Slide 1: 2021 Second Quarter Financial and Corporate Update
2021 Second Quarter Financial and Corporate Update AUGUST 3, 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: the potential approval and launch of tafasitamab (Min
Slide 3: Second Quarter Review
SECOND QUARTER REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Strong Growth in Q2; Multiple Pipeline Achievements
STRONG GROWTH IN Q2; MULTIPLE PIPELINE ACHIEVEMENTS Q2 2021 Q2’21/Q2’20 Revenues Growth Positive CHMP opinion for tafasitamab in the EU $529m +12% Multiple regulatory applications under review (2 FDA; 1 EMA) Product revenues Ruxolitinib cream for atopic dermatitis (FDA) $28m +24% Ruxolitinib for
Slide 5: Opportunities for Growth in Ex-US Markets
OPPORTUNITIES FOR GROWTH IN EX-US MARKETS PEMAZYRE ® LAUNCH ONGOING; TAFASITAMAB RECEIVES POSITIVE CHMP OPINION Pemazyre tafasitamab European & Japan approval in H1’21: European Commission decision in H2’21 First targeted therapy approved in the EU for patients +CHMP opinion received with CCA in
Slide 6: Key Business Objectives in H2 2021
KEY BUSINESS OBJECTIVES IN H2 2021 Grow Drive new patient starts with Jakafi in MPNs current Accelerate Monjuvi uptake in 2L+ DLBCL in the US portfolio Maintain momentum with Pemazyre® in US, Europe and Japan Execute ruxolitinib cream in atopic dermatitis on new ruxolitinib in steroid-refr
Slide 7: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 8: Jakafi: Growth Returning to Pre-COVID Levels
JAKAFI: GROWTH RETURNING TO PRE-COVID LEVELS 600 3,000 Q2’21 sales $529 million Jakafi Net Sales ($m) $529 # of New Patients 500 $474 Q2’21 performance in line with expectations: Net sales grew 12% year over year $410 400 2,000 # of new Patient growth across all indications patient starts $346
Slide 9: Pemazyre: Outpacing Expectations
PEMAZYRE: OUTPACING EXPECTATIONS 20 US ex-US + 33% Q2’21 sales $18 1million Sales growth continues +33% Q/Q Pemazyre net product revenues ($m) 15 Duration of therapy driving performance as use in 2L increases ~60% of patients since launch have been 2L In a recent survey, ~80% of prescribing
Slide 10: Monjuvi: Q2 Showing Positive Signs of Growth
MONJUVI: Q2 SHOWING POSITIVE SIGNS OF GROWTH 19 Q2’21 sales $18 million1 18 18 Q/Q growth of 16% Double digit demand growth; strong momentum exiting June Monjuvi net product revenues ($m) 17 Positive trends in new patient share Increasing use in 2L DLBCL 16 Positive feedback from HCPs on M
Slide 11: Ruxolitinib Cream in Atopic Dermatitis
RUXOLITINIB CREAM IN ATOPIC DERMATITIS OPPORTUNITY TO ADDRESS A SIGNIFICANT UNMET NEED HCPs and patients eager for new effective therapies ~5.5M A significant number of AD patients continue to experience symptoms despite treatment AD Patients Age 12+ Currently Receive Rx for AD High awareness an
Slide 12: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 13: Rux Cream: Long-Term Safety & Disease Control in AD
RUX CREAM: LONG-TERM SAFETY & DISEASE CONTROL IN AD 52-WEEK SAFETY AND EFFICACY DATA FROM TRuE-AD PROGRAM PRESENTED AT RAD % of patients with clear or almost clear skin Key Takeaways TRuE-AD2 Long-term disease control achieved with as-needed use of ruxolitinib 100 cream Patients with Clear or Almo
Slide 14: Rux Cream: Successful Phase 3 Program in Vitiligo
RUX CREAM: SUCCESSFUL PHASE 3 PROGRAM IN VITILIGO PRIMARY AND KEY SECONDARY ENDPOINTS ACHIEVED IN TR uE-V1 AND TRuE-V2 Phase 3 Results (Wk 24) Phase 2 Results Primary endpoint met (F-VASI75; TRuE-V1: p<0.0001; Continued improvement through 52 weeks TRuE-V2: p<0.01)1 No treatment-related seriou
Slide 15: Tafasitamab: 3-Year L-MIND Data Show Durable Responses
TAFASITAMAB: 3-YEAR L-MIND DATA SHOW CLINICALLY SIGNIFICANT DURABLE RESPONSES WITH REGIMEN Pivotal, single-arm trial of tafasitamab plus LEN, followed Overall Survival by Best Response by tafasitamab monotherapy in adults with r/r DLBCL 1.0 0.9 ≥35m follow-up data 0.8 0.7 Probability of OS Efficacy
Slide 16: Tafasitamab: Robust Clinical Program
TAFASITAMAB: ROBUST CLINICAL PROGRAM PIVOTAL TRIAL IN R/R CLL TO INITIATE IN 2021; MULTIPLE POC STUDIES TO START Proof-of-Concept Pivotal tafasitamab + LEN + R-CHOP 1L DLBCL Primary endpoint: PFS vs R-CHOP tafasitamab + LEN + rituximab (R2) r/r FL & MZL Primary endpoint: PFS vs R2 tafasitamab + bend
Slide 17: LIMBER: Multiple Strategies Underway
LIMBER: MULTIPLE STRATEGIES UNDERWAY REGULATORY APPROVAL FOR ONCE-DAILY RUXOLITINIB EXPECTED END 2022 QD ruxolitinib Potential for fixed-dose combinations in MF parsaclisib + ruxolitinib combination trials BA/BE study complete; results published at EHA 2021 Phase 3: Suboptimal responders to ruxoli
Slide 18: Ruxolitinib: Results Published in NEJM
RUXOLITINIB: RESULTS PUBLISHED IN NEJM Phase 3, multicenter, open-label, randomized (1:1) trial SR chronic GVHD aged ≥ 12 years (n=329) Ruxolitinib (10mg BID) vs best available therapy (BAT) Efficacy Results (ruxolitinib vs BAT) ORR at Week 24: 49.7% vs 25.6% Best ORR: 76.4% vs 60.4% Failu
Slide 19: Parsaclisib: Phase 2 in Autoimmune Hemolytic Anemia
PARSACLISIB: PHASE 2 IN AUTOIMMUNE HEMOLYTIC ANEMIA DATA PRESENTED AT EHA 2021 SHOW HIGH RESPONSE RATES; PHASE 3 START IN 2021 Parsaclisib was generally well tolerated and demonstrated preliminary efficacy over the initial 12-week treatment period in the ongoing Phase 2 study Parsaclisib Parsaclisib
Slide 20: 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 LIMBER: JAK+ALK2 PoC trial to begin Jakafi ® : FDA decision (SR chronic GVHD) tafasitamab: frontMIND to begin (P3, 1L DLBCL) tafasitamab: MAA decision (r/r DLBCL)
Slide 21: Financial Results
FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO
Slide 22: Non-GAAP Adjustments
NON-GAAP ADJUSTMENTS Management has chosen to present financial highlights for the quarter and year -to-date periods ended June 30, 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
Slide 23: Financial Highlights: Revenues
FINANCIAL HIGHLIGHTS: REVENUES $ millions Q2 2021 Q2 2020 YoY H1 2021 H1 2020 YoY GAAP GAAP Change GAAP GAAP Change Net product revenues 575 500 15% 1,080 987 9% Jakafi 529 474 12% 995 933 7% Iclusig 28 23 24% 54 50 8% Pemazyre 18 4 373% 31 4 728% Royalties 121 93 30% 220 175 26% Jakavi 82 66 24% 14
Slide 24: Financial Highlights: Operating Expenses
FINANCIAL HIGHLIGHTS: OPERATING EXPENSES $ millions Q2 2021 Q2 2020 YoY H1 2021 H1 2020 YoY GAAP GAAP Change GAAP GAAP Change COGS 38 33 14% 67 61 11% As a percentage of net product revenues 7% 7% 6% 6% 1 R&D 344 287 20% 650 1,372 -53% R&D – ongoing 339 283 20% 634 563 13% 1 R&D – upfront and milest
Slide 25: Financial Guidance: Full Year 2021 - GAAP
FINANCIAL GUIDANCE: FULL YEAR 2021 - GAAP FY 2021 Updated Previous Net product revenues Jakafi $2,125 – $2,170 million $2,125 – $2,200 million Other Hematology/Oncology (Iclusig in EU and Pemazyre in U.S.) $155 – $170 million $145 - $160 million Costs and expenses COGS 6 – 7% net product revenues Un
Slide 26: 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 LIMBER: JAK+ALK2 PoC trial to begin Jakafi ® : FDA decision (SR chronic GVHD) tafasitamab: frontMIND to begin (P3, 1L DLBCL) tafasitamab: MAA decision (r/r DLBCL)
Slide 27: Financial Back-up Slides
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Slide 28: Financial Highlights: Q2
FINANCIAL HIGHLIGHTS: Q2 Q2 2021 Q2 2020 Q2 2021 Q2 2020 $ millions GAAP GAAP Non-GAAP Non-GAAP Net product revenues 575 500 575 500 Jakafi 529 474 529 474 Iclusig 28 23 28 23 Pemazyre 18 4 18 4 Royalties 121 93 121 93 Jakavi 82 66 82 66 Olumiant 36 26 36 26 Tabrecta 2 1 2 1 Total product and royalt
Slide 29: Financial Highlights: Year to Date
FINANCIAL HIGHLIGHTS: YEAR TO DATE H1 2021 H1 2020 H1 2021 H1 2020 $ millions GAAP GAAP Non-GAAP Non-GAAP Net product revenues 1,080 987 1,080 987 Jakafi 995 933 995 933 Iclusig 54 50 54 50 Pemazyre 31 4 31 4 Royalties 220 175 220 175 Jakavi 148 123 148 123 Olumiant 68 51 68 51 Tabrecta 5 1 5 1 Tota
Slide 30: ir@incyte.com investor.incyte.com
ir@incyte.com investor.incyte.com