Slide 1: 2022 Fourth Quarter Financial and Corporate Update
2022 Fourth Quarter Financial and Corporate Update F E B R U A R Y 7, 2 0 2 3
Slide 2: Forward-Looking Statements
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 growth and diversification; Incyte’s financi
Slide 3: Fourth Quarter Review
FOURTH QUARTER REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Strong double-digit growth with increasing contribution from new launches
Strong double-digit growth with increasing contribution from new launches Product revenues ($m) FY’22 +18% Total $3.4 billion $3.4 billion Revenues (+14% Y/Y) $129 million (FY’22 net sales) FY’22 Launched in vitiligo Strong growth in AD $2.4 billion $2,747 $2,322 $3.4 billion ~190,000 patients
Slide 5: 2022 a year of portfolio expansion and pipeline progress
2022 a year of portfolio expansion and pipeline progress Key Pipeline Updates Regulatory Approvals Ruxolitinib XR (QD): NDA accepted (PDUFA March 23, 2023) Vitiligo in the U.S. Zilurgisertib (ALK2): Established proof of mechanism in improving anemia MPNs/ GVHD MLN with FGFR1 rearrangement in the
Slide 6: Product revenues have grown at 18% CAGR from 2017-2022
Product revenues have grown at 18% CAGR from 2017-2022 Product Revenue (2017-2022) 5-yr CAGR +18% $2.7b $2.3b $2.1b $1.8b $1.5b $1.2b FY'17 FY'18 FY'19 FY'20 FY'21 FY'22 6 xx
Slide 7: Delivering operational performance over the past 5 years
Delivering operational performance over the past 5 years Total Revenue vs 5-yr CAGR Total Oncology Revenue vs 5-yr CAGR 3,500 Operating Expenses 3,500 Total R&D + Oncology SG&A Total Revenue +17% Total Oncology Revenue +16% 3,000 3,000 2,500 Total R&D & SG&A 2,500 +13% Total R&D & Oncology SG&A +9%
Slide 8: Multiple drivers of future growth; important updates expected in 2023
Multiple drivers of future growth; important updates expected in 2023 Drivers of sustainable growth 2023 Key Updates Approval of ruxolitinib XR (QD) MPNs/GVHD Pivotal data for rux + parsa in MF + Pivotal data for axatilimab in cGVHD Extending leadership Updated combo data for BET/ALK2 Opzelu
Slide 9: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 10: Jakafi growth driven by new patient starts in MF, PV and GVHD
Jakafi growth driven by new patient starts in MF, PV and GVHD Q4’22 net sales $647m (+9% Y/ Y) Total patients on Jakafi by indication % by FY’22 net sales $2,409m (+13% Y/ Y) indication 25,000 FY’22 Patient demand grew across all indications in FY’22 20,000 MF: 43% Total patients on therapy Growth
Slide 11: Jakafi net product revenues
Expect continued growth of new patients and increased treatment duration Jakafi net product revenues Key drivers of future growth 2,500 $2,409 Established SOC in MF, PV and GVHD with long-term benefit +$275 +$197 Increase in new patient starts Jakafi net product revenues ($m) +$253 2,000 Earli
Slide 12: Opzelura: Continued growth in AD and successful launch in vitiligo
Opzelura: Continued growth in AD and successful launch in vitiligo Q4’22 net sales $61m (+61% vs Q3’22) Opzelura Total Demand1 vs Total Paid Demand2 FY’22 net sales $129m Total Demand Paid Demand +34% ~84,700 >7,500 dermatologists have prescribed Opzelura Total unit demand grew 34% to 84,700 in
Slide 13: Driving continued uptake in AD and vitiligo; new approvals to add to growth
Driving continued uptake in AD and vitiligo; new approvals to add to growth Opportunity in AD Opportunity in vitiligo Efficacy, including itch relief, driving demand First and only FDA-approved therapy for repigmentation Patient adherence program increasing refills Positive physician / patie
Slide 14: Direct-to-consumer opportunities focus on motivating vitiligo patients
Direct-to-consumer opportunities focus on motivating vitiligo patients Strong Patient Social Media Advocacy Activity TV DTC * Launching Q1 14 *Photo credit: Non-segmental vitiligo patient, Alicia R., shares repigmentation progress as a result of using Opzelura for three months. xx
Slide 15: Continued uptake of Monjuvi/Minjuvi and new approval for Pemazyre
Continued uptake of Monjuvi/Minjuvi and new approval for Pemazyre Q4’22 net sales $25m 1 ; FY’22 net sales $89m Q4’22 net sales $23m (+17% Y/ Y) Q4’22 net sales $5m ; FY’22 net sales $20m FY’22 net sales $83m (+22% Y/ Y) Monjuvi sales up 13% Y/Y; continued growth in Community Continued growth in
Slide 16: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 17: Extensive pipeline across three therapeutic focus areas
Extensive pipeline across three therapeutic focus areas LIMBER Other Hematology/Oncology Dermatology PoC Pivotal PoC Pivotal PoC Pivotal + Zilurgisertib Ruxolitinib XR INCB99280 Tafasitamab Auremolimab Ruxolitinib cream (ALK2) (QD) (oral PD-L1) (CD19) (IL-15Rβ) (JAK1/JAK2) + INCB57643 + Parsaclisib
Slide 18: Multiple important updates from LIMBER program expected in 2023
Multiple important updates from LIMBER program expected in 2023 LIMBER Ruxolitinib XR + Parsaclisib + Zilurgisertib + INCB57643 + Axatilimab INCA33989 Axatilimab CK0804 Novel Targets (QD) (PI3Kδ) (ALK2) (BET) (CSF-1R) (mCALR) (CSF-1R) (CB-Tregs) Zilurgisertib established proof of mechanism INCA33989
Slide 19: Progress in Hematology/Oncology pipeline across all stages of development
Progress in Hematology/Oncology pipeline across all stages of development Other Hematology/Oncology INCB99280 INCB99318 Retifanlimab Parsaclisib Tafasitamab Pemigatinib INCB123667 INCB106385 INCA00186 (oral PD-L1) (oral PD-L1) (PD-1) (PI3Kδ) (CD19) (FGFR1/2/3) (CDK2) (A2A/A2B) (CD73) Complete Respon
Slide 20: Dermatology franchise expanding into new indications; new approvals in '23
Dermatology franchise expanding into new indications; new approvals in ‘23 Dermatology Ruxolitinib Cream Povorcitinib Auremolimab (JAK1/JAK2) (JAK1) (IL-15Rβ) Key Updates in 2023: H1’2023 Ruxolitinib cream: CHMP opinion for vitiligo Ruxolitinib cream: Phase 3 vitiligo maintenance data Povorcit
Slide 21: Important updates expected in 2023
Important updates expected in 2023 1H 2023 2H 2023 Ruxolitinib XR (QD) MF, PV, GVHD PDUFA (March 23) Axatilimab cGVHD Pivotal data mid-23 (AGAVE-201) MPNs/GVHD Parsaclisib + ruxolitinib myelofibrosis Pivotal data (suboptimal responders) ALK2 + ruxolitinib myelofibrosis Combination data BET + ruxolit
Slide 22: Financial Results
FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO
Slide 23: Non-GAAP adjustments
Non-GAAP adjustments Management has chosen to present financial highlights for the quarter and year ended December 31, 2022 and 2021 on both a GAAP and Non-GAAP basis in the belief that this Non-GAAP information is useful for investors. Management uses such information internally and externally
Slide 24: Financial highlights: Revenues
Financial highlights: Revenues YoY Change YoY Change Q4 2022 Q4 2021 YoY Change (constant YTD 2022 YTD 2021 YoY Change (constant $ millions GAAP GAAP (as reported) currency 2 ) GAAP GAAP (as reported) currency 2 ) Net product revenues 764 648 18% 19% 2,747 2,322 18% 19% Jakafi 647 592 9% 9% 2,409 2,
Slide 25: Opzelura: Broadening payer access and gross-to-net evolution
Opzelura: Broadening payer access and gross-to-net evolution 80% 73% 2022 GTN Exit 70% 64% Rate: 60% 50% % of Covered Claims 50% 41% 40% 30% 27% 20% 10% 0% Q1'22 Q2'22 Q3'22 Q4'22 GTN discount rate: Q1: 86% Q2: 81% Q3: 71% Q4: 57% 25 % covered claims includes total covered claims, whereas prior meth
Slide 26: IQVIA, Total demand and Paid demand
IQVIA, Total demand and Paid demand 100,000 90,000 80,000 70,000 60,000 73% 50,000 40,000 64% 30,000 20,000 41% 10,000 27% 0 Q1'22 Q2'22 Q3'22 Q4'22 1 2 3 1Source: IQVIA NPA Market Dynamics Monthly Data Dec’22. 2Total demand = Units shipped to pharmacies + free drug (internal data). 26 3Paid Demand
Slide 27: Financial highlights: Operating expenses
Financial highlights: Operating expenses Q4 2022 Q4 2021 YTD 2022 YTD 2021 $ millions GAAP GAAP YoY Change GAAP GAAP YoY Change COGS 59 44 35% 207 151 37% As a percentage of net product revenues 8% 7% 8% 7% R&D1 501 473 6% 1,586 1,458 9% R&D – ongoing 431 345 25% 1,460 1,309 12% R&D – upfront and mi
Slide 28: Financial guidance: Full year 2023
Financial guidance: Full year 2023 FY 2023 GAAP FY 2023 Non-GAAP2 Net product revenues Jakafi net product revenues $2.53 - $2.63 billion $2.53 - $2.63 billion Other Hematology/Oncology net product revenues1 $215 - $225 million $215 - $225 million Costs and expenses Cost of product revenues 7 – 8% of
Slide 29: Q&A
Q&A
Slide 30: Financial Back-up Slides
s = FINANCIAL BACK-UP SLIDES
Slide 31: Financial highlights: Q4
Financial highlights: Q4 $ millions Q4 2022 Q4 2021 Q4 2022 Q4 2021 YoY Change GAAP GAAP Non-GAAP Non-GAAP Net product revenues 764 648 764 648 18% Jakafi 647 592 647 592 9% Iclusig 28 27 28 27 2% Pemazyre 23 20 23 20 17% Minjuvi 5 4 5 4 10% Opzelura 61 5 61 5 NM Royalty revenues 132 165 132 165 (20
Slide 32: Financial highlights: Year to date
Financial highlights: Year to date $ millions YTD 2022 YTD 2021 YTD 2022 YTD 2021 YoY Change GAAP GAAP Non-GAAP Non-GAAP Net product revenues 2,747 2,322 2,747 2,322 18% Jakafi 2,409 2,135 2,409 2,135 13% Iclusig 106 109 106 109 (3%) Pemazyre 83 69 83 69 22% Minjuvi 20 5 20 5 300% Opzelura 129 5 129
Slide 33: Financial guidance Non-GAAP reconciliation
2022 Financial guidance Non-GAAP reconciliation GAAP Adjustments Non-GAAP Guidance Guidance Net product revenues Jakafi $2.53 – $2.63 billion - $2.53 – $2.63 billion Other Hematology/Oncology1 $215 – $225 million - $215 – $225 million Costs and expenses COGS 7 – 8% net product revenues Amortization