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Incyte Reports 2020 Third Quarter Financial Results and Provides Updates on Key Clinical Programs - Total product and royalty revenues of $621 million (+16% vs Q3 2019) for the quarter ended

Key Takeaway: Incyte Reports 2020 Third Quarter Financial and Provides Updates on Key Clinical Programs Conference Call and Webcast Scheduled Today WILMINGTON, Del. - November 5, 2020 - Incyte (Nasdaq: INCY) today reports 2020 third quarter financial results, and provides a status update o

Full Press Release Details

Incyte Reports 2020 Third Quarter Financial
and Provides Updates on Key Clinical Programs
Conference Call and Webcast Scheduled Today
WILMINGTON, Del. - November 5, 2020 - Incyte
(Nasdaq: INCY) today reports 2020 third quarter financial results, and provides a status update on the Company's development
"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 Herv 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
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 + PI3K ) 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
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 (PI3K ).
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
Indication and status
ruxolitinib (JAK1/JAK2) Steroid-refractory chronic GVHD: Phase 3 (REACH3) 1 primary endpoint met
itacitinib (JAK1) Treatment-na ve 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 (PI3K ) in preparation
parsaclisib (PI3K ) 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
Inflammation and Autoimmunity (IAI) - key highlights
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
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
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.
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 (PI3K ) 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 antibodies 2 INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies MCLA-145 (PD-L1xCD137) 3
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
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 (RUXCOVID 1 ; DEVENT)
baricitinib (JAK1/JAK2) 2 Hospitalized patients with COVID-19: Phase 3 (ACTT-2 3 ; COV-BARRIER)
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
2020 Third Quarter Financial Results
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
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
Last updated: Nov 5, 2020