NMRD Nemaura Medical
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2021
¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-38355
|Nemaura Medical Inc.|
|(Exact name of registrant as specified in its charter)|
|(State or other jurisdiction of incorporation or organization)||(I.R.S. Employer Identification No.)|
57 West 57th Street
Manhattan, NY 10019
|(Address of Principal Executive Offices) (Zip Code)|
|(Registrant’s Telephone Number, Including Area Code)|
|(Former name, former address and former fiscal year, if changed since last report)|
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
|Name of each exchange on which registered|
|Common Stock||NMRD||The Nasdaq Stock Market LLC|
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 þ No o
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 þ No o
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 o||Accelerated filer o|
Non-accelerated Filer þ
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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No☒
The number of shares of common stock, par value $0.001 per share, outstanding as of August 13, 2021 was .
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements, other than statements of historical fact, included in this Quarterly Report on Form 10-Q regarding development of our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management are forward-looking statements. Forward-looking statements may include, but are not limited to, statements about:
- any statements of the plans, strategies and objectives of management for future operations;
- any statements concerning proposed new products, services or developments;
- any statements regarding future economic conditions or performance;
- our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
- our estimates regarding the sufficiency of our cash resources and our need for additional funding;
- any statement that our business, financial condition and results of operations may be materially adversely affected by global health epidemics, including the recent COVID-19 pandemic; and
- any statement regarding the effectiveness of our continuous temperature monitoring system to assist with the diagnosis and monitoring of symptoms of COVID-19 or the effectiveness of our continuous lactate monitoring system (CLM) to monitor disease progression in COVID -19 patients.
The words "believe," "anticipate," "design," "estimate," "plan," "predict," "seek," "expect," "intend," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect our current views with respect to future events, are based on assumptions and are subject to risks and uncertainties. We cannot guarantee that we actually will achieve the plans, intentions or expectations expressed in our forward-looking statements and you should not place undue reliance on these statements. There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements. These factors and the other cautionary statements made in this Quarterly Report on Form 10-Q should be read as being applicable to all related forward-looking statements whenever they appear herein. Except as required by law, we do not assume any obligation to update any forward-looking statement. We disclaim any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
NEMAURA MEDICAL INC.
INDEX TO QUARLTERLY REPORT ON FORM 10-Q
FOR THE PERIOD ENDED JUNE 30, 2021
TABLE OF CONTENTS
|PART I: FINANCIAL INFORMATION|
|ITEM 1||FINANCIAL STATEMENTS|
|Condensed Consolidated Balance Sheets as of June 30, 2021 (unaudited) and March 31, 2021||4|
|Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended June 30, 2021 and 2020 (unaudited)||5|
|Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three Months Ended June 30, 2021 and 2020 (unaudited)||6|
|Condensed Consolidated Statements of Cash Flows for the Three Months Ended June 30, 2021 and 2020 (unaudited)||7|
|Notes to Condensed Consolidated Financial Statements (unaudited)||8-13|
|ITEM 2||MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS||14-17|
|ITEM 3||QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK||18|
|ITEM 4||CONTROLS AND PROCEDURES||18|
|PART II: OTHER INFORMATION||19|
|ITEM 1||LEGAL PROCEEDINGS||19|
|ITEM 1A||RISK FACTORS||19|
|ITEM 2||UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS||19|
|ITEM 3||DEFAULTS UPON SENIOR SECURITIES||19|
|ITEM 4||MINE SAFETY DISCLOSURES||19|
|ITEM 5||OTHER INFORMATION||19|
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
|NEMAURA MEDICAL INC.|
|Condensed Consolidated Balance Sheets|
As of June 30,
As of March 31, 2021
|Prepaid expenses and other receivables||1,819,724||1,269,513|
|Accounts receivable - related party||107,788||0|
|Total current assets||34,069,469||33,985,506|
|Property and equipment, net of accumulated depreciation||255,899||202,145|
|Intangible assets, net of accumulated amortization||1,357,299||1,055,256|
|Total other assets||1,613,198||1,257,401|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Liability due to related parties||0||148,795|
|Other liabilities and accrued expenses||543,604||180,552|
|Notes payable, current portion||11,142,795||5,733,370|
|Total current liabilities||12,422,784||6,419,881|
|Non-current portion of notes payable||14,025,742||19,188,724|
|Non-current portion of deferred revenue||1,266,742||1,276,130|
|Total non-current liabilities||15,292,484||20,464,854|
|Commitments and contingencies:|
|Common stock, $par value, shares authorized and and shares issued and outstanding at June 30, 2021 and March 31, 2021, respectively||23,308||22,941|
|Additional paid-in capital||35,007,626||32,044,335|
|Accumulated other comprehensive income||124,861||135,567|
|Total stockholders’ equity||7,967,399||8,358,172|
|Total liabilities and stockholders’ equity||35,682,667||35,242,907|
See notes to the unaudited condensed consolidated financial statements.
NEMAURA MEDICAL INC.
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
(in Dollars, except Share Amounts)
|Three Months Ended June 30,|
|Research and development||288,484||315,312|
|General and administrative||1,332,185||595,720|
|Total operating expenses||1,620,669||911,032|
|Loss from operations||(1,620,669||)||(911,032||)|
|Other comprehensive (loss) income:|
|Foreign currency translation adjustment||(10,706||)||4,823|
|Net loss per share, basic and diluted||(0.14||)||(0.05||)|
|Weighted average number of shares outstanding||23,109,897||20,879,446|
See notes to the unaudited condensed consolidated financial statements.
NEMAURA MEDICAL INC.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
Three Months Ended June 30, 2021 and 2020 (Unaudited)
|Common Stock||Additional Paid-in||Accumulated||Accumulated Other Comprehensive||Total Stockholders’|
|(Loss) / Income|
|Balance at March 31, 2021||22,941,157||22,941||32,044,335||(23,844,671||)||135,567||8,358,172|
|Exercise of warrants||366,892||367||2,963,291||—||—||2,963,658|
|Foreign currency translation adjustment||—||—||—||—||(10,706||)||(10,706||)|
|Balance at June 30, 2021||23,308,049||23,308||35,007,626||(27,188,396||)||124,861||7,967,399|
|Balance at March 31, 2020||20,850,848||20,851||16,589,272||(17,586,075||)||(336,992||)||(1,312,944||)|
|Issuance of common shares under ATM financing, net of costs of $122,913||393,352||393||3,973,777||—||—||3,974,170|
|Exercise of warrants||37,933||38||394,437||—||—||394,475|
|Foreign currency translation adjustment||—||—||—||—||4,823||4,823|
|Balance at June 30, 2020||21,282,133||21,282||20,957,486||(18,686,131||)||(332,169||)||(1,960,468||)|
See notes to the unaudited condensed consolidated financial statements.
|NEMAURA MEDICAL INC.|
|Condensed Consolidated Statements of Cash Flows|
|Three Months Ended|
|Cash Flows From Operating Activities:|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Depreciation and amortization||36,133||20,168|
|Accretion of debt discount||1,723,056||188,579|
|Changes in assets and liabilities:|
|Prepaid expenses and other receivables||(550,211||)||152,438|
|Liability due to related parties||(256,583||)||(284,453||)|
|Other liabilities and accrued expenses||363,052||43,950|
|Net cash used in operating activities||(1,690,028||)||(1,077,594||)|
|Cash Flows from Investing Activities:|
|Capitalized patent costs||(22,714||)||(10,283||)|
|Capitalized software development costs||(293,285||)||0|
|Purchase of property and equipment||(82,222||)||(1,999||)|
|Net cash used in investing activities||(398,221||)||(12,282||)|
|Cash Flows from Financing Activities:|
|Costs incurred in relation to equity financing||0||(61,424||)|
|Commission paid on note payable||0||(325,000||)|
|Proceeds from issuance of notes||0||4,943,074|
|Proceeds from issuance of common stock in relation to equity financing||0||2,047,462|
|Proceeds from warrant exercise||2,963,658||394,475|
|Repayments of note payable||(1,500,000||)||0|
|Repayment of insurance financing||0||(40,936||)|
|Net cash provided by financing activities||1,463,658||6,957,651|
|Net (decrease) increase in cash||(624,591||)||5,867,775|
|Effect of exchange rate changes on cash||18,973||(20,948||)|
|Cash at beginning of period||31,865,371||106,107|
|Cash at end of period||31,259,753||5,952,934|
|Supplemental disclosure of non-cash financing activities:|
|Prepayment of equity compensation||25,000||0|
|Increase in stock subscriptions receivable||0||1,988,132|
See notes to the unaudited condensed consolidated financial statements.
NEMAURA MEDICAL INC.
Notes to Condensed Consolidated 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 100% owns 100% of the stock in Dermal Diagnostic (Holdings) Limited, an England and Wales corporation (“DDHL”) formed on December 11, 2013, which in turn owns 100% of Dermal Diagnostics Limited, an England and Wales corporation formed on January 20, 2009 (“DDL”), and 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 wireless transmitter with a re-chargeable power source, which is designed to enable trending or tracking of blood glucose levels. While the Company’s key operations and assets are located in England, the Company has recently commenced commercial operations in the United States.
During the fiscal year ended March 31, 2021, the Board of Directors assessed the adequacy of the group’s organizational structure and concluded that the intermediate holding company that sat below Nemaura Medical Inc., Region Green Limited (a British Virgin Islands corporation), was no longer required as the entity had been effectively dormant since inception and no longer represented a requirement to be maintained. It was therefore determined that Region Green Limited should be unwound, with the intention that the assets held by Region Green Limited be transferred up to Nemaura Medical Inc. following which Region Green Limited would be dissolved.
The transfer of assets took place on March 5, 2021 and Region Green Limited was formally dissolved as of April 23, 2021.
The following diagram illustrates Nemaura’s corporate structure as of June 30, 2021:
The Company was incorporated in 2013 and has reported recurring losses from operations to date and an accumulated deficit of $27,188,396 as of June 30, 2021. These operations have resulted in the successful completion of clinical programs to support a CE mark (European Union approval of the product) approval, and a Pre-Market Application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for sugarBEAT® is currently under review.
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 decrease over time. Management has entered into licensing, supply, or collaboration agreements with unrelated third parties relating to the United Kingdom (“UK”), Europe, Qatar, and all countries in the Gulf Cooperation Council.
The Company has $31,259,753 of readily available cash at June 30, 2021, and management has evaluated the expected expenses to be incurred in relation to 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 unaudited condensed consolidated financial statements.
Following the receipt of the CE mark approval in the EU, and in support of our plans for similar certification with the FDA in the U.S., our plan is to utilize the cash on hand to continue establishing commercial manufacturing operations for the commercial supply of the sugarBEAT® device and sensor patches in our target markets.
Management's strategic plans include the following:
|–||support the UK and EU launch of sugarBEAT®;|
|–||obtaining further regulatory approval for the sugarBEAT® device in other countries such as the U.S.;|
|–||exploring licensing and partnership opportunities in other territories;|
|–||developing the sugarBEAT® device platform for commercialization across other applications; and|
|–||pursue additional capital raising opportunities should they be required to further enhance our growth plans.|
NOTE 2 – BASIS OF PRESENTATION
(a) Basis of presentation
The accompanying unaudited 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, 2021 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 8 of Regulation S-X. It is suggested that these unaudited condensed consolidated financial statements be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended March 31, 2021, as filed with the SEC.
The accompanying unaudited 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 unaudited 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 U.S. Dollar (“USD”).
|(b)||Changes to significant accounting policies|
Derivative Financial Instruments
Derivative financial instruments are used as part of the overall strategy to manage exposure to foreign currency primarily associated with fluctuations in foreign currency exchange rates. Derivative financial instruments are included in the consolidated balance sheets and are measured at fair value on a recurring basis.
The Company is exposed to the impact of foreign currency exchange fluctuations as a significant proportion of our expenses are incurred within our UK subsidiary which is denominated in Great Britain Pounds Sterling (“GBP”), with the remaining portion denominated in U.S. dollars and a small amount in Euro’s (“EUR”). In addition to this we hold the majority of our cash in USD, with amounts also held in GBP and, to a much smaller amount, in EUR’s. The Company’s objective is to reduce the volatility associated with these foreign exchange rate changes to allow management to focus our attention on our core business strategy and objectives. Accordingly, during the three month period ended June 30, 2021 the Company entered into a target accrual redemption forward contract (“TARF”) agreement to sell USD and buy GBP across 25 defined monthly fixings, in order to fix the costs associated with the foreign currency exchange fluctuations associated with its GBP denominated expenses. These fixings allow for $250,000 to be converted to GBP at a fixed rate of $1.369 subject to the spot rate on the fixing date being above the fixed rate. Should the spot rate fall below the fixed rate on the scheduled fixing date, the Company is obligated to convert $500,000 to GBP at the fixed rate. The exchange rate range experienced by the company over the last 2 years for USD : GBP has seen a high of approximately $1.163 in March 2020 and a low of approximately $1.423 in June 2021. Cumulative profit on the sale of USD is capped at an aggregate of approximately $55,000 over the shorter of the life of the contract fixings or the utilization of the cap.
At June 30, 2021, the Company held a forward contract to sell up to $63,068 which has been captured within the other comprehensive loss for the period. No such similar derivative financial instrument was in place at March 31, 2021 or June 30, 2020.million, which when remeasured at fair value generated a loss of $
The Company’s foreign currency forward contracts are measured at fair value on a recurring basis and are classified as Level 2 under our fair value of financial instruments policy, as set out in the March 31, 2021 Form 10-K.
There have been no other material changes to our significant accounting policies from those detailed in the Company’s Annual Report on Form 10-K for the year ended March 31, 2021, as filed with the SEC on June 29, 2021.
(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 consolidated financial statements and assures that there are proper controls in place to ascertain that the Company's consolidated financial statements properly reflect the change.
This Quarterly Report on Form 10-Q does not discuss recent pronouncements that are not anticipated to have a current and/or future impact on the Company, or are unrelated to the Company’s financial condition, results of operations, cash flows or disclosures.
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 (the “Marketing Rights Agreement”) with an unrelated third party (the “Licensee”), that granted to the Licensee 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 $1.38 million and $1.38 million as of June 30, 2021 and March 31, 2021, respectively), which is wholly non-refundable, upon signing the Marketing Rights Agreement. The upfront payment received from the Marketing Rights Agreement has been deferred and will be recorded as income over the term of the Marketing Rights Agreement. Consequently, approximately $115,000 and $103,000 of the deferred revenue has been classified as a current liability as of June 30, 2021 and March 31, 2021, respectively.
The Company is in ongoing dialogue with the Licensee about the timing of its plans with respect to its product launch. The current expectation is for this to occur in the quarter ending December 31, 2021, with the initial order placed with the Company in April 2021 being scheduled to commence delivery during the quarter ending September 30, 2021, in order to enable the Licensee to hold inventory on-hand to support their launch. Under the terms of the contact, the Company is able to issue a ‘deposit’ invoice to cover costs for purchases directly incurred in order to service orders made by the Licensee, as such an invoice was raised at the end of the quarter for approximately $513,000 and will be recorded as income once delivery of the order commences. As at June 30, 2021 this invoice has been treated as deferred revenue within current liabilities with the debit balance being captured within other receivables, the cash payment for which is anticipated in line with the agreed standard contractual terms.
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, President, director and majority stockholder, Dewan F.H. Chowdhury.
These unaudited 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, Pharma invoices DDL 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 table below provides a summary of activity between the Company and Pharma and NDM for the three months ended June 30, 2021 and 2020, and the year ended March 31, 2021.
|Schedule of Related Party Transactions|
Three Months Ended
June 30, 2021
Three Months Ended
June 30, 2020
March 31, 2021
|Amounts due to related parties at beginning of period||148,795||830,093||830,093|
|Amounts invoiced by Pharma to DDL, NDM and TCL (1)||597,594||298,999||2,441,108|
|Amounts invoiced by DDL to Pharma||—||—||(17,213||)|
|Amounts paid by DDL to Pharma||(856,904||)||(582,089||)||(3,209,084||)|
|Foreign exchange differences||2,727||(2,922||)||103,891|
|Amounts due from / to related parties at end of period||(107,788||)||544,081||148,795|
|(1)||These amounts are primarily incurred as a result of research and development expenses charged to the Company by Pharma.|
The Company routinely reviews its condensed consolidated statements 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 – NOTES PAYABLE
NOTE PURCHASE AGREEMENT 1
On April 15, 2020, the Company entered into a note purchase agreement (the “Note Purchase Agreement 1”) by and among the Company, DDL, TCL and a third-party investor (the “Investor”).
Pursuant to the terms of the Note Purchase Agreement, the Company agreed to issue and sell to the Investor and the Investor agreed to purchase from the Company a secured promissory note (the “Secured Note”) in the original principal amount of $6,015,000. In consideration thereof, on April 15, 2020 (the closing date), (i) the Investor (a) paid $1,000,000 in cash, (b) issued to the Company (1) Investor Note #1 in the principal amount of $2,000,000 (“Investor Note #1”), and (2) Investor Note #2 in the principal amount of $2,000,000 (“Investor Note #2” and together with Investor Note #1, the “Investor Notes”), and (ii) the Company delivered the Secured Note on behalf of the Company, to the Investor, against delivery of the Purchase Price. For these purposes, the “Purchase Price” means the Investor’s initial cash purchase price, together with the sum of the initial principal amounts of the Investor Notes.
The Secured Note is secured by the Collateral (as hereinafter defined). The Secured Note carries an original issue discount (“OID”) of $1,000,000 (16.7%). In addition, the Company agreed to pay $15,000 to the Investor to cover the Investor’s legal fees, accounting costs, due diligence, monitoring and other transaction costs incurred in connection with the purchase and sale of the Secured Note (the “Transaction Expense Amount”). In addition to this, a payment of $325,000 was made to Ascendiant Capital Markets, LLC, (the “Commission”) for structuring the agreement between both parties. The Purchase Price for the Secured Note is $4,675,000, computed as follows: $6,015,000 original principal balance, less: OID, Transaction Expense Amount, and commission paid.
The borrowing period is 24 months, and the Company shall pay the outstanding balance and all fees on maturity. A monitoring fee equal to 0.833% of the outstanding balance will automatically be added to the outstanding balance on the first day of each month. The debt less the discount and transaction expenses will be accreted over the term of the Note using the effective interest method.
On April 15, 2020, the Company entered into the Security Agreement by the Company, DDL and TCL, in favor of the Investor (the “Security Agreement”). Pursuant to the terms of the Security Agreement, the Company granted the Investor a first-priority security interest in all rights, title, interest, claims and demands of the Company in and to all of the Company’s patents and all other proprietary rights, and all rights corresponding to the Company’s patents throughout the world, now owned and existing, and all replacements, proceeds, products, and accessions thereof.
NOTE PURCHASE AGREEMENT 2
On February 8, 2021, the Company entered into an additional note purchase agreement (“Note Purchase Agreement 2”) with the Investor. Pursuant to the terms of Note Purchase Agreement 2, the Company agreed to issue and sell to the Investor and the Investor agreed to purchase from the Company, a secured promissory note (“Secured Note 2”) in the original principal amount of $24,015,000. The Secured Note carries an OID of $4,000,000 (16.7%), and the Company agreed to pay $15,000 to the Investor to cover the Investor’s transaction expenses. In addition to this, a Commission of $1,200,000 was also payable to Ascendiant Capital Partners, LLC.
In consideration thereof, on February 9, 2021 (the “closing date”), (i) the Investor paid $20,000,000 in cash to the Company, and (ii) the Company delivered Secured Note 2 on behalf of the Company, to the Investor, against the delivery of the Purchase Price. For these purposes, the “Purchase Price” means the Investor’s initial cash purchase price. After adjusting for transaction expenses of $1,200,000, cash proceeds received were $18,800,000.
The borrowing terms for Note Purchase Agreement 2 are consistent with those of Note Purchase Agreement 1, with the borrowing period being 24 months from the date of the agreement, the Company being required to pay the outstanding balance and all fees on maturity, and a monitoring fee equal to 0.833% of the outstanding balance being automatically added to the outstanding balance on the first day of each month. The debt less discount and transaction expenses will be accreted over the term of the Note using the effective interest rate method.
On February 8, 2021, the Security Agreement established in respect to Note Purchase Agreement 1 was extended to include Note Purchase Agreement 2, which is also secured against all of the Company’s assets owned as of the closing date and extends to any assets acquired at any time that the Company’s obligations under Secured Note 2 are outstanding.
As of June 30, 2021, long-term debt matures as follows:
|Schedule of long term debt|
NOTE 6 – STOCKHOLDERS’ EQUITY
During the three month period ended June 30, 2021, 366,892 warrants were exercised, generating gross proceeds of $2,963,658. There was a total of 1,573,098 warrants outstanding at this date. No other shares were issued during this period.
During the three month period ended June 30, 2020, a total of 393,352 shares were issued, generating gross proceeds of $4,097,083 with associated costs of $122,913. $1,986,038 was received net of ATM financing costs through June 30, 2020 and $1,988,132 was presented as stock subscriptions receivable as of June 30, 2020 and was collected on July 1, 2020.
During the three month period ended June 30, 2020, 394,475 in additional funds. At June 30, 2020 there were 147,637 warrants outstanding.warrants were exercised, generating $
Loss per share
The following table sets forth the computation of basic and diluted loss per share for the periods indicated.
|Schedule of earnings (loss) per share|
|Three months ended June 30,|
|Net loss attributable to common stockholders||(3,343,725||)||(1,100,056||)|
|Weighted average basic and diluted shares outstanding||23,109,897||20,879,446|
|Basic and diluted loss per share:||(0.14||)||(0.05||)|
The Company excludes warrants outstanding, which are anti-dilutive given the Company is in a loss position, from the basic and diluted loss per share calculation.
Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average number of common shares outstanding during the period. For the three month period ended June 30, 2021 warrants to purchase 1,573,098 shares of common stock and a unit purchase option to purchase 9,710 shares of common stock as well as 9,710 warrants were considered anti-dilutive and were excluded from the calculation of diluted loss per share. For the three month period ended June 30, 2020 shares of common stock and a unit purchase option to purchase 9,710 shares of common stock as well as warrants were considered anti-dilutive and were also excluded from the calculation of diluted loss per share.
NOTE 7 – OTHER ITEMS
(a) COVID-19 Pandemic
The outbreak of COVID-19 originating in Wuhan, China, in December 2019 has since rapidly increased its exposure globally. On March 11, 2020, the World Health Organization declared the outbreak a pandemic. We continue to monitor the impact of COVID-19 on our own operations and are working with our employees, suppliers and other stakeholders to mitigate the risks posed by its spread, COVID-19 is not expected to have any long-term detrimental effect on the Company’s success. While key suppliers have not been accessible throughout the whole period of the outbreak, we have been able to be flexible in our priorities and respond favorably to the challenges faced during the outbreak. We have also seen a surge in the uptake of technologies for remote patient monitoring and patient self-monitoring, which potentially enhances the prospects for the Company, its CGM product and its planned digital healthcare offering.
(b) Management consultancy agreements
During the three month period ended June 30, 2021 and 2020, the Company did not issue any restricted common stock to management consultants; the stock based compensation expense during the three month period ended June 30, 2020 of $related to the release of prepayments and accrued expenses.
(c) Investor relations agreements
The Company has entered into contracts with several investor relations specialists to help support the ongoing financing activities of the business.
During the three month periods ended June 30, 2021, and 2020, fees paid to an investor relations company were $122,000 and $21,000, respectively.
(d) Subsequent events
On July 23, 2021, Nemaura Medical Inc. (the “Company”) entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Agent”) pursuant to which the Company may offer and sell from time to time to or through the Agent shares of the Company’s common stock,par value per share (“Common Stock”).
The offer and sale of shares of Common Stock through the Agent will be made pursuant to the Registration Statement on Form S-3 (File No. 333-230535), which was declared effective by the Securities and Exchange Commission (the “SEC”) on April 8, 2019, and a related prospectus supplement filed with the SEC on the date hereof pursuant to which the Company is offering shares of its Common Stock having an aggregate offering price of up to $100,000,000.
Under the ATM Agreement, the Company may offer and sell shares of Common Stock through the Agent by any method deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended, including sales made directly on or through The Nasdaq Capital Market, sales made to or through a market maker other than on an exchange or otherwise, directly to the Agent as principal, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or in any other method permitted by law. If the Company elects to utilize the ATM Agreement, the Agent would be obligated to use commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell such shares in accordance with the Company’s instructions (including as to price, time or size limit or other parameters or conditions the Company may impose). The Company will pay the Agent a commission of 3.0% of the gross sales price of any shares of Common Stock sold under the ATM Agreement. The Company has also provided the Agent with customary indemnification rights and has agreed to reimburse the Agent for certain specified expenses up to $20,000 plus up to $2,500 per quarter while the ATM Agreement remains in effect.
The Company is not obligated to sell, and the Agent is not obligated to buy or sell, any shares of Common Stock under the ATM Agreement. The Company or the Agent may terminate the ATM Agreement by providing notice to the other party. The Company intends to use the net proceeds from any ATM offering for general corporate purposes, which include, but are not limited to, the targeted launch of sugarBEAT® into other European markets outside of the UK; the development of the subscription-based service for the US under the Wellness category that was launched in December 2020; establishing a business-to-consumer offering for a metabolic health program; research and development of our BEAT platform for other, non, CGM purposes, such as Lactate monitoring, as well as potential acquisition of other companies, products or technologies that are complementary to the delivery of our mission. Accordingly, our management will have broad discretion as to the use of the net proceeds from any ATM offering under this agreement.
ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion in conjunction with the Condensed Consolidated Financial Statements and accompanying notes included elsewhere in this Quarterly Report on Form 10-Q. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements. The matters discussed in these forward-looking statements are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from those made, projected or implied in the forward-looking statements. See "Cautionary Statement Concerning Forward-Looking Statements" below, and "Item 1A. Risk Factors" in our Annual Report filed on Form 10-K for the fiscal year ended March 31, 2021, as the same may be updated from time to time, for a discussion of the uncertainties, risks and assumptions associated with these statements
We are a medical technology company developing sugarBEAT®, a non-invasive, affordable, and flexible continuous glucose monitoring system for adjunctive use by persons with diabetes. sugarBEAT® consists of a disposable adhesive skin-patch connected to a rechargeable wireless transmitter that displays glucose readings at regular five minute intervals via a mobile app. sugarBEAT® works by extracting glucose from the skin into a chamber in the patch that is in direct contact with an electrode-based sensor. The transmitter sends the raw data to a mobile app where it is processed by an algorithm and displayed as a glucose reading, with the ability to track and trend the data over days, weeks, and months. While sugarBEAT® requires once per day calibration by the patient using a blood sample obtained by a finger stick, we believe sugarBEAT® will be adopted by non-insulin dependent persons with diabetes alongside insulin-injecting persons with diabetes, who all perform multiple daily finger sticks to manage their disease.
CE approval was granted by the European Notified Body BSI in May 2019, allowing the product to be made available for commercial sale, this approval is subject to an annual review of the underlying ISO 13485 accredited Quality Management System, the accreditation was successfully renewed during November 2020. In conjunction with the UK licensee (DB Ethitronix), the Company commenced a phase 1 launch whereby devices were made available to limited cohorts of users to gauge their feedback so that any fine-tuning could be completed prior to a mass market launch. A larger market launch is expected to commence in the UK in the coming months via the UK licensee, whereby sugarBEAT® will be available via a number of subscription models the exact nature of which is at the discretion of the UK licensee. In order to support the larger launch, the UK licensee placed their initial order with the Company at the end of April 2021, and the Company is currently gearing up production to deliver against this over the coming months. In addition to this a 24 month forecast for expected future orders was also received from the UK licensee to enable the Company to establish future production volume estimates.
In July 2020, Nemaura filed a PMA application with the FDA to use sugarBEAT® as an adjunct to finger prick testing for blood glucose trending. We, along with other applicants, were then informed by the FDA that the approval process was currently subject to delays as a result of the FDA’s Center for Devices and Radiological Health (“CDRH”) being actively engaged in responding to the current pandemic caused by COVID-19 which resulted in staff being reallocated to other approval requests associated with COVID-19. During April 2021 the FDA confirmed that they would recommence their review of the PMA application and this is now ongoing and in-progress.
In addition to this, Nemaura established that proBEATTM which is based on the sugarBEAT® platform, can be classified under the Wellness guidance when it is used according to the FDA Wellness guidance notes, to provide prompts and educate users on factors affecting their blood sugar profiles. Nemaura launched proBEAT™ in the U.S. in December 2020, as part of a diabetes prevention and reversal program branded BEATdiabetes.life. During the quarter ended December 31, 2020, Nemaura licensed a clinically validated weight loss program for the management of diabetes from Healthimation, LLC, which was originally developed at the Joslin Diabetes Center, an affiliate of Harvard Medical School. This program, together with proBEATTM, forms the BEATdiabetes.life program currently being developed for commercialization in the United States.
We believe there are additional applications for sugarBEAT® and the underlying BEAT technology platform, which may include:
|·||a web-server accessible by physicians and diabetes professionals to track the condition remotely, thereby reducing healthcare costs and managing the condition more effectively;|
|·||a complete virtual doctor that monitors a person's vital signs and transmits results via the web;|
|·||other patches using the BEAT technology platform to measure alternative analytes, including lactate, uric acid, lithium and drugs. This would be a step-change in the monitoring of conditions, particularly in the hospital setting. Lactate monitoring is currently used to determine the relative fitness of professional athletes and we completed preliminary studies demonstrating the application of the BEAT technology for continuous lactate monitoring;|
|·||a continuous temperature monitoring system which could have various applications, including use for individuals to monitor their temperature in connection with diagnosis and monitoring of symptoms of novel coronavirus (COVID-19);|
|·||monitoring disease progression in COVID-19 patients using continuous lactate monitoring (CLM).|
During this period of product development, the Company has experienced recurring losses and negative cash flows from operations. As of June 30, 2021, the Company had cash balances of $31,259,753, working capital of $21,646,685, total stockholders' equity of $7,967,399 and an accumulated deficit of $27,188,396. The Company expects to continue to incur losses from operations for the near-term and these losses could be significant as product development, regulatory activities, clinical trials, and other commercial and product development related expenses are incurred.
Management's strategic assessment includes the following potential options:
|·||obtaining further regulatory approval for the sugarBEAT® device in other countries, such as the United States;|
|·||pursuing further capital raising opportunities to support and accelerate the commercialization strategy;|
|·||exploring licensing and collaboration opportunities; and|
|·||developing the sugarBEAT® device platform for commercialization for other applications.|
The outbreak of COVID-19 originating in Wuhan, China, in December 2019 has since rapidly increased its exposure globally. On March 11, 2020, the World Health Organization declared the outbreak a pandemic. We continue to monitor the impact of COVID-19 on our own operations and are working with our employees, suppliers, and other stakeholders to mitigate the risks posed by its spread, COVID-19 is not expected to have any long-term detrimental effect on the Company’s success as while key suppliers have not always been accessible throughout the whole period of the outbreak, we have been able to be flexible in our priorities and respond favorably to the challenges faced during this period. We also recognize that one of the consequences of this pandemic, has been a surge in the uptake of technologies for remote monitoring of patients and patient self-monitoring, which potentially enhances the prospects for the Company, its CGM product and its planned digital healthcare offering.
Results of Operations
Comparative Results for the Three Months Ended June 30, 2021 and 2020
There was no revenue recognized in the three months ended June 30, 2021 and 2020. In 2014, we received an upfront non-refundable cash payment of GBP 1 million (approximately $1.38 million and $1.38 million as of June 30, 2021 and March 31, 2021, respectively) in connection with an Exclusive Marketing Rights Agreement with an unrelated third party that provides the third party (the “UK Licensee”) the exclusive right to market and promote the sugarBEAT® device and related patch under its own brand in the United Kingdom and the Republic of Ireland. We have deferred this licensing revenue until sales are due to commence, and we expect to record the revenue as income over an approximately 10-year term from the date sales commence. Although the revenue has been treated as deferred at June 30, 2021, the cash payment became immediately available and has been used to fund our operations, including research and development costs associated with successfully obtaining the CE mark approval.
During the three month period ended June 30, 2021 the Company received its first order from the UK Licensee in preparation for its own product launch plan, which is anticipated to occur in the quarter ending December 31, 2021. The initial order is scheduled to commence delivery during the quarter ending September 30, 2021, in order to enable the UK Licensee to hold inventory on-hand to support its launch. Under the terms of the contact, the Company was able to issue a ‘deposit’ invoice to cover costs incurred associated with purchases directly incurred to service orders made by the UK Licensee, as such an invoice was raised at the end of the quarter for approximately $513,000. We anticipate that this will be recorded as income upon delivery of the order or in part thereof. As of June 30, 2021, this invoice has been treated as deferred revenue within current liabilities with the debit balance being captured within other receivables, the cash payment for which is anticipated in line with the agreed standard contractual terms.
Research and Development Expenses
Research and development expenses were $288,484 and $315,312 for the three months ended June 30, 2021 and 2020, respectively. This amount consisted primarily of expenditures on wages and sub-contractor activities incurred for improvements made to the sugarBEAT® device. The decrease of $26,828 is largely driven by a reduction in sub-contractor costs as the sugarBEAT® product moves to commercial launch. Moving forward we anticipate that the cost reductions seen in this area will continue as we see a re-balancing across general and administrative expenses driven by the commercial operations of the business become more relevant albeit it is expected that the company will continue to incur expenses in this area in relation to new pipeline products are moved through their respective development phases.
General and Administrative Expenses
General and administrative expenses were $1,332,185 and $595,720 for the three months ended June 30, 2021 and 2020, respectively. These consisted of fees for legal, professional, consultancy, audit services, investor relations, insurance, advertising and wages. The increase in expenses being driven predominantly by increased wages as additional headcount has been added to support the operational scale up process across both our UK and US teams. Increases have also been seen in insurance and advertising costs which are considered to be directly related to the commercialization steps taken during the period.
We anticipate that general and administrative expenses will continue to increase moving forward, as the business transitions to a more operational focused base that will encompass an increase in functions expenses associated with sales, marketing, customer service, as well as enhancements to other existing functions.
Other Comprehensive (Loss) / Income
For the three months ended June 30, 2021 and 2020, other comprehensive (loss) / income was ($10,706) and $4,823, respectively. Currently all transactions recorded through other comprehensive (loss) / income arise from fluctuations in the USD: GBP exchange rate and the impact that this has on consolidation of the Company’s non-USD denominated assets and liabilities.
Liquidity and Capital Resources
We have experienced net losses and negative cash flows from operations since our inception. We have sustained cumulative losses of $27,188,396 through June 30, 2021. We have historically financed our operations through the issuances of equity and contributions of services from related entities. While no shares were issued during the quarter, 366,892 warrants were exercised which provided $2,963,658 of additional funding.
As of June 30, 2021, the Company had net working capital of $21,646,685 which included cash balances of $31,259,753. The Company reported a net loss for the three month period ended June 30, 2021 of $3,343,725. This loss is after taking account of interest and debt accretion charges arising from the note purchase agreements for the three month period ended June 30, 2021 of $1,723,056.
We believe the cash position as of June 30, 2021, is adequate for our current planned level of operations, through at least August 2022, which encompasses the continued establishment of commercial manufacturing operations for the supply of the sugarBEAT® device and patches in relation to our existing licensing agreements, combined with the on-going steps that the Company is taking to identify and attract market growth opportunities elsewhere.
Net cash used in operating activities for the three months ended June 30, 2021 was $1,690,028 which reflected our net loss of $3,343,725, adjusted for the add back of the accretion of debt discount expense of $1,723,056 and depreciation and amortization charge of $36,133. Cash was also impacted by increases in prepayments of $550,211 and inventory of $31,583 as well as reductions in accounts payable ($145,898), related party balances ($256,583), offset by an increase in accruals of $363,052 and deferred revenue of $515,731.
Net cash used in operating activities for the three months ended June 30, 2020 was $1,077,594 which reflected our net loss of $1,100,056, accretion of debt discount $188,579, a decrease in prepaid expenses of $152,438, an increase in accruals of $43,950, non-cash stock-based compensation of $59,000, a decrease in liability due to related parties of $284,453 and a decrease in accounts payable of $103,135.
Net cash used in investing activities was $398,221 for the three months ended June 30, 2021, which reflected patent filing costs of $22,714, the purchase of property and equipment of $82,222 and $293,285 in software development costs.
Net cash used in investing activities was $12,282 for the three months ended June 30, 2020, which reflected patent filing costs of $10,283 and the purchase of property and equipment of $1,999.
Net cash provided by financing activities for the three months ended June 30, 2021 was $1,463,658, comprising $2,963,658 of proceeds from warrants exercised offset by $1,500,000 for the scheduled repayments of notes payable.
Net cash provided by financing activities for the three months ended June 30, 2020 was $6,957,651. The ATM facility delivered proceeds of $2,047,462 and proceeds from issuance of notes totalled $4,943,074 less commission expense of $325,000. In addition, $394,475 was raised in relation to the exercise of 37,933 warrants.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements, including unrecorded derivative instruments that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Critical Accounting Policies
When we prepare our unaudited condensed consolidated financial statements and accompanying notes in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”), we must make estimates and assumptions about future events that affect the amounts we report. Certain of these estimates result from judgements that can be subjective and complex. As a result of that subjectivity and complexity, and because we continuously evaluate these estimates and assumptions based on a variety of factors, actual results could materially differ from our estimates and assumptions if changes in one or more factors require us to make accounting adjustments. We believe our critical accounting policies affect our more significant judgments and estimates used in the preparation of the unaudited condensed consolidated financial statements. During the three months ended June 30, 2021, we have made no material changes or additions with regard to such policies and estimates.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Foreign Exchange Risk
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective in alerting them in a timely manner to material information required to be disclosed in our periodic reports filed with the SEC.
Changes in Internal Control over Financial Reporting
There have been no changes in the Company's internal controls over financial reporting identified in connection with the evaluation required by Rules 13a-15 under the Exchange Act during the first fiscal quarter ended June 30, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
ITEM 1A. RISK FACTORS
There have been no material changes to the risk factors disclosed in the Company’s Annual Report on Form 10-K for the year ended March 31, 2021, filed with the SEC on June 29, 2021.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
ITEM 4. MINE SAFETY DISCLOSURES
ITEM 5. OTHER INFORMATION
ITEM 6. EXHIBITS
The exhibits listed on the Exhibit Index below are filed as part of this report.
|Exhibit No.||Document Description|
|31.1||Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002|
|31.2||Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002|
|32.1||Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002|
|101.INS||XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document|
|101.SCH||Inline XBRL Taxonomy Extension Schema Document|
|101.CAL||Inline XBRL Taxonomy Extension Calculation Linkbase Document|
|101.DEF||Inline XBRL Taxonomy Extension Definition Linkbase Document|
|101.LAB||Inline XBRL Taxonomy Extension Label Linkbase Document.|
|101.PRE||Inline XBRL Taxonomy Extension Definition Linkbase Document|
|104||Cover Page Interactive Data File – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|NEMAURA MEDICAL INC.|
|Date: August 16, 2021||By:||/s/ Dewan F.H. Chowdhury|
Dewan F.H. Chowdhury
Chief Executive Officer and President
(Principal Executive Officer)
|Date: August 16, 2021||By:||/s/ Justin J. Mclarney|
Justin J. Mclarney
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)