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Incyte Corporation Q2 2016 Financial and Corporate Update August 9, - PowerPoint PPT Presentation

Incyte Corporation Q2 2016 Financial and Corporate Update August 9, 2016 Speakers Herv Hoppenot David Gryska Chief Executive Officer Chief Financial Officer Barry Flannelly Reid Huber General Manager, U.S. Chief Scientific Officer


  1. Incyte Corporation Q2 2016 Financial and Corporate Update August 9, 2016

  2. Speakers Hervé Hoppenot David Gryska Chief Executive Officer Chief Financial Officer Barry Flannelly Reid Huber General Manager, U.S. Chief Scientific Officer Steven Stein Chief Medical Officer 2

  3. 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; the Company’s revise d 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 receive a positive opinion in Europe, whether and when Lilly will launch baricitinib and whether baricitinib will be a successful product and become an important source of revenue for the Company; whether the Company’s exp anded European team will grow the Iclusig brand or contribute to clinical development; 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 timelines for releasing trial data, and whether any specific program will be successful - including, without limitation, with respect to its selective JAK1 inhibitor, IDO1 inhibitor (epacadostat), FGFR inhibitor, BRD inhibitor, GITR, OX40, LSD1, PI3K-delta, c-Met, PD-1, PIM, GVHD and topical ruxolitinib programs; whether the plans and expectat ions regarding the Company’s pipeline over the next 12 months will drive potential value; anticipated future investments and accomplishments in drug discovery and development; the potential therapeutic and commercial value of our drug candidates; and the planned accounting treatment for the recent ARIAD transaction. 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 our products; the acceptance of our 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 produ cts; 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 March 31, 2016. The Company disclaims any intent or obligation to update these forward-looking statements. 3

  4. Building Value Hervé Hoppenot President & CEO

  5. Incyte is Building a World-Class Biopharmaceutical Organization ECHO GVHD FGFR Global RA GITR market 1 Portfolio Progress Global Expansion Baricitinib Opportunity Jakafi Growth 5 1. IMS data 2015; RA = rheumatoid arthritis

  6. Commercial Update Barry Flannelly General Manager, U.S.

  7. New Data Reinforces Jakafi’s Leadership Position in MPNs • Myelofibrosis 46% increase - Jakafi is standard of care in the U.S. 1 14% increase Jakafi net product revenue (US$m) - Five year overall survival data published - Benefit of early intervention • Polycythemia Vera - Two successful Phase 3 trials for Jakafi - Durable control of hematocrit & splenomegaly - Improved PV related symptoms • Updated FY 2016 Guidance - $825-835 million 7 1. For patients with intermediate or high-risk myelofibrosis

  8. Five-Year Survival Data now Available from COMFORT-I and COMFORT-II Phase 3 Trials of Jakafi in Myelofibrosis 1,2 • 5-year analyses support Jakafi as COMFORT-I Overall Survival Assessed by Kaplan-Meier effective long-term treatment 3  Durable reductions in splenomegaly  Significantly longer overall survival, irrespective of cross-over from placebo  No new or unexpected adverse events were identified with long-term treatment  Adverse events were consistent with the well characterized safety profile of ruxolitinib 8 1. Gupta V, et al, ASCO 2016 2. Harrison C, et al, Leukemia accepted article preview 23 May 2016; doi: 10.1038/leu.2016.148. 3. Intermediate-2 and high-risk myelofibrosis

  9. Second Positive Phase 3 Trial for Jakafi in Polycythemia Vera 1 • RESPONSE-2 in PV patients without Primary Response in RESPONSE-2: Hematocrit Control at Week 28 enlarged spleens, Jakafi was: P < .0001 Odds ratio 7.28 (95% CI, 3.43-15.45)  Well tolerated 80 68.2% 62.2% Ruxolitinib 53.3%  Superior to Best Available Therapy 60 BAT Patients, %  Controlling Hct without phlebotomy 40 20.0% 18.7% 16.7%  Achieving complete hematologic remission 20  Improving PV-related symptoms 0 All Patients HU Resistant HU Intolerant  Findings from RESPONSE and RESPONSE-2 suggest that Jakafi should be considered as a standard of care for second-line therapy in this post-HU patient population 9 1. Passamonti F, et al, EHA 2016 Hct = hematocrit, HU = hydroxyurea

  10. Portfolio Update Steven Stein Chief Medical Officer

  11. Epacadostat plus PD-1/L1 Therapies in Multiple Tumor Types; Phase 3 Trial now Underway in Melanoma Dose escalation Dose expansion Pivotal ECHO-301, KEYNOTE-252 (w/ pembrolizumab) 1 st line advanced or metastatic melanoma 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 ECHO-203 (w/ durvalumab) Non-small cell lung cancer, head & neck cancer, triple-negative breast cancer, genitourinary transitional call carcinoma, gastric cancer, melanoma 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 11

  12. Ruxolitinib Granted Breakthrough Therapy Designation For Treatment of acute GVHD; Pivotal Program in Preparation • U.S. registration program for Jakafi - Steroid-refractory setting - Trials planned in acute & chronic GVHD • Proof-of- concept trial for ‘39110 - Enrollment completed - Data expected in H2 2016 Incidence = 7,000 new GVHD patients in the U.S.  Prevalence = 10,000 GVHD patients in the U.S.  12

  13. New Phase 2 Trial of INCB54828 (FGFR Inhibitor) in Bladder Cancer to Begin in H2 2016 INCB54828: Dose-escalation ongoing Phase 2: Bladder Cancer (Solid tumors, regardless of FGF/FGFR status) (Harboring FGFR pathway alterations)  Attractive clinical pharmacokinetics  Dosing: 13.5mg QD, 2 weeks on / 1 week off  High magnitude receptor inhibition  Primary endpoint = overall response rate  No off-target dose-limiting toxicities  Secondary endpoints to include PFS and overall survival  Evidence of clinical activity in FGFR mutated malignancies Approximately 15% of bladder cancer cases K650E have activating FGFR3 mutations (as shown) S371C K650M R248C G370C G380R K650Q Approximately 5% of bladder cancer cases have S249C Y373C A391E K650T activating FGFR3 translocations (not shown) TM TK Extracellular Intracellular Adapted from Iyer et al JCO 2012, Guo et al Nature Genetics 2013, The Cancer Genome Atlas, Nature 2014 13

  14. INCAGN1876 (anti-GITR agonist) Proof-of-Concept Trial now Underway in Patients with Solid Tumors Combination of INCAGN1876 and anti-PD1 antibodies Monotherapy now recruiting: Target ~150 patients enhances T effector cell function 1 2 5 0 0 Dose-escalation, 3+3 design Dose-expansion at RP2D 2 0 0 0 • Endometrial adenocarcinoma • Melanoma Advanced or metastatic IL 2 p g /m L 1 5 0 0 • Non-small cell lung cancer solid tumors • Renal cell carcinoma 1 0 0 0 5 0 0 Combination therapy strategy • Potential for GITR combinations, including with: 0 IN C A G N 1 8 7 6 N iv o P e m b ro IN C A G N 1 8 7 6 + N iv o IN C A G N 1 8 7 6 + P e m b ro - PD-1, IDO1, chemotherapy, radiation therapy 14 1. Data on file, Incyte

  15. A Balanced and Diversified Development Portfolio of Large and Small Molecules 1. Jakafi marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-US 4. Registration program expected to begin in H2 2016 15 2. Patients with intermediate or high-risk myelofibrosis; Patients with polycythemia vera 5. Co-development with Agenus who have had an inadequate response to or are intolerant of hydroxyurea 6. Worldwide rights to baricitinib licensed to Lilly, SLE = Systemic lupus erythematosus 3. European rights to Iclusig licensed from ARIAD 7. Worldwide rights to capmatinib licensed to Novartis, GBM = Glioblastoma multiforme

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