- Total revenues of $1,138 million in the third quarter (Q3'24)
(+24% Y/Y)
- Jakafi® (ruxolitinib) net product revenues of $741 million in
Q3'24 (+16% Y/Y); raising full year 2024 Jakafi guidance to a new
range of $2,740 - $2,770 million
- Opzelura® (ruxolitinib) cream net product revenues of $139
million in Q3'24 (+52% Y/Y); launch momentum continues in the U.S.
supported by reimbursement expansion in Europe
- Niktimvo™ (axatilimab-csfr) approved by FDA for the treatment
of chronic graft-versus-host disease after failure of at least two
prior lines of systemic therapy in adult and pediatric
patients
- Regulatory and development progress with supplemental New Drug
Application (sNDA) for ruxolitinib cream in pediatric atopic
dermatitis filed and positive data presented for CDK2 inhibitor,
retifanlimab and tafasitamab
Conference Call and Webcast Scheduled Today
at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today reports 2024 third quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
"In the third quarter of 2024, we delivered significant
achievements, including strong revenue growth for both Jakafi®
(ruxolitinib) and Opzelura® (ruxolitinib) cream, and the
advancement of our clinical pipeline highlighted by the submission
to the FDA of the supplemental New Drug Application (sNDA) for
ruxolitinib cream in pediatric atopic dermatitis and several key
data readouts including CDK2i, retifanlimab, tafasitamab,
povorcitinib and ruxolitinib cream, which all hold near to mid-term
launch potential. Additionally, in August, the FDA approved
Niktimvo™ (axatilimab-csfr) for patients with chronic
graft-versus-host disease, after failure of two prior lines of
therapy, making it the first anti-CSF-1R antibody approved to
target the inflammation and fibrosis associated with chronic GVHD,"
said Hervé Hoppenot, Chief Executive Officer, Incyte. “We are on
track to achieve over ten impactful launches by 2030.”
Key Recent Company Updates
- In October, the sNDA submission for ruxolitinib cream in
pediatric atopic dermatitis was filed with the FDA with approval
anticipated in the second half of 2025.
- In October, Opzelura was granted a Notice of Compliance by
Health Canada for the topical treatment of both mild to moderate
atopic dermatitis and nonsegmental vitiligo in patients 12 years of
age and older.
- In September, Incyte presented late-breaking Phase 3 results
for retifanlimab (Zynyz®) and initial data from the Phase 1 CDK2
inhibitor program at the 2024 European Society for Medical Oncology
(ESMO) Congress.
- Featured during the Presidential Symposium, the Phase 3
POD1UM-303/InterAACT2 trial for retifanlimab met the primary
endpoint of progression free survival (PFS) and demonstrated
improvement across secondary endpoints in patients with squamous
cell anal carcinoma (SCAC) receiving retifanlimab in combination
with platinum-based chemotherapy (carboplatin-paclitaxel). Incyte
plans to file a supplemental Biologics License Application (sBLA)
for retifanlimab in SCAC by the end of 2024. A potential approval
in 2025 could represent the first PD-(L)1 antibody for patients
with SCAC.
- Phase 1 data of INCB123667, a highly selective and potentially
first-in-class CDK2 inhibitor, were presented demonstrating
single-agent antitumor activity across a range of doses and
regimens, notably in patients with ovarian cancer and endometrial
cancer whose tumors overexpress Cyclin E1. The Phase 1 trial of
INCB123667 in combination with other agents is ongoing. Incyte
plans to initiate a pivotal trial in ovarian cancer in 2025.
- In August, Incyte and its partner Syndax announced the U.S.
Food and Drug Administration (FDA) approval of Niktimvo, 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 adult and pediatric patients.
Niktimvo is the first approved anti-CSF-1R antibody targeting the
drivers of inflammation and fibrosis seen in chronic GVHD. In
September, Incyte and Syndax announced the New England Journal of
Medicine publication of data from the pivotal AGAVE-201 trial of
Niktimvo in chronic GVHD and the addition of Niktimvo to the NCCN
Clinical Practice Guidelines in Oncology for the treatment of
chronic GVHD.
- In August, Incyte announced positive topline results from the
Phase 3 clinical study evaluating tafasitamab (Monjuvi®) in
relapsed or refractory follicular lymphoma (FL). The pivotal Phase
3 inMIND trial met the primary endpoint of PFS by investigator
assessment in FL. The trial also met key secondary endpoints. No
new safety signals with tafasitamab were observed. The full dataset
is anticipated to be presented at an upcoming medical meeting in
2024 and Incyte expects to file an sBLA for tafasitamab in
combination with lenalidomide and rituximab in FL by the end of
2024.
Jakafi:
Net product revenues for the third quarter 2024 of $741
million (+16% Y/Y):
- Net product revenues were primarily driven by patient demand,
which increased 10% in the third quarter of 2024 versus the same
quarter in the prior year, with growth across all indications.
Opzelura:
Net product revenues for the third quarter 2024 of $139
million (+52% Y/Y):
- Net product revenues of $119 million in the third quarter of
2024 in the U.S. were primarily driven by patient demand and
refills in both atopic dermatitis (AD) and vitiligo.
- Net product revenues of $20 million in the third quarter of
2024 ex-U.S. were primarily driven by sales in Germany and
France.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host
Disease (GVHD) – key highlights
- A bioequivalence study of ruxolitinib extended-release (XR) is
enrolling. The data are anticipated in the first half of 2025.
- A Phase 2 trial evaluating the safety and efficacy of
axatilimab in combination with ruxolitinib in patients with newly
diagnosed chronic GVHD is enrolling.
- Trials of ruxolitinib twice daily (BID) with BETi and
zilurgisertib are ongoing. Additional data for BETi and
zilurgisertib are anticipated in the fourth quarter of 2024.
- The Phase 1 studies evaluating mCALR and JAK2V617Fi are ongoing
and enrolling patients. Initial data for both studies are
anticipated in 2025.
MPN and GVHD Programs
Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and
GVHD
Ruxolitinib + zilurgisertib
(JAK1/JAK2 + ALK2i)
Myelofibrosis: Phase 2
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi)
Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3 in preparation
INCA33989
(mCALR)
Myelofibrosis, essential thrombocythemia:
Phase 1
INCB160058
(JAK2V617Fi)
Myelofibrosis: Phase 1
1 Clinical development of axatilimab in
GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
- Following the announcement of the positive topline results from
the Phase 3 study evaluating retifanlimab, a humanized monoclonal
antibody targeting programmed cell death receptor-1 (PD-1), in
non-small cell lung cancer (NSCLC), Incyte anticipates sharing the
full dataset at an upcoming medical meeting in the fourth quarter
of 2024.
- The Phase 3 study evaluating tafasitamab in first-line diffuse
large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are
anticipated in the first half of 2025.
- The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 are
ongoing and enrolling patients. Initial data for both studies are
anticipated in 2025.
Heme/Oncology Programs
Indication and status
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): Phase 3 (inMIND)
Retifanlimab (Zynyz®)1
(PD-1)
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)
INCB123667
(CDK2i)
Solid tumors with Amplification/
Overexpression of CCNE1: Phase 1
INCB161734
(KRASG12D)
Advanced metastatic solid tumors with a
KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase
1
1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
- In September 2024, Incyte presented multiple datasets for
ruxolitinib cream at the 2024 European Academy of Dermatology and
Venereology (EADV) Congress including late-breaking oral
presentations for vitiligo, atopic dermatitis, hidradenitis
suppurativa (HS) and lichen planus.
- Two Phase 3 trials (TRuE-PN1 and TRuE-PN2) evaluating
ruxolitinib cream in prurigo nodularis (PN) are ongoing. The Phase
3 data are anticipated in the first half of 2025.
- The Phase 3 trial for ruxolitinib cream in mild to moderate HS
is on track to initiate in the first half of 2025 following
achieving alignment on the study design with FDA. Ruxolitinib cream
has the potential to provide a new therapeutic option for the
approximately 150,000 mild to moderate HS patients in the U.S.
Povorcitinib (INCB54707)
- In September 2024, Incyte presented long-term extension data at
the 2024 EADV Congress from the Phase 2 randomized, double-blind,
placebo-controlled study evaluating the efficacy and safety of
povorcitinib in patients with PN. In October 2024, two Phase 3
studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib versus
placebo were initiated and are enrolling.
- The Phase 3 studies of povorcitinib in patients with
hidradenitis suppurativa (STOP-HS1 and STOP-HS2) are enrolling well
with data anticipated in the first quarter of 2025.
- Two Phase 2 trials evaluating povorcitinib in asthma and
chronic spontaneous urticaria (CSU) are enrolling. Data for CSU are
anticipated in the first half of 2025 and data in asthma are
anticipated in the second half of 2025.
INCB000262 (MRGPRX2)
- Three clinical studies evaluating INCB000262 in CSU (Phase 2),
chronic inducible urticaria (CIndu) (Phase 1b) and atopic
dermatitis (AD) (Phase 2a) are ongoing. Data for all three studies
are anticipated in the first quarter of 2025.
INCB000547 (MRGPRX4)
- The phase 2 clinical study evaluating MRGPRX4 in cholestatic
pruritus is ongoing with data expected in the first quarter of
2025.
IAI and Dermatology Programs
Indication and status
Ruxolitinib cream (Opzelura®)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study
(TRuE-AD3)
Hidradenitis suppurativa: Phase 2; Phase 3
expected to initiate in 2025
Prurigo nodularis: Phase 3 (TRuE-PN1,
TRuE-PN2)
Povorcitinib
(JAK1)
Hidradenitis suppurativa: Phase 3
(STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1,
STOP-PN2)
Asthma: Phase 2
Chronic spontaneous urticaria: Phase 2
INCB000262
(MRGPRX2)
Chronic spontaneous urticaria: Phase 2
Chronic inducible urticaria: Phase 1b
Atopic dermatitis: Phase 2a
INCB000547
(MRGPRX4)
Cholestatic pruritus: Phase 2a
INCA034460
(anti-CD122)
Vitiligo: Phase 1
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
2024 Third Quarter Financial Results
The financial measures presented in this press release for the
three and nine months ended September 30, 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
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Total GAAP revenues
$
1,137,871
$
919,025
$
3,062,519
$
2,682,308
Total GAAP operating income (loss)
146,085
214,705
(240,147
)
433,255
Total Non-GAAP operating income
255,236
273,294
37,618
625,081
GAAP net income (loss)
106,456
171,269
(168,597
)
396,520
Non-GAAP net income (loss)
209,651
248,719
(53,762
)
556,325
GAAP basic EPS
$
0.55
$
0.76
$
(0.80
)
$
1.77
Non-GAAP basic EPS
$
1.09
$
1.11
$
(0.25
)
$
2.49
GAAP diluted EPS1
$
0.54
$
0.76
$
(0.80
)
$
1.76
Non-GAAP diluted EPS1
$
1.07
$
1.10
$
(0.25
)
$
2.46
1 All stock options and stock awards were
excluded from the diluted share calculation for the nine months
ended September 30, 2024 because their effect would have been
anti-dilutive, as we were in a net loss position.
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
September 30,
%
Change
(as reported)
%
Change
(constant currency)1
Nine Months Ended
September 30,
%
Change
(as reported)
%
Change
(constant currency)1
2024
2023
2024
2023
Net product revenues:
Jakafi
$
741,181
$
636,252
16
%
16
%
$
2,018,993
$
1,898,605
6
%
6
%
Opzelura
139,272
91,836
52
%
51
%
346,691
228,621
52
%
52
%
Iclusig
29,745
27,721
7
%
6
%
86,950
84,493
3
%
2
%
Pemazyre
20,661
18,942
9
%
9
%
58,606
62,989
(7
%)
(7
%)
Minjuvi/ Monjuvi
31,439
8,348
277
%
276
%
86,429
28,063
208
%
208
%
Zynyz
694
98
608
%
608
%
1,812
668
171
%
171
%
Total net product revenues
962,992
783,197
23
%
23
%
2,599,481
2,303,439
13
%
13
%
Royalty revenues:
Jakavi
115,741
96,551
20
%
20
%
304,653
263,691
16
%
16
%
Olumiant
34,796
29,615
17
%
22
%
97,087
95,779
1
%
5
%
Tabrecta
5,928
4,139
43
%
NA
16,460
13,115
26
%
NA
Pemazyre
414
523
(21
%)
NM
1,838
1,284
43
%
NM
Total royalty revenues
156,879
130,828
20
%
420,038
373,869
12
%
Total net product and royalty revenues
1,119,871
914,025
23
%
3,019,519
2,677,308
13
%
Milestone and contract revenues
18,000
5,000
260
%
260
%
43,000
5,000
760
%
760
%
Total GAAP revenues
$
1,137,871
$
919,025
24
%
$
3,062,519
$
2,682,308
14
%
NM = not meaningful NA = not applicable 1
Percentage change in constant currency is calculated using 2023
foreign exchange rates to recalculate 2024 results.
Product and Royalty Revenues Total net product and
royalty revenues for the quarter and nine months ended September
30, 2024 increased 23% and 13%, respectively, over the prior year
comparative periods, primarily driven by the following:
- For the quarter ended September 30, 2024, Jakafi net product
revenue increased 16% primarily driven by a 10% increase in total
demand. Channel inventory at the end of the third quarter of 2024
was within the normal range. For the nine months ended September
30, 2024, Jakafi net product revenue increased 6% primarily driven
by a 7% increase in total demand.
- For the quarter and nine months ended September 30, 2024,
Opzelura net product revenue increased 52% due to continued growth
in new patient starts and refills in the U.S. and increased
contribution from Europe, driven by continued uptake in Germany and
the launch in France.
- For the quarter and nine months ended September 30, 2024,
Minjuvi/Monjuvi net product revenue increased 277% and 208%,
respectively, following the acquisition of the exclusive global
rights to tafasitamab in February 2024.
- For the quarter ended September 30, 2024, total royalty
revenues grew by 20%, driven by 20% and 17% growth in Jakavi and
Olumiant royalty revenues, respectively. For the nine months ended
September 30, 2024, total royalty revenues grew by 12%, driven
primarily by 16% growth in Jakavi royalty revenues.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
September 30,
%
Change
Nine Months Ended
September 30,
%
Change
2024
2023
2024
2023
GAAP cost of product revenues
$
85,993
$
60,091
43
%
$
223,583
$
185,239
21
%
Non-GAAP cost of product revenues1
79,981
53,914
48
%
205,839
166,733
23
%
GAAP research and development
573,174
375,709
53
%
2,140,814
1,183,100
81
%
Non-GAAP research and development2
525,343
348,868
51
%
2,002,870
1,092,409
83
%
GAAP selling, general and
administrative
309,209
267,893
15
%
915,447
867,428
6
%
Non-GAAP selling, general and
administrative3
277,311
241,896
15
%
817,217
798,943
2
%
GAAP loss (gain) on change in fair value
of acquisition-related contingent consideration
23,410
(426
)
(5595
%)
23,847
14,144
69
%
Non-GAAP loss (gain) on change in fair
value of acquisition-related contingent consideration4
—
—
—
%
—
—
—
%
GAAP loss and (profit) sharing under
collaboration agreements
—
1,053
—
%
(1,025
)
(858
)
19
%
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, MorphoSys transition costs,
and Escient acquisition related compensation expense related to
cash settled unvested Escient equity awards and severance payments.
3 Non-GAAP selling, general and administrative expenses exclude the
cost of stock-based compensation, MorphoSys transition costs,
Escient acquisition related compensation expense related to cash
settled unvested Escient equity awards and severance payments, and
asset impairments. 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 and nine months ended September
30, 2024 increased 43% and 48%, and 21% and 23%, respectively,
compared to the same periods in 2023 primarily due to growth in net
product revenues, increased royalty expense and increased
manufacturing related costs.
Research and development expenses GAAP and Non-GAAP
research and development expense for the quarter ended September
30, 2024 increased 53% and 51%, respectively, compared to the same
period in 2023 primarily due to the $100.0 million milestone
payment made to MacroGenics during the third quarter of 2024 and
continued investment in our late stage development assets.
Excluding upfront and milestone payments and Escient severance
payments, research and development expense for the quarter ended
September 30, 2024 increased 26% compared to the same period in
2023 due to continued investment in our late stage development
assets, additional expenses resulting from the Escient acquisition,
and timing of certain expenses. For the nine months ended September
30, 2024, excluding upfront and milestone payments and the Escient
acquisition related compensation expense and severance payments,
research and development expense increased 15% compared to the same
period in 2023 due to continued investment in our late stage
development assets, additional expenses resulting from the Escient
acquisition, and timing of certain expenses.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the
quarter ended September 30, 2024 increased 15% compared to the same
period in 2023 primarily due to timing of consumer marketing
activities and of certain other expenses.
GAAP and Non-GAAP selling, general and administrative expenses
for the nine months ended September 30, 2024 increased 6% and 2%,
respectively, compared to the same period in 2023 primarily due to
$22.0 million of Escient acquisition related compensation expense
including severance payments and timing of consumer marketing
activities and of certain other expenses. Excluding the Escient
acquisition related compensation expense and severance payments,
selling, general and administrative expenses for the nine months
ended September 30, 2024 increased 3% compared to the same period
in 2023.
Other Financial
Information
Change in fair value of acquisition-related contingent
consideration The change in fair value of contingent
consideration during the quarter ended September 30, 2024, compared
to the same period in 2023, was primarily due 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 September 30, 2024 decreased 32% and 7%,
respectively, compared to the same period in 2023, driven primarily
by the $100.0 million milestone payment made to MacroGenics during
the third quarter of 2024. Excluding upfront and milestone payments
and Escient severance payments, operating income for the three
months ended September 30, 2024 increased 14% compared to the same
period in 2023 primarily driven by growth in net product
revenue.
GAAP and Non-GAAP operating income for the nine months ended
September 30, 2024 decreased 155% and 94%, respectively, compared
to the same period in 2023, driven primarily by the $679.4 million
of expense relating to the IPR&D assets acquired in the Escient
acquisition, $36.3 million of Escient acquisition related
compensation expense and severance payments, and the $100.0 million
milestone payment made to MacroGenics during the third quarter of
2024. Excluding upfront and milestone payments and the Escient
acquisition related compensation expense and severance payments,
operating income for the nine months ended September 30, 2024
increased 29% compared to the same period in 2023 primarily driven
by growth in net product revenue.
Cash, cash equivalents and marketable securities position
As of September 30, 2024 and December 31, 2023, cash, cash
equivalents and marketable securities totaled $1.8 billion and $3.7
billion, respectively. The decrease in cash, cash equivalents and
marketable securities during 2024 was driven primarily by the $2.0
billion share repurchase completed during June 2024, and the total
cash consideration paid to Escient shareholders of $783 million,
partially offset by proceeds of sales of equity investments during
the nine months ended September 30, 2024.
2024 Financial Guidance
Incyte is raising its full year 2024 Jakafi revenue guidance, as
well as updating its full year 2024 Other Hematology/Oncology
revenue guidance. In addition, Incyte is updating the full year
research and development guidance to include the $100 million
milestone payment to MacroGenics. The full year GAAP and Non-GAAP
research and development guidance now includes $791 million in
one-time expenses related to the $691 million of upfront
consideration recorded for the acquisition of Escient
Pharmaceuticals and the $100 million milestone payment to
MacroGenics. Incyte is also maintaining its full year 2024 cost of
product revenue and selling general and administrative guidance.
Incyte’s guidance is summarized below. The guidance does not
include revenue from any potential new product launches or the
impact of one-time items and any potential future strategic
transactions.
Current
Previous
Jakafi net product revenues
$2,740 - $2,770 million
$2,710 - $2,750 million
Other Hematology/Oncology net product
revenues(1)
$310 - $320 million
$325 - $360 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
$2,545 - $2,590 million
$2,445 - $2,490 million
Non-GAAP Research and development
expenses(3)
$2,395 - $2,435 million
$2,295 - $2,335 million
GAAP Selling, general and administrative
expenses
Unchanged
$1,210 - $1,240 million
Non-GAAP Selling, general and
administrative expenses(3)
Unchanged
$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. 3Adjusted to exclude the estimated cost
of stock-based compensation and Escient acquisition related
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, 13749146.
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, 13749146.
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 Opzelura®
(ruxolitinib) cream, 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 (registered) trademarks of Incyte.
About Pemazyre® (pemigatinib) Pemazyre® (pemigatinib) 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 Iclusig® (ponatinib)
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 press
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 reimbursement for
Opzelura in Europe; expectations regarding the potential and
progress of our pipeline, including expectations for ruxolitinib
cream, ruxolitinib extended-release (XR), povorcitinib, INCB000262,
INCB000547, axatilimab, mCALR, JAK2V617Fi, retifanlimab,
tafasitamab, INCB123667, BETi, zilurgisertib, KRASG12D and our TGFβ
program; Incyte’s ability to develop new transformative therapies
to treat myeloid disease and cure MPNs; expectations regarding
ongoing clinical trials and clinical trials to be initiated;
expectations regarding data flow/readouts; expectations regarding
regulatory filings, potential regulatory approvals and potential
product launches; and 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 possibility that results of clinical trials
will be negative and/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 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 supply of and/or 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
quarterly report on form 10-Q for the quarter ended June 30, 2024.
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
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP
GAAP
Revenues:
Product revenues, net
$
962,992
$
783,197
$
2,599,481
$
2,303,439
Product royalty revenues
156,879
130,828
420,038
373,869
Milestone and contract revenues
18,000
5,000
43,000
5,000
Total revenues
1,137,871
919,025
3,062,519
2,682,308
Costs, expenses and other:
Cost of product revenues (including
definite-lived intangible amortization)
85,993
60,091
223,583
185,239
Research and development
573,174
375,709
2,140,814
1,183,100
Selling, general and administrative
309,209
267,893
915,447
867,428
Loss (gain) on change in fair value of
acquisition-related contingent consideration
23,410
(426
)
23,847
14,144
Loss and (profit) sharing under
collaboration agreements
—
1,053
(1,025
)
(858
)
Total costs, expenses and other
991,786
704,320
3,302,666
2,249,053
Income (loss) from operations
146,085
214,705
(240,147
)
433,255
Interest income and other, net
24,195
46,371
118,708
121,912
Interest expense
(774
)
(623
)
(1,861
)
(1,747
)
Realized and unrealized (loss) gain on
equity investments
(12,982
)
(26,654
)
126,206
9,839
Income before provision for income
taxes
156,524
233,799
2,906
563,259
Provision for income taxes
50,068
62,530
171,503
166,739
Net income (loss)
$
106,456
$
171,269
$
(168,597
)
$
396,520
Net income (loss) per share:
Basic
$
0.55
$
0.76
$
(0.80
)
$
1.77
Diluted
$
0.54
$
0.76
$
(0.80
)
$
1.76
Shares used in computing net income (loss)
per share:
Basic
192,629
224,078
211,763
223,428
Diluted
195,838
226,167
211,763
225,756
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in
thousands)
September 30,
2024
December 31,
2023
ASSETS
Cash, cash equivalents and marketable
securities
$
1,771,344
$
3,656,043
Accounts receivable
758,450
743,557
Property and equipment, net
773,102
751,513
Finance lease right-of-use assets, net
25,072
25,535
Inventory
368,416
269,937
Prepaid expenses and other assets
247,243
236,782
Short and long term equity investments
30,910
187,716
Other intangible assets, net
119,994
123,545
Goodwill
155,593
155,593
Deferred income tax asset
762,310
631,886
Total assets
$
5,012,434
$
6,782,107
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,602,059
$
1,347,669
Finance lease liabilities
32,155
32,601
Acquisition-related contingent
consideration
207,000
212,000
Stockholders’ equity
3,171,220
5,189,837
Total liabilities and stockholders’
equity
$
5,012,434
$
6,782,107
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
(LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP Net Income (Loss)
$
106,456
$
171,269
$
(168,597
)
$
396,520
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
45,808
26,841
117,141
90,691
Non-cash stock compensation from equity
awards (SG&A)2
31,486
20,366
75,607
62,854
Non-cash stock compensation from equity
awards (COGS)2
628
793
1,592
2,354
Non-cash interest3
81
108
333
355
Realized and unrealized gain on equity
investments4
12,982
26,654
(126,206
)
(9,839
)
Amortization of acquired product
rights5
5,384
5,384
16,152
16,152
Loss (gain) on change in fair value of
contingent consideration6
23,410
(426
)
23,847
14,144
Asset impairment7
—
5,631
—
5,631
MorphoSys transition costs8
132
—
7,084
—
Escient acquisition related compensation
expense9
2,303
—
36,342
—
Tax effect of Non-GAAP pre-tax
adjustments10
(19,019
)
(7,901
)
(37,057
)
(22,537
)
Non-GAAP Net Income (Loss)
$
209,651
$
248,719
$
(53,762
)
$
556,325
Non-GAAP net income (loss) per share:
Basic
$
1.09
$
1.11
$
(0.25
)
$
2.49
Diluted11
$
1.07
$
1.10
$
(0.25
)
$
2.46
Shares used in computing Non-GAAP net
income (loss) per share:
Basic
192,629
224,078
211,763
223,428
Diluted11
195,838
226,167
211,763
225,756
1 Included within the Milestone and
contract revenues line item in the Condensed Consolidated
Statements of Operations (in thousands) for the three and nine
months ended September 30, 2024 are milestones of $18,000 and
$43,000, respectively, earned from our collaborative partners, as
compared to $5,000 of milestones earned for both the three and nine
months ended September 30, 2023. Included within the Research and
development expenses line item in the Condensed Consolidated
Statements of Operations (in thousands) for the three and nine
months ended September 30, 2024 are upfront consideration and
milestones of $100,000 and $101,414, respectively, related to our
collaborative partners as compared to upfront consideration and
milestones of $2,950 and $12,650, respectively, for the three and
nine months ended September 30, 2023. 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
Realized and unrealized gain on equity 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 (gain) on change in fair value of
acquisition-related contingent consideration line item in the
Condensed Consolidated Statements of Operations. 7 As included
within the Selling, general and administrative expenses line item
in the Condensed Consolidated Statements of Operations. 8 Included
within the Research and development line item in the Condensed
Consolidated Statements of Operations (in thousands) is $226 and
$6,489 for the three and nine months ended September 30, 2024,
respectively, and included within the Selling, general and
administrative expenses line item in the Condensed Consolidated
Statements of Operations (in thousands) is a benefit of $94 and
expense of $595 for the three and nine months ended September 30,
2024, respectively. 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. 9 Included within
the Research and development line item in the Condensed
Consolidated Statements of Operations (in thousands) is $1,797 and
$14,314, respectively, for the three and nine months ended
September 30, 2024, and included within the Selling, general and
administrative expenses line item in the Condensed Consolidated
Statements of Operations (in thousands) is $506 and $22,028,
respectively, for the three and nine months ended September 30,
2024. Escient acquisition related compensation expense represents
non-recurring charges associated with (i) cash settled unvested
Escient equity awards in connection with the acquisition, and (ii)
severance payments to former Escient employees. 10 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. 11 All stock options and stock awards were excluded
from the diluted share calculation for the nine months ended
September 30, 2024 because their effect would have been
anti-dilutive, as we were in a Non-GAAP net loss position.
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