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
Q2 2016 Financial and Corporate Update August 9, 2016
Hervé Hoppenot Chief Executive Officer Barry Flannelly General Manager, U.S. Steven Stein Chief Medical Officer
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David Gryska Chief Financial Officer Reid Huber Chief Scientific Officer
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, 2016. The Company disclaims any intent or obligation to update these forward-looking statements.
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President & CEO
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ECHO GVHD FGFR GITR
Global RA market1 Baricitinib Opportunity Jakafi Growth Portfolio Progress Global Expansion
1. IMS data 2015; RA = rheumatoid arthritis
General Manager, U.S.
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46% increase 14% increase
Jakafi net product revenue (US$m)
1. For patients with intermediate or high-risk myelofibrosis
effective long-term treatment3
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
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COMFORT-I Overall Survival Assessed by Kaplan-Meier
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
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enlarged spleens, Jakafi was:
Well tolerated Superior to Best Available Therapy
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
Primary Response in RESPONSE-2: Hematocrit Control at Week 28
62.2% 53.3% 68.2% 18.7% 16.7% 20.0% 20 40 60 80 All Patients HU Resistant HU Intolerant Patients, % Ruxolitinib BAT P < .0001 Odds ratio 7.28 (95% CI, 3.43-15.45)
1. Passamonti F, et al, EHA 2016 Hct = hematocrit, HU = hydroxyurea
Chief Medical Officer
ECHO-301, KEYNOTE-252 (w/ pembrolizumab)
1st line advanced or metastatic melanoma
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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
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
Incidence = 7,000 new GVHD patients in the U.S. Prevalence = 10,000 GVHD patients in the U.S.
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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
INCB54828: Dose-escalation ongoing
(Solid tumors, regardless of FGF/FGFR status)
Adapted from Iyer et al JCO 2012, Guo et al Nature Genetics 2013, The Cancer Genome Atlas, Nature 2014
TM TK
Intracellular Extracellular R248C S249C S371C G370C Y373C G380R A391E K650E K650M K650Q K650T Approximately 15% of bladder cancer cases have activating FGFR3 mutations (as shown) Approximately 5% of bladder cancer cases have activating FGFR3 translocations (not shown)
Monotherapy now recruiting: Target ~150 patients Combination therapy strategy
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Advanced or metastatic solid tumors
Dose-escalation, 3+3 design Dose-expansion at RP2D
Combination of INCAGN1876 and anti-PD1 antibodies enhances T effector cell function1
1. Data on file, Incyte 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 5 0 0 1 0 0 0 1 5 0 0 2 0 0 0 2 5 0 0
IL 2 p g /m L
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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 H2 2016 5. 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
Dose escalation data available Advanced malignancies
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Ruxolitinib JAK1/JAK2
Initiate pivotal program GVHD
INCB39110 JAK1
Initiate proof-of-concept trial NSCLC
INCB54828 FGFR
Initiate Phase 2 trial Bladder cancer Dose escalation data available Advanced malignancies
INCB54329 BRD
Additional proof-of-concept data available (+PD-1 / PD-L1) Multiple tumor types
Epacadostat IDO1
Phase 1 data (+pembrolizumab) Solid tumors
INCAGN1949 OX40
Initiate proof-of-concept trial Solid tumors
Topical Ruxolitinib JAK1/JAK2
Proof-of-concept results Alopecia areata
Baricitinib JAK1/JAK2
FDA and EMA decisions Rheumatoid arthritis Proof-of-concept results GVHD
Chief Financial Officer
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Updated FY 2016 Guidance Current Previous Jakafi net product revenue $825-$835m $815-$830m Iclusig net product revenue $25-$30m Unchanged R&D expenses $620-$630m $635-$660m SG&A expenses $285-$310m Unchanged Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 Total revenues 246,288 162,984 509,752 322,260 Costs and expenses: Cost of product revenues (including definite-lived intangible amortization) 12,367 6,254 18,372 9,229 Research and development 120,269 112,445 277,092 230,809 Selling, general and administrative 66,792 51,679 131,390 96,548 Change in fair value of acquisition-related contingent consideration 2,271
201,699 170,378 429,125 336,586 Income (loss) from operations 44,589 (7,394) 80,627 (14,326) Other income (expense), net (9,379) 16,824 (20,970) 5,766 Income (loss) before provision for income taxes 35,210 9,430 59,657 (8,560) Provision for income taxes 785 136 1,185 503 Net income (loss) $34,425 $9,294 $58,472 ($9,063)
Three Months Ended June 30, 2016 2015 Total revenues 246,288 162,984 Costs and expenses: Cost of product revenues (including definite-lived intangible amortization) 12,367 6,254 Research and development 120,269 112,445 Selling, general and administrative 66,792 51,679 Change in fair value of acquisition-related contingent consideration 2,271
201,699 170,378 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 785 136 Net income $34,425 $9,294
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June 30, 2016 ASSETS 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 Straight line amortization Change in fair value
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Hervé Hoppenot Chief Executive Officer Barry Flannelly General Manager, U.S. Steven Stein Chief Medical Officer David Gryska Chief Financial Officer Reid Huber Chief Scientific Officer