STRATA Skin Sciences(SSKN)
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STRATA Skin Sciences(SSKN) - 2025 Q3 - Quarterly Report
2025-11-14 22:25
Revenue Performance - Total revenues for the three months ended September 30, 2025, were $6.9 million, a decrease from $8.8 million in the same period of 2024, while total revenues for the nine months ended September 30, 2025, were $21.4 million, down from $24.0 million in 2024[158]. - Recurring treatment revenue for the three months ended September 30, 2025, was $5.5 million, representing approximately 67,000 XTRAC treatments, compared to $5.4 million for approximately 64,000 treatments in the same period of 2024[159]. - Dermatology procedures equipment revenues for Q3 2025 were $1.4 million, a decrease from $3.4 million in Q3 2024, representing a 58.8% decline[164]. - Dermatology recurring procedures revenues for Q3 2025 were $5.5 million, slightly up from $5.4 million in Q3 2024, with a gross profit percentage of 61.6% compared to 65.4%[170]. Device Placement and Usage - The number of XTRAC systems placed in dermatologists' offices decreased from 864 as of December 31, 2024, to 838 as of September 30, 2025[146]. - As of September 30, 2025, there were 161 TheraClear devices placed in dermatologists' offices, an increase from 135 devices in the same period of 2024[161]. - International sales included 8 systems in Q3 2025 (6 XTRAC and 2 VTRAC) compared to 20 systems in Q3 2024 (20 XTRAC)[165]. Financial Performance - Gross profit for Q3 2025 decreased to $4.2 million from $5.3 million in Q3 2024, with a gross profit percentage of 60.4% compared to 60.1%[168]. - For the nine months ended September 30, 2025, gross profit was $12.3 million, down from $13.5 million in the same period in 2024, with a gross profit percentage increase to 57.3% from 56.1%[169]. - As of September 30, 2025, the company reported a net loss of $1.622 million, an improvement from a net loss of $2.074 million for the same period in 2024[182]. - The company had negative working capital of $0.8 million as of September 30, 2025, compared to positive working capital of $3.2 million as of December 31, 2024[183]. - Cash and cash equivalents decreased to $7.1 million as of September 30, 2025, down from $8.6 million as of December 31, 2024[183]. - Net cash used in operating activities increased to $2.6 million for the nine months ended September 30, 2025, compared to $0.5 million for the same period in 2024[191]. Expenses and Gains - Selling and marketing expenses increased to $3.2 million in Q3 2025 from $3.0 million in Q3 2024, driven by higher employee-related expenses and advertising campaigns[175]. - General and administrative expenses decreased to $2.7 million in Q3 2025 from $3.6 million in Q3 2024, primarily due to an increase in sales tax accrual in 2024[177]. - Settlement gains for Q3 2025 were $0.7 million, compared to no settlement gains in Q3 2024, due to supplier obligation settlements[178]. - Engineering and product development expenses for the nine months ended September 30, 2025, were $0.4 million, down from $0.7 million in the same period in 2024[174]. - Interest expense remained stable at $0.5 million for Q3 2025 and Q3 2024, with a total of $1.5 million for the nine months ended September 30, 2025, compared to $1.6 million in the same period in 2024[179]. Market and Operational Challenges - The impact of the COVID-19 pandemic has led to the suspension of elective procedures and the temporary closure of many physician practices, affecting operational and financial performance[150]. - The company has faced supply chain challenges due to the Russia-Ukraine war, impacting the availability and price of essential gases for laser operations[151]. - The U.S. introduced trade policy actions in 2025 that increased import tariffs, potentially affecting product costs and demand in the dermatology procedures equipment segment[153]. Future Plans and Financing - The company plans to increase direct-to-patient advertising for XTRAC treatments targeting psoriasis and vitiligo patients through various media, including social media platforms[162]. - The company expects to write off a product technology intangible asset with a net carrying value of $0.7 million and derecognize a liability for contingent consideration of $1.2 million in Q4 2025[187]. - Net cash provided by financing activities was $2.2 million for the nine months ended September 30, 2025, compared to $1.9 million for the same period in 2024[193]. - The company amended its credit facility in November 2025, pausing the measurement of net revenue for financial covenant compliance through September 30, 2026[186]. - The company has the potential to incur a royalty of 5% on sales of TheraClear® X devices starting January 1, 2027, contingent on achieving certain revenue milestones[188]. - The company may sell up to an additional $6.5 million of its common stock under an existing equity distribution agreement as of September 30, 2025[189].
Strata Skin Sciences outlines threefold market expansion opportunity as CPT code revisions approach 2027 (NASDAQ:SSKN)
Seeking Alpha· 2025-11-14 00:42
Group 1 - The article does not provide any relevant content regarding company or industry insights [1]
STRATA Skin Sciences(SSKN) - 2025 Q3 - Earnings Call Transcript
2025-11-13 22:30
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $6.9 million, down 20% compared to Q3 2024, primarily due to a challenging international environment [10] - Recurring revenue remained solid, with gross code sales up 4.1% and net U.S. recurring XTRAC revenue up 2.8% [10] - Global recurring revenue of $5.5 million increased 3% year over year, while equipment revenue decreased 60% [10] - Gross profit for Q3 2025 was $4.2 million, representing a gross margin of approximately 60%, which was flat compared to the prior year [11] - Net loss for Q3 2025 was $1.6 million, or EPS of negative $0.36, compared to a net loss of $2.1 million, or EPS of negative $0.51 in Q3 2024 [11] - Adjusted EBITDA was slightly positive in the quarter compared to negative $240,000 in the comparable quarter of the prior year [11] Business Line Data and Key Metrics Changes - Average gross billings per device for U.S. partner clinics was $5,981 for Q3 2025, an increase of 8.5% versus Q3 2024, marking the highest since Q4 2022 [7] - 99 out of approximately 838 clinics have entered the Elevate 360 program, resulting in an average growth of 7% year over year for those businesses [6] Market Data and Key Metrics Changes - The expansion of CPT codes for STRATA's XTRAC laser is expected to increase the addressable market to over 30 million patients, tripling the total available market [6] - The company is experiencing challenges in its international business, primarily due to current U.S. trade policies, which have pressured total revenue [8] Company Strategy and Development Direction - The company is focused on expanding reimbursement eligibility for excimer laser treatments to include multiple inflammatory and autoimmune skin conditions, which is pivotal for future growth [4] - STRATA is strengthening practice partnerships through the Elevate 360 consulting model and innovative direct-to-consumer (DTC) campaigns [6] - The company aims to increase utilization of existing devices while removing non-productive devices from the market [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about a seasonally stronger Q4 2025, driven by expanded indications for the excimer laser and favorable reimbursement trends [12] - The lingering impact of tariffs on international business was acknowledged, with hopes for improvement in the future [13] Other Important Information - The company raised $2.2 million net in a common registered direct offering during the quarter [11] - The litigation against LaserOptic is progressing positively, with potential for significant damages and an injunction limiting further damage to the domestic recurring business [9] Q&A Session Summary Question: Can you talk about average revenue per device in Q3 and trends for Q4? - The average revenue per device was $5,981, the highest since 2022, with expectations for continued growth due to increased utilization and removal of non-productive devices [15] Question: Any increase in show-up rates from DTC campaigns? - DTC campaigns have shown improved cost per acquisition and better conversion rates, contributing to increased recurring revenue [20] Question: What is the installed base for TheraClearX by the end of 2025? - The U.S. install base for TheraClearX is about 161 devices, with expectations to approach 200 devices by the end of 2025 [26] Question: Any updates on the litigation and potential device recoveries? - The company is actively pursuing the return of approximately 75-100 accounts affected by false claims, with a significant number of devices expected to come back [38] Question: Will there be temporary codes for 2026? - CMS has indicated that they do not plan to create temporary codes for 2026, focusing instead on the expanded codes effective January 1, 2027 [44]
STRATA Skin Sciences(SSKN) - 2025 Q3 - Quarterly Results
2025-11-13 21:16
Revenue Performance - Revenue for Q3 2025 was $6.9 million, a decrease of 21% compared to Q3 2024[6] - Total revenues for the three months ended September 30, 2025, decreased by 21.2% to $6.929 million from $8.797 million in the same period of 2024[28] - Global recurring revenue increased by 3% year-over-year to $5.5 million, while equipment revenue decreased by 60% to $1.4 million[6] Profitability and Loss - Net loss for Q3 2025 was $1.6 million, or EPS of negative $0.36, an improvement from a net loss of $2.1 million, or EPS of negative $0.51, in Q3 2024[7] - Net loss for the three months ended September 30, 2025, was $1.622 million, compared to a net loss of $2.074 million in the same period of 2024, representing a 22% improvement[28] - Gross profit for the nine months ended September 30, 2025, was $12.267 million, down 8.9% from $13.459 million in 2024[28] Operating Expenses - Total operating expenses decreased to $5.4 million from $6.9 million in the prior-year period[7] - Operating expenses for the nine months ended September 30, 2025, totaled $17.455 million, a decrease of 5.3% from $18.429 million in 2024[28] - The company recorded a stock-based compensation expense of $469,000 for the nine months ended September 30, 2025, compared to $301,000 in 2024[31] Cash and Assets - Cash and cash equivalents at September 30, 2025, were $7.1 million[8] - Cash and cash equivalents at the end of the period were $7.076 million, down from $8.396 million at the end of September 2024[30] - Total current assets decreased by 14% to $14.272 million as of September 30, 2025, from $16.595 million at December 31, 2024[26] Liabilities - Total liabilities decreased slightly by 1.8% to $29.403 million as of September 30, 2025, from $29.956 million at December 31, 2024[26] Market and Growth Potential - Positive developments in ongoing litigation are expected to translate to increased revenue in the coming quarters[3] - The company anticipates growth from newly approved reimbursement codes for XTRAC treatments, potentially tripling the covered patient population in the U.S.[5] Device Install Base - The U.S. install base of XTRAC devices declined by 6 to 838, while the install base of TheraClearX was 161[5] Billing Metrics - Average gross billings per device increased by 8.5% to $5,981, the highest since Q4 2022[5] Shareholder Information - The weighted average shares of common stock outstanding for the three months ended September 30, 2025, increased to 4,481,337 from 4,038,988 in 2024[28]
STRATA Skin Sciences Reports Third Quarter 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2025-11-13 21:05
Core Insights - STRATA Skin Sciences, Inc. reported a revenue of $6.9 million for Q3 2025, a decrease of 21% compared to Q3 2024, with global recurring revenue increasing by 3% year-over-year [4][7] - The company anticipates growth due to newly approved reimbursement codes for its XTRAC Excimer laser treatment, which is expected to enhance patient and practitioner interest [3][6] - STRATA's ongoing litigation has resulted in positive outcomes, potentially leading to increased revenue from new customers [3][6] Financial Performance - Total revenue for Q3 2025 was $6.9 million, down from $8.8 million in Q3 2024, with gross profit at $4.2 million, representing a gross margin of 60% [4][24] - Operating expenses decreased to $5.4 million in Q3 2025 from $6.9 million in the prior-year period [5][24] - The net loss for Q3 2025 was $1.6 million, or EPS of negative $0.36, an improvement from a net loss of $2.1 million, or EPS of negative $0.51, in Q3 2024 [7][24] Business Developments - STRATA is making progress in expanding CPT codes for reimbursement, effectively tripling the covered patient population in the U.S. [6] - The company received clearance for TheraClearX in Mexico, marking its first commercial placements [6] - XTRAC has been validated through multiple peer-reviewed publications for its clinical outcomes in treating autoimmune diseases [6] Market Position - The average gross billings per XTRAC device increased by 8.5% year-over-year to $5,981, the highest since Q4 2022 [6] - The U.S. install base of XTRAC devices decreased by 6 to 838, while the install base of TheraClearX stands at 161 [6] - STRATA continues to manage costs carefully while expanding its patient pool through direct-to-consumer efforts [3][6]
STRATA Skin Sciences Announces CMS Recognition of Expanded CPT Codes for Inflammatory and Autoimmune Dermatologic Conditions with Company Anticipating Wider Excimer Adoption Ahead Of 2027 CPT Expansion
Globenewswire· 2025-11-06 13:00
Core Insights - STRATA Skin Sciences, Inc. has received confirmation from the Centers for Medicare & Medicaid Services (CMS) regarding continued reimbursement for excimer laser treatments, with an expansion of CPT code descriptors expected in 2027 [1][2][7] Group 1: Reimbursement and Regulatory Updates - CMS has affirmed ongoing reimbursement for excimer laser treatments under CPT codes 96920, 96921, and 96922, ensuring uninterrupted patient access [7] - The Final Rule indicates a payment increase of approximately 3.5% for all three codes in calendar year 2026 compared to 2025 [7] - The current CPT code family remains exclusive to excimer laser technology until at least the 2027 descriptor updates, reinforcing STRATA's position against other technologies being billed under these codes [7] Group 2: Future Indications and Clinical Engagement - CMS recognizes the upcoming expansion of excimer laser procedure eligibility to include additional inflammatory and autoimmune conditions, effective January 1, 2027 [7] - STRATA is actively engaging with commercial insurance providers to ensure that individual coverage policies extend the excimer laser exclusivity beyond 2027 [3][4] - The company plans to incorporate extensive clinical and real-world cost data in the 2027 rulemaking process, which will be reviewed alongside recommendations from the American Medical Association (AMA) [2][4] Group 3: Commitment to Patients and Providers - STRATA's XTRAC excimer laser is FDA-cleared and clinically proven for treating various dermatologic conditions, including psoriasis and vitiligo [6] - The company is committed to partnering with clinicians, patient advocates, and payers to ensure the availability of safe and effective treatment options [6] - STRATA supports over 840 partner clinics and aims to expand the adoption of excimer laser procedures across immune-mediated skin diseases [4]
STRATA Skin Sciences to Report Third Quarter 2025 Financial Results on November 13, 2025 and Provide Corporate Update
Globenewswire· 2025-11-05 13:00
Core Insights - STRATA Skin Sciences, Inc. will report its third quarter 2025 financial results on November 13, 2025, after market close [1] - A conference call will be held on the same day at 4:30 p.m. ET to discuss the financial results and corporate developments [2] Company Overview - STRATA Skin Sciences is a medical technology company focused on developing, commercializing, and marketing innovative products for dermatologic conditions such as psoriasis, vitiligo, and acne [5] - The company's product offerings include the XTRAC excimer laser, VTRAC lamp systems, and the TheraClearX Acne Therapy System [5] Partnership Program - STRATA offers a unique Partnership Program in the U.S., which includes a fee per treatment cost structure instead of requiring equipment purchase [6] - The program provides on-site training, service and maintenance, dedicated account support, and co-op advertising to promote awareness [6]
STRATA Skin Sciences Announces COFEPRIS Clearance of TheraClear® in Mexico and First Commercial Placements
Globenewswire· 2025-10-28 12:00
Core Insights - STRATA Skin Sciences, Inc. has received regulatory clearance from COFEPRIS in Mexico for its TheraClearX® acne treatment system, valid through November 2029 [1][3] - This certification marks a significant step in STRATA's international expansion strategy, allowing for the commercialization and clinical use of TheraClearX® in Mexico [2] Regulatory Clearance and Initial Launch - The COFEPRIS registration process typically takes 6 to 12 months and confirms that STRATA's technologies meet Mexico's regulatory standards for dermatologic devices [3] - STRATA has partnered with MINO Labs for the commercial rollout, with the first system placed with Dr. Melissa Lomelí Canedo in Mexico City [4] Market Potential in Mexico - The acne treatment market in Mexico is rapidly growing, with a projected CAGR of approximately 10.2% for the professional acne medication segment by 2030 [9] - An average acne treatment session costs around MXN 3,200 (approximately USD 174), positioning TheraClearX® competitively in the premium in-office care segment [9] Strategic Partnership with MINO Labs - MINO Labs has a nationwide network of over 3,000 dermatologists and aesthetic practitioners, providing STRATA with immediate access to a robust professional base [7] - The partnership aims to enhance the standard of dermatologic care in Mexico by bridging the gap in access to advanced treatment technologies [8] Usage-Based Model - TheraClearX® will be offered under a usage-based partnership model in Mexico, allowing physicians to operate the device without upfront capital investment, thus minimizing financial barriers [10] Forward Outlook - STRATA plans to expand device deployment to major metropolitan areas in Mexico, including Guadalajara, Monterey, Puebla, and Tijuana [11] - The company aims to launch clinical education programs with MINO Labs and gather real-world clinical data to support broader adoption [16]
STRATA Skin Sciences Reinforces Market Leadership Following Key Litigation Milestones Against LaserOptek
Globenewswire· 2025-10-20 12:00
Core Insights - STRATA Skin Sciences, Inc. has successfully strengthened its competitive position through ongoing litigation against LaserOptek America Corp. and its affiliates, with a recent court ruling in its favor [2][3][8] - The company has regained market share by converting dermatology clinics misled by false advertising claims to its XTRAC excimer laser technology, resulting in over $1 million in annualized revenue [5][6][9] - STRATA is poised for growth as the American Medical Association has reaffirmed the exclusive use of excimer lasers under specific CPT codes, allowing for the treatment of a broader range of dermatologic conditions [8][9] Legal Developments - The U.S. District Court for the Eastern District of Pennsylvania partially granted STRATA's motion for a preliminary injunction, adding LaserOptek Korea as a defendant [2] - The court's ruling allows STRATA to hold all responsible parties accountable for false advertising and unfair trade practices under the Lanham Act [2][3] Market Positioning - STRATA has engaged over 20 clinics previously using LaserOptek's Pallas laser, converting them to XTRAC excimer laser users [5][6] - Approximately 1,200 U.S. dermatology clinics currently utilize excimer laser therapy, with 844 of these clinics under STRATA's partnership program [6][8] Partnership Program - STRATA's partnership program is designed for individual clinic owners and includes over 358 clinics owned by private equity-backed national accounts, indicating potential expansion to over 2,000 additional clinics [7][8] - The program offers a fee-per-treatment structure, on-site training, and marketing support, enhancing the attractiveness of STRATA's offerings [12] Future Outlook - The expansion of CPT codes to include up to 30 dermatologic conditions is expected to significantly increase patient access and revenue for STRATA and its partner clinics [9] - The company is committed to defending its market share and ensuring ethical billing practices in collaboration with CMS and private payers [9][10]
Excimer Laser Demonstrates Promising Results in Treating Rare Variant of Cutaneous Lymphoma, Mycosis Fungoides
Globenewswire· 2025-10-14 12:15
Core Insights - The article highlights a groundbreaking clinical case study demonstrating the successful use of a 308-nm excimer laser in treating poikilodermatous mycosis fungoides (pMF), a rare subtype of cutaneous T-cell lymphoma [1][2][8] Company Overview - STRATA Skin Sciences, Inc. is a medical technology company focused on developing and marketing innovative products for dermatologic conditions, including the XTRAC excimer laser [1][12] - The company is actively working with the Centers for Medicare and Medicaid Services (CMS) to expand reimbursement codes for a wider range of conditions treated by the XTRAC laser [3] Clinical Study Details - The study, led by dermatology researchers at Tohoku University, is the first English-language report validating excimer laser therapy as a safe and effective treatment for pMF [2][3] - The case study involved a 50-year-old female patient with a 3-year history of progressive lesions, who showed marked improvement after treatment with the excimer laser [6][7] Treatment Efficacy - A systematic review published in 2022 indicated that 73.6% of patients with mycosis fungoides achieved a complete clinical response using the 308-nm excimer laser, with a low relapse rate of 5.7% [4] - The excimer laser offers a targeted treatment option that minimizes exposure to unaffected skin, contrasting with traditional therapies that require whole-body exposure [9][10] Market Implications - The successful application of the excimer laser in treating pMF could influence future treatment guidelines and improve patient quality of life in this rare disease population [11] - Japan is identified as a significant market for the XTRAC excimer laser, with local dermatologists pioneering new uses for the technology [3]