Novocure Limited · NASDAQ:NVCR
Novocure — Investor Presentation (May 2017)
44 slides from Novocure's investor presentation, May 2017
Slide 1: Novocure (NVCR) overview
Novocure (NVCR) overview updated May 2017
Slide 2: Forward-looking statements
forward-looking statements This presentation contains certain forward-looking statements with respect to the business of Novocure and certain of its plans and objectives, including with respect to the development and commercialization of its lead product candidate, Optune, for a number of oncology i
Slide 3: Contents
contents company overview mechanism of action EF-14 clinical data commercial execution clinical development financial highlights © Novocure 2017 3
Slide 4: Company overview
company Overview patientforward
Slide 5: About Novocure
PATIENT-FORWARD MISSION about novocure global proven lead rich clinical organization product pipeline • Headquartered in Jersey • Approved in the U.S., • Broadly applicable mechanism • Five currently active EMEA and Japan for the of action across multiple solid commercial markets treatment of gliobl
Slide 6: Three strategic objectives
three strategic objectives Drive commercial adoption of Optune Advance the clinical pipeline Focus on improving operating leverage © Novocure 2017 6
Slide 7: Mechanism of action
mechanism of action
Slide 8: Low-intensity alternating electric fields
low-intensity alternating electric fields USED ALONE OR IN COMBINATION TO TREAT SOLID TUMORS surgery radiation pharmacological tumor treating fields treatments (TTFields) • Most frequently • Kills cells when • Includes • Low-intensity, employed delivered at high chemotherapy, alternating electric th
Slide 9: Electric fields exert forces on electrically polarized molecules
electric fields exert forces on electrically polarized molecules GRAVITATIONAL FIELDS MAGNETIC FIELDS ELECTRIC FIELDS exert force on masses exert force on iron exert force on charges & other magnets & polarized molecules uniform field Earth Magnet Charged Plates © Novocure 2017 9
Slide 10: Frequency of electric fields determines their biological effect
frequency of electric fields determines their biological effect LOW FREQUENCIES Intermediate Frequencies High Frequencies less than 1 kHz 100 to 500 kHz greater than 1,000 kHz Depolarization of excitable Inhibition of cell proliferation Tissue heating cells (eg, neurons, cardiac Increased cell death
Slide 11: TTFields impact metaphase
TTFields impact metaphase normal metaphase effect of TTFields on metaphase tubulin subunits tubulin subunits align with align properly, TTFields forming a normal mitotic misaligned spindle tubulin disrupts mitotic spindle tubulin subunits have a high uniform dipole moment electric field © Novocure 2
Slide 12: TTFields are delivered via a non-invasive, portable medical device
TTFields are delivered via a non-invasive, portable medical device • Battery or wall-powered electric field generator • Single-use transducer arrays replaced 2–3 times/week • Should be used at least 18 hours/day • Mild side-effect profile, no known systemic toxicity © Novocure 2017 13
Slide 13: EF-14 clinical data
novocure" EF-14 clinical data patientforward
Slide 14: EF-14 phase 3 pivotal trial design
COMBINATION THERAPY FOR NEWLY DIAGNOSED GBM EF-14 phase 3 pivotal trial initiated in 2009 A prospective, multicenter trial of TTFields together with temozolomide compared to standard-of-care temozolomide alone in patients with newly diagnosed GBM • 83 centers; 695 newly diagnosed GBM patients random
Slide 15: EF-14 progression free survival
EF-14 FIVE-YEAR SURVIVAL ANALYSIS: INTENT-TO-TREAT POPULATION EF-14 progression free survival OPTUNE + TMZ TMZ ALONE 1.0 (n=466)1,2 (n=229) 1,2 Optune + TMZ Median PFS from 0.9 6.7 4.0 TMZ alone randomization, mo 0.8 95% CI, mo 6.1-8.1 3.8-4.4 Stratified log-rank p=0.00005 0.7 Fraction survival HR (
Slide 16: EF-14 overall survival
EF-14 FIVE-YEAR SURVIVAL ANALYSIS: INTENT-TO-TREAT POPULATION EF-14 overall survival OPTUNE + TMZ TMZ ALONE 1.0 (n=466)1,2 (n=229) 1,2 Optune + TMZ Median OS from 0.9 20.9 16.0 TMZ alone randomization, mo 0.8 95% CI, mo 19.3-22.7 14.0-18.4 Stratified log-rank p=0.0006 0.7 Fraction survival HR (95% C
Slide 17: EF-14 annual survival rates
EF-14 FIVE-YEAR SURVIVAL ANALYSIS EF-14 annual survival rates 80% p=0.029 Optune + TMZ (n=466) 70% 73% TMZ alone (n=229) Overall Survival rate (%)1,2 60% 65% p=0.001 50% 40% 43% p=0.004 30% p=0.0002 31% 26% p=0.004 20% 20% 16% 10% 13% 8% 5% 0% 1 2 3 4 5 TMZ, temozolomide; ITT, intent-to-treat. Year
Slide 18: EF-14 subgroup analysis
EF-14 FIVE-YEAR SURVIVAL ANALYSIS EF-14 subgroup analysis MEDIAN SURVIVAL (MONTHS) SUBGROUP NO. OF PATIENTS (%) HAZARD RATIO OPTUNE + TMZ1 TMZ ALONE1 Overall 695 (100) 20.9 16.0 MGMT (central) Unmethylated 304 (44) 16.9 14.7 Methylated 214 (31) 31.6 21.2 Resection Biopsy 89 (13) 16.5 11.6 Partial 23
Slide 19: Commercial execution
novecure’ commercial execution patientforward
Slide 20: Global commercial presence
ADULT PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED GBM global commercial presence global active markets as of March 31, 2017 EMEA UNITED STATES EMEA 11 538 179 sales force certified centers colleagues certified centers JAPAN UNITED STATES 131 45 certified centers sales force colleagues JAPAN 2 certif
Slide 21: Direct to patient distribution model
direct to patient distribution model Physician sends prescription order to Novocure Physician or Novocure uses NovoTAL System to create array placement map Novocure delivers Optune and trains patient/family Novocure provides 24/7 tech support and supplies transducer arrays Novocure bills third-party
Slide 22: Q1 2017 operating statistics
q1 2017 operating statistics Q 1 2017 Q 1 2016 % GR OWTH Q 4 2016 % GR O WTH Prescriptions 894 755 18% 706 27% United States 685 684 0% 544 26% Germany, Switzerland and other EMEA Markets 206 71 190% 162 27% Japan 3 - N/A - N/A Active patients at period end 1,266 797 59% 1,091 16% United States 933
Slide 23: Active patient growth
active patient growth global active patients at period end 1400 1,266 1200 1000 797 891 985 1,091 9 CONSECUTIVE 800 QUARTERS OF 605 ACTIVE PATIENT 469 GROWTH SINCE 600 425 PRESENTATION OF 372 EF-14 DATA 400 225 200 0 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 U.S
Slide 24: Expanding market access
expanding market access >187 • As of March 31, 2017, payers administering plans for more than 187 million U.S. lives had issued positive coverage policies • As of March 31, 2017, contracts negotiated to establish Optune as MILLION COVERED LIVES IN THE U.S. an in-network benefit for more than 137 mil
Slide 25: Revenue growth
revenue growth global net revenues by quarter (U.S. dollars in thousands) $40,000 $34,880 $35,000 $30,000 $21,674 $30,242 167% YEAR-OVER-YEAR $25,000 REVENUE GROWTH $17,919 $20,000 $12,383 $13,053 $15,000 $8,953 $6,543 $10,000 $5,208 $3,801 $5,000 $0 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q
Slide 26: Clinical development
clinical development Actor Portrayal
Slide 27: Broad applicability to solid tumors
broad applicability to solid tumors © Novocure 2017 28
Slide 28: Ongoing clinical trials
ongoing clinical trials PRE- PHASE 2 PHASE 3 CLINICAL PILOT PIVOTAL EXPECTED NEXT MILESTONE INDICATIONS Brain Metastases METIS trial last patient in 2019 with final data collection in 2020 NSCLC LUNAR trial last patient in 2019 with final data collection in 2021 Pancreatic Cancer phase three pivotal
Slide 29: Transducer array placement
transducer array placement abdominal torso pelvic array placement array placement array placement © Novocure 2017 30
Slide 30: METIS phase 3 pivotal trial initiated in 2016
BRAIN METASTASES FROM NON-SMALL CELL LUNG CANCER METIS phase 3 pivotal trial initiated in 2016 A prospective, randomized controlled, multicenter trial testing efficacy, safety and neurocognitive outcomes of TTFields at 150 kHz following stereotactic radiosurgery in advanced non-small cell lung cance
Slide 31: Phase 2 pilot EF-15 trial
SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER phase 2 pilot EF-15 trial A prospective, open label, single-arm, non-randomized, multicenter study of TTFields at 150 kHz to estimate efficacy and determine safety together with pemetrexed in pretreated patients with locally advanced non-
Slide 32: LUNAR phase 3 pivotal trial initiated in 2017
SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER LUNAR phase 3 pivotal trial initiated in 2017 A prospective, randomized controlled, multicenter trial testing efficacy and safety of TTFields at 150 kHz in combination with docetaxel or PD-1 inhibitors as second-line treatment in patients
Slide 33: Phase 2 pilot PANOVA trial
ADVANCED PANCREATIC CANCER phase 2 pilot PANOVA trial A prospective, open label, single-arm, non-randomized, multicenter study testing feasibility, safety and preliminary efficacy of TTFields at 150 kHz together with gemcitabine or gemcitabine plus nab- paclitaxel in patients with advanced pancreati
Slide 34: Phase 2 pilot PANOVA trial results
ADVANCED PANCREATIC CANCER phase 2 pilot PANOVA trial FIRST COHORT SECOND COHORT GEMCITABINE- NAB-PACLITAXEL ALONE TTFIELDS WITH PLUS GEMCITABINE TTFIELDS WITH HISTORICAL NAB-PACLITAXEL HISTORICAL EFFICACY ENDPOINTS GEMCITABINE 1 RESULTS 2 PLUS GEMCITABINE 3 RESULTS 2 Median PFS 8.3 months 3.7 month
Slide 35: Phase 2 pilot INNOVATE trial
RECURRENT OVARIAN CANCER phase 2 pilot INNOVATE trial A prospective, open label, single-arm, non-randomized, multicenter study testing feasibility, safety, toxicity and preliminary efficacy of TTFields at 200 kHz together with weekly paclitaxel in patients with recurrent ovarian cancer versus histor
Slide 36: Phase 2 pilot STELLAR trial
FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA phase 2 pilot STELLAR trial A prospective, open label, single-arm, non-randomized, multicenter study testing safety and preliminary efficacy of TTFields at 150 kHz together with pemetrexed and cisplatin or carboplatin in patients with previously
Slide 37: Phase 2 pilot STELLAR trial interim results
FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA phase 2 pilot STELLAR trial interim results PROGRESSION-FREE SURVIVAL (N=42) OVERALL SURVIVAL (N=42) Cerasoli, G.L. International Association for the Study of Lung Cancer. OA22.01 – STELLAR – Interim Results of a Phase 2 Trial of TTFields with C
Slide 38: Financial highlights
financial highlights
Slide 39: Transition to accrual-based revenue recognition
transition to accrual-based revenue recognition 2017 2016 U. S . D O L L A R S I N M I L L I O N S Q1 Q4 Q3 Q2 Q1 Gross billings $ 73.2 $ 63.8 $ 57.5 $ 54.0 $ 45.5 Revenue recorded on accrual basis $ 14.7 $ 8.5 $ 0.0 $ 0.0 $ 0.0 Revenue recorded on cash basis for therapy provided in the period 5.9 6
Slide 40: Q1 2017 selected financial highlights
q1 2017 selected financial highlights U.S. DOLL AR S I N THOUSANDS Q 1 2017 Q 1 2016 % GR O WTH Net revenues $ 34,880 $ 13,053 167% Cost of revenues 11,664 7,982 46% Impairment of field equipment - - - Gross profit 23,216 5,071 358% Research, development and clinical trials 9,411 11,445 -18% Sales a
Slide 41: Appendix
novecure’ BODeENdIx patientforward
Slide 42: TTFields are frequency-tuned to cell size to maximize effects on mitosis
TTFields are frequency-tuned to cell size to maximize effects on mitosis EFFECTS ON CELLS ARE FREQUENCY SPECIFIC AND INVERSELY RELATED TO CELL SIZE Normal Intestine Pancreatic NSCLC Ovarian Cancer GBM Cancer ~50 kHz 150 kHz 150 kHz 200 kHz 200 kHz © Novocure 2017 43
Slide 43: EF-11 overall survival
MONOTHERAPY TREATMENT FOR RECURRENT GBM EF-11 overall survival OPTUNE CHEMOTHERAPY (n=120) (n=117) Median OS, months 6.6 6.0 HR and p value HR=0.86, p=0.27 4-year survival 8% 0% n = 85 n = 13 © Novocure 2017 44
Slide 44: Active patients drive revenue
active patients drive revenue • Increase or decrease in active patients in any given period reflects the number of new patients less the number of patients discontinuing therapy • The conversion of prescriptions to new patients is driven by the prescription fill rate and the time to fill the prescri