Q3 2024 revenues were $9.4 million, up 89% from Q3 2023.  This was an all-time quarterly record for the Company. 

Q3 2024 gross margin was 75.5%, vs 71.5% in Q3 2023

GAAP Operating Income was $2.0 million

Company provides guidance for revenue growth of 40-50% for Q4 2024 versus Q4 2023

EDEN PRAIRIE, MN -- November 8, 2024 -- InvestorsHub NewsWire -- SANUWAVE Health, Inc. (the "Company" or "SANUWAVE") (OTCQB: SNWV), a leading provider of next-generation FDA-approved wound care products, is pleased to provide its financial results for the three months ended September 30, 2024.

Q3 2024 ended September 30, 2024

  • Revenue for the three months ended September 30, 2024, totaled $9.4 million, an increase of 89%, as compared to $5.0 million for the same period of 2023.  This growth is greater than the previously provided guidance for a 65 – 75% increase.
  • 124 UltraMist® systems were sold in Q3 2024 up from 55 in Q3 2023 and from 72 in Q2 2024.
  • UltraMist® consumables revenue increased by 75% to $5.4 million (58% of revenues) in Q3 2024, versus $3.1 million for the same quarter last year. UltraMIST systems and consumables remained the primary revenue growth driver and continued to represent over 97% of SANUWAVE's overall revenues in Q3 2024.
  • Gross margin as a percentage of revenue amounted to 75.5% for the three months ended September 30, 2024, versus 71.5% for the same period last year.
  • For the three months ended September 30, 2024, operating income totaled $2.0 million, an increase of $2.5 million compared to Q3 2023 as a result of the Company's continued efforts to drive profitable growth and manage expenses.
  • Net loss for the third quarter of 2024 was $20.7 million, driven predominantly by the change in the fair value of derivative liabilities.  This compares to a net loss of $23.7 million in the third quarter of 2023.  Net loss year to date was $18.6 million versus a net loss of $44.0 million in the nine months ended September 30, 2023.
  • Adjusted EBITDA [1] for the three months ended September 30, 2024, was $2.1 million versus Adjusted EBITDA of $(0.3) million for the same period last year, an improvement of $2.4 million.  Year to date Adjusted EBITDA was $3.5 million versus a loss of $1.8 million in the prior year period.

"The third quarter showed acceleration in revenue growth rate from the first half of the year with growth of 89% year on year (and 31% sequentially) leading the company to a growth rate of 68% for the first nine months of 2024 as compared to the same period in 2023," said Morgan Frank, CEO.  "Obviously, we're very pleased with these results, especially to have achieved operating income and Adjusted EBITDA positivity again this quarter and, for the first time, became cash generative from operations even after cash interest expense.  We have begun to gain traction with some larger customers and our sales funnel remains the most promising it has ever been.  As we look to the fourth quarter, we will seek to build on this progress as we continue to hire additional sales and commercial staff.  We expect to experience a bit of a 'pigs through a python' scenario for us over the coming months and quarters, as large orders move the needle on revenues in significant and variable fashion, but we anticipate finishing 2024 strongly as a breakout year for SANUWAVE."

Financial Outlook

The Company forecasts Q4 2024 revenue of $9.7 to $10.5 million (40-50% increase from Q4 2023) and therefore for revenues for 2024 as a whole to be in excess of $32 million (an increase of 57% vs full year 2023).  The Company forecasts Q4 gross margin as a percentage of revenue to remain in the mid-70s.

Subsequent to quarter end, the Company effected a 1-for-375 reverse stock split on October 18, 2024, completed its note and warrant exchange, and raised $10.3 million in a private placement, simplifying the Company's capital structure and leaving it with approximately 8.5 million shares outstanding.  Details of this transaction can be found on the SANUWAVE website https://sanuwave.com/investors/press-release-details?newsId=OxzYFl0t620enXp1VyUG or in its filings with the SEC.

As previously announced, a business update will occur via conference call on November 8, 2024 at 8:30 a.m. EST. Materials for the conference call are included on the Company's website at http://www.sanuwave.com/investors

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

Toll Free: 1-800-267-6316

Toll/International: 1-203-518-9783

Conference ID: SANUWAVE

OR click the link for instant telephone access to the event.

https://viavid.webcasts.com/starthere.jsp?ei=1692398&tp_key=e3cff43c54

A replay will be made available through November 29, 2024:

Toll-Free: 1-844-512-2921

Toll/International: 1-412-317-6671

Replay Access ID: 11157276

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

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. 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 (loss) as a measure of financial performance or any other performance measure derived in accordance with U.S. 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 U.S. 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 U.S. 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 U.S. 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 U.S. 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 income (loss).

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 plans for future business development activities. 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 regulatory oversight, the Company's ability to manage its capital resources, competition 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

 

SELECTED FINANCIAL DATA

FOR THE QUARTERS ENDED SEPTEMBER 30, 2024 AND 2023

(in thousands)

 

 

2024

 

2023

 

 

 

 

 

 

Revenue

 

 

$           9,360  

 

$           4,953  

            Cost of Revenues

 

 

             2,293  

 

             1,412  

 

 

 

 

 

 

Gross Margin

 

 

             7,067  

 

             3,541  

            Gross Margin %

 

 

75.5 %

 

71.5 %

 

 

 

 

 

 

            Total operating expenses

 

 

             5,114  

 

             4,072  

Operating Income (Loss)

 

 

$           1,953  

 

$           (531) 

 

 

 

 

 

 

Total other expense

 

 

              (22,610) 

 

              (23,169) 

 

 

 

 

 

 

Net Income (Loss)

 

 

$            (20,657) 

 

$            (23,700) 

 

NON-GAAP ADJUSTED EBITDA

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

(in thousands)

2024

 

2023

 

2024

 

2023

 

 

 

 

 

 

 

 

Net Income/(Loss)

$                  (20,657)

 

$                  (23,700)

 

$                  (18,624)

 

$                  (44,042)

Non-GAAP Adjustments:

 

 

 

 

 

 

 

Interest expense

              3,661

 

              3,845

 

              11,004

 

              12,504

Depreciation and amortization

             256

 

             266

 

             736

 

             780

EBITDA

                    (16,740)

 

                    (19,589)

 

             (6,884)

 

                    (30,758)

 

 

 

 

 

 

 

 

Non-GAAP Adjustments for Adjusted EBITDA:

 

 

 

 

 

 

 

Change in fair value of derivative liabilities

              18,849

 

              19,325

 

              17,633

 

              29,943

Other non-cash or non-recurring charges:

 

 

 

 

 

 

 

Gain on extinguishment of debt

                             -

 

                             -

 

             (5,205)

 

                             -

Severance agreement and legal settlement

                             -

 

                             -

 

             585

 

                             -

Release of historical accrued expenses

                             -

 

                             -

 

              (579)

 

              (1,250)

Shares for services

                             -

 

                             -

 

                             -

 

             224

License and option agreement

                             -

 

                             -

 

             (2,500)

 

                             -

Prepaid legal fees expensed from termination of Merger Agreement

                             -

 

                             -

 

             457

 

                             -

Adjusted EBITDA

$            2,109

 

$            (264)

 

$            3,507

 

$            (1,841)

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

September 30, 2024

 

December 31, 2023

ASSETS

 

 

 

Current Assets:

 

 

 

Cash and cash equivalent

$           3,259

 

$           1,797

Accounts receivable, net of allowance of $1,056 and $1,237, respectively

             2,836

 

             3,314

Inventory

             3,431

 

             2,951

Prepaid expenses and other current assets

                           378

 

             1,722

Total Current Assets

             9,904

 

             9,784

Non-Current Assets:

 

 

 

Property, equipment and other, net

                           774

 

                           938

Intangible assets, net

             3,906

 

             4,434

Goodwill

             7,260

 

             7,260

Total Non-current Assets

              11,940

 

              12,632

 

 

 

 

Total Assets

$            21,844

 

$            22,416

 

 

 

 

LIABILITIES

 

 

 

Current Liabilities:

 

 

 

Senior secured debt, in default

$            24,426

 

$            18,278

Convertible promissory notes payable

             4,817

 

             5,404

Convertible promissory notes payable, related parties

             2,838

 

             1,705

Asset-backed secured promissory notes payable

                             —

 

             3,117

Asset-backed secured promissory notes, related parties

                             —

 

             1,458

Promissory note payable, related party

                           500

 

                           -

Accounts payable

             4,137

 

             5,705

Accrued expenses

             5,241

 

             5,999

Factoring liabilities

             1,938

 

             1,490

Warrant liability

              35,509

 

              14,447

Accrued interest

                           643

 

             5,444

Accrued interest, related parties

                           952

 

                           669

Current portion of contract liabilities

                           137

 

                             92

Other

                           375

 

                           947

Total Current Liabilities

              81,513

 

              64,755

Non-current Liabilities

 

 

 

Lease liabilities, less current portion

                           236

 

                           492

Contract liabilities, less current portion

                           358

 

                           347

Total Non-current Liabilities

                           594

 

                           839

 

 

 

 

Total Liabilities

$            82,107

 

$            65,594

 

 

 

 

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 authorized; no shares issued and outstanding at September 30, 2024 and December 31, 2023

$                         -

 

$                         -

Common stock, par value $0.001, 2,500,000,000 shares authorized; 3,150,062 and 3,041,492 issued and outstanding at September 30, 2024 and December 31, 2023, respectively *

                           3

 

                           3

Additional paid-in capital

              178,397

 

              176,979

Accumulated deficit

             (238,673)

 

             (220,049)

Accumulated other comprehensive income (loss)

                             10

 

              (111)

Total Stockholders' Deficit

              (60,263)

 

              (43,178)

Total Liabilities and Stockholders' Deficit

$            21,844

 

$            22,416

 

 

 

 

* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands, except share data)

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

2024

 

2023

 

2024

 

2023

 

 

 

 

 

 

 

 

Revenue

$           9,360

 

$           4,953

 

$                 22,308

 

$                 13,404

Cost of Revenues

             2,293

 

             1,412

 

             5,799

 

             3,876

 

 

 

 

 

 

 

 

Gross Margin

             7,067

 

             3,541

 

                  16,509

 

             9,528

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

General and administrative

             2,545

 

             2,681

 

             8,059

 

             6,678

Selling and marketing

             2,202

 

             1,039

 

             4,468

 

             3,430

Research and development

              161

 

              165

 

              519

 

              436

Depreciation and amortization

              206

 

              187

 

              568

 

              563

Total Operating Expenses

             5,114

 

             4,072

 

                  13,614

 

                  11,107

 

 

 

 

 

 

 

 

Operating Income (Loss)

             1,953

 

              (531)

 

             2,895

 

                  (1,579)

 

 

 

 

 

 

 

 

Other Income (Expense):

 

 

 

 

 

 

 

Interest expense

                  (3,315)

 

                  (2,907)

 

                  (9,948)

 

                 (10,125)

Interest expense, related party

              (346)

 

              (938)

 

                  (1,056)

 

                  (2,379)

Gain on extinguishment of debt

              —

 

              -

 

             5,205

 

              -

Change in fair value of derivative liabilities

                 (18,849)

 

                 (19,325)

 

                 (17,633)

 

                 (29,943)

Other expense

              (106)

 

              -

 

             (893)

 

              (16)

Other income

              6

 

              1

 

             2,806

 

              -

Total Other Expense

                 (22,610)

 

                 (23,169)

 

                 (21,519)

 

                 (42,463)

 

 

 

 

 

 

 

 

Net Loss

                 (20,657)

 

                 (23,700)

 

                 (18,624)

 

                 (44,042)

 

 

 

 

 

 

 

 

Other Comprehensive Loss

 

 

 

 

 

 

 

Foreign currency translation adjustments

              —

 

              7

 

              121

 

              (6)

Total Comprehensive Loss

$               (20,657)

 

$               (23,693)

 

$               (18,503)

 

$               (44,048)

 

 

 

 

 

 

 

 

Net Loss per share:

 

 

 

 

 

 

 

   Basic and Diluted *

$           (6.49)

 

$           (9.95)

 

$                  (5.92)

 

$                 (24.15)

Weighted average shares outstanding:

 

 

 

 

 

 

 

   Basic and Diluted *

             3,185

 

             2,381

 

             3,146

 

             1,823

* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024

 

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT

(In thousands, except share data)

Three Months Ended September 30, 2024

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Number of Shares

 Issued and Outstanding

 

Par Value

 

Additional Paid-

in Capital

 

Accumulated

Deficit

 

Accumulated Other Comprehensive

Loss

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of June 30, 2024

 

3,150,062

 

$                  3

 

$                  178,397

 

$               (218,016)

 

$                                   10

 

$               (39,606)

Net loss

 

-

 

                    -

 

                              -

 

                  (20,657)

 

                                       -

 

                (20,657)

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of September 30, 2024

 

3,150,062

 

$                  3

 

$                  178,397

 

$               (238,673)

 

$                                   10

 

$               (60,263)

 

Three Months Ended September 30, 2023

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Number of Shares

Issued and Outstanding

 

Par Value

 

Additional Paid-

in Capital

 

Accumulated Deficit

 

Accumulated Other Comprehensive

Loss

 

 Total

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of June 30, 2023

 

1,497,700

 

$                  2

 

$                  153,824

 

$               (214,584)

 

$                                  (80)

 

$               (60,838)

Shares issued for settlement of debt

 

1,238,509

 

                    1

 

                      18,576

 

                           -

 

                                       -

 

$                18,577

Foreign currency translation adjustment

 

-

 

                    -

 

                              -

 

                           -

 

                                      7

 

$           7

Net loss

 

-

 

                    -

 

                              -

 

                  (23,700)

 

                                       -

 

$               (23,700)

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of September 30, 2023

 

2,736,209

 

$                  3

 

$                  172,400

 

$               (238,284)

 

$                                  (73)

 

$               (65,954)

* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024
 

Nine Months Ended September 30,

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Number of Shares

 Issued and Outstanding

 

Par Value

 

Additional Paid-

in Capital

 

Accumulated

Deficit

 

Accumulated Other Comprehensive

Loss

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of December 31, 2023

 

3,041,492

 

$                  3

 

$                  176,979

 

$               (220,049)

 

$                                (111)

 

$               (43,178)

Shares issued for settlement of warrants

 

14,440

 

                    -

 

                             6

 

                           -

 

                                       -

 

             6

Shares issued for settlement of debt

 

94,130

 

                    -

 

                       1,412

 

                           -

 

                                       -

 

             1,412

Foreign currency translation adjustment

 

-

 

                    -

 

                              -

 

                           -

 

                                   121

 

              121

Net loss

 

-

 

                    -

 

                              -

 

                  (18,624)

 

                                       -

 

                (18,624)

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of September 30, 2024

 

3,150,062

 

$                  3

 

$                  178,397

 

$               (238,673)

 

$                                   10

 

$               (60,263)

 

Nine Months Ended September 30, 2023

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

Number of Shares

Issued and Outstanding

 

Par Value

 

Additional Paid-

in Capital

 

Accumulated Deficit

 

Accumulated Other Comprehensive

Loss

 

 Total

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of December 31, 2022

 

1,463,300

 

$                  1

 

$                  153,298

 

$               (194,242)

 

$                                  (67)

 

$               (41,010)

Shares issued for services

 

34,400

 

                    1

 

                          526

 

                           -

 

                                       -

 

              527

Shares issued for settlement of debt

 

1,238,509

 

                    1

 

                      18,576

 

                           -

 

                                       -

 

$                18,577

Foreign currency translation adjustment

 

-

 

                    -

 

                              -

 

                           -

 

                                     (6)

 

              (6)

Net loss

 

-

 

                    -

 

                              -

 

                  (44,042)

 

                                       -

 

                (44,042)

 

 

 

 

 

 

 

 

 

 

 

 

 

Balances as of September 30, 2023

 

2,736,209

 

$                  3

 

$                  172,400

 

$               (238,284)

 

$                                  (73)

 

$               (65,954)


* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

Nine Months Ended September 30,

 

2024

 

2023

Cash Flows - Operating Activities:

 

 

 

Net Loss

$                  (18,624)

 

$                  (44,042)

Adjustments to reconcile net loss to net cash used by operating activities

 

 

 

Depreciation and amortization

              736

 

              780

Bad debt expense

                           16

 

              547

Shares issued for services

                              -

 

              224

Gain on extinguishment of debt

              (5,205)

 

                              -

Change in fair value of derivative liabilities

              17,633

 

              29,943

Amortization of debt issuance costs and original issue discount

              4,792

 

              5,656

Accrued interest

              2,749

 

              5,529

Changes in operating assets and liabilities

 

 

 

Accounts receivable

                           66

 

              253

Inventory

              (480)

 

              (844)

Prepaid expenses and other assets

              225

 

              (487)

Accounts payable

              (1,013)

 

              464

Accrued expenses

              763

 

              (1,326)

Contract liabilities

                           56

 

                           50

Net Cash Provided by (Used in) Operating Activities

              1,714

 

              (3,253)

 

 

 

 

Cash Flows - Investing Activities

 

 

 

Proceeds from sale of property and equipment

                              -

 

                           13

Purchase of property and equipment

              (254)

 

              (169)

Net Cash Flows Used in Investing Activities

              (254)

 

              (156)

 

 

 

 

Cash Flows - Financing Activities

 

 

 

Proceeds from convertible promissory notes

                              -

 

              1,202

Payment of note payable

              (2,175)

 

                              -

Proceeds from convertible notes payable

              1,300

 

                              -

Proceeds from promissory note payable, related party

              500

 

                              -

Proceeds from bridge notes advance

                              -

 

              2,994

Proceeds (Payments) from factoring, net

              449

 

              (710)

Payments of principal on finance leases

              (193)

 

              (130)

Net Cash Flow (Used in) Provided by Financing Activities

              (119)

 

              3,356

 

 

 

 

Effect of Exchange Rates on Cash

              121

 

                            (5)

 

 

 

 

Net Change in Cash During Period

              1,462

 

              (58)

 

 

 

 

Cash at Beginning of Period

              1,797

 

              1,153

Cash at End of Period

$            3,259

 

$            1,095

 

 

 

 

Supplemental Information:

 

 

 

Cash paid for interest

$            3,189

 

$            984

Non-cash Investing and Financing Activities:

 

 

 

Shares issued for settlement of debt

              1,412

 

                              -

Write off deferred merger costs

              1,226

 

                              -

Warrants issued in conjunction with convertible promissory notes

              3,633

 

              570

Conversion of convertible notes payable to common stock

                              -

 

              18,577

Capitalize default interest into senior secured debt

              3,850

 

                              -

Conversion of asset-based secured promissory notes to convertible promissory notes

              4,584

 

                              -

Embedded conversion feature on convertible promissory notes payable

                              -

 

              (520)

Common shares issued for advisory shares

                              -

 

              302

 

 

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