- $276 million of 2017 second-quarter net
product revenues from Jakafi® (ruxolitinib), representing 33
percent growth over the same period last year
- Proof-of-concept data for the
combination of epacadostat plus PD-1 inhibition presented at the
American Society of Clinical Oncology Annual Meeting (ASCO) 2017
across multiple tumor types; expanded Phase 3 program on track for
planned initiation in 2017
- Multiple product candidates in
late-stage clinical development illustrates transformational growth
potential of Incyte’s portfolio
Conference Call and Webcast Scheduled Today at
10:00 a.m. ET
Incyte Corporation (Nasdaq: INCY) today reports 2017
second-quarter financial results, highlighting strong revenue
growth driven by increased sales of Jakafi® (ruxolitinib) in the
U.S. and Iclusig® (ponatinib) in Europe, and royalties from ex-U.S.
sales of Jakavi® (ruxolitinib) by Novartis and Olumiant®
(baricitinib) by Lilly. Recent highlights also include the
initiation of two pivotal studies (ruxolitinib for
treatment-refractory chronic graft versus host disease (GVHD);
itacitinib for steroid-naïve acute GVHD), and the presentation of
multiple data sets at ASCO 2017 supporting the expansion of the
pivotal trial program for epacadostat.
“Revenue growth from Jakafi and Iclusig continues to be very
robust, driven by strong demand, and we have also made significant
progress across our clinical portfolio. As we look forward to the
second half of 2017, we anticipate the publication of important
data from our development candidates, as well as the initiation of
multiple additional pivotal combination studies with epacadostat,”
stated Hervé Hoppenot, Chief Executive Officer, Incyte. “Investment
in innovation has created significant value for Incyte, our
stakeholders and for the patients that our products treat. With
strong revenue growth, a broad clinical development portfolio,
comprehensive drug discovery capabilities and an expanded
geographic footprint which now includes the U.S., Europe and Japan,
we believe that we are well positioned for long-term value
creation.”
Portfolio Update
Cancer – Targeted Therapies
In July, the latest National Comprehensive Cancer Network®
(NCCN®) Clinical Practice Guidelines in Oncology for
myeloproliferative neoplasms (MPNs) were published, and now include
Jakafi as a recommended treatment for patients with myelofibrosis
and patients with polycythemia vera who have had an inadequate
response to first-line therapies, such as hydroxyurea.
In June, REACH3, a Phase 3 trial of ruxolitinib as a treatment
for patients with steroid-refractory chronic GVHD, was initiated.
REACH3 is being conducted in collaboration with Novartis.
RESET-272, the double-blind, randomized pivotal trial of
ruxolitinib versus anagrelide for the treatment of patients with
essential thrombocythemia who are resistant to or intolerant of
hydroxyurea, is now open for enrollment.
GRAVITAS-301, the Phase 3 trial of itacitinib, Incyte’s
selective JAK1 inhibitor, in patients with treatment-naïve acute
GVHD, began dosing in July.
Following a review of the clinical profiles of Incyte’s two BRD
inhibitors, INCB54329 and INCB57643, including data expected to be
presented at medical meetings in the second half of 2017, the
Company intends to focus future development efforts on
INCB57643.
In June, Incyte initiated the Phase 1/2 dose-escalation trial of
its FGFR4 inhibitor, INCB62079, in patients with hepatocellular
carcinoma.
Indication Status Update
Ruxolitinib (JAK1/JAK2) Steroid-refractory
acute GVHD Pivotal Phase 2 (REACH1) and Phase 3
(REACH2)
Ruxolitinib (JAK1/JAK2) Steroid-refractory chronic
GVHD Phase 3 (REACH3)
Ruxolitinib (JAK1/JAK2) Essential
thrombocythemia Pivotal Phase 2 (RESET-272) open for enrollment
Itacitinib (JAK1) Treatment-naïve acute GVHD Phase 3
(GRAVITAS-301)
Itacitinib (JAK1) Non-small cell lung cancer
Phase 1/2 in combination with osimertinib (EGFR)
INCB52793
(JAK1) Advanced malignancies Phase 1/2 dose-escalation
INCB50465 (PI3Kδ) Diffuse large B-cell lymphoma Phase 2
(CITADEL-202)
INCB54828 (FGFR1/2/3) Bladder cancer,
cholangiocarcinoma; 8p11 MPNs
Phase 2 (FIGHT-201, FIGHT-202,
FIGHT-203)
INCB57643 (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
INCB62079
(FGFR4) Hepatocellular carcinoma
Phase 1/2 dose-escalation
Cancer – Immune Therapies
At ASCO 2017 in June, new data from the ECHO-202 and ECHO-204
Phase 1/2 trials of epacadostat plus PD-1 inhibitors were presented
in multiple tumor types. These data formed the basis of the
decisions to proceed into multiple Phase 3 trials, in collaboration
with each of Merck and Bristol-Myers Squibb, respectively, as
announced earlier this year.
In June 2017, Incyte and Roche/Genentech decided to close the
ECHO-110 trial of epacadostat plus atezolizumab to further
enrollment because of slow study recruitment.
Indication Status Update
Epacadostat (IDO1) Unresectable or metastatic
melanoma Phase 3 (ECHO-301) in combination with
pembrolizumab (PD-1)
Epacadostat (IDO1) NSCLC, renal,
bladder and head & neck cancer Phase 3 in combination with
pembrolizumab (PD-1) expected to begin in 2017
Epacadostat
(IDO1) NSCLC, head & neck cancer Phase 3 in combination
with nivolumab (PD-1) expected to begin in 2017
Epacadostat
(IDO1) Multiple tumor types Phase 2 (ECHO-202) expansion
cohorts in combination with pembrolizumab (PD-1)
Epacadostat
(IDO1) Multiple tumor types Phase 2 (ECHO-204) expansion
cohorts in combination with nivolumab (PD-1)
Epacadostat
(IDO1) Multiple tumor types Phase 2 (ECHO-203) expansion
cohorts in combination with durvalumab (PD-L1)
INCB01158
(ARG)1 Solid tumors Phase 1/2 dose-escalation
INCSHR1210 (PD-1)2 Solid tumors Phase 1/2
dose-escalation completed; enrollment suspended
INCAGN1876
(GITR)3 Solid tumors Phase 1/2 dose-escalation
INCAGN1949 (OX40)3 Solid tumors Phase 1/2
dose-escalation
PD-1 platform study Solid tumors Phase 1/2,
pembrolizumab (PD-1) in combination with itacitinib (JAK1) or
INCB50465 (PI3Kδ)
JAK1 platform study Solid
tumors Phase 1/2, itacitinib (JAK1) in combination
with epacadostat (IDO1) or INCB50465 (PI3Kδ) Notes:
1) INCB01158 co-developed with
Calithera 2) INCSHR1210 licensed from Hengrui 3) INCAGN1876 &
INCAGN1949 from discovery alliance with Agenus
Non-oncology
In June, Incyte initiated a Phase 2 trial of topical ruxolitinib
for the treatment of patients with vitiligo.
Indication Status Update
Topical ruxolitinib (JAK1/JAK2) Atopic
dermatitis, vitiligo Phase 2
Partnered
In July 2017, Lilly and Incyte announced that Japan's Ministry
of Health, Labor and Welfare granted marketing approval for
Olumiant for the treatment of rheumatoid arthritis (including the
prevention of structural injury of joints) in patients with
inadequate response to standard-of-care therapies.
In July 2017, Lilly and Incyte announced that a resubmission to
the U.S. Food and Drug Administration (FDA) for the New Drug
Application (NDA) for baricitinib will be delayed for a period
anticipated to be a minimum of 18 months. The companies will be
further discussing the path forward with the agency and evaluating
options for resubmission, including the potential for an additional
clinical study, as requested by the FDA.
Novartis has stated that it anticipates submitting an NDA for
capmatinib, Incyte’s potent and selective c-MET inhibitor, in
2018.
Indication Status Update
Baricitinib (JAK1/JAK2)1 Rheumatoid
arthritis Approved in Europe and Japan; CRL issued by
FDA
Baricitinib (JAK1/JAK2)1 Psoriatic arthritis
Lilly no longer expects Phase 3 to begin in 2017
Baricitinib
(JAK1/JAK2)1 Atopic dermatitis, systemic lupus
erythematosus Phase 2
Capmatinib (c-MET)2
Non-small cell lung cancer, liver cancer Phase
2 in EGFR wild-type ALK negative NSCLC patients with c-MET
amplification and mutation Notes:
1) Baricitinib licensed to Lilly 2) Capmatinib
licensed to Novartis
Corporate Update
In June 2017, Lothar Finke, M.D. joined the Incyte Executive
Management team as Head of Development Japan and General Manager,
Japan. Dr. Finke was most recently the Head of Oncology Development
and Medical Affairs Japan for Novartis where he was responsible for
leading an integrated organization to support oncology development.
He has significant experience developing drugs in all classes of
oncology including immuno-oncology, targeted therapies and cell
therapies in the EU, U.S., Canada, and Japan.
2017 Second-Quarter Financial Results
Revenues For the quarter ended June 30, 2017, net product
revenues of Jakafi were $276 million as compared to $208 million
for the same period in 2016, representing 33 percent growth. For
the six months ended June 30, 2017, net product revenues of Jakafi
were $527 million as compared to $391 million for the same period
in 2016, representing 35 percent growth. For the quarter ended June
30, 2017, net product revenues of Iclusig were $16 million as
compared to $4 million for the same period in 2016. For the six
months ended June 30, 2017, net product revenues of Iclusig were
$29 million as compared to $4 million for the same period in
20161.
For the quarter and six months ended June 30, 2017, product
royalties from sales of Jakavi, which has been out-licensed to
Novartis outside of the United States, were $34 million and $63
million, respectively, as compared to $26 million and $48 million
for the same periods in 2016. For the quarter and six months ended
June 30, 2017, product royalties from sales of Olumiant outside of
the United States received from Lilly were $1 million.
For the quarter and six months ended June 30, 2017, contract
revenues were $0 million and $90 million, respectively, as compared
to $8 million and $66 million for the same periods in 2016. These
contract revenues relate to milestone payments earned.
For the quarter ended June 30, 2017, total revenues were $326
million as compared to $246 million for the same period in 2016.
For the six months ended June 30, 2017, total revenues were $711
million as compared to $510 million for the same period in
2016.
Year Over Year Revenue Growth (in thousands,
unaudited) Three
Months Ended Six Months Ended June 30, %
June 30, % 2017 2016 Change
2017 2016 Change Revenues: Jakafi net product
revenue $ 276,038 $ 208,126 33% $ 527,115 $ 391,393 35% Iclusig net
product revenue 15,629 3,990 - 29,359 3,990 - Product royalty
revenues 34,769 25,958 34% 63,990 47,860 34% Contract revenues -
8,214 - 90,000 66,429 - Other revenues 8 - -
62 80 - Total revenues $ 326,444 $ 246,288 33% $ 710,526 $
509,752 39%
Research and development expenses Research and
development expenses for the quarter and six months ended June 30,
2017 were $202 million and $610 million, respectively, as compared
to $120 million and $277 million for the same periods in 2016.
Included in research and development expenses for the quarter and
six months ended June 30, 2017 were non-cash expenses related to
equity awards to our employees of $23 million and $44 million,
respectively. The increase in research and development expenses was
primarily due to the expansion of the Company’s clinical portfolio
as well as upfront and milestone expenses of $209 million related
to our collaboration and license agreements with Agenus, Calithera
and Merus.
Selling, general and administrative expenses Selling,
general and administrative expenses for the quarter and six months
ended June 30, 2017 were $90 million and $177 million,
respectively, as compared to $67 million and $131 million for the
same periods in 2016. Included in selling, general and
administrative expenses for the quarter and six months ended June
30, 2017 were non-cash expenses related to equity awards to our
employees of $11 million and $20 million, respectively. Increased
selling, general and administrative expenses were driven primarily
by additional costs related to the commercialization of Jakafi and
the geographic expansion in Europe.
Change in fair value of acquisition-related contingent
consideration The change in fair value of acquisition-related
contingent consideration for the quarter and six months ended June
30, 2017 were $7 million and $14 million, respectively, as compared
to $2 million for the same periods in 2016. The change in fair
value of acquisition-related contingent consideration represents
the fair market value adjustments of the Company’s contingent
liability related to the acquisition of the European business of
ARIAD Pharmaceuticals, Inc.
Unrealized loss on long term investments Unrealized loss
on long term investments for the quarter and six months ended June
30, 2017 were $20 million and $25 million, respectively, as
compared to $1 million and $4 million for the same periods in 2016.
The unrealized loss on long term investments for the quarter and
six months ended June 30, 2017 represents the fair market value
adjustments of the Company’s investments in Agenus and Merus.
Expense related to senior note conversions Expense
related to senior note conversions for the quarter and six months
ended June 30, 2017 were $1 million and $55 million, respectively,
related to the conversions of certain of our 2018 and 2020
convertible senior notes.
Net income (loss) Net loss for the quarter ended June 30,
2017 was $12 million, or $0.06 per basic and diluted share, as
compared to net income of $34 million, or $0.18 per basic and
diluted share for the same period in 2016. Net loss for the six
months ended June 30, 2017 was $200 million, or $1.00 per basic and
diluted share, as compared to net income of $58 million, or $0.31
per basic and $0.30 per diluted share for the same period in
2016.
Cash, cash equivalents and marketable securities position
As of June 30, 2017, cash, cash equivalents and marketable
securities totaled $609 million as compared to $809 million as of
December 31, 2016.
2017 Financial Guidance
The Company has updated its full year 2017 financial guidance,
as detailed below.
Current Previous Jakafi net
product revenues $1,090-$1,120 million
$1,020-$1,070 million Iclusig net product revenues $60-$65 million
Unchanged Research and development expenses* $1,050-$1,150 million
$1,000-$1,100 million Selling, general and administrative expenses
$340-$360 million Unchanged Change in fair value of
acquisition-related contingent consideration $30-$35
million Unchanged * Includes upfront and milestone
expenses of $209 million related to the amended Agenus
collaboration, and the Merus and Calithera collaborations
Conference Call and Webcast Information
Incyte will hold its 2017 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, 13665688.
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, 13665688.
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,
since acquired by Takeda Pharmaceutical Company Limited, 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 release contain predictions, estimates
and other forward-looking statements, including without limitation
statements regarding: the Company’s financial guidance for 2017 and
the expectations underlying such guidance; whether baricitinib for
RA will be approved in the U.S., whether and when a new clinical
trial will be undertaken for baricitinib for RA in the U.S.,
whether and when the NDA for baricitinib for RA will be resubmitted
to the FDA, whether baricitinib will ever be approved in the U.S.
for any indication and whether development of baricitinib in other
indications will be successful or will continue as currently
planned; whether we will receive any further milestones from Lilly
in connection with baricitinib development; plans and expectations
regarding our product pipeline and strategy (including without
limitation plans and expectations relating to epacadostat,
ruxolitinib, itacitinib, INCB50465 and INCB54828) - including
timelines for advancing our drug candidates through clinical trials
(including enrollment and commencement), whether certain trials
will serve as the basis for registration, timelines for regulatory
submissions and timelines for releasing trial data, the number of
potential clinical trials, and whether any specific program will be
successful - and plans and expectations regarding development
activities of our collaboration partners (including without
limitation collaboration development activities relating to
capmatinib and baricitinib); whether the Company’s development
portfolio will lead to transformational growth; and whether Incyte
will become a highly profitable biopharmaceutical company.
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,
including pivotal 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; determinations made by the FDA; 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,
2017. The Company disclaims any intent or obligation to update
these forward-looking statements.
1 In June 2016, Incyte obtained an exclusive license from
ARIAD to develop and commercialize Iclusig in Europe and other
select ex-U.S. countries.
INCYTE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Six Months
Ended June 30, June 30, 2017 2016
2017 2016 Revenues: Product revenues, net $ 291,667 $
212,116 $ 556,474 $ 395,383 Product royalty revenues 34,769 25,958
63,990 47,860 Contract revenues - 8,214 90,000 66,429 Other
revenues 8 - 62 80
Total revenues 326,444 246,288
710,526 509,752 Costs and
expenses: Cost of product revenues (including definite-lived
intangible amortization) 20,260 12,367 35,084 18,372 Research and
development 201,839 120,269 609,811 277,092 Selling, general and
administrative 90,072 66,792 177,306 131,390 Change in fair value
of acquisition-related contingent consideration 7,073
2,271 14,429 2,271 Total
costs and expenses 319,244 201,699
836,630 429,125 Income (loss)
from operations 7,200 44,589 (126,104 ) 80,627 Interest and other
income, net 4,125 1,137 5,329 2,630 Interest expense (384 ) (9,662
) (6,323 ) (19,796 ) Unrealized loss on long term investments
(19,574 ) (854 ) (25,388 ) (3,804 ) Expense related to senior note
conversions (751 ) - (54,881 ) -
Income (loss) before provision (benefit) for income taxes
(9,384 ) 35,210 (207,367 ) 59,657 Provision (benefit) for income
taxes 3,100 785 (7,800 )
1,185 Net income (loss) $ (12,484 ) $ 34,425 $
(199,567 ) $ 58,472 Net income (loss) per share:
Basic $ (0.06 ) $ 0.18 $ (1.00 ) $ 0.31 Diluted $ (0.06 ) $ 0.18 $
(1.00 ) $ 0.30 Shares used in computing net income (loss)
per share: Basic 205,141 187,682 200,200 187,433 Diluted 205,141
193,015 200,200 192,820
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in
thousands) June 30, December 31,
2017 2016 ASSETS Cash, cash equivalents and
marketable securities $ 608,606 $ 808,546 Restricted cash and
investments 943 886 Accounts receivable 169,516 148,758 Property
and equipment, net 218,878 167,679 Inventory 14,837 19,299 Prepaid
expenses and other assets 66,976 35,412 Long term investments
144,425 31,987 Other intangible assets, net 247,669 258,437
In-process research and development 12,000 12,000 Goodwill
155,593 155,593 Total assets $ 1,639,443 $ 1,638,597
LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable,
accrued expenses and other liabilities $ 283,180 $ 266,649
Convertible senior notes 23,428 651,481 Acquisition-related
contingent consideration 306,000 301,000 Stockholders’ equity
1,026,835 419,467 Total liabilities and stockholders’
equity $ 1,639,443 $ 1,638,597
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version on businesswire.com: http://www.businesswire.com/news/home/20170801005504/en/
Incyte CorporationMediaCatalina Loveman, +1
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil, +1 302-498-5914mbooth@incyte.com
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