2023 Second Quarter
Financial and Corporate Update
A U G U S T 1 , 2 0 2 3
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte's potential for continued performance and growth; Incyte's financial guidance for 2023, including its expectations regarding sales of Jakafi; expectations with respect to demand for and uptake of Opzelura; the potential for ruxolitinib cream to expand into other indications; expectations regarding the potential and progress of programs in our pipeline, including axatilimab in chronic graft-versus-host disease and ruxolitinib cream in pediatric atopic dermatitis; expectations regarding ongoing clinical trials and clinical trials to be initiated, including the LIMBER program, Incyte's oral PD-L1 program, various phase 2 and phase 3 trials for ruxolitinib cream, phase 2 and 3 trials of povorcitinib in multiple indications, and a phase 1 trial of auremolimab in vitiligo; our and our collaborators' potential for receiving additional regulatory approvals within the next 1-2 years and the corresponding potential for launches of new products and/or indications; expectations regarding ongoing launches by us and our collaborators; and our expectations regarding 2023 newsflow items.
These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA, EMA, and other regulatory agencies; Incyte's dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte's products and the products of Incyte's collaboration partners; the acceptance of Incyte's products and the products of Incyte's collaboration partners in the marketplace; market competition; unexpected variations in the demand for Incyte's products and the products of Incyte's collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte's products and the products of Incyte's collaboration partners; sales, marketing, manufacturing and distribution requirements, including Incyte's and its collaboration partners' ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte's reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2022. Incyte disclaims any intent or obligation to update these forward- looking statements.
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SECOND QUARTER REVIEW
HERVÉ HOPPENOT - CEO
Product revenues up 25% driven by Opzelura launch momentum
$682m
(+14% Y/Y)
$80m
(+384% Y/Y)
$64m
(+30% Y/Y)
900 | +25% | |||||
800 | ||||||
($m) | 700 | |||||
600 | ||||||
Revenues | 500 | |||||
Product | 400 | |||||
300 | ||||||
Total | 200 | |||||
100 | ||||||
0 | ||||||
Q2 2021 | Q2 2022 | Q2 2023 | ||||
Total Product | $827 million |
Revenues | (+25% Y/Y) |
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Continued execution across research and development
Clinical development
- Positive topline results for two high potential programs:
Ruxolitinib cream in pediatric AD | Primary endpoint met |
Axatilimab1 in chronic GVHD | Primary endpoint met |
across all treatment cohorts | |
Pipeline advancement
Zilurgisertib (ALK2)
INCB57643 (BET)
INCA33989 (mCALR)
INCB99280 (oral PD-L1)
Tafasitamab2 (CD19)
Ruxolitinib Cream
Povorcitinib (JAK1)
Updated data presented at ASCO
Updated data presented at ASCO
Phase 1 study initiated
Mono and combo studies initiated
Phase 3 FL/MZL (inMIND): fully enrolled
Phase 2 LS, LP and HS: completed enrollment
Phase 2 asthma and CSU studies initiated
R&D
- New Head of R&D
Pablo J. Cagnoni, M.D.
AD= atopic dermatitis; GVHD= graft-versus-host disease; FL= follicular lymphoma; MZL= marginal zone lymphoma; LS= lichen sclerosus; LP= lichen planus; HS= hidradenitis suppurativa; CSU= chronic spontaneous urticaria
1Development of axatilimab in collaboration with Syndax Pharmaceuticals. | 5 |
2Development and U.S. commercialization of tafasitamab in collaboration with MorphoSys. |
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Incyte Corporation published this content on 01 August 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 01 August 2023 11:38:21 UTC.