Full Press Release Details
Incyte Reports 2020 Fourth Quarter and
Year-End Financial Results,
Provides 2021 Financial Guidance and Updates on Key Clinical Programs
Conference Call and Webcast Scheduled Today
WILMINGTON, Del. - February 9, 2021 - 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 Herv 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."
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 + PI3K ) | 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 + CK0804 1 (JAK1/JAK2 + CB-Tregs) | Myelofibrosis: PoC in preparation | |
| ruxolitinib (JAK1/JAK2) | Steroid-refractory chronic GVHD 2 : sNDA submitted | |
| itacitinib (JAK1) | Treatment-na ve chronic GVHD: Phase 3 (GRAVITAS-309) |
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
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 (PI3K ) in preparation r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation 2 | |
| 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 | 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
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
Inflammation and Autoimmunity (IAI) - key highlights
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 (PI3K ) | 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 |
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) |
1. 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
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
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