Notes
to Condensed Consolidated Financial Statements
(Unaudited)
INTERIM
FINANCIAL STATEMENTS
NOTE
1 – ORGANIZATION AND PRINCIPAL ACTIVITIES
Nemaura
Medical Inc. (“Nemaura” or the “Company”), through its operating subsidiaries, performs medical device
research and manufacturing of a continuous glucose monitoring system (“CGM”), named sugarBEAT. The sugarBEAT device
is a non-invasive, wireless device for use by persons with Type I and Type II diabetes and may also be used to screen pre-diabetic
patients. The sugarBEAT device extracts analytes, such as glucose, to the surface of the skin in a non-invasive manner where it
is measured using unique sensors and interpreted using a unique algorithm.
Nemaura
is a Nevada holding company organized in 2013. Nemaura owns one hundred percent (100%) of Region Green Limited, a British Virgin
Islands corporation (“RGL”) formed on December 12, 2013. RGL owns one hundred percent (100%) of the stock in Dermal
Diagnostic (Holdings) Limited, an England and Wales corporation (“DDHL”) formed on December 11, 2013, which in turn
owns one hundred percent (100%) of Dermal Diagnostics Limited, an England and Wales corporation formed on January 20, 2009 (“DDL”),
and one hundred percent (100%) of Trial Clinic Limited, an England and Wales corporation formed on January 12, 2011 (“TCL”).
DDL
is a diagnostic medical device company headquartered in Loughborough, Leicestershire, England, and is engaged in the discovery,
development and commercialization of diagnostic medical devices. The Company’s initial focus has been on the development
of the sugarBEAT device, which consists of a disposable patch containing a sensor, and a non-disposable miniature electronic watch
with a re-chargeable power source, which is designed to enable trending or tracking of blood glucose levels. All of the Company’s
operations and assets are located in England.
The
following diagram illustrates Nemaura’s corporate structure as of June 30, 2019:
The
Company was incorporated in 2013, and has reported recurring losses from operations to date and an accumulated deficit of $14,677,144
as of June 30, 2019. These operations have resulted in the successful completion of clinical programs to support a CE mark (European
Union approval of the product) approval, as well as a De Novo 510(k) medical device application to the US Food and Drug Administration
(“FDA”) submission. The Company expects to continue to incur losses from operations until revenues are generated through
licensing fees or product sales. However, given the completion of the requisite clinical programs, these losses are expected to
be reduced over time. Management has entered into licensing agreements with unrelated third parties relating to the United Kingdom,
Europe, Qatar and all countries in the Gulf Cooperation Council.
Management
has evaluated the expected expenses to be incurred along with its available cash and has determined that the Company has the ability
to continue as a going concern for at least one year subsequent to the date of issuance of these condensed consolidated financial
statements. The Company had an $8 million unsecured senior credit facility made available from certain major stockholders
on August 1, 2019. The first $3.5 million became available immediately for draw down, to help fund the Company’s European
commercial launch. The credit facility carries an 8% interest with quarterly interest only payments. The principal is due on maturity
in 5 years.
The
Company has $3,068,541 of readily available cash on hand at June 30, 2019. We believe the cash position as of June 30, 2019, plus
the credit facility made available from certain major stockholders, is adequate for our current level of operations through at
least August 2020, and for the achievement of certain of our product development milestones. Our plan is to utilize
the cash on hand plus loan draw down to continue establishing commercial manufacturing operations for the commercial supply of
the sugarBEAT device and patches now that CE mark approval has been received.
Management's
strategic plans include the following:
•
obtaining further regulatory approval for the sugarBEAT device in other countries such as the USA;
•
exploring licensing opportunities;
•
developing the sugarBEAT device for commercialization for other applications; and
•
secure funding, in the form of conventional interest bearing loans from stockholders, to fund product launch in Europe.
NOTE
2 – BASIS OF PRESENTATION
|
(a)
|
Basis
of presentation
|
The
accompanying condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the U.S.
Securities and Exchange Commission (the “SEC”), and do not include all of the information and footnotes required by
U.S. generally accepted accounting principles (“U.S. GAAP”) for complete financial statements. However, such information
reflects all adjustments consisting of normal recurring accruals which are, in the opinion of management, necessary for a fair
statement of the financial condition and results of operations for the interim periods. The results for the three months ended
June 30, 2019 are not indicative of annual results. The accompanying unaudited condensed consolidated financial statements have
been prepared in accordance with U.S. GAAP for interim financial information and with the instructions to Form 10-Q and Article
10 of Regulation S-X.
The
accompanying condensed consolidated financial statements include the accounts of the Company and the Company’s subsidiaries.
References to “we,” “us,” “our,” or the “Company” refer to Nemaura Medical Inc.
and its consolidated subsidiaries. The condensed consolidated financial statements are prepared in accordance with U.S. GAAP,
and all significant intercompany balances and transactions have been eliminated in consolidation.
The
functional currency for the majority of the Company’s operations is the Great Britain Pound Sterling (“GBP”),
and the reporting currency is the US Dollar (“USD”).
|
(b)
|
Changes
to significant accounting policies
|
There
have been no material changes to our significant accounting policies as reported in our Annual Report on Form 10-K for the year
ended March 31, 2019.
(c)
Recently adopted accounting pronouncements
The
Company continually assesses any new accounting pronouncements to determine their applicability. When it is determined that a
new accounting pronouncement affects the Company's financial reporting, the Company undertakes a study to determine the consequences
of the change to its condensed consolidated financial statements and assures that there are proper controls in place to ascertain
that the Company's condensed consolidated financial statements properly reflect the change.
In
May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Updates ("ASU") No.
2014-09 (“ASC 606”), Revenue from Contracts with Customers. ASC 606 has been modified multiple times since its initial
release. This ASU outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with
customers and will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. ASC 606, as amended,
becomes effective for annual reporting periods beginning after December 15, 2017. Early adoption is permitted. As an Emerging
Growth Company, the Company is allowed to adopt new, or updated, accounting standards using the same time frame that applies to
private companies. The Company adopted this standard on April 1, 2019.
While
the Company is not currently recognizing revenue, we have implemented the guidelines within ASC Topic 606,
Revenue from Contracts
with Customers.
This standard applies to all contracts with customers, except for contracts that are within the scope of other
standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC Topic 606, an entity recognizes
revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the
entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity
determines are within the scope of ASC Topic 606, the entity performs the following five steps: (i) identify the contract(s) with
a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the
transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies
a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect
the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception,
once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within
each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct.
The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation
when (or as) the performance obligation is satisfied.
The
Company may enter into product development and other agreements with collaborative partners. The terms of the agreements may include
non-refundable signing and licensing fees, milestone payments and royalties on any product sales derived from collaborations.
The
Company has entered into license agreements and for these, recognizes up front license payments as revenue upon delivery of the
license only if the license has stand-alone value to the customer. However, where further performance criteria must be met, revenue
is deferred and recognized over the period the Company is expected to complete its performance obligations. Royalty revenue will
be recognized upon the sale of the related products provided the Company has no remaining performance obligations under the agreement.
In
June 2018, the FASB issued ASU 2018-07,
Improvements to Nonemployee Share-Based Payment Accounting
, or ASU 2018-07. ASU
2018-07 simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based
payments to employees, with certain exceptions. The Company adopted ASU 2018-07 as of April 1, 2019. The adoption of ASU 2018-07
has not had a material impact on the Company’s financial position, results of operations or related disclosures and no transition
adjustment at date of adoption was required.
Recent
accounting pronouncements
In
March 2016, the FASB issued ASU No. 2016-02, Leases. The main difference between the provisions of ASU No. 2016-02 and previous
U.S. GAAP is the recognition of right-of-use assets and lease liabilities by lessees for those leases classified as operating
leases under previous U.S. GAAP. ASU No. 2016-02 retains a distinction between finance leases and operating leases, and the recognition,
measurement, and presentation of expenses and cash flows arising from a lease by a lessee have not significantly changed from
previous U.S. GAAP. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by
class of underlying asset not to recognize right-of-use assets and lease liabilities. The accounting applied by a lessor is largely
unchanged from that applied under previous U.S. GAAP. In transition, lessees and lessors are required to recognize and measure
leases at the beginning of the earliest period presented using a modified retrospective approach. This ASU is effective for public
business entities in fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption
is permitted as of the beginning of any interim or annual reporting period. As an Emerging Growth Company, the Company is allowed
to adopt new, or updated, accounting standards using the same time frame that applies to private companies. The Company will adopt
this standard on April 1, 2020. Management is currently evaluating the impact of adoption of this ASU on the Company’s condensed
consolidated financial statements.
In
August 2018, the FASB issued ASU No. 2018-13,
Fair Value Measurement: Disclosure Framework
–
Changes to the Disclosure Requirements for Fair Value Measurement
(ASU 2018-13), which adds and modifies certain disclosure
requirements for fair value measurements. Under the new guidance, entities will no longer be required to disclose the amount and
reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, or valuation processes for Level 3 fair value measurements.
However, public business entities will be required to disclose the range and weighted average of significant unobservable inputs
used to develop Level 3 fair value measurements, and related changes in unrealized gains and losses included in other comprehensive
income. ASU 2018-13 is effective for public business entities for fiscal years beginning after December 15, 2019, including interim
periods. Management is currently evaluating the impact that this guidance will have on the Company’s condensed consolidated
financial statements.
NOTE
3 – LICENSING AGREEMENTS
United
Kingdom and the Republic of Ireland, the Channel Islands and the Isle of Man
In
March 2014, the Company entered into an Exclusive Marketing Rights Agreement with an unrelated third party, that granted to the
third party the exclusive right to market and promote the sugarBEAT device and related patches under its own brand in the United
Kingdom and the Republic of Ireland, the Channel Islands and the Isle of Man. The Company received a non-refundable, up-front
cash payment of GBP 1,000,000 (approximately $1.277 million and $1.303 million as of June 30, 2019 and March 31, 2019, respectively),
which is wholly non-refundable, upon signing the agreement.
As
the Company has continuing performance obligations under the agreement, the up-front fees received from this agreement have been
deferred and will be recorded as income over the term of the commercial licensing agreement. As the Company now expects commercialization
of the sugarBEAT device to occur in the first quarter ending June 30, 2020, approximately $36,000 and $65,000 of the deferred
revenue has been classified as a current liability as ofJune 30, 2019 and March 31, 2019, respectively.
Further
details of licensing agreements are disclosed in the Form 10-K as of and for the year ended March 31, 2019.
NOTE
4 – RELATED PARTY TRANSACTIONS
Nemaura
Pharma Limited (“Pharma”), NDM Technologies Limited (“NDM”) and Black and White Health Care Limited (“B&W”)
are entities controlled by the Company’s Chief Executive Officer and majority stockholder, Dewan F.H. Chowdhury.
In
accordance with the SEC Staff Accounting Bulletin 55, these condensed consolidated financial statements are intended to reflect
all costs associated with the operations of DDL and TCL. Pharma has a service agreement with DDL, to undertake development, manufacture
and regulatory approvals under Pharma’s ISO13485 Accreditation. In lieu of these services, DDL invoices Pharma on a periodic
basis for said services. Services are provided at cost plus a service surcharge amounting to less than 10% of the total costs
incurred.
The
following is a summary of activity between the Company and Pharma and NDM for the three months ended June 30, 2019 and 2018, and
the year ended March 31, 2019. These amounts are unsecured, interest free, and payable on demand.
|
|
Three
Months Ended
June 30, 2019
(unaudited)
($)
|
|
Three
Months Ended
June 30, 2018
(unaudited)
($)
|
|
Year
Ended
March 31, 2019
($)
|
Balance
due to Pharma and NDM at beginning of period
|
|
|
964,679
|
|
|
|
613,818
|
|
|
|
613,818
|
|
Amounts
invoiced by DDL to Pharma
|
|
|
—
|
|
|
|
—
|
|
|
|
(977
|
)
|
Amounts
invoiced by Pharma to DDL, NM and TCL (1)
|
|
|
431,416
|
|
|
|
521,085
|
|
|
|
2,312,412
|
|
Amounts
repaid by DDL to Pharma
|
|
|
(305,060
|
)
|
|
|
(308,434
|
)
|
|
|
(1,569,496
|
)
|
Amounts
invoiced by B&W to DDL
|
|
|
—
|
|
|
|
—
|
|
|
|
2,206
|
|
Amounts
repaid by DDL to B&W
|
|
|
—
|
|
|
|
—
|
|
|
|
(5,622
|
)
|
Foreign
exchange differences
|
|
|
(22,359
|
)
|
|
|
(68,920
|
)
|
|
|
(84,843
|
)
|
Forgiveness
of payable accounted for as an equity contribution
|
|
|
—
|
|
|
|
—
|
|
|
|
(302,819
|
)
|
Balance
due to Pharma and NDM at end of the period
|
|
|
1,072,676
|
|
|
|
757,549
|
|
|
|
964,679
|
|
|
(1)
|
These
amounts are included primarily in research and development expenses charged to the Company
by Pharma.
|
The
Company routinely reviews its statement of cash flows presentation of related party transactions for financing or operating classification
based on the underlying nature of the item and intended repayment.
NOTE
5 – STOCKHOLDERS’ EQUITY
On
October 5, 2017, the Company entered into common stock exchange agreements with each of its three largest stockholders, to exchange,
in the aggregate, 137,324,000 shares of the Company’s common stock for 137,324 shares of Series A Convertible Preferred
Stock (the “Series A Preferred”). Each share of Series A Preferred is convertible into 1,000 shares of the Company’s
common stock, automatically upon the occurrence of all of certain triggering events, as set forth in the Certificate of Designation
for the Series A Preferred, namely (a) the sugarBEAT device to be commercialized has CE mark regulatory approval; (b) retail sales
having commenced; and (c) retail sales exceeding $5 million, inclusive of advanced sales or voluntarily by the holder after February
7, 2018, if these triggering events have not occurred. Each holder of issued and outstanding Series A Preferred is entitled
to a number of votes equal to the number of shares of common stock into which the Series A Preferred is convertible. Holders of
Series A Preferred are entitled to vote on any and all matters presented to stockholders of the Company, except as provided by
law. The Series A Preferred has no preference to the common stock as to dividends or distributions of assets upon liquidation
or winding up of the Company (which has been agreed to by the holders of the Series A Preferred). The Company determined
that the fair value of the shares of Series A Preferred issued for the shares of common stock was equivalent to the fair value
of the shares of common stock exchanged.
On
November 6, 2017, the transactions contemplated by the exchange agreements were consummated and 137,324,000 shares of common stock
were cancelled. As a result, the Company had 67,676,000 shares of common stock issued and outstanding as of March 31, 2018.
On
June 5, 2018, the three holders of the Company’s Series A Preferred each delivered notices of conversion to voluntarily
convert their Series A Preferred, in the aggregate amount of 137,324 of Series A Preferred shares, into 137,324,000 shares of
common stock. The holders had the right to voluntarily convert each share of Series A Preferred into 1,000 shares of common
stock of the Company.
On
October 19, 2018, the Company entered into an Equity Distribution Agreement (“Distribution Agreement”) with Maxim
Group LLC, as sales agent (“Maxim”), pursuant to which the Company may offer and sell, from time to time, through
Maxim (the “Offering”), up to $20,000,000 in shares of its common stock (the “Shares”). Between October
31, 2018, and March 31, 2019, the Company issued 234,998 shares of its common stock through the Distribution Agreement and received
gross proceeds of $455,105. $161,102 of costs were incurred in relation to this transaction. In the three months ended June 30,
2019, an additional 143,388 shares were issued under the Distribution Agreement generating gross proceeds of $152,493 and costs
of $9,575. As of June 30, 2019, the Company may sell, from time to time, the remaining $19,392,402 in shares of common stock under
the Distribution Agreement.
On
December 18, 2018, the Company entered into a placement agency agreement with Dawson James Securities, Inc. with respect to the
issuance and sale of an aggregate of up to 2,400,000 units, each unit consisting of one share of common stock, par value $0.001
per share, together with one warrant to purchase one share of common stock at an exercise price equal to $1.04 per share, in a
public offering. The warrants offered in the public offering will terminate on the fifth anniversary of the date of issuance.
The public offering price for each unit was $1.04.
The
closing of the offering occurred on December 20, 2018 and at such closing the Company sold 1,942,061 shares of common stock and
1,942,061 warrants for gross proceeds of $2,019,743. The net proceeds to the Company from the sale of the shares of common stock
and the warrants was $1,691,443, after deducting $328,302 of placement agent commissions and other offering expenses payable by
the Company. As of June 30, 2019, 86,357 of the warrants had been exercised, generating $89,811 of additional proceeds.
Effective
December 18, 2018, the Company issued a unit purchase option to the placement agent to purchase 97,103 shares and 97,103 warrants.
The Company has classified this option as equity. The unit purchase option has a term of three years and an exercise price of
$1.30.
Earnings
(loss) per share
The
following table sets forth the computation of basic and diluted earnings (loss) per share (“EPS”) for the periods
indicated.
|
|
Three
months ended June 30,
|
|
|
2019
|
|
2018
|
|
|
|
($)
|
|
|
|
($)
|
|
Basic
and diluted earnings (loss) per share:
Net
loss attributable to common stockholders
|
|
|
(1,251,265
|
)
|
|
|
(763,154
|
)
|
Weighted
average basic and diluted shares outstanding
|
|
|
207,836,368
|
|
|
|
105,821,556
|
|
Basic
and diluted earnings (loss) per share:
|
|
|
(0.01
|
)
|
|
|
(0.01
|
)
|
|
|
|
|
|
|
|
|
|
The
Company excludes warrants outstanding, which are anti-dilutive given the Company is in a loss position, from the basic and diluted
earnings per share calculation.
Basic
earnings (loss) per share is computed by dividing income (loss) available to common stockholders by the weighted-average number
of common shares outstanding during the period. For the three months ended June 30, 2019 and 2018, warrants to purchase 10 million
shares of common stock were anti-dilutive and were excluded from the calculation of diluted loss per share
.
For the three month period ended June 30, 2019, warrants to purchase 1,855,704 shares of common stock and a unit purchase
option to purchase 97,103 shares of common stock as well as 97,103 warrants were considered anti-dilutive and were also excluded
from the calculation of diluted loss per share.
NOTE
6 – OTHER ITEMS
(a)
Investor relations agreements
The
Company currently has contracts with several investor relations specialists to help support the ongoing financing activities of
the business. Further details of historic fees paid and arrangements are detailed in our Form 10-K for the year ended March 31,
2019.
Investor
Relations Company 2 -
On May 1, 2019, the existing agreement with investor relations company 2 was restated, still as a rolling
monthly contract with a three month assumed length, although cancellable after each completed month. A payment of $7,500 was agreed
at the beginning of each month, plus an additional $2,500 per month for additional services, if taken; and if the contract runs
for the whole three month term, 12,500 shares will be issued at the end of the term. $20,000 was expensed in the three months
ended June 30, 2019 relating to cash payments.
Investor
Relations Company 3 -
On March 18, 2019 the Company cancelled its existing agreement with investor relations company 3 and
entered into a new agreement. The term of this contract has been agreed to be on a month to month basis. Compensation is partly
in cash and partly in restricted common stock. At the beginning of each monthly term a cash payment of $5,000 will be made and
7,500 shares of restricted stock will be issued. This contract ended in May 2019. 7,500 shares with a fair value of $1.04 were
issued in April and 7,500 shares with a fair value of $0.90 were issued in May totaling $14,550. $13,320 was expensed in relation
to cash paid for this agreement during the three months ended June 30, 2019, including $2,097 released from prepaid expenses at
April 1, 2019. Total stock compensation expense for the three months ended June 30, 2019 was $17,888.
(b)
Management Consultancy Agreement
Management
Consulting Company 1
-
On June 1, 2019, the terms for management consulting company 1 were amended being for a 4-month
period from June 1, 2019 to September 30, 2019, with $40,000 cash to be paid up front and 27,500 shares issued up front. $30,000
of this cash expense is within prepaid expenses at June 30, 2019. The shares were recorded at fair value on the first day of the
contract of $0.87 and the cost will be expensed over the 4-month term of which $18,434 was included in prepaid expenses at June
30, 2019. Cash payments expensed of $36,667 include the release of $26,667 prepaid at April 1, 2019 and $26,091 was expensed for
share expense including $20,600 in prepaid expenses at April 1, 2019, all of which were expensed during the quarter ended June
30, 2019.
Management
Consulting Company 2 -
On January 7, 2019 the Company entered into a six-month contract with management consulting company
2 for the provision of specialist consulting services. 150,000 restricted shares were issued on the fourth month after commencement
of the original contract, being May 2019. A fair value of $0.94, being the share price on May 7, 2019 (the first day of the first
amendment of the consulting agreement) was applied as the shares were issued fully and irrecoverably on the first day of the contract.
The cost is being expensed evenly over the 5-month contract term, with a prepaid expense of $84,600 at June 30, 2019. $118,275
was expensed in relation to this agreement for the quarter ended June 30, 2019, including $61,875 released from prepaid expenses
at April 1, 2019.
Total
stock based compensation recognized during the quarter ended June 30, 2019 was $162,254.
(c)
Subsequent events
On
July 10, 2019 the Company submitted its De Novo 510(k) medical device application to the US Food and Drug Administration for sugarBEAT,
following clinical studies and usability studies.
The
Company was notified by NASDAQ on July 15, 2019 that the Company no longer meets the requirements of NASDAQ Rule 5550(a)(2) requiring
listed securities to maintain a minimum closing bid price of $1 per share. If the closing bid price of the Company’s common
stock is $1.00 per share or more for a minimum of 10 consecutive business days at any time prior to January 11, 2020, the Company
will regain compliance.
On
July 31, 2019, the Company entered into a loan agreement with Carter Gem Properties Limited (“Carter Gem”) pursuant
to which Carter Gem agreed to lend the Company up to $8,000,000 in tranches with a 20 day calendar notice prior to each tranche.
The loan carries an 8% interest rate with quarterly interest payments and balloon maturity date in five years. Carter Gem has
discretion to proceed with each tranche. The first $3.5 million became available immediately for draw down, to help fund the Company’s
European commercial launch. Carter Gem is a company owned by a trust designed to benefit the family of Sufyan Ismail, who is a
major stockholder of the Company. The transaction was approved by the Company’s Audit Committee, as a related party transaction