Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
The following financial
data in this narrative are expressed in
thousands
, except for stock and stock data or as otherwise noted.
On February 26,
2016, we affected a 1-for-18 reverse stock split of our outstanding common stock, which we refer to herein as the “reverse
split”. Our authorized common stock and the par value of our common stock were not impacted by the reverse split. References
in this Quarterly Report to our capitalization and other matters pertaining to our common stock relate to our capitalization and
common stock after giving effect to the reverse split.
The following discussion
should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly
Report on Form 10-Q and the consolidated financial statements and related notes thereto in our Annual Report on Form 10-K for the
year ended December 31, 2015.
This discussion
contains certain forward-looking statements that involve risks and uncertainties. Our actual results and the timing of certain
events could differ materially from those discussed in these forward-looking statements as a result of certain factors, including,
but not limited to, those set forth herein and elsewhere in this Quarterly Report and in our other filings with the Securities
and Exchange Commission. See “Cautionary Note Regarding Forward-Looking Statements.”
We are a digital health
(mHealth) company that is developing and commercializing a patented and proprietary technology providing consumers with laboratory-testing
capabilities using smart phones and other mobile devices. Our principal operating subsidiary, LabStyle Innovation Ltd., is an Israeli
company with its headquarters in Caesarea, Israel. We were formed on August 11, 2011 as a Delaware corporation. Effective as of
July 28, 2016, we changed our name from LabStyle Innovations Corp. to DarioHealth Corp. Our flagship product, Dario
TM
,
is a mobile, real-time, cloud-based, diabetes management solution based on an innovative, multi-feature software application combined
with a stylish, ‘all-in-one’, pocket-sized, blood glucose monitoring device, which we call the Dario
TM
Smart
Meter.
We commenced a commercial
launch of the free Dario
TM
application in the United Kingdom in late 2013 and commenced an initial soft launch of the
full Dario
TM
solution (including the app and the Smart Meter) 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. We are
consistently adding additional features and functionality in making Dario
TM
Smart Diabetes Management Solution the new
standard of care in diabetes data management.
In the United States
we commenced commercialization in March 2016 and intend to continue to generate demand through a digital direct to consumer marketing
campaign. Customers are currently able to purchase the product directly through our proprietary e-store where they can also subscribe
to a subscription-based service. In July 2016, we signed an agreement with GEMCO Medical, an established healthcare distributor
and a pioneer in the diabetes supply industry, to become the first authorized United States distributor of Dario
TM
and
to complement the Company's direct-to-consumer model to further expand and strengthen its presence in the United States. Also during
July 2016, we launched our Australian proprietary e-store where customers may subscribe to a subscription-based service. Additional
third party distribution channels are expected to be established through the fourth quarter of 2016, although there is no guarantee
we will be successful. We also intend to continue to broaden our reach via distribution agreements with national and regional durable
medical equipment and pharmacy chains.
Through our Israeli
subsidiary, LabStyle Innovation Ltd., our plan of operations is to continue the development of our software and hardware offerings
and related technology. To date, we successfully launched the Dario
TM
Smart Diabetes Management Solution according to
plan and are currently expanding the launch to other jurisdictions. In support of these goals, we intend to utilize our funds for
the following activities:
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•
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ramp up of mass production, marketing, distribution and sales efforts related to the Dario
TM
application, Smart Meters and test strips;
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•
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investing in our digital marketing efforts in the United States and expand them to other markets like Australia and Canada;
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•
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continued product 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
TM
solution);
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•
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continued work on registration of our patents worldwide;
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•
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professional fees associated with being a publicly reporting company; and
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•
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general and administrative matters.
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According to our management’s
estimates, based on our budget and the launch of our commercial sales, we believe that we will have sufficient resources to continue
our activity only into March 2017. This includes anticipated inflows from sales of Dario
TM
through distribution partners
and our sales in the United States. If we are unable to scale up our commercial launch of Dario
TM
or meet our commercial
sales targets (or if we are unable to increase our revenues), and if we are unable to obtain additional capital resources, we may
be unable to continue activities, absent a material alterations in our business plans and our business might fail as a result.
Critical Accounting Policies
Reference is made to
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation of our Annual Report on Form
10-K for the year ended December 31, 2015 (filed on February 8, 2016) with respect to our Critical Accounting Policies, which have
not changed, except for:
Revenues are recognized in accordance with
Staff Accounting Bulletin ("SAB") No. 104, Revenue Recognition, when delivery has occurred or services have been rendered,
persuasive evidence of an agreement exists, the seller's price to the buyer is fixed or determinable and collectability is probable.
We derive revenues from the sale of our
Dario™ Smart Meter and its related device-specific disposables test strip cartridges and lancets through independent distributors
or directly to end users. The Dario™ software application is offered for a free download and we do not obtain a recurring
hosting commitment towards the end users relating specifically to the application.
We generally have a standard contract with
our distributors. According to the agreements, all sales to distributors are final, no right of return or price protection right
is granted to such distributors and we are not a party to the agreements between distributors and their customers.
Commencing July 1, 2016, product sales to
distributors are recognized as revenues upon delivery as the fee is fixed or determinable and collectability is probable.
We also generate revenues from arrangements
with health care providers which include supply of Dario™ Smart Meters and software platform that requires certain customization
followed by monthly service, support and maintenance.
When a sales arrangement contains multiple
elements, such as software and non-software components, we allocate revenue to each element based on a selling price
hierarchy as required according to ASC 605-25, “Multiple-Element Arrangements”. The selling price for a deliverable
is based on its Vendor Specific Objective Evidence (“VSOE”), if available, third party evidence (“TPE”)
if VSOE is not available, or estimated selling price (“ESP”) if neither VSOE nor TPE is available. The best estimate
of selling price is established considering several internal factors including, but not limited to, historical sales, pricing practices
and geographies in which the Company offers its products. The determination of ESP is judgmental.
Revenues from software components in sales
arrangement contains multiple elements are recognized when all criteria outlined in ASC 985-605, “Software Revenue Recognition”
(“ASC 985-605”), are met. Revenue from services is recognized when persuasive evidence of an arrangement exists, delivery
of the product has occurred or the services have been rendered, the fee is fixed or determinable and collectability is probable.
For multiple element arrangements within
ASC 985-605, revenues are allocated to the different elements in the arrangement under the “residual method” when VSOE
of fair value exist for all undelivered elements and no VSOE exists for the delivered elements. Under the residual method, at the
outset of the arrangement with the customer, the fair value of the undelivered elements is deferred and the remaining portion of
the arrangement fee is allocated to the delivered elements and is recognized as revenue when the basic criteria in ASC 985-605
have been met. Any discount in the arrangement is allocated to the delivered element.
Since VSOE does not exist for undelivered
elements, revenues are recognized as one unit of accounting, on a straight-line basis over the term of the last deliverable based
on ASC 605-15, “Products” and ASC 985-605.
Deferred revenues include advances and payments
received from customers, for which revenue has not yet been recognized.
Results of Operations
Comparison of the three and nine months ended September
30, 2016 and 2015 (in thousands)
Revenues
Revenues for the three
and nine months ended September 30, 2016 amounted to $728 and $1,965, respectively, compared to $273 and $515 during the three
and nine months ended September 30, 2015, respectively. The increase in revenues in the three and nine months ended September 30,
2016 compared to the three and nine months ended September 30, 2015 is mainly a result of our continuing market penetration in
the United Kingdom, the Netherlands, New Zealand, Australia, Israel, Canada and the United States.
Revenues are derived
from the successful launch of the Dario™ Smart Meter and related disposables in the United Kingdom, the Netherlands, New
Zealand, Australia, Israel, Canada and the United States as well as services rendered to Maccabi Healthcare in Israel. We recognize
revenue when delivery has occurred or services have been rendered, persuasive evidence of an agreement exists, the seller's price
to the buyer is fixed or determinable and collectability is probable.
Cost of Revenues
In the quarter ended
September 30, 2016, we reached gross profit. During the three and nine months ended September 30, 2016, we recorded costs related
to revenues in the amount of $652 and $2,148, out of which $32 resulted from a write off of deferred inventory balance that was
recorded as a result of a legal settlement with a former distributor and write offs of an inventory balance of $48 and of machinery
equipment of $14 that was recorded as a result of a change in manufacturer that allowed us to increase our manufacturing capacity.
In addition, our cost of revenues for the nine month period ended September 30, 2016 also includes $118 that was recorded to cover
inventory write-downs due to net realized value which was lower than original cost. During the three and nine months ended September
30, 2015, we recorded cost of revenues and costs related to ramp up of manufacturing in the amount of $404 and $1,111, respectively,
out of which $32 and $138, respectively, were recorded to cover inventory write-downs due to net realized value which was lower
than original cost. The gross profit recorded in the quarter ended September 30, 2016, was a result from the increase in the volume
of revenue during the quarter.
Cost of revenues consists
mainly of the cost of device and consumables production, employees’ salaries and related overhead costs, depreciation of
production line and related cost of equipment used in production, shipping and handling costs and inventory write-downs.
Research and Development Expenses
Our research and development
expenses decreased by $8, or 1%, to $659 for the three months ended September 30, 2016 compared to $667 for the three months ended
September 30, 2015, and decreased by $414, or 21%, to $1,577 for the nine months ended September 30, 2016 compared to $1,991 for
the nine months ended September 30, 2015. This decrease was mainly due to decreases in our stock based compensation, product development,
clinical trials, and regulation and overhead costs.
Research and development
expenses consist mainly of payroll expenses to personnel involved in research and development activities, patent registration
costs and expenses related to our Dario
TM
software application and related Smart Meter device.
Sales, Marketing and Pre-Production Expenses
Our sales, marketing and pre-production
expenses increased by $1,116, or 268%, to $1,533 for the three months ended September 30, 2016 compared to $417 for the three months
ended September 30, 2015, and increased by $2,263, or 243%, to $3,194 for the nine months ended September 30, 2016 compared to
$931 for the nine months ended September 30, 2015. These increases were mainly due to the commencement of our sales and marketing
efforts in the United States, increase in costs of on line marketing campaigns, sales and marketing consultants and subcontractors
and employee payroll.
Sales
and marketing expenses consist mainly of payroll expenses, on line marketing of the Dario
TM
, and marketing consultants
and subcontractors.
General and Administrative Expenses
Our general and administrative expenses
decreased by $727, or 55%, to $605 for the three months ended September 30, 2016 compared to $1,332 for the three months ended
September 30, 2015, and decreased by $5, or 0%, to $2,313 for the nine months ended September 30, 2016 compared to $2,318 for the
nine months ended September 30, 2015. These decreases were mainly due to decreases in our stock based compensation offset by increases
in employee payroll and bonuses.
Our general and administrative expenses
consist mainly of payroll, bonus and stock based compensation expenses for management and employees, legal and professional expenses
and office rent and related expenses.
Financial Income, net
Our finance income, net for the three and
nine months ended September 30, 2016 was $980 and $1,618, respectively, compared to financial income, net of $718 and $366 for
the three and nine months ended September 30, 2015, respectively. The increases in financial income were mainly due to revaluation
of warrants issued to investors, which are recorded as liability and presented at fair value each reporting period, offset by finance
expense recorded in the third quarter of 2016 with respect to a registration right waiver obtained in exchange for warrants.
Finance expenses or income include mainly
the results of a revaluation of warrants to investors and a former placement agent, which are recorded as a liability and presented
at fair value each reporting period.
Net loss
Net loss decreased by $88, or 5%, to $1,741
for the three months ended September 30, 2016 compared to $1,829 for the three months ended September 30, 2015 and increased by
$179, or 3%, to $5,649 for the nine months ended September 30, 2016 compared to $5,470 for the nine months ended September 30,
2015. The decrease in net loss for the three months ended September 30, 2016 compared to the three months ended September 30, 2015
was mainly due to gross profit of $76 we recognized in the three months ended September 30, 2016 as well as financial income of
$980 that was recognized in the three months ended September 30, 2016 offset by an increase of $381 in operating expenses compared
to the three months ended September 30, 2015. The increase in net loss for the nine month period ended September 30, 2016 compared
to the nine month period ended September 30, 2015 was mainly due to a decrease of $413 in the gross loss we recorded in the nine
month period ended September 30, 2016 as well as financial income of $1,618 that was recognized during the nine month period ended
September 30, 2016, offset by an increase of $1,844 in operating expenses compared to the nine month period ended September 30,
2015.
Liquidity and Capital Resources
As of September 30, 2016, we had approximately
$3,339 in cash and cash equivalents compared to $1,908 at September 30, 2015.
We have experienced cumulative losses of
$49,723 from inception (August 11, 2011) through September 30, 2016, and have a stockholders’ equity of $4,360 at September
30, 2016. 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. There is no assurance that we will be
able to obtain an adequate level of financing needed for the long-term development and commercialization of our product. These
conditions raise substantial doubt about our ability to continue as a “going concern”.
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 $38,780 as of September 30, 2016, approximately $5,038 and $2,500 of which were raised
during March 2016 pursuant to a concurrent public offering and private placement, respectively, pursuant to which we issued a total
of 1,333,333 and 555,555, respectively, shares of our common stock and 1,533,333 and 666,666, respectively, warrants to purchase
an aggregate of 2,199,999 shares of our common stock. In connection with the public offering, we agreed to grant to the placement
agent up to 153,333 warrants at an exercise price of $5.625 per share, and to certain finders that assisted with the private placement
44,444 restricted shares of common stock, 38,889 non-plan stock options to purchase 38,889 shares of our common stock, and 73,333
warrants at an exercise price of $4.50 per share. In addition, we have an effective Registration Statement on Form S-3, filed under
the Securities Act of 1933, as amended, with the Securities and Exchange Commission using a “shelf” registration process.
Under this shelf registration process, we may, from time to time, sell common stock, warrants or units in one or more offerings
up to a total dollar amount of $40 million.
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 into March 2017 without raising additional capital. This includes
an amount of anticipated inflows from sales of Dario
TM
through distribution partners and to direct customers.
While we previously reported that we believed we would have sufficient resources to continue our activity into June 2017, we
have revised our estimates due to increased costs associated with the marketing of our products.
As such, we have a significant present need
for capital. If we are unable to scale up our commercial launch of Dario
TM
or meet our commercial sales targets (or
if we are unable to generate any revenue at all), 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.
Additionally, our available resources may
be consumed more rapidly than we currently anticipate, resulting in the need for additional funding sooner than we expect. Should
this occur, we will need to seek additional capital earlier than anticipated in order to fund (1) further development and, if needed,
testing of our Dario
TM
Smart Meter and its related application and data storage components, (2) our efforts to obtain
regulatory clearances or approvals necessary to be able to commercially launch Dario
TM
, (3) expenses which will be required
in order to expand production of Dario
TM
, (4) sales and marketing efforts and (5) 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 launch Dario
TM
in the jurisdictions and in the timeframes we expect.
Cash Flows
The following tables sets forth selected
cash flow information for the periods indicated:
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September 30,
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2016
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2015
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$
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$
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Cash used in operating activities:
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(6,520
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)
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(4,214
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)
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Cash used in investing activities:
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(560
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)
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(65
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)
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Cash provided by financing activities:
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7,748
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4,734
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668
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455
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Net cash used in operating activities
Net cash used in operating
activities was $6,520 for the nine months ended September 30, 2016 compared to $4,214 used in operations for the same period in
2015. Cash used in operations increased due to the increase in the volume of our operations
and market penetration activities that we carry out
.
Net cash used in investing activities
Net cash used in investing activities was
$560 for the nine months ended September 30, 2016 compared to $65 for the same period in 2015. Cash used in investing activities
increased due to production line investments that we made during the nine month period ended September 30, 2016 with the aim of
improving the capabilities and efficiency of our production lines..
Net cash provided by financing
activities
Net cash provided by
financing activities was $7,748 for the nine months ended September 30, 2016 compared to $4,734 for the same period in 2015. During
the nine months ended September 30, 2016 we raised net proceeds of approximately $7,538 through our March 2016 public offering
and private placement transactions. During the nine months ended September 30, 2015 we raised net proceeds in an amount of $4,734,
of which $1,956 was raised through our February 2015 Private Placement, $450 was raised in May 2015 through our warrant exercise
and replacement agreements with the purchasers from our February 2015 private placement and $2,325 was raised through our July
2015 Private Placement.
Off-Balance Sheet Arrangements
As of September 30,
2016, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.