- Total revenues increased 29% year-over-year (Y/Y) to $911
million; total product revenues of $664 million (+15% Y/Y)
- Jakafi® (ruxolitinib) net product revenues of $598 million in
Q2’22 (+13% Y/Y) driven by volume growth; raising the bottom end of
full year guidance to new range of $2.36 to $2.40 billion
- Opzelura™ (ruxolitinib) cream approved as first and only
treatment for repigmentation of nonsegmental vitiligo in patients
aged 12 and older; launch progressing in atopic dermatitis
(AD)
- Multiple approvals including Olumiant® (baricitinib) as the
first and only systemic treatment approved for alopecia areata in
the U.S., Europe and Japan and Jakavi® (ruxolitinib) approved as
the first post-steroid treatment for acute and chronic
graft-versus-host disease in Europe
Conference Call and Webcast Scheduled Today at
8:00 a.m. EDT
Incyte (Nasdaq:INCY) today reports 2022 second quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
“The second quarter was strong with total revenues up 29%
year-over-year, multiple approvals and the continued advancement of
our pipeline. The launch of Opzelura in atopic dermatitis continues
to progress well and in recent weeks, improvements in reimbursement
have translated into an increase in covered claims. Revenues in the
second quarter were temporarily impacted by the shift from free
drug to paid prescription. Patient demand and satisfaction remain
strong,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “In
July, Opzelura was also approved by the FDA in nonsegmental
vitiligo, creating a new growth opportunity as the first therapy
approved for repigmentation of vitiligo.”
Portfolio Updates
MPNs and GVHD – key highlights
LIMBER (Leadership In MPNs BEyond Ruxolitinib) program:
The LIMBER development program is advancing with the FDA acceptance
of the NDA for once-daily (QD) ruxolitinib, and the progression of
multiple ongoing and planned combination trials with ruxolitinib.
The Prescription Drug User Fee Act (PDUFA) target action date for
QD ruxolitinib extended release (XR) formulation is March 23, 2023.
Incyte’s partner, Cellenkos, announced the FDA clearance of its
Investigational New Drug (IND) application to initiate a Phase 1b,
open-label study of CK0804 as an add on therapy to ruxolitinib in
patients with myelofibrosis who experience a suboptimal response to
ruxolitinib. Combination trials of parsaclisib, INCB57643 (BET) and
INCB00928 (ALK2) with ruxolitinib are also ongoing.
Itacitinib in chronic graft-versus-host disease (GVHD):
Incyte no longer intends to develop itacitinib, a selective JAK1
inhibitor, in treatment-naïve chronic GVHD (cGVHD). Based on
efficacy data from Part 1 of the Phase 2/3 GRAVITAS-309 trial, it
was determined that a pivotal trial was unlikely to be
successful.
Indication and status
QD ruxolitinib
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and GVHD:
clinical pharmacology studies; 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®): A Phase 2 open-label study
evaluating the efficacy and safety of pemigatinib in adults with
previously treated glioblastoma or other primary central nervous
system tumors harboring activating FGFR1-3 alterations (FIGHT-209)
and a Phase 2 open-label study evaluating the efficacy and safety
of pemigatinib in adults with relapsed or refractory advanced
non-small cell lung cancer with an FGFR alteration (FIGHT-210) are
ongoing.
Indication and status
pemigatinib (FGFR1/2/3)
Cholangiocarcinoma (CCA): Phase 3
(FIGHT‑302) Myeloid/lymphoid neoplasms (MLN): Phase 2 (FIGHT‑203)
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 (topMIND) with parsaclisib (PI3Kδ) 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
Continued momentum with Opzelura launch in atopic dermatitis
(AD) in the U.S.: Coverage for Opzelura has been established
with the three largest PBM/GPOs and more plans continue to add
Opzelura to formularies. The demand for Opzelura continues to be
strong with nearly 48,000 units of Opzelura shipped in the second
quarter and we expect strong physician and patient perceptions of
Opzelura to drive increased usage in mild to moderate AD
patients.
Opzelura approved for vitiligo in the U.S.; under review in
Europe: Opzelura was approved as a treatment for nonsegmental
vitiligo - which account for ~85% of patients with vitiligo - in
adolescents and adults in the U.S., becoming the first and only
medicine approved for repigmentation in vitiligo. The marketing
authorization application (MAA) is under review at the European
Medicines Agency (EMA) with an expected decision from the Committee
for Medicinal Products for Human Use (CHMP) by the end of the
year.
Povorcitinib (INCB54707): Povorcitinib is currently in
Phase 2 trials for hidradenitis suppurativa (HS), vitiligo and
prurigo nodularis. Based on findings from the Phase 2 trial, Incyte
intends to initiate a Phase 3 study in HS later 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
CHE: Phase 3 (TRuE-CHE1 and TRuE-CHE2) 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.
Discovery and early development – key highlights
Incyte’s portfolio of other earlier-stage clinical candidates is
summarized below.
INCB123667 (CDK2): INCB123667 is a novel, potent and
selective oral small molecule inhibitor of CDK2 which has been
shown to suppress tumor growth as monotherapy and in combination
with standard of care, in Cyclin E amplified tumor models, in vivo.
A Phase 1 dose-escalation and dose-expansion study of INCB123667 in
adults with selected advanced or metastatic solid tumors has been
initiated.
INCA32459 (LAG-3xPD-1): In collaboration with Merus,
Incyte has developed INCA32459, a novel LAG3xPD-1 bispecific
antibody that is planned to enter clinical studies later this
year.
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),
INCAGN1949 (OX40), 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
Jakavi® (ruxolitinib) approved for acute and chronic GVHD in
Europe: In May, Incyte and Novartis announced the European
Commission (EC) approval of Jakavi as the first post-steroid
treatment for acute and chronic graft-versus-host disease
(GVHD).
Olumiant® (baricitinib) approved for alopecia areata (AA) in
U.S., Europe and Japan: In June, Incyte and Eli Lilly announced
the approval of Olumiant for the treatment of adults with severe
alopecia areata in the U.S., becoming the first-in-disease systemic
treatment. Olumiant was also approved in Europe and Japan in June.
The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials,
which showed one in three adults taking Olumiant 4-mg/day achieved
significant hair regrowth resulting in 80% or more scalp
coverage.
Tabrecta® (capmatinib) approved in non-small cell lung cancer
(NSCLC) with MET exon-14 in Europe: In June, Tabrecta was
approved by the European Commission as a monotherapy for the
treatment of adults with advanced NSCLC harboring alterations
leading to mesenchymal-epithelial-transition factor gene (MET) exon
14 (METex14) skipping who require systemic therapy following prior
treatment with immunotherapy and/or platinum-based
chemotherapy.
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 Second Quarter Financial Results
The financial measures presented in this press release for the
three and six months ended June 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.
Financial Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Total GAAP revenues
$
911,397
$
705,709
$
1,644,632
$
1,310,427
Total GAAP operating income
254,431
140,836
370,971
239,633
Total Non-GAAP operating income
309,624
195,568
481,771
365,871
GAAP net income
161,432
149,456
199,424
202,991
Non-GAAP net income
226,353
178,833
349,220
327,589
GAAP basic EPS
$
0.73
$
0.68
$
0.90
$
0.92
Non-GAAP basic EPS
$
1.02
$
0.81
$
1.58
$
1.49
GAAP diluted EPS
$
0.72
$
0.67
$
0.89
$
0.91
Non-GAAP diluted EPS
$
1.01
$
0.80
$
1.56
$
1.48
Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended
Six Months Ended
June 30,
%
June 30,
%
2022
2021
Change
2022
2021
Change
Net product revenues:
Jakafi
$
597,673
$
529,055
13%
$
1,142,137
$
994,765
15%
Iclusig
26,224
28,189
(7%)
52,293
53,834
(3%)
Pemazyre
18,983
17,906
6%
37,015
31,362
18%
Minjuvi
4,411
—
NM
8,913
—
NM
Opzelura
16,560
—
NM
29,314
—
NM
Royalty revenues:
Jakavi
83,711
82,038
2%
154,578
147,640
5%
Olumiant
30,254
36,045
(16%)
78,318
68,303
15%
Tabrecta
3,581
2,476
45%
7,064
4,523
56%
Total product and royalty revenues
781,397
695,709
12%
1,509,632
1,300,427
16%
Milestone and contract revenues
130,000
10,000
1,200%
135,000
10,000
1,250%
Total GAAP revenues
$
911,397
$
705,709
29%
$
1,644,632
$
1,310,427
26%
NM = not meaningful
Product and Royalty Revenues Product and royalty revenues
for the quarter ended June 30, 2022 increased 12% over the prior
year comparative period primarily as a result of increases in
Jakafi and Opzelura net product revenues, and higher royalty
revenues from Jakavi. Jakafi net product revenues for the quarter
ended June 30, 2022 increased 13% over the prior year comparative
period, primarily driven by growth in patient demand across all
indications.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended
Six Months Ended
June 30,
%
June 30,
%
2022
2021
Change
2022
2021
Change
GAAP cost of product revenues
$
50,636
$
38,028
33%
$
93,250
$
67,248
39%
Non-GAAP cost of product revenues1
44,575
32,302
38%
81,194
55,898
45%
GAAP research and development
347,196
343,511
1%
700,569
650,407
8%
Non-GAAP research and development2
319,059
315,473
1%
646,104
592,495
9%
GAAP selling, general and
administrative
253,277
168,859
50%
462,861
322,654
43%
Non-GAAP selling, general and
administrative3
235,595
152,523
54%
428,277
275,836
55%
GAAP change in fair value of
acquisition-related contingent consideration
3,313
4,632
(28%)
9,695
10,158
(5%)
Non-GAAP change in fair value of
acquisition-related contingent consideration4
—
—
—
—
GAAP collaboration loss sharing
2,544
9,843
(74%)
7,286
20,327
(64%)
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
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 June 30,
2022 increased 1%, compared to the same period in 2021 primarily
due to continued investment in our late stage development
assets.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the
quarter ended June 30, 2022 increased 50% and 54%, 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 pre-launch activities for vitiligo.
Other Financial
Information
Operating income GAAP operating income for the quarter
ended June 30, 2022 increased compared to the same period in 2021,
driven by growth in product revenues.
Cash, cash equivalents and marketable securities position
As of June 30, 2022 and December 31, 2021, cash, cash equivalents
and marketable securities totaled $2.7 billion and $2.3 billion,
respectively.
2022 Financial Guidance
Incyte is tightening its full year 2022 guidance for Jakafi net
product revenues as a result of our strong second quarter
performance.
Current
Previous
Jakafi net product revenues
$2.36 - $2.40 billion
$2.33 - $2.40 billion
Other Hematology/Oncology net product
revenues(1)
$210 - $240 million
Unchanged
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, 13731520.
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, 13731520.
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
monoclonal antibody. 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 the EU.
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).
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; Incyte’s expectations
with regard to its NDA submission for once-daily ruxolitinib;
Incyte’s expectations with respect to Opzelura, including the
Company’s ongoing discussions with payers and regulatory review in
the EU; Incyte’s expectations regarding ongoing clinical trials and
clinical trials to be initiated, including the LIMBER program, a
phase 3 trial of povorcitinib in hidradenitis suppurativa, a phase
2 trial of ruxolitinib cream in vitiligo to determine whether
phototherapy might enhance repigmentation response, phase 3 trials
for ruxolitinib cream in chronic hand eczema and clinical studies
regarding INCA32459.
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; and other risks
detailed in the Company’s reports filed with the Securities and
Exchange Commission, including its annual report on Form 10-K for
the year ended December 31, 2021. 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,
2022
2021
2022
2021
GAAP
GAAP
Revenues:
Product revenues, net
$
663,851
$
575,150
$
1,269,672
$
1,079,961
Product royalty revenues
117,546
120,559
239,960
220,466
Milestone and contract revenues
130,000
10,000
135,000
10,000
Total revenues
911,397
705,709
1,644,632
1,310,427
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
50,636
38,028
93,250
67,248
Research and development
347,196
343,511
700,569
650,407
Selling, general and administrative
253,277
168,859
462,861
322,654
Change in fair value of
acquisition-related contingent consideration
3,313
4,632
9,695
10,158
Collaboration loss sharing
2,544
9,843
7,286
20,327
Total costs and expenses
656,966
564,873
1,273,661
1,070,794
Income from operations
254,431
140,836
370,971
239,633
Other income (expense), net
522
4,390
1,782
2,983
Interest expense
(678)
(358)
(1,358)
(717)
Unrealized (loss) gain on long term
investments
(24,897)
26,765
(71,482)
(944)
Income before provision for income
taxes
229,378
171,633
299,913
240,955
Provision for income taxes
67,946
22,177
100,489
37,964
Net income
$
161,432
$
149,456
$
199,424
$
202,991
Net income per share:
Basic
$
0.73
$
0.68
$
0.90
$
0.92
Diluted
$
0.72
$
0.67
$
0.89
$
0.91
Shares used in computing net income per
share:
Basic
221,660
220,083
221,493
219,942
Diluted
223,661
222,250
223,277
222,061
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in
thousands)
June 30,
December 31,
2022
2021
ASSETS
Cash, cash equivalents and marketable
securities
$
2,722,425
$
2,348,192
Accounts receivable
682,968
616,300
Property and equipment, net
721,328
723,920
Finance lease right-of-use assets, net
27,349
27,548
Inventory
94,128
56,938
Prepaid expenses and other assets
190,606
165,302
Long term investments
149,784
221,266
Other intangible assets, net
139,987
150,755
Goodwill
155,593
155,593
Deferred income tax asset
434,867
467,538
Total assets
$
5,319,035
$
4,933,352
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
962,781
$
885,081
Finance lease liabilities
34,193
34,267
Acquisition-related contingent
consideration
237,000
244,000
Stockholders’ equity
4,085,061
3,770,004
Total liabilities and stockholders’
equity
$
5,319,035
$
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
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
GAAP Net Income
$
161,432
$
149,456
$
199,424
$
202,991
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
28,137
28,038
54,465
57,912
Non-cash stock compensation from equity
awards (SG&A)2
17,682
16,354
34,584
33,596
Non-cash stock compensation from equity
awards (COGS)2
677
342
1,288
582
Non-cash interest3
108
—
216
—
Changes in fair value of equity
investments4
24,897
(26,765)
71,482
944
Amortization of acquired product
rights5
5,384
5,384
10,768
10,768
Change in fair value of contingent
consideration6
3,313
4,632
9,695
10,158
Legal settlements7
—
(18)
—
13,222
Tax effect of Non-GAAP pre-tax
adjustments8
(15,277)
1,410
(32,702)
(2,584)
Non-GAAP Net Income
$
226,353
$
178,833
$
349,220
$
327,589
Non-GAAP net income per share:
Basic
$
1.02
$
0.81
$
1.58
$
1.49
Diluted
$
1.01
$
0.80
$
1.56
$
1.48
Shares used in computing Non-GAAP net
income per share:
Basic
221,660
220,083
221,493
219,942
Diluted
223,661
222,250
223,277
222,061
1 Included within the Milestone and contract revenues line item
in the Condensed Consolidated Statements of Operations (in
thousands) for the three and six months ended June 30, 2022 are
milestones of $130,000 and $135,000, respectively, earned from our
collaborative partners, as compared to milestones of $10,000 for
both the three and six months ended June 30, 2021. Included within
the Research and development expenses line item in the Condensed
Consolidated Statements of Operations (in thousands) for the three
and six months ended June 30, 2022 are upfront consideration and
milestones of $2,500 and $22,500, respectively, related to our
collaborative partners, as compared to upfront consideration and
milestones of $5,000 and $16,500, respectively, for the three and
six months ended June 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
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/20220802005416/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com Investors Christine Chiou +1 302 274
4773 cchiou@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jun 2024 to Jul 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jul 2023 to Jul 2024