- Total FY revenues of $2.67 billion (+24% y/y); total FY
product and royalty revenues increased 18% to $2.46 billion; three
new FDA approvals in 2020
- Jakafi®(ruxolitinib) FY revenue increased to $1.94 billion
(+15% y/y); Jakafi® guidance range of $2.125 to $2.20 billion for
2021
- Successful launches of Monjuvi®(tafasitamab-cxix) and
Pemazyre® (pemigatinib) in the U.S.
- Opportunities for additional growth provided by broad
late-stage pipeline, with the potential approval of ruxolitinib
cream for atopic dermatitis in the U.S. and six other regulatory
approval decisions expected across the U.S., EU and Japan during
2021
Conference Call and Webcast Scheduled Today at
8:00 a.m. EDT
Incyte (Nasdaq: INCY) today reports 2020 fourth quarter and full
year financial results, and provides a status update on the
Company’s development portfolio.
“Our team achieved many important accomplishments in the past
year. Revenue growth was strong, driven by demand for Jakafi®
(ruxolitinib), and the launches of Monjuvi® (tafasitamab-cxix) and
Pemazyre® (pemigatinib) continue to gain momentum. During 2020, we
also announced positive results across multiple late-stage
programs, including the pivotal trials of ruxolitinib in chronic
GVHD, ruxolitinib cream in atopic dermatitis, parsaclisib in NHL,
and retifanlimab in SCAC,” stated Hervé Hoppenot, Chief Executive
Officer, Incyte. “During 2021, we expect regulatory decisions on
seven applications seeking approval, including four in the U.S, two
in Europe and one in Japan, and we are working towards the
potential U.S. launch of ruxolitinib cream, which we expect to be
approved by the FDA in the middle of the year.”
Portfolio Updates
MPNs and GVHD – key highlights
Our LIMBER development program, to improve patient outcomes in
MPNs and GHVD, is progressing well.
The two Phase 3 trials of ruxolitinib in combination with
parsaclisib are both underway, evaluating the combination versus
monotherapy ruxolitinib as a first-line therapy for patients with
myelofibrosis (MF) (LIMBER-313) and as a therapy for MF patients
with a suboptimal response to ruxolitinib monotherapy
(LIMBER-304).
Monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are
underway, and are expected to lead to proof-of-concept combination
trials of both agents with ruxolitinib in patients with
myelofibrosis. A monotherapy trial of itacitinib (JAK1) in patients
previously treated with ruxolitinib is ongoing.
In December 2020, Incyte and Cellenkos announced a development
collaboration to investigate the combination of ruxolitinib and
CK0804, Cellenkos’ cryopreserved CXCR4 enriched, allogeneic,
umbilical cord blood-derived T-regulatory cells, in patients with
myelofibrosis. In addition, Incyte obtained an exclusive option to
acquire sole rights to develop and commercialize CK0804, and
genetically-modified variants of CK0804, in benign and malignant
hematology indications.
The sNDA seeking approval of Jakafi in steroid-refractory
chronic graft-versus-host disease (GVHD) has been submitted, based
on data from the successful results of the REACH3 trial, which were
presented at ASH 2020.
Indication and status
Once-a-day ruxolitinib
(JAK1/JAK2)
Myelofibrosis, polycythemia vera &
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 in preparation
ruxolitinib + INCB00928 (JAK1/JAK2 +
ALK2)
Myelofibrosis: Phase 2 in preparation
itacitinib (JAK1)
Myelofibrosis: Phase 2 (low platelets)
ruxolitinib + CK08041 (JAK1/JAK2 +
CB-Tregs)
Myelofibrosis: PoC in preparation
ruxolitinib (JAK1/JAK2)
Steroid-refractory chronic GVHD2: sNDA
submitted
itacitinib (JAK1)
Treatment-naïve chronic GVHD: Phase 3
(GRAVITAS-309)
- Development collaboration with Cellenkos
- Clinical development of ruxolitinib in GVHD conducted in
collaboration with Novartis
Other Hematology/Oncology – key highlights
Momentum is strong behind the U.S. launch of Monjuvi
(tafasitamab-cxix), with good uptake in both academic and community
settings and illustrated by the market share gained in the first
several months since launch.
The Phase 3 inMIND trial evaluating tafasitamab plus
lenalidomide and rituximab (R-squared) versus R-squared in patients
with relapsed or refractory follicular or marginal zone lymphoma is
open for recruitment, and the Phase 3 frontMIND trial of
tafasitamab plus lenalidomide and R-CHOP versus R-CHOP as a
first-line treatment in patients with DLBCL is expected to open in
the coming months.
The U.S. launch of Pemazyre (pemigatinib) has been successful
and, in January, Incyte announced that the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) issued a positive opinion recommending the conditional
marketing authorization of pemigatinib for the treatment of adults
with unresectable locally advanced or metastatic cholangiocarcinoma
with an FGFR2 fusion or rearrangement that is relapsed or
refractory, after at least one line of systemic therapy.
In December 2020, data from three ongoing Phase 2 studies
evaluating parsaclisib for the treatment of patients with relapsed
or refractory follicular (CITADEL-203), marginal zone (CITADEL-204)
and mantle cell (CITADEL-205) lymphomas were presented at ASH 2020.
Data from the CITADEL program are expected to form the basis of an
NDA seeking FDA approval of parsaclisib, which is expected to be
submitted in the second half of 2021.
In January 2021, Incyte announced that the FDA had accepted for
Priority Review its Biologics License Application (BLA) for
retifanlimab as a treatment for previously treated patients with
advanced squamous cell anal carcinoma (SCAC) who have progressed
following standard platinum-based chemotherapy. The BLA submission
was based on data from the Phase 2 POD1UM-202 trial evaluating
retifanlimab in previously treated patients with advanced SCAC who
have progressed following standard platinum-based chemotherapy; the
Phase 3 POD1UM-303 trial in patients with SCAC is underway.
Indication and status
pemigatinib (FGFR1/2/3)
CCA: Phase 2 (FIGHT-202), Phase 3
(FIGHT-302); J-NDA under review
8p11 MPN: Phase 2 (FIGHT-203)
Tumor agnostic: Phase 2 (FIGHT-207)
tafasitamab
(CD19)1
r/r DLBCL: Phase 2 (L-MIND); Phase 3
(B-MIND); MAA under review
1L DLBCL: Phase 1b (firstMIND); Phase 3
(frontMIND) in preparation
r/r FL and r/r MZL: Phase 3 (inMIND) open
for recruitment
r/r B-cell malignancies: PoC with
parsaclisib (PI3Kδ) in preparation
r/r B-cell malignancies: PoC with
lenalidomide and plamotamab in preparation2
parsaclisib (PI3Kδ)
r/r follicular lymphoma: Phase 2
(CITADEL-203)
r/r marginal zone lymphoma: Phase 2
(CITADEL-204)
r/r mantle cell lymphoma: Phase 2
(CITADEL-205)
retifanlimab (PD-1)3
SCAC: Phase 2 (POD1UM-202); Phase 3
(POD1UM-303); BLA under review
MSI-high endometrial cancer: Phase 2
(POD1UM-101, POD1UM-204)
Merkel cell carcinoma: Phase 2
(POD1UM-201)
NSCLC: Phase 3 (POD1UM-304)
CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma;
SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL
= marginal zone lymphoma
- Development of tafasitamab in collaboration with MorphoSys
- 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.
- retifanlimab licensed from MacroGenics
Incyte’s emerging clinical candidates in hematology/oncology
include INCB86550, the first in a series of selective oral
inhibitors of PD-L1; INCB81776, a dual AXL/MER inhibitor;
INCB106385, an adenosine (A2A/A2B) inhibitor and, via a
collaboration with Merus, MCLA-145, a PD-L1xCD137 bispecific
antibody.
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
As planned, the NDA seeking approval of ruxolitinib cream as a
treatment for patients with atopic dermatitis was submitted to the
FDA late in the fourth quarter of 2020, including use of the
previously acquired priority review voucher (PRV). The use of the
PRV is expected to accelerate the time to an FDA decision.
Recruitment has been completed in both Phase 3 trials in the
TRuE-V development program evaluating ruxolitinib cream as a
treatment for patients with vitiligo, and topline results are
expected to be announced in the first half of 2021. If successful,
data from TRuE-V are expected to form the basis of an sNDA seeking
approval of ruxolitinib cream as a treatment for patients with
vitiligo, which would be submitted as soon as practicable after the
FDA decision on the atopic dermatitis NDA.
Indication and status
ruxolitinib cream (JAK1/JAK2)
Atopic dermatitis: NDA submitted
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2;
recruitment complete in both trials)
INCB54707 (JAK1)
Hidradenitis suppurativa: Phase 2b
parsaclisib (PI3Kδ)
Autoimmune hemolytic anemia: Phase 2
INCB00928 (ALK2)
Fibrodysplasia ossificans progressiva:
Phase 2 in preparation
Partnered – key highlights
In December 2020, Incyte and Lilly announced that Olumiant had
been approved in Japan as a treatment of patients with atopic
dermatitis who have inadequate response to conventional
therapies.
Indication and status
baricitinib (JAK1/JAK2)1
Atopic dermatitis: Phase 3 (BREEZE-AD);
approved in EU and Japan
Systemic lupus erythematosus: Phase 3
(BRAVE I, BRAVE II)
Severe alopecia areata: Phase 3
(BRAVE-AA1, BRAVE-AA2)
capmatinib (MET)2
NSCLC (with MET exon 14 skipping
mutations): Approved as Tabrecta in U.S. and Japan
- 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
- Worldwide rights to capmatinib licensed to Novartis
Potential therapies for patients with COVID-19
In November 2020, Incyte and Lilly announced that the U.S. Food
and Drug Administration (FDA) issued an Emergency Use Authorization
(EUA) for the distribution and emergency use of baricitinib to be
used in combination with remdesivir in hospitalized adult and
pediatric patients two years of age or older with suspected or
laboratory confirmed COVID-19 who require supplemental oxygen,
invasive mechanical ventilation, or extracorporeal membrane
oxygenation.
In December 2020, the New England Journal of Medicine published
peer-reviewed results from the Adaptive COVID-19 Treatment Trial
(ACTT-2) sponsored by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH). The Phase 3 study included 1,033 patients from 67
trial sites in eight countries. These results supported the EUA
issued by the FDA.
Status
ruxolitinib (JAK1/JAK2)
COVID-19 associated cytokine storm: Phase
3 (369-DEVENT)
baricitinib (JAK1/JAK2)1
Hospitalized patients with COVID-19: Phase
3 (COV-BARRIER)
- 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
2020 Fourth Quarter and Year-End Financial Results
The financial measures presented in this press release for the
quarter and year ended December 31, 2020 and 2019 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
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019
Total GAAP revenue
$
789,509
$
579,389
$
2,666,702
$
2,158,759
Total GAAP operating income (loss)
164,229
95,008
(263,676
)
402,006
Total Non-GAAP operating income (loss)
218,469
145,538
(40,878
)
609,812
GAAP net income (loss)
149,850
111,005
(295,697
)
446,906
Non-GAAP net income (loss)
204,773
141,936
(90,510
)
615,459
GAAP basic EPS
$
0.68
$
0.51
$
(1.36
)
$
2.08
Non-GAAP basic EPS
$
0.93
$
0.66
$
(0.42
)
$
2.86
GAAP diluted EPS
$
0.68
$
0.51
$
(1.36
)
$
2.05
Non-GAAP diluted EPS
$
0.93
$
0.65
$
(0.42
)
$
2.83
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
Twelve Months Ended
December 31,
%
December 31,
%
2020
2019
Change
2020
2019
Change
Revenues:
Jakafi net product revenues
$
516,882
$
466,464
11%
$
1,937,850
$
1,684,968
15%
Iclusig net product revenues
28,576
24,314
18%
105,002
89,954
17%
Pemazyre net product revenues
14,009
-
NM
25,884
-
NM
Jakavi product royalty revenues
87,046
65,007
34%
277,902
225,913
23%
Olumiant product royalty revenues
30,996
23,604
31%
110,920
80,424
38%
Tabrecta product royalty revenues
2,000
-
NM
4,144
-
NM
Product and royalty revenues
679,509
579,389
17%
2,461,702
2,081,259
18%
Milestone and contract revenues
110,000
-
NM
205,000
77,500
NM
Total GAAP revenues
$
789,509
$
579,389
36%
$
2,666,702
$
2,158,759
24%
NM = not meaningful
Product and Royalty Revenues Product and royalty revenues
for the quarter and year ended December 31, 2020 increased 17% and
18%, respectively, over the prior year comparative periods
primarily as a result of increases in Jakafi net product revenues,
the launch of Pemazyre and higher product royalty revenues from
Jakavi and Olumiant. Jakafi net product revenues for the quarter
and year ended December 31, 2020 increased 11% and 15%,
respectively, over the prior year comparative periods, primarily
driven by growth in patient demand across all indications.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
Twelve Months Ended
December 31,
%
December 31,
%
2020
2019
Change
2020
2019
Change
GAAP cost of product revenues
$
36,323
$
32,215
13%
$
131,328
$
114,249
15%
Non-GAAP cost of product revenues1
30,693
26,658
15%
108,830
92,015
18%
GAAP research and development
405,945
312,867
30%
2,215,942
1,154,111
92%
Non-GAAP research and development2
375,770
284,389
32%
2,095,586
1,040,169
101%
GAAP selling, general and
administrative
166,988
136,177
23%
516,922
468,711
10%
Non-GAAP selling, general and
administrative3
152,148
122,804
24%
460,363
416,763
10%
GAAP change in fair value of
acquisition-related contingent consideration
3,595
3,122
15%
23,385
19,682
19%
Non-GAAP change in fair value of
acquisition-related contingent consideration4
-
-
-
-
GAAP collaboration loss sharing
12,429
-
NM
42,801
-
NM
Non-GAAP collaboration loss sharing
12,429
-
NM
42,801
-
NM
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. 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 quarter ended December 31,
2020 increased 30% and 32%, respectively, compared to the same
period in 2019 primarily due to our 55% share of the global and
U.S. specific development costs for tafasitamab, product supply
related costs to support the potential launch of ruxolitinib cream
as a treatment for atopic dermatitis in 2021 and an increase in
upfront and milestone payments under our collaborative agreements.
Excluding the $42 million impact of product supply costs and the
upfront and milestone payments, research and development expense
for the quarter ended December 31, 2020 increased approximately 17%
compared to the same period in 2019.
For the year ended December 31, 2020, GAAP and Non-GAAP research
and development expense increased 92% and 101%, respectively,
compared to the year ended December 31, 2019 primarily due to
higher upfront and milestone payments under our collaborative
agreements which includes upfront consideration of $805 million
related to our collaborative agreement with MorphoSys, $120 million
of expense related to the purchase of an FDA priority review
voucher (“PRV”) utilized to accelerate the FDA review of
ruxolitinib cream in atopic dermatitis, our 55% share of the global
and U.S. specific development costs for tafasitamab, and product
supply costs to support the potential launch of ruxolitinib cream.
Excluding the $1.02 billion impact of upfront consideration and
milestone payments, purchase of the PRV and product supply related
costs, research and development expense for the year ended December
31, 2020 increased approximately 4% compared with the prior year
period.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the
quarter ended December 31, 2020 increased 23% and 24%,
respectively, compared to the same period in 2019, primarily due to
the timing of certain expenses. GAAP and Non-GAAP selling, general
and administrative expenses for the year ended December 31, 2020
increased 10% compared to the year ended December 31, 2019
primarily due to an increase in sales and marketing spend to
support the commercialization of Pemazyre in the US and to prepare
for the potential launch of ruxolitinib cream in the U.S. and
pemigatinib and tafasitamab in the EU.
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating
income for the quarter ended December 31, 2020 increased compared
to the same period in 2019, due to the growth in total revenues
exceeding the growth in operating expenses. For the year ended
December 31, 2020, Incyte recorded an operating loss compared to
operating income for the same period in 2019, on both a GAAP and
Non-GAAP basis, primarily due to upfront consideration related to
our collaboration with MorphoSys and expense related to the PRV,
partially offset by the growth in product and royalty revenues.
Cash, cash equivalents and marketable securities position
As of December 31, 2020 and 2019, cash, cash equivalents and
marketable securities totaled $1.8 billion and $2.1 billion,
respectively. The decrease is primarily due to the upfront payment
and stock purchase related to our collaborative agreement with
MorphoSys and purchase of the PRV, partially offset by the cash
flow generated in 2020.
2021 Financial Guidance
Due to the continuing growth and diversification of Incyte’s
commercial product portfolio, 2021 net product revenue guidance is
being provided for Jakafi and in total for other
Hematology/Oncology products, which currently include Iclusig in
Europe and Pemazyre in the U.S. Guidance does not include revenue
from any potential new product launches. However, GAAP and Non-GAAP
selling, general and administrative expense guidance for 2021
includes costs to support the potential launches of ruxolitinib
cream as a treatment for atopic dermatitis in the U.S., pemigatinib
as a treatment for cholangiocarcinoma in the EU and Japan, and
tafasitamab as a treatment for DLBCL in the EU. The 2021 financial
guidance does not include the impact of any potential future
strategic transactions.
Jakafi net product revenues
$2,125 - $2,200 million
Other Hematology/Oncology net product
revenues
$145 - $160 million
GAAP Cost of product revenues
6 – 7% of net product revenues
Non-GAAP Cost of product revenues(1)
5 – 6% of net product revenues
GAAP Research and development expenses
$1,350 - $1,390 million
Non-GAAP Research and development
expenses(2)
$1,220 - $1,250 million
GAAP Selling, general and administrative
expenses
$735 - $775 million
Non-GAAP Selling, general and
administrative expenses(2)
$665 - $700 million
(1) 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. (2) 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. EDT. 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, 13715042.
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, 13715042.
The conference call will also be webcast; the livestream and the
replay 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 steroid-refractory acute GVHD 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 as well as adults with intermediate or high-risk
myelofibrosis (MF), including primary MF, post-polycythemia vera MF
and post-essential thrombocythemia MF.
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 Monjuvi® (tafasitamab-cxix)
Monjuvi 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).
Monjuvi is approved by the U.S. Food and Drug Administration in
combination with lenalidomide for the treatment of adult patients
with relapsed or refractory diffuse large B-cell lymphoma (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 January 2020, MorphoSys and Incyte entered into a
collaboration and licensing agreement to further develop and
commercialize tafasitamab globally. Monjuvi is being
co-commercialized by Incyte and MorphoSys in the United States.
Incyte has exclusive commercialization rights outside the United
States.
A marketing authorization application (MAA) seeking the approval
of tafasitamab in combination with lenalidomide in the EU has been
validated by the European Medicines Agency (EMA) and is currently
under review for the treatment of adult patients with relapsed or
refractory DLBCL, including DLBCL arising from low grade lymphoma,
who are not candidates for ASCT.
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in a number of ongoing combination
trials.
Monjuvi is a registered trademark of MorphoSys AG. 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 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. Incyte has
granted Innovent Biologics, Inc. rights to develop and
commercialize pemigatinib in hematology and oncology in Mainland
China, Hong Kong, Macau and Taiwan. Incyte has retained all other
rights to develop and commercialize pemigatinib outside of the
United States.
Additionally, the European Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) has issued a positive
opinion recommending the conditional marketing authorization of
pemigatinib for the treatment of adults with unresectable locally
advanced or metastatic cholangiocarcinoma with a fibroblast growth
factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed
or refractory, after at least one line of systemic therapy.
Pemazyre is a trademark of Incyte Corporation.
About Iclusig® (ponatinib) tablets
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.
Incyte has an exclusive license from ARIAD Pharmaceuticals,
Inc., since acquired by Takeda Pharmaceutical Company Limited, to
develop and commercialize Iclusig in the European Union and 22
other countries, including Switzerland, Norway, Turkey, Israel and
Russia.
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 without limitation
statements regarding expectations for up to seven drug application
approvals in 2021 in the U.S, Europe and Japan; the Company’s
ongoing clinical development program for ruxolitinib cream as well
as its dermatology program generally; whether and when ruxolitinib
cream will be approved in the U.S. or elsewhere for atopic
dermatitis and the extent of our launch readiness; the expected
timing of receipt and announcement of results for ruxolitinib cream
for vitiligo; continued development of our LIMBER program,
including expectations for, and timing and results of, ruxolitinib
combination trials with parsaclisib; expectations for our
monotherapy trials for INCB57643 (BET), and INCB00928 (ALK2); our
collaboration with Cellenkos investigating the combination of
ruxolitinib and CK0804; whether and when Jakafi will be approved in
the U.S. or elsewhere for steroid-refractory chronic
graft-versus-host disease (GVHD); whether and when the BLA for
retifanlimab for SCAC will be approved; expectations for
tafasitamab development, including the inMIND and frontMIND trials
and plans to further broaden the development program of tafasitamab
in other B-cell malignancies and clinical trial plans for such
program; whether or when the European Commission will grant
marketing authorization for pemigatinib in Europe; plans for
ongoing and further development of parsaclisib in the CITADEL
program and the planned timing of an NDA submission based on that
program; and the expected timing of receipt and announcement of
clinical trial results for INCB86550; and our financial guidance
for 2021 and the expectations underlying such guidance.
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:; the actual
time required by the FDA to review the Company’s NDA for approval
for ruxolitinib cream in atopic dermatitis, the Company’s sNDA for
Jakafi in steroid-refractory chronic graft-versus-host disease
(GVHD) and the Company’s BLA for retifanlimab in SCAC, and the
results of such reviews; 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 and regulatory
agencies outside of the United States; 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 from time to time in the Company’s reports filed with the
Securities and Exchange Commission, including its quarterly report
on Form 10-Q for the quarter ended September 30, 2020. 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
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019
GAAP
GAAP
Revenues:
Product revenues, net
$
559,467
$
490,778
$
2,068,736
$
1,774,922
Product royalty revenues
120,042
88,611
392,966
306,337
Milestone and contract revenues
110,000
-
205,000
77,500
Total revenues
789,509
579,389
2,666,702
2,158,759
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
36,323
32,215
131,328
114,249
Research and development
405,945
312,867
2,215,942
1,154,111
Selling, general and administrative
166,988
136,177
516,922
468,711
Change in fair value of
acquisition-related contingent consideration
3,595
3,122
23,385
19,682
Collaboration loss sharing
12,429
-
42,801
-
Total costs and expenses
625,280
484,381
2,930,378
1,756,753
Income (loss) from operations
164,229
95,008
(263,676
)
402,006
Other income (expense), net
4,810
15,848
23,206
52,182
Interest expense
(428
)
(607
)
(2,174
)
(1,855
)
Unrealized gain (loss) on long term
investments
(509
)
15,755
10,426
34,458
Income (loss) before provision for income
taxes
168,102
126,004
(232,218
)
486,791
Provision for income taxes
18,252
14,999
63,479
39,885
Net income (loss)
$
149,850
$
111,005
$
(295,697
)
$
446,906
Net income (loss) per share:
Basic
$
0.68
$
0.51
$
(1.36
)
$
2.08
Diluted
$
0.68
$
0.51
$
(1.36
)
$
2.05
Shares used in computing net income (loss)
per share:
Basic
219,239
215,770
218,073
214,913
Diluted
221,228
218,542
218,073
217,657
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
December 31,
December 31,
2020
2019
ASSETS
Cash, cash equivalents and marketable
securities
$
1,801,377
$
2,117,554
Accounts receivable
481,994
308,809
Property and equipment, net
559,625
377,567
Finance lease right-of-use assets, net
28,451
29,058
Inventory
35,973
16,505
Prepaid expenses and other assets
103,313
94,179
Long term investments
222,301
133,657
Other intangible assets, net
172,291
193,828
Goodwill
155,593
155,593
Total assets
$
3,560,918
$
3,426,750
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
648,793
$
500,462
Finance lease liabilities
34,857
32,582
Convertible senior notes
-
18,300
Acquisition-related contingent
consideration
266,000
277,000
Stockholders’ equity
2,611,268
2,598,406
Total liabilities and stockholders’
equity
$
3,560,918
$
3,426,750
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
INCOME (LOSS) TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019
GAAP Net Income (Loss)
$
149,850
$
111,005
$
(295,697
)
$
446,906
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
30,175
28,478
120,356
113,942
Non-cash stock compensation from equity
awards (SG&A)2
14,840
13,373
56,559
51,948
Non-cash stock compensation from equity
awards (COGS)2
246
173
962
698
Non-cash interest expense related to
convertible notes3
66
221
683
867
Changes in fair value of equity
investments4
509
(15,755
)
(10,426
)
(34,458
)
Amortization of acquired product
rights5
5,384
5,384
21,536
21,536
Change in fair value of contingent
consideration6
3,595
3,122
23,385
19,682
Tax effect of Non-GAAP adjustments7
108
(4,065
)
(7,868
)
(5,662
)
Non-GAAP Net Income (Loss)
$
204,773
$
141,936
$
(90,510
)
$
615,459
Non-GAAP net income (loss) per share:
Basic
$
0.93
$
0.66
$
(0.42
)
$
2.86
Diluted
$
0.93
$
0.65
$
(0.42
)
$
2.83
Shares used in computing Non-GAAP net
income (loss) per share:
Basic
219,239
215,770
218,073
214,913
Diluted
221,228
218,542
218,073
217,657
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, 2020
are milestones of $110,000 and $205,000, respectively, earned from
our collaborative partners as compared to upfront consideration and
milestones of $0 and $77,500, respectively, for the same periods in
2019. 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, 2020
are upfront consideration and milestones of $25,600 and $976,082,
respectively, related to our collaborative partners and FDA
priority review voucher as compared to $2,500 and $27,500,
respectively, for the same periods in 2019. 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 Change in fair value of
acquisition-related contingent consideration line item in the
Condensed Consolidated Statements of Operations. 7. As included
within the Provision for income taxes line item in the Condensed
Consolidated Statements of Operations. Income tax effects of
Non-GAAP 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.
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Incyte Media Catalina
Loveman +1 302 498 6171 cloveman@incyte.com Investors
Michael Booth, DPhil +1 302 498 5914 mbooth@incyte.com Christine
Chiou +1 302 274 4773 cchiou@incyte.com
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