- $208 million of 2016 second-quarter net
product revenues from Jakafi® (ruxolitinib), representing
46 percent growth over the same period last year
- ECHO-301, the first Phase 3 trial
evaluating epacadostat, now underway in combination with
pembrolizumab as first-line treatment of patients with advanced or
metastatic melanoma
- New Phase 3 clinical data from
COMFORT-I in myelofibrosis and RESPONSE-2 in polycythemia vera
reinforce the leadership position of Jakafi in the treatment of
patients with these myeloproliferative neoplasms (MPNs)
- Ruxolitinib granted Breakthrough
Therapy Designation by the FDA for the treatment of patients with
acute graft-versus-host disease (GVHD)
Conference Call and Webcast Scheduled Today at
10:00 a.m. ET
Incyte Corporation (Nasdaq: INCY) today reports 2016
second-quarter financial results, including strong revenue growth
driven by increased sales of Jakafi® (ruxolitinib) in the U.S. as
well as continued growth in the royalties from ex-U.S. sales of
Jakavi® (ruxolitinib) by Novartis.
The long-term clinical profile of Jakafi was reinforced by the
presentation of five-year overall survival data from the COMFORT-I
trial in patients with myelofibrosis at the recent American Society
of Clinical Oncology (ASCO) meeting and the successful results from
the RESPONSE-2 Phase 3 trial in patients with uncontrolled
polycythemia vera highlighted at the European Hematology
Association (EHA) congress. Additionally, ruxolitinib has been
granted Breakthrough Therapy Designation by the U.S. Food and Drug
Administration (FDA) for the treatment of patients with acute
GVHD.
Baricitinib, currently under global regulatory review for the
treatment of patients with rheumatoid arthritis, may provide Incyte
with a further valuable source of revenue, given the potential for
milestones and royalties under the Company’s license agreement with
Eli Lilly and Company. The first regulatory approval for
baricitinib is anticipated in the first quarter of next year.
Incyte has a growing international footprint, which was
accelerated by the recent ARIAD transaction in Europe, and now has
a development, medical and commercial organization in Europe to
complement its fully-integrated U.S. business. The expanded
European team is fully operational, and will continue to grow the
Iclusig® (ponatinib) brand as well as contribute to the
clinical development of Incyte’s portfolio of 14 product
candidates.
Within the R&D group, and during the second quarter of 2016,
Incyte initiated the first pivotal Phase 3 trial of epacadostat,
added a new clinical program with the initiation of a first-in-man
trial of INCAGN1876, an anti-GITR agonist antibody, and signed a
drug discovery alliance with the Moffitt Cancer Center –
collectively illustrating the depth and breadth of Incyte’s
discovery and development programs.
“Incyte is in an excellent position both financially and
operationally as we enter the second half of the year,” stated
Hervé Hoppenot, Incyte’s Chief Executive Officer. “Jakafi continues
to grow rapidly in the U.S., and we have successfully incorporated
our expanded European team. The recent initiation of the first
Phase 3 trial of epacadostat was a significant milestone for
Incyte, and we are preparing to launch the pivotal program for
ruxolitinib in GVHD.”
2016 Second-Quarter Financial Results
Revenues For the quarter ended June 30, 2016, net product
revenues of Jakafi were $208 million as compared to $142 million
for the same period in 2015, representing 46 percent growth. For
the six months ended June 30, 2016, net product revenues of Jakafi
were $391 million as compared to $258 million for the same period
in 2015, representing 52 percent growth. For the quarter and six
months ended June 30, 2016, net product revenues of Iclusig were $4
million. For the quarter and six months ended June 30, 2016,
product royalties from sales of Jakavi outside of the United States
received from Novartis were $26 million and $48 million,
respectively, as compared to $17 million and $33 million,
respectively, for the same periods in 2015. For the quarter and six
months ended June 30, 2016, contract revenues were $8 million and
$66 million, respectively, as compared to $3 million and $31
million, respectively, for the same periods in 2015. The increase
in contract revenues relates to milestone payments earned. For the
quarter ended June 30, 2016, total revenues were $246 million as
compared to $163 million for the same period in 2015. For the six
months ended June 30, 2016, total revenues were $510 million as
compared to $322 million for the same period in 2015.
Year Over Year Revenue Growth (in thousands,
unaudited) Three Months Ended
Six Months Ended June 30, %
June 30, % 2016 2015
Change 2016 2015 Change
Revenues: Jakafi net product revenue $ 208,126 $ 142,406 46% $
391,393 $ 257,736 52% Iclusig net product revenue 3,990 - - 3,990 -
- Product royalty revenues 25,958 17,364 49% 47,860 33,037 45%
Contract revenues 8,214 3,214 - 66,429 31,429 - Other revenues
- - - 80 58 - Total revenues $ 246,288
$ 162,984 51% $ 509,752 $ 322,260 58%
Research and development expenses Research and
development expenses for the quarter and six months ended June 30,
2016 were $120 million and $277 million, respectively, as compared
to $112 million and $231 million, respectively, for the same
periods in 2015. Included in research and development expenses for
the quarter and six months ended June 30, 2016 were non-cash
expenses related to equity awards to our employees of $14 million
and $27 million, respectively. The increase in research and
development expenses for the six months ended June 30, 2016 was
primarily due to the previously announced $35 million upfront
payment to acquire the rights from Lilly to develop ruxolitinib for
the treatment of patients with GVHD and the expansion of the
Company’s clinical portfolio.
Selling, general and administrative expenses Selling,
general and administrative expenses for the quarter and six months
ended June 30, 2016 were $67 million and $131 million,
respectively, as compared to $52 million and $97 million,
respectively, for the same periods in 2015. Included in selling,
general and administrative expenses for the quarter and six months
ended June 30, 2016 were non-cash expenses related to equity awards
to our employees of $8 million and $16 million, respectively.
Increased selling, general and administrative expenses are driven
primarily by additional costs related to the commercialization of
Jakafi.
Unrealized loss on long term investment Unrealized loss
on long term investment of $1 million and $4 million for the
quarter and six months ended June 30, 2016 represents the fair
market value adjustments of the Company’s investment in Agenus.
Net income / (loss) Net income for the quarter ended June
30, 2016 was $34 million, or $0.18 per basic and diluted share, as
compared to net income of $9 million, or $0.05 per basic and
diluted share for the same period in 2015. Net income for the six
months ended June 30, 2016 was $58 million, or $0.31 per basic and
$0.30 per diluted share, as compared to net loss of $9 million, or
$0.05 per basic and diluted share for the same period in 2015.
Cash, cash equivalents and marketable securities position
As of June 30, 2016, cash, cash equivalents and marketable
securities totaled $629 million, as compared to $708 million as of
December 31, 2015.
2016 Financial Guidance
The Company has updated its full year 2016 financial guidance,
as detailed below.
Current
Previous Jakafi net product revenues
$825-$835 million $815-$830 million
Iclusig net product
revenues $25-$30 million Unchanged
Research and development
expenses $620-$630 million $635-$660 million
Selling,
general and administrative expenses $285-$310 million
Unchanged
Corporate Update
In June 2016, Jonathan Dickinson joined the Executive Management
team as Senior Vice President and General Manager, Europe, leading
the commercial and medical affairs functions for Incyte in Europe.
He joined Incyte from ARIAD Pharmaceuticals (Europe) Sàrl where he
held the position of General Manager, Europe. Prior to his tenure
at ARIAD, Jonathan worked at Bristol-Myers Squibb as the European
oncology brand lead and at Hoffmann-La Roche where he had
assignments both in the U.S. and Switzerland.
Portfolio Update
Cancer – Targeted Therapies
In April 2016, Incyte announced an agreement with Lilly,
enabling Incyte to develop and commercialize ruxolitinib in the
U.S. for the treatment of GVHD, and an agreement granting Novartis
exclusive research, development and commercialization rights for
ruxolitinib in GVHD ex-U.S. Incyte recently announced that the FDA
has granted Breakthrough Therapy Designation for ruxolitinib in
patients with acute GVHD.
A proof-of-concept trial of INCB39110, a selective JAK1
inhibitor, in patients with GVHD has completed recruitment and
initial data is expected before the end of 2016.
In April 2016, preliminary data from an open-label Phase 1 dose
escalation trial of INCB50465, Incyte’s second-generation, highly
selective PI3K delta inhibitor, was presented at AACR 2016.
INCB50465 showed promising efficacy in B-cell malignancies and was
generally well tolerated at all doses tested.
A Phase 2 trial of INCB54828, a selective FGFR inhibitor, in
patients with bladder cancer harboring FGFR pathway alterations is
expected to start in the second half of 2016.
Indication
Status Update Ruxolitinib (JAK1/JAK2)
Graft versus host disease Pivotal program expected to begin
in the second half of 2016
INCB39110 (JAK1) Graft
versus host disease Phase 1/2 fully recruited, data expected
before the end of 2016
INCB39110 (JAK1) Lung cancer
Phase 1/2 in combination with osimertinib (EGFR) expected to
initiate in the second half of 2016
INCB52793 (JAK1)
Advanced malignancies Phase 1/2 dose-escalation
INCB50465
(PI3Kδ) B-cell malignancies Phase 1/2 as
monotherapy and in combination with INCB39110 (JAK1)
INCB54828
(FGFR) Bladder cancer Phase 2 expected to
initiate in the second half of 2016
INCB54329 (BRD)
Advanced malignancies Phase 1/2 dose-escalation
INCB53914
(PIM) Advanced malignancies Phase 1/2
dose-escalation
INCB59872 (LSD1) Acute myeloid
leukemia, small cell lung cancer Phase 1/2 dose-escalation
Cancer – Immune Therapies
The Phase 3 ECHO-301 study evaluating epacadostat in combination
with the anti-PD-1 antibody, pembrolizumab, for the first-line
treatment of patients with advanced or metastatic melanoma is now
recruiting patients. The randomized, double-blind and placebo
controlled trial, is planned to enroll 600 patients and to have
dual-primary endpoints of progression-free survival and overall
survival.
Updated data from the Phase 1 portion of ECHO-202, which was
initially presented at SITC 2015 and drove the decision to initiate
the Phase 3 trial, have been accepted for presentation at the
European Society for Medical Oncology (ESMO) congress taking place
in Copenhagen in October 2016.
In June 2016, the proof-of-concept trial of INCAGN1876, an
anti-GITR agonist antibody being co-developed with Agenus, began
dosing patients with solid tumors.
Indication
Status Update Epacadostat First line,
advanced melanoma Phase 3 (ECHO-301) in combination with
pembrolizumab (PD-1) Multiple tumor types
Phase 2 (ECHO-202) expansion cohorts in combination with
pembrolizumab (PD-1) Multiple tumor types
Phase 2 (ECHO-204) expansion cohorts in combination with nivolumab
(PD-1) Multiple tumor types Phase 2 (ECHO-203)
expansion cohorts in combination with durvalumab (PD-L1)
Non-small cell lung cancer Phase 1/2 (ECHO-110)
dose-escalation in combination with atezolizumab (PD-L1)
INCSHR1210 (PD-1, licensed from
Hengrui)
Solid tumors Phase 1/2 dose-escalation
INCAGN1876 (GITR, co-developed with
Agenus)
Solid tumors Phase 1/2 dose-escalation
INCAGN1949 (OX40, co-developed with
Agenus)
Solid tumors Phase 1/2 expected to initiate in the
second half of 2016
PD-1
platform study Solid tumors Phase 1/2,
pembrolizumab (PD-1) in combination with INCB39110 (JAK1) or
INCB50465 (PI3Kδ)
JAK1 platform study Solid tumors
Phase 1/2, INCB39110 (JAK1) in combination with epacadostat
(IDO1) or INCB50465 (PI3Kδ)
Non Oncology
In October 2015, Incyte initiated a Phase 2 trial of topical
ruxolitinib for the treatment of alopecia areata. This study builds
on published data showing the efficacy of oral JAK inhibitors,
including ruxolitinib, in alopecia areata.
Indication
Status Update Topical ruxolitinib (JAK1/JAK2)
Alopecia areata Phase 2
Partnered
Baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly, is under
global regulatory review for the treatment of patients with
rheumatoid arthritis. If approved, Incyte will become eligible to
earn regulatory and commercial milestones as well as royalties on
global net sales. Baricitinib is also in Phase 2 trials for the
treatment of patients with atopic dermatitis and systemic lupus
erythematosus.
In June 2016, safety and efficacy data from several Phase 1 and
Phase 2 trials of capmatinib, Incyte’s potent and selective c-MET
inhibitor licensed to Novartis, as single agent and in combination
with gefitinib in patients with c-MET positive non-small cell lung
cancer and liver cancer, were presented at ASCO. Novartis
anticipates submitting an NDA for capmatinib in 2018.
Indication
Status Update Baricitinib (JAK1/JAK2, licensed to
Lilly) Rheumatoid arthritis NDA & MAA
submitted Atopic dermatitis, systemic lupus
erythematosus Phase 2
Capmatinib (c-MET, licensed to
Novartis) Non-small cell lung cancer, glioblastoma,
liver cancer Phase 2 in EGFR wild-type ALK negative NSCLC
patients with c-MET amplification and mutation
Conference Call and Webcast Information
Incyte will hold its 2016 second-quarter financial results
conference call and webcast this morning at 10:00 a.m. ET. To
access the conference call, please dial 877-407-9221 for domestic
callers or 201-689-8597 for international callers. When prompted,
provide the conference identification number, 13641107.
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, 13641107.
The conference call will also be webcast live and can be
accessed at www.incyte.com in the Investors section under “Events
and Presentations”.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
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.
About Iclusig® (ponatinib) tablets
Iclusig targets not only native BCR-ABL but also its isoforms
that carry mutations that confer resistance to treatment, including
the T315I mutation, which has been associated with resistance to
other approved TKIs.
In the EU, Iclusig is approved for the treatment of adult
patients with chronic phase, accelerated phase or blast phase
chronic myeloid leukemia (CML) who are resistant to dasatinib or
nilotinib; who are intolerant to dasatinib or nilotinib and for
whom subsequent treatment with imatinib is not clinically
appropriate; or who have the T315I mutation, or the treatment of
adult patients with Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib;
who are intolerant to dasatinib and for whom subsequent treatment
with imatinib is not clinically appropriate; or who have the T315I
mutation.
Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc
to develop and commercialize Iclusig in the European Union and 22
other countries, including Switzerland, Norway, Turkey, Israel and
Russia.
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 revised financial
guidance for 2016 and the expectations underlying such guidance;
whether and when the Company will receive potential milestone
payments or royalty payments from Lilly with respect to
baricitinib, whether baricitinib will be approved in the U.S. or
receive a positive opinion in Europe, and whether and when Lilly
will launch baricitinib; whether the Company’s expanded European
team will grow the Iclusig brand or contribute to clinical
development; plans and expectations regarding the Company’s product
pipeline and strategy - including timelines for advancing its drug
candidates through clinical trials, including enrollment and
commencement, timelines for regulatory submissions and timelines
for releasing trial data, and whether any specific program will be
successful - including, without limitation, with respect to its
GVHD, ruxolitinib, selective JAK1 inhibitor, IDO1 inhibitor
(epacadostat), FGFR inhibitor, OX40 and c-Met programs; and whether
Novartis will submit an NDA for capmatinib in 2018.
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 our products; the acceptance of our products in the
marketplace; market competition; further research and development;
sales, marketing and distribution requirements; clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; 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; the Company's
dependence on its relationships with its collaboration partners;
greater than expected expenses; expenses relating to litigation or
strategic activities; our ability to obtain additional capital when
needed; obtaining and maintaining effective patent coverage for the
Company’s products; 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 March 31,
2016. 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
Six Months Ended June 30, June 30,
2016 2015 2016 2015
Revenues: Product revenues, net $ 212,116 $ 142,406 $ 395,383 $
257,736 Product royalty revenues 25,958 17,364 47,860 33,037
Contract revenues 8,214 3,214 66,429 31,429 Other revenues -
- 80 58 Total
revenues 246,288 162,984 509,752
322,260 Costs and expenses: Cost of
product revenues (including definite-lived intangible amortization)
12,367 6,254 18,372 9,229 Research and development 120,269 112,445
277,092 230,809 Selling, general and administrative 66,792 51,679
131,390 96,548 Change in fair value of acquisition-related
contingent consideration 2,271 -
2,271 - Total costs and expenses
201,699 170,378 429,125
336,586 Income (loss) from operations 44,589 (7,394 )
80,627 (14,326 ) Interest and other income, net 1,137 1,144 2,630
2,773 Interest expense (9,662 ) (11,494 ) (19,796 ) (24,181 )
Unrealized gain (loss) on long term investment (854 )
27,174 (3,804 ) 27,174 Income (loss)
before provision for income taxes 35,210 9,430 59,657 (8,560 )
Provision for income taxes 785 136
1,185 503 Net income (loss) $ 34,425
$ 9,294 $ 58,472 $ (9,063 ) Net income
(loss) per share: Basic $ 0.18 $ 0.05 $ 0.31 $ (0.05 ) Diluted $
0.18 $ 0.05 $ 0.30 $ (0.05 ) Shares used in computing net
income (loss) per share: Basic 187,682 178,676 187,433 175,373
Diluted 193,015 186,493 192,820 175,373
INCYTE
CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands) June 30,
December 31, 2016 2015 ASSETS Cash,
cash equivalents and marketable securities $ 629,191 $ 707,783
Restricted cash and investments 938 14,493 Accounts receivable
129,486 114,450 Property and equipment, net 138,513 86,006
Inventory 21,664 19,338 Prepaid expenses and other assets 29,809
30,122 Long term investment 31,444 35,248 Other intangible assets,
net 269,205 - In-process research and development 12,000 - Goodwill
155,725 - Total assets $ 1,417,975 $ 1,007,440
LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable,
accrued expenses and other liabilities $ 185,338 $ 203,880 Deferred
revenue—collaborative agreements 6,083 12,512 Convertible senior
notes 635,491 619,893 Acquisition-related contingent consideration
294,000 - Stockholders’ equity 297,063 171,155 Total
liabilities and stockholders’ equity $ 1,417,975 $ 1,007,440
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Incyte CorporationMediaCatalina Loveman, +1
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil, +1 302-498-5914mbooth@incyte.com
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