SANUWAVE Announces Q3 2023 Financial Results

SANUWAVE Health, Inc.

EDEN PRAIRIE, MN,, Nov. 10, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – SANUWAVE Health, Inc. (the “Company” or “SANUWAVE”) (OTCQB: SNWV), a leading provider of next-generation FDA-approved wound care products, today announced its 3rd quarter 2023 results.

For the three months ended September 30, 2023:

• Revenue for the three months ended September 30, 2023 totaled $5.0 million, an increase of 19%, as compared to $4.2 million for the same period of 2022. This growth falls within the previously provided guidance range of an approximately 15 to 25% increase for Q3 2023 as compared to Q3 2022. Revenue for the nine months ended September 30, 2023 totaled $13.4 million, an increase of 19%, as compared to $11.2 million for the same period of 2022.

• 55 UltraMist® systems were sold in Q3 2023, up from 28 in Q1 2023 and 49 in Q2 2023.

• UltraMist® consumables revenue increased by 24% to $3.1 million, versus $2.5 million for the same quarter last year and constituted 62% of overall revenues in the three months ended September 30, 2023. UltraMIST systems and consumables remained the primary revenue growth driver and represented in excess of 90% of SANUWAVE’s overall revenues in Q3.

• Gross margin as a percentage of revenue amounted to 71% for the three months ended September 30, 2023, vs 72% for the same period last year. For the nine-months ended September 30, 2023, gross margins amounted to 71% vs. 72% for the same period last year.

• For the three months ended September 30, 2023, operating loss totaled $0.5 million, which is an improvement of $2.0 million compared to the same period in 2022 as a result of the Company’s efforts to drive profitable growth and manage expenses during 2023.

• Net loss for the three months ended September 30, 2023 was $23.7 million, compared to a net loss of $1.1 million for the same period in 2022. Net loss for the three months ended September 30, 2023 was primarily due to continued non-cash losses on the fair value of derivative liabilities.

• Adjusted EBITDA loss^[1] for the three months ended September 30, 2023 was $0.3 million versus a loss of $2.2 million for the same period last year, an improvement of $1.9 million.

Recent Highlights:

• In July 2023, the Company issued Asset-Backed Secured Promissory Notes for which it received total proceeds of approximately $3.0 million.

• SANUWAVE Health entered into an Agreement and Plan of Merger with Sweat Equity Partners and Mercury Life Sciences-affiliated SEP Acquisition Corp., a Nasdaq-listed company, in August 2023. Upon closing, subject to the satisfaction of the agreed upon closing conditions, the combined company is expected to trade on the Nasdaq Capital Market under the symbol “SNWV”.

• On July 31^st, Sanuwave hired industry veteran Andrew Walko as President and head of UltraMist manufacturing.

• SANUWAVE showcased its innovative non-invasive, regenerative medicine solutions for the treatment of chronic wounds at the Symposium on Advanced Wound Care in Las Vegas.

“Q3 2023 was a quarter of acceleration at Sanuwave and one in which our manufacturing constraints began to be eliminated.  August and September saw large production upticks from July, and as our production bottlenecks are put behind us, we are now gearing up for the next stage of increasing our sales force and sales reach, exploring some promising new sales models, and beginning to engage with larger customers that had previously been beyond our reach as we had lacked the capacity to serve them,” said CEO Morgan Frank. “We will continue to focus on rapid, profitable growth, and we believe our planned increase in production capacity to 2-3 times the level of 2023 will set us up for 2024 to be a transformational year at the Company.”

Guidance

The Company anticipates Q4 2023 revenue will increase approximately 15% to 25% as compared to Q4 2022.

As previously announced, a business update will occur via conference call today at 8:00 a.m. ET.  Materials for the conference call are included on the Company’s website, www.sanuwave.com/investors.

Telephone access is available by dialing the following numbers:

Conference ID:  13742652

Telephone access to the call will be available by dialing the following numbers:

Participant Listening: 1-877-407-0784 or 1-201-689-8560

OR click the Call me™ link for instant telephone access to the event.

https://callme.viavid.com/viavid/?callme=true&passcode=13732361&h=true&info=company&r=true&B=6

A replay will be made available through November 24, 2023:

Replay Dial-In: 1-844-512-2921 or 1-412-317-6671

Access ID: 13742652

About SANUWAVE

SANUWAVE Health is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

SANUWAVE’s end-to-end wound care portfolio of regenerative medicine products and product candidates helps restore the body’s normal healing processes. SANUWAVE applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.

Non-GAAP Financial Measures

This press release includes certain financial measures that are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S.) (“U.S. GAAP”). These financial measures are considered "non-GAAP financial measures" and are intended to supplement, and should not be considered as superior to, or a replacement for, financial measures presented in accordance with U.S. GAAP.

The Company uses Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) and Adjusted EBITDA to assess its operating performance. Adjusted EBITDA is Earnings before Interest, Taxes, Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or infrequent charges.  EBITDA and Adjusted EBITDA should not be considered as alternatives to net income as a measure of financial performance or any other performance measure derived in accordance with GAAP, and they should not be construed as an inference that the Company’s future results will be unaffected by unusual or infrequent items. These non-GAAP financial measures are presented in a consistent manner for each period, unless otherwise disclosed. The Company uses these measures for the purpose of evaluating its historical and prospective financial performance, as well as its performance relative to competitors. These measures also help the Company to make operational and strategic decisions. The Company believes that providing this information to investors, in addition to GAAP measures, allows them to see the Company’s results through the eyes of management, and to better understand its historical and future financial performance. These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when considered alongside other GAAP measures.

EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of the Company’s results as reported under GAAP. Some of these limitations are that EBITDA and Adjusted EBITDA:

• Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments.

• Do not reflect all changes in our working capital needs.

• Do not reflect interest expense, or the amount necessary to service our outstanding debt.

As presented in the GAAP to Non-GAAP Reconciliations section below, the Company’s non-GAAP financial measures exclude the impact of certain charges that contribute to our net loss.

		Three months ended September 30,								Nine months ended September 30,
(in thousands)			2023				2022				2023				2022
Net (Loss)/Income		$	(23,700	)		$	(1,139	)		$	(44,042	)		$	(4,596	)
Non-GAAP Adjustments:
	Interest expense		3,845				3,821				12,504				9,972
	Depreciation and amortization		266				235				780				681
EBITDA			(19,589	)			2,917				(30,758	)			6,057
Non-GAAP Adjustments for Adjusted EBITDA:
	Change in fair value of derivative liabilities		19,325				(5,252	)			29,943				(16,597	)
	Other non-cash or one-time charges:
	Release of historical accrued employee compensation expenses		-				-				(1,250	)			-
	Shares for Services		-				-				224				888
	Loss on issuance of debt		-				-				-				3,434
	Loss on extinguishment of debt		-				86				-				297
Adjusted EBITDA		$	(264	)		$	(2,249	)		$	(1,841	)		$	(5,921	)

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, production expectations and constraints, plans for future business development activities and the Company’s proposed business combination with SEP Acquisition Corp. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s  products, supply chain and production constraints, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, the Company’s ability to consummate the proposed business combination with SEP Acquisition Corp. and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

CONTACT:
Investors@Sanuwave.com

^[1] This is a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” and the reconciliations in this release for further information.

PART I -- FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
		SANUWAVE HEALTH, INC. AND SUBSIDIARIES
		CONDENSED CONSOLIDATED BALANCE SHEETS
		(UNAUDITED)
		(In thousands, except share data)
					September 30, 2023				December 31, 2022
ASSETS
Current Assets:
	Cash				$	1,095			$	1,153
	Accounts receivable, net of allowance of $1,247 and $1,037, respectively					3,231				4,029
	Inventory					1,713				868
	Prepaid expenses and other current assets					1,355				570
Total Current Assets						7,394				6,620
	Property, equipment and other, net					1,079				856
	Intangible assets, net					4,609				5,137
	Goodwill					7,260				7,260
Total Non-current Assets						12,948				13,253
Total Assets					$	20,342			$	19,873
LIABILITIES
Current Liabilities:
	Senior secured debt, in default				$	17,645			$	14,416
	Convertible promissory notes payable					7,553				16,713
	Convertible promissory notes payable, related parties					2,495				7,409
	Asset-backed secured promissory notes					6,576				-
	Asset-backed secured promissory notes, related parties					3,094				-
	Accounts payable					4,623				4,400
	Accrued expenses					6,359				8,512
	Factoring liabilities					1,814				2,130
	Warrant liability					28,106				1,416
	Accrued interest					5,369				4,052
	Accrued interest, related parties					729				788
	Current portion of contract liabilities					68				60
	Other					1,003				291
Total Current Liabilities						85,434				60,187
Non-current Liabilities
	Lease liabilities					550				438
	Contract liabilities					284				230
	Deferred tax liability					28				28
Total Non-currrent Liabilities						862				696
Total Liabilities					$	86,296			$	60,883
Commitments and Contingencies (Footnote 13)
STOCKHOLDERS' DEFICIT
Preferred Stock, par value $0.001, 5,000,000 shares authorized;
	6,175 shares Series A, 293 shares Series B, 90 shares Series C and 8 shares Series D				$	-			$	-
	no shares issued and outstanding at September 30, 2023 and December 31, 2022
Common stock, par value $0.001, 2,500,000,000 shares authorized; 1,026,078,464 and 548,737,651
	issued and outstanding at September 30, 2023 and December 31, 2022, respectively					1,026				549
Additional paid-in capital						171,377				152,750
Accumulated deficit						(238,284	)			(194,242	)
Accumulated other comprehensive loss						(73	)			(67	)
Total Stockholders' Deficit						(65,954	)			(41,010	)
Total Liabilities and Stockholders' Deficit					$	20,342			$	19,873
The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.

SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)/INCOME
(UNAUDITED)
(In thousands, except share data)
			Three Months Ended september 30,								Nine Months Ended September 30,
				2023				2022				2023				2022
Revenue			$	4,953			$	4,166			$	13,404			$	11,242
Cost of Revenues				1,412				1,157				3,876				3,141
Gross Margin				3,541				3,009				9,528				8,101
Operating Expenses:
	General and administrative			2,681				3,498				6,678				9,484
	Selling and marketing			1,039				1,650				3,430				5,037
	Research and development			165				157				436				494
	Depreciation and amortization			187				189				563				575
Total Operating Expenses				4,072				5,494				11,107				15,590
Operating Loss				(531	)			(2,485	)			(1,579	)			(7,489	)
Other (Expense)/Income:
	Interest expense			(2,907	)			(3,382	)			(10,125	)			(9,421	)
	Interest expense, related party			(938	)			(439	)			(2,379	)			(551	)
	Change in fair value of derivative liabilities			(19,325	)			5,252				(29,943	)			16,597
	Loss on issuance of debt			-				-				-				(3,434	)
	Loss on extinguishment of debt			-				(86	)			-				(297	)
	Other (expense) income			1				1				(16	)			(1	)
Total Other (Expense)/Income				(23,169	)			1,346				(42,463	)			2,893
Net Loss before Income Taxes				(23,700	)			(1,139	)			(44,042	)			(4,596	)
Provision for Income Taxes				-				-				-				-
Net Loss				(23,700	)			(1,139	)			(44,042	)			(4,596	)
Other Comprehensive Loss
	Foreign currency translation adjustments			7				-				(6	)			6
Total Comprehensive Loss			$	(23,693	)		$	(1,139	)		$	(44,048	)		$	(4,590	)
Loss per Share:
	Basic and diluted		$	(0.03	)		$	(0.00	)		$	(0.06	)		$	(0.01	)
Weighted average shares outstanding
	Basic and diluted			892,956,020				561,069,625				683,771,214				542,484,779
The accompanying notes to condensed consolidated financial
statements are an integral part of these financial statements.

	SANUWAVE HEALTH, INC. AND SUBSIDIARIES
	CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT
	(UNAUDITED)
	(In thousands, except share data)
Three Months Ended September 30, 2023
				Common Stock
				Number of												Accumulated
				Shares												Other
				Issued and					Additional Paid-			Accumulated				Comprehensive
				Outstanding		Par Value			in Capital			Deficit				Loss				Total
Balances as of June 30, 2023				561,637,651		$	562		$	153,264		$	(214,584	)		$	(80	)		$	(60,838	)
	Shares issued for settlement of debt			464,440,813			464			18,113			-				-				18,577
	Net loss			-			-	-		-			(23,700	)			-				(23,700	)
	Foreign currency translation adjustment			-			-			-			-				7				7
Balances as of September 30, 2023				1,026,078,464		$	1,026		$	171,377		$	(238,284	)		$	(73	)		$	(65,954	)
Three Months Ended September 30, 2022
				Common Stock
				Number of												Accumulated
				Shares												Other
				Issued and					Additional Paid-			Accumulated				Comprehensive
				Outstanding		Par Value			in Capital			Deficit				Loss				Total
Balances as of June 30, 2022				529,293,205		$	529		$	151,409		$	(187,406	)		$	(67	)		$	(35,535	)
	Shares issued for settlement of debt and warrants			19,444,446			20			1,341			-				-				1,361
	Net loss			-			-	-		-			(1,139	)	-		-				(1,139	)
Balances as of September 30, 2022				548,737,651		$	549		$	152,750		$	(188,545	)		$	(67	)		$	(35,313	)
	The accompanying notes to condensed consolidated financial
	statements are an integral part of these financial statements.
	SANUWAVE HEALTH, INC. AND SUBSIDIARIES
	CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT
	(UNAUDITED)
	(In thousands, except share data)
Nine Months Ended September 30, 2023
				Common Stock
				Number of												Accumulated
				Shares												Other
				Issued and					Additional Paid-			Accumulated				Comprehensive
				Outstanding		Par Value			in Capital			Deficit				Loss				Total
Balances as of December 31, 2022				548,737,651		$	549		$	152,750		$	(194,242	)		$	(67	)		$	(41,010	)
	Shares issued for services			12,900,000			13			514			-				-				527
	Shares issued for settlement of debt			464,440,813			464			18,113			-				-				18,577
	Net loss			-			-			-			(44,042	)			-				(44,042	)
	Foreign currency translation adjustment			-			-			-			-				(6	)			(6	)
Balances as of September 30, 2023				1,026,078,464		$	1,026		$	171,377		$	(238,284	)		$	(73	)		$	(65,954	)
Nine Months Ended September 30, 2022
				Common Stock
				Number of												Accumulated
				Shares												Other
				Issued and					Additional Paid-			Accumulated				Comprehensive
				Outstanding		Par Value			in Capital			Deficit				Loss				Total
Balances as of December 31, 2021				481,619,621		$	482		$	144,582		$	(183,949	)		$	(73	)		$	(38,958	)
	Cashless warrant exercise			14,000,000			14			2,152			-				-				2,166
	Warrant exercise			909,091			1			99			-				-				100
	Shares issued in conjunction with Note Payable			20,666,993			20			3,700			-				-				3,720
	Shares issued for settlement of debt and warrants			19,444,446			20			1,341			-				-				1,361
	Shsares issued for services			12,097,500			12			876			-				-				888
	Net loss			-			-			-			(4,596	)			-				(4,596	)
	Foreign currency translation adjustment			-			-			-			-				6				6
Balances as of September 30, 2022				548,737,651		$	549		$	152,750		$	(188,545	)		$	(67	)		$	(35,313	)

	SANUWAVE HEALTH, INC. AND SUBSIDIARIES
	CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
	(UNAUDITED)
	(In thousands)
			Nine Months Ended September 30,
				2023				2022
Cash Flows - Operating Activities:
Net loss			$	(44,042	)		$	(4,596	)
Adjustments to reconcile net loss to net cash used by operating activities
	Depreciation and amortization			780				681
	Bad debt expense			547				62
	Shares issued for services			224				888
	Change in fair value of derivative liabilities			29,943				(16,597	)
	Loss on extinguishment of debt			-				297
	Loss on issuance of debt			-				3,434
	Amortization of debt issuance costs and original issue discount			5,656				2,998
	Accrued interest			5,529				2,004
	Gain on sale of property and equipment, net			-				51
	Changes in operating assets and liabilities
	Accounts receivable - trade			253				69
	Inventory			(844	)			178
	Prepaid expenses and other assets			(487	)			(656	)
	Accounts payable			464				(1,693	)
	Accrued expenses			(1,326	)			(202	)
	Contract liabilities			50				(94	)
Net Cash Used in Operating Activities				(3,253	)			(13,176	)
Cash Flows - Investing Activities
	Proceeds from sale of property and equipment			13				1,022
	Purchase of property and equipment			(169	)			-
Net Cash Flows (Used in)/Provided by Investing Activities				(156	)			1,022
Cash Flows - Financing Activities
	Proceeds from senior promissory notes			-				2,940
	Proceeds from convertible promissory notes payable			1,202				12,366
	Proceeds from bridge notes payable			2,994				640
	Payments to factoring agent, net			(710	)			(227	)
	Proceeds from warrant exercises			-				100
	Payments of principal on finance leases			(130	)			(174	)
	Payments of principal on convertible promissory notes and SBA loans			-				(2,981	)
Net Cash Flows Provided by Financing Activities				3,356				12,664
Effect of Exchange Rates on Cash				(5	)			(17	)
Net Change in Cash and Restricted Cash During Period				(58	)			493
Cash and Restricted Cash at Beginning of Period				1,153				619
Cash and Restricted Cash at End of Period			$	1,095			$	1,112
Supplemental Information:
	Cash paid for interest		$	984			$	3,345
Non-cash Investing and Financing Activities:
	Warrants issued in conjunction with senior secured promissory note payable and convertible promissory notes payable		$	570			$	4,117
	Conversion of convertible notes payable to common stock			18,577				-
	Common shares issued for advisory shares			302				-
	Embedded conversion feature on convertible promissory notes payable and bridge notes payable			(520	)			2,309
	Reclassification of warrant liability due to cashless warrant exercise			-				2,166
	Working capital balances refinanced into convertible notes payable							2,273
	Settlement of debt and warrants with stock							1,361
	Common shares issued in conjunction with senior secured promissory note payable			-				3,720
	The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.