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Novocure (NVCR) overview updated July 2017
© Novocure 2017
forward-looking statements
2
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 indications. These forward-looking statements
can be identified in this presentation by the fact that they do not relate only to historical or current facts. Forward-looking statements often use words “expect”,
“intend”, “anticipate”, “plan”, “may”, “should”, “would”, “could” or other words of similar meaning. These statements are based on assumptions and assessments made
by Novocure in light of industry experience and perception of historical trends, current conditions, expected future developments and other appropriate factors. By
their nature, forward-looking statements involve risk and uncertainty, and Novocure's performance and financial results could differ materially from those expressed
or implied in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and
uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2017, or in subsequent quarterly filings with the U.S.
Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those described in this presentation. Novocure assumes no obligation to update or correct the information contained in this
presentation, whether as a result of new information, future events or otherwise, except to the extent legally required.
The statements contained in this presentation are made as at the date of this presentation, unless some other time is specified in relation to them, and service of
this presentation shall not give rise to any implication that there has been no change in the facts set out in this presentation since such date. Nothing contained in
this presentation shall be deemed to be a forecast, projection or estimate of the future financial performance of Novocure, except where expressly stated.
As of the date of this presentation, Optune is only FDA-approved for the treatment of adults with glioblastoma, or GBM, and its approval for other indications is not
certain. Novocure can provide no assurances regarding market acceptance of Optune or its successful commercialization, and can provide no assurances regarding
the company’s results of operations or financial condition in the future. This presentation is for informational purposes only and may not be relied upon in
connection with the purchase or sale of any security.
© Novocure 2017
contents company overview
mechanism of action
EF-14 clinical data
commercial execution
clinical development
financial highlights
3
company overview
© Novocure 2017
about novocure PATIENT-FORWARD MISSION
5
global organization
proven lead product
rich clinical pipeline
• Headquartered in Jersey • Five currently active
commercial markets (U.S., Germany, Switzerland, Israel and Japan)
• Research facility in Israel • Ownership of IP and sole
distribution rights of Tumor Treating Fields
• 450+ employees globally
• Approved in the U.S., EMEA and Japan for the treatment of adults with glioblastoma (GBM)
• Supported by successful EF-14 phase 3 pivotal trial
• Broadly applicable mechanism of action across multiple solid tumor types
• Recruiting for phase 3 pivotal trials in brain metastases and non-small cell lung cancer
• Completed or ongoing phase 2 pilot trials in: • Pancreatic cancer • Ovarian cancer • Mesothelioma
© Novocure 2017
three strategic objectives
6
Drive commercial adoption of Optune
Focus on improving operating leverage
Advance the clinical pipeline
mechanism of action
© Novocure 2017
low-intensity alternating electric fields
8
radiation pharmacological treatments
tumor treating fields (TTFields)
• Most frequently employed therapy
• Reduces size of a tumor prior to initiation of additional therapies
• Kills cells when delivered at high doses
• Injures healthy tissues with numerous potential toxic side effects
• Includes chemotherapy, targeted therapies and immuno-oncology
• Limited by potential side effects
• Resistance can develop over time
• Low-intensity, alternating electric fields
• Mild side effect profile
• No known resistance or cumulative toxicity
• Can be used in combination with other treatment modalities
USED ALONE OR IN COMBINATION TO TREAT SOLID TUMORS
surgery
© Novocure 2017
electric fields exert forces on electrically polarized molecules
9
Earth
ELECTRIC FIELDS
exert force on charges & polarized molecules
Charged Plates
GRAVITATIONAL FIELDS MAGNETIC FIELDS
Magnet
exert force on masses exert force on iron & other magnets
uniform field
© Novocure 2017
TTFields impact metaphase
10
normal metaphase effect of TTFields on metaphase
tubulin subunits align properly, forming a normal mitotic spindle
tubulin subunits have a high dipole moment
tubulin subunits align with TTFields
misaligned tubulin disrupts mitotic spindle
uniform electric field
© Novocure 2017
• 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
11
TTFields are delivered via a non-invasive, portable medical device
EF-14 clinical data
© Novocure 2017
EF-14 phase 3 pivotal trial initiated in 2009 COMBINATION THERAPY FOR NEWLY DIAGNOSED GBM
13
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 randomized 2:1 (TTFields plus TMZ vs TMZ alone)
• Treated until second progression or 24 months
• Pre-specified interim analysis 18 months after enrollment of the 315th patient
• Endpoints:
• Primary endpoint — progression-free survival (PFS) (intent to treat)
• Secondary endpoint — overall survival (OS) (as treated)
surgery/ biopsy RT (45–70 Gy) +
TMZ
enrollment window
(4–7 weeks after RT + TMZ)
ran
do
miz
atio
n 2
:1
TTFields + TMZ (6 cycles)
MRI q2m until progression
TTFields + second line chemo
TMZ (6 cycles) MRI q2m until progression
second line chemo
Novocure, Ltd. Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017 Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT00916409. NLM Identifier: NCT00916409
© Novocure 2017
EF-14 progression free survival EF-14 FIVE-YEAR SURVIVAL ANALYSIS: INTENT-TO-TREAT POPULATION
14
0 6 12 18 24 30
Progression Free Survival (months)
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0.9
1.0
Frac
tio
n s
urv
ival
OPTUNE + TMZ (n=466)1,2
TMZ ALONE (n=229) 1,2
Median PFS from randomization, mo 6.7 4.0
95% CI, mo 6.1-8.1 3.8-4.4
Stratified log-rank p=0.0001
HR (95% CI) 0.63 (0.52-0.76)
Median PFS from diagnosis, mo
11.2 7.8
*Both interim and final analyses are protocol prespecified.1,2
TMZ, temozolomide; ITT, intent-to-treat; PFS, progression-free survival; CI confidence interval; HR, hazard ratio. 1. Stupp R, et al; on behalf of EF-14 trial investigators. Slides presented at: AACR
Annual Meeting 2017; April 1-5, 2017; Washington, DC. 2. Optune Instructions for Use. Novocure 2016.
Optune + TMZ TMZ alone
© Novocure 2017
EF-14 overall survival EF-14 FIVE-YEAR SURVIVAL ANALYSIS: INTENT-TO-TREAT POPULATION
15
Optune + TMZ TMZ alone
0 6 12 48 54 60 18 24 30 36 42
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0.0
0.9
1.0
Frac
tio
n s
urv
ival
Overall Survival (months)
OPTUNE + TMZ (n=466)1,2
TMZ ALONE (n=229) 1,2
Median OS from randomization, mo 20.9 16.0
95% CI, mo 19.3-22.7 14.0-18.4
Stratified log-rank p=0.0001
HR (95% CI) 0.63 (0.53-0.76)
Median OS from diagnosis, mo
24.5 19.8
*Both interim and final analyses are protocol prespecified.1,2
TMZ, temozolomide; ITT, intent-to-treat; PFS, progression-free survival; CI confidence interval; HR, hazard ratio. 1. Stupp R, et al; on behalf of EF-14 trial investigators. Slides presented at: AACR
Annual Meeting 2017; April 1-5, 2017; Washington, DC. 2. Optune Instructions for Use. Novocure 2016.
© Novocure 2017
EF-14 annual survival rates EF-14 FIVE-YEAR SURVIVAL ANALYSIS
16
73%
43%
26%
20%
13%
65%
31%
16%
8% 5% 0%
10%
20%
30%
40%
50%
60%
70%
80%
1 2 3 4 5
Ove
rall
Su
rviv
al r
ate
(%)1,
2
Year from randomization
p=0.0258
p=0.0008
p=0.0039
p=0.0002
p=0.0037
Optune + TMZ (n=466)
TMZ alone (n=229)
TMZ, temozolomide. 1. Stupp R, et al; on behalf of EF-14 trial investigators. Slides presented at: AACR Annual Meeting 2017; April 1-5, 2017; Washington, DC. 2. Novocure Data on File. OPT-129.1
© Novocure 2017
EF-14 subgroup analysis EF-14 FIVE-YEAR SURVIVAL ANALYSIS
17
TMZ, temozolomide; MGMT, O6-methylguanine-DNA methyltransferase; KPS, Karnofsky Performance Score. 1. Stupp R, et al; on behalf of EF-14 trial investigators. Slides presented
at: AACR Annual Meeting 2017; April 1-5, 2017; Washington, DC
SUBGROUP NO. OF PATIENTS (%) HAZARD RATIO
MEDIAN SURVIVAL (MONTHS) 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 234 (34) 21.4 15.1 Gross total 372 (53) 22.6 18.5 Age <65 y 583 (84) 21.6 17.1 65+ y 112 (16) 16.0 10.9 KPS 90-100 457 (67) 23.3 17.8 ≤80 228 (33) 14.9 11.0 Gender Female 222 (32) 24.6 18.5 Male 473 (68) 19.1 15.5
0.0 0.1 0.5 0.7 0.9 1.0 1.1 1.2 0.8 0.2 0.3 0.4 0.6
OPTUNE + TMZ BETTER TMZ ALONE BETTER
commercial execution
© Novocure 2017
global commercial presence ADULT PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED GBM
19
JAPAN
2 sales force colleagues
UNITED STATES
47 sales force colleagues
JAPAN
150 certified centers
EMEA
207 certified centers
UNITED STATES
605 certified centers
certified centers
sales force colleagues
EMEA
10 sales force colleagues
global active markets as of June 30, 2017
© Novocure 2017
direct to patient distribution model
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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 payer and patient1 for each month of therapy
Physician sees patient for regular compliance monitoring and follow-up appointments
We expect to distribute our product through hospitals in Japan 1. Subject to patient assistance programs.
© Novocure 2017
q2 2017 operating statistics
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Q2 2017 Q2 2016 % GROWTH Q1 2017 % GROWTH
Prescriptions 1,059 657 61% 894 18%
United States 803 547 47% 685 17%
Germany, Switzerland and other EMEA Markets 255 110 132% 206 24%
Japan 1 - N/A 3 -67%
Active patients at period end 1,460 891 64% 1,266 15%
United States 1,083 736 47% 933 16%
Germany, Switzerland and other EMEA Markets 376 155 143% 331 14%
Japan 1 - N/A 2 -50%
• Growth driven primarily by commercial activities in our active markets, benefitting from Novocure’s ongoing
emphasis on building prescriber confidence in Optune for the treatment of GBM
• Year-over-year increase in active patients driven primarily by prescription growth
• In Q2 2017, more than 55% of prescriptions received were for patients with newly diagnosed GBM
© Novocure 2017
0
200
400
600
800
1000
1200
1400
1600
Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017
active patient growth
22
global active patients at period end
10 CONSECUTIVE QUARTERS OF ACTIVE PATIENT GROWTH SINCE PRESENTATION OF EF-14 DATA
U.S. active patients EMEA and Japan active patients
225
372 425 469
605
797 891
985 1,091
1,266
1,460
© Novocure 2017
expanding U.S. commercial market access
>204 MILLION COVERED LIVES
IN THE U.S.
>174 MILLION CONTRACTED LIVES IN THE U.S.
93%
OF AMERICANS WITH PRIVATE HEALTH INSURANCE1,2
NOW HAVE POSITIVE COVERAGE OF OPTUNE
1. U.S. population insured with employers, non-group insurance or Medicare Advantage plans
2. Appealing Medicare fee-for-service denials, impacting 20-25% of U.S. active patients
23
© Novocure 2017
$0
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
$40,000
$45,000
Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017
revenue growth
24
global net revenues by quarter (U.S. dollars in thousands)
114% YEAR-OVER-YEAR REVENUE GROWTH
$3,801 $5,208
$6,543 $8,953
$12,383 $13,053
$17,919
$21,674
$30,242
U.S. net revenues EMEA and Japan net revenues
$34,880
$38,376
clinical development
© Novocure 2017
broad applicability to solid tumors
26
© Novocure 2017
PRE-CLINICAL PHASE II
PILOT PHASE III PIVOTAL EXPECTED NEXT MILESTONE
Brain metastases METIS trial last patient in 2019 with final data collection in 2020
Non-small cell lung cancer LUNAR trial last patient in 2019 with final data collection in 2021
Pancreatic cancer phase three pivotal trial first patient in 2H 2017
Ovarian cancer phase three pivotal trial first patient in 2018
Mesothelioma STELLAR trial final data collection in 2018
ongoing clinical trials
27
Trial complete Trial ongoing
© Novocure 2017
transducer array placement
28
abdominal array placement
torso array placement
pelvic array placement
© Novocure 2017
METIS phase 3 pivotal trial initiated in 2016 BRAIN METASTASES FROM NON-SMALL CELL LUNG CANCER
29
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 cancer patients with 1-10 brain metastases
• 270 patients internationally, randomized 1:1 (TTFields vs supportive care) • Last patient enrollment expected in 2019, twelve month follow-up after final patient enrollment • Endpoints:
• Primary endpoint — time to first cerebral progression • Secondary endpoints include neurocognitive failure, overall survival, radiological response rate
Novocure, Ltd. Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT02831959. NLM Identifier: NCT02831959
© Novocure 2017
phase 2 pilot EF-15 trial SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER
30
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-small cell lung cancer versus historical controls
• 42 patients in Switzerland with locally advanced and/or metastatic non-small cell lung cancer • Last patient enrolled May 2011 with six month follow-up, data published in Lung Cancer in 2013 • Primary endpoint – severity and frequency of adverse events
Novocure, Ltd. NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT00749346. NLM Identifier: NCT00749346 1. Pless M., Droege C., von Moos R., et al. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-50. doi:
10.1016/j.lungcan.2013.06.025 2. Hanna N., Shepherd F.A., Fossella F.V., et al. Randomized Phase III Trial of Pemetrexed Versus Docetaxel in Patients With Non–Small-Cell Lung Cancer Previously Treated With Chemotherapy. J Clin Oncol. 2004 May 1;22(9):1589-97.
doi: 10.1200/JCO.2004.08.163
EFFICACY ENDPOINTS
TTFIELDS WITH PEMETREXED1
PEMETREXED-ALONE HISTORICAL RESULTS2
Median in-field PFS 6.5 months n/a
Median PFS 5 months 2.9 months
Median OS 13.8 months 8.3 months
One-year survival rate 57% 29.7%
© Novocure 2017
LUNAR phase 3 pivotal trial initiated in 2017 SECOND LINE TREATMENT FOR ADVANCED NON-SMALL CELL LUNG CANCER
31
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 with unresectable, locally advanced or metastatic non-small cell lung cancer
• 512 patients (TTFields plus docetaxel or PD-1 inhibitors vs docetaxel or PD-1 inhibitors alone) • Last patient enrollment expected in 2019, eighteen month follow-up after final patient enrollment • Endpoints:
• Primary – overall survival (OS) (superiority) • Secondary –
• OS of TTFields + docetaxel vs docetaxel alone (superiority) • OS of TTFields + PD-1 inhibitor vs PD-1 inhibitor alone (superiority) • OS of TTFields + docetaxel vs PD-1 inhibitor alone (non-inferiority)
Novocure, Ltd. Effect of Tumor Treating Fields (TTFields) (150 kHz) as Second Line Treatment of Non-small Cell Lung Cancer (NSCLC) in Combination With PD-1 Inhibitors or Docetaxel (LUNAR) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT02973789. NLM Identifier: NCT02973789
© Novocure 2017
phase 2 pilot PANOVA trial ADVANCED PANCREATIC CANCER
32
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 pancreatic cancer versus historical controls
• 40 patients in Europe with locally advanced or metastatic pancreatic cancer • First cohort (n=20) of TTFields at 150 kHz with gemcitabine • Second cohort (n=20) of TTFields at 150 kHz with gemcitabine and nab-paclitaxel
• Last patient enrolled May 2016 with six month follow-up • Endpoints:
• Primary endpoint – severity and frequency of adverse events, as well as feasibility based on compliance with TTFields therapy
• Secondary endpoints include progression free survival, overall survival, overall response rate
Novocure, Ltd. Safety Feasibility and Effect of TTFields (150 kHz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017 Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT01971281. NLM Identifier: NCT01971281
© Novocure 2017
phase 2 pilot PANOVA trial ADVANCED PANCREATIC CANCER
33
EFFICACY ENDPOINTS
FIRST COHORT
TTFIELDS WITH GEMCITABINE1
GEMCITABINE-ALONE
HISTORICAL RESULTS2
SECOND COHORT
TTFIELDS WITH NAB-PACLITAXEL
PLUS GEMCITABINE3
NAB-PACLITAXEL
PLUS GEMCITABINE HISTORICAL
RESULTS2
Median PFS 8.3 months 3.7 months 12.7 months 5.5 months
Median OS 14.9 months 6.7 months Not yet reached 8.5 months
One-year survival rate 55% 22% 72% 35%
Partial response rate 30% 7% 40% 23%
Stable disease 30% 28% 47% 27%
1. Rivera F., et al. PANOVA: A pilot study of TTFields concomitant with gemcitabine for front-line therapy of advanced pancreatic adenocarcinoma. In: 2016 Gastrointestinal Cancers Symposium; 2016 Jan 21-23; San Francisco, CA. Alexandria (VA): ASCO; 2016. Abstract 682.
2. Von Hoff D.D., Ervin T., Arena F.P., et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369 3. Benavides M. et.al. PANOVA: A phase II study of TTFields (150kHz) concomitant with standard chemotherapy for front line therapy of advanced pancreatic adenocarcinoma In: Proceedings of the 107th Annual Meeting of the American
Association for Cancer Research; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; 2017. Abstract CT130.
© Novocure 2017
phase 2 pilot INNOVATE trial RECURRENT OVARIAN CANCER
34
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 historical controls
• 30 patients in Europe with recurrent ovarian cancer • Last patient enrolled May 2016 with six month follow-up • Primary endpoint – severity and frequency of adverse events
Novocure, Ltd. Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT02244502. NLM Identifier: NCT02244502 1. Vergote I., et.al. INNOVATE: a phase II study of TTFields (200 kHz) concomitant with weekly paclitaxel for recurrent ovarian carcinoma. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research;
2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; 2017. Abstract CT135. 2. Poveda A.M., Selle F., Hiplert F. et al. Bevacizumab Combined With Weekly Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan in Platinum-Resistant Recurrent Ovarian Cancer: Analysis by Chemotherapy Cohort of the
Randomized Phase III AURELIA Trial. J of Clin Onc. 2015 Nov 10;33(32):3836-8. doi: 10.1200/JCO.2015.63.1408. * Median PFS reflects the weekly paclitaxel subgroup; Median PFS for all chemotherapies was 3.4 months
EFFICACY ENDPOINTS
TTFIELDS WITH PACLITAXEL1
PACLITAXEL-ALONE HISTORICAL RESULTS2
Median PFS 8.9 months 3.9 months*
Median OS Not yet reached 13.2 months
One-year survival rate 61%
© Novocure 2017
phase 2 pilot STELLAR trial FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA
35
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 untreated malignant pleural mesothelioma versus historical controls
• 80 patients in Europe with unresectable, previously untreated malignant mesothelioma • Actively recruiting patients since February 2015, interim data presented at IASLC in December 2016 • Primary endpoint – overall survival (OS)
Novocure, Ltd. Safety and Efficacy of TTFields (150 kHz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-[cited 2017Jul]. Available from: https://clinicaltrials.gov/ct2/show/NCT02397928. NLM Identifier: NCT02397928 1. Cerasoli, G.L. International Association for the Study of Lung Cancer. OA22.01 – STELLAR – Interim Results of a Phase 2 Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma. Oral Session: Novel
Trials and Biomarkers in Malignant Pleural Mesothelioma. Wednesday, Dec. 7, 2016, 2:20 p.m. CET 2. Vogelzang N.J., Rusthoven J.J., Symanowski J., et al. Phase III Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Alone in Patients With Malignant Pleural Mesothelioma J Clin Oncol. 2003 Jul 15;21(14):2636–44. doi:
10.1200/JCO.2003.11.136
EFFICACY ENDPOINTS
TTFIELDS WITH PEMETREXED AND
CISPLATIN OR CARBOPLATIN1
PEMETREXED AND CISPLATIN-ALONE
HISTORICAL RESULTS2
Median PFS 7.3 months 5.7 months
Median OS Not yet reached 12.1 months
One-year survival rate 79.7% 50.3%
© Novocure 2017
phase 2 pilot STELLAR trial interim results FIRST LINE TREATMENT OF MALIGNANT PLEURAL MESOTHELIOMA
36
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 Chemotherapy for First Line Treatment of Malignant Mesothelioma. Oral Session: Novel Trials and Biomarkers in Malignant Pleural Mesothelioma. Wednesday, Dec. 7, 2016, 2:20 p.m. CET
financial highlights
© Novocure 2017
transition to accrual-based revenue recognition
• Gross billings reflect total charges for active patients on therapy without any deductions or adjustments for payer
discounts, patient financial assistance or charitable care
• Revenue recorded on a cash basis during the second quarter 2017 was $19.3 million
• Twenty-four percent of second quarter gross billings qualified for accrual-based revenue recognition treatment
- All net revenues recognized on an accrual basis represent charges to certain U.S.-based third-party payers
- Revenue recorded on an accrual basis during the second quarter 2017 was $19.1 million
2017 2016
U.S. DOLLARS IN MILLIONS Q2 Q1 Q4 Q3 Q2 Q1
Gross billings $ 87.2 $ 73.2 $ 63.8 $ 57.5 $ 54.0 $ 45.5
Revenue recorded on accrual basis $ 19.1 $ 14.7 $ 8.5 $ 0.0 $ 0.0 $ 0.0
Revenue recorded on cash basis for therapy provided in the period 5.7 5.9 6.3 8.9 7.6 5.6
Revenue recorded on cash basis for therapy provided in previous period 13.6 14.3 15.5 12.7 10.3 7.4
Net revenues $ 38.4 $ 34.9 $ 30.2 $ 21.7 $ 17.9 $ 13.1
38
© Novocure 2017
q2 2017 selected financial highlights
39
U.S. DOLLARS IN THOUSANDS
Q2 2017 Q2 2016 % GROWTH
Net revenues $ 38,376 $ 17,919 114% Cost of revenues 13,152 9,797 34% Impairment of field equipment - 6,412 -
Gross profit 25,224 1,710 1375%
Research, development and clinical trials 9,371 11,318 -17% Sales and marketing 16,360 14,598 12% General and administrative 15,023 13,031 15% Total operating costs and expenses 40,754 38,947 5%
Operating income (loss) (15,530 ) (37,237 ) 58% Financial expenses, net 2,183 555 293%
Income (loss) before income taxes (17,713 ) (37,792 ) 53% Income tax expense 3,461 2,820 23%
Net income (loss) $ (21,174 ) $ (40,612 ) 48%
Cash and cash equivalents $ 80,190 $ 80,871 Short-term investments 104,186 119,979
appendix
© Novocure 2017
frequency of electric fields determines their biological effect
41
M E D I C A L E X A M P L E S
LOW FREQUENCIES less than 1 kHz
Depolarization of excitable cells (eg, neurons, cardiac
myocytes, skeletal muscle cells)
cardiac defibrillator/pacemaker electromyography
Intermediate Frequencies 100 to 500 kHz
Inhibition of cell proliferation Increased cell death
Tumor Treating Fields
High Frequencies greater than 1,000 kHz
Tissue heating
diathermy radiofrequency ablation
© Novocure 2017
TTFields impact telophase
42
cleavage furrow
non-uniform electric field
movement of polar cellular components due to electric field
normal telophase effect of TTFields on telophase
© Novocure 2017
TTFields are frequency-tuned to cell size to maximize effects on mitosis
43
Normal Intestine
~50 kHz
Pancreatic Cancer
150 kHz
NSCLC
150 kHz
Ovarian Cancer
200 kHz
GBM
200 kHz
EFFECTS ON CELLS ARE FREQUENCY SPECIFIC AND INVERSELY RELATED TO CELL SIZE
© Novocure 2017
EF-11 overall survival MONOTHERAPY TREATMENT FOR RECURRENT GBM
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OPTUNE (n=120)
CHEMOTHERAPY (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
active patients drive revenue
45
• 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 prescription
• The rate of patients
discontinuing therapy is
determined by the treatment
duration for patients starting
therapy in prior periods Active patientsat prior period
end
Prescriptionsin period
Prescriptionsfrom prior
period filled inperiod
Prescriptionsfrom periodnot yet filled
Patientsdiscontinuing
therapy inperiod
Active patientsat period end
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