- Total FY'23 net product and royalty revenues of $3.7 billion
(+14% Y/Y); total FY'23 net product revenues of $3.2 billion (+15%
Y/Y)
- Jakafi® (ruxolitinib) net revenues of $2.6 billion (+8%) for
FY'23; Jakafi net revenues guidance range of $2,690 - $2,750
million for FY 2024
- Opzelura® (ruxolitinib) cream net revenues of $109 million in
Q4'23 and $338 million for FY'23, driven by strong demand in atopic
dermatitis and the successful launch in vitiligo
- Advancing high potential pipeline provides opportunity for over
10 new launches by 2030
- Incyte to host an in-person and webcast investor event on
Monday, March 11, 2024 from 9:00-10:30 a.m. PT to discuss key data
presentations across its dermatology pipeline at the 2024 AAD
Annual Meeting in San Diego, CA
Conference Call and Webcast Scheduled Today
at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today reports 2023 fourth quarter financial
results, provides 2024 financial guidance and provides a status
update on the Company’s research and development portfolio.
"We delivered a strong 2023 with total net product and royalty
revenues of $3.7 billion, increasing 14% versus 2022. In the fourth
quarter, we achieved for the first time, a new milestone of $1
billion in total quarterly revenues, driven by the continued growth
of Jakafi® (ruxolitinib) and the successful launch of Opzelura®
(ruxolitinib) cream," said Hervé Hoppenot, Chief Executive Officer,
Incyte. "Throughout 2023, we focused our R&D efforts on high
potential programs and believe we are positioned to deliver more
than ten high impact launches by 2030."
Key Product Sales Performance
Jakafi:
Net product revenues for the fourth quarter of 2023 of $695
million; 2023 full year net product revenues of $2.59
billion
- Fourth quarter 2023 net product revenues grew 7% compared with
the fourth quarter of 2022 and grew 8% for the full year 2023 when
compared to 2022.
- Fourth quarter revenues were negatively impacted by an increase
in the number of Medicare Part D patients receiving free product
and were positively impacted by an increase in channel
inventory.
Opzelura:
Net product revenues for the fourth quarter of 2023 of $109
million; 2023 full year net product revenues of $338
million:
- Net product revenues of $109 million grew 78% compared with the
fourth quarter of 2022, driven by growth in patient demand, refills
and expansion in payer coverage as the launch in atopic dermatitis
(AD) and vitiligo continues. For the full-year, 2023 net product
revenues grew 162% over the prior year to $338 million.
- On January 31, 2024, Incyte received approval in France to
promote and distribute Opzelura for vitiligo under a process called
“Accès Direct.” This process is intended to allow for early access
to a therapy while a final price is negotiated, which is expected
to take up to twelve months. Once price reimbursement is
determined, Incyte will begin recognizing revenue in France.
Key Recent Updates
- 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). Under the terms
of the agreement, MorphoSys received a payment of $25 million from
Incyte, and Incyte gained global development and commercialization
rights for tafasitamab. Incyte will recognize revenue and cost for
all U.S. commercialization and clinical development and MorphoSys
will no longer be eligible to receive future milestone, profit
split and royalty payments.
- In January 2024, Incyte announced the primary endpoint was met
in its randomized, placebo-controlled, Phase 2 study evaluating the
safety and efficacy of ruxolitinib cream (Opzelura®) in adults with
mild/moderate hidradenitis suppurativa (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. The Phase 2 data is anticipated to be presented at
an upcoming scientific meeting in 2024. A Phase 3 study is
currently being evaluated.
- In January 2024, Incyte highlighted promising early clinical
efficacy data for its selective 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 for
INCB123667 aligns with the mechanism of action. Additional data is
expected to be presented in 2024.
- In December 2023, in collaboration with Syndax Pharmaceuticals,
the Biologics License Application (BLA) was submitted for
axatilimab in chronic graft-versus-host disease (cGVHD) with
approval anticipated in the second half of 2024. Plans are underway
to initiate two combination trials with axatilimab in cGVHD in
mid-2024, including a Phase 2 combination trial with ruxolitinib
and a Phase 3 combination trial with steroids.
- JAK2V617Fi (INCB160058), a potent and selective JAK2
pseudokinase domain binder, cleared the Investigational New Drug
(IND) process with the FDA and a Phase 1 study is anticipated to
initiate in the first half of 2024. INCB160058 has the potential to
be a disease modifying therapy and to address a significant patient
population. The JAK2 mutation is found in 55% of primary
myelofibrosis, 95% of polycythemia vera and 60% of essential
thrombocythemia patients.
- A Phase 1 study of KRASG12D (INCB161734) in patients with
advanced metastatic solid tumors with a KRAS G12D mutation was
recently initiated and the first patient was dosed. KRAS mutations
are one of the most common genetic abnormalities in cancer,
especially pancreatic and colorectal cancers.
- In December 2023, Incyte received FDA feedback and agreed to
the path forward for once daily (QD) ruxolitinib (XR). The
potential approval of QD ruxolitinib (XR) is anticipated in
approximately two years.
Additional Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host
Disease (GVHD) – key highlights
- In December 2023, Incyte presented more than 40 hematology and
oncology abstracts including a Plenary Scientific Session at the
2023 ASH Annual Meeting. The plenary presentation featured the full
data from AGAVE-201 evaluating axatilimab, an anti-CSFR-1R
monoclonal antibody, in patients with cGVHD. Other key highlights
included additional data from the Phase 1/2 Study of zilurgisertib
(INCB000928), Phase 1 data of BETi (INCB057643) and preclinical
data of JAK2V617Fi (INCB160058).
- Combination trials of ruxolitinib twice daily (BID) with
zilurgisertib (INCB000928) and BETi (INCB057643) are ongoing and
continue to enroll. Incyte anticipates initiating a Phase 3 study
for BETi in the second half of 2024 and achieving clinical
proof-of-concept for zilurgisertib by mid-2024.
- The Phase 1 study evaluating the mCALR monoclonal antibody
(INCA033989) is ongoing and enrolling patients.
MPN and GVHD Programs
Indication and Phase
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); BLA under review in the
U.S.
Ruxolitinib +
axatilimab2
(JAK1/JAK2 +
anti-CSF-1R)
Chronic GVHD: Phase 1/2 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
CDK2i (INCB123667)
- 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 for INCB123667 aligns with the mechanism of
action. Additional data is expected to be presented in 2024.
Oncology Programs
Indication and Phase
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®)
(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
Ruxolitinib Cream
- Incyte announced the primary endpoint was met in 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 is consistent with previous data, and
no new safety signals were observed. The Phase 2 data is
anticipated to be presented at an upcoming scientific meeting in
2024. A Phase 3 study is currently being evaluated.
- Two Phase 2 studies in lichen planus and lichen sclerosus have
completed enrollment. Two Phase 3 trials evaluating ruxolitinib
cream in prurigo nodularis (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 met its primary endpoint. 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 Phase
Ruxolitinib cream
(Opzelura®)1
(JAK1/JAK2)
AD: 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 2; Phase
3 in planning
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.
2023 Fourth Quarter and Year-end Financial Results
The financial measures presented in this press release for the
quarter and year ended December 31, 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
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
Total GAAP revenues
$
1,013,341
$
926,700
$
3,695,649
$
3,394,635
Total GAAP operating income
187,270
70,093
620,525
579,440
Total Non-GAAP operating income
267,702
152,503
892,783
801,545
GAAP provision for income taxes
69,877
52,154
236,616
188,456
GAAP net income
201,079
28,461
597,599
340,660
Non-GAAP net income
239,124
139,661
795,449
622,676
GAAP basic EPS
$
0.90
$
0.13
$
2.67
$
1.53
Non-GAAP basic EPS
$
1.07
$
0.63
$
3.56
$
2.80
GAAP diluted EPS
$
0.89
$
0.13
$
2.65
$
1.52
Non-GAAP diluted EPS
$
1.06
$
0.62
$
3.52
$
2.78
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
December 31,
%
Change
(as
reported)
%
Change
(constant
currency)1
Twelve Months Ended
December 31,
%
Change
(as
reported)
%
Change
(constant
currency)1
2023
2022
2023
2022
Net product revenues:
Jakafi
$
695,127
$
647,493
7
%
7
%
$
2,593,732
$
2,409,225
8
%
8
%
Opzelura
109,243
61,281
78
%
78
%
337,864
128,735
162
%
162
%
Iclusig
27,130
27,616
(2
%)
(6
%)
111,623
105,838
5
%
3
%
Pemazyre
20,653
23,016
(10
%)
(11
%)
83,642
83,445
—
%
1
%
Minjuvi
8,994
4,809
87
%
79
%
37,057
19,654
89
%
87
%
Zynyz
582
—
NM
NM
1,250
—
NM
NM
Total net product revenues
861,729
764,215
13
%
13
%
3,165,168
2,746,897
15
%
15
%
Royalty revenues:
Jakavi
103,892
91,189
14
%
14
%
367,583
331,575
11
%
12
%
Olumiant
40,359
35,858
13
%
12
%
136,138
134,547
1
%
4
%
Tabrecta
4,678
4,233
11
%
NA
17,793
15,411
15
%
NA
Pemazyre
683
1,205
NM
NM
1,967
1,205
NM
NM
Total royalty revenues
149,612
132,485
13
%
523,481
482,738
8
%
Total net product and royalty revenues
1,011,341
896,700
13
%
3,688,649
3,229,635
14
%
Milestone and contract revenues
2,000
30,000
(93
%)
(93
%)
7,000
165,000
(96
%)
(96
%)
Total GAAP revenues
$
1,013,341
$
926,700
9
%
$
3,695,649
$
3,394,635
9
%
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 December 31, 2023 both
increased 13%, and product revenues and product and royalty
revenues for the year ended December 31, 2023 increased 15% and
14%, respectively, over the prior year comparative periods,
primarily driven by increases in Jakafi and Opzelura net product
revenues. Jakafi fourth quarter revenues were negatively impacted
by an increase in the number of Medicare Part D patients receiving
free product and were positively impacted by an increase in channel
inventory. Opzelura net product revenues for the quarter were $109
million, representing a 78% increase year-over-year driven by
growth in new patient starts and refills. Olumiant royalties for
the quarter were impacted by favorable changes in foreign currency
exchange rates.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
December 31,
%
Change
Twelve Months Ended
December 31,
%
Change
2023
2022
2023
2022
GAAP cost of product revenues
$
69,751
$
59,163
18
%
$
254,990
$
206,997
23
%
Non-GAAP cost of product revenues1
63,575
53,022
20
%
230,308
182,737
26
%
GAAP research and development
444,494
501,360
(11
%)
1,627,594
1,585,936
3
%
Non-GAAP research and development2
408,488
469,048
(13
%)
1,500,897
1,473,420
2
%
GAAP selling, general and
administrative
293,865
272,819
8
%
1,161,293
1,002,140
16
%
Non-GAAP selling, general and
administrative3
270,673
253,209
7
%
1,069,616
928,960
15
%
GAAP loss on change in fair value of
acquisition-related contingent consideration
15,058
24,347
(38
%)
29,202
12,149
140
%
Non-GAAP loss on change in fair value of
acquisition-related contingent consideration4
—
—
—
%
—
—
—
%
GAAP (profit) and loss sharing under
collaboration agreements
2,903
(1,082
)
(368
%)
2,045
7,973
(74
%)
1 Non-GAAP cost of product
revenues excludes the amortization of licensed intellectual
property for Iclusig relating to the acquisition of the European
business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based
compensation.
2 Non-GAAP research and
development expenses exclude the cost of stock-based
compensation.
3 Non-GAAP selling, general and
administrative expenses exclude the cost of stock-based
compensation and asset impairments.
4 Non-GAAP 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 December 31, 2023 increased
18% and 20%, respectively, and for the year ended December 31, 2023
increased 23% and 26% compared to the same periods in 2022 due to
growth in net product revenues and inventory reserves for
obsolescence.
Research and development expenses GAAP and Non-GAAP
research and development expense for the quarter ended December 31,
2023 decreased 11% and 13%, respectively, and for the year ended
December 31, 2023 increased 3% and 2%, respectively, compared to
the same periods in 2022. The decrease for the quarter was
primarily due to the $70 million upfront payment made as part of
the Villaris asset acquisition during the fourth quarter of 2022,
offset in part by the $20 million development milestone payment to
former Villaris stockholders in the fourth quarter of 2023. The
increase for the full year was 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 December 31, 2023 increased 8% and 7%, respectively,
and for the year ended December 31, 2023 increased 16% and 15%,
respectively, compared to the same periods in 2022, primarily due
to expenses related to promotional activities to support the launch
of Opzelura for the treatment of vitiligo.
Other Financial
Information
Change in fair value of acquisition-related contingent
consideration The change in fair value of contingent
consideration during the quarter and year ended December 31, 2023,
compared to the same periods in 2022, 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 year ended December 31, 2023 increased 7% and 11%,
respectively, compared to the same period in 2022, primarily driven
by growth in product revenues.
Cash, cash equivalents and marketable securities position
As of December 31, 2023 and 2022, cash, cash equivalents and
marketable securities totaled $3.7 billion and $3.2 billion,
respectively.
2024 Financial Guidance
Incyte's guidance includes revenues and expenses related to the
recently announced acquisition of exclusive global rights to
tafasitamab and excludes any potential impact related to the
accounting treatment of the $25 million purchase price paid.
Guidance does not include revenue from any potential new product
launches or the impact of any potential future strategic
transactions. Incyte’s guidance is summarized below.
Current
Jakafi net product revenues
$2,690 - $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
1 Pemazyre in the U.S., EU and
Japan; Monjuvi and 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, 13744020.
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, 13744020.
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®/Minjuvi® (tafasitamab)
Tafasitamab is a humanized Fc-modified CD19 targeting
immunotherapy. 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). Please see the U.S. full Prescribing Information for
Monjuvi for important safety information.
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. Its safety and efficacy for these investigational uses have
not been established in pivotal trials.
Minjuvi® and Monjuvi® are registered trademarks of Incyte.
Tafasitamab is marketed by under the brand name Monjuvi® in the
U.S., and under the brand name Minjuvi® in Europe and Canada.
Xencor is eligible to receive tiered royalties on global net
sales of tafasitamab in the single-digit to sub-teen double-digit
percentage range. 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 2024, including its
expectations regarding sales of Jakafi; expectations regarding
demand for and sales of Opzelura, among other products;
expectations regarding the potential and progress of programs in
our pipeline, including INCB123667, INCB160058 and INCB161734;
expectations regarding ongoing clinical trials and clinical trials
to be initiated, including combination trials of ruxolitinib twice
daily (BID) with zilurgisertib (INCB000928) and BETi (INCB057643),
a phase 3 study of BETi and achieving clinical proof-of-concept for
zilurgisertib, a phase 1 study evaluating the mCALR monoclonal
antibody (INCA033989), a phase 3 trial of povorcitinib in prurigo
nodularis, a phase 1/2 trial of ruxolitinib and axatilimab in
chronic GVHD, various trials in our oral small molecule PD-L1
program, various phase 2 and 3 trials for ruxolitinib cream, and
additional clinical trials across our MPH/GVHD, oncology, IAI and
dermatology programs; our expectations regarding regulatory
filings; expectations regarding the potential approval of QD
Ruxolitinib (XR) in approximately two years; expectations regarding
the number of products Incyte may launch by 2030, 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
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
GAAP
GAAP
Revenues:
Product revenues, net
$
861,729
$
764,215
$
3,165,168
$
2,746,897
Product royalty revenues
149,612
132,485
523,481
482,738
Milestone and contract revenues
2,000
30,000
7,000
165,000
Total revenues
1,013,341
926,700
3,695,649
3,394,635
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
69,751
59,163
254,990
206,997
Research and development
444,494
501,360
1,627,594
1,585,936
Selling, general and administrative
293,865
272,819
1,161,293
1,002,140
Loss on change in fair value of
acquisition-related contingent consideration
15,058
24,347
29,202
12,149
(Profit) and loss sharing under
collaboration agreements
2,903
(1,082
)
2,045
7,973
Total costs and expenses
826,071
856,607
3,075,124
2,815,195
Income from operations
187,270
70,093
620,525
579,440
Interest income and other, net
50,436
26,637
172,348
39,932
Interest expense
(804
)
(667
)
(2,551
)
(2,666
)
Unrealized gain (loss) on long term
investments
34,054
(15,448
)
43,893
(87,590
)
Income before provision for income
taxes
270,956
80,615
834,215
529,116
Provision for income taxes
69,877
52,154
236,616
188,456
Net income
$
201,079
$
28,461
$
597,599
$
340,660
Net income per share:
Basic
$
0.90
$
0.13
$
2.67
$
1.53
Diluted
$
0.89
$
0.13
$
2.65
$
1.52
Shares used in computing net income per
share:
Basic
224,226
222,615
223,628
222,004
Diluted
226,125
224,840
225,928
223,958
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
December 31,
2023
December 31,
2022
ASSETS
Cash, cash equivalents and marketable
securities
$
3,656,043
$
3,238,965
Accounts receivable
743,557
644,879
Property and equipment, net
751,513
739,310
Finance lease right-of-use assets, net
25,535
26,298
Inventory
269,937
120,959
Prepaid expenses and other assets
236,782
194,144
Long term investments
187,716
133,676
Other intangible assets, net
123,545
129,219
Goodwill
155,593
155,593
Deferred income tax asset
631,886
457,941
Total assets
$
6,782,107
$
5,840,984
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,347,669
$
1,216,603
Finance lease liabilities
32,601
33,262
Acquisition-related contingent
consideration
212,000
221,000
Stockholders’ equity
5,189,837
4,370,119
Total liabilities and stockholders’
equity
$
6,782,107
$
5,840,984
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
December 31,
Twelve Months
Ended December 31,
2023
2022
2023
2022
GAAP Net Income
$
201,079
$
28,461
$
597,599
$
340,660
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
36,006
32,312
126,697
112,516
Non-cash stock compensation from equity
awards (SG&A)2
23,192
19,610
86,046
73,180
Non-cash stock compensation from equity
awards (COGS)2
792
757
3,146
2,724
Non-cash interest3
108
143
463
431
Changes in fair value of equity
investments4
(34,054
)
15,448
(43,893
)
87,590
Amortization of acquired product
rights5
5,384
5,384
21,536
21,536
Loss on change in fair value of contingent
consideration6
15,058
24,347
29,202
12,149
Asset impairment7
—
—
5,631
—
Tax effect of Non-GAAP pre-tax
adjustments8
(8,441
)
13,199
(30,978
)
(28,110
)
Non-GAAP Net Income
$
239,124
$
139,661
$
795,449
$
622,676
Non-GAAP net income per share:
Basic
$
1.07
$
0.63
$
3.56
$
2.80
Diluted
$
1.06
$
0.62
$
3.52
$
2.78
Shares used in computing Non-GAAP net
income per share:
Basic
224,226
222,615
223,628
222,004
Diluted
226,125
224,840
225,928
223,958
1 Included within the Milestone
and contract revenues line item in the Condensed Consolidated
Statements of Operations (in thousands) for the three and twelve
months ended December 31, 2023 are milestones of $2,000 and $7,000,
respectively, earned from our collaborative partners, as compared
to milestones of $30,000 and $165,000, respectively, for the three
and twelve months ended December 31, 2022. Included within the
Research and development expenses line item in the Condensed
Consolidated Statements of Operations (in thousands) for the three
and twelve months ended December 31, 2023 are upfront consideration
and milestones of $24,000 and $36,650, respectively, related to our
collaborative partners, as compared to upfront consideration and
milestones of $70,000 and $125,950, respectively, for the three and
twelve months ended December 31, 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 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 Loss 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 Income tax effects of Non-GAAP
pre-tax adjustments are calculated using the applicable statutory
tax rate for the jurisdictions in which the charges are incurred,
while taking into consideration any valuation allowances against
related deferred tax assets. The tax benefit for the three months
ended December 31, 2022 includes a true up from the interim
quarters related to valuation allowances against deferred tax
assets associated with the loss on equity investments.
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