On November 2, 2021 Incyte (Nasdaq:INCY) reported 2021 third quarter financial results and provides a status update on the Company’s development portfolio (Press release, Incyte, NOV 2, 2021, View Source [SID1234594127]).

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"Incyte has transformed as a Company over the last two years, as we deliver on our goal of diversifying and growing our revenue," said Hervé Hoppenot, Chief Executive Officer, Incyte. "Multiple product approvals and global launches have significantly expanded our portfolio; our robust development pipeline continues to mature and progress; and we expect several additional regulatory submissions to occur over the coming months. Our strong third quarter performance is the result of an increasingly diversified portfolio, driven by double-digit growth in patient demand for Jakafi (ruxolitinib), continued uptake of both Pemazyre (pemigatinib) and Monjuvi/Minjuvi (tafasitamab) as well as a significant and rapidly-growing royalty revenue stream."

Portfolio Update

MPNs and GVHD – key highlights

Jakafi approval in chronic graft-versus-host disease (GVHD): In September, the U.S. Food and Drug Administration (FDA) granted approval of Jakafi for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. There are approximately 14,000 people in the U.S. living with chronic GVHD, with more than half requiring therapy beyond systemic corticosteroids.

Collaboration with Syndax Pharmaceuticals: In September, Incyte and Syndax Pharmaceuticals announced an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody, in chronic GVHD and other fibrotic diseases, pending regulatory clearance. The global pivotal Phase 2 AGAVE-201 trial of axatilimab monotherapy in patients with chronic GVHD in the third line setting is ongoing. Additional trials of axatilimab are planned, including a Phase 2 trial in combination with a JAK inhibitor in patients with steroid-refractory chronic GVHD.

LIMBER (Leadership In MPNs BEyond Ruxolitinib) program: Once-daily (QD) ruxolitinib is in stability testing and is on track for a new drug application (NDA) submission early next year. Multiple JAK-based combination studies are either ongoing or planned.

Indication and status

QD ruxolitinib
(JAK1/JAK2)

Myelofibrosis, polycythemia vera and GVHD: clinical pharmacology studies

ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)

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

ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)

Myelofibrosis: PoC in preparation

itacitinib (JAK1)

Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS‑309)

axatilimab (anti-CSF-1R)2

Chronic GVHD (third-line therapy): Phase 2 (AGAVE-201)

1 Development collaboration with Cellenkos, Inc.
2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals.

Other Hematology/Oncology – key highlights

Minjuvi approval in relapsed or refractory DLBCL: In August, Incyte and MorphoSys announced that the European Commission granted conditional marketing authorization for Minjuvi in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL, of which the majority would be eligible for Minjuvi.

Parsaclisib in non-Hodgkin lymphomas (NHLs): In November, we announced that the FDA accepted a NDA seeking approval of parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma. The submission is based on data from several Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory NHLs (follicular, marginal zone and mantle cell). Priority Review was granted by the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with MCL who have received at least one prior therapy; the Prescription Drug User Fee Act (PDUFA) target action date for these indications is April 30, 2022. The NDA for use of parsaclisib in adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies will have a Standard Review and a PDUFA target action date of August 30, 2022.

Parsaclisib in hemolytic anemia: A Phase 3 trial evaluating the efficacy and safety of parsaclisib in adults with warm autoimmune hemolytic anemia is planned.

Retifanlimab: In October, Incyte withdrew the marketing authorization application (MAA) seeking approval of retifanlimab in squamous cell carcinoma of the anal canal (SCAC) in Europe. The withdrawal was based on the provisional view of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) that the available data to date, provided in the MAA, were not sufficient to permit an approval for the proposed indication.

Indication and status1

pemigatinib
(FGFR1/2/3)

CCA: Phase 3 (FIGHT‑302)
Myeloid/lymphoid neoplasms (MLN): Phase 2 (FIGHT‑203)
Tumor agnostic: Phase 2 (FIGHT-207)
Glioblastoma: Phase 2 in preparation
NSCLC: Phase 2 in preparation

tafasitamab
(CD19)2

Relapsed or refractory DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND)
First-line DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND)
Relapsed or refractory FL and Relapsed or refractory MZL: Phase 3 (inMIND)
Relapsed or refractory CLL: Phase 2 (coreMIND) in preparation
Relapsed or refractory B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ)
Relapsed or refractory B-cell malignancies: PoC with lenalidomide and plamotamab in preparation3

parsaclisib
(PI3Kδ)

Relapsed or refractory FL: Phase 2 (CITADEL‑203)
Relapsed or refractory MZL: Phase 2 (CITADEL‑204)
Relapsed or refractory MCL: Phase 2 (CITADEL‑205)
Relapsed or refractory FL and Relapsed or refractory MZL: Phase 3 (CITADEL‑302)
in preparation
First-line MCL: Phase 3 (CITADEL‑310) in preparation
Autoimmune hemolytic anemia: Phase 2; Phase 3 in preparation

retifanlimab
(PD‑1)4

SCAC: Phase 2 (POD1UM‑202); Phase 3 (POD1UM‑303)
MSI-high endometrial cancer: Phase 2 (POD1UM‑101, POD1UM‑204)
Merkel cell carcinoma: Phase 2 (POD1UM‑201)
NSCLC: Phase 3 (POD1UM‑304)

1 CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma; MCL = mantle cell lymphoma; CLL = chronic lymphocytic leukemia
2 Development of tafasitamab in collaboration with MorphoSys.
3 Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab.
4 Retifanlimab licensed from MacroGenics.

Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

Opzelura (ruxolitinib) cream approval in atopic dermatitis (AD): In September, Incyte announced that the FDA approved Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Ruxolitinib cream in vitiligo: In October, full 24-week safety and efficacy data from the two Phase 3 TRuE-V studies evaluating ruxolitinib cream in vitiligo were presented at the European Academy of Dermatology and Venereology (EADV) 30th Congress. In October, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. A supplementary NDA is in progress.

INCB54707: In October, Incyte initiated a Phase 2 trial evaluating adults with prurigo nodularis. Phase 2 trials in vitiligo and in hidradenitis suppurativa are ongoing.

Other IAI

INCB00928 in fibrodysplasia ossificans progressiva (FOP): A Phase 2 trial evaluating adults with FOP is in preparation. The FDA has granted Fast Track designation and orphan drug designation to INCB00928 as a treatment for patients with FOP.

Indication and status

ruxolitinib cream1
(JAK1/JAK2)

Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2, primary endpoint met in both studies); sNDA
and MAA in progress

INCB54707 (JAK1)

Hidradenitis suppurativa: Phase 2b
Vitiligo: Phase 2
Prurigo nodularis: Phase 2

INCB00928 (ALK2)

Fibrodysplasia ossificans progressiva: Phase 2 in preparation

1 Novartis’ rights for ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.

Discovery and early development – key highlights

Incyte’s portfolio of other earlier-stage clinical candidates is summarized below.

Modality

Candidates

Small molecules

INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1), INCB99280 (PD-
L1), INCB99318 (PD-L1), INCB106385 (A2A/A2B)

Monoclonal antibodies1

INCAGN1876 (GITR), INCAGN2385 (LAG‑3), INCAGN1949 (OX40), INCAGN2390
(TIM‑3), INCA00186 (CD73)

Bispecific antibodies

MCLA‑145 (PD-L1xCD137)2

1 Discovery collaboration with Agenus.
2 MCLA‑145 development in collaboration with Merus.

Partnered – key highlights

Baricitinib in alopecia areata: In September, Incyte and Lilly announced detailed results from BRAVE-AA1 and BRAVE-AA2 at the European Academy of Dermatology and Venereology Congress (EADV). The two studies showed statistically significant improvement in scalp hair regrowth across both baricitinib dosing groups when compared to placebo.

Indication and status

baricitinib (JAK1/JAK2)1

Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU and Japan; sNDA under
review
Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2)
Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II)

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; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis.
2 Worldwide rights to capmatinib licensed to Novartis.

2021 Third Quarter Financial Results

The financial measures presented in this press release for the three and nine months ended September 30, 2021 and 2020 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.