Sanuwave Health Inc

Good day, everyone, and welcome to today's Samuel Wave earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star, then the 1 key on your telephone keypad. You may withdraw yourself from the queue by pressing the star 2 key. Please note, today's conference is being recorded. I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Morgan Frank, Chairman and CEO of Sanyu Wave.

Thank you, Margo. Good morning, everyone. Welcome to Sanyu Wave's fourth quarter and full year 2024 earnings call. Our Form 10-K was filed with the SEC last night. Our earnings release was issued this morning, and our updated presentation was made available on the website in our investor section. You can please refer to that during the presentation. Joining me on this call is Peter Sorensen, our CFO, and after the presentation, we'll open the call up to Q&A. So let me begin with the obligatory forward-looking statements. This call may contain forward-looking statements, such as statements relating to future financial results and production expectations and plans for future business development activities. Investors are cautioned that any such forward-looking statements are not guaranteed to future performance and involve risks and uncertainties, many of which are beyond the company's ability to control. Description of these risks and uncertainties and other factors that could affect our financial results is included in our SEC filings, and actual results may differ materially from those projected in the forward-looking statements. The company undertakes no obligation to update any forward-looking statements. Okay. As a reminder today, our discussion will include non-GAAP numbers. Reconciliations between our GAAP and our non-GAAP results can be found in our recently filed 10-K for the year ended December 31st, 2024. Okay, with that out of the way, let's get to good stuff. So last conference call, we spoke about pigs and pythons and how engaging with larger and more sophisticated customers who were capable of purchasing large boluses of products and having profound effect on our quarterly numbers was going to be one of the key characteristics of our revenue stream going forward. Q3, as I think many of you noticed, was definitely a pig quarter. Q4 gives us a chance to look at what a non-lumpy, sort of non-pegged quarter looks like, as we had no outsized orders in the quarter, nor any customers exceeding 7% of sales. We're pleased to come in around the high end of our quarterly guidance and slightly above our guidance for the full year, and have set yet another record revenue for revenue and systems in the quarter. Breaking into eight figures at 10.3 million was a meaningful milestone for the company, And it was the result of strong growth in both our systems and our consumables. We sold 135 Ultima systems in the quarter, outpacing even the 124 Pig quarter from Q3 and far exceeding the 79 that we placed in Q4 of 2023. That's 71% growth in systems sold year over year. We ended 2024 with 1,047 systems in the field, up from 647 at the end of 2023. Applicator sales in Q4 were $5.9 million, up 68% from Q4 2023, and up 11% sequentially from Q3. They constituted 58% of our overall revenue in the quarter, in line with our 55% to 65% target for consumable sales, and we're really excited to be performing on model there and with reasonable predictability. Benefits from scale, new manufacturing agreements, and from price discipline have resulted in increased gross margins that have reached 77.9% in the quarter. This extra margin and our focus on cost controls led to expansion in operating and adjusted EBITDA margins for the quarter, and the company was, the second quarter in a row, cash-generative from operations, even after making its cash interest payments. So the last several months have really been a pivotal time for Sanyu Wave, and what has come to be internally referred to as shock and awe Friday, last October 18th, represented a major step in simplifying our cap structure by exchanging our convertible notes and warrants, rationalizing our share price through a reverse split, strengthening our balance sheet with a $10.3 million pipe transaction. We paid off some of our noncompliant debt. We also paid down a $2.8 million revenue factoring facility to zero by the end of Q4. This set the stage for the company to uplift NASDAQ, which occurred on March 7th of this year and represents a major step toward our long-cherished goal of becoming a company that can be valued for the quality of its business instead of the complexities of its cap structure. So now to walk you through some further financials and to help you assess this alleged quality of our business, I will hand you over to Peter Sorensen, our CFO.

Again, achieving 10% sequential growth from last quarter's previous record, as well as strong year-over-year growth at 47%. In addition to top-line expansion, we also saw continued improvement in gross margins both year-over-year and sequentially, reinforcing the strength of our business model. We continue to execute on our goal of rapid, profitable growth. With that, let's take a closer look at the numbers. Revenue for the three months ended December 31st, 2024 totaled $10.3 million, an increase of 47% as compared to $7 million for the same period of 2023. This growth is in line with our previous guidance of 40 to 50%. Gross margin as a percentage of revenue amounted to 77.9% for the three months ended December 31st, 2024 versus 69.1% for the same period last year. For the three months ended December 31st, 2024, Operating income totaled $2.5 million, which is an improvement of $1.5 million compared to the same period last year, which aligns with our continued initiative to drive towards profitable growth and managed spend effectively. Operating expenses for the three months ended December 31st, 2024 amounted to $5.5 million compared to $3.8 million for the same period last year, an increase of $1.7 million. This change was largely driven by an increase in non-cash expense of stock comp of $1.5 million as we granted stock options to our employees and board of directors for the first time in over six years. Net loss for the three months ended December 31st, 2024 was $12.7 million compared to net income of $18.2 million for the same period in 2023. The decrease in net income was primarily due to a change in the fair value of derivative liabilities, which was a $20.3 million gain in 2023 versus a $13.3 million loss in 2024. Most of the derivative tail wagging should be behind us in future quarters as part of the note and warrant exchange that Morgan alluded to that we completed in Q4 2024. EBITDA for the three months ended December 31st, 2024 was negative $9.7 million. However, adjusted EBITDA for the three months ended December 31st, 2024 was a positive $3.7 million versus $0.7 million for the same period last year, an improvement of $3 million year over year. We'd like to take a moment to walk through the bridge from EBITDA to adjusted EBITDA this quarter, particularly to highlight several non-cash infrequent items related to cap table restructuring and cleanup activities completed in October 2024. First, consistent with our historical practice, we adjusted EBITDA for the non-cash change and fair value derivative liabilities, primarily related to the quarterly valuation of warrants. This adjustment reflects the impact of warrants that were exchanged for common stock in October. Additionally, we adjusted for a non-cash gain recognized from the conversion of principal and interest associated with our convertible notes, which were also exchanged for common stock. The gain resulted from our stock price being below the note conversion price at the time of exchange, $12 per share versus the $15 issuance price. We further adjusted EBITDA for legal settlement and severance expense, totaling $156,000 during the fourth quarter. And finally, we adjusted EBITDA to exclude stock-based compensation, which is a non-cash expense, This adjustment was partially offset by the release of certain historical accruals following our Board of Directors' decision to remove their previously accrued cash compensation. Going forward, the Board of Directors' compensation will be paid in stock options as opposed to cash. As previously discussed with our operating expenses, we are pleased to be able to grant stock options to our employees and Board of Directors in Q4 for the first time in over six years. A detailed reconciliation and further breakdown of adjusted EVA that can be found in our recently filed 10-K and accompanying press release. We remain focused on executing our financial strategy, driving operational profitability, and maintaining disciplined management of operating expenses. Total current assets amounted to $18.4 million as of December 31st, 2024, versus $9.8 million as of December 31st, 2023. Cash totaled $10.2 million as of December 31st, 2024. We appreciate the continuous support of Staneway through this transformative past year and look forward to building on this momentum in 2025. With that, I'll turn the call back over to Morgan.

Thanks, Peter. So moving on to guidance, as you likely saw in our press release, we're guiding to $8.4 to $9 million in revenue for Q1, which would represent 45% to 55% growth from Q1 of 2024. Q1 is always a somewhat seasonally slower period. for medical device, including both systems and consumables as both budgets reset and sort of customer deductibles. We're expecting a slightly smaller drop on a percentage basis versus Q4 than the drop that occurred in Q1 of 2024 as compared to Q4 of 2023. But alas, Q1 seasonality remains a fact of life and lifestyle. For the year, we're initiating guidance of 48 to 50 million in revenues, representing a 50% year-on-year growth rate, plus or minus 3%. We feel good about our opportunity, about our sales funnel, and about our sales and productions teams and their ability to generate and meet demand. I mean, it's sort of wild to me. It's already been 22 months for me here as CEO. I guess time flies when you're having fun. And it really does seem like we're getting the good part here. I just want to reemphasize that none of this just happens. Companies exist downstream of their culture, and I could not be more proud or grateful to the team at Sandy Wave. And as ever, our highest reward for good work is more work. So we keep at it, and we look forward to speaking to you again soon about our further progress. And with that, let's open the call up to questions. Margo, if you could begin to give them up.

Thank you very much. At this time, if you'd like to ask a question, please press the star 1 on your telephone keypad. You may remove yourself from the queue at any time by pressing star 2. And once again, that is star 1 for a question. We'll take our first question from Chris Flam with Tall Pines Capital. Please go ahead.

Thanks, guys. Great year. I noticed you hired a new salesman.

Good morning.

Good morning. I noticed you guys hired a new head of sales back in January. Can you walk us through what's changing versus last year and how it's going so far? Sure.

Yeah, good question. So we started 2024 with two salespeople. We ended the year with nine. And we will likely end Q3 also with about nine. But three of them will be different than the nine that we ended Q4 with. Ultimately, sort of the change in strategy is reflective of kind of our change in the perception of the best way to sell and market this product. Like we have moved to a deeper, more sort of consultative sale where we're going past sort of the easy economics of engaging with customers and trying to find ways to build long-term partnerships where we are built into their treatment plans, their therapy plans, even their patient enrollment guidelines. And so, this takes a different kind of sale. It tends to come more from the top down. We're starting to engage with, because we've discussed, some substantially larger customers. And so we've changed the sales force and the head of sales as a way to reflect that. We're really excited about hiring Tim Wern. He is, I'm not sure if you're aware, he's the, so Tim was the number two for our board member, Jeff Blizzard, when Jeff was the head of sales at Hobby of Med. And so, you know, these are sort of the two guys that took that company from, you know, $15 million to $400 million. And so, you know, he came highly recommended, and we're really excited to get the band back together again with those two.

Great. Thanks.

And our next question comes from Carl Burns with Northland Capital Markets. Please go ahead. Thanks for the question, and congratulations on the quarter and the progress.

Hey, Charles, good morning. Okay. Thanks. Good morning to you as well. You noted in your prepared comments that no customer represented more than 7% of revenue. And I'm wondering with the 135 ultra-miss placements or installs in the fourth quarter, how you might characterize these placements with respect to, you know, large multi-order enterprise-type accounts or small kind of, you know, one-two system order accounts. And the same with respect to your outlook for 2025 placements. And this is obviously as you move to a larger customer focus. Thanks.

So the answer to that question gets a little bit complex. We certainly sold a number of ones and twos in the quarter. We were excited to see a substantial number of new customers in the quarter. We're also excited to see some of our existing customers growing their businesses substantially. We had one significant size customer in the quarter come back and order, I believe, almost 20 systems. So, you know, it's going to be a mix. And I think, you know, as we sort of think about planning for our base business, you know, we're assuming sort of an ongoing pace of smaller sales, of ongoing uptake from our existing customers. And we're sort of looking at the really big potential sales that might be out there as upside. It's still early for us in terms of getting the grips with exactly how some of these bigger customers are going to want to roll out, whether they want to do things all at once, whether they want to do things on a more measured pace. And so I think it's difficult to give too, too much guidance about that. But What we are gearing up for internally is to be able to take yes for an answer in a situation like that where we're trying to build up our inventory of systems quite substantially. We're currently manufacturing Ultramus systems at a pace of about 25 a week, and we're working – We're working to be able to double that on 60 days of notice. That's sort of the challenge I've given to the ops team is if we need to double that, let's be able to do it in 60 days, and I think we're starting to get close to being ready to do that. Or at least able to do that is probably a better way to describe that.

Great. Thanks. That's very helpful. And, you know, with respect to the larger customers, I mean, with, you know, essentially – you know, 20 plus placement orders. Is there any way that you can manage that so there's not, you know, lumpy scenarios in any particular quarter?

Well, I mean, I guess I'm not entirely sure what you mean by manage it just from a standpoint of, you know, if somebody wants to put, getting systems in the field is obviously our goal and systems in the field generate consumables. And so, you know, from our standpoint, you know, we're always sort of excited to do that earlier and, you know, to get, to get more patients under care. So I think, you know, there's, it is going to continue to be like when we, when we give guidance, I think we sort of like to talk about what we think the base rate of the business likely is. And, you know, this is what we plan to, you know, you don't want to build your business on the assumption that, you know, there's going to be a, there's going to be a pig for the Python every quarter, but, I think when they come, we want to be able to move with them quite rapidly.

I've got it. That totally makes sense. Thanks so much, and congrats again. Thanks.

Thank you. And we'll next go to Ian Castle with IFCM. Please go ahead.

Hi, Martin. Hey, Ian. Good morning. Good morning. Thanks. I was wondering if you could provide some color on advancing additional kind of confirmatory studies and also maybe perhaps new studies. to potentially open up more use cases for Ultramist?

Yeah, sure. It's a good question. I guess we're looking at it a couple of ways. Obviously, with the company now on sort of sounder financial footing, it's great to be able to start to think about these things again. We've started some more concerted outreach with, some of our KOLs with some of the researchers who have done some studies in the past. I think we'll – a couple of our customers have some very significant repositories of data. And so I think a couple of – at least one or two will likely have papers, posters at SAWC this year. One I know of that has an – that actually has an interesting new – application of the product. I don't want to get into too much detail and steal their thunder, but we're excited about that. As we go back and look, you know, but those obviously would tend to be retrospective data analyses. I think as we go forward and say, okay, what, you know, what prospective studies would we want to do going forward? You know, there are a number that have been interesting to us, particularly several that were done in the past showed really promising results, but that were simply underpowered. We had some study, we had a study in, it's up on our website, we had a study in 2015 on the split thickness donor sites that result from skin grafts. And despite only having 27 people in the study, it hit statistical significance on time to re-epithelialization, first time to no drainage, and very nearly hit STAT-SIG on wound recurrence at six weeks. And that's a big deal because these split-thickness wounds are really painful and they have a nasty tendency to come back. The recurrence rate at six weeks under standard of care was 45%. And the recurrence rate at six weeks under Ultramis was 8%. And so, you know, to only kind of hit up 06 p-value there was, I mean, it's disappointing, but I think it really was just a fun meet. If we can replicate that with a larger study size that is sufficiently powered, you know, that seems like a really interesting application. And I think that, you know, there are a number of other places we could take that sort of idea forward. Recurrence rates are a big cost. They're a big fear in things like diabetic foot ulcers. There are lots of places where it stands to reason that we could have a useful effect on recurrence rates. I think getting into the clinic and trying to validate it could get pretty interesting. So stay tuned on that. I think over the next quarter or two, we should start to get some concrete plans in motion.

Great to hear. Thanks for the call, Eric.

Thank you, and at this time, we have no further questions. I'd like to turn the call back over to Morgan Frank for any final or closing remarks.

Well, thank you, guys. I appreciate everyone attending this morning, and have a great Friday.

Thank you, and ladies and gentlemen, that does conclude today's program. Thank you for your participation. You may disconnect at any time.