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NovoCure Limited

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FY2015 Annual Report · NovoCure Limited
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patientforward

Novocure 2015 Annual Report

patientforward

2

We are pursuing dramatic improvements in cancer patient survival while maintaining quality of life  using a novel technology that changes the way we  view the treatment of solid tumor cancers. Instead of targeting cancer with drugs or ionizing radiation, we have created a therapy that uses  low-intensity electric fields to disrupt cancer cell division without causing many of the typical side  effects of other cancer treatments. We call our therapy Tumor Treating Fields, or TTFields. For over 15 years,  we have studied TTFields in the laboratory and,  more recently, performed clinical trials that strengthen our belief that TTFields therapy provides a viable  path forward to revolutionize cancer care.We are dedicated to implementing patient-forward cancer treatment protocols utilizing TTFields. Patients’ health. Patients’ lives. Patients’ families and caregivers. They are what matter most to us, and  they will guide us forward in our mission to deliver a new cancer therapy that lengthens patients’ lives while maintaining quality of life.NOVOCURE 2015 ANNUAL REPORT

Martin Romero Sanchez 
Optune™ patient 
Houston, Texas

3

3the business 
of Novocure

Asaf Danziger, CEO (left)

William Doyle, Chairman    

Professor Palti founded Novocure™ to provide patients 
with a new cancer treatment based on his hypothesis, 
since proven, that low-intensity, alternating electric 
fields, when applied at specific frequencies, can disrupt 
cancer cell division and cause cancer cell death.  
This innovative treatment—Tumor Treating Fields, or  
TTFields—has become a completely new approach  
to cancer therapy. 

When we started, it seemed incredible to many that 
electric fields could be tuned to kill cancer cells without 
inducing the systemic side effects so common with 
cancer therapies currently in use. But the strength of our 

data and the growing body of patient stories now speak 
for themselves.  

Establishing, building and growing an innovative 
company to provide patients with a new cancer 
treatment modality demands determination, 
perseverence and an unwavering focus on the  
scientific evidence to keep moving forward  
regardless of the obstacles or resistance that may  
be encountered. This is how we operate.

We are dedicated to our mission of making TTFields 
available to all cancer patients who may benefit from it. 

4

In the early 2000s, Professor Yoram Palti, our founder and professor emeritus of physiology and biophysics at the Technion—Israel  Institute of Technology, sought to leverage his expertise in biophysics to develop a new way to treat cancer that would destroy tumor  cells while sparing healthy tissue and avoiding the life-altering side effects of existing cancer therapies. NOVOCURE 2015 ANNUAL REPORT

MORE THAN

300

EMPLOYEES

2

4

APPROVED INDICATIONS

CURRENTLY ACTIVE MARKETS

5

ONGOING OR COMPLETED  
PHASE 2 PILOT TRIALS

2

PHASE 3 PIVOTAL TRIALS  
PLANNED IN 2016

In the fourth quarter of 2015, we achieved several  
key milestones supporting our mission. On October 5, 
2015, we received U.S. Food and Drug Administration 
approval of Optune—a portable, noninvasive device that 
delivers TTFields therapy—together with temozolomide 
for newly diagnosed glioblastoma (GBM). On December 
15, 2015, the results of our EF-14 phase 3 pivotal trial  
of Optune together with temozolomide were published 
in the Journal of the American Medical Association  
with the conclusion that adding TTFields therapy to 
maintenance temozolomide chemotherapy significantly 
prolonged progression-free and overall survival in newly 
diagnosed GBM. As of December 31, 2015, we had  
605 active patients on Optune therapy compared to 225 
at the end of 2014, an increase of 169 percent. We 
continue to see growth in the number of active patients 
in the first quarter of 2016 and recently crossed the  
700 active patient mark.

The strength of our data and the 
growing body of patient stories 
now speak for themselves. 

We also continue to improve our treatment for GBM. 
Our second generation Optune system, which is half  
the size and half the weight of our first generation 
Optune system, is available to all new patients in Europe. 
We have filed for regulatory approval with the FDA  
and, assuming we do not receive comments or requests 
for additional information, we hope to begin marketing 
our second generation Optune system in the United 
States after approval later this year. 

We are making progress toward treating other solid 
tumors in addition to GBM. We have five ongoing or 
completed phase 2 pilot trials in brain metastases, non-
small cell lung cancer, ovarian cancer, pancreatic cancer 
and mesothelioma. Early in 2016, we presented data 
from the first cohort of our PANOVA phase 2 pilot trial in 
advanced pancreatic cancer demonstrating that TTFields 
may improve survival of patients with this terrible 
disease. Based on the positive data from the first cohort 
of PANOVA patients, we have accelerated our planning 
of a phase 3 pivotal trial in pancreatic cancer. We also 
expect to open phase 3 pivotal trials in brain metastases 
and non-small cell lung cancer in 2016. 

Over a decade ago, we joined Novocure for the 
opportunity to make a meaningful difference in the lives 
of cancer patients. We reached a pivotal milestone in 
2015 with the FDA approval of Optune for newly 
diagnosed GBM in the United States. Our passion to 
bring Optune to all GBM patients who may benefit from 
it and to develop TTFields for additional solid tumor 
cancers is greater than ever.

Asaf Danziger, CEO

William Doyle, Chairman 

5

 
With more than 15 years of research, we believe we 
have gained a deep understanding of the underlying 
mechanisms of action and the multiple pathways 
through which TTFields exert their effects within 
dividing cancer cells. In the lab, we have demonstrated 
that TTFields have an anti-mitotic effect in over 15 
different solid tumor types. We have translated this 
preclinical research into clinical results in glioblastoma, 
for which we have an approved and marketed product, 
as well as in non-small cell lung cancer and pancreatic 
cancer, for which we have phase 2 pilot trial results. 
We are conducting ongoing clinical research in brain 
metastases, pancreatic cancer, ovarian cancer and 
mesothelioma.

TTFields therapy delivers low-intensity, alternating 
electric fields through the skin to the region of a tumor. 
Due to the unique shape formed by cancer cells as they 
divide, TTFields can cause cellular building blocks to pile 
up and destroy the cells. Also during division, proteins 
form structures to pull essential cellular components 
into new daughter cells. TTFields can prevent the proper 
formation of these structures and prevent the proper 
movement of the cellular components again resulting 
in cell death. Laboratory experiments show these 

mechanisms of action inhibit tumor growth and can lead 
to tumor shrinkage. Laboratory experiments also show 
TTFields affect healthy cells much less than cancer cells 
since healthy cells multiply at a much slower rate, if  
at all, and TTFields are frequency tuned to target cancer 
cells with specific physical properties.

We believe TTFields may be combined with other 
existing and future solid tumor therapies offering the 
potential for more effective, safer treatments. We are 
conducting research and supporting independent 
research to determine the optimal combinations of 
TTFields with radiation and pharmacological therapies  
to enhance the therapeutic benefits of TTFields and 
expand the population of patients who may benefit  
from treatment with TTFields.

We plan to continue to invest in our clinical pipeline and 
expect to open phase 3 pivotal trials for brain metastases 
and non-small cell lung cancer in 2016.

We believe we will establish TTFields as a new treatment 
for a variety of solid tumors that increases survival 
without significantly increasing side effects when used  
in combination with other cancer treatments.

6

moving forwardwith clinical trialsNOVOCURE 2015 ANNUAL REPORT

Novocure pipeline

INDICATIONS

Recurrent GBM with Optune

Newly Diagnosed GBM with Optune

Brain Metastases

NSCLC

Pancreatic Cancer

Ovarian Cancer

Mesothelioma

Pre-
clinical

Phase 2
pilot

Phase 3 
pivotal

Marketed Expected next milestone

METIS trial first patient in 2016

LUNAR trial first patient in 2016

PANOVA trial 2nd cohort last patient in 2016

INNOVATE trial last patient in 2016

STELLAR trial last patient in 2017

Trial expected to open in 2016

7

patientforward
Michael Davies

In May 2015, Michael Davies was settling into 
his new position as an executive assistant  
at a TV production company, planning to move 
to his own place and establishing roots in West 
Hollywood when a shocking glioblastoma 
diagnosis put his plans on hold. 

8

NOVOCURE 2015 ANNUAL REPORT

99

“I was starting my life,” said the 24-year-old who lives  

production company. He has always been fascinated by 

in La Habra, California.

TV and movie making, and studied the industry in 

Michael’s tumor was surgically removed at St. Jude 

Medical Center. Michael knew he would need the 

support of his mother and stepfather and the comfort of 

home as he began standard-of-care radiation and 

college. He hopes one day to work in development for a 

network while also engaging his passion for writing  

and performing stand-up comedy. Writing and humor 

have helped Michael cope with his diagnosis. 

chemotherapy at City of Hope. He decided to postpone 

Michael begins each day with a two-hour commute to 

his move to West Hollywood. 

West Hollywood and participates in a recreational sports 

Michael recalled when his doctor introduced Optune as 

a treatment option with chemotherapy. It took him a 

couple of days to process the idea of using Optune, and 

league twice a week after work. On weekends, he 

spends time with friends, relaxes and exercises. In April, 

Michael plans to visit Las Vegas, one of his favorite cities. 

once he started Optune therapy, some trial and error 

“I do whatever I have to do to make sure I’m living as 

was required as he incorporated it into his life. He 

much of my normal life as possible,” Michael said.

learned to dress in ways to cover parts of the device and 

created an array-change schedule to facilitate his 

exercise routines. Soon Michael started feeling like 

himself again. 

“It was a process to get used to,” Michael said. “But we 

figured out what works for us.” 

In the face of his diagnosis, Michael strives to maintain 

normalcy and continue his personal and professional 

pursuits. He enjoys the entertainment industry and 

appreciates the foundational knowledge he’s gaining 

from working in the legal department of a TV  

He feels optimistic that researchers will one day find a 

cure. However, today, he aims to maintain a positive 

attitude and remain focused on moving his life forward.   

“I just hope that one day this will all be behind me and I’ll 

still be living the normal life that I’m trying to live now,” 

he said. “I just want to be happy.” 

“I do whatever I have to do 
to make sure I’m living as 
much of my normal life as 
possible.”

10

NOVOCURE 2015 ANNUAL REPORT

11patientforward
Amy Luton, DSS (Device Support Specialist) 

Our Device Support Specialists (DSSs)  
embody our patient-forward mission and set 
our business apart from other companies  
that market cancer therapies. Our DSSs work 
one-on-one with patients—educating them 
about Optune, and providing technical support 
and personal contact with Novocure.  

12

NOVOCURE 2015 ANNUAL REPORT

13

“The DSS is on the journey with the patient the entire 

reach out to new patients within a few days of starting 

time he or she is on therapy,” said Kenda Pennington, 

treatment and visit monthly to download compliance 

Novocure’s Director of Device Support Specialists.

reports that show patients how many hours of therapy 

Amy Luton, who lives in the Houston metropolitan area, 

has been a DSS in Texas for six years. Amy worked in 

medical device and surgical support for five years before 

they received each day. If a patient has a problem or 

needs support in between visits, a DSS will communicate 

via phone or in person. 

joining Novocure. At the time, Novocure was just  

Amy said, “Given what patients and their families are 

starting out in the United States. Amy remembers her first 

going through, a DSS must be flexible, compassionate 

meeting with the original patient support team. 

and considerate to address their needs and help them 

“You could just tell their heart was in this, and I wanted to 

be a part of that,” she said. 

Amy enjoys interacting with patients and caregivers, and 

helping them while on Optune therapy. On any given 

day, she might train a new patient starting therapy, meet 

with caregivers, assist patients over the phone or handle 

with Optune through their treatment.” 

Working with families facing a life-threatening illness 

keeps Amy grounded and reinforces what she values 

most in her own life: spending time with her husband, 

Clay, and daughters, Charlotte Rose, 6 months, and  

Ella Reese, 3.   

administrative tasks. She said Novocure’s personalized 

“It’s very humbling to be a DSS at Novocure, knowing 

focus provides patients and their families with a high level 

we’re providing such an innovative therapy to these 

of support.  

patients. Being a part of that is wonderful,” she said. 

DSSs most often assist patients in their homes. When a 

new patient starts therapy, a DSS will spend about two 

hours with the patient and their caregivers, teaching them 

how to shave the patient’s head, place the arrays, use 

the equipment and care for the patient’s skin. A DSS will 

“The DSS is on the  
journey with the patient  
the entire time he  
or she is on therapy.”

14
14

NOVOCURE 2015 ANNUAL REPORT

financial 
highlights

prescriptions

active patients

Prescriptions Received by Region

Active Patients By Region

net revenues* 

(USD THOUSANDS) 

2,000

1,500

1,000

500

0

800

700

600

500

400

300

200

100

0

35,000

30,000

25,000

20,000

15,000

10,000

5,000

0

2013

2014

2015

2013

2014

2015

2013

2014

2015

* We account for revenues when cash is 
collected and all other revenue recognition 
criteria have been met.

Our financial results should be considered in the 
context of our key operating statistics—prescriptions 
and active patients. Prescriptions are a leading indicator 
of demand. The conversion of prescriptions to new 
patients is driven by the prescription fill rate and the 
time to fill a prescription. The relationship between filled 
prescriptions and active patients is driven by treatment 
duration. We bill a single monthly fee at the start of each 
month of therapy for each active patient. 

We invest in our business both to grow revenue in 
the near term through expansion in glioblastoma 
and to advance our pipeline in a variety of additional 
solid tumors. We hope to broaden our commercial 
opportunity and, ultimately, to lengthen the lives  
of patients while maintaining their quality of life. Our 
balance sheet remains strong with more than  
$269 million in cash, cash equivalents and short-term 
investments at December 31, 2015.

$111

$269

MILLION IN GROSS BILLINGS FOR 
THE FULL YEAR 2015

MILLION IN CASH, CASH EQUIVALENTS AND  
SHORT-TERM INVESTMENTS AT YEAR END

16

NOVOCURE 2015 ANNUAL REPORT

consolidated statement  
of operations

USD Thousands
Net revenues 

Cost of revenues 

Gross profit 

Operating costs and expenses: 

Research, development and clinical trials 

Sales and marketing 

General and administrative 

Total operating costs and expenses 

Operating loss 

Financial expenses, net 

Loss before income taxes 

Income taxes 

Net loss 

Year ended December 31,

2015

2014

2013

$

33,087

$

15,490

$

10,359

20,610

12,477

43,748

38,861

33,864

116,473

(103,996)

(3,151)

(107,147)

4,434

10,036

5,454

40,381

21,177

24,052

85,610

(80,156)

(144)

(80,300)

382

7,013

3,346

34,797

16,406

16,602

67,805

(64,459)

(12,558)

(77,017)

353

$

(111,581)

$

(80,682)

$

(77,370)

leadership

Corporate Officers and 
Executive Leadership

William F. Doyle 
Chairman

Asaf Danziger 
Chief Executive Officer

Mike Ambrogi 
Chief Operating Officer

Wilco Groenhuysen 
Chief Financial Officer

Eilon Kirson, M.D., Ph.D. 
Chief Science Officer and  
Head of Research and Development

Todd Longsworth 
General Counsel

Peter Melnyk 
Chief Commercial Officer

Yoram Palti, M.D., Ph.D. 
Chief Technology Officer

Board of Directors

William F. Doyle 
Chairman

William Burkoth

Asaf Danziger

Timothy Langloss

Louis Lavigne, Jr.

Kinyip Gabriel Leung

Robert J. Mylod, Jr.

Yoram Palti, M.D., Ph.D.

Gert Lennart Perlhagen

Charles G. Phillips III

Tony Vernon

17

market price of and dividends on the registrants’ 
common equity and related stockholder matters
This graph is not “soliciting material,” is not deemed “filed” with the SEC 
and is not to be incorporated by reference into any of our filings under the 
Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, 
as amended, whether made before or after the date hereof and irrespective 
of any general incorporation language in any such filing.

The following graph shows the total stockholder return of an investment 
of $100 in cash at market close on October 2, 2015 (the first day of trading 

of our ordinary shares) through December 31, 2015 for (1) our ordinary 
shares, (2) the Russell 2000 Index, and (3) the NASDAQ Biotechnology Index. 
Pursuant to applicable SEC rules, all values assume reinvestment of the full 
amount of all dividends; however, no dividends have been declared on our 
ordinary shares to date. The stockholder return shown on the graph below 
is not necessarily indicative of future performance, and we do not make or 
endorse any predictions as to future stockholder returns.

comparison of cumulative total return
COMPARISON OF CUMULATIVE TOTAL RETURN
COMPARISON OF CUMULATIVE TOTAL RETURN
Among NovoCure Limited, the Russell 2000 Index, and the NASDAQ Biotechnology Index
Among NovoCure Limited, the Russell 2000 Index, and the NASDAQ Biotechnology Index

$ 140
$ 120
$ 100
$ 80
$ 60
$ 40
$ 20
$ 0
10/2/2015

$ 140
$ 120
$ 100
$ 80
$ 60
$ 40
$ 20
$ 0
10/2/2015

10/31/2015

10/31/2015

11/30/2015

11/30/2015

12/31/2015

12/31/2015

NovoCure Limited

NovoCure Limited

NASDAQ Biotechnology Index

NASDAQ Biotechnology Index

Russell 2000 Index

Russell 2000 Index

Assumes $100 invested on October 2, 2015
Assumes $100 invested on October 2, 2015
Assumes dividend reinvested
Assumes dividend reinvested
Fiscal year ending December 31, 2015
Fiscal year ending December 31, 2015

total return annual comparison 
cumulative total return summary
COMPARISON OF CUMULATIVE TOTAL RETURN
COMPARISON OF CUMULATIVE TOTAL RETURN
Among Novocure Limited, the Russell 2000 Index, and the Nasdaq Biotechnology Index
Among Novocure Limited, the Russell 2000 Index, and the Nasdaq Biotechnology Index
NovoCure Limited

10/2/2015

Return%

10/31/2015

22.92

11/30/2015

12/31/2015

8.37

133.21

-8.17

122.32

100.00

122.92

$ 140
$ 140
$ 120
$ 120
$ 100
$ 100
NASDAQ Biotechnology Index
$ 80
$ 80
$ 60
$ 60
$ 40
$ 40
Russell 2000 Index
$ 20
$ 20
$ 0
$ 0
10/2/2015
10/2/2015

Cum $

Return%

Cum $

Return%

Cum $

10/31/2015

10/31/2015

3.25

2.62

1.25

100

103.25

105.96

107.29

100.00
11/30/2015

11/30/2015

4.35

104.35

3.25

107.74

-5.02

102.33
12/31/2015

12/31/2015

Novocure Limited

Novocure Limited

NASDAQ Biotechnology Index

NASDAQ Biotechnology Index

Russell 2000 Index

Russell 2000 Index

Indications For Use
Optune is intended as a treatment for adult patients (22 years of age or older) 
with histologically-confirmed glioblastoma multiforme (GBM).

Assumes $100 invested on October 2, 2015
Assumes $100 invested on October 2, 2015
Assumes dividend reinvested
Assumes dividend reinvested
Fiscal year ending December 31, 2015
Fiscal year ending December 31, 2015

Warnings and Precautions 
Use Optune only after receiving training from qualified personnel, such as 
your doctor, a nurse, or other medical personnel who have completed a 
training course given by Novocure (the device manufacturer).

Optune with temozolomide is indicated for the treatment of adult patients 
with newly diagnosed, supratentorial glioblastoma following maximal 
debulking surgery and completion of radiation therapy together with 
concomitant standard of care chemotherapy.

For the treatment of recurrent GBM, Optune is indicated following 
histologically-or radiologically-confirmed recurrence in the supratentorial 
region of the brain after receiving chemotherapy. The device is intended to be 
used as a monotherapy, and is intended as an alternative to standard medical 
therapy for GBM after surgical and radiation options have been exhausted.

Summary of Important Safety Information 

Contraindications 
Do not use Optune if you have an active implanted medical device, a skull 
defect (such as, missing bone with no replacement), or bullet fragments. Use 
of Optune together with implanted electronic devices has not been tested 
and may theoretically lead to malfunctioning of the implanted device. Use of 
Optune together with skull defects or bullet fragments has not been tested 
and may possibly lead to tissue damage or render Optune ineffective.

Do not use Optune if you are known to be sensitive to conductive hydrogels. 
In this case, skin contact with the gel used with Optune may commonly 
cause increased redness and itching, and rarely may even lead to severe 
allergic reactions such as shock and respiratory failure. 

18

Do not use Optune if you are pregnant, you think you might be pregnant 
or are trying to get pregnant. It is not known if Optune is safe or effective in 
these populations.

The most common (≥10%) adverse events involving Optune in combination 
with temozolomide were low blood platelet count, nausea, constipation, 
vomiting, fatigue, scalp irritation from device use, headache, convulsions, 
and depression.

All servicing procedures must be performed by qualified and trained 
personnel.

Do not use any parts that do not come with the Optune Treatment Kit, or 
that were not sent to you by the device manufacturer or given to you by 
your doctor.

Do not wet the device or transducer arrays.

If you have an underlying serious skin condition on the scalp, discuss  
with your doctor whether this may prevent or temporarily interfere with 
Optune treatment.

Please visit www.optune.com/safety for Optune Instructions for Use 
(IFU) for complete information regarding the device’s indications, 
contraindications, warnings, and precautions.

 
looking 
ahead

NOVOCURE 2015 ANNUAL REPORT

As far as we’ve come in the last 15 years, we are 
intensely focused on the future. With a patient-
forward approach, we will continue to develop and 
commercialize TTFields to treat solid tumor cancers.

We will work relentlessly to make our therapy available 
to all glioblastoma (GBM) patients who may benefit 
from TTFields. We will work with regulatory agencies  
to gain approval of our smaller, lighter, second 
generation Optune system in the United States and to 
gain approval of Optune for the treatment of newly 
diagnosed GBM in Japan.

We are more committed than ever to developing 
TTFields to treat other solid tumors. We will continue  
to support the patients in our ongoing clinical  
trials and will work to open at least two new phase 3  
pivotal trials in the upcoming year.

Throughout it all, we will remain patient-forward.

19

Le Masurier House 
La Rue Le Masurier 
St Helier, Jersey JE2 4YE

www.novocure.com