5/13/2026

speaker
Nikki
Operator

Please stand by, your meeting is about to begin. Hello and welcome everyone joining today's Sanyo 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. To register to ask a question at any time, please press star 1 on your telephone keypad. Please note this call is being recorded. We are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Morgan Frank, Chairman and CEO of SaniWave. Please go ahead.

speaker
Morgan Frank
Chairman & CEO

Morgan Frank, Chairman & CEO, SaniWave Thank you, Nikki. Welcome to SaniWave's first quarter 2026 earnings call. Our Form 10-Q was filed with the SEC last night. along with our earnings release and our updated presentation was made available on our website in the investor section. Please refer to that during the presentation. Joining me on the call is Peter Sorensen, our CFO, and after the presentation, we will open up for Q&A. So let's begin with the forward-looking statements and disclosures. This call may contain forward-looking statements, such as statements relating to future financial results, production expectations, plans for future business development activities, and expectations regarding the impact of changes in reimbursement levels and tariff rates. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involves certain 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. Actual results may differ materially from those projected in the forward-looking statements, The company undertakes no obligation to update any forward-looking statement. Certain percentages discussed in this call are calculated from the underlying whole dollar amounts and therefore may not recalculate from the rounded numbers used for disclosure purposes. As a reminder, our discussion today will include non-GAAP numbers. Reconciliations between our GAAP and non-GAAP results can be found in our recently filed 10-Q for the period of March 31st, 2026. Okay, so... As we mentioned in our press release, Q1 basically started out with sort of a shock pause in January in which the whole advanced wound care market seemed to sort of lock up for a moment and basically freeze solid. It was pretty dramatic. And in essence, it seemed like a great many market participants were not expecting the new CMS pricing for skin subs to actually be applied. And you were confident in some sort of kind of 11th hour rescission or modification. Obviously, this did not come. So it took the market a little time to come to terms with this, but at least from where we sit, it seems to have started doing so in February and we saw improvement all quarter with each month being better than the one before. So despite a very slow first 30 days and some ongoing elevated churn rates due to financial stress at practitioners, the company sold 97 systems in Q1 and our active systems number rose to $1,382 up from $1,292 at year end. A quick reminder on our methodology here. Active systems is a measure of systems owned by customers who have ordered applicators in the trailing six months or according to a specific schedule in a few corner cases. This figure includes churn, customer loss, customer reactivation, which is to say churn customers who began ordering again, new customer acquisitions of machines, and then sell through out of resellers while netting out sales into reseller inventory. So because channel inventory obviously are not systems that are in use. So the goal here is to give you as good a sense as we can of how many systems are actually being used in the field. So essentially, this change in active systems number is a flow number, and it's just showing you the number of systems in the market whose owners are actively ordering. Net change in active systems during Q1 was plus 90. This increase and a bit of recovery in usage rates from some existing customers drove Q1 to an all-time record in applicator unit sales. This did not translate into an all-time record for applicator revenues, owing predominantly to a greater quantity of sales going through resellers who buy at wholesale price This trend was accentuated by the transition of a couple of our longstanding distributors becoming resellers, and therefore the customers they serve moving to wholesale pricing from what was previously retail with commission paid on the back end. This worked out pretty similarly for us on the operating line, but obviously that does affect revenues and ASPs, so there was a bit of a step function there. but one that's also behind us. We take this record unit volume as a good sign for the market. And after some suppression over the last six or seven months, a sign that patient counts are starting to trend better again. Many have asked about a number of markets for us and sort of where our current focus lies. So we remain committed to serving all of advanced wound care and are expanding our presence in hospitals, wound centers, physicians' offices, and in particular, we're seeing a lot of renewed interest in long-term care and nursing facilities seeking to perform their own wound care. The hospitals are showing a particular strength as well. But we're also seeing some meaningful and encouraging progress in mobile wound, a space that a number of folks seem to have had a lot of questions and concerns about. So there seems to be a misconception that mobile wound is going away or would need to be de-emphasized. From where we sit, we simply don't believe this to be the case. As with the market as a whole, the patients and the wounds there are not going away, and most of them are neither interested in nor, in many cases, capable of sort of jumping up and heading to a wound center. The care-to-the-edge philosophy of CMS remains very much alive, and mobile wound care will remain an important part of that. But like a lot of this industry, mobile wound care is changing because the needs of the market have changed. We're seeing sort of a reevaluation and a consolidation. CMS and MAC standards for documentation have tightened. This is selecting for more sophisticated providers. This issue is compounded by the expense of the significant back office staff that's required to run a mobile wound care system properly. that takes scale and revenues dropping from mobile wound as a result of lower allograft reimbursement models that once worked, you know, these models can no longer support themselves. So the new reality is that you need enough revenue to cover the back office nut and you need a high enough root density so that you can cover the expense of practitioners. And that's driving consolidation. Like you just, you need more revenue and more patients per practitioner. So, I mean, look, I'm making these numbers up, but, if you have 30 patients being covered by 10 mobile wound care companies, you know, now perhaps you're going to need, you know, now perhaps you're going to have those 30 covered by five or maybe even three companies. Like the patient count stays the same, but the market adapts. So in many ways, this is favorable to SanuWave, you know, both because Ultramist remains such an effective treatment modality that generates strong clinical outcomes. And, you know, for SanuWave as a company, because, you know, Working with a smaller number of larger, more sophisticated companies is actually easier for us. And this allows us to provide more engagement and more individual attention. The one place we have some concern is rural, where the patients are far apart and the pay rates are often paradoxically lower. So pay rate in rural areas gets indexed to the low local wages. And so the reward for 90 minutes of windshield time to reach a patient in an underserved community with no other healthcare options, often lower payout. And something's going to need to give around that. We suspect that a re-indexing or a payment for travel time may be required and that the payer system has a great deal of incentive to figure this out because, I mean, honestly, the cost of not treating these wounds would rapidly swell to many multiples of any cost to provide care. So, you know, overall, the market freeze seems to be beginning to thaw out, and we expect this ice to sort of break up further as we get temporally further from the aggressive CMS Skintub audits and clawbacks of claims made in Q4, which have been freezing capital budgets as providers sort of played cautious until they're sure they're not going to face large recoupments. We've been seeing some more movement there. We've been seeing a lot more movement around requests and inquiries, but sales cycles do still remain a bit extended. We expect this to improve as customer clarity into their own finances improves. As we mentioned in the past, we had a very successful SAWC in April, and we really started to sense that the question in the industry is shifting from, you know, is the sky falling to, you know, so what now? And an increasing, you know, move to thoughts of kind of more holistic and unified patient care, the development of more rigorous wound care protocols, and a general focus on Evidence-based medicine, all of which we see as incrementally very positive developments that will be beneficial to Sandy Wave in the long run. With that, I'll now turn you over to Peter Sorensen, our CFO, who can walk you through the quarter's financials.

speaker
Peter Sorensen
CFO

Thank you, Morgan. We deliver the highest Q1 revenues in company history, surpassing last year's previous record by 3%. We're encouraged by consumable utilization, which grew 22% year-over-year and 4% sequentially from Q4 2025. Before turning to the financials in more detail, I want to provide an update on the sales tax issue as discussed in the 10-K and our prior call. We've entered into voluntary disclosure agreements with almost all the applicable states. The benefits of these VDAs are limiting the look-back period of potential tax exposure and abating potential penalties in some states. We continue to push forward in this process at full speed and have made meaningful progress in our remediation activities with our third-party tax advisors. With that, let's take a closer look at the financial results for the quarter. Revenue for the three months ended March 31, 2026, totaled $9.6 million, an increase of 3%, as compared to $9.3 million for the same period of 2025. This growth was on the low end of our guidance for the quarter of 3% to 10%. Growth margin as a percentage of revenue for the three months ended March 31, 2026, came in at 77.3%, a decrease of 177 basis points year-over-year, driven by a decrease in pricing on Ultramus system and applicators, resulting from wholesale pricing to resellers. For the three months ended March 31, 2026, operating loss totaled $1.1 million, which is a $1.7 million swing compared to the same period last year, which had operating income of $0.6 million. Operating expenses for the three months ended March 31, 2026 amounted to $8.6 million compared to $6.8 million for the same period last year, an increase of $1.8 million. The change in operating expenses was driven by several key factors. Non-cash stock-based compensation increased by $380,000. Payroll-related headcount expenses were $384,000 higher in Q1 compared to Q1 2025 due to increased headcounts. And R&D non-personnel expenses increased by $346,000, reflecting investments in ongoing product development initiatives. We also had non-incurring expenses of about $300,000 in restatement work on the 10-K from tax, legal, and audit fees in Q1 2026. Sales and marketing costs increased about $400,000 year-over-year as well to support increased outreach of Ultramus. Despite these expense increases, we remain focused on discipline cost management and expect operating leverage to improve as revenue scales throughout the year. Net loss for the three months ended March 31, 2026 with $1.4 million compared to net loss of $6.1 million for the same period in 2025, an improvement of $4.7 million. The improvement was primarily attributable to the $4.9 million non-cash loss and the change in fair value of derivative liabilities that did not recur in Q1, 2026. Interest expense was also $1.4 million lower year over year, primarily reflecting the senior debt refinancing with JP Morgan at the end of Q3, 2025. EBITDA for the three months ended March 31, 2026 with negative $0.6 million. Adjusted EBITDA was positive $1.1 million versus $2.3 million for the same period last year. The year-over-year decline reflects planned investments and headcount R&D and commercial expansion. Total current assets amounted to $24 million as of March 31, 2026 versus $24.6 million as of December 31, 2025. Cash and cash equivalents totaled $10.8 million as of March 31st, 2026. We're grateful for the continued trust and support of our stakeholders. Q1 of 26 was a record start to the year for SanuWave, with all-time Q1 revenue, continued mementos in consumable utilization, and growing traction across our commercial channels. As we move through the balance of 2026, we remain focused on operational discipline, expanding adoption of Ultramist, and positioning SanuWave for sustained, profitable growth. With that, I'll turn the call back over to Morgan.

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