EDEN PRAIRIE, MN – (NewMediaWire) – November 10, 2023 – 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 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.
● 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 31st, 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.”
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.
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
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,|
|Depreciation and amortization||266||235||780||681|
|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|
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.
This is a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” and the reconciliations in this release for further information.