Incyte Corporation. J.P. Morgan Healthcare Conference January 9, 2017

Transcription

1 Incyte Corporation J.P. Morgan Healthcare Conference January 9, 2017

2 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: continued growth in sales and market share of Jakafi, including whether Jakafi will continue to be a revenue driver for the Company and whether opportunities for further development will be successful; expected peak net product revenue for Jakafi; the Company s financial guidance for 2016 and the expectations underlying such guidance; whether and when the Company will receive potential regulatory milestone payments or royalty payments from Lilly with respect to baricitinib, whether baricitinib will be approved in the U.S. or Europe, whether and when Lilly will launch baricitinib and whether baricitinib will be a successful product or become an important source of revenue for the Company; whether Lilly will initiate pivotal trials in 2017 for baricitinib in psoriatic arthritis; whether the Company will initiate pivotal trials in 2017 for: epacadostat plus pembrolizumab in bladder cancer, head and neck cancer, non-small cell lung cancer or renal cell carcinoma; ruxolitinib in essential thrombocythemia; or itacitinib in GVHD; plans and expectations regarding the Company s product pipeline and strategy - including timelines for advancing its drug candidates through clinical trials (including enrollment and commencement), timelines for regulatory submissions and for releasing trial data, and whether any specific program will be successful or ever be approved for use in humans anywhere in the world as well as regarding the Company s partnered programs; whether and when the planned collaboration with Merus will close, whether it will effectively expand Incyte s discovery capabilities and large-molecule portfolio and represent a long-term growth opportunity, and whether any of the 11 programs under the collaboration will be successful or will produce any products that will be approved for use in humans anywhere or will be commercialized anywhere successfully or at all; anticipated future investments and accomplishments in drug discovery and development; whether the plans and expectations regarding the Company s pipeline over the next 12 months will drive potential value; and the potential therapeutic and commercial value of our drug candidates. These forward-looking statements are based on the Company s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the efficacy or safety of the Company s products; the acceptance of the Company s products in the marketplace; market competition; further research and development; sales, marketing and distribution requirements; clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; other market, economic or strategic factors and technological advances; unanticipated delays; the ability of the Company to compete against parties with greater financial or other resources; the Company's dependence on its relationships with its collaboration partners; greater than expected expenses; expenses relating to litigation or strategic activities; our ability to obtain additional capital when needed; obtaining and maintaining effective patent coverage for the Company s products and product candidates; and other risks detailed from time to time in the Company s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, The Company disclaims any intent or obligation to update these forward-looking statements. 2

3 Driven by Innovation Incyte believes that investment in drug discovery creates value for patients, society and for our shareholders

4 Investment in New and Innovative Medicines Creates the Foundation for Additional Growth Innovative Medicines 4

5 Innovation Drives Growth Incyte has a portfolio of 17 molecules against 13 different targets

6 1. Jakafi marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-us 2. Patients with intermediate or high-risk myelofibrosis; Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea 3. European rights to Iclusig licensed from ARIAD 4. Pivotal trials expected to begin in Co-development with Agenus 6. AA = alopecia areata, AtD = atopic dermatitis 7. Worldwide rights to baricitinib licensed to Lilly, SLE = systemic lupus erythematosus 8. Worldwide rights to capmatinib licensed to Novartis, GBM = glioblastoma multiforme 6

7 Five-Year Data Further Supports Overall Survival Advantage Observed in Patients with Myelofibrosis Treated With Jakafi 1 st JAK inhibitor approved for any indication Only therapy FDA approved for myelofibrosis Only therapy FDA approved for polycythemia vera More than 35,000 patients treated 1 Verstovsek,et al, 2016 ASH poster (abstract 3110) RPSFT = rank-preserving structural failure time Jakafi (ruxolitinib) is marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-us Jakafi is FDA approved for patients with intermediate or high-risk myelofibrosis and for patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea 1. Data on file, Incyte does not include estimate of number of patients treated on commercial Jakavi by Novartis 7

8 Jakafi is a Long-term Revenue Driver for Incyte, with Multiple Opportunities for Further Development Updated: Peak Jakafi net product revenue guidance: $2.0 billion 2016 Jakafi net product revenue guidance: $ million Note: Jakafi net product revenue as reported in 2012, 2013, 2014 and Full year guidance used for

9 Time Course Chronic Acute Graft-versus-Host Disease (GVHD) is a Frequent Complication of Allogeneic Bone Marrow Transplant Therapy Treatment-naïve Steroid-refractory Incidence = 7,000 new patients in the U.S. each year Prevalence = 10,000 patients in the U.S. Source: Decision Resources & GlobalData 9

10 Time Course Chronic Acute Both Ruxolitinib and Itacitinib (INCB39110) Are Potential New Treatments for Patients with GVHD Therapy Treatment-naïve Steroid-refractory Itacitinib (JAK1) Pivotal program in preparation Ruxolitinib (JAK1/JAK2) Pivotal program underway 2 PoC data at ASH REACH-1 Acute GVHD: Single-arm, pivotal Phase 2 (n=70) REACH-2 Acute GVHD: Randomized Phase 3 vs BAT (n=300) REACH-3 Chronic GVHD 1. Schroeder et al ASH presentation 2016 (abstract 390) 2. Development in collaboration with Novartis 10

11 Incyte has a Broad and Deep Portfolio of First-in-Class and Best-in-Class Product Candidates Multiple Incyte programs are now on a defined path towards registration Epacadostat (IDO1) Ruxolitinib (JAK1/2) Itacitinib (JAK1) Partnered Baricitinib (JAK1/2) (PI3Kδ) (FGFR) Capmatinib (c-met) (BRD) (BRD) (JAK1) (PIM) (LSD1) 1876 (GITR) 1949 (OX40) (FGFR4) Discovery alliances Agenus Merus Note: 1876 (GITR) and 1949 (OX40) co-developed with Agenus 11

12 The ECHO Program is Investigating Epacadostat in Multiple Combination Settings Checkpoint combinations Vaccine combinations Epigenetic combinations Chemotherapy combinations 12

13 Epacadostat plus PD-1/L1 Therapies in Multiple Tumor Types; Phase 3 Trial Underway in Melanoma ECHO-301, KEYNOTE-252 (w/ pembrolizumab) 1 st line advanced or metastatic melanoma Dose escalation Dose expansion Pivotal ECHO-202, KEYNOTE-037 (w/ pembrolizumab) Non-small cell lung cancer, genitourinary transitional cell carcinoma, head & neck cancer, renal cell carcinoma, triple-negative breast cancer, ovarian cancer, DLBCL, melanoma, MSI-H CRC 1 ECHO-203 (w/ durvalumab) Non-small cell lung cancer, head & neck cancer, triple-negative breast cancer, gastric cancer, genitourinary transitional call carcinoma, melanoma, pancreatic cancer ECHO-204 (w/ nivolumab) Non-small cell lung cancer, glioblastoma, head & neck cancer, melanoma, DLBCL, colorectal cancer, ovarian cancer ECHO-110 (w/ atezolizumab) Non-small cell lung cancer, bladder cancer 1. DLBCL: Diffuse large B-cell lymphoma MSI-H CRC: Microsatellite-instability high colorectal cancer 13

14 Epacadostat plus Pembrolizumab Generates Durable Responses and is Well-Tolerated in Patients with Treatment-naïve Melanoma 1 Combination well tolerated; MTD not reached 5 patients (8%) experienced treatment-related AEs that led to discontinuation There were no treatment-related deaths 1. Gangadhar et al, ESMO 2016 (abstract 1110PD) * Objective response is PD (SD for target lesions; PD per new lesions). No change from baseline. Objective response is PD (CR for target lesions; PD per new lesions). Objective response is PR (CR for target lesions; non target lesions still present). Of the 19 evaluable patients, data are shown for the 18 patients with post baseline scans that included assessment of target lesions. One patient discontinued treatment for PD per new lesions (target lesions not assessed) and is not included in this figure. 14

15 Epacadostat plus Pembrolizumab: Investigating a New Treatment Paradigm in Immuno-Oncology Epacadostat plus PD-1 expected to enter additional pivotal trials in 2017 ECHO-202 Phase 2 Bladder cancer Diffuse large b-cell lymphoma Head and neck cancer Melanoma MSI-high colorectal cancer Non-small cell lung cancer Ovarian cancer Renal cell carcinoma Triple-negative breast cancer Data collection ongoing: Diffuse large b-cell lymphoma MSI-high colorectal cancer No current Phase 3 plans: Ovarian cancer Triple-negative breast cancer Currently in Phase 3: Melanoma Planned Phase 3 initiations: Bladder cancer Head and neck cancer Non-small cell lung cancer Renal cell carcinoma 15

16 Introducing the CITADEL Development Program: PI3Kδ Inhibition in Mono- and Combination Therapy Updated INCB50465 data at ASH Overall well tolerated at all doses No significant transaminase elevations Phase 2 in DLBCL in preparation Single-arm, open-label (n=120) Relapsed, refractory population Expected to start in H Phillips et al, 2016 ASH abstract 4195; All INCB50465 doses are once daily. * Response by CT was different from response by PET (patients with fluorodeoxyglucose-avid lymphoma who were PET-positive at baseline could achieve a PET-based response per the Lugano classification of lymphoma response criteria). Spleen size was used as the primary parameter to assess response in splenic MZL. Includes extranodal MZL of MALT type (n=1), nodal MZL (n=1), and splenic MZL (n=2). Best percent change from baseline in target lesion size >100%. CR, complete response; CT, computed tomography; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; MALT, mucosa-associated lymphatic tissue; MCL, mantle cell lymphoma; MZL, marginal zone lymphoma; NHL, non-hodgkin lymphoma; PD, progressive disease; PET, positron emission tomography; PR, partial response; SD, stable disease. 16

17 The INCB54828 Clinical Development Program is Directed at Patients with FGFR Alterations Dose escalation data: Attractive clinical pharmacokinetics High magnitude receptor inhibition No off-target dose-limiting toxicities Evidence of clinical activity in FGFR mutated malignancies Phase 2: Bladder cancer (n=100) Primary endpoint: Overall response rate (ORR) ~15% have activating FGFR3 mutations ~5% have activating FGFR3 translocations Phase 2: Cholangiocarcinoma (n=100) Primary endpoint: ORR in patients with FGFR2 translocations 6-13% have FGFR2 translocations ~5% have other FGF/FGFR alterations Phase 2: 8p11 MPNs (n=46) Primary endpoint: Efficacy in patients w/ FGFR1 rearrangement Ultra-orphan indication 17

18 Incyte has a Broad and Deep Portfolio of First-in-Class and Best-in-Class Product Candidates Epacadostat (IDO1) Ruxolitinib (JAK1/2) Itacitinib (JAK1) Partnered Baricitinib (JAK1/2) (PI3Kδ) (FGFR) Capmatinib (c-met) Incyte has a rich collection of earlier-stage development compounds (BRD) (BRD) (JAK1) (PIM) (LSD1) 1876 (GITR) 1949 (OX40) (FGFR4) Discovery alliances Agenus Merus Note: 1876 (GITR) and 1949 (OX40) co-developed with Agenus 18

19 T u m o r V o lu m e (m m 3 ) + /- S E M INCB62079 is a Selective, Irreversible Inhibitor of FGFR4 Activation of the FGF19-FGFR4 pathway is an oncogenic driver in subsets of HCC 1 FGF19 gene amplification in 6-10% Hep3b HCC xenograft FGF19 protein overexpression in 30% V e h ic le 5 m g /k g B ID 1 0 m g /k g B ID Potent, irreversible inhibitor of FGFR m g /k g B ID Greater than 250x selectivity against FGFR1/2/3 Selective for FGF19-FGFR4 dependent cancer cell lines Dose-dependent, single-agent activity in HCC models Clinical program expected to begin in /9 PR, 0/9 CR 2/9 PR, 6/9 CR D a y p o s t in o c u la tio n Data on file, Incyte 1. Repana et al, Diseases (2015), 3, ; doi: /diseases ; HCC = hepatocellular carcinoma 19

20 Strategic Collaboration with Merus to Discover, Develop and Commercialize Bispecific Antibodies Fully human antibodies Adding to Incyte s Long-term Growth & Innovation Engine Uses native IgG format Leading bispecific technology Up to 11 discovery programs Long-term growth opportunity Potential in oncology and beyond Functional screening Simplicity of manufacturing 20

21 Growth Drives Strength Incyte s revenue growth enables significant reinvestment into the portfolio, driving long-term value creation

22 Incyte has Delivered Five Years of Dynamic Revenue Growth Jakafi approval in PV Jakafi approval in MF Jakafi (ruxolitinib) is marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-us Jakafi is FDA approved for patients with intermediate or high-risk myelofibrosis (MF) and for patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea 22

23 Incyte has Delivered Five Years of Dynamic Revenue Growth Jakafi approval in PV Jakafi approval in MF Over $700m cash and equivalents at Q Jakafi (ruxolitinib) is marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-us Jakafi is FDA approved for patients with intermediate or high-risk myelofibrosis (MF) and for patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea 23

24 Baricitinib Expected to Provide Incyte with a Significant Additional Source of Revenue Multiple indications now in development Incyte eligible for tiered royalties on global net sales between 20-29% Rheumatoid arthritis Positive CHMP opinion EC decision $65m upon EC approval FDA decision $100m if FDA approved Other global approvals Phase 3 indication Psoriatic arthritis Initiation expected in 2017 $30m milestone to Incyte 1 Phase 2 indications Atopic dermatitis Trial fully recruited Data available in 2017 Systemic lupus erythematosus Trial underway Data available in 2018 Incyte has opted-into co-development of baricitinib in rheumatoid arthritis and psoriatic arthritis 1. Milestone for initiation of Phase 3 trial in second indication 24

25 Multiple Potential Value Drivers Expected in Next Twelve Months Ruxolitinib JAK1/JAK2 Initiate pivotal program Essential thrombocythemia Itacitinib JAK1 Initiate pivotal program Graft-versus-host disease INCB54828 FGFR Dose escalation data Advanced malignancies INCB54329 & INCB57643 BRD Dose escalation data Advanced malignancies INCB53914 PIM Dose escalation data Advanced malignancies Epacadostat IDO1 (+pembrolizumab) Full recruitment of ECHO-301 (Phase 3) First-line advanced / metastatic melanoma Initiate additional pivotal trials NSCLC, renal, head & neck, bladder Epacadostat IDO1 Phase 2 data (+PD-1 / PD-L1) Multiple tumor types I-O Doublets JAK1,PD-1,IDO1,PI3Kδ Phase 2 data (paired biopsy trials) Multiple tumor types Topical Ruxolitinib JAK1/JAK2 Initiate PoC trials Atopic dermatitis, vitiligo Phase 2 results Alopecia areata Baricitinib JAK1/JAK2 FDA and EC decisions Rheumatoid arthritis PoC data Atopic dermatitis Lilly to initiate pivotal program Psoriatic arthritis 25

26 Incyte has the Portfolio, Footprint and Financial Strength to Drive Global Growth Earlier-stage programs (FGFR) & (Pi3Kδ) Ruxolitinib & itacitinib in GVHD Epacadostat in multiple tumor types Baricitinib milestones & royalties Jakafi in MF & PV Current portfolio and geographic expansion to make Incyte an innovative, global, fast-growing and highly-profitable biopharmaceutical company Jakafi (ruxolitinib) is marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-us Jakafi is FDA approved for patients with intermediate or high-risk myelofibrosis (MF) and for patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea 26

27 Science Drives Success To be a leading, global biosciences company with novel medicines approved in major geographies delivering significant value to patients and society