– Total FY'22 net product revenues grew 18% to $2.75 billion;
total FY'22 revenues of $3.4 billion (+14% Y/Y)
– Jakafi® (ruxolitinib) net revenues of $647 million (+9% Y/Y)
in Q4'22 and $2.41 billion (+13%) in FY'22; Jakafi net revenues
guidance range of $2.53 - $2.63 billion for FY 2023
– Opzelura™ (ruxolitinib) Cream net revenues of $61 million in
Q4'22 and $129 million in FY'22, driven by strong demand in atopic
dermatitis, a successful launch in vitiligo and broadening
formulary access
Conference Call and Webcast Scheduled Today
at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today reports 2022 fourth quarter financial
results, provides 2023 financial guidance and provides a status
update on the Company’s clinical development portfolio.
"We are entering 2023 with significant momentum, following a
year of strong commercial performance and progress of several
important mid-to-late stage programs across our pipeline. Opzelura
has now become the market share leader among branded agents for new
atopic dermatitis patients and the adoption in vitiligo has been
strong,” said Hervé Hoppenot, Chief Executive Officer, Incyte. "We
are well positioned for strong growth with our current product
portfolio and we expect to deliver many important updates this year
as we continue to execute on our growth and diversification
strategy."
Portfolio Updates
MPNs and GVHD – key highlights
LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib)
program: Important LIMBER updates were presented at the
American Society of Hematology (ASH) Annual Meeting in December
2022:
- Parsaclisib + ruxolitinib in myelofibrosis (MF): Final
results from the Phase 2 trial in MF patients with a suboptimal
response to ruxolitinib demonstrated additional spleen volume
response and symptom improvement with the addition of parsaclisib.
Add-on parsaclisib was generally well-tolerated. A Phase 3 trial
evaluating parsaclisib as an add-on to ruxolitinib in suboptimal
responders is ongoing with results expected at the end of
2023.
- Zilurgisertib (ALK2) ± ruxolitinib in MF: Initial
results from the Phase 1 study evaluating zilurgisertib as
monotherapy or in combination with ruxolitinib in patients with
anemia due to MF were presented, establishing proof of mechanism in
improving anemia. Updated combination data with ruxolitinib are
expected later this year.
- INCA33989 (mCALR) in MF and essential thrombocythemia
(ET): A novel anti-mutant calreticulin (mCALR) monoclonal
antibody was unveiled during the ASH plenary session. These data
highlight Incyte's discovery capabilities and research progress in
MF and ET; two patient populations where 25-35% of patients have a
CALR mutation. INCA33989 is expected to enter the clinic later this
year.
Ruxolitinib extended release (XR) formulation: The New
Drug Application (NDA) was accepted by the U.S. Food and Drug
Administration (FDA) with a Prescription Drug User Fee Act (PDUFA)
target action date of March 23, 2023.
Axatilimab in chronic graft-versus-host disease (GVHD):
In December, Syndax and Incyte announced that results from the
Phase 1/2 trial of axatilimab in patients with recurrent or
refractory chronic GVHD following two or more prior lines of
therapy were published in the Journal of Clinical Oncology. The
data demonstrate that treatment with axatilimab resulted in an
overall response rate (ORR) by cycle 7, day 1 of 67% across all
patients. 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 expected to initiate later
this year.
Jakafi patent extension: Incyte was granted pediatric
exclusivity which adds six months to the expiration for all
ruxolitinib patents, thereby extending the patent expiry for Jakafi
through December 2028.
Indication and status
Ruxolitinib XR (QD)
(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 + zilurgisertib
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2
Ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)
Myelofibrosis: Phase 1
(LIMBER-TREG108)
Axatilimab (anti-CSF-1R)2
Chronic GVHD: Pivotal Phase 2 (third-line
plus therapy) (AGAVE-201)
Ruxolitinib + axatilimab2
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD (newly diagnosed): Phase 1/2
in preparation
1
Development collaboration with Cellenkos,
Inc.
2
Clinical development of axatilimab in GVHD
conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
Oral PD-L1: In November, data from Incyte's oral, small
molecule PD-L1 program, including Phase 1 data evaluating the
safety and tolerability of INCB99280 and INCB99318, were presented
at the Society for Immunotherapy of Cancer (SITC) meeting. Both
INCB99280 and INCB99318 demonstrated clinical activity with tumor
shrinkage and were generally well-tolerated. Updated data are
expected later in 2023.
INCB99280 (Oral PD-L1) + adagrasib (KRASG12C): In
November, Incyte and Mirati announced a clinical trial
collaboration and supply agreement to investigate the combination
of INCB99280 and adagrasib, a KRASG12C selective inhibitor, in
patients with KRASG12C-mutated solid tumors. We expect to initiate
a Phase 1/1b trial evaluating the combination this year.
Indication and status
Pemigatinib (Pemazyre®)
(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
(Monjuvi®/Minjuvi®)1
(CD19)
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)
Parsaclisib
(PI3Kδ)
Warm autoimmune hemolytic anemia: Phase 3
(PATHWAY)
Retifanlimab2
(PD-1)
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)
Non-small cell lung cancer (NSCLC): Phase
3 (POD1UM-304)
INCB99280
(Oral PD-L1)
Solid tumors: Phase 1
KRASG12C-mutated solid tumors: Phase 1/1b
in combination with adagrasib, in preparation
INCB99318
(Oral PD-L1)
Solid tumors: Phase 1
1
Development of tafasitamab in
collaboration with MorphoSys.
2
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.: More than 84,000 units of Opzelura were
shipped in the fourth quarter of 2022 driven by strong growth in
new patient starts across AD and vitiligo, as well as broadening
formulary coverage. Refills grew across both indications, helping
drive net product revenues to $61 million, a growth of 61% versus
the third quarter. Additionally, in late 2022, Incyte received an
issued patent and allowed claims directed to the treatments of
atopic dermatitis and vitiligo, respectively, with expiration dates
of 2040.
Ruxolitinib cream in pediatric AD: A Phase 3 trial of
ruxolitinib cream in pediatric AD is ongoing, with results expected
by end of year. There are an estimated 2 million pediatric AD
patients ages 2 to 11 in the U.S.
Ruxolitinib cream in vitiligo in Europe: A marketing
authorization application (MAA) is under review at the European
Medicines Agency (EMA), with the Committee for Medicinal Products
for Human Use (CHMP) opinion expected in the first half of
2023.
Ruxolitinib cream in other indications: Incyte continues
to expand the development of ruxolitinib cream into new indications
to maximize the opportunity with Opzelura. In December, a Phase 2
trial evaluating ruxolitinib cream in mild to moderate hidradenitis
suppurativa (HS) was initiated. Two Phase 2 trials in lichen planus
(LP) and lichen sclerosus (LS) are ongoing. There are no topical
therapies approved in hidradenitis suppurativa, lichen planus or
lichen sclerosus.
Povorcitinib in multiple indications: In December, two
Phase 3 trials (STOP-HS1 and STOP-HS2) in moderate to severe HS
were initiated. Additionally, two Phase 2 trials in vitiligo and
prurigo nodularis are ongoing, with results expected in 2023.
Indication and status
Ruxolitinib cream (OpzeluraTM)1
(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
Lichen sclerosus: Phase 2
Hidradenitis suppurativa: Phase 2
Ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy)
Vitiligo: Phase 2
Povorcitinib
(JAK1)
Hidradenitis suppurativa: Phase 2b; Phase
3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 2
Prurigo nodularis: Phase 2
Auremolimab
(anti-IL-15Rβ)
Vitiligo: Phase 1 in preparation
1
Novartis’ rights to 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
below.
Modality
Candidates
Small molecules
INCB81776 (AXL/MER), INCB106385 (A2A/A2B),
INCB123667 (CDK2)
Monoclonal antibodies
INCAGN1876 (GITR)1, INCAGN2385 (LAG-3)1,
INCAGN2390 (TIM-3)1, INCA00186 (CD73), INCA33989 (mCALR)
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
Ruxolitinib1
(JAK1/JAK2)
Acute and chronic GVHD: approved in
Europe; J-NDA under review
Baricitinib2
(JAK1/JAK2)
AD: approved in Europe and Japan
Severe AA: approved in the U.S., Europe
and Japan
Capmatinib3
(MET)
NSCLC (with MET exon 14 skipping
mutations): approved in the U.S., Europe and Japan
1
ruxolitinib licensed to Novartis ex-US for
use in hematology and oncology excluding topical
administration.
2
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
capmatinib licensed to Novartis.
2022 Fourth Quarter and Year-end Financial Results
The financial measures presented in this press release for the
quarter and year ended December 31, 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 December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
Total GAAP revenues
$
926,700
$
862,853
$
3,394,635
$
2,986,267
Total GAAP operating income
70,093
110,734
579,440
585,777
Total Non-GAAP operating income
152,503
166,013
801,545
825,032
GAAP provision (benefit) for income
taxes
52,154
(443,831
)
188,456
(378,137
)
GAAP net income
28,461
563,851
340,660
948,581
Non-GAAP net income
139,661
22,565
622,676
611,978
GAAP basic EPS
$
0.13
$
2.55
$
1.53
$
4.30
Non-GAAP basic EPS
$
0.63
$
0.10
$
2.80
$
2.78
GAAP diluted EPS
$
0.13
$
2.54
$
1.52
$
4.27
Non-GAAP diluted EPS
$
0.62
$
0.10
$
2.78
$
2.76
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended December
31,
% Change (as
reported)
% Change (constant
currency)1
Twelve Months Ended December
31,
% Change (as
reported)
% Change (constant
currency)1
2022
2021
2022
2021
Net product revenues:
Jakafi
$
647,493
$
592,370
9%
9%
$
2,409,225
$
2,134,508
13%
13%
Iclusig
27,616
27,039
2%
8%
105,838
109,395
(3%)
8%
Pemazyre
23,016
19,607
17%
37%
83,445
68,531
22%
26%
Minjuvi
4,809
4,354
10%
54%
19,654
4,910
300%
350%
Opzelura
61,281
4,668
NM
NM
128,735
4,668
NM
NM
Total net product revenues
764,215
648,038
18%
19%
2,746,897
2,322,012
18%
19%
Royalty revenues:
Jakavi
91,189
95,696
(5%)
10%
331,575
337,991
(2%)
11%
Olumiant
35,858
66,000
(46%)
(31%)
134,547
220,875
(39%)
(32%)
Tabrecta
4,233
3,119
36%
NA
15,411
10,389
48%
NA
Pemazyre
1,205
—
NM
NM
1,205
—
NM
NM
Total royalty revenues
132,485
164,815
(20%)
482,738
569,255
(15%)
Total net product and royalty revenues
896,700
812,853
10%
3,229,635
2,891,267
12%
Milestone and contract revenues
30,000
50,000
(40%)
(40%)
165,000
95,000
74%
74%
Total GAAP revenues
$
926,700
$
862,853
7%
$
3,394,635
$
2,986,267
14%
NM = not meaningful
NA = not available
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 and year ended December 31, 2022 increased over the
prior year comparative periods as a result of net product revenues
increasing 18% for both periods year-over-year, primarily driven by
increases in Jakafi and Opzelura net product revenues. Jakafi net
product revenues for the year ended December 31, 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 year 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.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended December
31,
% Change
Twelve Months Ended December
31,
% Change
2022
2021
2022
2021
GAAP cost of product revenues
$
59,163
$
43,874
35
%
$
206,997
$
150,991
37
%
Non-GAAP cost of product revenues1
53,022
37,886
40
%
182,737
127,749
43
%
GAAP research and development
501,360
472,827
6
%
1,585,936
1,458,179
9
%
Non-GAAP research and development2
469,048
442,693
6
%
1,473,420
1,343,863
10
%
GAAP selling, general and
administrative
272,819
226,202
21
%
1,002,140
739,560
36
%
Non-GAAP selling, general and
administrative3
253,209
208,718
21
%
928,960
652,604
42
%
GAAP loss on change in fair value of
acquisition-related contingent consideration
24,347
1,673
1355
%
12,149
14,741
(18
%)
Non-GAAP loss on change in fair value of
acquisition-related contingent consideration4
—
—
—
%
—
—
—
%
GAAP (profit) and loss sharing under
collaboration agreements
(1,082
)
7,543
(114
%)
7,973
37,019
(78
%)
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 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 December 31,
2022 increased 6% and for the year ended December 31, 2022
increased 9% and 10%, respectively, compared to the same periods in
2021 primarily due to continued investment in our late stage
development assets and the $70 million upfront payment made as part
of the Villaris acquisition.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the
quarter ended December 31, 2022 increased 21% and for the year
ended December 31, 2022 increased 36% and 42%, respectively,
compared to the same periods 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 and Non-GAAP operating income for
the year ended December 31, 2022 decreased 1% and 3%, 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.
Cash, cash equivalents and marketable securities position
As of December 31, 2022 and 2021, cash, cash equivalents and
marketable securities totaled $3.2 billion and $2.3 billion,
respectively.
2023 Financial Guidance
Guidance does not include revenue from any potential new product
launches or the impact of any potential future strategic
transactions. Incyte’s guidance is summarized below.
Current
Jakafi net product revenues
$2.53 - $2.63 billion
Other Hematology/Oncology net product
revenues(1)
$215 - $225 million
GAAP Cost of product revenues
7 – 8% of net product revenues
Non-GAAP Cost of product revenues(2)
6 – 7% of net product revenues
GAAP Research and development expenses
$1,610 - $1,650 million
Non-GAAP Research and development
expenses(3)
$1,485 - $1,520 million
GAAP Selling, general and administrative
expenses
$1,050 - $1,150 million
Non-GAAP Selling, general and
administrative expenses(3)
$965 - $1,060 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, 13735569.
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, 13735569.
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 growth and diversification;
Incyte’s financial guidance for 2023, including its expectations
regarding sales of Jakafi; expectations with regard to Incyte’s NDA
submission in the U.S. for once-daily ruxolitinib; expectations
with respect to demand for and uptake of Opzelura, including
expectations for broadening formulary coverage; the marketing
authorization application for ruxolitinib cream in vitiligo under
review at the European Medicines Agency; the potential for
ruxolitinib cream to expand into other indications; 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, INCA33989 (mCALR) in MF
and essential thrombocythemia, axatilimab in GVHD, Incyte’s oral
PD-L1 program, a phase 3 trial of ruxolitinib cream in pediatric
AD, phase 2 and 3 trials of povorcitinib in multiple indications
and a phase 1 trial of auremolimab in vitiligo; and our
expectations regarding 2023 newsflow items.
These forward-looking statements are based on Incyte’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 Incyte’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; Incyte’s dependence on its
relationships with and changes in the plans of its collaboration
partners; the efficacy or safety of Incyte’s products and the
products of Incyte’s collaboration partners; the acceptance of
Incyte’s products and the products of Incyte’s collaboration
partners in the marketplace; market competition; unexpected
variations in the demand for Incyte’s products and the products of
Incyte’s collaboration partners; the effects of announced or
unexpected price regulation or limitations on reimbursement or
coverage for Incyte’s products and the products of Incyte’s
collaboration partners; sales, marketing, manufacturing and
distribution requirements, including Incyte’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 Incyte’s reports filed with the Securities
and Exchange Commission, including its annual report. 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 December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
GAAP
GAAP
Revenues:
Product revenues, net
$
764,215
$
648,038
$
2,746,897
$
2,322,012
Product royalty revenues
132,485
164,815
482,738
569,255
Milestone and contract revenues
30,000
50,000
165,000
95,000
Total revenues
926,700
862,853
3,394,635
2,986,267
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
59,163
43,874
206,997
150,991
Research and development
501,360
472,827
1,585,936
1,458,179
Selling, general and administrative
272,819
226,202
1,002,140
739,560
Loss on change in fair value of
acquisition-related contingent consideration
24,347
1,673
12,149
14,741
(Profit) and loss sharing under
collaboration agreements
(1,082
)
7,543
7,973
37,019
Total costs and expenses
856,607
752,119
2,815,195
2,400,490
Income from operations
70,093
110,734
579,440
585,777
Other income (expense), net
26,637
5,716
39,932
10,647
Interest expense
(667
)
(752
)
(2,666
)
(1,908
)
Unrealized (loss) gain on long term
investments
(15,448
)
4,322
(87,590
)
(24,072
)
Income before provision (benefit) for
income taxes
80,615
120,020
529,116
570,444
Provision (benefit) for income taxes
52,154
(443,831
)
188,456
(378,137
)
Net income
$
28,461
$
563,851
$
340,660
$
948,581
Net income per share:
Basic
$
0.13
$
2.55
$
1.53
$
4.30
Diluted
$
0.13
$
2.54
$
1.52
$
4.27
Shares used in computing net income per
share:
Basic
222,615
220,984
222,004
220,428
Diluted
224,840
221,989
223,958
222,074
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
December 31,
2022
December 31,
2021
ASSETS
Cash, cash equivalents and marketable
securities
$
3,238,965
$
2,348,192
Accounts receivable
644,879
616,300
Property and equipment, net
739,310
723,920
Finance lease right-of-use assets, net
26,298
27,548
Inventory
120,959
56,938
Prepaid expenses and other assets
194,144
165,302
Long term investments
133,676
221,266
Other intangible assets, net
129,219
150,755
Goodwill
155,593
155,593
Deferred income tax asset
457,941
467,538
Total assets
$
5,840,984
$
4,933,352
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,216,603
$
885,081
Finance lease liabilities
33,262
34,267
Acquisition-related contingent
consideration
221,000
244,000
Stockholders’ equity
4,370,119
3,770,004
Total liabilities and stockholders’
equity
$
5,840,984
$
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 December
31,
Twelve Months Ended December
31,
2022
2021
2022
2021
GAAP Net Income
$
28,461
$
563,851
$
340,660
$
948,581
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
32,312
30,134
112,516
114,316
Non-cash stock compensation from equity
awards (SG&A)2
19,610
17,484
73,180
66,984
Non-cash stock compensation from equity
awards (COGS)2
757
604
2,724
1,706
Non-cash interest3
143
109
431
181
Changes in fair value of equity
investments4
15,448
(4,322
)
87,590
24,072
Amortization of acquired product
rights5
5,384
5,384
21,536
21,536
Loss on change in fair value of contingent
consideration6
24,347
1,673
12,149
14,741
Legal settlements7
—
—
—
19,972
Non-operating tax adjustments8
—
(568,988
)
—
(568,988
)
Tax effect of Non-GAAP pre-tax
adjustments9
13,199
(23,364
)
(28,110
)
(31,123
)
Non-GAAP Net Income
$
139,661
$
22,565
$
622,676
$
611,978
Non-GAAP net income per share:
Basic
$
0.63
$
0.10
$
2.80
$
2.78
Diluted
$
0.62
$
0.10
$
2.78
$
2.76
Shares used in computing Non-GAAP net
income per share:
Basic
222,615
220,984
222,004
220,428
Diluted
224,840
221,989
223,958
222,074
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, 2022 are milestones of $30,000 and $165,000,
respectively, earned from our collaborative partners, as compared
to milestones of $50,000 and $95,000, respectively, for the three
and twelve months ended December 31, 2021. 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, 2022 are upfront consideration
and milestones of $70,000 and $125,950, respectively, related to
our collaborative partners, as compared to upfront consideration
and milestones of $128,152 and $148,985, respectively, for the
three and twelve months ended December 31, 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)
gain 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 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
Included within the Provision (benefit)
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. The tax benefit for the three months ended
December 31, 2022 includes a true up from the interim quarters
related to valuation allowances against deferred tax assets
associated with the loss on equity investments.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230207005303/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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