Incyte Corporation (Nasdaq: INCY) today reported 2014 first-quarter
financial results, including revenue from Jakafi®
(ruxolitinib), which is approved by the U.S. Food & Drug Administration
(FDA) for the treatment of patients with intermediate or high-risk
myelofibrosis (MF). The Company also highlighted multiple achievements
in its clinical programs, including positive top-line results from
RESPONSE, a pivotal Phase III study of ruxolitinib in patients with
uncontrolled polycythemia vera (PV); the initiation of its first of two
Phase III trials of ruxolitinib in patients with advanced or metastatic
pancreatic cancer; and the finalization of the protocol for the Phase
I/II trial combining its investigational IDO1 inhibitor, INCB24360, with
Merck’s investigational anti-PD-1 immunotherapy, MK-3475.
“Underlying demand for Jakafi in myelofibrosis continues to grow, and
the positive results from the pivotal Phase III trial, RESPONSE, support
our confidence in the potential value that ruxolitinib can bring to
patients with uncontrolled polycythemia vera,” stated Hervé Hoppenot,
Incyte’s President and Chief Executive Officer. “Additionally, we’re
strengthening our existing programs in JAK inhibition with new
indications and combinations, advancing our novel IDO1 inhibitor in the
rapidly evolving field of immunotherapy, and progressing with clinical
trials with our own PI3K-delta inhibitor.”
2014 First-Quarter Financial Results
Revenues
For the quarter ended March 31, 2014, net product revenues of Jakafi
were $69.7 million as compared to $48.3 million for the same period in
2013, representing 44 percent growth.
For the quarter ended March 31, 2014, product royalties from sales of
Jakavi® (ruxolitinib) outside the United States received from
the Company’s collaboration partner Novartis were $9.8 million as
compared to $5.9 million for the same period in 2013.
For the quarter ended March 31, 2014, contract revenues were $10.2
million as compared to $16.7 million for the same period in 2013.
Included in contract revenues for the quarter ended March 31, 2014, was
a $7.0 million milestone earned related to c-MET inhibitor INC280 under
the Company’s collaboration with Novartis. The decrease in 2014 contract
revenues compared to the same period in 2013 relates to the Novartis
upfront payment received under the collaboration being fully amortized
at December 31, 2013, partially offset by the $7.0 million milestone
earned related to INC280 under the collaboration with Novartis.
For the quarter ended March 31, 2014, total revenues were $89.8 million
as compared to $71.1 million for the same period in 2013.
Non-Cash Stock Expense
Included in operating expenses for the quarter ended March 31, 2014, was
$15.3 million of non-cash expense related to equity awards to our
employees, of which $8.3 million was included in research and
development expenses and $7.0 million was included in selling, general
and administrative expenses.
Operating Expenses
Research and development expenses for the quarter ended March 31, 2014,
were $75.6 million as compared to $52.8 million for the same period in
2013.
The increase in research and development expenses for the quarter ended
March 31, 2014, compared to the comparable prior year period, was
primarily due to the expansion of the Company’s pipeline, which included
the costs related to two Phase III trials of ruxolitinib in pancreatic
cancer; Phase II trials of ruxolitinib in non-small cell lung cancer,
colorectal cancer and breast cancer; a Phase II trial of INCB39110 in
non-small cell lung cancer; and the Phase III program for baricitinib in
rheumatoid arthritis.
Selling, general and administrative expenses for the quarter ended March
31, 2014, were $37.0 million as compared to $22.3 million for the same
period in 2013.
Increased selling, general and administrative expenses for the quarter
ended March 31, 2014, compared to the comparable prior year period
reflected the additional costs related to the commercialization of
Jakafi in MF and preparation for the anticipated launch in PV.
Interest Expense and Convertible Senior Notes
Interest expense for the quarter ended March 31, 2014, was $11.4 million
as compared to $11.7 million for the same period in 2013. Included in
interest expense for the quarter ended March 31, 2014, was $8.8 million
of non-cash charges to amortize the discount on the Company’s 4.75%
Convertible Senior Notes due 2015 (2015 Notes), 0.375% Convertible
Senior Notes due 2018 and 1.25% Convertible Senior Notes due 2020, as
compared to $7.0 million to amortize the discount on the Company’s 2015
Notes for the same period in 2013.
During the quarter, the Company entered into a negotiated agreement with
a holder of the 2015 Notes pursuant to which the holder agreed to
exchange $4.9 million aggregate principal amount of the 2015 Notes for
the shares of the Company’s stock into which the 2015 Notes were
convertible, aggregating 0.6 million shares, and $0.3 million in cash.
The Company recorded $0.3 million in debt exchange expense on senior
note conversions for the quarter ended March 31, 2014.
Net Loss
Net loss for the quarter ended March 31, 2014, was $34.0 million, or
$0.21 per basic and diluted share, as compared to a net loss of $15.7
million, or $0.12 per basic and diluted share, for the same period in
2013. The increase in net loss in the first quarter of 2014 as compared
to the same period of 2013 is primarily due to the Company’s broad
investment in its clinical pipeline and additional costs related to the
commercialization of Jakafi in MF and preparation for the anticipated
launch in PV.
Cash and Marketable Securities Position
As of March 31, 2014, cash, cash equivalents and marketable securities
totaled $519.2 million compared to $509.0 million as of December 31,
2013.
Recent Clinical Highlights
Jakafi® (ruxolitinib) - a JAK1 and JAK2 Inhibitor
Myeloproliferative Neoplasms
RESPONSE, a Phase III trial conducted under a Special Protocol
Assessment (SPA) in collaboration with Novartis to evaluate ruxolitinib
in patients with PV who are resistant to or intolerant of hydroxyurea,
met its primary endpoint of achieving phlebotomy independence and
reducing spleen size by 35 percent or more. Additionally, the safety
profile of ruxolitinib was generally consistent with previous studies.
The filing of a supplemental new drug application with the FDA is
expected in the second quarter of 2014.
RESPONSE data will be presented in an oral session at the American
Society of Clinical Oncology (ASCO) annual meeting in June.
Data for RELIEF, a Phase III trial measuring disease-related symptoms in
patients with PV, are expected in mid-2014, followed by presentation at
an upcoming scientific meeting.
Solid Tumors
The results from RECAP, the Phase II trial of ruxolitinib in combination
with capecitabine in metastatic pancreatic cancer, will be presented in
an oral session at ASCO in June.
JANUS 1, a double-blinded, placebo-controlled Phase III trial for
advanced or metastatic pancreatic cancer, which is being conducted under
an SPA, was initiated in March 2014. A second nearly identical Phase III
trial (JANUS 2) is planned to begin in the second quarter of 2014. Both
trials are designed to examine the subgroup identified in the Phase II
clinical trial, RECAP.
Three additional blinded Phase II proof-of-concept trials of ruxolitinib
focusing on survival in non-small cell lung cancer, breast cancer and
colorectal cancer among patients in the subgroup identified in RECAP are
open, with first patients receiving ruxolitinib in the colorectal cancer
trial.
INCB39110 – a JAK1 Inhibitor
The clinical program to evaluate INCB39110 in solid tumors is planned to
start with two randomized, double-blind Phase II trials in non-small
cell lung cancer. The first trial is expected to initiate in the second
quarter of 2014; the second trial is planned for later this year. Both
trials will only include patients in the subgroup identified in RECAP
with overall survival as the primary endpoint.
Baricitinib - a JAK1 and JAK2 Inhibitor
The Phase III clinical program to evaluate baricitinib in patients with
rheumatoid arthritis, being conducted by the Company’s collaboration
partner Lilly, is ongoing.
Phase II trials in patients with moderate-to-severe psoriasis and
patients with diabetic nephropathy are also ongoing. Results for the
psoriasis trial were presented in early 2014, and results for the
diabetic nephropathy trial are anticipated in 2015.
INCB24360 – an IDO1 Inhibitor
INCB24360 is currently being evaluated in a Phase I/II trial in
combination with ipilimumab for metastatic melanoma and in a Phase II
trial as monotherapy for ovarian cancer.
Preliminary data from the combination trial will be presented as part of
a poster discussion at ASCO in June.
The Investigational New Drug application for a Phase I/II trial to
evaluate the combination of INCB24360 and Merck’s investigational
anti-PD-1 immunotherapy, MK-3475, in previously treated metastatic and
recurrent non-small cell lung cancer and other advanced or metastatic
cancers has been cleared by the FDA, and the trial is expected to
initiate in the second quarter of 2014.
INCB40093 – a PI3K-delta Inhibitor
INCB40093 is currently in a Phase I dose-escalation trial in patients
with B-lymphoid malignancies. A second trial, which started in January
2014, is evaluating INCB40093 in combination with the Company’s JAK1
inhibitor, INCB39110.
INC280 – a c-MET Inhibitor
Under the Incyte-Novartis collaboration and license agreement, Novartis
is conducting a Phase II trial to evaluate INC280 as monotherapy in
advanced c-MET positive hepatocellular carcinoma. In addition, the
initiation of a Phase II trial to evaluate INC280 in a second
indication, c-MET positive/EGFR-TKI-resistant non-small cell lung
cancer, triggered a $7.0 million milestone from Novartis.
Additionally, there are ongoing Phase II trials in c-MET dependent
advanced solid malignancies.
Conference Call Information
Incyte will hold its 2014 first-quarter 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,
13580001.
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, 13580001.
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 experienced in the discovery, development and commercialization
of proprietary small molecule drugs focused primarily on oncology. For
additional information on Incyte, please visit the Company’s website at www.incyte.com.
Important Safety Information
Jakafi can cause serious side effects including:
Low blood counts: Jakafi may cause your platelet, red blood cell,
or white blood cell counts to be lowered. If you develop bleeding, stop
taking Jakafi and call your healthcare provider. Your healthcare
provider will perform blood tests to check your blood counts before you
start Jakafi and regularly during your treatment. Your healthcare
provider may change your dose of Jakafi or stop your treatment based on
the results of your blood tests. Tell your healthcare provider right
away if you experience unusual bleeding, bruising, fatigue, shortness of
breath, or a fever.
Infection: You may be at risk for developing a serious infection
while taking Jakafi. Tell your healthcare provider if you develop
symptoms such as chills, nausea, vomiting, aches, weakness, fever, or
painful skin rash or blisters.
The most common side effects of Jakafi include dizziness and headache.
These are not all the possible side effects of Jakafi. Ask your
healthcare provider or pharmacist for more information. Tell your
healthcare provider about any side effect that bothers you or that does
not go away.
Before taking Jakafi, tell your healthcare provider about all the
medications, vitamins, and herbal supplements you are taking and all
your medical conditions, including if you have an infection, have or had
liver or kidney problems, are on dialysis, or have any other medical
condition. Do not drink grapefruit juice while taking Jakafi.
Women should not take Jakafi while pregnant or planning to become
pregnant, or if breast-feeding.
Please see the Full Prescribing Information available at www.jakafi.com,
which includes a more complete discussion of the risks associated with
Jakafi.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release, including without limitation statements
regarding the potential value that Jakafi® (ruxolitinib) can
bring to patients with uncontrolled polycythemia vera; the Company’s
plans and expectations with respect to Jakafi, including its potential
efficacy and therapeutic and commercial value; the Company’s expectation
to file a supplemental new drug application for ruxolitinib for
polycythemia vera in the second quarter of 2014; the Company’s
expectation of data from the RELIEF trial in mid-2014 and their
presentation at a scientific meeting; the Company’s plans to begin the
second Phase III trial of ruxolitinib in advanced or metastatic
pancreatic cancer in the second quarter of 2014; the Company’s plans for
INCB39110 to initiate two Phase II trials in patients with non-small
cell lung cancer, one in the second quarter of 2014 and one later in the
year; the Company’s expectation of results from the trials conducted by
its collaboration partner Lilly evaluating baricitinib in patients with
diabetic nephropathy in 2015; and the Company’s expectation to initiate
a Phase I/II trial evaluating the combination of INCB24360 and MK-3475
in the second quarter of 2014 contain predictions, estimates and other
forward-looking statements.
These forward-looking statements are based on the Company’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,
economic or strategic factors and technological advances, unanticipated
delays, the ability of the Company to compete against parties with
greater financial or other resources, risks associated with the
Company's dependence on its relationships with its collaboration
partners, and other risks detailed from time to time in the Company’s
reports filed with the Securities and Exchange Commission, including its
Form 10-K for the year ended December 31, 2013.
|
INCYTE CORPORATION
|
Condensed Consolidated Statements of Operations
|
(unaudited, in thousands, except per share amounts)
|
|
|
|
Three Months Ended March 31,
|
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
Product revenues, net
|
|
$
|
69,651
|
|
|
$
|
48,289
|
|
Product royalty revenues
|
|
|
9,826
|
|
|
|
5,909
|
|
Contract revenues
|
|
|
10,214
|
|
|
|
16,737
|
|
Other revenues
|
|
|
101
|
|
|
|
142
|
|
|
|
|
|
|
Total revenues
|
|
|
89,792
|
|
|
|
71,077
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
Cost of product revenues
|
|
|
168
|
|
|
|
150
|
|
Research and development
|
|
|
75,585
|
|
|
|
52,763
|
|
Selling, general and administrative
|
|
|
36,974
|
|
|
|
22,261
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
112,727
|
|
|
|
75,174
|
|
|
|
|
|
|
Loss from operations
|
|
|
(22,935
|
)
|
|
|
(4,097
|
)
|
Interest and other income, net
|
|
|
735
|
|
|
|
199
|
|
Interest expense
|
|
|
(11,443
|
)
|
|
|
(11,728
|
)
|
Debt exchange expense on senior note conversions
|
|
|
(265
|
)
|
|
|
-
|
|
|
|
|
|
|
Loss before provision for income taxes
|
|
|
(33,908
|
)
|
|
|
(15,626
|
)
|
|
|
|
|
|
Provision for income taxes
|
|
|
49
|
|
|
|
43
|
|
|
|
|
|
|
Net loss
|
|
$
|
(33,957
|
)
|
|
$
|
(15,669
|
)
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(0.21
|
)
|
|
$
|
(0.12
|
)
|
|
|
|
|
|
Shares used in computing basic and diluted
|
|
|
|
|
Net loss per share
|
|
|
165,357
|
|
|
|
134,345
|
|
|
|
|
|
|
|
INCYTE CORPORATION
|
Condensed Consolidated Balance Sheet Data
|
(in thousands)
|
|
|
|
March 31, 2014 (unaudited)
|
|
December 31, 2013
|
|
|
|
|
|
Cash, cash equivalents, and short-term marketable securities
|
|
$
|
519,231
|
|
|
$
|
509,004
|
|
Accounts receivable, net
|
|
|
46,394
|
|
|
|
35,374
|
|
Total assets
|
|
|
666,826
|
|
|
|
629,568
|
|
Convertible senior notes(1)
|
|
|
665,222
|
|
|
|
661,567
|
|
Total stockholders’ deficit
|
|
|
(162,422
|
)
|
|
|
(193,108
|
)
|
|
|
|
|
|
|
|
|
|
(1) Net of unamortized debt discount of $176.4 million and $185.0
million at March 31, 2014, and December 31, 2013, respectively.
Copyright Business Wire 2014