyte's President and
Chief Executive Officer.
Below is a summary of recent developments for our most advanced product
candidates:
Janus Kinase (JAK) Inhibitor Program
INCB18424: (oral formulation) Myelofibrosis, Polycythemia Vera and
Essential Thrombocythemia
-
Agreement reached with the U.S. Food and Drug Administration (FDA) for
a Special Protocol Assessment (SPA) for INCB18424 as a treatment in
myelofibrosis (MF).
-
Announcement that the Phase III trial under the SPA, COMFORT-I, is
expected to begin patient enrollment in August and involve 240
patients with primary myelofibrosis (PMF), post polycythemia vera
myelofibrosis (PPV-MF) and post essential thrombocythemia
myelofibrosis (PET-MF). COMFORT-I is scheduled to include over 90
clinical sites in the U.S., Canada and Australia.
-
Initiation of a second Phase III trial, COMFORT-II, in Europe began
enrolling patients in July and is expected to enroll 150 patients in
approximately 70 clinical sites.
INCB18424: (topical formulation) Psoriasis and Other Inflammatory
Conditions of the Skin
-
Completed a three-month multiple-dose Phase IIb trial in patients with
mild to moderate psoriasis. Results from this trial are expected later
this summer.
INCB28050: JAK Inhibitor Compound for Rheumatoid Arthritis and Other
Inflammatory Conditions
-
Initiated a six-month double-blind placebo-controlled dose-ranging
Phase II trial that is scheduled to include 100 patients with active
rheumatoid arthritis who have had inadequate response to currently
available disease modifying therapies.
11beta-HSD1 Inhibitor Program
INCB13739: Type 2 Diabetes
-
Presented clinical results at the American Diabetes Association 69th
Scientific Sessions from a 3-month placebo-controlled, dose-ranging
Phase IIb trial involving over 300 patients with type 2 diabetes which
demonstrated that treatment with once-daily doses of INCB13739
significantly improved glycemic control, as measured by hemoglobin
A1c, insulin sensitivity and total-cholesterol levels.
Sheddase Inhibitor Program
INCB7839: Breast Cancer
-
Continued enrollment of a Phase II trial in combination with Herceptin(R)
in breast cancer patients. We expect to present results from this
trial at the San Antonio Breast Cancer Symposium in December 2009.
Second Quarter 2009 Financial Results
Cash Position
As of June 30, 2009, cash, short-term and long-term marketable
securities totaled $147.5 million, compared to $217.8 million as of
December 31, 2008.
During the six months ended June 30, 2009, we used $70.3 million in cash
and marketable securities. Cash use guidance of $122 to $128 million for
2009 remains unchanged.
Revenues
Total revenues for the quarter ended June 30, 2009 were $0.8 million as
compared to $0.6 million for the same period in 2008. Total revenues for
the six months ended June 30, 2009 were $1.5 million, as compared to
$1.9 million for the same period in 2008.
Net Loss
The net loss for the quarter ended June 30, 2009 was $40.0 million, or
$0.41 per share, as compared to $45.6 million, or $0.54 per share, for
the same period in 2008.
The net loss for the six months ended June 30, 2009 was $80.1 million,
or $0.82 per share, as compared to $85.7 million or $1.01 per share, for
the same period in 2008.
Included in the net loss for the quarter and the six months ended June
30, 2009 were $2.5 million and $5.9 million, respectively, of non-cash
expense related to the impact of expensing share-based payments,
including employee stock options, as compared to $3.9 million and $7.3
million, respectively, for the same periods in 2008.
Operating Expenses
Research and development expenses for the quarter ended June 30, 2009
were $29.0 million, as compared to $38.1 million for the same period
last year. Research and development expenses for the six months ended
June 30, 2009 were $58.6 million, as compared to $71.1 million for the
same period last year. The decrease in research and development expenses
was due to prioritization of our pipeline to focus on products we
believe have a greater likelihood of creating near-term value. 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 research and development expenses for the quarter and the
six months ended June 30, 2009 were $1.8 million and $4.2 million,
respectively, of non-cash expense related to the impact of expensing
share-based payments, including employee stock options, as compared to
$2.9 million and $5.3 million, respectively, for the same periods in
2008.
Selling, general and administrative expenses for the quarter and the six
months ended June 30, 2009 were $4.1 million and $8.9 million,
respectively, as compared to $4.1 million and $8.5 million,
respectively, for the same periods in 2008. Increased selling, general
and administrative expenses for the six months ended June 30, 2009
reflected our initial sales and marketing preparations for the potential
commercialization of INCB18424 for myeloproliferative disorders. Also
included in selling, general and administrative expenses for the quarter
and the six months ended June 30, 2009 were $0.7 million and $1.7
million, respectively, of non-cash expense related to the impact of
expensing share-based payments, including employee stock options, as
compared to $1.0 million and $2.0 million, respectively, for the same
periods in 2008.
Interest Income (Expense)
Interest income for the quarter and the six months ended June 30, 2009
was $0.4 million and $0.9 million, respectively, as compared to $1.4
million and $3.5 million, respectively, for the same periods in 2008.
The decrease was due to a lower average cash balance and a lower yield
for the three and six months ended June 30, 2009 as compared to the
corresponding periods in 2008. Included in interest and other income
(expense), net for the three and six months ended June 30, 2009 was a
$1.3 million non-cash charge recognized pursuant to the provisions of
SFAS 115 and FASB Staff Position FAS 115-2 Recognition and
Presentation of Other-Than-Temporary Impairments.
Interest expense for the quarter and the six months ended June 30, 2009
was $6.4 million and $12.7 million, respectively, as compared to $6.2
million and $12.4 million, respectively, for the same periods in 2008.
Included in interest expense for the quarter and the six months ended
June 30, 2009, was $2.3 million and $4.6 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 second quarter 2009 financial results conference
call this morning at 8:30 a.m. ET Thursday, July 30, 2009. 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 328036.
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 328036.
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 for oncology, inflammation and diabetes. Incyte’s most advanced
compound, INCB18424, is in Phase III development for myelofibrosis. 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 our
belief that we are in a strong position to create and capture value from
our clinical programs both on our own and through strategic
partnerships, the expected times to begin enrollment of patients in
COMFORT-I, the expected number of clinical sites and patients for
COMFORT-I and the expected number of patients and clinical sites for
COMFORT-II, the expectation of final results from the Phase IIb trial
for topical INCB18424 in psoriasis in the summer of 2009, the expected
number of patients in our Phase II program for INCB28050, our JAK1/JAK2
inhibitor compound for rheumatoid arthritis patients who have had
inadequate response to currently available disease modifying therapies,
the expected presentation of results from our sheddase inhibitor program
for breast cancer in December, financial guidance about expected cash
use, and expectations regarding variations in our quarterly research and
development expenses, 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 and potential
problems that may arise in the regulatory approval processes,
uncertainty regarding the timing of patient enrollment in the COMFORT-I
trial, Incyte's ability to enroll a sufficient number of patients
for the COMFORT-I and COMFORT-II clinical trials in a timely manner or
at all, unanticipated developments in the efficacy or safety of our
compounds in clinical trials, 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 March
31, 2009. Financial guidance regarding cash use excludes any effects of
strategic collaboration or capital market activities, including
activities with respect to outstanding convertible notes. 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
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Contract revenues
|
|
$
|
-
|
|
|
$
|
57
|
|
|
$
|
-
|
|
|
$
|
644
|
|
|
License and royalty revenues
|
|
|
789
|
|
|
|
557
|
|
|
|
1,460
|
|
|
|
1,276
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
789
|
|
|
|
614
|
|
|
|
1,460
|
|
|
|
1,920
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
29,035
|
|
|
|
38,132
|
|
|
|
58,622
|
|
|
|
71,087
|
|
|
Selling, general and administrative
|
|
|
4,086
|
|
|
|
4,103
|
|
|
|
8,906
|
|
|
|
8,456
|
|
|
Other expenses
|
|
|
406
|
|
|
|
(918
|
)
|
|
|
915
|
|
|
|
(795
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
33,527
|
|
|
|
41,317
|
|
|
|
68,443
|
|
|
|
78,748
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(32,738
|
)
|
|
|
(40,703
|
)
|
|
|
(66,983
|
)
|
|
|
(76,828
|
)
|
|
Interest and other income (expense), net
|
|
|
(915
|
)
|
|
|
1,353
|
|
|
|
(368
|
)
|
|
|
3,493
|
|
|
Interest expense
|
|
|
(6,382
|
)
|
|
|
(6,213
|
)
|
|
|
(12,720
|
)
|
|
|
(12,386
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(40,035
|
)
|
|
$
|
(45,563
|
)
|
|
$
|
(80,071
|
)
|
|
$
|
(85,721
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.41
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(0.82
|
)
|
|
$
|
(1.01
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
97,643
|
|
|
|
84,871
|
|
|
|
97,491
|
|
|
|
84,736
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCYTE CORPORATION
|
|
Condensed Consolidated Balance Sheet Data
|
|
(in thousands)
|
|
|
|
|
|
June 30,
2009
|
|
December 31, 2008
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term and long-term marketable
securities
|
|
$
|
147,485
|
|
|
$
|
217,783
|
|
|
Total assets
|
|
|
159,016
|
|
|
|
232,388
|
|
|
Convertible senior notes
|
|
|
135,598
|
|
|
|
130,969
|
|
|
Convertible subordinated notes
|
|
|
265,627
|
|
|
|
265,198
|
|
|
Total stockholders’ deficit
|
|
|
(291,430
|
)
|
|
|
(220,750
|
)
|
|
|
|
|
|
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Incyte Corporation
Pamela M. Murphy
Vice
President, Investor Relations & Corporate Communications
302-498-6944