Incyte Corporation · NASDAQ:INCY
Incyte — Q3 2020 Earnings Presentation
28 slides from Incyte's earnings presentation, Nov 5, 2020
Slide 1: 2020 Third Quarter Financial and Corporate Update
2020 Third Quarter Financial and Corporate Update NOVEMBER 5, 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: Third Quarter Review
THIRD QUARTER REVIEW HERVÉ HOPPENOT – CEO
Slide 4: Strong Performance in Third Quarter
STRONG PERFORMANCE IN THIRD QUARTER Revenues Y/Y Growth Commercial $488m +13% Jakafi®: Growth in all three indications Product revenues Monjuvi® & Pemazyre®: Launches progressing well $26m +28% Regulatory $8m ̶ tafasitamab: MAA under review in r/r DLBCL $5m1 ̶ pemigatinib: MAA and J-NDA now
Slide 5: Incyte Dermatology: Dedicated Franchise Established in the U.S.
INCYTE DERMATOLOGY DEDICATED FRANCHISE ESTABLISHED IN THE U.S. Discovery expertise in immunology Bringing innovative science to medical dermatology Multiple first-in-class clinical candidates Experienced global development team Specialty U.S. commercial presence planned 5
Slide 6: 2020 Newsflow Progress by Program
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 7: Important updates to come
1H 2020 2H 2020 GVHD ruxolitinib1 Phase 3 data (REACH3) steroid-refractory cGVHD 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-a-da
Slide 8: U.S. Commercial Update
U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA
Slide 9: Jakafi: Strong Sales Growth Year to Date
JAKAFI ®: STRONG SALES GROWTH YEAR TO DATE UPDATED FULL YEAR 2020 GUIDANCE RANGE OF $1.910-1.940 BILLION Proportion by 1,500 +17% indication end Q3’20 1,400 1,421 MF: 47% 1,300 Jakafi net product revenues ($m) 1,200 Patients on therapy1 1,219 1,100 1,000 1,007 900 PV: 33% 800 831 700 600 615 500 GVH
Slide 10: Jakafi: Recovery of New Patient Starts in Q3
JAKAFI ®: RECOVERY OF NEW PATIENT STARTS IN Q3 Sequential new patient growth 18,000 Existing Patients 20% New patient growth New Patients 10% 16,000 0% (QoQ) -10% Q1 2020 Q2 2020 Q3 2020 14,000 -20% Total patients on therapy1 -30% 12,000 10,000 New patients 8,000 <10% of total patients 6,000 COV
Slide 11: Monjuvi: Launch on Track
MONJUVI ®: LAUNCH ON TRACK INCREASING AWARENESS DRIVING GOOD MOMENTUM Q3 2020 sales: $5 million Share of voice* MONJUVI® compared to: Kymriah, Polivy, Xpovio, Yescarta Increasing awareness levels Market-leading share of voice Inclusion in NCCN guidelines Physician feedback Depth and duration of resp
Slide 12: Pemazyre: Rapid Adoption
PEMAZYRE ®: RAPID ADOPTION FGFR TESTING DRIVING IDENTIFICATION OF APPROPRIATE PATIENTS Q3 2020 sales: $8 million Effective HCP targeting Broad uptake nationally, with >200 prescribers >60% prescribers from community oncology centers Rapid patient adoption ~200 patients treated since launch ~2/3 of d
Slide 13: Clinical Development
CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER
Slide 14: Ruxolitinib Cream: Pooled Phase 3 Data
RUXOLITINIB CREAM: POOLED PHASE 3 DATA CYTOKINE INHIBITION LEADS TO RAPID ITCH REDUCTION AND IMPROVED SLEEP QUALITY Key pooled results 0.75% BID 1.5% BID Vehicle Rapid, substantial and sustained itch reduction Primary endpoint Notable improvements in quality of life measures n=483 n=481 n=244
Slide 15: Ruxolitinib Cream: Updated Timelines
RUXOLITINIB CREAM: UPDATED TIMELINES PRIORITY REVIEW VOUCHER EXPECTED TO ACCELERATE FDA DECISION Estimated FDA decision Atopic Dermatitis NDA submission with voucher: without voucher: expected end 2020 June 2021 October 2021 Phase 3 primary endpoints met; LT extension ongoing Priority review voucher
Slide 16: INCB54707: Initial Data in Hidradenitis Suppurativa
INCB54707: INITIAL DATA IN HIDRADENITIS SUPPURATIVA JAK1 INHIBITION SHOWS POTENTIAL IN PATIENTS WITH MODERATE -TO-SEVERE DISEASE EoT Phase 2, PBO-controlled, dose-escalation study AN Count1 INCB54707 or placebo for 8 weeks, 30-day safety follow-up Moderate-to-severe HS (Stage II/III) of ≥6m dura
Slide 17: Tafasitamab: Global Clinical Development
TAFASITAMAB: GLOBAL CLINICAL DEVELOPMENT Study Arms Status PoC Pivotal L-MIND (~80 pts) + lenalidomide FDA approved in 2L+ DLBCL Primary endpoint: ORR DLBCL (2-year analysis presented at EHA 2020) r/r + bendamustine Primary endpoint: PFS B-MIND (~450 pts) Ongoing, data expected 2022 vs bendamustine
Slide 18: Continued Progress in PD-1 & PD-L1 Programs
CONTINUED PROGRESS IN PD-1 & PD-L1 PROGRAMS MULTIPLE OPPORTUNITIES FOR RETIFANLIMAB; INITIAL ‘86550 DATA AT SITC retifanlimab1 (PD-1) SCAC Phase 2 (POD1UM-202); Phase 3 (POD1UM-303) Phase 2 results at ESMO 2020 DCR: 49% Median DoR: 9.5 months Merkel cell Phase 2 (POD1UM-201) No unexpected safe
Slide 19: COVID-19 Clinical Development
COVID-19 CLINICAL DEVELOPMENT RUXCOVID TOPLINE RESULTS EXPECTED BY YEAR END On ventilation Size, Age Arms Status & Primary endpoint at recruitment Fully recruited RUXCOVID1 n~400 A: ruxolitinib 5mg BID + SoC Not allowed Proportion of patients who die, develop (ruxolitinib) 12+ yrs B: SoC respiratory
Slide 20: Financial Results
FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO
Slide 21: Non-GAAP Adjustments
NON-GAAP ADJUSTMENTS Management has chosen to present financial highlights and operating income (loss) for the three and nine months ended September 30, 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 info
Slide 22: Financial Highlights: Third Quarter
FINANCIAL HIGHLIGHTS: THIRD QUARTER Three Months Ended Three Months Ended Three Months Ended Three Months Ended $ millions Sep 30, 2020 Sep 30, 2019 Sep 30, 2020 Sep 30, 2019 YoY Change GAAP GAAP Non-GAAP Non-GAAP Net product revenues 522 454 522 454 15% Jakafi 488 433 488 433 13% Iclusig 26 21 26 2
Slide 23: Financial Guidance: Full Year 2020
FINANCIAL GUIDANCE: FULL YEAR 2020 FY 2020 $ millions Updated Previous Net product revenues Jakafi net product revenues 1,910 – 1,940 1,880 – 1,950 Iclusig net product revenues 100 – 105 Unchanged Costs and expenses Cost of product revenues1 130 – 135 Unchanged Research and development expenses (exc
Slide 24: Important newsflow to come
1H 2020 2H 2020 GVHD ruxolitinib1 Phase 3 data (REACH3) steroid-refractory cGVHD 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-a-da
Slide 25: Financial Back-Up Slides
cs - FINANCIAL BACK-UP SLIDES oe
Slide 26: Financial Highlights: Year to Date
FINANCIAL HIGHLIGHTS: YEAR TO DATE Nine Months Ended Nine Months Ended Nine Months Ended Nine Months Ended $ millions Sep 30, 2020 Sep 30, 2019 Sep 30, 2020 Sep 30, 2019 YoY Change GAAP GAAP Non-GAAP Non-GAAP Net product revenues 1,509 1,284 1,509 1,284 18% Jakafi 1,421 1,219 1,421 1,219 17% Iclusig
Slide 27: 2020 and 2019 Non-GAAP Reconciliation
2020 AND 2019 NON-GAAP RECONCILIATION Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended $ millions Sep 30, 2020 Sep 30, 2019 Sep 30, 2020 Sep 30, 2019 GAAP operating income (loss) 5 134 (428) 307 Adjustments Non-cash stock compensation from equity awards 44 43 133 125 Amortiz
Slide 28: ir@incyte.com investor.incyte.com
ir@incyte.com investor.incyte.com