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(Mark One)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2021
☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______________to________________
Commission File No. 001-37704
DARIOHEALTH CORP.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
18 W. 18th St.
New York, New York
(Address of principal executive offices)
45-2973162
(I.R.S. Employer
Identification Number)
10011
(Zip Code)
(972)-4 770-6377
(Registrant’s telephone number, including area code)
Securities Registered pursuant to Section 12(b) of the Act
Common Stock, par value $0.0001 per share
Title of each class
Trading Symbol(s)
DRIO
Name of each exchange on which registered:
The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(b) of the Exchange Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock, par value $0.0001 per share; Warrants to purchase Common Stock
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☑
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 ☑
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 ☑ 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 ☑ 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
Non-accelerated filer
Emerging growth company
☐
☑
☐
Accelerated filer
Smaller reporting 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial
reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☑
The aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the closing price as of the last business day of the
registrant’s most recently completed second fiscal quarter is $307,551,746.
As of March 17, 2022, the registrant had outstanding 21,814,967 shares of common stock, $0.0001 par value per share.
Documents Incorporated By Reference: None.
Table of Contents
Item No.
Description
Page
TABLE OF CONTENTS
Cautionary Note Regarding Forward-Looking Statements
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Item 9C
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities
[Reserved]
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
PART III
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
PART IV
Item 15.
Item 16.
Signatures
Exhibits and Financial Statement Schedules
Form 10-K Summary
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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, or the Annual Report, contains “forward-looking statements,” which includes
information relating to future events, future financial performance, financial projections, strategies, expectations,
competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,”
“continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well
as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a
guarantee of future performance or results and may not be accurate indications of when such performance or results will be
achieved. Forward-looking statements are based on information we have when those statements are made or management’s
good faith belief as of that time with respect to future events, and are subject to significant risks and uncertainties that
could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking
statements. Important factors that could cause such differences include, but are not limited to:
● our current and future capital requirements and our ability to satisfy our capital needs through financing
transactions or otherwise;
● our product launches and market penetration plans;
● the execution of agreements with various providers for our solution;
● our ability to maintain our relationships with key partners, including Sanofi U.S. Services Inc. (“Sanofi”);
● our ability to complete required clinical trials of our product and obtain clearance or approval from the
United States Food and Drug Administration (the “FDA”), or other regulatory agencies in different
jurisdictions;
● our ability to maintain or protect the validity of our U.S. and other patents and other intellectual property;
● our ability to retain key executive members;
● our ability to internally develop new inventions and intellectual property;
● the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy;
● interpretations of current laws and the passages of future laws; and
● acceptance of our business model by investors.
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking
statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those
anticipated in our forward-looking statements. Please see “Risk Factors” for additional risks that could adversely impact
our business and financial performance.
Moreover, new risks regularly emerge and it is not possible for our management to predict or articulate all the
risks we face, nor can we assess the impact of all risks on our business or the extent to which any risk, or combination of
risks, may cause actual results to differ from those contained in any forward-looking statements. All forward-looking
statements included in this Annual Report are based on information available to us on the date of this Annual Report.
Except to the extent required by applicable laws or rules, we undertake no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information, future events or otherwise. All subsequent written and
oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by
the cautionary statements contained above and throughout this Annual Report.
When used in this Annual Report, the terms “DarioHealth,” “the Company,” “we,” “our,” and “us” refer to
DarioHealth Corp., a Delaware corporation and our subsidiary LabStyle Innovation Ltd., and Upright Technologies Ltd.,
each of which are Israeli companies, Upright Technologies Inc. and PsyInnovations Inc., each a Delaware company, and
PsyInnovations India Private Limited, an Indian company. “Dario” is registered as a trademark in the United States, Israel,
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China, Canada, Hong Kong, South Africa, Japan, Costa Rica, and Panama. “DarioHealth” is registered as a trademark in
the United States and Israel.
Item 1. Business
PART I
We are revolutionizing how people with chronic conditions manage their health through the innovation of a new
category of digital health: Digital Therapeutics as a Service (DTaaS). We believe that our innovative approach to digital
therapeutics disrupts the traditional provider-centered system of health care delivery by offering user-centric care that is
continuous, customized and multi-condition. Our solutions combine the power of technologies and behavior science to
make better health accessible, affordable, and easy for all by solving for what people need, when and where they want it,
with hyper-personalized care that is always connected – to services, devices, and people – and delivered continuously. This
is how we deliver meaningful and sustainable results that result in measurable value for all stakeholders, supporting the full
transformation of health care into a more effective and affordable ecosystem.
Market Environment
The United States health care industry is becoming increasingly inefficient, incurring higher, unsustainable health
care costs while the chronic conditions that it seeks to address continue to worsen. According to the Centers of Medicare
and Medicaid Services (CMS), the U.S. spent $4.1 trillion on health care in 2020, with 75% of the costs attributed to care
for chronic conditions. We believe that addressing the cost challenges in chronic condition management will require three
main shifts.
First, the market must shift from a provider-centric approach to a consumer centric approach, embracing the
transformative effects of consumerization as a means to engage more patients in their own treatment to scale effective
chronic condition management. This consumerization of health care will change how people experience care, create new
opportunities to engage people and help them change their behaviors for better health and lower cost of care.
Second, the digitalization of health will enable scale by connecting patients to health care professionals and
payers, giving patients access to care for their health between provider visits and shifting healthcare from episodic to
continuous care. Telehealth addresses the synchronous portion of the problem, while digital health provides continuous
support at scale.
Finally, value-driven care should become the standard. In fact, performance-based models are already becoming a
reality as the industry reckons with unsustainable costs and growing demands for transparency, creating pressure on
stakeholders to find solutions that will address poor health and lower costs of care.
Overview
We began as a direct-to-consumer digital therapeutics company, solving first for the problem of how to engage
users and support behavior change to improve clinical outcomes in diabetes. In the last two years, we made two strategic
shifts to transform our business: first, we significantly expanded commercial growth opportunities by adding a business-to-
business product (B2B) and a commercial team alongside the legacy direct-to-consumer channel. In addition, we began
targeting three traditional health business verticals – health plans, employers, and provider groups. As a result, we believe
that our new B2B business now leverages our consumer-centric capabilities as a competitive advantage.
Second, we transitioned from a single condition platform to a multi-condition platform, creating a robust suite of
solutions to address the five most commonly co-occurring and expensive chronic conditions, which are also representative
of some of the most sought-after digital health solutions: diabetes, hypertension, pre-diabetes/weight management,
musculoskeletal and behavioral health. After building weight loss and hypertension management into the legacy diabetes
platform, we made three acquisitions in order to expand into musculoskeletal and behavioral health.
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Our acquisition of Upright Technologies Ltd. (“Upright”) in early 2021 and Physimax in early 2022 enables our
musculoskeletal (“MSK”) solutions – “Dario Move.”, our digital behavioral health capabilities were secured through the
acquisition of PsyInnovations, Inc. (dba wayForward) in mid-2021.
We believe a key success factor is our ability to integrate multiple chronic conditions into a single digital
therapeutics platform, the “Dario One.” During 2021 we successfully won contracts in all three B2B business segments,
including several contracts for Dario One, creating a compounding effect as more members enroll and many in multiple
programs. The combination of moving from direct-to-consumer to the enterprise business market (B2B2C) and expanding
from a single condition to multi condition platform, created multiple commercial growth engines as well as a multiplying
impact that we believe will improve our financial profile by increasing potential revenue per account and per user.
Recent Developments
Agreement with a Leading Employer Benefits Brokerage
In December 2021, we announced that we entered into a strategic partnership with a leading employer benefits
brokerage (the “Partner”) to sell its digital therapeutic solutions for diabetes, hypertension and musculoskeletal health as
part of a new premier employee health benefits product for small businesses. The product has been made available to the
Partner's more than 2,300 clients since early 2022.
Employer Contracts and Health Providers
Dario closed 2021 with a total of 54 new contracts in its first full year of selling digital therapeutics in the
business-to-business market. We have a range of health plans, providers and employers taking advantage of our digital
therapeutics platform designed to address the most common chronic conditions: diabetes, hypertension, weight
management, musculoskeletal, and behavioral health.
In January 2022, we announced two new contracts with a large U.S. northeast regional employer in the finance
industry set to deploy the Company's full suite of solutions, and a northeast regional employer in the food industry
contracted to deploy the Company's digital therapeutic solution for diabetes. In January 2022, we also announced that we
have contracted with a large regional health plan provider to deliver its digital therapeutic solution for diabetes for eligible
U.S. Medicaid members in and around the mid-Atlantic region. The contract is expected to contribute to revenue beginning
in the second quarter of 2022.
In addition, in February 2022, we announced several new contracts to deliver the Company’s digital therapeutics
solutions for four new employers. The new accounts are expected to launch during the first and second quarters of 2022.
The new clients include a northeast regional employer contracted for the Company's diabetes solution and three employers
- including two educational organizations and a regional professional services firm - launching with the Company's
behavioral health solution. In March 2022, we also announced new agreements with a regional employer and a regional
provider. The new employer client will deploy Dario's digital behavioral solution to improve access to outcomes-based
care, and the new provider contract will deliver both diabetes and hypertension solutions to patients. The contracts are
expected to launch in the second quarter of 2022.
Agreement with Physimax
In January 2022, we announced that we have entered into an agreement to purchase all of the right, title and
interest in certain assets of Physimax Technologies Ltd. ("Physimax"), a leading provider of computer vision (CV)
technology for Musculoskeletal (MSK) functional screening and predictive risk of injury assessment. Physimax's
technology is currently in commercial use by NBA and NFL teams, the U.S. military and health care facilities specializing
in orthopedic care. The closing of the acquisition of Physimax's assets is subject to customary closing conditions, including
the approval of the Israeli Innovation Authority. The technology enables automated MSK and injury risk screenings with
validated accuracy and Physimax's Artificial Intelligence (AI) engine generates evidence-based personal training programs
based on the user's objective scoring outcome to aid in effective injury prevention and recovery. Physimax's unique
technology is validated by a professional motion lab as well as industry experts and proven to be comparable to trained
human professionals. In consideration for the acquisition of Physimax's assets, the Company agreed to issue up to 256,660
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shares of its common stock, subject to a lock up period, plus a cash payment of $500,000, as well as agreed to assume
certain liabilities in an approximate amount of $1,020,000.
Agreement with Sanofi U.S.
In March 2022, we announced our entering into a strategic agreement with Sanofi U.S., an innovative global
healthcare company. The multi-year, $30 million-dollar agreement, which is subject to certain contingencies, will help
accelerate commercial adoption of Dario's full suite of digital therapeutics and drive the expansion of digital health
solutions on the Dario platform. Dario and Sanofi will collaborate on promoting the Dario multi-condition digital
therapeutics solution, significantly increasing Dario's sales reach in the health plan market and selectively in the employer
channel. In addition, the agreement calls for Dario and Sanofi to develop new or enhanced solutions leveraging the Dario
platform, and for the parties to generate robust evidence to support future commercialization in the health plan channel.
Competitive Advantages
Our competitive advantage is driven by several unique capabilities, including:
Consumer-centric design. Most digital health solutions are built to address the needs of a business and then sold
directly to the business, bypassing the difficult step of achieving consumer buy-in with respect to the product. Our
experience as a direct-to-consumer company now leverages those insights to drive B2B2C commercial growth by working
with health plans, employers, and provider groups and providing them a solution that their end users are more likely to
utilize. Our current and potential customers recognize that consumer engagement insights are critical to success, and they
are prioritizing solutions with more of a consumer focused experience.
Hyper-personalization. Unlike other digital health solutions, we personalize the user journey to anticipate and
adapt to each individual’s unique circumstances, preferences and changes over time. Our solution has a 40% member
enrollment rate. Our customized, dynamic user journeys are delivered by our artificial intelligence (“AI”)-driven journey
engine which personalizes user experience across a range of factors including timing, tone, channel, content, frequency and
intervention. We believe that this creates an adherence to our solutions that leads to an 80% year-over-year retention rate
for consumers on our platform and the ability to sustain clinical improvements for more than two years, as demonstrated in
our published studies as discussed more fully below.
Therapeutic value at scale. The digitization of health care has created an ecosystem of access points and point
solutions that are largely disconnected, creating waste and inefficiency without sustainable value. We believe that our
unique approach to connected and continuous health care through the use of our single integrated multi-condition platform
leads to superior engagement and retention, reduced costs, and ultimately, improved user health that can be delivered at
scale.
These advantages combine to ensure that our users have a better overall experience, with stronger engagement,
superior clinical and financial outcomes and a simplified integrated platform that addresses the conditions that matter most
to our customers and users.
Our Product Offering
Our user-centric software platform integrates digital therapeutics, coaching, professional human support and
medical devices to drive superior clinical and financial outcomes. Our suite of offerings is modular, allowing for enterprise
clients to purchase one or more of our chronic condition management solutions, while enjoying the same best-in-class
experience supported by our behavior change journey engine so our partners can be confident in achieving sustainable
outcomes and value. Our suite of digital offerings include:
Dario Metabolic (“Dario Evolve”)
Dario’s metabolic solutions are designed to address some of the most commonly co-occurring metabolic health needs -
diabetes, hypertension, and weight management - through a combination of software, our smartphone-connected tools,
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interaction with live coaches, and real-time data analysis to help inform and educate users of the relationship between their
behaviors and their health outcomes to drive changes that last.
Dario Musculoskeletal (“Dario Move”)
Our unique approach prevents and treats the most common MSK conditions, including chronic pain, by dealing with the
cause and empowers users to create behavioral change. Dario Move’s digital physical therapy programs and posture
training help people improve strength and mobility by using a combination of software, wearable biofeedback sensors, and
coaching to drive sustainable improvements in musculoskeletal health.
Dario Behavioral Health (“Dario Elevate”)
Dario’s behavioral health solution optimizes access to evidence-based care by using an AI-driven screener to triage users
and connect them to the most appropriate support across a wide range of mental health needs, including our integrated
digital tools and coaching, giving patients a seamless path to proven mental health support.
Dario Full Suite (“Dario One”)
Dario’s full suite of chronic condition management solutions offers the maximum benefit for our partners with a
completely seamless and holistic approach to managing chronic conditions. In addition to a better member experience, our
partners deploying Dario One enjoy several benefits from purchasing the entire suite of solutions: better overall health as
evidenced by recent research published by us; the convenience and ease of a single vendor to manage; less strain on
internal resources spread across several chronic condition management programs; and a more affordable program launches
due to lower costs of implementation.
Dario Health Solution Main Components
Users vary significantly in their interests and preferences, and unique user preferences also vary over time with
respect to the optimal timing, tone, content, channel, frequency, and interventions required to produce sustained behavior
change. Users’ interactions with devices, smartphones, coaches, providers, and third-party solutions must be personalized
along these axes to ensure optimal engagement, retention, and outcomes. Furthermore to engage and sustain user interest
and participation, and drive outcomes, platforms must be dynamically responsive. Due to a lack of responsiveness to these
types of variances, most digital health platforms that achieve high initial engagement often fail to retain users over time.
Key to our ability to accommodate user behavioral changes is our mature AI-driven user journey engine. While
several in-market solutions now integrate health signals across a range of categories to apply limited, nominal
personalization, primarily in the form of nudges, our solution is informed by years of user experience data from over
223,000 users, enabling us to continually personalize and adapt user journeys themselves (and not just messages) over
time. Our journey engine drives our multichannel targeted outreach and enrollment campaigns, informs specific
recommendations around a range of categories such as diet, physical activity, self-care, coaching interventions, and
provider engagement, and evolves in real time in response to the data exhaust from a user’s interaction with the care
ecosystem.
Our journey engine combines complex behavioral science insights with data from hundreds of thousands of users
over several years to recommend AI-driven initial and updated care journeys in response to a user’s engagement with the
platform. Most digital health solutions consist primarily of tracking, content, and nudges. These are often perceived by
users as non-rewarding work, and often do not feel relevant to their concerns, particularly as they evolve over time. We
believe that current in-market solutions trivialize within person changes over time and do not appropriately respond to the
dynamically evolving interests of users. This results in reduced engagement and impaired outcomes. Our journey engine
adapts user journeys to drive engagement, retention, and clinical outcomes by optimizing timing, tone, channel, content,
frequency and intervention to deliver dynamically personalized user journeys that are more likely to result in the behavior
changes needed to drive improved outcomes across a range of conditions. As we partner with solutions in additional
conditions or categories, we engage new populations and generate fresh insights, enhancing the engagement and efficacy of
these partnered solutions to deliver additional value to our users. The engine is designed for integration and scale; as
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we add populations and conditions for which behaviors are primary drivers of outcomes, our engine becomes more adept at
customizing a user’s evolving preferences and needs.
Software Applications
Our chronic condition management solutions are designed as three separate software applications to provide the
best possible user experience across metabolic, MSK and behavioral health needs. Each application is integrated with
Dario’s single digital therapeutics platform and behavior change journey engine to ensure the same hyper-personalized
experience across each person’s unique health needs and preferences to keep them on track with healthy changes over time.
Dario Evolve
Dario Evolve helps users change their behaviors and help better manage their diabetes, blood pressure and weight.
Using real-time data and analysis, the app helps users track their progress and offers real-time feedback and customized
content to support each individual’s needs and goals. Integration with the Dario journey engine ensure that each user
receives holistic support and a highly personalized experience that keeps them on track for long-lasting results.
Dario Move
Dario Move helps users improve strength and mobility to help address chronic pain and improve overall
musculoskeletal health. After completing an online assessment, each user receives a personalized, evidence-based exercise
program that can be adjusted throughout their journey based on sensor data or self-reported feedback to a coach or in the
app. Dario Move guides members through their tailored program with educational content to support long-term outcomes.
Dario Elevate
Dario’s Elevate helps people get the help they need to address common mental health needs. Starting with a
responsive, AI-driven screener, elevate triages users to understand the need and recommend the most appropriate support to
help them feel better. Our integrated, evidence-based digital tools and coaching help people learn proven techniques to
better manage their emotional health.
DarioEngage and Coaching
Our member health is managed through our proprietary care management platform DarioEngage, an integrated
experience from contracting through onboarding, data exchange, enrollment, outcomes, and reporting. Regardless of which
conditions or populations our customers select, and independent of whether they choose to deploy portions of their strategy
through other partners, we present a unified application experience in DarioEngage to reporting that simplifies
deployments, creates market-leading transparency, and accelerates and broadens user engagement.
DarioEngage also serves to support our coaching staff by providing a member-level view to help monitor progress
and track escalations in real-time. Our professional staff includes trained and certified health coaches who serve as a
personal support for each member throughout their journey, and clinical experts who provide expert-level care when
members need additional support. Our clinical coaches include Certified Diabetes Educators (CDCES), Registered Nurses,
Pharmacists and Mental Health Clinicians who are able to assist members throughout their journey.
Dario User Devices
Our product offerings include integrated devices to capture relevant clinical and biofeedback data to support
continuous, real-time monitoring of member health. Our native devices include:
● All-in-one smart glucose meter
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● Bluetooth connected blood pressure cuff
● Digital Scale
● Biofeedback sensor device
Sales and Marketing
In 2021, we invested in building a robust U.S. commercial team with deep experience in the health care industry
to sell into the three key industry segments: health plans, employers, and providers. Dario’s sales teams are aligned to
commercial channels and charged with maximizing revenue by selling multiple product lines in each channel.
Dario’s marketing resources are focused on three key objectives: first, engage new consumers on the platform to
provide early feedback on new and enhanced solutions; second, engage eligible individuals with our services as part of an
enterprise client population; and third, attract new enterprise clients across all three sales segments.
Our Commercial Channels
Our software solutions are sold across a range of channels to create multiple growth engines and support rapid
adoption across all segments of the market. Our integrated product suite is designed to address a common and growing
sentiment from enterprise customers expressing frustration with the large number of condition-specific solutions, lack of
transparency, lackluster results and poor member experiences. Our software solutions align to meet the pain points across
the three key buyer segments – health plans, employers, and providers – while also delivering value to strategic partners
through our differentiated approach in the market. Finally, our consumer-centric legacy remans a key component of our
commercial strategy, bolstering our ongoing solution development by serving as proving grounds for new services and
product enhancements.
Health Plans: Although health plans represent the longest and most complex purchasing cycle across our client
base, these contracts often represent sizeable opportunities as they typically offer much larger potential member
populations. We currently have two live contracts with health plans, one a regional payer and one a large national plan,
with several additional plans in negotiation and contracting at present day.
Employers: Our most robust growth in 2021 came from the employer market, a key buyer to help demonstrate our
ability to deliver results. Today, we have several dozen employer populations actively on our platform, and growth of our
employer pipeline continues to grow and mature.
Providers: The Centers for Medicare and Medicaid released additional proposed Current Procedural Terminology
(“CPT”) codes for remote therapeutics in 2021, expanding our ability to support providers using our solutions to provide
Remote Patient Monitoring (RPM) services. We won provider RPM contracts from several large regional practices in 2021
and continue to see pipeline growth thanks to the growing regulatory acceptance of digital health as form of care delivery,
with several practices actively in the negotiation and contracting phase.
Partnerships: As part of our strategy for rapid growth, strategic partnerships play a key role in helping to expand
our reach across markets quickly and efficiently. One such significant partnership agreement to come to fruition in early
2022 is our collaboration with Sanofi, a global leader in health care. The multi-year, $30 million-dollar agreement, as
described more fully below, will help accelerate commercial adoption of our full suite of digital therapeutics through the
promotion of our solutions in Sanofi sales channels and the collaborative development of new products. We also entered
into partner agreements with several large employer benefits platforms such as Virgin Health Pulse in 2021, helping expand
our reach within the employer market.
Consumers: Our ability to engage members and improve health begins with our consumer-centric approach, and
this audience remains key to our commercialization at the enterprise client level. Our direct-to-consumer channel continues
to attract members to our platform and provides a neutral audience for testing and learning about our products. These
insights inform both our AI-driven behavior change journey engine, helping continuously improve engagement and
retention, and inform product design to ensure our solutions remain at the forefront of consumer expectations.
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Sanofi U.S. Agreement
On February 28, 2022, we entered into an exclusive preferred partner, co-promotion, development collaboration
and license agreement (the “Agreement”) with Sanofi for a term of five (5) years. Pursuant to the Agreement, we and
Sanofi will collaborate as preferred partners to co-promote certain of our products and services, including devices and
accessories, and to develop new products and services based on insights derived from our data relating to the use of those
devices and services. In addition, we granted Sanofi a license to access and use certain of our data to derive insights from
and improve our products or services, and Sanofi granted us a license under certain intellectual property of Sanofi for
purpose of creating and promoting certain products and services in the United States.
Pursuant to the Agreement, in consideration of the preferred co-promotion and development rights granted by us,
Sanofi agreed to pay us an aggregate amount of up to $30 million over the initial term of the Agreement, consisting of (i)
an upfront payment, (ii) annual compensation for development costs per annual development plans to be agreed upon
annually and (iii) certain contingent milestone payments upon meeting certain net sales and enrollment rate milestones at
any time during the term of the Agreement. The Agreement also provides for us to make certain revenue sharing payments
to Sanofi in a percentile beginning in the low double digits to low twentieth percentile of specified revenues upon
qualifying sales through Sanofi introductions achieving a minimum revenue amount, and provided that the qualifying sales
through Sanofi introductions remain above a specified percentage of total sales after year 3 of the collaboration. Revenue
sharing in the thirtieth percentile will apply with respect to new solutions or services developed under the collaboration.
The Agreement has a term of five (5) years and may be renewed for a subsequent five (5) year term upon the
mutual agreement of the parties. The Agreement may be terminated (i) by either party for a material breach, force majeure
or insolvency; (ii) by us if net sales requirements are not reached; (iii) by either party for convenience, upon sixty days’
prior notice, beginning in the third year of the Agreement; or (iv) by Sanofi if we fail to complete a development plan
within nine (9) months of the Effective Date, or upon our change of control.
Our Growth Strategies
As a company with multiple product lines operating in several channels, we have multiple growth engines.
Furthermore, because we often bill on a per member per month basis, this enables recurring revenue that grows when users
are enrolled into the platform. The below key factors should have high impact on the business ability to grow.
Add customers across a range of markets and channels. In 2021, we established a client footprint across all three
key enterprise verticals – providers, employers, and health plans – with contracts representing a mix of our solutions. Each
additional contract not only increases revenues, but also the likelihood of attracting additional new customers as they
recognize our solutions being adopted and trusted by peers and competitors. With new and existing clients, we are also
focused on expanding client solution contracts across product lines to increase our ability to maximize revenue per member
through engagement in multiple condition management programs.
Increase the eligible populations within customers. The expansion of our solution set to include MSK and
behavioral health increases our ability to cover larger portions of our customers’ populations, thereby reducing the need for
our customers to engage multiple vendors, and reducing their costs as compared to the alternative of partnering with
multiple solutions to cover the conditions and categories that we cover on one single platform. The addition of medical
conditions on our platform in the future can also accelerate the eligible populations for our services.
Drive Engagement. Our business model is predominantly a subscription model, where we charge per user engaged
on the platform. As our AI matures and as we deploy increasingly dynamic and adaptive personalization, we intend to
engage a large portion of eligible populations, potentially driving increased revenue.
Optimize solutions for value. Our customers primarily engage for 2 key reasons: the opportunity for cost savings
and our competitive advantage in breadth of conditions serviced and our AI technology. Our pricing strategy is designed to
deliver return on investment to our customers soon after engagement, and steadily over time. As we evolve our solutions to
deliver increased value to our users, we can offer customers value-based pricing models that can lead to greater revenue.
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Operations
The onboarding of client populations across multiple product lines requires the ability to outreach and engage to
large numbers of individuals in a coordinated and responsive manner. We are focused on scaling operations to meet the
rapid growth our of enterprise client member base by investing in platform and process technologies.
We also maintain supply agreements with commercial-scale manufacturers to produce our consumer devices, and
owns the specialized equipment used to manufacture the Dario Blood Glucose Monitoring System.
Clinical Studies
Main Highlights
Our studies below demonstrate the clinical value of our legacy digital therapeutic devices and the ability of our
solutions to deliver sustainable outcomes over time.
Dario reported an Average Reduction in Estimated HbA1C of 1.4% for High-Risk type 2 Diabetes Users.
Dario presented at the 77th ADA session a study that was titled “Reducing A1C Levels in Individuals with High-
Risk Diabetes Using the Mobile Glucose Meter Technology.” In the study Dario reported an average reduction in estimated
HbA1C of 1.4% for high-risk type 2 Diabetes users.
At the ADA 2018 session, Dario presented three real-world-data analysis studies, as detailed below.
Type 2 Diabetes Users of Dario Digital Diabetes Management System Experience a Shift from Greater than 180
mg/dL to Normal Glucose Levels with Sustainable Results
●
●
Reduction of 19.3% in high glucose readings within 12 months
Increase of 11.3% in in-range readings within 12 months
Method: A retrospective data evaluation study was performed on the DarioTM cloud database. A population of all
active Type 2 Diabetic (T2D) users that took measurements with DarioTM BGMS on average of 20 measurements per
month during 2017. The study assessed the ratio of all high blood glucose readings (180-400 mg/dL) and the ratio of all
normal blood glucose readings (80-120 mg/dL) in their first month of use to their last month of use during 2017 as
recorded in the database.
Results: For 17,156 T2D users activated during 2017 the average ratio of high events (180-400 mg/dL) was
reduced by 19.3% (from 28.4% to 22.9% of the entire measurements). While at the same time, the ratio of normal range
readings (80-120 mg/dL) was increased by 11.3% (from 25.6% to 28.5% of the entire measurements). The most significant
shift occurred after one month of usage (14% decrease) and maintained stability over the following months throughout the
full year.
Updated Analysis combining 2017 and 2018 data totals 38,838 Type 2 Diabetes active users and 3,318,014
measurements show 14.3% decrease in high readings (180-400 mg/dL) and 9.2 % increase in In-range (80-120 mg/dL)
readings
A decrease in High Readings and Severe Hyperglycemic Events for People with T2D over the Full Year of 2017 in
Users Monitoring with Dario Digital Diabetes Management System
●
●
Reduction of 20% of High events (180-400 mg/dL) in T2D sustained within 12 months
Reduction of 58% of Hyper events (>400mg/dL) in T2D within 12 months
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Method: A retrospective data evaluation study was performed on the DarioTM cloud database. A population of
active Type 2 Diabetic (T2D) users that continuously measured their blood glucose using DarioTM BGMS during the full
year of 2017 was evaluated. The study assessed the ratio of high (180-400 mg/dL) and hyperglycemic (>400mg/dL) blood
glucose readings during full year of 2017 as recorded in the database. The average of high and hyperglycemic glucose
readings were calculated in periods of 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-
330, 330-360 days and compared to first 30 days as a starting point of analysis.
Results: For 225 T2D active users the ratio of high events (180-400 mg/dL) was reduced gradually in 19.6%
(from 23.4% to 18.8% of the entire measurements) from baseline compared to the 12th month of the year. Moreover, the
ratio of severe hyperglycemia events (>400 mg/dL) was decreased in 57.8% (from 0.90% to 0.38% of the entire
measurements) at the same period.
Continuous Reduction of Blood Glucose Average during One Year of Glucose Monitoring Using Dario Digital
Monitoring System in a High-Risk Population
●
●
Reduction of 14% Blood Glucose average was observed in T2D within 12 months
76% of the population showed 24% improvement in Blood glucose average within 12 months
Methods: An exploratory data analysis study reviewed a population of high risk active type 2 Diabetic users with
initial 30 days glucose average above 180 mg/dL during a full calendar year. The study assessed the average blood glucose
readings along a year of usage. The average of glucose readings was calculated per user in periods of 30 days intervals
from 30-60 to 330-360 days and compared to the first 30 days as the starting point baseline of analysis.
Results: Overall of 238 highly engaged T2D users (more than one daily measurement in average) whose average
blood glucose level was above 180mg/dL in the first 30 days of measurements (225±45 mg/dL) showed continuous
reduction in glucose level average vs. baseline. Reduction in blood glucose average level was demonstrated gradually, in
the succeeding 3, 6 and 12 months showing average decrease of 7%, 11% and 14% vs. baseline, respectively. Furthermore,
76% of the entire population (180 out of 238 users) improved their average blood glucose level over a year. Those 180
users (average blood glucose 228±46) showed an average decrease of 10%, 16% and 24% in their glucose average
following 3, 6 and 12 months, respectively.
At the American Association of Diabetes Educators (AADE) 2018 Dario presented a study titled “Decrease in
Estimated A1C for people in High-risk over a full year of users monitoring with a digital Diabetes management
system.”
A reduction of 1.4% in estimated HbA1C in Type 2 Diabetes high risk users from baseline after one year of the
Dario system use.
Method: A retrospective data evaluation study was performed on the DarioTM cloud database. A population of
high-risk (with baseline A1C > 7.5 percent), active users that continuously measured their blood glucose using DarioTM
BGMS during a full year was evaluated. The study assessed estimated A1C values based on blood glucose readings during
a full year as recorded in the database. The estimated A1C values were calculated in periods of 3, 6, 9 and 12 months and
compared to first 30 days as a starting point of analysis.
Results: A group of 363 high-risk Dario BGMS users (A1C>7.5) with greater than two blood glucose
measurements taken per day in the first 30 days and in the 12th month of the year was selected. Estimated A1C was
improved by -0.7, -0.8 and -1 percent from baseline to 3, 6 and 9 months respectively, and remained -1 percent lower
following 12 months of usage (8.65±0.96 vs.7.65±1.0). Moreover, subgroup analyses by diabetes type revealed substantial
estimated A1C improvement among people with T2D showing improvement of -1 percent from baseline to 3, 6 months and
1.4 percent following 12 months (8.5 ± 0.91% vs. 7.14% ± 0.98%).
An additional study evaluated on the potential improvement in glycemic variability in Type 2 diabetes over six
months in patients monitoring with Dario Digital Diabetes Management System. Dario presented the study results at the
Advance Technologies and Treatment for Diabetes (ATTD) conference in February 2019 in Berlin. We presented two
additional studies outcomes at ADA 2019 conference.
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Decrease in Glycemic Variability for T2D over Six Months in Patients Monitoring with Dario Digital Diabetes
Management System
●
●
Reduction of 14%-18% in measurements variability was observed in T2D within 6 months
Hypo events (<70 mg/dL) remained <1 event on average
Method: A retrospective data evaluation study was performed on the DarioTM database. A population of T2D
high-risk patients (blood glucose measurements average (GMavg) >180 mg/dL) measuring more than 20 times in the first
30 days (analysis baseline) was evaluated on days 60-90 (3 months) and 150-180 days (6 months). Standard deviation (SD)
and GMavg were calculated and compared to the baseline.
Results: A group of 698 T2D high-risk DarioTM users was selected. GV was reduced by 10% and 14% from
baseline through 3 and 6 months, respectively (SD of 55.7, 58.4 vs.65.0). GMavg was reduced by 8% and 12% from
baseline through 3 and 6 months, respectively (201.1±25.57, 192.8±54.3 vs. 219.5±38.5) while patient’s hypoglycemic
event (<70mg/dL) was in average, less than one (<1) during this period. Subgroup analyses (355 patients) revealed
substantial GV improvement among non-Insulin T2D patients. The GV was reduced by 14% and 18% from baseline
through 3 and 6 months, respectively (SD of 52.8, 50.7 vs.61.7).
T2D Users of Dario Digital Diabetes Management System Experience an Increase of in-range Glucose Levels
Linked to App Engagement
Relative Increase of 10 % In-range linked to App engagement
Method: A retrospective data evaluation study was performed on the DarioTM cloud database. A population of
active Type 2 Diabetic (T2D) users (>15 measurements per month on average) was evaluated. The study assessed the ratio
of in-range blood glucose readings (70-140 mg/dL) as a function of App engagement level for 6 months as recorded in the
database compared to first 30 days as a starting point of analysis.
Results: A population of 4917 T2D non-insulin users measuring more than 15 times per month on average during
6 months in a row was evaluated. The ratio of in-range (70-140 mg/dL) readings was increased following 3 months in
correlation to the level of tagging meal reference/carbs/physical activity occurrences (4.0%, 9.1% and 11.9% for tagging
0-1, 1-2 and >2 times per day on average, respectively) and sustained for 6 months (3.1%, 7.0% and 12.2%, respectively).
In subgroup analysis focusing on users entering their meal reference, high correlation was observed following 3 months
with an increase of in-range measurements in 4.6%, 8.4% and 12.0% for 0-1, 1-2 and >2 meal reference tagging per day
on average, respectively, and maintained stability over 6 months period (3.2%, 7.4%, and 12.5%, respectively).
Reduction of Blood Glucose Average Less than 140mg/dL in People with Type2 Diabetes Using Dario Digital
Diabetes Management System
30-40% of T2D Dario users experienced Reduction of Blood Glucose Average below 140 mg/dL
Method: A retrospective data evaluation study was performed on the DarioTM cloud database. A population of
active T2D users that continuously measured for 6 months was evaluated. The study assessed their BG avg and estimated
A1C (eA1C) values based on blood glucose readings as recorded in the database. Values were calculated in periods of 3
and 6 months and compared to their first 30 days as a starting point analysis.
Results: A group of 1248 Dario BGMS T2D active users (1.98 measurements per day on average during 6 months
in a row) with BG avg >140mg/dL (eA1C>6.5) was evaluated.100% reduced their BG avg along 6 months on average.
A group of 31% (387) achieved BG avg of <140 mg/dL (eA1C<6.5) following 3 months showing 19% reduction
on average from baseline (132.38±13.36 vs.162.79±25.41 mg/dL and eA1C 6.24±0.46 vs 7.3±0.88) and sustained their
glycemic control during a 6 months period (131.57±13.86 mg/dL and eA1C 6.21±0.48).
Subgroup analyses of 568 non-insulin users revealed that 40% (226) achieved a BG avg <140 mg/dL following 3
months (131.95±13.21 vs.161.67±24.18 mg/dL and eA1C 6.22±0.46 vs 7.26±0.84) and sustained for 6 months period
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(131.03±13.70 mg/dL and eA1C 6.19±0.47). Along the 6 months period, hypo events (<50mg/dL) per user per month on
average remained stable.
In August 2019 another study was presented at the AADE 2019 in Atlanta. The study evaluated the “Impact of
Digital Intervention on In-range Glucose Levels in Users with Diabetes.” The study results showed 6% improvement in
average blood glucose levels over 3 months intervention program for a group of 162 users. A 39% increase in the in-range
measurements was observed in a subgroup of 101 patients who started with average blood glucose levels of over
140mg/dL.
In February 2020, we presented an additional clinical study at the Advanced Technologies & Treatments for
Diabetes (“ATTD”) conference in Madrid, Spain. The presented data shows the Dario digital therapeutics platform
successfully assists insulin dependent patients with diabetes in reducing hypoglycemic events.
Decrease in Hypoglycemia Events Over Two Years in Patients Monitoring with Dario’s Digital Diabetes
Management System
Method: A retrospective data analysis was performed on the Dario real-world database. Insulin dependent of
users with type 1 or type 2 diabetes population was evaluated for two year of continuous system use. Average numbers of
level 1 hypoglycemia (<70mg/dL) and level 2 hypoglycemia (<54 mg/dL) events were calculated monthly and compared to
baseline (first month).
Results: For 1481 type 1 and type 2 insulin dependent users, average of level 1 hypoglycemia events and level 2
were reduced by 24% and by 17% after 6 months and by 50% and 57% after 2 years vs. baseline respectively. Users with
type 1 diabetes (N=363) reduced level 1 hypoglycemia events by 50% and Level 2 by 55% after 2 years. Moreover, a 40%
reduction in high blood glucose readings was observed as well after 2 years.
In November 2020, we presented additional clinical study data at the Virtual Diabetes Technology Society (DTS)
meeting. The presented data indicated the potential for a digital diabetes management solution to effect and sustain
glycemic control improvements and demonstrated long term reduction of blood glucose average (eA1c) and glycemic
variability in type 2 diabetes over two years. The system assists users through a variety of mechanisms including behavior
modification in diabetes self-management and in long-term routines for self-care.
The Effect of a Digital Therapeutic Platform on Glycemic Control in Adults above Age 65 with Type 2
Diabetes.
Reduction of 13% blood glucose average in age group ≥65 (N=298) at six months by 13% sustained for 12
months.
months.
Reduction of 38.1% in high readings ratio (>250 mg/dL) in the ≥65 age group at six months and by 41.5% at 12
Method: A retrospective study of high-risk users (BG avg >180 mg/dL equivalent to e A1c 8.0) 2 with type 2
diabetes that measured their blood glucose using the Dario® platform database over two consecutive years was performed.
The minimum engagement level for inclusion was at least two blood glucose measurements per day on average taken in
Month 1 and Month 24. Actual blood glucose readings were taken by the Dario meter and loaded into the cloud database.
These were evaluated for the blood glucose average (BGavg), estimated A1c (eA1c)values and glycemic variability (by
Standard Deviation; SD) following 24 months compared to the first month (baseline).
Results: 368 high-risk, T2D active and engaged users for at least consecutive 2 years were identified and assessed
for their risk-level and insulin usage. A group of 148 T2D, non-Insulin users that started with a blood glucose average (BG
avg) >180 mg/dl (equivalent to eA1c>8.0) consistently reduced their BG avg by 18% on average and sustained these
values (179±45 vs. 219±56 mg/dL) following 2 years on the Dario platform. Glycemic variability was reduced over two
years by 20% on average (SD:45 vs. 56) . Substantial reductions were observed for higher risk groups (insulin and non-
insulin treated). The subset that started with average BG levels > 212 mg/dL (eA1c >9.0) and average BG levels >240
mg/dL (eA1c>10) reduced their average BG by 22.5% and 25.7% respectively on average over two years. The equivalent
reductions in eA1c were 1.95% and 2.42%
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In August 2020, we presented an additional clinical study at the Virtual Association of Diabetes Care & Education
Specialists (ADCES) conference. The presented observational study data demonstrated better glycemic and blood pressure
control. Patients using an integrated chronic disease management digital platform have the potential to improve user
activation which may assist to better manage their blood glucose and blood pressure levels and sustain behavioral change.
Impact of Digital Management on Clinical Outcome in Patients with Chronic Conditions: Diabetes and
Hypertension.
Hypertension: Increase in normal level % measurements from 6% to 12% while hypertension stage 2
measurements decreased from 53% to 45%. 70% of the users (243 out of 345) improved their blood pressure levels by 8.4
mmHg Systolic and 6.2 mmHg on average.
Glucose levels: A reduction of 33% in high readings (>250 mg/dL) and 67% in severe events (>400 mg/dL) was
observed over six months.
Methods: A retrospective data evaluation study was performed on the DarioTM cloud database. A population of
active users that measured both blood pressure and blood glucose for at least 3 months was observed. Blood pressure and
blood glucose levels were evaluated. First month measuring on Dario platform was used as study baseline. Clinical
outcomes examined were blood pressure values, percentage of blood pressure categories, average blood glucose (BGavg)
and high blood glucose readings (>250 mg/dL, >400 mg/dL) ratios.
Results: A group of 345 active users started at baseline with Hypertension stage 1, 2 or hypertensive crisis levels
and measured following 3 months was evaluated.
●
●
Blood pressure:
o Normal levels increased from 6% to 12% and percentage of users with hypertension stage 2 decreased from
o
53% to 45%
70% of the users (243 out of 345) improved their blood pressure levels in 8.4 mmHg Systolic and 6.2 mmHg
on average (Systolic 134.2±12 vs.142.6±14; Diastolic 89.9 ±11 vs.83.7 ±8.7)
Blood Glucose:
o A group of 345 users measured with Dario their blood glucose in addition to blood pressure, 89% are type 2
o
and pre-diabetes - average age is 60.4.
For the group of 345 users a reduction of 33% (5.4% vs.8.0%) in high readings ratio (>250 mg/dL) and 67%
(0.3%vs.0.9%) in severe events ratio (>400 mg/dL) was observed following six months on average.
A subset of 114 users with diabetes in higher risk started with BG average >160 mg/dL improved their average
blood glucose by 14% (207±47 vs.177±50 mg/dL) following six months.
In June 2020, we presented two clinical studies at the ADA Virtual conference. The presented data from these
studies showed:
● The use of a digital diabetes platform resulted in a large population are consistent with previous studies and
show the potential to promote behavior modification in users with T2D. The study demonstrated that digital
management platforms may assist user to better control their blood glucose levels and sustain behavioral
change. This observational data presented an improvement in high glycemia readings ratios, and an increase
in prediabetes fasting blood glucose levels sustained over one year.
● The additional study confirmed the potential of digital diabetes solutions to sustain glycemic achievements in
users with type 2 diabetes over two years. The system may assist the users to experience an actual behavior
modification in their diabetes self-management as well as in their long-term routine for self-care.
Users with type 2 diabetes using a digital platform experienced sustained improvement in blood glucose levels.
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Method: A retrospective data evaluation (Q1:2018-2019) was performed on the Dario® data base. A population of active
users (18 measurements per month with the Dario® System on average) with T2D, non-Insulin treated was evaluated over a
full year. High blood glucose readings (180-400 mg/dL, >250 mg/dL), fasting readings (<126 mg/dL) and post-meal
readings (<180mg/dL) ratios were assessed in their first month of use until the 12th month.
Results: For 9,200 users with T2D, non-Insulin users, the average ratio of high glycemia events (180-400 mg/dL) from
entire set of measurements was reduced by 26% (18.62% vs. 23.43%) while readings of >250mg/dL were reduced by 33%
(4.65% vs. 6.93%) over a year. Fasting measurements analysis revealed an increase of 16% in ratios of readings <126
mg/dL per entire set of fasting measurements (40.59% vs. 34.92%) on average. Post-meal readings ratio of <180 mg/dL per
entire post-meal measurements increased by 5% (73.75% vs. 70.42%) on average over a year.
Estimated A1C Reduction in High-Risk Patients over Two Years of Using a Digital Diabetes Management Platform
Method: A retrospective data evaluation study was performed on high-risk users with type 2 diabetes that measured their
blood glucose using Dario® platform database for two consecutive years. The study assessed BGavg, estimated A1c (eA1c)
values and glycemic variability following 24 months compared to the first month (baseline).
Results: A group of 148 high-risk users with type 2 diabetes, non-Insulin treated was evaluated. Their BGavg was of
>180mg/dL (eA1c>8.0) for users taking ∼2 blood glucose measurements per day in the first month and in the 24th month
on average. Their BGavg was consistently reduced by 18% and sustained (179±45 vs. 219±56 mg/dL) and eA1c was
reduced by 1.5 percentage points (9.26±1.3 vs. 7.86±1.8). Glycemic variability was reduced by 20% (SD: 45 vs. 56) at the
end of 2 years. Additional analysis of 220 users with type 2 diabetes,147 started with eA1c >9.0% and 73 started with eA1c
>10%, revealed substantial eA1c reduction of 2.0 percentage points (10.31 ± 1.8% vs. 8.36 ± 1.2%) and 2.4 percentage
points (11.15 ± 1.2% vs. 8.73% ± 2.1%) from baseline after 2 years, respectively. Glycemic variability was reduced by
20% for both (SD: 55 vs. 69 and 59 vs. 74, respectively).
The potential benefit of implementing a real-time digital diabetes intervention journey to recognize episodes of
high blood glucose measurement clusters and assist patients in improving self-management and clinical outcomes.
Method: A retrospective data evaluation study was performed on a population of 3,609 users who experienced a cluster
event of frequent high blood glucose levels above 250 mg/dL (>=4 times in 4 different days along 7 days) and measured
with Dario at least one month before and after the event during 2021. A group of 1,084 users was assigned to a Test group
who experienced a digital intervention flow with personalized messages via various channels. The remaining 2,525 users
were assigned to a Control group. The clinical outcome examined was the monthly average of high blood glucose readings
ratio calculated as the number of blood glucose measurements >250 mg/dL per total number of measurements in a month.
This was measured during the event month and in the following month. T-test was used to compare the changes in high
readings ratio in the Test group and Control group in the following month versus event month.
Results: A significant difference of 19% vs. control group (N=3,609), 18% for the group with type 2 (N=2307) and 42%
for the group with type 2 non-insulin, in the reduction in average monthly ratio of high readings (above 250 mg/dL) per
total blood glucose measurements in the following month. The results indicate personalized communications are effectively
influencing positive lifestyle behavior change
A group of 454 users experienced the cluster event in a 6-month period before the digital journey was activated and after. A
significant difference was observed after the digital journey versus before the digital journey in the following month's
change in high readings ratio (-8% vs. +5%; P-value <0.03)
Product updates to digital platforms that guide on healthy eating and help users understand their glucose
readings in context may assist users in improving the management of their diabetes.
Method: A retrospective data evaluation study was performed on Dario TM members during the time before and after
product modification. Digital engagement and clinical outcomes were measured on first to six months per each period to
examine if habit formation was achieved.
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Results: A group of total 9794 users who had enrolled in a membership for 6 months or longer was evaluated. The ratio of
measurements logged with context (fasting, pre-meal, post-meal, bedtime) was increased significantly by 56% in the first
month following product modification on average (51.3%. vs. 32.8%) (P<0.001). Differences in the level of digital
engagement remained stable over a 6 months period. The average number of days between measurements, i.e. “recency”
decreased by 21% on average (2.71 vs. 3.45). Average ratios of high readings (180-400 mg/dL) were reduced by 12% on
average over six months.
Digital diabetes platform has the potential to enhance self-care behaviors across socioeconomic statuses and
among different language speakers.
Method: A retrospective data evaluation study was performed on the DarioTM data base. A population (“high-risk users”)
of all users with type 2 diabetes activated during 2017-2020 who took measurements with Dario in the first 2 months and
who started with an average blood glucose above 180 mg/dL was evaluated. The ratios assessed were target range (70-180
mg/dL) and high blood glucose (>180 mg/dL) readings over a year. Socioeconomic status was matched by applying zip
code data to census.gov data.
Results: For 11,101 users, the average ratio of target range readings (70-180 mg/dL) was significantly increased from
28.4% to 54.8% (P<0.001). Average high events ratio (>180 mg/dL) was significantly reduced from 71.3% to 44.4% over a
full year usage (P<0.001). The change appeared in the earliest months and was maintained over a year. Average number of
days between measurements, i.e., “recency” was 3.3 days. A subset of Spanish language app users (N=169) was also
evaluated, and comparable trends were observed. Matching Census.gov data on study population showed that 20% of users
resided in low income zip codes, 70% in middle and 10% in upper income zip codes.
The benefit of implementing a digital diabetes interaction platform to durably improve self-management
among users who had not recently measured their blood glucose.
Method: A retrospective study was performed on a population of 246 Dario active members who had not measured blood
glucose for a 7-day period. 127 of these users were randomly assigned to a Test group and experienced a digital
intervention flow, and the remaining 119 users were assigned to a Control group.
Results: Digital engagement levels were observed following 60 days in both groups. Differences between Test group and
Control group were observed. In the Test group, the percent of users who measured blood glucose was significantly higher
(P<0.001): 14% in first 30 days and 22% in 30-60 days; average number of measurements was 6% higher in the first 30
days and 17% in 30-60 days; number of interactions (e.g. logging fasting glucose) with the digital platform was 10%
higher in first 30 days and 15% in 30-60 days. Difference in average days between measurements, defined as “recency”
was 30% lower in the test group.
The potential benefit of a digital diabetes management platform in the self-management required from insulin
treated users, incorporating its use on a daily base, and sustaining behavioral change.
Method: A retrospective study was performed on a population of 285 active Dario users (85% with type 2) under insulin
therapy, that measured with Dario for at least three months and logged basal insulin usage. The group included 112 users
whose starting average blood glucose >180 mg/dL. Among this group the average age was 55. The group also included
173 users whose starting average blood glucose was <180 mg/dL with average age 59. First month measuring on platform
was used as study baseline.
Results: In the sub-group of 112 users the average amount of basal insulin increased by six units after three months (45
vs.39). Their fasting blood glucose was significantly reduced (9%) after three months (186±40.6 vs. 204±42.7) without
change in hypoglycemia events ratio (<70 mg/dL) on average, and 15% of the users reduced their fasting average to <126
mg/dL. However, in the sub-group of 173 users, basal insulin usage and fasting glucose levels remained stable following
three months.
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Government Regulation
The principal markets that we have initially targeted for Dario are the United States, Canada, the European Union,
Australia, and New Zealand. The following is an overview of the regulatory regimes in these jurisdictions.
United States Regulation Generally
In the United States, devices are subject to varying levels of regulatory control, the most comprehensive of which
requires that a clinical evaluation is conducted before a device receives clearance for commercial distribution. Under
Section 201(h) of the Food, Drug, and Cosmetic Act, a medical device is an article, which, among other things, is intended
for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man
or other animals. The Dario Blood Glucose Monitoring System is classified as a medical device and subject to regulation
by numerous agencies and legislative bodies, including the FDA and its foreign counterparts. FDA regulations govern
product design and development, pre-clinical and clinical testing, manufacturing, labeling, storage, pre-market clearance or
approval, advertising and promotion, and sales and distribution. Specifically, the FDA classifies medical devices into one
of three classes. Class I devices are relatively simple and can be manufactured and distributed with general controls. Class
II devices are somewhat more complex and require greater scrutiny. Class III devices are new and frequently help sustain
life.
Unless an exemption applies, each medical device commercially distributed in the United States will require a
510(k) clearance, 510(k)+ “de-novo” clearance, or pre-market approval (or PMA) from the FDA.
510(k) Clearance Process. After a device receives 510(k) clearance, any modification that could significantly
affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k)
clearance or could even require a premarket application approval. The FDA requires each manufacturer to make this
determination in the first instance, but the FDA can review any such decision. If the FDA disagrees with the
determination, the agency may retroactively require the manufacturer to seek 510(k) clearance or premarket application
approval. The FDA also can require the manufacturer to cease marketing and/or recall the modified device until 510(k)
clearance or premarket application approval is obtained.
De Novo Classification. If the FDA denies 510(k) clearance of a device because it is novel and an adequate
predicate device does not exist, the “de novo classification” procedure can be invoked based upon a reasonable assurance
that the device is safe and effective for its intended use. This procedure approximates the level of scrutiny in the 510(k)
process but may add several months to the clearance process. If the FDA grants the request, the device is permitted to enter
commercial distribution in the same manner as if 510(k) clearance had been granted.
Premarket Application Approval Process. After approval of a premarket application, a new premarket application
or premarket application supplement is required in the event of a modification to the device, its labeling or its
manufacturing process. The premarket application approval pathway is much more costly, lengthy and uncertain. It
generally takes from one to three years or longer.
European and Non-European Regulation Generally
Sales of medical devices outside the United States are subject to foreign regulatory requirements that vary widely
from country to country. These laws and regulations range from simple product registration requirements in some countries
to complex clearance and production controls in others. As a result, the processes and time periods required to obtain
foreign marketing clearance may be longer or shorter than those necessary to obtain FDA clearance.
The commercialization of medical devices in Europe is regulated by the European Union. The European Union
presently requires that all medical products bore the CE mark, an international symbol of adherence to quality assurance
standards and demonstrated clinical effectiveness. Compliance with the Medical Device Directive (MDD) or the Active
Implantable Medical Device Directive (AIMD) or the In Vitro Diagnostic Medical Device Directive (IVDD) as audited by
a notified body and certified by a recognized European Competent Authority, permits the manufacturer to affix the CE
mark on its products.
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In September 2013, we obtained ISO 13485 certification for our quality management system and CE Mark
certification to market Dario, and in May 2015 Dario was cleared to fulfill the criteria according to EN ISO
15197:2013 The granting of the CE Mark allows Dario to be marketed and sold in 32 countries across Europe as well as in
certain other countries worldwide. On November 21, 2014, MDSS, our European Authorized Representative, completed
the registration of the Dario Blood Glucose Monitoring System with the German Authority as required by Article 10 of
Directive 98/79/EC on in vitro diagnostic medical devices. We commenced an initial soft launch of the product in Europe
in 2014, created initial demand for the product and established brand awareness and marketing techniques to reach our
target market with a goal to continue expansion to new markets and territories.
We achieved regulatory clearance to market Dario in other countries that do not rely on the CE Mark. To date, the
non-CE Mark jurisdictions which we have begun to market Dario include the United States, New Zealand, Canada, and
Australia.
To the extent that we seek to market our product in other non-CE Mark countries in the future, we will be required
to comply with the applicable regulatory requirements in each such country. Such regulatory requirements vary by country
and may be tedious. As a result, no assurance can be given that we will be able to satisfy the regulatory requirements to
sell our products in any such country.
Clinical Studies
Even when a clinical study has an approved Investigational Device Exemption (IDE) from the FDA under
significant risk (SR) determination, has been approved by an Institutional Review Board (IRB) under non-significant risk
(NSR) determination and/or has been approved by local or regional Ethics Committee, the study is subject to factors
beyond a manufacturer’s control, including, but not limited to the fact that the institutional review board at a given clinical
site might not approve the study, might decline to renew approval which is required annually, or might suspend or
terminate the study before the study has been completed. There is no assurance that a clinical study at any given site will
progress as anticipated; the interim results of a study may not be satisfactory leading the sponsor or others to terminate the
study, there may be an insufficient number of patients who qualify for the study or who agree to participate in the study or
the investigator at the site may have priorities other than the study. Also, there can be no assurance that the clinical study
will provide sufficient evidence to assure regulatory authorities that the product is safe, effective and performs as intended
as a prerequisite for granting market clearance. See “Clinical Trials” above for clinical trials performed to date.
Post-Clearance Matters
Even if the FDA or other non-US regulatory authorities approve or clear a device, they may limit its intended uses
in such a way that manufacturing and distributing the device may not be commercially feasible. After clearance or approval
to market is given, the FDA and foreign regulatory agencies, upon the occurrence of certain events, are authorized under
various circumstances to withdraw the clearance or approval or require changes to a device, its manufacturing process or
its labeling or additional proof that regulatory requirements have been met.
A manufacturer of a device approved through the premarket approval application process is not permitted to make
changes to the device which affects its safety or effectiveness without first submitting a supplement application to its
premarket approval application and obtaining FDA clearance for that supplement. In some instances, the FDA may require
a clinical trial to support a supplement application. A manufacturer of a device cleared through a 510(k) submission or a
510(k)+ “de-novo” submission must submit another premarket notification if it intends to make a change or modification in
the device that could significantly affect the safety or effectiveness of the device, such as a significant change or
modification in design, material, chemical composition, energy source or manufacturing process. Any change in the
intended uses of a premarket approval application device or a 510(k) device requires an approval supplement or cleared
premarket notification. Exported devices are subject to the regulatory requirements of each country to which the device is
exported, as well as certain FDA export requirements.
Mobile Medical Applications Guidance
On September 23, 2013, the FDA issued final guidance for developers of mobile medical applications, or apps,
which are software programs that run on mobile communication devices and perform the same functions as traditional
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medical devices. The guidance outlines the FDA’s tailored approach to mobile apps. The FDA plans to exercise
enforcement discretion (meaning it will not enforce requirements under the Federal Food, Drug & Cosmetic Act) for the
majority of mobile apps as they pose minimal risk to consumers. The FDA plans to focus its regulatory oversight on a
subset of mobile medical apps that present a greater risk to patients if they do not work as intended. The FDA is focusing
its oversight on mobile medical apps that:
● are intended to be used as an accessory to a regulated medical device – for example, an application that
allows a health care professional to make a specific diagnosis by viewing a medical image from a picture
archiving and communication system (PACS) on a smart mobile device or a mobile tablet; or
● transform a mobile platform into a regulated medical device – for example, an application that turns a smart
mobile device into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a
patient is experiencing a heart attack.
Ongoing Regulation by FDA
Even after a device receives clearance or approval and is placed on the market, numerous regulatory requirements
apply. These include:
● establishment registration and device listing;
● quality system regulation, which requires manufacturers, including third-party manufacturers, to follow
stringent design, testing, control, documentation, and other quality assurance procedures during all phases of
the product life-cycle;
● labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or
“off-label” uses, and other requirements related to promotional activities;
● medical device reporting regulations, which require that manufacturers report to the FDA if their device may
have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or
contribute to a death or serious injury if the malfunction were to recur;
● corrections and removals reporting regulations, which require that manufacturers report to the FDA field
corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to
remedy a violation of the Federal Food, Drug and Cosmetic Act that may present a risk to health; and
● post-market surveillance regulations, which apply when necessary to protect the public health or to provide
additional safety and effectiveness data for the device.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which
may include any of the following sanctions: fines, injunctions, civil or criminal penalties, recall or seizure of our current or
future products, operating restrictions, partial suspension or total shutdown of production, refusing our request for 510(k)
clearance or PMA approval of new products, rescinding previously granted 510(k) clearances or withdrawing previously
granted PMA approvals.
We may be subject to announced and unannounced inspections by the FDA, and these inspections may include the
manufacturing facilities of our subcontractors. If, as a result of these inspections, the FDA determines that our or our
subcontractor’s equipment, facilities, laboratories or processes do not comply with applicable FDA regulations and
conditions of product clearance, the FDA may seek civil, criminal or administrative sanctions and/or remedies against us,
including the suspension of our manufacturing and selling operations.
Ongoing Regulation by International Regulators
International sales of medical devices are subject to foreign government regulations, which may vary substantially
from country to country.
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In order to maintain the right to affix the CE Mark to sell medical devices in the European Union, an annual
surveillance audit in the company premises and, if needed, at major subcontractors’ premises needs to be carried out by the
notified body. Additionally, European Directives dictate the following requirements:
● Vigilance system, which requires the manufacturer to immediately notify the relevant Competent Authority
when a company product has been involved in an incident that led to a death; led to a serious injury or
serious deterioration in the state of health of a patient, user or another person; or might have led to death,
serious injury or serious deterioration in health; and
● Post-market surveillance including a documented procedure to review experience gained from devices on the
market and to implement any necessary corrective action, commensurate with nature and risks involved with
the product.
Failure to comply with applicable regulatory requirements can result in enforcement action by the regulatory
agency, which may include any of the following sanctions: fines, injunctions, civil or criminal penalties, recall or seizure of
our current or future products, operating restrictions, partial suspension or total shutdown of production, refusing our
request for renewing clearance and/or registration of our products or granting clearance/registration for new products.
State Licensure Requirements
Several states require that Durable Medical Equipment (“DME”) providers be licensed in order to sell products to
patients in that state. Certain of these states require that DME providers maintain an in-state location. If these rules are
determined to be applicable to us and if we were found to be noncompliant, we could lose our licensure in that state, which
could prohibit us from selling our current or future products to patients in that state.
Federal Anti-Kickback and Self-Referral Laws
The Federal Anti-Kickback Statute prohibits the knowing and willful offer, payment, solicitation or receipt of any
form of remuneration in return for, or to induce the:
● referral of a person;
● furnishing or arranging for the furnishing of items or services reimbursable under Medicare, Medicaid or
other governmental programs; or
● purchase, lease, or order of, or the arrangement or recommendation of the purchasing, leasing, or ordering of
any item or service reimbursable under Medicare, Medicaid or other governmental programs.
To the extent we are required to comply with these regulations, it is possible that regulatory authorities could
allege that we have not complied, which could subject us to sanction. Noncompliance with the federal anti-kickback
legislation can result in exclusion from Medicare, Medicaid or other governmental programs, restrictions on our ability to
operate in certain jurisdictions, as well as civil and criminal penalties, any of which could have an adverse effect on our
business and results of operations.
Federal law also includes a provision commonly known as the “Stark Law,” which prohibits a physician from
referring Medicare or Medicaid patients to an entity providing “designated health services,” including a company that
furnishes durable medical equipment, in which the physician has an ownership or investment interest or with which the
physician has entered into a compensation arrangement. Violation of the Stark Law could result in denial of payment,
disgorgement of reimbursements received under a noncompliant arrangement, civil penalties, and exclusion from
Medicare, Medicaid or other governmental programs.
Federal False Claims Act
The Federal False Claims Act provides, in part, that the federal government may bring a lawsuit against any
person whom it believes has knowingly presented, or caused to be presented, a false or fraudulent request for payment
from the federal government, or who has made a false statement or used a false record to get a claim approved. In addition,
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amendments in 1986 to the Federal False Claims Act have made it easier for private parties to bring “qui tam”
whistleblower lawsuits against companies. Penalties include fines ranging from $5,500 to $11,000 for each false claim,
plus three times the number of damages that the federal government sustained because of the act of that person.
Civil Monetary Penalties Law
The Federal Civil Monetary Penalties Law prohibits the offering or transferring of remuneration to a Medicare or
Medicaid beneficiary that the person knows or should know likely to influence the beneficiary’s selection of a particular
supplier of Medicare or Medicaid payable items or services. Noncompliance can result in civil money penalties of up to
$10,000 for each wrongful act, assessment of three times the amount claimed for each item or service and exclusion from
the Federal healthcare programs.
State Fraud and Abuse Provisions
Many states have also adopted some form of anti-kickback and anti-referral laws and false claims acts. A
determination of liability under such laws could result in fines and penalties and restrictions on our ability to operate in
these jurisdictions.
Administrative Simplification of the Health Insurance Portability and Accountability Act of 1996
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, mandated the adoption of standards
for the exchange of electronic health information in an effort to encourage overall administrative simplification and
enhance the effectiveness and efficiency of the healthcare industry. Ensuring the privacy and security of patient information
is one of the key factors driving the legislation.
Intellectual Property
Patent applications
On May 8, 2011, certain of our founders filed a Patent Cooperation Treaty (PCT) Application No.
PCT/IL2011/000369, titled “Fluids Testing Apparatus and Methods of Use.” This PCT claimed priority from two
preceding U.S. provisional applications filed by our founders, with the earliest priority date being May 9, 2010. The PCT
application was transferred to us by our founders on October 27, 2011.
This application covers the novel blood glucose measurement device, comprising the glucose meter; and an
adaptor that connects the glucose meter to a smart-phone to receive power supply and data display, storage, and analysis. A
PCT search report and written opinion on patentability that we received from World Intellectual Property Organization
(known as WIPO) that included only two “Y” citations and one additional non-relevant reference. Corresponding national
applications of our PCT were filed in the U.S., Europe, Japan, China, Australia and Israel.
On May 1, 2014, we announced the receipt of a U.S. Notice of Allowance for a key patent relating to how the
Dario Blood Glucose Monitoring System draws power from and transmits data to a smartphone via the audio jack port.
This patent was issued as U.S. Patent No. 8,797,180 in August 2014, and in August2015, we received U.S. patent (No.
9,125,549) that broadened our registered patent No. 8,797,180 to include testing of other bodily fluids through an audio
jack connection. We believe these early patents represent critical intellectual property recognition and a significant initial
validation of our intellectual property efforts. Further, a corresponding European patent was granted to us in May 2016, as
European patent No. 2569622 for testing of fluids through an audio jack connection. An additional corresponding patent
was granted in Israel in April 2016. In February 2016 we were granted U.S. patent No. 9,257,038, which is a further
Continuation application connected to the U.S. patent No. 8,797,180, this new patent enhanced the way the Dario Blood
Glucose Monitoring System communicates with the end user’s smartphone devices.
In November 11, 2017, U.S. patent No. 9,832,301 titled “Systems and methods for adjusting power levels on a
monitoring device” was granted. This patent enhances the way the Dario Blood Glucose Monitoring System communicates
with users’ smartphone devices. This family includes a corresponding pending application in China.
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Additionally, we recently received U.S. patent No. 10,445,072 that enables optical communication between the
Dario Blood Glucose Monitoring System and the end user’s smartphone devices.
Additional patent applications are in the process of being discussed and developed, and we believe that we have a
rich potential pipeline of future technologies that we intend to develop.
For example, we are further seeking to develop and protect new intellectual property around future generations of
our hardware and software with the goal of achieving enhanced functionality, user interface, data usability, cyber
protection, and artificial intelligence enhancement.
In 2021, we acquired Upright and acquired the following patents which were added to our portfolio:
“BODY MOVEMENT FEEDBACK SYSTEM AND METHOD”, Patent App# 15/749,335 which is in National
Phase (USPTO). The application was published Aug. 9, 2018.
In addition, a patent on PCT rout #PCT/IL2021/050739 was filed on June 17, 2021 titled “Posture detection
device and system.”
In early 2022, we acquired Physimax and acquired the following patent – US 10,709,374 B2 titled “System and
Method for Assessment of Musculoskeletal Profile of a Target Individual.”
Design patents and patent applications on the Dario Blood Glucose Monitoring System
To further protect our market distinction and branding for the Dario Blood Glucose Monitoring System, three U.S.
Design Applications have been filed and granted covering the glucose meter, the cartridge, and connection dongle. At least
some of these applications were granted and registered in the United States, as well as Brazil, Canada, China, Europe, and
Hong Kong.
Trademark applications
We have also filed several families of trademark applications covering the “Dario” name (wordmark), the Dario
name and logo (logo), the Dario logo alone (logo), the DARIO-LITE wordmark, the LABSTYLE INNOVATIONS
wordmark, the DARIOHEALTH wordmark, and the DARIOHEALTH logo. In particular, the “Dario” wordmark is
registered as a trademark in the Australia, Canada, China, Costa Rica, United States, Israel, China, Canada, Hong Kong,
South Africa, Japan, Costa Rica, Europe, Israel, Japan, Korea, Mexico, New Zealand, Panama, Russia, South Africa, and
the USA. The “DARIOHEALTH” wordmark is registered as a trademark in the United States, Canada, China and India.
Upright also added the following trademarks to our list: UPRIGHT, UPRIGHT GO – registered in the US, AU
and EM, and UPRIGHT DASHBOARD, UPRIGHT DESKTOP, UPRIGHT GO 2, UPRIGHT PRO, UPRIGHT POSTURE
IS WITHING REACH – registered in the US.
Utility Models
We have been granted Utility Models for our core invention in Japan and Germany.
Other intangible assets
As the number of Dario users grows, an ever-growing amount of data is being collected from diabetic patients,
including their blood sugar levels, meal compositions, routines, physical exercise (intensity and duration) as well as many
other factors, and lately also blood pressure data, which are all useful for creating meaningful correlations between these
factors and insulin use. We expect that this database will be highly valuable and may be capitalized in many ways. The
accumulation of this type of know-how and related algorithms are protected as trade secrets using specialized
confidentiality protocols.
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Competition
In recent years, a number of digitally supported solutions have emerged to manage diabetes and other chronic
conditions. Competitors are developing new technologies rapidly and, in some cases, are also expanding to manage other
chronic conditions. In this crowded field, our success is predicated on our flexibility to adapt to evolving customer
requirements in digital health and superior execution in engagement, retention and clinical outcomes in a manner that
delivers clear return on investment in required time-horizons and in complex, highly regulated business environments. We
expect new entrants in the field and the emergence of novel technologies, as well as competition from larger technology
platform players such as Amazon, Apple and Google. Dario’s competitors vary by intervention (devices, applications,
coaching and analytics), by channel (health plan, pharma, provider, employer) and by condition (including, for example,
diabetes, MSK, HTN, behavioral health and others). Certain of our competitors offer this integrated approach in varying
degrees, including, among others, Hinge Health, Inc., Livongo Health Inc. (acquired by Teladoc Health Inc.), Omada
Health, Inc., Vida Health, Inc.and. Virta Health Corp. We believe that our competitors are comparatively disadvantaged
along several axes:
● Our competitors offer point solutions for a single condition (which model is unattractive to enterprise customers
needing to manage multiple vendor relationships and who recognize that conditions frequently overlap in the
same individual);
● Our competitors fail to share member-level data or granular reporting with partners, which prevents these
partners from leveraging their own assets to support care;
● Competitor applications have limited or minimal levels of personalization, where communications (or “nudge”)
from the application may be somewhat personalized, but actual user experiences are heavily templated, and not
personalized or dynamic;
● Competitor applications are supported only by short term outcome data, as compared to our studies which cover
a 2-year period and offer 7 years of direct-to-consumer data;
● Failure of any one of our competitors to successfully engage and retain a substantial portion of the base
population, as few have the direct-to-consumer experience or data required, resulting in frustrated customers who
cannot realize promised cost savings;
● Customers of our competitors suffer an inadequate user experience, as evidenced by few app store reviews and
low scores in Apple, Google and Amazon stores;
● Our competitors offer medical device-oriented approaches with delayed product update cadences, rather than
our more agile, software-driven approaches that push out new products every few weeks;
● Our competitors have slowed their improvements in the area of clinical metrics (including, for example, blood
pressure, HbA1c, and pain), which decreases the solution’s return on investment;
● Our competitors often utilize cumbersome form factors and alternative connected devices, which are not easily
portable or that otherwise require significant user effort for connectivity. By contrast, our diabetes solution, for
example, utilizes lancets, strips and a dongle held in a lipstick-sized device that physically connects to a user’s
phone and doesn’t require independent charging. As another example, our MSK device is small and easily
attaches to body parts for convenient and easy use;
● Our competitors’ applications experience limited interoperability and connectivity, such that they are unable to
integrate with third party devices, electronic health records or partnered solutions; and
● Our competitors have higher costs; our solutions are priced 30-50% lower than current comparable in-market
solutions.
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Employees
As of March 10, 2022, we had 200 full-time employees and 14 part-time employees. We have employment
agreements with our five executive officers. See “Management – Employment Agreements.”
Item 1A. Risk Factors
Investing in our securities is highly speculative and involves a high degree of risk. You should carefully consider
the following factors and other information in this Annual Report and our other SEC filings before making a decision to
invest in our securities. Additional risks and uncertainties that we are unaware of may become important factors that affect
us. If any of the following events occur, our business, financial conditions and operating results may be materially and
adversely affected. In that event, the trading price of our common stock and warrants may decline, and you could lose all
or part of your investment.
Summary of Risk Factors
Our business is subject to a number of risks, including risks that may adversely affect our business, financial condition and
results of operations. These risks are discussed more fully below and include, but are not limited to, risks related to:
Risks Related to Our Financial Position and Capital Requirements
● Risks associated with our relatively new business;
● our future capital needs and their potential impact on our existing stockholders;
● our history of losses and stockholder’s inability to rely upon our historical operating performance;
Risks Related to Our Business
● the acceptance of our products in the market and our exposure to market trends;
● the impact of COVID-19 on our operations;
● our risks of basing our business on the sale of our principal technology;
● our reliance on manufacturers and distributors;
● the impact of a failure of our digital marketing efforts;
● our reliance on the Apple App Store and Google’s Android platform;
● the risks associated with conducting business internationally;
● potential errors in our business processes and product offerings;
● our reliance on the performance of key members of our management team and our need to attract highly skilled
personnel;
● the integration of Upright and PsyInnovations into our business;
Risks Related to Product Development and Regulatory Approval
● the expense and time required to obtain regulatory clearance of our products;
● our limited clinical studies and the susceptibility to varying interpretations of such studies;
● our ability to complete clinical trials;
● the failure to comply with the FDA’s Quality System Regulation or any applicable state equivalent;
● our reliance on third parties to conduct clinical trial work;
● the impact of legislation and federal, state and foreign laws on our business, including protecting the
confidentiality of patient health information;
● the potential impact of product liability suits;
Risks Related to Our Intellectual Property
● the risks relating to obtaining or maintaining our intellectual property;
● potential litigation relating to the protection of our intellectual property;
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● our limited foreign intellectual property rights;
● Our reliance on confidentiality agreements and the difficulty in enforcing such agreements;
Risks Related to Our Industry
● the intense competition we face in the markets we operate;
● our need to respond quickly to technological developments;
● the risks relating to obtaining or maintaining our intellectual property;
● the risks relating to third-party payors not providing for adequate coverage and reimbursement for our products;
Risks Related to Our Operations in Israel
● the risks relating to the political, economic and military instability that may exist in Israel;
● the potential for operations to be disrupted as a result of obligations of Israeli citizens to perform military service;
● the difficulty in enforcing judgements against us or certain of our executive officers and directors;
Risks Related to the Ownership of Our Common Stock and Warrants
● the ability for our officers, directors and founding stockholders to exert influence over our affairs;
● the potential lack of liquidity, or volatility, of our common stock and warrants;
● the impact of analysts not publishing research or reports about us;
● the expense relating to our requirements as a U.S. public company;
● the potential failure to maintain effective internal controls over financial reporting;
● the existence of anti-takeover provisions in our charter documents and Delaware law; and
● that we do not intend to pay dividends on our common stock.
Risks Related to Our Financial Position and Capital Requirements
We were formed in August 2011 and are thus subject to the risks associated with new businesses.
We were formed in August 2011 as a new business and, commencing from 2015, we entered the
commercialization stage of our technology. As such, this limited operating history may not be adequate to enable you to
fully assess our ability to develop and commercialize the Dario Smart Diabetes Management Solution, achieve market
acceptance of the Dario Smart Diabetes Management Solution, develop other products and respond to competition. We
commenced a commercial launch of the free Dario Smart Diabetes Management application in the United Kingdom in late
2013 and commenced an initial soft launch of the full Dario Smart Diabetes Management Solution (including the app and
the Dario Blood Glucose Monitoring System) in selected jurisdictions in March 2014 with the goal of collecting customer
feedback to refine our longer-term roll-out strategy and continued to scale up launch during 2014 in the United Kingdom,
the Netherlands and New Zealand, in 2015 in Australia, Israel and Canada and in 2016 in the United States. These efforts
have not generated sufficient revenues, and we will need to generate additional revenues over the next years. Therefore, we
are, and expect for the foreseeable future to be, subject to all the risks and uncertainties, inherent in a new business and the
development and sale of new medical devices and related software applications. As a result, we may be unable to fully
develop, obtain regulatory approval for, commercialize, manufacture, market, sell and derive material revenues in the
timeframes we project, if at all, and our inability to do so would materially and adversely impact our viability as a
company. In addition, we still must establish many functions necessary to operate a business, including finalizing our
managerial and administrative structure, continuing product and technology development, assessing and commencing our
marketing activities, implementing financial systems and controls and personnel recruitment.
Accordingly, you should consider our prospects in light of the costs, uncertainties, delays and difficulties
frequently encountered by companies in their initial revenue generating stages, particularly those in the medical device and
mobile health fields. In particular, potential investors should consider that there is a significant risk that we will not be able
to:
● implement or execute our current business plan, or that our business plan is sound;
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● maintain our management team and the Company’s board of directors (the “Board of Directors”);
● raise sufficient funds in the capital markets or otherwise to effectuate our business plan;
● determine that our technologies that we have developed are commercially viable; and/or
● attract, enter into or maintain contracts with, and retain customers.
In the event that we do not successfully address these risks, our business, prospects, financial condition, and
results of operations could be materially and adversely affected.
Given our limited revenue and lack of positive cash flow, we will need to raise additional capital, which may be
unavailable to us or, even if consummated, may cause dilution or place significant restrictions on our ability to operate.
According to our management’s estimates, based on our current cash on hand and further based on our budget and
the assumption that initial commercial sales will commence during our anticipated timeframes, we believe that we will
have sufficient resources to continue our activities through 2023.
Since we might be unable to generate sufficient revenue or cash flow to fund our operations for the foreseeable
future, we will need to seek additional equity or debt financing to provide the capital required to maintain or expand our
operations. We may also need additional funding for developing products and services, increasing our sales and marketing
capabilities, and promoting brand identity, as well as for working capital requirements and other operating and general
corporate purposes. Moreover, the regulatory compliance arising out of being a publicly registered company has
dramatically increased our costs.
We do not currently have any arrangements or credit facilities in place as a source of funds, and there can be no
assurance that we will be able to raise sufficient additional capital on acceptable terms, or at all. If such financing is not
available on satisfactory terms, or is not available at all, we may be required to delay, scale back or eliminate the
development of business opportunities and our operations and financial condition may be materially adversely affected.
If we raise additional capital by issuing equity securities, the percentage ownership of our existing stockholders
may be reduced, and accordingly these stockholders may experience substantial dilution. We may also issue equity
securities that provide for rights, preferences and privileges senior to those of our common stock. Given our need for cash
and that equity raising is the most common type of fundraising for companies like ours, the risk of dilution is particularly
significant for stockholders of our company.
Debt financing, if obtained, may involve agreements that include liens on our assets, covenants limiting or
restricting our ability to take specific actions, such as incurring additional debt, could increase our expenses and require
that our assets be provided as a security for such debt. Debt financing would also be required to be repaid regardless of our
operating results.
If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish
some rights to our technologies or candidate products, or to grant licenses on terms that are not favorable to us.
Funding from any source may be unavailable to us on acceptable terms, or at all. If we do not have sufficient
capital to fund our operations and expenses, we may not be able to achieve or maintain competitiveness, which could lead
to the failure of our business and the loss of your investment.
We have incurred significant losses since inception. As such, you cannot rely upon our historical operating
performance to make an investment decision regarding our company.
Since our inception, we have engaged primarily in research and development activities and in 2015 entered the
commercialization stage. We have financed our operations primarily through private placements and public offerings of
common stock and have incurred losses in each year since inception including net losses of $[ ],000 and $29,445,000 in
2021 and 2020, respectively. Our accumulated deficit at December 31, 2021 was approximately $[ ],000. We do not know
whether or when we will become profitable. Our ability to generate revenue and achieve profitability depends upon
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our ability, alone or with others, to launch Dario in additional European countries, and elsewhere and manufacture, market
and sell Dario where approved. We may be unable to achieve any or all of these goals.
We may be subject to claims for rescission or damages in connection with certain sales of shares of our securities.
In March 2016, the Securities and Exchange Commission declared effective a registration statement that we filed
to cover 66,667 shares 76,667 warrants to purchase common stock, 76,667 shares of common stock underlying such
warrants, and underwriters’ warrants to purchase up to 7,172 shares of common stock. Sales of approximately 2,778 shares
of common stock, approximately 12,778 shares of common stock underlying warrants and approximately 1,278 shares of
common stock underlying underwriters’ warrants may not have been made in accordance with Section 5 of the Securities
Act of 1933, as amended. Accordingly, the purchasers of those securities may have rescission rights or be entitled to
damages. The amount of such liability, if any, is uncertain. In the event that we are required to make payments to investors
as a result of these unregistered sales of securities, our liquidity could be negatively impacted.
Risks Related to Our Business
There is no assurance that our DarioEngage software platform will succeed or be adopted by healthcare providers.
Our product offering consists of our DarioEngage software platform, where we digitally engage with Dario users,
assist them in monitoring their chronic illnesses and provide them with coaching, support, digital communications, and
real-time alerts, trends and pattern analysis. We expect that the DarioEngage software platform may be leveraged by our
potential partners, such as clinics, health care service providers, employers, and payers for scalable monitoring of people
with diabetes in a cost-effective manner, which we expect will open for us additional revenue streams. While we have
begun to execute agreements with employers and health plans in the United States, we have not yet seen wide adoption of
our platform. Therefore, the success of our DarioEngage software platform will depend entirely on our potential partners’
adoption of the platform and we cannot assure you that our potential partners will do so, or, if adopted, that they will
continue to use the platform continually and for an extended period of time. If we cannot encourage potential partners to
utilize our DarioEngage software platform we may not succeed in marketing the product to our potential partners, the
failure of which may materially and adversely affect our business and operating results.
We only recently began commercializing Dario, and our success will depend on the acceptance of Dario in the
healthcare market.
Dario has been CE marked since 2013, enabling us to commercialize in 32 countries across Europe as well as in
certain other countries worldwide. It was also approved by the regulatory authorities in Australia, New Zealand, Canada,
Israel and South Africa, and most recently in December 2015, we received FDA clearance. As a result, we have a limited
history of commercializing Dario and commenced selling Dario in the United States in 2016. We have limited experience
engaging in commercial activities and limited established relationships with physicians and hospitals as well as third-party
suppliers on whom we depend for the manufacture of our product. We are faced with the risk that the marketplace will not
be receptive to Dario over competing products and that we will be unable to compete effectively. Factors that could affect
our ability to establish Dario or any potential future product include:
● the development of products or devices which could result in a shift of customer preferences away from our
device and services and significantly decrease revenue;
● the increased use of improved diabetes drugs that could encourage certain diabetics to test less often,
resulting in less usage of a self-monitoring test device for certain types of diabetics;
● the challenges of developing (or acquiring externally-developed) technology solutions that are adequate and
competitive in meeting the requirements of next-generation design challenges, including interoperability with
various electronic health records;
● the significant number of current competitors in the BGMS market who have significantly greater brand
recognition and more recognizable trademarks and who have established relationships with healthcare
providers and payors; and
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● intense competition to attract acquisition targets, which may make it more difficult for us to acquire
companies or technologies at an acceptable price or at all.
We cannot assure you that Dario or any future product will gain broad market acceptance. If the market for Dario
or any future product fails to develop or develops more slowly than expected, or if any of the technology and standards
supported by us do not achieve or sustain market acceptance, our business and operating results would be materially and
adversely affected.
A pandemic, epidemic or outbreak of an infectious disease in the United States, Israel or elsewhere may adversely affect
our business.
A regional or global health pandemic, including COVID-19, could severely affect our business, results of
operations and financial condition. A regional or global health pandemic, depending upon its duration and severity, could
have a material adverse effect on our business. For example, the COVID-19 pandemic has had numerous effects on the
global economy and governmental authorities around the world have implemented measures to reduce the spread of
COVID-19. In addition, the COVID-19 pandemic has negatively impacted the global economy, disrupted consumer
spending and global supply chains, and created significant volatility of financial markets. The COVID-19 pandemic
continues may also impact our supply chain partners, including third-party manufacturers, logistics providers and other
vendors. Current vessel, container and other transportation shortages, labor shortages and port congestion globally have
delayed and may continue to delay inventory orders and, in turn, it may delay the delivery of our products to customers. In
addition, the impact of COVID-19 on macroeconomic conditions may impact the proper functioning of financial and
capital markets, foreign currency exchange rates, commodity prices, and interest rates. Even after the COVID-19 global
pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic
recession that has occurred or may occur in the future.
As a result of the COVID-19 pandemic, many of our personnel previously worked remotely, and if we return to a
remote working environment, is possible that this could have a negative impact on the execution of our business plans and
operations. If a natural disaster, power outage, connectivity issue, or other event occurred that impacted our employees’
ability to work remotely, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial
period of time. The increase in remote working may also result in consumer privacy, IT security and fraud concerns as well
as increase our exposure to potential wage and hour issues.
We are unable to accurately predict the impact that COVID-19 will have on our operations going forward due to
uncertainties that will be dictated by the length of time that the pandemic and related disruptions continue, the impact of
governmental regulations that might be imposed in response to the pandemic and overall changes in consumer behavior.
The extent to which COVID-19 will impact our results will depend on future developments, which are highly
uncertain and cannot be predicted, including new information which may emerge concerning the severity of the
coronavirus, including the actions to contain COVID-19 or treat its impact, the efficacy and scale of the various vaccines
currently deployed across the world, among others. Moreover, COVID-19 has had indeterminable adverse effects on
general commercial activity and the world economy, and our business and results of operations could be adversely affected
to the extent that COVID-19 or any other epidemic continues to harm the global economy generally. To the extent the
COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many
of the other risks described in this “Risk factors” section.
We cannot accurately predict the volume or timing of any future sales, making the timing of any revenues difficult to
predict.
We may be faced with lengthy customer evaluation and approval processes associated with Dario. Consequently,
we may incur substantial expenses and devote significant management effort and expense in developing customer adoption
of Dario which may not result in revenue generation. We must also obtain regulatory approvals of Dario in certain
jurisdictions as well as approval for insurance reimbursement in order to initiate sales of Dario, each of which is subject to
risk and potential delays, and neither of which may actually occur. As such, we cannot accurately predict the volume or
timing of any future sales.
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If Dario fails to satisfy current or future customer requirements, we may be required to make significant expenditures to
redesign the product, and we may have insufficient resources to do so.
Dario is being designed to address an evolving marketplace and must comply with current and evolving customer
requirements in order to gain market acceptance. There is a risk that Dario will not meet anticipated customer requirements
or desires. If we are required to redesign our products to address customer demands or otherwise modify our business
model, we may incur significant unanticipated expenses and losses, and we may be left with insufficient resources to
engage in such activities. If we are unable to redesign our products, develop new products or modify our business model to
meet customer desires or any other customer requirements that may emerge, our operating results would be materially
adversely affected, and our business might fail.
We expect to derive substantially all of our revenues from our principal technology, which leaves us subject to the risk
of reliance on such technology.
We expect to derive substantially all of our revenues from sales of products derived from our principal technology.
Our initial product utilizing this technology is Dario. As such, any factor adversely affecting sales of Dario, including the
product release cycles, regulatory issues, market acceptance, product competition, performance and reliability, reputation,
price competition and economic and market conditions, would likely harm our operating results. We may be unable to
develop other products utilizing our technology, which would likely lead to the failure of our business. Moreover, in spite
of our efforts related to the registration of our technology, if patent protection is not available for our principal technology,
the viability of Dario and any other products that may be derived from such technology would likely be adversely impacted
to a significant degree, which would materially impair our prospects.
We are dependent upon third-party manufacturers and suppliers making us vulnerable to supply shortages and
problems and price fluctuations, which could harm our business.
We do not own or operate manufacturing facilities for clinical or commercial production of the Dario Blood
Glucose Monitoring System, and we lack the resources and the capability to manufacture the Dario Blood Glucose
Monitoring System on a commercial scale. Therefore, we rely on a limited number of suppliers who manufacture and
assemble certain components of the Dario Blood Glucose Monitoring System. Our suppliers may encounter problems
during manufacturing for a variety of reasons, including, for example, failure to follow specific protocols and procedures,
failure to comply with applicable legal and regulatory requirements, equipment malfunction and environmental factors,
failure to properly conduct their own business affairs, and infringement of third-party intellectual property rights, any of
which could delay or impede their ability to meet our requirements. Our reliance on these third-party suppliers also
subjects us to other risks that could harm our business, including:
● we are not a major customer of many of our suppliers, and these suppliers may therefore give other
customers’ needs higher priority than ours;
● third parties may threaten or enforce their intellectual property rights against our suppliers, which may cause
disruptions or delays in shipment, or may force our suppliers to cease conducting business with us;
● we may not be able to obtain an adequate supply in a timely manner or on commercially reasonable terms;
● our suppliers, especially new suppliers, may make errors in manufacturing that could negatively affect the
efficacy or safety of the Dario Blood Glucose Monitoring System or cause delays in shipment;
● we may have difficulty locating and qualifying alternative suppliers;
● switching components or suppliers may require product redesign and possibly submission to FDA, European
Economic Area Notified Bodies, or other foreign regulatory bodies, which could significantly impede or
delay our commercial activities;
● one or more of our sole- or single-source suppliers may be unwilling or unable to supply components of the
Dario Blood Glucose Monitoring System;
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● other customers may use fair or unfair negotiation tactics and/or pressures to impede our use of the supplier;
● the occurrence of a fire, natural disaster or other catastrophe impacting one or more of our suppliers may
affect their ability to deliver products to us in a timely manner; and
● our suppliers may encounter financial or other business hardships unrelated to our demand, which could
inhibit their ability to fulfill our orders and meet our requirements.
We may not be able to quickly establish additional or alternative suppliers if necessary, in part because we may
need to undertake additional activities to establish such suppliers as required by the regulatory approval process. Any
interruption or delay in obtaining products from our third-party suppliers, or our inability to obtain products from qualified
alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and
cause them to switch to competing products. Given our reliance on certain single-source suppliers, we are especially
susceptible to supply shortages because we do not have alternate suppliers currently available.
We rely in part on a small group of third-party distributors to effectively distribute our products.
We depend in part on medical device distributors for the marketing and selling of our products in certain
territories in which we have launched product sales. We depend on these distributors’ efforts to market our products, yet we
are unable to control their efforts completely. These distributors typically sell a variety of other, non-competing products
that may limit the resources they dedicate to selling Dario. In addition, we are unable to ensure that our distributors comply
with all applicable laws regarding the sale of our products. If our distributors fail to effectively market and sell Dario, in
full compliance with applicable laws, our operating results and business may suffer. Recruiting and retaining qualified
third-party distributors and training them in our technology and product offering requires significant time and resources. To
develop and expand our distribution, we must continue to scale and improve our processes and procedures that support our
distributors. Further, if our relationship with a successful distributor terminates, we may be unable to replace that
distributor without disruption to our business. If we fail to maintain positive relationships with our distributors, fail to
develop new relationships with other distributors, including in new markets, fail to manage, train or incentivize existing
distributors effectively, or fail to provide distributors with competitive products on attractive terms, or if these distributors
are not successful in their sales efforts, our revenue may decrease and our operating results, reputation and business may be
harmed.
Failure in our online and digital marketing efforts could significantly impact our ability to generate sales.
In several of our principal target markets, we utilize online and digital marketing in order to create awareness to
Dario. Our management believes that using online advertisement through affiliate networks and a variety of other pay-for-
performance methods will be superior for marketing and generating sales of Dario rather than utilizing traditional,
expensive retail channels. However, there is a risk that our marketing strategy could fail. Because we plan to use non-
traditional retail sales tools and to rely on healthcare providers to educate our customers about Dario, we cannot predict the
level of success, if any, that we may achieve by marketing Dario via the internet. The failure of our online marketing
efforts would significantly and negatively impact our ability to generate sales.
Our Dario Smart Diabetes Management application, which is a key to our business model, is available via Apple’s App
Store and via Google’s Android platforms and maybe in the future via additional platforms. If we are unable to achieve
or maintain a good relationship with each of Apple and Google or similar platforms, or if the Apple App Store or the
Google Play Store or any other applicable platform were unavailable for any prolonged period of time, our business will
suffer.
A key component of the Dario Smart Diabetes Management Solution is an iPhone or Android application which
includes tools to help diabetic patients manage their disease. This application is compatible with Apple’s iOS and with
Google’s Android platforms and may in the future become compatible via additional platforms. If we are unable to make
our Dario Smart Diabetes Management application compatible with these platforms, or if there is any deterioration in our
relationship with either Apple or Google or others after our application is available, our business would be materially
harmed.
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We are subject to each of Apple’s and Google’s standard terms and conditions for application developers, which
govern the promotion, distribution, and operation of games and other applications on their respective storefronts. Each of
Apple and Google has broad discretion to change its standard terms and conditions, including changes which could require
us to pay to have our Dario Smart Diabetes Management application available for downloading. In addition, these standard
terms and conditions can be vague and subject to changing interpretations by Apple or Google. We may not receive any
advance warning of such changes. In addition, each of Apple and Google has the right to prohibit a developer from
distributing its applications on its storefront if the developer violates its standard terms and conditions. In the event that
either Apple or Google ever determines that we are in violation of its standard terms and conditions, including by a new
interpretation, and prohibits us from distributing our Dario Smart Diabetes Management application on its storefront, it
would materially harm our business.
Additionally, we will rely on the continued function of the Apple App Store and the Google Play Store as digital
storefronts where our Dario Smart Diabetes Management application may be obtained. There have been occasions in the
past when these digital storefronts were unavailable for short periods of time or where there have been issues with the in-
app purchasing functionality within the storefront. In the event that either the Apple App Store or the Google Play Store is
unavailable or if in-app purchasing functionality within the storefront is non-operational for a prolonged period of time, it
would have a material adverse effect on the ability of our customers to secure the Dario Smart Diabetes Management
application, which would materially harm our business.
We rely upon Software-as-a-Services, or SAAS, technologies from third parties to operate our business, and
interruptions or performance problems with these technologies may adversely affect our business, financial condition
and results of operations.
We rely on hosted SaaS applications from third parties in order to operate critical functions of our business,
including platform delivery, enterprise resource planning, customer relationship management, billing, project management
and accounting and financial reporting. If these services become unavailable due to extended outages, interruptions or
because they are no longer available on commercially reasonable terms, our expenses could increase, our ability to manage
finances could be interrupted and our processes for managing sales of our platform and products and supporting our
customers could be impaired until equivalent services, if available, are identified, obtained and implemented, all of which
could adversely affect our business, financial condition and results of operations.
The SaaS pricing model is evolving and our failure to manage its evolution and demand could lead to lower than
expected revenue and profit.
We derive most of our revenue growth from subscription offerings and, specifically, SaaS offerings. This business
model depends heavily on achieving economies of scale because the initial upfront investment is costly and the associated
revenue is recognized on a ratable basis. If we fail to achieve appropriate economies of scale or if we fail to manage or
anticipate the evolution and demand of the SaaS pricing model, then our business and operating results could be adversely
affected.
Our results of operations may fluctuate significantly due to the timing of our recognition of SaaS revenues.
We may experience volatility in our reported revenues and operating results due to the differences in timing of
revenue recognition between our SaaS offerings and our traditional on-premise software and hardware sales. SaaS revenues
are generally recognized ratably over the life of the subscriptions. In contrast, revenue from our on-premise software and
hardware sales is generally recognized in full at the time of delivery. Accordingly, the SaaS delivery model creates risks
related to the timing of revenue recognition not associated with our traditional on-premise software delivery model and
hardware sales. A portion of our SaaS revenue results from the recognition of deferred revenue relating to subscription
agreements entered into during prior reporting periods. A decline in new or renewed subscriptions in any period may not be
immediately reflected in our reported financial results for that period, but may result in a decline in our revenue in future
reporting periods. If any of our assumptions about revenue from our SaaS delivery model prove incorrect, our actual results
may vary materially from those anticipated, estimated, or projected.
Any damage, failure or disruption of our SaaS network infrastructure or data centers could impair our ability to
effectively provide our solution, harm our reputation and adversely affect our business.
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Our SaaS network infrastructure is a critical part of our business operations. Our clients access our solution
through standard web browsers, smart phones, tablets and other web-enabled devices and depend on us for fast and reliable
access to our solution. We serve all of our clients from our data centers located in the United-States. Our SaaS network
infrastructure and data centers are vulnerable to damage, failure and disruption.
In the future, we may experience issues with our computing and communications infrastructure, or data centers
caused by the following factors:
•human error;
•telecommunications failures or outages from third-party providers;
• computer viruses or cyber-attacks;
•break-ins or other security breaches;
•acts of terrorism, sabotage, intentional acts of vandalism or other misconduct;
•tornadoes, fires, earthquakes, hurricanes, floods and other natural disasters;
•power loss; and
•other unforeseen interruptions or damages.
If our SaaS network infrastructure or our clients’ ability to access our solution is interrupted, client and employee
data from recent transactions may be permanently lost, and we could be exposed to significant claims by clients,
particularly if the access interruption is associated with problems in the timely delivery of funds payable to employees or
tax authorities. Further, any adverse changes in service levels at our data centers resulting from damage to or failure of our
data centers could result in disruptions in our services. Any significant instances of system downtime or performance
problems at our data centers could negatively affect our reputation and ability to attract new clients, prevent us from
gaining new or additional business from our current clients, or cause our current clients to terminate their use of our
solution, any of which would adversely impact our revenues. In addition, if our network infrastructure and data centers fail
to support increased capacity due to growth in our business, our clients may experience interruptions in the availability of
our solution. Such interruptions may reduce our revenues, cause us to issue refunds to clients or adversely affect our
retention of existing clients, any of which could have a negative impact on our business, operating results or financial
condition.
Our products are subject to technological changes which may impact their use.
Our Dario Blood Glucose Monitoring System is currently designed to be plugged into the Lighting jack for Apple
devices or the USB-C jack for other mobile devices. As a result, our products are subject to future technological changes to
mobile devices that may occur in the future. If we are unable to modify our products to keep pace with such technological
changes, it would have a material adverse effect the ability of our customers to use our products, which would materially
harm our business.
As we conduct business internationally, we are susceptible to risks associated with international relationships.
Outside of the United States, we operate our business internationally, presently in Europe, Australia and Canada.
The international operation of our business requires significant management attention, which could negatively affect our
business if it diverts their attention from their other responsibilities. In the event that we are unable to manage the
complications associated with international operations, our business prospects could be materially and adversely affected.
In addition, as a result of the crisis in Ukraine, both the United States and the EU have implemented sanctions against
certain Russian individuals and entities, as well with respect to Belarus, and may impact the economic and political
stability in the EU. If the EU experiences economic and political instability as a result of these current tensions, our
business, including revenue, profitability and cash flows, and operations could be adversely affected. In addition, doing
business
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with foreign customers subjects us to additional risks that we do not generally face in the United States. These risks and
uncertainties include:
● management, communication and integration problems resulting from cultural differences and geographic
dispersion;
● localization of products and services, including translation of foreign languages;
● delivery, logistics and storage costs;
● longer accounts receivable payment cycles and difficulties in collecting accounts receivable;
● difficulties supporting international operations;
● difficulties supporting customer services;
● changes in economic and political conditions;
● impact of trade protection measures;
● complying with import or export licensing requirements;
● exchange rate fluctuations;
● competition from companies with international operations, including large international competitors and
entrenched local companies;
● potentially adverse tax consequences, including foreign tax systems and restrictions on the repatriation of
earnings;
● maintaining and servicing computer hardware in distant locations;
● keeping current and complying with a wide variety of foreign laws and legal standards, including local labor
laws;
● securing or maintaining protection for our intellectual property; and
● reduced or varied protection for intellectual property rights, including the ability to transfer such rights to
third parties, in some countries.
The occurrence of any or all of these risks could adversely affect our international business and, consequently, our
results of operations and financial condition.
We expect to be exposed to fluctuations in currency exchange rates, which could adversely affect our results of
operations.
Because we expect to conduct a material portion of our business outside of the United States but report our
financial results in U.S. Dollars, we face exposure to adverse movements in currency exchange rates. Our foreign
operations will be exposed to foreign exchange rate fluctuations as the financial results are translated from the local
currency into U.S. Dollars upon consolidation. Specifically, the U.S. Dollar cost of our operations in Israel is influenced by
any movements in the currency exchange rate of the New Israeli Shekel (NIS). Such movements in the currency exchange
rate may have a negative effect on our financial results. If the U.S. Dollar weakens against foreign currencies, the
translation of these foreign currencies denominated transactions will result in increased revenue, operating expenses and
net income. Similarly, if the U.S. Dollar strengthens against foreign currencies, the translation of these foreign currencies
denominated transactions will result in decreased revenue, operating expenses and net income. As exchange
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rates vary, sales and other operating results, when translated, may differ materially from our or the capital market’s
expectations.
Non-U.S. governments often impose strict price controls, which may adversely affect our future profitability.
We intend to seek approval to market Dario and any future product in both the U.S. and in non-U.S. jurisdictions.
If we obtain approval in one or more non-U.S. jurisdictions, we will be subject to rules and regulations in those
jurisdictions relating to our products. In some countries, particularly countries of the European Union, each of which has
developed its own rules and regulations, pricing may be subject to governmental control under certain circumstances. In
these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing
approval for a medical device candidate. To obtain reimbursement or pricing approval in some countries, we may be
required to conduct a clinical trial that compares the cost-effectiveness of our product to other available products. If
reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory
levels, we may be unable to achieve or sustain profitability.
Our Dario Smart Diabetes Management Solution and associated business processes may contain undetected errors,
which could limit our ability to provide our services and diminish the attractiveness of our service offerings.
The Dario Smart Diabetes Management Solution may contain undetected errors, defects or bugs. As a result, our
customers or end users may discover errors or defects in our products, software or the systems we design, or the products
or systems incorporating our designs and intellectual property may not operate as expected. We may discover significant
errors or defects in the future that we may not be able to fix. Our inability to fix any of those errors could limit our ability
to provide our products, impair the reputation of our brand and diminish the attractiveness of our product offerings to our
customers.
In addition, we may utilize third-party technology or components in our products, and we rely on those third
parties to provide support services to us. Failure of those third parties to provide necessary support services could
materially adversely impact our business.
Our future performance will depend on the continued engagement of key members of our management team.
Our future performance depends to a large extent on the continued services of members of our current
management including, in particular, Erez Raphael, our Chief Executive Officer and a member of our Board of Directors
and Zvi Ben David, our Chief Financial Officer, Treasurer and Secretary, Dror Bacher, our Chief Operating Officer, and
Richard Anderson, our President and General Manager for North America. In the event that we lose the continued services
of such key personnel for any reason, this could have a material adverse effect on our business, operations, and prospects.
If we are not able to attract and retain highly skilled managerial, scientific and technical personnel, we may not be able
to implement our business model successfully.
We believe that our management team must be able to act decisively to apply and adapt our business model in the
rapidly changing markets in which we will compete. In addition, we will rely upon technical and scientific employees or
third-party contractors to effectively establish, manage and grow our business. Consequently, we believe that our future
viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical
personnel. In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we
currently expect, and such higher compensation payments would have a negative effect on our operating results.
Competition for experienced, high-quality personnel is intense and we cannot assure that we will be able to recruit and
retain such personnel. We may not be able to hire or retain the necessary personnel to implement our business strategy. Our
failure to hire and retain such personnel could impair our ability to develop new products and manage our business
effectively.
We may not generate the expected benefits of our recent acquisition of Upright and PsyInnovations, and the integration
of these businesses could disrupt our ongoing business, distract our management and increase our expenses.
Through our acquisitions of Upright and PsyInnovations, we expanded our product offering to include solutions
for MSK as well as behavioral conditions. We believe that the successful integration of Upright and PsyInnovations
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businesses into our operations is important for our future financial performance. This will require that we integrate more
closely the companies’ product offerings and research and development capabilities, retain key employees, assimilate
diverse corporate cultures, further integrate management information systems and consolidate the acquired operations, each
of which could pose significant challenges. The difficulty of combining Upright and PsyInnovations with our company
may be increased by the need to integrate personnel, and changes effected in the combination may cause key employees to
leave.
It is possible that the integration process could take longer than anticipated and could result in the loss of valuable
employees, additional and unforeseen expenses, the disruption of our ongoing business, processes and systems, or
inconsistencies in standards, controls, procedures, practices, policies and compensation arrangements, any of which could
adversely affect our ability to achieve the anticipated benefits of the acquisitions. The diversion of the attention of
management created by the integration process, any disruptions or other difficulties encountered in the integration process,
and unforeseen liabilities or unanticipated problems with the acquired businesses could have a material adverse effect on
our business, operating results and financial condition. There can be no assurance that these acquisitions will provide the
benefits we expect or that we will be able to integrate and develop the operations of Upright and PsyInnovations
successfully. Any failure to do so could have a material adverse effect on our business, operating results and financial
condition.
Risks Related to Product Development and Regulatory Approval
The regulatory clearance process which we must navigate is expensive, time-consuming, and uncertain and may
prevent us from obtaining clearance for the commercialization of Dario or our any future product.
We are not permitted to market Dario until we receive regulatory clearance. To date, we have received regulatory
clearance in Australia, Canada, Israel, Italy, the Netherlands, New Zealand, the United Kingdom, and the United States.
The research, design, testing, manufacturing, labeling, selling, marketing and distribution of medical devices are
subject to extensive regulation by the FDA and non-U.S. regulatory authorities, which regulations differ from country to
country. There can be no assurance that even after such time and expenditures, we will be able to obtain necessary
regulatory approvals for clinical testing or for the manufacturing or marketing of any products. In addition, during the
regulatory process, other companies may develop other technologies with the same intended use as our products.
We are also subject to numerous post-marketing regulatory requirements, which include labeling regulations and
medical device reporting regulations, which may require us to report to different regulatory agencies if our device causes or
contributes to a death or serious injury, or malfunctions in a way that would likely cause or contribute to a death or serious
injury. In addition, these regulatory requirements may change in the future in a way that adversely affects us. If we fail to
comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action
by regulatory agencies, which may include, among others, any of the following sanctions:
● untitled letters, warning letters, fines, injunctions, consent decrees, and civil penalties;
● customer notification, or orders for repair, replacement or refunds;
● voluntary or mandatory recall or seizure of our current or future products;
● imposing operating restrictions, suspension or shutdown of production;
● refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses or
modifications to Dario or future products;
● rescinding 510(k) clearance or suspending or withdrawing pre-market approvals that have already been
granted; and
● criminal prosecution.
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The occurrence of any of these events may have a material adverse effect on our business, financial condition and
results of operations.
In addition, on September 23, 2013, the FDA issued final guidance (which we refer to herein as the Guidance) for
developers of mobile medical applications, or apps, which are software programs that run on mobile communication
devices and perform the same functions as traditional medical devices. The Guidance outlines the FDA’s tailored approach
to mobile apps. The FDA plans to exercise enforcement discretion (meaning it will not enforce requirements under the
Federal Food, Drug and Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA
plans to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do
not work as intended. We anticipate that the Dario Smart Diabetes Management application will be subject to FDA
regulation as a “mobile medical app.”
We have conducted limited clinical studies of Dario. Clinical and pre-clinical data is susceptible to varying
interpretations, which could delay, limit or prevent additional regulatory clearances.
To date, we have conducted limited clinical studies on Dario. There can be no assurance that we will successfully
complete additional clinical studies necessary to receive additional regulatory approvals in certain jurisdictions. While
studies conducted by us have produced results we believe to be encouraging and indicative of the potential efficacy of
Dario, data already obtained, or in the future obtained, from pre-clinical studies and clinical studies do not necessarily
predict the results that will be obtained from later pre-clinical studies and clinical studies. Moreover, pre-clinical and
clinical data are susceptible to varying interpretations, which could delay, limit or prevent additional regulatory approvals.
A number of companies in the medical device and pharmaceutical industries have suffered significant setbacks in advanced
clinical studies, even after promising results in earlier studies. The failure to adequately demonstrate the safety and
effectiveness of an intended product under development could delay or prevent regulatory clearance of the device, resulting
in delays to commercialization, and could materially harm our business. Even though we have received CE mark and FDA
clearance of Dario, there can be no assurance that we will be able to receive approval for other potential applications of our
principal technology, or that we will receive regulatory clearances from other targeted regions or countries.
We may be unable to complete required clinical trials, or we may experience significant delays in completing such
clinical trials, which could significantly delay our targeted product launch timeframe and impair our viability and
business plan.
The completion of any future clinical trials for Dario or other trials that we may be required to undertake in the
future could be delayed, suspended or terminated for several reasons, including:
● our failure or inability to conduct the clinical trial in accordance with regulatory requirements;
● sites participating in the trial may drop out of the trial, which may require us to engage new sites for an
expansion of the number of sites that are permitted to be involved in the trial;
● delays that we may experience in enrollment, or completion of certain trials, as a result of COVID-19;
● patients may not enroll in, remain in or complete, the clinical trial at the rates we expect; and
● clinical investigators may not perform our clinical trial on our anticipated schedule or consistent with the
clinical trial protocol and good clinical practices.
If our clinical trial is delayed it will take us longer to further commercialize Dario and generate additional
revenues. Moreover, our development costs will increase if we have material delays in our clinical trial or if we need to
perform more or larger clinical trials than planned. We may be faced with similar risks in connection with future trials we
conduct. See “Business - Clinical Trials” for a description of our clinical trials performed to date.
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If we or our manufacturers fail to comply with the FDA’s Quality System Regulation or any applicable state equivalent,
our operations could be interrupted, and our operating results could suffer.
We, our manufacturers and suppliers must, unless specifically exempt by regulation, follow the FDA’s Quality
System Regulation (QSR) and are also subject to the regulations of foreign jurisdictions regarding the manufacturing
process. If our affiliates, our manufacturers or suppliers are found to be in significant non-compliance or fail to take
satisfactory corrective action in response to adverse QSR inspectional findings, the FDA could take enforcement actions
against us and our manufacturers which could impair our ability to produce our products in a cost-effective and timely
manner in order to meet our customers’ demands. Accordingly, our operating results could suffer.
We are subject to the risk of reliance on third parties to conduct our clinical trial work.
We depend on independent clinical investigators to conduct our clinical trials. Contract research organizations
may also assist us in the collection and analysis of data. These investigators and contract research organizations will not be
our employees and we will not be able to control, other than by contract, the number of resources, including the time that
they devote to products that we develop. If independent investigators fail to devote sufficient resources to our clinical trials,
or if their performance is substandard, it will delay the approval or clearance and commercialization of any products that
we develop. Further, the FDA and other regulatory bodies around the world require that we comply with standards,
commonly referred to as good clinical practice, for conducting, recording and reporting clinical trials to assure that data
and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
If our independent clinical investigators and contract research organizations fail to comply with good clinical practice, the
results of our clinical trials could be called into question and the clinical development of our product candidates could be
delayed. Failure of clinical investigators or contract research organizations to meet their obligations to us or comply with
federal regulations could adversely affect the clinical development of our product candidates and harm our business.
Moreover, we intend to have several clinical trials in order to support our marketing efforts and business development
purposes. Such clinical trials will be conducted by third parties as well. Failure of such clinical trials to meet their primary
endpoints could adversely affect our marketing efforts.
Legislative reforms to the United States healthcare system may adversely affect our revenues and business.
From time to time, legislative reform measures are proposed or adopted that would impact healthcare expenditures
for medical services, including the medical devices used to provide those services. For example, in March 2010, U.S.
President Barack Obama signed the Patient Protection and Affordable Care Act, as amended by the Health Care and
Education Reconciliation Act, collectively referred to as the Affordable Care Act. The Affordable Care Act made a number
of substantial changes in the way health care is financed by both governmental and private insurers and the way that
Medicare providers are reimbursed. Among other things, the Affordable Care Act requires certain medical device
manufacturers and importers to pay an excise tax equal to 2.3% of the price for which such medical devices are sold,
beginning January 1, 2013.
In addition, other legislative changes have been proposed and adopted since the Affordable Care Act was enacted.
On August 2, 2011, the President signed into law the Budget Control Act of 2011, which, among other things, created the
Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select
Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering
the legislation’s automatic reduction to several government programs. This includes reductions to Medicare payments to
providers of 2.0% per fiscal year. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act
of 2012, or the ATRA, which delayed for another two months the budget cuts mandated by these sequestration provisions
of the Budget Control Act of 2011. On March 1, 2013, the President signed an executive order implementing sequestration,
and on April 1, 2013, the 2% Medicare payment reductions went into effect. The Bipartisan Budget Act of 2013, enacted
on December 26, 2013, extends these cuts to 2023. The ATRA also, among other things, reduced Medicare payments to
several providers, including hospitals, imaging centers, and cancer treatment centers, and increased the statute of
limitations period for the government to recover overpayments to providers from three to five years. In December 2014,
Congress passed an omnibus funding bill (the Consolidated and Further Continuing Appropriations Act, 2015) and a tax
extenders bill, both of which may negatively impact coverage and reimbursement of healthcare items and services. We
expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit
the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced
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demand for our products or additional pricing pressure. For example, former U.S. President Donald Trump publicly
indicated an intent to lower healthcare costs through various potential initiatives. In addition, former President Trump and
other U.S. lawmakers have made statements about potentially repealing and/or replacing the Affordable Care Act, although
specific legislation for such repeal or replacement has not yet been introduced. While we are unable to predict what
changes may ultimately be enacted, to the extent that future changes affect how our products are paid for and reimbursed
by government and private payers our business could be adversely impacted.
Government and private sector initiatives to limit the growth of health care costs, including price regulation,
competitive pricing, coverage and payment policies, comparative effectiveness reviews of therapies, technology
assessments, and managed-care arrangements, are continuing. Government programs, including Medicare and Medicaid,
private health care insurance and managed-care plans have attempted to control costs by limiting the amount of
reimbursement they will pay for particular procedures or treatments, tying reimbursement to outcomes, and other
mechanisms designed to constrain utilization and contain costs, including delivery reforms such as expanded bundling of
services. Hospitals are also seeking to reduce costs through a variety of mechanisms, which may increase price sensitivity
among customers for our products, and adversely affect sales, pricing, and utilization of our products. Some third-party
payors must also approve coverage for new or innovative devices or therapies before they will reimburse health care
providers who use medical devices or therapies. We cannot predict the potential impact of cost-containment trends on
future operating results.
We may be subject to federal, state and foreign healthcare fraud and abuse laws and regulations.
Many federal, state and foreign healthcare laws and regulations apply to the BGMS business and medical devices.
We may be subject to certain federal and state regulations, including the federal healthcare programs’ Anti-Kickback Law,
the federal Health Insurance Portability and Accountability Act of 1996, and other federal and state false claims laws. The
medical device industry has been under heightened scrutiny as the subject of government investigations and enforcement
actions involving manufacturers who allegedly offered unlawful inducements to potential or existing customers in an
attempt to procure their business, including arrangements with physician consultants. If our operations or arrangements are
found to be in violation of such governmental regulations, we may be subject to civil and criminal penalties, damages,
fines, exclusion from the Medicare and Medicaid programs and the curtailment of our operations. All of these penalties
could adversely affect our ability to operate our business and our financial results.
Product liability suits, whether or not meritorious, could be brought against us due to an alleged defective product or for
the misuse of Dario or our potential future products. These suits could result in expensive and time-consuming
litigation, payment of substantial damages, and an increase in our insurance rates.
If Dario or any of our future products are defectively designed or manufactured contain defective components or
are misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial
and costly litigation. Misusing our device or failing to adhere to the operating guidelines or the device producing inaccurate
meter readings could cause significant harm to patients, including death. In addition, if our operating guidelines are found
to be inadequate, we may be subject to liability. Product liability claims could divert management’s attention from our core
business, be expensive to defend and result in sizable damage awards against us. While we maintain product liability
insurance, we may not have sufficient insurance coverage for all future claims. Any product liability claims brought against
us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing
coverage, could harm our reputation in the industry and could reduce revenue. Product liability claims in excess of our
insurance coverage would be paid out of cash reserves harming our financial condition and adversely affecting our results
of operations.
If we are found to have violated laws protecting the confidentiality of patient health information, we could be subject to
civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
Part of our business plan includes the storage and potential monetization of medical data of users of Dario. There
are a number of federal and state laws protecting the confidentiality of certain patient health information, including patient
records, and restricting the use and disclosure of that protected information. In particular, the U.S. Department of Health
and Human Services promulgated patient privacy rules under the Health Insurance Portability and Accountability Act of
1996 (which we refer to as HIPAA). These privacy rules protect medical records and other personal health information by
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limiting their use and disclosure, giving individuals the right to access, amend and seek accounting of their own health
information and limiting most use and disclosures of health information to the minimum amount reasonably necessary to
accomplish the intended purpose. We may face difficulties in holding such information in compliance with applicable law.
If we are found to be in violation of the privacy rules under HIPAA, we could be subject to civil or criminal penalties,
which could increase our liabilities, harm our reputation and have a material adverse effect on our business, financial
condition and results of operations.
Risks Related to Our Intellectual Property
The failure to obtain or maintain patents, licensing agreements and other intellectual property could materially impact
our ability to compete effectively.
In order for our business to be viable and to compete effectively, we need to develop and maintain, and we will
heavily rely on, our proprietary position with respect to our technologies and intellectual property. We filed a Patent
Cooperation Treaty (or PCT) application for a “Fluids Testing Apparatus and Methods of Use” in May 2011 which
incorporates two U.S. provisional applications submitted in the preceding year. The PCT covers the specific processes
related to blood glucose level measurement as well as more general methods of rapid tests of body fluids and has
subsequently been converted into several national phase patent applications. We have also filed patent applications for
other aspects of the Dario Blood Glucose Monitoring Solution. We have also obtained numerous Web domains.
However, to date, we have only been issued four patents (three of which were issued in the United States) relating
to how the Dario Blood Glucose Monitoring System draws power from and transmits data to a smartphone via the audio
jack port. None of our other patents have been granted by a patent office. In addition, there are significant risks associated
with our actual or proposed intellectual property. The risks and uncertainties that we face with respect to our pending patent
and other proprietary rights principally include the following:
● pending patent applications we have filed or will file may not result in issued patents or may take longer than
we expect to result in issued patents;
● we may be subject to interference proceedings;
● we may be subject to opposition proceedings in foreign countries;
● any patents that are issued to us may not provide meaningful protection;
● we may not be able to develop additional proprietary technologies that are patentable;
● other companies may challenge patents licensed or issued to us;
● other companies may have independently developed and/or patented (or may in the future independently
develop and patent) similar or alternative technologies, or duplicate our technologies;
● other companies may design their technologies around technologies we have licensed or developed; and
● enforcement of patents is complex, uncertain and very expensive.
We cannot be certain that patents will be issued as a result of any of our pending or future applications, or that any
of our patents, once issued, will provide us with adequate protection from competing products. For example, issued patents
may be circumvented or challenged, declared invalid or unenforceable, or narrowed in scope. In addition, since the
publication of discoveries in scientific or patent literature often lags behind actual discoveries, we cannot be certain that we
were the first to make our inventions or to file patent applications covering those inventions.
It is also possible that others may have or may obtain issued patents that could prevent us from commercializing
our products or require us to obtain licenses requiring the payment of significant fees or royalties in order to enable us to
conduct our business. As to those patents that we have licensed, our rights depend on maintaining our obligations to the
licensor under the applicable license agreement, and we may be unable to do so.
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Costly litigation may be necessary to protect our intellectual property rights and we may be subject to claims alleging the
violation of the intellectual property rights of others.
We may face significant expense and liability as a result of litigation or other proceedings relating to patents and
intellectual property rights of others. In the event that another party has also filed a patent application or been issued a
patent relating to an invention or technology claimed by us in pending applications, we may be required to participate in an
interference proceeding declared by the United States Patent and Trademark Office to determine priority of invention,
which could result in substantial uncertainties and costs for us, even if the eventual outcome was favorable to us. We, or
our licensors, also could be required to participate in interference proceedings involving issued patents and pending
applications of another entity. An adverse outcome in an interference proceeding could require us to cease using the
technology, substantially modify it or to license rights from prevailing third parties.
The cost to us of any patent litigation or other proceeding relating to our licensed patents or patent applications,
even if resolved in our favor, could be substantial, especially given our early stage of development. Our ability to enforce
our patent protection could be limited by our financial resources and may be subject to lengthy delays. A third party may
claim that we are using inventions claimed by their patents and may go to court to stop us from engaging in our normal
operations and activities, such as research, development and the sale of any future products. Such lawsuits are expensive
and would consume significant time and other resources. There is a risk that a court will decide that we are infringing the
third party’s patents and will order us to stop the activities claimed by the patents. In addition, there is a risk that a court
will order us to pay the other party damages for having infringed their patents.
Moreover, there is no guarantee that any prevailing patent owner would offer us a license so that we could
continue to engage in activities claimed by the patent, or that such a license if made available to us, could be acquired on
commercially acceptable terms. In addition, third parties may, in the future, assert other intellectual property infringement
claims against us with respect to our services, technologies or other matters.
We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights
throughout the world.
We have limited intellectual property rights outside the United States. Filing, prosecuting and defending patents
on devices in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in
some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some
foreign countries do not protect intellectual property to the same extent as laws in the United States. Consequently, we may
not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling
or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use
our technologies in jurisdictions where we have not obtained patents to develop their own products and further, may export
otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the United
States.
Many companies have encountered significant problems in protecting and defending intellectual property in
foreign jurisdictions. The legal systems of certain countries, particularly China and certain other developing countries, do
not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to medical
devices and biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or
marketing of competing products in violation of our proprietary rights generally. To date, we have not sought to enforce
any issued patents in these foreign jurisdictions. Proceedings to enforce our patent rights in foreign jurisdictions could
result in substantial costs and divert our efforts and attention from other aspects of our business could put our patents at risk
of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third
parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies
awarded, if any, may not be commercially meaningful. The requirements for patentability may differ in certain countries,
particularly developing countries. Certain countries in Europe and developing countries, including China and India, have
compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those
countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled
to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential
revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be
inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
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We rely on confidentiality agreements that could be breached and may be difficult to enforce, which could result in third
parties using our intellectual property to compete against us.
Although we believe that we take reasonable steps to protect our intellectual property, including the use of
agreements relating to the non-disclosure of confidential information to third parties, as well as agreements that purport to
require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our
employees and consultants while we employ them, the agreements can be difficult and costly to enforce. Although we seek
to enter into these types of agreements with our contractors, consultants, advisors and research collaborators, to the extent
that employees and consultants utilize or independently develop intellectual property in connection with any of our
projects, disputes may arise as to the intellectual property rights associated with our technology. If a dispute arises, a court
may determine that the right belongs to a third party. In addition, enforcement of our rights can be costly and unpredictable.
We also rely on trade secrets and proprietary know-how that we seek to protect in part by confidentiality agreements with
our employees, contractors, consultants, advisors or others. Despite the protective measures we employ, we still face the
risk that:
● these agreements may be breached;
● these agreements may not provide adequate remedies for the applicable type of breach;
● our proprietary know-how will otherwise become known; or
● our competitors will independently develop similar technology or proprietary information.
We may be subject to claims challenging the inventorship of our patents and other intellectual property.
We may be subject to claims that former employees, collaborators or other third parties have an interest in our
patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise
from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation
may be necessary to defend against these and other claims challenging inventorship. If we fail in defending any such
claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive
ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our
business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a
distraction to management and other employees. In addition, the Israeli Supreme Court ruled in 2012 that an employee who
receives a patent or contributes to an invention during his employment may be allowed to seek compensation for such
contributions from his or her employer, even if the employee’s contract of employment specifically states otherwise and the
employee has transferred all intellectual property rights to the employer. The Israeli Supreme Court ruled that the fact that a
contract revokes an employee’s right for royalties and compensation, does not rule out the right of the employee to claim
their right for royalties. As a result, it is unclear whether and, if so, to what extent our employees may be able to claim
compensation with respect to our future revenue. We may receive less revenue from future products if any of our
employees successfully claim for compensation for their work in developing our intellectual property, which in turn could
impact our future profitability.
Risks Related to Our Industry
We face intense competition in the digital support solution and the self-monitoring of blood glucose market, and as a
result we may be unable to effectively compete in our industry.
In recent years, a number of digitally supported solutions have emerged to manage diabetes and other chronic
conditions. Competitors are developing new technologies rapidly and, in some cases, are also expanding to manage other
chronic conditions. With our first product, Dario, we compete directly and primarily with large pharmaceutical and medical
device companies such as Abbott Laboratories, Asensia (formerly Bayer Diabetes Care), Johnson & Johnson LifeScan,
Roche Diagnostics and Sanofi. The first four of these companies has a combined majority market share of the BGMS
business and strong research and development capacity for next-generation products. Their dominant market position since
the late 1990s, and significant control over the market could significantly limit our ability to introduce Dario or effectively
market and generate sales of the product. We will also compete with numerous second-tier and third-tier competitors.
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In addition, we only recently transformed our business to primarily focus on the sale of our digital support
solution, which joins a crowded field of competitors such as Amazon, Apple and Google. Our competitors vary by
intervention (devices, applications, coaching and analytics), by channel (health plan, pharma, provider, employer) and by
condition (including, for example, diabetes, MSK, blood hypertension, and others). Certain of our competitors offer this
integrated approach in varying degrees, including, among others, , Hinge Health, Inc., Livongo Health Inc. (acquired by
Teladoc Health Inc.), Omada Health, Inc., Vida Health, Inc., Virta Health Corp., Informed Data Systems Inc. (OneDrop),
Glooko, Inc., and OnDuo LLC.
We only recently commenced sales of our products, and most of our competitors have long histories and strong
reputations within the industry. They have significantly greater brand recognition, financial and human resources than we
do. They also have more experience and capabilities in researching and developing testing devices, obtaining and
maintaining regulatory clearances and other requirements, manufacturing and marketing those products than we do. There
is a significant risk that we may be unable to overcome the advantages held by our competition, and our inability to do so
could lead to the failure of our business and the loss of your investment.
Competition in the digitally supported solutions market and BGMS market is extremely intense, which can lead
to, among other things, price reductions, longer selling cycles, lower product margins, loss of market share and additional
working capital requirements. To succeed, we must, among other critical matters, gain consumer acceptance for Dario and
potential future devices incorporating our principal technology and offer better strategic concepts, technical solutions,
prices and response time, or a combination of these factors, than those of other competitors. If our competitors offer
significant discounts on certain products, we may need to lower our prices or offer other favorable terms in order to
compete successfully. Moreover, any broad-based changes to our prices and pricing policies could make it difficult to
generate revenues or cause our revenues, if established, to decline. Some of our competitors may bundle certain software
products offering competing applications for diabetes management at low prices for promotional purposes or as a long-
term pricing strategy. These practices could significantly reduce demand for Dario or potential future products or constrain
prices we can charge. Moreover, if our competitors develop and commercialize products that are more effective or
desirable than Dario or the other products that we may develop, we may not convince our customers to use our products.
Any such changes would likely reduce our commercial opportunity and revenue potential and could materially adversely
impact our operating results.
If we fail to respond quickly to technological developments our products may become uncompetitive and obsolete.
The BGMS market and other markets in which we plan to compete experience rapid technological developments,
changes in industry standards, changes in customer requirements and frequent new product introductions and
improvements. If we are unable to respond quickly to these developments, we may lose competitive position, and Dario or
any other device or technology may become uncompetitive or obsolete, causing revenues and operating results to suffer. In
order to compete, we must develop or acquire new devices and improve our existing device on a schedule that keeps pace
with technological developments and the requirements for products addressing a broad spectrum and designers and
designer expertise in our industries. We must also be able to support a range of changing customer preferences. For
instance, as non-invasive technologies become more readily available in the market, we may be required to adopt our
platform to accommodate the use of non-invasive or continuous blood glucose sensors. We cannot guarantee that we will
be successful in any manner in these efforts.
If third-party payors do not provide adequate coverage and reimbursement for the use of our products and services, our
revenue will be negatively impacted.
In the United States and other jurisdictions such as Germany and England, we expect that our products and
services should generally be available for full or partial patient reimbursement by third-party payers. Our success in
marketing our services depend and will depend in large part on whether U.S. and international government health
administrative authorities, private health insurers and other organizations adequately cover and reimburse customers for the
cost of our products and services.
In the United States, we expect to derive nearly all our sales from sales directly to consumers as well as retail
pharmacy and DME distributors who typically bill various third-party payors, including Medicare, Medicaid, private
commercial insurance companies, health maintenance organizations, health plans and other healthcare-related
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organizations, to cover all or a portion of the costs and fees associated with our products and services and bill patients for
any applicable deductibles or co-payments. Access to adequate coverage and reimbursement for Center for Medicare and
Medicaid Services (CMS) procedures using our products and services (and our other products and services in development)
by third-party payors is essential to the acceptance of our products by our customers.
Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly
sophisticated methods of controlling healthcare costs. In addition, in the United States, no uniform policy of coverage and
reimbursement for medical device products and services exists among third-party payors. Therefore, coverage and
reimbursement for medical device products and services can differ significantly from payor to payor. In addition, payors
continually review new technologies for possible coverage and can, without notice, deny coverage for these new products
and procedures. As a result, the coverage determination process is often a time-consuming and costly process that will
require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance
that coverage and adequate reimbursement will be obtained, or maintained if obtained.
Reimbursement systems in international markets vary significantly by country and by region within some
countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a
product must be approved for reimbursement before it can be approved for sale in that country. Further, many international
markets have government-managed healthcare systems that control reimbursement for new devices and procedures. In
most markets, there are private insurance systems as well as government-managed systems. If sufficient coverage and
reimbursement are not available for our current or future products, in either the United States or internationally, the demand
for our products and our revenues will be adversely affected.
Risks Related to Our Operations in Israel
Potential political, economic and military instability in the State of Israel, where our management team and our
research and development facilities are located, may adversely affect our results of operations.
Our operating subsidiary, along with our management team and our research and development facilities, is located
in Israel. Accordingly, political, economic and military conditions in Israel and the surrounding region may directly affect
our business and operations. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken
place between Israel and its neighboring countries. Any hostilities involving Israel or the interruption or curtailment of
trade between Israel and its trading partners could adversely affect our operations and results of operations. The hostilities
involved missile strikes against civilian targets in various parts of Israel, including areas in which our employees and some
of our consultants are located, and negatively affected business conditions in Israel. Our offices, located in Caesarea, Israel,
are within the range of the missiles and rockets that have been fired at Israeli cities and towns from Gaza sporadically since
2006, with escalations in violence (such as the recent escalation in July 2014) during which there were a substantially
larger number of rocket and missile attacks aimed at Israel. In addition, since February 2011, Egypt has experienced
political turbulence and an increase in terrorist activity in the Sinai Peninsula. Such political turbulence and violence may
damage peaceful and diplomatic relations between Israel and Egypt, and could affect the region as a whole. Similar civil
unrest and political turbulence has occurred in other countries in the region, including Syria which shares a common border
with Israel, and is affecting the political stability of those countries. This instability and any outside intervention may lead
to deterioration of the political and economic relationships that exist between the State of Israel and some of these
countries, and may have the potential for causing additional conflicts in the region. In addition, Iran has threatened to
attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence
among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, and various rebel militia groups in
Syria. Additionally, a violent jihadist group named Islamic State of Iraq and Levant (ISIL) is involved in hostilities in Iraq
and Syria and have been growing in influence. Although ISIL’s activities have not directly affected the political and
economic conditions in Israel, ISIL’s stated purpose is to take control of the Middle East, including Israel. These situations
may potentially escalate in the future to more violent events which may affect Israel and us. Any armed conflicts, terrorist
activities or political instability in the region could adversely affect business conditions and could harm our results of
operations and could make it more difficult for us to raise capital. Parties with whom we do business may decline to travel
to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary in
order to meet our business partners face to face. In addition, the political and security situation in Israel may result in
parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform
their commitments under those agreements pursuant to force majeure provisions in such agreements. Further, in the past,
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the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business
with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our
operating results, financial condition or the expansion of our business.
Our commercial insurance does not cover losses that may occur as a result of events associated with the security
situation in the Middle East. Although the Israeli government currently covers the reinstatement value of direct damages
that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained.
Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or
political instability in the region would likely negatively affect business conditions and could harm our results of
operations.
Further, the State of Israel and Israeli companies have been subjected to an economic boycott. Several countries
still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an
adverse impact on our operating results, financial condition or the expansion of our business.
Our operations may be disrupted as a result of the obligation of Israeli citizens to perform military service.
Many Israeli citizens are obligated to perform several days, and in some cases more, of annual military reserve
duty each year until they reach the age of 40 (or older, for reservists who are military officers or who have certain
occupations) and, in the event of a military conflict, may be called to active duty. In response to increases in terrorist
activity, there have been periods of significant call-ups of military reservists. It is possible that there will be military reserve
duty call-ups in the future. Our operations could be disrupted by such call-ups, which may include the call-up of members
of our management. Such disruption could materially adversely affect our business, financial condition and results of
operations.
Investors may have difficulties enforcing a U.S. judgment, including judgments based upon the civil liability provisions
of the U.S. federal securities laws, against us, or our executive officers and directors or asserting U.S. securities laws
claims in Israel.
Certain of our directors and officers are not residents of the United States and whose assets may be located outside
the United States. Service of process upon us or our non-U.S. resident directors and officers and enforcement of judgments
obtained in the United States against us or our non-U.S. our directors and executive officers may be difficult to obtain
within the United States. We have been informed by our legal counsel in Israel that it may be difficult to assert claims
under U.S. securities laws in original actions instituted in Israel or obtain a judgment based on the civil liability provisions
of U.S. federal securities laws. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws against
us or our officers and directors because Israel may not be the most appropriate forum to bring such a claim. In addition,
even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim.
If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-
consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case
law in Israel addressing the matters described above. Israeli courts might not enforce judgments rendered outside Israel,
which may make it difficult to collect on judgments rendered against us or our officers and directors.
Moreover, among other reasons, including but not limited to, fraud or absence of due process, or the existence of a
judgment which is at variance with another judgment that was given in the same matter if a suit in the same matter between
the same parties was pending before a court or tribunal in Israel, an Israeli court will not enforce a foreign judgment if it
was given in a state whose laws do not provide for the enforcement of judgments of Israeli courts (subject to exceptional
cases) or if its enforcement is likely to prejudice the sovereignty or security of the State of Israel.
Risks Related to the Ownership of Our Common Stock
Our officers and directors may exert significant influence over our affairs, including the outcome of matters requiring
stockholder approval.
As of the date of this Annual Report, our officers and directors collectively have a beneficial ownership interest of
approximately 9.0% of our Company. As a result, such individuals will have the ability, acting together, to control the
election of our directors and the outcome of corporate actions requiring stockholder approval, such as: (i) a merger or a sale
of our company, (ii) a sale of all or substantially all of our assets, and (iii) amendments to our certificate of
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incorporation and bylaws. This concentration of voting power and control could have a significant effect in delaying,
deferring or preventing an action that might otherwise be beneficial to our other stockholders and be disadvantageous to
our stockholders with interests different from those individuals. Certain of these individuals also have significant control
over our business, policies and affairs as officers or directors of our company. Therefore, you should not invest in reliance
on your ability to have any control over our company.
Our common stock has less liquidity than many other stocks listed on the Nasdaq Capital Market.
Historically, the trading volume of our common stock has been relatively low when compared to larger companies
listed on the Nasdaq Capital Market or other stock exchanges. While we have experienced increased liquidity in our stock
during the year ended December 31, 2021, we cannot say with certainty that a more active and liquid trading market for
our common stock will continue to develop. Because of this, it may be more difficult for shareholders to sell a substantial
number of shares for the same price at which shareholders could sell a smaller number of shares.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our
market, or if they change their recommendations regarding our common stock adversely, the price of our common stock
and trading volume could decline.
The trading market for our common stock may be influenced by the research and reports that securities or industry
analysts may publish about us, our business, our market or our competitors. If any of the analysts who may cover us change
their recommendation regarding our common stock adversely, or provide more favorable relative recommendations about
our competitors, the price of our common stock would likely decline. If any analyst who may cover us were to cease
coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which
in turn could cause the price of our common stock or trading volume to decline.
The market price of our common stock may be significantly volatile.
The market price for our common stock may be significantly volatile and subject to wide fluctuations in response
to factors including the following:
● actual or anticipated fluctuations in our quarterly or annual operating results;
● changes in financial or operational estimates or projections;
● conditions in markets generally;
● changes in the economic performance or market valuations of companies similar to ours; and
● general economic or political conditions in the United States or elsewhere.
In particular, the market prices for securities of mHealth and medical device have historically been particularly
volatile. Some of the factors that may cause the market price of our common stock and warrants to fluctuate include:
● any delay in or the results of our clinical trials;
● any delay in manufacturing of our products;
● any delay with the approval for reimbursement for the patients from their insurance companies;
● our failure to comply with regulatory requirements;
● the announcements of clinical trial data, and the investment community’s perception of and reaction to those
data;
● the results of clinical trials conducted by others on products that would compete with ours;
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● any delay or failure to receive clearance or approval from regulatory agencies or bodies;
● our inability to commercially launch products or market and generate sales of our products, including Dario;
● failure of Dario or any other products, even if approved for marketing, to achieve any level of commercial
success;
● our failure to obtain patent protection for any of our technologies and products (including those related to
Dario) or the issuance of third-party patents that cover our proposed technologies or products;
● developments or disputes concerning our product’s intellectual property rights;
● our or our competitors’ technological innovations;
● general and industry-specific economic conditions that may affect our expenditures;
● changes in market valuations of similar companies;
● announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint
ventures, capital commitments, new technologies, or patents;
● future sales of our common stock or other securities, including shares issuable upon the exercise of
outstanding warrants or otherwise issued pursuant to certain contractual rights;
● period-to-period fluctuations in our financial results; and
● low or high trading volume of our common stock due to many factors, including the terms of our financing
arrangements.
In addition, if we fail to reach important research, development or commercialization milestone or result by a
publicly expected deadline, even if by only a small margin, there could be a significant impact on the market price of our
common stock and warrants. Additionally, as we approach the announcement of anticipated significant information and as
we announce such information, we expect the price of our common stock and warrants to be particularly volatile, and
negative results would have a substantial negative impact on the price of our common stock and warrants.
In some cases, following periods of volatility in the market price of a company’s securities, stockholders have
often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in
substantial costs and diversion of management attention and resources, which could significantly harm our business
operations and reputation.
Shares eligible for future sale may adversely affect the market for our common stock and warrants.
From time to time, certain of our stockholders may be eligible to sell all or some of their shares of common stock
by means of ordinary brokerage transactions in the open market pursuant to Rule 144, promulgated under the Securities
Act, subject to certain limitations. In general, pursuant to Rule 144, after satisfying a six month holding period: (i) affiliated
stockholder (or stockholders whose shares are aggregated) may, under certain circumstances, sell within any three month
period a number of securities which does not exceed the greater of 1% of the then outstanding shares of common stock or
the average weekly trading volume of the class during the four calendar weeks prior to such sale and (ii) non-affiliated
stockholders may sell without such limitations, provided we are current in our public reporting obligations. Rule 144 also
permits the sale of securities by non-affiliates that have satisfied a one year holding period without any limitation or
restriction. Any substantial sale of our common stock pursuant to Rule 144 or pursuant to any resale report may have a
material adverse effect on the market price of our securities.
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Our compliance with complicated U.S. regulations concerning corporate governance and public disclosure is expensive.
Moreover, our ability to comply with all applicable laws, rules and regulations is uncertain given our management’s
relative inexperience with operating U.S. public companies.
As a publicly reporting company, we are faced with expensive and complicated and evolving disclosure,
governance and compliance laws, regulations and standards relating to corporate governance and public disclosure,
including the Sarbanes-Oxley Act and the Dodd-Frank Act, and, to the extent we complete our anticipated public offering,
the rules of the Nasdaq Stock Market. New or changing laws, regulations and standards are subject to varying
interpretations in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over
time as new guidance is provided by regulatory and governing bodies, which could result in continuing uncertainty
regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
As a result, our efforts to comply with evolving laws, regulations and standards of a U.S. public company are likely to
continue to result in increased general and administrative expenses and a diversion of management time and attention from
revenue-generating activities to compliance activities.
Moreover, our executive officers have little experience in operating a U.S. public company, which makes our
ability to comply with applicable laws, rules and regulations uncertain. Our failure to company with all laws, rules and
regulations applicable to U.S. public companies could subject us or our management to regulatory scrutiny or sanction,
which could harm our reputation and stock price.
If we fail to maintain effective internal control over financial reporting, the price of our common stock may be adversely
affected.
Our internal control over financial reporting may have weaknesses and conditions that could require correction or
remediation, the disclosure of which may have an adverse impact on the price of our common stock. We are required to
establish and maintain appropriate internal control over financial reporting. Failure to establish those controls, or any
failure of those controls once established, could adversely affect our public disclosures regarding our business, prospects,
financial condition or results of operations. In addition, management’s assessment of internal control over financial
reporting may identify weaknesses and conditions that need to be addressed in our internal control over financial reporting
or other matters that may raise concerns for investors. Any actual or perceived weaknesses and conditions that need to be
addressed in our internal control over financial reporting or disclosure of management’s assessment of our internal control
over financial reporting may have an adverse impact on the price of our common stock.
Anti-takeover provisions in our charter documents and Delaware law could discourage, delay or prevent a change in
control of our company and may affect the trading price of our common stock and warrants.
We are a Delaware corporation and the anti-takeover provisions of the Delaware General Corporation Law may
discourage, delay or prevent a change in control by prohibiting us from engaging in a business combination with an
interested stockholder for a period of three years after the person becomes an interested stockholder, even if a change in
control would be beneficial to our existing stockholders. In addition, our certificate of incorporation and bylaws may
discourage, delay or prevent a change in our management or control over us that stockholders may consider favorable. Our
certificate of incorporation and bylaws:
● authorize the issuance of “blank check” preferred stock that could be issued by our Board of Directors to
thwart a takeover attempt;
● provide that vacancies on our Board of Directors, including newly created directorships, may be filled only
by a majority vote of directors then in office;
● provide that special meetings of stockholders may only be called by our Chairman, Chief Executive Officer
and/or President or other executive officer, our Board of Directors or a super-majority (66 2/3%) of our
stockholders;
● place restrictive requirements (including advance notification of stockholder nominations and proposals) on
how special meetings of stockholders may be called by our stockholders;
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● do not provide stockholders with the ability to cumulate their votes; and
● provide that our Board of Directors or a super-majority of our stockholders (66 2/3%) may amend our
bylaws.
We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, your
ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
We have never declared or paid cash dividends on our common stock and do not anticipate paying any cash
dividends to holders of our common stock in the foreseeable future. Consequently, investors must rely on sales of their
common stock after price appreciation, which may never occur, as the only way to realize any future gains on their
investments. There is no guarantee that shares of our common stock will appreciate in value or even maintain the price at
which our stockholders have purchased their shares.
Item 1B. Unresolved Staff Comments
Not applicable.
Item 2. Properties
We do not own any real property. Currently, we maintain offices at 8 HaTokhen St., Caesarea Industrial Park,
3088900, Israel. On September 8, 2016, we signed a lease agreement for these facilities for a period of 5 years
commencing upon the completion of construction of the new office building. We moved into these offices during
November 2017. The rental agreement will be extended automatically for an additional 60 months following expiration of
the initial term. The monthly rent and management services under this lease are approximately $19,140. In December 2017
we signed a lease agreement for our new U.S. headquarters facilities in New York, New York for a monthly rent and
management services of approximately $6,557.
Item 3. Legal Proceedings
We are currently not a party to any pending legal proceeding, nor is our property the subject of a pending legal
proceeding, that we believe is not ordinary routine litigation incidental to our business or otherwise material to the financial
condition of our business.
Item 4. Mine Safety Disclosures
Not applicable.
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PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Market Information
Our common stock is quoted on the Nasdaq Capital Market under the symbol “DRIO”. Our warrants to purchase
common stock are quoted on the Nasdaq Capital Market under the symbol “DRIOW”.
Record Holders
As of March 17, 2022, we had 380 stockholders of record of our common stock.
Dividends
We have never paid any cash dividends on our common stock. We anticipate that we will retain funds and future
earnings to support operations and to finance the growth and development of our business. Therefore, we do not expect to
pay cash dividends in the foreseeable future. Any future determination to pay dividends will be at the discretion of our
Board of Directors and will depend on our financial condition, results of operations, capital requirements and other factors
that our Board of Directors deems relevant. In addition, the terms of any future debt or credit financings may preclude us
from paying dividends.
Securities Authorized for Issuance Under Equity Compensation Plans as of December 31, 2021:
The following table provides information as of December 31, 2021, with respect to options outstanding under the
Company’s Amended and Restated 2012 Equity Incentive Plan (the “2012 Equity Incentive Plan”), the Company’s 2020
Equity Incentive Plan (the “2020 Equity Incentive Plan”), and the Company’s other equity compensation arrangements.
Plan category
Equity compensation plans approved by
security holders
Equity compensation plans not approved by
security holders (1)
Equity compensation plans not approved by
security holders (2)
Equity compensation plans not approved by
security holders (3)
Equity compensation plans not approved by
security holders (4)
Equity compensation plans not approved by
security holders (5)
Equity compensation plans not approved by
security holders (6)
Equity compensation plans not approved by
security holders (7)
Total
Number of securities
to be issued upon
exercise of
outstanding options,
Weighted-average
exercise price of
outstanding options,
Number of securities
remaining available
Forfeited shares
(8)
warrants and rights warrants and rights for future issuance
12,616
1,435,368
587
213
157,500
50,000
75,000
20,000
12,616
140,000
1,878,668
$
$
$
$
$
$
$
$
18.25
633,366
2,523.62
2,502.00
8.41
5.75
20.53
18.62
16.70
—
—
—
—
633,366
(1)
In March 2013, our Board adopted a non-employee director’s remuneration policy.
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(2)
(3)
(4)
(5)
(6)
(7)
On May 2014, our Board approved the grant of non-plan options to the Company’s Scientific Advisory Board
(“SAB”). These options have an exercise price of $2,502.00 vest in 4 quarterly installments in arrears, have a
cashless exercise feature and a ten-year term.
In January 2020, our Board approved the grant of non-plan options as a material inducement for employment, in
accordance with Nasdaq Listing Rule 5635(c)(4), to our newly hired President and General Manager for North
America. The options have an exercise price of $8.41 per share. 90,000 options are time based and vest over a
three-year period. One third vests after one year and the balance vests over eight quarterly installments after the
first anniversary; these options have a cashless exercise feature and a six-year term. An additional 90,000 options
are performance based, and vest over a three-year period. One third vest after one year and the balance vest over
eight quarterly installments after the first anniversary; these options have a cashless exercise feature and a six-year
term. 22,500 options will commence vesting every calendar year for the next four years, commencing in 2021, and
only if certain performance milestones were met in the immediately preceding year. 22,500 of these options have
expired on January 1, 2021 as the performance milestones were not met.
In March 2020, our Board approved the grant of certain non-plan options as a material inducement for
employment, in accordance with Nasdaq Listing Rule 5635(c)(4), to our newly hired Chief Medical Officer. The
options have an exercise price of $5.75 per share, and vest over a three-year period with one third vesting after one
year and the balance vesting over eight quarterly installments after the first anniversary; these options have a
cashless exercise feature and a six-year term.
In June 2021, our Board approved the grant of certain non-plan options as a material inducement for employment,
in accordance with Nasdaq Listing Rule 5635(c)(4), to our newly hired Head of Behavioral Health. The options
have an exercise price of $20.53 per share. 60,000 options are time based and vest over a three-year period in
twelve equal quarterly installments from the grant date; these options have a cashless exercise feature and a ten-
year term. An additional 15,000 options are performance based, and have vested in full during 2021.
In July 2021, our Board approved the grant of certain non-plan options as a material inducement for employment,
in accordance with Nasdaq Listing Rule 5635(c)(4), to our newly hired Special Vice President of Market Access.
The options have an exercise price of $18.62 per share, and vest over a three-year period with one third vesting
after one year and the balance vesting over eight quarterly installments after the first anniversary; these options
have a cashless exercise feature and a ten-year term.
In November 2021, our Board approved the grant of certain non-plan options, issued as a material inducement for
employment, in accordance with Nasdaq Listing Rule 5635(c)(4), to our newly hired Chief Commercial Officer.
The options have an exercise price of $16.70 per share. 80,000 options are time based and vest over a three-year
period with one third vesting after one year and the balance vesting over eight quarterly installments after the first
anniversary; these options have a cashless exercise feature and a ten-year term. An additional 60,000 options are
performance based, and vest over a three-year period in three annual installments subject to reaching annual
revenue thresholds during each of the 2022, 2023 and 2024 fiscal years.
(8)
12,616 restricted shares of common stock issued to employees of the company were forfeited, as they were not
vested upon certain employee departures.
On January 23, 2012, our Board of Directors and a majority of the holders of our then outstanding shares of our
common stock adopted our 2012 Equity Incentive Plan (which includes both U.S. and Israeli sub-plans). On January 23,
2012, an Israeli sub-plan was adopted under our 2012 Equity Incentive Plan, which sets forth the terms for the grant of
stock awards to Israeli employees or Israeli non-employees. The sub-plan was adopted in accordance with the amended
sections 102 and 3(i) of Israel’s Income Tax Ordinance. The sub-plan is part of the 2012 Equity Incentive Plan and subject
to the same terms and conditions. On September 26, 2016 and November 30, 2016, respectively, our Board of Directors
and stockholders approved an amendment to the 2012 Equity Incentive Plan increasing the number of shares of common
stock available under the plan to 1,873,000 as well as amended the 2012 Equity Incentive Plan to permit grants of shares of
common stock. On February 2, 2017 and March 9, 2017, respectively, our Board of Directors and stockholders approved
an amendment to the 2012 Equity Incentive Plan increasing the number of shares of common stock available under the
plan to 2,373,000. On October 9, 2017 and December 4, 2017, respectively, our Board of Directors and stockholders
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approved an amendment to the 2012 Equity Incentive Plan increasing the number of shares of common stock available
under the plan to 3,873,000. On March 26, 2018 and May 18, 2018, respectively, our Board of Directors and stockholders
approved an amendment to the 2012 Equity Incentive Plan increasing the number of shares of common stock available
under the plan to 5,373,000. On October 7, 2018 and November 29, 2018, respectively, our Board of Directors and
stockholders approved an amendment to the 2012 Equity Incentive Plan increasing the number of shares of common stock
available under the plan to 7,873,000. On September 3, 2019 and November 6, 2019, respectively, our Board of Directors
and stockholders approved an amendment to the 2012 Equity Incentive Plan increasing the number of shares of common
stock available under the plan to 618,650 on a post reverse stock split basis. On December 26, 2019 and February 5, 2020,
respectively, our Board of Directors and stockholders approved an amendment to the 2012 Equity Incentive Plan increasing
the number of shares of common stock available under the plan to 1,968,650. The 2012 Equity Incentive Plan expired on
January 23, 2022. On September 2, 2020 and October 14, 2020, respectively, our Board of Directors and stockholders
approved and adopted the Company’s 2020 Equity Incentive Plan (the “2020 Equity Incentive Plan”), reserving for
issuance a pool of 900,000 shares of the Company’s common stock under the plan. On January 1, 2021 the number of
shares of common stock available under the plan increased to 1,828,890 according to the terms thereof. On June 7, 2021
the number of shares of common stock available under the plan increased to 2,528,890 according to the terms thereof. On
January 1, 2022 the number of shares of common stock available under the plan increased to 3,868,514 according to the
terms thereof. As of March 17, 2022, there are 1,426,244 shares of Common Stock reserved for issuance thereunder. The
Company’s officers and directors are among the persons eligible to receive awards under the 2020 Equity Incentive Plan in
accordance with the terms and conditions thereunder.
The purpose of both our 2012 and 2020 Equity Incentive Plans is to attract and retain directors, officers,
consultants, advisors and employees whose services are considered valuable, to encourage a sense of proprietorship and to
stimulate an active interest of such persons in our development and financial achievements. Each of the 2012 and 2020
Equity Incentive Plans will be administered by the Compensation Committee of our Board of Directors or by the full
board, which may determine, among other things, the (a) terms and conditions of any option or stock purchase right
granted, including the exercise price and the vesting schedule, (b) persons who are to receive options and stock purchase
rights and (c) the number of shares to be subject to each option and stock purchase right. The 2012 and 2020 Equity
Incentive Plans will each provide for the grant of (i) ”incentive” options (qualified under section 422 of the Internal
Revenue Code of 1986, as amended) to employees of our company and (ii) non-qualified options to directors and
consultants of our company. In addition, our Board of Directors has authorized the appointment of IBI Capital
Compensation and Trusts (2004) Ltd. to act as a trustee for grants of options under the Israeli sub-plan to Israeli residents.
In connection with the administration of our 2012 and 2020 Equity Incentive Plans, our Compensation Committee
will:
● determine which employees and other persons will be granted awards under our 2012 and 2020 Equity
Incentive Plans;
● grant the awards to those selected to participate;
● determine the exercise price for options; and
● prescribe any limitations, restrictions and conditions upon any awards, including the vesting conditions of
awards.
Our Compensation Committee will: (i) interpret our 2012 and 2020 Equity Incentive Plans; and (ii) make all other
determinations and take all other action that may be necessary or advisable to implement and administer our 2012 and 2020
Equity Incentive Plans.
The 2012 and 2020 Equity Incentive Plans each provide that in the event of a change of control event, the
Compensation Committee or our Board of Directors shall have the discretion to determine whether and to what extent to
accelerate the vesting, exercise or payment of an award.
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In addition, our Board of Directors may amend our 2012 or 2020 Equity Incentive Plan at any time. However,
without stockholder approval, our 2012 or 2020 Equity Incentive Plan may not be amended in a manner that would:
● increase the number of shares that may be issued under such Equity Incentive Plan;
● materially modify the requirements for eligibility for participation in such Equity Incentive Plan;
● materially increase the benefits to participants provided by such Equity Incentive Plan; or
● otherwise disqualify such Equity Incentive Plan for coverage under Rule 16b-3 promulgated under the
Exchange Act.
Awards previously granted under our 2012 or 2020 Equity Incentive Plans may not be impaired or affected by any
amendment of such without the consent of the affected grantees.
Option Exercises
To date, no options have been exercised by our directors or officers.
Unregistered Sales of Equity Securities and Use of Proceeds
During the fourth quarter of 2021, we issued an aggregate 55,194 shares of our common stock to certain of our
service providers as compensation to them for services rendered. We claimed exemption from registration under the
Securities Act of 1933, as amended, or the Securities Act, for the foregoing transactions under Section 4(a)(2) of the
Securities Act.
Item 6. [Reserved]
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Readers are advised to review the following discussion and analysis of our financial condition and results of
operations together with our consolidated financial statements and the related notes and other financial information
included elsewhere in this Annual Report. Some of the information contained in this discussion and analysis or set forth
elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, includes
forward-looking statements that involve risks and uncertainties. See “Cautionary Note Regarding Forward-Looking
Statements”. You should review the “Risk Factors” section of this Annual Report for a discussion of important factors that
could cause actual results to differ materially from the results described in or implied by the forward-looking statements
contained in the following discussion and analysis.
Overview
We are a leading global DTx company revolutionizing the way people manage their health across the chronic
condition spectrum to live a better and healthier life. Our mission is to transform how affected individuals manage their
health and chronic conditions by empowering our customers to easily manage their conditions and take steps to improve
their overall health. Most chronic conditions are driven by personal behaviors and the actions that are or are not taken. We
believe that changing these behaviors can dramatically improve our customers’ overall health and substantially reduce
unnecessary health spending. However, behavioral change and habit formation are difficult, especially in managing chronic
disease and related conditions. Our digital therapeutics endeavor to produce lasting behavior changes in our customers by
applying a novel combination of AI-driven dynamic personalization and behavioral science at scale. This allows us to
engage and support our customers, and offer them a complete virtual care solution, ideally resulting in improved health
outcomes and reduced total cost of care.
Our principal operating subsidiary, LabStyle Innovation Ltd., is an Israeli company (“LabStyle”) with its
headquarters in Caesarea, Israel. We were formed on August 11, 2011, as a Delaware corporation with the name LabStyle
Innovations Corp. On July 28, 2016, we changed our name to DarioHealth Corp. We began our sales in the direct-to-
consumer space, solving first for what we deemed the most difficult problems: how to engage users and support behavior
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change to improve clinical outcomes in diabetes. Our most developed AI tools leverage the direct-to-consumer experience
from over 150,000 members to drive superior engagement and outcomes. In early 2020, we broadened our solutions to
include other medical conditions in addition to diabetes, and to serve business customers who seek to improve the health of
their stakeholders. Presently, we have deployed solutions for diabetes, hypertension, and pre-diabetes, and through our
acquisition of Upright, we now offer solutions for musculoskeletal (“MSK”) conditions. We intend to deploy behavioral
health and other condition solutions in 2021, which conditions will also be powered by our AI-driven behavior change
platform. We are currently delivering B2B2C solutions for providers, employers, and pharmaceutical companies.
We commenced a commercial launch of our free application in the United Kingdom in late 2013 and commenced
an initial soft launch of the full Dario solution (including the app and the Dario Blood Glucose Monitoring System) in
selected jurisdictions in March 2014. We continued to scale up launch during 2014 in the United Kingdom, the Netherlands
and New Zealand, and during 2015 in Australia, Israel and Canada, with the goal of collecting customer feedback to refine
our longer-term roll-out strategy. We are consistently adding new additional features and functionality in making Dario the
new standard of care in diabetes data management.
Through our Israeli subsidiary, Labstyle, and its subsidiary Upright, our plan of operations is to continue the
development of our software and hardware offerings and related technology. During 2015, we successfully launched the
Dario Smart Diabetes Management Solution according to plan and are currently expanding the launch to other
jurisdictions. In 2016, we established our direct-to-consumer model in the U.S. to achieve higher and faster penetration into
the market during the launch phase. We have invested in a robust digital marketing department with in-house platforms,
experienced personnel and robust infrastructures to support expected growth of users and online subscribers in this market.
During the third quarter of 2016 we expanded these efforts to include Australia as well. In 2017, we expanded our direct-
to-consumer marketing efforts in the United Kingdom in cooperation with our local distributor and launched similar
marketing efforts in Germany. In support of these goals, we intend to utilize our funds for the following activities:
● ramp up of mass production, marketing and distribution and sales efforts related to the Dario Smart Diabetes
Management Solution and the DarioEngage platform;
● develop our customer support and telemarketing services in order to support the expect growth of our
revenues and the increase of user, and service provider who will use our platform to better serve people with
diabetes and improve their clinical outcome;
● continued product and software development, and related activities (including costs associated with
application development and data storage capabilities as well as any necessary design modifications to the
various elements of the Dario Smart Diabetes Management Solution, the DarioEngage platform and the
Dario Loop tools and capabilities);
● continued work on registration of our patents worldwide;
● Regulatory and quality assurance matters;
● professional fees associated with being a publicly reporting company; and
● general and administrative matters.
On January 26, 2021, Dario, Labstyle, Upright Technologies Ltd., an Israeli limited company, Vertex C (C.I.)
Fund L.P. (in its capacity as the representative of the Selling Shareholders), and all holders of Upright’s outstanding
securities (the “Selling Shareholders”), entered into a share purchase agreement (the “Upright Agreement”) pursuant to
which Dario, through Labstyle, acquired all of the outstanding securities of Upright. The agreement was consummated on
February 1, 2021, and Upright now operates as a wholly owned subsidiary of the Company. As part of the acquisition,
Dario issued the Selling Shareholders 1,687,612 shares of the Company’s common stock, and agreed to assume options to
purchase up to 100,193 shares of the Company’s common stock, subject to certain escrow and indemnity provisions
contained in the Upright Agreement (in the aggregate, the “Consideration Shares”). In addition, the shares issued are
subject to the terms of a lock-up agreement, pursuant to which the Selling Shareholders (subject to certain exceptions) have
agreed to restrict their ability to transfer their shares as follows: (i) shares representing 20% of their respective
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Consideration Shares will be restricted from transfer for a period of one hundred and eighty (180) days from the date of the
closing of the acquisition (the “Closing Date”), (ii) shares representing 30% of their respective Consideration Shares will
be restricted from transfer for a period of two hundred and seventy (270) days from the Closing Date, (iii) shares
representing 30% of their respective Consideration Shares will be restricted from transfer for a period of three hundred and
sixty (360) days from the Closing Date and (iv) shares representing 20% of their respective Consideration Shares will be
restricted from transfer for a period of four hundred and fifty (450) days from the Closing Date. The Company has also
agreed to file a registration statement covering the resale of the shares within ninety (90) days following the Closing Date.
In addition, 30% of the Consideration Shares issuable to Upright’s founder, Mr. Oded Cohen, shall be held in a specific
holdback retention mechanism, of which 50% shall be released at the lapse of twelve (12) months of retention following
the Closing Date, and the balance of 50% shall be released at the lapse of eighteen (18) months of retention following the
Closing Date.
On February 1, 2021, the Company, through Labstyle, has also agreed to enter into an employment agreement
with Mr. Cohen, pursuant to which he will serve as General Manager of MSK. In consideration for Mr. Cohen’s duties, he
will be entitled to (a) a monthly salary of NIS 63,000, (b) an annual bonus of up to four times his monthly salary, and (c) up
to 220,980 shares of restricted stock of the Company, subject to meeting certain key performance metrics. See
“Management – Employment Agreements.”
Readers are cautioned that, according to our management’s estimates, based on our budget and the initial launch
of our commercial sales, we believe that we will have sufficient resources to continue our activity only into June 2021
without raising additional capital. This includes an amount of anticipated inflows from sales of Dario through direct sales
in the United States and through distribution partners. As such, we have a significant present need for capital. If we are
unable to scale up our commercial launch of Dario or meet our commercial sales targets (or if we are unable to ramp up
revenues), and if we are unable to obtain additional capital resources in the near term, we may be unable to continue
activities, absent material alterations in our business plans, and our business might fail.
Critical Accounting Policies
Our consolidated financial statements are prepared using the accrual basis of accounting in accordance with
accounting principles generally accepted in the United States (“U.S. GAAP”). Our fiscal year ends December 31.
This Management’s Discussion and Analysis of Financial Condition and Results of Operations discuss our
consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these
consolidated financial statements requires making estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well
as the reported revenues and expenses for the reporting periods. On an ongoing basis, we evaluate such estimates and
judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and
liabilities that are not readily apparent from other sources. Actual results may differ (perhaps significantly) from these
estimates under different assumptions or conditions.
While all the accounting policies impact the consolidated financial statements, certain policies may be viewed to
be critical. Our management believes that the accounting policies which involve more significant judgments and estimates
used in the preparation of our consolidated financial statements, include revenue recognition, inventories, liability related
to certain warrants, and accounting for production lines and its related useful life and impairment.
Revenue Recognition
We derive our revenue principally from:
● sale of our products, device-specific disposables test strip cartridges, lancets and our Dario Blood Glucose
Monitoring System through distributors or directly to end users;
● revenue from providing Remote Patient Monitoring services to healthcare providers through the DarioEngage
platform; and
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● revenue from ongoing membership programs, providing our users personalized diabetes management programs,
including lifestyle changes, healthy eating, advanced tracking and live coaching.
Revenue is recognized under the five-step methodology in accordance with Accounting Standards Codification
(“ASC”) - ASC 606, which requires us to identify the contract with the customer, identify the performance obligations in
the contract, determine the transaction price, allocate the transaction price to the performance obligations identified, and
recognize revenue when (or as) each performance obligation is satisfied.
Revenue from product sales is recognized in the period in which the products are provided to customers.
Revenues are recognized when control of the promised products is transferred to customers, in an amount that reflects the
consideration to which we expect to receive from patients.
Revenues from ongoing membership programs and Remote Patient Monitoring services are recognized for each
individual performance obligation when delivery has occurred, by fulfillment of product and service to the customer. Our
revenues are recognized in the period in which services and related products are provided to customers and are recorded
either at a point in time for the sale of products, or over the fixed service period for membership. The fee paid in upfront,
fixed or determinable, the allocation of the transaction price to each performance obligations product and service based on
the best estimate of selling price which is established considering several internal factors including, but not limited to,
historical sales, pricing practices and geographies in which we offer our products.
Inventories
Inventory write-down is measured as the difference between the cost of the inventory and net realized value based
upon assumptions about future demand, and is charged to the cost of sales. At the point of the loss recognition, a new,
lower-cost basis for that inventory is established, and subsequent changes in facts and circumstances do not result in the
restoration or increase in that newly established cost basis.
If there were to be a sudden and significant decrease in demand for our products or if there were a higher
incidence of inventory obsolescence because of rapidly changing technology and customer requirements, we could be
required to increase our inventory write-downs and our gross margin could be adversely affected. Inventory and supply
chain management remain areas of focus as we balance the need to maintain supply chain flexibility, to help ensure
competitive lead times with the risk of inventory obsolescence.
During the year ended December 31, 2021, total inventory write-downs expenses amounted to $73,000.
Production Lines
Capitalization of Costs. We capitalize direct incremental costs of third-party manufacturers related to the
equipment in our production lines. We cease construction cost capitalization relating to our production lines once they are
ready for its intended use and held available for occupancy. All renovations and betterments that extend the economic
useful lives of assets and/or improve the performance of the production lines are capitalized.
Useful Lives of Assets. We are required to make subjective assessments as to the useful lives of our production
lines for purposes of determining the amount of depreciation to record on an annual basis with respect to our construction
of the production lines. These assessments have a direct impact on our net income (loss). Production lines are usually
depreciated on a straight-line basis over a period of up to seven years, except any renovations and betterments which are
depreciated over the remaining life of the production lines.
Impairment of production lines. We are required to review our production lines for impairment in accordance with
ASC 360, “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount
of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the
carrying amount of an asset to the future undiscounted cash flows expected to be generated by the assets. If such assets are
considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of
the assets exceeds the fair value of the assets.
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Results of Operations
Comparison of the Year Ended December 31, 2021 to Year Ended December 31, 2020
Revenues
Revenues for the year ended December 31, 2021 amounted to $20,513,000 compared to $7,576,000 during the
year ended December 31, 2020.
Revenues generated during the year ended December 31, 2021 were derived mainly from the sales of the
hardware and services, through direct sales to consumers located mainly in the United States through our on-line store and
through distributors, and from the offering of our membership services to our customers located mainly in the United
States.
Cost of Revenues
During the years ended December 31, 2021 and 2020, we recorded costs related to revenues in the amount of
$16,550,000 and $5,063,000, respectively. The increase in cost of revenues was mainly due to higher costs related to
shipping of inventory, and amortization of inventory step up and acquired technology in the amount of $4,106,000 as a
result of the acquisition of Upright and WayForward.
Cost of revenues consist mainly of cost of device production, employees’ salaries and related overhead costs,
depreciation of production line and related cost of equipment used in production, amortization of technologies, hosting
costs, shipping and handling costs and inventory write-downs.
Gross Profit
Gross profit for the year ended December 31, 2021, amounted to $3,963,000 (19.3% of revenues) compared to
$2,513,000 (33.2% of revenues) for the year ended December 31, 2020. The decrease in gross profit as a percentage of
revenue for the year ended December 31, 2021, compared to the year ended December 31, 2020, is mainly as a result of
amortization of inventory step up and acquired technology following the acquisition of Upright and WayForward
amounting to $4,106,000, decrease in profitability generated from products and higher shipping costs of inventory. Gross
profit excluding these amortizations was $8,069,000 (39.3% of revenues).
Research and Development Expenses
Our research and development expenses increased by $12,786,000 to $17,219,000 for the year ended December
31, 2021 compared to $4,433,000 for the year ended December 31, 2020. This increase was mainly due to the increase in
our activities during the year ended December 31, 2021. Our research and development expenses, excluding stock-based
compensation and depreciation, for the year ended December 31, 2021, were $13,272,000 compared to $3,584,000 for the
year ended December 31, 2020, an increase of $9,688,000. This increase is mainly as a result of an increase in salaries and
software development expenses.
Research and development expenses consist mainly of payroll expenses to employees involved in research and
development activities, expenses related to: (i) our solutions including our Dario Smart Diabetes Management Solution,
DarioEngage platform, Dario Move solution and our digital behavioral health solution, (ii) labor contractors and
engineering expenses, (iii) depreciation and maintenance fees related to equipment and software tools used in research and
development, (iv) clinical trials performed in the United States to satisfy the FDA product approval requirements and (v)
facilities expenses associated with and allocated to research and development activities.
Sales and Marketing
Our sales and marketing expenses increased by $24,479,000 to $39,706,000 for the year ended December 31,
2021 compared to $15,227,000 for the year ended December 31, 2020. This increase was mainly due to the increases in our
digital marketing, payroll related expenses, stock-based compensation during the year ended December 31, 2021. Our sales
and marketing expenses, excluding stock-based compensation, depreciation and amortization, for the year ended December
31, 2021 were $33,555
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,000 compared to $12,452,000 for the year ended December 31, 2020, an increase of $21,103,000. This increase was due to
an increase in our digital marketing, and payroll related expenses, as a result of hiring our sales and marketing team in the
U.S. to lead the penetration into the B2B2C market.
Sales and marketing expenses consist mainly of payroll expenses, online marketing campaigns of our service
offering, trade show expenses, customer support expenses and marketing consultants and subcontractors.
General and Administrative Expenses
Our general and administrative expenses increased by $10,776,000 to $23,532,000 for the year ended December
31, 2021 compared to $12,756,000 for the year ended December 31, 2020. The increase was mainly due to an increase in
our stock-based compensation, investor relations, insurance expenses and the costs related with the acquisitions performed
during the year ended December 31, 2021. Our general and administrative expenses, excluding stock-based compensation,
acquisition costs and depreciation, for the year ended December 31, 2021 were $8,150,000 compared to $5,239,000 for the
year ended December 31, 2020, an increase of $2,911,000. This increase was due to an increase in insurance, consulting
services, legal expenses and investor relations expenses.
Our general and administrative expenses consist mainly of payroll and stock-based compensation expenses for
management, employees, directors and consultants, legal and accounting fees, patent registration, expenses related to
investor relations, as well as our office rent and related expenses.
Finance income (expenses), net
Our finance expenses, net, increased by $693,000 to $235,000 for the year ended December 31, 2021 compared to
$458,000 financing income for the year ended December 31, 2020. The changes in our financial expenses were mainly due
to foreign currency translation differences.
Financial (income) expenses, net mainly include bank charges, interest income, lease liability and foreign
currency translation differences.
Income tax
Income tax expenses were $32,000 for the year ended December 31, 2021. as compared to none for the year ended
December 31, 2020.
Net loss
Net loss for the year ended December 31, 2021 was $76,761,000. Net loss for the year ended December 31, 2020
was $29,445,000. The increase from 2020 was mainly due to the increase in our operating expenses.
Net operating loss carryforwards
As of December 31, 2021, we and WayForward had a U.S. federal net operating loss carryforward of
approximately $37,910, of which $7,491 were generated from tax years 2011-2017 and can be carried forward and offset
against taxable income, which expires during the years 2031 to 2037.
On December 22, 2017, the U.S. Tax Cuts and Jobs Act of 2017 (the “TCJA”) modified the rules regarding
utilization of net operating loss and net operating losses generated subsequent to the TCJA can only be used to offset 80%
of taxable income with an indefinite carryforward period for unused carryforwards (i.e., they should not expire). During
2018 - 2021, we generated additional $30,419,000 of net operating losses carryforwards which are not subject to the annual
limitation described above.
Our Israeli subsidiaries, Labstyle and Upright, have accumulated net operating losses for Israeli income tax
purposes as of December 31, 2021 in the amount of approximately $133,960,000. The net operating losses may be carried
forward and offset against taxable income in the future for an indefinite period.
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In accordance with U.S. GAAP, it is required that a deferred tax asset be reduced by a valuation allowance if,
based on the weight of available evidence it is more likely than not (a likelihood of more than 50 percent) that some portion
or all of the deferred tax assets will not be realized. The valuation allowance should be sufficient to reduce the deferred tax
asset to the amount which is more likely than not to be realized. As a result, we recorded a valuation allowance with
respect to our deferred tax asset. Under Sections 382 and 383 of the Internal Revenue Code, if an ownership change occurs
with respect to a “loss corporation” (as defined in the Internal Revenue Code), there are annual limitations on the amount
of the net operating loss and other deductions which are available to us.
The factors described above resulted in net loss attributable to common stockholders of $78,766,000 and
$33,103,000 for the year ended December 31, 2021 and 2020, respectively.
Non-GAAP Financial Measures
To supplement our consolidated financial statements presented in accordance with U.S. GAAP within this Annual
Report on Form 10-K, management provides certain non-GAAP financial measures (“NGFM”) of the Company’s financial
results, including such amounts captioned: “net loss before interest, taxes, depreciation, and amortization” or “EBITDA,”
and “Non-GAAP Adjusted Loss,” as presented herein below. Importantly, we note the NGFM measures captioned
“EBITDA” and “Non-GAAP Adjusted Loss” are not recognized terms under U.S. GAAP, and as such, they are not a
substitute for, considered superior to, considered separately from, nor as an alternative to, U.S. GAAP and /or the most
directly comparable U.S. GAAP financial measures.
Such NGFM are presented with the intent of providing greater transparency of information used by us in our
financial performance analysis and operational decision-making. Additionally, we believe these NGFM provide meaningful
information to assist investors, shareholders, and other readers of our consolidated financial statements, in making
comparisons to our historical financial results, and analyzing the underlying financial results of our operations. The NGFM
are provided to enhance readers’ overall understanding of our current financial results and to provide further information to
enhance the comparability of results between the current year period and the prior year period.
We believe the NGFM provide useful information by isolating certain expenses, gains, and losses, which are not
necessarily indicative of our operating financial results and business outlook. In this regard, the presentation of the NGFM
herein below, is to help the reader of our consolidated financial statements to understand the effects of the non-cash impact
on our (U.S. GAAP) unaudited statement of operations of the revaluation of the warrants and the expense related to stock-
based compensation, each as discussed herein above.
A reconciliation to the most directly comparable U.S. GAAP measure to NGFM, as discussed above, is as
follows:
Net Loss Reconciliation
Net loss - as reported
Adjustments
Depreciation expense
Inventory step up amortization
Amortization of acquired technology
Other financial expenses (income), net
Income Tax
EBITDA
Acquisition costs
Revaluation of earn-out
Stock-based compensation expenses
Year Ended December 31,
(in thousands)
2020
2021
$ Change
$
(76,761)
$
(29,445)
$
(47,316)
282
1,140
3,035
235
32
190
—
—
(458)
—
92
1,140
3,035
693
32
(72,037)
(29,713)
(42,324)
880
(503)
24,971
—
—
11,102
880
(503)
13,869
Non-GAAP adjusted loss
$
(46,689)
$
(18,611)
$
(28,078)
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Liquidity and Capital Resources
As of December 31, 2021, we had approximately $35,808,000 in cash and cash equivalents compared to
$28,590,000 at December 31, 2020.
We have experienced cumulative losses of $222,014,000 from inception (August 11, 2011) through December 31,
2021 and have a stockholders’ equity of $85,549,000 at December 31, 2021. In addition, we have not completed our efforts
to establish a stable recurring source of revenues sufficient to cover our operating costs and expect to continue to generate
losses for the foreseeable future.
Since inception, we have financed our operations primarily through private placements and public offerings of our
common stock and warrants to purchase shares of our common stock, receiving aggregate net proceeds totaling
$189,685,000 as of December 31, 2021.
On February 28, 2018 and March 6, 2018, we closed two concurrent private placements offerings consisting of
113,110 shares of our common stock at $28.00 per share, 61,704 shares of our Series C Convertible Preferred Stock at
$56.00 per share and warrants to purchase up to 189,218 shares of common stock for aggregate gross proceeds of
approximately $6,623,000.
On September 13, 2018 and September 26, 2018, we closed two concurrent private placements offerings
consisting of 213,340 shares our common stock at $18.00 per share, 94,513 shares of our Series D Convertible Preferred
Stock at $72.00 per share and warrants to purchase up to 473,114 shares of common stock, for aggregate gross proceeds of
approximately $10,645,000.
On December 13, 2018 and December 27, 2018, we closed a private placement offering of 152,504 shares of our
common stock at a purchase price of $20.00 per share and warrants to purchase up to 152,500 shares of our common stock
at $25.00 per share for aggregate gross proceeds of approximately $3,050,000.
On November 27, 2019, we entered into subscription agreements with accredited investors relating to an offering
with respect to the sale of an aggregate of 8,361 shares of newly designated Series A Convertible Preferred Stock and an
aggregate of 5,200 shares of newly designated Series A-1 Convertible Preferred Stock, at a purchase price of $1,000 for
each share of Series A Preferred Stock and Series A-1 Preferred Stock, for aggregate gross proceeds to the Company of
$13,560,000. The initial closing of the offering took place on November 27, 2019. On December 3, 2019, we entered into
subscription agreements with accredited investors relating to an offering and the sale of an aggregate of 1,915 shares of
newly designated Series A-2 Preferred Stock, at a purchase price of $1,000 per share, for aggregate gross proceeds to the
Company of $1,915,000. On December 4, 2019, we into subscription agreements with accredited investors relating to an
offering and the sale of an aggregate of 3,808 shares of newly designated Series A-3 Preferred Stock, at a purchase price of
$1,000 per share, for aggregate gross proceeds to the Company of $3,808,000. On December 5, 2019, we entered into
subscription agreements with accredited investors relating to an offering and the sale of an aggregate of 745 shares of
newly designated Series A-4 Preferred Stock, at a purchase price of $1,000 per share, for aggregate gross proceeds to the
Company of $745,000. On December 19, 2019, we entered into subscription agreements with accredited investors relating
to an offering and the sale of an aggregate of 1,346 shares of newly designated Series A-3 Preferred Stock, at a purchase
price of $1,000 per share, for aggregate gross proceeds to the Company of $1,346,000. The total aggregate gross proceeds
of the offering described above, together with gross proceeds from the closing of the offering of Series A Preferred Stock,
Series A-1 Preferred Stock, Series A-2 Preferred Stock, Series A-3 Preferred Stock and Series A-4 Preferred Stock was
$21,375,000.
On July 28, 2020, we entered into subscription agreements with accredited investors relating to an offering with
respect to the sale of an aggregate of (i) 2,969,266 shares of our common stock, at a purchase price of $7.47 per share, and
(ii) pre-funded warrants to purchase 824,689 shares of common stock, at a purchase price of $7.4699 per pre-funded
warrant. In addition, on July 30, 2020, we entered into a subscription agreement with an accredited investor for the
purchase of 31,486 shares of our common stock at a purchase price per share of $7.94 per share. The aggregate gross
proceeds were approximately $28,591,000.
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In September 2020, we and an existing warrant holder entered into an agreement pursuant to which we agreed to
lower the exercise price of certain warrants issued in September 2018, from $25.00 to $13.00 per share. As a result, the
warrant holder exercised warrants to purchase 88,889 shares of our common stock, resulting in aggregate gross proceeds of
approximately $1,156,000.
On January 26, 2021, we entered into securities purchase agreements with institutional accredited investors
relating to an offering with respect to the sale of an aggregate of 3,278,688 shares of the Company’s common stock at a
purchase price of $21.35 per share, for aggregate gross proceeds of $70,000,000. The closing of the offering was
consummated on February 1, 2021. The purchase price per share represents the “Minimum Price” of the Company’s
Common Stock pursuant to Nasdaq Rule 5635(d) as of the date of execution of each respective securities purchase
agreement. The Company and the investors participating in the offering also executed a registration rights agreement
pursuant to which the Company agreed to file a registration statement covering the resale of the shares within sixty (60)
days following the final closing of the offering.
On February 28, 2022, we entered into securities purchase agreements with institutional accredited investors
relating to a registered direct offering with respect to the sale of an aggregate of 4,674,454 shares of our common stock and
pre-funded warrants to purchase an aggregate of 667,559 shares of our common stock, at a purchase price of $7.49 per
share. The aggregate gross proceeds were approximately $40,000,000.
Readers are advised that available resources may be consumed more rapidly than currently anticipated, resulting
in the need for additional funding sooner than expected. Should this occur, we will need to seek additional capital earlier
than anticipated in order to fund (1) further development and, if needed (2) expenses which will be required in order to
expand manufacturing of our products, (3) sales and marketing efforts and (4) general working capital. Such funding may
be unavailable to us on acceptable terms, or at all. Our failure to obtain such funding when needed could create a negative
impact on our stock price or could potentially lead to the failure of our company. This would particularly be the case if we
are unable to commercially distribute our products and services in the jurisdictions and in the timeframes we expect.
Cash Flows
The following tables sets forth selected cash flow information for the periods indicated:
Cash used in operating activities:
Cash used in investing activities:
Cash provided by financing activities:
Net cash used in operating activities
December 31,
2021
$
(50,409,000)
(8,134,000)
65,766,000
2020
$
(17,736,000)
(1,622,000)
27,548,000
Net cash used in operating activities was $50,409,000 for the year ended December 31, 2021 compared to
$17,736,000 used in operations for the same period in 2020. Cash used in operations increased mainly due to the increase
in our marketing activities and the consolidation of each of Upright and WayForward, which we acquired in 2021.
Net cash used in investing activities
Net cash used for investing activities was $8,134,000 for the year ended December 31, 2021 compared to cash
used in investing activities of $1,622,000 for the year ended December 31, 2020. Cash used in investing activities increased
mainly due to the repayment of a loan we made to Upright, the acquisition of WayForward and cash acquired as part of the
acquisition of each of Upright and WayForward.
Net cash provided by financing activities
Net cash provided by financing activities was $65,766,000 for the year ended December 31, 2021 compared to
$27,548,000 for the year ended December 31, 2020. During the year ended December 31, 2021, we raised net proceeds in
an amount of approximately $65,766,000 mainly through our January 2021 offering.
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Contractual Obligations
Set forth below is a summary of our current obligations as of December 31, 2021 to make future payments due by
the period indicated below, excluding payables and accruals. We expect to be able to meet our obligations in the ordinary
course. Operating lease obligations are for motor vehicle and real property leases which we use in our business. Purchasing
obligations consists of outstanding purchase orders for materials and services from our vendors.
Contractual Obligations
Operating Lease Obligations
Purchasing Obligations
$
Total
846
12,190
Less than 1 year
Payments due by period
(In U.S. dollars thousands)
Over 4 years
1-3 years
—
351
$
—
—
495
12,190
$
$
Total contractual cash obligations
$ 13,036
$
12,685
$
351
$
—
Contingencies
We account for our contingent liabilities in accordance with ASC 450 “Contingencies“. A provision is recorded
when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated.
With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated
settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter.
Currently, we are not a party to any ligation that we believe could have a material adverse effect on our business, financial
position, results of operations or cash flows.
Recently Issued and Adopted Accounting Pronouncements
In September 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update
(“ASU”) 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments” (“ASU 2016-13”). ASU 2016-13 changes the impairment model for most financial assets and certain other
instruments. For trade and other receivables, held-to-maturity debt securities, loans, and other instruments, entities will be
required to use a new forward-looking “expected loss” model that generally will result in the earlier recognition of
allowances for losses. The guidance also requires increased disclosures. For the Company, the amendments in the update
were originally effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal
years. In November 2019, the FASB issued ASU No. 2019-10 which delayed the effective date of ASU 2016-13 for
smaller reporting companies (as defined by the U.S. Securities and Exchange Commission) and other non-SEC reporting
entities to fiscal years beginning after December 15, 2022, including interim periods within those fiscal periods. Early
adoption is permitted. The Company is currently assessing the impact the guidance will have on its consolidated financial
statements.
Item 7A. Quantitative and Qualitative Disclosure About Market Risk
Not applicable.
Item 8. Financial Statements and Supplementary Data
Our consolidated financial statements and notes thereto and the report of Kost Forer Gabbay & Kasierer, a
member of Ernst & Young Global, our independent registered public accounting firm, are set forth on pages F-1 through F-
31 of this Annual Report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
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Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive Officer and
our Chief Financial Officer, we carried out an evaluation of the effectiveness of the design and operation of our disclosure
controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation,
our Chief Executive Officer and our Chief Financial Officer have concluded that, at December 31, 2021, such disclosure
controls and procedures were effective.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information
required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed
or submitted under the Exchange Act is accumulated and communicated to management, including our Chief Executive
Officer and Chief Financial Officer, or persons performing similar functions, as appropriate, to allow timely decisions
regarding required disclosure.
Limitations on the Effectiveness of Internal Controls
Readers are cautioned that our management does not expect that our disclosure controls and procedures or our
internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no
matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the
control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide
absolute assurance that all control issues and instances of fraud, if any, within our control have been detected. The design
of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can
be no assurance that any control design will succeed in achieving its stated goals under all potential future conditions. Over
time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or
procedures may deteriorate.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended
December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Management’s Report on Internal Control Over Financial Reporting
As required by the SEC rules and regulations, our management is responsible for establishing and maintaining
adequate internal control over financial reporting. Our internal control over financial reporting is designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of our consolidated financial
statements for external reporting purposes in accordance with U.S. GAAP. Our internal control over financial reporting
includes those policies and procedures that:
(1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions
and dispositions of the assets of our company;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
consolidated financial statements in accordance with accounting principles generally accepted in the United
States of America, and that our receipts and expenditures are being made only in accordance with
authorizations of our management and directors; and
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the consolidated financial statements.
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Because of its inherent limitations, internal control over financial reporting may not prevent or detect errors or
misstatements in our consolidated financial statements. Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree or
compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of our internal control
over financial reporting at December 31, 2021. In making these assessments, management used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission (2013 Framework). Based on our assessments and
those criteria, management determined that we maintained effective internal control over financial reporting at
December 31, 2021.
A registrant may omit an assessment of an acquired business’s internal control over financial reporting from the
registrant’s assessment of its internal control; however, such an exclusion may not extend beyond one year from the date of
the acquisition, nor may such assessment be omitted from more than one annual management report on internal control
over financial reporting. We acquired PsyInnovations, Inc. (dba wayForward) during 2021, and we excluded from the
assessment of the effectiveness of our internal control over financial reporting as of December 31, 2021, the acquired
entity’s internal control over financial reporting associated with the assets we acquired. We are finalizing the process of
integrating our acquisition of PsyInnovations, Inc. (dba wayForward), including evaluating our internal controls, and
designing and implementing an internal control structure over PsyInnovations, Inc. (dba wayForward), which will be
complete in the 2022 fiscal year.
Item 9B. Other Information
None
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
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Item 10. Directors, Executive Officers and Corporate Governance
PART III
The following sets forth information regarding our executive officers and the members of our Board of Directors
as of the date of this Annual Report. All directors hold office for one-year terms until the election and qualification of their
successors. Officers are appointed by our Board of Directors and serve at the discretion of our Board of Directors, subject
to applicable employment agreements.
Name
Erez Raphael
Zvi Ben David
Dror Bacher
Richard Anderson
Yoav Shaked
Dennis Matheis
Hila Karah
Dennis M. McGrath
Adam Stern
Prof. Richard B. Stone
Age
48
61
47
52
50
61
53
65
57
79
Position(s)
Chief Executive Officer and Director
Chief Financial Officer, Treasurer and Secretary
Chief Operating Officer
President and General Manager of North America
Chairman of the Board of Directors
Director
Director
Director
Director
Director
Erez Raphael has served as our Chief Executive Officer since August 9, 2013 and as a director of our company
since December 2013. Mr. Raphael served as Chairman of the Board of Directors from November 2014 to July 2018, and
as a director from November 2014 to the present. He previously and until October 2012 served as our Vice President of
Research and Development. Mr. Raphael has over 17 years of industry experience, having been responsible in his career
for product delivery, technology and business development. Prior to joining us, from 2010 to 2012, Mr. Raphael served as
Head of Business Operations for Nokia Siemens Networks, where he was responsible for establishing and implementing a
new portfolio business unit directed towards marketing and sales of complimentary products. Prior to that, from 1998 to
2010, he held increasingly senior positions at Amdocs Limited (Nasdaq:DOX) where he was ultimately responsible for
advising the Chief Technology Officer and implementing matters of overall business strategy. Mr. Raphael holds a B.A. in
economics and business management from Haifa University. We believe Mr. Raphael is qualified to serve on our Board of
Directors because of his extensive experience with technology companies and in sales and marketing.
Zvi Ben David has served as our Chief Financial Officer, Treasurer and Secretary since January 7, 2015. Mr. Ben
David has over 25 years of experience in corporate and international financial management, including at both publicly-
listed and private companies. Since 2012, he has acted as an independent entrepreneur with, and investor in, various
medical device ventures. From 2005 to 2012, Mr. Ben David served as the Chief Financial Officer of UltraShape Medical
Ltd., a developer, manufacturer and marketer of innovative non-invasive technologies for fat cell destruction and body
sculpting. While with UltraShape, he helped lead the company through $35 million in private financing, followed by the
company’s merger with a Tel Aviv Stock Exchange company and ultimately the company’s sale to Syneron Medical Ltd.
From 2000 to 2005, he served as Vice President and Chief Financial Officer of Given Imaging Ltd., where he was part of
the management team that led that company’s 2001 initial public offering and 2004 follow-on offering, and served as a
director of that company from its establishment in 1998 to 2000. From 1995 to June 2000, Mr. Ben David served as Vice
President and Chief Financial Officer of RDC Rafael Development Corporation, one of Given Imaging Ltd.’s principal
shareholders. From 1994 to 1995, Mr. Ben David served as manager of the finance division of Electrochemical Industries
(Frutarom) Ltd., an Israeli company traded on the Tel-Aviv Stock Exchange and the American Stock Exchange, and from
1989 to 1993, Mr. Ben David served as the manager of that company’s economy and control department. From 1984 to
1988, Mr. Ben David worked at Avigosh & Kerbs, an accounting firm in Haifa, Israel. Mr. Ben David is a certified public
accountant in Israel and holds a B.A. in economics and accounting from Haifa University.
Dror Bacher has served as our Chief Operating Officer since July 25, 2017. Mr. Bacher previously served as our
Vice President of Research and Development as well as Vice President of Operations since 2013 where he worked on
product development as well as building a scalable supply chain. Mr. Bacher has over 18 years of experience in various
technological companies and his expertise includes product management, product development and business operations in
multi disciplinary environments. Between 2008 and 2013, Mr. Bacher Served in several leadership roles at Amdocs
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Limited (Nasdaq:DOX), including working as a part of the Chief Technology Office, managing enterprise development
programs for a variety of software products associated with service delivery, as well as serving as head of process Prior to
Amdocs, Mr. Bacher served in a senior role at Tower Semiconductor (Nasdaq:TSEM), the global specialty foundry leader
for IC manufacturing, where he was responsible for business operations and commercialization expansion. Mr. Bacher
holds a B.Sc. in computer science and an MBA degree from Haifa University.
Richard Anderson has served as our President and General Manager of North America since January 7, 2020.
From November 2003 to December 2019, Mr. Anderson worked for Catasys, Inc. (Nasdaq: CATS), where he served as
President and Chief Operating Officer from July 2008 to December 2019, and as a member of its board of directors from
November 2003 to July 2019. Prior to Catasys, Inc., Mr. Anderson served as Senior Executive Vice President of Hythiam,
Inc., a predecessor company of Catasys, Inc., from 2005 to 2008. From 1999 to 2005, he also served as Chief Financial
Officer and Secretary of Clearant, Inc., a biotechnology company. Prior to Clearant, from 1999 to 2001, he served as the
Chief Financial Officer and Managing Director of Intellect Capital Group, a venture consulting firm. Earlier in his career,
Mr. Anderson was a Senior Manager/Director for PricewaterhouseCoopers. Mr. Anderson holds a B.A. in Business
Economics from the University of California at Santa Barbara.
Yoav Shaked has served as the Chairman of our Board of Directors since July 5, 2018. Since 2011, Mr. Shaked
has served as a partner at Sequoia Capital, a leading global venture capital firm. In 2005, he co-founded Medpoint Ltd., a
private medical device distribution company offering a wide range of medical products. Previously, he founded and served
as Chief Executive Officer of Y-Med Inc. from May 2004 through November 2009, until its sale to C.R. Bard, Inc. After
the sale of Y-Med Inc., Mr. Shaked served as the director of research at ThermopeutiX, a developer of innovative products
for strokes and peripheral artery disease. Mr. Shaked currently serves on the board of directors of several biotechnology
companies, including Endospan, Vibrant Gastro, B-Lite (G&G Biotechnology) and Orasis Pharmaceuticals, the latter of
which he serves as Chairman of the Board. Mr. Shaked has a B.A. in biology from The Hebrew University of Jerusalem.
We believe that Mr. Shaked is qualified to serve as Chairman of the Board because of his extensive experience both in
biotechnology companies and in the venture capital realm.
Dennis Matheis has been a director of our company since July 2, 2020. Mr. Matheis spent nearly 30 years in
various senior leadership roles in health insurance and healthcare. Since October 2017, he has served as the President and
Chief Executive Officer of Optima Health, Inc. and the Executive Vice President of Sentara Healthcare Plans, Inc. Prior to
that, he spent 13 years in leadership roles at Anthem, Inc., serving as President of Central Region and Exchanges
encompassing six states and representing $12 billion in annual revenue. Mr. Matheis also served in senior leadership roles
at Anthem Blue Cross and Blue Shield of Missouri, CIGNA Healthcare and Humana Health Plan, as well as Advocate
Health Care in Chicago. Mr. Matheis has a B.S. in Accounting from the University of Kentucky and practiced as a
Certified Public Accountant before entering the healthcare industry. We believe that Mr. Matheis is qualified to serve on
our Board of Directors because of his experience in the healthcare business.
Hila Karah has been a director of our company since November 23, 2014. Ms. Karah is an independent business
consultant and an investor in several high-tech, biotech and internet companies. From 2006 to 2013, she served as a
partner and Chief Investment Officer of Eurotrust Ltd., a family office. From 2002 to 2005, she served as a research
analyst at Perceptive Life Sciences Ltd., a New York-based hedge fund. Prior to that, Ms. Karah served as research analyst
at Oracle Partners Ltd., a health care-focused hedge fund. Ms. Karah has served as a director in several private and public
companies including Intec Pharma, since 2009 and Cyren Ltd since 2008. Ms. Karah holds a B.A. in Molecular and Cell
Biology from the University of California, Berkeley, and studied at the University of California, Berkeley-University of
California, San Francisco Joint Medical Program. We believe Ms. Karah is qualified to serve on our Board of Directors
because of her experience as an investor in and advisor to high-tech, biotech and internet companies.
Dennis M. McGrath has been a director of our company since November 12, 2013. Mr. McGrath is a seasoned
medical device industry executive with extensive public company leadership experience possessing a broad range of skills
in corporate finance, business development, corporate strategy, operations and administration. After an 18 year career at
PhotoMedex, Inc. (Nasdaq: PHMD), he recently joined PAVmed, Inc (Nasdaq: PAVM, PAVMW) as the its Executive Vice
President and Chief Financial Officer. Previously, from 2000 to 2017 Mr. McGrath served in several senior level positions
of PhotoMedex, Inc. (Nasdaq: PHMD), a global manufacturer and distributor of medical device equipment and services,
including from 2011 to 2017 as director, President, and Chief Financial Officer. Prior to PhotoMedex’s reverse merger with
Radiancy, Inc. in December 2011, he also served as Chief Executive Officer from 2009 to 2011 and served
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as Vice President of Finance and Chief Financial Officer from 2000 to 2009. He received honors as a P.A.C.T.
(Philadelphia Alliance for Capital and Technology) finalist for the 2011 Investment Deal of the Year, award winner for the
SmartCEO Magazine 2012 CEO of the Year for Turnaround Company, and finalist for the Ernst & Young 2013
Entrepreneur of the Year. He has extensive experience in mergers and acquisitions, both domestically and internationally,
and particularly involving public company acquisitions, including Surgical Laser Technologies, Inc, (formerly, Nasdaq:
SLTI), ProCyte Corporation (formerly, Nasdaq: PRCY), LCA Vision, Inc. (formerly, Nasdaq: LCAV) and Think New
Ideas, Inc. (formerly, Nasdaq: THNK). Prior to PhotoMedex, he served in several senior level positions of AnswerThink
Consulting Group, Inc. (then, Nasdaq: ANSR, now, The Hackett Group, Nasdaq: HCKT), a business consulting and
technology integration company, including from 1999 to 2000 as Chief Operating Officer of the Internet Practice, the
largest division of AnswerThink Consulting Group, Inc., while concurrently during the merger of the companies, serving as
the acting Chief Financial Officer of Think New Ideas, Inc. (then, Nasdaq: THNK, now, Nasdaq: HCKT), an interactive
marketing services and business solutions company. Mr. McGrath also served from 1996 until 1999 as Chief Financial
Officer, Executive Vice President and director of TriSpan, Inc., an internet commerce solutions and technology consulting
company, which was acquired by AnswerThink Consulting Group, Inc. in 1999. During his tenure at Arthur Andersen &
Co., where he began his career, he became a Certified Public Accountant in 1981 and he holds a B.S., maxima cum laude,
in accounting from LaSalle University. In addition to serving as a director of PhotoMedex, he serves as the audit chair and
a director of several medical device companies, including Noninvasive Medical Technologies, Inc. and Cagent Vascular,
LLC, and as an advisor to the board of an orphan drug company, Palvella Therapeutics, LLC. Formerly from 2007 to 2009,
Mr. McGrath served as a director of Embrella Cardiovascular, Inc. (sold to Edwards Lifesciences Corporation, NYSE:
EW). He also serves on the Board of Trustees for Manor College and the Board of Visitors for Taylor University. We
believe Mr. McGrath is qualified to serve on our Board of Directors because of his accounting expertise and his
experiences serving as an officer and director of public and private companies.
Adam Stern has been a director of our company since March 1, 2020. Mr. Stern, age 55, has been the head Private
Equity Banking at Aegis Capital Corp. and CEO of SternAegis Ventures since 2012 and was a member of our board of
directors between October 2011 and May 2014. Prior to Aegis, from 1997 to November 2012, he was with Spencer Trask
Ventures, Inc., most recently as a Senior Managing Director, where he managed the structured finance group focusing
primarily on the technology and life science sectors. Mr. Stern held increasingly responsible positions from 1989 to 1997
with Josephthal & Co., Inc., members of the New York Stock Exchange, where he served as Senior Vice President and
Managing Director of Private Equity Marketing. He has been a FINRA licensed securities broker since 1987 and a General
Securities Principal since 1991. Mr. Stern is a director of Aerami Therapeutics Holdings (formerly Dance Biopharm, Inc.),
Matinas BioPharma Holdings, Inc. Adgero Biopharmaceuticals Holdings and Hydrofarm Holdings Group, Inc. Mr. Stern is
a former director of InVivo Therapeutics Holdings Corp. (OTCQB: NVIV), Organovo Holdings, Inc. (NYSE MKT:
ONVO) and PROLOR Biotech Ltd., which was sold to Opko Health, Inc. (NYSE: OPK) for approximately $600 million in
2013. Mr. Stern holds a Bachelor of Arts degree with honors from The University of South Florida in Tampa. We believe
Mr. Stern is qualified to serve on our Board of Directors because of his experience in the capital markets, his experiences
serving as a director of public and private companies and his experience with life sciences companies.
Prof. Richard B. Stone has been a director of our company since July 7, 2014. For more than twenty-five years,
Prof. Stone has been active participant in early stage business enterprises as a director or investor, including technology and
biotechnology companies. He currently serves on the board of directors of multiple technology companies, including
Powermat, Espro-Accoustiguide Group, Wellsense Technologies, NanoX Imaging Plc, Illumigyn Ltd, Cardiologic
Innovations, Quality Inflow Ltd., and Check-Cap. Since 1974, Prof. Stone has been a member of the faculty of Columbia
Law School, where he held the Wilbur Friedman Chair in Tax Law for twenty years. In addition to basic and advanced tax
courses, Prof. Stone has taught in the areas of contracts, business planning and real estate planning. Among other not-for-
profit organizations he has been associated with, from 2011 to 2013, Prof. Stone served as Chairman of the Conference of
Presidents of Major American Jewish Organizations. Prof. Stone began his career in 1967 in private practice in
Washington, D.C, and thereafter joined the staff of the Solicitor General of the United States, where from 1969 to 1973 he
was Assistant to the Solicitor General. He is a graduate of Harvard College and Harvard Law School. We believe Prof.
Stone is qualified to serve on our Board of Directors because of his legal expertise and experience with life sciences
companies.
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Scientific Advisory Board
We have established a Scientific Advisory Board (SAB), whose members will be available to us to advise on our
scientific and business plans and operational strategies. Below is the biography of our current SAB member.
Eric Miledge - Chairman of our Advisory Board, has worked in the healthcare field for his entire career, with a
focus on pharmaceuticals and medical devices. With more than 34 years at Johnson & Johnson (JNJ) in roles of increasing
responsibility, he built a vast network of relationships across the healthcare landscape. As president of Ortho McNeil
Pharmaceutical, Eric led in the licensing and successful introduction of levofloxacin (antibiotic), tramadol (analgesic) and
the commercialization of Topamax (anticonvulsant), building a multi-billion dollar U.S. pharmaceutical business. Eric also
served as Company Group Chairman for Johnson & Johnson Healthcare Systems which oversaw the negotiation and
management of JNJ’s medical device, diagnostic and pharmaceutical U.S. hospital contracts. Eric also served as Company
Group Chairman of LifeScan Inc., the blood glucose division of JNJ. Under Eric’s leadership, LifeScan Global Diabetes
franchise experienced rapid organic and inorganic growth, including the acquisition of Inverness Medical Technology’s
Diabetes Care Products business. His leadership helped transform LifeScan into a global organization with thousands of
employees and billions in annual revenues. After retiring from JNJ, Eric served as chairman for a number of medical
device startup companies including chairman of Nfocus Neuromedical, Symetis SA and CeQur SA. Eric also served as an
operating partner for Geneva based Endeavour Vision Growth, a medical device growth fund.
Dr. David Horwitz – Advisory Board Member, is presently a Senior Consultant with Numerof & Associates and
also President of DLH Biomedical Consulting. He previously served as the Global Chief Medical Officer of the Johnson
and Johnson Diabetes Institute. Prior to this, he was Vice President, Worldwide Clinical Affairs & Evidence-Based
Medicine at LifeScan, Inc., a Johnson & Johnson company. During his time at LifeScan, Dr. Horwitz had, at various times,
been responsible for Clinical Research, Medical Affairs, Regulatory Affairs, and Advocacy & Professional Affairs. Dr.
Horwitz has previously held faculty positions in the medical schools at the University of Chicago and the University of
Illinois, where he was a clinical professor of medicine. He is a Board-Certified internist and endocrinologist, and a Fellow
of the American College of Physicians. He has published over 100 articles in scientific and clinical journals, primarily in
the areas of diabetes and metabolism. He has completed a term as an industry representative on the Clinical Chemistry and
Toxicology advisory panel of the U.S. Food and Drug Administration. He is presently serving as a volunteer physician for
a charity-supported clinic.
Dr. Marilyn Ritholz –Advisory Board Member, is a Senior Psychologist at the Joslin Diabetes Center and treats
both adults and adolescents with diabetes. In addition, she is on the faculty at Beth Israel Deaconess Medical Center
(BIDMC) and is an Assistant Professor of Psychology at Harvard Medical School. Dr. Ritholz is an experienced qualitative
researcher. In collaboration with colleagues, she has explored qualitative aspects of healthcare regarding the patient-
provider relationship, provider communication about diabetes complications, and psychosocial factors associated with
diabetes technology, including continuous glucose monitoring. She has published more than 20 qualitative articles on these
topics.
Board Composition
Our business is managed under the direction of our Board of Directors. Our Board of Directors currently consists
of seven members.
Pursuant to the terms of the placement agency agreement between us and Aegis Capital Corp., dated October 22,
2019, we granted Aegis the right to nominate an individual to the Board of Directors for a period of three years, which
resulted in the appointment of Mr. Stern to serve on our Board of Directors.
There are no arrangements between our directors and any other person pursuant to which our directors were
nominated or elected for their positions.
Board Committees
Our Board of Directors has three standing committees: An Audit Committee, a Compensation Committee and a
Nominating and Corporate Governance Committee.
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Audit Committee
Our Audit Committee is comprised of Messrs. Shaked, McGrath and Stone, each of whom is an independent
director. Mr. McGrath is the Chairman of the Audit Committee. Mr. McGrath is an “audit committee financial expert” as
defined in Item 407(d)(5)(ii) of Regulation S-K.
Our Audit Committee oversees our corporate accounting, financial reporting practices and the audits of financial
statements. For this purpose, the Audit Committee has a charter (which is reviewed annually) and performs several
functions. The Audit Committee charter is available on our website at www.mydario.com under the Investors / Governance
section. The Audit Committee:
● evaluates the independence and performance of, and assesses the qualifications of, our independent auditor
and engage such independent auditor;
● approves the plan and fees for the annual audit, quarterly reviews, tax and other audit-related services and
approve in advance any non-audit service to be provided by our independent auditor;
● monitors the independence of our independent auditor and the rotation of partners of the independent auditor
on our engagement team as required by law;
● reviews the financial statements to be included in our Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q and reviews with management and our independent auditor the results of the annual audit and
reviews of our quarterly financial statements; and
● oversees all aspects our systems of internal accounting control and corporate governance functions on behalf
of the Board of Directors.
Compensation Committee
Our Compensation Committee is comprised of Messrs. Shaked, McGrath and Ms. Karah. Mr. McGrath is the
Chairman of the Compensation Committee.
The Compensation Committee reviews or recommends the compensation arrangements for our management and
employees and also assists our Board of Directors in reviewing and approving matters such as company benefit and
insurance plans, including monitoring the performance thereof. The Compensation Committee has a charter (which is
reviewed annually) and performs several functions. The Compensation Committee charter is available on our website at
www.mydario.com under the Investors / Governance section.
The Compensation Committee has the authority to directly engage, at our expense, any compensation consultants
or other advisers as it deems necessary to carry out its responsibilities in determining the amount and form of employee,
executive and director compensation.
Nominating and Corporate Governance Committee
Our Nominating and Corporate Governance Committee is currently comprised of Prof. Stone and Mr. Shaked.
Prof. Stone is the Chairman of the Nominating and Corporate Governance Committee.
The Nominating and Corporate Governance Committee is charged with the responsibility of reviewing our
corporate governance policies and with proposing potential director nominees to the Board of Directors for consideration.
This committee also has the authority to oversee the hiring of potential executive positions in our company. The
Nominating and Corporate Governance Committee operates under a written charter, which will be reviewed and evaluated
at least annually.
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Director Independence
Our Board of Directors has reviewed the materiality of any relationship that each of our directors has with us,
either directly or indirectly. Based on this review, our Board of Directors has determined that Prof. Stone, Messrs. Shaked,
Matheis and McGrath, and Ms. Karah are “independent directors” as defined in the Nasdaq Listing Rules and Rule 10A-3
promulgated under the Exchange Act.
Code of Ethics
On March 5, 2013, our Board of Directors adopted a Code of Business Conduct and Ethics and Insider Trading
Policy. Our Code of Business Conduct and Ethics is available on our website at www.mydario.com under the
Investors/Governance section. The information on our website is not incorporated by reference into this Report. We intend
to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of
our Code of Ethics by posting such information on the website address specified above.
Limitation of Directors Liability and Indemnification
The Delaware General Corporation Law authorizes corporations to limit or eliminate, subject to certain
conditions, the personal liability of directors to corporations and their stockholders for monetary damages for breach of
their fiduciary duties. Our certificate of incorporation limits the liability of our directors to the fullest extent permitted by
Delaware law.
We have director and officer liability insurance to cover liabilities our directors and officers may incur in
connection with their services to us, including matters arising under the Securities Act. Our certificate of incorporation and
bylaws also provide that we will indemnify our directors and officers who, by reason of the fact that he or she is one of our
officers or directors, is involved in a legal proceeding of any nature.
We have entered into indemnification agreements with our directors and officers pursuant to which we agreed to
indemnify each director and officer for any liability he or she may incur by reason of the fact that he or she serves as our
director or officer, to the maximum extent permitted by law.
There is no pending litigation or proceeding involving any of our directors, officers, employees or agents in which
indemnification will be required or permitted. We are not aware of any threatened litigation or proceeding that may result
in a claim for such indemnification.
Item 11. Executive Compensation
The following table summarizes compensation of our named executive officers, as of December 31, 2021 and
2020.
Summary Compensation Table
Option
Awards
($)**
—
—
—
Name and
Principal Position
Erez Raphael
(Chief
Officer)
Executive
Year Salary ($)* Bonus ($) Stock Awards
2021
$ 460,787 (1) $ 345,906 (2) $ 7,450,399 (3) $
2020
$ 284,062 (1) $ 251,313 (2) $ 2,484,049 (3) $
Zvi Ben David
2021
(Chief Financial Officer) 2020
$ 248,026 (5)
$ 137,202 (5)
118,596 (6) $ 2,020,474 (7) $
—
$
559,112 (7) $ 172,222 (8)
Dror Bacher
(Chief
Officer)
Operating
Richard Anderson
(President and General
Manager
of North
America)
2021
$ 226,060 (10)$ 118,596 (11)$ 1,827,964 (12)$
—
2020
$ 181,917 (10)$
—
$
463,874 (12)$ 177,401 (13)
2021
$ 335,000 (15) 212,500 (16)$ 1,960,853 (17)$ 1,244,726 (18)
2020
$ 308,098 (15) 100,000 (16)$
163,433 (17)$ 479,160 (18)
70
Non-equity
incentive plan
compensation compensation
Non-qualified
incentive plan Compensation
All Other
($)
179,475 (4) $ 8,436,567
Total
($)
— $
—
—
—
—
—
—
—
—
— $
130,482 (4) $ 3,149,906
— $
— $
70,988 (9) $ 2,458,084
901,982
33,446 (9) $
— $
84,559 (14)$ 2,257,179
— $
66,713 (14)$
889,905
— $
35,172 (19)$ 3,788,251
— $
16,328 (19)$ 1,067,019
Table of Contents
* Certain compensation paid by the company is denominated in New Israeli Shekel (or the NIS). Such compensation is
calculated for purposes of this table based on the annual average currency exchange for such period.
** Amount shown does not reflect dollar amount actually received. Instead, this amount reflects the aggregate grant date
fair value of each stock option granted in the fiscal years ended December 31, 2021 and December 31, 2020,
computed in accordance with the provisions of ASC 718 “Compensation-Stock Compensation,” or ASC 718.
Assumptions used in accordance with ASC 718 are included in Note 9 to our consolidated financial statements
included in this Annual Report.
(1) In accordance with his second amendment to the employment agreement with our company effective August 11, 2013,
Mr. Raphael was entitled to a monthly salary of NIS 44,000, commencing April 1, 2016, his monthly salary was
increased to NIS 80,000 (approximately $24,691 per month). On June 1, 2018, his monthly salary was increased to
NIS 134,167 (approximately $41,410) and on April 1, 2021 his monthly salary was increased to NIS 137,466
(approximately $42,428 per month). During 2020 and 2021, Mr. Raphael agreed to a waiver of 36.4% and 9.4% of his
cash salary according to our salary program (see further details in “Employment and Related Agreements” below).
(2) On September 2020, Mr. Raphael was paid a bonus of $251,313 for the successful completion of the July 2020 private
placement. On March 2021, Mr. Raphael was paid a bonus of $345,906 for his performance during 2020.
(3) On January 28, 2020, Mr. Raphael was granted 15,602 shares of our common stock under our 2012 Equity Incentive
plan against waiver of cash salary for the period from January to March 2020. On April 3, 2020, Mr. Raphael was
granted 15,146 shares of our common stock under our 2012 Equity Incentive plan against waiver of cash salary for the
period from April to June 2020. On July 20, 2020, Mr. Raphael was granted 15,593 shares of our common stock under
our 2012 Equity Incentive plan against waiver of cash salary for the period from July to September 2020. On October
16, 2020, Mr. Raphael was granted 2,127 shares of our common stock under our 2012 Equity Incentive plan against
waiver of cash salary for the period from October to December 2020, and 5,060 shares of our common stock under our
2012 Equity Incentive plan against an additional cash waiver during the period April – July 2020. On February 12,
2020, Mr. Raphael was granted 351,546 shares of our common stock under our 2012 Equity Incentive Plan.
On January 19, 2021, Mr. Raphael was granted 2,268 shares of our common stock under our 2012 Equity Incentive
plan against waiver of cash salary for the period from January to March 2021. On May 3, 2021, Mr. Raphael was
granted 673 shares of our common stock under our 2020 Equity Incentive plan against waiver of cash salary for the
period from April to June 2021. On July 18, 2021, Mr. Raphael was granted 688 shares of our common stock under
our 2012 Equity Incentive plan against waiver of cash salary for the period from July to September 2021. On October
10, 2021, Mr. Raphael was granted 695 shares of our common stock under our 2012 Equity Incentive plan against
waiver of cash salary for the period from October to December 2021. On January 19, 2021, Mr. Raphael was granted
413,158 restricted shares of our common stock under our 2020 Equity Incentive Plan.
(4) In addition to his salary, Mr. Raphael is entitled to receive a leased automobile and mobile phone during his
employment as well as reimbursements for expenses accrued. These benefits, as well as other social benefits under
Israeli law, are included as part of his “All Other Compensation.”
(5) In accordance with his employment agreement with our company effective January 8, 2015, Mr. Ben David was
initially entitled to a monthly salary and additional compensation (excluding social benefits under applicable Israeli
law) of NIS 31,200 (approximately $9,630) for providing eighty percent of his working time to our company.
Beginning on March 1, 2015, Mr. Ben David began working for us on a full-time basis pursuant to the terms of his
employment agreement at which point Mr. Ben David’s salary was increased to NIS 39,000 (approximately $12,037
per month, commencing April 1, 2016, his monthly salary was updated to NIS 60,000 (approximately $18,519).
Commencing June 1, 2018, his monthly salary was updated to NIS 67,200 (approximately $20,741), and commencing
April 1, 2021, his monthly salary was updated to NIS 74,620 (approximately $23,031). During 2020 and 2021, Mr.
Ben David agreed to a waiver of 42% and 9.3% of his cash salary according to our salary program (see further details
in “Employment and Related Agreements” below).
(6) In March 2021, Mr. Ben David was paid a bonus of $118,596 for his performance during 2020.
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(7) On January 28, 2020, Mr. Ben David was granted 7,287 shares of our common stock under our 2012 Equity Incentive
plan against waiver of cash salary for the period from January to March 2020. On April 3, 2020, Mr. Ben David was
granted 7,074 shares of our common stock under our 2012 Equity Incentive plan against waiver of cash salary for the
period from April to June 2020. On July 20, 2020, Mr. Ben David was granted 7,283 shares of our common stock
under our 2012 Equity Incentive plan against waiver of cash salary for the period from July to September 2020. On
October 16, 2020 Mr. Ben David was granted 4,235 shares of our common stock under our 2012 Equity Incentive plan
against waiver of cash salary for the period from October to December 2020, and 2,006 shares of our common stock
under our 2012 Equity Incentive plan against an additional cash waiver during the period of April through July 2020.
On February 12, 2020, Mr. Ben David was granted 45,000 shares of our common stock under our 2012 Equity
Incentive Plan. On September 9, 2020, Mr. Ben David was granted 10,000 shares of our common stock under our
2012 Equity Incentive Plan.
On January 19, 2021, Mr. Ben David was granted 1,152 shares of our common stock under our 2012 Equity Incentive
plan against waiver of cash salary for the period from January to March 2021. On May 3, 2021, Mr. Ben David was
granted 357 shares of our common stock under our 2020 Equity Incentive plan against waiver of cash salary for the
period from April to June 2021. On July 18, 2021, Mr. Ben David was granted 365 shares of our common stock under
our 2012 Equity Incentive plan against waiver of cash salary for the period from July to September 2021. On October
10, 2021 Mr. Ben David was granted 369 shares of our common stock under our 2012 Equity Incentive plan against
waiver of cash salary for the period from October to December 2021. On January 19, 2021, Mr. Ben David was
granted 111,228 restricted shares of our common stock under our 2020 Equity Incentive Plan.
(8) On February 12, 2020, Mr. Ben David was granted 27,827 options to purchase shares of our common stock under our
2012 Equity Incentive Plan, at an exercise price of $7.736 per share.
(9) In addition to his salary, Mr. Ben David is entitled to receive a mobile phone during his employment as well as
reimbursements for expenses accrued. These benefits, as well as other social benefits under Israeli law, are included as
part of his “All Other Compensation.”
(10) In accordance with his second amendment to the employment agreement with our company effective April 2016, Mr.
Bacher was entitled to a monthly salary of NIS 48,000 (approximately $14,815 per month), commencing July 1, 2017,
Mr. Dror was appointed as our Chief Operating Officer and his monthly salary was increased to NIS 55,000
(approximately $16,975 per month). Commencing June 1, 2018 his monthly salary was increased to NIS 61,490
(approximately $18,978 per month), and. commencing April 1, 2021 his monthly salary was increased to NIS 68,910
(approximately $21,269 per month). During 2020 and 2021, Mr. Bacher agreed to a waiver of 10.6% and 9.6% of his
cash salary respectively, according to our salary program (see further details in “Employment and Related
Agreements” below).
(11) In March 2021, Mr. Bacher was paid a bonus of $118,596 for his performance during 2020.
(12) On January 28, 2020, Mr. Bacher was granted 1,677 shares of our common stock under our 2012 Equity Incentive plan
against waiver of cash salary for the period from January to March 2020. On April 3, 2020, Mr. Bacher was granted
1,628 shares of our common stock under our 2012 Equity Incentive plan against waiver of cash salary for the period
from April to June 2020. On July 20, 2020, Mr. Bacher was granted 1,676 shares of our common stock under our 2012
Equity Incentive plan against waiver of cash salary for the period from July to September 2020. On October 16, 2020,
Mr. Bacher was granted 974 shares of our common stock under our 2012 Equity Incentive plan against waiver of cash
salary for the period from October to December 2020, and 3,772 shares of our common stock under our 2012 Equity
Incentive plan against an additional cash waiver during the period from April through July 2020. On February 12,
2020, Mr. Bacher was granted 45,000 shares of our common stock under our 2012 Equity Incentive Plan. On
September 9, 2020, Mr. Bacher was granted 10,000 shares of our common stock under our 2012 Equity Incentive Plan.
On January 19, 2021, Mr. Bacher was granted 1,039 shares of our common stock under our 2012 Equity Incentive plan
against waiver of cash salary for the period from January to March 2021. On May 3, 2021, Mr. Bacher was granted
346 shares of our common stock under our 2020 Equity Incentive plan against waiver of cash salary for the period
from April to June 2021. On July 18, 2021, Mr. Bacher was granted 353 shares of our common stock under
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our 2012 Equity Incentive plan against waiver of cash salary for the period from July to September 2021. On October
10, 2021, Mr. Bacher was granted 357 shares of our common stock under our 2012 Equity Incentive plan against
waiver of cash salary for the period from October to December 2021. On January 19, 2021, Mr. Bacher was granted
100,580 restricted shares of our common stock under our 2020 Equity Incentive Plan.
(13) On February 12, 2020, Mr. Bacher was granted 28,664 options to purchase shares of our common stock under our
2012 Equity Incentive Plan, at an exercise price of $7.736 per share.
(14) In addition to his salary, Mr. Bacher is entitled to receive a leased automobile and mobile phone during his
employment as well as reimbursements for expenses accrued. These benefits, as well as other social benefits under
Israeli law, are included as part of his “All Other Compensation.”
(15) In accordance with his employment agreement, effective in January 2020, Mr. Anderson was entitled to a monthly
salary of $27,916.67.
(16) In September 2020, Mr. Anderson was paid a bonus of $100,000 for the successful completion of the July 2020 private
placement. In March 2021, Mr. Anderson was paid a bonus of $212,500 for his performance during 2020.
(17) On October 16, 2020, Mr. Anderson was granted 5,182 shares of our common stock under our 2012 Equity Incentive
Plan against a cash salary waiver during the period from April through July 2020. On September 9, 2020, Mr.
Anderson was granted 10,000 shares of our common stock under our 2012 Equity Incentive Plan.
On January 19, 2021, Mr. Anderson was granted 91,652 restricted shares of our common stock under our 2020 Equity
Incentive Plan, and on July 18, 2021, Mr. Anderson was granted 20,000 restricted shares of our common stock under
our 2020 Equity Incentive Plan following the closing of the acquisition of wayForward.
(18) On January 30, 2020, Mr. Anderson was granted 90,000 options to purchase shares of our common stock as an
inducement grant pursuant to Nasdaq Listing Rule 5635 (c)(4), at an exercise price of $8.41 per share. On January 19,
2021, Mr. Anderson was granted 91,652 options to purchase shares of our common stock under our 2020 Equity
Incentive Plan, at an exercise price of $17.89 per share
(19) In addition to his salary, Mr. Anderson is entitled to participate in any and other benefit plans and programs that the
Company may offer to its employees from time to time according to the terms of such plans and the Company’s
practices and policies as well as reimbursements for expenses accrued. These benefits are included as part of his “All
Other Compensation.”
All compensation awarded to our executive officers was independently reviewed by our Compensation
Committee.
Employment and Related Agreements
Except as set forth below, we currently have no other written employment agreements with any of our officers and
directors. The following is a description of our current executive employment agreements:
Erez Raphael, Chief Executive Officer and a Member of the Board of Directors – On August 30, 2013, LabStyle
Innovation Ltd., our Israeli subsidiary, entered into an amendment to a Personal Employment Agreement with Mr. Raphael
in connection with his August 2013 appointment as our President and Chief Executive Officer. Pursuant to the terms of his
employment agreement as amended, Mr. Raphael is entitled to a monthly salary of NIS 137,466 (approximately $42,428
per month). During 2020 and 2021, Mr. Raphael agreed to a waiver of 36.4% and 9.4% of his cash salary according to our
salary program pursuant to which Mr. Raphael received compensation shares of restricted common stock as consideration
for cash salary waived.
On July 25, 2017, we, through our Israeli subsidiary, LabStyle Innovation Ltd., executed an Amended and
Restated Employment Agreement with Mr. Raphael. Pursuant to the agreement, Mr. Raphael kept his monthly salary and
shall be eligible for an annual bonus equal to up to 60% of his annual base salary. Mr. Raphael’s employment agreement
expires on December 31, 2020. In the event Mr. Raphael’s employment agreement is terminated by us at will, by Mr.
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Raphael for good reason as provided thereby, or in conjunction with a change of control, Mr. Raphael shall be entitled to
receive 24 months base salary and severance payment pursuant to applicable Israeli severance law, provided, however, that
in the event such termination occurs during the final year of the term, or within the last 6 months of a renewal period of the
term, Mr. Raphael shall be entitled to receive 12 months base salary and severance payment pursuant to applicable Israeli
severance law. In the event the employment agreement is terminated by us for cause, Mr. Raphael will only be entitled to a
severance pay under applicable Israeli severance law. Mr. Raphael’s employment agreement also includes a one-year non-
competition and non-solicitation provision, certain confidentiality covenants and assignment of any of his company-related
inventions. Under the terms of the agreement, Mr. Raphael is entitled to certain expense reimbursements and other standard
benefits, including vacation, sick leave, contributions to a manager’s insurance policy and study fund and car and mobile
phone allowances. On February 12, 2020, we extended the term of Mr. Raphael’s employment to expire on December 31,
2022.
On January 28, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Raphael of 15,602 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of
the waiver of $67,247 of salary otherwise payable to Mr. Raphael from January to March 2020.
On April 3, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Raphael
of 15,146 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver
of $65,280 of salary otherwise payable to Mr. Raphael from April to June 2020.
On July 20, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Raphael
of 15,593 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver
of $67,208 of salary otherwise payable to Mr. Raphael from July to September 2020.
On October 16, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Raphael of 2,127 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $15,894 of salary otherwise payable to Mr. Raphael from October to December 2020, and 5,060 shares of our
common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of $21,809 of salary
otherwise payable to Mr. Raphael from April to July 2020.
On January 19, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Raphael of 2,268 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $16,942 of salary otherwise payable to Mr. Raphael from January to March 2021.
On May 3, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Raphael of
673 shares of our common stock under our 2020 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$14,380 of salary otherwise payable to Mr. Raphael from April to June 2021.
On July 20, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Raphael
of 688 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$14,698 of salary otherwise payable to Mr. Raphael from July to September 2021.
On October 10, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Raphael of 695 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $14,853 of salary otherwise payable to Mr. Raphael from October to December 2021.
Zvi Ben David, Chief Financial Officer, Treasurer and Secretary – On January 8, 2015, LabStyle Innovation Ltd.,
our Israeli subsidiary, entered into a Personal Employment Agreement with Mr. Ben David. Pursuant to his employment
agreement, Mr. Ben David was initially entitled to a monthly salary and additional compensation (excluding social benefits
under applicable Israeli law) of NIS 31,200 (approximately $8,774) for providing eighty percent of his working time to our
company. Beginning on March 1, 2015, Mr. Ben David began working for us on a full-time basis pursuant to the terms of
his employment agreement at which point Mr. Ben David’s salary was increased to NIS 39,000 (approximately $12,037).
Commencing April 1, 2016, Mr. Ben David’s Salary was updated to NIS 60,000 (approximately $18,519) per month.
Commencing June 1, 2018, his monthly salary was updated to NIS 67,200 (approximately $20,741), and
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commencing April 1, 2021, his monthly salary was updated to NIS 74,620 (approximately $23,031). During 2020 and
2021, Mr. Ben David agreed to a waiver of 42% and 9.3% respectively of his cash salary according to our salary program
pursuant to which Mr. Ben David received compensation shares of restricted common stock as consideration for cash
salary waived.
Mr. Ben David's employment agreement may be terminated by either party at will upon 90 days prior written
notice or terminated by us for cause, as defined under the employment agreement. In the event the employment agreement
is terminated by us at will, Mr. Ben David shall be entitled to receive 90 days of severance plus any required severance
payment pursuant to applicable Israeli severance law. In the event the employment agreement is terminated by us for cause,
Mr. Ben David will only be entitled to a severance pay under applicable Israeli severance law. The employment agreement
also includes a twelve-month non-competition and non-solicitation provision, certain confidentiality covenants and
assignment of any of his company-related inventions to the company. Under the terms of the employment agreement, Mr.
Ben David is entitled to certain expense reimbursements and other standard benefits, including vacation, sick leave,
contributions to a manager’s insurance policy and study fund and mobile phone allowances.
On January 28, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 7,287 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $31,409 of salary otherwise payable to Mr. Ben David from January to March 2020.
On April 3, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 7,074 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $30,490 of salary otherwise payable to Mr. Ben David from April to June 2020.
On July 20, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 7,283 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $31,391 of salary otherwise payable to Mr. Ben David from July to September 2020.
On October 16, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 4,235 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $31,638 of salary otherwise payable to Mr. Ben David from October to December 2020, and 2,006 shares of our
common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of $8,645 of salary
otherwise payable to Mr. Ben David from April to July 2020.
On January 19, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 1,152 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $8,610 of salary otherwise payable to Mr. Ben David from January to March 2021.
On May 3, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben David
of 357 shares of our common stock under our 2020 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$7,637 of salary otherwise payable to Mr. Ben David from April to June 2021.
On July 18, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 365 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $7,805 of salary otherwise payable to Mr. Ben David from July to September 2021.
On October 10, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Ben
David of 369 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $7,887 of salary otherwise payable to Mr. Ben David from October to December 2021.
Dror Bacher, Chief Operating Officer – On August 30, 2013, LabStyle Innovation Ltd., our Israeli subsidiary,
entered into an employment agreement with Mr. Bacher, pursuant to which Mr. Bacher receives an annual base salary of
NIS 55,000 (approximately $16,975), effective as of July 2017. Commencing June 1, 2018 his monthly salary was
increased to NIS 61,490 (approximately $18,978 per month), and commencing April 1, 2021 his monthly salary was
increased to NIS 68,910 (approximately $21,269 per month). Pursuant to Mr. Bacher’s existing personal employment
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agreement as amended, either Mr. Bacher or we may terminate his employment agreement upon four months’ notice,
provided, however, that in the event of a termination for cause, Mr. Bacher’s employment may be terminated immediately.
Mr. Bacher’s employment agreement also includes a twelve (12) month non-competition and non-solicitation provision,
certain confidentiality covenants and assignment of any of his company-related inventions. Under the terms of Mr.
Bacher’s employment agreement, Mr. Bacher is entitled to certain expense reimbursements and other standard benefits,
including vacation, sick leave, life, and disability insurance and car and mobile phone allowances. In addition, in
conjunction with his appointment as Chief Operating Officer, we issued Mr. Bacher 500 shares of common stock, and 500
options that will vest in 12 equal quarterly installments over a three-year period with an exercise price of $49.20 per share,
all issued pursuant to the Registrant’s Amended and Restated 2012 Equity Incentive Plan.
On January 28, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Bacher of 1,677 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $7,228 of salary otherwise payable to Mr. Bacher from January to March 2020.
On April 3, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Bacher of
1,628 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$7,017 of salary otherwise payable to Mr. Bacher from April to June 2020.
On July 20, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Bacher of
1,676 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$7,224 of salary otherwise payable to Mr. Bacher from July to September 2020.
On October 16, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Bacher of 974 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $7,281 of salary otherwise payable to Mr. Bacher from October to December 2020, and 3,772 shares of our
common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of $16,256 of salary
otherwise payable to Mr. Bacher from April to July 2020.
On January 19, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Bacher of 1,039 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $7,761 of salary otherwise payable to Mr. Bacher from January to March 2021.
On April 3, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Bacher of
346 shares of our common stock under our 2020 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$7,394 of salary otherwise payable to Mr. Bacher from April to June 2021.
On July 20, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr. Bacher of
353 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the waiver of
$7,558 of salary otherwise payable to Mr. Bacher from July to September 2021.
On October 16, 2021, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Bacher of 357 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of the
waiver of $7,635 of salary otherwise payable to Mr. Bacher from October to December 2021.
Richard Anderson, President and General Manager of North America – On January 7, 2020, we appointed Mr.
Anderson as our President and General Manager of North America. In connection with Mr. Anderson’s appointment, the
Company agreed to pay Mr. Anderson an annual base salary of $335,000. Mr. Anderson shall also be subject to a six-
month non-competition and one-year non-solicitation provision, certain confidentiality covenants and assignment of any of
his company-related inventions. Mr. Anderson will also be entitled to certain expense reimbursements and other standard
benefits, including vacation and sick leave. In addition, Mr. Anderson will be entitled to receive an annual incentive bonus
of up to $250,000, subject to certain milestones and performance targets. In addition, and in conjunction with his
appointment as President and General Manager of North America, the Company agreed to issue Mr. Anderson a stock
option to purchase up to 90,000 shares of common stock at an exercise price of $8.41 per share, subject to vesting. Mr.
Anderson was also issued a stock option to purchase up to 90,000 shares of common stock at an exercise price of
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$8.41 per share, subject to vesting and the achievement of certain business revenue targets. In that regard, Mr. Anderson’s
option will vest as follows: (i) 22,500 shares shall vest following fiscal year 2020 if our business-to-business revenues
reach or exceed $6 million in the aggregate, or a pro-rated amount equal to the percentage achievement of such target,
assuming the Company’s GAAP revenues in 2020 will reach at least $11 million in the aggregate; (ii) 22,500 shares shall
vest following fiscal year 2021 if our business-to-business revenues reach or exceed $15 million in the aggregate, or a pro-
rated amount equal to the percentage achievement of such target, assuming the Company’s GAAP revenues in 2021 will
reach at least $19.5 million in the aggregate; (iii) 22,500 shares shall vest following fiscal year 2022 if our business-to-
business revenues reach or exceed $40 million in the aggregate, or a pro-rated amount equal to the percentage achievement
of such target, assuming the Company’s GAAP revenues in 2022 will reach at least $38 million in the aggregate; and (iv)
22,500 shares shall vest following fiscal year 2023 if our business-to-business revenues reach or exceed $80 million in the
aggregate, or a pro-rated amount equal to the percentage achievement of such target, assuming the Company’s GAAP
revenues in 2023 will reach at least $62 million in the aggregate. The performance options for 2020 and 2021 did not vest
and have expired.
On October 16, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Anderson of 5,182 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of
the waiver of $23,333 of salary otherwise payable to Mr. Anderson from April to July 2020.
Outstanding Equity Awards at December 31, 2021
Name
Erez Raphael
(Chief Executive Officer)
Zvi Ben David
(Chief Financial Officer, Secretary
Treasurer)
and
Dror Bacher
(Chief Operating Officer)
Number of
securities
underlying
unexercised
options (#)
Number of
securities
underlying
unexercised
options (#)
exercisable unexercisable
101
12
167
45
234
7,159
1,592
—
—
—
—
—
—
—
Equity
incentive
plan awards:
Number of
securities
underlying
unexercised
unearned
options (#)
Option
exercise
price ($)
— $ 2,430
— $ 5,400
— $ 4,806
— $ 3,330
— $ 1,764
— $ 64.04
Option
expiration
date
March 14, 2023
June 5, 2023
August 28, 2023
January 6, 2024
July 6, 2024
January 30, 2023
— $ 64.04
January 30, 2023
18,552
9,275 (1)
$ 7.736
February 12, 2026
67
67
1,375
500
19,110
—
—
—
—
9,554 (1)
— $ 3,330
— $ 1,764
— $ 64.04
— $ 49.20
$ 7.736
January 6, 2024
July 6, 2024
January 30, 2023
July 25, 2023
February 12, 2026
Richard Anderson
(President and General Manager of North
America)
60,000
30,000 (2)
$
8.41
January 30, 2026
30,551
61,101
$ 17.89
January 19, 2031
Total Option Shares
139,532
109,930
— $
—
—
(1) Vests in 12 equal quarterly installments over a three-year period.
(2) Vests in 3 equal annual installments over a three-year period.
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Non-Employee Director Remuneration Policy
In March 2013, our Board of Directors adopted the following non-employee director remuneration policy:
Cash Awards
Our non-employee directors (currently Messrs. Shaked, Matheis, McGrath, Prof. Stone and Ms. Karah) will
receive the following cash payments for each fiscal year: (i) $50,000 per year, to be paid quarterly in arrears and (ii)
$25,000 for Board committee service, to be paid quarterly in arrears.
Stock and Option Awards
On January 28, 2020, the Compensation Committee of our Board of Directors approved the issuance to each of
Prof. Stone, Mr. Shaked, Mr. McGrath, and Ms. Karah of 2,378 shares of our common stock under our 2012 Equity
Incentive Plan. Such shares were issued in lieu of $10,250 in fees otherwise payable to each of Prof. Stone, Mr. Shaked,
Mr. McGrath, and Ms. Karah for the period from October 1, 2019, to December 31, 2019. The Compensation Committee
of our Board of Directors also approved the issuance to each of Mr. Farhi, Mr. Moller and Mr. Kamer of 1,450 shares of
our common stock under the 2012 Equity Incentive Plan. Such shares were issued in lieu of $6,250 in fees otherwise
payable to each of Mr. Farhi, Mr. Moller and Mr. Kamer for the period October 1, 2019, to December 31, 2019. In addition,
the Compensation Committee of our Board of Directors approved the issuance to Mr. Moller 396 shares of our common
stock under the 2012 Equity Incentive Plan. Such shares were issued to Mr. Moller upon his resignation from the Board of
Directors.
On February 12, 2020, the Compensation Committee of our Board of Directors approved the following issuances,
each was done under our 2012 Equity Incentive Plan: (i) 60,000 shares of our common stock to Mr. Shaked; (ii) 30,000
shares of our common stock to Ms. Karah; (iii) 7,000 shares of our common stock to Mr. Farhi; (iv) 7,000 shares of our
common stock to Mr. Kamer; (v) 13,000 shares of our common stock to Prof. Stone; and (vi) 50,000 shares of our common
stock to Mr. McGrath.
On April 3, 2020, the Compensation Committee of our Board of Directors approved the issuance to each of Prof.
Stone, Mr. Shaked, Mr. McGrath, and Ms. Karah of 2,378 shares of our common stock under our 2012 Equity Incentive
Plan. Such shares were issued in lieu of $10,250 in fees otherwise payable to each of Prof. Stone, Mr. Shaked, Mr.
McGrath, and Ms. Karah for the period from January 1, 2020, to March 31, 2020. The Compensation Committee of our
Board of Directors also approved the issuance to each of Mr. Farhi and Mr. Kamer of 1,450 shares of our common stock
under the 2012 Equity Incentive Plan. Such shares were issued in lieu of $6,250 in fees otherwise payable to Mr. Farhi and
Mr. Kamer for the period January 1, 2020, to March 31, 2020. In addition, the Compensation Committee of our Board of
Directors approved the issuance to Mr. Stern 493 shares of our common stock under the 2012 Equity Incentive Plan. Such
shares were issued in lieu of $2,129 in fees otherwise payable to Mr. Stern for March 2020. In addition, the Compensation
Committee of our Board of Directors approved the issuance to Mr. Farhi 4,638 shares of our common stock under the 2012
Equity Incentive Plan. Such shares were issued to Mr. Farhi upon his voluntary resignation from the Board of Directors in
April 2020.
On July 20, 2020, the Compensation Committee of our Board of Directors approved the issuance to each of Prof.
Stone, Mr. Shaked, Mr. McGrath, and Ms. Karah of 2,378 shares of our common stock under our 2012 Equity Incentive
Plan. Such shares were issued in lieu of $10,250 in fees otherwise payable to each of Prof. Stone, Mr. Shaked, Mr.
McGrath, and Ms. Karah for the period from April 1, 2020, to June 30, 2020. The Compensation Committee of our Board
of Directors also approved the issuance to each of Mr. Stern and Mr. Kamer of 1,450 shares of our common stock under the
2012 Equity Incentive Plan. Such shares were issued in lieu of $6,250 in fees otherwise payable to Mr. Farhi and Mr.
Kamer for the period April 1, 2020, to June 30, 2020.
On August 18, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr.
Matheis 15,000 shares of our common stock under our 2012 Equity Incentive Plan, and the grant of 20,000 options. These
options have an exercise price of $18.68 per share. One third of the options will become fully vested and exercisable on the
first anniversary of the grant date, and the balance will vest in eight equal quarterly installments following the first
anniversary of the grant date, subject to Mr. Matheis’s continued membership on the Company’s Board of Directors.
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On October 9, 2020, the Compensation Committee of our Board of Directors approved the issuance to Mr. Kamer
of 10,000 shares of our common stock under the 2012 Equity Incentive Plan. Such shares were issued to Mr. Kamer upon
his withdrawal from the Board of Directors in October 2020.
On October 16, 2020, the Compensation Committee of our Board of Directors approved the issuance to Ms. Karah
of 1,372 shares of our common stock under our 2012 Equity Incentive Plan. Such shares were issued in lieu of $10,250 in
fees otherwise payable to Ms. Karah for the period from July 1, 2020, to September 30, 2020.
On April 3, 2020, the Audit and Compensation Committees of the Board of Directors approved the monthly grant
of 1,500 shares of the Company’s Common Stock, to be granted monthly over a 12 month period pursuant to a certain
consulting agreement with said service providers. During the fiscal year ended December 31, 2020, a total of 5,691 shares
of the Company’s common stock were issued under the said approval to Mr. Adam Stern, a member of our Board.
On January 19, 2021, the Compensation Committee of our Board of Directors approved the following issuances,
each was done under our 2020 Equity Incentive Plan: (i) 16,609 restricted shares of our common stock to Mr. Shaked; (ii)
20,147 restricted shares of our common stock to Ms. Karah; (iii) 17,620 restricted shares of our common stock to Mr.
Matheis; (iv) 43,850 restricted shares of our common stock to Mr. Stern; (v) 20,000 restricted shares of our common stock
to Prof. Stone; and (vi) 29,616 restricted shares of our common stock to Mr. McGrath.
Compensation Committee Review
The Compensation Committee shall, if it deems necessary or prudent in its discretion, reevaluate and approve in
January of each such year (or in any event prior to the first board meeting of such fiscal year) the cash and equity awards
(amount and manner or method of payment) to be made to non-employee directors for such fiscal year. In making this
determination, the Compensation Committee shall utilize such market standard metrics as it deems appropriate, including,
without limitation, an analysis of cash compensation paid to independent directors of our peer group.
The Compensation Committee shall also have the power and discretion to determine in the future whether non-
employee directors should receive annual or other grants of options to purchase shares of common stock or other equity
incentive awards in such amounts and pursuant to such policies as the Compensation Committee may determine utilizing
such market standard metrics as it deems appropriate, including, without limitation, an analysis of equity awards granted to
independent directors of our peer group.
Participation of Employee Directors; New Directors
Unless separately and specifically approved by the Compensation Committee in its discretion, no employee
director of our company shall be entitled to receive any remuneration for service as a director (other than expense
reimbursement as per prevailing policy).
New directors joining our Board of Directors shall be entitled to a pro-rated portion (based on months to be served
in the fiscal year in which they join) of cash and stock option or other equity incentive awards (if applicable) for the
applicable fiscal year at the time they join the board.
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Summary Director Compensation Table
The following table summarizes the annual compensation paid to our non-employee directors for the fiscal year
ended December 31, 2021:
Name and
Principal
Position
Dennis McGrath
Prof. Richard B.
Stone
Fees Paid
or
Earned in
Cash
($)
Year
2021 $ 75,000
Option
Awards
Non-equity
incentive
plan
($)*
compensation
Non-
qualified
deferred
compensation
earnings
All other
compensation
($)
Total ($)
Stock
Awards
$ 529,830 (1) $ — (2) $
— $
— $
— $ 604,830
2021 $ 75,000
$ 357,800 (3) $ — (4) $
— $
— $
— $ 432,800
Dennis Matheis
2021 $ 50,000
$ 315,222 (5) $ — (6) $
— $
— $
— $ 365,222
Hila Karah
2021 $ 75,000
$ 360,430 (7) $ — (8) $
— $
— $
— $ 435,430
Yoav Shaked
2021 $ 75,000
$ 297,135 (9) $ — (10)$
— $
— $
— $ 372,135
Adam Stern
2021 $ 50,000
$ 784,476 (11)$ — (12)$
— $
— $
— $ 834,476
* Amount shown does not reflect dollar amount actually received. Instead, this amount reflects the aggregate grant date
fair value of each stock option granted in the fiscal year ended December 31, 2021, computed in accordance with the
provisions of ASC 718. Assumptions used in accordance with ASC 718 are included in Note 9 to our consolidated
financial statements included in this Annual Report.
(1) 29,616 stock awards are outstanding as of December 31, 2021.
(2) 899 option awards are outstanding as of December 31, 2021.
(3) 49,999 stock awards are outstanding as of December 31, 2021.
(4) 885 option awards are outstanding as of December 31, 2021.
(5) 32,620 stock awards are outstanding as of December 31, 2021.
(6) 20,000 option awards are outstanding as of December 31, 2021.
(7) 68,751 stock awards are outstanding as of December 31, 2021.
(8) 801 option awards are outstanding as of December 31, 2021.
(9) 103,895 stock awards are outstanding as of December 31, 2021.
(10) No option awards are outstanding as of December 31, 2021.
(11) 53,341 stock awards are outstanding as of December 31, 2021.
(12) No option awards are outstanding as of December 31, 2021.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The following table sets forth information regarding the beneficial ownership of our common stock as of March
17, 2022 by:
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● each person known by us to be the beneficial owner of more than 5% of our outstanding shares of common
stock;
● each of our named executive officers and directors; and
● all our executive officers and directors as a group.
Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment
power with respect to the securities. Except as otherwise indicated, each person or entity named in the table has sole voting
and investment power with respect to all shares of our capital shown as beneficially owned, subject to applicable
community property laws.
In computing the number and percentage of shares beneficially owned by a person, shares that may be acquired by
such person within 60 days of the date of this Annual Report are counted as outstanding, while these shares are not counted
as outstanding for computing the percentage ownership of any other person. Unless otherwise indicated, the address of
each person listed below is c/o DarioHealth Corp., 18 W. 18th St., New York, New York 10011.
Name of Beneficial Owner
Officers and Directors
Erez Raphael (2)
Zvi Ben David (3)
Dror Bacher (4)
Richard Anderson (5)
Dennis M. McGrath (6)
Prof. Richard B. Stone (7)
Hila Karah (8)
Yoav Shaked (9)
Adam Stern(10)
Dennis Mathies (11)
All Executive Officers and Directors as a group (10 persons)**
5% Stockholders
Nantahala Capital Management, LLC (12)
Collaborative Holdings Master Fund LP (13)
Clal Insurance Enterprises Holdings Ltd. (14)
*
less than 1%.
Percent of
Common
Stock
Beneficially
Stock Owned Owned (1)
Shares of
Common
Beneficially
642,845
210,401
135,762
156,423
10,771
38,251
58,339
98,172
539,243
80,875
1,971,082
2,241,870
1,489,304
1,869,158
2.9 %
1.0 %
* %
* %
* %
* %
* %
* %
2.4 %
* %
9.0 %
9.9 %
6.9 %
8.6 %
(1) Percentage ownership is based on 21,814,967 shares of our common stock outstanding as of March 17, 2022 and, for
each person or entity listed above, warrants or options to purchase shares of our common stock which exercisable
within 60 days of the such date.
(2) Includes 7,718 vested options to purchase common stock and 172,150 vested restricted shares. Also includes 37,876
shares of our common stock, held by Dicilyon Consulting and Investment Ltd. Erez Raphael is the natural person with
voting and dispositive power over our securities held by Dicilyon Consulting and Investment Ltd. The address of
Dicilyon Consulting and Investment Ltd. is 10 Nataf St., Ramat Hasharon 4704063, Israel.
(3) Includes 22,463 vested options to purchase common stock and 46,345 vested restricted shares. Excludes 6,956 options
which are not vested. Includes 1,786 shares owned by his spouse, for which Mr. Ben David disclaims beneficial
ownership except to the extent of his pecuniary interest therein.
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(4) Includes 23,507 vested options to purchase common stock and 41,909 vested restricted shares. Excludes 7,166 options
which are not vested.
(5) Includes 105,689 vested options to purchase common stock and 35,552 vested restricted shares. Excludes 75,963
options which are not vested.
(6) Includes 899 vested options to purchase common stock and 9,872 vested restricted shares.
(7) Includes 885 vested options to purchase common stock and 6,667 vested restricted shares.
(8) Includes 801 vested options to purchase common stock and 8,395 vested restricted shares.
(9) Includes 6,921 vested restricted shares. Includes 1,667 shares owned by his spouse, for which Mr. Shaked disclaims
beneficial ownership except to the extent of his pecuniary interest therein.
(10) Includes 14,617 vested restricted shares and 300 Series A Preferred Shares convertible into 74,100 shares of common
stock. Includes warrants exercisable into 409,535 shares of common stock, subject to a contractual beneficial
ownership limitation of 4.99%.
(11) Includes 10,001 vested options to purchase common stock and 5,874 vested restricted shares. Excludes 9,999 options
which have not vested.
(12) Based solely on information contained in Form 13G/A filed with the SEC on February 16, 2021, and data provided by
the holder. Includes 358,779 pre-funded warrants to purchase common stock issued in May 2019 and preferred shares
convertible into 471,410 shares of common stock, subject to a contractual beneficial ownership limitation of 9.9% and
excludes preferred shares convertible into 812,990 shares of common stock and 824,689 pre-funded warrants issued
on July 31, 2020, and 667,559 pre-funded warrants issued on February 28, 2022.
(13) Based solely on information contained in Form 13G filed with the SEC on February 14, 2022.
(14) Based Solely on information contained in form 13G filed with the SEC on March, 7, 2022.
Item 13. Certain Relationships and Related Party Transactions
Executive Officers and Directors
We have entered into employment and consulting agreements and granted stock awards to our executive officers
and directors as more fully described in “Executive Compensation” above.
Executive Officers and Directors
We have entered into employment agreements and granted stock awards to our executive officers as more fully
described in “Executive Compensation” above.
Statement of Policy
All transactions (if any) between us and our officers, directors or five percent stockholders, and respective
affiliates will be on terms no less favorable than could be obtained from unaffiliated third parties and will be approved by a
majority of our independent directors who do not have an interest in the transactions and who had access, at our expense, to
our legal counsel or independent legal counsel.
On April 3, 2020, we entered into a financial advisory agreement with Aegis Capital Corp., pursuant to which we
agreed to pay Aegis Capital Corp. (“Aegis”) certain a fee of up to 3% of any proceeds from sales derived by us through
commercial transactions entered into with parties introduced by Aegis. In addition, on April 3, 2020, we entered into a
Sales Fee Agreement with Aegis, pursuant to which we agreed to pay Aegis a fee of up 4.5% of consideration we may
receive in a business development transaction (including, any joint-venture, partnership, strategic collaboration or
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investment, licensing transaction, co-promotion or distribution agreement or other profit or revenue sharing, or similar
business arrangement) from parties introduced by Aegis. To date, we have not paid Aegis any fees as a result of these
agreements. Adam Stern, a member of our Board, has an interest, and will receive fees due to, Aegis.
To the best of our knowledge, other than as set forth above, there were no material transactions, or series of
similar transactions, or any currently proposed transactions, or series of similar transactions, to which we were or are to be
a party, in which the amount involved exceeds the lesser of $120,000 or 1% of the average of our total assets at year-end
for the last two completed fiscal years, and in which any director or executive officer, or any security holder who is known
by us to own of record or beneficially more than 5% of any class of our common stock, or any member of the immediate
family of any of the foregoing persons, has an interest (other than compensation to our officers and directors in the ordinary
course of business).
Item 14. Principal Accounting Fees and Services
The following table sets forth fees billed to us by Kost Forer Gabbay & Kasierer, a member of Ernst & Young
Global, our independent registered public accounting firm, during the fiscal years ended December 31, 2021 and
December 31, 2020 for: (i) services rendered for the audit of our annual financial statements and the review of our
quarterly financial statements; (ii) services by our independent registered public accounting firms that are reasonably
related to the performance of the audit or review of our financial statements and that are not reported as audit fees; (iii)
services rendered in connection with tax compliance, tax advice and tax planning; and (iv) all other fees for services
rendered.
December 31, 2021
December 31, 2020
Audit Fees
Audited Related Fees
Tax Fees (1)
All Other Fees (2)
Total
$
$
$
$
$
(1) Consists of fees relating to our tax compliance and tax planning.
(2) Consists of fees relating to our private placements.
Audit Committee Policies
196,289
$
— $
$
$
$
77,000
179,155
452,444
111,000
—
15,000
43,500
169,500
The Audit Committee of our Board of Directors is solely responsible for the approval in advance of all audit and
permitted non-audit services to be provided by the independent auditors (including the fees and other terms thereof),
subject to the de minimus exceptions for non-audit services provided by Section 10A(i)(1)(B) of the Exchange Act, which
services are subsequently approved by the Board of Directors prior to the completion of the audit. None of the fees listed
above are for services rendered pursuant to such de minimus exceptions.
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Table of Contents
Item 15. Exhibits, Financial Statement Schedules.
The following exhibits are filed with this Annual Report.
PART IV
Exhibit No.
3.1
Description
3.2
3.3
3.4
3.5
3.6
3.7
4.1
4.2
4.3
4.4
4.5
4.6
4.7
10.1+
10.2+
10.3+
Composite copy of Certificate of Incorporation, as amended (incorporated by reference to the Company’s
Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2020).
Bylaws (incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the
Commission on August 16, 2021).
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock
of the Company (incorporated by reference to the Company’s Current Report on Form 8-K/A filed with
the Securities and Exchange Commission on December 3, 2019).
Certificate of Designation of Preferences, Rights and Limitations of Series A-1 Convertible Preferred
Stock of the Company (incorporated by reference to the Company’s Current Report on Form 8-K/A filed
with the Securities and Exchange Commission on December 3, 2019).
Certificate of Designation of Preferences, Rights and Limitations of Series A-2 Convertible Preferred
Stock of the Company (incorporated by reference to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on December 6, 2019).
Certificate of Designation of Preferences, Rights and Limitations of Series A-3 Convertible Preferred
Stock of the Company (incorporated by reference to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on December 6, 2019).
Certificate of Designation of Preferences, Rights and Limitations of Series A-4 Convertible Preferred
Stock of the Company (incorporated by reference to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on December 6, 2019).
Form of Representatives’ Warrant (incorporated by reference to the Company’s Current Report on Form 8-
K filed with the Securities and Exchange Commission on March 9, 2016).
Form of Warrant (incorporated by reference to the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on December 18, 2018).
Form of Pre-Funded Warrant (incorporated by reference to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on May 22, 2019).
Amendment No. 1 To Pre-Funded Warrant (incorporated by reference to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on July 9, 2019).
Description of Securities (incorporated by reference to the Company’s Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 17, 2020).
Form of Placement Agent Warrant (incorporated by reference to the Company’s Annual Report on Form
10-K filed with the Securities and Exchange Commission on March 17, 2020).
Form of 2022 Pre-Funded Warrant (incorporated by reference to the Company’s Current Report on Form
8-K filed with the Securities and Exchange Commission on March 2, 2022).
Personal Employment Agreement, dated January 8, 2015, between the Company and Zvi Ben David
(incorporated by reference to the Company’s Current Report on Form 8-K, filed with the Securities and
Exchange Commission on January 9, 2015).
Amended and Restated 2012 Equity Incentive Plan of the Company (incorporated by reference to the
Company’s Definitive Proxy Statement filed with the Securities and Exchange Commission on October
19, 2016).
Amendment to the Amended and Restated 2012 Equity Incentive Plan of the Company+ (incorporated by
reference to the Company’s Current Report on Form 8-K, filed with the Securities and Exchange
Commission on November 6, 2019).
10.4+
2020 Equity Incentive Plan of the Company (incorporated by reference to the Company’s Current Report
on Form 8-K filed with the Securities and Exchange Commission on October 14, 2020).
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10.5+
10.6+
10.7+
10.8+
10.9+
10.10+
10.11
10.12+
10.13˄
Amended and Restated Employment Agreement, dated as of July 25, 2017, between Erez Raphael and
LabStyle Innovation Ltd. (incorporated by reference to the Company’s Current Report on Form 8-K filed
with the Securities and Exchange Commission on July 26, 2017).
Employment Agreement, dated as of September 22, 2013, and as amended on August 1, 2014, April 27, 2015
and May 1, 2016, between Dror Bacher and Labstyle Innovation Ltd. (incorporated by reference to the
Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 26,
2017).
Amendment No. 1 to Amended and Restated Employment Agreement, dated as of February 12, 2020,
between Erez Raphael and LabStyle Innovation Ltd. (incorporated by reference to the Company’s Annual
Report on Form 10-K filed with the Securities and Exchange Commission on March 17, 2020).
Stock Option Agreement between DarioHealth Corp. and Richard Anderson (incorporated by reference to the
Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 17,
2020).
Conditional Stock Option Agreement between DarioHealth Corp. and Richard Anderson (incorporated by
reference to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 17, 2020).
Representative Form of Indemnification Agreements between DarioHealth Corp. and each of its directors and
officers (incorporated by reference to the Company’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission on March 17, 2020).
Share Purchase Agreement by and among DarioHealth Corp., LabStyle Innovation Ltd., Upright
Technologies Ltd., Vertex C (C.I.) Fund L.P., as holder representative and certain holders of Upright’s
outstanding securities, dated January 26, 2021 (incorporated by reference to the Company’s Annual Report
on Form 10-K filed with the Securities and Exchange Commission on March 7, 2021).
First Amendment to the 2020 Equity Incentive Plan (incorporated by reference to Annex A to the Company’s
Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 26, 2021).
Form of 2022 Securities Purchase Agreement (incorporated by reference to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on March 2, 2022).
21.1*
23.1*
31.1*
List of Subsidiaries of the Company
Consent of Kost Forer Gabbay and Kaiserer
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities
Exchange Act of 1934.
31.2*
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities
Exchange Act of 1934.
32.1** Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. 1350.
101*
The following financial statements from the Company’s annual report on Form 10-K for the year ended
December 31, 2021, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Consolidated
Balance Sheets, (ii) Consolidated Statements of Comprehensive Loss, (iii) Statements of Changes in
Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows and (v) the Notes to Consolidated
Financial Statements, tagged as blocks of text and in detail.
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
104
+ Management contract or compensatory plan or arrangement
*
Filed herewith
** Furnished herewith
˄ Certain identified information in the exhibit has been excluded from the exhibit because it is both (i) not material and
(ii) would likely cause competitive harm to DarioHealth Corp. if publicly disclosed
Item 16. Form 10-K Summary.
None.
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SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized.
Date: March 21, 2022
DARIOHEALTH CORP.
By:/s/ Erez Raphael
Name:Erez Raphael
Title: Chief Executive Officer
By:/s/ Zvi Ben David
Name:Zvi Ben David
Title: Chief Financial Officer, Secretary and Treasurer
In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Person
/s/ Erez Raphael
Erez Raphael
/s/ Zvi Ben David
Zvi Ben David
/s/ Yoav Shaked
Yoav Shaked
/s/ Dennis Matheis
Dennis Matheis
/s/ Hila Karah
Hila Karah
/s/ Dennis M. McGrath
Dennis M. McGrath
/s/ Adam Stern
Adam Stern
/s/ Richard B. Stone
Richard B. Stone
Capacity
Date
Chief Executive Officer and
Director (Principal Executive Officer)
March 21, 2022
Chief Financial Officer, Secretary and
Treasurer (Principal Financial and
Accounting Officer)
March 21, 2022
Chairman of the Board
March 21, 2022
Director
Director
Director
Director
Director
86
March 21, 2022
March 21, 2022
March 21, 2022
March 21, 2022
March 21, 2022
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2021
INDEX
Report of Independent Registered Public Accounting Firm (PCAOB - Firm ID: 1281)
Consolidated Balance Sheets
Consolidated Statements of Comprehensive Loss
Statements of Changes in Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
- - - - - - - - - - - - - - -
Page
F-2 – F-4
F-5 – F-6
F-7
F-8
F-9
F-10 – F-39
Table of Contents
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A,
Tel-Aviv 6492102, Israel
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of DarioHealth Corp.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of DarioHealth Corp. and its subsidiaries (the
Company) as of December 31, 2021 and 2020, the related consolidated statements of comprehensive loss, changes in
stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2021, 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, 2021 and 2020, and the
results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity
with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express
an opinion on the Company’s 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 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 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters 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
(i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our
especially challenging, subjective, or complex judgments. The communication of critical audit matters 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 separate opinion on the critical audit matter or on the accounts or disclosures to which they
relate.
F - 2
Table of Contents
Revenue Recognition
Description of the Matter
How We Addressed the Matter in
Our Audit
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A,
Tel-Aviv 6492102, Israel
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
As discussed in Note 2 to the consolidated financial statements, a
significant portion of the Company's revenue is derived from the
offering of a membership package which contains multiple goods
and services that are accounted for as separate performance
obligations. Such agreements require the Company to allocate the
transaction price to the separate performance obligations based on
their relative standalone selling price. The Company does not offer
the services included in the membership package on a standalone
basis, and estimates the standalone selling price of the performance
obligations based on, among others, comparable companies'
lists, pricing practices,
offerings, customer
government backed reimbursement programs, and market standard
prices.
type and price
Auditing the Company's estimates of the standalone selling prices
for the performance obligations included in the membership
package was challenging and required complex auditor judgment
due to the significant judgment required by management in
determining the relevant comparable data used, the extent of
required adjustments to the data, the effects of market conditions
and customer demographics.
the comparability of
To test management’s estimate of standalone selling prices our audit
procedures included, among others, understanding the methodology
applied and testing the accuracy and completeness of the underlying
data used in the Company’s estimate. We obtained and evaluated
management’s analysis of comparable companies and services by
assessing
the comparable companies,
reviewing the list of the Company’s services and prices and
comparing that list with the services and prices of comparable
companies. We analyzed the government backed reimbursement
programs and market standards used in the Company's assessment,
including the review of the aforementioned programs and their
relation to the Company’s services. We also performed inquiry of
key personnel and inspected supporting documentation to evaluate
the adjustments made to the comparable data, including effects of
market conditions and customer demographics.
F - 3
Table of Contents
Business Combinations
Description of the Matter
How We Addressed the Matter in Our
Audit
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A,
Tel-Aviv 6492102, Israel
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
As described in Note 1 to the consolidated financial statements, during 2021, the
Company completed its acquisitions of Upright Technologies Ltd. ("Upright "),
And PsyInnovations Inc. ("Wayforward") for total considerations of $33,578 and
$21,079
(collectively, "the acquisitions"). The
Acquisitions were accounted for as business combinations in accordance with
ASC 805 “Business Combination”.
respectively
thousands,
Auditing the Company's accounting for its acquisitions was complex due to
the significant estimation required by management in determining the fair value
of the technology-related intangible assets of Upright and Wayforward in the
amounts of $9,599 thousands and $5,520 thousands, respectively (collectively,
“the intangible assets"). The significant estimation was primarily due to the
judgmental nature of the inputs to the valuation models used to measure the fair
value of these intangible assets, as well as the sensitivity of the respective fair
values to the underlying significant assumptions. The Company used the
discounted cash flow method to measure the fair value of the intangible assets.
The significant assumptions used to estimate the fair value of the intangible assets
included, among others, discount rates, projected financial information and profit
margins. These significant assumptions are forward-looking and could be affected
by future economic and market conditions.
To test the fair value of the acquired intangible assets and brand, our audit
procedures included, among others, evaluating the Company's use of appropriate
valuation methodologies, evaluating the prospective financial information and
testing the completeness and accuracy of underlying data supporting the
significant assumptions and estimates. For example, we compared the significant
assumptions to current industry, market and economic trends, historical results of
the acquired business and to other relevant factors.
We involved our valuation professionals to assist in evaluation of the
methodology used by the Company and certain assumptions included in the fair
value estimates. For example, our valuation professionals performed independent
comparative calculations to estimate the acquired entity discount rate. In
addition, we assessed the adequacy of the related disclosures in the
consolidated financial statements.
/s/ KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
We have served as the Company’s auditor since 2012.
Tel-Aviv, Israel
March 21, 2022
F - 4
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
Short-term restricted bank deposits
Trade receivables
Inventories
Other accounts receivable and prepaid expenses
Total current assets
NON-CURRENT ASSETS:
Deposits
Operating lease right of use assets
Long-term assets
Property and equipment, net
Intangible assets, net
Goodwill
Total non-current assets
Total assets
The accompanying notes are an integral part of the consolidated financial statements.
F-5
December 31,
2021
2020
$
$
35,808
192
1,310
6,228
2,067
28,590
187
124
2,293
2,934
45,605
34,128
20
287
57
702
12,460
41,640
55,166
20
498
185
576
—
—
1,279
$
100,771
$
35,407
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except stock and stock data)
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
Deferred revenues
Operating lease liabilities
Other accounts payable and accrued expenses
Total current liabilities
NON-CURRENT LIABILITIES
Operating lease liabilities
Earn out liability
Total non-current liabilities
STOCKHOLDERS’ EQUITY
Common Stock of $0.0001 par value
- Authorized: 160,000,000 shares at
December 31, 2021 and 2020; Issued and Outstanding: 16,573,420 and 8,119,493 shares
at December 31, 2021 and 2020, respectively
shares at
Preferred Stock of $0.0001 par value
December 31, 2021 and 2020; Issued and Outstanding: 11,927 and 15,823 shares at
December 31, 2021 and 2020, respectively
Additional paid-in capital
Accumulated deficit
- Authorized: 5,000,000
Total stockholders’ equity
December 31,
2021
2020
$
$
5,109
1,195
266
7,806
14,376
21
825
846
2,480
1,224
310
3,020
7,034
222
—
222
2
*) -
*) -
307,561
(222,014)
*) -
171,399
(143,248)
85,549
28,151
Total liabilities and stockholders’ equity
$
100,771
$
35,407
The accompanying notes are an integral part of the consolidated financial statements.
*) Represents an amount lower than $1.
F-6
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except stock and stock data)
Revenues
Cost of revenues (excluding of amortization shown separately below)
Amortization of acquired intangible assets and inventories step-up
Gross profit
Operating expenses:
Research and development
Sales and marketing
General and administrative
Total operating expenses
Operating loss
Total financial (income) expenses, net
Loss before taxes
Income Tax
Net loss
Deemed dividend
Net loss attributable to holders of Common Stock
Net loss per share:
Basic and diluted loss per share
Weighted average number of Common Stock used in computing basic and diluted
net loss per share
Year ended
December 31,
$
$
2021
20,513
12,444
4,106
3,963
17,219
39,706
23,532
80,457
76,494
235
2020
7,576
5,063
—
2,513
4,433
15,227
12,756
32,416
29,903
(458)
76,729
29,445
32
—
76,761
$
29,445
2,005
3,658
78,766
$
33,103
4.07
$
4.01
$
$
$
$
$
16,591,718
5,963,305
The accompanying notes are an integral part of the consolidated financial statements.
F-7
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
U.S. dollars in thousands (except stock and stock data)
Common Stock
Preferred shares
Balance as of January 1, 2020
Payment for executives and directors under stock for salary program
Exercise of agent warrants
Exercise of repriced warrants
Issuance of common stock to consultants and service provider
Issuance of common stock to directors and employees
Deemed dividend related to warrants exchange
Deemed dividend related to issuance of Preferred Stock
Conversion of preferred stock to common stock
Issuance of warrants to service providers
Issuance of common stock, net of issuance cost
Stock-based compensation
Net loss
Balance as of December 31, 2020
Payment for executives and directors under stock for salary program
Exercise of Options
Exercise of agent warrants
Exercise of warrants
Issuance of common stock to consultants and service provider
Issuance of common stock to directors and employees
Deemed dividend related to issuance of Preferred Stock
Conversion of preferred stock to common stock
Issuance of warrants to service providers
Issuance of common stock, net of issuance cost
Issuance of Common Stock, net of issuance cost upon Acquisitions
Stock-based compensation
Net loss
Balance as of December 31, 2021
*) Represents an amount lower than $1.
Number Amount Number Amount
*) -
2,235,649
21,375
*) -
$
$
$
164,875
222,016
88,889
245,480
721,820
161,317
—
1,278,695
—
3,000,752
—
—
8,119,493
10,934
40,545
111,061
219,992
342,947
18,885
—
918,237
—
3,278,688
2,418,011
1,094,627
—
16,573,420
*) -
*) -
*) -
*) -
*) -
*) -
-
*) -
-
*) -
—
—
*) -
*) -
*) -
*) -
*) -
*) -
*) -
-
*) -
-
1
1
—
—
2
$
—
—
—
—
—
—
—
(5,552)
—
—
—
—
15,823
—
—
—
—
—
—
—
(3,896)
—
—
—
—
—
11,927
—
—
—
—
—
—
—
*) -
—
—
—
—
*) -
—
—
—
—
—
—
—
*) -
—
—
—
—
—
*) -
Additional
paid-in
capital
$ 129,039
1,003
—
1,088
1,993
4,913
599
3,059
—
1,487
26,460
1,758
—
$ 171,399
152
256
—
633
4,626
303
2,005
—
6,817
64,876
43,421
13,073
—
307,561
Total
Accumulated shareholders’
deficit
(110,145)
$
equity
$
18,894
—
—
—
—
—
(599)
(3,059)
—
—
—
—
(29,445)
(143,248)
$
$
—
—
—
—
—
—
(2,005)
—
—
—
—
—
(76,761)
(222,014)
1,003
—
1,088
1,993
4,913
—
—
*) -
1,487
26,460
1,758
(29,445)
28,151
152
256
*) -
633
4,626
303
—
*) -
6,817
64,877
43,422
13,073
(76,761)
85,549
The accompanying notes are an integral part of the consolidated financial statements.
F-8
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENT OF CASH FLOWS
U.S. dollars in thousands
Cash flows from operating activities:
Net loss
Adjustments required to reconcile net loss to net cash used in operating activities:
Stock-based compensation, common stock, and payment in stock to directors, employees, consultants, and
service providers
Depreciation
Change in operating lease right of use assets
Amortization of acquired inventories step-up
Amortization of acquired intangible assets
Decrease (increase) in trade receivables
Decrease (increase) in other accounts receivable, prepaid expense and long-term assets
Decrease (increase) in inventories
Increase in trade payables
Increase (decrease) in other accounts payable and accrued expenses
Increase (decrease) in deferred revenues
Change in operating lease liabilities
Revaluation of earn-out
Net cash used in operating activities
Cash flows from investing activities:
Investment in deposit
Purchase of property and equipment
Cash paid as part of PsyInnovations Inc. (dba WayForward) acquisition
Cash paid as part of Upright Technologies Ltd. acquisition
Loans receivables
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs
Proceeds from exercise of warrants
Proceeds from exercise of options
Net cash provided by financing activities
Increase in cash, cash equivalents and restricted cash and cash equivalents
Cash, cash equivalents and restricted cash and cash equivalents at beginning of period
Year ended
December 31,
2021
2020
$
(76,761)
$
(29,445)
24,971
282
211
1,140
3,035
(351)
(16)
(2,230)
1,080
(865)
(157)
(245)
(503)
11,102
190
267
—
—
548
(1,152)
(879)
824
1,048
1
(240)
—
(50,409)
(17,736)
—
(261)
(4,997)
(2,476)
(400)
(8,134)
64,877
633
256
65,766
7,223
28,725
(4)
(118)
—
—
(1,500)
(1,622)
27,548
—
—
27,548
8,190
20,535
Cash, cash equivalents and short-term restricted bank deposits at end of period
$
35,948
$
28,725
F-9
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 1:- GENERAL
a. DarioHealth Corp. (the “Company”) was incorporated in Delaware and commenced operations on
August 11, 2011.
DarioHealth is a Global Digital Therapeutics (DTx) company changing the way people with chronic
conditions manage their health. By delivering personalized evidence-based interventions that are driven
by precision data analytics, software, and personalized coaching, DarioHealth has developed an approach
that empowers individuals to adjust their lifestyle in holistic way.
DarioHealth’s cross-functional team operates at the intersection of life sciences, behavioral science, and
software technology to deliver seamlessly integrated and highly engaging digital therapeutics
interventions. Our diabetes solutions, its user-centric approach is used by tens of thousands of customers
around the globe. DarioHealth is rapidly expanding its solutions for additional chronic conditions such as
hypertension and moving into new geographic markets.
DarioHealth’s digital therapeutic platform has been designed with a ‘user-first’ strategy, focusing on the
user’s needs first and foremost, and user experience and satisfaction. User satisfaction is constantly
measured and drives, all company processes, including our technology design.
The Company has one reporting unit and one operating segment.
b. The Company has a wholly owned subsidiary, LabStyle Innovation Ltd. (“LabStyle”), which was
incorporated and commenced operations on September 14, 2011 in Israel. Its principal business activity
is to hold the Company’s intellectual property and to perform research and development, manufacturing,
marketing and other business activities.
c. On January 26, 2021, the Company entered into a share purchase agreement (the “Share Purchase
Agreement”) pursuant to which the Company, through LabStyle, acquired all of the outstanding
securities of Upright Technologies Ltd. and its wholly owned subsidiary Upright Technologies Inc.
(“Upright”). Upright is a digital musculoskeletal (“MSK”) health company focused on preventing and
treating the most common MSK conditions through behavioral science, biofeedback, coaching, and
wearable tech. See note (4a).
d. On May 15, 2021, the Company entered into an agreement and plan of merger (the “Agreement and Plan
of Merger”) pursuant to which the Company, through its fully owned subsidiary WF Merger Sub, Inc.
(“Merger Sub”) merged with PsyInnovations Inc. (“WayForward”), pursuant to which the Merger Sub
was the surviving company. PsyInnovations Inc. (dba WayForward) is a mental health company who
develops the WayForward behavioral digital health platform with artificial intelligence (AI) enabled
screening to triage and navigate members to specific interventions, digital cognitive behavioral therapy
(CBT), self-directed care, expert coaching and access to in-person and telehealth provider visits. See
note (4b).
F-10
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 1:- GENERAL (Cont.)
e. During the year ended December 31, 2021, the Company incurred operating losses and negative cash
flows from operating activities amounting to $76,494 and $50,409, respectively. On December 31, 2021,
we had $35,808 in available cash and cash equivalent. On February 28, 2022, the Company entered into
securities purchase agreements with accredited investors relating to an offering of its common stock,
resulting in aggregate gross proceeds of approximately $40,000 ($38,026 net of issuance expenses).
Management believes that the proceeds from the recent securities purchase agreements, combined with
our cash on hand are sufficient to meet our obligations as they come due for at least a period of twelve
months from the date of the issuance of these consolidated financial statements. There are no assurances,
however, that the Company will be able to obtain an adequate level of financial resources that are
required for the long-term development and commercialization of its product offering.
f.
In December 2015, the United States Food and Drug Administration granted LabStyle 510(k) clearance
for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose
Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the
Apple iOS 6.1 platform and higher.
g. On March 4, 2016, the Company’s Common Stock, par value $0.0001 per share (the “Common Stock”)
and warrants to purchase shares of Common Stock were approved for listing on the Nasdaq Capital
Market under the symbols “DRIO” and “DRIOW,” respectively. Our listed warrants expired in March
2021 and ceased trading on the Nasdaq Capital Market as a result.
h. The Company has been carefully monitoring the COVID-19 pandemic and its impact on its business. In
that regard, the Company has continued to sell its DarioTM Blood Sugar Monitor and has not experienced
disruptions in its supply chains. With respect to the Company’s DTx platform, it has observed that some
of its business-to-business prospective partners have been addressing their business needs as a result of
the COVID-19 pandemic, which has resulted in a slowdown of negotiations and discussions with some
of these potential partners. In addition, the Company has also seen an increase in interest from other
business-to-business prospective partners in its DTx platform, as certain parties are seeking tele-health
products. The Company expects the significance of the COVID-19 pandemic, including the extent of its
effect on the Company’s financial and operational results, to be dictated by, among other things, its
duration, the success of efforts to contain it and the impact of actions taken in response. While the
Company is not able at this time to estimate the impact of the COVID-19 pandemic on its financial and
operational results, it could be material.
F-11
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES
The consolidated financial statements are prepared according to United States generally accepted accounting
principles (“U.S. GAAP”).
a. Use of estimates:
The preparation of the consolidated financial statements and related disclosures in conformity with U.S.
GAAP requires the Company’s management to make judgments, assumptions and estimates that affect
the amounts reported in its consolidated financial statements and accompanying notes. Management
bases its estimates on historical experience and on various other assumptions it believes to be reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities. Actual results may differ from these estimates, and such differences may
be material.
Management believes the Company’s critical accounting policies and estimates are reasonable based
upon information available at the time they are made. These estimates, judgments and assumptions can
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the dates of the financial statements, and the reported amounts of revenue and expenses during the
reporting period. Actual results could differ from those estimates.
b. Financial statements in U.S. dollars (“$,” “dollar” or “dollars”):
The functional currency of the Company and its subsidiaries is the U.S dollar.
The Company’s revenues and financing activities are incurred in U.S. dollars. Although a portion of
LabStyle and Upright expenses is denominated in New Israeli Shekels (“NIS”) (mainly cost of
personnel), a substantial portion of its expenses is denominated in dollars. Accordingly, the Company’s
management believes that the currency of the primary economic environment in which the Company and
its subsidiaries operate is the dollar; thus, the dollar is the functional currency of the Company.
Transactions and balances denominated in dollars are presented at their original amounts. Monetary
accounts denominated in currencies other than the dollar are re-measured into dollars in accordance with
Accounting Standard Codification (“ASC”) 830, “Foreign Currency Matters”. All transaction gains and
losses of the re-measurement of monetary balance sheet items are reflected in the consolidated statements
of comprehensive loss as financial income or expenses, as appropriate.
c. Principles of consolidation:
The consolidated financial statements include the accounts of the Company and its subsidiaries.
Intercompany accounts and transactions have been eliminated upon consolidation.
d. Cash and cash equivalents:
The Company considers all highly liquid investments, which are readily convertible to cash with a
maturity of three months or less at the date of acquisition, to be cash equivalents.
F-12
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
e. Short-term restricted bank deposits:
Short-term restricted bank deposits are restricted deposits with maturities of up to one year and are
pledged in favor of the bank as a security for the bank guaranties issued to the landlords of the
Company’s offices and credit card payments. The short-term restricted bank deposits are denominated in
NIS and USD and bear interest at an average rate of 0.01%as of December 31, 2021 and 2020,
respectively. The short-term restricted bank deposits are presented at their cost, including accrued
interest.
As of December 31, 2021, and 2020, the Company had a short-term restricted bank deposit which are
used as collateral for rent in the amount of $127 and $123, respectively.
As of December 31, 2021, and 2020, the Company had short-term restricted bank deposits which are
used as collateral for credit payments in amounts of $65 and $64, respectively.
The following table provides a reconciliation of the cash balances reported on the balance sheets and the
cash, cash equivalents and short-term restricted bank deposits balances reported in the statements of cash
flows:
Cash, and cash equivalents as reported on the balance sheets
Short-term restricted bank deposits, as reported on the balance
sheets
December 31,
2021
2020
$ 35,808 $ 28,590
$
140 $
135
Cash, restricted cash, cash equivalents and restricted cash and
cash equivalents as reported in the statements of cash flows
$ 35,948 $ 28,725
f. Inventories:
Inventories are stated at the lower of cost or net realized value. Cost is determined on a first in first out
(“FIFO”) basis. Inventory write-downs are provided to cover technological obsolescence, excess
inventories and discontinued products. Inventory write-downs represent the difference between the cost
of the inventory and net realizable value. Inventory write-downs are charged to the cost of revenues and
ramp up of manufacturing when a new lower cost basis is established. Subsequent changes in facts and
circumstances do not result in the restoration or increase in that newly established cost basis.
Work-in-process is immaterial, given the typically short manufacturing cycle, and therefore is disclosed
in conjunction with raw materials.
Total write-downs during the years ended December 31, 2021 and 2020 amounted to $73 and $99,
respectively.
g. Property and equipment:
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated
using the straight-line method over the estimated useful lives of the assets at the following annual rates:
F-13
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
Computers, and peripheral equipment
Office furniture and equipment
Production lines
Leasehold improvements
%
15-33
6-15
14-20
Over the shorter of the lease term or
useful economic life
h. Impairment of long-lived assets:
The Company's long lived assets are reviewed for impairment in accordance with ASC 360, “Property,
Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of
an asset may not be recoverable. Recoverability of assets to be held and used is measured by a
comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be
generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is
measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets.
As of December 31, 2021, and 2020, no impairment was recorded.
i. Revenue recognition
The Company recognizes revenue in accordance with ASC 606, revenue from contracts with customers,
when (or as) it satisfies performance obligations by transferring promised products or services to its
customers in an amount that reflects the consideration the Company expects to receive. The Company
applies the following five steps: (1) identify the contract with a customer, (2) identify the performance
obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the
performance obligations in the contract, and (5) recognize revenue when a performance obligation is
satisfied.
The Company considers customer and distributers purchase orders to be the contracts with a customer.
For each contract, the Company considers the promise to transfer tangible products and\or services, each
of which are distinct, to be the identified performance obligations. In determining the transaction price,
the Company evaluates whether the price is subject to rebates and adjustments to determine the net
consideration to which the Company expects to receive. As the Company’s standard payment terms are
less than one year, the contracts have no significant financing component. The Company allocates the
transaction price to each distinct performance obligation based on their relative standalone selling price.
Revenue from tangible products is recognized when control of the product is transferred to the customer
(i.e., when the Company’s performance obligation is satisfied), which typically occurs at shipment. The
revenues from fixed-price services are recognized ratably over the contract period and the costs
associated with these contracts are recognized as incurred.
j. Cost of revenues:
Cost of revenues is comprised of the cost of production, data center costs, shipping and handling
inventory, personnel and related overhead costs, depreciation of production line and related equipment
costs, amortization of deferred costs and inventory write-downs.
k. Concentrations of credit risk:
Financial instruments that potentially subject the Company to concentrations of credit risk consist
principally of cash and cash equivalents, short-term restricted bank deposits and trade receivables.
F-14
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
All of the cash and cash equivalents and short-term restricted bank deposits of the Company and its
Subsidiaries are invested in deposits and current accounts with major U.S. and Israeli banks. Such cash
and cash equivalents and short-term restricted bank deposits may be in excess of insured limits and are
not insured in other jurisdictions. Generally, cash and cash equivalents and short-term restricted bank
deposits may be redeemed and therefore a minimal credit risk exists with respect to these deposits and
investments.
The Company’s trade receivables are derived mainly from sales to distributers and to end-users world-
wide. The Company performs ongoing credit evaluations of its customers. An allowance for doubtful
accounts is determined with respect to those specific amounts that the Company has determined to be
doubtful of collection.
The Company had no off-balance-sheet concentration of credit risk such as foreign exchange contracts,
option contracts or other foreign hedging arrangements.
l. Income taxes:
The Company accounts for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”).
This guidance prescribes the use of the liability method whereby deferred tax asset and liability account
balances are determined based on differences between financial reporting and tax bases of assets and
liabilities and are measured using the enacted tax rates and laws that will be in effect when the
differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce
deferred tax assets to amounts that are more likely than not to be realized. As of December 31, 2021, and
2020 a full valuation allowance was provided by the Company.
ASC 740 contains a two-step approach to recognizing and measuring a liability for uncertain tax
positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by
determining if the weight of available evidence indicates that it is more likely than not that, on an
evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any
related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount
that is more than 50% likely to be realized upon ultimate settlement. As of December 31, 2021, and
2020, no liability for unrecognized tax benefits was recorded as a result of the implementation of ASC
740.
m. Research and development costs:
Research and development costs are charged to the consolidated statements of comprehensive loss, as
incurred.
n. Accounting for stock-based compensation:
The Company accounts for stock-based compensation in accordance with ASC 718, “Compensation -
Stock Compensation” (“ASC 718”), which requires companies to estimate the fair value of equity-based
payment awards on the date of grant using an option-pricing model. The value of the portion of the
award that is ultimately expected to vest is recognized as an expense over the requisite service periods in
the Company’s consolidated statement of comprehensive loss.
F-15
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
The Company recognizes compensation expenses for the value of its awards granted based on the
straight-line method over the requisite service period of each of the awards, net of estimated forfeitures.
ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent
periods if actual forfeitures differ from those estimates.
The Company estimates the fair value of stock options granted using the Black-Scholes-Merton option-
pricing model. The option-pricing model requires a number of assumptions, of which the most significant
are the expected stock price volatility and the expected option term. Expected volatility was calculated
based upon historical volatility of the Company. The expected option term represents the period that the
Company’s stock options are expected to be outstanding and is determined based on the simplified
method until sufficient historical exercise data will support using expected life assumptions. The risk-free
interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has
historically not paid dividends and has no foreseeable plans to pay dividends.
o. Fair value of financial instruments:
The Company applies ASC 820, “Fair Value Measurements and Disclosures” (“ASC 820”). Under this
standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a
liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement
date.
In determining fair value, the Company uses various valuation approaches. ASC 820 establishes a
hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and
minimizes the use of unobservable inputs by requiring that the most observable inputs be used when
available. Observable inputs are inputs that market participants would use in pricing the asset or liability
developed based on market data obtained from sources independent from the Company. Unobservable
inputs are inputs that reflect the Company’s assumptions about the assumptions market participants
would use in pricing the asset or liability developed based on the best information available in the
circumstances.
The hierarchy is broken down into three levels based on the inputs as follows:
Level 1 -
Valuations based on quoted prices in active markets for identical assets that the Company
has the ability to access. Valuation adjustments and block discounts are not applied to Level
1 instruments. Since valuations are based on quoted prices that are readily and regularly
available in an active market, valuation of these products does not entail a significant
degree of judgment.
Level 2 -
Valuations based on one or more quoted prices in markets that are not active or for which
all significant inputs are observable, either directly or indirectly.
Level 3 -
Valuations based on inputs that are unobservable and significant to the overall fair value
measurement.
The availability of observable inputs can vary from investment to investment and is affected by a wide
variety of factors, including, for example, the type of investment, the liquidity of markets and other
characteristics particular to the transaction. To the extent that valuation is based on models or inputs that
are less observable or unobservable in the market, the determination of fair value requires more judgment
and the investments are categorized as Level 3.
F-16
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
The carrying amounts of cash and cash equivalents, short-term restricted bank deposits, trade receivables,
other accounts receivable and prepaid expenses, trade payables and other accounts payable and accrued
expenses approximate their fair value due to the short-term maturity of such instruments. The Company's
earn-out liability is measured at fair value using Level 3 unobservable inputs (see note 4b). The Company
utilized a Monte Carlo simulation model for the initial and subsequent valuations of the earn-out liability.
p. Basic and diluted net loss per share:
The Company computes net loss per share using the two-class method required for participating
securities. The two-class method requires income available to common stockholders for the period to be
allocated between shares of Common Stock and participating securities based upon their respective rights
to receive dividends as if all income for the period had been distributed. The Company considers its
Convertible Preferred shares to be participating securities as the holders of the Convertible Preferred
shares would be entitled to dividends that would be distributed to the holders of Common Stock, on a
pro-rata basis assuming conversion of all Convertible Preferred shares into shares of Common Stock.
These participating securities do not contractually require the holders of such shares to participate in the
Company’s losses. As such, net loss for the period presented was not allocated to the Company’s
participating securities.
The Company’s basic net loss per share is calculated by dividing net loss attributable to common
stockholders by the weighted-average number of shares of Common Stock, without consideration of
potentially dilutive securities. The diluted net loss per share is calculated by giving effect to all
potentially dilutive securities outstanding for the period using the treasury share method or the if-
converted method based on the nature of such securities. Diluted net loss per share is the same as basic
net loss per share in periods when the effects of potentially dilutive shares of Common Stock are anti-
dilutive.
The total number of potential common shares related to the outstanding options, warrant and preferred
shares excluded from the calculations of diluted net loss per share due to their anti-dilutive effect was
7,155,744 and 6,636,437 for the year ended December 31, 2021 and 2020, respectively.
q. Severance pay:
Since inception date, all Ltd. employees who are entitled to receive severance pay in accordance with the
applicable law in Israel, have been included under section 14 of the Israeli Severance Compensation Law
(“Section 14”). Under this section, they are entitled only to monthly deposits, at a rate of 8.33% of
their monthly salary, made by the employer on their behalf with insurance companies. Payments in
accordance with Section 14 release Ltd. from any future severance payments in respect of those
employees. Payments under Section 14 are not recorded as an asset in the Company’s balance sheet.
Severance pay expense for the year ended December 31, 2021 and 2020 amounted to $870 and $387,
respectively.
The Company has a 401(k) defined contribution plan covering certain employees in the U.S. All eligible
employees may elect to contribute up to 92%, but generally not greater than $20 per year (for certain
employees over 50 years of age the maximum contribution is $26 per year), of their annual compensation
to the plan through salary deferrals, subject to Internal Revenue Service limits.
F-17
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
r. Legal and other contingencies:
The Company accounts for its contingent liabilities in accordance with ASC 450 “Contingencies”. A
provision is recorded when it is both probable that a liability has been incurred and the amount of the loss
can be reasonably estimated. With respect to legal matters, provisions are reviewed and adjusted to
reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other
information and events pertaining to a particular matter. As of December 31, 2021 and 2020, the
Company is not a party to any litigation that could have a material adverse effect on the Company’s
business, financial position, results of operations or cash flows. Legal costs incurred in connection with
loss contingencies are expensed as incurred.
s. Leases:
Lessee accounting:
The Company determines if an arrangement is a lease and the classification of that lease at inception
based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the
Company obtains the right to substantially all the economic benefits from the use of the asset throughout
the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected
to not recognize a lease liability or right-of-use ("ROU") asset for leases with a term of twelve months or
less. The Company also elected the practical expedient to not separate lease and non-lease components
for its leases.
ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent
the obligation to make minimum lease payments arising from the lease. ROU assets are initially
measured at amounts, which represents the discounted present value of the lease payments over the lease,
plus any initial direct costs incurred. The ROU assets are reviewed for impairment. The lease liability is
initially measured at lease commencement date based on the discounted present value of minimum lease
payments over the lease term. The implicit rate within the operating leases is generally not determinable;
therefore, the Company uses the Incremental Borrowing Rate ("IBR") based on the information available
at commencement date in determining the present value of lease payments. The Company’s IBR is
estimated to approximate the interest rate on similar terms and payments and in economic environments
where the leased asset is located.
Certain leases include options to extend or terminate the lease. An option to extend the lease is
considered in connection with determining the ROU asset and lease liability when it is reasonably certain
that the Company will exercise that option. An option to terminate is considered unless it is reasonably
certain that the Company will not exercise the option.
t. Business combination:
The Company applies the provisions of ASC 805, “Business Combination” and allocates the fair value of
purchase consideration to the tangible assets acquired, liabilities assumed, and intangible assets acquired
based on their estimated fair values. The excess of the fair value of purchase consideration over the fair
values of these identifiable assets and liabilities is recorded as goodwill. When determining the fair
values of assets acquired and liabilities assumed, management makes significant estimates and
assumptions, especially with respect to intangible assets.
F-18
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
Significant estimates in valuing certain intangible assets include, but are not limited to future expected
cash flows from acquired technology and acquired brand from a market participant perspective, useful
lives and discount rates. Management's estimates of fair value are based upon assumptions believed to be
reasonable, but which are inherently uncertain and unpredictable and, as a result, actual results may differ
from estimates. Acquisition-related expenses are recognized separately from the business combination
and are expensed as incurred.
The Company accounts for a transaction as an asset acquisition pursuant to the provisions of ASU 2017-
01, “Clarifying the Definition of a Business,” when substantially all of the fair value of the gross assets
acquired is concentrated in a single identifiable asset or group of similar identifiable assets, or otherwise
does not meet the definition of a business. Asset acquisition-related direct costs are capitalized as part of
the asset or assets acquired.
u. Goodwill:
Goodwill represents the excess of the purchase price in a business combination over the fair value of the
net tangible and intangible assets acquired. Under ASC 350, "Intangible - Goodwill and Other" ("ASC
350"), goodwill is not amortized, but rather is subject to an annual impairment test.
ASC 350 allows an entity to first assess qualitative factors to determine whether it is necessary to perform
the quantitative goodwill impairment test. If the qualitative assessment does not result in a more likely
than not indication of impairment, no further impairment testing is required. If the Company elects not to
use this option, or if the Company determines that it is more likely than not that the fair value of a
reporting unit is less than its carrying value, then the Company prepares a quantitative analysis to
determine whether the carrying value of a reporting unit exceeds its estimated fair value. If the carrying
value of a reporting unit would exceed its estimated fair value, the Company would have recognized an
impairment of goodwill for the amount of this excess, in accordance with the guidance in FASB
Accounting Standards Update (“ASU”) No. 2017-04, Intangibles - Goodwill and Other (Topic 350),
Simplifying the Test for Goodwill Impairment, which was adopted as of January 1, 2020.
For the years ended December 31, 2021 and 2020, no impairment of goodwill has been recorded.
v. Recently adopted accounting pronouncements:
In December 2019, the FASB issued Accounting Standard Update No. 2019-12, Income Taxes (Topic
740): Simplifying the Accounting for Income Taxes (ASU 2019-12), which simplifies the accounting for
income taxes, eliminates certain exceptions within ASC 740, Income Taxes, and clarifies certain aspects
of the current guidance. ASU 2019-12 is effective for the Company as of January 1, 2021 and the
adoption of this standard did not have a material impact on the Company's consolidated financial
statements.
w. Recently issued accounting pronouncements, not yet adopted:
1.
In September 2016, the Financial Accounting Standards Board (the "FASB") issued ASU 2016-13,
“Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments” (“ASU 2016-13”). ASU 2016-13 changes the impairment model for most financial
assets and certain other instruments. For trade and other receivables, held-to-maturity debt securities,
loans, and other instruments, entities will be required to use a new forward-looking “expected loss”
model that generally will result in the earlier recognition of allowances for losses.
F-19
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
The guidance also requires increased disclosures. For the Company, the amendments in the update
were originally effective for
fiscal years beginning after December 15, 2019, including interim periods within those fiscal years.
In November 2019, the FASB issued ASU No. 2019-10 which delayed the effective date of ASU
2016-13 for smaller reporting companies (as defined by the U.S. Securities and Exchange
Commission) and other non-SEC reporting entities to fiscal years beginning after December 15,
2022, including interim periods within those fiscal periods. Early adoption is permitted. The
Company is currently assessing the impact the guidance will have on its consolidated financial
statements.
2.
3.
In August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on the issuer’s
accounting for convertible debt instruments by removing the separation models for (1) convertible
debt with a cash conversion feature and (2) convertible instruments with a beneficial conversion
feature. As a result, entities will not separately present in equity an embedded conversion feature in
such debt. Instead, they will account for a convertible debt instrument wholly as debt, unless certain
other conditions are met. The elimination of these models will reduce reported interest expense and
increase reported net income for entities that have issued a convertible instrument that was within
the scope of those models before the adoption of ASU 2020-06. ASU 2020-06 also requires that the
effect of potential share settlement be included in the diluted earnings per share calculation when an
instrument may be settled in cash or share. This amendment removes current guidance that allows an
entity to rebut this presumption if it has a history or policy of cash settlement. Furthermore, ASU
2020-06 requires the application of the if-converted method for calculating diluted earnings per
share, the treasury stock method will be no longer available. The provisions of ASU 2020-06 are
applicable for fiscal years beginning after December 15, 2023, with early adoption permitted for
fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of
ASU 2020-06 on its consolidated financial statements.
In October 2021, the FASB issued ASU 2021-08, which requires companies to apply ASC 606 to
recognize and measure contract assets and contract liabilities from contracts with customers acquired
in a business combination. This creates an exception to the general recognition and measurement
principle in ASC 805. requires companies to apply ASC 606 to recognize and measure contract
assets and contract liabilities from contracts with customers acquired in a business combination. For
the Company, the guidance is effective for fiscal years beginning after 15 December 2022 and
interim periods within those fiscal years. The Company is currently evaluating the impact of ASU
2021-08 on its consolidated financial statements.
NOTE 3:- OTHER ACCOUNTS RECEIVABLE AND PREPAID EXPENSES
Prepaid expenses
Government authorities
Loan receivables (*)
*) see notes 4a and 17.
F-20
December 31,
$
2021
1,591
76
400
$
2020
1,354
80
1,500
$
2,067
$
2,934
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 4:- ACQUISITIONS
a. Acquisition of Upright
On February 1, 2021 (the “Acquisition Date”), the Company completed the acquisition, through its subsidiary
LabStyle, of Upright. The acquisition was accounted as a business combination.
The consideration transferred included 1,649,887 shares of Common Stock, the repayment of Upright's
outstanding debt in the amount of $3,020, a settlement of a loan previously granted by the Company to
Upright in the amount of $1,500 and an issuance of a replacement share based compensation awards in the
amount of $712. The total consideration transferred in the acquisition of Upright was $33,578.
Goodwill is primarily attributable to expected synergies arising from technology integration and expanded
product availability to the Company’s existing and new customers. Goodwill is not deductible for income tax
purpose.
In addition, the Company incurred acquisition-related costs in a total amount of $378. Acquisition-related
costs include legal and accounting services which were included in general and administrative expenses in the
Consolidated Statements of Comprehensive loss.
Purchase price allocation:
Under business combination accounting principles, the total purchase price was allocated to Upright’s net
tangible and intangible assets based on their estimated fair values as set forth below. The excess of the
purchase price over the net tangible and identifiable intangible assets was recorded as goodwill.
The allocation of the purchase price to the assets acquired and liabilities assumed based on management’s
estimate of fair values at the date of acquisition as follows:
Tangible assets acquired (including cash of $544)
Inventory *)
Liabilities assumed
Net liabilities assumed
Technology
Goodwill
Total purchase price
*) Including step-up in inventory fair value of $1,140
F-21
Amortization
period (Years)
4
Infinite
$ 1,405
2,845
(6,001)
(1,751)
9,599
25,730
$ 33,578
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 4:- ACQUISITIONS (Cont.)
b. Acquisition of WayForward
On June 7, 2021, the Company through the Merger Sub, completed the acquisition of WayForward
through the merger of WayForward into Merger Sub, which changed its name to PsyInnovations, Inc. The
acquisition was accounted for as a business combination.
The consideration transferred included 768,124 restricted shares of Common Stock, cash consideration of
$5,387 and an earn-out consideration payable in up to 237,076 restricted shares of Common Stock, subject to
certain revenue thresholds that will be resolved in 2022. The fair value total consideration transferred in the
acquisition of WayForward was $21,079.
The fair value, as of the closing date, of the earn-out consideration was $1,328 and was included as part of the
consideration transferred. Since the earn-out arrangement is not indexed to the Company's own stock, the
earn-out arrangement was accounted for as a liability, subsequently measured at fair value through earnings
until settlement. Goodwill is primarily attributable to expected synergies arising from technology integration
and expanded product availability to the Company’s existing and new customers. Goodwill is not deductible
for income tax purpose.
As of December 31, 2021, the earn-out liability fair value was $825. For the year ended December 31, 2021,
the Company recorded reevaluation income in the amount of $503.
In addition, the Company incurred acquisition-related costs in a total amount of $502 acquisition-related costs
which include legal and accounting acquisition-related costs include legal and accounting services which
were included in general and administrative expenses in the Consolidated Statements of Comprehensive loss.
Purchase price allocation:
Under business combination accounting principles, the total purchase price was allocated to WayForward’s
net tangible and intangible assets based on their estimated fair values as set forth below. The excess of the
purchase price over the net tangible and identifiable intangible assets was recorded as goodwill.
The allocation of the purchase price to the assets acquired and liabilities assumed based on management’s
estimate of fair values at the date of acquisition as follows:
Tangible assets acquired (including cash of $139)
Liabilities assumed
Net liabilities assumed
Technology
Brand
Goodwill
Total purchase price
Amortization
period (years)
4
3
Infinite
$
349
(1,076)
(727)
5,520
376
15,910
$ 21,079
F-22
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 4:- ACQUISITIONS (Cont.)
Pro forma results
The following table sets forth a summary of the unaudited pro forma results of the Company as if the
acquisitions of Upright, which closed in February 2021, had taken place on the first day of the period
presented. These combined results are not necessarily indicative of the results that may have been achieved
had Upright been acquired as of January 1, 2020. The following table doesn’t include WayForward results
prior to the acquisition date due to lack of materiality.
Total revenue
Total expenses
Preferred stock Deemed dividend
Net loss attributable to holders of common stock
Year ended
Year ended
December 31,
December 31,
$
2021
21,568 $
98,379
2,005
78,816
2020
20,533
64,704
3,658
47,829
Basic and diluted net loss per share
$
3.95
$
4.10
NOTE 5:- INVENTORIES
Raw materials
Finished products
NOTE 6:- REVENUE
December 31,
2021
$
714 $
5,514
2020
377
1,916
$
6,228
$
2,293
The following tables represent the Company total revenues for the year ended December 31, 2021 and 2020
by performance obligation type as a result of implementing ASC 606:
Hardware and consumable products
Services (*)
(*) Software application and remote monitoring services
F-23
December 31,
2021
17,793 $
2,720
2020
5,767
1,809
$
$
20,513 $
7,576
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 6:- REVENUE (Cont.)
The Company recognizes contract liabilities, or deferred revenues, when it receives advance payments from
customers before performance obligations primarily related services have been performed. Advance payments
are received at the beginning of the service period and the related deferred revenues are reclassified to
revenue ratably over the service period. The balance of deferred revenues approximates the aggregate amount
of the transaction price allocated to the unsatisfied performance obligations at the end of reporting period.
The following table presents the significant changes in the deferred revenue balance during the year ended
December 31, 2021:
Balance, beginning of the period
New performance obligations
Reclassification to revenue as a result of satisfying performance obligations
Balance, end of the period
$
$
1,224
3,633
(3,662)
1,195
Because all performance obligations in the Company’s contracts with customers relate to contracts
with a duration of less than one year, the Company has elected to apply the optional exemption and is not
required to disclose the aggregate amount of the transaction price allocated to performance obligations that
are unsatisfied or partially unsatisfied at the end of the reporting period.
NOTE 7:- LEASES
The Company has entered into various non-cancelable operating lease agreements for certain of its offices
and car leases. The Company's leases have original lease periods expiring between 2021 and 2023. Many
leases include one or more options to renew. The Company does not assume renewals in determination of the
lease term unless the renewals are deemed to be reasonably certain at lease commencement. The Company's
lease agreements do not contain any material residual value guarantees or material restrictive covenants, the
Company elected the practical expedient for short term leases.
The components of lease costs, lease term and discount rate are as follows:
Lease cost
Operating lease cost
Short term lease cost
Variable lease cost
Total lease cost
Weighted Average Remaining Lease Term
Operating leases
Weighted Average Discount Rate
Operating leases
F-24
Twelve
Months Ended
December 31,
2021
$
$
344
415
8
767
1.03 years
7.28 %
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 7: - LEASES (Cont.)
The following is a schedule, by years, of maturities of lease liabilities as of December 31, 2021:
2022
2023
Total undiscounted cash flows
Less imputed interest
Present value of lease liabilities
Supplemental cash flow information related to leases are as follows:
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
Lease liabilities arising from obtaining right-of-use assets:
Operating leases
NOTE 8:- PROPERTY AND EQUIPMENT, NET
Composition of assets, grouped by major classification, is as follows:
Cost:
Computers and peripheral equipment
Office furniture and equipment
Production lines
Leasehold improvement
Accumulated depreciation:
Computers and peripheral equipment
Office furniture and equipment
Production lines
Leasehold improvement
Operating
Leases
$
$
271
27
298
(11)
287
Year ended
December 31,
2021
$
$
344
56
December 31,
2021
2020
$
$
805
161
812
150
326
132
763
147
1,928
1,368
460
57
647
62
1,226
179
41
526
46
792
Property and equipment, net
$
702
$
576
Depreciation expenses for the year ended December 31, 2021 and 2020 amounted to $282 and $190,
respectively.
F-25
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 9:- OTHER INTANGIBLE ASSETS, NET
a. Definite-lived other intangible assets:
Original amounts:
Technology
Brand
Accumulated amortization:
Technology
Brand
Other intangible assets, net
b. Amortization expense amounted to $3,035 for the year ended December 31,
2021.
c. Estimated amortization expense:
For the year ended December 31,
2022
2023
2024
2025
December 31,
2021
$
$
15,119
376
15,495
2,964
71
3,035
12,460
$
$
3,905
3,905
3,845
805
12,460
NOTE 10:- GOODWILL
Following the Company's acquisitions in 2021 as described in Note 4, the changes in the carrying amount of
goodwill allocated to reportable segments for the year ended December 31, 2021 are as follows:
As of January 1, 2021
Acquisitions
As of December 31, 2021
NOTE 11:- OTHER ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Employees and payroll accruals
Accrued expenses
December 31,
2021
$
$
—
41,640
41,640
December 31,
$
2021
3,408
4,398
$
2020
2,140
880
$
7,806
$
3,020
F-26
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 12:- COMMITMENTS AND CONTINGENT LIABILITIES
As of December 31, 2021, LabStyle. had established guarantees to cover rent agreements and credit cards
commitments that amounted to $192.
NOTE 13:- LONG-LIVED ASSETS
As of December 31, 2021, substantially all of the Company long live assets are located in Israel.
NOTE 14:- TAXES ON INCOME
The Company and its subsidiaries are separately taxed under the domestic tax laws of the country of
incorporation of each entity.
a. Tax Reform
On December 22, 2017, the U.S. Tax Cuts and Jobs Act of 2017 (the “TCJA”) was signed into law. The
TCJA makes broad and complex changes to the Internal Revenue Code of 1986 (the “Code”) that may
impact the Company’s provision for income taxes. The changes include, but are not limited to:
● Decreasing the corporate income tax rate from 35% to 21% effective for tax years beginning after
December 31, 2017 (“Rate Reduction”);
● The Deemed Repatriation Transition Tax; and
● Taxation of Global Intangible Low-Taxed Income (“GILTI”) earned by foreign subsidiaries
beginning after December 31, 2017. The GILTI tax imposes a tax on foreign income in excess of a
deemed return on tangible assets of foreign corporations.
Net Operating Losses- Before the TCJA, taxable losses generated in the U.S. were able to be carried
back for two years or carried forward for 20 years to offset prior/future year taxable income. TCJA
changes the rule, and allows losses generated after 2017 (i.e. starting in 2018) to be carried forward
indefinitely, but only to offset 80% of future year income. Carryback losses are no longer allowed.
In response to the COVID-19 pandemic, the U.S. passed the Coronavirus Aid, Relief, and Economic
Security Act (CARES) in March 2020. The CARES Act changed the treatment of net operating
losses (“NOLS”) generated in tax years 2018, 2019 and 2020. Losses generated in these years are
able to be carried backward for 5 years, and carried forward indefinitely, without the 80% limitation.
b. Tax rates applicable to Labstyle and Upright.:
The Corporate tax rate in Israel in 2020 and 2021 was 23%.
c. Net operating loss carryforward:
Labstyle and Upright have accumulated net operating losses for Israeli income tax purposes as of
December 31, 2021, in the amount of approximately $100,120 and $33,840, respectively. The net
operating losses may be carried forward and offset against taxable income in the future for an indefinite
period.
F-27
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 14:- TAXES ON INCOME (Cont.)
As of December 31, 2021, the Company and WayForward had a U.S. federal net operating loss
carryforward of approximately $30,306 and 7,604, of which $7,120 and $371, respectively, were
generated from tax years 2011-2017 and can be carried forward and offset against taxable income and
that expires during the years 2031 to 2037. Under Sections 382 and 383 of the IRC, utilization of the U.S.
loss carryforward may be subject to substantial annual limitation due to the “change in ownership”
provisions of the Code and similar state provisions. The annual limitations may result in the expiration of
losses before utilization. Since the Company has not yet utilized the losses to offset income, no study has
been performed to assess the potential limitations, but when relevant, a study will be performed.
The remaining NOLs of the Company and WayForward are approximately $23,186 and $7,233, were
generated in years 2018-2021, and are subject to the TCJA, which modified the rules regarding
utilization of NOLs. NOLs generated after December 31, 2017, can only be used to offset 80% of taxable
income with an indefinite carryforward period for unused carryforwards (i.e., they should not expire).
Utilization of the federal and state net operating losses and credits may be subject to a substantial annual
limitation due to an additional ownership change. The annual limitation may result in the expiration of
net operating losses and credits before utilization and in the event, the Company has a change of
ownership, utilization of the carryforwards could be restricted.
As discussed above, under the CARES Act, the losses from 2018-2021 are excluded from the limitation
and can be carried forward indefinitely to offset 100% of future net income.
d. Deferred income taxes:
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts
of assets and liabilities for financial purposes and the amounts used for income tax purposes. Significant
components of the Company’s deferred tax assets are as follows:
Deferred tax assets:
Net operating loss and capital losses carry forward
Temporary differences - Research and development expenses
Temporary differences - Accrued employees costs
Temporary differences - Stock-based compensation
Deferred tax assets:
Less: Valuation allowance
Deferred tax assets
Deferred tax liability:
Temporary differences - Intangible Assets
Deferred tax liability
Net deferred tax asset
F-28
December 31,
2021
2020
$ 39,328
2,654
320
1,426
$ 23,326
912
197
—
43,728
(41,520)
24,435
(24,435)
2,208
—
(2,208)
(2,208)
$
— $
—
—
—
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 14:- TAXES ON INCOME (Cont.)
The deferred tax balances included in the consolidated financial statements as of December 31, 2021, are
calculated according to the tax rates that were in effect as of the reporting date and do not take into
account the potential effects of the changes in the tax rate.
The net change in the total valuation allowance for the year ended December 31, 2021, was an increase
of $17,085 and is mainly relates to increase in deferred taxes on net operating loss for which a full
valuation allowance was recorded. In assessing the realizability of deferred tax assets, management
considers whether it is more likely than not that some or all of the deferred tax assets will not be realized.
The ultimate realization of deferred tax assets depends on the generation of future taxable income during
the periods in which those temporary differences and tax loss carryforward are deductible. Management
considers the projected taxable income and tax-planning strategies in making this assessment. In
consideration of the Company’s accumulated losses and the uncertainty of its ability to utilize its deferred
tax assets in the future, management currently believes that it is more likely than not that the Company
will not realize its deferred tax assets and accordingly recorded a valuation allowance to fully offset all
the deferred tax assets.
e. Loss before taxes on income consists of the following:
Domestic
Foreign
Year ended
December 31,
2021
$ 21,065
55,664
2020
$ 12,471
16,974
$ 76,729
$ 29,445
f. The main reconciling item between the statutory tax rate of the Company and the effective tax rate is the
recognition of valuation allowance in respect of deferred taxes relating to accumulated net operating
losses carried forward due to the uncertainty of the realization of such deferred taxes.
F-29
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY
a. The holders of Common Stock have the right to one vote for each share of Common Stock held of record
by such holder with respect to all matters on which holders of Common Stock are entitled to vote, to
receive dividends as they may be declared at the discretion of the Company’s Board of Directors and to
participate in the balance of the Company’s assets remaining after liquidation, dissolution or winding up,
ratably in proportion to the number of shares of Common Stock held by them after giving effect to any
rights of holders of preferred stock. Except for contractual rights of certain investors, the holders of
Common Stock have no pre-emptive or similar rights and are not subject to redemption rights and carry
no subscription or conversion rights.
b. On April 3, 2015, the Company’s Board of Directors approved stock for salary program pursuant to
which the Company will issue compensation shares of restricted Common Stock (“Compensation
Shares”) to directors, officers, and employees of the Company as consideration for a reduction in or
waiver of cash salary, bonus or fees owed to such individuals. The waiver of cash salary will be done
upon the average closing price of the Common Stock for the 30 trading days prior to the date the
Compensation Shares are granted or as otherwise defined by the Compensation Committee of the Board
of Directors.
In September 2019, the Company’s Compensation Committee of the Board of Directors approved the
grant of an aggregate of 5,378 shares of Common Stock to service providers of which 4,753 shares were
issued during the third and fourth quarters of 2019 and the remainder of 625 shares were issued during
the first quarter of 2020.
During the year ended December 31, 2020, the Company issued 164,479 Compensation Shares to certain
members of the Board of Directors, officers, and employees as consideration for a waiver of cash owed
to such individuals amounting to $1,001. In addition, the Company granted 15,034 shares to directors
upon departure from the Board of Directors.
During the year ended December 31, 2020, the Board of Directors approved the grant of 170,229 shares
of Common Stock to certain consultants of the Company, a portion of which were made in lieu of cash
owed to such consultants.
During the year ended December 31, 2020, the Company’s Compensation Committee of the Board of
Directors approved the grant of an aggregate of 707,182 shares to directors, officers, employees and
consultants of the Company.
In January 2020, the Board of Directors authorized the Company to issue warrants to purchase up to
13,750, and 250,000 shares of Common Stock, respectively, to certain consultants of the Company, at a
purchase price of $12.00 and $6.56, respectively. As such, the Company recorded a warrant
compensation expense for service providers in the amount of $1,131.
In April 2020, the Compensation Committee of the Board of Directors approved a monthly grant of
shares of the Company’s Common Stock equal between $12.00 to $18.00 of restricted shares to certain
service providers per month, to be granted monthly during the period that the certain consulting
agreement remains in effect. During the years ended December 31, 2021 and 2020, a total of 16,126 and
11,033 restricted unregistered shares of Common Stock, respectively, were issued to certain service
providers under this approval. During the year ended December 31, 2020 and 2021, the Company
recorded compensation expense for service providers in the amount of $113 and $159, respectively.
F-30
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
In April 2020, the Audit and Compensation Committee of the Board of Directors approved monthly
grants of 1,500 shares of the Company’s Common Stock, of which 639 shares were issued to a board
member under the 2012 Plan, and 861 restricted shares to certain service providers to be granted monthly
during the 12-month period that the certain consulting agreement with said service providers is in effect.
During the year ended December 31, 2020, a total of 13,500 shares of the Company’s Common Stock
were issued under the said approval of which 9,195 shares were issued under the plan including 5,691 to
a board member and the remaining 4,305 shares were issued as restricted shares to certain service
providers. The Company recorded compensation expense for service providers in the amount of $55.
During the year ended December 31, 2021, a total of 4,500 shares of Common Stock were issued under
the said approval of which 1,857 shares were issued to a board member and 2,643 shares were issued to
certain service providers under the 2012 and 2020 Plans. The Company recorded compensation expense
for service providers in the amount of $21.
In May 2020, the Compensation Committee of the Board of Directors authorized the Company to issue,
in several installments, 45,000 shares and warrants to purchase 110,000 shares of Common Stock, to
certain consultants of the Company, of which warrants to purchase 60,000 shares of Common Stock
which shall vest over a 12-month period. The warrants exercise prices are between $6.39 and $10.00 per
share. During the year ended December 31, 2020 and 2021, the Company issued all said shares and
warrants, and recorded compensation expense for service providers in the amount of $576 and $18,
respectively.
During the year ended December 31, 2021, the Company’s Compensation Committee of the Board of
Directors approved an aggregate of 10,934 shares of Common Stock to certain officers and employees of
the Company as consideration for a reduction in, or waiver, of cash salary, or fees owed to such
individuals and the grant of 5,000 restricted shares of Common Stock to employee. 14,180 shares were
issued under the Company’s 2012 Plan and 1,754 shares were issued under the 2020 Plan.
During the year ended December 31, 2021, the Board of Directors approved the grant of an aggregate of
18,885 shares of Common Stock, to officers, employees, and consultants of Upright. The shares were
issued under the Company’s 2020 Plan.
During the year ended December 31, 2021, the Board of Directors approved the grant of 319,414
unregistered shares of Common Stock to certain consultants and service providers of the Company, of
which 7,500 were issued under the 2012 Plan.
During the year ended December 31, 2021, the Company’s Compensation Committee approved the grant
of an aggregate of 1,102,243 restricted shares of Common Stock, subject to time vesting to directors,
officers, employees and consultants of the Company. The time vesting restricted shares vest over a period
of three years commencing on the respective grant dates. The shares were issued under the 2020 Plan.
In February 2021, the Board of Directors authorized the Company to issue warrants to purchase up to
400,000, shares of Common Stock, to a certain consultant of the Company, at a purchase price of $25.00.
As such, the Company recorded compensation expense for service providers in the amount of $5,700.
In April 2021, the Compensation Committee authorized the Company to issue warrants to purchase
30,000 shares of Common Stock, to a certain consultant of the Company, with an exercise price of
$30.00 per share, and warrants to purchase 12,500 shares of Common Stock with an exercise price of
$18.57 per share. As such, the Company recorded compensation expense for service providers in the
amount of $387.
F-31
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
In July 2021, the Compensation Committee authorized the Company to issue warrants to purchase
30,000 shares of Common Stock, to certain consultants of the Company, with an exercise price of $23.30
per share, and warrants to purchase 83,948 shares of Common Stock with an exercise price of $16.06 per
share. Of these warrants, warrants to purchase 35,000 shares of Common Stock shall vest over a 48-
month period and warrants to purchase 48,948 shares of Common Stock are subjected to certain
performance terms. As of December 31, 2021, the terms of 3,000 performance-based warrants were met.
As such, the Company recorded a warrant compensation expense for service providers in the amount of
$312.
In September 2021, the Compensation Committee authorized the Company to issue warrants to purchase
25,000 shares of Common Stock, to certain consultant of the Company, with an exercise price of $13.88
per share. As such, the Company recorded a warrant compensation expense for service providers in the
amount of $194.
In October and December 2021, the Compensation Committee authorized the Company to issue 8,000
shares which shell vest over a six-month period, and warrants to purchase up to 40,000, and 208,000
shares of Common Stock, to certain consultants of the Company, at a purchase price of $25.10 and
$13.60, respectively. As such, the Company recorded compensation expense for service providers in the
amount of $214.
c.
In November and December, 2019, the Company entered into subscription agreements (the “Series A, A-
1, A-2, A-3 and A-4 Subscription Agreement”) for a sale of an aggregate of 21,375 shares of newly
designated Series A, A-1, A-2, A-3 and A-4 Preferred Stock (the “Series A Preferred Stock”), at a
purchase price of $1,000 per share (the “Stated Value”), for aggregate gross proceeds, of approximately
$21,375 ($18,689 net of issuance expenses). The initial conversion price for the Series A, A-1, A-2, A-3
and A-4 Preferred Stock was $4.05, $4.05, $4.28, $4.98 and $5.90, respectively, subject to adjustment in
the event of stock splits, stock dividends, and similar transactions). As such, the Company recorded a
deemed dividend during 2019 in the amount of $2,860 for the benefit created to the series A-2, A-3 and
A-4 holders.
During the year ended December 31, 2021 and 2020, a total of 3,896 and 5,552 of certain Series A
Convertible Preferred Stock, were converted into 918,237 and 1,278,695 shares of Common Stock,
respectively, including issuance of dividend shares.
The holders of series A Preferred Stock (excluding Series A-1 Preferred Stock, which do not possess any
voting rights) shall be entitled to cast the number of votes equal to the number of whole shares of
Common Stock into which the shares of Series A Preferred Stock held by such holder are convertible as
of the record date for determining stockholders entitled to vote on such matter. Except as provided by law
or by the other provisions of the Certificate of Incorporation, Holders of Series A Preferred Stock shall
vote together with the holders of Common Stock as a single class. Upon any liquidation, dissolution or
winding-up of the Company, after the satisfaction in full of the debts of the Company and payment of the
liquidation preference to the Senior Securities, holders of Series A Preferred Stock shall be entitled to be
paid, on a pari passu basis with the payment of any liquidation preference afforded to holders of any
Parity Securities, the remaining assets of the Company available for distribution to its stockholders. For
these purposes, (i) “Parity Securities” means the Common Stock, Series A Preferred Stock and any other
class or series of capital stock of the Company hereinafter created that expressly ranks pari passu with the
Series A Preferred Stock; and (ii) “Senior Securities” shall mean any class or series of capital stock of the
Company hereafter created which expressly ranks senior to the Parity Securities.
F-32
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
Each share of Series A Preferred Stock is convertible at the option of the holder, subject to certain
beneficial ownership limitations as set forth in the Series A Certificate of Designation into such number
of shares of Company’s Common Stock equal to the number of Series A Preferred Shares to be
converted, multiplied by the Stated Value, divided by the conversion price in effect at the time of the
conversion.
The Series A Preferred Stock will automatically convert into shares of Common Stock, subject to certain
beneficial ownership limitations, on the earliest to occur of (i) upon the approval of the holders at least
50.1% of the outstanding shares of Series A Preferred with respect to the Series A Preferred Stock; or (ii)
the 36-month anniversary of each of the Series A Effective Date. The holders of Series A Preferred Stock
will also be entitled dividends payable as follows: (i) a number of shares of Common Stock equal to ten
percent (10%) of the number of shares of Common Stock issuable upon conversion of the Series A
Preferred Stock then held by such holder on the 12-month anniversary of the Series A Effective Date, (ii)
a number of shares of Common Stock equal to fifteen percent (15%) of the number of shares of Common
Stock issuable upon conversion of the Series A Preferred then held by such holder on the 24-month
anniversary of the Series A Effective Date, and (iii) a number of shares of Common Stock equal to
twenty percent (20%) of the shares of Common Stock issuable upon conversion of the Series A Preferred
Stock then held by such holder on the 36-month anniversary of the Series A Effective Date. During the
year ended December 31, 2021 and 2020, The Company accounted for the dividend as a deemed
dividend in a total amount of $2,005 and $3,059, respectively.
Pursuant to the Placement Agency Agreement (the “Placement Agency Agreement”) executed by and
between the Company and the registered broker dealer retained to act as the Company’s exclusive
placement agent (the “Placement Agent”) for the offering of the Series A Preferred Stock, the Company
paid the Placement Agent an aggregate cash fee of $1,788, non-accountable expense allowance of $641
and was required to issue to the Placement Agent or its designees warrants to purchase 719,243 shares of
Common Stock at an exercise price ranging from $4.05 to $5.90 per share (the “Placement Agent
Warrants”). The Placement Agent Warrants are exercisable for a period of five years from the date of the
final closing of the Series A Preferred Stock Offering.
As of December 31, 2021, out of the Placement Agent Warrants that were issued in December 2019 and
July 2020, 451,226 were exercised into 333,077 shares of Common Stock.
d.
In March 2020, the Board of Directors authorized the Company to enter into an agreement to issue in the
future warrants to purchase up to 500,000 shares of Common Stock to a business partner of the
Company, upon reaching certain performance criteria, at a purchase price of $5.94. Certain performance
criteria with respect to the first and the second tranches of 250,000 warrants to purchase shares were not
met and that portion of such warrant expired as of December 31, 2021.
e. On July 28, 2020, the Company entered into subscription agreements with accredited investors relating
to an offering with respect to the sale of an aggregate of (i) 2,969,266 shares of the Company’s Common
Stock, at a purchase price of $7.47 per Share, and (ii) pre-funded warrants to purchase 824,689 shares of
Common Stock, at a purchase price of $7.4699 per Pre-Funded Warrant. In addition, on July 30, 2020,
the Company entered into a subscription agreement with an accredited investor for the purchase of
31,486 shares of Common Stock at a purchase price per share of $7.94 per Share. The aggregate gross
proceeds were approximately $28,591 ($26,460 net of issuance costs).
F-33
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
f. On February 1, 2021, the Company entered into securities purchase agreements with institutional
accredited investors relating to an offering with respect to the sale of an aggregate of 3,278,688 shares of
Common Stock, at a purchase price of $21.35 per share. The aggregate gross proceeds were
approximately $70,000 ($64,877, net of issuance expenses).
g. During the year ended December 31, 2021, options were exercised into 40,545 shares of Common Stock,
with aggregate gross proceeds of approximately $256.
h. The table below summarizes the outstanding warrants as of December 31, 2021:
March 2017 Public Offering - Representative’s
Warrants
Placement Agent Warrants A-1 December 2019
Placement Agent Warrants A-2 December 2019
Placement Agent Warrants A-3 December 2019
Placement Agent Warrants A-4 December 2019
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Agent warrants B-1 July 31 2020
Agent warrants B-1 July 31 2020
Consultants
Consultants
Consultants
Consultants
Consultants
Consultants
Warrants
outstanding as of
December 31, 2021
Exercise
price $
Expiration date
1,820 77.50
March 31, 2022
233,347
25,034
47,527
5,839
300,000
10,000
12,500
10,000
10,000
20,000
35,000
3,000
60,000
30,000
30,000
150,070
2,393
25,000
40,000
8,000
100,000
100,000
13,750
25.00
7.50
18.57
8.00
9.00
4.05 December 19, 2024
4.28 December 19, 2024
4.98 December 19, 2024
5.90 December 19, 2024
February 16, 2024
April 6, 2024
April 13, 2024
June 17, 2024
September 9, 2024
10.00 November 9, 2024
December 1, 2024
16.06
December 1, 2024
16.06
February 12, 2025
6.39
April 1, 2025
30.00
July 1, 2025
23.30
July 31, 2025
7.47
July 31, 2025
7.94
September 26, 2025
13.88
25.10
October 1, 2025
13.60 December 31, 2025
13.60 December 31, 2026
13.60 December 31, 2026
12.00
August 1, 2029
Total outstanding
1,273,280
F-34
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
During the year ended December 31, 2021 and 2020, certain Company warrant holders have exercised
and exchanged Company warrants as detailed here below:
In January and July 2020, the Company entered into exchange agreements (each an “Exchange
Agreement”) with certain Company warrant holders who were granted warrants to purchase up to an
aggregate of 230,452 shares of Common Stock in September 2018. Pursuant to the terms of the
Exchange Agreements, the warrant holders agreed to surrender such warrants for cancellation and
received, as consideration for the cancellation of such 2018 warrants, an aggregate of 161,317 restricted
shares of Common Stock, thereby creating a benefit to these warrant holders. As such the Company
recorded a deemed dividend in the amount of $599.
In September 2020, the Company entered into an agreement with a certain warrant holder who was
granted warrants to purchase up to an aggregate of 88,889 shares of Common Stock in September 2018.
Warrants to purchase 88,889 shares of Common Stock were exercised into shares of Common Stock at an
exercise price of $13.00 per share. The aggregate gross proceeds were approximately $1,156 ($1,088 net
of issuance expenses costs).
During the year ended December 31, 2021, certain Company warrants holders have exercised warrants
into 219,992 shares for total proceeds of $633.
i.
Stock-based compensation:
On January 23, 2012, the Company’s 2012 Plan was adopted by the Board of Directors of the Company
and approved by a majority of the Company’s stockholders, under which options to purchase shares of
Common Stock have been reserved. Under the 2012 Plan, options to purchase shares of Common Stock
may be granted to employees and non-employees of the Company or any affiliate, each option granted
can be exercised to one share of Common Stock.
On February 5, 2020, the Company’s stockholders approved an amendment to the 2012 Plan to increase
the number of shares authorized for issuance under the 2012 Plan by 1,350,000 shares, from 618,650 to
1,968,650.
On October 14, 2020, the Company’s stockholders approved the 2020 Equity incentive Plan (the “2020
Plan”) and the immediate reservation of 900,000 shares under this Plan for the remainder of the 2020
fiscal year. Under the 2020 Plan, options to purchase shares of Common Stock may be granted to
employees and non-employees of the Company or any affiliate, each option granted can be exercised to
one share of Common Stock.
During 2021, pursuant to the terms of the 2020 Plan as approved by the Company’s stockholders, the
number of shares authorized for issuance under the 2020 Plan increased by 1,628,890 shares, from
900,000 to 2,528,890.
j.
The following options were issued under the 2012 Plan during 2020 and 2021:
During the year ended December 31, 2020, the Company’s Compensation Committee of the Board of
Directors approved the grant of an aggregate of 623,491 options to employees, directors and consultants
of the Company, at exercise prices between $6.35 and $18.68 per share. The stock options vest over a
period of three years commencing on the respective grant dates. The options have a six-year term and
were issued under the 2012 Plan.
F-35
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
In January and March 2020, the Compensation Committee of the Board of Directors approved an
inducement grant of a non-qualified stock option award to purchase 140,000 shares of the Company’s
Common Stock, as well as an additional inducement grant consisting of a non-qualified performance-
based stock option award to purchase an additional 90,000 shares of the Company’s Common Stock
outside of the Company’s Amended and Restated 2012 Equity Incentive Plan, as amended (the “2012”
Plan”), pursuant to Nasdaq Listing Rule 5635(c)(4), in connection with the employment of its President
and General Manager of North America and of its Chief Medical Officer.
In March and May 2020, the Board of Directors approved the grant of fully vested options to purchase
5,540 shares of Common Stock to certain consultants of the Company, a portion of which were made in
lieu of cash owed to such consultants.
During the year ended December 31, 2021, the Board of Directors approved of 99,074 options to
purchase Common Stock to officers, employees, and consultants of Upright, at exercise prices between
$0.01 to $24.48 per share. The stock options vest over a period of four years or less commencing on the
respective original grant dates. The options have a ten-year term. The shares and options were issued
under the Company’s 2020 Plan.
During the year ended December 31, 2021, the Company’s Compensation Committee approved the grant
of 763,999 options to purchase Common Stock, and 10,000 performance-based options to purchase
Common Stock to officers, employees and consultants of the Company, at exercise prices between
$12.77 and $25.84 per share. The time vesting restricted shares and stock options vest over a period of
three years commencing on the respective grant dates. The options have a ten-year term and were issued
under the 2020 Plan. As of December 31, 2021, the terms of the performance-based stock options were
met.
In May 2021, the Compensation Committee of the Board of Directors approved an inducement grant of a
non-qualified performance-based stock option award to purchase 60,000 shares of the Company’s
Common Stock, as well as an additional inducement grant consisting of a non-qualified performance-
based stock option award to purchase an additional 15,000 shares of the Company’s Common Stock
outside of the Company’s 2020 Plan, pursuant to Nasdaq Listing Rule 5635(c)(4),in connection with the
employment of one employee as part of the acquisition of WayForward (see note 4), the options were
granted on June 7, 2021 as part of the closing of the Merger. As of December 31, 2021, the terms of the
performance-based stock options were met.
In July 2021, the Compensation Committee of the Board of Directors approved the grant of a non-
qualified stock option award to purchase 20,000 shares of the Company’s Common Stock outside of the
Company’s existing equity incentive plans, pursuant to Nasdaq Listing Rule 5635(c)(4), in connection
with the employment of its Special Vice President of Market Access.
On November 9, 2021, the Compensation Committee of the Board of Directors approved the grant of a
non-qualified stock option award to purchase 140,000 shares of the Company’s Common Stock outside
of the Company’s existing equity incentive plans, pursuant to Nasdaq Listing Rule 5635(c)(4), in
connection with the employment of a Chief Commercial Officer.
F-36
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
Transactions related to the grant of options to employees, directors and non-employees under the above
plans and non-plan options during the year ended December 31, 2021 were as follows:
Options outstanding at beginning of year
Options granted (*)
Options exercised
Options expired
Options forfeited
Weighted
average
exercise
price
$
17.56
19.32
6
43.90
15.39
Weighted
average
remaining
contractual
life
Years
4.99
—
—
—
—
Aggregate
Intrinsic
value
$
5,510
—
—
—
—
Number of
options
973,575
1,108,073
(40,545)
(58,947)
(103,988)
Options outstanding at end of year
1,878,168
17.04
6.96
3,861
Options vested and expected to vest at end of
year
1,744,846
18.27
6.92
3,655
Exercisable at end of year
590,060
22.47
5.04
2,243
Weighted average grant date fair value of options granted during the year ended December 31, 2021 and
2020 is $13.59 and $5.19, respectively.
The aggregate intrinsic value in the table above represents the total intrinsic value (the difference
between the Company’s closing stock price on the last day of fiscal 2021 and the exercise price,
multiplied by the number of in-the-money options) that would have been received by the option holders
had all option holders exercised their options on December 31, 2021. This amount is impacted by the
changes in the fair market value of the Common Stock
Transactions related to restricted shares granted\forfeited during the year ended December 31, 2021 were
as follows
Restricted shares outstanding at beginning of
year
Restricted shares granted
Restricted shares forfeited
Restricted shares outstanding at end of year
F-37
Number of
Restricted shares
-
1,107,243
(12,616)
1,094,627
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 15:- STOCKHOLDERS’ EQUITY (Cont.)
The following table presents the assumptions used to estimate the fair values of the options granted to
employees, non-employees and directors in the period presented:
Volatility
Risk-free interest rate
Dividend yield
Expected life (years)
Year ended
December 31,
2021
2020
93.34%-111.82 % 87.55%-99.39 %
0.2%-1.56 %
0 %
0.11%-1.37 %
0 %
2.09-5.86
3.5-4.5
As of December 31, 2021, the total unrecognized estimated compensation cost related to non-vested
stock options and restricted shares granted prior to that date was $26,067, which is expected to be
recognized over a weighted average period of approximately 1.15 year.
The total compensation cost related to all the Company’s equity-based awards, recognized during year
ended December 31, 2021 and 2020 were comprised as follows:
Cost of revenues
Research and development
Sales and marketing
General and administrative
Year ended
December 31,
2021
$
97
3,872
6,039
14,963
$
2020
35
824
2,741
7,502
Total stock-based compensation expenses
$ 24,971
$ 11,102
NOTE 16:- SELECTED STATEMENTS OF OPERATIONS DATA
Financial (income) losses, net:
Bank charges
Foreign currency adjustments (income) expenses, net
Interest income
Total Financial (income) losses, net
Year ended
December 31,
2021
2020
$
$
84
195
(44)
49
(446)
(61)
$
235
$
(458)
F-38
Table of Contents
DARIOHEALTH CORP. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except stock and stock data)
NOTE 17:- SUBSEQUENT EVENTS
a.
In April 2020, the Compensation Committee of the Board of Directors approved a monthly grant of
shares of the Company’s Common Stock equal up to $16 of restricted shares to certain service providers
per month, to be granted monthly during the period that the certain consulting agreement remains in
effect. During the first quarter of 2022, the Company issued a total of 4,983 restricted shares of the
Company’s Common Stock to certain service providers.
b. On January 4, 2022, out of the pre-funded warrants that were issued in May 2019, 81,233 were exercised
on a cashless basis into 81,221 shares of Common Stock.
c.
d.
In January 2022, pursuant to the terms of the 2020 Plan as approved by the Company’s stockholders, the
Company increased the number of shares authorized for issuance under the 2020 Plan by 1,339,624
shares, from 2,528,890 to 3,868,514.
In January 2022, the Company entered into a Technology Purchase Agreement, to acquire certain assets
of Physimax Technologies Ltd. in consideration of the Company’s issuing up to 256,660 shares of the
Company’s Common Stock representing a purchase price of $5,500 in the aggregate, at a price per share
equal to $21.35, plus a cash payment of $500, of which $400 were transferred as convertible loan and
$100 are payable at closing, as well as assume certain liabilities in an approximate amount of $1,020.
e. On February 28, 2022, the Company entered into securities purchase agreements with institutional
accredited investors relating to an offering with respect to the sale of an aggregate of 4,674,454 shares of
the Company’s Common Stock and pre-funded warrants to purchase an aggregate of 667,559 shares of
Common Stock, at a purchase price of $7.49 per share. The aggregate gross proceeds were
approximately $40,000 ($38,026, net of issuance expenses).
f. On February 28, 2022, the company entered into a strategic service agreement with Sanofi U.S for a
term of five years. Pursuant to the Agreement, the company will develop new products and services
based on insights derived from the Company’s historical and current data relating to the use of current
services.
g. On March 9, 2022, the Company’s Compensation Committee of the Board of Directors approved the
grant of 24,191 shares of the Company’s Common Stock to employees of the Company, the grant of
149,550 restricted shares of the Company’s Common Stock to employees and consultants. The shares
vest over a period of three years commencing on the respective grant dates. The Compensation
Committee also approved the grant of 396,050 options to employees and a consultant of the Company, at
exercise prices between $6.67 and $8.0957 per share. The stock options vest over a three year period
commencing on the respective grant dates. The options have a ten-year term and were issued under the
2020 Plan.
h. During the first quarter of 2022, certain series A Convertible Preferred Stockholders converted 1,030
shares of various classes of the Company’s A Convertible Preferred Stock into 254,322 shares of
Common Stock.
i. During the first quarter of 2022, 61,730 shares of common Stock were issued as dividend to certain
Series A Convertible Preferred Stockholders upon conversion of such shares.
- - - - - - - - - - - - - - -
F-39
Subsidiaries of the Registrant
Exhibit 21.1
Labstyle Innovation Ltd., an Israeli company
Upright Technologies Ltd., an Israeli company
Upright Technologies Inc., a Delaware company
PsyInnovations Inc., a Delaware company
PsyInnovations India Private Limited., an Indian company
Consent of Independent Registered Public Accounting Firm
Exhibit 23.1
We consent to the incorporation by reference in the Registration Statements on Form S-8 (File Nos. 333-262056, 333-256897, 333-
251968 and 333-249474) and the Registration Statements on Form S-3 (File No. 333-260439 and 333-254968, 333-248653 and 333-
237275) of DarioHealth Corp. (“the Company”), of our report dated March 21, 2022 with respect to the consolidated financial statements
of the Company and its subsidiary included in this Annual Report on Form 10-K for the year ended December 31, 2021.
Tel-Aviv, Israel
March 21, 2022
/s/ Kost Forer Gabbay & Kasierer
A Member of Ernst & Young Global
Exhibit 31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO RULE 13A-14(A) AND 15D-14(A)
UNDER THE SECURITIES EXCHANGE ACT OF 1934
I, Erez Raphael, certify that:
1. I have reviewed this Annual Report on Form 10-K of DarioHealth Corp. (the “Registrant”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13-a13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures; and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such
evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: March 21, 2022
/s/ Erez Raphael
Erez Raphael
Chief Executive Officer
(Principal Executive Officer)
Exhibit 31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULE 13A-14(A) AND 15D-14(A)
UNDER THE SECURITIES EXCHANGE ACT OF 1934
I, Zvi Ben David, certify that:
1. I have reviewed this Annual Report on Form 10-K of DarioHealth Corp. (the “Registrant”);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13-a13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed
under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures; and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such
evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting
which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
Date: March 21, 2022
/s/ Zvi Ben David
Zvi Ben David
Chief Financial Officer, Secretary and Treasurer
(Principal Financial Officer)
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER AND
PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U. S. C. SECTION 1350,
Exhibit 32.1
In connection with the Annual Report of DarioHealth Corp. (the “Company”) on Form 10-K for the period ended December 31,
2021 (the “Report”), I, Erez Raphael, Chief Executive Officer of the Company, and I, Zvi Ben David, Chief Financial Officer of the
Company, hereby certify pursuant to 18 U.S.C. Section 1350, that to my knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934;
and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of
the Company.
Date: March 21, 2022
Date: March 21, 2022
/s/ Erez Raphael
Erez Raphael
Chief Executive Officer
(Principal Executive Officer)
/s/ Zvi Ben David
Zvi Ben David
Chief Financial Officer, Secretary and Treasurer
(Principal Financial Officer)