Novocure analyst and investor briefing · 9/25/2018 · contained in this presentation shall be deemed to be a forecast, projection or estimate of the future financial performance

Novocure analyst and investor briefing IASLC 19th World Conference on Lung Cancer

September 25, 2018

Toronto, Ontario

© Novocure 2018 2

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 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 22, 2018, 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 supratentorial 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 2018 3

agenda and speakers

1 Opening remarks William Doyle, Executive Chairman, Novocure

2 Tumor Treating Fields, a platform therapy Eilon Kirson, MD, PhD, Chief Science Officer and Head of R&D, Novocure

3 STELLAR final results Giovanni L. Ceresoli, MD and Principal Investigator, Humanitas Gavazzeni Hospital

4 Mesothelioma in clinical practice Charles B. Simone II, MD, University of Maryland Medical System

5 The path forward Eilon Kirson, MD, PhD, Chief Science Officer and Head of R&D, Novocure

6 Question and answer session

Tumor Treating Fields, a platform therapy Eilon Kirson, MD, PhD

© Novocure 2018 5

we can leverage physics to fight cancer

AN ELECTRIC FIELD EXERTS FORCES ON CHARGED OBJECTS

TUMOR TREATING FIELDS USES ELECTRIC FIELDS TO DISRUPT CELL DIVISION

+ + + + + + + + + + + + + + +

- - - - - - - - - - - - - - -

+ +

- MISALIGNED

TUBULINS INTERFERE WITH FORMATION OF

MITOTIC SPINDLE

MISALIGNED SEPTINS

INTERFERE WITH FORMATION OF

CONTRACTILE RING

ALTERNATING ELECTRIC FIELDS DISRUPT CANCER

CELL DIVISION

CANCER CELL DEATH

TUMOR TREATING FIELDS DESCRIBES ELECTRIC FIELDS THAT ALTERNATE 100,000 TO 300,000 TIMES PER SECOND TO TARGET CANCER CELLS

© Novocure 2018 6

PRE-CLINICAL EVIDENCE

FIRST IN HUMAN EVIDENCE

CLINICAL EVIDENCE

FDA APPROVAL

CANCERS

OF THE CENTRAL

NERVOUS SYSTEM

Glioblastoma

Brain metastases from non-small cell lung cancer

Brain metastases from breast cancer

Brain metastases from melanoma

Ependymoma

Gliosarcoma

Medulloblastoma

Meningioma

CANCERS OF THE CHEST

Mesothelioma

Non-small cell lung cancer

Small cell lung cancer

CANCERS OF THE

ABDOMEN

Pancreatic cancer

Ovarian cancer

Cervical cancer

Colorectal carcinoma

Gastric adenocarcinoma

Liver cancer

Renal cell adenocarcinoma

Urinary transitional cell carcinoma

OTHER Breast cancer

Malignant melanoma

single therapy provides multiple opportunities in solid tumor cancers

© Novocure 2018 7

Tumor Treating Fields induced severe spindle damage in cancer cell lines

A549 cells in lung tissue were treated with Tumor Treating Fields for 24 hours. Tubulin fluorescence images were inverted and pseudocolored so that increasing fluorescence intensity is indicated from blue to red (scale bar represent arbitrary units). Dashed lines define the region between the two spindle poles (white) and overall tubulin fluorescence within the cell (Red).

CONTROL TUMOR TREATING FIELDS

Giladi M., et al. Sci Rep. 2015 Dec 11;5:18046.

© Novocure 2018 8

Tumor Treating Fields resulted in abnormal chromosomal segregation

A2780 cells were treated with TTFields for 96 hours. Chromosome number was evaluated every 24 hours. Horizontal bars indicate median values (p < 0.0001 ; Brown-Forsythe test).

Spectral karyotyping of A2780 cells showing numerical aberrations following TTFields treatment.

HYPODIPLOIDY AFTER TREATMENT

TETRAPLOIDY AFTER TREATMENT

Giladi M., et al. Sci Rep. 2015 Dec 11;5:18046.

© Novocure 2018 9

Tumor Treating Fields interfered with DNA damage response

TTF+IR triggers multinucleation and mitotic abnormalities in glioblastoma cells. Cells were exposed to 24 h of TTF, 5 Gy of γ-rays or 5 Gy of γ-rays followed by 24 h of TTF, indicated as the TTF, IR and TTF+IR treatments, respectively. Immunofluorescence microscopy image of cells stained for α-tubulin (green) and DAPI. The histograms summarize the results of three independent experiments (with at least 100 cells counted in each experiment in each column). The values represent the means of three experiments ± SD; *p < 0.05, **p < 0.001. Cells were scored for the presence (abnormal) or absence (normal) of chromosome alignment and se.

Kim, E.H., et al. Oncotarget. 2016 Sep 20; 7(38): 62267–62279.

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Tumor Treating Fields inhibited metastases and activated an immune response CONTROL

Exemplary photos of surface lung metastases in Tumor Treating Fields treated versus sham control rabbits.

Treatment was initiated on day 12 from implantation of the kidney tumor. The average total number (±SD) of surface metastases in control versus treated rabbits

TUMOR TREATING FIELDS

Discrete intra-tumoral infiltration of CD45 positive T cells in control tumors and abundant intra tumoral CD45 positive T cells in Tumor Treating Fields treated tumors. Scale bar 100 lm

CONTROL TUMOR TREATING FIELDS

Kirson, E.D., et al. Clin Exp Metastasis. 2009;26(7):633-40.

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Combination of Tumor Treating Fields and paclitaxel chemotherapy

Ovarian Cancer Cells were treated for 72 hr with paclitaxel alone (1–100 nM) and in combination with TTFields (2.7 V/cm pk‐pk, 200 kHz). Dose–response plots of A2780, OVCAR‐3 and Caov‐3 cells. CI: combination index.

Tumor Treating Fields offered additive or synergistic benefits in combination with chemotherapy A2780 OVCAR3 Caov-3

Voloshin, T. et al. Int J Cancer. 2016 Aug 25. doi: 10.1002/ijc.30406.

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• Tumor Treating Fields exhibited increased survival across a range of solid tumors

• FDA approval in newly diagnosed GBM with unprecedented 5-year survival

• Registration trial data in mesothelioma

• Phase 2 pilot trial data in non-small cell lung cancer, pancreatic cancer and ovarian

cancer

• No significant increase in serious adverse events has been seen with the addition of

Tumor Treating Fields to standard treatments across clinical trials

• In newly diagnosed GBM, patients treated with Optune and temozolomide maintained

quality of life for up to one year and across predefined daily functioning domains

Tumor Treating Fields has repeatedly increased survival without systemic toxicity

© Novocure 2018 13

Publications on Tumor Treating Fields

increasing visibility of Tumor Treating Fields in the clinical and research communities

Abstracts at four key congresses

16 20 21

5

14 6 3

7

0

5

10

15

20

25

30

35

40

2016 2017 2018 YTD

Primary Paper(s) Review(s) Editorial(s)

3

38

24

4 10

60

35

13

53

65

0

10

20

30

40

50

60

70

AACR ASTRO EANO SNO

2016 2017 2018

© Novocure 2018 14 © Novocure 2018 14

advancing clinical pipeline

PHASE II PILOT

PHASE III PIVOTAL

IN REGISTRATION MILESTONES

Mesothelioma HDE application to the FDA in 2H 2018

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 PANOVA 3 trial last patient in 2020 with final data collection in 2022

Ovarian cancer phase three pivotal trial open in 2H 2018

Liver cancer HEPANOVA trial first patient in 2H 2018

Trial complete Trial ongoing

STELLAR final results Giovanni L. Ceresoli, MD

Actor portrayal

© Novocure 2018 16

• Malignant pleural mesothelioma arises from the

mesothelial lining covering external surface of lungs and

inside of chest wall

• Vast majority of cases attributed to asbestos exposure1

• Asbestos used commonly in 1940s-1970s for insulation,

textiles, heat protectors, filters, construction materials

• Long latency period of at least 20-30 years following

exposure

• Mesotheliomas belong to three main histological

subtypes: epithelioid (60-80%), sarcomatoid (10%) or

mixed (10-20%)2

malignant pleural mesothelioma overview

1. Marinaccio et al. Int J Ca, 2005; 2.Robinson et al. NEJM 2005

© Novocure 2018 17

malignant pleural mesothelioma epidemiology

U.S. JAPAN

GERMANY

U.S.1,2 GERMANY3 JAPAN4

incidence 3,000 1,400 deaths per year at peak 1,000

eligible patient population, excluding patients eligible for surgical resection4

2,400 1,100 800

1 SEER Cancer Statistics Review, 1975-2015. Available at https://seer.cancer.gov/csr/1975_2015/. Updated April, 2018. 2 Mesothelioma Cancer Detailed Guide. Atlanta: American Cancer Society, 2016. 3 Peto J, Br J Cancer 1999;79:666–72.. 4 Robinson B.M. Ann Cardiothorac Surg. 2012; 1(4): 491–496.

© Novocure 2018 18

current standard of care

• Only 15-20% of mesothelioma patients are candidates for surgical resection1

• Most patients treated in the first-line setting with chemotherapy

• Since 2003, pemetrexed plus platinum-based therapy (cisplatin or carboplatin) has

been the standard of care for patients with malignant pleural mesothelioma

• Pemetrexed plus cisplatin (median OS 12.1 months)2; pemetrexed/carboplatin

show similar outcomes3,4

• No standard treatment in the second-line setting5

• Radiation therapy can play a role throughout treatment pathway

• New treatments are urgently needed

1. Bueno R et al., J Thorac Oncol 2018; 2. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. J Clin Oncol. 2003;21:2636–2644. doi: 10.1200/JCO.2003.11.136; 3. Ceresoli GL, Zucali PA, Favaretto AG et al., J Clin Oncol. 2006 Mar 20;24(9):1443-8 DOI: 10.1200/JCO.2005.04.3190; 4.Santoro A, O'Brien ME, Stahel RA, et al. J Thorac Oncol. 2008; 3(7):756-63. doi: 10.1097/JTO.0b013e31817c73d6; 5. Kindler et al., J Clin Oncol 2018

STELLAR - Final Results of a Phase 2 Trial of TTFields with Chemotherapy for First-Line Treatment of

Malignant Pleural Mesothelioma

Giovanni L. Ceresoli1, Joachim Aerts2, Jaroslaw Madrzak3, Rafal Dziadziuszko3, Rodryg Ramlau4, Susana Cedres5, Birgitta Hiddinga6, Jan P. Van Meerbeeck6, Manlio Mencoboni7, David Planchard8, Antonio Chella9,

Lucio Crinò10, Maciej Krzakowski11, Federica Grosso12

1Cliniche Humanitas Gavazzeni, Bergamo; 2Erasmus MC, Rotterdam; 3Medical University of Gdansk, Gdansk; 4Poznan University of Medical Science, Poznan; 5Vall d’Hebron University Hospital, Barcelona; 6University Hospital Antwerp, Edegem;

7Villa Scassi Hospital, Genova; 8Gustave Roussy, Villejuif; 9Ospedale di Pisa, Pisa; 10Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori – IRCCS, Meldola; 11Maria Sklodowska Curie Memorial Cancer Centre, Warsaw; 12SS Antonio e Biagio

Hospital, Alessandria

Abstract Number MA12.06: STELLAR: Phase 2 Trial of TTFields with Standard First Line for MPM Giovanni Luca Ceresoli, MD

© Novocure 2018 20

STELLAR study design & patient characteristics

Cerasoli, G.L. International Association for the Study of Lung Cancer. MA 12.06 – STELLAR Final Results of a Phase 2 Trial of TTFields with Chemotherapy for First-Line Treatment of Malignant Pleural Mesothelioma. Mini Oral Abstract Session: Mesothelioma Surgery and Novel Targets for Prognosis and Therapy. Tuesday, Sept. 25, 2018, 10:30 p.m. ET. 1. Vogelzang et al., J Clin Oncol 2003

Primary Endpoint: OS Secondary Endpoints: ORR, PFS, Safety

• Pemetrexed IV, 500 mg/m2 day 1 • Cisplatin 75 mg/m2 day 1 • Carboplatin AUC 5 day 1 q3w up to 6 cycles

• Follow-up q3w • CT scan q6w:

Modified RECIST

Key Inclusion Criteria: • Pathological evidence of unresectable MPM • At least one measurable lesion (mRECIST) • ECOG PS score 0-1

Key Exclusion Criteria: • Candidate for curative treatment • Significant comorbidities • Implanted electronic medical devices

The sample size provides 80% power (ɑ, 0.05) to detect an increase in median OS of 5.5 months vs historical data1 (i.e. mOS of 17.6 mo, HR of 0.67)

Median age, years (range) 67 (27–78) Epithelioid histology 53 (66%)

Male 67 (84%) Sarcomatoid/Biphasic 21 (26%)

ECOG PS 0 45 (56%) Unspecified histology 6 (8%)

• TTFields cycles: Median (range): 8.0 (2–41) • Chemotherapy cycles: Median (range): 6.0 (1–7) • Carboplatin: 50 patients (63%)

TTFields (150kHz, ≥ 18 h/day) + Pemetrexed/Cisplatin or

Pemetrexed/Carboplatin x 6

TTFields alone until Disease Progression

Follow-up for survival

Unresectable malignant pleural mesothelioma

N=80

© Novocure 2018 21

STELLAR efficacy results: primary endpoint met

Cerasoli, G.L. International Association for the Study of Lung Cancer. MA 12.06 – STELLAR Final Results of a Phase 2 Trial of TTFields with Chemotherapy for First-Line Treatment of Malignant Pleural Mesothelioma. Mini Oral Abstract Session: Mesothelioma Surgery and Novel Targets for Prognosis and Therapy. Tuesday, Sept. 25, 2018, 10:30 p.m. ET. 1. Vogelzang et al., J Clin Oncol 2003

Median OS (all pts) 18.2 months (95% CI 12.1-25.8)

1-year OS (all pts) 62.2% (95% CI 50.3%–72.0%)

Median OS (epithelioid pts only) 21.2 months (95% CI 13.2-25.8)

Median PFS 7.6 months (95% CI 6.7-8.6)

mRECIST PR; DCR* [best response in 72 patients] 29 (40%); 70 (97%)

The threshold for significant extension in OS compared to historical control1 was met (HR 0.663; 95% CI 0.558-0.826; p=0.043).

* Investigator-assessed partial response & disease control rate (PR + stable disease)

© Novocure 2018 22

STELLAR safety results

Cerasoli, G.L. International Association for the Study of Lung Cancer. MA 12.06 – STELLAR Final Results of a Phase 2 Trial of TTFields with Chemotherapy for First-Line Treatment of Malignant Pleural Mesothelioma. Mini Oral Abstract Session: Mesothelioma Surgery and Novel Targets for Prognosis and Therapy. Tuesday, Sept. 25, 2018, 10:30 p.m. ET.

• Thirty-seven patients (46%) had TTFields-

related skin toxicity

• Four patients (5%) had Grade 3 skin toxicity

(rash or skin irritation)

• Resolved after treatment with topical

corticosteroids or a short treatment break

• No serious adverse event was related to

TTFields

Adverse event reported in >1 patient Grade ≥3 AE

n (%)

Patients with ≥1 AE, n(%) 21 (26)

Hematologic Disorders

Anemia 6 (8)

Leukopenia 3 (4)

Neutropenia 6 (8)

Thrombocytopenia 2 (3)

Non-hematologic Disorders

Fatigue 3 (4)

Skin-related toxicity 4 (5)

Dyspnea 2 (3) Median compliance with TTFields was 68% (16.3 hours/day)

© Novocure 2018 23

comparison of STELLAR and recent studies

STELLAR Vogelzang et al. MAPS LUME-Meso

pem+platinum pem+cis pem+cis pem+cis

Characteristics

Number of patients 80 226 225 229

Male 84% 81% 76% 74%

Median age 67 (27-78) 61 (29-85) 66 (61-70) 66

Epithelioid histology 66% 68% 81% 100%

Sarcomatoid/mixed histology 26% 24% 19% -

Outcomes

mOS (months, 95% CI) 18.2 12.1 16.1 16.1

mOS epithelioid (months, 95% CI) 21.2 (13.2-25.8) 16.1

mPFS 7.6 5.7 7.3 7.0

mPFS epithelioid (months, 95% CI) 8.3 (7.1-9.7) 7.0


© Novocure 2018 24

median overall survival of 12.2 months from clinical trials reported between 2003 and 2018

02468

1012141618

2002 2004 2006 2008 2010 2012 2014 2016 2018

Median survival plotted against time for clinical trial patients receiving pemetrexed with platinum agents1-9

trend line

A Pubmed search was performed in September 2018 using the following search term “(mesothelioma OR MPM) AND pemetrexed”. The search retrieved 691 abstracts which were reviewed manually to include only prospective trials using pemetrexed (or raltitrexed – a similar drug approved in EU for MPM) together with platinum agents (cisplatin or carboplatin) as front line treatment in inoperable MPM. Only randomized controlled trials or single arm trials with >50 patients which reported overall survival outcomes were included. The search led to the identification of 9 trials reported between 2003 and 2018. 1. Vogelzang N.J., et al. J Clin Oncol. 2003 Jul 15;21(14):2636-44. 2. van Meerbeeck J.P., et al. J Clin Oncol. 2005 Oct 1;23(28):6881-9. 3. Cerasoli, G.L., et al. J Clin Oncol. 2006 Mar 20;24(9):1443-8. 4. Castagneto B., et al. Ann Oncol. 2008 Feb;19(2):370-3. 5. Katirtzoglou N., et al. Clin Lung Cancer. 2010 Jan;11(1):30-5. 6. Krug L.M., et al. Lung Cancer. 2014 Sep;85(3):429-34. 7. Zalcman G., et al. Lancet. 2016 Apr 2;387(10026):1405-1414. 8. Grosso F., et al. J Clin Oncol. 2017 Nov 1;35(31):3591-3600. 9. Tsao, A.S., et al. J Clin Oncol. 36, 2018 (suppl; abstr 8514).

© Novocure 2018 25

TTFields in combination with pemetrexed and a platinum agent

showed improved outcomes compared to historical controls

for the treatment of unresectable malignant pleural mesothelioma

• Median OS (18.2 months) was significantly longer than historical control (12.1 months)

• Despite the lower rate of patients with epithelioid histology, OS was better than the

pemetrexed/platinum arm in recent trials (MAPS, LUME-Meso)

• There was no increase in systemic toxicity with TTFields

• Only TTFields-related adverse event was skin irritation beneath the transducer arrays

conclusions and take home message


mesothelioma in clinical practice Charles B. Simone, II, MD

Actor portrayal

© Novocure 2018 27

malignant pleural mesothelioma presentation

• Male predominance (male:female = 5:1)

• Median age of 65-72 years

• Typical presentation includes locally advanced clinical stage and other medical

comorbidities

• 90% with dyspnea, non-pleuritic chest wall pain, or both

• 10-20% present with spontaneous pneumothorax

• Advanced disease: clotting abnormalities, respiratory failure, pneumonia, small

bowel obstruction, myocardial involvement (cause of death in ~10%)

• Exam: dullness at the lung base

• Workup: CRX and CT chest imaging

© Novocure 2018 28

• Epithelial histology

• Young age (<55 years, <75 years)

• Good performance status

• Early-stage disease (stage I)

• Female gender

• Lack of weight loss

• Normal platelet count

• Normal hemoglobin

• Lack of chest pain at diagnosis

• Pleural fluid pH >7.3

• High pleural/serum glucose ratio

favorable prognostic factors1,2

1. Edwards JG, et al. Thorax. 2000;55(9):731-5.

2. Lianes P, et al. Clin Transl Oncol. 2011;13(8):569-73.

EORTC and CALGB prognostic factors in malignant pleural mesothelioma

© Novocure 2018 29

• Median survival untreated:

4-8 months

• Trimodality treatment can

improve survival to 20-38

months in well selected,

early-stage patients

• Median survival for stage

III-IV patients treated with

multiagent chemotherapy:

12 months

natural history and current NCCN guidelines

© Novocure 2018 30

• Diagnostic

• Percutaneous needle biopsy (40-69%)

• Needle biopsy combined with cytology (80-90%)

• Thoracoscopic pleural biopsy (80-100%)

• Palliative

• Talc pleurodesis

• Pleurectomy/decortication

• Radical

• Goal is complete gross cytoreduction of tumor

• Extended pleurectomy or extrapleural pneumonectomy

• Conduit for multimodality therapy

roles of surgery

Survival by stage in surgery patients1

1. Flores RM, et al. J Thorac Cardiovasc Surg. 2008;135(3):620-6.

© Novocure 2018 31

• First-line combination chemotherapy:

• Q3 week pemetrexed 500 mg/m2 D1 +

cisplatin 75 mg/m2 D1

• Pemetrexed + cisplatin + bevacizumab

• Alternative first-line chemotherapy:

• Pemetrexed + carboplatin

• Gemcitabine + cisplatin

• Pemetrexed alone

• Vinorelbine

chemotherapy regimens

• Second-line chemotherapy:

• Pemetrexed alone (if not given first-line)

• Gemcitabine (+/- cisplatin)

• Vinorelbine

• Under investigation: doxorubicin +/-

onconase, vorinostat, bortezomib,

antineoplaston, erlotinib +

bevacizumab, imatinib, carboplatin +

vinorelbin, AZD2171 and PXD2171 (VEGF)

© Novocure 2018 32

reasons to administer radiation therapy

• Following surgery:

• After extrapleural pneumonectomy, radiation therapy traditionally administered in all

patients with good performance status to treat microscopic residual disease

• Beginning to be used after radical pleurectomy, ideally on protocol due to increased

concern of pulmonary toxicity

• After extrapleural pneumonectomy or radical pleurectomy: R2 resection, pN2 nodal

metastasis

• For prevention of instrument tract recurrence

• As definitive therapy, may provide durable local control for non-surgical candidates or

in cases of progression on chemotherapy

• For palliation to decrease pain, stop bleeding and decrease coughing/wheezing

© Novocure 2018 33

• Systemic therapy:

• Chemotherapy combined with targeted or immune agents

• Maintenance chemotherapy or low dose chemotherapy

• Exploit the immunological effects of gemcitabine

• Gene therapy

• PD-1/PD-L1 inhibitors and other immunotherapies

• Intrapleural photodynamic therapy

• Radiation therapy with radio-immunomodulation, with

radiosensitizing chemotherapy

• Intensity-modulated radiation therapy (IMRT)

• Intensity-modulated proton therapy (IMPT)

emerging therapeutic approaches

Intrapleural

photodynamic therapy

Intensity-modulated

radiation therapy

© Novocure 2018 34

• Chemotherapy is the only standard modality, with pemetrexed and cisplatin

combination being first line

• Long term survival is uncommon, typically only seen in patients undergoing surgery

• Surgical technique is evolving with a trend towards more lung-sparing procedures

• Radiation therapy has an important role in local control, but the technique and its use

are evolving as the surgical standard evolves; Innovative techniques like IMRT and

IMPT on an intact lung will become more widely utilized

• Second-line treatment and combining immunotherapeutic agents with

chemotherapy, RT, and surgery are promising avenues currently being explored

conclusions

the path forward Eilon Kirson, MD, PhD

Actor portrayal

© Novocure 2018 36

humanitarian use device (HUD) designation allows for FDA approval via HDE pathway

HDE application PMA application

Indication for use Based on HUD designation Proposed by applicant

Safety Will not expose patients to an unreasonable or significant risk of illness or injury

Reasonable assurance of safety

Effectiveness Demonstration of probable benefit; exempt from demonstrating effectiveness

Reasonable assurance of effectiveness

FDA review days 75 days to determine a decision

180 days – if no panel 320 days – if panel

© Novocure 2018 37

Organization ready at FDA approval: • Promotion initially targeted to

centers of excellence, largely leveraging existing sales force

• Initiate process towards payer coverage and contracting

• Engagement with advocacy groups

US regulatory submission for second generation torso system

EU regulatory package prepared

current status of HDE application and anticipated preparation for commercial launch

Pre-submission meeting held with FDA in Q3 2018

HDE application package in final stages of preparation

Anticipate Q4 2018 filing

75 day review clock to FDA decision letter

Q4 2018 Today 2019

Full commercial launch with: • Approval of second generation

torso system • Established commercial

reimbursement

2020 and beyond

question and answer session

Documents

Novocure analyst and investor briefing · 9/25/2018 · contained in this presentation shall be deemed to be a forecast, projection or estimate of the future financial performance