8/13/2025

speaker
Operator
Conference Operator

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Strata Skin Sciences second quarter 2025 financial results and corporate update conference call. At this time, all participants are in the listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. Participants of this call are advised that the audio of this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call through February 13, 2026. I would like to turn the call over to Jules Abram of CoreIR, the company's investor relation firm. Please go ahead, sir.

speaker
Jules Abram
Investor Relations, CoreIR

Thank you, Steve. Good afternoon, and thank you all for participating in today's conference call. Earlier this afternoon, the company released its financial results for the quarter ended June 30, 2025. A copy of that press release can be found on the company's website at www.strataskinsciences.com under the Investors tab. Joining me on today's earnings call from Strataskin Sciences management team are Dr. Dola Raffaele, Chief Executive Officer, and John Gillings, Vice President of Finance. During this call, management will be making forward-looking statements, including statements that address Stratiskin 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 Stratiskin Sciences' most recently filed annual report on Form 10-K and subsequent periodic reports filed with the SEC and Stratiskin 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, August 13th, 2025, and except as required by law, Stravinsky & 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 CEO, Dr. Doliv Raffaelli. Doliv.

speaker
Dr. Dola Raffaele
Chief Executive Officer

Thank you, Jules, and good afternoon to everyone on the call. The second quarter of 2025 saw pivotal developments positioning our business for future growth and lasting shareholder value creation. We're especially heartened by the American Medical Association, the AMA, CPT editorial panels, the historic expansion of CPT codes for Stratus Extract 308 nanometer eczema laser in May of this year. The revision of these codes expands reimbursement eligibility for eczema 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 fungoids, lichen planus, alopecia areata, and cutaneous T cell lymphoma, better known as CTCL, among approximately 30 indications. The implications of these changes could not be more dramatic for us and our providers. While the revisions are set to go into effect on January 1, 2027, we have commenced the process to accelerate access to these revised codes through temporary G-codes. Assuming successful implementation of the temporary G-codes into the 2026 reimbursement period, we have the potential to pull forward revenue opportunities by one year as we expand into new indications. These developments open our addressable market to 30 million patients, expanding our total available market, FEMM, threefold In addition, we have submitted economic data to support a potential increase in the reimbursement rates for each of our codes. Should rates increase be approved, we could be headed into a period where both the number of patients eligible for the treatments and the revenue per patient procedure are increasing simultaneously. We've also continued to strengthen our practice partners through our Elevate360 consulting model and our innovative DTC campaigns. Elevate360 focuses on improving revenue for both clinics and strata by supporting the implementation of best practices to drive optimal use of the extract lasers. By providing deeper analytics We help physicians 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 extra scheduling. Having these best practices in place lays the groundwork for effectively managing and benefiting from the dramatic increase in patients eligibility for reimbursement under the expanded CPT codes I mentioned previously. Optimizing extract devices placement in physicians practices facilitates more procedures and opportunity to utilize this the resources we provide. Further, simultaneously expanding our direct-to-consumer marketing campaign increases extract device utilization and recurring revenue per device across our domestic install base. We ended the second quarter with 844 units placed with Partners Clinics in the US, down from 846 at the end of the first quarter. While we continue to seek optimization of the install base, the activity behind the numbers paints a more complete picture. During the second quarter, we removed 21 devices from suboptimal partners and placed 19 devices with new accounts that are interested in growing with us. Importantly, these 19 placements represent the highest number of placements in the United States in the last six quarters, which we view as a positive leading indicator for the future revenue growth. Given these initiatives and these growth driving codes developments, We continue to believe that the opportunity to increase utilization for our extract devices is significant, and we continue to see positive results from the refocus of our DTC strategy. We generated roughly 1,100 DTC-driven patient appointments in the second quarter with a 61% show rate. In addition, our proprietary RDX system handled benefits for approximately 5,100 patients in the second quarter. Of these patients, roughly 1,000 were acne patients with our TheraClear X partner clinics, and about 2,500 were psoriasis patients. The balance of patients were other indications treated by extract, that would have generally involved extra effort and pre-approvals illustrating the strong demand for eczema laser therapy among these patients who will soon be more easily covered under the updated CPT codes. Turning briefly to TheraClearX, we reached an installed base of 161 TheraClearX devices in the US at the end of the second quarter. up from 117 devices at the end of Q2 2024. TerraClear X continues to be a small but growing portion of our revenue. On the first quarter call in May, we highlighted the potential impact of the tariffs on our international business. While we were able to complete some sales in China during the 90-day tariff pause, The uncertainty about the future they have caused has created a temporary drag on our international business. We generated international revenue of 2.6 million in the second quarter, which declined 15% compared to the prior year period. International equipment sales were significantly affected by lingering trade disruptions in China, and distributor challenges in Korea. We continue to see strong underlying demand in these markets and expect these geographies to return to growth once things stabilize. While we will continue navigating the seasonality of our business, specifically a slower first and second quarters as we turn to the second half of 2025, we continue to anticipate normal seasonality gaining positive momentum heading into the year end, with the caveat that tariffs still represent a significant unknown. In 2026, we look forward to the potential positive impact of our ongoing discussions with the Centers of Medicare and Medicaid Services, or CMS, to obtain temporary codes that would accelerate access to our recently expanded reimbursement for extract. Notably, we have secured strong support from members of the legislature, patient advocacy groups, and leading academic key opinion leaders. We are further encouraged by the growing body of peer-reviewed publicly available clinical study supporting eczema laser therapy. which points to the new and enhanced application adding to the hundreds of other studies published over the years. Last Thursday, we published a press release with reimbursement and clinical updates that we would point out to you if you have not already read it. In addition, this press release offered a brief update on our litigation against LaserOptic 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. We are pleased that the court agreed with our position that LaserOptic Korea the parent of Laseroptic America, should be added as a defendant. In addition, Sea Dolphin LLC, the entity that represented Laseroptic Korea interests in the United States, has been added as a defendant. These are important developments and help ensure that should damages be awarded, these responsible will not be able to shield themselves behind other legal entities. Before turning the call over to John for our financial discussion, let me take a moment to discuss the three recent publications that support eczema laser and vitiligo and atopic dermatitis, expanding the potential use of extract. In a peer reviewed study, Featured in the International Journal of Dermatology, a multicenter randomized controlled trial evaluated the efficacy and safety of 308 nanometer eczema laser therapy in combination with oral JAK inhibitors. Oral JAK inhibitors is a novel class of immune modulating drugs. A total of 240 adult patients were enrolled and monitored over the 52-week period. The study demonstrated superior repigmentation in combination therapy, with patients receiving 308 nanometer ExCimer laser combined with the JEC inhibitor reporting 100% overall response rate and 96% pigment stability, indicating a durable response. The study showed that treatment was well tolerated across all groups with no serious adverse events reported over the 52-week trial. It is noteworthy to point out that there is no other technology that is enabling such results and that the addition of vitiligo as a covered indication will open the door for somewhere between 3 and 4 million existing patients seeking not only temporary remission gained from the pharmaceuticals, but full repigmentation. A second study published in Human Vaccine and Immunotherapy highlights conjunctive use of eczema laser with JAK inhibitor on a patient that has developed segmental vitiligo one week after her third HPV vaccine, achieving approximately 70% repigmentation. Further, a third study published in Dermatology Therapy evaluated the safety and efficacy of 308-nanometer eczema laser therapy in conjunction with JET inhibitors for treatment of refractory vitiligo in patients complicated by moderate to severe atopic dermatitis. The trial involved 19 patients who had not responded to conventional therapy. Patients showing a mean 55% VASI improvement with facial and neck areas responding best with greater than 70% improvement. Importantly, the 55% mean VASI improvement in these challenging patients compared to 39% improvement with the JAK inhibitor alone, suggesting a strong synergistic mechanism. The domestic market has approximately 18 million atopic dermatitis patients. Importantly, Strata has been preparing for the potential expansion into combined therapy and owns patents that were granted recently for the methods of combining systemic, biologic, and JAK inhibitor medication with extramural laser dosimetry-controlled treatments. This positions us well for the potential market expansion associated with combination treatment for more challenging patients. With that, I'd like to turn the call over to John, who will review our financial results in more detail. John?

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