Incyte (Nasdaq:INCY) today reports 2022 first quarter financial
results, and provides a status update on the Company’s clinical
development portfolio.
“Our double-digit growth in the first quarter reflects the
strong performance of Jakafi® (ruxolitinib) – supported by the
successful launch in chronic graft-versus-host disease (GVHD) in
the United States – as well as continued growth for Pemazyre®
(pemigatinib) in Europe and Japan and, importantly, the fast uptake
of Opzelura™ (ruxolitinib) cream in atopic dermatitis in the United
States,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
“Opzelura is an important growth driver for Incyte and the U.S.
launch is off to an excellent start with over 38,000 patients
treated during the first quarter and significant progress with
payers on securing access for patients. Later this year we have the
potential to launch Opzelura in a second indication in the U.S. and
we expect a regulatory decision in Europe for the treatment of
patients with vitiligo who currently have no approved therapies for
repigmentation. Our strong product growth and robust pipeline
position us well for long-term growth and diversification.”
Portfolio Updates
MPNs and GVHD – key
highlights
LIMBER (Leadership In MPNs BEyond Ruxolitinib) program:
The new drug application (NDA) for once-daily ruxolitinib (QD) is
on track for submission in the first half of this year. Initial
data from the ongoing combination trials of ruxolitinib with
INCB57643 (BET) and INCB00928 (ALK2) are expected later this
year.
Indication and status
QD ruxolitinib
(JAK1/JAK2)
Myelofibrosis, polycythemia vera and GVHD:
clinical pharmacology studies
ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)
Myelofibrosis: Phase 3 (first-line
therapy) (LIMBER‑313) Myelofibrosis: Phase 3 (suboptimal responders
to ruxolitinib) (LIMBER‑304)
ruxolitinib + INCB57643
(JAK1/JAK2 + BET)
Myelofibrosis: Phase 2
ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2
ruxolitinib + CK08041 (JAK1/JAK2
+ CB-Tregs)
Myelofibrosis: PoC in preparation
itacitinib (JAK1)
Treatment-naïve chronic GVHD: Phase 2/3
(GRAVITAS‑309)
axatilimab (anti-CSF-1R)2
Chronic GVHD (third-line plus therapy):
Pivotal Phase 2 (AGAVE-201)
1 Development collaboration with Cellenkos, Inc. 2 Clinical
development of axatilimab in GVHD conducted in collaboration with
Syndax Pharmaceuticals.
Other Hematology/Oncology – key
highlights
Pemazyre: The ongoing launches in the U.S., Europe and
Japan continue to go well. In March, Pemazyre was approved in China
by the National Medical Products Administration (NMPA) for the
treatment of adults with locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth receptor 2 (FGFR2)
fusion or rearrangement as confirmed by a validated diagnostic test
that have progressed after at least one prior line of systemic
therapy.
A Phase 2 open-label study evaluating the efficacy and safety of
pemigatinib in adults with previously treated glioblastoma or other
primary central nervous system tumors harboring activating FGFR1-3
alterations (FIGHT-209) and a Phase 2 open-label study evaluating
the efficacy and safety of pemigatinib in adults with relapsed or
refractory advanced non-small cell lung cancer with an FGFR
alteration (FIGHT-210) are being initiated.
Indication and status
pemigatinib (FGFR1/2/3)
Cholangiocarcinoma (CCA): Phase 3
(FIGHT‑302) Myeloid/lymphoid neoplasms (MLN): Phase 2 (FIGHT‑203)
Glioblastoma: Phase 2 (FIGHT-209) being initiated Non-small cell
lung cancer (NSCLC): Phase 2 (FIGHT-210) being initiated
tafasitamab (CD19)1
Relapsed or refractory diffuse large
B-cell lymphoma (DLBCL): Phase 2 (L-MIND); 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) Relapsed or refractory B-cell
malignancies: PoC (topMIND) with parsaclisib (PI3Kδ) Relapsed or
refractory B-cell malignancies: PoC with lenalidomide and
plamotamab being initiated2
parsaclisib (PI3Kδ)
Autoimmune hemolytic anemia: Phase 3
(PATHWAY)
retifanlimab (PD‑1)3
Squamous cell anal cancer (SCAC): Phase 3
(POD1UM‑303) MSI-high endometrial cancer: Phase 2 (POD1UM‑101,
POD1UM‑204) Merkel cell carcinoma: Phase 2 (POD1UM‑201) NSCLC:
Phase 3 (POD1UM‑304)
1 Development of tafasitamab in collaboration with MorphoSys. 2
Clinical collaboration with MorphoSys and Xencor, Inc. to
investigate the combination of tafasitamab plus lenalidomide in
combination with Xencor’s CD20xCD3 XmAb bispecific antibody,
plamotamab. 3 Retifanlimab licensed from MacroGenics.
Inflammation and Autoimmunity
(IAI) – key highlights
Dermatology
Strong U.S. launch of Opzelura in atopic dermatitis (AD):
Over 38,000 new patients were prescribed Opzelura in the first
quarter with positive physician and patient feedback driving the
robust uptake. Refill rates continue to increase with refills
comprising 23% of total prescriptions in the last week of Q1.
Substantial progress has been made in securing access to Opzelura
for patients, and we now have agreements in place with payers which
account for 146 million total lives covered including 82 million
commercial lives.
We have established a broad clinical development program within
dermatology that includes multiple new indications for ruxolitinib
cream, as well as new products.
Ruxolitinib cream in vitiligo in the U.S. and Europe: In
March, 52-week safety and efficacy data from the two Phase 3 TRuE-V
studies evaluating ruxolitinib cream in vitiligo, presented at the
American Academy of Dermatology (AAD) annual meeting, demonstrated
that a longer duration of therapy with ruxolitinib cream was
associated with greater repigmentation in patients with vitiligo. A
supplemental new drug application (sNDA) and a marketing
authorization application (MAA) for ruxolitinib cream as a
treatment for vitiligo are under review at the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA),
respectively. The Prescription Drug User Fee Act (PDUFA) target
action date was extended to July 18, 2022. Ruxolitinib cream has
the potential to become the first product approved for
repigmentation in vitiligo and would be a new therapeutic option
for the millions of patients living with the disease today, pending
regulatory decision.
A Phase 2 open-label study is being initiated to assess whether
repigmentation response in some patients with vitiligo may be
enhanced by adding phototherapy to treatment with ruxolitinb
cream.
Ruxolitinib cream in chronic hand eczema (CHE): Incyte
continues to expand the development of ruxolitinib cream into new
indications as part of its life cycle management strategy. Two
Phase 3 trials evaluating ruxolitinib cream in chronic hand eczema
are being initiated (TRuE-CHE1 and TRuE-CHE2).
INCB54707 (JAK1) development across three indications: We
are also assessing INCB54707, our JAK1 specific inhibitor, in Phase
2 studies for hidradenitis suppurativa, prurigo nodularis and
vitiligo. There is significant potential with each of these
indications where there are limited, and in some cases, no
FDA-approved therapies.
Indication and status
ruxolitinib cream1
(JAK1/JAK2)
AD: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2, primary endpoint met in both
studies); sNDA and MAA under review CHE: Phase 3 (TRuE-CHE1 and
TRuE-CHE2) being initiated
ruxolitinib cream + UVB (JAK1/JAK2 +
phototherapy)
Vitiligo: Phase 2 being initiated
INCB54707 (JAK1)
Hidradenitis suppurativa: Phase 2b
Vitiligo: Phase 2 Prurigo nodularis: Phase 2
1 Novartis’ rights for ruxolitinib outside of the United States
under our Collaboration and License Agreement with Novartis do not
include topical administration.
Discovery and early development –
key highlights
Incyte’s portfolio of other earlier-stage clinical candidates is
summarized below:
Oral PD-L1 Program: At SITC last year, Incyte highlighted
clinical safety and efficacy data for the oral PD-L1 program which
included three compounds, INCB86550, INCB99280 and INCB99318. Tumor
shrinkage was observed for all three oral PD-L1 inhibitors. With
regards to safety, both INCB99280 and INCB99318 did not show
peripheral neuropathy seen with INCB86550. In May, the decision was
made to prioritize the development of INCB99280 and INCB99318 based
on positive therapeutic ratios.
INCB123667 (CDK2): In the cell cycle, the serine
threonine kinase, CDK2, regulates the transition from the G1 phase
(cell growth) to the S-phase (DNA replication). INCB123667 is a
novel, potent and selective oral small molecule inhibitor of CDK2
which has been shown to suppress tumor growth as monotherapy and in
combination with standard of care, in Cyclin E amplified tumor
models, in vivo. A Phase 1 dose-escalation and dose-expansion study
of INCB123667 in adults with selected advanced or metastatic solid
tumors is being initiated.
Modality
Candidates
Small molecules
INCB81776 (AXL/MER), epacadostat (IDO1),
INCB99280 (PD-L1), INCB99318 (PD-L1), INCB106385 (A2A/A2B),
INCB123667 (CDK2)
Monoclonal antibodies1
INCAGN1876 (GITR), INCAGN2385 (LAG‑3),
INCAGN1949 (OX40), INCAGN2390 (TIM‑3), INCA00186 (CD73)
1 Discovery collaboration with Agenus.
Partnered – key
highlights
Ruxolitinib in acute and chronic GVHD: In March, Incyte
and Novartis announced a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) for ruxolitinib in acute and chronic GVHD, based on
data from the Phase 3 REACH2 and REACH3 trials. GVHD is a
life-threatening complication of stem cell transplants, with no
established standard of care in Europe for patients who do not
adequately respond to first-line steroid treatment.
Baricitinib in alopecia areata (AA): In March, Incyte and
Eli Lilly presented 52-week data at the American Academy of
Dermatology (AAD) annual meeting demonstrating that nearly 40% of
adults with alopecia areata and who were taking baricitinib 4mg saw
at least 80% scalp hair coverage. There are no approved treatments
for AA.
Capmatinib in NSCLC: In April, Incyte and Novartis
announced a positive opinion from the CHMP based on data from the
Phase 2 GEOMETRY mono-1 study showing an overall response rate
(ORR) of 51.6% in a cohort evaluating second-line patients only and
44% in all previously-treated patients with advanced non-small cell
lung cancer (NSCLC) harboring alterations leading to MET exon 14
skipping.
Indication and status
ruxolitinib (JAK1/JAK2)1
Acute and chronic GVHD: MAA and J-NDA
under review; positive CHMP opinion received
baricitinib (JAK1/JAK2)2
AD: Phase 3 (BREEZE-AD); approved in EU
and Japan Severe AA: Phase 3 (BRAVE-AA1, BRAVE-AA2); Submissions in
U.S., EU, and Japan
capmatinib (MET)3
NSCLC (with MET exon 14 skipping
mutations): Approved as Tabrecta in U.S. and Japan; MAA under
review; positive CHMP opinion received
1 Jakavi (ruxolitinib) licensed to Novartis ex-US. 2 Worldwide
rights to baricitinib 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 Worldwide
rights to capmatinib licensed to Novartis.
2022 First Quarter Financial
Results
The financial measures presented in this press release for the
three months ended March 31, 2022 and 2021 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.
Financial
Highlights
Financial Highlights
(unaudited, in thousands, except per share amounts)
Three Months Ended
March 31,
2022
2021
Total GAAP revenue
$
733,235
$
604,718
Total GAAP operating income
116,540
98,797
Total Non-GAAP operating income
172,147
170,303
GAAP net income
37,992
53,535
Non-GAAP net income
122,867
148,756
GAAP basic EPS
$
0.17
$
0.24
Non-GAAP basic EPS
$
0.56
$
0.68
GAAP diluted EPS
$
0.17
$
0.24
Non-GAAP diluted EPS
$
0.55
$
0.67
Revenue
Details
Revenue Details (unaudited, in
thousands)
Three Months Ended
March 31,
%
2022
2021
Change
Net product revenues:
Jakafi
$
544,464
$
465,710
17
%
Iclusig
26,069
25,645
2
%
Pemazyre
18,032
13,456
34
%
Minjuvi
4,502
—
NM
Opzelura
12,754
—
NM
Royalty revenues:
Jakavi
70,867
65,602
8
%
Olumiant
48,064
32,258
49
%
Tabrecta
3,483
2,047
70
%
Total product and royalty revenues
728,235
604,718
20
%
Milestone and contract revenues
5,000
—
NM
Total GAAP revenues
$
733,235
$
604,718
21
%
NM = not meaningful
Product and Royalty Revenues Product and royalty revenues
for the three months ended March 31, 2022 increased 20% over the
prior year comparative period primarily as a result of increases in
Jakafi, Pemazyre and Opzelura net product revenues, and higher
royalty revenues from Jakavi and Olumiant. Jakafi net product
revenues for the three months ended March 31, 2022 increased 17%
over the prior year comparative period, primarily driven by growth
in patient demand. The 49% growth in Olumiant royalty revenues for
the quarter ended March 31, 2022 reflects an increase in net
product sales as a result of the use of Olumiant for the treatment
of COVID-19.
Operating
Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended
March 31,
%
2022
2021
Change
GAAP cost of product revenues
$
42,614
$
29,220
46
%
Non-GAAP cost of product revenues1
36,619
23,596
55
%
GAAP research and development
353,373
306,896
15
%
Non-GAAP research and development2
327,045
277,022
18
%
GAAP selling, general and
administrative
209,584
153,795
36
%
Non-GAAP selling, general and
administrative3
192,682
123,313
56
%
GAAP change in fair value of
acquisition-related contingent consideration
6,382
5,526
15
%
Non-GAAP change in fair value of
acquisition-related contingent consideration4
—
—
GAAP collaboration loss sharing
4,742
10,484
(55
%)
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 legal settlements. 4 Non-GAAP
change in fair value of acquisition-related contingent
consideration is null.
Research and development expenses GAAP and Non-GAAP
research and development expense for the three months ended March
31, 2022 increased 15% and 18%, respectively, compared to the same
period in 2021 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 three
months ended March 31, 2022 increased 36% and 56%, respectively,
compared to the same period in 2021, primarily due to expenses
related to our dermatology commercial organization and activities
to support the launch of Opzelura for the treatment of atopic
dermatitis.
Other
Financial Information
Operating income GAAP operating income for the three
months ended March 31, 2022 increased compared to the same period
in 2021, driven by growth in product and royalty revenues.
Cash, cash equivalents and marketable securities position
As of March 31, 2022 and 2021, cash, cash equivalents and
marketable securities totaled $2.5 billion and $2.3 billion,
respectively.
2022 Financial Guidance
The Company has reaffirmed its full year 2022 financial
guidance, as detailed below. Guidance does not include revenue from
Opzelura or the impact of any potential future strategic
transactions.
Current
Previous
Jakafi net product revenues
$2.33 - $2.40 billion
$2.3 - $2.4 billion
Other Hematology/Oncology net product
revenues(1)
$210 - $240 million
Unchanged
GAAP Cost of product revenues
6 – 7% of net product
revenues
Unchanged
Non-GAAP Cost of product revenues(2)
5 – 6% of net product
revenues
Unchanged
GAAP Research and development expenses
$1,550 - $1,590 million
Unchanged
Non-GAAP Research and development
expenses(3)
$1,420 - $1,455 million
Unchanged
GAAP Selling, general and administrative
expenses
$950 - $1,000 million
Unchanged
Non-GAAP Selling, general and
administrative expenses(3)
$880 - $925 million
Unchanged
1 Pemazyre in the U.S., EU and Japan 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, 13728884.
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, 13728884.
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 is a first-in-class
JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of
chronic GVHD after failure of one or two lines of systemic therapy
in adult and pediatric patients 12 years and older.
Jakafi is also indicated for treatment of polycythemia vera (PV)
in adults who have had an inadequate response to or are intolerant
of hydroxyurea, in adults with intermediate or high-risk
myelofibrosis (MF), including primary MF, post-polycythemia vera MF
and post-essential thrombocythemia MF and for treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
About Opzelura™ (ruxolitinib) Cream Opzelura
(ruxolitinib) cream is a novel cream formulation of Incyte’s
selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only
topical JAK inhibitor approved for use in the United States 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 October 2021, Incyte announced the validation of the European
Marketing Authorization Application (MAA) for ruxolitinib cream as
a potential treatment for adolescents and adults (age >12 years)
with non-segmental vitiligo with facial involvement. Additionally,
in December 2021, Incyte announced the acceptance and priority
review of the supplemental New Drug Application (sNDA) for
ruxolitinib cream as a potential treatment for adolescents and
adults (age ≥12 years) with vitiligo.
Incyte has worldwide rights for the development and
commercialization of ruxolitinib cream, marketed in the United
States as Opzelura.
Opzelura is a trademark of Incyte.
About Monjuvi®/Minjuvi® (tafasitamab) Tafasitamab 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).
In the United States, Monjuvi® (tafasitamab-cxix) is
approved by the U.S. Food and Drug Administration in combination
with lenalidomide for the treatment of adult patients with relapsed
or refractory DLBCL not otherwise specified, including DLBCL
arising from low grade lymphoma, and who are not eligible for
autologous stem cell transplant (ASCT). This indication is approved
under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval,
in combination with lenalidomide, followed by Minjuvi monotherapy,
for the treatment of adult patients with relapsed or refractory
diffuse large B-cell lymphoma (DLBCL) who are not eligible for
autologous stem cell transplant (ASCT).
Tafasitamab is being clinically
investigated as a therapeutic option in B-cell malignancies in
several ongoing combination trials.
Minjuvi® and Monjuvi® are registered
trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte
and MorphoSys under the brand name Monjuvi® in the U.S., and
marketed by Incyte under the brand name Minjuvi® in the EU.
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).
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 Corporation.
* 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.
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 long-term growth and
diversification; Incyte’s financial guidance for 2022, including
its expectations regarding sales of Jakafi; Incyte’s expectations
with regard to the regulatory submissions seeking approval of
ruxolitinib cream in vitiligo; Incyte’s expectations with regard to
filing an NDA for once-daily ruxolitinib; Incyte’s expectations
with respect to Opzelura, including the Company’s ongoing
discussions with payers; Incyte’s expectations regarding ongoing
clinical trials and clinical trials to be initiated, including the
LIMBER program, phase 2 trials of pemigatinib in glioblastoma and
non-small cell lung cancer, a phase 2 trial of ruxolitinib cream in
vitiligo to determine whether phototherapy might enhance
repigmentation response, phase 3 trials for ruxolitinib cream in
chronic hand eczema and a phase 1 dose-escalation and
dose-expansion study of INCB123667 in adults with selected advanced
or metastatic solid tumors; and the potential for INCB54707 in
hidradenitis suppurativa, prurigo nodularis and vitiligo.
These forward-looking statements are based on the Company’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;
the effects of the COVID 19 pandemic and measures to address the
pandemic on the Company’s clinical trials, supply chain and other
third-party providers, sales and marketing efforts and business,
development and discovery operations; determinations made by the
FDA, EMA, and other regulatory agencies; the Company’s dependence
on its relationships with and changes in the plans of its
collaboration partners; the efficacy or safety of the Company’s
products and the products of the Company’s collaboration partners;
the acceptance of the Company’s products and the products of the
Company’s collaboration partners in the marketplace; market
competition; unexpected variations in the demand for the Company’s
products and the products of the Company’s collaboration partners;
the effects of announced or unexpected price regulation or
limitations on reimbursement or coverage for the Company’s products
and the products of the Company’s collaboration partners; sales,
marketing, manufacturing and distribution requirements, including
the Company’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; and other risks
detailed in the Company’s reports filed with the Securities and
Exchange Commission, including its annual report on Form 10-K for
the year ended December 31, 2021. The Company disclaims any intent
or obligation to update these forward-looking statements.
INCYTE CORPORATION CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands,
except per share amounts)
Three Months Ended
March 31,
2022
2021
GAAP
Revenues:
Product revenues, net
$
605,821
$
504,811
Product royalty revenues
122,414
99,907
Milestone and contract revenues
5,000
—
Total revenues
733,235
604,718
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
42,614
29,220
Research and development
353,373
306,896
Selling, general and administrative
209,584
153,795
Change in fair value of
acquisition-related contingent consideration
6,382
5,526
Collaboration loss sharing
4,742
10,484
Total costs and expenses
616,695
505,921
Income from operations
116,540
98,797
Other income (expense), net
1,260
(1,407
)
Interest expense
(680
)
(359
)
Unrealized loss on long term
investments
(46,585
)
(27,709
)
Income before provision for income
taxes
70,535
69,322
Provision for income taxes
32,543
15,787
Net income
$
37,992
$
53,535
Net income per share:
Basic
$
0.17
$
0.24
Diluted
$
0.17
$
0.24
Shares used in computing net income per
share:
Basic
221,326
219,801
Diluted
222,950
221,867
INCYTE CORPORATION CONDENSED
CONSOLIDATED BALANCE SHEETS (unaudited, in thousands)
March 31, 2022
December 31,
2021
ASSETS
Cash, cash equivalents and marketable
securities
$
2,544,160
$ 2,348,192
Accounts receivable
562,344
616,300
Property and equipment, net
729,217
723,920
Finance lease right-of-use assets, net
27,392
27,548
Inventory
70,841
56,938
Prepaid expenses and other assets
179,253
165,302
Long term investments
174,681
221,266
Other intangible assets, net
145,371
150,755
Goodwill
155,593
155,593
Deferred income tax asset
465,369
467,538
Total assets
$
5,054,221
$ 4,933,352
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
914,968
$ 885,081
Finance lease liabilities
34,181
34,267
Acquisition-related contingent
consideration
242,000
244,000
Stockholders’ equity
3,863,072
3,770,004
Total liabilities and stockholders’
equity
$
5,054,221
$ 4,933,352
INCYTE CORPORATION
RECONCILIATION OF GAAP NET INCOME TO SELECTED NON-GAAP ADJUSTED
INFORMATION (unaudited, in thousands, except per share
amounts)
Three Months Ended
March 31,
2022
2021
GAAP Net Income
$
37,992
$
53,535
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
26,328
29,874
Non-cash stock compensation from equity
awards (SG&A)2
16,902
17,242
Non-cash stock compensation from equity
awards (COGS)2
611
240
Non-cash interest3
108
—
Changes in fair value of equity
investments4
46,585
27,709
Amortization of acquired product
rights5
5,384
5,384
Change in fair value of contingent
consideration6
6,382
5,526
Legal settlements7
—
13,240
Tax effect of Non-GAAP pre-tax
adjustments8
(17,425
)
(3,994
)
Non-GAAP Net Income
$
122,867
$
148,756
Non-GAAP net income per share:
Basic
$
0.56
$
0.68
Diluted
$
0.55
$
0.67
Shares used in computing Non-GAAP net
income per share:
Basic
221,326
219,801
Diluted
222,950
221,867
1 Included within the Milestone and contract revenues line item
in the Condensed Consolidated Statements of Operations (in
thousands) for the three months ended March 31, 2022 and 2021 are
milestones of $5,000 and $0, respectively, earned from our
collaborative partners. Included within the Research and
development expenses line item in the Condensed Consolidated
Statements of Operations (in thousands) for the three months ended
March 31, 2022 and 2021 are upfront consideration and milestones of
$20,000 and $11,500, respectively, related to our collaborative
partners. 2 As included within the Cost of product revenues
(including definite-lived intangible amortization) line item; the
Research and development expenses line item; and the Selling,
general and administrative expenses line item in the Condensed
Consolidated Statements of Operations. 3 As included within the
Interest expense line item in the Condensed Consolidated Statements
of Operations. 4 As included within the Unrealized 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 Change in fair value of
acquisition-related contingent consideration line item in the
Condensed Consolidated Statements of Operations. 7 As included
within 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220503005331/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jun 2024 to Jul 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jul 2023 to Jul 2024