Slide 1: 2021 Third Quarter Financial and Corporate Update
2021 Third Quarter Financial and Corporate Update NOVEMBER 2, 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 statements regarding: our and our collaborators’ potential for receiving regulatory approvals w
Slide 3: Third Quarter Review
THIRD QUARTER REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Executing on Growth and Diversification
EXECUTING ON GROWTH AND DIVERSIFICATION Product & Royalty Revenue +46% Approved Approved Indications U.S. EU Japan Indications U.S. EU Japan MF, PV, aGVHD $778m MF, PV, aGVHD, cGVHD CML CML Products CCA/BTC1 $534m DLBCL2 AD MF, PV MF, PV Royalties RA RA, AD3, COVID-194
Slide 5: Multiple Opportunities for Additional Growth
MULTIPLE OPPORTUNITIES FOR ADDITIONAL GROWTH Peak Sales Guidance Upcoming and ongoing regulatory reviews MPN/GVHD MF, PV, GVHD $3+ Billion franchise U.S. Parsaclisib NDA in NHL $500 - $750 Million1 QD ruxolitinib NDA (2022) Heme/Onc 2L DLBCL U.S. Partnered regulatory reviews Ruxolitinib un
Slide 6: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 7: Strong Patient Demand Driving Jakafi Growth
STRONG PATIENT DEMAND DRIVING JAKAFI GROWTH Q3’21 sales $547m (+12% Y/Y) New patient starts at pre-pandemic levels for past 3 quarters Total patients on therapy grew year over year Strong new patient growth across all indications % by indication Approval in chronic GVHD at end of September e
Slide 8: Second-Line Adoption of Monjuvi Driving Persistency
SECOND-LINE ADOPTION OF MONJUVI DRIVING PERSISTENCY Academic & Community Q3’21 sales $22.0m1 (+22% Q/Q) Cumulative Purchasing Accounts ~850 accounts by end Sep-21 Penetration into key accounts Continued growth in new academic and community accounts Q/Q ~70% of ordering accounts are in the comm
Slide 9: Opzelura: First FDA-Approved Topical JAK Inhibitor for Atopic Dermatitis
OPZELURA: FIRST FDA-APPROVED TOPICAL JAK INHIBITOR FOR MILD-TO-MODERATE ATOPIC DERMATITIS Launched October 11th Focus on specialists treating atopic dermatitis Medical dermatologists, allergists and NP/PAs 11,000 targets; top 20% write 78% of market prescriptions1 for AD Reducing barriers to
Slide 10: Opzelura: Significant Progress with Stakeholders
OPZELURA: SIGNIFICANT PROGRESS WITH STAKEHOLDERS HCPs Patients Payers 76% ~61,000 Advanced discussions of target HCPs reached unique website users with largest payers ~8,500 >1,500 Expect broad HCP direct calls patient registrations for co-pay card coverage in Q1’22 >95% of direct calls are in-perso
Slide 11: Opzelura: Strong Initial Launch Data
OPZELURA: STRONG INITIAL LAUNCH DATA POSITIVE FEEDBACK AND HIGH LEVEL OF INTEREST FROM HCP s AND PAYERS Patients new to market or switch to Opzelura Units shipped from wholesaler to pharmacies2 969 NBRx1 2,224 units shipped to since launch pharmacies since launch 1115 October 11th October 11th Launc
Slide 12: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 13: Multiple Clinical and Regulatory Achievements in Q3
MULTIPLE CLINICAL AND REGULATORY ACHIEVEMENTS IN Q3 Three Regulatory Approvals Pivotal Detailed Results at EADV Approved in EU in 2L DLBCL Ruxolitinib cream in vitiligo: Significant improvement in F-VASI75 at week 24 Only topical JAKi approved in U.S. for AD Baricitinib in alopecia areata: Signi
Slide 14: Parsaclisib in Three Types of Non-Hodgkin Lymphomas
PARSACLISIB IN THREE TYPES OF NON-HODGKIN LYMPHOMAS PRIORITY REVIEW FOR MZL AND MCL; STANDARD REVIEW FOR FL Parsaclisib NDA under FDA review: CITADEL Safety & Efficacy1 Data ORR DOR PFS r/r marginal zone lymphoma Patients with at least 1 prior anti-CD20-based regimen r/r marginal zone lymphoma 5
Slide 15: Parsaclisib in Warm Autoimmune Hemolytic Anemia
PARSACLISIB IN WARM AUTOIMMUNE HEMOLYTIC ANEMIA PRELIMINARY EFFICACY DEMONSTRATED IN PHASE 2; PHASE 3 INITIATION BY END OF YEAR Phase 3 Trial Design Baseline Week 24 Week 48 Prevalence: Screening Double-blind period Extension period (up to 28 days) (24 weeks) (24 weeks) 1 in 8,000 living with wAIHA1
Slide 16: Multiple Programs Across MPNs and GVHD
MULTIPLE PROGRAMS ACROSS MPNs AND GVHD New Program: Axatilimab (Anti-CSF-1R mAb) Asset Status MF, PV QD ruxolitinib Stability testing GVHD + PI3Kδ Phase 3 (inadequate responders & 1L) + BET PoC MF + ALK2 PoC CK08041 (Cellenkos) PoC PV Novel targets Preclinical Complementary effects on inflammatory
Slide 17: Facial and Total Body Repigmentation with Ruxolitinib Cream in Vitiligo
SUBSTANTIAL FACIAL AND TOTAL BODY REPIGMENTATION AT 24 WEEKS WITH RUXOLITINIB CREAM IN VITILIGO Phase 2 & TRuE-V results Significant opportunity to address unmet need Week 24 Week 52 1.5 million+ patients living with vitiligo in the U.S. 51.5 No FDA-approved therapy for repigmentation F-VASI75
Slide 18: Ongoing Development Programs in Dermatology
ONGOING DEVELOPMENT PROGRAMS IN DERMATOLOGY Atopic Hidradenitis Prurigo Indication Vitiligo Dermatitis Suppurativa Nodularis Ruxolitinib Ruxolitinib Drug INCB54707 INCB54707 INCB54707 Cream Cream Draining fistula Patients Pediatric BSA≤10% BSA≥8% count ≤20 ≥20 nodules TRuE-V1 TRuE-AD3 Phase 2 Phase
Slide 19: Key Updates in 2021
KEY UPDATES 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) Hematology
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 and year -to-date periods ended September 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 intern
Slide 22: Financial Highlights: Revenues
FINANCIAL HIGHLIGHTS: REVENUES $ millions Q3 2021 Q3 2020 YoY YTD 2021 YTD 2020 YoY GAAP GAAP Change GAAP GAAP Change Net product revenues 594 522 14% 1,674 1,509 11% Jakafi 547 488 12% 1,542 1,421 9% Iclusig 29 26 8% 82 76 8% Pemazyre 18 8 117% 49 12 312% Minjuvi 1 - NM 1 - NM Royalties 184 98 87%
Slide 23: Financial Highlights: Operating Expenses
FINANCIAL HIGHLIGHTS: OPERATING EXPENSES $ millions Q3 2021 Q3 2020 YoY YTD 2021 YTD 2020 YoY GAAP GAAP Change GAAP GAAP Change COGS 40 34 16% 107 95 13% As a percentage of net product revenues 7% 7% 6% 6% 2 1, 2 R&D 335 438 -24% 985 1,810 -46% R&D – ongoing 331 297 11% 964 860 12% 2 1, 2 R&D – upfr
Slide 24: Financial Guidance: Full Year 2021 - GAAP
FINANCIAL GUIDANCE: FULL YEAR 2021 - GAAP FY 2021 Current Previous Net product revenues Jakafi $2,125 – $2,170 million Unchanged Other Hematology/Oncology (Iclusig in EU and Pemazyre in U.S.) $155 – $170 million Unchanged Costs and expenses COGS 6 – 7% net product revenues Unchanged R&D $1,350 – $1,
Slide 25: Key Updates in 2021
KEY UPDATES 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) Hematology
Slide 26: Financial Back-Up Slides
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Slide 27: Financial Highlights: Q3
FINANCIAL HIGHLIGHTS: Q3 Q3 2021 Q3 2020 Q3 2021 Q3 2020 $ millions GAAP GAAP Non-GAAP Non-GAAP Net product revenues 594 522 594 522 Jakafi 547 488 547 488 Iclusig 29 26 29 26 Pemazyre 18 8 18 8 Minjuvi 1 - 1 - Royalties 184 98 184 98 Jakavi 95 68 95 68 Olumiant 87 29 87 29 Tabrecta 3 1 3 1 Total pr
Slide 28: Financial Highlights: Year to Date
FINANCIAL HIGHLIGHTS: YEAR TO DATE YTD 2021 YTD 2020 YTD 2021 YTD 2020 $ millions GAAP GAAP Non-GAAP Non-GAAP Net product revenues 1,674 1,509 1,674 1,509 Jakafi 1,542 1,421 1,542 1,421 Iclusig 82 76 82 76 Pemazyre 49 12 49 12 Minjuvi 1 - 1 - Royalties 404 273 404 273 Jakavi 242 191 242 191 Olumiant