– Total revenues of $919 million in the third quarter (Q3'23)
(+12% Y/Y)
– Jakafi® (ruxolitinib) net product revenues of $636 million
(+3% Y/Y) in Q3'23, $1.9 billion (+8% Y/Y) YTD 2023, driven by
growth in total patients across all indications; tightening full
year 2023 guidance to a new range of $2.59 - $2.62 billion
– Opzelura® (ruxolitinib) cream net product revenues of $92
million (+141% Y/Y) in Q3'23, $229 million YTD 2023; continued
uptake in atopic dermatitis (AD) and vitiligo and enhanced payer
coverage
– Phase 2 study evaluating povorcitinib in prurigo nodularis
(PN) met its primary endpoint
Conference Call and Webcast Scheduled Today
at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today reports 2023 third quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
"Our double-digit revenue growth during the quarter was driven
by sustained performance of Jakafi® (ruxolitinib) and an increasing
contribution from Opzelura® (ruxolitinib) with continued strong
patient demand and enhanced payer coverage," said Hervé Hoppenot,
Chief Executive Officer, Incyte. "We made significant progress with
our early programs in myeloproliferative neoplasms (MPNs),
including mCALR and JAK2V617F, which have the potential to be
disease modifying therapies that represent a fundamentally new
approach to the way patients with MPNs are treated. Additionally,
we recently received positive top line results from the Phase 2
study of povorcitinib in prurigo nodularis (PN) and plans are
underway to initiate a Phase 3 study in 2024. With approximately
100,000 treated PN patients in the U.S., povorcitinib has the
potential to be an efficacious therapy for those patients who
currently have limited treatment options.”
Key Company Updates
- In September, Incyte was notified by the Centers for Medicare
and Medicaid Services that ruxolitinib phosphate qualified for the
Small Biotech Exception.
- Beginning January 1, 2024, Opzelura will be listed as a
Preferred Brand on the CVS Caremark and Aetna formularies impacting
roughly 30 million commercial lives in the U.S.
Key Product Sales Performance
Jakafi:
Net product revenues for the quarter of $636 million:
- Net product revenues grew 3% compared with the third quarter of
2022.
- Channel inventory at the end of the third quarter of 2023
decreased by approximately $14 million versus the second quarter of
2023. Underlying demand in the third quarter of 2023 continued to
grow both year-over-year and quarter-over-quarter.
Opzelura:
Net product revenues for the quarter of $92 million:
- Net product revenues of $92 million grew 141% compared with the
third quarter of 2022, driven by growth in patient demand, refills
and expansion in payer coverage as the launch in AD and vitiligo
continues.
Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host
Disease (GVHD) – key highlights
- Combination trials of ruxolitinib twice daily (BID) with
zilurgisertib (ALK2) and INCB57643 (BET) are ongoing and
continue to enroll. Additional data from these studies are
anticipated to be shared in the fourth quarter of 2023.
- The Phase 1 study evaluating INCA033989 (mCALR) is
ongoing and enrolling patients.
- In October, we announced the development of a new program
targeting the JAK2V617F mutation, which is present in 55-60% of
myelofibrosis (MF) and essential thrombocythemia (ET) patients, and
in 95% of polycythemia vera (PV) patients. INCB100658 is a
small molecule inhibitor, targeting the JAK2V617F mutation and we
expected to file the IND by year-end 2023.
Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and
GVHD
Ruxolitinib + zilurgisertib
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2
Ruxolitinib + INCB57643
(JAK1/JAK2 + BET)
Myelofibrosis: Phase 2
Ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)
Myelofibrosis: Phase 1
(LIMBER-TREG108)
Axatilimab (anti-CSF-1R)2
Chronic GVHD: Pivotal Phase 2 (third-line
plus therapy) (AGAVE-201)
Ruxolitinib + axatilimab2
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 1/2 in preparation
INCA033989
(mCALR)
Myelofibrosis, essential thrombocythemia:
Phase 1
1 Development collaboration with
Cellenkos, Inc.
2 Clinical development of axatilimab in
GVHD conducted in collaboration with Syndax Pharmaceuticals.
Other Hematology/Oncology – key highlights
Oral small molecule PD-L1 program: Combination studies
evaluating INCB99280 in combination with axitinib (VEGF) and in
combination with ipilimumab (CTLA-4) are enrolling. Two Phase 2
monotherapy studies evaluating INCB99280 in patients with select
solid tumors who are checkpoint inhibitor naive and in metastatic
cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC,
are enrolling.
Indication and status
Pemigatinib (Pemazyre®)
(FGFR1/2/3)
Myeloid/lymphoid neoplasms (MLN): approved
in the U.S. and Japan
Cholangiocarcinoma (CCA): Phase 3
(FIGHT-302)
Glioblastoma: Phase 2 (FIGHT-209)
Tafasitamab
(Monjuvi®/Minjuvi®)1
(CD19)
Relapsed or refractory diffuse large
B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma
(FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase
3 (inMIND)
Retifanlimab (Zynyz®)2
(PD-1)
Merkel cell carcinoma (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
1 Development of tafasitamab in
collaboration with MorphoSys.
2 Retifanlimab licensed from
MacroGenics.
3 Clinical trial collaboration and supply
agreement with Mirati Therapeutics.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Opzelura
- New results of a pooled analysis of long-term extension (LTE)
data from the pivotal Phase 3 TRuE-V program assessing
Opzelura cream 1.5% in patients 12 years of age and older
with nonsegmental vitiligo who previously experienced limited or no
response to treatment at Week 24 were presented at the European
Academy of Dermatology and Venereology (EADV) Congress 2023 as a
late-breaking oral presentation . These results showed patients who
initially experienced limited or no facial or total body
repigmentation at six months achieved improved repigmentation after
continued treatment with Opzelura for up to two years.
- Expanded results from the pivotal Phase 3 TRuE-AD3 study
evaluating the safety and efficacy of ruxolitinib cream
(Opzelura) in children (age ≥2 to <12 years) with atopic
dermatitis (AD), the most common type of eczema, met its primary
endpoint and was presented at EADV. Significantly more patients
treated with ruxolitinib cream (0.75% and 1.5%) achieved
Investigator’s Global Assessment Treatment Success than patients
treated with vehicle control (non-medicated cream).
- Ruxolitinib cream in other indications: three Phase 2
studies in lichen planus, lichen sclerosus and mild to moderate
hidradenitis suppurativa (HS) have completed enrollment. Two Phase
3 trials evaluating ruxolitinib cream in prurigo nodularis (PN) are
ongoing.
Povorcitinib (INCB54707)
- Positive 52-week data from a Phase 2b clinical trial evaluating
the safety and efficacy of povorcitinib, an investigational
oral JAK1 inhibitor, in adult patients with extensive nonsegmental
vitiligo were presented at EADV as a late-breaking oral
presentation. Results showed that treatment with oral povorcitinib
was associated with substantial total body and facial
repigmentation across all treatment groups at Week 52 and further
reinforces the efficacy profile and potential of povorcitinib as an
oral treatment for patients with extensive nonsegmental
vitiligo.
- 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.
Indication and status
Ruxolitinib cream (Opzelura®)1
(JAK1/JAK2)
AD: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2);
approved in the U.S. and Europe
Lichen planus: Phase 2
Lichen sclerosus: Phase 2
Hidradenitis suppurativa: Phase 2
Prurigo nodularis: Phase 3 (TRuE-PN1,
TRuE-PN2)
Ruxolitinib cream + UVB
(JAK1/JAK2 + phototherapy)
Vitiligo: Phase 2
Povorcitinib
(JAK1)
Hidradenitis suppurativa: Phase 2b; Phase
3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 2; Phase 3 planned
Prurigo nodularis: Phase 2
Asthma: Phase 2
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.
Discovery and other early development – key
highlights
INCA33890 (TGFβR2xPD-1): A Phase 1 study evaluating
INCA33890 in patients with select advanced solid tumors has been
initiated.
Modality
Candidates
Small molecules
INCB123667 (CDK2)
Monoclonal antibodies
INCAGN2385 (LAG-3)1, INCAGN2390
(TIM-3)1
Bi-specific antibodies
INCA32459 (LAG-3xPD-1)2, INCA33890
(TGFβR2xPD-1)2
1 Discovery collaboration with Agenus.
2 Development in collaboration with
Merus.
Partnered – key highlights
Jakavi® (ruxolitinib)- In August, Novartis announced that
Jakavi was approved in Japan for the use in GVHD after
hematopoietic stem cell transplant.
Indication and status
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 Third Quarter Financial Results
The financial measures presented in this press release for the
three and nine months ended September 30, 2023 and 2022 have been
prepared by the Company in accordance with U.S. Generally Accepted
Accounting Principles (“GAAP”), unless otherwise identified as a
Non-GAAP financial measure. Management believes that Non-GAAP
information is useful for investors, when considered in conjunction
with Incyte’s GAAP disclosures. Management uses such information
internally and externally for establishing budgets, operating goals
and financial planning purposes. These metrics are also used to
manage the Company’s business and monitor performance. The Company
adjusts, where appropriate, for expenses in order to reflect the
Company’s core operations. The Company believes these adjustments
are useful to investors by providing an enhanced understanding of
the financial performance of the Company’s core operations. The
metrics have been adopted to align the Company with disclosures
provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set
of accounting rules and should only be used in conjunction with and
to supplement Incyte’s operating results as reported under GAAP.
Non-GAAP measures may be defined and calculated differently by
other companies in our industry.
As changes in exchange rates are an important factor in
understanding period-to-period comparisons, Management believes the
presentation of certain revenue results on a constant currency
basis in addition to reported results helps improve investors’
ability to understand its operating results and evaluate its
performance in comparison to prior periods. Constant currency
information compares results between periods as if exchange rates
had remained constant period over period. The Company calculates
constant currency by calculating current year results using prior
year foreign currency exchange rates and generally refers to such
amounts calculated on a constant currency basis as excluding the
impact of foreign exchange or being on a constant currency basis.
These results should be considered in addition to, not as a
substitute for, results reported in accordance with GAAP. Results
on a constant currency basis, as the Company presents them, may not
be comparable to similarly titled measures used by other companies
and are not measures of performance presented in accordance with
GAAP.
Financial Highlights
Financial Highlights
(unaudited, in thousands,
except per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Total GAAP revenues
$
919,025
$
823,303
$
2,682,308
$
2,467,935
Total GAAP operating income
214,705
138,376
433,255
509,347
Total Non-GAAP operating income
273,294
167,271
625,081
649,042
GAAP net income
171,269
112,775
396,520
312,199
Non-GAAP net income
248,719
133,795
556,325
483,015
GAAP basic EPS
$
0.76
$
0.51
$
1.77
$
1.41
Non-GAAP basic EPS
$
1.11
$
0.60
$
2.49
$
2.18
GAAP diluted EPS
$
0.76
$
0.50
$
1.76
$
1.40
Non-GAAP diluted EPS
$
1.10
$
0.60
$
2.46
$
2.16
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
2023
2022
2023
2022
Net product revenues:
Jakafi
$
636,252
$
619,595
3%
3%
$
1,898,605
$
1,761,732
8%
8%
Opzelura
91,836
38,140
141%
140%
228,621
67,454
239%
239%
Iclusig
27,721
25,929
7%
(1%)
84,493
78,222
8%
7%
Pemazyre
18,942
23,414
(19%)
(20%)
62,989
60,429
4%
5%
Minjuvi
8,348
5,932
41%
43%
28,063
14,845
89%
90%
Zynyz
98
—
NM
NM
668
—
NM
NM
Total net product revenues
783,197
713,010
10%
10%
2,303,439
1,982,682
16%
16%
Royalty revenues:
Jakavi
96,551
85,808
13%
11%
263,691
240,386
10%
12%
Olumiant
29,615
20,371
45%
47%
95,779
98,689
(3%)
2%
Tabrecta
4,139
4,114
1%
NA
13,115
11,178
17%
NA
Pemazyre
523
—
NM
NM
1,284
—
NM
NM
Total royalty revenues
130,828
110,293
19%
373,869
350,253
7%
Total net product and royalty revenues
914,025
823,303
11%
2,677,308
2,332,935
15%
Milestone and contract revenues
5,000
—
NM
NM
5,000
135,000
(96%)
(96%)
Total GAAP revenues
$
919,025
$
823,303
12%
$
2,682,308
$
2,467,935
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 September 30, 2023
increased 10% and 11%, respectively, over the prior year
comparative period, primarily driven by increases in Jakafi and
Opzelura net product revenues. The increase in Jakafi net product
revenues was primarily driven by growth in patient demand and was
partially offset by a decrease in inventory. Total Opzelura net
product revenues for the quarter were $92 million, representing a
141% increase year-over-year driven by increased patient demand and
expanded coverage. Jakavi royalties for the quarter were impacted
by favorable changes in foreign currency exchange rates and
Olumiant royalties for the quarter were impacted by unfavorable
changes in foreign currency exchange rates. In the third quarter of
2022, Olumiant royalties were impacted by a one-time deduction
related to securing intellectual property rights.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
September 30,
% Change
Nine Months Ended
September 30,
% Change
2023
2022
2023
2022
GAAP cost of product revenues
$
60,091
$
54,584
10%
$
185,239
$
147,834
25%
Non-GAAP cost of product revenues1
53,914
48,521
11%
166,733
129,715
29%
GAAP research and development
375,709
384,007
(2%)
1,183,100
1,084,576
9%
Non-GAAP research and development2
348,868
358,268
(3%)
1,092,409
1,004,372
9%
GAAP selling, general and
administrative
267,893
266,460
1%
867,428
729,321
19%
Non-GAAP selling, general and
administrative3
241,896
247,474
(2%)
798,943
675,751
18%
GAAP (gain) loss on change in fair value
of acquisition-related contingent consideration
(426)
(21,893)
(98%)
14,144
(12,198)
(216%)
Non-GAAP (gain) loss on change in fair
value of acquisition-related contingent consideration4
—
—
—%
—
—
—%
GAAP loss and (profit) sharing under
collaboration agreements5
1,053
1,769
(40%)
(858)
9,055
(109%)
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 (gain) loss on change in fair
value of acquisition-related contingent consideration is null.
5 Growth rate in GAAP loss and (profit)
sharing under collaboration agreements represents a decrease in
loss position for the three and nine months ended September 30,
2023.
Cost of product revenues GAAP and Non-GAAP cost of
product revenues for the quarter ended September 30, 2023 increased
10% and 11%, respectively, compared to the same period in 2022
primarily due to growth in net product revenues.
Research and development expenses GAAP and Non-GAAP
research and development expense for the quarter ended September
30, 2023 decreased 2% and 3%, respectively, compared to the same
period in 2022 primarily due to a decrease in one-time
collaboration related expenses partially offset by continued
investment in our late stage development assets 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, 2023 increased 1% and decreased 2%,
respectively, compared to the same period in 2022. The Non-GAAP
decrease is driven by the $5.6 million asset impairment charge
relating to assets written off under an agreement with Wilmington
Friends School Inc. to purchase property.
Other Financial
Information
Operating income GAAP and Non-GAAP operating income for
the three months ended September 30, 2023 increased 55% and 63%,
respectively, compared to the same period in 2022, driven by growth
in product revenues.
Cash, cash equivalents and marketable securities position
As of September 30, 2023 and December 31, 2022, cash, cash
equivalents and marketable securities totaled $3.5 billion and $3.2
billion, respectively.
2023 Financial Guidance
Incyte is tightening its full year 2023 guidance for Jakafi net
product revenues. Incyte’s guidance is summarized below. Guidance
does not include revenue from any potential new product launches or
the impact of any potential future strategic transactions.
Current
Previous
Jakafi net product revenues
$2.59 - $2.62 billion
$2.58 - $2.63 billion
Other Hematology/Oncology net product
revenues(1)
Unchanged
$215 - $225 million
GAAP Cost of product revenues
Unchanged
7 – 8% of net product revenues
Non-GAAP Cost of product revenues(2)
Unchanged
6 – 7% of net product revenues
GAAP Research and development expenses
Unchanged
$1,610 - $1,650 million
Non-GAAP Research and development
expenses(3)
Unchanged
$1,485 - $1,520 million
GAAP Selling, general and administrative
expenses
Unchanged
$1,050 - $1,150 million
Non-GAAP Selling, general and
administrative expenses(3)
Unchanged
$965 - $1,060 million
1Pemazyre in the U.S., EU and Japan; 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, 13741786.
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, 13741786.
The conference call will also be webcast live and can be
accessed at investor.incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the
U.S. FDA for treatment of polycythemia vera (PV) in adults who have
had an inadequate response to or are intolerant of hydroxyurea;
intermediate or high-risk myelofibrosis (MF), including primary MF,
post-polycythemia vera MF and post-essential thrombocythemia MF in
adults; steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older; and chronic GVHD after failure of one
or two lines of systemic therapy in adult and pediatric patients 12
years and older.
Jakafi is a registered trademark of Incyte.
About Opzelura® (ruxolitinib) Cream 1.5%
Opzelura, a novel cream formulation of Incyte’s selective
JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food &
Drug Administration for the topical treatment of nonsegmental
vitiligo in patients 12 years of age and older, is the first and
only treatment for repigmentation approved for use in the United
States. Opzelura is also approved in the U.S. for the topical
short-term and non-continuous chronic treatment of mild to moderate
atopic dermatitis (AD) in non-immunocompromised patients 12 years
of age and older whose disease is not adequately controlled with
topical prescription therapies, or when those therapies are not
advisable. Use of Opzelura in combination with therapeutic
biologics, other JAK inhibitors, or potent immunosuppressants, such
as azathioprine or cyclosporine, is not recommended.
In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for
the treatment of non-segmental vitiligo with facial involvement in
adults and adolescents from 12 years of age.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura and the Opzelura logo are registered trademarks of
Incyte.
About Monjuvi®/Minjuvi® (tafasitamab)
Tafasitamab is a humanized Fc-modified CD19 targeting
immunotherapy. In 2010, MorphoSys licensed exclusive worldwide
rights to develop and commercialize tafasitamab from Xencor, Inc.
Tafasitamab incorporates an XmAb® engineered Fc domain, which
mediates B-cell lysis through apoptosis and immune effector
mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity
(ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is
approved by the U.S. Food and Drug Administration in combination
with lenalidomide for the treatment of adult patients with relapsed
or refractory DLBCL not otherwise specified, including DLBCL
arising from low grade lymphoma, and who are not eligible for
autologous stem cell transplant (ASCT). This indication is approved
under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s). 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 MorphoSys AG.
Tafasitamab is co-marketed by Incyte and MorphoSys under the brand
name Monjuvi® in the U.S., and marketed by Incyte under the brand
name Minjuvi® in Europe and Canada.
XmAb® is a registered trademark of Xencor, Inc.
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in the United States
for the treatment of adults with previously treated, unresectable
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or other rearrangement as
detected by an FDA-approved test*. This indication is approved
under accelerated approval based on overall response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial(s).
Pemazyre is also the first targeted treatment approved for use
in the United States for treatment of adults with relapsed or
refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1
rearrangement.
In Japan, Pemazyre is approved for the treatment of patients
with unresectable biliary tract cancer (BTC) with a fibroblast
growth factor receptor 2 (FGFR2) fusion gene, worsening after
cancer chemotherapy.
In Europe, Pemazyre is approved for the treatment of adults with
locally advanced or metastatic cholangiocarcinoma with a fibroblast
growth factor receptor 2 (FGFR2) fusion or rearrangement that have
progressed after at least one prior line of systemic therapy.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms
1, 2 and 3 which, in preclinical studies, has demonstrated
selective pharmacologic activity against cancer cells with FGFR
alterations.
Pemazyre is marketed by Incyte in the United States, Europe and
Japan.
Pemazyre is a trademark of Incyte.
* Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE:
Incyte; 2020.
About Iclusig® (ponatinib) tablets
Ponatinib (Iclusig®) targets not only native BCR-ABL but also
its isoforms that carry mutations that confer resistance to
treatment, including the T315I mutation, which has been associated
with resistance to other approved TKIs.
In the EU, Iclusig is approved for the treatment of adult
patients with chronic phase, accelerated phase or blast phase
chronic myeloid leukemia (CML) who are resistant to dasatinib or
nilotinib; who are intolerant to dasatinib or nilotinib and for
whom subsequent treatment with imatinib is not clinically
appropriate; or who have the T315I mutation, or the treatment of
adult patients with Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib;
who are intolerant to dasatinib and for whom subsequent treatment
with imatinib is not clinically appropriate; or who have the T315I
mutation.
Click here to view the Iclusig EU Summary of Medicinal Product
Characteristics.
Incyte has an exclusive license from Takeda Pharmaceuticals
International AG to commercialize ponatinib in the European Union
and 29 other countries, including Switzerland, UK, Norway, Turkey,
Israel and Russia. Iclusig is marketed in the U.S. by Millennium
Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited.
About Zynyz™ (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor
indicated in the U.S. for the treatment of adult patients with
metastatic or recurrent locally advanced Merkel cell carcinoma
(MCC). This indication is approved under accelerated approval based
on tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered
into an exclusive collaboration and license agreement with
MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a trademark of Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this release contain predictions, estimates
and other forward-looking statements, including any discussion of
the following: Incyte’s potential for continued performance and
growth; Incyte’s financial guidance for 2023, including its
expectations regarding sales of Jakafi; expectations with respect
to demand for and payer coverage of Opzelura; expectations
regarding the potential and progress of programs in our pipeline,
including mCALR and JAK2V617F; expectations regarding ongoing
clinical trials and clinical trials to be initiated, including
combination trials of ruxolitinib twice daily (BID) with
zilurgisertib (ALK2) and INCB57643 (BET), a phase 3 trial of
povorcitinib in prurigo nodularis and phase 2 trials of
povorcitinib in asthma and chronic spontaneous urticaria, 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; our expectations regarding
regulatory filings, including the planned submission of an IND for
INCB100658 by year-end 2023; and our expectations regarding 2023
newsflow items.
These forward-looking statements are based on Incyte’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments in and risks related to: further research and
development and the results of clinical trials possibly being
unsuccessful or insufficient to meet applicable regulatory
standards or warrant continued development; the ability to enroll
sufficient numbers of subjects in clinical trials and the ability
to enroll subjects in accordance with planned schedules;
determinations made by the FDA, EMA, and other regulatory agencies;
Incyte’s dependence on its relationships with and changes in the
plans of its collaboration partners; the efficacy or safety of
Incyte’s products and the products of Incyte’s collaboration
partners; the acceptance of Incyte’s products and the products of
Incyte’s collaboration partners in the marketplace; market
competition; unexpected variations in the demand for Incyte’s
products and the products of Incyte’s collaboration partners; the
effects of announced or unexpected price regulation or limitations
on reimbursement or coverage for Incyte’s products and the products
of Incyte’s collaboration partners; sales, marketing, manufacturing
and distribution requirements, including Incyte’s and its
collaboration partners’ ability to successfully commercialize and
build commercial infrastructure for newly approved products and any
additional products that become approved; greater than expected
expenses, including expenses relating to litigation or strategic
activities; variations in foreign currency exchange rates; and
other risks detailed in Incyte’s reports filed with the Securities
and Exchange Commission, including its annual report for the year
ended December 31, 2022. Incyte disclaims any intent or obligation
to update these forward-looking statements.
INCYTE CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited, in thousands,
except per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
GAAP
GAAP
Revenues:
Product revenues, net
$
783,197
$
713,010
$
2,303,439
$
1,982,682
Product royalty revenues
130,828
110,293
373,869
350,253
Milestone and contract revenues
5,000
—
5,000
135,000
Total revenues
919,025
823,303
2,682,308
2,467,935
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
60,091
54,584
185,239
147,834
Research and development
375,709
384,007
1,183,100
1,084,576
Selling, general and administrative
267,893
266,460
867,428
729,321
(Gain) loss on change in fair value of
acquisition-related contingent consideration
(426)
(21,893)
14,144
(12,198)
Loss and (profit) sharing under
collaboration agreements
1,053
1,769
(858)
9,055
Total costs and expenses
704,320
684,927
2,249,053
1,958,588
Income from operations
214,705
138,376
433,255
509,347
Interest income and other, net
46,371
11,513
121,912
13,295
Interest expense
(623)
(641)
(1,747)
(1,999)
Unrealized (loss) gain on long term
investments
(26,654)
(660)
9,839
(72,142)
Income before provision for income
taxes
233,799
148,588
563,259
448,501
Provision for income taxes
62,530
35,813
166,739
136,302
Net income
$
171,269
$
112,775
$
396,520
$
312,199
Net income per share:
Basic
$
0.76
$
0.51
$
1.77
$
1.41
Diluted
$
0.76
$
0.50
$
1.76
$
1.40
Shares used in computing net income per
share:
Basic
224,078
222,415
223,428
221,801
Diluted
226,167
224,175
225,756
223,626
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
September 30,
2023
December 31,
2022
ASSETS
Cash, cash equivalents and marketable
securities
$
3,516,453
$
3,238,965
Accounts receivable
657,263
644,879
Property and equipment, net
733,046
739,310
Finance lease right-of-use assets, net
24,880
26,298
Inventory
199,286
120,959
Prepaid expenses and other assets
254,421
194,144
Long term investments
153,663
133,676
Other intangible assets, net
129,249
129,219
Goodwill
155,593
155,593
Deferred income tax asset
564,385
457,941
Total assets
$
6,388,239
$
5,840,984
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
1,217,869
$
1,216,603
Finance lease liabilities
31,923
33,262
Acquisition-related contingent
consideration
207,000
221,000
Stockholders’ equity
4,931,447
4,370,119
Total liabilities and stockholders’
equity
$
6,388,239
$
5,840,984
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
(LOSS) INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
GAAP Net Income
$
171,269
$
112,775
$
396,520
$
312,199
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
26,841
25,739
90,691
80,204
Non-cash stock compensation from equity
awards (SG&A)2
20,366
18,986
62,854
53,570
Non-cash stock compensation from equity
awards (COGS)2
793
679
2,354
1,967
Non-cash interest3
108
72
355
288
Changes in fair value of equity
investments4
26,654
660
(9,839)
72,142
Amortization of acquired product
rights5
5,384
5,384
16,152
16,152
(Gain) loss on change in fair value of
contingent consideration6
(426)
(21,893)
14,144
(12,198)
Asset impairment7
5,631
—
5,631
—
Tax effect of Non-GAAP pre-tax
adjustments8
(7,901)
(8,607)
(22,537)
(41,309)
Non-GAAP Net Income
$
248,719
$
133,795
$
556,325
$
483,015
Non-GAAP net income per share:
Basic
$
1.11
$
0.60
$
2.49
$
2.18
Diluted
$
1.10
$
0.60
$
2.46
$
2.16
Shares used in computing Non-GAAP net
income per share:
Basic
224,078
222,415
223,428
221,801
Diluted
226,167
224,175
225,756
223,626
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, 2023 are milestones of $5,000 for both
periods, as compared to milestones of $0 and $135,000,
respectively, earned from our collaborative partners for the three
and nine months ended September 30, 2022. 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, 2023 are upfront consideration
and milestones of $2,950 and $12,650, respectively, related to our
collaborative partners, as compared to upfront consideration and
milestones of $33,450 and $55,950, respectively, for the three and
nine months ended September 30, 2022.
2 As included within the Cost of product
revenues (including definite-lived intangible amortization) line
item; the Research and development expenses line item; and the
Selling, general and administrative expenses line item in the
Condensed Consolidated Statements of Operations.
3 As included within the Interest expense
line item in the Condensed Consolidated Statements of
Operations.
4 As included within the Unrealized loss
on long term investments line item in the Condensed Consolidated
Statements of Operations.
5 As included within the Cost of product
revenues (including definite-lived intangible amortization) line
item in the Condensed Consolidated Statements of Operations.
Acquired product rights of licensed intellectual property for
Iclusig is amortized utilizing a straight-line method over the
estimated useful life of 12.5 years.
6 As included within the (Gain) 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 an estimated annual effective tax
rate, taking into consideration any permanent items and valuation
allowances against related deferred tax assets.
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Investors ir@incyte.com
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