Slide 1: 2020 Second Quarter Financial and Corporate Update
2020 Second Quarter Financial and Corporate Update AUGUST 4, 2020
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 impacts of the COVID-19 pandemic and mea
Slide 3: Second Quarter Review
SECOND QUARTER REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Continued Strong Execution
CONTINUED STRONG EXECUTION Q2 2020 Q2 2020 Y/Y Revenues Growth $474M +16% Multiple successes across key clinical programs Product revenues Two additional FDA approvals: $23M (7%) TabrectaTM (capmatinib)1 Monjuvi® (tafasitamab-cxix)2 $4M ̶ Successful REACH3 trial of ruxolitinib in steroid-ref
Slide 5: New Approvals Add to Momentum
NEW APPROVALS ADD TO MOMENTUM MULTIPLE REVENUE SOURCES EXPECTED TO DRIVE GROWTH AND DIVERSIFIC ATION 600 Jakafi Opportunities and key objectives for 2020 Iclusig Pemazyre Revenue growth: 500 1 Royalty revenues Maintain momentum of Jakafi® in MPNs Product & royalty revenues ($m) Drive growth of
Slide 6: Business Update in the Time of COVID-19
BUSINESS UPDATE IN THE TIME OF COVID-19 Commercial & Supply Clinical development Revenues Continued progress of key pipeline programs No material impact to date Both ruxolitinib cream programs on schedule Product Launches QD ruxolitinib submission still expected 2021 Launch of Pemazyre
Slide 7: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 8: Jakafi: Growth in All Three Indications
JAKAFI ®: GROWTH IN ALL THREE INDICATIONS POTENTIAL FOR FOURTH INDICATION WITH SUCCESS OF REACH3 IN CHRONIC GVHD 500 474 Strong growth of Jakafi in Q2 +16% vs. Q2’19 Robust demand in all three indications 400 Growing pool of total patients on therapy Jakafi net product revenues ($m) 410 Regi
Slide 9: Pemazyre: Successful Cholangiocarcinoma Launch
PEMAZYRE ®: SUCCESSFUL CHOLANGIOCARCINOMA LAUNCH ~1,000 HCP targets 2/3 already Jakafi® prescribers Targeting Education & Access Multi-channel engagement to educate HCPs during COVID-19 Co-approval of product and FMI Good depth of prescribers; both companion diagnostic1 academic and community settin
Slide 10: Monjuvi (Tafasitamab): Now FDA Approved
MONJUVI ® (TAFASITAMAB): NOW FDA APPROVED OPPORTUNITY TO TRANSFORM SECOND-LINE TREATMENT OF DLBCL Commercial & medical teams ready Joint field team c. 150 FTEs 11,000 potential prescribers 1. First FDA approved 2L therapy in DLBCL ~80% overlap with Jakafi® 2. New, non-chemotherapeutic option f
Slide 11: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 12: REACH3: Ruxolitinib Success in cGVHD
REACH3: RUXOLITINIB SUCCESS IN cGVHD A PHASE 3, RANDOMIZED, SUPERIORITY STUDY OF RUXOLITINIB VERSUS B AT Key Results REACH3 Study Design Ruxolitinib met primary endpoint of superior overall response rate (ORR) at Week 24 compared to BAT1 Statistically significant improvements in both Randomized,
Slide 13: LIMBER: Two Pivotal Phase 3 Trials to Start
LIMBER: TWO PIVOTAL PHASE 3 TRIALS TO START RUXOLITINIB + PARSACLISIB TO ENTER COMPREHENSIVE DEVELOPMENT PRO GRAM Spleen Volume Reduction at Weeks 12 and 241 Two pivotal trials planned in myelofibrosis (MF) patients Inadequate responders to ruxolitinib MF patients with suboptimal response to ruxolit
Slide 14: Tafasitamab: Updated L-MIND Data Presented at EHA
TAFASITAMAB: UPDATED L-MIND DATA PRESENTED AT EHA Primary analysis Updated 2-yr data presented at ICML’19 presented at EHA’20 Data presented at EHA 20202 IRC-assessed duration of response Nov 2018 data-cut1 Nov 2019 data-cut2 1.0 0.9 ORR 60% (48/80) 59% (47/80) 0.8 CR 43% (34/80) 41% (33/80) 0.7 0.6
Slide 15: Tafasitamab: Clinical Development Overview
TAFASITAMAB: CLINICAL DEVELOPMENT OVERVIEW NEAR-TERM OPPORTUNITIES IN DLBCL AND OTHER NON-HODGKIN LYMPHOMAS Study Arms Status Proof-of-Concept Pivotal L-MIND + lenalidomide Approved Primary Endpoint: ORR DLBCL (~80 pts) (2-year analysis presented at EHA 2020) r/r B-MIND + bendamustine Ongoing Primar
Slide 16: Two Key Ruxolitinib Cream Development Programs
TWO KEY RUXOLITINIB CREAM DEVELOPMENT PROGRAMS NDA SUBMISSION IN ATOPIC DERMATITIS ON TRACK FOR END 2020 Reprint Now Available: The Journal of Allergy and Clinical Immunology Atopic dermatitis NDA expected FDA decision end 2020 expected late 2021 Phase 3 primary endpoints met; long-term extension on
Slide 17: Expected Newsflow Throughout 2020
1H 2020 2H 2020 ruxolitinib1 GVHD steroid-refractory cGVHD Phase 3 results (REACH3) ruxolitinib cream Phase 3 results (TRuE-AD1/AD2) NDA submission Derm atopic dermatitis PI3Kδ+ruxolitinib myelofibrosis PoC data Phase 3 initiation LIMBER PIM+ruxolitinib Program discontinued myelofibrosis once
Slide 18: COVID-19 Clinical Development
COVID-19 CLINICAL DEVELOPMENT RUXOLITINIB AND BARICITINIB TRIALS UNDERWAY On ventilation Size, Age Arms Status & Primary endpoint at recruitment Ongoing RUXCOVID1 n~400 A: ruxolitinib 5mg BID + SoC Not allowed Proportion of patients who die, develop (ruxolitinib) 12+ yrs B: SoC respiratory failure,
Slide 19: Financial Results
FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO
Slide 20: Non-GAAP Adjustments
NON-GAAP ADJUSTMENTS The financial measures other than Non -GAAP operating income / (loss) presented in this presentation for the three and six months ended June 30, 2020 and 2019 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). Managem
Slide 21: Financial Highlights: Three Months Ended Jun 30, 2020
Three Months Ended Three Months Ended Three Months Ended Three Months Ended Financial Highlights YoY Change Jun 30, 2020 Jun 30, 2019 Jun 30, 2020 Jun 30, 2019 $ millions Non-GAAP GAAP GAAP Non-GAAP1 Non-GAAP1 Net product revenues 500 434 500 434 15% Jakafi 474 410 474 410 16% Iclusig 23 24 23 24 (7
Slide 22: Financial Guidance: Full Year 2020
FINANCIAL GUIDANCE: FULL YEAR 2020 $ millions FY 2020 GAAP FY 2020 Non-GAAP1 Net product revenues Jakafi 1,880 – 1,950 1,880 – 1,950 Iclusig 100 – 105 100 – 105 Costs and expenses COGS 130 – 135 107 – 112 R&D2 1,210 – 1,280 1,079 – 1,149 SG&A 505 – 535 447 – 477 Change in fair value of contingent co
Slide 23: Expected Newsflow Throughout 2020
1H 2020 2H 2020 ruxolitinib1 GVHD steroid-refractory cGVHD Phase 3 results (REACH3) ruxolitinib cream Phase 3 results (TRuE-AD1/AD2) NDA submission Derm atopic dermatitis PI3Kδ+ruxolitinib myelofibrosis PoC data Phase 3 initiation LIMBER PIM+ruxolitinib Program discontinued myelofibrosis once
Slide 24: Financial Back-Up Slides
cs - FINANCIAL BACK-UP SLIDES oe
Slide 25: 2020 and 2019 Non-GAAP Reconciliation
2020 AND 2019 NON-GAAP RECONCILIATION Three Months Ended Three Months Ended Six Months Ended Six Months Ended $ millions Jun 30, 2020 Jun 30, 2019 Jun 30, 2020 Jun 30, 2019 GAAP operating income (loss) 231 99 (433) 173 Adjustments Non-cash stock compensation from equity awards 46 41 89 81 Amortizati
Slide 26: Financial Highlights: Six Months Ended Jun 30, 2020
Six Months Ended Six Months Ended Six Months Ended Six Months Ended Financial Highlights YoY Change Jun 30, 2020 Jun 30, 2019 Jun 30, 2020 Jun 30, 2019 $ millions Non-GAAP GAAP GAAP Non-GAAP1 Non-GAAP1 Net product revenues 987 830 987 830 19% Jakafi 933 785 933 785 19% Iclusig 50 45 50 45 11% Pemazy
Slide 27: 2020 Financial Guidance Non-GAAP Reconciliation
2020 FINANCIAL GUIDANCE NON-GAAP RECONCILIATION GAAP Non-GAAP $ millions Adjustments Guidance Guidance Net product revenues Jakafi 1,880 – 1,950 - 1,880 – 1,950 Iclusig 100 – 105 - 100 – 105 Costs and expenses COGS 130 – 135 Amortization of acquired product rights for Iclusig and stock-based compens
Slide 28: ir@incyte.com investor.incyte.com
ir@incyte.com investor.incyte.com