Incyte Corporation. Q Financial and Corporate Update August 9, 2016

Transcription

1 Incyte Corporation Q Financial and Corporate Update August 9, 2016

2 Speakers Hervé Hoppenot Chief Executive Officer David Gryska Chief Financial Officer Barry Flannelly General Manager, U.S. Reid Huber 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 revised 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 expanded 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 expectations 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 products; 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, 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 market 1 GITR Portfolio Progress Global Expansion Baricitinib Opportunity Jakafi Growth 1. IMS data 2015; RA = rheumatoid arthritis 5

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

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

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 effective long-term treatment 3 COMFORT-I Overall Survival Assessed by Kaplan-Meier 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 1. Gupta V, et al, ASCO Harrison C, et al, Leukemia accepted article preview 23 May 2016; doi: /leu Intermediate-2 and high-risk myelofibrosis 8

9 Patients, % Second Positive Phase 3 Trial for Jakafi in Polycythemia Vera 1 RESPONSE-2 in PV patients without enlarged spleens, Jakafi was: Primary Response in RESPONSE-2: Hematocrit Control at Week 28 Well tolerated Superior to Best Available Therapy P <.0001 Odds ratio 7.28 (95% CI, ) 62.2% 53.3% 68.2% Ruxolitinib BAT Controlling Hct without phlebotomy Achieving complete hematologic remission % 16.7% 20.0% 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 1. Passamonti F, et al, EHA 2016 Hct = hematocrit, HU = hydroxyurea 9

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

14 IL 2 p g /m L INCAGN1876 (anti-gitr agonist) Proof-of-Concept Trial now Underway in Patients with Solid Tumors Monotherapy now recruiting: Target ~150 patients Combination of INCAGN1876 and anti-pd1 antibodies enhances T effector cell function Dose-escalation, 3+3 design Dose-expansion at RP2D Advanced or metastatic solid tumors Endometrial adenocarcinoma Melanoma Non-small cell lung cancer Renal cell carcinoma Combination therapy strategy Potential for GITR combinations, including with: - PD-1, IDO1, chemotherapy, radiation therapy 1. Data on file, Incyte 0 IN C A G N N iv o P e m b r o IN C A G N N iv o IN C A G N P e m b r o 14

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 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. Registration program expected to begin in H Co-development with Agenus 6. Worldwide rights to baricitinib licensed to Lilly, SLE = Systemic lupus erythematosus 7. Worldwide rights to capmatinib licensed to Novartis, GBM = Glioblastoma multiforme 15

16 Multiple Potential Value Drivers for Incyte in Next Twelve Months Ruxolitinib JAK1/JAK2 INCB39110 JAK1 INCB54828 FGFR INCB54329 BRD Epacadostat IDO1 INCAGN1949 OX40 Topical Ruxolitinib JAK1/JAK2 Baricitinib JAK1/JAK2 Initiate proof-of-concept trial NSCLC Initiate Phase 2 trial Bladder cancer Phase 1 data (+pembrolizumab) Solid tumors Initiate proof-of-concept trial Solid tumors Initiate pivotal program GVHD Proof-of-concept results GVHD Dose escalation data available Advanced malignancies Dose escalation data available Advanced malignancies FDA and EMA decisions Rheumatoid arthritis Additional proof-of-concept data available (+PD-1 / PD-L1) Multiple tumor types Proof-of-concept results Alopecia areata 16

17 Financial Results David Gryska Chief Financial Officer

18 Q2 Financial Performance and Update FY 2016 Guidance Three Months Ended Six Months Ended June 30, June 30, Total revenues 246, , , ,260 Costs and expenses: Cost of product revenues (including definite-lived intangible amortization) 12,367 6,254 18,372 9,229 Research and development 120, , , ,809 Selling, general and administrative 66,792 51, ,390 96,548 Change in fair value of acquisition-related contingent consideration 2,271-2,271 - Total costs and expenses 201, , , ,586 Jakafi net product revenue Iclusig net product revenue Updated FY 2016 Guidance Current $825-$835m $25-$30m Previous $815-$830m Unchanged R&D expenses $620-$630m $635-$660m Income (loss) from operations 44,589 (7,394) 80,627 (14,326) Other income (expense), net (9,379) 16,824 (20,970) 5,766 SG&A expenses $285-$310m Unchanged Income (loss) before provision for income taxes 35,210 9,430 59,657 (8,560) Provision for income taxes , Net income (loss) $34,425 $9,294 $58,472 ($9,063) 18

19 Accounting for the ARIAD European Transaction Three Months Ended June 30, Total revenues 246, ,984 Costs and expenses: Cost of product revenues (including definite-lived intangible amortization) 12,367 6,254 Research and development 120, ,445 Selling, general and administrative 66,792 51,679 Change in fair value of acquisition-related contingent consideration 2,271 - Total costs and expenses 201, ,378 Income (loss) from operations 44,589 (7,394) Other income (expense), net (9,379) 16,824 Income before provision for income taxes 35,210 9,430 Provision for income taxes Net income $34,425 $9,294 Straight line amortization Change in fair value ASSETS June 30, 2016 Cash and cash equivalents $629,191 Restricted cash and investments 938 Accounts receivable 129,486 Property and equipment, net 138,513 Inventory 21,664 Prepaid expenses and other assets 29,809 Long term investment 31,444 Intangible product rights, net 269,205 In-process research and development 12,000 Goodwill 155,725 Total assets $1,417,975 LIABILITIES AND STOCKHOLDERS EQUITY Accounts payable, accrued expenses and other liabilities $185,338 Deferred revenue collaborative agreements 6,083 Convertible senior notes 635,491 Acquisition-related contingent consideration 294,000 Stockholders equity 297,063 Total liabilities and stockholders equity $1,417,975 19

20 Q&A

21 Speakers Hervé Hoppenot Chief Executive Officer David Gryska Chief Financial Officer Barry Flannelly General Manager, U.S. Reid Huber Chief Scientific Officer Steven Stein Chief Medical Officer 21