november 2014 (rwlk: nasdaq) - jefferies · experienced management team larry jasinski ceo dr. amit...

25
1 November 2014 (RWLK: NASDAQ)

Upload: others

Post on 24-Aug-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

1

November 2014 (RWLK: NASDAQ)

Page 2: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Safe Harbor

This presentation is for informational purposes only and is not an offer to sell securities or a solicitation of an offer to buy any

securities, and may not be relied upon in connection with the purchase or sale of any security. Sales and offers to sell

ReWalk Robotics Ltd. securities will only be made in accordance with the Securities Act of 1933, as amended (the “Act”),

and applicable Securities and Exchange Commission (“SEC”) regulations, including the written prospectus requirements.

This presentation is proprietary and is intended solely for the information of the persons to whom it is presented. It may not

be retained, reproduced or distributed, in whole or in part, by any means (including electronic) without the prior written

consent of ReWalk Robotics Ltd. Certain statements contained in this presentation constitute forward-looking information.

These statements reflect management’s current beliefs and are based on information currently available to management.

Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ

materially from those expressed or implied in such statements. These risks and uncertainties should be considered carefully

and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking

statements contained in this document are based upon what management believes to be reasonable assumptions,

management’s current beliefs are based on information currently available to management. Certain material factors or

assumptions are applied in making forward-looking statements, and actual results may differ materially. Management

cannot provide assurance that actual results will be consistent with these forward-looking statements. The Company

undertakes no obligation to update or revise any forward-looking statements. This presentation contains statistical data that

we obtained from industry publications and reports generated by third parties. Although we believe that the publications and

reports are reliable, we have not independently verified this statistical data. The Company is an “emerging growth

company” as defined under the Act. These slides and the accompanying oral presentation are intended to qualify as

communications permitted pursuant to Section 5(d) of the Act. The Company has filed a registration statement (including a

prospectus) under the Act with the SEC for the transaction to which this communication relates. You should read the

prospectus in that registration statement and other documents the Company files with the SEC for more complete

information about the Company and the proposed offering. When available, you may obtain those documents for free by

visiting EDGAR on the SEC Web site at www.sec.gov. The trademarks included herein are the property of the owners

thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or

services of the Company or this proposed offering.

1

Page 3: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

About ReWalk Robotics (RWLK: Nasdaq)

1Disruptive platform technology enabling many individuals with paralysis to walk

independently

2“More Than Walking”: Potential to reduce secondary medical complications and lower

healthcare costs

3Only exoskeleton with FDA clearance (June 26, 2014) and CE mark clearance for both

Personal and Rehabilitation use

4 Demonstrated reimbursement success in the U.S. and Germany

5 Direct sales force in U.S. & Germany; distributors elsewhere in Europe & Asia

6 Addressing unpenetrated, multi-billion dollar market opportunity

Fundamentally changing the health and life experiences

of individuals with spinal cord injury

3

Page 4: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Experienced Management Team

Larry Jasinski CEO

Dr. Amit Goffer Founder, President & CTO

Ami Kraft CFO

Ofir Koren VP of R&D

Jodi Gricci VP of Global Marketing

Ori Schellas Director of Operations

John Hamilton VP of Regulatory / Reimbursement

Miri Pariente Global Director of Quality

5

Page 5: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

The Need…

Wheelchair confinement can cause severe physical and psychological

deterioration, resulting in bad health, poor quality of life, low self-esteem and

significant medical expenses

Secondary medical

consequences of paralysis:

Difficulty with bowel and urinary tract

function

Osteoporosis

Loss of lean mass / gain in fat mass

Insulin resistance

Diabetes

Heart disease

Increased

healthcare costs due to

paraplegia-related

complications

87% of spinal cord injury

patients discharged to private,

non-institutional residences

Increased

need for in-home

personal device

6

Page 6: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

U.S. Prevalence of SCI

…And the Opportunity

273,000 people in the U.S. living with SCI

An estimated 218,000 (or ~80%) are

candidates for ReWalk (1)

12,000 new cases of SCI annually

Implies potential for annual market growth

of $670 mm (3)

U.S. SCI Market Potential ($mm) (2)

273,000 Individuals with SCI in U.S.

___________________________

1. National Spinal Cord Injury Statistics Center (NSCISC).

2. Based on U.S. Census Bureau data.

3. Assumes 80% of 12,000 new annual injuries are candidates for ReWalk at $70,000 per unit.

Note: The metrics provided above are forward-looking in nature and are subject to significant business,

economic and competitive uncertainties and contingencies, many of which are beyond the control of the

Company. Please refer to the Safe Harbor statement for more information.

Potential ReWalk Population

7

Page 7: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

The ReWalk Solution

ReWalk Personal and ReWalk Rehabilitation designed to fundamentally change the

health and life expectancies of users

Enables walking in multiple environments, as well as

ability to sit, stand, turn and, in some cases, climb and

descend stairs (1)

Light, wearable exoskeleton designed for all-day use

User-initiated walking, powered by patented tilt-sensor

technology

Supports its own weight; user does not expend

unnecessary energy while walking

Rechargeable battery power

Published clinical studies demonstrate

ReWalk’s ability to mimic a natural gait and

deliver functional walking speed

Computer,

software and

batteries

Tilt sensor

Pelvic support

Motors, gears

and software

Shoe insert

___________________________

1. Use of stairs is cleared under the CE mark, Canadian and Israeli registration; not cleared for

stairs by the FDA in the U.S.

8

Page 8: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

The ReWalk Difference: Patented Tilt Sensor Technology & Gait Algorithm

Mimics natural gait

Designed for all-day use by

minimizing the amount of

effort required to use device

Enables user control of system

Proprietary Gait AlgorithmPatented Tilt Sensor

Technology

Results Mimic Natural Walking Experience

10

Page 9: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

9

Page 10: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Largest Body of Published Clinical Data

Data supports:

• ReWalk safety as an ambulatory device

• Secondary health benefits of ReWalk use

• A more natural walking experience than competing devices

11

Page 11: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Demonstrated Secondary Health Benefits

“Exoskeletal-assisted

walking and other

mobility skills can be

performed

independently by persons

with motor-complete SCI.”

- Exoskeletal-Assisted Walking for

Persons with Motor-Complete

Paraplegia. STO-MP-HFM-228.

6:1-14.

“ReWalk holds

considerable potential as a

safe ambulatory

powered orthosis for

motor-complete thoracic-

level spinal cord injury

patients.”

- American Journal of Physical

Medicine & Rehabilitation

“Powered exoskeleton-

assisted walking in

persons with motor-

complete SCI generated

vGRF similar in

magnitude and pattern

to that of able-bodied

walking.”

- The Journal of Spinal Cord

Medicine

“…this technology may

potentially be adapted in

the future for others with

walking dysfunction from

stroke, cerebral palsy,

myelomeningocele,

traumatic brain injury,

and Guillain Barré

syndrome.”

- The Journal of Spinal Cord

Medicine

11

Reduction in

Medication

Dependency

Improvement in

Bowel and

Urinary Tract

Function

Improvement in

Body and Bone

Composition

Improvement in

Metabolism

and Physical

Fitness

Reduction in

Hospitalization

Reduction in

Pain and

Spasticity

“More Than Walking”: benefits of mobility serve as a pathway to better health

Page 12: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

ReWalk: Positioned to Drive Market Adoption and Capture the Personal Opportunity

Regulatory

Clearance

FDA

CE

Demonstrated

Reimbursement

U.S.

EU

Personal / Home Use

Independent Walking /

Functional Speed

Manufacturing

Clinical Data

Commercial Early-Stage

Too early

Too earlyToo early

Too early

12

Page 13: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Market

PenetrationDistribution

R&DScalable

Infrastructure

Reimbursement

Five-Part Execution Strategy

2

3

4

5

1

13

Page 14: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Market Penetration Strategy

In 80+

rehabilitation

centers

worldwide

Covered vastly

more miles

than any other

technology

Over 1,000

ReWalk users

trained

Classifying

personal “leads”

and customer

conversion

Laying the foundation: Direct outreach, data generation, market education and

awareness, building leads / referrals

Penetrate

rehabilitation

centers, hospitals

and similar facilities

that treat patients

with SCI

Position ReWalk

as an integral

part of their

rehab programs

Develop broad-

based training

network within

these facilities

Prepare users

for home

and community

use

1

14

Page 15: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Distribution: Core Markets

Building our direct field organization

Leveraging distributors to extend reach

Broad Current and Targeted Distribution Platform

2

___________________________

1. Current distribution: Austria, China (including Hong Kong and Macau), France, Italy, Japan, Russia,

Singapore, South Korea, Taiwan, Thailand, Turkey, UK.

2. Targeted distribution: Australia, Canada, India, Kazakhstan, Middle East, New Zealand.

Note: The metrics provided above are forward-looking in nature and are subject to significant business,

economic and competitive uncertainties and contingencies, many of which are beyond the control of the

Company. Please refer to the Safe Harbor statement for more information.

Direct Sales

Distributors – Near-term Targets (2)

Distributors – Current (1)

Training Center Locations

15

Page 16: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Scalable Infrastructure: Established Quality and Manufacturing Capability

Current capacity meets expected needs; expansion capacity meets the five-year horizon

Established internal quality control organization

Contract manufacturing with Sanmina

Corporation (NASDAQ: SANM)

Well-established OEM with $5.9bn FY13

revenues (1)

Expertise in medical device industry

Complies with all U.S. and international

regulatory requirements

Sanmina assumed production of all ReWalk

systems beginning Q1 2014

3

Sanmina provides ReWalk with

significant scale-up capacity

___________________________

1. Source: Sanmina Corporation FY 2013 10-K.

16

Page 17: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Reimbursement Strategy

Self-Pay

National

Coverage

Insurance

Companies Initial focus on

penetrating substantial

private payor market

Strong precedent of

payments received

Sustainable business

model

Will be driven by

success in private

payor market and

additional ongoing

clinical studies

4

Near-term

Focus

Long-term

Focus

We expect to generate revenues from a combination of self-payors and third-party payors

Dept. of Veterans Affairs

Workers’ Compensation

Private Insurance

Direct Purchase

Foundations

Fundraisers

Legal Settlements

Individual Applications

Code Generation

17

Page 18: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Reimbursement Strategy (cont’d)

Leveraging case-by-case success in the U.S. and EU

U.S.

James J. Peters VA (Bronx, New York) is fully committed to supporting

the procurement of ReWalk Personal for all eligible veterans with SCI

1st hospital to research health-related benefits of an exoskeletal

walking device for people with SCI

Europe

Received coverage decisions from four large German insurers

~30 pending cases in Germany; have won coverage decisions on four

cases thus far

In direct markets, insurers have been covering basic codes for reimbursement

4

18

Personal

Systems

Rehabilitation

Systems

Page 19: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Research & Development Pipeline: Building on Our Platform

ReWalk - NG

ReWalk - MS

ReWalk - Q

ReWalk -

Cerebral

Palsy

Continued

Innovation

ReWalk -

Stroke

Quadriplegia

Add-on

sophisticated

crutches

Hemiplegia /

Hemiparesis

Adapted “half

ReWalk” suit

Enhance the

Physio &

Hydro therapy

possibilities via

motorized

exoskeleton Multiple Sclerosis

Adaptive software

to manage various

disease stages

Next generation

technology

More efficient drive

mechanism

Slimmer profile

Lighter body

Down the Road FutureCurrent R&D

5

Existing Market New Market Opportunity

19

Page 20: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Strong Intellectual Property Position

U.S.

Method patent issued

for proprietary tilt

sensor technology

One apparatus patent

issued as a gait-

locomotor

Europe & Rest of World

One active patent in

Europe

Six pending patent

applications in various

countries around the

world

Internal & external reviews

show freedom to operate

Multiple divisionals and

other filings

Title Status About

Gait-Locomotor

ApparatusGranted in U.S. and Europe

General view including concept of

utilization of a tilt sensor to function

Locomotion Assisting

Device and Method

4 divisionals

pendingGround forces – based algorithms

Locomotion Assisting

Device and Method2 divisionals pending Walk using ground forces

Integrated Tilt Sensor

Pending

Locations of tilt sensor

PCT 1st Notice 24.5.2012

Motorized

Exoskeleton UnitPending

2 motors on each thigh, next

generation concept

Prevent Fall Injuries in

Exoskeletons

Submitted

e.o. 5.2012Airbag

Exoskeleton

QuadriplegicsApplication Incorporate controlled crutches

20

Page 21: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Strategic Alliance with Yaskawa, A Global Robotics Leader

Unique combination of product expertise, name / brand recognition and

opportunity for Asian market penetration

Background

Provides Technology ValidationScope of Agreement

Penetrating the Asian Market

Multi-billion dollar global leader in

industrial robotics and automation

Strategic alliance formed in 2013; $10

million investment in ReWalk Robotics

Exclusive distributor of ReWalk in select

Asian markets

Application of Yaskawa expertise to

ReWalk product improvement and

quality

Exploration of joint research and

development

Reciprocal product marketing and

distribution

“Robotics has the potential to change the world of healthcare and

rehabilitation, and [ReWalk’s] knowhow in the field will allow us to

contribute to quality of life improvements of people around the

world.”

“We are looking forward to developing and expanding this

strategic partnership in the years to come as we strive to achieve

the goals we set for ourselves in our Vision 2015.”

Junji Tsuda, Yaskawa CEO

21

Page 22: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Revenues $1.5mm

277% growth Y-o-Y

Sold 26 ReWalk systems globally

Expanded sales, marketing and

training infrastructure

Invested further in R&D

Financial Highlights

22

Closed Q3 with $47.7mm cash, equivalents, short-term deposits

IPO net proceeds of $38.7mm

$12.8 mm from a pre-IPO financing round

$1.1 mm from the exercise of warrants to purchase convertible preferred shares

No debt

Q3 2014 Highlights Strong Revenue Growth

Strong Balance Sheet

1H

Q3

$2.5M

$1.2M

Page 23: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Investment Highlights

1Disruptive platform technology enabling many individuals with paralysis to walk

independently

2“More Than Walking”: Potential to reduce secondary medical complications and lower

healthcare costs

3Only exoskeleton with FDA clearance and CE mark clearance for Personal use and

Rehabilitation center use

4Growth supported by solid underlying demand for ReWalk systems + expanding user

base + increasing reimbursement success in the U.S. and Germany

5Building sales through direct sales force (U.S. & Germany) + distributors (elsewhere in

Europe and Asia)

6Uniquely positioned to continue as leader in multi-billion dollar powered exoskeleton

market

Fundamentally changing the health and life experiences

of individuals with spinal cord injury

23

Page 24: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

ReWalk NASDAQ / Times Square 17 Sept

26

Page 25: November 2014 (RWLK: NASDAQ) - Jefferies · Experienced Management Team Larry Jasinski CEO Dr. Amit Goffer Founder, President & CTO Ami Kraft CFO Ofir Koren VP of R&D Jodi Gricci

Thank You!