Sign in

You're signed outSign in or to get full access.

Sanuwave Health - Q1 2023

May 12, 2023

Transcript

Operator (participant)

Greetings, welcome to the Sanuwave Health Business Update conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Kevin Richardson, Chief Executive Officer. Thank you, sir. You may begin.

Kevin A. Richardson, II (Chairman and CEO)

Thank you, Christine. Welcome to Sanuwave's first quarter 2023 earnings call. The Form 10-Q was filed with the SEC Thursday night. Our earnings release was issued this morning, our updated investor presentation was made available on our website in the investor section. Please refer to that during the presentation. Joining me on the call today are Toni Rinow, our CFO, and Tim Hendricks, our Executive Vice President of Wound Care Sales. After the presentation, we'll open the call to Q&A. Let me begin with the forward-looking statement. This call may contain forward-looking statements such as statements relating to financial results and 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.

Actual results may differ materially from those projected in the forward-looking statements. The company undertakes no obligation to update any forward-looking statement. With that out of the way, 2023 is off to a positive start. First quarter revenue recorded mid-teens growth, driven by demand in consumables and systems. We began 2023, first quarter up 18% compared to our guidance of 14%-20%, which was issued on our last conference call. Demand for our products remains robust. As we discussed on our last conference call, we are still working through supply chain issues as currently demand is far outstripping supply. We are on track to receive over 400 devices this year, which compares to 217 sold last year.

This is not to say we will sell all 400. As we work our way through the year, the supply chain issues will abate, and we will hopefully be able to balance supply and demand. This demand was evident at the three conferences we participated in recently. At Leaders in Wound Care, held in New Orleans, Dr. Johnson, a relatively new user of UltraMIST, presented his clinical findings to the invite-only crowd. At Symposium on Advanced Wound Care, SAWC, we had six posters presented. Finally, in Milan, at the European Wound Management Association meeting, two of our KOLs, Dr. Meyer and Dr. Cassino, presented their various use cases for the product. From these events, we can safely say over 20 new accounts with purchasing interests were added to our pipeline. This demand will be fulfilled later in the year when the supply issues mentioned earlier abate.

Let's get into the details of the quarter. Revenue continued mid-teens growth in Q1 2023, despite the challenges we face with our supply chain. Units shipped achieved the highest level for the first quarter in company history. Importantly, the number of treatments reached 43,000 was a record as well as the continued adoption of UltraMIST grows. Gross margins were down in Q1 as compared to the prior year due to cost increases year-over-year associated with the servicing of refurbished equipment and as part of our push to get more product out to market. Management continues to have tight management of our supply chain, pushes for higher pricing of our products, and continues to execute a host of projects internally, all focused on automation and driving costs lower. OpEx increased year-over-year, even though headcount was down.

The largest driver of the increase is from professional fees, particularly year-end audit being higher in Q1, 2023 as compared to Q1, 2022. Management plans to continue to focus on leveraging the existing infrastructure as we grow and gain operating leverage to achieve profitable growth. Let me turn the call over to Toni Rinow to walk through the numbers. She'll pass it back to me to review more of the update slides. Tim, our Head of Sales, will speak, and I will conclude with our near-term outlook. Toni?

Toni Rinow (CFO)

Thank you, Kevin. Q1 revenues for the three months ending March thirty-first, 2023 amounted to $3.8 million, an increase of 18% over the same period last year and in line with the guidance of 14%-20% provided prior. Gross margin decreased year-over-year, reaching 67% of revenue for the three months ended March thirty-first, 2023 versus 72% for Q1 of 2022. Operating expenses for the three months ended March thirty-first, 2023 totaled $4.5 million. This is an increase of 4.7% versus prior year three-month period. This is due to an increase in general administrative expenses incurred in Q1, 2023. Operating expenses decreased as a percentage of revenue, and this shows the effectiveness of the cost and expense management initiatives. Operating loss remained flat year-over-year three-month period.

Sanuwave continues to execute on its financial strategy to improve profitability and manage operating expenses. Total current assets amount to $4.5 million as of March 31, 2023, versus $6.6 million as of December 31, 2022. Cash totals $0.1 million as of March 31. In May 2023, the company closed an additional private placement with proceeds receiving totaling $1.2 million to support operations. We thank you for your continued support of Sanuwave, I'm transferring back to Kevin. Kevin?

Kevin A. Richardson, II (Chairman and CEO)

Thank you, Toni. Next on the call will be Tim Hendricks. Tim joined us in January from Byram Healthcare. He has been in the wound care industry for 20-plus years with experience at firms like Smith & Nephew and Osiris, and he got his early start at Boston Scientific. We're very pleased to have Tim on board. Tim?

Tim Hendricks (Executive VP of Wound Care Sales)

Thank you, Kevin. Good morning. It's a pleasure to join this call. I'm happy to share my perspective since I joined the organization not quite four months ago when I was asked to come in and lead our U.S. wound sales efforts. I first came to Sanuwave with the exciting prospect of two devices that I knew had a great reputation in the marketplace for clinical efficacy but also reimbursement possibilities. The number one thing I can share with you months later is that my enthusiasm is only heightened by the reality that we are uniquely positioned with our products that you don't often see in the medical device space. Too often products are in a crowded marketplace where the devices or products are commoditized. It's all about pricing and me-too efficacy.

Speaking of UltraMIST in particular, it really is unique and offers a one-two punch of a long history of strong clinical data and feedback that is very positive, but now strong reimbursement in multiple places of service. Simple fact is we are not able to meet the strong demand right now. This is a great problem to have that speaks to the opportunity to treat a great number of patients with our unique modality. I will turn the call back over to Kevin.

Kevin A. Richardson, II (Chairman and CEO)

Thank you, Tim. Before we go to Q&A, I wanted to provide some guidance on Q2. For those following along, this is page six on the investor deck from our website. We currently anticipate revenue to grow 15%-25% in Q2. The gating item governing that growth will be how smoothly the supply rolls in during the remainder of May and June. As we have mentioned earlier, demand is and has not been our issue. The issue is supply, and we have all eyes in the company focused on initiatives to address and fix that issue, so we have sustainable supply stream through the remainder of 2023 and into 2024. Many have also asked when we will be more active on the investor relations front.

The answer is soon. We have been in somewhat of a quiet period through the first part of the year as the Q4 report is almost the same time that the Q1 quiet period begins. We plan to attend some investor conference over the next few quarters and work with our new investor relations group on a clear communications plan with that regard. We have wonderful products, passionate, dedicated team members, and demand far exceeding supply. We should be able to achieve record revenue growth and profitability in 2023. Finally, I wanna thank our employees for driving our success, shareholders who have invested in us, has allowed us to ramp the product, and most importantly, meet our mission, which is about saving limbs and saving lives through healing wounds. With that, I'll open the call to questions. Christine?

Operator (participant)

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, if you would like to ask a question, press star one on your telephone keypad. One moment please while we poll for questions. Thank you. Our first question comes from the line of Satyan Shah, a private investor. Please proceed with your question.

Speaker 4

Hey, Kevin and team. How are you guys doing?

Kevin A. Richardson, II (Chairman and CEO)

Great. Thank you, Satyan. How are you doing?

Speaker 4

Good. Good. I had a couple questions. First, for Tim, you know, congratulations for joining the team. You had mentioned that you are seeing good reimbursement in multiple places of service. Can you little expand on that? Like, what does that mean exactly?

Tim Hendricks (Executive VP of Wound Care Sales)

Sure. Hi, thanks for the question. In my experience with a device that has strong reimbursement or reimbursement in different Places of Service, you'll find that it's reimbursed maybe in a hospital and maybe another setting. What we're finding now is that UltraMIST has had reimbursement in the hospital setting, in the wound care and inpatient setting, and it has very strong reimbursement in the private office, which is new Medicare designates that as Place of Service 11. Our fastest growing channels are from home health, where there is a growing number of wound care-based mobile practices treating patients in their home, and that's Place of Service 12, assisted living facilities, which is Place of Service 13.

Nursing homes are quickly becoming our number one channel because they're seeing the results, not only just reimbursement, but more importantly, what UltraMISTs can do for chronic wounds, but also for deep tissue injuries. The ability to see

Kevin A. Richardson, II (Chairman and CEO)

To clinically work and see and have reasonable reimbursement in five places of service is very dynamic, and that gives us multiple channels to go after.

Speaker 4

Okay, that's great. Then for you, Kevin, just a quick question. In terms of the supply constraints that you guys are facing, is that something that we should anticipate as a year-long? Like, is it gonna be prolonged? Like, is it gonna continue for a while? Is it certain products within the mix that are, the supply constraint is within? Like, is it for dermaPACE versus UltraMIST or is it a combination? Because.

Kevin A. Richardson, II (Chairman and CEO)

Yeah. I, the supply constraints are primarily around UltraMIST. It was the line that produced it was, you know, not producing it for a period of time, the restart of that line has taken longer to get all the kinks worked out and make sure we have high quality product coming to us on a consistent basis. We're getting close to the point where I'm comfortable and confident that we have the supply we need on a weekly basis. We're not there yet. It will hopefully not be a year-long thing. I can't imagine that happening. It appears that we're getting close to the point where we'll have that abated. Right now it's-

Speaker 4

Understood.

Kevin A. Richardson, II (Chairman and CEO)

That's the issue we're working through. I think we're on track to get to $400 for the year, $400 plus..

Speaker 4

Right.

Kevin A. Richardson, II (Chairman and CEO)

...devices for the year, and that's really what we're focused on, is making sure we can meet demand for the full year.

Speaker 4

Gotcha. Just to clarify, I mean, based on your projections guidance for the next quarter, like, did investors assume with some level of confidence that going forward you'll sort of be at a break even to profitability at this point, or is that still a little bit, too, I don't know, optimists?

Kevin A. Richardson, II (Chairman and CEO)

No, no. It's a good question, Sachin. I mean, our goal this year is we gotta get to profitable growth. You know-

Speaker 4

Yeah.

Kevin A. Richardson, II (Chairman and CEO)

We can't rely on going back to the markets. You know, we have to get to that point. For us, as you can see on page six in the slide deck, our break even's about $1.8 million a month when we have

Speaker 4

Yeah.

Kevin A. Richardson, II (Chairman and CEO)

Gross margins of 75%. We're close. That's about 25 ± systems gets us to that level. Right now we're tracking close to that. Once the supply is there, the demand is there. I mean, there's a backlog of a host of customers that are just waiting for product right now. Getting to that break even point, once we have that supply constraint fixed, won't be an issue and we should be able to hop over into the profitable section.

Speaker 4

Okay, that's great. Then one last thing. In terms of the operating costs, you had mentioned the increase that was due to professional services. Is that sort of a one-time hit that we shouldn't anticipate going forward?

Kevin A. Richardson, II (Chairman and CEO)

You know, I'll let Toni address that. You know, we're still.

Toni Rinow (CFO)

Yes.

Kevin A. Richardson, II (Chairman and CEO)

Uh, twen-

Toni Rinow (CFO)

I-

Kevin A. Richardson, II (Chairman and CEO)

Go ahead. Go ahead, Toni. Thank you.

Toni Rinow (CFO)

Yeah. No worries. I can address that, Kevin. Yes, it's more like 1 time because during that quarters we had a number of SEC initiatives. We filed the S-1 as assessment amendment. We also got back on the OTCQB, and we got back up listed. These kind of, you know, singular and unique events were driving some of the professional service cost during the quarter, and we don't expect them to be coming back. I would also like to mention that overall operating expenses have been increasing much slower to a 4.57% compared to revenue. It really shows the effectiveness of our cost control initiatives that we started last year. Back to you, Kevin.

Kevin A. Richardson, II (Chairman and CEO)

Great. Thanks, Satyan Shah?

Speaker 4

Yeah. That's great. Thank you very much. Yep.

Operator (participant)

A final reminder, if you would like to ask a question, press star one on your telephone keypad. We'll take a moment just to re-poll for any additional questions. Thank you. It appears we have no further questions at this time. I would like to turn the floor back over to management for closing comments.

Kevin A. Richardson, II (Chairman and CEO)

Great. Thank you, Christine. Well, first, thank you everyone for your participation in the call. We'll have the recording of this live for the next few weeks. We'll also try to get it on the website so you can re-listen to it if you want. Our next update, it will be for Q2. Hopefully, we'll see some people at some investor conferences moving forward. Thank you. Have a good day.

Operator (participant)

Ladies and gentlemen, this does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.