STRATA Skin Sciences, Inc. Aktie

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the STRATA Skin Sciences, Inc. Third Quarter 2025 Financial Results and Corporate Update Conference Call. [Operator Instructions] Please note, today's event is being recorded.

I would now like to turn the call over to Jules Abraham, Core IR, the company's Investor Relations firm. Please go ahead.

Thank you, Arielle. Good afternoon, everyone, and thank you all for participating in today's conference call. Earlier this afternoon, the company released its financial results for the quarter ended September 30, 2025. A copy of that press release can also be found on the company's website at www.strataskinsciences.com under the Investors tab. Joining me on today's earnings call from STRATA Skin Sciences management team are Dr. Dolev Rafaeli, Chief Executive Officer; and John Gillings, Vice President of Finance.

During this call, management will be making forward-looking statements, including statements that address STRATA Skin Sciences' expectations for future performance or operational results. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in STRATA Skin Sciences' most recently filed annual report on Form 10-K and subsequent periodic reports filed with the SEC and STRATA Skin Sciences press release that accompanies this call, particularly the cautionary statements within. The content of this call contains time-sensitive information that is accurate only as of today, November 13, 2025, and except as required by law, STRATA Skin Sciences disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call.

It's now my pleasure to turn the call over to Dr. Dolev Rafaeli, CEO of STRATA Skin Sciences. Dolev?

Thank you, Jules, and good afternoon to everyone on the call. During the third quarter of 2025, we continued to position our business for future growth and lasting shareholder value creation. Key to the progress will be the historic expansion of CPT codes for STRATA's XTRAC 308-nanometer excimer laser, which are expected to become effective January 1, 2027. As a reminder, the revision of these codes expands reimbursement eligibility for excimer laser treatments to include multiple inflammatory and autoimmune skin conditions beyond their original psoriasis indication, enabling coverage for conditions such as vitiligo, atopic dermatitis, mycosis fungiodes, lichen planus, alopecia areata, and cutaneous T-cell lymphoma, better known as CTCL, among approximately 30 indications. The implication of these changes are pivotal to our future business and that of our partners as they exponentially expand our opportunity to provide services to patients in need while creating a meaningful increase in potential revenue from procedures, which until now would not be within reach.

While the revisions are set to go into effect on January 1, 2027, we have commenced the process to expand this change to private payers as well. The latest progress of the recognition of these expanded codes is the Centers of Medicare and Medicaid Services, or CMS, has recognized both the existing psoriasis-only codes and the expanded ones in its Calendar Year 2026 Medicare Physician Fee Schedule Final Rule publication, which will then reflect into the 2027 reimbursement codes. As we have previously indicated, these additional reimbursement codes open our addressable markets to over 30 million patients, expanding our total available markets by threefold. In addition, we have submitted economic data to support a potential increase in the reimbursement rate for each of our codes, which the CMS 2026 Final Rule has indicated will be reviewed for consideration.

We've also continued to strengthen our practice partners through our Elevate 360 consulting model and our innovative DTC campaign. Elevate 360 focuses on improving utilization of the partner clinics by supporting the implementation of best practices to drive optimal use of XTRAC lasers. Since the beginning of 2025, 99 of our approximately 838 clinics operating under our XTRAC usage agreement have entered the Elevate 360 program, which has resulted in an average of 7% growth year-over-year for those businesses, completing a review as a part of the program's design. Additionally, average gross billings per device for all 838 of our U.S. partner clinics of $5,981 for the third quarter of 2025 increased 8.5% versus the third quarter of 2025 and represents the highest gross billings per device since the fourth quarter of 2022.

Turning back to Elevate 360. I want to share a specific example of a partner, which began with 2 clinics in the first half of 2024 and after adopting the Elevate 360 program expanded to 9 clinics and revenue contribution from the account increased tenfold. By providing deeper analytics, we help these partners better understand the financial opportunities associated with the patients they already see in their clinics and those they have prescribed but did not follow through with XTRAC scheduling. We expect that these kinds of improvements will become exponential in the coming year with the addition of new reimbursement opportunities resulting from the expansion of indications for which XTRAC treatment will become available.

Turning to TheraClearX. While this remains a small but growing portion of our revenue, we reached an important milestone with the regulatory approval and subsequent initial commercial placement in Mexico. We believe the continued international expansion of both the XTRAC and TheraClearX technologies represents significant opportunity for growth and value generation. During the third quarter, we continued to experience challenges in our international business, which we believe is attributable mainly to the current trade policy of the United States government, creating uncertainty and pressuring our total revenue for the quarter.

Turning to litigation. We offered an update on our case against LaserOptek regarding its use of false and misleading statements in its marketing. We believe we are strongly positioned in this suit and have the potential to be awarded significant damages. Additionally, an injunction issued late last year was very helpful in limiting any further damage to our domestic recurring business. We are pleased that the court agreed with our position that LaserOptek Korea, the parent of LaserOptek America, as well as another entity, which was used as the face for LaserOptek's U.S. sales efforts, should be added as defendants. We believe this will result in our ability to collect damages.

In the meantime, the injunction and clarity offered by the litigation allowed us to engage multiple dermatology clinics that had been previously misled by false claims about the PALLAS solid-state lasers. To date, over 20 such LaserOptek buyers have partnered back with STRATA under our program or have purchased XTRAC excimer lasers directly from us, which represents more than $1 million in annual capital and recurring revenue, emphasizing XTRAC as the recognized gold standard in the targeted UVB therapy.

With that, I'd like to turn the call over to John Gillings, who will review our financial results in more detail. John?

Thanks, Dolev. Our total revenue for the third quarter of 2025 was $6.9 million, down 20% compared to Q3 of 2024. This was driven primarily by the challenging international environment Dolev described. That said, recurring revenue remains solid, with gross [ code ] sales up 4.1% and net U.S. recurring XTRAC revenue up 2.8%. Global recurring revenue of $5.5 million increased 3% year-over-year, and equipment revenue of $1.4 million decreased 60% in the third quarter of 2025 compared with the prior year period. Gross profit for the third quarter of 2025 was $4.2 million, or 60% of revenue. Gross margin was roughly flat versus the prior year period. Total operating expenses were $5.4 million in the third quarter of 2025 versus $6.9 million in the prior year period.

The meaningful reduction was primarily due to higher costs in the prior year period related to a onetime $1.8 million accrual for sales tax in New York State recorded in G&A in the third quarter of 2024 and settlement gains booked this quarter for roughly $680,000. Net loss for the third quarter of 2025 was $1.6 million, or EPS of negative $0.36 per basic and diluted common share as compared to a net loss of $2.1 million, or EPS of negative $0.51 per basic and diluted common share in the third quarter of 2024. Adjusted EBITDA was slightly positive in the quarter compared to negative $240,000 in the comparable quarter of the prior year. The improvement was driven primarily by lower operating expenses. During the quarter, we raised $2.2 million net in a straight common registered direct offering. Cash and cash equivalents at September 30, 2025, were $7.1 million.

That concludes my prepared remarks, and I'd like to turn the call back over to Dolev for any remaining comments. Dolev?

Thank you, John. In summary, our team is extremely passionate about our business, focused on driving growth. We are excited about what lies ahead, including a seasonally stronger fourth quarter 2025, the tripling of our patient population with expanded indications for use of our excimer laser, and favorable reimbursement trends. That said, we believe it is important to continue to remind investors about the lingering impact of tariffs on our international business. While there were no meaningful impacts on our business in the first quarter, we saw some weakening in China in the second quarter and continued weakness in the third quarter. We hope to move past these issues and hope to be able to offer greater clarity on the fourth quarter call, which we expect to hold in early March.

Now I'd like to turn the call over to the operator so that we can begin the question-and-answer session. Operator?

[Operator Instructions] Our first question comes from Jeff Cohen of Ladenburg Thalmann.

This is Destiny on for Jeff. Could you maybe talk to the average revenue per device in the third quarter? And any trends you're seeing going into the fourth quarter in terms of treatment volumes?

Yes. Hi, Destiny, and nice hearing from you. As I mentioned in my prepared remarks, the average revenue -- the gross average revenue per device was $5,981, just shy of $6,000. It's the highest average revenue per device we had since 2022.

We're in a growth trend. If you followed the last few quarters, you'll see this is growing, and it's growing because of the increased utilization of devices, which is driven mostly by 2 things. One, we're removing nonproductive devices. So we're moving them back into inventory. That helps us in not having to build new devices, not having to invest into CapEx. We own these devices. They're on our balance sheet. And two, we're focusing on increasing utilization through our Elevate 360 and our normal DTC operations.

And we anticipate this to continue going up. As you can recall, just 3 years ago, our average revenue per device was in the range of $7,500. So we see this as a huge opportunity because if we could increase our average revenue per device from $6,000 to $7,500, that's $6,000 per device per year times the $800 and some devices, just that is an increase in top line of about $5 million. So we're very aggressively pursuing that. And we're using these 2 tools, removing nonproductive devices and increasing utilization on the existing ones. We do anticipate that towards the end of this year, our installed base is going to start increasing again. I hope I answered your question.

Yes, you did. And then sticking on the theme of your DTC campaigns, I'm wondering if there has been any increase in your show-up rates, and if that's helping or improving the revenue per device as well? And then can you just remind me how many clinics are part of your -- or clinic groups are part of your Elevate 360 program currently?

Well, that's a very complex question, so I'll break it into parts. We have -- as of the end of Q3, we had 838 partner clinics that are part of our usage agreement relationship. These are -- of these, we have managed to perform Elevate 360 with 99, and I covered that in our prepared remarks. And we're actively pursuing others. As you can see in our investor presentation, we have approximately 25 territories covered by 25 territory managers. So it's approximately 4 accounts per territory managers that were covered from the beginning of this year. We hope to accelerate the pace and get to a much bigger number than that. Obviously, we're going after those that we see the potential, those that either had [ test ] higher performance or we have the reason to believe that they can grow, whether it's because of their patient population or because of the history that we had with them. So these are the more lower-hanging fruits.

We're going after these. And as you can see, not only our gross and net recurring revenue grew, and I'll spend a minute talking about this in a second, but not only the gross and net recurring revenue grew, but also the average revenue per device grew, which means the utilization per device. As I mentioned in our prepared remarks, approximately 2 dozen devices were comebacks as a result of the litigation. We were able to bring them back. These were accounts that were very productive in the past and were approached by another company with false pretense and giving them false claims. We lost them either in 2023 or 2024. We were able to bring them back, a big chunk of that, almost half of these 2 dozen devices is coming back towards the back half of this year. And they're going to be -- just these 10 accounts are going to be accountable for an increase of just about $0.5 million a year in revenue. So we're doing this one piece at a time, making sure that our installed base and presence in the market is ready towards the end of 2026 for the expansion of the codes and being able to handle more patients coming in because of the expanded indications, but also being able to handle the existing patients more effectively.

Now going back to your -- the beginning of your question, which is DTC, our DTC covers nationwide, but we cover -- we go in geographies, we go after the accounts that could see the benefits from having DTC patients. And these accounts would be the accounts that are already very good at converting their own patients and see the benefit of an increased patient flow and utilization. So what we do see in DTC, and that's not geography specific, is that in the second half of 2025, because of a variety of reasons, we have better, much lower cost per acquisition of DTC patients, which is driven both by better cost per lead, so our cost of media, better conversion. That means the efficiency of our call center and being able to place them into appointments. And then down the funnel, better show rates and better conversion rates. And that is mostly because of the focus we have with these accounts. We stop sending patients to accounts that are not converting, and we're using these patients with accounts that do convert. We redirect patients from accounts that are not very good at converting and use them better. So these numbers are basically across the funnel of DTC. And this is why we can see with more or less the same sales and marketing expense, we're getting better results in recurring revenue, which is converting into better contribution margins from the business.

And may I point out that our gross margin stayed flat even though we lost international business. So we're actually doing better as a core recurring revenue business in the U.S. Again, I hope I answered the question in full.

And then one last one for me on TheraClear. Can you remind us what the installed base on that might look like by the end of '25? And I think you previously mentioned 2026. But I'm also curious to understand how the -- moving into Mexico and having commercial placements there may tie into the overall strategy of TheraClear.

Sure. So let me start with Mexico. And Mexico, interestingly enough, is a country that lies just south of the U.S. So we don't need to travel far to support them, whether it's marketing-wise, clinically wise, or even technical support. We are actively pursuing -- we were actively pursuing throughout 2024 and 2025 the registrations with COFEPRIS, which is the registering body in Mexico. And just a few weeks ago, we were happy to announce that we got the TheraClear registered with COFEPRIS and are able to report the first commercial placement. Our approach in Mexico is very much like the one in the U.S. Instead of trying to sell capital equipment and run into issues of us having to get paid a very meaningful sums of money. And as you probably know, because I know that you are also covering other capital equipment companies, the capital equipment markets are suffering from high interest rates, from tariffs, and so on.

Our approach with Mexico from the beginning was if we can get the registrations, we can expand by placing into Mexico. We were hoping to get the XTRAC registered in Mexico first, but that did not happen. It's still in progress. We got the TheraClear registered in Mexico. And we already announced the first commercial placement, and we are -- and we hope to be able to announce by the end of 2025, a significant number of placements in Mexico, which are going to be following the same commercial relationship we have in the U.S. in which we take the risk of the equipment, we take the risk of training the account and supporting the account, and the account shares the revenue with us.

The average rate of payment that a patient pays in Mexico for an acne visit is about the equivalent of about $140. And we don't see a reason why we cannot collect the same levels we collect in the U.S. which is approximately 40% of that, $50 to $60 of our money. And our technical support teams and our clinical support teams are able to support in Mexico. We've spent multiple visits in Mexico in the last 3 months, getting the local sales team of the distribution partner we have in Mexico, a company by the name of MINO Labs ready to do the sales. We've participated with them in some of the initial meetings with customers. They have access to -- there's over 3,000 dermatologists in Mexico, and they have access to many, many of them. And we believe that -- we believe in the trust in the technology and the need in the market are going to show up as early as in Q4 this year. We are participating with them in a national dermatology conference next week. And I think that's going to be the trigger for these placements.

Now going back to the first part of your question, our U.S. installed base is about 161 devices. We are -- even though we don't parse -- we do not parse in our financials the portion of what TheraClear means inside the recurring revenue that John discussed. As I mentioned in my prepared remarks, it's still a small portion, but it's a growing portion. And more importantly, it gives us a second touch point within the same account. So all of these 161 accounts are within these 838 XTRAC accounts. So for our territory managers, when they visit an account, they cover both the XTRAC and the TheraClear. We have been at the process of expanding usage of TheraClear in the U.S. now for about a year. We are happy to report that the use of the dedicated CPT code 10040 is expanding. About 2/3 of our 161 accounts are using that code for insurance reimbursement. The other 1/3 is -- are charging patients cash for the treatment. And we anticipate -- to wrap up my answer to your question, we're still hoping to get much closer to 200 devices deployed whether in the U.S. or elsewhere under the usage agreement by the end of 2025.

Our next question comes from Jeremy Pearlman of Maxim Group.

First one, maybe you could help us understand a little bit the delta, if I heard correctly. So you said that there was 7% year-over-year growth from those businesses that were part of the Elevate 360 program, but then you said overall average gross billings were up 8.5%. So maybe help us understand where that delta is coming from.

Yes. So first of all, I owe a portion of the answer that -- to the question that was asked before by Destiny. So just as a reminder, we report 2 numbers on the recurring revenue. We report a gross number and a net number. The difference between the gross and the net is, even though it's itemized in our financial reports and in our releases, it includes 2 components. One, we are netting out some of our support to the market. So for example, the -- our coupons given to patients for reimbursing their co-pays are netted out. But the bigger portion of changes happens because we need to defer out revenue that came in during the last part of the quarter, and we defer that into the following quarter. So there's always going to be a difference between our gross numbers and our net numbers. Then in addition to that, I reported 2 growth numbers. One has to do with these -- specifically these 99 accounts that were handled through Elevate 360. And with these accounts, we have seen a growth of 7% in revenue.

These accounts, as I mentioned before, are -- we break our accounts into 5 tiers, tier 1 to tier 5, tier 1 being the highest-producing tiers and tier 5 being the lowest-producing tiers. And we are focused on -- with our Elevate 360, we're focused on tiers 2, 3, and 4 being able to move accounts from tier 4 to tier 3 or tier 3 to tier 2. And with tier 5s, we're either removing them or they have to move up on their own because they're too small for us to focus on. We're not really focused on tier 1 with Elevate 360. These are the accounts that got it and know how to make it work. That 7% number is a 7% growth over these 99 accounts. The 8.5% growth in average recurring revenue per device is across the 838 devices. So it's 2 different populations. The 7%, if you wish, is what we were able to get in growth for these 99 accounts that are mostly tier 2, 3 and 4, where the 8.5% is across the board. And across the board could be also from tier 1s and tier 5. I hope that helps answer the question. And again, the 8.5% is a gross number. So it gets netted out. When we grow, you can actually see these in the net numbers going up slower. That's why when John went through his numbers, you saw a number that's about 4% in overall numbers because the average numbers are per device. I hope that the math makes sense.

Yes. No, I understand. So it's how the -- what tiered clinics are within -- are in the program versus the overall. Got it. That 4%, is that a net revenue growth number? Is that something we could -- or are you not providing that number this quarter?

John, do you mind jumping in on gross to net?

Yes. So that is -- the 4% is the net number. And just in general terms, because anything can happen later in the quarter. But in general terms, if you see the gross number growing a bit faster than the net number, that's usually a positive leading indicator.

And then maybe just talking about the litigation. You said that you had roughly 24, 2 dozen devices that are coming back based on litigation. Is there anything else left in the field that you could -- you think you can pull back? And just what's -- roughly how many more devices do you think you can get from that?

Yes. So I'm not going to go into specific account numbers, quantities of accounts, but I will say that the overall damage caused by the false claims is in the range of 75 to 100 accounts. And we are actively pursuing bringing all of them back. So again, if you take a perspective over the last 1.5 years, even though you saw our top line number -- since 2024, you saw our top line number slightly decrease because of removals, you should look at them, at what happened between 2023 and 2024. And this is when we lost these accounts. More importantly, these accounts were very productive accounts, and they were lost based on false claims. And the false claims had to do with 2 major areas. One was the technical and clinical equivalence or superiority, which the defendants in this case cannot support because they do not have not even one clinical study to their name that shows clinical efficacy on treating of psoriasis. And they have one 16-patient case done in Korea for vitiligo. And that's it. That's what they have in clinical studies.

And the technical claims that have to do with speed and ease of use and performance, which are far from being substantiated. But more importantly, they claimed that their device can be used for treatment for reimbursement. And the CPT codes are very specific. They say excimer laser treatment for psoriasis. And so there's no 2 ways to understand that. It says excimer laser. If you have something that's not excimer laser, then it's not excimer laser. And these very productive accounts do not want to face both -- the first part, which is not getting clinical efficacy for their patients and being straddled with something that works slower and maybe does not work. But also, most importantly, they do not want to face the potential of being pursued for nonethical billing of something that cannot be billed. So this is why they tend to come back and work with us. And in addition to the fact that we give them a full envelope of services that includes helping them with preauthorization of patients and driving DTC patients to them and so on and so forth.

So there is a meaningful additional upside of comebacks to come from them. Just as a reminder, in the past, we had a similar situation with a competitor, a company called Ra Medical, which we ended up eventually acquiring the business in 2021. But before that, they had a few hundred devices, and we were actively pursuing them, and we were able to convert a few hundred devices of the Ra Medical Pharos device into being XTRAC users.

That's good information. And then just 2 questions. I think I might have missed this on the call. Did you say how many patients the DTC marketing campaign drove through this quarter into clinics? Or I might have missed that.

Good catch. No, we did not. We will probably have to follow up with a press release that outlines that.

Okay. And then just last question for me. You mentioned, I think, last quarter that I know you got the CPT codes to hopefully go into effect, the expanded codes in 2027. And you did say there's a possibility of getting temporary codes. Is that something that's still on the table for 2026? And when would that -- when might that be, if that's a possibility?

So the CMS Physician Fee Schedule that came out about 10 days ago, the Final Rule for 2026, CMS specifically related to our request and said that they do not want to create confusion in the market, considering that there is the existing codes for psoriasis only. There is a change of expanded codes coming in, in January 1, 2027. And then there is the ongoing examination of the value of the codes, which is right now in the hands of the RUC committee, which are -- between these 3 things, the CMS thought it would not be a good or wise thing to create temporary codes for the 2026 cycle.

[Operator Instructions] This concludes the question-and-answer session. I would like to turn the conference back over to Dolev Rafaeli for any closing remarks.

Thank you, everyone, for showing up for this call. I appreciate your interest in the company. We will be presenting again in the middle of March, presenting our fourth quarter results. Thank you very much.

Thank you. This conference call has now concluded. You may disconnect your lines. Thank you for attending today's presentation.