- Total product and royalty revenues of $813 million (+20%) in
Q4’21 and $2.891 billion (+17%) in FY’21
- Jakafi® (ruxolitinib) net product revenues of $592 million
(+15%) in Q4’21 and $2.135 billion (+10%) in FY’21; Jakafi guidance
range of $2.3 to $2.4 billion for 2022
- Successful U.S. launch of Opzelura™ (ruxolitinib) cream in
atopic dermatitis with nearly 19,000 patients treated from launch
(October 11th) through the end of the year
- Vitiligo is the next substantial growth opportunity for
ruxolitinib cream – under Priority Review in the U.S. and under
review in Europe
Conference Call and Webcast Scheduled Today at
8:00 a.m. EST
Incyte (Nasdaq:INCY) today reports 2021 fourth quarter financial
results, provides 2022 financial guidance and a status update on
the Company’s clinical development portfolio.
“2021 was a year of important accomplishments for Incyte. Growth
of product and royalty revenues was strong, led by robust demand
for Jakafi® (ruxolitinib), continued uptake of Pemazyre®
(pemigatinib) in the U.S., and a rapidly growing royalty revenue
stream. Throughout the year, we significantly expanded our
commercial portfolio with several new approvals, including
Pemazyre® (pemigatinib) in cholangiocarcinoma (CCA) in Europe and
Japan; Minjuvi® (tafasitamab) in relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) in Europe; and, in the U.S., both
Jakafi in steroid-refractory chronic graft-versus-host disease
(GVHD) and Opzelura™ (ruxolitinib) cream in atopic dermatitis,”
said Hervé Hoppenot, Chief Executive Officer, Incyte. “Our launch
of Opzelura has been very successful thus far. Nearly 19,000
patients were treated in the fourth quarter and feedback from both
dermatologists and patients has been very positive. Importantly, we
have also made significant progress towards ensuring optimal
patient access to Opzelura.”
Portfolio Updates
MPNs and GVHD – key
highlights
Axatilimab (anti-CSF-1R monoclonal antibody) in chronic
GVHD: In December, updated positive data from the Phase 1/2
trial evaluating axatilimab as a monotherapy in patients with
recurrent or refractory chronic GVHD despite two or more prior
lines of therapy were presented at ASH. A 68% overall response rate
and broad clinical benefit across multiple organs were observed at
doses being assessed in the pivotal AGAVE-201 trial. Additional
trials of axatilimab are planned in patients with
steroid-refractory chronic GVHD, including a Phase 2 trial in
combination with a JAK inhibitor.
LIMBER (Leadership In MPNs BEyond Ruxolitinib) program:
The new drug application (NDA) for once-daily ruxolitinib (QD) is
on track for submission in the first half of this year. Two Phase 3
trials of ruxolitinib in combination with parsaclisib as a
first-line therapy for patients with MF and as a therapy for MF
patients with a suboptimal response to ruxolitinib monotherapy are
both underway. Combination trials of ruxolitinib with INCB57643
(BET) and INCB00928 (ALK2) are in preparation with initial data
expected later this year.
Indication and status
QD ruxolitinib
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and GVHD:
clinical pharmacology studies
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 in preparation
ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2 in preparation
ruxolitinib + CK08041 (JAK1/JAK2
+ CB-Tregs)
Myelofibrosis: PoC in preparation
itacitinib (JAK1)
Treatment-naïve chronic GVHD: Phase 2/3
(GRAVITAS‑309)
axatilimab (anti-CSF-1R)2
Chronic GVHD (third-line plus therapy):
Pivotal Phase 2 (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
Parsaclisib in warm autoimmune hemolytic anemia (wAIHA):
Following positive Phase 2 results, a Phase 3 randomized trial
evaluating the efficacy and safety of parsaclisib in adults with
wAIHA has been initiated. There are currently no FDA approved
treatments for wAIHA in the United States, and there are
approximately 1 in 8,000 patients living with wAIHA, of which 30%
are treatable.
Parsaclisib in non-Hodgkin lymphomas: In January, Incyte
announced the withdrawal of the New Drug Application (NDA) in the
United States for parsaclisib for the treatment of patients with
relapsed or refractory follicular lymphoma (FL), marginal zone
lymphoma (MZL) and mantle cell lymphoma (MCL). The decision to
withdraw the NDA followed discussions with U.S. Food and Drug
Administration (FDA) regarding confirmatory studies that Incyte
determined cannot be completed within a reasonable period to
support an accelerated approval. The withdrawal of the NDA is a
business decision and is not related to any changes in either the
efficacy or safety of parsaclisib. The decision impacts only the
FL, MZL and MCL indications in the U.S., and does not affect other
ongoing clinical trials in the U.S. or other countries. An MAA
submission for parsaclisib in MZL is under review with the EMA.
Indication and status1
pemigatinib (FGFR1/2/3)
CCA: Phase 3 (FIGHT‑302) Myeloid/lymphoid
neoplasms (MLN): Phase 2 (FIGHT‑203) Glioblastoma: Phase 2 in
preparation
NSCLC: Phase 2 in preparation
tafasitamab
(CD19)2
Relapsed or refractory DLBCL: Phase 2
(L-MIND); Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory FL and Relapsed or
refractory 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 plamotamab in
preparation3
parsaclisib (PI3Kδ)
Autoimmune hemolytic anemia: Phase 3
(PATHWAY)
retifanlimab (PD‑1)4
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 CCA = cholangiocarcinoma; DLBCL =
diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma;
FL = follicular lymphoma; MZL = marginal zone lymphoma; MCL =
mantle cell lymphoma; CLL = chronic lymphocytic leukemia
2 Development of tafasitamab in
collaboration with MorphoSys.
3 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.
4 Retifanlimab licensed from
MacroGenics.
Inflammation and Autoimmunity
(IAI) – key highlights
Dermatology
Opzelura launch in AD in the U.S.: In October, Incyte
launched its first dermatology product with the FDA approval of
Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2
inhibitor ruxolitinib, in AD. Nearly 19,000 new patients started
Opzelura in the fourth quarter and feedback from dermatologists and
patients has been very positive with efficacy, and in particular
the rapid onset and itch reduction, as a top reason for
prescribing.
Ruxolitinib cream in vitiligo in the U.S. and Europe: In
December, Incyte announced the FDA accepted for Priority Review the
supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5%
(Opzelura) as a potential treatment for adolescents and adults (age
≥12 years) with vitiligo. The Prescription Drug User Fee Act
(PDUFA) target action date is April 18, 2022. The Marketing
Authorization Application (MAA) is under review at the European
Medicines Agency (EMA). Vitiligo represents the second substantial
opportunity for Opzelura, an indication where there are no approved
therapies for repigmentation. There are over 1.5 million patients
living with vitiligo in the United States and over 2 million in
Europe.
Ruxolitinib cream in pediatric AD: A Phase 3 randomized
trial (TRuE-AD3) evaluating the efficacy and safety of ruxolitinib
cream in children ages two to twelve years old with AD is currently
ongoing.
Ruxolitinib cream in chronic hand eczema (CHE): Incyte
continues to expand the development of ruxolitinib cream into new
indications as part of its life cycle management strategy. A Phase
3 trial evaluating ruxolitinib cream in chronic hand eczema is
being initiated.
INCB54707 (JAK1) in multiple dermatology indications:
Incyte’s growing dermatology portfolio includes INCB54707, a JAK1
specific inhibitor, which is being evaluated across multiple
indications. Phase 2 trials are currently ongoing in vitiligo,
hidradenitis suppurativa and prurigo nodularis, with data in
vitiligo and hidradenitis suppurativa expected later this year.
Indication and status
ruxolitinib cream1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study
(TRuE-AD3) Vitiligo: Phase 3 (TRuE-V1, TRuE-V2, primary endpoint
met in both studies); sNDA under Priority Review and MAA under
review
Chronic hand eczema: Phase 3 (TRuE-CHE1)
being initiated
INCB54707 (JAK1)
Hidradenitis suppurativa: Phase 2b
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.
Oral PD-L1 Program: In November, Incyte presented data
from a Phase 1 study evaluating INCB86550, the first in a series of
oral PD-L1 inhibitors in the clinic. INCB86550 is the first oral
PD-L1 inhibitor to demonstrate clinical efficacy. Early data were
presented for INCB99280 and INCB99318, two other oral PD-L1
inhibitors which are also in the clinic.
MCLA-145 (CD137/PD-L1 bispecific antibody): In January,
Incyte announced the decision to opt-out of the continued
development of MCLA-145 as part of its ongoing portfolio
prioritization and capital allocation review. Incyte will continue
to collaborate with Merus and leverage their platform to develop a
pipeline of novel agents, as the Company continues to hold
worldwide development and commercialization rights to up to ten
additional programs.
Modality
Candidates
Small molecules
INCB81776 (AXL/MER), epacadostat (IDO1),
INCB86550 (PD-L1), INCB99280 (PD-L1), INCB99318 (PD-L1), INCB106385
(A2A/A2B)
Monoclonal antibodies1
INCAGN1876 (GITR), INCAGN2385 (LAG‑3),
INCAGN1949 (OX40), INCAGN2390 (TIM‑3), INCA00186 (CD73)
1 Discovery collaboration with Agenus.
Partnered – key
highlights
Baricitinib in alopecia areata (AA): Regulatory
applications for baricitinib as a treatment for alopecia areata
have been submitted in the U.S., Europe and Japan. Submissions were
based on results from two pivotal Phase 3 trials (BRAVE-AA1 and
BRAVE-AA2), which found once-daily baricitinib 4-mg was superior to
placebo in achieving significant scalp hair regrowth as early as 24
weeks in adults with severe AA as defined by ≥50% scalp hair loss
at baseline. Baricitinib has the potential to be a first-in-disease
treatment for the millions of adults worldwide living with AA.
Baricitinib in AD in the U.S.: In January, Incyte and
Lilly provided a regulatory update on the sNDA for baricitinib in
AD. Based on ongoing discussions with the FDA, Lilly announced that
alignment on the indicated population had not yet been reached and
given the FDA’s position, there would be the possibility of a
Complete Response Letter (CRL).
Baricitinib in systemic lupus erythematosus (SLE): In
January, Incyte and Lilly announced the discontinuation of the
Phase 3 development program for baricitinib in SLE based on
top-line efficacy results from two pivotal Phase 3 trials
(SLE-BRAVE-I and –II). The primary endpoint of SRI-4 response was
reached in SLE-BRAVE-I but was not reached in SLE-BRAVE-II and key
secondary endpoints were not met in either study.
Indication and status
ruxolitinib (JAK1/JAK2)1
Acute and chronic GVHD: MAA and J-NDA
under review
baricitinib (JAK1/JAK2)2
Atopic dermatitis: Phase 3 (BREEZE-AD);
approved in EU and Japan Severe alopecia areata: Phase 3
(BRAVE-AA1, BRAVE-AA2); Submissions in U.S., EU, and Japan
capmatinib (MET)3
NSCLC (with MET exon 14 skipping
mutations): Approved as Tabrecta in U.S. and Japan; MAA under
review
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.
2021 Fourth Quarter and Year-End
Financial Results
The financial measures presented in this press release for the
quarter and year ended December 31, 2021 and 2020 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
Twelve Months Ended
December 31,
December 31,
2021
2020
2021
2020
Total GAAP revenue
$
862,853
$
789,509
$
2,986,267
$
2,666,702
Total GAAP operating income (loss)
110,734
164,229
585,777
(263,676
)
Total Non-GAAP operating income (loss)
166,013
218,469
825,032
(40,878
)
GAAP (benefit) provision for income
taxes
(443,831
)
18,252
(378,137
)
63,479
GAAP net income (loss)
563,851
149,850
948,581
(295,697
)
Non-GAAP net income (loss)
22,565
204,773
611,978
(90,510
)
GAAP basic EPS
$
2.55
$
0.68
$
4.30
$
(1.36
)
Non-GAAP basic EPS
$
0.10
$
0.93
$
2.78
$
(0.42
)
GAAP diluted EPS
$
2.54
$
0.68
$
4.27
$
(1.36
)
Non-GAAP diluted EPS
$
0.10
$
0.93
$
2.76
$
(0.42
)
Revenue
Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
Twelve Months Ended
December 31,
%
December 31,
%
2021
2020
Change
2021
2020
Change
Net product revenues:
Jakafi
$
592,370
$
516,882
15%
$
2,134,508
$
1,937,850
10%
Iclusig
27,039
28,576
(5)%
109,395
105,002
4%
Pemazyre
19,607
14,009
40%
68,531
25,884
165%
Minjuvi
4,354
—
NM
4,910
—
NM
Opzelura
4,668
—
NM
4,668
—
NM
Royalty revenues:
Jakavi
95,696
87,046
10%
337,991
277,902
22%
Olumiant
66,000
30,996
113%
220,875
110,920
99%
Tabrecta
3,119
2,000
56%
10,389
4,144
151%
Total product and royalty revenues
812,853
679,509
20%
2,891,267
2,461,702
17%
Milestone and contract revenues
50,000
110,000
NM
95,000
205,000
NM
Total GAAP revenues
$
862,853
$
789,509
9%
$
2,986,267
$
2,666,702
12%
NM = not meaningful
Product and Royalty Revenues Product and royalty revenues
for the quarter and year ended December 31, 2021 increased 20% and
17%, respectively, over the prior year comparative periods
primarily as a result of increases in Jakafi and Pemazyre net
product revenues, and higher product royalty revenues from Jakavi
and Olumiant. Jakafi net product revenues for the quarter and year
ended December 31, 2021 increased 15% and 10%, respectively, over
the prior year comparative periods, primarily driven by growth in
patient demand across all indications. The 113% growth in Olumiant
royalty revenues for the quarter ended December 31, 2021 reflects
an increase in net product sales as a result of the use of Olumiant
for the treatment of COVID-19.
Operating
Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
Twelve Months Ended
December 31,
%
December 31,
%
2021
2020
Change
2021
2020
Change
GAAP cost of product revenues
$
43,874
$
36,323
21%
$
150,991
$
131,328
15%
Non-GAAP cost of product revenues1
37,886
30,693
23%
127,749
108,830
17%
GAAP research and development
472,827
405,945
16%
1,458,179
2,215,942
(34)%
Non-GAAP research and development2
442,693
375,770
18%
1,343,863
2,095,586
(36)%
GAAP selling, general and
administrative
226,202
166,988
35%
739,560
516,922
43%
Non-GAAP selling, general and
administrative3
208,718
152,148
37%
652,604
460,363
42%
GAAP change in fair value of
acquisition-related contingent consideration
1,673
3,595
(53)%
14,741
23,385
(37)%
Non-GAAP change in fair value of
acquisition-related contingent consideration4
—
—
—
—
GAAP collaboration loss sharing
7,543
12,429
(39)%
37,019
42,801
(14)%
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 December 31,
2021 increased 16% and 18%, respectively, compared to the same
period in 2020 primarily due to the upfront consideration of $127
million related to our collaborative agreement with Syndax.
For the year ended December 31, 2021, GAAP and Non-GAAP research
and development expense decreased 34% and 36%, respectively,
compared to the year ended December 31, 2020 primarily due to lower
upfront and milestone payments when compared to the prior year
period which included upfront consideration of $805 million related
to our collaborative agreement with MorphoSys and $120 million of
expense related to the purchase of an FDA priority review voucher
(“PRV”) utilized to accelerate the FDA review of Opzelura.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the
quarter ended December 31, 2021 increased 35% and 37% respectively,
and for the year ended December 31, 2021 increased 43% and 42%,
respectively, compared to the same periods in 2020, primarily due
to expenses related to the establishment of our dermatology
commercial organization and activities to support the launch of
Opzelura for the treatment of atopic dermatitis.
Other
Financial Information
Operating income (loss) GAAP and Non-GAAP operating
income for the quarter ended December 31, 2021 decreased compared
to the same period in 2020, due to expenses related to the
establishment of our dermatology commercial organization and the
launch of Opzelura and upfront consideration related to our
collaborative agreement with Syndax, partially offset by growth in
total revenues. For the year ended December 31, 2021, Incyte
recorded operating income compared to an operating loss for the
same period in 2020, on both a GAAP and Non-GAAP basis, primarily
due to growth in total revenues, lower upfront consideration and
milestones related to our collaborative agreements, and the 2020
PRV purchase, partially offset by higher selling, general and
administrative expenses.
(Benefit) provision for income taxes The company
released the valuation allowance on the majority of its U.S.
deferred tax assets in the fourth quarter of 2021 based on, among
other things, its achievement of cumulative profitability over the
last several years and its expectations regarding future
profitability. The release of this valuation allowance accounts for
a $569 million GAAP income tax benefit. This was partially offset
by higher reported tax expense from 2021 operations.
Cash, cash equivalents and marketable securities position
As of December 31, 2021 and 2020, cash, cash equivalents and
marketable securities totaled $2.3 billion and $1.8 billion,
respectively.
2022 Financial Guidance
Guidance does not include revenue from Opzelura or the impact of
any potential future strategic transactions.
Current
Jakafi net product revenues
$2.3 - $2.4 billion
Other Hematology/Oncology net product
revenues(1)
$210 - $240 million
GAAP Cost of product revenues
6 – 7% of net product revenues
Non-GAAP Cost of product revenues(2)
5 – 6% of net product revenues
GAAP Research and development expenses
$1,550 - $1,590 million
Non-GAAP Research and development
expenses(3)
$1,420 - $1,455 million
GAAP Selling, general and administrative
expenses
$950 - $1,000 million
Non-GAAP Selling, general and
administrative expenses(3)
$880 - $925 million
1 Pemazyre in the U.S., EU and Japan and
Iclusig and Minjuvi in the EU.
2 Adjusted 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, 13726298.
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, 13726298.
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
(ruxolitinib) cream is 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 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. Additionally,
in December 2021, Incyte announced the acceptance and priority
review of the supplemental New Drug Application (sNDA) for
ruxolitinib cream as a potential treatment for adolescents and
adults (age ≥12 years) with vitiligo.
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. Incyte has granted Innovent
Biologics, Inc. rights to develop and commercialize pemigatinib in
hematology and oncology in Mainland China, Hong Kong, Macau and
Taiwan. Incyte has retained all other rights to develop and
commercialize pemigatinib outside of the United States.
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 financial guidance for 2022, including its
expectations regarding sales of Jakafi; Incyte’s expectations with
regard to the regulatory submissions seeking approval of
ruxolitinib cream in vitiligo; Incyte’s expectations with regard to
filing an NDA for once-daily ruxolitinib; Incyte’s expectations
with respect to Opzelura, including the Company’s ongoing
discussions with payers; Incyte’s expectations regarding ongoing
clinical trials and clinical trials to be initiated, including
trials of axatilimab in chronic GVHD, the LIMBER program, a phase 3
clinical trials of parsaclisib in warm autoimmune hemolytic anemia,
Phase 2 trials of pemigatinib in glioblastoma and non-small cell
lung cancer, a proof of concept trial of tafasitamab in combination
with lenalidomide and plamotamab in relapsed/refractory B-cell
malignancies, phase 3 trials for ruxolitinib cream in pediatric AD
and chronic hand eczema, and a Phase 2 trial of INCB00928 in
fibrodysplasia ossificans progressiva; Incyte’s life cycle
management strategy for ruxolitinib cream; Incyte’s expectations
with regard to its ongoing partnership with Merus; and Incyte’s
expectations with regard to regulatory submissions for baricitinib
and capmatinib.
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. 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
Twelve Months Ended
December 31,
December 31,
2021
2020
2021
2020
GAAP
GAAP
Revenues:
Product revenues, net
$
648,038
$
559,467
$
2,322,012
$
2,068,736
Product royalty revenues
164,815
120,042
569,255
392,966
Milestone and contract revenues
50,000
110,000
95,000
205,000
Total revenues
862,853
789,509
2,986,267
2,666,702
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
43,874
36,323
150,991
131,328
Research and development
472,827
405,945
1,458,179
2,215,942
Selling, general and administrative
226,202
166,988
739,560
516,922
Change in fair value of
acquisition-related contingent consideration
1,673
3,595
14,741
23,385
Collaboration loss sharing
7,543
12,429
37,019
42,801
Total costs and expenses
752,119
625,280
2,400,490
2,930,378
Income (loss) from operations
110,734
164,229
585,777
(263,676
)
Other income (expense), net
5,716
4,810
10,647
23,206
Interest expense
(752
)
(428
)
(1,908
)
(2,174
)
Unrealized (loss) gain on long term
investments
4,322
(509
)
(24,072
)
10,426
Income (loss) before (benefit) provision
for income taxes
120,020
168,102
570,444
(232,218
)
(Benefit) provision for income taxes
(443,831
)
18,252
(378,137
)
63,479
Net income (loss)
$
563,851
$
149,850
$
948,581
$
(295,697
)
Net income (loss) per share:
Basic
$
2.55
$
0.68
$
4.30
$
(1.36
)
Diluted
$
2.54
$
0.68
$
4.27
$
(1.36
)
Shares used in computing net income (loss)
per share:
Basic
220,984
219,239
220,428
218,073
Diluted
221,989
221,228
222,074
218,073
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
December 31,
December 31,
2021
2020
ASSETS
Cash, cash equivalents and marketable
securities
$
2,348,192
$
1,801,377
Accounts receivable
616,300
481,994
Property and equipment, net
723,920
559,625
Finance lease right-of-use assets, net
27,548
28,451
Inventory
56,938
35,973
Prepaid expenses and other assets
165,302
101,259
Long term investments
221,266
222,301
Other intangible assets, net
150,755
172,291
Goodwill
155,593
155,593
Deferred income tax asset
467,538
2,054
Total assets
$
4,933,352
$
3,560,918
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
885,081
$
648,793
Finance lease liabilities
34,267
34,857
Acquisition-related contingent
consideration
244,000
266,000
Stockholders’ equity
3,770,004
2,611,268
Total liabilities and stockholders’
equity
$
4,933,352
$
3,560,918
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
INCOME (LOSS) TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2021
2020
2021
2020
GAAP Net Income (Loss)
$
563,851
$
149,850
$
948,581
$
(295,697
)
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
30,134
30,175
114,316
120,356
Non-cash stock compensation from equity
awards (SG&A)2
17,484
14,840
66,984
56,559
Non-cash stock compensation from equity
awards (COGS)2
604
246
1,706
962
Non-cash interest3
109
66
181
683
Changes in fair value of equity
investments4
(4,322
)
509
24,072
(10,426
)
Amortization of acquired product
rights5
5,384
5,384
21,536
21,536
Change in fair value of contingent
consideration6
1,673
3,595
14,741
23,385
Legal settlements7
—
—
19,972
—
Non-operating tax adjustments8
(568,988
)
—
(568,988
)
—
Tax effect of Non-GAAP pre-tax
adjustments9
(23,364
)
108
(31,123
)
(7,868
)
Non-GAAP Net Income (Loss)
$
22,565
$
204,773
$
611,978
$
(90,510
)
Non-GAAP net income (loss) per share:
Basic
$
0.10
$
0.93
$
2.78
$
(0.42
)
Diluted
$
0.10
$
0.93
$
2.76
$
(0.42
)
Shares used in computing Non-GAAP net
income (loss) per share:
Basic
220,984
219,239
220,428
218,073
Diluted
221,989
221,228
222,074
218,073
1 Included within the Milestone and
contract revenues line item in the Condensed Consolidated
Statements of Operations (in thousands) for the three and twelve
months ended December 31, 2021 are milestones of $50,000 and
$95,000, respectively, earned from our collaborative partners as
compared to $110,000 and $205,000, respectively, for the same
periods in 2020. Included within the Research and development
expenses line item in the Condensed Consolidated Statements of
Operations (in thousands) for the three and twelve months ended
December 31, 2021 are upfront consideration and milestones of
$128,152 and $148,985, respectively, related to our collaborative
partners as compared to upfront consideration and milestones of
$25,600 and $976,082, respectively, related to our collaborative
partners and FDA priority review voucher for the same periods in
2020.
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 gain
(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 Included within the (Benefit) provision
for income taxes line item in the Condensed Consolidated Statements
of Operations is portions of the provision for income taxes that
are not associated with normal, recurring operations. For the three
and twelve months ended December 31, 2021 (in thousands), the
company recorded a one-time non-cash benefit from income taxes of
$568,988 related to the release of its valuation allowance on the
majority of its U.S. deferred tax assets.
9 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/20220208005340/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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