-
$43.7 million of Jakafi® (ruxolitinib)
recognized as third-quarter U.S. net product revenue including $9.0
million of previously deferred revenue
-
Third quarter dispenses to patients increased 16 percent over
second quarter
-
Ruxolitinib approved for use in the European Union
Conference Call Scheduled Today at 8:30 a.m. ET
WILMINGTON, Del.--(BUSINESS WIRE)--Nov. 1, 2012--
Incyte Corporation (Nasdaq: INCY) today reported third-quarter 2012
financial results, including revenue from its first commercial product,
Jakafi® (ruxolitinib), which was approved by the U.S. Food &
Drug Administration (FDA) for the treatment of patients with
intermediate or high-risk myelofibrosis (MF) in November 2011. Novartis,
the Company’s collaboration partner, announced that Jakafi, marketed as
Jakavi® outside the United States, received approval from the
European Commission for the treatment of disease-related splenomegaly or
symptoms in adult patients with primary MF, post-polycythemia vera MF or
post-essential thrombocythemia MF. Jakafi/Jakavi is the first medicine
to receive FDA and European Commission approval to treat patients with
myelofibrosis and the first JAK inhibitor to be approved for any
indication.
“We’re encouraged by the underlying demand for Jakafi, and we are
building a strong foundation for long-term growth. With continued
efforts to expand the use of Jakafi among new and existing prescribers,
extensive educational efforts around the optimal use of Jakafi, and
additional data being presented at the upcoming American Society of
Hematology annual meeting, we’re confident that we will continue to see
steady, consistent growth,” stated Paul A. Friedman, M.D., Incyte’s
President and Chief Executive Officer.
2012 Third-Quarter Financial Results
Product Revenues
For the quarter and nine months ended September 30, 2012, net product
revenues of Jakafi were $43.7 million and $92.7 million, respectively.
As expected, in the third quarter, the Company transitioned to the
sell-in revenue recognition method from the sell-through method. Under
the sell-in method, revenue is recognized when product is received by
the specialty pharmacy, whereas under the sell-through method, revenue
is recognized when the specialty pharmacy sends product to the patient,
which reflects clinical demand. As a result, the $43.7 million of net
product revenues for the third quarter of 2012 included $9.0 million of
previously deferred revenue, representing product held by the specialty
pharmacies at June 30, 2012.
For comparative purposes, the following table presents the Company’s net
product revenues as recognized for the three months ended March 31,
2012, and June 30, 2012, under the sell-through method, and as if the
Company were still using the sell-through method for the three months
ended September 30, 2012, which reflects a 16 percent increase in
dispenses to patients from the second quarter to the third quarter:
|
|
|
|
|
|
|
Sell-Through Method
|
|
Three Months Ended
|
|
Three Months Ended
|
|
Three Months Ended
|
|
March 31, 2012
|
|
June 30, 2012
|
|
September 30, 2012
|
Product revenues, net
(in millions)
|
|
$ 19.3
|
|
$ 29.7
|
|
$ 34.5*
|
|
|
|
|
|
|
|
* The $34.5 million excludes $9.0 million of previously deferred
revenue and $0.2 million of gross-to-net adjustments and changes in
inventory levels at the specialty pharmacies during the quarter.
2012 Guidance Update
The Company is updating its 2012 guidance and now anticipates that
Jakafi net product revenues will be in the range of $130 million to $135
million, a change from the previous range of $120 million to $135
million.
Total Revenues
Total revenues for the quarter and nine months ended September 30, 2012,
were $60.5 million and $183.2 million, respectively, as compared to
$16.8 million and $65.6 million, respectively, for the same periods in
2011. Included in total revenues for the quarter and nine months ended
September 30, 2012, were net product revenues of $43.7 million and $92.7
million, respectively.
Included in total revenues for the nine months ended September 30, 2012,
was a $40 million European Union regulatory milestone payment received
from Novartis related to Jakavi. Included in total revenues for the nine
months ended September 30, 2011, was a $15 million milestone payment
received from Novartis related to INCB28060.
Net Loss
Net loss for the quarter ended September 30, 2012, was $21.7 million, or
$0.17 per basic and diluted share, as compared to $53.1 million, or
$0.42 per basic and diluted share, for the same period in 2011. Net loss
for the nine months ended September 30, 2012, was $63.1 million, or
$0.49 per basic and diluted share, as compared to a net loss of $131.5
million, or $1.05 per basic and diluted share, for the same period in
2011. Included in net loss for the nine months ended September 30, 2012,
was a $40 million European Union regulatory milestone payment received
from Novartis related to Jakavi. Included in net loss for the nine
months ended September 30, 2011, was a $15 million milestone payment
received from Novartis related to INCB28060.
Also included in net loss for the quarter and nine months ended
September 30, 2012, were $9.5 million and $29.4 million, respectively,
of non-cash expenses related to the impact of expensing employee stock
options, compared to $7.4 million and $21.5 million, respectively, for
the same periods in 2011.
Operating Expenses
Research and development expenses for the quarter and nine months ended
September 30, 2012, were $50.1 million and $150.6 million, respectively,
as compared to $44.6 million and $126.8 million, respectively, for the
same periods in 2011. Included in research and development expenses for
the quarter and nine months ended September 30, 2012, were non-cash
expenses of $6.4 million and $19.6 million, respectively, related to the
impact of expensing employee stock options, as compared to $4.8 million
and $14.0 million, respectively, for the same periods in 2011.
The increases in research and development expenses for the quarter and
nine months ended September 30, 2012, compared to the prior year periods
were primarily a result of increased clinical development costs related
to the advancement of the Company's pipeline and increased non-cash
employee stock option expense. The Company expects its research and
development expenses to vary from period to period, mainly due to the
timing of its clinical development activities.
Selling, general and administrative expenses for the quarter and nine
months ended September 30, 2012, were $20.5 million and $61.6 million,
respectively, as compared to $14.3 million and $37.1 million,
respectively, for the same periods in 2011. Included in selling, general
and administrative expenses for the quarter and nine months ended
September 30, 2012, were non-cash expenses of $3.1 million and $9.8
million, respectively, related to the impact of expensing employee stock
options, as compared to $2.6 million and $7.5 million, respectively, for
the same periods in 2011.
Increased selling, general and administrative expenses for the quarter
and nine months ended September 30, 2012, compared to the prior year
periods reflected the additional costs related to the Company's sales
force and the commercialization efforts for the launch of Jakafi.
Interest Expense
Interest expense for the quarter and nine months ended September 30,
2012, was $11.6 million and $34.3 million, respectively, as compared to
$11.0 million and $32.7 million, respectively, for the comparable
periods in 2011. Included in interest expense for the quarter and nine
months ended September 30, 2012, were $6.8 million and $20.0 million,
respectively, of non-cash charges to amortize the discount on the
Company's 4.75% Convertible Senior Notes due 2015, as compared to $6.3
million and $18.4 million, respectively, for the same periods in 2011.
Cash Position
As of September 30, 2012, cash, cash equivalents and marketable
securities totaled $243.6 million compared to $277.6 million as of
December 31, 2011. These amounts exclude $9.5 million and $19.0 million,
as of September 30, 2012, and December 31, 2011, respectively, of
restricted cash and investments held in an escrow account reserved for
interest payments through October 2012 on the 4.75% Convertible Senior
Notes.
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
-
The use of Jakafi to treat patients with intermediate or high-risk
myelofibrosis (MF) is further supported by presentations to be made at
the American Society of Hematology annual meeting in December,
including updates from COMFORT-I and COMFORT-II.
-
Verstovsek, S, et al. Long-Term Outcome of Ruxolitinib
Treatment in Patients with Myelofibrosis: Durable Reductions in
Spleen Volume, Improvements in Quality of Life, and Overall
Survival Advantage in Comfort-I. Dec. 10, 2012, at 6:30 p.m.
-
Cervantes, F, et al. Long-Term Safety, Efficacy, and Survival
Findings From Comfort-II, a Phase 3 Study Comparing Ruxolitinib
with Best Available Therapy (BAT) for the Treatment of
Myelofibrosis (MF). Dec. 10, 2012, at 6:45 p.m.
-
Vannucchi, A, et al. Reductions in JAK2 V617F Allele Burden
with Ruxolitinib Treatment in Comfort-II, A Phase 3 Study
Comparing the Efficacy and Safety of Ruxolitinib with Best
Available Therapy (BAT). Dec. 10, 2012, at 7 p.m.
-
Two Phase III clinical trials (RESPONSE and RELIEF), in partnership
with Novartis, are underway to evaluate ruxolitinib in patients with
polycythemia vera (PV) with results expected to be part of a
supplemental new drug application submission in 2014. The FDA has
granted fast track designation for PV, specifically for the treatment
of patients with PV who are resistant to or intolerant of hydroxyurea.
-
A randomized Phase II trial of ruxolitinib in combination with
capecitabine is actively recruiting patients with recurrent or
treatment refractory metastatic pancreatic cancer (the RECAP trial).
The RECAP trial is designed to enroll approximately 130 patients by
late 2012, with final results expected in the second half of 2013.
-
Multiple investigator-sponsored trials evaluating ruxolitinib are
ongoing, including two Phase I/II trials in adults with advanced
hematologic malignancies (acute myeloid leukemia, acute lymphocytic
leukemia, myelodysplastic syndrome and chronic myelogenous leukemia)
and relapsed or refractory acute leukemia; a Phase I/II trial in
children with hematologic malignancies and solid tumors; and a Phase
II trial in patients with lymphoma. In addition, the first of several
planned investigator-sponsored Phase II trials to evaluate ruxolitinib
in treating patients with breast cancer was recently initiated.
Baricitinib, formerly known as LY3009104 (INCB28050) - a JAK1 and JAK2
Inhibitor
-
Data from the six-month Phase IIb trial of baricitinib in patients
with rheumatoid arthritis, conducted by our collaboration partner Eli
Lilly and Company, will be presented at the American College of
Rheumatology Annual Scientific Meeting in November 2012.
-
A Phase III trial of baricitinib in patients with rheumatoid
arthritis, conducted by Lilly, began screening patients in October
2012.
-
A Phase IIb trial in patients with moderate to severe psoriasis,
conducted by Lilly, is ongoing with primary endpoint results expected
in 2013.
-
A Phase II trial in patients with diabetic nephropathy, conducted by
Lilly, was initiated in August 2012, and results are expected in 2014.
INCB28060 (also known as INC280) – a c-MET Inhibitor
-
The initial Phase I trial in patients with solid tumors is nearing
completion. This compound is licensed to Novartis as part of the
Incyte-Novartis collaboration, and further development will be
conducted by Novartis.
INCB24360 – an Indoleamine Dioxygenase-1 (IDO1) Inhibitor
-
INCB24360 is currently in Phase I/II clinical development for
metastatic melanoma in combination with ipilimumab and as monotherapy
for ovarian cancer.
Early-Stage Development and Discovery Programs
-
Several early development and discovery programs in oncology and
inflammation are also ongoing.
Conference Call Information
Incyte will hold its third-quarter 2012 financial results conference
call this morning at 8:30 a.m. ET. To access the conference call, please
dial 877-407-8037 for domestic callers or 201-689-8037 for international
callers. When prompted, provide the conference identification number,
401502.
If you are unable to participate, a replay of the conference call will
be available for 30 days. The replay dial-in number for the United
States is 877-660-6853 and the dial-in number for international callers
is 201-612-7415. To access the replay you will need the conference
identification number, 401502.
The conference call will also be webcast live and can be accessed at www.incyte.com
under Investor Relations – Events and Webcasts.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary small molecule drugs for oncology and inflammation. For
additional information on Incyte, please visit the Company’s website at www.incyte.com.
About Jakafi
Jakafi is a prescription medicine used to treat people with intermediate
or high-risk myelofibrosis (MF), including primary MF, post–polycythemia
vera MF and post–essential thrombocythemia MF.
Important Safety Information
-
Treatment with Jakafi can cause hematologic adverse reactions,
including thrombocytopenia, anemia and neutropenia, which are each
dose-related effects, with the most frequent being thrombocytopenia
and anemia. A complete blood count must be performed before initiating
therapy with Jakafi. Complete blood counts should be monitored as
clinically indicated and dosing adjusted as required. The three most
frequent non-hematologic adverse reactions were bruising, dizziness
and headache
-
Patients with platelet counts <200 × 109/L at the start
of therapy are more likely to develop thrombocytopenia during
treatment. Thrombocytopenia was generally reversible and was usually
managed by reducing the dose or temporarily withholding Jakafi. If
clinically indicated, platelet transfusions may be administered
-
Patients developing anemia may require blood transfusions. Dose
modifications of Jakafi for patients developing anemia may also be
considered
-
Neutropenia (ANC <0.5 × 109/L) was generally reversible
and was managed by temporarily withholding Jakafi
-
Patients should be assessed for the risk of developing serious
bacterial, mycobacterial, fungal and viral infections. Active serious
infections should have resolved before starting Jakafi. Physicians
should carefully observe patients receiving Jakafi for signs and
symptoms of infection (including herpes zoster) and initiate
appropriate treatment promptly
-
A dose modification is recommended when administering Jakafi with
strong CYP3A4 inhibitors or in patients with renal or hepatic
impairment [see Dosage and Administration]. Patients should be
closely monitored and the dose titrated based on safety and efficacy
-
There are no adequate and well-controlled studies of Jakafi in
pregnant women. Use of Jakafi during pregnancy is not recommended and
should only be used if the potential benefit justifies the potential
risk to the fetus
-
Women taking Jakafi should not breast-feed. Discontinue nursing or
discontinue the drug, taking into account the importance of the drug
to the mother
For Full Prescribing Information for Jakafi, visit www.Jakafi.com.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including without limitation statements
regarding our plans and expectations with respect to Jakafi
(ruxolitinib), including the potential efficacy and therapeutic and
commercial value of Jakafi, our expectation regarding continued steady,
consistent growth, our expectation that results from the RESPONSE and
RELIEF trials are expected to be part of a sNDA submission in 2014, our
expectation that the RECAP trial will enroll approximately 130 patients
by late 2012 with final results expected in the second half of 2013, our
expectation that results from the trials conducted by our collaboration
partner Eli Lilly and Company evaluating baricitinib in patients with
moderate to severe psoriasis and diabetic nephropathy will be available
in 2013 and 2014, respectively, our expectation that the initial Phase I
trial evaluating INCB28060 is nearing completion, updated financial
guidance about expected net product revenues, and expectations regarding
variations in research and development expenses, contain predictions,
estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to the efficacy or safety of Jakafi,
the acceptance of Jakafi in the marketplace, risks related to market
competition, the results of further research and development, risks and
uncertainties associated with sales, marketing and distribution
requirements, risks that results of clinical trials may be unsuccessful
or insufficient to meet applicable regulatory standards, the ability to
enroll sufficient numbers of subjects in clinical trials, other market
or economic factors and technological advances, unanticipated delays,
the ability of Incyte to compete against parties with greater financial
or other resources, risks associated with Incyte's dependence on its
relationships with its collaboration partners, and other risks detailed
from time to time in Incyte’s reports filed with the Securities and
Exchange Commission, including our Form 10-Q for the quarter ended June
30, 2012.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
|
INCYTE CORPORATION
|
Condensed Consolidated Statements of Operations
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
|
2012
|
|
|
2011
|
|
|
2012
|
|
|
2011
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenues, net
|
|
$
|
43,695
|
|
$
|
-
|
|
$
|
92,700
|
|
$
|
-
|
Contract revenues
|
|
|
16,737
|
|
|
16,737
|
|
|
90,211
|
|
|
65,211
|
Other revenues
|
|
|
60
|
|
|
45
|
|
|
302
|
|
|
354
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
60,492
|
|
|
16,782
|
|
|
183,213
|
|
|
65,565
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of product revenues
|
|
|
31
|
|
|
-
|
|
|
58
|
|
|
-
|
Research and development
|
|
|
50,079
|
|
|
44,604
|
|
|
150,627
|
|
|
126,830
|
Selling, general and administrative
|
|
|
20,520
|
|
|
14,282
|
|
|
61,634
|
|
|
37,067
|
Other expenses
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
712
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
70,630
|
|
|
58,886
|
|
|
212,319
|
|
|
164,609
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(10,138)
|
|
|
(42,104)
|
|
|
(29,106)
|
|
|
(99,044)
|
Interest and other income, net
|
|
|
27
|
|
|
45
|
|
|
393
|
|
|
249
|
Interest expense
|
|
|
(11,573)
|
|
|
(11,019)
|
|
|
(34,293)
|
|
|
(32,666)
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(21,684)
|
|
|
(53,078)
|
|
|
(63,006)
|
|
|
(131,461)
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
|
26
|
|
|
-
|
|
|
93
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(21,710)
|
|
$
|
(53,078)
|
|
$
|
(63,099)
|
|
$
|
(131,461)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.17)
|
|
$
|
(0.42)
|
|
$
|
(0.49)
|
|
$
|
(1.05)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
130,851
|
|
|
126,260
|
|
|
129,093
|
|
|
125,019
|
|
|
|
|
|
|
|
|
|
|
INCYTE CORPORATION
|
Condensed Consolidated Balance Sheet Data
|
(in thousands)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2012
|
|
2011
|
|
|
|
|
|
Cash, cash equivalents, and short-term marketable securities
|
|
$
|
243,599
|
|
$
|
277,594
|
Accounts receivable, net
|
|
|
16,540
|
|
|
6,415
|
Deferred revenue – Product revenues
|
|
|
-
|
|
|
2,332
|
Total assets
|
|
|
296,535
|
|
|
328,962
|
Convertible senior notes
|
|
|
315,874
|
|
|
298,193
|
Convertible subordinated notes
|
|
|
18,725
|
|
|
17,960
|
Total stockholders’ deficit
|
|
|
(219,950)
|
|
|
(227,077)
|
|
|
|
|
|

Source: Incyte Corporation
Incyte Corporation
Pamela M. Murphy
Vice
President, Investor Relations & Corporate Communications
302-498-6944