Incyte Corporation · NASDAQ:INCY

Incyte — Q1 2020 Earnings Presentation

27 slides from Incyte's earnings presentation, May 5, 2020

  1. Slide 1: 2020 First Quarter Financial and Corporate Update

    2020 First Quarter Financial and Corporate Update M AY 5 , 2 0 2 0

  2. 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

  3. Slide 3: First Quarter Review

    FIRST QUARTER REVIEW HERVÉ HOPPENOT – CEO

  4. Slide 4: Business Update in the Time of COVID-19

    BUSINESS UPDATE IN THE TIME OF COVID-19 PRIORITY IS TO ENSURE PATIENTS MAINTAIN ACCESS TO MEDICINES Limited impact of COVID-19 to date Clinical trials to address COVID-19  Commercial & Supply  ruxolitinib  No impact to date  Two randomized Phase 3 trials  Manufacturing proceeding uninterrupted

  5. Slide 5: Strong Business Performance in Q1

    STRONG BUSINESS PERFORMANCE IN Q1 Robust top-line growth Execution across key programs Q1 2020 Q1 2020 Y/Y  FDA approval of PemazyreTM (pemigatinib) for cholangiocarcinoma1 Revenues Growth  MAA accepted for review by the EMA  Positive Phase 3 data presentation at RAD2 conference; $459M +22% NDA f

  6. Slide 6: Ongoing Revenue Momentum

    ONGOING REVENUE MOMENTUM PEMAZYRE TM (pemigatinib) APPROVAL PROVIDES FIFTH SOURCE OF REVENUE 600 +24% vs. Q1’19 Key priorities for 2020 Jakafi Jakavi  Commercial priorities: 500 Iclusig  Maintain emphasis on Jakafi® in the U.S. Product & royalty revenues ($m) Olumiant 400  Execute successful laun

  7. Slide 7: U.S. Commercial Update

    U.S. COMMERCIAL UPDATE BARRY FLANNELLY – GENERAL MANAGER, NORTH AMERICA

  8. Slide 8: Strong Growth from Jakafi in Q1 2020

    STRONG GROWTH FROM JAKAFI ® IN Q1 2020 Patient growth YoY (%)1 500 +22% vs. Q1’19 14,000 459 Myelofibrosis 12,000 +5% 400 Jakafi net product revenues ($m) Total patients on therapy 376 10,000 300 314 8,000 251 200 6,000 Polycythemia vera 183 +16% 4,000 100 2,000 GVHD 0 0 Q1 2016 Q1 2017 Q1 2018 Q1 2

  9. Slide 9: REACH2 Published in NEJM

    REACH2 PUBLISHED IN NEJM  Phase 3, multicenter, open-label, randomized trial of ruxolitinib (10mg BID) vs best available therapy (BAT)  309 patients aged ≥12 years  Steroid-refractory acute GVHD after alloSCT  Efficacy  ORR at Day 28:ruxolitinib 62% vs BAT 39%  ORR at Day 56: ruxolitinib 40% v

  10. Slide 10: Pemazyre: Launch Already Underway

    PEMAZYRE: LAUNCH ALREADY UNDERWAY ESTABLISH FIRST-IN-CLASS THERAPY FOR CCA PATIENTS WITH FGFR2 ALT ERATIONS Targeting appropriate healthcare providers  ~1,000 HCP targets; 2/3 are already Jakafi® prescribers  Able to leverage existing relationships within oncology Driving HCP education, promotion

  11. Slide 11: Clinical Development

    CLINICAL DEVELOPMENT STEVEN STEIN – CHIEF MEDICAL OFFICER

  12. Slide 12: Rux Cream: Successful Phase 3 in Atopic Dermatitis

    RUX CREAM: SUCCESSFUL PHASE 3 IN ATOPIC DERMATITIS Efficacy Proportion (SE) of IGA  Statistical significance achieved across primary and Responders, %† key secondary endpoints  IGA-TS at Week 8  Itch NRS4 at Week 8  EASI-75 at Week 8  Rapid, substantial, and sustained reduction in itch  1.5% d

  13. Slide 13: Two Key Ruxolitinib Cream Development Programs

    TWO KEY RUXOLITINIB CREAM DEVELOPMENT PROGRAMS NDA SUBMISSION ON TRACK FOR END 2020 Atopic dermatitis NDA expected FDA decision late 2020 expected late 2021 Phase 3 primary endpoints met; long-term extension ongoing Vitiligo Results & data expected 2021 Phase 3 recruitment ongoing 13

  14. Slide 14: Pemigatinib: First-in-Class for Cholangiocarcinoma

    PEMIGATINIB: FIRST-IN-CLASS FOR CHOLANGIOCARCINOMA Efficacy  Potent, selective oral inhibitor of FGFR isoforms 1/2/3  Accelerated approval based on FIGHT-202 trial1  Overall response rate of 36%  Median duration of response of over 9 months Safety  Most common AE was hyperphosphatemia, of which

  15. Slide 15: JAK Inhibition to Prevent Cytokine Storm

    JAK INHIBITION TO PREVENT CYTOKINE STORM CYTOKINE STORM IS A SEVERE IMMUNE OVER-REACTION THAT CAN LEAD TO RESPIRATORY FAILURE IN COVID-19 PATIENTS Adapted from McGonagle et al., 2020, Autoimmun Rev. 2020 Apr 3:102537. doi: 10.1016/j.autrev.2020.102537. 15

  16. Slide 16: Ruxolitinib Evaluation in COVID-19

    RUXOLITINIB EVALUATION IN COVID-19 Two randomized Phase 3 trials  Co-sponsored by Incyte and Novartis (RUXCOVID)  Patients with COVID-19 associated cytokine storm  n≈400, aged 12+ years, not requiring mechanical ventilation  ruxolitinib 5mg BID + standard-of-care (SoC) versus SoC  Composite pri

  17. Slide 17: Expected Newsflow Throughout 2020

    1H 2020 2H 2020 GVHD ruxolitinib1 Phase 3 results (REACH3) steroid-refractory cGVHD ruxolitinib cream Phase 3 results (TRuE-AD1/AD2)  NDA submission Derm atopic dermatitis PI3Kδ+ruxolitinib PoC data Phase 3 initiation myelofibrosis LIMBER PIM+ruxolitinib PoC data myelofibrosis once-a-day ruxolitin

  18. Slide 18: Financial Results

    FINANCIAL RESULTS CHRISTIANA STAMOULIS – CFO

  19. Slide 19: Non-GAAP Adjustments

    NON-GAAP ADJUSTMENTS  The financial measures other than Non -GAAP operating income / (loss) presented in this presentation for the three months ended March 31, 2020 and 2019 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”).  Management has

  20. Slide 20: MorphoSys Collaboration Accounting Overview

    MORPHOSYS COLLABORATION ACCOUNTING OVERVIEW P&L Line Item Accounting Treatment • U.S. product sales will be recorded by MorphoSys Net product sales – tafasitamab1 • Product sales outside of the U.S. will be recorded by Incyte • COGS outside of the U.S. will be recorded by Incyte and will include roy

  21. Slide 21: Financial Highlights: First Quarter 2020

    FINANCIAL HIGHLIGHTS: FIRST QUARTER 2020 Q1 2020 Q1 2019 Q1 2020 Q1 2019 YoY Change $ millions GAAP GAAP Non-GAAP1 Non-GAAP1 Non-GAAP Net product revenues 487 396 487 396 23% Jakafi 459 376 459 376 22% Iclusig 27 21 27 21 32% Royalties 82 62 82 62 33% Jakavi 56 46 56 46 24% Olumiant 25 16 25 16 59%

  22. 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

  23. Slide 23: Expected Newsflow Throughout 2020

    1H 2020 2H 2020 GVHD ruxolitinib1 Phase 3 results (REACH3) steroid-refractory cGVHD ruxolitinib cream Phase 3 results (TRuE-AD1/AD2)  NDA submission Derm atopic dermatitis PI3Kδ+ruxolitinib PoC data Phase 3 initiation myelofibrosis LIMBER PIM+ruxolitinib PoC data myelofibrosis once-a-day ruxolitin

  24. Slide 24: Financial Back-Up Slides

    cs - FINANCIAL BACK-UP SLIDES oe

  25. Slide 25: 2020 and 2019 Non-GAAP Reconciliation

    2020 AND 2019 NON-GAAP RECONCILIATION Three Months Ended Three Months Ended $ millions Mar 31, 2020 Mar 31, 2019 GAAP operating income (664) 74 Adjustments Non-cash stock compensation from equity awards 43 41 Amortization of acquired product rights 5 5 Change in fair value of contingent consideratio

  26. Slide 26: 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

  27. Slide 27: ir@incyte.com investor.incyte.com

    ir@incyte.com investor.incyte.com

Incyte — Q1 2020 Earnings Presentation on 6ix