Incyte Corporation (Nasdaq: INCY) today reported 2015 first-quarter
financial results, including revenue from Jakafi®
(ruxolitinib). As well as the strong performance of Jakafi in the
quarter, the Company highlighted the successful result of the second
baricitinib Phase III trial in rheumatoid arthritis, as announced with
Lilly, and the publication, in the New England Journal of Medicine,
of the Phase III RESPONSE trial results of Jakafi in patients with
uncontrolled polycythemia vera (PV). During the first quarter Incyte
expanded its discovery capabilities with an immuno-therapeutic alliance
with Agenus Inc. (Agenus), and has recently further highlighted its
emerging pipeline with the publication of eleven abstracts at the annual
meeting of the American Association for Cancer Research (AACR).
“We are very pleased with the ongoing commercialization of Jakafi. It is
establishing itself as the standard of care in patients with
intermediate or high-risk myelofibrosis, and the initial uptake of
Jakafi in patients with uncontrolled PV has also met our expectations,”
stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer.
“We continue to recruit patients into the multiple clinical trials being
run across our broad clinical portfolio, and we have recently showcased
the strength of our emerging development pipeline, which provides us
with multiple potential routes to future success.”
In April 2015, Incyte announced its intention to establish the new
headquarters of Incyte Europe Sarl (Incyte Europe) in Geneva,
Switzerland. The Company intends to use Incyte Europe as the base from
which to conduct its European clinical development operations.
Jakafi® is approved by the U.S. Food & Drug Administration
(FDA) for the treatment of patients with intermediate or high-risk
myelofibrosis and for the treatment of patients with PV who have had an
inadequate response to or are intolerant of hydroxyurea.
2015 First-Quarter Financial Results
Revenues
For the quarter ended March 31, 2015, net product revenues of Jakafi
were $115 million as compared to $70 million for the same period in
2014, representing 66 percent growth.
For the quarter ended March 31, 2015, product royalties from sales of
Jakavi® (ruxolitinib) outside of the United States received
from Novartis, the Company’s collaborator, were $16 million as compared
to $10 million for the same period in 2014.
For the quarter ended March 31, 2015, contract revenues were $28 million
as compared to $10 million for the same period in 2014. The $18 million
increase in contract revenues for the quarter ended March 31, 2015
compared to the same period in 2014 relates to an increase in milestone
payments earned from Novartis.
For the quarter ended March 31, 2015, total revenues were $159 million
as compared to $90 million for the same period in 2014.
Operating Expenses
Research and development expenses for the quarter ended March 31, 2015
were $118 million as compared to $76 million for the same period in 2014.
The increase in research and development expenses for the quarter ended
March 31, 2015, compared to the same prior year period, was primarily
due to the expansion of the Company’s clinical portfolio, which included
the costs related to the continued development of ruxolitinib, as well
as our JAK1 and IDO1 inhibitor programs, in various clinical trials.
Also included in research and development expenses for the quarter ended
March 31, 2015 was the one-time upfront payment to Agenus related to our
license, development and commercialization agreement.
Selling, general and administrative expenses for the quarter ended March
31, 2015 were $45 million as compared to $37 million for the same period
in 2014.
Increased selling, general and administrative expenses for the quarter
ended March 31, 2015 compared to the same prior year period reflected
additional costs related to the commercialization of Jakafi for patients
with myelofibrosis and uncontrolled PV.
Non-Cash Stock Expense
Included in operating expenses for the quarter ended March 31, 2015 was
$18 million of non-cash expense related to equity awards to our
employees, of which $10 million was included in research and development
expenses and $8 million was included in selling, general and
administrative expenses.
Interest Expense
Interest expense for the quarter ended March 31, 2015 was $13 million as
compared to $11 million for the same period in 2014. Included in
interest expense for the quarter ended March 31, 2015 was $9 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 (2018 Notes) and 1.25% Convertible Senior Notes
due 2020 (2020 Notes), as compared to $9 million for the same period in
2014.
Net Loss
Net loss for the quarter ended March 31, 2015 was $18 million, or $0.11
per basic and diluted share, as compared to a net loss of $34 million,
or $0.21 per basic and diluted share, for the same period in 2014.
Cash and Marketable Securities Position
As of March 31, 2015, cash, cash equivalents and marketable securities
totaled $585 million, compared to $600 million as of December 31, 2014.
Recent Clinical Highlights
Jakafi (ruxolitinib) – JAK1 and JAK2 Inhibitor
Myeloproliferative Neoplasms
In January 2015 the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) adopted a positive opinion
for Jakavi (ruxolitinib) for the treatment of adult patients with PV who
are resistant to or intolerant of hydroxyurea. In March 2015, the
European Commission formally approved Jakavi in this second indication.
In January 2015 The New England Journal of Medicine published
results from the pivotal Phase III RESPONSE clinical trial demonstrating
that, compared to standard therapy, Jakafi significantly improved
hematocrit control and reduced spleen volume in patients with
uncontrolled PV.
Solid Tumors
The pivotal Phase III JANUS 1 and JANUS 2 studies of ruxolitinib in
second line metastatic pancreatic cancer are ongoing. Patient accrual
into JANUS 1 is running ahead of JANUS 2, and while the Company
continues to expect data from JANUS 1 in 2016, results from JANUS 2 are
now expected at a later date. The Company believes, if the results are
sufficiently robust, that JANUS 1 could support an application for
approval as a single pivotal trial.
Three Phase II trials of ruxolitinib are being conducted in colorectal,
breast and non-small cell lung cancer (NSCLC) patients. Competitive
trial recruitment, including from studies of immune-directed agents, has
significantly impacted recruitment into the NSCLC trial. Recruitment
into the colorectal and breast cancer trials is as expected.
INCB39110 & INCB52793 – JAK1-Selective Inhibitors
INCB39110 is in two Phase II NSCLC trials, one in combination with
docetaxel and the other in combination with erlotinib. INCB39110 is also
in a dose-expansion proof-of-concept trial, in combination with
gemcitabine and nab-paclitaxel, for the first-line treatment of patients
with pancreatic cancer.
INCB39110 is also being studied in combination with the Company’s PI3Kδ
inhibitor INCB40093 in B-cell malignancies, initial results of which are
to be presented at the 2015 American Society of Clinical Oncology (ASCO)
meeting.
INCB52793 is in a Phase I/II dose-escalation trial in liquid tumors.
INCB50465 & INCB40093 – PI3Kδ Inhibitors
The combination of INCB40093 and the JAK1-selective inhibitor INCB39110
is being tested in a Phase I/II trial in B-cell malignancies, initial
results of which are to be presented at the 2015 ASCO meeting.
INCB50465 is a highly-potent PI3Kδ inhibitor and an open-label,
dose-escalation study of INCB50465 in subjects with previously treated
B-cell malignancies has been initiated.
epacadostat (INCB24360) – IDO1 Inhibitor
Four clinical trials to evaluate epacadostat in combination with immune
checkpoint inhibitors are all recruiting patients. These trials are
evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor
Keytruda® (pembrolizumab), AstraZeneca/MedImmune’s
investigational PD-L1 inhibitor, MEDI4736, Bristol-Myers Squibb’s PD-1
inhibitor, Opdivo® (nivolumab), and Roche/Genentech’s
investigational PD-L1 inhibitor, MPDL3280A. Tumor types under
investigation include NSCLC, melanoma, head and neck, colorectal,
ovarian and pancreatic cancer, as well as lymphoma.
Immuno-Oncology Portfolio
In January 2015 Incyte and Agenus announced a global license,
development and commercialization agreement focused on novel
immuno-therapeutics using Agenus’ proprietary Retrocyte Display™
antibody discovery platform. This alliance will initially focus on the
development of checkpoint modulator antibodies directed against GITR,
OX40, LAG-3 and TIM-3.
At the American Association for Cancer Research (AACR) Annual Meeting in
April 2015, the Company presented eleven abstracts detailing the
strategy, science and data behind the Company’s emerging portfolio.
These abstracts included data supporting the potential
immuno-therapeutic activity of the Company’s portfolio of JAK and PI3Kδ
inhibitors, alone and in combination, including with epacadostat,
Incyte’s leading IDO1 inhibitor.
INCB54828 – FGFR Inhibitor
In the first quarter of 2015, INCB54828 entered an open-label,
dose-escalation study in subjects with advanced malignancies. The FGFR
family of receptor tyrosine kinases can act as oncogenic drivers in a
number of liquid and solid tumor types, most notably squamous NSCLC,
gastric and bladder cancer, and glioblastoma.
INCB54329 – BRD Inhibitor
Bromodomains (BRDs) are a family of proteins which play important roles
in mediating gene transcription, most notably by facilitating the
expression of oncogenes such as MYC, one of the most frequently
dysregulated oncogenes in all human cancer. The Company expects to begin
clinical trials of INCB54329, its BRD inhibitor, in the second quarter
of 2015.
baricitinib – JAK1 and JAK2 Inhibitor
In February 2015 the Company and Eli Lilly and Company (Lilly) announced
that the Phase III RA-BUILD study of baricitinib met its primary
endpoint of improved ACR20 response, compared to placebo, after 12 weeks
of treatment. The RA-BUILD study included patients with
moderately-to-severely active rheumatoid arthritis (RA) who had an
inadequate response to, or were intolerant of, at least one conventional
disease-modifying antirheumatic drug (cDMARD).
RA-BUILD is part of the global Phase III program of baricitinib in RA.
Top-line results from RA-BEACON were announced in December 2014, and
results of both trials are expected to be presented at an upcoming
scientific meeting.
The Company and Lilly also expect to share results of two further Phase
III studies in various disclosures during 2015.
capmatinib (INC280) – c-MET Inhibitor
Novartis continues to make progress in the clinical development of
capmatinib, a potent and selective c-MET inhibitor, in a variety of
solid tumors including advanced c-MET positive hepatocellular carcinoma
and c-MET positive/EGFR-TKI-resistant NSCLC. Capmatinib is being
investigated both as monotherapy and in combination, including with
Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor, Opdivo
(nivolumab), in a Phase II trial of patients with NSCLC.
Conference Call Information
Incyte will hold its 2015 first-quarter financial results conference
call this morning at 8:00 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,
13604399.
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, 13604399.
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 therapeutics, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food
and Drug Administration for treatment of people with polycythemia vera
(PV) who have had an inadequate response to or are intolerant of
hydroxyurea.
Jakafi is also indicated for treatment of people with intermediate or
high-risk myelofibrosis (MF), including primary MF, post–polycythemia
vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by Incyte in the United States and by Novartis as
Jakavi® (ruxolitinib) outside the United States.
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
during treatment with Jakafi. Tell your healthcare provider if you
develop any of the following symptoms of infection: chills, nausea,
vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain
types of non-melanoma skin cancers. Tell your healthcare provider if you
develop any new or changing skin lesions.
The most common side effects of Jakafi include: anemia, low
platelet count, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider 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
tuberculosis (TB), or have been in close contact with someone who has
TB, have or had liver or kidney problems, are on dialysis, had skin
cancer or have any other medical condition. Take Jakafi exactly as your
healthcare provider tells you. Do not change or stop taking Jakafi
without first talking to your healthcare provider. Do not drink
grapefruit juice while on 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 contain predictions, estimates and other
forward-looking statements, including without limitation statements
regarding: the Company’s emerging development pipeline and the potential
success of any of those product candidates; whether Jakafi will
eventually become the standard of care for patients with intermediate or
high-risk myelofibrosis; the Company’s plans and expectations regarding
its European headquarters and European clinical operations; whether the
data from the JANUS 1 trial will be sufficiently robust to allow for
product registration; the expected timing of data from the JANUS 1 and
JANUS 2 trials; and the ability to recruit into the three Phase II
trials of ruxolitinib in colorectal, breast and NSCLC; the Company’s
expectation of results in the first half of 2015 from the study of
INCB39110 in combination with INCB40093 in B-cell malignancies and from
the study of INCB39110 in combination with the Company’s PI3Kδ inhibitor
INCB40093 in B-cell malignancies, and the plan to present initial
results of each study at the 2015 ASCO meeting; the Company’s plans for
the Agenus alliance to initially focus on the development of checkpoint
modulator antibodies directed against GITR, OX40, LAG-3 and TIM-3; the
Company’s plans to advance INCB54329 into clinical development in the
second quarter of 2015; and the Company’s expectation to disclose with
Lilly the results from other ongoing Phase III studies evaluating
baricitinib in rheumatoid arthritis in 2015.
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, 2014. The Company disclaims
any intent or obligation to update these forward-looking statements.
|
|
|
|
|
|
INCYTE CORPORATION
|
Condensed Consolidated Statements of Operations
|
(unaudited, in thousands, except per share amounts)
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
Product revenues, net
|
|
$
|
115,330
|
|
|
$
|
69,651
|
|
Product royalty revenues
|
|
|
15,673
|
|
|
|
9,826
|
|
Contract revenues
|
|
|
28,214
|
|
|
|
10,214
|
|
Other revenues
|
|
|
58
|
|
|
|
101
|
|
|
|
|
|
|
Total revenues
|
|
|
159,275
|
|
|
|
89,792
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
Cost of product revenues
|
|
|
2,974
|
|
|
|
168
|
|
Research and development
|
|
|
118,365
|
|
|
|
75,585
|
|
Selling, general and administrative
|
|
|
44,871
|
|
|
|
36,974
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
166,210
|
|
|
|
112,727
|
|
|
|
|
|
|
Loss from operations
|
|
|
(6,935
|
)
|
|
|
(22,935
|
)
|
Interest and other income, net
|
|
|
1,630
|
|
|
|
735
|
|
Interest expense
|
|
|
(12,687
|
)
|
|
|
(11,443
|
)
|
Debt exchange expense
|
|
|
—
|
|
|
|
(265
|
)
|
|
|
|
|
|
Loss before income taxes
|
|
|
(17,992
|
)
|
|
|
(33,908
|
)
|
|
|
|
|
|
Provision for income taxes
|
|
|
367
|
|
|
|
49
|
|
|
|
|
|
|
Net loss
|
|
$
|
(18,359
|
)
|
|
$
|
(33,957
|
)
|
|
|
|
|
|
Net loss per basic and diluted share
|
|
$
|
(0.11
|
)
|
|
$
|
(0.21
|
)
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
172,070
|
|
|
|
165,357
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCYTE CORPORATION
|
Condensed Consolidated Balance Sheet Data
|
(unaudited, in thousands)
|
|
|
|
|
|
|
|
March 31, 2015
|
|
December 31, 2014
|
|
|
|
|
|
Cash, cash equivalents, and short-term marketable securities
|
|
$
|
585,424
|
|
|
$
|
600,263
|
|
Accounts receivable
|
|
|
69,604
|
|
|
|
57,933
|
|
Long term investment - Agenus Inc.
|
|
|
39,829
|
|
|
|
—
|
|
Total assets
|
|
|
862,624
|
|
|
|
830,069
|
|
Convertible senior notes(1)
|
|
|
697,547
|
|
|
|
689,118
|
|
Total stockholders’ deficit
|
|
|
(41,413
|
)
|
|
|
(81,628
|
)
|
|
|
|
|
|
(1) Net of unamortized debt discount of $143 million and $152
million at March 31, 2015, and December 31, 2014, respectively.
|
|
|
Copyright Business Wire 2015