NanoVibronix Reports Third Quarter 2021 Financial Results

Rhea-AI Summary

NanoVibronix, Inc. (NASDAQ: NAOV) reported significant growth in its third quarter 2021, with revenues of $499,000, a 233% increase year-over-year. The company introduced a new CBD gel for pain management and expanded into the workers' compensation market. A backlog of orders exceeds $600,000, indicating strong sales momentum. Despite a net loss of $6.7 million, the balance sheet remains robust with $8.6 million in cash and no long-term debt. Future catalysts include new product launches and expanding markets.

Positive

• Revenue increased by 233% year-over-year to $499,000.
• Backlog of orders exceeds $600,000, indicating strong future sales.
• Introduced new CBD gel product, expanding treatment options.
• Strong balance sheet with $8.6 million in cash and no debt.

Negative

• Net loss of $6.7 million, an increase from a loss of $922,000 the previous quarter.
• Gross profit margin decreased to 46% from 66% due to rising manufacturing costs.

Momentum Continues with Solid Execution of Product Commercialization Strategy

ELMSFORD, N.Y.--(BUSINESS WIRE)-- NanoVibronix, Inc. (NASDAQ: NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today reported its financial results for the quarter ended September 30, 2021.

Third Quarter Financial and Business Highlights

• Revenue of $499,000, an increase of 233% compared to the prior year period
• Introduced CBD gel for topical treatment of pain and in combination with PainShield, to product line-up
• Expanded total addressable market with entry into worker's compensation market through agreement with one of the largest national payers
• Backlog of orders in excess of $600,000 as of September 30, 2021
• Balance sheet remains strong with $8.6 million in cash and $0 long-term debt as of September 30, 2021

“We are increasingly encouraged by the progress we believe we are making towards broad adoption and commercialization of our products,” stated Brian Murphy, CEO of NanoVibronix. “As of September 30, we had a backlog of orders that exceeded this quarter’s revenue, a telling metric that demonstrates growing sales throughput of our product and revenue to be recognized in the future. Looking beyond year end, we have commitments to deliver a more significant quantity of product than ever before and an improved contract manufacturing position that we expect will enable a significant increase in product delivery through the first quarter of 2022.

“Potential near term catalysts for our business include the recent launch of our first non-prescription device, PainShield Relief, for the mass consumer market, adoption of UroShield by the National Healthcare Service (NHS) in the U.K., expanded sales distribution as we enter the Canadian and Middle Eastern markets and increasing adoption of our products through our existing distributor network and finalizing CMS reimbursement for PainShield and UroShield, all of which we believe are advancing towards effectiveness later this year and early in 2022,” Murphy added.

Murphy continued, “Given the current macro environment, we are working diligently to strengthen and optimize our inventory position by exploring additional componentry sources and manufacturing alternatives. In doing so, we are also identifying opportunities to rationalize our cost of goods and potentially improve unit economics on future sales as our business scales.”

Murphy concluded, “Our balance sheet remains strong with $8.6 million in cash on hand and zero debt at the end of the third quarter. We are in a solid position to fund our growth and continue to advance our products towards full commercialization.”

Third Quarter 2021 Financial Summary

Revenues were $499,000 for the third quarter of 2021, up 233% compared with $150,000 for the third quarter of 2020. The increase was primarily due to increased sales of PainShield devices as a result of new distribution agreements, including one new distributor that sells product to Veterans Administration (VA) facilities.

Gross profit was $228,000, or 46% of revenue, in the third quarter of 2021 compared with $99,000, or 66% of revenue, in the 2020 period. The increase in gross profit was primarily driven by higher sales while the decline in gross profit margin was the result of increased costs of manufacturing and shipping compared to last year.

Total operating expenses were $1.1 million in the third quarter of 2021 compared with $903,000 in the prior year period. The 10.7% increase was the result of an increase in general and administrative expense, primarily professional fees related to the company’s special shareholder meeting and the addition of two new employees in the 2021 period compared to the prior year period.

Net loss was $6.7 million, or $(0.26) per basic and diluted share, compared with a net loss of $922,000 or $(0.10) per basic and diluted share for the previous quarter. Third quarter 2021 results include a change in fair value of derivative liabilities resulting in a non-cash loss of $5.7 million.

About NanoVibronix, Inc.

NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s primary products include PainShield® and UroShield®, which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) the geographic, social and economic impact of COVID-19 on the Company’s ability to conduct its business and raise capital in the future when needed, (ii) market acceptance of our existing and new products or lengthy product delays in key markets; (iii) negative or unreliable clinical trial results; (iv) inability to secure regulatory approvals for the sale of our products; (v) intense competition in the medical device industry from much larger, multinational companies; (vi) product liability claims; (vii) product malfunctions; (viii) our limited manufacturing capabilities and reliance on subcontractor assistance; (ix) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (x) our ability to successfully obtain and maintain intellectual property protection covering our products; (xi) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xii) our reliance on single suppliers for certain product components, (xiii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiv) our conducting business in foreign jurisdictions exposing us to additional challenges, such as foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xv) market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at: http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

NanoVibronix, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(Amounts in thousands, except share and per share data)
		September 30, 2021				December 31, 2020
ASSETS:
Current assets:
Cash and cash equivalents		$	8,599			$	7,142
Restricted cash			-				391
Trade receivables			28				25
Other accounts receivable and prepaid expenses			597				267
Inventory			201				145
Total current assets			9,425				7,970
Non-current assets:
Fixed assets, net			6				4
Other assets			16				25
Severance pay fund			199				199
Operating lease right-of-use assets, net			20				31
Total non-current assets			241				259
Total assets		$	9,666			$	8,229
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Trade payables		$	62			$	144
Other accounts payable and accrued expenses			194				488
Shares issued in excess of authorized			-				2,257
Operating lease liabilities - current			10				13
Total current liabilities			266				2,902
Non-current liabilities:
Accrued severance pay		$	243				245
Deferred licensing income			165				199
Deferred revenue			271				-
Derivative liabilities			-				2,471
Operating lease liabilities, non-current			10				18
Total liabilities			955				5,835
Commitments and contingencies (Note 9)
Stockholders’ equity:
Series C Preferred stock of $0.001 par value - Authorized: 3,000,000 shares at September 30, 2021 and December 31, 2020; Issued and outstanding: 666,667 at September 30, 2021 and December 31, 2020			1				1
Series D Preferred stock of $0.001 par value - Authorized: 506 shares at September 30, 2021 and December 31, 2020; Issued and outstanding: 153 at September 30, 2021 and December 31, 2020			-				-
Series E Preferred stock of $0.001 par value - Authorized: 1,999,494 shares at September 30, 2021 and December 31, 2020, respectively; Issued and outstanding: 0 at September 30, 2021 and 875,000 at December 31, 2020			1				1
Common stock of $0.001 par value - Authorized: 40,000,000 shares at September 30, 2021 and 24,109,634 at December 31, 2020; Issued and outstanding: 27,178,126 and 21,246,523 shares at September 30, 2021 and December 31, 2020, respectively			27				22
Additional paid in capital			63,086				44,959
Accumulated other comprehensive income			59				66
Accumulated deficit			(54,463	)			(42,655	)
Total stockholders’ equity			8,711				2,394
Total liabilities and stockholders’ equity		$	9,666			$	8,229

NanoVibronix, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
(Amounts in thousands except share and per share data)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2021				2020				2021				2020
Revenues		$	499			$	150			$	920			$	533
Cost of revenues			271				51				407				345
Gross profit			228				99				513				188
Operating expenses:
Research and development			50				68				178				131
Selling and marketing			245				289				852				723
General and administrative			801				546				2,656				2,513
Total operating expenses			1,096				903				3,686				3,367
Loss from operations			(868	)			(804	)			(3,173	)			(3,179	)
Interest expense			-				(123	)			-				(123	)
Financial income (expense), net			(23	)			(15	)			(29	)			(25	)
Change in fair value of derivative liabilities			(5,714	)			-				(6,956	)			-
Gain on purchase of warrants			-				-				64				-
Warrant modification expense			-				-				(1,627	)			-
Loss before taxes on income			(6,605	)			(942	)			(11,721	)			(3,327	)
Income tax benefit / (expense)			(70	)			20				(87	)			7
Net loss		$	(6,675	)		$	(922	)		$	(11,808	)		$	(3,320	)
Basic and diluted net loss available for holders of common stock, Series C Preferred Stock and Series D Preferred Stock		$	(0.26	)		$	(0.10	)		$	(0.47	)		$	(0.43	)
Weighted average common shares outstanding:
Basic and diluted			26,096,957				9,344,254				25,014,919				7,649,242
Comprehensive loss:
Net loss available to common stockholders			(6,675	)			(922	)			(11,808	)			(3,320
Change in foreign currency translation adjustments			1				-				(7	)			-
Comprehensive loss available to common stockholders			(6,674	)			(922	)			(11,815	)			(3,320	)

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211116005528/en/

Investor Contact:



Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What were NanoVibronix's Q3 2021 earnings results?

NanoVibronix reported revenues of $499,000 for Q3 2021, a 233% increase year-over-year, with a net loss of $6.7 million.

What is the total backlog of orders for NanoVibronix as of September 30, 2021?

The total backlog of orders for NanoVibronix exceeds $600,000 as of September 30, 2021.

What new products did NanoVibronix introduce in Q3 2021?

NanoVibronix introduced a CBD gel for topical pain treatment and launched the PainShield Relief device for the mass consumer market.

How did NanoVibronix's financial position change in Q3 2021?

The company's cash position remained strong at $8.6 million, with no long-term debt reported.

What are NanoVibronix's future growth catalysts?

Future catalysts include product launches, market expansions, and potential CMS reimbursement for current products.