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Sanuwave Health - Q4 2023

March 22, 2024

Transcript

Operator (participant)

Today's call will be recorded, and 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 SANUWAVE. Please go ahead.

Morgan Frank (Chairman and CEO)

Thanks very much. Welcome everyone to SANUWAVE's Fourth Quarter and Fiscal 2023 Earnings Call. Our Form 10-K was filed with the SEC last night. Our earnings release was issued this morning, and the updated presentation to go along with this call was made available on our website in the investor section. You can refer to that presentation during the call. Joining me on this call is Toni Rinow, our CFO, and after the presentation, we will open the call up to question and answer. First, let me begin with the always scintillating forward-looking statements disclaimer. This call may contain forward-looking statements, such as statements relating to future financial results, production expectations and constraints, plans for future business development activities.

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. 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. 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-K for 2023. Okay, so with that out of the way, Q4 was another busy and productive quarter for SANUWAVE, and we continued our progress from Q3 on business model development, management, and manufacturing.

Q4 was the first quarter in which the company was not limited by production and inventory constraints, and we now find ourselves with product on hand. This enabled 27% year-over-year earnings growth, up against what had previously been the best quarter in the company's history, and 40% growth versus the third quarter. In Q4, the company emphasized strong price discipline and did not engage in year-end sales or promotions, as had been, as had been common in prior years. As a result, and in spite of taking some pretty significant charges to cost of goods sold, our operating profitability and the positive adjusted EBITDA were achieved this quarter. The UltraMIST systems sold were up 44% from Q3, and another 19 were placed into the rent-to-own program that we discussed last quarter.

This took total placements for the quarter up to 98 versus 55 from Q3, and total active systems to a somewhat ominous 666 at end of year versus 581 at the end of Q3. This number would have been higher, but one of our customers adopting the RTO program had previously been renting systems from us, and so they were sort of a net wash on total active systems. Overall, UltraMIST revenues rose 77% sequentially in Q3. Of the 79 - I'm sorry, systems revenues rose 77% sequentially from Q3. Of the 79 systems sold in the quarter, 47% were sold to new customers, continuing our trend of expanding our user base.

This higher system count and better pricing for applicators led to a 16% sequential growth in applicators revenue, which amounted to 51% of overall revenues in the quarter. Down a bit as an overall percentage from previous quarters, but this was predominantly because our systems revenue is up so much, so we're actually pretty pleased by that outcome. We're also pleased to view this largely recurring applicator sales as the core business of our company. Like, this is really what we're focused on, and, and to our mind, it's a very simple equation. The number of active systems in the field, times the number of applicators per case used per system per week, times the price per case is applicator revenue. And so those are the three variables that we really manage to.

You know, we're starting to do very well on growing the active system count, which was up 14% sequentially, and we've become much more disciplined on pricing. The one that really moves the needle is applicators used per active system, and this is going to be our big focus for 2024. In pursuit of this, we are seeking to both learn from and teach our customers, sharing best practices and processes from our network to help them identify and treat patients. We're also looking to focus our sales efforts in high usage environments and, you know, physician practices that see a lot of patients.

A practice that's become possible as the alleviation of production constraints has given us the manufacturing capacity and the inventory to start engaging with much bigger customers from whom we were simply not in a position to take yes for an answer from previously. This makes us optimistic about 2024 as the breakout year for SANUWAVE, and we are gearing up accordingly. We brought three new salespeople on board in March, and we've been expanding our commercial ops and clinical training teams to support growth as we come to balance expansion against our goals of rapid, profitable growth. I'll now turn this over to Toni to walk you through the numbers. Toni?

Toni Rinow (CFO)

Thank you, Morgan. Revenue for the three months ended December 31st, 2023, totaled $7 million, an increase of 27% as compared to $5.5 million for the same period of 2022. This growth is slightly higher than the previous guidance range of 20%-24%. Revenue for fiscal year 2023, ended December 31st, totaled $20.4 million, an increase of 22% as compared to $16.7 million for the same period of 2022. Gross margin as a percentage of revenue amounted to 69.1% for the three months ended December 31st, 2023, versus 78.1% for the same period last year.

For fiscal year 2023, gross margin amounted to 70.4% versus 74.1% for fiscal year 2022, mainly driven by non-recurring inventory write-offs and some ramp-up expenses to support greater production. Operating expenses for the three months ended December 31st, 2023, operating income totaled $1 million, which is an improvement of $2.5 million compared to the same period last year, which aligns with our initiative to drive profitable growth and manage spend through 2023. Operating expenses for the three months ended December 31st, 2023, amounted to $3.8 million, compared to $5.8 million for the three months ended December 31st, 2022. A decrease of $2 million, which we believe shows the effectiveness of our cost and expense management initiatives.

Net loss for fiscal year 2023, ended December 31st, 2023, was $25.8 million, compared to a net loss of $10.3 million for 2022. The increase in net loss was primarily due to continued non-cash losses on the change in fair value of our derivative liabilities, which contributes to volatility and net loss. Adjusted EBITDA for the three months ended December 31st, 2023, was $0.7 million versus -$1.3 million for the same period last year, an improvement of $2 million. Adjusted EBITDA for fiscal year 2023 was -$1.2 million, versus -$7.3 million for the same period last year. An improvement of $6.1 million, indicating improved operational efficiencies. SANUWAVE continues to execute its financial strategy to improve operational profitability and manage operating expenses.

Total current assets amount to $9.8 million as of December 31st, 2023, versus $6.6 million as of December 31, 2022. Cash totaled $1.8 million as of December 31st, 2023. We thank you for your continued support of SANUWAVE, and I'm now transferring the call back to Morgan. Morgan?

Morgan Frank (Chairman and CEO)

Thanks, Toni. So as I suspect may have seen in our GAAP figures, you know, we continue to have a bit of a derivative tail wagging the operating company dog, like, when it comes to the net income line. You know, we've tried to provide some detail and transparency in the release to help people work through that and get a sense of, you know, the operating business itself. You know, part of the reason we're pursuing a merger and uplist is to eliminate this complexity and to simplify our capital structure. You know, as people are bound to be curious, our merger with SEPA remains ongoing and active.

Our financials went stale back in February, and so getting today's numbers out was important to being able to file the Super 8-K for the business combination, and de-SPACs do not get a grace period on that. So we were sort of up against it. We're continuing to work toward finalizing the exchange listing, and these numbers are obviously going to help. And the timing, however, is a bit out of our hands at the moment, and we hope to have more clarity and hopefully a closed deal soon. Meanwhile, our business continues to perform well, and as our systems and pipeline now seem sufficient to support it, we're going to give revenue guidance not just for Q1, but for 2024 as a whole. So for Q1, the company expects revenue growth in the 45%-55% range versus Q1 of 2023.

You know, there's always some Q1 seasonality in our business and in wound care and a lot of healthcare in general, but we expect this to be much more muted than in past years as these new growth trends take hold. We also expect gross margins to snap back to a range in the mid-seventies. We're also initiating guidance for the year ending December 31st, 2024. We anticipate revenue growth of 50% compared to 2023, with revenues expected to exceed $30 million. So, I mean, all in all, this is an exciting time at SANUWAVE. We're starting to string together some success and build on it for the benefits of our patients and for our shareholders alike. I really want to take this opportunity to thank the whole SANUWAVE team for all of their commitment and their hard work.

Like, this has been an amazing thing to be a part of. I will open this up for questions. Toni, if you could let me know.

Toni Rinow (CFO)

Moderator, Todd?

Morgan Frank (Chairman and CEO)

Todd, [cross talk] sorry.

Operator (participant)

Yes, at this time, if you would like to ask a question, please press star one on your telephone keypad. You may remove yourself at any time by pressing star two. Once again, to ask a question, please press star one. We'll pause just a moment to allow questions to queue. And again, that's star one to ask a question. We'll go to the first question from Satin Shah. Please go ahead.

Speaker 4

Hey, guys. Congratulations on a great year and a great quarter. Great to see the company being profitable now. Can you comment a little more, again, on kind of where things stand in terms of some of the other things you're dealing with, like, with the patents and with Shockwave? And has there been any advancement there in terms of talks with them and where that stands?

Morgan Frank (Chairman and CEO)

Well, I mean, as you probably saw in our 8-K, we announced an intellectual property deal earlier this month. There's just not a ton of detail that it's appropriate to go into in this venue. But I think it would be reasonable to assume that SANUWAVE remains very cognizant of the value of its intellectual property portfolio and is looking for ways to realize it.

Speaker 4

Gotcha. Okay. And in terms of when should investors expect to see the consummation of the deal with the listing? Is it sort of in the next few months, or is supposed to—we should see this happen quite soon?

Morgan Frank (Chairman and CEO)

I mean, you've got all the easy questions today. So, you know, if all of these matters were within our control, I would be, you know, more comfortable providing a timeframe. Obviously, you know, now we have our financials, you know, now we're capable of finalizing pro formas and filings. You know, things like being able to finalize an exchange listing depend on, you, groups and matters somewhat outside our control. I mean, I think it should be... Our hope is that it won't be long now. But it's... yeah, I just, I hesitate to put too fine a timeline on it, just based on the fact that these matters are, still, somewhat opaque and out of our control.

Speaker 4

Yeah, understood. All right, great. Thanks, though.

Morgan Frank (Chairman and CEO)

Thanks.

Operator (participant)

Thank you. Once again, that's star one, if you would like to ask a question. Our next question will come from Candace Laryea with MD Catastrophic Care Consultants. Please go ahead.

Speaker 3

Hi, also congratulating you on your performance. And so the question is also: is it a legal matter that you can't disclose regarding the merger? That was one question.

Morgan Frank (Chairman and CEO)

I'm not sure I understand the question.

Speaker 3

Well, you were saying that the merger may take place soon, but it's out of your control. And so I was asking if it's a legal matter that is,

Morgan Frank (Chairman and CEO)

It isn't, it is not.

Speaker 3

Okay.

Morgan Frank (Chairman and CEO)

It's not. It's, it's just finishing pro formas, SEC filings, and exchange, and the finalization of exchange listings. So no, there's no, there's no legal matter holding it up.

Speaker 3

Okay. Thank you. And then question number two is, if there are doctors that I'm aware of who might want to be involved, in SANUWAVE, as far as, I don't know if you're offering this for them to trial this out on patients, how would they contact someone?

Morgan Frank (Chairman and CEO)

Obviously, there's contact information on our website.

Speaker 3

Okay.

Morgan Frank (Chairman and CEO)

Tim Hendricks, our head of sales, would love to hear from people who want to try the product. So I think-

Speaker 3

Okay.

Morgan Frank (Chairman and CEO)

You can get a hold of him or our customer service department through our newly revamped and extra pretty website.

Speaker 3

Okay, thank you.

Morgan Frank (Chairman and CEO)

Thank you.

Operator (participant)

Thank you. At this time, we have no further questions in queue.