- Total product and royalty revenues of $621 million (+16% vs Q3
2019) for the quarter ended September 30, 2020; Jakafi®
(ruxolitinib) revenues of $488 million in Q3 2020 (+13% vs Q3
2019); Incyte tightens full year 2020 Jakafi revenue guidance to a
range of $1.910 to $1.940 billion
- Strong momentum behind commercial launches of both Monjuvi®
(tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.
- Incyte Dermatology established as a new franchise in the U.S.;
priority review voucher acquired and expected to be used in NDA
seeking approval for ruxolitinib cream in atopic dermatitis
- Late-stage clinical development pipeline continues to progress
with multiple pivotal trials in oncology and dermatology
Conference Call and Webcast Scheduled Today at
8:00 a.m. EDT
Incyte (Nasdaq: INCY) today reports 2020 third quarter financial
results, and provides a status update on the Company’s development
portfolio.
“We are pleased to report another strong quarter for Incyte,
with continued strength across all Jakafi® (ruxolitinib)
indications, good momentum behind the U.S. launches of both
Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib), as well as
increasing royalty contributions from our partnered medicines
globally,” stated Hervé Hoppenot, Chief Executive Officer, Incyte.
“In addition, we have now established Incyte Dermatology as a new
franchise for Incyte in the U.S., and we are on track to submit the
NDA for ruxolitinib cream at the end of this year which, by using
our priority review voucher, could lead to an FDA decision in the
middle of next year.”
Portfolio Update
LIMBER – key highlights
Two pivotal trials are being initiated to evaluate the
combination of ruxolitinib and parsaclisib as both first-line
therapy for myelofibrosis (MF) patients and in MF patients with an
inadequate response to ruxolitinib monotherapy.
The Phase 2 monotherapy trial of INCB57643 (BET) in patients
with refractory myelofibrosis are now recruiting and the Phase 2
monotherapy trial of INCB00928 (ALK2) in patients with
myelofibrosis is being opened. Both programs are expected to
proceed to ruxolitinib combination trials upon completion of
monotherapy cohorts.
Indication and status
Once-a-day ruxolitinib
(JAK1/JAK2)
Myelofibrosis and polycythemia vera:
clinical pharmacology studies
ruxolitinib + parsaclisib (JAK1/JAK2 +
PI3Kδ)
Myelofibrosis: Phase 3 in preparation
Myelofibrosis: Phase 3 in preparation (inadequate responders to
ruxolitinib)
ruxolitinib + INCB57643 (JAK1/JAK2 +
BET)
Myelofibrosis: Phase 2 in preparation
ruxolitinib + INCB00928 (JAK1/JAK2 +
ALK2)
Myelofibrosis: Phase 2 in preparation
Oncology beyond MPNs – key highlights
In August, Monjuvi® (tafasitamab-cxix) in combination with
lenalidomide was included in the latest National Comprehensive
Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for
B-cell Lymphomas with a Category 2A designation as an option for
the treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (r/r DLBCL) and who are not eligible for
autologous stem cell transplant (ASCT).
The European Marketing Authorization Application (MAA) for
tafasitamab as a treatment for patients with r/r DLBCL is under
review. Incyte has exclusive development and commercialization
rights to tafasitamab outside of the U.S.
Incyte and MorphoSys plan to further broaden the development
program of tafasitamab in other B-cell malignancies. Multiple
trials are in preparation, including Phase 3 trials in both first
line DLBCL and relapsed/refractory follicular lymphoma, as well as
a proof-of-concept trial of tafasitamab plus parsaclisib
(PI3Kδ).
In September, initial results from the Phase 2 POD1UM-202 trial
of retifanlimab in previously treated patients with advanced
squamous cell anal carcinoma (SCAC) who have progressed following
standard platinum-based chemotherapy were presented at the European
Society for Medical Oncology (ESMO) annual meeting. The Phase 3
POD1UM-303 trial of retifanlimab in combination with platinum-based
chemotherapy as a first-line treatment for patients with SCAC is
open for recruitment.
Given the rapidly evolving treatment landscape for bladder
cancer and recent regulatory feedback, Incyte is reevaluating its
development strategy for pemigatinib in bladder cancer. As part of
that reevaluation, new patient recruitment into FIGHT-205, which is
assessing pemigatinib in cisplatin-ineligible bladder cancer
patients whose tumors express FGFR3 mutation or rearrangement, has
been stopped, and Incyte no longer intends to use data from
FIGHT-201 to seek accelerated approval for pemigatinib in patients
with previously treated bladder cancer whose tumors express FGFR3
mutation or rearrangement.
Indication and status
ruxolitinib (JAK1/JAK2)
Steroid-refractory chronic GVHD: Phase 3
(REACH3)1 primary endpoint met
itacitinib (JAK1)
Treatment-naïve chronic GVHD: Phase 3
(GRAVITAS-309)
pemigatinib (FGFR1/2/3)
CCA: Phase 2 (FIGHT-202), Phase 3
(FIGHT-302); MAA, NDS and J-NDA under review
8p11 MPN: Phase 2 (FIGHT-203)
Tumor agnostic: Phase 2 (FIGHT-207)
tafasitamab
(CD19)2
r/r DLBCL: Phase 2 (L-MIND); Phase 3
(B-MIND); MAA under review
1L DLBCL: Phase 1b (First-MIND); Phase 3
(Front-MIND) in preparation
r/r follicular lymphoma: Phase 3 in
preparation
r/r B-cell malignancies: PoC with
parsaclisib (PI3Kδ) in preparation
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
MSI-high endometrial cancer: Phase 2
(POD1UM-101); Phase 2 (POD1UM-204) in preparation
Merkel cell carcinoma: Phase 2
(POD1UM-201)
SCAC: Phase 2 (POD1UM-202); Phase 3
(POD1UM-303) open for recruitment
NSCLC: Phase 3 (POD1UM-304)
CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma;
SCAC = squamous cell anal carcinoma
1)
Clinical development of ruxolitinib in
GVHD conducted in collaboration with Novartis
2)
Development of tafasitamab in
collaboration with MorphoSys
3)
retifanlimab licensed from MacroGenics
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Incyte Dermatology has been established as a new franchise for
Incyte in the U.S., which will include dedicated teams for the
development and commercialization of Incyte’s dermatology
portfolio.
The NDA for ruxolitinib cream in atopic dermatitis is on track
for submission at the end of 2020. Incyte has acquired a priority
review voucher, which it intends to use to accelerate the timeline
to FDA decision.
Pooled results from the TRuE-AD studies were presented at the
European Academy of Dermatology and Venereology (EADV) Congress.
Ruxolitinib cream demonstrated clinically meaningful improvements
in patient-reported quality of life assessments, such as the PROMIS
(patient-reported outcomes measurement information system) sleep
disturbance (8b) score, as well as substantial and sustained itch
reduction, reinforcing its potential as an important treatment
option for atopic dermatitis patients.
The two randomized Phase 3 trials in the TRuE-V pivotal program
evaluating ruxolitinib cream in patients with vitiligo are fully
recruited, with results expected in 2021.
Other IAI
Initial clinical results from INCB54707, a JAK1 selective
inhibitor, were presented in October. INCB54707 demonstrated
preliminary efficacy, improved quality of life (QoL) including a
reduction in skin pain and a tolerable safety profile in patients
with moderate-to-severe hidradenitis suppurativa (HS). A Phase 2b,
randomized, double-blind, placebo-controlled trial evaluating
INCB54707 in HS is ongoing.
Indication and status
ruxolitinib cream (JAK1/JAK2)
Atopic dermatitis: Phase 3 (TRuE-AD1,
TRuE-AD2; primary endpoints met)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2)
INCB54707 (JAK1)
Hidradenitis suppurativa: Phase 2b
parsaclisib (PI3Kδ)
Autoimmune hemolytic anemia: Phase 2
INCB00928 (ALK2)
Fibrodysplasia ossificans progressiva:
Phase 2 in preparation
Discovery and early development – key highlights
Incyte’s portfolio of other earlier-stage clinical candidates is
summarized below.
Clinical translational data from the ongoing proof-of-concept
trial of INCB86550, Incyte’s first-in-class oral small molecule
inhibitor of PD-L1, have been accepted for presentation at the 2020
Society for Immunotherapy for Cancer (SITC) meeting. As previously
disclosed, initial clinical efficacy and safety data from this
trial are expected to be presented in 2021, once these data
mature.
Modality
Candidates
Small molecules
INCB01158 (ARG)1, INCB81776 (AXL/MER),
epacadostat (IDO1), INCB86550 (PD-L1)
Monoclonal antibodies2
INCAGN1876 (GITR), INCAGN2385 (LAG-3),
INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies
MCLA-145 (PD-L1xCD137)3
1)
INCB01158 licensed from Calithera
2)
Discovery collaboration with Agenus
3)
MCLA-145 development in collaboration with Merus
Potential therapies for patients with COVID-19
Patient recruitment into the Phase 3 RUXCOVID study evaluating
ruxolitinib versus standard-of-care in hospitalized patients with
COVID-19 associated cytokine storm has been completed, and topline
results are expected to be available before the end of 2020.
In September, Incyte and Eli Lilly announced initial results
from the baricitinib arm of the National Institute of Allergy and
Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial
(ACTT-2), where baricitinib in combination with remdesivir reduced
the time to recovery (primary endpoint) in comparison with
remdesivir alone.
Additional data announced in October showed that baricitinib
plus remdesivir resulted in a numerical decrease in mortality
through Day 29 compared to remdesivir alone, with a more pronounced
reduction seen in more severely ill patients.
Status
ruxolitinib (JAK1/JAK2)
COVID-19 associated cytokine storm: Phase
3 (RUXCOVID1; DEVENT)
baricitinib (JAK1/JAK2)2
Hospitalized patients with COVID-19: Phase
3 (ACTT-23; COV-BARRIER)
1)
Sponsored by Incyte in the United States and by Novartis outside
of the United States
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
for moderate to severe atopic dermatitis.
3)
ACTT-2 agreement with the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health
Partnered – key highlights
In October, Lilly announced that the European Commission granted
marketing authorization for Olumiant® (baricitinib) 4mg and 2mg
tablets in Europe for the treatment of adults with moderate to
severe atopic dermatitis (AD) who are candidates for systemic
therapy, becoming the first JAK-inhibitor indicated to help treat
patients with AD.
In September, Incyte and Novartis announced that GEOMETRY mono-1
results of TabrectaTM (capmatinib) in patients with METex14
metastatic non-small cell lung cancer (NSCLC) were published in The
New England Journal of Medicine.
Indication and status
baricitinib (JAK1/JAK2)1
Atopic dermatitis: Phase 3 (BREEZE-AD);
approved in EU
Systemic lupus erythematosus: Phase 3
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
1)
Worldwide rights to baricitinib licensed to Lilly: approved as
Olumiant in multiple territories globally for certain patients with
moderate-to-severe rheumatoid arthritis
2)
Worldwide rights to capmatinib licensed to Novartis
2020 Third Quarter Financial Results
The financial measures presented in this press release for the
three and nine months ended September 30, 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
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Total GAAP revenue
$
620,643
$
551,581
$
1,877,193
$
1,579,370
Total GAAP operating income (loss)
5,326
134,316
(427,905
)
306,998
Total Non-GAAP operating income (loss)
61,619
186,338
(259,347
)
464,274
GAAP net income (loss)
(15,203
)
128,271
(445,547
)
335,901
Non-GAAP net income (loss)
50,059
179,019
(295,283
)
476,030
GAAP basic EPS
$
(0.07
)
$
0.60
$
(2.05
)
$
1.57
Non-GAAP basic EPS
$
0.23
$
0.83
$
(1.36
)
$
2.22
GAAP diluted EPS
$
(0.07
)
$
0.59
$
(2.05
)
$
1.55
Non-GAAP diluted EPS
$
0.23
$
0.82
$
(1.36
)
$
2.19
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
Nine Months Ended
September 30,
%
September 30,
%
2020
2019
Change
2020
2019
Change
Revenues:
Jakafi net product revenue
$
487,783
$
433,387
13
%
$
1,420,968
$
1,218,504
17
%
Iclusig net product revenue
26,380
20,611
28
%
76,426
65,640
16
%
Pemazyre net product revenue
8,089
-
11,875
-
Jakavi product royalty revenues
68,306
58,440
17
%
190,856
160,906
19
%
Olumiant product royalty revenues
28,647
21,643
32
%
79,924
56,820
41
%
Tabrecta product royalty revenues
1,438
-
2,144
-
Product and royalty revenues
620,643
534,081
16
%
1,782,193
1,501,870
19
%
Milestone and contract revenues
-
17,500
(100
%)
95,000
77,500
23
%
Total GAAP revenues
$
620,643
$
551,581
13
%
$
1,877,193
$
1,579,370
19
%
Product and Royalty Revenues Product and royalty revenues
for the three and nine months ended September 30, 2020 increased
16% and 19%, 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 three and
nine months ended September 30, 2020 increased 13% and 17%,
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
Nine Months Ended
September 30,
%
September 30,
%
2020
2019
Change
2020
2019
Change
GAAP cost of product revenues
$
34,322
$
30,040
14
%
$
95,005
$
82,034
16
%
Non-GAAP cost of product revenues1
28,693
24,483
17
%
78,137
65,357
20
%
GAAP research and development
438,109
281,336
56
%
1,809,997
841,244
115
%
Non-GAAP research and development2
409,134
250,910
63
%
1,719,816
755,780
128
%
GAAP selling, general and
administrative
120,788
102,608
18
%
349,934
332,534
5
%
Non-GAAP selling, general and
administrative3
106,208
89,850
18
%
308,215
293,959
5
%
GAAP change in fair value of
acquisition-related contingent consideration
7,109
3,281
117
%
19,790
16,560
20
%
Non-GAAP change in fair value of
acquisition-related contingent consideration4
-
-
-
-
GAAP collaboration loss sharing
14,989
-
30,372
-
Non-GAAP collaboration loss sharing
14,989
-
30,372
-
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 three months ended
September 30, 2020 increased 56% and 63%, respectively, compared to
the same period in 2019, primarily due to $120 million of expense
related to the purchase of an FDA priority review voucher from a
third party, which we intend to use to accelerate the FDA review of
ruxolitinib cream for the treatment of atopic dermatitis and an
increase in milestone expenses related to our collaborative
agreements. For the nine months ended September 30, 2020, GAAP and
Non-GAAP research and development expense increased 115% and 128%,
respectively, compared to the same period in 2019, primarily due to
upfront consideration of $805 million related to our collaborative
agreement with MorphoSys and expense related to the purchase of the
FDA priority review voucher.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the three
months and nine months ended September 30, 2020 increased 18% and
5%, respectively, compared to the same periods in 2019, primarily
due to increased headcount and activities supporting the
commercialization of our products and the timing of certain
expenses.
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating
income for the three months ended September 30, 2020 decreased
compared to the same period in 2019, primarily due to $120 million
of expense related to the purchase of the FDA priority review
voucher and milestone expenses related to our collaborative
agreements. For the nine months ended September 30, 2020 we
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 FDA priority review voucher,
partially offset by the growth in product and royalty revenues.
Cash, cash equivalents and marketable securities position
As of September 30, 2020 and December 31, 2019, cash, cash
equivalents and marketable securities totaled $1.7 billion and $2.1
billion, respectively. The decrease is primarily driven by the
upfront payment and stock purchase related to our collaborative
agreement with MorphoSys and purchase of the FDA priority review
voucher and is partially offset by the cash flow generated during
this nine-month period.
2020 Financial Guidance
Incyte has tightened its full year 2020 guidance for Jakafi net
product revenues, as detailed below. The company’s full year 2020
financial guidance is summarized in the following table. The
R&D expense guidance excludes $805 million of upfront
consideration paid under the MorphoSys collaboration and $120
million of expense related to the purchase of the FDA priority
review voucher (PRV). The financial guidance also excludes the
impact of any potential future strategic transactions.
All data in millions1
Current
Previous
Jakafi net product revenues
$1,910 - $1,940
$1,880 - $1,950
Iclusig net product revenues
$100 - $105
Unchanged
Cost of product revenues
$130 - $135
Unchanged
Research and development expenses (Excl.
MOR upfront cons. & PRV)
$1,210 - $1,280
Unchanged
Selling, general and administrative
expenses
$505 - $535
Unchanged
Change in fair value of
acquisition-related contingent consideration
$25 - $27
Unchanged
1. Amounts exclude Non-GAAP adjustments (e.g., stock based comp,
amortization of acquired product rights for Iclusig and change in
fair value of estimated future royalties for Iclusig). Research and
development expenses also excludes $805 million of upfront
consideration paid under the MorphoSys collaboration and $120
million of expense related to the purchase of the FDA priority
review voucher.
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, 13711777.
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, 13711777.
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).
In January 2020, MorphoSys and Incyte entered into a
collaboration and licensing agreement to further develop and
commercialize Monjuvi globally. Monjuvi will be 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 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.
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, Incyte’s marketing authorization application (MAA)
seeking the approval of pemigatinib for patients with
cholangiocarcinoma in the EU has been validated by the European
Medicines Agency (EMA) and is currently under review for the
treatment of adults with 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: the expected use of the priority review
voucher and its effect on the timing of the FDA review process, the
expected timing for the submission of the an NDA for ruxolitinib
cream for atopic dermatitis and the expected timing of any FDA
decision with respect to such NDA; plans for ruxolitinib
combination trials with INCB57643 (BET) and INCB00928 (ALK2); plans
to further broaden the development program of tafasitamab in other
B-cell malignancies and clinical trial plans for such program; the
expected timing of receipt of clinical trial results for
ruxolitinib cream for vitiligo and ruxolitinib for COVID-19; the
expected timing of receipt and announcement of clinical trial
results for INCB86550; and the Company’s reaffirmed and updated
financial guidance for 2020 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: unanticipated
delays in the submission of the Company’s NDA for ruxolitinib cream
for atopic dermatitis; the actual time required by the FDA to
review the Company’s NDA for approval for ruxolitinib cream in
atopic dermatitis, should such NDA be submitted, and the results of
such review; 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 June 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
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
GAAP
GAAP
Revenues:
Product revenues, net
$
522,252
$
453,998
$
1,509,269
$
1,284,144
Product royalty revenues
98,391
80,083
272,924
217,726
Milestone and contract revenues
-
17,500
95,000
77,500
Total revenues
620,643
551,581
1,877,193
1,579,370
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
34,322
30,040
95,005
82,034
Research and development
438,109
281,336
1,809,997
841,244
Selling, general and administrative
120,788
102,608
349,934
332,534
Change in fair value of
acquisition-related contingent consideration
7,109
3,281
19,790
16,560
Collaboration loss sharing
14,989
-
30,372
-
Total costs and expenses
615,317
417,265
2,305,098
1,272,372
Income (loss) from operations
5,326
134,316
(427,905
)
306,998
Other income (expense), net
4,917
11,961
18,396
36,334
Interest expense
(544
)
(597
)
(1,746
)
(1,248
)
Unrealized gain (loss) on long term
investments
(13,207
)
2,339
10,935
18,703
Income (loss) before provision for income
taxes
(3,508
)
148,019
(400,320
)
360,787
Provision for income taxes
11,695
19,748
45,227
24,886
Net income (loss)
$
(15,203
)
$
128,271
$
(445,547
)
$
335,901
Net income (loss) per share:
Basic
$
(0.07
)
$
0.60
$
(2.05
)
$
1.57
Diluted
$
(0.07
)
$
0.59
$
(2.05
)
$
1.55
Shares used in computing net income (loss)
per share:
Basic
218,784
215,199
217,684
214,628
Diluted
218,784
217,791
217,684
217,393
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
September 30,
December 31,
2020
2019
ASSETS
Cash, cash equivalents and marketable
securities
$
1,734,800
$
2,117,554
Accounts receivable
356,182
308,809
Property and equipment, net
498,335
377,567
Finance lease right-of-use assets, net
29,123
29,058
Inventory
25,709
16,505
Prepaid expenses and other assets
107,203
94,179
Long term investments
222,810
133,657
Other intangible assets, net
177,675
193,828
Goodwill
155,593
155,593
Total assets
$
3,307,430
$
3,426,750
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
597,871
$
500,462
Finance lease liabilities
34,826
32,582
Convertible senior notes
11,900
18,300
Acquisition-related contingent
consideration
272,000
277,000
Stockholders’ equity
2,390,833
2,598,406
Total liabilities and stockholders’
equity
$
3,307,430
$
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
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
GAAP Net Income (Loss)
$
(15,203
)
$
128,271
$
(445,547
)
$
335,901
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
28,975
30,426
90,181
85,464
Non-cash stock compensation from equity
awards (SG&A)2
14,580
12,758
41,719
38,575
Non-cash stock compensation from equity
awards (COGS)2
245
173
716
525
Non-cash interest expense related to
convertible notes3
168
218
617
646
Changes in fair value of equity
investments4
13,207
(2,339
)
(10,935
)
(18,703
)
Amortization of acquired product
rights5
5,384
5,384
16,152
16,152
Change in fair value of contingent
consideration6
7,109
3,281
19,790
16,560
Tax effect of Non-GAAP adjustments7
(4,406
)
847
(7,976
)
910
Non-GAAP Net Income (Loss)
$
50,059
$
179,019
$
(295,283
)
$
476,030
Non-GAAP net income (loss) per share:
Basic
$
0.23
$
0.83
$
(1.36
)
$
2.22
Diluted
$
0.23
$
0.82
$
(1.36
)
$
2.19
Shares used in computing Non-GAAP net
income (loss) per share:
Basic
218,784
215,199
217,684
214,628
Diluted
221,357
217,791
217,684
217,393
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, 2020
are milestones of $0 and $95,000, respectively, earned from our
collaborative partners as compared to upfront consideration and
milestones of $17,500 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 nine months ended
September 30, 2020 are upfront consideration and milestones of
$141,450 and $950,482, respectively, related to our collaborative
partners and FDA priority review voucher as compared to $0 and
$25,000, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005177/en/
Incyte Contacts 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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