- Total net product revenues of $827 million in the second
quarter (Q2'23) (+25% Y/Y)
- Jakafi® (ruxolitinib) net product revenues of $682 million
(+14% Y/Y) in Q2'23; raising the bottom end of full year guidance
to a new range of $2.58 - $2.63 billion for FY 2023
- Opzelura® (ruxolitinib) cream net product revenues of $80
million (+384% Y/Y) in Q2'23; continued uptake in atopic dermatitis
(AD) and vitiligo
- Two pivotal studies in high potential programs met their
primary endpoint: ruxolitinib cream in pediatric atopic dermatitis
(TRuE-AD3) and axatilimab in chronic GVHD (AGAVE-201)
- Conference Call and Webcast Scheduled Today
at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today reports 2023 second quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
"We delivered a strong quarter with total net product revenues
growing 25% year over year led by double-digit Jakafi®
(ruxolitinib) growth and continued momentum from Opzelura®
(ruxolitinib) cream in atopic dermatitis and vitiligo in the United
States," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We
continue to advance multiple programs in our pipeline, and recently
announced positive topline results for two high potential programs,
ruxolitinib cream in pediatric atopic dermatitis and axatilimab in
chronic graft-versus-host disease."
Key Product Sales Performance
Jakafi:
Net product revenues for the quarter of $682 million:
- Net product revenues grew 14% compared with the second quarter
of 2022, driven by strong underlying patient demand growth across
all indications.
- Channel inventory at the end of the second quarter of 2023
returned to normal levels.
Opzelura:
Net product revenues for the quarter of $80 million:
- Net product revenues of $80 million grew 384% compared with the
second quarter of 2022, driven by growth in patient demand and
expansion in payer coverage as the launch in AD and vitiligo
continues.
- Opzelura was approved in Europe for the treatment of
nonsegmental vitiligo with facial involvement and is now available
in Germany and Austria.
Pipeline Updates
MPNs and GVHD – key highlights
LIMBER (Leadership In MPNs and GVHD BEyond
Ruxolitinib):
- AGAVE-201, a global pivotal Phase 2 trial of axatilimab
in patients with chronic GVHD met its primary endpoint across all
cohorts with an overall response rate (ORR) of 74% at the dose of
0.3 mg/kg administered every two weeks. We plan to share the full
dataset at a future medical meeting. A Phase 1/2 combination trial
of axatilimab in combination with ruxolitinib is planned to
initiate by year-end 2023.
- Combination trials of ruxolitinib twice daily (BID) with
zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and
progressing well. At this year's American Society of Clinical
Oncology (ASCO) annual meeting, updated data for zilurgisertib in
both monotherapy and in combination with ruxolitinib BID
demonstrated early signals of clinical activity with hepcidin
reduction and anemia improvement observed. Also at ASCO, data for
INCB57643 (BET) demonstrated improvements in spleen size and
symptom burden at > 8mg monotherapy
and 4mg in combination with ruxolitinib.
- A Phase 1 study evaluating INCA033989 (mCALR) has been
initiated. Additionally, a Phase 1 study evaluating ruxolitinib BID
in combination with Cellenkos' CK0804 in MF is continuing to
recruit patients.
Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and
GVHD
Ruxolitinib + zilurgisertib
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2
Ruxolitinib + INCB57643
(JAK1/JAK2 + BET)
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: Phase 1/2 in preparation
INCA033989
(mCALR)
Myelofibrosis, essential thrombocythemia:
Phase 1 initiated
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 small molecule PD-L1 program: Two studies evaluating
INCB99280 in combination with axitinib (VEGF) and in combination
with ipilimumab (CTLA-4) have been initiated. A Phase 2 study
evaluating INCB99280 in patients with select solid tumors who are
checkpoint inhibitor naive was also initiated. Additionally, a
Phase 2 study evaluating INCB99280 in metastatic cutaneous squamous
cell carcinoma (cSCC) or locally advanced cSCC was initiated.
Collaboration with Replimune Group, Inc. In July, Incyte
and Replimune Group, Inc. announced a clinical trial collaboration
and supply agreement to investigate the combination of INCB99280
and RP1 in patients with cutaneous squamous cell carcinoma. RP1 is
Replimune’s lead oncolytic immunotherapy product candidate and is
based on a proprietary new strain of herpes simplex virus
engineered for robust tumor selective replication and genetically
armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to
maximize tumor killing potency, the immunogenicity of tumor cell
death, and the activation of a systemic anti-tumor immune
response.
Indication and status
Pemigatinib (Pemazyre®)
(FGFR1/2/3)
Myeloid/lymphoid neoplasms (MLN): approved
in the U.S. and Japan
Cholangiocarcinoma (CCA): Phase 3
(FIGHT-302)
Glioblastoma: Phase 2 (FIGHT-209)
Tafasitamab
(Monjuvi®/Minjuvi®)1
(CD19)
Relapsed or refractory diffuse large
B-cell lymphoma (DLBCL): 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)
Retifanlimab (Zynyz™)2
(PD-1)
Merkel cell carcinoma: approved in the
U.S.
Squamous cell anal cancer (SCAC): Phase 3
(POD1UM-303)
Non-small cell lung cancer (NSCLC): Phase
3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2
(POD1UM-101, POD1UM-204)
INCB99280
(Oral PD-L1)
Solid tumors (combination): Phase 1
Solid tumors (monotherapy): Phase 2
Cutaneous squamous cell carcinoma (cSCC):
Phase 2 initiated
INCB99318
(Oral PD-L1)
Solid tumors: Phase 1
1 Development of tafasitamab in
collaboration with MorphoSys.
2 Retifanlimab licensed from
MacroGenics.
3 Clinical trial collaboration and supply
agreement with Mirati Therapeutics.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
- Ruxolitinib cream in pediatric AD: The Phase 3 trial of
ruxolitinib cream in pediatric AD (TRuE-AD3) met its primary
endpoint. The study demonstrated that significantly more patients
treated with ruxolitinib cream 0.75% and 1.5% achieved
Investigator's Global Assessment Treatment Success (IGA-TS) than
patients treated with vehicle control. There are an estimated 2-3
million pediatric AD patients (ages 2-11) in the United
States.
- Ruxolitinib cream in other indications: Three Phase 2
studies in lichen planus, lichen sclerosus and mild to moderate
hidradenitis suppurativa (HS) have completed enrollment. Two Phase
3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) are
ongoing.
Povorcitinib
- Asthma and chronic spontaneous urticaria: Two Phase 2
trials in asthma and chronic spontaneous urticaria have been
initiated.
Auremolimab
- IND cleared: Auremolimab, an anti-IL-15Rβ monoclonal
antibody, received IND clearance and is expected to enter the
clinic later this year.
Indication and status
Ruxolitinib cream (Opzelura®)1
(JAK1/JAK2)
AD: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2);
approved in the U.S. and Europe
Lichen planus: Phase 2
Lichen sclerosus: Phase 2
Hidradenitis suppurativa: Phase 2
Prurigo nodularis: Phase 3 initiated
(TRuE-PN1, TRuE-PN2)
Ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy)
Vitiligo: Phase 2
Povorcitinib
(JAK1)
Hidradenitis suppurativa: Phase 2b; Phase
3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 2; Phase 3 planned
Prurigo nodularis: Phase 2
Asthma: Phase 2 initiated
Chronic spontaneous urticaria: Phase 2
initiated
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 other early development – key
highlights
INCA33890 (TGFβR2xPD-1): A Phase 1 study evaluating
INCA33890 in patients with select advanced solid tumors has been
initiated.
Modality
Candidates
Small molecules
INCB123667 (CDK2)
Monoclonal antibodies
INCAGN2385 (LAG-3)1, INCAGN2390
(TIM-3)1
Bi-specific antibodies
INCA32459 (LAG-3xPD-1)2, INCA33890
(TGFβR2xPD-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 (Jakavi®) licensed to
Novartis ex-U.S. for use in hematology and oncology excluding
topical administration.
2 Baricitinib (Olumiant®) 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 (Tabrecta®) licensed to
Novartis.
Organizational Update
Dr. Dashyant Dhanak, who has served as Incyte's Chief Scientific
Officer since 2018, will be leaving the Organization effective
August 2, 2023, in order to pursue other interests. Under his
leadership, Incyte has filed more than fifteen Investigational New
Drug (IND) applications, and has made great advancements in the
biotherapeutics and small molecule pipeline.
2023 Second Quarter Financial Results
The financial measures presented in this press release for the
three and six months ended June 30, 2023 and 2022 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 June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Total GAAP revenues
$
954,610
$
911,397
$
1,763,283
$
1,644,632
Total GAAP operating income
193,780
254,431
218,550
370,971
Total Non-GAAP operating income
262,058
309,624
351,787
481,771
GAAP net income
203,548
161,432
225,251
199,424
Non-GAAP net income
223,029
226,353
307,606
349,220
GAAP basic EPS
$
0.91
$
0.73
$
1.01
$
0.90
Non-GAAP basic EPS
$
1.00
$
1.02
$
1.38
$
1.58
GAAP diluted EPS
$
0.90
$
0.72
$
1.00
$
0.89
Non-GAAP diluted EPS
$
0.99
$
1.01
$
1.36
$
1.56
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended June
30,
% Change (as
reported)
% Change (constant
currency)1
Six Months Ended June
30,
% Change (as
reported)
% Change (constant
currency)1
2023
2022
2023
2022
Net product revenues:
Jakafi
$
682,384
$
597,673
14
%
14
%
$
1,262,353
$
1,142,137
11
%
11
%
Opzelura
80,233
16,560
384
%
384
%
136,785
29,314
367
%
367
%
Iclusig
29,087
26,224
11
%
9
%
56,772
52,293
9
%
11
%
Pemazyre
21,572
18,983
14
%
14
%
44,047
37,015
19
%
21
%
Minjuvi
13,159
4,411
198
%
191
%
19,715
8,913
121
%
122
%
Zynyz
570
—
NM
NM
570
—
NM
NM
Total net product revenues
827,005
663,851
25
%
24
%
1,520,242
1,269,672
20
%
20
%
Royalty revenues:
Jakavi
90,448
83,711
8
%
10
%
167,140
154,578
8
%
12
%
Olumiant
32,009
30,254
6
%
10
%
66,164
78,318
(16
%)
(10
%)
Tabrecta
4,799
3,581
34
%
NA
8,976
7,064
27
%
NA
Pemazyre
349
—
NM
NM
761
—
NM
NM
Total royalty revenues
127,605
117,546
9
%
243,041
239,960
1
%
Total net product and royalty revenues
954,610
781,397
22
%
1,763,283
1,509,632
17
%
Milestone and contract revenues
—
130,000
(100
%)
(100
%)
—
135,000
(100
%)
(100
%)
Total GAAP revenues
$
954,610
$
911,397
5
%
$
1,763,283
$
1,644,632
7
%
NM = not meaningful
NA = not available
1 Percentage change in constant currency
is calculated using 2022 foreign exchange rates to recalculate 2023
results.
Product and Royalty Revenues Product revenues and product
and royalty revenues for the quarter ended June 30, 2023 increased
25% and 22%, respectively, over the prior year comparative period,
primarily driven by increases in Jakafi and Opzelura net product
revenues. The increase in Jakafi net product revenues was primarily
driven by growth in patient demand across all indications and
inventory level normalizing at the end of the second quarter of
2023. Total Opzelura net product revenues for the quarter were $80
million, representing a 384% increase year-over-year driven by
increased patient demand and expanded coverage. Among other
Hematology and Oncology, Minjuvi net product revenues grew 198%
driven in part by the recognition of $6 million of previously
deferred revenue related to the Early Access Program in France,
which ended in June 2023. Jakavi and Olumiant royalties for the
quarter were impacted by unfavorable changes in foreign currency
exchange rates.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended June
30,
% Change
Six Months Ended June
30,
% Change
2023
2022
2023
2022
GAAP cost of product revenues
$
68,326
$
50,636
35
%
$
125,148
$
93,250
34
%
Non-GAAP cost of product revenues1
62,150
44,575
39
%
112,819
81,194
39
%
GAAP research and development
400,750
347,196
15
%
807,391
700,569
15
%
Non-GAAP research and development2
367,921
319,059
15
%
743,541
646,104
15
%
GAAP selling, general and
administrative
283,929
253,277
12
%
599,535
462,861
30
%
Non-GAAP selling, general and
administrative3
263,030
235,595
12
%
557,047
428,277
30
%
GAAP loss on change in fair value of
acquisition-related contingent consideration
8,374
3,313
153
%
14,570
9,695
50
%
Non-GAAP loss on change in fair value of
acquisition-related contingent consideration4
—
—
—
%
—
—
—
%
GAAP (profit) and loss sharing under
collaboration agreements5
(549
)
2,544
(122
%)
(1,911
)
7,286
(126
%)
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.
4 Non-GAAP loss on change in fair value of
acquisition-related contingent consideration is null.
5 Growth rate in GAAP (profit) and loss
sharing under collaboration agreements represents a decrease in
loss position for the three and six months ended June 30, 2023.
Cost of product revenues GAAP and Non-GAAP cost of
product revenues for the quarter ended June 30, 2023 increased 35%
and 39%, respectively, compared to the same period in 2022
primarily due to growth in net product revenues.
Research and development expenses GAAP and Non-GAAP
research and development expense for the quarter ended June 30,
2023 increased 15%, compared to the same period in 2022 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, 2023 increased 12% compared to the same
period in 2022, primarily due to expenses related to promotional
activities to support the launch of Opzelura for the treatment of
vitiligo.
Other Financial
Information
Operating income GAAP and Non-GAAP operating income for
the three months ended June 30, 2023 decreased 24% and 15%,
respectively, compared to the same period in 2022, primarily due to
lower milestone and contract revenue for the quarter ended June 30,
2023 compared to the same period in 2022, and increased investment
in our late stage development assets and in supporting the launch
of Opzelura for the treatment of vitiligo.
Cash, cash equivalents and marketable securities position
As of June 30, 2023 and December 31, 2022, cash, cash equivalents
and marketable securities totaled $3.4 billion and $3.2 billion,
respectively.
2023 Financial Guidance
Incyte is tightening its full year 2023 guidance for Jakafi net
product revenues as a result of its strong second quarter
performance. Incyte’s guidance is summarized below. Guidance does
not include revenue from any potential new product launches or the
impact of any potential future strategic transactions.
Current
Previous
Jakafi net product revenues
$2.58 - $2.63 billion
$2.55 - $2.63 billion
Other Hematology/Oncology net product
revenues(1)
Unchanged
$215 - $225 million
GAAP Cost of product revenues
Unchanged
7 – 8% of net product revenues
Non-GAAP Cost of product revenues(2)
Unchanged
6 – 7% of net product revenues
GAAP Research and development expenses
Unchanged
$1,610 - $1,650 million
Non-GAAP Research and development
expenses(3)
Unchanged
$1,485 - $1,520 million
GAAP Selling, general and administrative
expenses
Unchanged
$1,050 - $1,150 million
Non-GAAP Selling, general and
administrative expenses(3)
Unchanged
$965 - $1,060 million
1 Pemazyre in the U.S., EU and Japan;
Zynyz in the U.S.; 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, 13739925.
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, 13739925.
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® (ruxolitinib) is a
JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of
polycythemia vera (PV) in adults who have had an inadequate
response to or are intolerant of hydroxyurea; intermediate or
high-risk myelofibrosis (MF), including primary MF,
post-polycythemia vera MF and post-essential thrombocythemia MF in
adults; steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older; and chronic GVHD after failure of one
or two lines of systemic therapy in adult and pediatric patients 12
years and older.
Jakafi is a registered trademark of Incyte.
About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, a
novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor
ruxolitinib, approved by the U.S. Food & Drug Administration
for the topical treatment of nonsegmental vitiligo in patients 12
years of age and older, is the first and only treatment for
repigmentation approved for use in the United States. Opzelura is
also approved in the U.S. 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 Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for
the treatment of non-segmental vitiligo with facial involvement in
adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of
Incyte.
About Monjuvi®/Minjuvi® (tafasitamab) Tafasitamab is a
humanized Fc-modified 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 marketing
authorization 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.
* 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.
About Zynyz™ (retifanlimab-dlwr) Zynyz
(retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in
the U.S. for the treatment of adult patients with metastatic or
recurrent locally advanced Merkel cell carcinoma (MCC). This
indication is approved under accelerated approval based on tumor
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered
into an exclusive collaboration and license agreement with
MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a trademark of Incyte.
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 continued performance and growth; Incyte’s financial
guidance for 2023, including its expectations regarding sales of
Jakafi; expectations with respect to demand for and uptake of
Opzelura; the potential for ruxolitinib cream to expand into other
indications; expectations regarding the potential and progress of
programs in our pipeline, including axatilimab in chronic
graft-versus-host disease and ruxolitinib cream in pediatric atopic
dermatitis; expectations regarding ongoing clinical trials and
clinical trials to be initiated, including the LIMBER program,
Incyte’s oral PD-L1 program, various phase 2 and phase 3 trials for
ruxolitinib cream, phase 2 and 3 trials of povorcitinib in multiple
indications, and a phase 1 trial of auremolimab in vitiligo; 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 launches by us and our
collaborators; 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;
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 for the year
ended December 31, 2022. Incyte disclaims any intent or obligation
to update these forward-looking statements.
INCYTE CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited, in thousands,
except per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
GAAP
GAAP
Revenues:
Product revenues, net
$
827,005
$
663,851
$
1,520,242
$
1,269,672
Product royalty revenues
127,605
117,546
243,041
239,960
Milestone and contract revenues
—
130,000
—
135,000
Total revenues
954,610
911,397
1,763,283
1,644,632
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
68,326
50,636
125,148
93,250
Research and development
400,750
347,196
807,391
700,569
Selling, general and administrative
283,929
253,277
599,535
462,861
Loss on change in fair value of
acquisition-related contingent consideration
8,374
3,313
14,570
9,695
(Profit) and loss sharing under
collaboration agreements
(549
)
2,544
(1,911
)
7,286
Total costs and expenses
760,830
656,966
1,544,733
1,273,661
Income from operations
193,780
254,431
218,550
370,971
Interest income and other, net
42,668
522
75,541
1,782
Interest expense
(655
)
(678
)
(1,124
)
(1,358
)
Unrealized gain (loss) on long term
investments
41,811
(24,897
)
36,493
(71,482
)
Income before provision for income
taxes
277,604
229,378
329,460
299,913
Provision for income taxes
74,056
67,946
104,209
100,489
Net income
$
203,548
$
161,432
$
225,251
$
199,424
Net income per share:
Basic
$
0.91
$
0.73
$
1.01
$
0.90
Diluted
$
0.90
$
0.72
$
1.00
$
0.89
Shares used in computing net income per
share:
Basic
223,248
221,660
223,104
221,493
Diluted
225,649
223,661
225,541
223,277
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
June 30, 2023
December 31,
2022
ASSETS
Cash, cash equivalents and marketable
securities
$
3,423,366
$
3,238,965
Accounts receivable
637,994
644,879
Property and equipment, net
749,352
739,310
Finance lease right-of-use assets, net
25,631
26,298
Inventory
177,985
120,959
Prepaid expenses and other assets
200,561
194,144
Long term investments
170,316
133,676
Other intangible assets, net
134,954
129,219
Goodwill
155,593
155,593
Deferred income tax asset
532,507
457,941
Total assets
$
6,208,259
$
5,840,984
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,217,910
$
1,216,603
Finance lease liabilities
32,657
33,262
Acquisition-related contingent
consideration
217,000
221,000
Stockholders’ equity
4,740,692
4,370,119
Total liabilities and stockholders’
equity
$
6,208,259
$
5,840,984
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
(LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
GAAP Net Income
$
203,548
$
161,432
$
225,251
$
199,424
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
32,829
28,137
63,850
54,465
Non-cash stock compensation from equity
awards (SG&A)2
20,899
17,682
42,488
34,584
Non-cash stock compensation from equity
awards (COGS)2
792
677
1,561
1,288
Non-cash interest3
139
108
247
216
Changes in fair value of equity
investments4
(41,811
)
24,897
(36,493
)
71,482
Amortization of acquired product
rights5
5,384
5,384
10,768
10,768
Loss on change in fair value of contingent
consideration6
8,374
3,313
14,570
9,695
Tax effect of Non-GAAP pre-tax
adjustments7
(7,125
)
(15,277
)
(14,636
)
(32,702
)
Non-GAAP Net Income
$
223,029
$
226,353
$
307,606
$
349,220
Non-GAAP net income per share:
Basic
$
1.00
$
1.02
$
1.38
$
1.58
Diluted
$
0.99
$
1.01
$
1.36
$
1.56
Shares used in computing Non-GAAP net
income per share:
Basic
223,248
221,660
223,104
221,493
Diluted
225,649
223,661
225,541
223,277
1 There were no milestones 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, 2023, as compared to milestones of
$130,000 and $135,000, respectively, earned from our collaborative
partners for the three and six months ended June 30, 2022. 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, 2023 are upfront
consideration and milestones of $7,000 and $9,700, respectively,
related to our collaborative partners, as compared to upfront
consideration and milestones of $2,500 and $22,500, respectively,
for the three and six months ended June 30, 2022.
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 Loss on change in
fair value of acquisition-related contingent consideration line
item in the Condensed Consolidated Statements of Operations.
7 Income tax effects of Non-GAAP pre-tax
adjustments are calculated using an estimated annual effective tax
rate, taking into consideration any permanent items and valuation
allowances against related deferred tax assets.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230801845264/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Greg Shertzer +1 302 274 4779
gshertzer@incyte.com
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