On November 5, 2020 Incyte (Nasdaq: INCY) reported 2020 third quarter financial results, and provides a status update on the Company’s development portfolio (Press release, Incyte, NOV 5, 2020, View Source [SID1234570109]).
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"We are pleased to report another strong quarter for Incyte, with continued strength across all Jakafi (ruxolitinib) indications, good momentum behind the U.S. launches of both Monjuvi (tafasitamab-cxix) and Pemazyre (pemigatinib), as well as increasing royalty contributions from our partnered medicines globally," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "In addition, we have now established Incyte Dermatology as a new franchise for Incyte in the U.S., and we are on track to submit the NDA for ruxolitinib cream at the end of this year which, by using our priority review voucher, could lead to an FDA decision in the middle of next year."
Portfolio Update
LIMBER – key highlights
Two pivotal trials are being initiated to evaluate the combination of ruxolitinib and parsaclisib as both first-line therapy for myelofibrosis (MF) patients and in MF patients with an inadequate response to ruxolitinib monotherapy.
The Phase 2 monotherapy trial of INCB57643 (BET) in patients with refractory myelofibrosis are now recruiting and the Phase 2 monotherapy trial of INCB00928 (ALK2) in patients with myelofibrosis is being opened. Both programs are expected to proceed to ruxolitinib combination trials upon completion of monotherapy cohorts.
Indication and status
Once-a-day ruxolitinib
(JAK1/JAK2)
Myelofibrosis and polycythemia vera: clinical pharmacology studies
ruxolitinib + parsaclisib
(JAK1/JAK2 + PI3Kδ)
Myelofibrosis: Phase 3 in preparation
Myelofibrosis: Phase 3 in preparation (inadequate responders to ruxolitinib)
ruxolitinib + INCB57643
(JAK1/JAK2 + BET)
Myelofibrosis: Phase 2 in preparation
ruxolitinib + INCB00928
(JAK1/JAK2 + ALK2)
Myelofibrosis: Phase 2 in preparation
Oncology beyond MPNs – key highlights
In August, Monjuvi (tafasitamab-cxix) in combination with lenalidomide was included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell Lymphomas with a Category 2A designation as an option for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and who are not eligible for autologous stem cell transplant (ASCT).
The European Marketing Authorization Application (MAA) for tafasitamab as a treatment for patients with r/r DLBCL is under review. Incyte has exclusive development and commercialization rights to tafasitamab outside of the U.S.
Incyte and MorphoSys plan to further broaden the development program of tafasitamab in other B-cell malignancies. Multiple trials are in preparation, including Phase 3 trials in both first line DLBCL and relapsed/refractory follicular lymphoma, as well as a proof-of-concept trial of tafasitamab plus parsaclisib (PI3Kδ).
In September, initial results from the Phase 2 POD1UM-202 trial of retifanlimab in previously treated patients with advanced squamous cell anal carcinoma (SCAC) who have progressed following standard platinum-based chemotherapy were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting. The Phase 3 POD1UM-303 trial of retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with SCAC is open for recruitment.
Given the rapidly evolving treatment landscape for bladder cancer and recent regulatory feedback, Incyte is reevaluating its development strategy for pemigatinib in bladder cancer. As part of that reevaluation, new patient recruitment into FIGHT-205, which is assessing pemigatinib in cisplatin-ineligible bladder cancer patients whose tumors express FGFR3 mutation or rearrangement, has been stopped, and Incyte no longer intends to use data from FIGHT-201 to seek accelerated approval for pemigatinib in patients with previously treated bladder cancer whose tumors express FGFR3 mutation or rearrangement.
Indication and status
ruxolitinib
(JAK1/JAK2)
Steroid-refractory chronic GVHD: Phase 3 (REACH3)1 primary endpoint met
itacitinib
(JAK1)
Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309)
pemigatinib
(FGFR1/2/3)
CCA: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302); MAA, NDS and J-NDA under review
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); MAA under review
1L DLBCL: Phase 1b (First-MIND); Phase 3 (Front-MIND) in preparation
r/r follicular lymphoma: Phase 3 in preparation
r/r B-cell malignancies: PoC with parsaclisib (PI3Kδ) in preparation
parsaclisib
(PI3Kδ)
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
MSI-high endometrial cancer: Phase 2 (POD1UM-101); Phase 2 (POD1UM-204) in preparation
Merkel cell carcinoma: Phase 2 (POD1UM-201)
SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303) open for recruitment
NSCLC: Phase 3 (POD1UM-304)
CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma
1)
Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis
2)
Development of tafasitamab in collaboration with MorphoSys
3)
retifanlimab licensed from MacroGenics
Inflammation and Autoimmunity (IAI) – key highlights
Dermatology
Incyte Dermatology has been established as a new franchise for Incyte in the U.S., which will include dedicated teams for the development and commercialization of Incyte’s dermatology portfolio.
The NDA for ruxolitinib cream in atopic dermatitis is on track for submission at the end of 2020. Incyte has acquired a priority review voucher, which it intends to use to accelerate the timeline to FDA decision.
Pooled results from the TRuE-AD studies were presented at the European Academy of Dermatology and Venereology (EADV) Congress. Ruxolitinib cream demonstrated clinically meaningful improvements in patient-reported quality of life assessments, such as the PROMIS (patient-reported outcomes measurement information system) sleep disturbance (8b) score, as well as substantial and sustained itch reduction, reinforcing its potential as an important treatment option for atopic dermatitis patients.
The two randomized Phase 3 trials in the TRuE-V pivotal program evaluating ruxolitinib cream in patients with vitiligo are fully recruited, with results expected in 2021.
Other IAI
Initial clinical results from INCB54707, a JAK1 selective inhibitor, were presented in October. INCB54707 demonstrated preliminary efficacy, improved quality of life (QoL) including a reduction in skin pain and a tolerable safety profile in patients with moderate-to-severe hidradenitis suppurativa (HS). A Phase 2b, randomized, double-blind, placebo-controlled trial evaluating INCB54707 in HS is ongoing.
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 2b
parsaclisib
(PI3Kδ)
Autoimmune hemolytic anemia: Phase 2
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.
Clinical translational data from the ongoing proof-of-concept trial of INCB86550, Incyte’s first-in-class oral small molecule inhibitor of PD-L1, have been accepted for presentation at the 2020 Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) meeting. As previously disclosed, initial clinical efficacy and safety data from this trial are expected to be presented in 2021, once these data mature.
Modality
Candidates
Small molecules
INCB01158 (ARG)1, INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1)
Monoclonal antibodies2
INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies
MCLA-145 (PD-L1xCD137)3
1)
INCB01158 licensed from Calithera
2)
Discovery collaboration with Agenus
3)
MCLA-145 development in collaboration with Merus
Potential therapies for patients with COVID-19
Patient recruitment into the Phase 3 RUXCOVID study evaluating ruxolitinib versus standard-of-care in hospitalized patients with COVID-19 associated cytokine storm has been completed, and topline results are expected to be available before the end of 2020.
In September, Incyte and Eli Lilly announced initial results from the baricitinib arm of the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT-2), where baricitinib in combination with remdesivir reduced the time to recovery (primary endpoint) in comparison with remdesivir alone.
Additional data announced in October showed that baricitinib plus remdesivir resulted in a numerical decrease in mortality through Day 29 compared to remdesivir alone, with a more pronounced reduction seen in more severely ill patients.
Status
ruxolitinib
(JAK1/JAK2)
COVID-19 associated cytokine storm: Phase 3 (RUXCOVID1; DEVENT)
baricitinib
(JAK1/JAK2)2
Hospitalized patients with COVID-19: Phase 3 (ACTT-23; COV-BARRIER)
1)
Sponsored by Incyte in the United States and by Novartis outside of the United States
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 for moderate to severe atopic dermatitis.
3)
ACTT-2 agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health
Partnered – key highlights
In October, Lilly announced that the European Commission granted marketing authorization for Olumiant (baricitinib) 4mg and 2mg tablets in Europe for the treatment of adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy, becoming the first JAK-inhibitor indicated to help treat patients with AD.
In September, Incyte and Novartis announced that GEOMETRY mono-1 results of TabrectaTM (capmatinib) in patients with METex14 metastatic non-small cell lung cancer (NSCLC) were published in The New England Journal of Medicine.
Indication and status
baricitinib
(JAK1/JAK2)1
Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU
Systemic lupus erythematosus: Phase 3
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
Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis
Worldwide rights to capmatinib licensed to Novartis
2020 Third Quarter Financial Results
The financial measures presented in this press release for the three and nine months ended September 30, 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 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 three and nine months ended September 30, 2020 increased 16% and 19%, respectively, over the prior year comparative periods primarily as a result of increases in Jakafi net product revenues, the launch of Pemazyre and higher product royalty revenues from Jakavi and Olumiant. Jakafi net product revenues for the three and nine months ended September 30, 2020 increased 13% and 17%, respectively, over the prior year comparative periods, 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.
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 three months ended September 30, 2020 increased 56% and 63%, respectively, compared to the same period in 2019, primarily due to $120 million of expense related to the purchase of an FDA priority review voucher from a third party, which we intend to use to accelerate the FDA review of ruxolitinib cream for the treatment of atopic dermatitis and an increase in milestone expenses related to our collaborative agreements. For the nine months ended September 30, 2020, GAAP and Non-GAAP research and development expense increased 115% and 128%, respectively, compared to the same period in 2019, primarily due to upfront consideration of $805 million related to our collaborative agreement with MorphoSys and expense related to the purchase of the FDA priority review voucher.
Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the three months and nine months ended September 30, 2020 increased 18% and 5%, respectively, compared to the same periods in 2019, primarily due to increased headcount and activities supporting the commercialization of our products and the timing of certain expenses.
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating income for the three months ended September 30, 2020 decreased compared to the same period in 2019, primarily due to $120 million of expense related to the purchase of the FDA priority review voucher and milestone expenses related to our collaborative agreements. For the nine months ended September 30, 2020 we recorded an operating loss compared to operating income for the same period in 2019, on both a GAAP and Non-GAAP basis, primarily due to upfront consideration related to our collaboration with MorphoSys and expense related to the FDA priority review voucher, partially offset by the growth in product and royalty revenues.
Cash, cash equivalents and marketable securities position As of September 30, 2020 and December 31, 2019, cash, cash equivalents and marketable securities totaled $1.7 billion and $2.1 billion, respectively. The decrease is primarily driven by the upfront payment and stock purchase related to our collaborative agreement with MorphoSys and purchase of the FDA priority review voucher and is partially offset by the cash flow generated during this nine-month period.
2020 Financial Guidance
Incyte has tightened its full year 2020 guidance for Jakafi net product revenues, as detailed below. The company’s full year 2020 financial guidance is summarized in the following table. The R&D expense guidance excludes $805 million of upfront consideration paid under the MorphoSys collaboration and $120 million of expense related to the purchase of the FDA priority review voucher (PRV). The financial guidance also excludes the impact of any potential future strategic transactions.
1. Amounts exclude Non-GAAP adjustments (e.g., stock based comp, amortization of acquired product rights for Iclusig and change in fair value of estimated future royalties for Iclusig). Research and development expenses also excludes $805 million of upfront consideration paid under the MorphoSys collaboration and $120 million of expense related to the purchase of the FDA priority review voucher.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at 8:00 a.m. EDT. 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, 13711777.
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, 13711777.
The conference call will also be webcast; the livestream and the replay can be accessed at investor.incyte.com.