Slide 1: 2020 Fourth Quarter Financial and Corporate Update
2020 Fourth Quarter Financial and Corporate Update FEBRUARY 9, 2021
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS Except for the historical information set forth herein, the matters set forth in this presentation contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: our opportunities for growth and diversification, incl
Slide 3: Fourth Quarter and Year-End Review
FOURTH QUARTER AND YEAR-END REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Strength Across Entire Portfolio Fuels Growth
STRENGTH ACROSS ENTIRE PORTFOLIO FUELS GROWTH FY 2020 FY20/FY19 Total Rev3 Revenues Growth +24% 2,800 MPNs & GVHD $1,938m +15% (+15% y/y) 2,400 Heme/Onc $105m +17% 2,000 (+46% y/y) Total Revenues ($m) $26m ̶ 1,600 $22m1 ̶ Product & royalty 1,200 revenues +18% Royalties $278m +23% (+28% y/y) 800 $111
Slide 5: Opportunities for Growth and Diversification
OPPORTUNITIES FOR GROWTH AND DIVERSIFICATION SEVEN SUBMISSIONS SEEKING APPROVAL, ALL WITH DECISIONS DUE IN 2021 LIMBER development progressing (PI3Kδ, BET, ALK2, CK08041) MPNs and GVHD sNDA submitted for Jakafi® in steroid-refractory chronic GVHD Successful launches of Monjuvi® and Pemazyre®
Slide 6: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 7: Patient Demand Driving Jakafi Growth
PATIENT DEMAND DRIVING JAKAFI ® GROWTH FY2021 guidance: 2,200 $2.125 to $2.200 billion 2,000 FY2020 sales $1.94 billion 1,938 1,800 1,600 Excellent Jakafi performance in 2020 Jakafi® net product revenues ($m) Robust patient demand across MF, PV and GVHD 1,400 Total number of patients on therap
Slide 8: Launch of Pemazyre Progressing Well
LAUNCH OF PEMAZYRE ® PROGRESSING WELL DURATION OF THERAPY DRIVING PERFORMANCE Percent dispenses by Repeat/New Patients 100% FY2020 sales $26 million New patients 90% 80% ~300 prescribers since launch 70% >65% prescribers are community-based oncologists 60% Repeat patients 50% Testing for FGFR2
Slide 9: Monjuvi: Strong Product Profile Driving Uptake
MONJUVI ®: STRONG PRODUCT PROFILE DRIVING UPTAKE AS EXPECTED, HIGH ADOPTION BY COMMUNITY ONCOLOGISTS Monjuvi US Sales1 $17 million FY2020 sales $22 million1 400+ accounts have purchased Monjuvi More than doubled since Q3 update Continued strong growth of utilization in community setting Near
Slide 10: Ruxolitinib Cream: Planning for Launch
RUXOLITINIB CREAM: PLANNING FOR LAUNCH FDA DECISION FOR ATOPIC DERMATITIS EXPECTED MID -YEAR Promotional focus at launch US Epidemiology of AD ~5.5 million AD patients age 12+ receive Rx treatment 21.2m Prevalence High unmet need: Only 22% of patients report AD is (7.5% of US Population ≥12 year
Slide 11: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 12: Significant Clinical Progress in 2020
SIGNIFICANT CLINICAL PROGRESS IN 2020 Jakafi ® : REACH3 results in SR chronic GVHD; sNDA submitted MPNs and GVHD LIMBER: once-a-day ruxolitinib development progressing LIMBER: ruxolitinib+parsaclisib PoC data in MF LIMBER: ruxolitinib+parsaclisib Phase 3 program underway LIMBER: PoC trials
Slide 13: Multiple Regulatory Actions Expected in 2021
MULTIPLE REGULATORY ACTIONS EXPECTED IN 2021 7 expected approvals 6 expected submissions MPNs and GVHD Jakafi® in cGVHD Hematology/Oncology tafasitamab in DLBCL parsaclisib in NHL pemigatinib in CCA retifanlimab in SCAC Dermatology ruxolitinib cream in AD ruxolitinib cream in vitiligo
Slide 14: LIMBER: Opportunities for Growth in MPNs & GVHD
LIMBER: OPPORTUNITIES FOR GROWTH IN MPNs & GVHD 2021-2022 2023-2024 2025-2026 2027-2028 2029-2030+ QD ruxolitinib FDA decision U.S. patent exclusivity1 MF QD ruxolitinib (JAK1/2, 2033) rux+PI3Kδ P3 results FDA decision Opportunities for parsaclisib (PI3Kδ, 2032) FDCs with QD rux rux+BET PoC tr
Slide 15: Tafasitamab: Multiple Trials Initiating in 2021
TAFASITAMAB: MULTIPLE TRIALS INITIATING IN 2021 Phase/Indication Phase 3 in 1L DLBCL Phase 3 in r/r FL & MZL POC in NHL POC in NHL # patients ~900 ~600 NA NA Tafasitamab Tafasitamab + LEN + R-CHOP + LEN + rituximab (R2) Tafasitamab Tafasitamab Drug Arms vs vs + parsaclisib + LEN + plamotamab1 R-CHOP
Slide 16: Development Strategy for Retifanlimab
DEVELOPMENT STRATEGY FOR RETIFANLIMAB Retifanlimab (PD-1) INCB81776 (AXL/MER) 3000 Vehicle control (mean ± SEM, mm3) TGI Dual AXL/MER inhibition expected to Anti–PD-L1 Tumor Volume BLA under FDA review for SCAC impair oncogenic effects of TAM kinases 2000 INCB81776 INCB81776 + anti–PD-L1 31% PDUFA
Slide 17: Financial Results
FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO
Slide 18: Non-GAAP Adjustments
NON-GAAP ADJUSTMENTS Management has chosen to present financial highlights for the quarter and year ended December 31, 2020 and 2019 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 externall
Slide 19: Financial Highlights: Revenues
FINANCIAL HIGHLIGHTS: REVENUES Q4 2020 Q4 2019 YoY Change FY 2020 FY 2019 YoY Change $ millions GAAP GAAP GAAP GAAP Net product revenues 559 491 14% 2,069 1,775 17% Jakafi 517 466 11% 1,938 1,685 15% Iclusig 29 24 18% 105 90 17% Pemazyre 14 - NM 26 - NM Royalties 120 89 35% 393 306 28% Jakavi 87 65
Slide 20: Financial Highlights: Operating Expenses
FINANCIAL HIGHLIGHTS: OPERATING EXPENSES Q4 2020 Q4 2019 YoY Change FY 2020 FY 2019 YoY Change $ millions GAAP GAAP GAAP GAAP COGS 36 32 13% 131 114 15% R&D 406 313 30% 2,216 1,154 92% R&D – ongoing 380 310 23% 1,240 1,126 10% R&D – upfront and milestones 26 3 NM 976 28 NM SG&A 167 136 23% 517 469 1
Slide 21: Revenue Growth Exceeds Expense Growth
REVENUE GROWTH EXCEEDS EXPENSE GROWTH $m 2,500 Product & royalty revenue 2,000 1,500 GAAP R&D expense (ongoing) excluding upfront and milestones1 1,000 500 GAAP SG&A expense 0 FY 2015 FY 2016 FY 2017 FY 2018 FY 2019 FY 2020 21 1. Chart shows Product & royalty revenue, GAAP ongoing R&D expense (exclu
Slide 22: Financial Guidance: Full Year 2021
FINANCIAL GUIDANCE: FULL YEAR 2021 FY 2021 GAAP FY 2021 Non-GAAP1 Net product revenues Jakafi $2,125 – $2,200 million $2,125 – $2,200 million Other Hematology/Oncology (Iclusig in EU and Pemazyre in U.S.) $145 – $160 million $145 – $160 million Product revenue guidance does not include revenue from
Slide 23: 2021 Outlook
2021 OUTLOOK HERVÉ HOPPENOT – CEO
Slide 24: Important Updates Expected in 2021
IMPORTANT UPDATES EXPECTED IN 2021 H1 2021 H2 2021 LIMBER: QD ruxolitinib BA/BE data Jakafi ® : FDA decision (SR chronic GVHD) MPNs and GVHD LIMBER: JAK+BET PoC trial to begin LIMBER: JAK+ALK2 PoC trial to begin tafasitamab: frontMIND to begin (P3, 1L DLBCL) tafasitamab: MAA decision (r/r DLBCL) taf
Slide 25: Financial Back-Up Slides
cs - FINANCIAL BACK-UP SLIDES oe
Slide 26: Financial Highlights: Fourth Quarter
FINANCIAL HIGHLIGHTS: FOURTH QUARTER Q4 2020 Q4 2019 Q4 2020 Q4 2019 $ millions GAAP GAAP Non-GAAP1 Non-GAAP1 Net product revenues 559 491 559 491 Jakafi 517 466 517 466 Iclusig 29 24 29 24 Pemazyre 14 - 14 - Royalties 120 89 120 89 Jakavi 87 65 87 65 Olumiant 31 24 31 24 Tabrecta 2 - 2 - Total prod
Slide 27: Financial Highlights: Full Year 2020
FINANCIAL HIGHLIGHTS: FULL YEAR 2020 FY 2020 FY 2019 FY 2020 FY 2019 $ millions GAAP GAAP Non-GAAP1 Non-GAAP1 Net product revenues 2,069 1,775 2,069 1,775 Jakafi 1,938 1,685 1,938 1,685 Iclusig 105 90 105 90 Pemazyre 26 0 26 0 Royalties 393 306 393 306 Jakavi 278 226 278 226 Olumiant 111 80 111 80 T
Slide 28: 2020 and 2019 Non-GAAP Reconciliation
2020 AND 2019 NON-GAAP RECONCILIATION $ millions Q4 2020 Q4 2019 FY 2020 FY 2019 GAAP operating income (loss) 164 95 (264) 402 Adjustments Non-cash stock compensation from equity awards 45 42 178 167 Amortization of acquired product rights 5 5 22 22 Change in fair value of contingent consideration 4
Slide 29: 2021 Financial Guidance Non-GAAP Reconciliation
2021 FINANCIAL GUIDANCE NON-GAAP RECONCILIATION GAAP Guidance Adjustments Non-GAAP Guidance Net product revenues Jakafi $2,125 – $2,200 million - $2,125 – $2,200 million Other Hematology/Oncology $145 – $160 million - $145 – $160 million Costs and expenses COGS 6 – 7% net product revenues Amortizati
Slide 30: ir@incyte.com investor.incyte.com
ir@incyte.com investor.incyte.com