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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2020
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
Commission File No. 001-37854
Ekso Bionics Holdings, Inc.
(Exact name of registrant as specified in its
charter)
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Nevada |
99-0367049 |
(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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1414 Harbour Way South, Suite 1201
Richmond, California 94804
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code:
(510) 984-1761
Securities registered pursuant to section 12(b) of the
Act:
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Title of each class |
Trading Symbol |
Name of each exchange on which registered |
Common Stock, $0.001 par value |
EKSO |
Nasdaq Stock Market LLC
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(Nasdaq Capital Market) |
Securities registered pursuant to section 12(g) of the Act:
None
Indicate by check mark if the Registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities Act.
Yes
¨
No
ý
Indicate by check mark if the Registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the Act.
Yes
¨
No
ý
Indicate by check mark whether the registrant: (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes
ý
No
¨
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files).
Yes ý
No ¨
Indicate by check mark whether the Registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated
filer,”
“smaller reporting company,” and "emerging growth company" in Rule
12b-2 of the Exchange Act. Large accelerated filer
¨
Accelerated filer ¨
Non-accelerated filer ý
Smaller reporting company ☒
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
¨
Indicate by check mark whether the Registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
Yes
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No
☒
The aggregate market value of the registrant's common stock held by
non-affiliates of the registrant was $52,257,307 based on the last
sale price for such stock on June 30, 2020, the last business day
of the registrant's most recently completed second fiscal
quarter.
As of February 19, 2021 the registrant had 12,599,900
outstanding shares of common stock.
DOCUMENTS INCORPORATED BY REFERENCE:
Portions of the registrant’s Proxy Statement for the 2021 Annual
Meeting of Stockholders are incorporated herein by reference in
Part III of this Annual Report on Form 10-K to the extent stated
herein. Such proxy statement will be filed with the Securities and
Exchange Commission within 120 days of the registrant’s fiscal year
ended December 31, 2020.
Ekso Bionics Holdings, Inc.
ANNUAL REPORT ON FORM 10-K
For the Year Ended December 31, 2020
Table of Contents
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, or this Annual Report, contains
forward-looking statements, including, without limitation, in the
sections captioned “Business,” “Risk Factors,” “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations,” and elsewhere. Any and all statements contained in
this Annual Report that are not statements of historical fact may
be deemed forward-looking statements. Terms such as “may,” “might,”
“would,” “should,” “could,” “project,” “estimate,” “pro-forma,”
“predict,” “potential,” “strategy,” “anticipate,” “attempt,”
“develop,” “plan,” “help,” “believe,” “continue,” “intend,”
“expect,” “future,” and terms of similar import (including the
negative of any of the foregoing) may be intended to identify
forward-looking statements. However, not all forward-looking
statements may contain one or more of these identifying terms.
Forward-looking statements in this Annual Report may include,
without limitation, statements regarding (i) the plans and
objectives of management for future operations, including plans or
objectives relating to the design, development and
commercialization of exoskeleton products for humans, (ii) the
manufacturing of our products and strengthening our supply chain,
and potential opportunities for strategic partnerships, (iii)
future financial performance, including any projection of income
(including income/loss), earnings (including earnings/loss) per
share, capital expenditures, dividends, capital structure or other
financial items, (iv) our future financial performance, including
any statement contained in a discussion and analysis of financial
condition by management or in the results of operations included
pursuant to the rules and regulations of the Securities and
Exchange Commission ("SEC"), (v) our beliefs regarding the
potential for commercial opportunities, including for exoskeleton
technology in general and, our exoskeleton products in particular
and for strategic partnerships, (vi) our beliefs regarding
potential clinical and other health benefits of our medical
devices, (vii) the impact and effects of the COVID-19 pandemic and
other risk factors on our business, results of operations or
prospects, and (viii) the assumptions underlying or relating to any
statement described in points (i) through (viii)
above.
The forward-looking statements are not meant to predict or
guarantee actual results, performance, events or circumstances and
may not be realized because they are based upon our current
projections, plans, objectives, beliefs, expectations, estimates
and assumptions and are subject to a number of risks and
uncertainties and other influences, many of which we have no
control over. Actual results and the timing of certain events and
circumstances may differ materially from those described by the
forward-looking statements as a result of these risks and
uncertainties. Factors that may influence or contribute to the
inaccuracy of the forward-looking statements or cause actual
results to differ materially from expected or desired results may
include, without limitation, the ongoing COVID-19 pandemic and its
impact on the Company’s financial condition and business, the
highly competitive markets in which the Company’s products are
sold, the Company's significant losses to date and anticipated
future losses, the new and unproven nature of the market for the
Company’s products, the long and variable sales cycles for the
Company’s products, the factors outside the Company’s control that
affect the international sales of its products, the costs related
to and impacts of potential failure of the Company to obtain or
maintain protection for the Company's intellectual property rights,
the failure of the Company to obtain or maintain regulatory
approval to market the Company's medical devices, risks related to
product liability, recall and warranty claims, the volatility of
the market price of and limited trading in our common stock. A
description of some of the risks and uncertainties that could cause
our actual results to differ materially from those described by the
forward-looking statements in this Annual Report appears in the
section captioned “Risk Factors” and elsewhere in this Annual
Report.
Readers are cautioned not to place undue reliance on
forward-looking statements because of the risks and uncertainties
related to them and to the risk factors. We disclaim any obligation
to update the forward-looking statements contained in this Annual
Report to reflect any new information or future events or
circumstances or otherwise.
Readers should read this Annual Report in conjunction with the
discussion under the caption “Risk Factors,” our financial
statements and the related notes thereto in this Annual Report, and
other documents which we may file from time to time with the
SEC.
Notes regarding references to Ekso Bionics
In this Annual Report, the “Company”, “we”, “its” and “our” refers
to Ekso Bionics Holdings, Inc. and its wholly-owned subsidiaries,
and “Ekso Bionics” refers to Ekso Bionics, Inc. as it existed prior
to the January 15, 2014 merger of our wholly-owned subsidiary, Ekso
Acquisition Corp., with and into Ekso Bionics, Inc. or the Merger.
Ekso Bionics was the surviving corporation in the Merger and became
our wholly-owned subsidiary, and all of the outstanding Ekso
Bionics stock was converted into shares of our common stock.
Ekso®,
Ekso Bionics®,
EksoVest®,
EksoWorks®,
EksoGT™,
EksoNR™,
EksoZeroG™,
EVOTM,
EksoUE™,
and EksoPulse™
are registered and unregistered trademarks of the Company. All
other trademarks that may appear in this Annual Report are the
property of their respective owners.
PART I
Item 1. BUSINESS
Overview
We design, develop, sell, and rent exoskeleton products that
augment human strength, endurance and mobility. Our exoskeleton
technology serves multiple markets and can be utilized both by
able-bodied users and persons with physical disabilities. We have
sold or rented devices that (i) enable individuals with
neurological conditions affecting gait (acquired brain injury, or
ABI, and spinal cord injury, or SCI) to rehabilitate, and in some
cases, to walk again, (ii) assist individuals with a broad range of
upper extremity impairments, and (iii) allow industrial workers to
perform difficult repetitive work for extended
periods.
We believe that the commercial opportunity for exoskeleton
technology adoption is accelerating as a result of recent
advancements in material technologies, electronic and electrical
engineering, control technologies, and sensor and software
development. Taken individually, many of these advancements have
become ubiquitous in peoples’ everyday lives. Supported by an
industry-leading intellectual property portfolio, we believe that
we have learned how to integrate these existing technologies;
wrapping the result around a human being efficiently, elegantly and
safely. We further believe that we can do so across a broad
spectrum of applications, from persons with lower limb paralysis to
able-bodied users.
For medical applications we have two primary products.
•EksoNR
is used as a rehabilitation tool to allow physicians and therapists
to rehabilitate patients who have suffered a stroke or spinal cord
injury. In June 2020, we received 501(k) clearance from the U.S.
Food and Drug Administration, or FDA, to market our EksoNR for use
with patients with ABI. With its unique features designed
specifically for hospitals and its proprietary SmartAssist
software, EksoNR allows for the early mobilization of patients and,
increased endurance during rehabilitation sessions through higher
step counts and extended training durations. The intent is to allow
the patient's central nervous system to take advantage of a
patient's neuroplasticity to maximize recovery.
•EksoUE
is a wearable upper body exoskeleton that assists patients with a
broad range of upper extremity impairments and aims to provide a
wider active range of motion, increased endurance, and heightened
intensity during rehabilitation sessions.
For able-bodied industrial workers, we built on the leading market
position we achieved with EksoVest and EksoZeroG by introducing
EVO, a new wearable exoskeleton for overhead work.
Like EksoVest, EVO
is an upper body exoskeleton that elevates and supports a worker's
arms to assist them with tasks ranging from chest height to
overhead. Based on extensive customer feedback, EVO was designed
specifically to increase adoption of exoskeletons in the workplace.
Compared to EksoVest, EVO is lighter weight, lower profile, lower
cost, and has minimal contact with the body, making it comfortable
to wear while enabling an even broader free range of motion. The
goal is for workers using EVO to experience lower levels of fatigue
and reduce on-site injuries
while boosting productivity. In 2020, we introduced EVO into
targeted vertical markets including food processing, specific
construction trades, and manufacturing.
EksoHealth - Rehabilitation
Today, we focus our healthcare business on rehabilitation robotics.
We are leveraging our patented exoskeleton technology to develop
and market products intended to enable patients with lower limb
impairments to rehabilitate earlier and with better outcomes than
the current standard of care.
EksoNR
Our leading product, EksoNR, is a wearable bionic suit that allows
our hospital and rehabilitation customers to provide in-patients
and out-patients the ability to stand and walk over ground while
the device makes real-time adjustments to correct issues with the
patient’s reciprocal gait. Patients receive therapy in the device
under the supervision of a physical therapist, and typically use an
additional assistive device such as a cane, crutches or a walker.
Walking is achieved by a user shifting their weight, requiring the
user to achieve balance thereby replicating and reinforcing the
movements of a natural gait. If needed, some patients utilize
sensors in the device which assist in step initiation.
Battery-powered motors drive the legs, detecting the deficient
neuromuscular function and providing the level of assistance
necessary for a user to complete their step. Users can expect to
walk, with aid from the device, the first time they put on the
EksoNR exoskeleton (after passing an assessment). Physical
therapists can transfer patients to or from their wheelchair and
don or remove the EksoNR in less than ten minutes.
The EksoNR incorporates SmartAssist, our proprietary, adaptive
software that allows a patient to perform to their capability but
dynamically provides 0-100% power on either side of the body as
needed for successful walking. SmartAssist can promote a greater
number of high-quality steps in a short time period and support the
early re-learning of correct step patterns and weight shifts,
potentially mitigating compensatory behaviors. SmartAssist also has
allowed our customers to significantly expand the spectrum of
patients that can potentially benefit from robotic
rehabilitation.
In addition, SmartAssist can aid in promoting early mobility by
training patients (PreGait) to walk in an exoskeleton.We believe
this expands access of care to additional patients. SmartAssist
also includes next generation Variable Assist technology. Variable
Assist allows healthcare providers to adjust the level of
assistance provided by the EksoNR as necessary, in some instances
allowing patients to power themselves (FreeGait).
Another important feature of our EksoNR is its EksoPulse Analytics,
a real-time data capture program. EksoPulse gathers and transmits
statistics and device information during EksoNR walking sessions.
This information can be used to track patient progression and to
monitor device utilization. The EksoNR records data such as
steps, speed, step size, and other settings along with error logs
and operating parameters. Data is sent securely to our servers
where it is available for customers to view, filter, and export
through a secure web portal. This feature enables more
thorough patient care while reducing manual data entry. It
also enables us to provide a higher level of service through early
identification and thorough reporting of device errors, saving
customers the time and expense of unnecessary on-site
visits.
The EksoNR is used by customers in both in-patient and out-patient
settings. Our customers believe that for patients with some
preserved motor ability (for example, after a stroke, a traumatic
brain injury (TBI), or an incomplete SCI), the EksoNR exoskeleton
offers unique benefits. It helps therapists teach proper step
patterns and weight shifts, allowing patients potentially to
mobilize earlier and ultimately to walk again. By allowing
individuals to stand and walk in a full weight-bearing setting,
early clinical evidence is
beginning to show, that EksoNR may offer potential healthcare
benefits (inclusive of patients with complete SCI). These benefits
include a reduction in secondary complications such as pressure
sores, urinary tract infections, bowel problems, pneumonia and
other respiratory issues, bone loss/osteoporosis, cardiovascular
disease and psychological disorders resulting in reduced post
injury medical costs.
EksoGT
EksoGT, previously our leading rehabilitation product, has been
superseded by EksoNR. We may still sell small quantities of EksoGT
into certain foreign countries while awaiting regulatory clearance
for our EksoNR. For existing customers with one or more previously
purchased EksoGT, we offer an upgrade package.
As of December 31, 2020, we had shipped over 500 EksoGT and EksoNR
units combined to over 400 rehabilitation facilities or customers
worldwide. The number of units utilized at a facility varies from
one to six, and is driven by the number of beds and rehabilitation
sessions a hospital can offer and that hospital’s adoption of
robotics within its rehabilitation protocols.
EksoUE
In 2019, we entered the market for upper extremity rehabilitation
devices with EksoUE. EksoUE is a wearable assistive device that
helps to reduce the effect of gravity on the wearer’s shoulders and
arms. While worn, EksoUE allows longer, more intense rehabilitation
sessions by reducing fatigue, while also allowing the patient to
achieve a larger active range of motion. Similar to EksoNR, EksoUE
is a tool for use by trained clinicians, primarily physical and
occupational therapists, during rehabilitation sessions. Based on
the same technology that is used in our industrial products, EksoUE
uses a passive (non-motorized) design which avoids the need to
charge or manage batteries and other electrical
systems.
Market Overview
Rehabilitation clinics with significant stroke, TBI, and SCI
populations comprise the primary market for our medical products.
Due to their chronic nature, we believe that these conditions have
an enormous clinical and economic impact on both people with the
conditions and the healthcare system. According to the Centers for
Disease Control, there are approximately 800,000 strokes suffered
per year in the U.S. and approximately 15 million worldwide, making
stroke rehabilitation our largest target market. Likewise,
according to the National Spinal Cord Injury Statistical Center,
there are approximately 18,000 incidences of SCI per year in the
U.S., and according to the World Health Organization, between
250,000 to 500,000 incidences worldwide.
While the market opportunity for robotic exoskeleton rehabilitation
may be large, we also recognize that the path for medical devices
to become the standard of care is long and challenging. We believe
that our ability to accelerate adoption will also be based, in
part, on our ability to build on our partners’ early efforts: (i)
to expand clinical evidence and (ii) to drive toward
standard of care. We are already seeing customers appreciate that
one way for stroke patients at in-patient facilities to receive the
recommended amount of rehabilitation per guidelines is by using an
EksoNR, the only device currently in the market that has the
versatility to provide an over-ground gait training intervention
that is task-specific, high intensity and allows for a margin of
error, across the continuum of care.
Clinical Evidence
Many of our early clinical customers have participated in research
focusing on safety and feasibility of exoskeletons and robotics in
rehabilitation market development. These early studies were
favorable and have further developed to focus on efficacy and
outcomes. EksoNR technology is one of the most studied exoskeletons
in the market. World-renowned institutions are leading the charge
in research focused on acquired brain injury, stroke, spinal cord
injury, multiple sclerosis and others. EksoNR is involved in over
115 investigator-initiated studies with greater than 2000 enrolled
patient participants. Notable gains have been observed with
increased heart rate, rating of perceived exertion and metabolic
responses when walking in EksoNR. Also discussed is improved gait
speed, walking distance and standing balance out of EksoNR
demonstrating improvements in motor activity and functional
mobility independence. Our latest company sponsored WISE (Walking
Improvement for SCI with Exoskeleton) study demonstrates clinically
meaningful improvement in independent walking speed, functional
gains in shorter timeframe and influence of factors that may modify
gait recovery. The data is currently being submitted to journals
for publication.
The European Union also requires a two-track approach to market
penetration and subsequent coverage, requiring separate claims for
purchasing the device and for requests for reimbursement. We are
well represented in clinics run by German and Austrian accident
insurers, with four out of nine rehabilitation sites in Germany and
four out of four rehabilitation sites in Austria. We operate
out-patient rehabilitation sessions paid by an accident insurer,
where a patient trains using our EksoGT or EksoNR device twice a
week. We are using these examples to integrate exoskeletal therapy
in existing care pathways. In the United Kingdom, the National
Institute for Health and Care Excellence, or NICE, has selected us
as the first exoskeleton company to produce a Medtech Innovation
Briefing, or MIB, which are designed to support National Health
Services, or NHS, and social care commissioners and staff who are
considering using new medical devices and other medical or
diagnostic technologies. The MIB highlighted the innovative aspect
of our proprietary SmartAssist software, which differentiates our
EksoNR and EksoGT from other available exoskeletons.
Economic Value Proposition
We believe that our EksoNR allows our customers
to benefit economically without modifying the reimbursement model
or reimbursement codes. First, many of our customers have reported
that utilizing the EksoNR promotes continuous patient improvement
beginning sooner than with traditional rehabilitation methods,
potentially leading to a commensurate increase in insurance
reimbursements. Second, many of our customers report that
facilities equipped with EksoNR as part of their rehabilitation
programs attract more patients, thereby driving positive economic
benefits. Lastly, we believe that improvements in patient outcomes,
such as those seen with the use of EksoNR, translate positively to
other metrics including discharge to community, staffing efficiency
in the rehabilitation unit, and reductions in readmission
rates.
Current Sales and Marketing Efforts
Our key marketing goal today is the broad-based commercial adoption
of our EksoNR in the rehabilitation setting. We are focusing our
go-to-market protocols and collateral on our three target
audiences: medical administrators, medical directors/ therapists,
and patients. Working closely with thought leaders, we will
continue to build upon our early user-group exchanges, develop
clinical education programs, and grow our medical advisory
council.
There continues to be high market interest in expanding
neurosciences service lines. In alignment with this interest, our
sales priority involves the education of clinical and executive
stakeholders on the economic and clinical value of our EksoNR
Robotics Neuro Rehabilitation Program under our FDA indications of
Stroke, Acquired Brain Injury, and Spinal Cord Injury. In tandem,
we continue to leverage our EksoNR customer base to educate and
mentor strategic target centers that specialize in Stroke, ABI and
SCI rehabilitation in key market service areas across the US and
Canada. Geographically, the priorities have been Canada, the U.S.,
and Mexico in the Americas, Germany in EMEA (the Europe, the Middle
East, and Africa region), and Singapore, Hong Kong, and Australia
in APAC (the Asia Pacific region). Currently, we utilize a direct
sales force for the U.S., Canada, Singapore, Hong Kong, Germany and
Switzerland. We also have an expanding distributor network in EMEA
and Asia.
The sales and marketing team is principally based in the U.S.,
Germany, and Singapore, and is structured as follows:
•One
commercial leader each for the Americas, EMEA, and
APAC;
•Americas,
EMEA, and APAC sales professionals that pursue new prospects and
organize demonstrations;
•Clinical
professionals and physical therapists that provide peer-to-peer
demonstrations and trainings;
•Marketing
professionals and consultants to build awareness and generate
demand;
•Ambassadors,
who are stroke and SCI survivors, that provide demonstrations and
personal experiences.
The sales cycle for the EksoNR averages approximately eight to 12
months for a first device and six to eight months for subsequent
devices. Our typical sale is our EksoNR complete package, which
includes the device and all relevant components, two sets of
batteries for continuous run-time, training through two levels of
certification, and SmartAssist software. Customers also typically
purchase Ekso Care, which is our one- to four-year after-sales
service package.
Clinical Services and Customer Success
We have developed leading clinical capability in robotic
rehabilitation, and we provide extensive training and support to
our customers to ensure they are successful. All rentals or sales
include customer training. This is comprised of both on-line and
in-person training of our customers’ physical therapists. We have
made this a high priority as we recognize getting customers
comfortable using our product is a prerequisite to them
successfully implementing a robotic rehabilitation program. In
addition to the training that is included with each sale or rental,
we also offer additional training services for customers who are
interested in more advanced uses of the product or who desire more
supervised experiences.
After Sales Service
We provide direct service for the EksoNR at our facilities in
Richmond, California, and Germany.
In addition, we utilize third-party service providers for some
customers in EMEA and APAC. When maintenance or service is
required, a customer schedules service by contacting us directly.
We then arrange for the appropriate service, depending on the level
of Ekso Care the customer has purchased and the nature of the
service required. In some cases, we may decide it is appropriate to
send an Ekso field technician onsite to service the device.
However, many service issues are diagnosable remotely with the use
of EksoPulse.
In addition to the Ekso Care service programs we provide a
Fee-for-Service option. In this program, EksoNR repair is fulfilled
per quote on demand of the customer and as per our repair price
list.
Manufacturing and Supply Chain
We produce the EksoNR at our facilities in Richmond, California for
worldwide sales. We currently run one line for one shift per day
and believe we have the capacity to eventually run additional lines
and shifts should we deem it appropriate. The EksoNR uses over 700
purchased parts, which we source globally from over 70 suppliers.
Whenever possible, we seek to secure dual source suppliers for our
components.
Our commitment to the philosophy of continuous improvement has
continued to increase product performance and reliability over the
past year. As a result, we expect our cost of field service will
continue to decline over the next 12 months.
EksoWorks - Able-Bodied Industrial Applications
We continue to pursue market and product development opportunities
for the industrial market. Our initial efforts have included
EksoZeroG Arm, a mobile arm mount that makes heavy tools feel
weightless and enables workers to be more productive and safe, and
EksoVest,
an upper body exoskeleton that elevates and supports a worker's
arms to assist them with tasks ranging from chest height to
overhead.
Building on our existing EksoVest technology, in August of 2020 we
introduced EVO, an endurance-boosting assistive upper body
exoskeleton that alleviates the burden of repetitive work. EVO’s
innovative design is our latest product for able-bodied
applications. EVO is a passive, spring-loaded assistive upper-body
exoskeleton that aids workers with overhead work. It is designed to
reduce fatigue and shoulder and back muscle strain, with the goal
of eliminating work-related injuries to the neck, shoulder, and
back. EVO offers 5-15 pounds of lift assistance in each arm to
elevate and alleviate the day-to-day strain on workers across all
industries. Shoulder injuries caused by overhead work, repetitive
tasks, and overexertion is the leading cause of lost work days due
to workplace injuries. Ekso Bionics is striving to alleviate the
burden on skilled workers, drastically reducing the number of
workplace injuries and cutting down on worker fatigue.
Market feedback continues to indicate a growing imperative among
construction and manufacturing companies to drive adoption of
improved safety and health practices. Furthermore, based on initial
field-testing and market research, we believe that
industrial exoskeletons have the potential to help
prevent workforce injuries, improve productivity and over time
reduce
workers’ compensation and related costs. In the U.S. alone, our
target manufacturing and construction verticals employ a total of
18.4 million workers (according to U.S. Bureau of Labor
Statistics), many of whom can potentially benefit from our
assistive technology.
In addition, human augmentation technology is being viewed by
senior managers of companies that have participated in
field-testing as an opportunity to extend the careers of
experienced and skilled workers while also changing the work
environment to attract future workers to these
careers.
While we believe that the evidence clearly demonstrates that there
is significant demand for human augmentation in industrial
applications, adoption rates remain a challenge due to the nascent
nature of the technology. That said, we believe that there is
significant mid-to-long-term potential in the industrial markets,
and accordingly, we will continue our product development efforts
to expand our EksoWorks product offerings. Given the fragmented
nature of the industrial market we believe that the best approach
in this market involves collaboration with established strategic
partners that can help us target applications tailored for specific
use cases. We believe that leveraging our extensive exoskeleton
expertise and intellectual property portfolio with the established
channel and applying the expertise of one or more strategic
partners unlocks the highest value for us and our stockholders. We
continue to engage with multiple potential industrial partners, and
plan to continue this approach going forward.
China Joint Venture
We entered into a joint venture, or the China JV, to develop and
serve the exoskeleton market in China and certain other Asian
markets and to create a global exoskeleton manufacturing center.
The Equity Joint Venture Contract, dated January 30, 2019, between
us, Zhejiang Youchuang Venture Capital Investment Co., Ltd., and
another partner, collectively referred to as, the JV Partners, as
amended by the Amendment to the Joint Venture Contract, dated April
30, 2019, or the JV Agreement, provided for the establishment of
the China JV as a limited liability company pursuant to the Law on
Sino-foreign Equity Joint Ventures and the Regulations for the
Implementation of the Law on Sino-foreign Equity Joint Ventures. In
May 2020, the Company, and the JV Partners received notice from the
Committee on Foreign Investment in the United States, or CFIUS, in
connection with its review of the Company’s and the JV Partners’
investment in the China JV. The notice stated that CFIUS’s prior
national security concerns regarding the China JV could not be
mitigated. In connection with such determination, on July 13, 2020,
the Company and the JV Partners entered into a National Security
Agreement, or NSA, which, among other things, required the
termination of the Company’s agreements and role with the China JV.
On August 12, 2020, the Company and the JV Partners agreed to
terminate the agreements underlying the China JV. As of December
31, 2020, all agreements related to the China JV had been
terminated.
Intellectual Property
We have established an extensive intellectual property portfolio
that includes various U.S. patents and patent applications. The
table below provides a summary of U.S. patents by issuing status
and ownership status.
|
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|
|
|
|
|
|
|
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|
|
|
|
|
|
Issuing Status |
License Status |
|
Issued
Patents |
|
Pending
Applications |
Licensed to the Company |
|
15 |
|
|
— |
|
Exclusively licensed to the Company |
|
6 |
|
|
— |
|
Co-owned with Regents of the University of California, exclusively
licensed to the Company |
|
4 |
|
|
— |
|
Co-owned with the Regents of the University of
California |
|
3 |
|
|
— |
|
Sole ownership by the Company |
|
33 |
|
|
4 |
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Total: 65 |
|
61 |
|
|
4 |
|
Pending applications mean a complete application has been filed
with the applicable patent authority and additional action is
pending.
Many of these applications have also been filed internationally as
appropriate for their respective subject matter. As of December 31,
2020, 203 applications have issued or have been allowed as patents
internationally. Our patent portfolio contains 227 cases that have
issued or are in prosecution in 21 countries outside the
U.S.
Our patent portfolio includes product and method type claims, since
the devices that we produce and the processes performed by those
devices are patentable. Our patents encompass technologies relevant
to our devices, including medical exoskeletons, commercial
exoskeletons, actuators, and strength-enhancing exoskeletons. The
earliest priority date of the portfolio reaches back to 2003, and
new applications may continue to be filed from
time-to-time.
Licensors include the Regents of the University of California, or
UC Berkeley, and Garrett Brown (as a result of our acquisition of
technology of Equipois, LLC, or Equipois).
The license with UC Berkeley consists of two agreements and one
amendment to the agreement covering ten patent cases exclusively
licensed to us, nine of which have issued and one of which remains
in prosecution or the UC Berkeley License Agreements. Inventions
covered by a further three patent applications are co-owned by us
and UC Berkeley, with no license agreement between us and UC
Berkeley. As a result, UC Berkeley may license its rights in these
patents to a third party. With respect to two of these co-owned
patent applications, UC Berkeley has licensed their rights in the
U.S. to an unrelated third party. The third patent application will
need to be fully prosecuted before it can be determined which
claims are exclusive to us (through a previous license) and which
claims UC Berkeley may license to other entities.
Pursuant to the UC Berkeley License Agreements, Ekso Bionics
initially paid UC Berkeley consideration consisting of $5,000 in
cash and 310,400 common shares of Ekso Bionics, and committed to
pay a 1% royalty on sales, including sales generated by
sublicenses. In addition, the UC Berkeley License Agreements call
for minimum annual payments of $50,000. We do not pay royalties to
UC Berkeley on products sold or to be resold to the U.S.
government.
In some cases, as a result of government funding we receive, the
patents have a government use license, granting the U.S. government
a non-exclusive, non-transferable, irrevocable, paid-up license for
use of the inventions for or on behalf of the U.S. government, as
is typical in the case of government sponsored
research.
In connection with our acquisition of assets of Equipois, we
assumed the rights and obligations of Equipois under a license
agreement with Garrett Brown, the developer of certain intellectual
property related to mechanical balance and support arm
technologies, which grants us an exclusive license with respect to
the technology and patent rights for certain fields of use.
Pursuant to the terms of the license agreement, we will be required
to pay Mr. Brown a single-digit royalty on net receipts, subject to
a $50,000 annual minimum royalty requirement.
Intellectual Property Out-Licensing
We believe that the breadth of the coverage across various bionic
systems and technologies, together with our freedom to grant
sub-licenses under the UC Berkeley License Agreements gives us the
potential to generate licensing revenue in fields outside our
present areas of commercialization. Since 2009, we have generated
approximately $1.8 million in such licensing revenue from our two
licensees: Lockheed Martin Corporation or Lockheed and OttoBock
Healthcare Product GmbH or OttoBock.
We receive revenue pursuant to a Government Field Cross License
Agreement dated as of July 1, 2013 between Ekso Bionics, Inc. and
Lockheed and a Cross License Agreement dated as of July 1, 2013
between Ekso Bionics, Inc. and Lockheed. Pursuant to these
agreements, we have licensed to Lockheed certain rights with
respect to our anthropomorphic exoskeleton technology for which
Lockheed is obligated to pay us a royalty on sales of products
incorporating such technology. Royalty fees from Lockheed were
either de minimus or nil for the years ended December 31, 2020 and
2019, respectively.
With respect to OttoBock, we received exclusivity payments pursuant
to the License and Services Agreement dated October 27, 2014. The
License and Services Agreement grants OttoBock exclusive rights in
order to develop a semi-active prosthetic knee prototype for use in
medical prosthetics and provides that OttoBock will pay us a
royalty based on sales by OttoBock of products incorporating the
licensed technology. We did not receive any royalty fees from
Ottobock during the years ended December 31, 2020 and 2019,
respectively. In November of 2019, OttoBock informed us that they
will not be pursuing commercialization of products based on our
intellectual property. As a result, we do not expect additional
royalty revenue from OttoBock in the future.
In March 2018, we entered into a set of agreements with Daydo Co,
Ltd., or Daydo, related to distribution and cross-licensing of
EksoVest. Under these agreements, Daydo has exclusive distribution
rights for EksoVest within Japan and rights to modify EksoVest as
needed to address the Japanese market in exchange for royalty
payments to us. We also have rights to use any improvements made by
Daydo. Daydo released its localized version of EksoVest (called
Task AR) in January of 2019. Revenue from related royalty payments
was de minimis in 2020 and 2019.
In June 2020, we entered into a non-exclusive license agreement
with HAWE Hydraulik of Germany for rights to develop hydraulic
pumps covered by a family of our patents.
The agreement additionally includes an exclusivity option. We did
not receive any royalty revenue from this license in
2020.
Competition
The medical technology and industrial robotics industries are
characterized by intense competition and rapid technological
change. We believe that a number of other companies are developing
competitive technology and devices for both the able-bodied and
medical fields of use and many of these competitors have
significantly more financial and other resources than we
possess.
In the medical field, we face competition from companies that are
focused on technology for rehabilitation of patients suffering from
stroke and related neurological disabilities as well as from
companies that are focused on SCI. In stroke, Cyberdyne, Parker
Hannafin’s Indego, and ReWalk all now offer ambulatory exoskeletons
for rehabilitation use in various markets where we operate. While
not functionally equivalent, Hocoma, AlterG, Aretech and Reha
Technology are selling treadmill-based gait therapies. In SCI,
ReWalk Robotics and Parker Hannafin also sell ambulatory
exoskeletons. Other companies who have announced plans to
commercialize robotic exoskeletons include: Bionik Laboratories and
SuitX.
Technologies developed by competitors in the areas of stroke
rehabilitation and SCI represent therapeutic interventions with
utility at varying points of the continuum of care. Clinically, the
EksoNR is unique in its broad ability to mobilize pre- or even
non-ambulatory patients using a full weight bearing, over ground,
task-based platform. From a practice management perspective, the
EksoNR is less expensive than many other systems, has a smaller
footprint, the ability to move around the hospital, and uses
standard power requirements that make it easy to integrate into
existing infrastructure. Other over-ground exoskeletons were
initially designed for an individual to achieve ambulation reliant
on the device. By contrast, the EksoNR’s design accommodates
patients with complete paraplegia and additionally includes
features that are optimized to assist therapists in helping
patients with some motor ability learn to walk again in a clinical
setting, treating several patients and indications in a single
day.
Notwithstanding the foregoing, the most pressing challenges we face
are not necessarily competitive technologies, but rather achieving
rapid market awareness and adoption of this emerging technology
while acclimating prospects to a fundamentally new paradigm in
neuro-rehabilitation and mobility. In addition, it may be difficult
for the rehabilitation department of a hospital or clinic to secure
the funds for acquisition of an Ekso device in an environment where
capital expenditures of this magnitude are not commonly incurred by
those rehabilitation departments.
In the able-bodied field, Lockheed Martin, Raytheon, BAE Systems,
Panasonic, Honda, Daewoo, Noonee, Revision Military, SuitX,
Skel-ex, Levitate and Cyberdyne - among others - are each
developing or commercializing some form of exoskeleton for military
and/or industrial applications.
The field of robotic exoskeleton technology remains in its infancy.
As this field develops, we believe that we will face increased
competition on the basis of product features, clinical outcomes,
price, services and other factors. Our competitive position will
depend on multiple, complex factors, including our ability to
achieve market acceptance for our products, develop new products,
implement production and marketing plans, secure regulatory
approvals for products under development and protect our
intellectual property. In some instances, competitors may also
offer, or may attempt to develop, alternative therapies for disease
states that may be delivered without a medical device.
Governmental Regulation and Product Approval
U.S. Regulation
The U.S. government regulates the medical device industry through
various agencies, including but not limited to the FDA, which
administers the Federal Food, Drug and Cosmetic Act, or FDCA. The
design, testing, manufacturing, storage, labeling, distribution,
advertising, and marketing of medical devices are subject to
extensive regulation by federal, state, and local governmental
authorities in the United States, including the FDA, and by similar
agencies in other countries. Any medical device product that we
develop must receive all requisite regulatory approvals or
clearances, as the case may be, before it may be marketed in a
particular country.
Device Development, Marketing Clearance and
Approval. The
FDA classifies medical devices into one of three classes (Class I,
II or III) based on the degree of risk the FDA determines to be
associated with a device and the extent of control deemed necessary
to ensure the device’s safety and effectiveness. Devices requiring
fewer controls because they are deemed to pose
lower risk are placed in Class I or II. Class I devices are deemed
to pose the least risk and are subject only to general controls
applicable to all devices, such as requirements for device
labeling, premarket notification, and adherence to the FDA’s
current good manufacturing practice requirements, as reflected in
its Quality System Regulation, or QSR. Class II devices are
intermediate risk devices that are subject to general controls and
may also be subject to special controls such as performance
standards, product-specific guidance documents, special labeling
requirements, patient registries or post-market surveillance. Class
III devices are those for which insufficient information exists to
assure safety and effectiveness solely through general or special
controls, and include life- sustaining, life-supporting, or
implantable devices, and devices not “substantially equivalent” to
a device that is already legally marketed. Most Class I devices,
and some Class II devices are exempted by regulation from the
510(k) clearance requirement and can be marketed without prior
authorization from the FDA. Class I and Class II devices that have
not been so exempted are eligible for marketing through the 510(k)
clearance pathway. By contrast, devices placed in Class III
generally require premarket approval, or PMA, prior to commercial
marketing.
To obtain 510(k) clearance for a medical device, an applicant must
submit a premarket notification application to the FDA
demonstrating that the device is “substantially equivalent” to a
predicate device, which is typically a Class II device that is
legally marketed in the United States. A device is substantially
equivalent to a predicate device if it has the same intended use
and (i) the same technological characteristics, or (ii) has
different technological characteristics and the information
submitted demonstrates that the device is as safe and effective as
a legally marketed device and does not raise different questions of
safety or effectiveness. A showing of substantial equivalence
sometimes, but not always, requires clinical data. Generally, the
510(k) clearance process can exceed 90 days and may extend to a
year or more. After a device has received 510(k) clearance for a
specific intended use, any modification that could significantly
affect its safety or effectiveness, such as a significant change in
the design, materials, method of manufacture or intended use, will
require a new 510(k) clearance or if the device as modified is not
substantially equivalent to a legally marketed predicate device
PMA. While the determination as to whether new authorization is
needed is initially left to the manufacturer, the FDA may review
this determination and evaluate the regulatory status of the
modified product at any time and may request the manufacturer to
cease marketing and recall the modified device until 510(k)
clearance or PMA is obtained. The manufacturer may also be subject
to significant regulatory fines or penalties.
The second, more comprehensive, approval process applies to a new
device that is not substantially equivalent to a predicate device
or that is to be used in supporting or sustaining life or
preventing impairment. These devices are normally Class III devices
requiring PMA. The FDA will approve the PMA application if it finds
there is reasonable assurance that the device is safe and effective
for its intended use. The PMA process takes substantially longer
than the 510(k) process, approximately one to two years or
more.
In some instances, the FDA may find that a device is new and not
substantially equivalent to a predicate device but is also not a
high-risk device as is generally the case with Class III PMA
devices. In these instances, the FDA may allow a device to be
reclassified from Class III to Class I or II. The de novo
reclassification option is an alternate pathway to classify novel
devices of low to moderate risk that had automatically been placed
in Class III after receiving a “not substantially equivalent” (NSE)
determination in response to a 510(k) notification. The FDCA also
allows a sponsor to submit a de novo reclassification request to
the FDA for novel low to moderate risk devices without first being
required to submit a 510(k) application. These types of
applications are referred to as “Evaluation of Automatic Class III
Designation” or “de novo.” In instances where a device is deemed
not substantially equivalent to a Class II predicate device, the
candidate device may be filed as a de novo application which may
lead to delays in regulatory decisions by the FDA. FDA review of a
de novo application may lead the FDA to identify the device as
either a Class I or II device and subject to or exempt from 510(k)
premarket notification.
Clinical trials are generally required to support a PMA or de novo
reclassification application and are sometimes required for 510(k)
clearance. Clinical trials generally require an investigational
device exemption application, or IDE, approved in advance by the
FDA for a specified number of patients and study sites, unless the
product is deemed a non-significant risk device eligible for more
abbreviated IDE requirements. Clinical trials are subject to
extensive monitoring, recordkeeping and reporting requirements.
Clinical trials must be conducted under the oversight of an
institutional review board or an IRB, for the relevant clinical
trial sites and must comply with FDA regulations, including but not
limited to those relating to good clinical practices. Conducting a
clinical trial also requires obtaining the patients' informed
consent in form and substance compliant with both FDA requirements
and state and federal privacy and human subject protection
regulations. The FDA or the IRB could suspend a clinical trial at
any time for various reasons, including a belief that the risks to
study subjects outweigh the anticipated benefits. Even if a trial
is completed, the results of clinical testing may not adequately
demonstrate the safety and efficacy of the device or may otherwise
not be sufficient to obtain FDA approval to market the product in
the U.S. To date, the EksoGT has been the subject of several
clinical studies, some sponsored by us, as well as
non-Ekso-sponsored independent studies conducted by rehabilitation
institutions. In addition, we are currently conducting several
studies to investigate additional indications for use for the
EksoGT, as well as to evaluate clinical and non-clinical outcomes
of using the device.
Our current indication for use, or IFU, clearance for stroke, SCI,
and ABI.
On April 4, 2016, we received clearance from the
FDA to market our EksoGT robotic exoskeleton for use in the
treatment of individuals with hemiplegia due to stroke, individuals
with SCI at levels T4 to L5, and individuals with SCI at levels of
T3 to C7 (ASIA D), in accordance with the device’s labeling. On
July 19, 2016, we received clearance from the FDA to expand/clarify
the indications and labeling to expressly include individuals with
hemiplegia due to stroke who have upper extremity function of at
least 4 out of 5 strength in at least one arm.
On June 15, 2020, we received clearance from FDA to expand the
indications for use, or IFU, and labeling to expressly include
individuals with acquired brain injury, including traumatic brain
injury and stroke who have upper extremity function of at least 4
out of 5 strength in at least one arm.
After a device is placed on the market, numerous regulatory
requirements apply. These include:
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product listing and establishment registration, which helps
facilitate FDA inspections and other regulatory action; |
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QSR, which requires manufacturers, including third-party
manufacturers, to follow stringent design, testing, control,
documentation and other quality assurance procedures during all
aspects of the manufacturing process; |
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labeling regulations and FDA prohibitions against the promotion of
products for un-cleared, unapproved or off-label use or
indication; |
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510(k) clearance of product modifications that could significantly
affect safety or efficacy or that would constitute a major change
in intended use of one of our cleared devices; |
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medical device reporting regulations, which require that
manufacturers comply with FDA requirements to report if their
device may have caused or contributed to a death or serious injury,
or has malfunctioned in a way that would likely cause or contribute
to a death or serious injury if the malfunction of the device or a
similar device were to recur; |
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post-approval restrictions or conditions, including post-approval
study commitments; |
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post-market surveillance regulations, which apply when necessary to
protect the public health or to provide additional safety and
effectiveness data for the device; |
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the FDA's recall authority, whereby it can ask, or under certain
conditions order, device manufacturers to recall from the market a
product that is in violation of governing laws and
regulations; |
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regulations pertaining to voluntary recalls; and |
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notices provision regarding corrections or removals. |
Advertising and promotion of medical devices, in addition to being
regulated by the FDA, are also regulated by the Federal Trade
Commission and by state regulatory and enforcement authorities.
Recently, promotional activities for FDA-regulated products of
other companies have been the subject of enforcement action brought
under healthcare reimbursement laws and consumer protection
statutes. In addition, under the federal Lanham Act and similar
state laws, competitors and others can initiate litigation relating
to advertising claims. If the FDA determines that promotional or
training material related to an approved device constitute the
promotion of an un-cleared or unapproved use, the FDA could request
that the promotional or training materials related to such device
be modified or it could subject the manufacturer to regulatory or
enforcement actions. It is also possible that other federal, state
or foreign enforcement authorities might take action if they
consider our promotional or training materials to constitute
promotion of an unapproved use, which could result in significant
fines or penalties under other statutory authorities, such as laws
prohibiting false claims for reimbursement. In that event, our
reputation could be damaged and adoption of the products would be
impaired.
The FDA has broad post-market and regulatory enforcement powers. We
are subject to unannounced inspections by the FDA to determine our
compliance with the QSR and other regulations.
Since January 2020, there has been one report of an adverse event
relating to our EksoNR and none related to our EksoGT devices
reported to the FDA under the Manufacturer and User Facility Device
Experience Database.
Foreign Regulation
In addition to regulations in the U.S., we are subject to a variety
of foreign regulations governing clinical trials and commercial
sales and distribution of our products in foreign countries.
Regardless of the FDA’s approval requirements for a particular
product, we must obtain approval of a product by the comparable
regulatory authorities of foreign countries before we can commence
clinical trials or marketing of the product in those countries. The
approval process varies from country to country, and the time may
be longer or shorter than that required for FDA approval. The
requirements governing the conduct of clinical trials, product
licensing, pricing and reimbursement vary greatly from country to
country.
The policies of the FDA and foreign regulatory authorities may
change, and additional government regulations may be enacted which
could prevent or delay regulatory approval of our products and
could also increase the cost of regulatory compliance.
We
cannot predict the likelihood, nature or extent of adverse
governmental regulation that might arise from future legislative or
administrative action, either in the U.S. or abroad.
Human Capital Resources and Management
As of February 19, 2021, we had 40 employees, including 39
full time employees and one part-time employee. Seven employees
reside in Europe and two in Singapore. None of our employees are
covered by a collective bargaining agreement and we consider our
relationship with our employees to be good.
We endeavor to maintain a workplace that is free from
discrimination or harassment on the basis of color, race, sex,
national origin, ethnicity, religion, age, disability, sexual
orientation, gender identification or expression or any other
status protected by applicable law. We conduct annual training to
prevent harassment and discrimination and monitor employee conduct
year-round, including by providing employees with access to an
anonymous whistleblower hotline to report any violations. The basis
for recruitment, hiring, development, training, compensation and
advancement at the Company is qualifications, performance, skills
and experience. Our employees are fairly compensated, without
regard to gender, race and ethnicity, and routinely recognized for
outstanding performance and provided with training and professional
development opportunities. Our compensation program is designed to
attract and retain talent. We continually assess and strive to
enhance employee satisfaction and engagement. Our employees, many
of whom have been employed by us for the majority of our existence,
frequently express satisfaction with management including by
responding positively about our management in anonymous
surveys.
Corporate Information
We were incorporated as PN Med Group Inc. in Nevada on January 30,
2012. Prior to the Merger and Split-Off (each as defined below),
our business was to distribute medical supplies and equipment in
Chile.
On January 15, 2014, we consummated the Merger, in which our
wholly-owned subsidiary, Ekso Acquisition Corp., a corporation
formed in the State of Delaware on January 3, 2014, merged with and
into Ekso Bionics, Inc., a corporation incorporated in the State of
Delaware on January 19, 2005. Ekso Bionics was the surviving
corporation in the Merger and became our wholly-owned subsidiary.
All of the outstanding Ekso Bionics' capital stock was converted
into shares of our common stock in the Merger.
In connection with the Merger and pursuant to a split-off agreement
and general release, we transferred our pre-Merger assets and
liabilities to our pre-Merger majority stockholders, in exchange
for the surrender by them and cancellation of 2,497,586 shares of
our common stock, or the Split-Off, after adjusting to give effect
to the 1-for-7 reverse stock split, which occurred on May 4, 2016
and the subsequent 1-for-15 reverse stock split, which occurred on
March 24, 2020.
As a result of the Merger and Split-Off, we discontinued our
pre-Merger business and acquired the business of Ekso Bionics, and
have continued the existing business operations of Ekso Bionics as
a publicly-traded company under the name Ekso Bionics Holdings,
Inc.
Our principal executive office is located at 1414 Harbour Way
South, Suite 1201, Richmond, California, and our telephone
number is (510) 984-1761.
We make available free of charge on or through our website our
annual reports on Form 10-K, quarterly reports on Form 10-Q,
current reports on Form 8-K, and all amendments to those reports as
soon as reasonably practicable after they are electronically filed
with, or furnished to, the SEC. Our internet address is
www.eksobionics.com. This website address is intended to be an
inactive, textual reference only; none of the material on this
website is part of this Annual Report. Copies of our annual reports
on Form 10-K will be furnished without charge to any person who
submits a written request directed to the attention of our
Secretary, at our offices located at 1414 Harbour Way South,
Suite 1201, Richmond, California, 94804. The SEC maintains an
internet site (http://www.sec.gov) that contains reports, proxy and
information statements, and other information regarding issuers
that file electronically with the SEC.
Item 1A. RISK FACTORS
An investment in our securities is highly speculative and involves
a high degree of risk. We face a variety of risks that
may affect our operations or financial results and many of those
risks are driven by factors that we cannot control or
predict. Before investing in our securities, you should
carefully consider the following risks, together with the financial
and other information contained in this prospectus. If
any of the following risks actually occurs, our business,
prospects, financial condition and results of operations could be
materially adversely affected. In that case, the trading
price of our common stock would likely decline and investors may
lose all or a part of their investment.
This Annual Report contains certain statements relating to future
events or our future financial performance. Readers are cautioned
that such forward-looking statements are only predictions and
involve risks and uncertainties, and that actual events or results
may differ materially. In evaluating such statements, readers
should specifically consider the various factors identified in this
Annual Report, including the matters set forth below, which could
cause actual results to differ materially from those indicated by
such forward-looking statements.
The risks described below do not purport to be all the risks to
which we could be exposed. This section is a summary of certain
risks and is not set out in any particular order of priority. They
are the risks that we presently believe are material to our
operations. Additional risks of which we are not presently aware or
which we presently deem immaterial may also impair our business,
financial condition or results of operations.
Business and Operational Risks
The ongoing COVID-19 pandemic has adversely affected our financial
condition and there is little future certainty.
The COVID-19 pandemic has negatively impacted our business,
including our employees, suppliers, customers and other business
partners. We have seen demand for our exoskeleton products decrease
in the current business environment, as many inpatient
rehabilitation facilities temporarily shift priorities and delay
capital expenditures. Many of our customers are not able to access
their facilities, are not performing elective surgeries and are
sending patients home sooner than they otherwise would, all of
which may reduce their need for our products and impact their
decisions as to leasing or acquiring our products. It is also
harder for us to drive growth when our sales teams cannot visit
rehabilitation facilities and demonstrate our products in person
and given difficulties in presenting new data to the public and
attending professional conferences. In addition, there could be a
potential effect of a slowdown at FDA, which could result in delays
of regulatory correspondence that are necessary for us to maintain
or advance our product candidates in clinical studies.
We are also subject to other risks applicable to business operating
in the current environment. For example, our business insurance may
not provide coverage against economic loss or claims specifically
tied to COVID-19. A greater number of our employees are working
remotely, which exposes us to a greater risk of cybersecurity
breaches. The COVID-19 outbreak may also adversely impact our
ability to make requisite filings under federal securities laws on
a routine and timely basis. In addition, any deterioration in
economic conditions due to the COVID-19 pandemic or any related
market volatility may impact our ability to access the capital
markets or ability to obtain financing on favorable terms or at
all, which may affect our liquidity. The situation is constantly
evolving, however, so the extent to which the COVID-19 outbreak
will impact business and the economy is uncertain. Accordingly,
consequences stemming from the ongoing COVID-19 pandemic could have
a material adverse effect on our business, financial condition,
results of operations and cash flows.
We have a limited operating history upon which investors can
evaluate our future prospects.
Although we were incorporated in 2005, we did not sell our first
Ekso medical device until 2012 and did not sell our first
industrial unit until 2016. Therefore, we have limited operating
history upon which an evaluation of our business plan or
performance and prospects can be made. Our business and prospects
must be considered in light of the potential problems, delays,
uncertainties and complications encountered in connection with a
newly established business and creating a new industry. The risks
include, but are not limited to, the possibility that we will not
be able to develop functional and scalable products and services,
or that although functional and scalable, our products and services
will not be economical to market; that our competitors hold
proprietary rights that preclude us from marketing such products;
that our competitors market a superior or equivalent product; that
we are not able to upgrade and enhance our technologies and
products to accommodate new features and expanded service
offerings; or that we fail to receive necessary regulatory
clearances for our products. To successfully introduce and market
our products at a profit, we must establish brand name recognition
and competitive advantages for our products. There are no
assurances that we can successfully address these challenges. If we
are unsuccessful, we and our business, financial condition and
operating results could be materially and adversely affected.
The markets in which our products are sold are highly
competitive.
We face competition within the medical devices and industrial
robotics markets on the basis of product features, clinical
outcomes, price, services and other factors.
Our competitive position will depend on multiple, complex factors,
including our ability to achieve market acceptance for our
products, develop new products, implement production and marketing
plans, secure regulatory approvals for products under development
and protect our intellectual property. Competitors may offer, or
may attempt to develop, more efficacious, safer, cheaper, or more
convenient alternatives to our products, including alternatives
that could make the need for robotic exoskeletons obsolete. The
entry into the market of manufacturers located in low-cost
manufacturing locations may also create pricing pressure,
particularly in developing markets. Our future success depends,
among other things, upon our ability to compete effectively against
current technology, as well as to respond effectively to
technological advances, and upon our ability to successfully
implement our marketing strategies and execute our research and
development plan.
The market for our products is new and unproven, and susceptible to
technological change and scientific developments.
The market for medical and industrial exoskeletons is new and
unproven. We cannot be certain that the market for robotic
exoskeletons will continue to develop, or that robotic exoskeletons
for medical or industrial use will achieve market acceptance.
Additionally, the development of new or improved products,
processes or technologies by other companies may render our
products or proposed products obsolete or less competitive.
Furthermore, the use of robotic devices is not universally accepted
in the rehabilitation community. The exoskeleton market may fail to
develop, or may develop more slowly than we anticipate, or we may
be unable to respond effectively to technological changes or fail
to gain acceptance of our product in our target markets. Current or
future clinical trials and studies may not provide sufficient data
that the rehabilitation community interprets to support the use of
exoskeletons in rehabilitation, or such trials and studies may
actually prove the opposite. Any of these outcomes could materially
and adversely affect our business, financial condition and
operating results.
Coverage policies and reimbursement levels of third-party payers
may impact sales of our products.
To the extent that the adoption of our product by our customers
becomes dependent in the future on their ability to obtain adequate
reimbursement for treatments provided using our product from
third-party payers, the coverage policies and reimbursement levels
of these third-party payers may impact the decisions of healthcare
providers and facilities to purchase our products or the prices
they would be willing to pay for those products. Reimbursement
rates could also affect the acceptance rates of new technologies.
We have no control over these factors.
We will experience long and variable sales cycles.
The EksoNR has a lengthy sale and purchase order cycle because it
is a major capital expenditure item and generally requires the
approval of senior management at purchasing institutions, which may
contribute to substantial fluctuations in our quarterly operating
results.
International sales of our products are subject to factors outside
of our control.
Our business currently depends in part on our activities in the
EMEA, APAC, and other foreign markets. Our international activities
are subject to a number of risks inherent in selling and operating
abroad, including failure of local laws to provide the same degree
of protection against infringement of our intellectual property
rights; protectionist laws and business practices that favor local
competitors, which could slow our growth in international markets;
the expense of establishing facilities and operations in new
foreign markets; building an organization capable of supporting
geographically dispersed operations, challenges caused by distance,
language and cultural differences; challenges caused by differences
in legal regulations, markets, and customer preferences, which may
limit our ability to adapt our products or succeed in other
regions; multiple, conflicting, and changing laws and regulations,
including complications due to unexpected changes in regulatory
requirements, foreign laws, tax schemes, international import and
export legislation, trading and investment policies, exchange
controls and tariff and other trade barriers; foreign tax
consequences; fluctuations in currency exchange rates and foreign
currency translation adjustments; foreign exchange controls that
might prevent us from repatriating income earned outside the United
States; imposition of public sector controls; differing payer
reimbursement regimes, governmental payers or patient self-pay
systems and price controls; political, economic and social
instability; and restrictions on the export or import of
technology.
We rely on independent distributors for the sale and marketing of
our products in certain geographies.
In non-German-speaking European countries, other EMEA countries and
Central and South American countries, we rely on independent
distributors to distribute and assist us with the marketing and
sale of our products. These distributors are our principal
customers, and revenue growth will depend in large part on our
success in establishing and maintaining this sales and distribution
channel. However, there can be no assurance that our distributors
will be successful in selling our products to end users, or will
focus adequate resources on selling them, and they may not continue
to purchase or market our products for a
number of reasons.
Our business may suffer if we are not able to attract and retain
key employees.
Our success depends on our ability to identify, hire, train and
retain highly qualified managerial, technical and sales and
marketing personnel. In addition, as we introduce new products or
services, we will need to hire additional personnel. Currently,
competition for personnel with the required knowledge, skill and
experiences is intense, particularly in the San Francisco Bay area,
where we are headquartered, and we may not be able to attract,
assimilate or retain such personnel. The inability to attract and
retain the necessary managerial, technical and sales and marketing
personnel could have a material adverse effect on our business,
results of operations and financial condition.
The acquisition of other companies, businesses, or technologies
could result in operating difficulties, dilution, and other harmful
consequences.
We may selectively pursue strategic acquisitions, any of which
could be material to our business, operating results, and financial
condition. Future acquisitions could divert management’s time and
focus from operating our business. In addition, integrating an
acquired company, business or technology is risky and may result in
unforeseen operating difficulties and expenditures associated with
integrating employees from the acquired company into our
organization and integrating each company’s accounting, management
information, human resources and other administrative systems to
permit effective management. The anticipated benefits of future
acquisitions may not materialize. Future acquisitions or
dispositions could result in potentially dilutive issuances of our
equity securities, the incurrence of debt, contingent liabilities
or amortization expenses, or write-offs of goodwill, any of which
could harm our financial condition. Future acquisitions may also
require us to obtain additional financing, which may not be
available on favorable terms or at all.
Natural or other disasters could disrupt our business and result in
loss of revenue or in higher expenses.
Natural disasters, terrorist activities, military conflict and
other business disruptions could seriously harm our revenue and
financial condition and increase our costs and expenses. Our
corporate headquarters are located in California, a seismically
active region. A natural disaster in any of our major markets in
North America or Europe could have a material adverse impact on our
operations, operating results and financial condition. Further, any
unanticipated business disruption caused by Internet security
threats, damage to global communication networks or otherwise could
have a material adverse impact on our operating
results.
Financial & Accounting Risks
We have incurred significant losses to date and anticipate
continuing to incur losses in the future, and we may not achieve or
maintain profitability.
We have thus far been largely dependent on capital raised through
the sale of equity securities in various public and private
offerings, and we have incurred losses in each fiscal year since
our incorporation in 2005. Our net losses were $15.8 million and
$12.1 million for the years ended December 31, 2020 and 2019,
respectively (with losses from an increase in common stock purchase
warrant liabilities due to an increase in our stock price
accounting for a $3.1 million increase in net losses in 2020). As
of December 31, 2020 and 2019, we had an accumulated deficit of
$199.1 million and $183.3 million, respectively.
The operation of our business and our growth efforts will require
significant cash outlays and advance capital equipment expenditures
and commitments. We believe we have sufficient resources to operate
for the foreseeable future based upon our current cash resources,
the recent rate of using cash for operations and investment, and
assuming modest increases in current revenue offset by incremental
increases in expenses related to increased sales and marketing and
research and development, and a potential increase in rental
activity from our medical device business. However, unless we are
able to generate significant revenues from sales and rentals of our
products, we will not be able to achieve or maintain profitability
in the near future or at all, and we will remain largely dependent
on capital raised from past and future financings to implement our
business plan, support our operations and service our debt
obligations, which totaled $3.1 million as of January 31, 2021. Our
lack of profitability may depress our stock price, and if we are
unable become profitable, we may be required to reduce the scope of
our business development activities, which could harm our business
plans, financial condition and operating results, or to cease our
operations entirely.
Our loan agreement imposes certain financial, and operational
restrictions on us, limiting the discretion of our management in
operating our business.
Our loan agreement with Pacific Western Bank, which we entered into
in August 2020, or our PWB Loan Agreement, contains, subject to
certain carve-outs, various restrictive covenants that limit our
management's discretion in operating our business. In particular,
these instruments limit our ability to, among other things incur
additional debt, grant liens on assets, sell or
acquire
assets outside the ordinary course of business, pay dividends and
make certain fundamental business changes. Our obligations are also
secured by a security interest in all of our assets, exclusive of
intellectual property. As a result, we may need to use our capital
resources to repay the PWB Loan in order to undertake certain
financing or strategic transactions.
Management will have broad discretion as to our use of capital
resources.
As of December 31, 2020, we had $12.9 million in cash and cash
equivalents, and our recently completed public offering in February
2021 resulted in our receiving an additional $36.4 million in
estimated net proceeds. Our management will have broad discretion
in the application of these capital resources, including for
working capital and other general corporate purposes, which may
include repayment of debt, acquisitions and other business
opportunities. The amounts and timing of our use of proceeds will
vary depending on a number of factors, including the amount of cash
generated or used by our operations, and the rate of growth, if
any, of our business. In addition, while we have not entered into
any agreements, commitments or understandings relating to any
significant transaction as of the date of this Annual Report, we
may use a portion of the net proceeds to pursue acquisitions of
other businesses, products or technologies that are complementary
to our business, joint ventures and licensing arrangements, and
other strategic transactions and business opportunities. Our broad
use of these funds may not always align with the focus of our
investors, and our investors may not have the opportunity as part
of their investment decision in any such offering to assess whether
the net proceeds of such offering are being used appropriately.
Because of the number and variability of factors that will
determine our use of the net proceeds from any offering, their
ultimate use may vary from the intended use as may be stated in the
relevant prospectus related to such offering. The failure by our
management to apply these funds effectively could harm our
business. Pending their use, we may invest the net proceeds from
any offering in a variety of capital preservation investments.
These investments may not yield a favorable return to our
securityholders.
We may not be able to reduce the cost to manufacture or service our
products as planned.
Our business plan assumes that exoskeletons can be manufactured
more inexpensively than they are currently being manufactured.
However, we have not yet found a way to significantly reduce the
manufacturing cost of our products and doing so may prove more
difficult than expected or even impossible. For example, if
expectations for greater functionality of the products drive costs
up as other factors drive costs down, the result may be that the
overall cost of manufacturing the product stays the same or even
increases. Likewise, we currently provide service and support of
our products for our customers at a high standard (both in and out
of warranty), and plan on continuing to do so. Our business plan
also assumes that as we continue to improve our product, we achieve
improved levels of product reliability and decreased service cost
and frequency, which also may prove more difficult than
expected.
We may not be able to leverage our cost structure or achieve better
margins.
Due to the early stage of our commercial efforts, and particularly
the early stage of customer adoption of our products, our current
sales and marketing, research and development, and general and
administrative expenses are each a higher percentage of sales than
they will need to be for us to reach profitability. While we do
expect these expenses to grow as our business grows, we also expect
these expenses to decline as a percentage of revenues over time. If
we are unable to leverage these costs and grow revenues at a
greater pace than these operating expenses as we expect, we will
not be able to achieve viable operating margins and
profitability.
We
could fail to maintain effective internal control over our
financial reporting.
Section 404 of the Sarbanes-Oxley Act of 2002 requires us to
include in our annual reports on Form 10-K and quarterly reports on
Form 10-Q an assessment by management of the effectiveness of our
internal control over financial reporting. While we believe that
the policies, processes and procedures we have put in place will be
sufficient to render our internal controls over financial reporting
effective, our initiatives may not prove successful. If so,
management may not be able to conclude that our internal control
over financial reporting is effective. This could result in a loss
of investor confidence in the reliability of our financial
statements, which in turn could negatively affect the price of our
common stock. In addition, we must perform system and process
evaluation and testing of our internal control over financial
reporting to allow management to report on the effectiveness of our
internal control over financial reporting, as required by Section
404. Our compliance with Section 404 may require that we incur
substantial accounting expense and expend significant management
efforts.
Intellectual Property Risks
Protecting our intellectual proprietary rights can be costly, and
our success in doing so is not certain.
Our long-term success largely depends on our ability to market
technologically competitive products. Failure to protect or to
obtain, maintain or extend adequate patent and other intellectual
property rights could materially adversely impact our competitive
advantage and impair our business. Our issued patents may not be
sufficient to protect our intellectual property and our patent
applications may not result in issued patents. Even if our patent
applications issue as patents, they may not issue in a
form that will provide us with any meaningful protection, prevent
competitors from competing with us or otherwise provide us with any
competitive advantage. Our competitors may be able to circumvent
our patents by developing similar or alternative technologies or
products in a non-infringing manner or may challenge the validity
of our patents. Our attempts to prevent third parties from
circumventing our intellectual property and other rights ultimately
may be unsuccessful. We may also fail to take the required actions
or pay the necessary fees to maintain any of our patents that
issue.
Furthermore, we have not filed applications for all of our
inventions internationally and may not be able to prevent third
parties from using our proprietary technologies or may lose access
to technologies critical to our products in other countries. These
include, in some cases, countries in which we are currently selling
products and countries in which we intend to sell products in the
future.
Intellectual property litigation and infringement claims could
cause us to incur significant expenses or prevent us from selling
certain of our products.
The industries in which we operate, including, in particular, the
medical device industry, are characterized by extensive
intellectual property litigation and, from time to time, we might
be the subject of claims by third parties of potential infringement
or misappropriation. Regardless of outcome, such claims are
expensive to defend and divert the time and effort of our
management and operating personnel from other business issues. A
successful claim or claims of patent or other intellectual property
infringement against us could result in our payment of significant
monetary damages and/or royalty payments or negatively impact our
ability to sell current or future products in the affected category
and could have a material adverse effect on our business, cash
flows, financial condition or results of operations.
Because competition in our industry is intense, competitors may
infringe or otherwise violate our issued patents, patents of our
licensors or other intellectual property. To counter infringement
or unauthorized use, we may be required to file infringement
claims, which can be expensive and time-consuming. Any claims we
assert against perceived infringers could provoke these parties to
assert counterclaims against us alleging that we infringe their
patents. In addition, in a patent infringement proceeding, a court
may decide that a patent of ours is invalid or unenforceable, in
whole or in part, construe the patent’s claims narrowly, or refuse
to stop the other party from using the technology at issue on the
grounds that our patents do not cover the technology in question.
An adverse result in any litigation proceeding could put one or
more of our patents at risk of being invalidated or interpreted
narrowly. We may also elect to enter into license agreements in
order to settle patent infringement claims or to resolve disputes
prior to litigation, and any such license agreements may require us
to pay royalties and other fees that could be significant.
Furthermore, because of the substantial amount of discovery
required in connection with intellectual property litigation, there
is a risk that some of our confidential information could be
compromised by disclosure.
Some of the patents and patent applications in the intellectual
property portfolio are not within our complete control, which could
reduce the value of such patents.
Some of our U.S. patents (which have associated international
patents and applications) are co-owned by UC Berkeley. UC Berkeley
has exclusively licensed its rights under many of these patents to
us, but we do not have an exclusive license to UC Berkeley’s rights
under three of these patents.
UC Berkeley has licensed their U.S. rights in two of these three
co-owned patents to an unrelated third-party.
The third patent is a continuation-in-part of a patent that UC
Berkeley has licensed to us. Under the terms of the relevant
license agreement between us and UC Berkeley, we have exclusive
rights to any claims that are fully supported by the specification
in the parent application. However, any claims that are not based
on the specification in the parent application are co-owned by UC
Berkeley and us, and UC Berkeley’s rights in respect of such claims
are not exclusively licensed to us. There is no assurance that we
will be able to obtain a license to UC Berkeley’s rights in any
such claims on commercially reasonable terms or at all, and UC
Berkeley may choose to license its rights to third parties instead
of us.
In addition, in connection with our acquisition of certain assets
from Equipois, we assumed the rights and obligations of Equipois
with respect to certain patents and patent applications under an
in-license of intellectual property from a third-party and subject
to an out-license of that intellectual property to an unrelated
third-party for use in a particular field. We do not have complete
control over the prosecution of these patent applications. As well,
the license of intellectual property rights under these patents to
third parties could reduce the value of our patent portfolio and
limit any income or license fees that we might receive if we were
to attempt to transfer or license our rights under any of our
co-owned or licensed patents.
If we fail to comply with our obligations in the agreements under
which we license intellectual property rights from third-parties or
otherwise experience disruptions to our business relationships with
our licensors, we could lose intellectual property rights that are
important to our business.
We are a party to two exclusive license agreements and one
amendment to the license agreement with UC Berkeley, covering ten
patents exclusively licensed to us. In addition, in connection with
our acquisition of certain assets from Equipois, we
assumed the rights and obligations of Equipois with respect to
certain patents and patent applications under an in-license of
intellectual property from a third-party and subject to an
out-license of that intellectual property to an unrelated
third-party for use in a particular field. We may also need to
obtain additional licenses from others to advance our research and
development activities or allow the commercialization of our
devices or any other devices we may identify and pursue. Our
license agreements with UC Berkeley and the rights and obligations
that we assumed in connection with the Equipois acquisition impose
various development, diligence, commercialization, and other
obligations on us, and any future license agreements may impose
similar or other obligations on us. For example, under our license
agreements with UC Berkeley we are required to submit a
commercialization plan with performance milestones and progress
report to UC Berkeley, and must satisfy specified minimum annual
royalty payment obligations. In spite of our efforts, our licensors
might conclude that we have materially breached our obligations
under such license agreements and might therefore terminate the
license agreements, thereby removing or limiting our ability to
develop and commercialize products and technology covered by these
license agreements. If our license agreements with UC Berkeley are
terminated, or if our agreements granting us intellectual property
rights in connection with the Equipois acquisition or any future
agreements granting us material intellectual property rights are
terminated or impeded in a material way, competitors or other third
parties would have the freedom to seek regulatory approval of, and
to market, products that may be identical or functionally similar
to our devices and we may be required to cease our development and
commercialization of such devices. Any of the foregoing could have
a material adverse effect on our competitive position, business,
financial conditions, results of operations and
prospects.
Moreover, disputes may arise between us and our counterparties
regarding intellectual property subject to a licensing agreement,
including the scope of rights granted under the license agreement
and other interpretation-related issues; the extent to which our
devices, technology and processes infringe on intellectual property
of the licensor that is not subject to the licensing agreement; the
sublicensing of patent and other rights under our collaborative
research and development relationships; our diligence obligations
under the license agreement and what activities satisfy those
diligence obligations; the ownership of inventions and know-how
resulting from the joint creation or use of intellectual property
by our licensors and us and our partners; and the priority of
invention of patented or patentable technology. In addition,
certain provisions in our license agreement with UC Berkeley may be
susceptible to multiple interpretations. The resolution of any
contract interpretation disagreement that may arise could narrow
what we believe to be the scope of our rights to the relevant
intellectual property or technology, or increase what we believe to
be our financial or other obligations under the agreement, either
of which could have a material adverse effect on our business,
financial condition, results of operations and prospects. Moreover,
if disputes over intellectual property that we have licensed
prevent or impair our ability to maintain our current licensing
arrangements on commercially acceptable terms, we may be unable to
successfully develop and commercialize the affected devices, which
could have a material adverse effect on our business, financial
conditions, results of operations and prospects.
Patent terms may be inadequate to protect our competitive position
on our devices for an adequate amount of time.
Patents have a limited lifespan. In the United States, if all
maintenance fees are timely paid, the natural expiration of a
patent is generally 20 years from its earliest U.S. non-provisional
filing date. Various extensions may be available, but the life of a
patent, and the protection it affords, is limited. Even if patents
covering our devices are obtained, once the patent life has
expired, we may be open to competition from competitive products.
Given the amount of time required for the development, testing and
regulatory review of new devices, patents protecting such devices
might expire before or shortly after such devices are
commercialized. As a result, our owned and licensed patent
portfolio may not provide us with sufficient rights to exclude
others from commercializing products similar or identical to
ours.
Legal and Regulatory Compliance Risks
If we fail to obtain or maintain necessary regulatory clearances or
approvals for our medical device products, or if clearances or
approvals for future products or modifications to existing products
are delayed or not issued, our commercial operations would be
harmed.
Our EksoGT, EksoNR and EksoUE products are medical devices and are
regulated by the FDA, the European Union and other governmental
authorities both inside and outside of the United States. These
agencies enforce laws and regulations that govern the development,
testing, manufacturing, labeling, advertising, marketing and
distribution, and market surveillance of our medical products. Our
failure to comply with these complex laws and regulations could
have a material adverse effect on our business, results of
operations, financial condition and cash flows
In the United States, before we can market a new medical device, or
a new use of, new claim for or significant modification to an
existing product, we must first receive either clearance under
Section 510(k) of the FDCA or approval of a premarket approval or
PMA application from the FDA, unless an exemption applies. Both the
PMA and the 510(k) clearance process can be expensive, lengthy and
uncertain. The FDA’s 510(k) clearance process may take anywhere
from several months to over a year. The process of obtaining a PMA
is much more costly and uncertain than the 510(k) clearance process
and generally takes
from one to three years, or even longer, from the time the
application is filed with the FDA. In addition, PMA generally
requires the performance of one or more clinical
trials.
The FDA also has substantial discretion in the medical device
review process. Despite the time, effort and cost, we cannot assure
you that any particular device will be approved or cleared by the
FDA. Any delay or failure to obtain necessary regulatory approvals
could harm our business. Failure can occur at any stage, and we
could encounter problems that cause us to repeat or perform
additional development, standardized testing, pre-clinical studies
and clinical trials. Any delay or failure to obtain necessary
regulatory approvals could harm our business.
The FDA or other non-U.S. regulatory authorities can delay, limit
or deny clearance or approval of a medical device candidate for
many reasons, including a medical device candidate may not be
deemed to be substantially equivalent to a device lawfully marketed
either as a grandfathered device or one that was cleared through
the 510(k) premarket notification process; a medical device
candidate may not be deemed to be substantially equivalent to a
device lawfully marketed either as a grandfathered device or one
that was cleared through the 510(k) premarket notification process;
a medical device candidate may not be deemed to be in conformance
with applicable standards and regulations; FDA or other regulatory
officials may not find the data from pre-clinical studies and
clinical trials or other product testing date to be sufficient;
other non-U.S. regulatory authorities may not approve our processes
or facilities or those of any of our third-party manufacturers,
thereby restricting export; or the FDA or other non-U.S. regulatory
authorities may change clearance or approval policies or adopt new
regulations.
Even after regulatory clearance or approval has been granted, a
cleared or approved product and its manufacturer are subject to
extensive regulatory requirements relating to manufacturing,
labeling, packaging, adverse event reporting, storage, advertising
and promotion for the product. If we fail to comply with the
regulatory requirements of the FDA or other non-U.S. regulatory
authorities, or if previously unknown problems with our products or
manufacturing processes are discovered, we could be subject to
administrative or judicially imposed sanctions, including
restrictions on the products, manufacturers or manufacturing
process; adverse inspectional observations (Form 483), warning
letters, non-warning letters incorporating inspectional
observations; civil or criminal penalties or fines; injunctions;
product seizures, detentions or import bans; voluntary or mandatory
product recalls and publicity requirements; suspension or
withdrawal of regulatory clearances or approvals; total or partial
suspension of production; imposition of restrictions on operations,
including costly new manufacturing requirements; refusal to clear
or approve pending applications or premarket notifications; and
import and export restrictions.
If imposed on us, any of these sanctions could have a material
adverse effect on our reputation, business, results of operations
and financial condition.
Modifications to our EksoNR and our future products may require new
510(k) clearances or premarket approvals, or may require us to
cease marketing or recall the modified products until clearances
are obtained
On April 4, 2016, we received clearance from the FDA to market our
EksoGT robotic exoskeleton for use in the treatment of individuals
with hemiplegia due to stroke, individuals with SCI at levels T4 to
L5, and individuals with SCI at levels of T3 to C7 (ASIA D), in
accordance with the device’s labeling. On July 19, 2016, we
received clearance from the FDA to expand/clarify the indications
and labeling to expressly include individuals with hemiplegia due
to stroke who have upper extremity function of at least four-fifths
in only one arm. Our prior cleared indications for use statement
required that individuals with hemiplegia due to stroke have upper
extremity function of at least four-fifths in both
arms.
An element of our strategy is to continue to upgrade our robotic
exoskeleton platform to incorporate new software and hardware
enhancements. Any modification to a 510(k)-cleared device,
including our EksoGT, that could significantly affect its safety or
effectiveness, or that would constitute a major change in its
intended use, design, or manufacture, requires a new 510(k)
clearance or, possibly, a PMA. The FDA requires every manufacturer
to make this determination in the first instance based on the final
guidance document issued by the FDA in October 2017 addressing when
to submit a new 510(k) application due to modifications to
510(k)-cleared devices and a separate guidance document on when to
submit a new 510(k) application due to software changes to
510(k)-cleared devices. Although largely aligned with the FDA’s
longstanding guidance document issued in 1997, the 2017 guidance
includes targeted changes intended to provide additional clarity on
when a new 510(k) application is needed. The FDA may review our
determinations regarding whether new clearances or approvals are
necessary, and may not agree with our decisions. If the FDA
disagrees with our determinations for any future changes, or prior
changes to previously marketed products, as the case may be, we may
be required to cease marketing or to recall the modified products
until we obtain clearance or approval, and we may be subject to
significant regulatory fines or penalties.
We may introduce new products with enhanced features and extended
capabilities from time to time. The products may be subject to
various regulatory processes, and we may need to obtain and
maintain regulatory approvals in order to sell our new products. If
a potential purchaser of our products believes that we plan to
introduce a new product in the near future or if a potential
purchaser is located in a country where a new product that we have
introduced has not yet received regulatory approval, planned
purchases may be deferred or delayed. As a result, new product
introductions may adversely impact our financial
results.
Our
failure to meet strict post-market regulatory requirements with
respect to our products could require us to pay fines, incur other
costs or even close our facilities.
We are required to comply with the FDA’s Quality System Regulation,
or QSR, which is a complex regulatory scheme that covers the
procedures and documentation of the design, testing, production,
process controls, quality assurance, labeling, packaging, handling,
storage, distribution, installation, servicing and shipping of our
marketed products. These regulatory requirements may significantly
increase our production costs and may even prevent us from making
our products in amounts sufficient to meet market demand. If we
change our approved manufacturing process, the FDA may need to
review the process before it may be used. The FDA enforces the QSR
through periodic announced and unannounced inspections of
manufacturing facilities. Failure to comply with regulatory
requirements such as QSR may result in changes to labeling,
restrictions on such products or manufacturing processes,
withdrawal of the products from the market, voluntary or mandatory
recalls, a requirement to repair, replace or refund the cost of any
medical device we manufacture or distribute, fines, suspension of
regulatory approvals, product seizures, injunctions or the
imposition of civil or criminal penalties which would adversely
affect our business, operating results and prospects.
Federal, state and non-U.S. regulations regarding the manufacture
and sale of medical devices are subject to future changes. The
complexity, timeframes and costs associated with obtaining
marketing clearances are unknown. Although we cannot predict the
impact, if any, these changes might have on our business, the
impact could be material.
We may be subject to fines, penalties or injunctions if we are
determined to be promoting the use of our products for unapproved
or “off-label” uses.
Any cleared or approved product may be promoted only for its
indicated uses and our promotional materials must comply with FDA
and other applicable laws and regulations. We believe that the
specific use for which our products are marketed fall within the
scope of the indications for use that have been cleared by the FDA.
However, if the FDA determines that our promotional materials or
training constitutes promotion of an unapproved use, it could
request that we modify our promotional materials or subject us to
regulatory or enforcement actions, including the issuance of an
untitled letter, a warning letter, injunction, seizure, civil fine
and criminal penalties. It is also possible that other federal,
state or foreign enforcement authorities might take action if they
consider our promotional or training materials to constitute
promotion of an unapproved use, which could result in significant
fines or penalties under other statutory authorities, such as laws
prohibiting false claims for reimbursement. In that event, our
reputation could be damaged and adoption of the products would be
impaired.
We may be subject to adverse medical device reporting obligations,
voluntary corrective actions or agency enforcement
actions.
Under the FDA’s medical device reporting or MDR regulations, we are
required to report to the FDA any incident in which our product may
have caused or contributed to a death or serious injury or in which
our product malfunctioned and, if the malfunction were to recur,
would likely cause or contribute to death or serious injury. For
example, we have been informed of a limited number of events with
respect to our EksoNR or EksoGT devices that have been determined
to be reportable pursuant to the MDR regulations. In each case, the
required MDR report was filed with the FDA.
In addition, all manufacturers bringing medical devices to market
in the European Economic Area are legally bound to report any
incident that led or might have led to the death or serious
deterioration in the state of health of a patient, user or other
person, and which the manufacturer’s device is suspected to have
caused, to the competent authority in whose jurisdiction the
incident occurred. In such case, the manufacturer must file an
initial report with the relevant competent authority, which would
be followed by further evaluation or investigation of the incident
and a final report indicating whether further action is required.
The events described above that were reported to the FDA were also
reported to the relevant EU regulatory authorities.
We are also required to follow detailed recordkeeping requirements
for all Company-initiated medical device corrections and removals,
and to report such corrective and removal actions to the FDA if
they are carried out in response to a risk to health and have not
otherwise been reported under the MDR regulations. Any adverse
event involving our products could result in future voluntary
corrective actions, such as recalls or customer notifications, or
agency action, such as inspection or enforcement action. Recalls of
our products, or agency actions relating to our failure to comply
with our reporting or recordkeeping obligations, could harm our
reputation and financial results.
Failure to comply with anti-kickback and fraud regulations could
result in substantial penalties and changes in our business
operations.
Although we do not provide healthcare services, submit claims for
third-party reimbursement, or receive payments directly from
Medicare, Medicaid or other third-party payers for our products, we
are subject to healthcare fraud and abuse regulation and
enforcement by federal, state and foreign governments, which could
significantly impact our business. These laws may
constrain the business and financial arrangements and relationships
through which we conduct our operations, including how we research,
market, sell and distribute any product for which we have obtained
regulatory approval, or for which we obtain regulatory approval in
the future. The principal U.S. federal laws implicated include, but
are not limited to, those that prohibit, among other things, (i)
filing, or causing to be filed, false or improper claims for
federal payment, known as the false claims laws, (ii) payment,
solicitation or receipt of unlawful inducements, directly or
indirectly, for the referral of business reimbursable under
federally-funded health care programs, known as the anti-kickback
laws, and (iii) health care service providers from seeking
reimbursement for providing certain services to a patient who was
referred by a physician who has certain types of direct or indirect
financial relationships with the service provider, known as the
Stark law. Many states have similar laws that apply to
reimbursement by state Medicaid and other government funded
programs as well as in some cases to all payers. In addition, we
may be subject to federal and state data privacy laws that govern
the privacy and security of health information in specified
circumstances, many of which differ from each other in significant
ways and may not have the same effect, thus complicating compliance
efforts.
Efforts to ensure that our business arrangements will comply with
applicable healthcare laws and regulations will involve substantial
costs. We are subject to the risk that a person or government could
allege we have engaged in fraud or other misconduct, even if none
occurred. It is possible that governmental and enforcement
authorities will conclude that our business practices do not comply
with current or future statutes, regulations or case law
interpreting applicable fraud and abuse or other healthcare laws
and regulations. If our operations are found to be in violation of
any of the laws described above or any other governmental
regulations that apply to us now or in the future, we may be
subject to penalties, including civil and criminal penalties,
damages, fines, disgorgement, exclusion from governmental health
care programs, additional integrity oversight and reporting
obligations, contractual damages, reputational harm and the
curtailment or restructuring of our operations, any of which could
adversely affect our ability to operate our business and our
financial results.
Changes in law or regulation could make it more difficult and
costly for us to manufacture, market and distribute our products or
obtain or maintain regulatory approval of new or modified
products.
From time to time, legislation is drafted and introduced in
Congress that could significantly change the statutory provisions
governing the regulatory approval, manufacture and marketing of
regulated devices. In addition, FDA regulations and guidance are
often revised or reinterpreted by the FDA in ways that may
significantly affect our business and our products. Any new
regulations or revisions or reinterpretations of existing
regulations may impose additional costs or lengthen review times of
future products. In addition, FDA regulations and guidance are
often revised or reinterpreted by the agency in ways that may
significantly affect our business and our products. Elections could
result in significant changes in, and uncertainty with respect to,
legislation, regulation and government policy that could
significantly impact our business and the health care industry. It
is impossible to predict whether legislative changes will be
enacted or FDA regulations, guidance or interpretations changed,
and what the impact of such changes, if any, may be.
Any change in the laws or regulations that govern the clearance and
approval processes relating to our current and future products
could make it more difficult and costly to obtain clearance or
approval for new products, or to produce, market, and distribute
existing products. Significant delays in receiving clearance or
approval, or the failure to receive clearance or approval, for any
new products would have an adverse effect on our ability to expand
our business.
Healthcare changes in the U.S. and other countries, including
recently enacted legislation reforming the U.S. healthcare system,
could have a negative impact on our future operating
results.
In the United States and some foreign jurisdictions, there have
been a number of legislative and regulatory proposals to change the
health care system in ways that could affect our ability to sell
our products profitably. For example, in 2010, the Patient
Protection and Affordable Care Act, or ACA, was enacted into law.
The legislation seeks to reform the United States healthcare
system. It is far-reaching and is intended to expand access to
health insurance coverage, improve quality and reduce costs over
time. We expect the law will have a significant impact upon various
aspects of our business operations. The ACA reduces Medicare and
Medicaid payments to hospitals, clinical laboratories and
pharmaceutical companies, and could otherwise reduce the volume of
medical procedures. These factors, in turn, could result in reduced
demand for our products and increased downward pricing pressure. It
is also possible that the ACA will result in lower reimbursements.
While the ACA is intended to expand health insurance coverage to
uninsured persons in the United States, the impact of any overall
increase in access to healthcare on sales of our products remains
uncertain. The current U.S. Presidential administration and the
majority party in both Houses of U.S. Congress have indicated their
desire to repeal all or certain provisions of the ACA. It is
unclear whether, when and how that repeal could be effectuated and
what the effect on the healthcare sector might be. A number of
lawsuits have been filed challenging various aspects of the ACA and
related regulations. In addition, the efficacy of the ACA is the
subject of much debate among members of Congress and the public. On
December 14, 2018, the U.S. District Court for the Northern
District of Texas held the individual mandate provisions, and
therefore the entirety of ACA, unconstitutional. The impact of the
ruling is stayed as it is appealed to the Fifth Circuit Court of
Appeals. Our business may be materially and adversely
impacted
in the event that the ACA in part, or in its entirety, is ruled
unconstitutional. Furthermore, the uncertainty regarding the
constitutionality of the ACA, or specific provisions therein, may
negatively affect our business.
In December 2017, the Tax Cuts and Jobs Act was enacted and signed
into law, one part of which repeals the “individual mandate”
introduced by the ACA starting in 2019. The repeal of the
“individual mandate” may have an adverse effect on ACA insurance
markets and lead to further legislative changes. In addition, the
new law imposes a 2.3% excise tax on medical devices that will
apply to U.S. sales of our medical device products. In January
2018, President Trump signed into law a spending package that
included a two-year moratorium on the medical device excise tax,
which lapsed on December 31, 2019. This tax has had, and may
continue to have, a negative impact on our gross margin. There have
been other changes to the ACA since the enactment of the Tax Cuts
and Jobs Act, and Congress could still consider additional
legislation to repeal or replace all or certain elements of the
ACA. In addition, other reform legislation has been passed
subsequent to the enactment of the ACA, including measures that
reduced reimbursement for certain providers and entities under
federal health care programs. The outlook for the healthcare sector
is unclear, and we are unable to predict the future course of
federal or state healthcare legislation and regulations. Changes in
the law or regulatory framework that reduce our revenues or
increase our costs could also harm our business, financial
condition and results of operations and cash flows.
Future elections in the United States could result in significant
changes in, and uncertainty with respect to, legislation,
regulation, implementation of Medicare and/or Medicaid, and
government policy that could significantly impact our business and
the healthcare industry. In the event that legal challenges are
successful, or the ACA, is repealed or materially amended,
particularly any elements of the ACA that are beneficial to our
business or that cause changes in the health insurance industry,
including reimbursement and coverage by private payers or, Medicare
or Medicaid payers, our business, operating results and financial
condition could be harmed. While it is not possible to predict
whether and when any such changes may occur, certain proposals,
including a repeal or material amendment of the ACA, could harm our
business, operating results and financial condition. In addition,
even if the ACA is not amended or repealed, the President and the
executive branch of the federal government have a significant
impact on the implementation of the provisions of the ACA, and the
current or future administrations could make changes impacting the
implementation and enforcement of the ACA, which could harm our
business, operating results and financial
condition. If we are slow or unable to adapt to any such changes,
our business, operating results and financial condition could be
adversely affected.
Product Liability Risks
Our products may become subject to voluntary or involuntary
recall.
The FDA and similar foreign governmental authorities have the
authority to require the recall of commercialized products in the
event of material deficiencies or defects in design or manufacture
or in the event that a product poses an unacceptable risk to
health. In addition, manufacturers may, under their own initiative,
recall a product if any material deficiency in a device is found. A
government-mandated or voluntary recall by us could occur as a
result of an unacceptable risk to health, component failures,
manufacturing errors, design or labeling defects or other
deficiencies and issues. To date, we have initiated only one field
action in which we voluntarily accelerated our maintenance schedule
based on field usage.
When a medical human exoskeleton is used by a paralyzed individual
to walk, the individual relies completely on the exoskeleton to
hold them upright. There are many exoskeleton components that, if
they were to fail catastrophically, could cause a fall resulting in
severe injury or death of the patient. Certain of our competitors
have reported injuries caused by the malfunction of human
exoskeleton devices (in at least one case to the FDA). Injuries
caused by the malfunction or misuse of human exoskeleton devices,
even where such malfunction or misuse occurs with respect to one of
our competitor’s products, could cause regulatory agencies to
implement more conservative regulations on the medical human
exoskeleton industry, which could significantly increase our
operating costs.
Similarly, when an industrial exoskeleton is used by a healthy
individual - for example to operate heavy machinery overhead -
malfunction of the device at an inopportune moment could result in
severe injury or death of the person using the device. Such
occurrences could result in regulatory action on the part of OSHA
or its foreign counterparts.
Any future recalls of any of our products could divert managerial
and financial resources, impair our ability to manufacture our
products in a cost-effective and timely manner, and have an adverse
effect on our reputation, results of operations and financial
condition. In some circumstances, such adverse events could also
cause delays in new product approvals. We may also be required to
bear other costs or take other actions that may have a negative
impact on our future sales and our ability to generate
profits.
In addition, personal injuries relating to the use of our products
could also result in product liability claims being brought against
us. Any product liability claim brought against us, with or without
merit, could result in substantial damages, be costly and
time-consuming to defend and could increase our insurance rates or
prevent us from securing insurance coverage in the
future.
Our
product liability insurance may not adequately cover potential
claims or recalls.
The testing, manufacture, marketing and sale of medical devices and
industrial products entail the inherent risk of liability claims or
product recalls. Although we maintain product liability insurance,
the coverage is subject to deductibles and limitations, and may not
be adequate to cover future claims. A successful product liability
claim or product recall could inhibit or prevent the successful
commercialization of our products, cause a significant financial
burden on us, or both, which in either case could have a material
adverse effect on our business and financial condition.
Warranty claims and our accelerated maintenance program results in
additional operating costs to us.
Sales of our EksoNR and EksoGT generally include a one-year
warranty for parts and services in the U.S. and a two-year warranty
in Europe, the Middle East and Africa. We also generally provide
customers with an option to purchase an extended warranty for up to
an additional three years. The costs associated with such
warranties, including any warranty-related legal proceedings, could
have a material adverse effect on our results of operations, cash
flows and liquidity. As we enhance our product and in an effort to
build our brand and drive adoption, we have elected to incur
increased service expenses related to an accelerated maintenance
program, field corrections and the implementation of technological
improvements developed subsequent to many of our units being placed
into service, sometimes outside of its warranty and contractual
obligations. Continuation of these activities could have a material
adverse effect on our results of operations, cash flows and
liquidity.
Risks Related to Ownership of Common Stock
You may be diluted from future issuances of our equity securities,
including from compensatory equity awards, exercise of outstanding
warrants, or issuances of securities in financing or strategic
transactions, and such issuances, or perception that such issuances
may occur, could depress the market price of our common
stock.
Future operating or business decisions may cause dilution to our
stockholders. For example, we may sell equity securities or issue
securities exercisable or convertible into shares of our common
stock in connection with strategic transactions or for financing
purposes, including under an At The Market Offering Agreement we
entered into in October 2020 with H.C. Wainwright & Co., LLC or
our “shelf” registration statement on Form S-3 (File No.
333-239203) which was declared effective by the SEC on June 26,
2020. While in 2020, we sold no shares of common stock under our
“at the market offering” program, but from year-end to
February 25, 2021, we sold $0.8 million of common stock under
the program, leaving $6.7 million available for future offerings
under our current prospectus for the offering. After giving effect
to our public offering in February 2021, registered warrant
transactions and potential sales under our prospectus for the “at
the market offering” program, approximately $16.7 million of
registered securities are available for issuance under our shelf
registration statement.
We have also registered all of the shares of common stock that we
may issue pursuant to the exercise of 0.5 million stock options and
settlement of 0.1 million restricted stock units outstanding as of
December 31, 2020 and granted under our Amended and Restated 2014
Incentive Plan (the “Incentive Plan”), the 1.1 million shares
reserved for future issuance under the Incentive Plan, and all of
the 0.5 million shares of common stock that we may issue in the
future under our Employee Stock Purchase Plan. You may also be
subject to dilution from the exercise or settlement of outstanding
options or restricted stock units under the Incentive Plan, and
from the exercise of warrants, with respect to which as of
February 25, 2021, 1.0 million were exercisable at a weighted
average exercise price of $6.63 per share. In addition, sales or
issuances of a substantial number of shares of our common stock, or
other equity-related securities in the public markets, or the
perception that such sales or issuances could occur, could depress
the market price of our common stock.
The ability of our Board of Directors to issue additional stock may
prevent us from making more difficult transactions, including a
sale or merger.
Our Board of Directors is authorized to issue up to 10 million
shares of preferred stock with powers, rights and preferences
designated by it. Shares of voting or convertible preferred stock
could be issued, or rights to purchase such shares could be issued,
to create voting impediments or to frustrate persons seeking to
effect a takeover or otherwise gain control of us. The ability of
the Board of Directors to issue such additional shares of preferred
stock, with rights and preferences it deems advisable, could
discourage an attempt by a party to acquire control of us by tender
offer or other means. Such issuances could therefore deprive
stockholders of benefits that could result from such an attempt,
such as the realization of a premium over the market price for
their shares in a tender offer or the temporary increase in market
price that such an attempt could cause. Moreover, the issuance of
such additional shares of preferred stock to persons friendly to
the Board of Directors could make it more difficult to remove
incumbent officers and directors from office even if such change
were to be favorable to stockholders generally.
We have never paid and do not intend to pay cash
dividends.
Cash dividends have never been declared or paid on our common
stock, and we do not anticipate such a declaration or payment for
the foreseeable future. We expect to use future earnings, if any,
to fund business growth. Therefore, stockholders will not receive
any funds absent a sale of their shares of common stock. If we do
not pay dividends, our common stock may be less valuable because a
return on investment will only occur if our stock price
appreciates
The market price of our common stock has been, and may continue to
be, highly volatile.
During the period from our initial listing on Nasdaq on August 9,
2016 through December 31, 2020, the closing price of our common
stock fluctuated from a high of $93.15 per share to a low of $2.54
per share (on a split-adjusted basis), and our stock price
continues to fluctuate. The market price of our common stock may
continue to fluctuate significantly in response to numerous
factors, some of which are beyond our control, such as our ability
to grow our revenue and customer base; the announcement of new
products or product enhancements by us or our competitors;
developments concerning regulatory oversight and approvals;
variations in our and our competitors’ results of operations;
changes in earnings estimates or recommendations by securities
analysts, if our common stock is covered by analysts; successes or
challenges in our collaborative arrangements or alternative funding
sources; developments in the rehabilitation and industrial robotics
markets; the results of product liability or intellectual property
lawsuits; future issuances of common stock or other securities; the
addition or departure of key personnel; announcements by us or our
competitors of acquisitions, investments or strategic alliances;
and general market conditions and other factors, including factors
unrelated to our operating performance.
Trading of our common stock is limited, which may affect our stock
price.
Trading of our common stock is currently conducted on Nasdaq. The
liquidity of our common stock is limited, not only in terms of the
number of shares that can be bought and sold at a given price, but
also as it may be adversely affected by delays in the timing of
transactions and low coverage by research analysts’ the media, if
at all. These factors may result in different prices for our common
stock than might otherwise be obtained in a more liquid market and
could also result in a larger spread between the bid and asked
prices for our common stock. In addition, without a large public
float, our common stock is less liquid than the stock of companies
with broader public ownership, and, as a result, the trading prices
of our common stock may be more volatile. In the absence of an
active public trading market, an investor may be unable to
liquidate his or her investment in our common stock. Trading of a
relatively small volume of our common stock may have a greater
impact on the trading price of our stock than would be the case if
our public float were larger. Additionally, sales by stockholders
of substantial amounts of our shares of common stock, the issuance
of new shares of common stock by us or the perception that these
sales may occur in the future could materially and adversely affect
the market price of our common stock, and you may lose all or a
portion of your investment in our common stock.
Item 1B. UNRESOLVED STAFF
COMMENTS
None.
Item 2. PROPERTIES
Our principal executive offices are currently located at 1414
Harbour Way South, Suite 1201, Richmond, CA 94804, where we leased
approximately 45,000 square feet. The Richmond office serves as
headquarters for our medical device and industrial device sales
segments. In addition, we lease approximately 1,400 square feet of
office space at Friesenweg 4, House 13, 4th floor, 22763 Hamburg,
Germany for our European headquarters.
We do not own any real property.
Item 3. LEGAL PROCEEDINGS
From time to time we may be involved in litigation that we believe
is of the type common to companies engaged in our line of business,
including intellectual property and employment issues. While the
outcome of these other claims cannot be predicted with certainty,
we do not believe that the outcome of any of these other legal
matters will have a material adverse effect on our results of
operations, financial condition or cash flows.
Item 4. MINE SAFETY
DISCLOSURES
Not applicable.
PART II
Item 5. MARKET FOR REGISTRANT'S COMMON
EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY
SECURITIES
Market Information and Dividend Policy
Our common stock has been traded on the Nasdaq Capital Market under
the symbol “EKSO” since August 9, 2016. Prior to August 9, 2016,
our common stock was eligible for quotation and traded on the OTC
Market. The quotation of our common stock on the OTC market began
on or about January 16, 2014. The closing price of EKSO stock as of
February 19, 2021 was $9.22.
As of February 19, 2021, we had approximately 185 stockholders
of record of our common stock. This number does not include
stockholders whose shares are held in investment accounts by other
entities. We believe that the actual number of stockholders is
greater than the number of holders of record.
We have never declared or paid cash dividends on our common stock
and do not intend to pay cash dividends in the foreseeable future.
Payment of future dividends, if any, will be at the discretion of
our board of directors after taking into account various factors,
including our financial condition, operating results, restrictions
imposed by financing arrangements, if any, legal and regulatory
restrictions on the payment of dividends, current and anticipated
cash needs and other factors the board of directors deems
relevant.
Securities Authorized for Issuance Under Equity Compensation
Plans
See Item 12, “Security Ownership of Certain Beneficial Owners
and Management and Related Stockholder Matters” of this Annual
Report on Form 10-K for information regarding securities authorized
for issuance under equity compensation plans.
Item 6. SELECTED
FINANCIAL DATA
Not applicable.
Item 7. MANAGEMENT'S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following discussion contains forward-looking statements.
Actual results may differ significantly from those projected in the
forward-looking statements. Factors that might cause future results
to differ materially from those projected in the forward-looking
statements include, but are not limited to, those discussed in
"Risk Factors" and elsewhere in this Annual Report. See also
"Cautionary Note Regarding Forward-Looking
Statements."
On March 24, 2020, we effected a one-for-fifteen reverse stock
split, or the Reverse Stock Split, reducing the number of our
common shares outstanding on that date from 87.4 million shares to
approximately 5.8 million shares. Additionally, the exercise price
and number of all outstanding options and warrants, and the number
of shares reserved for future issuance pursuant to our equity
compensation plan were all adjusted proportionately. All such
amounts presented herein have been adjusted retroactively to
reflect these changes. The number of the Company’s authorized
shares were not proportionately reduced in the Reverse Stock Split
and remain at 141,428,571 shares.
Overview
The following discussion highlights the results of our operations
and the principal factors that have affected our financial
condition as well as our liquidity and capital resources for the
periods described, and provides information that management
believes is relevant for an assessment and understanding of our
financial condition and results of operations presented herein. The
following discussion and analysis is based on our audited
consolidated financial statements contained in this Annual Report
on Form 10-K, which have been prepared in accordance with generally
accepted accounting principles in the United States. You should
read the discussion and analysis together with such financial
statements and the related notes thereto.
COVID-19
In March 2020, the World Health Organization declared the COVID-19
outbreak to be a global pandemic. In response to this pandemic,
public health officials and governments across the world have
recommended and mandated actions to curb the spread of the
SARS-COV-2 virus, the pathogen that causes COVID-19. The COVID-19
pandemic and the related responses to the pandemic have caused a
significant adverse impact on the global economy, including
disruptions to supply chains, sharp increases in unemployment and
overall economic uncertainty.
This pandemic has negatively impacted our business, including our
employees, suppliers, customers and other business partners,
resulting in our terminating 23 employees in 2020. We have seen
demand for our exoskeleton products decrease in the current
business environment, as many inpatient rehabilitation facilities
temporarily shift priorities and delay capital expenditures,
resulting in 61 units booked (non-cancellable customer orders) in
2020 compared to 98 in 2019, a decrease of 38%. We have seen that
the clinical need has not diminished as more data is coming out
about the increase prevalence of strokes during this pandemic. As
such, we continue to engage with our current and prospective
customers through video conferencing, virtual training events and
online education demos to offer our support and showcase the value
of our Ekso devices. Although market uncertainties related to the
pandemic make it difficult for us to project the full impact on our
business and customers, we believe that we are well-positioned to
serve our customers when business conditions begin to
normalize.
We continue to instruct the majority of our employees to work from
home, restrict non-critical business travel and have enhanced the
use of personal protective equipment in our
facilities.
We are hopeful that COVID cases and hospitalizations will continue
to decrease, and now that our clinical team is fully vaccinated and
are active onsite at rehab centers, we expect to see an uptick in
live in-person interactions going forward. In fact, we are now
close to the number of onsite demos in the first quarter of 2021
compared to the previous three quarters combined. While we are
cautiously optimistic about the current COVID outlook, the
successful completion of our first virtual training sessions leave
us well-positioned to address existing pipeline opportunities,
mitigating the effects of future COVID-related lock downs or travel
restrictions.
Management continues to actively monitor the global situation and
its effects on our financial position and operations.
Business
We design, develop, sell, and rent exoskeleton products that
augment human strength, endurance and mobility. Our exoskeleton
technology serves multiple markets and can be utilized both by
able-bodied persons and persons with physical disabilities. We have
sold or leased devices that (i) enable individuals with
neurological conditions affecting gait (acquired brain injury and
spinal cord injury) to rehabilitate, and in some cases, to walk
again, (ii) assist individuals with a broad range of upper
extremity impairments, and (iii) allow industrial workers to
perform difficult repetitive work for extended
periods.
We believe that the commercial opportunity for exoskeleton
technology adoption is accelerating as a result of recent
advancements in material technologies, electronic and electrical
engineering, control technologies, and sensor and software
development. Taken individually, many of these advancements have
become ubiquitous in peoples’ everyday lives. We believe that we
have learned how to integrate these existing technologies and wrap
the result around a human being efficiently, elegantly and safely,
supported by an industry leading intellectual property portfolio.
We further believe that we can do so across a broad spectrum of
applications, from persons with lower limb paralysis to able-bodied
users.
EksoHealth
EksoHealth is our business unit focused on developing, marketing,
and selling exoskeletons for medical applications. Our leading
product in EksoHealth, the EksoNR, is a robotic exoskeleton used to
provide physical therapy for patients with lower extremity
impairment. EksoNR, which in 2019 superseded our EksoGT product in
this segment, includes unique features designed specifically to
assist physical therapists and other clinicians to teach patients
to walk again after suffering a neurological impairment. Typical
conditions that can be treated with the assistance of EksoNR
include acquired brain injuries, such as stroke and traumatic brain
injuries, as well as spinal cord injuries and others. The benefits
of using EksoNR for rehabilitation can include earlier mobilization
of patients, longer and more intense rehab sessions, and better
quality of sessions compared to alternative therapies. The product
is most typically used in a clinical setting, with the most common
among those being inpatient rehab facilities and stroke
centers.
EksoUE is a wearable upper body exoskeleton that is also used as a
tool during rehabilitation. EksoUE is designed to assists patients
with a broad range of upper extremity impairments and aims to
provide them with a wider active range of motion and increased
endurance for rehabilitation sessions of higher
intensity.
EksoWorks
EksoWorks is our business unit focused on developing, marketing,
and selling exoskeletons and other assistive tools for industrial
applications. The target users for these devices are generally
able-bodied, and as such the goal of these products is to reduce
fatigue for workers. The benefits of fatigue reduction can include
reduced rates of injuries, higher productivity, higher worker
morale, and lower turnover. Currently, we sell these products
primarily directly to companies that deploy them for use in their
operations.
Within EksoWorks we have two main categories of products. Our
wearable exoskeleton products include EksoVest and the new EVO,
both of which support the weight of a worker’s arms and tools,
reducing the fatigue associated with working at or above shoulder
height for extended periods. These products are currently targeted
at end markets in Manufacturing, Aerospace, Construction, and Food
Processing.
EksoZeroG is a tool holder that can mount on aerial lift platform
or scaffolding. This effectively reduces the weight of heavy tools
as felt by the operator. EksoZeroG has been sold primarily through
rental companies into the construction market.
Operational Highlights
•In
2020, we booked a total of 61 EksoGT and EksoNR units, 19 of which
were subscription units and 9 of which were previously rented units
that were converted to sales.
•We
recorded annual gross margins of approximately 57% in 2020,
compared to 49% in 2019.
•In
February 2020, we announced the worldwide launch of our upgraded
EksoPulse platform, an innovative cloud-based information
technology platform that measures and analyzes progress using the
EksoNR robotic exoskeleton. The improved analytics system provides
an easy-to-use dashboard to chart activity in rehabilitation
sessions, enhancing the clinician, institutional, and patient
experience of the most clinically used
exoskeleton.
•In
June 2020, we received FDA clearance to market our EksoNR robotic
exoskeleton for use with acquired brain injury
patients
•Also
in June 2020, we were named “Best Healthcare Robotics Company” in
2020 MedTech Breakthrough Awards Program
•In
August 2020, we launched EVO, an endurance-boosting assistive upper
body exoskeleton designed for industrial use.
2020 Financing Activities
•In
April 2020, we received proceeds of a $1.1 million unsecured loan
under the Paycheck Protection Program, or the PPP.
•In
June 2020, we sold 1,747,704 shares of our common stock
and warrants to purchase up to 873,852 shares of our
common stock, or June 2020 Investor Warrants, at a combined public
offering price of $4.51 per share for proceeds, net
of expenses and underwriting discount and commission, of
$7.1 million.
•In
August 2020, we paid off the entire amount of $1.5 million of the
Company's indebtedness to Western Alliance Bank with proceeds from
a new loan of $2.0 million from Pacific Western Bank. The terms of
the new loan agreement include monthly interest-only payments over
the next three years.
•During
the year ended December 31, 2020, we received $3.3 million in
proceeds from the exercise of 723,426 warrants.
•Subsequent
to year end, we received estimated net proceeds of $36.4 million
from an underwritten public offering, $1.4 million from
warrant exercises, and $0.7 million from sales under our "at the
market offering" program. Refer to Note. 18 in the notes to our
consolidated financial statements under the caption Subsequent
Events.
Critical Accounting Policies, Estimates, and Judgments
Our consolidated financial statements are prepared in accordance
with accounting principles generally accepted in the United States.
The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets
and liabilities, disclosure of contingent liabilities at the date
of the financial statements, and the reported amounts of revenues
and expenses during the reporting period. We continually evaluate
our estimates and judgments. We base our estimates and judgments on
historical experience and other factors that we believe to be
reasonable under the circumstances. Materially different results
can occur as circumstances change and additional information
becomes known. Besides the estimates identified below that are
considered critical, we make many other accounting estimates in
preparing our financial statements and related disclosures. All
estimates, whether or not deemed critical, affect reported amounts
of assets, liabilities, revenues and expenses, as well as
disclosures of contingent liabilities. These estimates and
judgments are also based on historical experience and other factors
that are believed to be reasonable under the circumstances.
Materially different results can occur as circumstances change and
additional information becomes known, even for estimates and
judgments that are not deemed critical.
Revenue Recognition
Revenue is recognized upon transfer of control of promised products
or services to customers in an amount that reflects the
consideration we expect to receive in exchange for those products
or services. We enter into contracts that can include various
combinations of products and services, which when capable of being
distinct, are accounted for as separate performance
obligations.
Our EksoHealth segment revenue is primarily generated through the
sale and rental of our EksoNR and associated software (SmartAssist
and VariableAssist), EksoUE, sale of accessories, and support and
maintenance contracts (Ekso Care). Revenue from EksoHealth sales is
recognized at the point in time when control of the product
transfers to the customer. Transfer of control generally occurs
upon shipment from our facility for sales of our EksoNR, software,
and accessories. Ekso Care support and maintenance contracts extend
coverage beyond our standard warranty agreements. The separately
priced Ekso Care contracts range from 12 to 48
months. We receive payment at the inception of the contract and
recognize revenue over the term of the agreement. Revenue from
medical device rentals is recognized over the lease term, typically
over 12 months.
Our EksoWorks segment revenue is generated by the sales of our
EksoVest, EksoZeroG and EVO. Revenue from EksoWorks device sales is
recognized at the point in time when control of the product
transfers to the customer. Transfer of control generally occurs
upon shipment from our facility.
Inventory valuation
Inventories are recorded at the lower of cost or net realizable
value. Cost is computed using standard cost, which approximates
actual cost on a first-in, first-out basis. Materials from vendors
are received and recorded as raw material. Once the raw materials
are incorporated in the fabrication of the product, the related
value of the component is recorded as work in progress, or WIP.
Direct and indirect labor and applicable overhead costs are also
allocated and recorded to WIP inventory. Finished goods are
comprised of completed products that are ready for customer
shipment. We periodically evaluate the carrying value of inventory
on hand for potential excess amounts over sales and forecasted
demand. Excess and obsolete inventories identified, if any, are
recorded as an inventory impairment charge to the consolidated
statements of operations and comprehensive loss. Our estimate of
write-downs for excess and obsolete inventory is based on a
detailed analysis of on-hand inventory and purchase commitments in
excess of forecasted demand. Subsequent disposals of
inventories are recorded as a reduction of an inventory
reserve.
Stock-based Compensation
We measure stock-based compensation expense for certain stock-based
awards made to employees and directors based on the estimated fair
value of the award on the date of grant using the Black-Scholes
option-pricing model, or the Black-Scholes Model, and
recognize the fair value on a straight-line basis over the
requisite service periods of the awards.
Our determination of the fair value of stock options on the date of
grant using the Black-Scholes Model is affected by our stock price
as well as assumptions regarding a number of highly complex and
subjective variables. These variables include, but are not limited
to, our expected stock price volatility over the term of the
awards, and actual and projected employee stock option exercise
behaviors. We adopted the simplified method of estimating the
expected term pursuant to SEC Staff Accounting Bulletin Topic 14.
On this basis, we estimate the expected term of options granted by
taking the average of the vesting term and the contractual term of
the option.
We have, from time to time, modified the terms of stock options
granted to our employees. We account for the incremental increase
in the fair value over the original award on the date of the
modification as an expense for vested awards or over the remaining
service (vesting) period for unvested awards. The incremental
compensation cost is the excess of the fair value based measure of
the modified award on the date of modification over the fair value
of the original award immediately before the
modification.
Warrant Valuation
We generally account for warrants issued in connection with debt
and equity financings as a component of equity, unless the warrants
include a conditional obligation to issue a variable number of
shares or there is a deemed possibility that we may need to settle
the warrants in cash.
Where there is a possibility that we may have to settle warrants in
cash, we estimate the fair value of the issued warrants as a
liability at each reporting date and record changes in the
estimated fair value as a non-cash gain or loss in the consolidated
statements of operations and comprehensive loss. The fair values of
these warrants have been determined using the Black-Scholes
option-pricing model (the “Black-Scholes Model”) and the Binomial
Lattice model (the “Lattice Model”). The Black-Scholes Model
requires inputs, such as the expected volatility, expected term,
exercise price, risk-free interest rate, and the value of the
underlying security. The Lattice Model provides for assumptions
regarding expected volatility, expected term, exercise price,
risk-free interest rates, the value of the underlying security, and
the probability of and likely timing of a specific event within the
period to maturity. These values are subject to a significant
degree of judgment on our part. Our common stock price represents a
significant input that affects the valuation of our
warrants.
Going Concern
We assess our ability to continue as a going concern at every
interim and annual period in accordance with Accounting Standards
Codification ("ASC") 205-40, Presentation
of Financial Statements – Going Concern.
The accompanying consolidated financial statements have been
prepared assuming that we will continue as a going
concern.
Comparison of the year ended December 31, 2020 to the year ended
December 31, 2019 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
|
|
|
2020 |
|
2019 |
|
Change |
|
% Change |
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
8,882 |
|
|
$ |
13,917 |
|
|
$ |
(5,035) |
|
|
(36) |
% |
Cost of revenue |
|
3,812 |
|
|
7,153 |
|
|
(3,341) |
|
|
(47) |
% |
Gross profit |
|
5,070 |
|
|
6,764 |
|
|
(1,694) |
|
|
(25) |
% |
Gross profit % |
|
57 |
% |
|
49 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Sales and marketing |
|
7,752 |
|
|
11,398 |
|
|
(3,646) |
|
|
(32) |
% |
Research and development |
|
2,474 |
|
|
4,596 |
|
|
(2,122) |
|
|
(46) |
% |
General and administrative |
|
7,702 |
|
|
7,409 |
|
|
293 |
|
|
4 |
% |
Impairment of goodwill |
|
189 |
|
|
— |
|
|
189 |
|
|
nm(1)
|
Restructuring |
|
244 |
|
|
— |
|
|
244 |
|
|
nm(1)
|
Total operating expenses |
|
18,361 |
|
|
23,403 |
|
|
(5,042) |
|
|
(22) |
% |
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(13,291) |
|
|
(16,639) |
|
|
3,348 |
|
|
(20) |
% |
|
|
|
|
|
|
|
|
|
Other (expense) income, net: |
|
|
|
|
|
|
|
|
Interest expense |
|
(139) |
|
|
(384) |
|
|
245 |
|
|
(64) |
% |
Finance cost associated with warrant issuance |
|
(329) |
|
|
(1,096) |
|
|
767 |
|
|
(70) |
% |
(Loss) gain on warrant liabilities |
|
(3,056) |
|
|
6,376 |
|
|
(9,432) |
|
|
nm(1)
|
Loss on modification of warrants |
|
— |
|
|
(257) |
|
|
257 |
|
|
nm(1)
|
Other income (expense), net |
|
990 |
|
|
(132) |
|
|
1,122 |
|
|
nm(1)
|
Total other (expense) income, net |
|
(2,534) |
|
|
4,507 |
|
|
(7,041) |
|
|
(156) |
% |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,825) |
|
|
$ |
(12,132) |
|
|
$ |
(3,693) |
|
|
30 |
% |
(1) Not meaningful
Revenue
Revenue decreased $5.0 million, or 36%, for the year ended December
31, 2020, compared to the same period of 2019. This decrease was
comprised of a $3.9 million decrease in EksoHealth and
a $1.1 million decrease in EksoWorks primarily due to a
decrease in volume of medical device sales driven by the impact of
the COVID-19 pandemic, as our customers shifted their priorities to
prepare for and manage their business during the
pandemic.
Gross Profit
Gross profit decreased $1.7 million, or 25%, for the year ended
December 31, 2020, compared to the same period of 2019,
primarily attributable to a decreased volume of device sales. Gross
margin was approximately 57% for the year ended December 31, 2020,
compared to a gross margin of 49% for the same period in 2019.
Gross margins increased primarily due to higher average selling
prices for EksoNR, an increased proportion of medical device sales
in overall revenue composition, lower unit production costs, the
introduction of EVO, and higher service margins.
Operating Expenses
Sales and marketing expenses decreased $3.6 million, or 32%, for
the year ended December 31, 2020, compared to the same period of
2019, primarily due to a decrease in employee compensation expenses
as a result of a furlough and a reduction in force in March and May
2020, respectively, lower selling expense as we shifted to video
conferencing, virtual training events and online education
demonstrations, lower general marketing and trade show activities,
and the absence of clinical trials expense due to the completion of
our main clinical trial in the first quarter of 2019.
Research and development expenses decreased $2.1 million, or 46%,
for the year ended December 31, 2020, compared to the same period
of 2019, primarily due to a decrease in employee compensation
expenses as a result of a furlough and a reduction in force in
March and May 2020, respectively, and a decrease in patent and
licensing costs.
General and administrative expenses increased $0.3 million, or 4%,
for the year ended December 31, 2020, compared to the same period
of 2019, primarily due to an increase in legal
expense.
Goodwill impairment charge of $0.2 million was recorded in the year
ended December 31, 2020, reducing the goodwill balance to zero. No
goodwill impairment charge was recorded in 2019.
Restructuring expense of $0.2 million was recorded in the year
ended December 31, 2020, and related to the completion of a
restructuring plan in May of 2020. We streamlined our operations
and reduced our workforce by approximately 35% to lower operating
expenses and reduce cash burn. The restructuring expense consisted
of employee severance payments.
The reduction in operating expenses reflects the continuation of
the company-wide initiatives we implemented last year, the
restructuring completed in May 2020, as well as improving overall
operational efficiencies. Our focus remains on optimizing the cost
structure of our organization.
Other (Expense) Income, Net
Interest expense decreased $0.2 million, or 64% for the year ended
December 31, 2020, compared to the same period of 2019, primarily
due to lower effective interest rates on our term
loans.
Loss on revaluation of warrant liabilities of $3.1 million for the
year ended December 31, 2020, was associated with the revaluation
of warrants issued in 2015, 2019 and 2020. Gain on revaluation of
warrant liabilities of $6.4 million for the year ended December 31,
2019, related to warrants issued in 2015 and 2019. Gains and losses
on revaluation of warrants are primarily driven by changes in our
stock price.
Loss on modification of warrants of $0.3 million for the year ended
December 31, 2019, was due to the reduction of the exercise price
of the 2015 Warrants from $56.10 per share to $41.25 per share, in
connection with an amendment of the 2015 Warrant Agreement, which
retroactively removed a provision from such securities purchase
agreement that prohibited the Company from effecting or entering
into an agreement to effect any issuance by the Company of its
common stock at a price determined based on the trading price of
the Company’s common stock or otherwise at a future determined
price. There was no comparable amount during the same period
in 2020.
Warrant issuance expense of $0.3 million for
the year ended December 31, 2020 was recorded in
connection with our private placement offerings of warrants to
purchase common stock concurrently with a registered direct
offering of our common stock in June 2020. We incurred $1.1 million
in direct financing costs, which were allocated on a relative fair
value basis between the common stock and warrant issuances, of
which $0.3 million was allocated to warrants and expensed
immediately. Warrant issuance expense of $1.1 million for the year
ended December 31, 2019 was recorded in connection with our May
2019 and December 2019 financings. We incurred $1.7
million in direct financing costs, which were allocated on a
relative fair value basis between the common stock and warrant
issuances, of which $1.1 million was allocated to
warrants and expensed immediately.
Other income, net was $1.0 million for the year ended
December 31, 2020, compared to other expense, net of $0.1 million
the same period of 2019, due to unrealized gains and losses on
foreign currency revaluations of our inter-company monetary assets
and liabilities.
Financial Condition, Liquidity and Capital Resources
Since our inception, we have devoted substantially all of our
efforts toward the development of exoskeletons for the medical and
industrial markets, toward the commercialization of medical
exoskeletons to rehabilitation centers and toward raising
capital. We have financed our operations primarily through the
issuance and sale of equity securities for cash consideration and
through bank debt.
Liquidity and Capital Resources
At December 31, 2020, we had working capital of $13.4
million, compared to working capital of $11.0 million
at December 31, 2019. The increase in working
capital is primarily due to higher cash balance from equity
financings, warrants exercises, and
the reduction of notes payable, current as a result of retiring our
WAB Term Loan. Our cash and cash equivalents as of December
31, 2020 consisted of bank deposits with third party financial
institutions. As of December 31, 2020, of
our $12.9 million of cash, $12.3 million was
held domestically while $0.6 million was held by foreign
subsidiaries.
As of December 31, 2020, we had an accumulated deficit of $199.1
million and cash on hand of $12.9 million. Largely as a
result of significant research and development activities related
to our advanced technology and commercialization of such technology
into our medical device business, we have incurred significant
operating losses and negative cash flows from operations since
inception. We have incurred net losses of $15.8 million and $12.1
million for the years ended December 31, 2020 and 2019,
respectively. In the year ended December 31, 2020, we received net
proceeds of $7.1 million from a registered direct offering and $3.3
million from warrant exercises, and used $8.8 million of cash in
our operations.
Subsequent to year-end through February 25, 2021, we received
estimated net proceeds of $36.4 million from an underwritten public
offering, $1.4 million from warrant exercises, and $0.7
million from sales under our "at the market offering" program.
Refer to Note. 18 in the notes to our consolidated financial
statements under the caption Subsequent Events.
In 2020, management took several actions to alleviate the
substantial doubt about the our ability to continue as a going
concern that existed as of the date of issuance of the December 31,
2019 consolidated financial statements, including, but not limited
to, the following:
•streamlined our operations and reduced our workforce by
approximately 35% to lower operating expenses and reduce cash
burn;
•conducted a registered direct offering of 1,747,704 shares of our
common stock for net proceeds of $7.1 million;
•paid off the entire amount of $1.5 million of our indebtedness to
Western Alliance Bank with proceeds from a new loan of $2.0 million
from Pacific Western Bank. The terms of the new loan agreement
include monthly interest-only payments over the next three
years.
•invested in the development and reliability of our
products;
•restructured our commercial organization and strategy which has
been gaining traction;
•received FDA clearance for ABI to market our product to a larger
patient population increasing the value proposition to our
customers.
As described in Note 9 in the notes to our consolidated financial
statements under the caption Notes Payable, net, borrowings
under our new secured term loan agreement with Pacific Western Bank
have a requirement of minimum cash on hand equivalent to the
current outstanding principal balance. As of December 31,
2020, $2.0 million of cash must remain as restricted. After
considering cash restrictions, effective unrestricted cash as
of December 31, 2020 is estimated to be $10.9 million.
With this unrestricted cash balance and the impact of management's
actions described above, and additional cash received after
year-end, we believe that we currently have sufficient cash to fund
our operations beyond the look forward period of one year from the
issuance of these consolidated financial statements.
Our actual capital requirements may vary significantly and will
depend on many factors. We plan to continue our investments in our
(i) sales initiatives to accelerate adoption of the Ekso robotic
exoskeleton in the rehabilitation market, (ii) research,
development and commercialization activities with respect to
exoskeletons for rehabilitation, and (iii) development and
commercialization of able-bodied exoskeletons for industrial use.
Consequently, we may require significant additional financing in
the future, which we intend to raise through corporate
collaborations, public or private equity offerings, debt
financings, or warrant solicitations. Sales of additional equity
securities by us could result in the dilution of the interests of
existing stockholders. There can be no assurance that financing
will be available when required in sufficient amounts, on
acceptable terms or at all. In the event that the necessary
additional financing is not obtained, we may be required to further
reduce our discretionary overhead costs substantially, including
research and development, general and administrative, and sales and
marketing expenses or otherwise curtail operations.
Cash and Cash Equivalents
The following table summarizes the sources and uses of cash for the
periods stated (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
2020 |
|
2019 |
Cash, beginning of year |
|
$ |
10,872 |
|
|
$ |
7,655 |
|
Net cash used in operating activities |
|
(8,755) |
|
|
(15,772) |
|
Net cash used in investing activities |
|
— |
|
|
(60) |
|
Net cash provided by financing activities |
|
10,704 |
|
|
19,039 |
|
Effect of exchange rate changes on cash |
|
41 |
|
|
10 |
|
Cash, end of year |
|
$ |
12,862 |
|
|
$ |
10,872 |
|
Net Cash Used in Operating Activities
Net cash used in operations decreased $7.0 million, or 44%,
for the year ended December 31, 2020, compared to the same
period of 2019, primarily due to the reduction in
operating expenses by improving overall operational efficiencies,
including but not limited to, the reduction of employee headcount.
In addition, increased collection efforts resulted in higher ratio
of accounts receivable collections to sales.
Net Cash Used in Investing Activities
Net cash used in investing activities decreased $0.1 million, or
100%, during the year ended December 31, 2020, compared to the same
period of 2019, primarily due to lower hardware and software
purchases due to lower headcount.
Net Cash Provided by Financing Activities
Net cash provided by financing activities of $10.7 million for
the year ended December 31, 2020 was from the sale of our
common stock for net proceeds of $7.1 million in connection with
the equity financing in June 2020, proceeds of $1.1 million from
our PPP loan, and proceeds of $3.3 million from the exercise of
June 2020 Warrants and May 2019 Warrants, partially offset by
aggregate principal payments of $1.3 million against our term loan
and the $1.5 million payoff of our loan with Western Alliance
Bank.
Net cash provided by financing activities of $19.0 million for the
year ended December 31, 2019 was from the sale of common stock and
warrants for net proceeds of $9.0 million in connection
with the equity financing in May 2019, net proceeds of $4.2 million
with the equity financing in December 2019, net proceeds of $2.8
million from our “at the market offering” program, net proceeds of
$5.0 million from equity investors associated with the JV
Agreement, and proceeds of $0.2 million from the exercise of stock
options, partially offset by aggregate principal payments
of $2.4 million against our term loan.
Off-Balance Sheet Arrangements
Our liquidity is not dependent on the use of off-balance sheet
financing arrangements (as that term is defined in Item 303(a) (4)
(ii) of Regulation S-K) and as of December 31, 2020, we had no such
arrangements. There has been no material change in our contractual
obligations other than in the ordinary course of business since our
fiscal year ended December 31, 2020.
Contractual Obligations and Commitments
The following table summarizes our outstanding contractual
obligations, including interest payments, as of December 31, 2020
and the effect those obligations are expected to have on our
liquidity and cash flows in future periods (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
|
Total |
|
Less than one year |
|
1-3 Years |
|
3-5 Years |
|
After 5 Years |
Term loan |
|
$ |
3,356 |
|
|
$ |
90 |
|
|
$ |
3,266 |
|
|
$ |
— |
|
|
$ |
— |
|
Facility operating leases |
|
836 |
|
|
599 |
|
|
237 |
|
|
— |
|
|
— |
|
Purchase obligations |
|
396 |
|
|
396 |
|
|
— |
|
|
— |
|
|
— |
|
Total |
|
$ |
4,588 |
|
|
$ |
1,085 |
|
|
$ |
3,503 |
|
|
$ |
— |
|
|
$ |
— |
|
In addition to the table above, which reflects only fixed payment
obligations, we have two license agreements to maintain exclusive
rights to certain patents. Under these license agreements, we are
required to pay 1% of net sales of products sold to entities other
than the U.S. government. In the event of a sublicense, we will owe
21% of license fees and must pass through 1% of the sub-licensee’s
net sales of products sold to entities other than the U.S.
government. The license agreements also stipulate minimum annual
royalties of $50,000 per year.
In connection with our acquisition of Equipois in December 2015, we
assumed the rights and obligations of Equipois under a license
agreement with the developer of certain intellectual property
related to mechanical balance and support arm technologies, which
grants us an exclusive license with respect to the technology and
patent rights for certain fields of use. Pursuant to the terms of
the license agreement, we will be required to pay a single-digit
royalty on net receipts, subject to a $50,000 annual minimum
royalty requirement.
We purchase components from a variety of suppliers and use contract
manufacturers to provide manufacturing services for our products.
Purchase obligations are defined as agreements that are enforceable
and legally binding and that specify all significant terms,
including: fixed or minimum quantities to be purchased; fixed,
minimum or variable price provisions; and the approximate timing of
the transaction. We had purchase obligations primarily for
purchases of inventory and manufacturing related service contracts
totaling $0.4 million as of December 31, 2020, which
is expected to be paid within a year. Timing of payments and actual
amounts paid may be different depending on the time of receipt of
goods or services or changes to agreed-upon amounts for some
obligations.
Recent Accounting Pronouncements
See Note 2 in the notes to our consolidated financial statements
under the caption
Recent Accounting Pronouncements
for a discussion of new accounting pronouncements.
ITEM 7A. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
Foreign Currency Risk
We report our financial results in U.S. dollars; however, we
conduct business in foreign countries. For U.S. reporting purposes,
we translate all assets and liabilities of our non-U.S.
subsidiaries at the period-end exchange rate, equity at historical
exchange rates, and revenue and expenses at the average exchange
rates in effect during the periods. The net effect of these
translation adjustments is shown in the accompanying consolidated
financial statements as a component of stockholders’
equity.
We generate a portion of our revenue and collect receivables in
foreign currencies outside of the U.S. and, as such, we have
foreign currency exposure. Currently, we sell our products mainly
in United States dollars, Euros, and Singapore dollars although we
may in the future transact business in other currencies. Future
fluctuations in the foreign exchange rates of these currencies can
result in foreign exchange gains and losses which may impact our
financial results. In the past, we have not hedged our exposures to
foreign currencies or entered into any other derivative instruments
and we have no current plans to do so. For the year ended December
31, 2020, sales denominated in foreign currencies were
approximately 33% of total revenue. A hypothetical 10% increase in
the United States dollar exchange rate used would have
resulted in a $0.3 million decrease to revenues for
2020.
Interest Rate Risk
Our exposure to market rate risk for changes in interest rates
relates primarily to our term loan. The variable interest rate
related to our long-term debt is charged at the greater of 0.50%
above the variable rate of interest announced by the lender as its
“prime rate” then in effect or 4.50. A hypothetical 10%
change in the lender's prime rate would have an immaterial impact
on our annualized interest expense.
ITEM 8. FINANCIAL STATEMENTS AND
SUPPLEMENTARY DATA
Table of Contents
The following financial statements are filed as part of this Annual
Report on Form 10-K
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
Stockholders and Board of Directors
Ekso Bionics Holdings, Inc.
Richmond, California
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of
Ekso Bionics Holdings, Inc. as of December 31, 2020 and 2019, the
related consolidated statements of operations and comprehensive
loss, stockholders’ equity, and cash flows for each of the two
years in the period ended December 31, 2020, and the related notes
(collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements
present fairly, in all material respects, the financial position of
the Company at December 31, 2020 and 2019, and the results of its
operations and its cash flows for each of the two years in the
period ended December 31, 2020,
in conformity with accounting principles generally accepted in the
United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of
the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on
our audits. We are a public accounting firm registered with the
Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and
the PCAOB.
We conducted our audits in accordance with the standards of the
PCAOB. Those standards require that we plan and perform the audit
to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatement, whether due
to error or fraud. The Company is not required to have, nor were we
engaged to perform, an audit of its internal control over financial
reporting. As part of our audits we are required to obtain an
understanding of internal control over financial reporting but not
for the purpose of expressing an opinion on the effectiveness of
the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of
material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a
test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation
of the consolidated financial statements. We believe that our
audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising
from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to
the audit committee and that: (1) relate to accounts or disclosures
that are material to the consolidated financial statements and (2)
involved our especially challenging, subjective, or complex
judgments. The communication of a critical audit matter does not
alter in any way our opinion on the consolidated financial
statements, taken as a whole, and we are not, by communicating the
critical audit matter below, providing a separate opinion on the
critical audit matter or on the accounts or disclosures to which it
relates.
Revenue Recognition
Description of the Matter
As described in Note 2 to the consolidated financial statements,
the Company’s contracts with customers sometimes contain multiple
performance obligations, which are accounted for separately if they
are distinct. In such cases, the transaction price is then
allocated to the distinct performance obligations on a relative
standalone selling price basis and revenue is recognized when the
distinct performance obligation is satisfied. For example, device
revenue is recognized at the point in time that the customer takes
control of the device, generally upon shipment, and subscription
and service revenues are recognized over time as the services are
performed.
Auditing the Company’s revenue recognition was challenging,
specifically related to the identification and determination of the
distinct performance obligations, the allocation of the transaction
price to the identified performance obligations and the timing of
revenue recognition. For example, certain arrangements required
judgment to determine the distinct performance
obligations,
how the transaction price is allocated to the identified
performance obligations, and the appropriate timing of revenue
recognition.
How We Addressed the Matter in Our Audit
We obtained an understanding and evaluated the design of the
Company’s process and controls to determine the distinct
performance obligations, allocation of the transaction price to the
identified performance obligations and the timing of revenue
recognition.
Among the procedures we performed to test the determination of the
distinct performance obligations, allocations of the transaction
price to the identified performance obligations and the timing of
revenue recognition, we read executed contracts and purchase orders
to understand the rights and obligations conveyed in the
contractual arrangement, evaluated management’s assessment of the
performance obligations and whether they were distinct, determined
the reasonableness of the standalone selling price used by
management in the allocation of the transaction price to the
performance obligations, and tested the timing of revenue
recognition for a sample of individual sales transactions. We
evaluated the accuracy of the Company’s accounting conclusions,
specifically related to the identification and determination of
distinct performance obligations, allocation of the transaction
price to the identified performance obligations, and the timing of
revenue recognition.
San Francisco, California
February 25, 2021
We have served as the Company's auditor since 2010.
Ekso Bionics Holdings, Inc.
Consolidated Balance Sheets
(In thousands, except par value amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
12,862 |
|
|
$ |
10,872 |
|
Accounts receivable, net of allowances of $42 and $121,
respectively
|
3,389 |
|
|
5,208 |
|
Inventories |
1,978 |
|
|
2,489 |
|
Prepaid expenses and other current assets |
191 |
|
|
238 |
|
Total current assets |
18,420 |
|
|
18,807 |
|
Property and equipment, net |
1,172 |
|
|
1,657 |
|
Right-of-use assets |
685 |
|
|
1,084 |
|
Goodwill |
— |
|
|
189 |
|
Other assets |
320 |
|
|
178 |
|
Total assets |
$ |
20,597 |
|
|
$ |
21,915 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,501 |
|
|
$ |
1,903 |
|
Accrued liabilities |
1,429 |
|
|
1,683 |
|
Deferred revenues, current |
1,496 |
|
|
1,492 |
|
Note payable, current |
— |
|
|
2,333 |
|
Lease liabilities, current |
548 |
|
|
421 |
|
Total current liabilities |
4,974 |
|
|
7,832 |
|
Deferred revenues |
1,806 |
|
|
1,789 |
|
Notes payable, net |
3,075 |
|
|
407 |
|
Lease liabilities |
233 |
|
|
711 |
|
Warrant liabilities |
6,037 |
|
|
4,307 |
|
Other non-current liabilities |
38 |
|
|
72 |
|
Total liabilities |
16,163 |
|
|
15,118 |
|
Commitments and contingencies (Note 16) |
|
|
|
Stockholders' equity: |
|
|
|
Convertible preferred stock, $0.001 par value; 10,000 shares
authorized; no shares issued and outstanding at December 31, 2020
and 2019
|
— |
|
|
— |
|
Common stock, $0.001 par value; 141,429 shares authorized; 8,349
and 5,795 shares issued and outstanding at December 31, 2020 and
2019, respectively
|
8 |
|
|
6 |
|
Additional paid-in capital |
204,376 |
|
|
190,019 |
|
Accumulated other comprehensive (loss) income |
(847) |
|
|
50 |
|
Accumulated deficit |
(199,103) |
|
|
(183,278) |
|
Total stockholders' equity |
4,434 |
|
|
6,797 |
|
Total liabilities and stockholders' equity |
$ |
20,597 |
|
|
$ |
21,915 |
|
See accompanying notes to consolidated financial
statements
Ekso Bionics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2020 |
|
2019 |
|
|
Revenue |
$ |
8,882 |
|
|
$ |
13,917 |
|
|
|
Cost of revenue |
3,812 |
|
|
7,153 |
|
|
|
Gross profit |
5,070 |
|
|
6,764 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Sales and marketing |
7,752 |
|
|
11,398 |
|
|
|
Research and development |
2,474 |
|
|
4,596 |
|
|
|
General and administrative |
7,702 |
|
|
7,409 |
|
|
|
Impairment of goodwill |
189 |
|
|
— |
|
|
|
Restructuring |
244 |
|
|
— |
|
|
|
Total operating expenses |
18,361 |
|
|
23,403 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(13,291) |
|
|
(16,639) |
|
|
|
|
|
|
|
|
|
Other (expense) income, net: |
|
|
|
|
|
Interest expense |
(139) |
|
|
(384) |
|
|
|
Finance cost associated with warrant issuance |
(329) |
|
|
(1,096) |
|
|
|
(Loss) gain on warrant liabilities |
(3,056) |
|
|
6,376 |
|
|
|
Loss on modification of warrants |
— |
|
|
(257) |
|
|
|
Other income (expense), net |
990 |
|
|
(132) |
|
|
|
Total other (expense) income, net |
(2,534) |
|
|
4,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
(15,825) |
|
|
(12,132) |
|
|
|
Foreign currency translation adjustments |
(897) |
|
|
142 |
|
|
|
Comprehensive loss |
$ |
(16,722) |
|
|
$ |
(11,990) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common
shareholders |
$ |
(2.21) |
|
|
$ |
(2.53) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding, basic and
diluted |
7,164 |
|
|
4,794 |
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial
statements
Ekso Bionics Holdings, Inc.
Consolidated Statements of Stockholders’ Equity
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
Preferred Stock |
|
Common Stock |
|
Additional
Paid-in
Capital |
|
Accumulated
Other
Comprehensive
Income (Loss) |
|
Accumulated
Deficit |
|
Total
Stockholders’
Equity |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
|
|
|
Balance at December 31, 2018 |
— |
|
|
$ |
— |
|
|
4,198 |
|
|
$ |
4 |
|
|
$ |
173,962 |
|
|
$ |
(92) |
|
|
$ |
(171,146) |
|
|
$ |
2,728 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(12,132) |
|
|
(12,132) |
|
Issuance of common stock under: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity financing, net |
— |
|
|
— |
|
|
1,534 |
|
|
2 |
|
|
12,442 |
|
|
— |
|
|
— |
|
|
12,444 |
|
Equipois sales earn-out |
— |
|
|
— |
|
|
1 |
|
|
— |
|
|
22 |
|
|
— |
|
|
— |
|
|
22 |
|
Equity incentive plan |
— |
|
|
— |
|
|
12 |
|
|
— |
|
|
228 |
|
|
— |
|
|
— |
|
|
228 |
|
Matching contribution to 401(k) plan |
— |
|
|
— |
|
|
9 |
|
|
— |
|
|
191 |
|
|
— |
|
|
— |
|
|
191 |
|
In lieu of employee cash bonus |
— |
|
|
— |
|
|
41 |
|
|
— |
|
|
919 |
|
|
— |
|
|
— |
|
|
919 |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,255 |
|
|
— |
|
|
— |
|
|
2,255 |
|
Foreign currency translation adjustments |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
142 |
|
|
— |
|
|
142 |
|
Balance at December 31, 2019 |
— |
|
|
$ |
— |
|
|
5,795 |
|
|
$ |
6 |
|
|
$ |
190,019 |
|
|
$ |
50 |
|
|
$ |
(183,278) |
|
|
$ |
6,797 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(15,825) |
|
|
(15,825) |
|
Issuance of common stock under: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity financing, net |
— |
|
|
— |
|
|
1,748 |
|
|
2 |
|
|
7,080 |
|
|
— |
|
|
— |
|
|
7,082 |
|
Equity incentive plan |
— |
|
|
— |
|
|
35 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Exercise of warrants |
— |
|
|
— |
|
|
723 |
|
|
— |
|
|
7,310 |
|
|
— |
|
|
— |
|
|
7,310 |
|
Matching contribution to 401(k) plan |
— |
|
|
— |
|
|
26 |
|
|
— |
|
|
155 |
|
|
— |
|
|
— |
|
|
155 |
|
In lieu of cash compensation |
— |
|
|
— |
|
|
9 |
|
|
— |
|
|
50 |
|
|
— |
|
|
— |
|
|
50 |
|
Shares issued as a result of rounding due to reverse-stock
split |
— |
|
|
— |
|
|
13 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Issuance of warrants |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(2,322) |
|
|
— |
|
|
— |
|
|
(2,322) |
|
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2,084 |
|
|
— |
|
|
— |
|
|
2,084 |
|
Foreign currency translation adjustments |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(897) |
|
|
— |
|
|
(897) |
|
Balance at December 31, 2020 |
— |
|
|
$ |
— |
|
|
8,349 |
|
|
$ |
8 |
|
|
$ |
204,376 |
|
|
$ |
(847) |
|
|
$ |
(199,103) |
|
|
$ |
4,434 |
|
See accompanying notes to consolidated financial
statements
Ekso Bionics Holdings, Inc.
Consolidated Statement of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
2020 |
|
2019 |
Operating activities |
|
|
|
Net loss |
$ |
(15,825) |
|
|
$ |
(12,132) |
|
Adjustments to reconcile net loss to net cash used in operating
activities |
|
|
|
Depreciation and amortization |
620 |
|
|
690 |
|
Changes in allowance for doubtful accounts |
65 |
|
|
52 |
|
Impairment of goodwill |
189 |
|
|
— |
|
Amortization of debt discount, change in contingent liability and
accretion of final payment fee |
28 |
|
|
64 |
|
Gain on modification of operating lease liabilities |
(38) |
|
|
— |
|
Loss on investment of unconsolidated affiliate |
66 |
|
|
— |
|
Common stock contribution to 401(k) plan |
169 |
|
|
142 |
|
Stock-based compensation expense |
2,410 |
|
|
2,255 |
|
Finance cost attributable to issuance of warrants |
329 |
|
|
1,096 |
|
Loss (gain) on revaluation of warrant liabilities |
3,056 |
|
|
(6,376) |
|
Loss on modification of warrants |
— |
|
|
257 |
|
Unrealized (gain) loss on foreign currency transactions |
(947) |
|
|
133 |
|
Changes in operating assets and liabilities: |
|
|
|
Accounts receivable |
1,754 |
|
|
(1,599) |
|
Inventories |
379 |
|
|
959 |
|
Prepaid expense, operating lease right-of-use assets, and other
assets, current and noncurrent |
247 |
|
|
369 |
|
Accounts payable |
(402) |
|
|
(1,231) |
|
Accrued and lease liabilities |
(876) |
|
|
(1,135) |
|
Deferred revenues |
21 |
|
|
684 |
|
Net cash used in operating activities |
(8,755) |
|
|
(15,772) |
|
Investing activities |
|
|
|
Acquisition of property and equipment |
— |
|
|
(60) |
|
Net cash used in investing activities |
— |
|
|
(60) |
|
Financing activities |
|
|
|
Proceeds from issuance of common stock and warrants,
net |
7,082 |
|
|
21,188 |
|
Principal payments on notes payable |
(1,278) |
|
|
(2,377) |
|
Payment of remaining balance on long-term debt |
(1,512) |
|
|
— |
|
Proceeds from exercise of stock options |
— |
|
|
228 |
|
Proceeds from exercise of common stock warrants |
3,334 |
|
|
— |
|
Proceeds from issuance of long-term debt, net of financing
costs |
3,078 |
|
|
— |
|
Net cash provided by financing activities |
10,704 |
|
|
19,039 |
|
Effect of exchange rate changes on cash |
41 |
|
|
10 |
|
Net increase in cash |
1,990 |
|
|
3,217 |
|
Cash at beginning of the year |
10,872 |
|
|
7,655 |
|
Cash at end of the year |
$ |
12,862 |
|
|
$ |
10,872 |
|
|
|
|
|
Supplemental disclosure of cash flow activities |
|
|
|
Cash paid for interest |
$ |
109 |
|
|
$ |
309 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
$ |
6 |
|
|
$ |
23 |
|
|
|
|
|
Supplemental disclosure of non-cash activities |
|
|
|
Reclassification of warrant liability to equity upon exercise of
warrants |
$ |
3,976 |
|
|
$ |
— |
|
Share issuance for common stock contribution to 401(k)
plan |
$ |
155 |
|
|
$ |
191 |
|
Transfer of inventory to (from) property and equipment |
$ |
132 |
|
|
$ |
(77) |
|
Share issuance in lieu of cash compensation |
$ |
50 |
|
|
$ |
919 |
|
Initial recognition of operating right-of-use assets |
$ |
— |
|
|
$ |
1,454 |
|
Initial recognition of operating lease liabilities |
$ |
— |
|
|
$ |
1,498 |
|
Share issuance for vesting of restricted stock |
$ |
— |
|
|
$ |
63 |
|
Change in deferred rent associated with ASC 842 |
$ |
— |
|
|
$ |
44 |
|
Equipois sales earn-out |
$ |
— |
|
|
$ |
22 |
|
See accompanying notes to consolidated financial
statements
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
1. Organization
Description of Business
Ekso Bionics Holdings, Inc. (the "Company"), designs, develops,
sells, and rents exoskeleton products to augment human strength,
endurance and mobility.
The Company’s exoskeleton technology serves multiple markets and
can be utilized both by able-bodied users and persons with physical
disabilities. The Company has sold and rented devices that (i)
enable individuals with neurological conditions affecting gait
(acquired brain injury and spinal cord injury) to rehabilitate and
to walk again, (ii) assist individuals with a broad range of upper
extremity impairments, and (iii) allow industrial workers to
perform difficult repetitive work for extended
periods.
Founded in 2005, the Company is headquartered in the San Francisco
Bay area and listed on the Nasdaq Capital Market under the symbol
“EKSO”.
Unless otherwise indicated, all dollar and share amounts included
in these notes to the consolidated financial statements are in
thousands.
Liquidity and Going Concern
As of December 31, 2020, the Company had an accumulated deficit of
$199,103. Largely as a result of significant research and
development activities related to the development of the Company’s
advanced technology and commercialization of such technology into
its medical device business, the Company has incurred significant
operating losses and negative cash flows from operations since
inception. In the year ended December 31, 2020, the Company
received net proceeds of $7,082 from a registered direct offering
and of $3,334 from warrant exercises, and used $8,755 of cash in
its operations. Cash on hand at December 31, 2020 was
$12,862.
Subsequent to year-end through February 25, 2021 the Company
received estimated net proceeds of $36,404 from an underwritten
public offering, $1,416 from warrant exercises, and $664 from ATM
sales. Refer to Note. 18,
Subsequent Events.
In 2020, management took several actions to alleviate the
substantial doubt about the Company’s ability to continue as a
going concern that existed as of the date of issuance of the
December 31, 2019 consolidated financial statements, including, but
not limited to, the following:
•streamlined
the Company's operations and reduced its workforce by approximately
35% to lower operating expenses and reduce cash burn;
•conducted
a registered direct offering for net proceeds of
$7,082;
•paid
off the entire amount of $1,512 of the Company's indebtedness to
Western Alliance Bank with proceeds from a new loan of $2,000 from
Pacific Western Bank. The terms of the new loan agreement include
monthly interest-only payments until August 2023.
•invested
in the development and reliability of its products;
•restructured
the Company's commercial organization and strategy which has been
gaining traction; and
•received
clearance from the U.S. Food and Drug Administration ("FDA") for
Acquired Brain Injury ("ABI") to market the Company's product to a
larger patient population increasing the value proposition to its
customers.
As described in Note 9,
Notes payable, net,
borrowings under the Company’s new secured term loan agreement with
Pacific Western Bank have a liquidity covenant requiring minimum
cash on hand equivalent to the current outstanding principal
balance. As of December 31, 2020, $2,000 of cash must remain as
restricted. After considering cash restrictions, effective
unrestricted cash as of December 31, 2020 is approximately $10,862.
With this unrestricted cash balance, the impact of management's
actions described above, and additional cash received after
year-end, the Company believes that it currently has sufficient
cash to fund its operations beyond the look forward period of one
year from the issuance of these consolidated financial
statements.
The Company’s actual capital requirements may vary significantly
and will depend on many factors. The Company plans to continue its
investments in its (i) sales initiatives to accelerate adoption of
the Ekso robotic exoskeleton in the rehabilitation
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
market, (ii) research, development and commercialization activities
with respect to exoskeletons for rehabilitation, and (iii)
development and commercialization of able-bodied exoskeletons for
industrial use. Consequently, the Company may require significant
additional financing in the future, which the Company intends to
raise through corporate collaborations, public or private equity
offerings, debt financings, or warrant solicitations. Sales of
additional equity securities by the Company could result in the
dilution of the interests of existing stockholders. There can be no
assurance that financing will be available when required in
sufficient amounts, on acceptable terms or at all. In the event
that the necessary additional financing is not obtained, the
Company may be required to further reduce its discretionary
overhead costs substantially, including research and development,
general and administrative, and sales and marketing expenses or
otherwise curtail operations.
2. Summary of Significant Accounting Policies and
Estimates
Principles of Consolidation and Basis of Presentation
The accompanying consolidated financial statements have been
prepared in accordance with accounting principles generally
accepted in the United States or U.S. GAAP. In the opinion of
management, all adjustments necessary for a fair presentation of
the financial position, results of operations and cash flows for
the periods presented have been included and are normal and
recurring in nature.
All significant intercompany transactions and balances have been
eliminated in consolidation.
Certain reclassifications have been made to prior year amounts to
conform to the current year’s presentation.
All common share and per share amounts have been adjusted to
reflect the one-for-fifteen reverse stock split completed on March
24, 2020. See Note 13,
Capitalization and Equity Structure – Reverse Stock
Split.
Use of Estimates
The preparation of the consolidated financial statements in
conformity with U.S. GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the balance sheet, and the reported amounts of revenues
and expenses during the reporting period. For the Company, these
estimates include, but are not limited to, revenue recognition,
deferred revenue and the deferral of the associated costs, the
valuation of warrants and employee stock options, future warranty
costs, accounting for leases, useful lives assigned to long-lived
assets, valuation of inventory, realizability of deferred tax
assets, and contingencies. Actual results could differ from those
estimates.
Foreign Currency
The assets and liabilities of foreign subsidiaries and equity
investments, where the local currency is the functional currency,
are translated from their respective functional currencies into
U.S. dollars at the rates in effect at the balance sheet date and
revenue and expense amounts are translated at average rates during
the period, with resulting foreign currency translation adjustments
recorded in accumulated other comprehensive (loss) income as a
component of stockholders’ equity. Gains and losses from the
re-measurement of balances denominated in currencies other than the
entities' functional currencies, are recorded in other expense, net
in the accompanying consolidated statements of operations and
comprehensive loss.
Accumulated Other Comprehensive (Loss) Income
The Company's accumulated other comprehensive (loss) income
consists of the accumulated net unrealized gains or losses on
foreign currency translation adjustments. The change in accumulated
other comprehensive (loss) income presented on the consolidated
balance sheets for the year ended December 31, 2020, is reflected
in the table below net of tax:
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
|
|
|
|
|
|
|
Accumulated Other Comprehensive (Loss) Income |
Balance at December 31, 2019 |
$ |
50 |
|
Net unrealized loss on foreign currency translation |
(897) |
|
Balance at December 31, 2020 |
$ |
(847) |
|
Cash
The Company places its cash in the custody of, financial
institutions with high credit ratings. The Company considers all
highly liquid investments purchased with a maturity of three months
or less to be cash equivalents. The Company did not have any cash
equivalents or investments in money market funds as of December 31,
2020 and 2019.
Concentration of Credit Risk and Other Risks and
Uncertainties
Financial instruments that potentially subject the Company to
concentrations of credit risk consist principally of cash and
accounts receivable. The Company maintains cash accounts in excess
of federally insured limits. However, the Company believes it is
not exposed to significant credit risk due to the financial
position of the depository institutions in which these deposits are
held. The Company extends credit to customers in the normal
course of business and performs ongoing credit evaluations of its
customers. Concentrations of credit risk with respect to accounts
receivable exist to the full extent of amounts presented in the
consolidated financial statements. The Company does not require
collateral from its customers to secure accounts
receivable.
Accounts receivable are derived from the sale of products shipped
and services performed for customers primarily located in the U.S.,
Europe, Asia, and Australia. Invoices are aged based on contractual
terms with the customer. The Company reviews accounts receivable
for collectability and provides an allowance for potential credit
losses. The Company has not experienced material losses related to
accounts receivable during the years ended December 31, 2020 and
2019. Many of the sales contracts with customers outside of the
U.S. are settled in a foreign currency other than the U.S. dollar.
The Company does not enter into any foreign currency hedging
agreements and is susceptible to gains and losses from foreign
currency fluctuations. To date, the Company has not experienced
significant gains or losses upon settling contracts denominated in
a foreign currency.
At December 31, 2020, the Company had two customers with an
accounts receivable balance totaling 10% or more of the Company’s
total accounts receivable (13% and 10%, respectively), as compared
with one customer at December 31, 2019 (11%).
The Company had no customers with sales of 10% or more of the
Company’s total revenue for the year ended December 31, 2020, as
compared with one for the year ended December 31, 2019 (15%). Refer
to
Note 17. Segment Disclosures
for more information.
Inventories
Inventories are recorded at the lower of cost or net realizable
value. Cost is computed using the standard cost method, which
approximates actual cost on a first-in, first-out basis. Materials
from vendors are received and recorded as raw material. Once the
raw materials are incorporated in the fabrication of the product,
the related value of the component is recorded as work in progress
("WIP"). Direct and indirect labor and applicable overhead costs
are also allocated and recorded to WIP inventory. Finished goods
are comprised of completed products that are ready for customer
shipment. The Company periodically evaluates the carrying value of
inventory on hand for potential excess amounts over sales and
forecasted demand. Excess and obsolete inventories identified, if
any, are recorded as an inventory impairment charge within the
consolidated statements of operations and comprehensive loss. The
Company's estimate of write-downs for excess and obsolete inventory
is based on a detailed analysis which includes on-hand inventory
and purchase commitments in excess of forecasted demand.
Subsequent disposals of inventories are recorded as a reduction of
inventory.
Inventories consisted of the following:
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2020 |
|
2019 |
Raw materials |
$ |
1,724 |
|
|
$ |
2,208 |
|
Work in progress |
18 |
|
|
29 |
|
Finished goods |
236 |
|
|
252 |
|
Inventories |
$ |
1,978 |
|
|
$ |
2,489 |
|
Leases
In February 2016, the Financial Accounting Standards Board
("FASB") issued Accounting Standard Update (“ASU”), No.
2016-02, Leases (Topic 842), to enhance the transparency and
comparability of financial reporting related to leasing
arrangements. The Company adopted the standard effective January 1,
2019.
At the inception of an arrangement, the Company determines whether
the arrangement is or contains a lease based on the unique facts
and circumstances present. Operating lease liabilities and their
corresponding right-of-use assets are recorded based on the present
value of lease payments over the expected lease term. The interest
rate implicit in lease contracts is typically not readily
determinable. As such, the Company utilizes its incremental
borrowing rate, which is the rate incurred to borrow on a
collateralized basis over a similar term an amount equal to the
lease payments in a similar economic environment. Certain
adjustments to the right-of-use asset may be required for items,
such as initial direct costs paid or incentives
received.
Lease expense is recognized over the expected lease term on a
straight-line basis. Operating leases are recognized on the balance
sheet as right-of-use assets, lease liabilities current and lease
liabilities non-current. As a result, the Company no longer
recognizes deferred rent on the balance sheet.
Leases with an initial term of 12 months or less are not recorded
on the balance sheet. The Company recognizes the lease expense for
such leases on a straight-line basis over the lease
term.
Restructuring
In May of 2020, the Company streamlined its operations and reduced
its workforce by approximately 35% to lower operating expenses and
reduce cash burn. The restructuring plan was completed by the end
of the second quarter of 2020.
The Company recorded restructuring expense of $244 for the year
ended December 31, 2020 comprised of termination benefit costs. As
of December 31, 2020, there was no accrued restructuring cost
remaining on the Company’s consolidated balance
sheets.
Property and Equipment, net
Property and equipment are stated at cost less accumulated
depreciation and are depreciated on a straight-line basis over the
estimated useful lives of the assets, generally ranging from
three to ten years. Leasehold improvements are amortized
over the shorter of the estimated useful life or the related term
of the lease. The costs of repairs and maintenance are expensed
when incurred, while expenditures for refurbishments and
improvements that significantly add to the productive capacity or
extend the useful life of an asset are
capitalized.
Impairment of Long-Lived Assets
The Company assesses the impairment of long-lived assets whenever
events or changes in circumstances indicate that their carrying
value may not be recoverable from the estimated future cash flows
expected to result from the Company’s use or eventual disposition.
If estimates of future undiscounted net cash flows are insufficient
to recover the carrying value of the assets, the Company will
record an impairment loss in the amount by which the carrying value
of the assets exceeds the fair value. If the assets are determined
to be recoverable, but the useful lives are shorter than originally
estimated, the Company will depreciate or amortize the net book
value of the assets over the newly determined remaining useful
lives. None of the Company’s property and equipment or intangible
assets were impaired as of December 31, 2020 and 2019. No
impairment loss has been recognized in the years ended December 31,
2020 and 2019.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
Goodwill
The Company records goodwill when the purchase price of an
acquisition exceeds the fair value of the net tangible and
identified intangible assets acquired. The Company performs an
annual impairment assessment, or more frequently if indicators of
potential impairment exist, which includes evaluating qualitative
and quantitative factors to assess the likelihood of an impairment
of goodwill. The Company performs impairment tests using a fair
value approach when necessary.
The Company previously maintained a goodwill balance as a result of
a prior acquisition of intangible assets from Equipois, LLC in
December 2015 consisting of mechanical balance and support arms
technologies, including the rights to the ZeroG
product.
As a result of declining sales and gross margin, combined with the
overall uncertainty about the future of the ZeroG product line, the
Company performed an impairment assessment of goodwill utilizing
the simplified method, which resulted in an impairment of goodwill
of $189 reducing the goodwill balance to zero. In estimating the
fair value, the Company utilized a discounted cash flow model,
which is dependent on a number of assumptions, including forecasted
revenues and profit margins. The following table sets forth the
changes to goodwill for the year ended December 31,
2020:
|
|
|
|
|
|
|
Goodwill |
Balance at December 31, 2019 |
$ |
189 |
|
Impairment of goodwill |
(189) |
|
Balance at Balance at December 31, 2020 |
$ |
— |
|
Warrant Valuation
The Company generally accounts for warrants issued in connection
with debt and equity financings as a component of equity, unless
the warrants include a conditional obligation to issue a variable
number of shares or there is a deemed possibility that it may need
to settle the warrants in cash.
Where there is a possibility that the Company may have to settle
warrants in cash, it estimates the fair value of the issued
warrants as a liability at each reporting date and record changes
in the estimated fair value as a non-cash gain or loss in the
consolidated statements of operations and comprehensive loss. The
fair values of these warrants have been determined using the
Black-Scholes option-pricing model (the “Black-Scholes Model”) and
the Binomial Lattice model (the “Lattice Model”). The Black-Scholes
Model requires inputs, such as the expected volatility, expected
term, exercise price, risk-free interest rate, and the value of the
underlying security. The Lattice Model provides for assumptions
regarding expected volatility, expected term, exercise price,
risk-free interest rates, the value of the underlying security, and
the probability of and likely timing of a specific event within the
period to maturity. These values are subject to a significant
degree of the Company’s judgment. The Company’s common stock price
represents a significant input that affects the valuation of the
warrants.
Going Concern
The Company assesses its ability to continue as a going concern at
every interim and annual period in accordance with ASC
205-40,
Presentation of Financial Statements – Going
Concern.
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern.
Revenue Recognition
Revenue is recognized upon transfer of control of promised products
or services to customers in an amount that reflects the
consideration the Company expects to receive in exchange for those
products or services. The Company enters into contracts that can
include various combinations of products and services, which when
capable of being distinct, are accounted for as separate
performance obligations.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
The Company’s medical device segment (EksoHealth) revenue is
primarily generated through the sale and rental of the EksoNR and
EksoGT, associated software (SmartAssist and VariableAssist), the
sale and rental of the EksoUE, the sale of accessories, and the
sale of support and maintenance contracts (Ekso Care). Revenue from
medical device product sales is recognized at the point in time
when control of the product transfers to the customer. Transfer of
control generally occurs upon shipment from the Company’s facility
for sales of the EksoNR or EksoGT, software and accessories. Ekso
Care support and maintenance contracts extend coverage beyond the
Company’s standard warranty agreements. The separately priced Ekso
Care contracts range from 12 to 48 months. The
Company receives payment at the inception of the contract and
recognizes revenue over the term of the agreement. Revenue from
medical device rentals is recognized over the rental term,
typically 12 months.
The Company’s industrial device segment (EksoWorks) revenue is
generated through the sale and rental of the upper body
exoskeletons (EksoVest and the recently introduced
EVOTM)
and the support arm (EksoZeroG). Revenue from industrial device
sales is recognized at the point in time when control of the
product transfers to the customer. Transfer of control generally
occurs upon shipment from the Company’s facility. Revenue from
industrial device rentals is recognized over the rental term,
typically 12 months.
Government Grants
The Company accounts for nonreciprocal government grants by
applying the contributions received in accordance with guidance in
ASC Topic 958-605. To determine if a grant is non-reciprocal or
reciprocal and whether the application of ASC 606 is required, the
Company considers whether the transfer of resources is one in which
commensurate value is exchanged. If commensurate value is not
exchanged for the goods or services provided, the Company assesses
whether the grant is conditional or unconditional. Grants
that contain both a barrier and right to return are considered
conditional and revenue is deferred until such conditions are
satisfied. In January 2019, the Company received a government grant
from the Singapore Economic Development Board (“SEDB”) in the
amount of approximately $1,500. The receipt of the funds is
conditional upon certain operational milestones that must be met
and maintained through December 31, 2021. Therefore, the Company
has not recognized revenue related to the government grant from the
SEBD nor received cash from the SEBD. The Company expects to
recognize revenue related to this grant in 2021.
Research and Development
Research and development costs consist of costs incurred for
internal research and development activities. These costs primarily
include salaries and other personnel-related expenses, contractor
fees, legal fees associated with developing and maintaining
intellectual property, prototype materials, facility costs,
supplies, and depreciation of equipment associated with the design
and development of new products prior to the establishment of their
technological feasibility. Such costs are expensed as
incurred.
Income Taxes
The Company accounts for income taxes using the asset and liability
method. Under this method, income tax expense or benefit is
recognized for the amount of taxes payable or refundable for the
current year and for deferred tax liabilities and assets for the
future tax consequences of events that have been recognized in the
Company's consolidated financial statements or tax returns. The
Company accounts for any income tax contingencies in accordance
with accounting guidance for income taxes. The measurement of
current and deferred tax assets and liabilities is based on
provisions of currently enacted tax laws. The effects of any future
changes in tax laws or rates have not been considered.
For the preparation of the Company's consolidated financial
statements included herein, the Company estimates its income taxes
and tax contingencies in each of the tax jurisdictions in which it
operates prior to the completion and filing of its tax returns.
This process involves estimating actual current tax expense
together with assessing temporary differences resulting from
differing treatment of items, such as deferred revenue, for tax and
accounting purposes. These differences result in net deferred tax
assets and liabilities. The Company must then assess the likelihood
that the deferred tax assets will be realizable, and to the extent
they believe that realizability is not likely, the Company must
establish a valuation allowance. In assessing the need for any
additional valuation allowance, the Company considers all the
evidence available to it, both positive and negative, including
historical levels of income, legislative developments, expectations
and risks associated with estimates of future taxable income, and
ongoing prudent and feasible tax planning strategies.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
Stock-based Compensation
The Company measures stock-based compensation expense for certain
stock-based awards made to employees and directors based on the
estimated fair value of the award on the date of grant using the
Black-Scholes Model and recognizes the fair value on a
straight-line basis over the requisite service periods of the
awards.
The Company’s determination of the fair value of stock options on
the date of grant using the Black-Scholes Model is affected by the
Company’s stock price as well as assumptions regarding a number of
highly complex and subjective variables. These variables include,
but are not limited to, the Company’s stock price, volatility over
the term of the awards, and actual and projected employee stock
option exercise behaviors (expected term). Due to the lack of
sufficient historical exercise data to provide a reasonable basis
upon which to estimate expected term, the Company adopted the
simplified method of estimating the expected term pursuant to SEC
Staff Accounting Bulletin Topic 14. On this basis, the Company
estimated the expected term of options granted by taking the
average of the vesting term and the contractual term of the
option.
The valuation of restricted stock units (“RSUs”) is determined at
the date of grant using the Company’s closing stock
price.
The Company records compensation expense for service-based awards
on a straight-line basis over the requisite service period, which
is generally the vesting period of the award, or to the date on
which retirement eligibility is achieved, if shorter. For awards
with performance-based conditions, at the point that it becomes
probable that the performance conditions will be met, the Company
records a cumulative catch-up of the expense from the grant date to
the current date, and then amortizes the remainder of the expense
over the remaining service period. Management evaluates when the
achievement of a performance-based condition is probable based on
the expected satisfaction of the performance conditions as of the
reporting date. The amount of stock-based compensation expense
recognized during a period is based on the value of the portion of
the awards that are ultimately expected to vest.
The Company has, from time to time, modified the terms of its stock
options to employees. The Company accounts for the incremental
increase in the fair value over the original award on the date of
the modification as an expense for vested awards or over the
remaining service (vesting) period for unvested awards. The
incremental compensation cost is the excess of the fair value of
the modified award on the date of modification over the fair value
of the original award immediately before the
modification.
Recent Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board ("FASB")
issued Accounting Standard Update ("ASU") No. 2016-13,
Financial Instruments-Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments
and subsequent amendments to the initial guidance under ASU
2018-19, ASU 2019-04, ASU 2019-05 and ASU 2019-10, which amends the
current approach to estimate credit losses on certain financial
assets, including trade and other receivables. Generally, this
amendment requires entities to establish a valuation allowance for
the expected lifetime losses of these certain financial assets.
Upon the initial recognition of such assets, which will be based
on, among other things, historical information, current conditions,
and reasonable supportable forecasts. Subsequent changes in the
valuation allowance are recorded in current earnings and reversal
of previous losses are permitted. Currently, U.S. GAAP requires
entities to write down credit losses only when losses are probable
and loss reversals are not permitted. The update will be effective
for the Company in the first quarter of 2023. Early adoption is
permitted. The Company is currently evaluating the impact the
adoption of this standard will have on its consolidated financial
statements and related disclosures.
In August 2020, the FASB issued ASU No. 2020-06,
Accounting for Convertible Instruments and Contracts in an Entity's
Own Equity,
which simplifies the accounting for convertible instruments. ASU
2020-06 eliminates certain models that require separate accounting
for embedded conversion features, in certain cases. Additionally,
among other changes, the guidance eliminates certain of the
conditions for equity classification for contracts in an entity’s
own equity. The guidance also requires entities to use the
if-converted method for all convertible instruments in the diluted
earnings per share calculation and include the effect of share
settlement for instruments that may be settled in cash or shares,
except for certain liability-classified share-based payment awards.
This guidance is effective for the Company beginning in the first
quarter of 2022 and must be applied using either a modified or full
retrospective approach. Early adoption is permitted. The Company is
currently evaluating the impact this guidance will have on its
consolidated financial statements.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
Accounting Pronouncements Adopted in 2020
In January 2017, the FASB issued ASU No. 2017-04,
Simplifying the Test for Goodwill Impairment,
which eliminates the computation of the implied fair value of
goodwill to measure a goodwill impairment charge. Instead, entities
will record a goodwill impairment charge based on the excess of a
reporting unit’s carrying amount over its fair value. The guidance
is effective for interim and annual reporting periods beginning
after December 15, 2019, with early adoption permitted. The Company
adopted the new guidance as of January 1, 2020, which reduced the
complexity surrounding the evaluation of goodwill for impairment.
The adoption of this guidance did not have a material impact on the
Company's consolidated financial statements.
In August 2018, the FASB issued ASU No. 2018-13,
Fair Value Measurement (Topic 820): Disclosure Framework - Changes
to the Disclosure Requirements for Fair Value
Measurement.
The standard modifies the disclosure requirements on fair value
measurements in Topic 820 by removing the requirement to disclose
the reasons for transfers between Level 1 and Level 2 of the fair
value hierarchy and the policy for timing of such transfers. The
standard expands the disclosure requirements for Level 3 fair value
measurement, primarily focused on changes in unrealized gains and
losses included in other comprehensive income. The amendments in
this update became effective for the Company in the first quarter
of 2020. The Company adopted ASU 2018-03 as of January 1, 2020. The
adoption of this ASU did not have a material impact on the
Company's consolidated financial statements and related
disclosures.
3. Net Loss Per Share of Common Stock
Basic net loss per share of common stock is computed using the
weighted average number of shares of common stock outstanding
during the period. Diluted net loss per share is computed using the
weighted average number of shares of common stock, adjusted to
include conversion of certain stock options and warrants for common
stock and release of common stock in connection with restricted
stock units during the period, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
2020 |
|
2019 |
Numerator: |
|
|
|
|
|
|
|
Net loss |
$ |
(15,825) |
|
|
$ |
(12,132) |
|
|
|
|
|
Adjusted net loss used for dilution calculation |
$ |
(15,825) |
|
|
$ |
(12,132) |
|
|
|
|
|
Denominator |
|
|
|
Weighted-average number of shares outstanding |
7,164 |
|
|
4,794 |
|
|
|
|
|
Dilutive weighted-average number of shares outstanding |
7,164 |
|
|
4,794 |
|
|
|
|
|
Net loss per share |
|
|
|
Basic |
$ |
(2.21) |
|
|
$ |
(2.53) |
|
Diluted |
$ |
(2.21) |
|
|
$ |
(2.53) |
|
The following table sets forth potential shares of common stock
that are not included in the calculation of diluted net loss per
share because to do so would be anti-dilutive as of the end of each
period presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
2020 |
|
2019 |
Options to purchase common stock |
529 |
|
|
494 |
|
Restricted stock units |
143 |
|
|
89 |
|
Warrants for common stock |
1,325 |
|
|
1,178 |
|
Total common stock equivalents |
1,997 |
|
|
1,761 |
|
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
4. Investment in Unconsolidated Affiliate
In May 2020, the Company, Zhejiang Youchuang Venture Capital
Investment Co., Ltd and another partner (collectively, the “JV
Partners”) received notice from the Committee on Foreign Investment
in the United States (“CFIUS”) in connection with its review of the
Company’s and the JV Partners’ investment in Exoskeleton
Intelligent Robotics Co. Limited (the “China JV”). The notice
stated that CFIUS’s prior national security concerns regarding the
China JV could not be mitigated. In connection with such
determination, on July 13, 2020, the Company and the JV Partners
entered into a National Security Agreement (“NSA”), which, among
other things, requires the termination of the Company’s agreements
and role with the China JV. The Company intends to work
cooperatively with the JV Partners and CFIUS to implement the terms
of the NSA. On August 12, 2020, the Company and the JV Partners
agreed to terminate the agreements underlying the China JV. As of
December 31, 2020, all agreements related to the China JV had been
terminated.
In accordance with the above, during the year ended December 31,
2020, the Company recorded a $66 loss on investment in
unconsolidated affiliate in the consolidated statements of
operations and comprehensive loss related to the write-off of
previously recorded direct costs related to establishing the China
JV.
5. Fair Value Measurement
Fair value is defined as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in
an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value
must maximize the use of observable inputs and minimize the use of
unobservable inputs. Three levels of inputs, of which the first two
are considered observable and the last unobservable, may be used to
measure fair value which are the following:
•Level
1—Quoted
prices in active markets for identical assets or liabilities. The
Company considers a market to be active when transactions for the
asset occur with sufficient frequency and volume to provide pricing
information on an ongoing basis.
•Level
2—Inputs
other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or
liabilities; quoted prices in markets that are not active; or other
inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or
liabilities.
•Level
3—Unobservable
inputs that are supported by little or no market activity and that
are significant to the fair value of the assets or liabilities. The
valuation of Level 3 investments requires the use of significant
management judgments or estimation.
The Company’s fair value hierarchies for its financial assets and
liabilities which require fair value measurement on a recurring
basis are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
Level 1 |
|
Level 2 |
|
Level 3 |
December 31, 2020 |
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
Warrant liabilities |
$ |
6,037 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
6,037 |
|
|
|
|
|
|
|
|
|
December 31, 2019 |
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
Warrant liabilities |
$ |
4,307 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
4,307 |
|
Contingent success fee liability |
$ |
6 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
6 |
|
During the years ended December 31, 2020 and 2019, there were no
transfers between Level 1, Level 2, or Level 3 assets or
liabilities reported at fair value on a recurring basis and the
valuation techniques used did not change compared to the Company’s
established practice.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
The following table sets forth a summary of the changes in the fair
value of Company’s Level 3 financial liabilities during the year
ended December 31, 2020, which were measured at fair value on
a recurring basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant
Liability |
|
Contingent
Success Fee
Liability |
Balance at December 31, 2019 |
$ |
4,307 |
|
|
$ |
6 |
|
Initial fair value of warrants in connection with June 2020
financing |
2,650 |
|
|
0 |
Loss on revaluation of warrants issued in June 2020, December 2019,
May 2019 financing, and December 2015 equity financings |
3,056 |
|
|
0 |
Reclassification of warrant liability to equity upon exercise of
warrants |
(3,976) |
|
|
— |
|
Gain on revaluation of contingent liability |
— |
|
|
(6) |
|
Balance at December 31, 2020 |
$ |
6,037 |
|
|
$ |
— |
|
See Note 13 in the notes to consolidated financial statements under
the caption
Capitalization and Equity Structure – Warrants
for a description of the warrants accounted for as a liability,
including the method and inputs used to estimate their fair
value.
6. Revenue Recognition
Revenue is recognized upon transfer of control of promised products
or services to customers in an amount that reflects the
consideration the Company expects to receive in exchange for those
products or services. The Company enters into contracts that can
include various combinations of products and services, which when
capable of being distinct, are accounted for as separate
performance obligations. Revenue recognition is evaluated based on
the following five steps: (i) identification of the contract with
the customer; (ii) identification of the performance obligations in
the contract; (iii) determination of the transaction price; (iv)
allocation of the transaction price to the performance obligations
in the contract; and (v) recognition of revenue when or as a
performance obligation is satisfied.
For multiple-element arrangements, revenue is allocated to each
performance obligation based on its relative standalone selling
price. Standalone selling prices are determined based on observable
prices at which the Company separately sells its products or
services. If a standalone selling price is not directly observable,
the Company estimates the selling price based on market conditions
and entity-specific factors including features and functionality of
the product and/or services, the geography of the Company’s
customers, type of the Company’s markets. Any discounts or other
reductions to the transaction price are allocated proportionately
to all performance obligations within the multiple-element
arrangement.
Contract Balances
Timing of revenue recognition may differ from the timing of
invoicing to customers and receipt of payment. For the sale of its
products, the Company generally recognizes revenue at a point in
time through the ship-and-bill performance obligations. For the
rental of its products, the Company generally recognizes revenue
over the rental term commencing upon the completion of customer
training. For service agreements, the Company generally invoices
customers at the beginning of the coverage period and records
revenue related to the billed amounts over time, equivalent to the
coverage period of the maintenance and support
contract.
Deferred revenue is comprised mainly of unearned revenue related to
extended support and maintenance contracts (Ekso Care), but also
includes other offerings for which the Company has been paid in
advance and earns revenue when the Company transfers control of the
product or service.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
Deferred revenue consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
Deferred extended maintenance and support |
$ |
2,902 |
|
|
$ |
2,837 |
|
Deferred royalties |
282 |
|
|
290 |
|
Deferred device, rental revenues and advances |
118 |
|
|
154 |
|
Total deferred revenues |
3,302 |
|
|
3,281 |
|
Less current portion |
(1,496) |
|
|
(1,492) |
|
Deferred revenues, non-current |
$ |
1,806 |
|
|
$ |
1,789 |
|
Deferred revenue activity consisted of the following for the year
ended December 31, 2020:
|
|
|
|
|
|
Beginning balance |
$ |
3,281 |
|
Deferral of revenue |
1,922 |
|
Recognition of deferred revenue |
(1,901) |
|
Ending balance |
$ |
3,302 |
|
At December 31, 2020, the Company’s deferred revenue
was $3,302. The
Company expects to recognize approximately $1,496 of the
deferred revenue during 2021, $908 in 2022,
and $898 thereafter.
In addition to deferred revenue, the Company has non-cancellable
backlog of $515 related to its contracts for rental units with
its customers. These rental contracts typically have 12-month lease
terms and rental income is recognized on a straight-line basis over
the lease term.
As of December 31, 2020 and 2019, accounts receivable, net of
allowance for doubtful accounts, were $3,389 and $5,208,
respectively, and are included in current assets on the Company’s
consolidated balance sheets. The allowance for doubtful accounts
reflects the Company’s best estimate of probable losses inherent in
the accounts receivable balance. The Company determines the
allowance based on known troubled accounts, historical experience,
and other currently available evidence. Payment terms and
conditions vary by contract type, although terms generally include
a requirement of payment within 30 to 90 days.
Disaggregation of revenue
The following table disaggregates the Company’s revenue by major
source for the year ended December 31, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EksoHealth |
|
EksoWorks |
|
Total |
Device revenue |
$ |
5,012 |
|
|
$ |
689 |
|
|
$ |
5,701 |
|
Service and support |
1,723 |
|
|
— |
|
|
1,723 |
|
Rentals |
782 |
|
|
55 |
|
|
837 |
|
Parts and other |
294 |
|
|
72 |
|
|
366 |
|
Collaborative arrangements |
255 |
|
|
— |
|
|
255 |
|
|
$ |
8,066 |
|
|
$ |
816 |
|
|
$ |
8,882 |
|
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
The following table disaggregates the Company’s revenue by major
source for the year ended December 31, 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EksoHealth |
|
EksoWorks |
|
Total |
Device revenue |
$ |
9,064 |
|
|
$ |
1,726 |
|
|
$ |
10,790 |
|
Service and support |
1,647 |
|
|
— |
|
|
1,647 |
|
Rentals |
913 |
|
|
— |
|
|
913 |
|
Parts and other |
259 |
|
|
234 |
|
|
493 |
|
Collaborative arrangements |
74 |
|
|
— |
|
|
74 |
|
|
$ |
11,957 |
|
|
$ |
1,960 |
|
|
$ |
13,917 |
|
7. Property and Equipment, net
Property and equipment, net consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
December 31, |
|
Life (Years) |
|
2020 |
|
2019 |
Company-owned fleet |
3-4
|
|
$ |
3,326 |
|
|
$ |
3,385 |
|
Computer software |
3-5
|
|
851 |
|
|
851 |
|
Leasehold improvement |
5-10
|
|
631 |
|
|
631 |
|
Furniture, office and leased equipment |
3-7
|
|
557 |
|
|
554 |
|
Machinery and equipment |
3-7
|
|
291 |
|
|
289 |
|
Tools, molds, dies and jigs |
5
|
|
96 |
|
|
96 |
|
Computers and peripherals |
3-5
|
|
77 |
|
|
77 |
|
|
|
|
5,829 |
|
|
5,883 |
|
Accumulated depreciation and amortization |
|
|
(4,657) |
|
|
(4,226) |
|
Property and equipment, net |
|
|
$ |
1,172 |
|
|
$ |
1,657 |
|
Depreciation and amortization expense of property and equipment,
net totaled $620 and $690 for the years ended December 31, 2020 and
2019, respectively.
8. Accrued Liabilities
Accrued liabilities consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
2020 |
|
2019 |
Salaries, benefits and related expenses |
$ |
1,194 |
|
|
$ |
1,098 |
|
Device warranty |
188 |
|
|
285 |
|
Other |
47 |
|
|
300 |
|
Total |
$ |
1,429 |
|
|
$ |
1,683 |
|
Warranty
Sales of devices generally include an initial warranty for parts
and services for one year in the Americas, two years in Europe, the
Middle East, Africa, and one or two years in the Asia Pacific
region. A liability for the estimated cost of product warranty is
established at the time revenue is recognized based on the
historical experience of known product failure rates and expected
material and labor costs to provide warranty services. Specific
additional warranty accruals may be made if unforeseen technical
problems arise. Alternatively, if estimates are determined to be
greater than the actual amounts necessary, a portion of the
liability may be reversed in future periods. Warranty costs
are reflected in the consolidated statements of operations and
comprehensive loss as a component of costs of revenue. The current
portion of the warranty liability is classified as a
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
component of accrued liabilities, while the long-term portion of
the warranty liability is classified as a component of other
non-current liabilities in the consolidated balance
sheets.
|
|
|
|
|
|
|
|
|
|
|
|
|
Warranty |
|
2020 |
|
2019 |
Balance at beginning of the period |
$ |
350 |
|
|
$ |
319 |
|
Additions for estimated future expense |
219 |
|
|
416 |
|
Incurred costs |
(343) |
|
|
(385) |
|
Balance at end of the period |
$ |
226 |
|
|
$ |
350 |
|
|
|
|
|
Current portion |
188 |
|
|
285 |
|
Long-term portion |
38 |
|
|
65 |
|
Total |
$ |
226 |
|
|
$ |
350 |
|
9. Notes payable, net
WAB and PWB Term Loans
WAB Term Loan
In December 2016, the Company entered into a loan agreement with
Western Alliance Bank ("WAB loan") and received a loan in the
principal amount of $7,000 that bore interest on the
outstanding daily balance at a floating per annum rate equal to the
30-day U.S. LIBOR plus 5.41%. The Company was required to pay
accrued interest on the WAB loan on the first day of each month
through and including January 1, 2018. Commencing on February 1,
2018, the Company was required to make equal monthly payments of
principal, together with accrued and unpaid interest maturing on
January 1, 2021. On April 29, 2020 the Company entered into a
second amendment to the December 2016 WAB loan agreement to defer
principal payments for three months beginning in May 2020, with
adjustments when the principal payments resumed on August 1, 2020.
During the three-month deferral period the Company was required to
make interest only payments.
The final payment fee, debt issuance costs, and the initial fair
value of the success fee combined with the stated interest resulted
in an effective interest rate for the WAB loan of 8.49% for the
year ended December 31, 2020. The final payment fee, initial fair
value of the success fee, and debt issuance costs were
accreted/amortized to interest expense using the effective interest
method over the life of the loan.
PWB Term Loan
In August 2020, the Company entered into a new loan agreement (the
"PWB Loan Agreement") with a different lender, Pacific Western
Bank, and received a loan in the principal amount of $2,000 (the
"PWB Term Loan") that bears interest on the outstanding daily
balance at a rate equal to the greater of: (a) 0.50% above the
variable rate of interest announced by the lender as its “prime
rate” then in effect; or (b) 4.50%. The PWB Loan Agreement created
a first priority security interest with respect to substantially
all assets of the Company, including proceeds of intellectual
property, but expressly excluding intellectual property
itself.
The proceeds of the PWB Term Loan were used to pay off the entire
amount of the Company's indebtedness on the WAB loan which amounted
to $1,512. Pursuant to the PWB Loan Agreement, the remainder of the
PWB Term Loan proceeds may be used for general corporate purposes
which totaled $480, net of debt discounts and issuance
costs.
The Company is required to pay accrued interest on the current loan
on the 13th day of each month through and including August 13,
2023. The principal balance of the PWB Term Loan matures on August
13, 2023, at which time all unpaid principal and accrued and unpaid
interest shall be due and payable in full. The interest rate of the
PWB Term Loan is subject to increase in the event of late payments
and after occurrence of and during the continuation of an event of
default. Upon maturity, all unpaid principal and accrued and unpaid
interest shall be due and payable in full. The Company may elect to
prepay the PWB Term Loan at any time, in whole or in part, without
penalty or premium.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
The PWB Loan Agreement contains a liquidity covenant, which
requires that the Company maintain unrestricted cash and cash
equivalents in accounts of the lender or subject to control
agreements in favor of the lender in an amount equal to at least
the outstanding balance of the PWB Term Loan, which was $2,000 as
of December 31, 2020. On December 31, 2020, with cash on hand of
$12,862, the Company was compliant with this liquidity covenant and
all other covenants.
The debt issuance costs and debt discounts combined with the stated
interest resulted in an effective interest rate of 4.64% for the
year ended December 31, 2020. The debt issuance costs will be
amortized to interest expense using the effective interest method
over the life of the loan.
The following table presents scheduled principal payments of the
Company's note payable as of December 31, 2020:
|
|
|
|
|
|
Period |
Amount |
2021 - 2022 |
$ |
— |
|
2023 |
2,000 |
|
Total principal payments |
2,000 |
|
Less final payment fee, discount and issuance cost |
11 |
|
Note payable, net |
$ |
1,989 |
|
|
|
Current portion |
$ |
— |
|
Long-term portion |
1,989 |
|
Note payable, net |
$ |
1,989 |
|
Paycheck Protection Program Loan
On April 20, 2020, the Company received an unsecured loan in the
principal amount of $1,086 under the Paycheck Protection Program
(the “PPP”) administered by the U.S. Small Business Administration,
or the SBA, pursuant to the Coronavirus Aid, Relief, and Economic
Security Act (the “CARES Act”), or the PPP loan. The PPP loan
provides for an interest rate of 1.00% per year, and matures two
years after the date of initial disbursement. The terms of the PPP
Loan were subsequently revised in accordance with the provisions of
the Paycheck Protection Flexibility Act of 2020, or the PPP
Flexibility Act, which was enacted on June 5, 2020. Based on
management's interpretation of the the PPP Flexibility Act, the
Company expects to begin making principal and interest payments on
the PPP loan beginning in 2022. The overall timing of payments with
respect to the amounts of principal and interest due could change
based on the ultimate determination of what may or may not be
forgiven. The PPP loan may be used for payroll costs, costs related
to certain group health care benefits and insurance premiums, rent
payments, utility payments, mortgage interest payments and interest
payments on any other debt obligation that were incurred before
February 15, 2020. Under the terms of the CARES Act and the PPP
Flexibility Act, the Company may apply for and be granted
forgiveness for all or a portion of loan granted under the PPP
loan, with such forgiveness to be determined, subject to
limitations (including where employees of the Company have been
terminated and not re-hired by a certain date), based on the use of
the loan proceeds for payment of payroll costs and any payments of
mortgage interest, rent, and utilities. The terms of any
forgiveness may also be subject to further requirements in
regulations and guidelines adopted by the SBA. While the Company
currently believes that the majority of the use of the PPP loan
proceeds will meet the conditions for forgiveness under the PPP, no
assurance is provided that the Company will obtain partial
forgiveness of the loan. Terms of the loan may change subject to
future enactments relating to the PPP.
The follow table presents the scheduled principal payments of the
Company's PPP loan note payable as of December 31, 2020, shown if
the loan is not forgiven:
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
|
|
|
|
|
|
Period |
Amount |
2021 |
$ |
— |
|
2022 |
1,086 |
|
Total principal payments |
$ |
1,086 |
|
|
|
Current portion |
$ |
— |
|
Long-term portion |
1,086 |
|
Note payable, net |
$ |
1,086 |
|
10. Lease Obligations
The Company maintains a five-year operating lease agreement for its
headquarters and manufacturing facility in Richmond, California, or
the Richmond Lease, which expires in May 2022, with no further
options to extend or terminate. The lease includes non-lease
components (i.e. common area maintenance costs) that are paid
separately from rent based on actual costs incurred. In June 2020,
the Company entered into an amendment to the Richmond Lease to make
a one-time payment of $300 to cover its remaining lease obligations
for the remainder of 2020, resulting in a $48 abatement and a lease
payment deferral of $79 to be paid in equal monthly installments in
2021.
The Company's five-year operating lease agreement for its European
operations office in Hamburg, Germany expires in July 2022. It has
an option to extend for another five-year term.
Through April 2019, the Company had an unoccupied leased sales
office in Freiburg, Germany, which had a lease term that expired in
December 2020. In April 2019, the Company entered an agreement with
the lessor of the Freiburg office releasing the Company from future
lease payments after April 30, 2019.
The Company’s future lease payments as of December 31, 2020 are as
follows, which are presented as lease liabilities on the Company’s
consolidated balance sheets:
|
|
|
|
|
|
|
|
|
Period |
|
Operating
Leases |
2021 |
|
$ |
599 |
|
2022 |
|
237 |
|
|
|
|
|
|
|
|
|
|
Total lease payments |
|
836 |
|
Less: imputed interest |
|
(55) |
|
Present value of lease liabilities |
|
$ |
781 |
|
|
|
|
Lease liabilities, current |
|
$ |
548 |
|
Lease liabilities, noncurrent |
|
233 |
|
Total lease liabilities |
|
$ |
781 |
|
|
|
|
Weighted-average remaining term (in years) |
|
1.44 |
Weighted-average discount rate |
|
10.5 |
% |
Lease expense under the Company’s operating leases was $537 and
$551, for the years ended December 31, 2020 and 2019,
respectively.
Practical Expedients
Leases with an initial term of 12 months or less are not recorded
on the balance sheet. The Company recognizes the lease expense for
such leases on a straight-line basis over the lease
term.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
As part of the transition to ASC 842, the Company elected to use
the modified retrospective transition method with the new standard
being applied as of the January 1, 2019 adoption date.
Additionally, the Company has elected, as of the adoption date, not
to reassess whether expired or existing contracts contain leases
under the new definition of a lease; the lease classification for
expired or existing leases; or whether previously capitalized
initial direct costs would qualify for capitalization under ASC
842.
11. Employee Benefit Plan
The Company administers a 401(k) retirement plan, or the 401(k)
Plan, in which all employees are eligible to participate. Each
eligible employee may elect to contribute to the 401(k) Plan. The
Company has made matching contributions in the form of shares of
the Company's common stock to the 401(k) Plan in an amount equal to
50% of employee contributions (up to the statutory limit),
subsequent to year-end. The expense related to the contribution was
$169 and $142 for the years ended December 31, 2020 and 2019,
respectively.
12. Related Party Transactions
One of the Company’s directors, Dr. Ted Wang, is the founder,
general partner and Chief Investment Officer of Puissance Capital
Management LP, or Puissance Capital, which is an affiliate of
Puissance Cross-Border Opportunities II LLC, one of the Company’s
largest stockholders until November 2020. Prior to Dr. Wang’s
appointment to the Board in connection with the Rights Offering in
September 2017, the Company entered into a one-year consulting
agreement with Angel Pond Capital LLC, or Angel Pond, an entity
solely owned and managed by Dr. Wang and affiliated with Puissance
Capital. Angel Pond provides consulting services to the Company
with respect to strategic positioning in the Asia Pacific region,
including introduction to potential strategic partners and the
development of strategic partnerships for the sale and manufacture
of the Company’s products in that market. During the year ended
December 31, 2019, Angel Pond provided consulting services
amounting to $30 during, which was expensed in the consolidated
statement of operations and comprehensive loss.
During the year ended December 31, 2020, the Company sold EksoVest
raw material inventory and tooling to the China JV for
$45.
13. Capitalization and Equity Structure
Reverse Stock Split
After the close of the stock market on March 24, 2020, the Company
effected a 1-for-15 reverse split of its common stock (the "Reverse
Stock Split"). As a result, all common stock share amounts included
in this filing have been retroactively reduced by a factor of
fifteen, rounded up to the nearest whole share, and all common
stock per share amounts have been increased by a factor of fifteen,
with the exception of the Company's common stock par value and the
Company's authorized shares. Amounts affected include common stock
outstanding, restricted stock units, common stock underlying stock
options and warrants.
As previously disclosed, on September 16, 2019, the Company
received a written notice from the Listing Qualifications
Department of The Nasdaq Stock Market LLC (“Nasdaq”) informing the
Company that because the closing bid price for the Company’s common
stock listed on the Nasdaq Capital Market was below $1.00 per share
for 30 consecutive business days, the Company did not meet the
minimum closing bid price requirement for continued listing on the
Nasdaq Capital Market. The reverse stock split was effected in
order to raise the per share trading price of its common stock
above $1.00 and regain compliance with Nasdaq’s listing
requirements. On April 7, 2020, the Company regained compliance
with the minimum bid price requirement required by the Nasdaq
listing rules.
Summary
The Company’s authorized capital stock at December 31, 2020
consisted of 141,429 shares of common stock and 10,000 shares of
preferred stock. The authorized capital was not reduced in
connection with the Reverse Stock Split. At December 31, 2020,
there were 8,349 shares of common stock issued and outstanding and
no shares of preferred stock issued and outstanding.
Common Stock
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
The holders of outstanding shares of common stock are entitled to
receive dividends out of assets or funds legally available for the
payment of dividends at such times and in such amounts as the Board
of Directors may determine. Holders of common stock are entitled to
one vote for each share held on all matters submitted to a vote of
stockholders. There is no cumulative voting for the election of
directors. The common stock is not entitled to preemptive rights
and is not subject to conversion or redemption. Upon liquidation,
dissolution or winding up of the Company, the assets legally
available for distribution to stockholders are distributable
ratably among the holders of the common stock after payment of
liquidation preferences, if any, on any outstanding payment of
other claims of creditors. Each outstanding share of common stock
is duly and validly issued, fully paid, and
non-assessable.
June 2020 Common Stock and Warrants to Purchase Common Stock
Offering
In June 2020, the Company entered into a securities purchase
agreement, or the June 2020 Purchase Agreement, with certain
purchasers. Pursuant to the June 2020 Purchase Agreement, the
Company sold in a registered direct offering, or the June 2020
Offering, an aggregate of 1,748 shares of its common stock.
Pursuant to such agreement, the Company also sold, in a concurrent
private placement offering, warrants to purchase 874 shares of its
common stock, or the June 2020 Investor Warrants. The gross
proceeds of the June 2020 Offering and the concurrent private
placement offering were $7,890, the June 2020 Gross Proceeds. Each
June 2020 Investor Warrant has an exercise price of $5.18 per
share, subject to adjustment in certain circumstances, and is
exercisable immediately and will expire five and one-half years
from issuance, or on December 10, 2025.
As compensation for services provided by the placement agent for
the June 2020 Offering, or the Placement Agent, the Company paid a
cash fee equal to 7.0% of the June 2020 Gross Proceeds ($552) and a
management fee equal to 1.0% of the June 2020 Gross Proceeds ($79),
and issued, in a concurrent private placement offering, warrants to
purchase shares of the Company's common stock, or the June 2020
Placement Agent Warrants, in an amount equal to up to 7.0% of the
aggregate number of shares of common stock sold in the June 2020
Offering, or 122 shares in the aggregate, in substantially the same
form as the June 2020 Investor Warrants, except that the June 2020
Placement Agent Warrants will expire five years from the effective
date of the June 2020 Offering, or on June 7, 2025, and have an
exercise price per share equal to $5.64. In connection with the
June 2020 Offering, the Company also incurred $98 in other expenses
of the Placement Agent paid for or reimbursed by the
Company.
Of the $7,890 in proceeds, $2,650 was allocated to the June 2020
Investor Warrants and June 2020 Placement Agent Warrants, or,
collectively, the June 2020 Warrants, based on the fair value
method, with the remaining proceeds of $5,240 allocated to the
common stock shares sold in the June 2020 Offering. In connection
with the June 2020 Offering and concurrent private placement
offerings, the Company incurred approximately $1,117 in direct
financing costs, including a fair value of $309 of June 2020
Placement Agent Warrants. Financing costs of $808, excluding the
fair value of the June 2020 Placement Agents Warrants, were
allocated on the fair value basis between the common stock shares
sold in the June 2020 Offering and the June 2020 Warrants, as
follows: $329 was allocated to the June 2020 Warrants and expensed
immediately in other income (expense), net in the accompanying
consolidated statements of operations and comprehensive income
(loss) and $479 was allocated to the common stock shares sold in
the June 2020 Offering and recorded as a reduction to additional
paid in capital. The direct financing cost of $309 associated with
the June 2020 Placement Agent warrants was also allocated to the
common stock shares sold in the June 2020 Offering and recorded as
a reduction to additional paid in capital.
At the Market Offering
In October 2020, the Company entered into an At The Market Offering
Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC
(the "Agent"), under which the Company may issue and sell shares of
its common stock, from time to time, to or through the Agent.
Offers and sales of shares of common stock by the Company through
the Agent may be made by any method deemed to be an “at the market
offering” as defined under SEC Rule 415 or in privately negotiated
transactions, subject to certain conditions. Such shares may be
offered pursuant to the registration statement on Form S-3 (File
No. 333-239203) (the “Registration Statement”), which was declared
effective by the SEC on June 26, 2020, and a related prospectus
supplement filed with the SEC on October 9, 2020 (the “ATM
Prospectus”). Pursuant to the Registration Statement and the ATM
Prospectus, shares having an aggregate offering price of up to
$7,500 may be offered and sold, subject to certain SEC rules
limiting the amount of shares of the Company’s common stock that
may be sold by the Company under the Registration Statement. Under
the ATM Agreement, shares of the Company's common stock may not be
sold for a price lower than $6.75 per share.
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
In August 2018, the Company entered into a Controlled Equity
OfferingSM
Sales Agreement with Cantor Fitzgerald & Co. (the "Cantor
Agreement"). Prior to entering into the ATM Agreement, the Company
terminated the Cantor Agreement in September 2020.
The Company did not sell any shares of common stock under the
Cantor Agreement or the ATM Agreement during the year ended
December 31, 2020.
Preferred Stock
The Company may issue shares of preferred stock from time to time
in one or more series, each of which will have such distinctive
designation or title as shall be determined by its Board of
Directors and will have such voting powers, full or limited, or no
voting powers, and such preferences and relative, participating,
optional or other special rights and such qualifications,
limitations or restrictions thereof, as shall be stated in such
resolution or resolutions providing for the issue of such class or
series of preferred stock as may be adopted from time to time by
the Board of Directors.
Warrants
Warrant shares outstanding as of December 31, 2019 and December 31,
2020 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Source |
Exercise
Price |
|
Term
(Years) |
|
December 31, 2019 |
|
Issued |
|
Expired |
|
Exercised |
|
December 31, 2020 |
June 2020 Investor Warrants |
$ |
5.18 |
|
|
5.5 |
|
— |
|
|
874 |
|
|
— |
|
|
(477) |
|
|
397 |
|
June 2020 Placement Agent Warrants |
$ |
5.64 |
|
|
5 |
|
— |
|
|
122 |
|
|
— |
|
|
— |
|
|
122 |
|
December 2019 Warrants |
$ |
8.10 |
|
|
5 |
|
556 |
|
|
— |
|
|
— |
|
|
— |
|
|
556 |
|
December 2019 Placement Agent Warrants |
$ |
8.44 |
|
|
5 |
|
52 |
|
|
— |
|
|
— |
|
|
— |
|
|
52 |
|
May 2019 Warrants |
$ |
3.52 |
|
|
5 |
|
444 |
|
|
— |
|
|
— |
|
|
(246) |
|
|
198 |
|
2017 Information Agent Warrants |
$ |
22.50 |
|
|
3 |
|
13 |
|
|
— |
|
|
(13) |
|
|
— |
|
|
— |
|
2015 Warrants |
$ |
41.25 |
|
|
5 |
|
107 |
|
|
— |
|
|
(107) |
|
|
— |
|
|
— |
|
Pre-2014 warrants |
$ |
144.90 |
|
|
9-10
|
|
6 |
|
|
— |
|
|
(6) |
|
|
— |
|
|
— |
|
|
|
|
|
|
1,178 |
|
|
996 |
|
|
(126) |
|
|
(723) |
|
|
1,325 |
|
June 2020 Investor Warrants
In June 2020, the Company issued the June 2020 Investor Warrants,
exercisable for up to 874 shares of the Company’s common stock at
an exercise price of $5.18 per share. The June 2020 Warrants were
issued as exercisable immediately, and will expire five and
one-half years from the date of issuance, or on December 10,
2025.
In addition, the June 2020 Investor Warrants contain a cashless
exercise provision, whereby, if, at the time a holder exercises its
June 2020 Investor Warrants, a registration statement registering
the issuance or the resale of the shares of common stock underlying
the June 2020 Investor Warrants under the Securities Act is not
then effective or available for the issuance of such shares, then
in lieu of making the cash payment otherwise contemplated to be
made to the Company upon such exercise in payment of the aggregate
exercise price, the holder may elect to instead receive, upon such
exercise (either in whole or in part), the net number of shares of
the Company’s common stock determined according to a formula set
forth in the June 2020 Investor Warrant. The June 2020 Investor
Warrants will be automatically exercised on a cashless basis on
their expiration date.
The June 2020 Investor Warrants could also require payment of
liquidated damages by the Company in the form of cash payments in
the event of a failure by the Company to timely deliver shares of
common stock upon exercise of such warrants. During the year ended
December 31, 2020, 477 shares of the June 2020 Warrants were
exercised.
The June 2020 Investor Warrants also contain a put option, under
which, if the Company enters into a Fundamental Transaction, as
defined in the June 2020 Investor Warrants, as defined in the June
2020 Investor Warrants, the holders of the June 2020 Investor
Warrants will be entitled to receive upon exercise of the June 2020
Investor Warrants the kind and amount
Ekso Bionics Holdings, Inc.
Notes to Consolidated Financial Statements
(In thousands, except per share amounts)
of securities, cash or other property that the holders would have
received had they exercised the June 2020 Investor Warrants
immediately prior to such fundamental transaction. Alternatively,
the Company or any successor entity will, at the option of a holder
of a June 2020 Investor Warrant, exercisable concurrently with or
at any time within 30 days after the consummation of such
Fundamental Transaction, purchase such holder’s June 2020 Investor
Warrant by paying to such holder an amount of cash equal to the
Black-Scholes value of the remaining unexercised portion of such
holder’s June 2020 Investor Warrant. Because of this put-option
provision, the June 2020 Investor Warrants are classified as a
liability and are marked to market at each reporting
date.
The warrant liability related to the June 2020 Investor Warrants is
measured at fair value upon issuance and at each reporting date
using certain estimated inputs, which are classified within Level 3
of the fair value hierarchy. The following assumptions were used in
the Black-Scholes Model to measure the fair value of the June 2020
Investor Warrants:
|
|
|
|
|
|
|
|
|
|
December 31, 2020 |
June 10, 2020 |
Current share price |
$ |
|