– Total revenues of $881 million in the first quarter (Q1'24)
(+9% Y/Y)
– Jakafi® (ruxolitinib) net product revenues of $572 million in
Q1'24, total paid patients increased +5% Y/Y; reiterating full year
2024 guidance of $2,690 - $2,750 million
– Opzelura® (ruxolitinib) net product revenues of $86 million
(+52% Y/Y) in Q1'24; continued uptake in atopic dermatitis (AD) and
vitiligo
– Incyte to acquire Escient Pharmaceuticals and its pipeline of
first-in-class oral MRGPR antagonists with the potential to treat
multiple mast cell-mediated diseases
Conference Call and Webcast Scheduled Today
at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today reports 2024 first quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
"In the first quarter of 2024, total revenues grew 9%
year-over-year driven by patient demand growth in the U.S. for
Opzelura® (ruxolitinib) cream and Jakafi® (ruxolitinib). As
anticipated, the revenue growth during the quarter was offset by an
inventory drawdown for Jakafi and the typical first quarter net
pricing dynamics," said Hervé Hoppenot, Chief Executive Officer,
Incyte. "We made important progress with our clinical pipeline
including the initiation of two Phase 1 studies evaluating our
JAK2V617F inhibitor and KRASG12D inhibitor. We also recently
announced an agreement to acquire Escient Pharmaceuticals, pending
the appropriate regulatory review process. Escient's lead compound
EP262, is a first-in-class, potent, highly selective, once-daily
small molecule designed to block mast cell activation, independent
from IgE. We believe this novel mechanism has broad clinical
utility in a number of conditions including chronic spontaneous
urticaria (CSU), chronic inducible urticaria (CIndU) and other
diseases."
Key First Quarter 2024 Company Updates
- In February 2024, Incyte announced that the U.S. Food and Drug
Administration (FDA) accepted for Priority Review the Biologics
License Application (BLA) for axatilimab, an anti-CSF-1R antibody,
for the treatment of chronic graft-versus-host disease (GVHD) after
failure of at least two prior lines of systemic therapy.
- In February 2024, Incyte entered into an asset purchase
agreement with MorphoSys AG which gave Incyte exclusive global
rights for tafasitamab, a humanized Fc-modified CD19-targeting
immunotherapy marketed in the U.S. as Monjuvi® (tafasitamab-cxix)
and outside of the U.S. as Minjuvi® (tafasitamab).
- In March 2024, multiple abstracts featuring data from Incyte's
dermatology portfolio were presented at the 2024 American Academy
of Dermatology (AAD) Annual Meeting, including two late-breaking
oral presentations for ruxolitinib cream (Opzelura) in hidradenitis
suppurativa (HS) and povorcitinib in prurigo nodularis (PN).
- In April 2024, Incyte and China Medical System Holdings Limited
announced the Companies entered into a Collaboration and License
Agreement, through a wholly-owned dermatology medical aesthetic
subsidiary CMS Skinhealth, for the development and
commercialization of povorcitinib, a selective oral JAK1 inhibitor,
in Mainland China, Hong Kong, Macau, Taiwan Region and eleven
Southeast Asian countries.
- In April 2024, Incyte and Escient Pharmaceuticals, a
clinical-stage drug development company advancing novel small
molecule therapeutics for systemic immune and neuro-immune
disorders, entered into a definitive agreement under which Incyte
has agreed to acquire Escient and its clinical development
portfolio, including EP262, a first-in-class, potent, highly
selective, once-daily small molecule antagonist of Mas-related G
protein-coupled receptor (MRGPRX2) and EP547, a first-in-class oral
MRGPRX4 antagonist. Under the terms of the agreement, Incyte will
acquire Escient and its assets for $750 million plus Escient’s net
cash remaining at the close of the transaction, subject to
customary adjustments. The acquisition is subject to clearance
under the Hart-Scott-Rodino Act, among other customary conditions,
and will become effective promptly following the satisfaction or
waiver of these conditions.
Jakafi:
Net product revenues for the first quarter 2024 of $572
million (-1% Y/Y):
- Total paid patients increased 5% in the first quarter of 2024
versus the same quarter in the prior year, with growth across all
indications and leading to the highest quarterly paid patient
demand for Jakafi since launch.
- Patients on free drug in the fourth quarter of 2023 gradually
returned to paid demand during the first quarter of 2024; as a
result, the percent of patients on free drug returned to more
normalized levels during the first quarter of 2024.
- Channel inventory at the end of the first quarter of 2024
decreased by approximately $55 million versus the fourth quarter of
2023.
Opzelura:
Net product revenues for the first quarter 2024 of $86
million (+52% Y/Y):
- Net product revenues growth in the first quarter of 2024 were
driven by patient demand, refills and expansion in payer coverage
as the launch in atopic dermatitis (AD) and vitiligo
continues.
- Net product revenues of $6 million in the first quarter of 2024
in Europe where the launch is ongoing in Germany, Austria and
initial uptake has begun in France.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host
Disease (GVHD) – key highlights
- Combination trials of ruxolitinib twice daily (BID) with
zilurgisertib (INCB000928) and BETi (INCB057643) are ongoing and
continue to enroll. A Phase 3 study for BETi is anticipated to
initiate in the second half of 2024 and clinical proof-of-concept
for zilurgisertib is anticipated by mid-2024.
- The Phase 1 studies evaluating INCA033989 (mCALR) and
INCB100658 (JAK2V617F) are ongoing and enrolling patients.
MPN and GVHD Programs
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
Axatilimab (anti-CSF-1R)2
Chronic GVHD: Pivotal Phase 2 (third-line
plus therapy) (AGAVE-201); BLA under review in the U.S.
Ruxolitinib + axatilimab2
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2 in preparation
Steroids + axatilimab2
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3 in preparation
INCA033989
(mCALR)
Myelofibrosis, essential thrombocythemia:
Phase 1
INCB160058
(JAK2V617Fi)
Phase 1
1 Development collaboration with Cellenkos, Inc.
2 Clinical development of axatilimab in GVHD conducted in
collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
- In January 2024, Incyte highlighted promising early clinical
efficacy data for its selective small molecule inhibitor of CDK2
(INCB123667), which demonstrated its potential use as monotherapy
or combination therapy for late-stage cancers. In a Phase 1 study
of INCB123667, early clinical activity was observed with several
partial responses (PR) achieved in patients with amplification/over
expression of CCNE1, a cell cycle regulator and potential
predictive biomarker. Tumor shrinkage was observed across multiple
tumor types, including CCNE1+ patients with ovarian cancer. The
safety profile of INCB123667 aligns with the mechanism of action.
Additional data is expected to be presented in 2024.
- In April 2024, Incyte presented new preclinical data at the
American Association for Cancer Research (AACR) Annual Meeting 2024
highlighting its KRASG12D inhibitor (INCB161734). INCB161734 is a
potent, selective, and orally bioavailable KRAS G12D inhibitor
which is efficacious against KRAS G12D mutant tumors in preclinical
models. The potential benefit of INCB161734 for patients with KRAS
G12D mutant disease is under investigation in an ongoing Phase 1
study. The KRASG12D mutation is found in 40% of pancreatic ductal
adenocarcinoma patients, 15% of colorectal cancer patients, and 5%
of non-small cell lung cancer patients and with no approved
G12D-targeting agents, represents a significant medical need.
Oncology Programs
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)
Tafasitamab (Monjuvi®/Minjuvi®)
(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®)1
(PD-1)
Merkel cell carcinoma (MCC): 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
INCB99318
(Oral PD-L1)
Solid tumors: Phase 1
INCB123667
(CDK2i)
Solid tumors with Amplification/
Overexpression of CCNE1: Phase 1
INCB161734
(KRASG12D)
Advanced metastatic solid tumors with a
KRAS G12D mutation: Phase 1
1 Retifanlimab licensed from MacroGenics.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
- In March 2024, Incyte presented data at the 2024 AAD Annual
Meeting from its randomized, placebo-controlled, Phase 2 study
evaluating the safety and efficacy of ruxolitinib cream (Opzelura®)
in adults with mild/moderate HS. At Week 16, patients receiving
ruxolitinib cream 1.5% twice daily (BID) had significantly greater
decreases from baseline versus placebo in total abscess and
inflammatory nodule (AN) count, the primary endpoint of the study.
The overall safety profile of ruxolitinib cream was consistent with
previous data, and no new safety signals were observed. A Phase 3
study is currently being evaluated.
- Ruxolitinib cream in other indications: Phase 2 studies in
lichen planus and lichen sclerosus have completed enrollment. Two
Phase 3 trials evaluating ruxolitinib cream in PN are ongoing.
Povorcitinib (INCB54707)
- The Phase 2, randomized, double-blind, placebo-controlled, dose
ranging study evaluating the efficacy and safety of povorcitinib in
participants with PN were presented at the 2024 AAD Annual Meeting
with the study meeting its primary and secondary endpoints
following 16 weeks of treatment across all dosing groups,
reinforcing povorcitinib’s potential role in treating PN. A Phase 3
study in PN is being planned.
- Asthma and chronic spontaneous urticaria: Two Phase 2 trials in
asthma and chronic spontaneous urticaria are enrolling.
IAI and Dermatology Programs
Indication and status
Ruxolitinib cream (Opzelura®)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study
(TRuE-AD3)
Vitiligo: Approved in the U.S. and
Europe
Lichen planus: Phase 2
Lichen sclerosus: Phase 2
Hidradenitis suppurativa: Phase 2; Phase 3
being evaluated
Prurigo nodularis: Phase 3 (TRuE-PN1,
TRuE-PN2)
Ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy)
Vitiligo: Phase 2
Povorcitinib
(JAK1)
Hidradenitis suppurativa: Phase 3
(STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 to start in
2024
Asthma: Phase 2
Chronic spontaneous urticaria: Phase 2
INCA034460
(anti-IL-15Rβ)
Vitiligo: Phase 1 initiated
1 Novartis’ rights to ruxolitinib outside of the United States
under our Collaboration and License Agreement with Novartis do not
include topical administration.
Other
Other Program
Indication and Phase
Zilurgisertib
(ALK2)
Fibrodysplasia ossificans progressiva:
Pivotal Phase 2
Discovery and other early development
Modality
Candidates
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
Partnered Programs
Indication and Phase
Ruxolitinib (Jakavi®)1
(JAK1/JAK2)
Acute and chronic GVHD: Approved in Europe
and Japan
Baricitinib (Olumiant®)2
(JAK1/JAK2)
AD: Approved in Europe and Japan
Severe alopecia areata (AA): Approved in
the U.S., Europe and Japan
Capmatinib (Tabrecta®)3
(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.
2024 First Quarter Financial Results
The financial measures presented in this press release for the
three months ended March 31, 2024 and 2023 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
March 31,
2024
2023
Total GAAP revenues
$
880,889
$
808,673
Total GAAP operating income
91,898
24,770
Total Non-GAAP operating income
161,183
89,729
GAAP net income
169,548
21,703
Non-GAAP net income
145,269
84,577
GAAP basic EPS
$
0.76
$
0.10
Non-GAAP basic EPS
$
0.65
$
0.38
GAAP diluted EPS
$
0.75
$
0.10
Non-GAAP diluted EPS
$
0.64
$
0.37
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
March 31,
%
Change
(as reported)
%
Change
(constant currency)1
2024
2023
Net product revenues:
Jakafi
$
571,839
$
579,969
(1
%)
(1
%)
Opzelura
85,724
56,552
52
%
51
%
Iclusig
30,343
27,685
10
%
8
%
Pemazyre
17,676
22,475
(21
%)
(22
%)
Minjuvi/Monjuvi
23,874
6,556
264
%
262
%
Zynyz
467
—
NM
NM
Total net product revenues
729,923
693,237
5
%
5
%
Royalty revenues:
Jakavi
89,595
76,692
17
%
19
%
Olumiant
30,589
34,155
(10
%)
(8
%)
Tabrecta
5,234
4,177
25
%
NA
Pemazyre
548
412
33
%
NM
Total royalty revenues
125,966
115,436
9
%
Total net product and royalty revenues
855,889
808,673
6
%
Milestone and contract revenues
25,000
—
NM
NM
Total GAAP revenues
$
880,889
$
808,673
9
%
NM = not meaningful
NA = not available
1.Percentage change in constant currency is calculated using
2023 foreign exchange rates to recalculate 2024 results.
Product and Royalty Revenues Product revenues and product
and royalty revenues for the quarter ended March 31, 2024 increased
5% and 6%, respectively, over the prior year comparative period,
primarily driven by a 52% year-over-year increase in Opzelura net
product revenue due to the growth in new patient starts and
refills, an increase in Minjuvi/Monjuvi net product revenues,
following the acquisition of the exclusive global rights to
tafasitamab in February 2024, and an increase in Jakavi royalty
revenues.
Operating
Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
March 31,
%
Change
2024
2023
GAAP cost of product revenues
$
60,956
$
56,822
7
%
Non-GAAP cost of product revenues1
54,959
50,669
8
%
GAAP research and development
429,260
406,641
6
%
Non-GAAP research and development2
388,437
375,620
3
%
GAAP selling, general and
administrative
300,256
315,606
(5
%)
Non-GAAP selling, general and
administrative3
277,335
294,017
(6
%)
GAAP (gain) loss on change in fair value
of acquisition-related contingent consideration
(456
)
6,196
(107
%)
Non-GAAP (gain) loss on change in fair
value of acquisition-related contingent consideration4
—
—
—
%
GAAP (profit) and loss sharing under
collaboration agreements
(1,025
)
(1,362
)
(25
%)
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 and MorphoSys transition costs.
3 Non-GAAP selling, general and administrative expenses exclude
the cost of stock-based compensation and MorphoSys transition
costs.
4 Non-GAAP (gain) loss on change in fair value of
acquisition-related contingent consideration is null.
Cost of product revenues GAAP and Non-GAAP cost of
product revenues for the quarter ended March 31, 2024 increased 7%
and 8%, respectively, compared to the same period in 2023 primarily
due to growth in net product revenues.
Research and development expenses GAAP and Non-GAAP
research and development expense for the quarter ended March 31,
2024 increased 6% and 3%, respectively, compared to the same period
in 2023 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 March 31, 2024 decreased 5% and 6%, respectively,
compared to the same period in 2023 primarily due to the timing of
consumer marketing activities and of certain other expenses.
Other Financial
Information
Change in fair value of acquisition-related contingent
consideration The change in fair value of contingent
consideration during the quarter ended March 31, 2024, compared to
the same periods in 2023, was due primarily to fluctuations in
foreign currency exchange rates impacting future revenue
projections of Iclusig.
Operating income GAAP and Non-GAAP operating income for
the three months ended March 31, 2024 increased 271% and 80%,
respectively, compared to the same period in 2023, driven by growth
in total revenues and stable operating expenses.
Cash, cash equivalents and marketable securities position
As of March 31, 2024 and December 31, 2023, cash, cash equivalents
and marketable securities totaled $3.9 billion and $3.7 billion,
respectively.
2024 Financial Guidance
Incyte is maintaining its full year 2024 revenue and expense
guidance. Incyte’s guidance is summarized below. Guidance does not
include revenue from any potential new product launches or the
impact of the acquisition of Escient Pharmaceuticals or any other
potential future strategic transactions.
Guidance
Jakafi net product revenues
$2,690 - $2,750 million
Other Hematology/Oncology net product
revenues(1)
$325 - $360 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
$1,720 - $1,760 million
Non-GAAP Research and development
expenses(3)
$1,580 - $1,615 million
GAAP Selling, general and administrative
expenses
$1,210 - $1,240 million
Non-GAAP Selling, general and
administrative expenses(3)
$1,115 - $1,140 million
1Pemazyre in the U.S., EU and Japan; Monjuvi and Zynyz in the
U.S.; and Iclusig and Minjuvi in the EU.
2Adjusted to exclude the amortization of licensed intellectual
property for Iclusig relating to the acquisition of the European
business of ARIAD Pharmaceuticals, Inc. and the estimated cost of
stock-based compensation.
3 Adjusted to exclude the estimated cost of stock-based
compensation.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at
8:00 a.m. ET. To access the conference call, please dial
877-407-3042 for domestic callers or 201-389-0864 for international
callers. When prompted, provide the conference identification
number, 13745743.
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, 13745743.
The conference call will also be webcast live and can be
accessed at investor.incyte.com.
About Incyte
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram, Facebook,
YouTube.
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® (tafasitamab-cxix)
Monjuvi® (tafasitamab-cxix) 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). MorphoSys and Incyte entered into: (a) in January 2020, a
collaboration and licensing agreement to develop and commercialize
tafasitamab globally; and (b) in February 2024, an agreement
whereby Incyte obtained exclusive rights to develop and
commercialize tafasitamab globally.
Following accelerated approval by the U.S. Food and Drug
Administration in July 2020, Monjuvi® (tafasitamab-cxix) is being
commercialized in the United States by Incyte. In Europe, Minjuvi®
(tafasitamab) received conditional Marketing Authorization from the
European Medicines Agency in August 2021.
XmAb® is a registered trademark of Xencor, Inc.
Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the
“triangle” design are trademarks of Incyte.
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 2024, including its
expectations regarding sales of Jakafi; expectations regarding
demand for and sales of Opzelura, among other products;
expectations regarding Incyte’s acquisition of Escient and the
potential of Escient’s pipeline; expectations regarding the
potential and progress of programs in our pipeline; expectations
regarding ongoing clinical trials and clinical trials to be
initiated, including a phase 3 study for BETi and a clinical
proof-of-concept for zilurgisertib, a phase 3 trial of povorcitinib
in prurigo nodularis, and various additional clinical trials across
our MPH/GVHD, oncology, IAI and dermatology programs; expectations
regarding data readouts; our expectations regarding regulatory
filings; and our expectations regarding 2024 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 on form 10-K
for the year ended December 31, 2023. 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
March 31,
2024
2023
GAAP
Revenues:
Product revenues, net
$
729,923
$
693,237
Product royalty revenues
125,966
115,436
Milestone and contract revenues
25,000
—
Total revenues
880,889
808,673
Costs, expenses and other:
Cost of product revenues (including
definite-lived intangible amortization)
60,956
56,822
Research and development
429,260
406,641
Selling, general and administrative
300,256
315,606
(Gain) loss on change in fair value of
acquisition-related contingent consideration
(456
)
6,196
(Profit) and loss sharing under
collaboration agreements
(1,025
)
(1,362
)
Total costs, expenses and other
788,991
783,903
Income from operations
91,898
24,770
Interest income and other, net
44,744
32,873
Interest expense
(430
)
(469
)
Unrealized gain (loss) on long term
investments
99,947
(5,318
)
Income before provision for income
taxes
236,159
51,856
Provision for income taxes
66,611
30,153
Net income
$
169,548
$
21,703
Net income per share:
Basic
$
0.76
$
0.10
Diluted
$
0.75
$
0.10
Shares used in computing net income per
share:
Basic
224,484
222,960
Diluted
227,219
225,589
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
March 31, 2024
December 31,
2023
ASSETS
Cash, cash equivalents and marketable
securities
$
3,850,688
$
3,656,043
Accounts receivable
745,526
743,557
Property and equipment, net
719,999
751,513
Finance lease right-of-use assets, net
25,533
25,535
Inventory
327,934
269,937
Prepaid expenses and other assets
238,262
236,782
Long term investments
287,663
187,716
Other intangible assets, net
117,841
123,545
Goodwill
155,593
155,593
Deferred income tax asset
666,566
631,886
Total assets
$
7,135,605
$
6,782,107
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,506,722
$
1,347,669
Finance lease liabilities
32,612
32,601
Acquisition-related contingent
consideration
202,000
212,000
Stockholders’ equity
5,394,271
5,189,837
Total liabilities and stockholders’
equity
$
7,135,605
$
6,782,107
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
March 31,
2024
2023
GAAP Net Income
$
169,548
$
21,703
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
36,792
31,021
Non-cash stock compensation from equity
awards (SG&A)2
22,373
21,589
Non-cash stock compensation from equity
awards (COGS)2
613
769
Non-cash interest3
108
108
Changes in fair value of equity
investments4
(99,947
)
5,318
Amortization of acquired product
rights5
5,384
5,384
(Gain) loss on change in fair value of
contingent consideration6
(456
)
6,196
MorphoSys transition costs7
4,579
—
Tax effect of Non-GAAP pre-tax
adjustments8
6,275
(7,511
)
Non-GAAP Net Income
$
145,269
$
84,577
Non-GAAP net income per share:
Basic
$
0.65
$
0.38
Diluted
$
0.64
$
0.37
Shares used in computing Non-GAAP net
income per share:
Basic
224,484
222,960
Diluted
227,219
225,589
1 Included within the Milestone and contract revenues line item
in the Condensed Consolidated Statements of Operations (in
thousands) for the three months ended March 31, 2024 are milestones
of $25,000 earned from our collaborative partners, as compared to
no milestones earned for the three months ended March 31, 2023.
Included within the Research and development expenses line item in
the Condensed Consolidated Statements of Operations (in thousands)
for the three months ended March 31, 2024 and 2023 are upfront
consideration and milestones of $1,000 and $2,700, respectively,
related to our collaborative partners.
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 (Gain) loss on change in fair value of
acquisition-related contingent consideration line item in the
Condensed Consolidated Statements of Operations.
7 Included within the Research and development line item in the
Condensed Consolidated Statements of Operations is $4,031 for the
three months ended March 31, 2024, and $548 is included within the
Selling, general and administrative expenses line item in the
Condensed Consolidated Statements of Operations for the three
months ended March 31, 2024. MorphoSys transition costs primarily
represent employee related costs to transition research and
development and selling, general and administrative activities to
us under the former collaboration agreement with MorphoSys.
8 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/20240430048388/en/
Media media@incyte.com
Investors ir@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Sep 2024 to Oct 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Oct 2023 to Oct 2024