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Novocure (NVCR) overview updated December 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
commercial execution
financial highlights
clinical development
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
commercial execution
© Novocure 2017
global commercial presence ADULT PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED GBM
13
JAPAN
2 sales force colleagues
UNITED STATES
47 sales force colleagues
JAPAN
150 certified centers
EMEA
232 certified centers
UNITED STATES
663 certified centers
certified centers
sales force colleagues
EMEA
10 sales force colleagues
global active markets as of September 30, 2017
© Novocure 2017
EF-14 phase 3 pivotal trial initiated in 2009 COMBINATION THERAPY FOR NEWLY DIAGNOSED GBM
14
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
15
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
16
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
17
73%
43%
26% 20%
13%
65%
31%
16% 8%
5% 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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
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
Optune + TMZ (n=466)
TMZ alone (n=229)
© Novocure 2017
EF-14 annual survival rates EF-14 FIVE-YEAR SURVIVAL ANALYSIS
18
86%
55%
29% 29% 29%
65%
31%
16% 8%
5% 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5
Ove
rall
su
rviv
al r
ate
(%)1
Year from randomization
Optune + TMZ (n=43)
TMZ alone (n=229)
TMZ, temozolomide. 1. Ram Z, Kim CY, Nicholas GA and Toms S on behalf of EF-14 investigators. Slides presented at: Society for Neuro Oncology Annual Meeting; November 16-19, 2017; San Francisco, CA.
PATIENTS WITH COMPLIANCE >90% HAD MAXIMAL SURVIVAL BENEFIT
© Novocure 2017
EF-14 subgroup analysis EF-14 FIVE-YEAR SURVIVAL ANALYSIS
19
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
© Novocure 2017
direct to patient distribution model
20
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
q3 2017 operating statistics
21 21
Q3 2017 Q3 2016 YOY
% GROWTH Q2 2017 QOQ
% GROWTH
Prescriptions 1,076 690 56% 1,059 2%
United States 805 569 41% 803 0%
Germany, Switzerland and other EMEA Markets 270 120 125% 255 6%
Japan 1 1 - 1 -
Active patients at period end 1,683 985 71% 1,460 15%
United States 1,234 783 58% 1,083 14%
Germany, Switzerland and other EMEA Markets 448 202 122% 376 19%
Japan 1 - N/A 1 -
• 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
• Increase in active patients driven primarily by prescription growth and an increase in the percentage of newly
diagnosed GBM patients who typically have a longer duration of treatment with Optune
© Novocure 2017
0
200
400
600
800
1000
1200
1400
1600
1800
Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017
active patient growth
22 22
active patients at period end
11 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
1,683
© Novocure 2017
expanding U.S. commercial market access
23
>210 MILLION COVERED LIVES
IN THE U.S.
>178 MILLION CONTRACTED LIVES IN THE U.S.
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
96%
OF AMERICANS WITH PRIVATE HEALTH INSURANCE1,2
NOW HAVE POSITIVE COVERAGE OF OPTUNE
© Novocure 2017
expanding global commercial market access
24
MARKET STATUS REIMBURSEMENT
STATUS GBM MARKET SIZE
ESTIMATION
Austria Commercial launch underway
National reimbursement contract signed in Q3 2017
280 annual cases diagnosed
Japan Commercial launch underway
National reimbursement contract signed in Q4 2017
1,500 annual cases diagnosed
Germany Receive reimbursement on case-by-case basis
• Pathway for national reimbursement via G-BA budgeted clinical trial established Q3 2017
• Clinical trial to begin 2H 2018
3,300 annual cases diagnosed
Switzerland Single-payer system National reimbursement application submitted Q2 2017
300 annual cases diagnosed
financial highlights
© Novocure 2017
$0
$10,000
$20,000
$30,000
$40,000
$50,000
Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 Q1 2016 Q2 2016 Q3 2016 Q4 2016 Q1 2017 Q2 2017 Q3 2017
revenue growth
26
global net revenues by quarter (U.S. dollars in thousands)
131% 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
$50,109
© Novocure 2017
transition to accrual-based revenue recognition
2017 2016
U.S. DOLLARS IN MILLIONS Q3 Q2 Q1 Q4 Q3 Q2 Q1
Gross billings $ 101.9 $ 87.2 $ 73.2 $ 63.8 $ 57.5 $ 54.0 $ 45.5
Accrual basis revenue $ 35.7 $ 19.1 $ 14.7 $ 8.5 $ 0.0 $ 0.0 $ 0.0
Cash basis revenue for therapy provided in the period 3.1 5.7 5.9 6.3 8.9 7.6 5.6
Cash basis revenue for therapy provided in previous periods $ 11.3 13.6 14.3 15.5 12.7 10.3 7.4
Net revenues $ 50.1 $ 38.4 $ 34.9 $ 30.2 $ 21.7 $ 17.9 $ 13.1
• Gross billings reflect total charges for active patients on therapy without any deductions or adjustments for payer
discounts, patient financial assistance or charitable care
• Net revenues recognized on an accrual basis represent charges to certain U.S.-based third-party payers and
certain German claims
- Net revenues as a percent of gross billings increased to 49% in Q3 2017 from 38% in Q3 2016
- Without the benefit from a transition to accrual-based revenue, we estimate that net revenues as a
percentage of gross billings will be approximately 46% in Q4 2017
27
© Novocure 2017
q3 2017 selected financial highlights
28
U.S. DOLLARS IN THOUSANDS
Q3 2017 Q3 2016 % GROWTH
Net revenues $ 50,109 $ 21,674 131% Cost of revenues 15,153 11,118 36% Impairment of field equipment - - -
Gross profit 34,956 10,556 231%
Research, development and clinical trials 9,273 10,233 -9% Sales and marketing 16,387 15,865 3% General and administrative 15,215 12,723 20% Total operating costs and expenses 40,875 38,821 5%
Operating income (loss) (5,919 ) (28,265 ) 79% Financial expenses, net 2,156 2,189 -1%
Income (loss) before income taxes (8,075 ) (30,454 ) 73% Income tax expense 3,423 3,174 8%
Net income (loss) $ (11,498 ) $ (33,628 ) 66%
Cash and cash equivalents $ 82,104 $ 115,822 Short-term investments 104,453 119,724
clinical development
© Novocure 2017
broad applicability to solid tumors
30
INDICATIONS IN-VITRO EVIDENCE IN-VIVO EVIDENCE FIRST IN HUMAN EVIDENCE
Glioblastoma
Malignant melanoma
Non-small cell lung cancer
Pancreatic cancer
Breast cancer
Mesothelioma
Ovarian carcinoma
Renal adenocarcinoma
Cervical cancer
Colorectal carcinoma
Gastric adenocarcinoma
Hepatocellular carcinoma
Small cell lung cancer
Urinary transitional cell carcinoma
© Novocure 2017
ongoing clinical trials
31
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 Q4 2017
Ovarian cancer phase three pivotal trial first patient in 2018
Mesothelioma STELLAR trial final data collection in 2018
Trial complete Trial ongoing
© Novocure 2017
transducer array placement
32
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
33
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
34
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
35
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
36
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
37
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
38
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
39
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
40
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
appendix
© Novocure 2017
frequency of electric fields determines their biological effect
42
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
43
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
44
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
45
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
46
• 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