– Total net product revenues grew to $713 million (+20% Y/Y) as
a result of strong Jakafi® (ruxolitinib) and Opzelura™
(ruxolitinib) cream net product revenues
– Jakafi net product revenues of $620 million in Q3’22 (+13%
Y/Y); raising the bottom end of full year guidance to a new range
of $2.38 to $2.40 billion
– Opzelura net product revenues of $38 million in Q3'22 driven
by robust demand and broadening payer access; launch in vitiligo
underway
– Pipeline progresses with positive povorcitinib data in
hidradenitis suppurativa at EADV, oral PD-L1 update at SITC and the
pending acquisition of Villaris Therapeutics and auremolimab, a
novel anti-IL-15Rβ mAb
Conference Call and Webcast Scheduled Today
at 8:00 a.m. EDT
Incyte (Nasdaq:INCY) today reports 2022 third quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
“Our total net product revenues grew 20% year over year led by
strong Jakafi® (ruxolitinib) performance and an increasing
contribution from Opzelura™ (ruxolitinib) cream. Over 62,000 units
of Opzelura were shipped in the quarter with growth fueled by both
atopic dermatitis and vitiligo. This strong demand, coupled with an
expansion of reimbursement coverage, positions Opzelura to become a
meaningful long-term growth driver for Incyte,” said Hervé
Hoppenot, Chief Executive Officer, Incyte. “Additionally, our
pipeline is progressing across Oncology and Dermatology, and we
continue to execute on our strategy for growth and diversification
with multiple updates on key programs expected over the next
several months.”
Portfolio Updates
MPNs and GVHD – key highlights
LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib)
program: Key LIMBER development programs, including combination
trials of ruxolitinib with parsaclisib, INCB57643 (BET) and
INCB00928 (ALK2), are ongoing. Additionally, the Prescription Drug
User Fee Act (PDUFA) target action date for once-daily (QD)
ruxolitinib extended release (XR) formulation is March 23,
2023.
Axatilimab in chronic graft-versus-host disease (cGVHD):
AGAVE-201, a global pivotal Phase 2 trial of axatilimab in patients
with cGVHD is ongoing with results expected mid-2023. A Phase 1/2
combination trial of axatilimab with ruxolitinib in patients with
newly-diagnosed cGVHD is in preparation and is expected to initiate
in the first quarter of 2023.
Indication and status
QD ruxolitinib
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and GVHD:
NDA under review
ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)
Myelofibrosis: Phase 3 (first-line
therapy) (LIMBER-313) Myelofibrosis: Phase 3 (suboptimal responders
to ruxolitinib) (LIMBER-304)
ruxolitinib + INCB57643
(JAK1/JAK2 + BET)
Myelofibrosis: Phase 2
ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2
ruxolitinib + CK08041 (JAK1/JAK2
+ CB-Tregs)
Myelofibrosis: PoC (LIMBER-TREG108)
axatilimab (anti-CSF-1R)2
Chronic GVHD: Pivotal Phase 2 (third-line
plus therapy) (AGAVE-201)
1 Development collaboration with Cellenkos, Inc. 2 Clinical
development of axatilimab in GVHD conducted in collaboration with
Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
Pemigatinib (Pemazyre®): In August, Pemazyre was approved
by the U.S. Food and Drug Administration (FDA) as the first and
only targeted treatment for myeloid/lymphoid neoplasms (MLNs) with
FGFR1 rearrangement. MLNs with FGFR1 rearrangement are extremely
rare and aggressive blood cancers and this approval demonstrates
Incyte's commitment to improving and expanding treatments for
patients living with rare blood cancers. Phase 2 open-label studies
evaluating pemigatinib in glioblastoma and relapsed or refractory
advanced non-small cell lung cancer are ongoing.
Indication and status
pemigatinib (FGFR1/2/3)
Myeloid/lymphoid neoplasms (MLN): approved
by FDA Cholangiocarcinoma (CCA): Phase 3 (FIGHT-302) Glioblastoma:
Phase 2 (FIGHT-209) Non-small cell lung cancer (NSCLC): Phase 2
(FIGHT-210)
tafasitamab (CD19)1
Relapsed or refractory diffuse large
B-cell lymphoma (DLBCL): Phase 2 (L-MIND); Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory
follicular lymphoma (FL) and relapsed or refractory marginal zone
lymphoma (MZL): Phase 3 (inMIND) Relapsed or refractory B-cell
malignancies: PoC with lenalidomide and plamotamab2
parsaclisib (PI3Kδ)
Warm autoimmune hemolytic anemia: Phase 3
(PATHWAY)
retifanlimab (PD-1)3
Squamous cell anal cancer (SCAC): Phase 3
(POD1UM-303) MSI-high endometrial cancer: Phase 2 (POD1UM-101,
POD1UM-204) Merkel cell carcinoma: Phase 2 (POD1UM-201) NSCLC:
Phase 3 (POD1UM-304)
1 Development of tafasitamab in collaboration with MorphoSys. 2
Clinical collaboration with MorphoSys and Xencor, Inc. to
investigate the combination of tafasitamab plus lenalidomide in
combination with Xencor’s CD20xCD3 XmAb bispecific antibody,
plamotamab. 3 Retifanlimab licensed from MacroGenics.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura growth coming from both atopic dermatitis (AD) and
vitiligo in the U.S.: Over 62,000 units of Opzelura were
shipped in the third quarter with positive physician and patient
experiences continuing to fuel uptake in AD. The launch in vitiligo
is progressing well, contributing to the growth in overall demand.
An increasing number of plans are adding Opzelura to formularies,
helping to drive net product revenues to $38 million, a growth of
130% versus prior quarter.
Ruxolitinib cream in other indications: Incyte continues
to expand the development of ruxolitinib cream into new indications
as we seek to maximize the opportunity with Opzelura. Two Phase 2
trials evaluating ruxolitinib cream in lichen planus and lichen
sclerosus are in preparation. Lichen planus is a recurrent
inflammatory condition affecting the skin and mucosal surfaces and
can result in itchy, purple bumps on the skin. Lichen sclerosus is
a chronic inflammatory skin disease most commonly affecting women
and can result in painful ulcers and intense itching.
Povorcitinib (INCB54707): In August, results from the
randomized Phase 2 trial evaluating povorcitinib in patients with
hidradenitis suppurativa (HS) were presented at the European
Academy of Dermatology and Venereology (EADV) 31st Congress. Based
on the positive Phase 2 results, Incyte plans to initiate a Phase 3
study in HS by end of this year.
Indication and status
ruxolitinib cream1
(JAK1/JAK2)
AD: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2); approved by FDA; MAA under
review Lichen planus: Phase 2 in preparation Lichen sclerosus:
Phase 2 in preparation
ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy)
Vitiligo: Phase 2
povorcitinib (JAK1)
Hidradenitis suppurativa: Phase 2b; Phase
3 in preparation Vitiligo: Phase 2 Prurigo nodularis: Phase 2
1 Novartis’ rights for ruxolitinib outside of the United States
under our Collaboration and License Agreement with Novartis do not
include topical administration.
Acquisition of Villaris Therapeutics further complements
dermatology portfolio: In October, Incyte announced an
agreement to acquire Villaris Therapeutics, an asset-centric
biopharmaceutical company focused on the development of novel
antibody therapeutics for vitiligo. Its lead asset, auremolimab
(VM6) is a novel, ultra-humanized anti-IL-15Rβ monoclonal antibody
designed to target and deplete autoreactive resident memory T cells
(TRM) that has demonstrated efficacy as a treatment for vitiligo in
preclinical models. Incyte will receive exclusive global rights to
develop and commercialize auremolimab for all uses, including in
vitiligo and other autoimmune and inflammatory diseases.
IND-enabling studies are currently underway, and clinical
development for auremolimab is expected to begin in 2023. The
agreement is subject to clearance by the U.S. antitrust authorities
under the Hart-Scott-Rodino Act and will become effective as soon
as this condition has been met.
Discovery and early development – key highlights
Incyte’s portfolio of other earlier-stage clinical candidates is
included below.
Modality
Candidates
Small molecules
INCB81776 (AXL/MER), INCB99280 (PD-L1),
INCB99318 (PD-L1), INCB106385 (A2A/A2B), INCB123667 (CDK2)
Monoclonal antibodies1
INCAGN1876 (GITR), INCAGN2385 (LAG-3),
INCAGN2390 (TIM-3), INCA00186 (CD73)
Bi-specific antibodies
INCA32459 (LAG-3xPD-1)2
1 Discovery collaboration with Agenus. 2 Development in
collaboration with Merus
Partnered – key highlights
Indication and status
ruxolitinib (JAK1/JAK2)1
Acute and chronic GVHD: approved in
Europe; J-NDA under review
baricitinib (JAK1/JAK2)2
AD: Phase 3 (BREEZE-AD); approved in
Europe and Japan Severe AA: Phase 3 (BRAVE-AA1, BRAVE-AA2);
approved in the U.S., Europe and Japan
capmatinib (MET)3
NSCLC (with MET exon 14 skipping
mutations): approved in the U.S., Europe and Japan
1 Jakavi (ruxolitinib) licensed to Novartis ex-US. 2 Worldwide
rights to baricitinib licensed to Lilly: approved as Olumiant in
multiple territories globally for certain patients with
moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU
and Japan for certain patients with atopic dermatitis. 3 Worldwide
rights to capmatinib licensed to Novartis.
2022 Third Quarter Financial Results
The financial measures presented in this press release for the
three and nine months ended September 30, 2022 and 2021 have been
prepared by the Company in accordance with U.S. Generally Accepted
Accounting Principles (“GAAP”), unless otherwise identified as a
Non-GAAP financial measure. Management believes that Non-GAAP
information is useful for investors, when considered in conjunction
with Incyte’s GAAP disclosures. Management uses such information
internally and externally for establishing budgets, operating goals
and financial planning purposes. These metrics are also used to
manage the Company’s business and monitor performance. The Company
adjusts, where appropriate, for expenses in order to reflect the
Company’s core operations. The Company believes these adjustments
are useful to investors by providing an enhanced understanding of
the financial performance of the Company’s core operations. The
metrics have been adopted to align the Company with disclosures
provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set
of accounting rules and should only be used in conjunction with and
to supplement Incyte’s operating results as reported under GAAP.
Non-GAAP measures may be defined and calculated differently by
other companies in our industry.
As changes in exchange rates are an important factor in
understanding period-to-period comparisons, Management believes the
presentation of certain revenue results on a constant currency
basis in addition to reported results helps improve investors’
ability to understand its operating results and evaluate its
performance in comparison to prior periods. Constant currency
information compares results between periods as if exchange rates
had remained constant period over period. The Company calculates
constant currency by calculating current year results using prior
year foreign currency exchange rates and generally refers to such
amounts calculated on a constant currency basis as excluding the
impact of foreign exchange or being on a constant currency basis.
These results should be considered in addition to, not as a
substitute for, results reported in accordance with GAAP. Results
on a constant currency basis, as the Company presents them, may not
be comparable to similarly titled measures used by other companies
and are not measures of performance presented in accordance with
GAAP.
Financial Highlights
Financial Highlights
(unaudited, in thousands,
except per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Total GAAP revenues
$
823,303
$
812,987
$
2,467,935
$
2,123,414
Total GAAP operating income
138,376
235,410
509,347
475,043
Total Non-GAAP operating income
167,271
293,148
649,042
659,019
GAAP net income
112,775
181,739
312,199
384,730
Non-GAAP net income
133,795
261,824
483,015
589,413
GAAP basic EPS
$
0.51
$
0.82
$
1.41
$
1.75
Non-GAAP basic EPS
$
0.60
$
1.19
$
2.18
$
2.68
GAAP diluted EPS
$
0.50
$
0.82
$
1.40
$
1.73
Non-GAAP diluted EPS
$
0.60
$
1.18
$
2.16
$
2.65
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
September 30,
% Change (as
reported)
% Change
(constant currency)1
Nine Months Ended
September 30,
% Change (as
reported)
% Change
(constant currency)1
2022
2021
2022
2021
Net product revenues:
Jakafi
$
619,595
$
547,373
13
%
13
%
$
1,761,732
$
1,542,138
14
%
14
%
Iclusig
25,929
28,522
(9
%)
6
%
78,222
82,356
(5
%)
6
%
Pemazyre
23,414
17,562
33
%
41
%
60,429
48,924
24
%
38
%
Minjuvi
5,932
556
967
%
1,143
%
14,845
556
2,570
%
2,916
%
Opzelura
38,140
—
NM
NM
67,454
—
NM
NM
Total net product revenues
713,010
594,013
20
%
21
%
1,982,682
1,673,974
18
%
20
%
Royalty revenues:
Jakavi
85,808
94,655
(9
%)
6
%
240,386
242,295
(1
%)
11
%
Olumiant
20,371
86,572
(76
%)
(71
%)
98,689
154,875
(36
%)
(33
%)
Tabrecta
4,114
2,747
50
%
NM
11,178
7,270
54
%
NM
Total royalty revenues
110,293
183,974
(40
%)
350,253
404,440
(13
%)
Total net product and royalty revenues
823,303
777,987
6
%
2,332,935
2,078,414
12
%
Milestone and contract revenues
—
35,000
(100
%)
(100
%)
135,000
45,000
200
%
200
%
Total GAAP revenues
$
823,303
$
812,987
1
%
$
2,467,935
$
2,123,414
16
%
NM = not meaningful
1.Percentage change in constant currency is calculated using
2021 foreign exchange rates to recalculate 2022 results.
Product and Royalty Revenues Product and royalty revenues
for the quarter ended September 30, 2022 increased over the prior
year comparative period as a result of net product revenues
increasing 20% year-over-year, primarily driven by increases in
Jakafi and Opzelura net product revenues. Jakafi net product
revenues for the quarter ended September 30, 2022 increased 13%
over the prior year comparative period, primarily driven by growth
in patient demand across all indications. Jakavi and Olumiant
royalties for the quarter were impacted by unfavorable changes in
foreign currency exchange rates, while Olumiant royalties were also
impacted by a decrease in net product sales of Olumiant for use as
a treatment for COVID-19 and a one-time deduction related to
securing intellectual property rights.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
September 30,
% Change
Nine Months Ended
September 30,
% Change
2022
2021
2022
2021
GAAP cost of product revenues
$
54,584
$
39,869
37
%
$
147,834
$
107,117
38
%
Non-GAAP cost of product revenues1
48,521
33,965
43
%
129,715
89,863
44
%
GAAP research and development
384,007
334,945
15
%
1,084,576
985,352
10
%
Non-GAAP research and development2
358,268
308,675
16
%
1,004,372
901,170
11
%
GAAP selling, general and
administrative
266,460
190,704
40
%
729,321
513,358
42
%
Non-GAAP selling, general and
administrative3
247,474
168,050
47
%
675,751
443,886
52
%
GAAP (gain) loss on change in fair value
of acquisition-related contingent consideration
(21,893
)
2,910
(852
%)
(12,198
)
13,068
(193
%)
Non-GAAP (gain) loss on change in fair
value of acquisition-related contingent consideration4
—
—
—
%
—
—
—
%
GAAP collaboration loss sharing
1,769
9,149
(81
%)
9,055
29,476
(69
%)
1 Non-GAAP cost of product revenues excludes the amortization of
licensed intellectual property for Iclusig relating to the
acquisition of the European business of ARIAD Pharmaceuticals, Inc.
and the cost of stock-based compensation. 2 Non-GAAP research and
development expenses exclude the cost of stock-based compensation.
3 Non-GAAP selling, general and administrative expenses exclude the
cost of stock-based compensation and legal settlements. 4 Non-GAAP
(gain) loss on change in fair value of acquisition-related
contingent consideration is null.
Research and development expenses GAAP and Non-GAAP
research and development expense for the quarter ended September
30, 2022 increased 15% and 16%, respectively, compared to the same
period in 2021 primarily due to continued investment in our late
stage development assets and certain upfront and milestone
payments. Excluding the $33.5 million of upfront and milestone
payments for the quarter ended September 30, 2022, GAAP and
Non-GAAP research and development expense increased approximately
6% and 7%, respectively, compared to the same period in 2021.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the
quarter ended September 30, 2022 increased 40% and 47%,
respectively, compared to the same period in 2021, primarily due to
expenses related to our dermatology commercial organization and
activities to support the launch of Opzelura for the treatments of
atopic dermatitis and vitiligo.
Other Financial
Information
Operating income GAAP operating income for the quarter
ended September 30, 2022 decreased compared to the same period in
2021, primarily due to an increase in operating expenses partially
offset by growth in net product revenues.
Cash, cash equivalents and marketable securities position
As of September 30, 2022 and December 31, 2021, cash, cash
equivalents and marketable securities totaled $3.0 billion and $2.3
billion, respectively.
2022 Financial Guidance
Incyte is tightening its full year 2022 guidance for Jakafi net
product revenues to reflect strong performance of Jakafi and is
revising the guidance range for other Hematology/Oncology net
product revenues to reflect unfavorable changes in foreign currency
exchange rates. In addition, the Company is reaffirming its
research and development guidance, which now also includes the
upfront payment to Villaris, anticipated in the fourth quarter, and
its selling, general and administrative expense guidance. Guidance
does not include revenue from any potential new product launches or
the impact of any potential future strategic transactions. Incyte’s
updated guidance is summarized below.
Current
Previous
Jakafi net product revenues
$2.38 - $2.40 billion
$2.36 - $2.40 billion
Other Hematology/Oncology net product
revenues(1)
$200 - $210 million
$210 - $240 million
GAAP Cost of product revenues
6 – 7% of net product revenues
Unchanged
Non-GAAP Cost of product revenues(2)
5 – 6% of net product revenues
Unchanged
GAAP Research and development expenses
$1,550 - $1,590 million
Unchanged
Non-GAAP Research and development
expenses(3)
$1,420 - $1,455 million
Unchanged
GAAP Selling, general and administrative
expenses
$950 - $1,000 million
Unchanged
Non-GAAP Selling, general and
administrative expenses(3)
$880 - $925 million
Unchanged
1Pemazyre in the U.S., EU and Japan and Iclusig and Minjuvi in
the EU. 2Adjusted to exclude the amortization of licensed
intellectual property for Iclusig relating to the acquisition of
the European business of ARIAD Pharmaceuticals, Inc. and the
estimated cost of stock-based compensation. 3 Adjusted to exclude
the estimated cost of stock-based compensation.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at
8:00 a.m. ET. To access the conference call, please dial
877-407-3042 for domestic callers or 201-389-0864 for international
callers. When prompted, provide the conference identification
number, 13733379.
If you are unable to participate, a replay of the conference
call will be available for 90 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, 13733379.
The conference call will also be webcast live and can be
accessed at investor.incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for treatment of chronic GVHD after failure of one or two
lines of systemic therapy in adult and pediatric patients 12 years
and older.
Jakafi is also indicated for treatment of polycythemia vera (PV)
in adults who have had an inadequate response to or are intolerant
of hydroxyurea, in adults with intermediate or high-risk
myelofibrosis (MF), including primary MF, post-polycythemia vera MF
and post-essential thrombocythemia MF and for treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
About Opzelura™ (ruxolitinib) Cream
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK
inhibitor approved for use in the United States, indicated for the
topical treatment of nonsegmental vitiligo in adult and pediatric
patients 12 years of age and older and for the topical short-term
and non-continuous chronic treatment of mild to moderate atopic
dermatitis (AD) in non-immunocompromised patients 12 years of age
and older whose disease is not adequately controlled with topical
prescription therapies, or when those therapies are not advisable.
Use of Opzelura in combination with therapeutic biologics, other
JAK inhibitors, or potent immunosuppressants, such as azathioprine
or cyclosporine, is not recommended.
In October 2021, Incyte announced the validation of the European
Marketing Authorization Application (MAA) for ruxolitinib cream as
a potential treatment for adolescents and adults (age >12 years)
with non-segmental vitiligo with facial involvement.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura is a trademark of Incyte.
About Monjuvi®/Minjuvi® (tafasitamab)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting
immunotherapy. In 2010, MorphoSys licensed exclusive worldwide
rights to develop and commercialize tafasitamab from Xencor, Inc.
Tafasitamab incorporates an XmAb® engineered Fc domain, which
mediates B-cell lysis through apoptosis and immune effector
mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity
(ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is
approved by the U.S. Food and Drug Administration in combination
with lenalidomide for the treatment of adult patients with relapsed
or refractory DLBCL not otherwise specified, including DLBCL
arising from low grade lymphoma, and who are not eligible for
autologous stem cell transplant (ASCT). This indication is approved
under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval,
in combination with lenalidomide, followed by Minjuvi monotherapy,
for the treatment of adult patients with relapsed or refractory
diffuse large B-cell lymphoma (DLBCL) who are not eligible for
autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in several ongoing combination
trials.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG.
Tafasitamab is co-marketed by Incyte and MorphoSys under the brand
name Monjuvi® in the U.S., and marketed by Incyte under the brand
name Minjuvi® in Europe and Canada.
XmAb® is a registered trademark of Xencor, Inc.
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in the United States
for the treatment of adults with previously treated, unresectable
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or other rearrangement as
detected by an FDA-approved test*. This indication is approved
under accelerated approval based on overall response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s).
Pemazyre is also the first targeted treatment approved for use
in the United States for treatment of adults with relapsed or
refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1
rearrangement.
In Japan, Pemazyre is approved for the treatment of patients
with unresectable biliary tract cancer (BTC) with a fibroblast
growth factor receptor 2 (FGFR2) fusion gene, worsening after
cancer chemotherapy.
In Europe, Pemazyre is approved for the treatment of adults with
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or rearrangement that have
progressed after at least one prior line of systemic therapy.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms
1, 2 and 3 which, in preclinical studies, has demonstrated
selective pharmacologic activity against cancer cells with FGFR
alterations.
Pemazyre is marketed by Incyte in the United States, Europe and
Japan.
Pemazyre is a trademark of Incyte Corporation.
* Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE:
Incyte; 2020.
About Iclusig® (ponatinib) tablets
Ponatinib (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.
Click here to view the Iclusig EU Summary of Medicinal
Product Characteristics. Incyte has an exclusive license from
Takeda Pharmaceuticals International AG to commercialize ponatinib
in the European Union and 29 other countries, including
Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is
marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly
owned subsidiary of Takeda Pharmaceutical Company Limited.
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 any discussion of
the following: Incyte’s potential for long-term growth and
diversification; Incyte’s financial guidance for 2022, including
its expectations regarding sales of Jakafi; expectations with
respect to demand for and uptake of Opzelura, including the
Company’s ongoing discussions with payers; expectations with regard
to the NDA submission for once-daily ruxolitinib; our and our
collaborators’ potential for receiving additional regulatory
approvals within the next 1-2 years and the corresponding potential
for launches of new products and/or indications; expectations
regarding ongoing clinical trials and clinical trials to be
initiated, including the LIMBER program, trials of axatilimab in
cGVHD, a phase 3 trial of povorcitinib in hidradenitis suppurativa
and phase 2 trials of ruxolitinib cream in lichen planus and lichen
sclerosus; expectations regarding our pending acquisition of
Villaris Therapeutics and auremolimab; and our expectations
regarding 2022 newsflow items.
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: further
research and development and the results of 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 and the
ability to enroll subjects in accordance with planned schedules;
the effects of the COVID 19 pandemic and measures to address the
pandemic on the Company’s clinical trials, supply chain and other
third-party providers, sales and marketing efforts and business,
development and discovery operations; determinations made by the
FDA, EMA, and other regulatory agencies; the Company’s dependence
on its relationships with and changes in the plans of its
collaboration partners; the efficacy or safety of the Company’s
products and the products of the Company’s collaboration partners;
the acceptance of the Company’s products and the products of the
Company’s collaboration partners in the marketplace; market
competition; unexpected variations in the demand for the Company’s
products and the products of the Company’s collaboration partners;
the effects of announced or unexpected price regulation or
limitations on reimbursement or coverage for the Company’s products
and the products of the Company’s collaboration partners; sales,
marketing, manufacturing and distribution requirements, including
the Company’s and its collaboration partners’ ability to
successfully commercialize and build commercial infrastructure for
newly approved products and any additional products that become
approved; greater than expected expenses, including expenses
relating to litigation or strategic activities; variations in
foreign currency exchange rates; and other risks detailed in the
Company’s reports filed with the Securities and Exchange
Commission, including its annual report and the quarterly report on
Form 10-Q for the quarter ended September 30, 2022. Incyte
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
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
GAAP
GAAP
Revenues:
Product revenues, net
$
713,010
$
594,013
$
1,982,682
$
1,673,974
Product royalty revenues
110,293
183,974
350,253
404,440
Milestone and contract revenues
—
35,000
135,000
45,000
Total revenues
823,303
812,987
2,467,935
2,123,414
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
54,584
39,869
147,834
107,117
Research and development
384,007
334,945
1,084,576
985,352
Selling, general and administrative
266,460
190,704
729,321
513,358
(Gain) loss on change in fair value of
acquisition- related contingent consideration
(21,893
)
2,910
(12,198
)
13,068
Collaboration loss sharing
1,769
9,149
9,055
29,476
Total costs and expenses
684,927
577,577
1,958,588
1,648,371
Income from operations
138,376
235,410
509,347
475,043
Other income (expense), net
11,513
1,948
13,295
4,931
Interest expense
(641
)
(439
)
(1,999
)
(1,156
)
Unrealized loss on long term
investments
(660
)
(27,450
)
(72,142
)
(28,394
)
Income before provision for income
taxes
148,588
209,469
448,501
450,424
Provision for income taxes
35,813
27,730
136,302
65,694
Net income
$
112,775
$
181,739
$
312,199
$
384,730
Net income per share:
Basic
$
0.51
$
0.82
$
1.41
$
1.75
Diluted
$
0.50
$
0.82
$
1.40
$
1.73
Shares used in computing net income per
share:
Basic
222,415
220,845
221,801
220,243
Diluted
224,175
222,248
223,626
222,113
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
September 30,
2022
December 31,
2021
ASSETS
Cash, cash equivalents and marketable
securities
$
2,977,122
$
2,348,192
Accounts receivable
618,188
616,300
Property and equipment, net
715,733
723,920
Finance lease right-of-use assets, net
26,679
27,548
Inventory
101,133
56,938
Prepaid expenses and other assets
205,199
165,302
Long term investments
149,124
221,266
Other intangible assets, net
134,603
150,755
Goodwill
155,593
155,593
Deferred income tax asset
426,840
467,538
Total assets
$
5,510,214
$
4,933,352
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,043,975
$
885,081
Finance lease liabilities
33,588
34,267
Acquisition-related contingent
consideration
206,000
244,000
Stockholders’ equity
4,226,651
3,770,004
Total liabilities and stockholders’
equity
$
5,510,214
$
4,933,352
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
GAAP Net Income
$
112,775
$
181,739
$
312,199
$
384,730
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
25,739
26,270
80,204
84,182
Non-cash stock compensation from equity
awards (SG&A)2
18,986
15,904
53,570
49,500
Non-cash stock compensation from equity
awards (COGS)2
679
520
1,967
1,102
Non-cash interest3
72
72
288
72
Changes in fair value of equity
investments4
660
27,450
72,142
28,394
Amortization of acquired product
rights5
5,384
5,384
16,152
16,152
(Gain) loss on change in fair value of
contingent consideration6
(21,893
)
2,910
(12,198
)
13,068
Legal settlements7
—
6,750
—
19,972
Tax effect of Non-GAAP pre-tax
adjustments8
(8,607
)
(5,175
)
(41,309
)
(7,759
)
Non-GAAP Net Income
$
133,795
$
261,824
$
483,015
$
589,413
Non-GAAP net income per share:
Basic
$
0.60
$
1.19
$
2.18
$
2.68
Diluted
$
0.60
$
1.18
$
2.16
$
2.65
Shares used in computing Non-GAAP net
income per share:
Basic
222,415
220,845
221,801
220,243
Diluted
224,175
222,248
223,626
222,113
1 Included within the Milestone and contract revenues line item
in the Condensed Consolidated Statements of Operations (in
thousands) for the three and nine months ended September 30, 2022
are milestones of $0 and $135,000, respectively, earned from our
collaborative partners, as compared to milestones of $35,000 and
$45,000, respectively, for the three and nine months ended
September 30, 2021. Included within the Research and development
expenses line item in the Condensed Consolidated Statements of
Operations (in thousands) for the three and nine months ended
September 30, 2022 are upfront consideration and milestones of
$33,450 and $55,950, respectively, related to our collaborative
partners, as compared to upfront consideration and milestones of
$4,333 and $20,833, respectively, for the three and nine months
ended September 30, 2021. 2 As included within the Cost of product
revenues (including definite-lived intangible amortization) line
item; the Research and development expenses line item; and the
Selling, general and administrative expenses line item in the
Condensed Consolidated Statements of Operations. 3 As included
within the Interest expense line item in the Condensed Consolidated
Statements of Operations. 4 As included within the Unrealized loss
on long term investments line item in the Condensed Consolidated
Statements of Operations. 5 As included within the Cost of product
revenues (including definite-lived intangible amortization) line
item in the Condensed Consolidated Statements of Operations.
Acquired product rights of licensed intellectual property for
Iclusig is amortized utilizing a straight-line method over the
estimated useful life of 12.5 years. 6 As included within the
(Gain) loss on change in fair value of acquisition-related
contingent consideration line item in the Condensed Consolidated
Statements of Operations. 7 As included within Selling, general and
administrative expenses line item in the Condensed Consolidated
Statements of Operations. 8 Income tax effects of Non-GAAP pre-tax
adjustments are calculated using the applicable statutory tax rate
for the jurisdictions in which the charges are incurred, while
taking into consideration any valuation allowances against related
deferred tax assets.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221101005407/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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