Incyte Corporation David Gryska, CFO William Blair 2017 Growth Stock Conference June 14, 2017

Transcription

1 Incyte Corporation David Gryska, CFO William Blair 2017 Growth Stock Conference June 14, 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: our financial guidance for 2017; continued growth in sales and market share of, and demand for, Jakafi, including whether Jakafi will continue to be a revenue driver for us, whether opportunities for further development will be successful and whether Jakafi will achieve our long-term net product revenue guidance in MF, PV and GVHD; whether baricitinib for RA will be approved in the U.S., whether and when Lilly will pursue possible next steps towards seeking or achieving approval in the U.S. for baricitinib for RA, whether baricitinib will ever be approved in the U.S. for any indication and whether development of baricitinib in other indications will be successful or will continue as currently planned; whether we will receive any further milestones from Lilly in connection with baricitinib development; plans and expectations regarding our product pipeline and strategy (including without limitation plans and expectations relating to epacadostat, ruxolitinib, itacitinib, INCB50465 and INCB54828) - including timelines for advancing our drug candidates through clinical trials (including enrollment and commencement), whether certain trials will serve as the basis for registration, timelines for regulatory submissions and timelines for releasing trial data, and whether any specific program will be successful - and plans and expectations regarding development activities of our collaboration partners (including without limitation collaboration development activities relating to capmatinib and baricitinib); whether and when any of our product candidates or those licensed to our collaborators will be approved for treatment in humans in any country in the world and, if approved, whether any such product candidate will contribute meaningfully to our revenue; whether the plans and expectations regarding the Company s pipeline over the next 12 months will occur as planned or drive potential value; the potential therapeutic and commercial value of our drug candidates; and whether Incyte will become a highly profitable biopharmaceutical company. These forward-looking statements are based on our current expectations and 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 our products; the acceptance of our products in the marketplace; market competition; further research and development; sales, marketing and distribution requirements; clinical trials, including pivotal trials, possibly being unsuccessful or insufficient to meet applicable regulatory standards for clinical advancement or approval 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; 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; expenses relating to litigation or strategic activities; our ability to obtain additional capital when needed; obtaining and maintaining effective patent coverage for our products; and other risks detailed from time to time in our reports filed with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended March 31, 2017, as amended. We disclaim any intent or obligation to update these forward-looking statements. 2

3 Incyte Corporation: Nasdaq INCY Emerging large-cap biotech - Market capitalization ~$25 billion - Part of S&P 500 index Global footprint - US - Europe - Japan Revenue guidance for ,2 - Jakafi (ruxolitinib): $ billion - Iclusig (ponatinib): $60 65 million 1. Jakafi marketed by Incyte in the US; ruxolitinib licensed to Novartis ex-us. 2. European rights to Iclusig licensed from ARIAD 3

4 Economic Impact of Efficacious Cancer Medications can Generate Major Savings to Healthcare System 1. Jason Millman, Wonkblog 2. National Cancer Institute, 2010 Cancer statistics 3. PhRMA, Chart Pack: Cancer Medicines Value in Context,

5 Combination Therapy May Maximize Patient Outcomes in Cancer Treatment 5

6 Incyte: Investment in Innovation creates Value Multiple revenue sources 43% YoY growth in Q1 Robust IP estate World-class drug discovery 18 drug candidates 14 molecular targets Large & small molecules Global development North America, Europe, Japan Multiple pivotal programs 6

7 Incyte: Five Years of Building our Capabilities, Expanding the Portfolio and Growing Revenue 1. Figure shows Incyte total revenue for (US$ millions); Jakavi (ruxolitinib) licensed to Novartis ex-us, Olumiant (baricitinib) licensed to Lilly worldwide 7

8 Incyte has Delivered Dynamic Revenue Growth in Recent Quarters 43% product revenue growth Jakafi sales Iclusig sales Jakavi royalties 1 Olumiant royalties 2 1. Jakavi (ruxolitinib) licensed to Novartis ex-us; 2. Olumiant (baricitinib) licensed to Lilly worldwide, launched by Lilly in Europe in Q1 2017, CRL received in the US 8

9 Five-Year Data Further Supports Overall Survival Advantage Observed in Patients with Myelofibrosis Treated With Jakafi Verstovsek,et al, 2016 ASH poster (abstract 3110) 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 9

10 Strong Jakafi Revenue in the U.S. Driven by Continued Demand 10

11 Jakafi is a Long-term Revenue Driver in the U.S. for Incyte Long-term Jakafi net product revenue guidance in MF, PV and GVHD 1 $2.0 billion 2017 Jakafi net product revenue guidance $ billion 1. Jakafi is approved for patients with intermediate or high-risk myelofibrosis and patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea; GVHD = graft versus host disease. Ruxolitinib is in a pivotal trial program for the treatment patients with steroid-refractory GVHD. 11

12 Incyte has Five Product Candidates in Late Stage Development Two Additional Candidates being Developed to Registration by Partners Clinical Portfolio Late Stage Development 1 1. Includes Phase 3 trials and Phase 1/2 trials being conducted in defined indications that have the potential to be registration-enabling 2. GVHD = graft versus host disease; ruxolitinib being developed in collaboration with Novartis for the treatment of steroid-refractory GVHD, itacitinib being developed for treatment-naïve GVHD 3. Pivotal development of epacadostat being undertaken in collaboration with Merck (with pembrolizumab) 4. Pivotal development of epacadostat being undertaken in collaboration with Bristol-Myers Squibb (with nivolumab) 5. Capmatinib licensed worldwide to Novartis. 6. Baricitinib licensed worldwide to Lilly 7. Olumiant (baricitinib) launched by Lilly in Europe in Q1 2017, CRL received in the US 12

13 Ruxolitinib and Itacitinib Are Potential New Treatments for Patients with Graft-vs-Host Disease 1. Trial not yet recruiting patients 2. Development in collaboration with Novartis 13

14 The CITADEL Development Program for Lymphoma INCB50465 is a 2 nd -Generation PI3Kδ Inhibitor DLBCL ASCO Follicular Marginal Zone Safety: Overall well tolerated at all doses No significant transaminase elevations Mantle Cell CITADEL-202 has been initiated CITADEL-203 and CITADEL-204 are not yet recruiting patients 1. Ramchandren et al, 2017 ASCO abstract 7530; All INCB50465 doses are once daily. * Response assessments occurred every 9 weeks. Includes extranodal MZL of MALT type (n = 2), nodal MZL (n = 5), and splenic MZL (n = 2). This patient had an assessment of PD by PET but not by overall assessment and continued on treatment.. AE, adverse event; CMR, complete metabolic response; 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; PD, progressive disease; PET, positron emission tomography; PMD, progressive metabolic disease; PMR, partial metabolic response; PR, partial response; QD, once daily. 14

15 The INCB54828 Clinical Program for Genetically-Driven Cancers Directed at Patients with FGFR1/2/3 Alterations All three FIGHT trials are open for enrollment 15

16 Epacadostat to be Investigated in Multiple Pivotal Studies In Combination with PD-1 Inhibitors epacadostat plus pembrolizumab Melanoma (already underway) Non-small cell lung cancer Head and neck cancer Urothelial cancer Renal cell carcinoma Triple-negative breast cancer Ovarian cancer epacadostat plus nivolumab Non-small cell lung cancer Head and neck cancer Colorectal cancer Ovarian cancer 16

17 Epacadostat: A Key Component of Combination Immunotherapy Improved Response Rates Compared to PD-1 Monotherapy Comparative anti-pd-1 monotherapy data are provided for illustrative purposes only; head-to-head comparative trials were not conducted. Epa = epacadostat, Pembro = pembrolizumab, Nivo = nivolumab; CR = complete response, PR = partial response; Treatment-naïve melanoma, all other tumor types in second-line setting ECHO-202 data for melanoma from ESMO 2016; all other ECHO-202 and ECHO-204 data from ASCO 2017 Keynote-006; Robert et al, NEJM Keynote-010; Herbst et al, Lancet Keynote-045; Bellmunt et al, NEJM Keynote-055; Bauml et al, JCO Checkmate-025; Motzer et al, NEJM

18 ECHO-202: Treatment-Related AEs Observed With Epacadostat 100 mg BID Plus Pembrolizumab 200 mg Q3W in the Overall Phase 2 Patient Population ( 5% of Patients) Total (N=294) AE, n (%) All Grade Grade 3/4* Total 197 (67) 52 (18) Across tumor types, 18% of patients experienced Grade 3/4 treatment-related adverse events Fatigue 85 (29) 4 (1) Rash 51 (17) 9 (3) Nausea 31 (11) 1 (<1) Pruritus 28 (10) 0 Diarrhea 23 (8) 4 (1) Decreased appetite 20 (7) 1 (<1) Arthralgia 17 (6) 1 (<1) ALT increased 16 (5) 2 (1) Lipase increased (asymptomatic) 16 (5) 12 (4) Vomiting 16 (5) 0 AST increased 15 (5) 2 (1) Pyrexia 15 (5) 1 (<1) Amylase increased 14 (5) 4 (1) AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; MedDRA, Medical Dictionary for Regulatory Activities; NSCLC, non-small cell lung cancer; OVC, ovarian cancer; Q3W, every 3 weeks; RCC, renal cell carcinoma; SCCHN, squamous cell carcinoma of head and neck; TNBC, triple-negative breast cancer; UC, urothelial carcinoma. * Other grade 3/4 not listed in table above includes: hyperglycemia (n=3); dehydration, neutropenia (n=2 each); abdominal pain, abdominal pain upper, ascites, aseptic meningitis, atrial fibrillation, autoimmune hepatitis, blood bilirubin increased, colitis, chronic obstructive pulmonary disease exacerbation, cranial nerve disorder, dyspnea, electrocardiogram QT, facial pain, facial paresis, failure to thrive, gait disturbance, hyponatremia, hypotension, hypoxia, infusion-related reaction, liver function test abnormal, musculoskeletal pain, pericardial effusion, pneumothorax, pyrexia, respiratory failure, sinus bradycardia, tremor, weight decreased, and uncoded diarrhea/pleural effusion/failure to thrive (n=1 each). Rash includes the following MedDRA preferred terms: rash, rash generalized, rash macular, rash maculo-papular, and rash pruritic. 18 Pruritus includes the following MedDRA preferred terms: pruritus and pruritus generalized.

19 Epacadostat has Potential in Multiple Tumor Types In Combination with PD-1 Inhibitors Incidence Data 1 Estimated Current I-O Market 2 Melanoma > 20,000 Keytruda Opdivo Yervoy > $2 billion Non-small cell lung cancer Head and neck cancer Renal cell carcinoma Urothelial carcinoma > 350,000 > 50,000 > 30,000 > 70, Diagnosed incidence plus newly-recurrent metastatic/unresectable disease in US, EU5 and Japan; Decision Resources, Incyte analyses 2. Estimated combined revenue from Keytruda, Opdivo and Yervoy in metastatic melanoma for 2016; Evaluate Pharma, Incyte analyses; I-O = immuno-oncology 19

20 Incyte is Building a Global, Fast-growing Biopharma Company 20

21 Multiple Sources of Current and Potential Future Revenue Currently Approved Products and Product Candidates in Late Stage Development 1 Worldwide rights to Olumiant (baricitinib) licensed to Lilly (CRL received in the US); ex-us rights to Jakavi (ruxolitinib) and worldwide rights to capmatinib licensed to Novartis 1. Includes Phase 3 trials and Phase 1/2 trials being conducted in defined indications that have the potential to be registration-enabling 21

22 Significant Newsflow Expected over the Next Twelve Months Ruxolitinib JAK1/JAK2 Initiate RESET pivotal program Essential thrombocythemia Pivotal Phase 2 (REACH1) trial results Steroid-refractory acute graft-vs-host disease Itacitinib JAK1 Initiate GRAVITAS pivotal program Treatment-naïve acute graft-vs-host disease INCB54329 & INCB57643 BRD Dose escalation data Advanced malignancies INCB53914 PIM Dose escalation data Advanced malignancies Epacadostat IDO1 (plus pembrolizumab) 1 Phase 2 (ECHO-202) trial data Melanoma Initiate additional Phase 3 trials NSCLC, renal, head & neck, bladder Phase 3 (ECHO-301) trial results Melanoma Epacadostat IDO1 (plus nivolumab) 2 Initiate Phase 3 trials NSCLC and head & neck I-O Doublets JAK1,PD-1,IDO1,PI3Kδ Phase 2 data (paired biopsy trials) Multiple tumor types Baricitinib 3 JAK1/JAK2 PoC data Atopic dermatitis Capmatinib 4 c-met Phase 1b/2 data (+EGFR) NSCLC 1. In collaboration with Merck 2. In collaboration with BMS 3. Worldwide rights to baricitinib licensed to Lilly 4. Worldwide rights to capmatinib licensed to Novartis 22

23 Incyte has the Portfolio, Footprint and Financial Strength to Set the Foundation for Global Growth World-class drug discovery - Small molecules - Large molecules 18 clinical candidates - Targeted therapy - Immuno-therapy Global footprint - US, Europe, Japan Strong financial position 1 - More than $500 million cash - Less than $50 million debt 1. As reported at end Q