On August 2, 2022 Incyte (Nasdaq:INCY) reported 2022 second quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, AUG 2, 2022, View Source [SID1234617270]).

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"In July, Opzelura was also approved by the FDA in nonsegmental vitiligo, creating a new growth opportunity as the first therapy approved for repigmentation of vitiligo."

"The second quarter was strong with total revenues up 29% year-over-year, multiple approvals and the continued advancement of our pipeline. The launch of Opzelura in atopic dermatitis continues to progress well and in recent weeks, improvements in reimbursement have translated into an increase in covered claims. Revenues in the second quarter were temporarily impacted by the shift from free drug to paid prescription. Patient demand and satisfaction remain strong," said Hervé Hoppenot, Chief Executive Officer, Incyte. "In July, Opzelura was also approved by the FDA in nonsegmental vitiligo, creating a new growth opportunity as the first therapy approved for repigmentation of vitiligo."

Portfolio Updates

MPNs and GVHD – key highlights

LIMBER (Leadership In MPNs BEyond Ruxolitinib) program: The LIMBER development program is advancing with the FDA acceptance of the NDA for once-daily (QD) ruxolitinib, and the progression of multiple ongoing and planned combination trials with ruxolitinib. The Prescription Drug User Fee Act (PDUFA) target action date for QD ruxolitinib extended release (XR) formulation is March 23, 2023. Incyte’s partner, Cellenkos, announced the FDA clearance of its Investigational New Drug (IND) application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib. Combination trials of parsaclisib, INCB57643 (BET) and INCB00928 (ALK2) with ruxolitinib are also ongoing.

Itacitinib in chronic graft-versus-host disease (GVHD): Incyte no longer intends to develop itacitinib, a selective JAK1 inhibitor, in treatment-naïve chronic GVHD (cGVHD). Based on efficacy data from Part 1 of the Phase 2/3 GRAVITAS-309 trial, it was determined that a pivotal trial was unlikely to be successful.

Indication and status

QD ruxolitinib
(JAK1/JAK2)

Myelofibrosis, polycythemia vera and GVHD: clinical pharmacology studies; NDA under review

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

ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)

Myelofibrosis: Phase 2

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

Myelofibrosis: PoC (LIMBER-TREG108)

axatilimab (anti-CSF-1R)2

Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (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

Pemigatinib (Pemazyre): A Phase 2 open-label study evaluating the efficacy and safety of pemigatinib in adults with previously treated glioblastoma or other primary central nervous system tumors harboring activating FGFR1-3 alterations (FIGHT-209) and a Phase 2 open-label study evaluating the efficacy and safety of pemigatinib in adults with relapsed or refractory advanced non-small cell lung cancer with an FGFR alteration (FIGHT-210) are ongoing.

Indication and status

pemigatinib
(FGFR1/2/3)

Cholangiocarcinoma (CCA): Phase 3 (FIGHT‑302)
Myeloid/lymphoid neoplasms (MLN): Phase 2 (FIGHT‑203)
Glioblastoma: Phase 2 (FIGHT-209)

Non-small cell lung cancer (NSCLC): Phase 2 (FIGHT-210)

tafasitamab

(CD19)1

Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 2 (L-MIND); Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND)
Relapsed or refractory B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ)
Relapsed or refractory B-cell malignancies: PoC with lenalidomide and plamotamab2

parsaclisib
(PI3Kδ)

Warm autoimmune hemolytic anemia: Phase 3 (PATHWAY)

retifanlimab
(PD‑1)3

Squamous cell anal cancer (SCAC): 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 Development of tafasitamab in collaboration with MorphoSys.
2 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.
3 Retifanlimab licensed from MacroGenics.

Inflammation and Autoimmunity (IAI) – key highlights

Dermatology

Continued momentum with Opzelura launch in atopic dermatitis (AD) in the U.S.: Coverage for Opzelura has been established with the three largest PBM/GPOs and more plans continue to add Opzelura to formularies. The demand for Opzelura continues to be strong with nearly 48,000 units of Opzelura shipped in the second quarter and we expect strong physician and patient perceptions of Opzelura to drive increased usage in mild to moderate AD patients.

Opzelura approved for vitiligo in the U.S.; under review in Europe: Opzelura was approved as a treatment for nonsegmental vitiligo – which account for ~85% of patients with vitiligo – in adolescents and adults in the U.S., becoming the first and only medicine approved for repigmentation in vitiligo. The marketing authorization application (MAA) is under review at the European Medicines Agency (EMA) with an expected decision from the Committee for Medicinal Products for Human Use (CHMP) by the end of the year.

Povorcitinib (INCB54707): Povorcitinib is currently in Phase 2 trials for hidradenitis suppurativa (HS), vitiligo and prurigo nodularis. Based on findings from the Phase 2 trial, Incyte intends to initiate a Phase 3 study in HS later this year.

Indication and status

ruxolitinib cream1
(JAK1/JAK2)

AD: Phase 3 pediatric study (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2); approved by FDA; MAA under review

CHE: Phase 3 (TRuE-CHE1 and TRuE-CHE2) in preparation

ruxolitinib cream + UVB

(JAK1/JAK2 + phototherapy)

Vitiligo: Phase 2

povorcitinib (JAK1)

Hidradenitis suppurativa: Phase 2b; Phase 3 in preparation
Vitiligo: Phase 2

Prurigo nodularis: Phase 2

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.

INCB123667 (CDK2): INCB123667 is a novel, potent and selective oral small molecule inhibitor of CDK2 which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models, in vivo. A Phase 1 dose-escalation and dose-expansion study of INCB123667 in adults with selected advanced or metastatic solid tumors has been initiated.

INCA32459 (LAG-3xPD-1): In collaboration with Merus, Incyte has developed INCA32459, a novel LAG3xPD-1 bispecific antibody that is planned to enter clinical studies later this year.

Modality

Candidates

Small molecules

INCB81776 (AXL/MER), INCB99280 (PD-L1), INCB99318 (PD-L1), INCB106385 (A2A/A2B), INCB123667 (CDK2)

Monoclonal antibodies1

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

Bi-specific antibodies

INCA32459 (LAG-3xPD-1)2

1 Discovery collaboration with Agenus.
2 Development in collaboration with Merus

Partnered – key highlights

Jakavi (ruxolitinib) approved for acute and chronic GVHD in Europe: In May, Incyte and Novartis announced the European Commission (EC) approval of Jakavi as the first post-steroid treatment for acute and chronic graft-versus-host disease (GVHD).

Olumiant (baricitinib) approved for alopecia areata (AA) in U.S., Europe and Japan: In June, Incyte and Eli Lilly announced the approval of Olumiant for the treatment of adults with severe alopecia areata in the U.S., becoming the first-in-disease systemic treatment. Olumiant was also approved in Europe and Japan in June. The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials, which showed one in three adults taking Olumiant 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage.

Tabrecta (capmatinib) approved in non-small cell lung cancer (NSCLC) with MET exon-14 in Europe: In June, Tabrecta was approved by the European Commission as a monotherapy for the treatment of adults with advanced NSCLC harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Indication and status

ruxolitinib (JAK1/JAK2)1

Acute and chronic GVHD: approved in Europe; J-NDA under review

baricitinib (JAK1/JAK2)2

AD: Phase 3 (BREEZE-AD); approved in Europe and Japan
Severe AA: Phase 3 (BRAVE-AA1, BRAVE-AA2); approved in the U.S., Europe and Japan

capmatinib (MET)3

NSCLC (with MET exon 14 skipping mutations): approved in the U.S., Europe and Japan

1 Jakavi (ruxolitinib) licensed to Novartis ex-US.
2 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.
3 Worldwide rights to capmatinib licensed to Novartis.

2022 Second Quarter Financial Results

The financial measures presented in this press release for the three and six months ended June 30, 2022 and 2021 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.

Product and Royalty Revenues Product and royalty revenues for the quarter ended June 30, 2022 increased 12% over the prior year comparative period primarily as a result of increases in Jakafi and Opzelura net product revenues, and higher royalty revenues from Jakavi. Jakafi net product revenues for the quarter ended June 30, 2022 increased 13% over the prior year comparative period, primarily driven by growth in patient demand across all indications.

1 Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.
2 Non-GAAP research and development expenses exclude the cost of stock-based compensation.
3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and legal settlements.
4 Non-GAAP change in fair value of acquisition-related contingent consideration is null.

Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2022 increased 1%, compared to the same period in 2021 primarily due to continued investment in our late stage development assets.

Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2022 increased 50% and 54%, respectively, compared to the same period in 2021, primarily due to expenses related to our dermatology commercial organization and activities to support the launch of Opzelura for the treatments of atopic dermatitis and pre-launch activities for vitiligo.

Other Financial Information

Operating income GAAP operating income for the quarter ended June 30, 2022 increased compared to the same period in 2021, driven by growth in product revenues.

Cash, cash equivalents and marketable securities position As of June 30, 2022 and December 31, 2021, cash, cash equivalents and marketable securities totaled $2.7 billion and $2.3 billion, respectively.

2022 Financial Guidance

Incyte is tightening its full year 2022 guidance for Jakafi net product revenues as a result of our strong second quarter performance.

1Pemazyre in the U.S., EU and Japan and Iclusig and Minjuvi in the EU.
2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.
3 Adjusted to exclude the estimated cost of stock-based compensation.

Conference Call and Webcast Information

Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877‑407‑3042 for domestic callers or 201‑389‑0864 for international callers. When prompted, provide the conference identification number, 13731520.

If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877‑660‑6853 and the dial-in number for international callers is 201‑612‑7415. To access the replay you will need the conference identification number, 13731520.

The conference call will also be webcast live and can be accessed at investor.incyte.com.