Incyte Corporation (Nasdaq: INCY) today reported 2014 third-quarter
financial results, including revenue from Jakafi®
(ruxolitinib). The Company highlighted the strength in Jakafi sales in
the U.S. as well as the recognition of two significant milestone
payments from Novartis related to Jakavi® (ruxolitinib),
totaling $85 million. The Company outlined its progress in recruiting
multiple clinical trials, including those investigating its JAK
inhibitors in solid tumors and its IDO1 inhibitor in combination with
other immuno-oncology agents. The Company also highlighted the Priority
Review granted by the U.S. Food and Drug Administration (FDA) to the
supplemental New Drug Application (sNDA) for ruxolitinib for the
treatment of patients with polycythemia vera who have had an inadequate
response to or are intolerant of hydroxyurea, as well as the expected
release of top-line results from the first trial in the Phase III
program of baricitinib in rheumatoid arthritis patients.
“The strong commercial performance of Jakafi in the U.S. speaks to the
long-term potential of the product to treat patients with intermediate
or high-risk myelofibrosis,” stated Hervé Hoppenot, Incyte’s President
and Chief Executive Officer. “In addition, we believe we are fully
prepared for the U.S. launch of ruxolitinib for patients with
uncontrolled polycythemia vera, pending expected FDA approval, and are
also making progress across our broad development pipeline.”
Jakafi® is approved by the U.S. Food & Drug Administration
(FDA) for the treatment of patients with intermediate or high-risk
myelofibrosis (MF).
2014 Third-Quarter Financial Results
Revenues
For the quarter ended September 30, 2014, net product revenues of Jakafi
were $97.8 million as compared to $60.2 million for the same period in
2013, representing 63 percent growth. For the nine months ended
September 30, 2014, net product revenues were $251.5 million as compared
to $162.6 million for the same period in 2013, representing 55 percent
growth.
The Company now expects that 2014 net product revenues from Jakafi will
be in the range of $350 million to $360 million, an increase from the
previous range of $330 million to $340 million. This range excludes any
product royalty revenues received from the Company’s collaboration
partner Novartis on sales of Jakavi® outside the United
States.
For the quarter and nine months ended September 30, 2014, product
royalties from sales of Jakavi® outside the United States
received from Novartis were $12.1 million and $34.3 million,
respectively, as compared to $8.2 million and $19.9 million,
respectively, for the same periods in 2013.
For the quarter ended September 30, 2014, contract revenues were $88.2
million as compared to $16.7 million for the same period in 2013. For
the nine months ended September 30, 2014, contract revenues were $101.6
million as compared to $75.2 million for the same period in 2013.
The increase in contract revenues for the quarter ended September 30,
2014 compared to the same period in 2013 relates to the $60.0 million
milestone related to reimbursement of Jakavi® in Europe and
the $25.0 million milestone in connection with the approval of Jakavi® in
Japan in the third quarter of 2014. The increase in contract revenues
for the nine months ended September 30, 2014 compared to the same period
in 2013 relates to the aforementioned $85.0 million in milestones
recognized in the third quarter of 2014 and the $7.0 million milestone
related to our c-MET program recognized in the first quarter of 2014
compared to the $25.0 million milestone related to our c-MET program
recognized in the second quarter of 2013.
For the quarter ended September 30, 2014, total revenues were $198.1
million as compared to $85.1 million for the same period in 2013. For
the nine months ended September 30, 2014, total revenues were $387.5
million as compared to $257.9 million for the same period in 2013.
Non-Cash Stock Expense
Included in operating expenses for the quarter ended September 30, 2014,
was $15.5 million of non-cash expense related to equity awards to our
employees, of which $8.4 million was included in research and
development expenses and $7.1 million was included in selling, general
and administrative expenses. For the year to date, non-cash expense
related to equity awards to our employees was $46.3 million, of which
$25.2 million was included in research and development expenses and
$21.1 million was included in selling, general and administrative
expenses.
Operating Expenses
Research and development expenses for the quarter and nine months ended
September 30, 2014, were $88.5 million and $248.8 million, respectively,
as compared to $71.7 million and $185.4 million, respectively, for the
same periods in 2013.
The increase in research and development expenses for the quarter and
nine months ended September 30, 2014, compared to the same prior year
periods, 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 and nine
months ended September 30, 2014, were $39.4 million and $117.3 million,
respectively, as compared to $26.4 million and $72.0 million,
respectively, for the same periods in 2013.
Increased selling, general and administrative expenses for the quarter
and nine months ended September 30, 2014, compared to the same prior
year periods reflected the additional costs related to the
commercialization of Jakafi in MF, including the expansion in our field
force, as well as preparation for the anticipated launch in polycythemia
vera.
Interest Expense
Interest expense for the quarter and nine months ended September 30,
2014, was $11.5 million and $34.3 million, respectively, as compared to
$7.7 million and $29.7 million, respectively, for the same periods in
2013. Included in interest expense for the quarter and nine months ended
September 30, 2014, were $8.9 million and $26.6 million, respectively,
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 $4.7 million and $17.9 million, respectively, to amortize
the discount on the Company’s 2015 Notes for the same periods in 2013.
Net Loss/Net Income
Net income for the quarter ended September 30, 2014, was $59.3 million,
or $0.35 per basic and $0.33 per diluted share, as compared to a net
loss of $22.0 million, or $0.14 per basic and diluted share, for the
same period in 2013. Net loss for the nine months ended September 30,
2014, was $11.5 million, or $0.07 per basic and diluted share, as
compared to a net loss of $40.3 million, or $0.28 per basic and diluted
share, for the same period in 2013.
Cash and Marketable Securities Position
As of September 30, 2014, cash, cash equivalents and marketable
securities totaled $532.4 million compared to $509.0 million as of
December 31, 2013.
Recent Clinical Highlights
Jakafi® (ruxolitinib) – a JAK1 and JAK2 Inhibitor
Myeloproliferative Neoplasms
In July 2014 the product label for Jakafi was expanded to include
overall survival data and additional safety and dosing information. This
new information is based on three-year data from the two pivotal Phase
III trials in myelofibrosis patients, COMFORT-I and II.
In August 2014 the FDA accepted for filing the sNDA for ruxolitinib as a
potential treatment of patients with polycythemia vera who have had an
inadequate response to or are intolerant of hydroxyurea. The sNDA
includes results from the RESPONSE Phase III trial, which was conducted
under a Special Protocol Assessment (SPA) from the FDA. The Prescription
Drug User Fee Act date for the sNDA for ruxolitinib, which is under
priority review, is December 5, 2014.
Solid Tumors
Two pivotal double-blind, placebo-controlled Phase III trials (JANUS 1
and JANUS 2) of ruxolitinib for advanced or metastatic pancreatic cancer
have been initiated and are recruiting patients. JANUS 1 is being
conducted under an SPA from the FDA. Both trials are designed to examine
the safety and efficacy of ruxolitinib in pancreatic cancer patients
with high levels of systemic inflammation, and data from both trials are
expected in 2016.
Three additional blinded Phase II proof-of-concept trials of ruxolitinib
focusing on survival in non-small cell lung cancer (NSCLC), breast
cancer and colorectal cancer patients with high levels of systemic
inflammation are also recruiting patients.
INCB39110 – a JAK1 Inhibitor
The clinical program to evaluate INCB39110, a selective JAK1 inhibitor,
in solid tumors includes one ongoing Phase I open-label safety study in
combination with gemcitabine and nab-paclitaxel in various tumor types,
and two blinded proof-of-concept Phase II trials in NSCLC. The first of
these, a randomized, double-blind Phase II trial of INCB39110 in
combination with docetaxel, was initiated in the second quarter of 2014.
The second trial, in EGFR-mutated NSCLC in combination with erlotinib,
is expected to be initiated later in 2014 or early in 2015. Both Phase
II trials are designed with overall survival as the primary endpoint,
and will only include patients with high levels of systemic inflammation.
INCB24360 – an IDO1 Inhibitor
The Company believes that the optimal development strategy for
INCB24360, its IDO1 inhibitor, is for the compound to be developed in
combination with other immuno-oncology agents. A Phase I/II trial to
evaluate the combination of INCB24360 and Merck’s anti-PD-1 immune
checkpoint inhibitor, pembrolizumab, has been initiated. This trial is
recruiting patients with previously treated metastatic and recurrent
NSCLC and other advanced or metastatic cancers.
A total of four clinical trial agreements have been signed to evaluate
INCB24360 in combination with immune checkpoint inhibitors. As well as
the agreement with Merck, the Company has signed agreements involving
AstraZeneca’s investigational PD-L1 inhibitor, MEDI4736, Bristol-Myers
Squibb’s investigational PD-1 inhibitor, nivolumab, and Genentech’s
investigational PD-L1 inhibitor, MPDL3280A.
INCB40093 – a PI3K-delta Inhibitor
INCB40093 is being studied as both monotherapy and in combination with
the Company’s JAK1 inhibitor, INCB39110, in patients with B-lymphoid
malignancies.
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. The first of four Phase III trials is
expected to be reported by Lilly in late 2014 or early 2015.
INC280 – a c-MET Inhibitor
Novartis is conducting a Phase II trial to evaluate INC280 as
monotherapy in advanced c-MET positive hepatocellular carcinoma and a
Phase II trial to evaluate INC280 in c-MET positive/EGFR-TKI-resistant
NSCLC. Novartis is also conducting Phase I/II trials in c-MET dependent
advanced solid malignancies.
Novartis has also announced that it has entered into a clinical
collaboration with Bristol-Myers Squibb to evaluate the safety,
tolerability and preliminary efficacy of INC280 in combination with
Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor,
nivolumab, in a Phase I/II trial of patients with NSCLC.
Conference Call Information
Incyte will hold its 2014 third-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,
13592296.
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, 13592296.
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, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
About Jakafi® (ruxolitinib)
Jakafi is a prescription medicine approved by the U.S. Food and Drug
Administration to treat 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
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. 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.incyte.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 financial guidance about expected net product revenues; the
Company’s plans and expectations with respect to Jakafi®
(ruxolitinib), including its potential efficacy and therapeutic and
commercial value; the Company’s expectations regarding the FDA approval
for, and launch of, ruxolitinib in uncontrolled polycythemia vera; the
Company’s expectation of data in 2016 from the JANUS 1 and JANUS 2
trials of ruxolitinib for advanced or metastatic pancreatic cancer; the
Company’s plans for INCB39110 to initiate the second Phase II trial in
patients with non-small cell lung cancer later in 2014 or early in 2015;
and the Company’s expectation that the results from the first Phase III
trial conducted by its collaboration partner Lilly evaluating
baricitinib in rheumatoid arthritis will be reported by Lilly in late
2014 or early 2015, 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-Q for the quarter ended June 30, 2014.
|
INCYTE CORPORATION
|
Condensed Consolidated Statements of Operations
|
(unaudited, in thousands, except per share amounts)
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenues, net
|
|
$
|
97,837
|
|
|
$
|
60,201
|
|
|
$
|
251,513
|
|
|
$
|
162,589
|
|
Product royalty revenues
|
|
|
12,093
|
|
|
|
8,184
|
|
|
|
34,259
|
|
|
|
19,893
|
|
Contract revenues
|
|
|
88,214
|
|
|
|
16,737
|
|
|
|
101,643
|
|
|
|
75,211
|
|
Other revenues
|
|
|
3
|
|
|
|
1
|
|
|
|
107
|
|
|
|
182
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
198,147
|
|
|
|
85,123
|
|
|
|
387,522
|
|
|
|
257,875
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
Cost of product revenues
|
|
|
221
|
|
|
|
155
|
|
|
|
576
|
|
|
|
463
|
|
Research and development
|
|
|
88,537
|
|
|
|
71,704
|
|
|
|
248,806
|
|
|
|
185,417
|
|
Selling, general and administrative
|
|
|
39,446
|
|
|
|
26,447
|
|
|
|
117,320
|
|
|
|
71,956
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
128,204
|
|
|
|
98,306
|
|
|
|
366,702
|
|
|
|
257,836
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
69,943
|
|
|
|
(13,183
|
)
|
|
|
20,820
|
|
|
|
39
|
|
Interest and other income, net
|
|
|
885
|
|
|
|
385
|
|
|
|
2,410
|
|
|
|
829
|
|
Interest expense
|
|
|
(11,463
|
)
|
|
|
(7,699
|
)
|
|
|
(34,312
|
)
|
|
|
(29,720
|
)
|
Debt exchange expense
|
|
|
-
|
|
|
|
(1,491
|
)
|
|
|
(265
|
)
|
|
|
(11,262
|
)
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
|
59,365
|
|
|
|
(21,988
|
)
|
|
|
(11,347
|
)
|
|
|
(40,114
|
)
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
|
72
|
|
|
|
49
|
|
|
|
191
|
|
|
|
162
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
59,293
|
|
|
$
|
(22,037
|
)
|
|
$
|
(11,538
|
)
|
|
$
|
(40,276
|
)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.35
|
|
|
$
|
(0.14
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.28
|
)
|
Diluted
|
|
$
|
0.33
|
|
|
$
|
(0.14
|
)
|
|
$
|
(0.07
|
)
|
|
$
|
(0.28
|
)
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net income (loss) per
share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
168,592
|
|
|
|
155,067
|
|
|
|
167,288
|
|
|
|
143,899
|
|
Diluted
|
|
|
189,046
|
|
|
|
155,067
|
|
|
|
167,288
|
|
|
|
143,899
|
|
|
|
|
|
|
|
|
|
|
|
INCYTE CORPORATION
|
Condensed Consolidated Balance Sheet Data
|
(in thousands)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2014
|
|
2013
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term marketable securities
|
|
$
|
532,359
|
|
|
$
|
509,004
|
|
Accounts receivable, net
|
|
|
109,599
|
|
|
|
35,374
|
|
Total assets
|
|
|
785,265
|
|
|
|
629,568
|
|
Convertible senior notes(1)
|
|
|
681,313
|
|
|
|
661,567
|
|
Total stockholders’ deficit
|
|
|
(89,591
|
)
|
|
|
(193,108
|
)
|
|
|
|
|
|
|
|
|
|
(1) Net of unamortized debt discount of $160.1 million and $185.0
million at September 30, 2014 and December 31, 2013, respectively.
Copyright Business Wire 2014