On August 3, 2021 Incyte (Nasdaq:INCY) reported 2021 second quarter financial results and provides a status update on the Company’s development portfolio (Press release, Incyte, AUG 3, 2021, View Source [SID1234585576]).
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"In the second quarter, we saw an acceleration of growth of Jakafi (ruxolitinib) and encouraging uptake in Europe for Pemazyre (pemigatinib). In addition, the recent positive CHMP opinion for tafasitamab and the potential subsequent launch of tafasitamab (Minjuvi) in Europe represents another significant growth opportunity for Incyte," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We continue to achieve clinical development success across our portfolio with positive outcomes from multiple programs, including topline results from ruxolitinib cream’s pivotal trials in vitiligo (TRuE-V), 52-week safety and efficacy data of ruxolitinib cream in atopic dermatitis (TRuE-AD), Phase 2 data of parsaclisib in autoimmune hemolytic anemia (AIHA) and the achievement of bioequivalence with once-daily (QD) ruxolitinib."
Portfolio Update
MPNs and GVHD – key highlights
Ruxolitinib in GVHD: Data from the REACH3 trial of ruxolitinib versus best available therapy (BAT) in patients with steroid-refractory chronic graft-versus-host disease (GVHD) have been published in The New England Journal of Medicine. The supplemental New Drug Application (sNDA) seeking approval of ruxolitinib for the treatment of steroid-refractory chronic GVHD is under review; the Prescription Drug User Fee Act (PDUFA) date was extended to September 22, 2021.
LIMBER (Leadership In MPNs BEyond Ruxolitinib): Bioavailability and bioequivalence data were published for ruxolitinib’s QD extended release (XR) formulation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress. QD ruxolitinib is in stability testing with an NDA submission planned for early 2022. Clinical studies evaluating ruxolitinib in combination with parsaclisib, INCB57643 (BET) and INCB00928 (ALK2), are progressing as expected.
Updated interim data from the proof-of-concept trial evaluating parsaclisib in combination with ruxolitinib in myelofibrosis (MF) patients with an inadequate response to ruxolitinib monotherapy were also presented at EHA (Free EHA Whitepaper).
Indication and status
Once-a-day 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
itacitinib
(JAK1)
Myelofibrosis: Phase 2 (second-line therapy)
ruxolitinib + CK08041
(JAK1/JAK2 + CB-Tregs)
Myelofibrosis: PoC in preparation
ruxolitinib
(JAK1/JAK2)
Steroid-refractory chronic GVHD2: sNDA under review
itacitinib
(JAK1)
Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS‑309)
1 Development collaboration with Cellenkos, Inc.
2 Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis
Other Hematology/Oncology – key highlights
Tafasitamab: In June, Incyte and MorphoSys 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 tafasitamab in combination with lenalidomide, followed by tafasitamab 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).
Updated three-year data from the Phase 2 L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL were presented at EHA (Free EHA Whitepaper). Multiple studies evaluating tafasitamab as a backbone therapy in various combinations for the treatment of patients with DLBCL, follicular lymphoma, marginal zone lymphoma and other B-cell malignancies are underway, including two Phase 3 trials (inMIND and frontMIND) currently ongoing. An additional proof of concept trial (coreMIND) of tafasitamab in combination with parsaclisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) is expected to start in the next six months.
Pemigatinib: The ongoing launch in the United States continues to go well and the recent launches in Europe and Japan are on track. FIGHT-207, evaluating pemigatinib in tumor agnostic FGFR malignancies, is now closed to recruitment. Based on findings from this study, Incyte has identified populations that may potentially benefit from treatment with pemigatinib and intends to initiate Phase 2 studies in glioblastoma and non-small cell lung cancer by early next year.
Retifanlimab: In July, Incyte announced that the FDA issued a complete response letter for the Biologics License Application (BLA) for retifanlimab as a treatment for squamous cell carcinoma of the anal canal (SCAC). Registration-directed trials of retifanlimab in MSI-high endometrial and Merkel cell carcinoma are ongoing. The Marketing Authorization Application (MAA) seeking approval of retifanlimab in SCAC remains under review with the European Medicines Agency (EMA).
Indication and status
pemigatinib
(FGFR1/2/3)
CCA: Phase 2 (FIGHT‑202), 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)1
r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); CHMP+ opinion
1L DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND)
r/r FL and r/r MZL: Phase 3 (inMIND)
r/r CLL: Phase 2 (coreMIND) in preparation
r/r B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ) in preparation
r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation2
parsaclisib
(PI3Kδ)
r/r FL: Phase 2 (CITADEL‑203)
r/r MZL: Phase 2 (CITADEL‑204)
r/r MCL: Phase 2 (CITADEL‑205)
r/r FL and r/r MZL: Phase 3 (CITADEL‑302) in preparation
1L MCL: Phase 3 (CITADEL‑310) in preparation
retifanlimab
(PD‑1)3
SCAC: Phase 2 (POD1UM‑202); Phase 3 (POD1UM‑303); CRL from FDA; MAA 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; MCL = mantle cell lymphoma; CLL = chronic lymphocytic leukemia
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
Ruxolitinib cream: In June, 52-week safety and efficacy data from the two Phase 3 TRuE-AD studies evaluating ruxolitinib cream in mild-to-moderate atopic dermatitis were presented at the Revolutionizing Atopic Dermatitis (RAD) virtual symposium. These data were the basis for an NDA seeking approval of ruxolitinib cream for the treatment of atopic dermatitis (AD); the PDUFA date has been extended to September 21, 2021.
A Phase 3 trial (TRuE-AD3) evaluating ruxolitinib cream in children (ages 2 to <12 years) with atopic dermatitis is ongoing.
In May, Incyte announced positive topline results from its pivotal Phase 3 TRuE-V program of ruxolitinib cream in adolescent and adult patients with vitiligo. Both TRuE-V1 and TRuE-V2 studies met the primary and key secondary endpoints, including patient reported outcomes. The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data, and no new safety signals were observed. The long-term efficacy and safety portions of both studies will continue as planned. The regulatory submission seeking approval of ruxolitinib cream in vitiligo is expected later this year.
Other IAI
Parsaclisib: At EHA (Free EHA Whitepaper), Incyte presented Phase 2 data evaluating parsaclisib in autoimmune hemolytic anemia. The majority of patients achieved a response with parsaclisib over the initial 12-week treatment period. Treatment with parsaclisib was generally well tolerated. Based on these results, Incyte plans to initiate a Phase 3 trial by end of year.
Indication and status
ruxolitinib cream
(JAK1/JAK2)
Atopic dermatitis: NDA under review; Phase 3 pediatric study ongoing (TRuE-AD3)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2, primary endpoint met in both studies); sNDA in preparation
INCB54707
(JAK1)
Hidradenitis suppurativa: Phase 2b
Vitiligo: Phase 2
parsaclisib
(PI3Kδ)
Autoimmune hemolytic anemia: Phase 2; Phase 3 in preparation
INCB00928
(ALK2)
Fibrodysplasia ossificans progressiva: Phase 2 in preparation
Discovery and early development – key highlights
Incyte’s portfolio of other earlier-stage clinical candidates is summarized below.
Modality
Candidates
Small molecules
INCB01158 (ARG)1, INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1), INCB106385 (A2A/A2B)
Monoclonal antibodies2
INCAGN1876 (GITR), INCAGN2385 (LAG‑3), INCAGN1949 (OX40), INCAGN2390 (TIM‑3), INCA00186 (CD73)
Bispecific antibodies
MCLA‑145 (PD-L1xCD137)3
1 INCB01158 development in collaboration with Calithera
2 Discovery collaboration with Agenus
3 MCLA‑145 development in collaboration with Merus
Partnered – key highlights
Baricitinib: In July, Incyte and Lilly announced that the FDA would not meet the PDUFA action date for the sNDA for baricitinib for the treatment of adults with moderate to severe atopic dermatitis. Baricitinib is also being studied in alopecia areata with an expected submission in H2 2021.
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
Corporate Update
After almost 20 years at Incyte, Wenqing Yao, Ph.D. has announced his retirement as Executive Vice President and Head of Medicinal Chemistry. Dr. Yao will be succeeded by a member of his senior leadership team.
2021 Second Quarter Financial Results
The financial measures presented in this press release for the three and six months ended June 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.
Financial Highlights
Product and Royalty Revenues Product and royalty revenues for the quarter ended June 30, 2021 increased 17% over the prior year comparative period as a result of increases in Jakafi, Iclusig and Pemazyre net product revenues and higher product royalty revenues from Jakavi, Olumiant and Tabrecta.
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 a legal reserve.
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, 2021 increased 20% and 24%, respectively, compared to the same period in 2020, primarily due to the progression of our pipeline including parsaclisib and our 55% share of the global and U.S. specific development costs for tafasitamab as well as product supply related costs to support the potential launch of ruxolitinib cream as a treatment for atopic dermatitis. Excluding the $12 million impact of incremental product supply costs and upfront and milestone payments, GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2021 increased approximately 16% and 20%, respectively, compared to the same period in 2020.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2021 increased 43% and 46%, respectively, compared to the same period in 2020, primarily due to expenses related to the establishment of our dermatology commercial organization and activities to support the potential launch of ruxolitinib cream for the treatment of atopic dermatitis.
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating income for the quarter ended June 30, 2021 decreased by $90 million and $93 million, respectively, compared to the same period in 2020 primarily due to an $85 million decrease in milestone and contract revenues.
Cash, cash equivalents and marketable securities position As of June 30, 2021 and December 31, 2020, cash, cash equivalents and marketable securities totaled $2.1 billion and $1.8 billion, respectively.
2021 Financial Guidance
Incyte is tightening its full year 2021 guidance for Jakafi net product revenues to reflect the impact of higher than anticipated government rebates and chargebacks and the new PDUFA date for ruxolitinib for the treatment of steroid-refractory chronic GVHD and is revising upward the range for other Hematology/Oncology net product revenues based on the performance of Pemazyre in the first half of 2021. In addition, the Company is reducing the range for selling, general and administrative expense to reflect lower expenses for ruxolitinib cream as a treatment for atopic dermatitis in the U.S. based on the PDUFA date extension to September 21, 2021. Guidance does not include revenue from any potential new product launches or the impact of any potential future strategic transactions. Incyte’s updated guidance is summarized below.
1 Adjusted 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.
2 Adjusted to exclude the estimated cost of stock-based compensation.
3 Adjusted to exclude the estimated cost of stock-based compensation and a legal reserve.
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, 13718346.
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, 13718346.
The conference call will also be webcast live and can be accessed at investor.incyte.com.