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Incyte Reports 2020 First Quarter Financial Results and Provides Updates on Key Clinical Programs - Total product and royalty revenues of $569 million (+24% vs Q1 2019) for the quarter ended

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

Full Press Release Details

Incyte Reports 2020 First Quarter Financial
and Provides Updates on Key Clinical Programs
Conference Call and Webcast Scheduled Today
WILMINGTON, Del. - May
5, 2020 - Incyte (Nasdaq: INCY) today reports 2020 first quarter financial results, and provides a status update
on the Company's development portfolio.
"Our strong first quarter results highlight continued
revenue momentum, led by robust demand across all three indications for Jakafi (ruxolitinib)," stated Herv
Hoppenot, Chief Executive Officer, Incyte. "As we navigate this unprecedented and uncertain time, we have implemented numerous
initiatives as we seek to ensure continuity of patient care. We are continuing to execute on our goals, and we were very pleased
to announce the FDA approval of PemazyreTM (pemigatinib), the first of three potential product approvals that we expect
to announce in 2020. The FDA review of the capmatinib NDA and tafasitamab BLA are proceeding as expected and, following positive
results from our Phase 3 TRuE-AD development program in atopic dermatitis, we are also on track to submit the NDA for ruxolitinib
cream at the end of 2020, all of which positions us for what I expect to be a transformational year."
Commercial, Supply and Clinical & Regulatory Impact
While it is currently not possible to predict the overall long-term
impact of the COVID-19 pandemic on Incyte's business, to-date, there has been no impact on the commercial side of the business,
and Incyte currently has ample commercial and clinical supply of our medicines to meet the needs of patients receiving Incyte's
approved medicines and those participating in global clinical trials. Incyte's manufacturing processes are proceeding as
usual, with increased manufacturing efforts for ruxolitinib in place to respond to the COVID-19 pandemic and study requests. Incyte
continues to move forward with its global clinical trials, and late-stage programs remain broadly on track, although short-term
effects may continue to emerge. For example, while ongoing monitoring of already-enrolled patients is expected to continue, new
patient recruitment in certain clinical studies may be impacted. The impact on clinical trials may also vary by disease state and
by severity of disease, as well as by geography, as some regions are more adversely impacted.
Ruxolitinib and baricitinib as potential therapies for patients
Incyte has initiated a Phase 3 clinical trial (RUXCOVID) to
evaluate the efficacy and safety of ruxolitinib plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19
associated cytokine storm. The collaborative study is sponsored by Incyte in the United States and by Novartis outside of the United
Incyte is also opening a second Phase 3 clinical trial in the
United States to evaluate the efficacy and safety of ruxolitinib plus SoC, compared to SoC therapy alone, in COVID-19 patients
on mechanical ventilation and who have acute respiratory distress syndrome (ARDS), a type of respiratory failure characterized
by rapid onset of widespread inflammation in the lungs.
Additionally, Incyte has launched an emergency Expanded Access
Program in the United States to allow eligible patients with COVID-19 associated cytokine storm to receive ruxolitinib.
In April, Lilly announced it has entered into an agreement with
the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study baricitinib
as an arm in NIAID's Adaptive COVID-19 Treatment Trial. The study will investigate the efficacy and safety of baricitinib as a
potential treatment for hospitalized patients diagnosed with COVID-19 in the US, and Lilly is also planning a study expansion to
include Europe and Asia.
LIMBER - key highlights
Key LIMBER development programs,
including the once-a-day (QD) formulation of ruxolitinib, and the ongoing and planned ruxolitinib combinations with parsaclisib
(PI3K ), PIM, BET and ALK2 are currently on track.
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
Oncology beyond MPNs - key highlights
In April, the FDA approved Pemazyre, Incyte's selective
fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated, unresectable locally advanced
or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test. Pemazyre was
reviewed under Breakthrough Therapy designation and granted accelerated approval based on overall response rate and duration of
response. The marketing authorization application (MAA) seeking approval for pemigatinib in Europe is under review by the European
Medicines Agency (EMA).
Delays in data collection and validation, caused by COVID-19
related disruption, mean that data from the FIGHT-201 clinical trial of pemigatinib in patients with bladder cancer are now expected
to be presented at a medical conference in early 2021; all other clinical trials of pemigatinib are currently progressing as expected.
Data from the Phase 3 REACH 2 trial of ruxolitinib versus best
available therapy (BAT) in patients with steroid-refractory acute graft-versus-host disease (GVHD) have been published in The
New England Journal of Medicine and are also expected to be presented at the 46th annual meeting of the European
Society for Blood and Marrow Transplantation (EBMT) in August 30-September 2, 2020 (postponed from March 22-25, 2020). The Phase
3 REACH 3 trial of ruxolitinib versus BAT in patients with steroid-refractory chronic GVHD has completed recruitment and results
are expected in the second half of 2020.
The collaboration and license agreement with MorphoSys for the
development and commercialization of tafasitamab became effective in March. In February, the FDA granted Priority Review for tafasitamab
in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and set
a PDUFA goal date of August 30, 2020.
Preparations are ongoing to initiate the Phase 3 POD1UM-304
trial of retifanlimab (formerly INCMGA0012) in combination with platinum-based chemotherapy as a first-line treatment for patients
with non-small cell lung cancer (NSCLC). Incyte no longer plans to pursue the Phase 3 POD1UM-301 trial of retifanlimab in combination
with chemoradiation therapy (CRT) in participants with unresectable, Stage III NSCLC.
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 2 (FIGHT-202), Phase 3 (FIGHT-302); MAA under review Bladder cancer: Phase 2 (FIGHT-201, FIGHT-205) 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); BLA under review 1L DLBCL: Phase 1b (First-MIND)
parsaclisib (PI3K ) Follicular lymphoma: Phase 2 (CITADEL-203) Marginal zone lymphoma: Phase 2 (CITADEL-204) Mantle cell lymphoma: Phase 2 (CITADEL-205)
retifanlimab (PD-1) 3 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-304) in preparation
Inflammation and Autoimmunity (IAI) - key highlights
In April, safety and efficacy data from the two Phase 3 trials
in the TRuE-AD program evaluating ruxolitinib cream in mild-to-moderate atopic dermatitis were presented at the Revolutionizing
Atopic Dermatitis (RAD) virtual symposium. The 44-week long-term safety and efficacy portion of both the TRuE-AD1 and TRuE-AD2
trials are ongoing and the NDA submission is expected before the end of 2020.
The two Phase 3 trials in the TRuE-V pivotal program evaluating
ruxolitinib cream in patients with vitiligo are currently proceeding as planned, and results are expected in 2021.
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 2
parsaclisib (PI3K ) Autoimmune hemolytic anemia: Phase 2
INCB00928 (ALK2) Fibrodysplasia ossificans progressiva: Phase 2 in preparation
Discovery and early development - key highlights
Based on emerging data from the FGFR4 inhibitor program, development
of INCB62079 has been discontinued because of insufficient efficacy in the target patient population. Incyte's portfolio
of other earlier-stage clinical candidates is summarized below.
Modality Candidates
Small molecules INCB01158 (ARG) 1 , INCB81776 (AXL/MER), 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 March, Incyte and Lilly announced the FDA has granted Breakthrough
Therapy designation for baricitinib for the treatment of alopecia areata, an autoimmune disorder that can cause unpredictable hair
loss on the scalp, face and other areas of the body. In January, Lilly submitted baricitinib for regulatory review in Europe and
Japan as a treatment for patients with moderate-to-severe atopic dermatitis, and has announced plans to submit for approval in
In February, Incyte and Novartis announced that the NDA for
capmatinib, seeking approval in patients with metastatic non-small cell lung cancer (NSCLC) and with a mutation leading to exon
14 skipping as detected by an FDA-approved test, was accepted for Priority Review by the FDA.
Indication and status
baricitinib (JAK1/JAK2) 1 Atopic dermatitis: Phase 3 (BREEZE-AD) Systemic lupus erythematosus: Phase 3 Severe alopecia areata: Phase 3 (BRAVE-AA1)
capmatinib (MET) 2 NSCLC (with MET exon 14 skipping mutations): NDA (by Novartis) under review
2020 First Quarter Financial Results
financial measures presented in this press release for the three months ended March 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
Last updated: May 5, 2020