Incyte Corporation. Hervé Hoppenot President & CEO. 34th J.P. Morgan Annual Healthcare Conference January 11, 2016

Transcription

1 Incyte Corporation Hervé Hoppenot President & CEO 34th J.P. Morgan Annual Healthcare Conference January 11, 2016

2 Forward-looking Statements Except for the historical information set forth herein, the matters set forth in this presentation - including without limitation statements regarding: our 2015 financial guidance; whether revenue from Jakafi and royalties from Jakavi will continue to grow; our expected peak revenue of Jakafi; our expectations for Jakafi patent protection; our ability to continue our potentially transformative progress and create value for all our stakeholders; whether combination therapy maximizes patient benefit in cancer treatment regimens; whether we will be able to effectively leverage and execute on the synergy and optionality in our development portfolio; whether we will maintain our leadership position in MPNs, including potentially expanding into new indications; the efficacy, safety and timing of our phase 3 trial of ruxolitinib in pancreatic cancer and our phase 2 trials in colorectal, breast and lung cancer; the efficacy and safety of our JAK1 portfolio, including in combination with other companies compounds; the potential of JAK inhibition in the treatment of GVHD and whether our JAK inhibitors will be effective or safe in GVHD studies; the potential, efficacy and safety of epacadostat in treating multiple cancers; the expected commencement of phase 3 development of epacadostat in advanced melanoma and the efficacy, safety, results and timing of such study and the planned development, safety and efficacy of epacadostat in multiple tumor types across multiple collaborations; the plans, expected timing and potential efficacy and safety of or regarding the rest of our product pipeline and strategy, including, without limitation, INCAGN1876, INCB59872, INCB50465, INCB54828, INCB54329, INCB53914 and INCSHR1210; anticipated future investments and accomplishments in drug discovery and development; plans and expected timelines for advancing our other drug candidates through clinical trials and regulatory submissions and releasing trial data; potential therapeutic and commercial value of our drug candidates; the ability to recruit subjects into, and the potential results of, our clinical studies; whether and when Lilly will complete global regulatory submissions for baricitinib, and whether and when we will receive milestone and royalty payments from Lilly; whether baricitinib will successfully shift the treatment paradigm in RA or provide us with a second revenue source and the size of the potential market for baricitinib; and our ability to achieve our planned growth drivers for contain predictions, estimates and other forward-looking statements. These forward-looking statements are 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 Jakafi or any of the compounds in our development portfolio, the continued acceptance of Jakafi in the marketplace, risks related to market competition, including potential generic competition, the results of and risks associated with research and development, the high degree of risk and uncertainty associated with drug development, clinical trials and regulatory approval processes, the risks and uncertainties associated with sales, marketing and distribution requirements, the risks that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, the ability to enroll sufficient numbers of subjects in clinical trials, other market or economic factors and technological advances, unanticipated delays, our ability to compete against parties with greater financial or other resources, our dependence on our relationships with our collaboration partners, greater than expected expenses, unanticipated or unpredictable expenses relating to litigation or strategic activities, our ability to obtain additional capital when needed, risks related to obtaining effective patent coverage for our products and other risks detailed from time to time in Incyte s reports filed with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended September 30, Incyte disclaims any intent or obligation to update these forward-looking statements. 2

3 Investing in Innovation Science Drives Success

4 Over the Last 24 Months, Incyte has Delivered Transformational Growth Across the Business Jakafi revenue in the U.S. $235m $ m % Top-line growth Diversified portfolio Financial strength Global expansion Clinical candidates 6 in portfolio 13 in portfolio +117% 1. Net product revenue guidance for Jakafi in the U.S. in

5 Progression-free survival (%) Combination Therapy May Maximize Patient Outcomes in Cancer Treatment Host-directed Immunotherapy Schematic Kaplan-Meier plots illustrating improved progression free survival in the treatment of melanoma * RAF results in BRAF +ve melanoma Targeted therapy Combinations can maximize patient benefit Chemotherapy DTIC CTLA-4 RAF* PD-1 Tumor-directed Months Sources: Hodi et al, N Engl J Med 2010;363: Chapman et al, N Engl J Med 2011;364: Robert et al, N Engl J Med 2011;364: Long et al, N Engl J Med 2014;371: Robert et al, N Engl J Med 2015;372: Larkin et al, N Engl J Med 2015;373:

6 Progression-free survival (%) Combination Therapy May Maximize Patient Outcomes in Cancer Treatment Host-directed Immunotherapy Schematic Kaplan-Meier plots illustrating improved progression free survival in the treatment of melanoma * RAF & RAF/MEK results in BRAF +ve melanoma Targeted therapy Combinations can maximize patient benefit RAF/MEK* CTLA-4/PD-1 RAF* PD-1 Chemotherapy DTIC CTLA-4 Tumor-directed Months Sources: Hodi et al, N Engl J Med 2010;363: Chapman et al, N Engl J Med 2011;364: Robert et al, N Engl J Med 2011;364: Long et al, N Engl J Med 2014;371: Robert et al, N Engl J Med 2015;372: Larkin et al, N Engl J Med 2015;373:

7 Incyte s Portfolio is Growing Host-directed Immunotherapy Targeted therapy Combinations can maximize patient benefit Chemotherapy Tumor-directed 7

8 Incyte s Portfolio is Growing, and Includes 10 Molecular Targets Host-directed Immunotherapy Targeted therapy Combinations can maximize patient benefit Chemotherapy Tumor-directed Incyte is investigating clinical candidates against 10 targets, and is developing them in monotherapy and combination therapy settings 8

9 A Unique Portfolio, Rich in Synergy and Optionality MPNs Solid tumors JAK1 Targeted Therapies Immuno- Oncology Other Indications Co-Dev/ Licensed Internal discovery, plus Agenus alliance Discovery Clinical Proof of Concept Pivotal Marketed Internal discovery LSD PIM GITR PD-1 Solid tumors JAK1 GVHD BRD Advanced malignancies FGFR Solid tumors Topical ruxolitinib Alopecia areata baricitinib Psoriasis, DN, atopic dermatitis 3, Advanced malignancies PI3Kδ ruxolitinib NSCLC, breast, & colon cancer Pancreatic cancer epacadostat IDO1 Multiple tumor types capmatinib c-met NSCLC, GBM & liver cancer 5,6 ruxolitinib Pancreatic cancer baricitinib Rheumatoid arthritis 3 Jakafi (ruxolitinib) MF and PV 1,2 1. Patients with intermediate or high-risk myelofibrosis 2. Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea 3. Worldwide rights to baricitinib licensed to Lilly 4. DN = Diabetic nephropathy 5. GBM = Glioblastoma multiforme 6. Worldwide rights to capmatinib licensed to Novartis 9

10 A Unique Portfolio, Rich in Synergy and Optionality MPNs Solid tumors JAK1 Targeted Therapies Immuno- Oncology Other Indications Co-Dev/ Licensed Internal discovery, plus Agenus alliance Discovery Clinical Proof of Concept Pivotal Marketed Internal discovery LSD PIM GITR PD-1 Solid tumors JAK1 GVHD BRD Advanced malignancies FGFR Solid tumors Topical ruxolitinib Alopecia areata baricitinib Psoriasis, DN, atopic dermatitis 3, Advanced malignancies PI3Kδ ruxolitinib NSCLC, breast, & colon cancer Pancreatic cancer epacadostat IDO1 Multiple tumor types capmatinib c-met NSCLC, GBM & liver cancer 5,6 ruxolitinib Pancreatic cancer baricitinib Rheumatoid arthritis 3 Jakafi (ruxolitinib) MF and PV 1,2 1. Patients with intermediate or high-risk myelofibrosis 2. Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea 3. Worldwide rights to baricitinib licensed to Lilly 4. DN = Diabetic nephropathy 5. GBM = Glioblastoma multiforme 6. Worldwide rights to capmatinib licensed to Novartis 10

11 T u m o r V o lu m e (m m 3 ± S E M ) T u m o r V o lu m e (m m 3 ± S E M ) Maintaining our Leadership in MPNs and Expanding into New Indications Jakafi (ruxolitinib) Approved in MF 1 Approved in PV 2 Phase 3 pancreatic Phase 2 colon, breast and lung INCB39110 JAK1 EGFR w/tagrisso (osimertinib)* IDO1 w/epacadostat PI3Kδ w/incb50465 PD-1 w/keytruda (pembrolizumab)* INCB52793 JAK1 Potential in multiple myeloma Potent anti-tumor effects Synergy shown in doublets & triplets Phase 1/2 combinations ongoing P re c lin ic a l E G F R m u ta n t N S C L C m o d e l D a y 2 3 P o s t T u m o r In o c u la tio n P re c lin ic a l M y e lo m a P D X M o d e l D a y 6 2 P o s t T u m o r Im p la n ta tio n Data on file, Incyte Data on file, Incyte /9 P R /9 P R MPNs = Myeloproliferative neoplasms 1. Patients with intermediate or high-risk myelofibrosis 2. Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea * The brand listed is not a trademark of Incyte Corporation. The maker of this brand is not affiliated with and does not endorse Incyte Corporation or its products 0 V e h ic le o s im e r tin ib o s im e r tin ib 0 v e h ic le le n d e x le n + d e x le n d e x le n + d e x

12 Epacadostat is a First-in-Class Immunotherapy Epacadostat is a potent, selective, oral inhibitor of IDO1 Reactivates effector T cells and provides potential therapeutic opportunities via combinations with: Checkpoint inhibitors Small molecule immune-modulators Vaccines Chemotherapy Radiation Cellular therapies 12

13 ECHO Program Underway: Multiple Combinations Across the Full Cycle of Anti-tumor Immunity Priming & activation Anti-CTLA-4 o Anti-GITR agonists o Anti-OX40 agonists Reducing immune suppression JAK inhibition PI3Kδ inhibition Antigen presentation Peptide vaccine Listeria vaccine Anti-Survivin vaccine NY-ESO-1 vaccine o EGFRvIII vaccine Cancer cell killing Anti-PD-1 Anti-PD-L1 NK cells + IL-2 o CAR-T o Anti-TIM-3 o Anti-LAG-3 ECHO: Epacadostat Clinical development in Hematology and Oncology 13

14 Rapid Progress: Expected to Enter Phase 3 in 2016, Phase 2 Development in Multiple Collaborations Phase 3 to begin in H (ECHO-301, KEYNOTE-252) Successful dose escalation First line, advanced melanoma Epacadostat plus pembrolizumab vs pembrolizumab Phase 2 now open (ECHO-204) Co-funded by Incyte & Merck Phase 2 ongoing (ECHO-202, KEYNOTE-037) Successful dose escalation Ongoing dose escalation (ECHO-110) Phase 2 to open (ECHO-203) 14

15 Multiple Tumor Types to be Investigated in Ongoing Clinical Collaborations Melanoma Triple-negative breast cancer ECHO-202 KEYNOTE-037 Melanoma Ovarian cancer ECHO-204 Non-small cell lung cancer Ovarian cancer Non-small cell lung cancer B-cell NHL Transitional cell carcinoma Diffuse large B cell lymphoma Glioblastoma HL including DLBCL Head & neck cancer Renal cell carcinoma Head & neck cancer Melanoma Triple-negative breast cancer ECHO-203 Non-small cell lung cancer ECHO-110 Non-small cell lung cancer Bladder cancer Head & neck cancer Gastric cancer 15

16 F re q u e n c y o f T c e ll p o p u la tio n s R e la tiv e L ig h t U n its INCAGN1876: Anti-GITR Agonist Antibody to Enter Clinical Studies in Early 2016 GITR is a co-stimulatory receptor on T cells INCAGN1876 GITR agonism enhances effector T cell activity GITR agonism reduces T-reg cell activity Successful discovery alliance with Agenus Clinical studies expected to begin in early INCAGN1876 enhances cytokine production FcR effector function requires IgG ' (Ig G 1 ) ' (Ig G 4 ) IF N + T N F + IF N + T N F C D 8 + T c e lls C D 4 + T c e lls L o g [G IT R A b ] ( g /m L ) Data on file, Incyte & Agenus 16

17 T u m o r V o lu m e (m m 3, m e a n + /-S E M ) INCB59872: A Potent and Selective Inhibitor of Lysine-Specific Demethylase 1 (LSD1) LSD1 is an epigenetic regulator Maintains oncogenic programs and prevents differentiation in both liquid (e.g. AML) and solid (e.g. SCLC) tumors Clinical studies expected to begin in early 2016 INCB59872 induces AML blast cell differentiation INCB59872 INCB59872 delays tumor growth in SCLC model DSMO Blast V e h ic le IN C B , 0.5 m g /k g, Q D IN C B , 1.5 m g /k g, Q D nM INCB Neutrophil Macrophage D ays post innoculation Data on file, Incyte 17

18 Significant Progress across Clinical Development Portfolio INCB50465 Expansion cohorts initiating in multiple B-cell malignancies INCB54828 Dose escalation ongoing, expansion cohorts in 2016 INCB54329 Dose escalation ongoing INCB53914 Dose escalation ongoing INCSHR1210 Dose escalation ongoing 18

19 A Unique Portfolio, Rich in Synergy and Optionality MPNs Solid tumors JAK1 Targeted Therapies Immuno- Oncology Other Indications Co-Dev/ Licensed Internal discovery, plus Agenus alliance Discovery Clinical Proof of Concept Pivotal Marketed Internal discovery LSD PIM GITR PD-1 Solid tumors JAK1 GVHD BRD Advanced malignancies FGFR Solid tumors Topical ruxolitinib Alopecia areata baricitinib Psoriasis, DN, atopic dermatitis 3, Advanced malignancies PI3Kδ ruxolitinib NSCLC, breast, & colon cancer Pancreatic cancer epacadostat IDO1 Multiple tumor types capmatinib c-met NSCLC, GBM & liver cancer 5,6 ruxolitinib Pancreatic cancer baricitinib Rheumatoid arthritis 3 Jakafi (ruxolitinib) MF and PV 1,2 1. Patients with intermediate or high-risk myelofibrosis 2. Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea 3. Worldwide rights to baricitinib licensed to Lilly 4. DN = Diabetic nephropathy 5. GBM = Glioblastoma multiforme 6. Worldwide rights to capmatinib licensed to Novartis 19

20 Combinatorial Optionality Within and Beyond the Incyte Portfolio Listeria vaccines Cellular therapies Anti- PD-L1 Anti- PD-1 Chemotherapies EGFR inhibitors Targeted therapies Peptide vaccines BTK inhibitors Clinical Preclinical 20

21 Investing in Innovation Financial Strength from Clinical Success

22 Jakafi (ruxolitinib) Momentum Driven by MF Growth and Successful PV Launch 1,2 Overall survival in myelofibrosis 2015 revenue guidance $ million Peak revenue in MF & PV ~$1.5 billion Patent protected until at least 2027 Duration of therapy in polycythemia vera RESPONSE Phase 3 The probability of maintaining the primary response in the ruxolitinib arm for at least 80 weeks from time of response was 92% MF = Patients with intermediate or high-risk myelofibrosis 2. PV = Patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea

23 Baricitinib Expected to Provide Incyte with Second Significant Source of Revenue Baricitinib is a once-a-day, oral therapy candidate for RA RA-BEGIN: Superior to methotrexate in early RA RA-BUILD: Met primary endpoint in DMARD-IR RA-BEACON: Met primary endpoint in TNF-IR RA-BEAM: Superior to Humira (adalimumab)* in DMARD-IR Global RA market (2014) 1 $18 billion U.S. and EU regulatory submissions expected in Q Incyte eligible for milestones & tiered royalties on global net sales RA = Rheumatoid arthritis * The brand listed is not a trademark of Incyte Corporation. The maker of this brand is not affiliated with and does not endorse Incyte Corporation or its products. 1) Source: IMS 23

24 Multiple Potential Value Drivers for Incyte in 2016 o o o o o o o o o Global regulatory submissions of baricitinib by Lilly Continued growth in revenues from Jakafi JANUS 1 (Phase 3) results for ruxolitinib in pancreatic cancer PoC data for ruxolitinib in colorectal and breast cancer Initiation of Phase 3 epacadostat + pembrolizumab in 1 st line melanoma Additional PoC data for epacadostat with anti-pd-1/l1 antibodies Initiation of 1876 (GITR) and (LSD1) clinical programs Clinical data from (PI3Kδ) Clinical data from (FGFR) o Clinical data from (BRD) Incyte s R&D Showcase event to be held during AACR (New Orleans), April

25 Incyte is a World-Class Biopharmaceutical Organization with a Diversified Growth Engine Diversified Global Growth Multiple revenue sources Significant portfolio optionality Small molecules and biologics New therapeutic targets Jakafi sales growth 64% 25