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Incyte Reports 2019 Fourth Quarter and Year-End Financial Results and Provides 2020 Financial Guidance and Updates on Key Clinical Programs - Total product and royalty revenues of $579 million (+24%

Key Takeaway: Fourth Quarter and Year-End Financial Results and Provides 2020 Financial Guidance and Updates on Key Clinical Programs Conference Call and Webcast Scheduled Today at 8:00 a.m. EST WILMINGTON, Del. - February 13, 2020 - Incyte (Nasdaq:INCY) today reports 2019 fourth quarter a

Full Press Release Details

Fourth Quarter and Year-End Financial Results and Provides 2020 Financial Guidance and Updates on Key Clinical Programs
Conference Call and Webcast
Scheduled Today at 8:00 a.m. EST
WILMINGTON, Del. - February 13, 2020
- Incyte (Nasdaq:INCY) today reports 2019 fourth quarter and year-end financial results, announces 2020 guidance and
provides a status update on the Company's development portfolio.
"Revenue growth continues to be very strong, driven by
robust demand across all three indications for Jakafi," stated Herv Hoppenot, Chief Executive Officer, Incyte. "As
we enter 2020, we have multiple opportunities for additional growth. We recently announced successful initial results from the
Phase 3 TRuE-AD program, which we plan to include as part of the NDA in the fourth quarter of 2020 seeking approval of ruxolitinib
cream for the treatment of patients with mild-to-moderate atopic dermatitis. We also look forward to the FDA decisions on the
potential approvals of pemigatinib and capmatinib later this year. The recent progress made within both oncology and dermatology,
as well as the recently announced MorphoSys collaboration for tafasitamab, positions Incyte very well as we deliver on our objectives
for diversification and growth."
LIMBER - key highlights
The LIMBER program, a key development priority
designed to maintain our Leadership In MPNs BEyond Ruxolitinib, is evaluating multiple monotherapy and combination strategies
to deliver improved therapies for patients with myeloproliferative neoplasms (MPNs). The program has three key areas of focus:
new formulations of ruxolitinib; JAK inhibitor-based combinations; and new targets beyond JAK inhibition.
A once-a-day formulation of ruxolitinib is
being developed and is currently being evaluated in clinical pharmacology studies. Following positive proof-of-concept data of
ruxolitinib plus parsaclisib in myelofibrosis (MF) patients with a suboptimal response to ruxolitinib monotherapy, a randomized
pivotal trial is being prepared in this setting. Additional JAK-based combinations are either ongoing or in preparation.
Indication and status
Once-a-day ruxolitinib (JAK1/JAK2) Myelofibrosis and polycythemia vera: clinical pharmacology studies
Ruxolitinib + parsaclisib (JAK1/JAK2 + PI3K ) Refractory myelofibrosis: Phase 3 in preparation
Ruxolitinib + INCB53914 (JAK1/JAK2 + PIM) Refractory myelofibrosis: Phase 2
Ruxolitinib + INCB57643 (JAK1/JAK2 + BET) Refractory myelofibrosis: Phase 2 in preparation
Ruxolitinib + INCB00928 (JAK1/JAK2 + ALK2) Myelofibrosis: Phase 2 in preparation
Recruitment has been discontinued in the RESET
trial evaluating ruxolitinib as a potential treatment for patients with essential thrombocythemia.
Oncology beyond MPNs - key highlights
Data from the randomized Phase 3 REACH2 trial
of ruxolitinib versus best available therapy (BAT) in patients with steroid-refractory acute graft-versus-host disease (GVHD)
have been accepted for presentation within the Presidential Symposium of the 46th annual meeting of the European Society for Blood
and Marrow Transplantation (EBMT, March 22-25). As previously announced, the trial, which was conducted in collaboration with
Novartis, met its primary endpoint of improving overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to BAT.
REACH3, the Phase 3 trial of ruxolitinib in
patients with steroid-refractory chronic GVHD being run in collaboration with Novartis, is ongoing and results are expected in
the second half of 2020. If successful, and if approved, steroid-refractory chronic GVHD would be the fourth Jakafi indication
available to patients in the US.
In January, it was announced that GRAVITAS-301,
the Phase 3 trial of itacitinib as a treatment for patients with newly diagnosed acute GVHD, did not meet the primary endpoint.
Clinical development of itacitinib also includes
GRAVITAS-309, a Phase 3 trial of itacitinib as a treatment for patients with newly diagnosed chronic GVHD.
In November, the FDA accepted the New Drug
Application (NDA) for pemigatinib in second-line cholangiocarcinoma for Priority Review. The Prescription Drug User Fee Act (PDUFA)
target action date is May 30, 2020. In early January, Incyte announced that the Marketing Authorization Application (MAA) seeking
approval in Europe for pemigatinib as a second-line treatment for cholangiocarcinoma patients with FGFR2 fusions or rearrangements
was validated by the EMA.
The CITADEL program is evaluating parsaclisib
as a monotherapy across three types of non-Hodgkin lymphoma: follicular lymphoma; marginal zone lymphoma; and mantle cell lymphoma.
Clinical development of INCMGA0012 includes
ongoing evaluation as a monotherapy in niche cancer opportunities as well as a planned program for the first-line treatment of
patients with non-small cell lung cancer (NSCLC).
Incyte recently announced a global collaboration
with MorphoSys for the development and commercialization of tafasitamab, an anti-CD19 monoclonal antibody. Pending clearance by
antitrust authorities, the collaboration agreement is expected to become effective in the first half of 2020.
Indication and status
Ruxolitinib (JAK1/JAK2) Steroid-refractory chronic GVHD: Phase 3 (REACH3) 1
Itacitinib (JAK1) Treatment-na ve chronic GVHD: Phase 3 (GRAVITAS-309)
Pemigatinib (FGFR1/2/3) Cholangiocarcinoma: Phase 3 (FIGHT-302); NDA and MAA under review Bladder cancer: Phase 2 (FIGHT-201, FIGHT-205) 8p11 MPN: Phase 2 (FIGHT-203) Tumor agnostic: Phase 2 (FIGHT-207)
Parsaclisib (PI3K ) Follicular lymphoma: Phase 2 (CITADEL-203) Marginal zone lymphoma: Phase 2 (CITADEL-204) Mantle cell lymphoma: Phase 2 (CITADEL-205)
INCMGA0012 (PD-1) 2 MSI-high endometrial cancer: Phase 2 (POD1UM-101) Merkel cell carcinoma: Phase 2 (POD1UM-201) Anal cancer: Phase 2 (POD1UM-202) NSCLC: Phase 3 (POD1UM-301, POD1UM-304) in preparation
Inflammation and Autoimmunity (IAI) -
TRuE-AD2, the first of two Phase 3 trials in
the TRuE-AD development program of ruxolitinib cream in patients with mild-to-moderate atopic dermatitis, met its primary endpoint.
The overall efficacy and safety profile observed in TRuE-AD2 was consistent with previous data, and no new safety signals were
The results of TRuE-AD1, the second of two
Phase 3 trials required for regulatory submission, are anticipated to be available in the first quarter of 2020. The NDA submission,
seeking approval of ruxolitinib cream in atopic dermatitis, is expected in the fourth quarter of 2020 following long-term safety
and efficacy data from both pivotal trials.
The two Phase 3 trials in the TRuE-V pivotal
program evaluating ruxolitinib cream in patients with vitiligo are recruiting well and results are expected in 2021.
Phase 2 trials of INCB54707 in hidradenitis
suppurativa and parsaclisib in autoimmune hemolytic anemia are progressing as planned.
The clinical program of INCB00928, Incyte's
ALK2 inhibitor, is in preparation in patients with fibrodysplasia ossificans progressiva, a disorder in which muscle tissue and
connective tissue such as tendons and ligaments are gradually replaced by bone.
The Phase 2 trial of low-dose itacitinib in
patients with ulcerative colitis has been discontinued, and initial data from the clinical evaluation of parsaclisib in patients
with Sj gren's syndrome did not warrant continuation of the trial.
Indication and status
Ruxolitinib cream (JAK1/JAK2) Atopic dermatitis: Phase 3 (TRuE-AD1 ongoing, TRuE-AD2 primary endpoint met) Vitiligo: Phase 3 (TRuE-V1, TRuE-V2)
INCB54707 (JAK1) Hidradenitis suppurativa: Phase 2
Parsaclisib (PI3K ) Autoimmune hemolytic anemia: Phase 2
INCB00928 (ALK2) Fibrodysplasia ossificans progressiva: Phase 2 in preparation
Discovery and early development -
Incyte's portfolio of earlier-stage clinical
candidates is summarized below.
Modality Candidates
Small molecules INCB01158 (ARG) 1 , INCB81776 (AXL/MER), INCB62079 (FGFR4), epacadostat (IDO1), INCB59872 (LSD1), INCB86550 (PD-L1)
Monoclonal antibodies 2 INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies MCLA-145 (PD-L1xCD137) 3
Partnered - key highlights
In January, Incyte and Lilly announced initial
results of BREEZE-AD4 and BREEZE-AD5, the final two trials in the pivotal program evaluating baricitinib in patients with moderate-to-severe
atopic dermatitis. Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate-to-severe
atopic dermatitis, and has announced plans to submit for approval in the U.S. and Japan in 2020.
In February, Incyte and Novartis announced
that the NDA for capmatinib was accepted for Priority Review by the FDA, seeking approval in patients with NSCLC and MET exon
14 skipping mutations.
Indication and status
Baricitinib (JAK1/JAK2) 1 Atopic dermatitis: Phase 3 (BREEZE-AD) Systemic lupus erythematosus: Phase 3 Severe alopecia areata: Phase 3
Capmatinib (MET) 2 NSCLC (with MET exon 14 skipping mutations): NDA submitted (by Novartis)
2019 Fourth Quarter and Year-End Financial
The financial measures presented in this press
release for the quarter and year ended December 31, 2019 and 2018 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.
Beginning in the first quarter of 2019, after
reviewing our Reconciliation of GAAP Net Income to Selected Non-GAAP Adjusted Information with the U.S. Securities & Exchange
Commission, we no longer adjust for upfront consideration and milestones that are part of collaboration agreements with new or
existing partners. This revised methodology is reflected in this press release for the quarter and year ended December 31, 2019
Last updated: Feb 13, 2020