Slide 1: 2021 First Quarter Financial and Corporate Update
2021 First Quarter Financial and Corporate Update M AY 4 , 2 0 2 1
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 and our collaborators’ potential new product appro
Slide 3: First Quarter Review
FIRST QUARTER REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Continued Execution of Growth and Diversification Strategy
CONTINUED EXECUTION OF GROWTH AND DIVERSIFICATION STRATEGY 700 Clinical and regulatory progress $605 Pemazyre® approved in Europe and Japan 600 $569 Product & royalty revenues ($m) Three applications under Priority Review at FDA; two at EMA 500 $458 Ruxolitinib cream for atopic dermatitis (FDA) 40
Slide 5: Several Potential Approvals Over the Next 1-2 Years
SEVERAL POTENTIAL APPROVALS OVER THE NEXT 1-2 YRS PEMAZYRE ® IS NOW APPROVED IN THE U.S., EUROPE AND JAPAN Approved products Commercialized by Incyte Commercialized by Partners Potential new approvals within next 1-2 yrs ruxolitinib cream in AD, vitiligo ruxolitinib cream in vitiligo Incyte ru
Slide 6: Key Business Objectives in 2021
KEY BUSINESS OBJECTIVES IN 2021 Execute on strong recovery in H2 2021 Grow Drive new patient starts with Jakafi® in MPNs current portfolio Accelerate Monjuvi® uptake in 2L+ DLBCL Maintain U.S. momentum with Pemazyre®; Launch in Europe and Japan ruxolitinib cream in atopic dermatitis Execut
Slide 7: Global Responsibility
GLOBAL RESPONSIBILITY IMPORTANT PROGRESS MADE ON ESG PRIORITIES 1 PATIENTS ENVIRONMENT 2 FDA approvals granted in orphan drug indications in 2020 and 2021 100% of our wholly-owned and fully functional buildings3 are now landfill free 2 FDA submissions currently under Priority Review in orphan drug i
Slide 8: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 9: Jakafi: New Patient Starts at Pre-COVID Levels
JAKAFI ®: NEW PATIENT STARTS AT PRE-COVID LEVELS FY GUIDANCE REAFFIRMED; ANTICIPATE APPROVAL IN CHRONIC GVHD IN JUNE Jakafi® Net Product Revenues ($m) New patient starts in Q1’21 at pre-COVID levels Q1’21 YoY Rev Growth (%) +1.4% Q1 Q2 Q3 Q4 Demand (%)1 +2.3% GTN (%) -2.6% Inventory (%)2 -3.3% 459 4
Slide 10: Total Number of Patients on Pemazyre Growing
TOTAL NUMBER OF PATIENTS ON PEMAZYRE ® GROWING CONTINUOUS FLOW OF NEW PATIENTS Increasing use of Pemazyre in 2L CCA Q1 2021 sales $13 million 100% 100% Growth in total patients versus Q4 59% Duration of therapy driving performance Rapid adoption of testing for FGFR2+ alterations % oncologists
Slide 11: Monjuvi Progressing Despite COVID-19 Headwinds
MONJUVI ® PROGRESSING DESPITE COVID-19 HEADWINDS Cumulative purchasing accounts Q1 2021 sales $15.5 million1 >500 accounts end-March Encouraging account trends >25% increase (since Q4) in purchasing accounts to 500+ Growth of utilization in community setting (~70%) Slight increase in underly
Slide 12: Profile of Rux Cream Differentiated as Topical JAK
PROFILE OF RUX CREAM DIFFERENTIATED AS TOPICAL JAK FIELD FORCE PREPARED FOR IMMEDIATE LAUNCH UPON APPROVAL Perspective on efficacy/safety from key stakeholders High potential for ruxolitinib cream in atopic dermatitis Efficacy Metrics MARKET POTENTIAL MAP | Total Dermatology HCPs1 Rapid improvemen
Slide 13: Unmet Need in Vitiligo Treatment with Rux Cream
POTENTIAL TO ADDRESS SIGNIFICANT UNMET NEED IN THE TREATMENT OF VITILIGO WITH RUX CREAM FDA vitiligo panel1 highlights: Vitiligo has a significant impact on a patient’s quality of life “Corrective cosmetics have been both my saving grace and Nearly all patients stated losing pigmentation on the
Slide 14: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 15: Rux Cream Improves Itch and Sleep Quality in AD
RUX CREAM IMPROVES ITCH AND SLEEP QUALITY IN AD Significantly more patients achieve rapid, substantial and Meaningful improvements in sleep impairment sustained itch reduction with ruxolitinib cream vs vehicle with ruxolitinib cream vs vehicle Proportion of Patients Achieving Itch NRS4 Proportion of
Slide 16: Rux Cream Efficacy in Vitiligo Through 104 Weeks
RUX CREAM EFFICACY IN VITILIGO THROUGH 104 WEEKS LONGER DURATION OF TREATMENT ASSOCIATED WITH GREATER REPIGMENTATION IN PHASE 2 Phase 2 vitiligo two-year results Continued F-VASI responses through Week 104 Treatment with ruxolitinib cream produced substantial with ruxolitinib cream 1.5% BID repigm
Slide 17: Tafasitamab: Robust Clinical Program
TAFASITAMAB: ROBUST CLINICAL PROGRAM MULTIPLE PIVOTAL TRIALS ONGOING/INITIATING; TWO POC STUDIES IN PREPARATION Proof-of-Concept Pivotal tafasitamab + LEN + R-CHOP vs R-CHOP 1L DLBCL Primary endpoint: PFS tafasitamab + LEN + rituximab (R2) vs (R2) r/r FL & MZL Primary endpoint: PFS tafasitamab + ben
Slide 18: LIMBER: Combination Programs Underway
LIMBER: COMBINATION PROGRAMS UNDERWAY INCB000928 (ALK2) in presence of ruxolitinib QD ruxolitinib can correct anemia of inflammation BA/BE data in-house; expected approval in 2022 parsaclisib + ruxolitinib combination trials Hemoglobin (g/dL) Inadequate responders to ruxolitinib 1L MF patients
Slide 19: Important Updates Expected in 2021
IMPORTANT UPDATES EXPECTED IN 2021 H1 2021 H2 2021 LIMBER: QD ruxolitinib BA/BE data LIMBER: JAK+BET PoC trial to begin MPNs and GVHD Jakafi ® : FDA decision (SR chronic GVHD) LIMBER: JAK+ALK2 PoC trial to begin tafasitamab: frontMIND to begin (P3, 1L DLBCL) tafasitamab: MAA decision (r/r DLBCL) Hem
Slide 20: Financial Results
FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO
Slide 21: Non-GAAP Adjustments
NON-GAAP ADJUSTMENTS Management has chosen to present financial highlights for the quarter ended March 31, 2021 and 2020 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 for establ
Slide 22: Financial Highlights: Revenues
FINANCIAL HIGHLIGHTS: REVENUES $ millions Q1 2021 Q1 2020 YoY Change GAAP GAAP Net product sales 505 487 4% Ja ka fi 466 459 1% Icl us i g 26 27 (6%) Pema zyre 13 - Royalties 100 82 22% Ja ka vi 66 56 16% Ol umi a nt 32 25 27% Ta brecta 2 - Total product and royalty revenues 605 569 6% Totals may no
Slide 23: Financial Highlights: Operating Expenses
FINANCIAL HIGHLIGHTS: OPERATING EXPENSES $ millions Q1 2021 Q1 2020 YoY Change GAAP GAAP COGS 29 27 7% As a percentage of net product revenues 6% 6% R&D 307 1,085 (72%) R&D – ongoi ng 295 279 6% R&D – upfront a nd mi l es tones 12 806 (99%) SG&A 154 111 38% SG&A - ongoi ng 141 111 27% SG&A - l ega l
Slide 24: Financial Guidance: Full Year 2021
FINANCIAL GUIDANCE: FULL YEAR 2021 FY 2021 GAAP FY 2021 Non-GAAP1 Net product revenues Jakafi $2,125 – $2,220 million $2,125 – $2,220 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 25: Important Updates Expected in 2021
IMPORTANT UPDATES EXPECTED IN 2021 H1 2021 H2 2021 LIMBER: QD ruxolitinib BA/BE data LIMBER: JAK+BET PoC trial to begin MPNs and GVHD Jakafi ® : FDA decision (SR chronic GVHD) LIMBER: JAK+ALK2 PoC trial to begin tafasitamab: frontMIND to begin (P3, 1L DLBCL) tafasitamab: MAA decision (r/r DLBCL) Hem
Slide 26: Financial Back-Up Slides
cs - FINANCIAL BACK-UP SLIDES oe
Slide 27: Financial Highlights: Year to Date
FINANCIAL HIGHLIGHTS: YEAR TO DATE Three Months Ended Three Months Ended Three Months Ended Three Months Ended $ millions Mar 31, 2021 Mar 31, 2020 Mar 31, 2021 Mar 31, 2020 YoY Change GAAP GAAP Non-GAAP1 Non-GAAP1 Net product revenues 505 487 505 487 4% Jakafi 466 459 466 459 1% Iclusig 26 27 26 27
Slide 28: 2021 and 2020 Non-GAAP Reconciliation
2021 AND 2020 NON-GAAP RECONCILIATION Three Months Ended Three Months Ended $ millions Mar 31, 2021 Mar 31, 2020 GAAP operating income (loss) 99 (664) Adjustments Non-cash stock compensation from equity awards 47 43 Amortization of acquired product rights 5 5 Change in fair value of contingent consi
Slide 29: ir@incyte.com investor.incyte.com
ir@incyte.com investor.incyte.com