STRATA Skin Sciences(SSKN)

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STRATA Skin Sciences(SSKN) - 2024 Q4 - Annual Report
2025-03-27 23:37
Technology and Products - The XTRAC excimer laser technology is FDA-cleared and has been shown to have an 89% efficacy rate in treating psoriasis with minimal side effects[30]. - The company acquired the TheraClear assets in January 2022, which offers a two-part process for treating various types of acne[40]. - The company manufactures XTRAC products at a 17,000 sq. ft. facility in Carlsbad, California, which is ISO 13485 compliant[43]. - The company has received FDA 510(k) clearance for its XTRAC and VTRAC systems for treating psoriasis, vitiligo, atopic dermatitis, and leukoderma[51]. - The TheraClear device has also been cleared by the FDA through the 510(k) process[53]. - The company is approved by the European Union to affix the CE mark to its XTRAC laser and VTRAC lamp systems, allowing marketing in all member countries[56]. - The company relies on third-party manufacturers for the production of its TheraClear device, which must comply with the same regulatory requirements[57]. - The company is subject to routine inspections by the FDA and must adhere to various regulatory requirements for medical device manufacturing[54]. - The company’s research and development efforts focus on the application of the XTRAC system for treating inflammatory skin disorders[44]. Market and Competition - As of December 31, 2024, there are over 1,000 XTRAC lasers in use in the U.S., with 864 systems included in the dermatology recurring procedures revenue model[28]. - The XTRAC system competes with pharmaceutical compounds and methodologies, with major competitors including The Daavlin Company and National Biologic Corporation[41]. - The company has 864 partner clinics in the United States as of December 31, 2024, primarily in the dermatology procedures recurring revenue model[80]. - The reimbursement for XTRAC treatments ranges from $155 to $232 per treatment for 2024, with expected changes in 2025[30]. - Approximately 56% of insurers now consider XTRAC treatments for vitiligo to be medically necessary and provide coverage[36]. - The national payment rates for phototherapy treatments in 2024 are $155 for areas less than 250 square centimeters, $170 for 250 to 500 square centimeters, and $232 for areas over 500 square centimeters[77]. - Third-party reimbursement for the company's phototherapy products is contingent on cost-effectiveness and may be denied if alternatives are available[74]. Business Operations - The company transitioned its international dermatology procedures equipment sales to a direct distribution model, signing distributor contracts in multiple countries since 2019[29]. - The company is transitioning to a direct distribution model for international sales, which varies by country and requires individual reimbursement approvals[75]. - The company has signed distributor contracts in various countries, including Korea (2019), Japan (2020), and China (2021), with recent contracts in Mexico and India (2023)[80]. - The COVID-19 pandemic has negatively impacted operational and financial performance, affecting the ability to execute business strategies[22]. - The Russia-Ukraine War has disrupted the supply of noble gases essential for laser operations, impacting prices and availability[23]. Compliance and Regulations - The company’s future activities related to product sales and documentation may be scrutinized under federal and state false claims laws[64]. - The California Consumer Privacy Act (CCPA) provides specific privacy protections for California residents, impacting the company's data handling practices[68]. - The HITECH Act has increased civil penalty amounts for HIPAA violations up to an annual maximum of $1.5 million for uncorrected violations based on willful neglect[70]. - Compliance with state privacy laws may necessitate modifications to the company's operations and procedures[71]. - The company is not currently classified as a covered entity under HIPAA but may need to comply with certain standards due to customer requirements[69]. Workforce - As of December 31, 2024, the company had 106 full-time employees, including three executive officers and 37 sales and marketing staff[79]. - The company collaborates with physicians and hospitals for research, which requires compliance with applicable laws impacting its business[73].
STRATA Skin Sciences(SSKN) - 2024 Q4 - Annual Results
2025-03-27 20:30
Revenue Performance - Revenue for Q4 2024 was $9.6 million, a 10% increase from $8.7 million in Q4 2023[2] - Full year 2024 revenue was $33.6 million, slightly up from $33.4 million in 2023[11] - Total revenues for the year ended December 31, 2024, were $33,562,000, a slight increase of 0.6% compared to $33,358,000 in 2023[31] Recurring and Equipment Revenue - Global recurring revenue in Q4 2024 was $5.8 million, compared to $5.6 million in the prior year[7] - Equipment revenue for Q4 2024 was $3.8 million, up 23% from $3.1 million in Q4 2023[2] Gross Margin and Profit - Gross margin improved to 60.1% in Q4 2024, up 480 basis points from 55.3% in Q4 2023[2] - Gross profit for 2024 was $19,081,000, representing a gross margin of approximately 56.8%, up from $18,461,000 in 2023[31] International Sales - International sales in Q4 2024 reached $4.1 million, a 41% increase year-over-year[6] Operating Expenses - Operating expenses for 2024 were $22.7 million, an 8.5% decrease from $24.8 million in 2023[2] - Operating expenses totaled $28,336,000 in 2024, an increase from $27,065,000 in 2023, driven by higher general and administrative costs[31] Net Loss - Net loss for Q4 2024 was $4.5 million, compared to a net loss of $3.8 million in Q4 2023[9] - The net loss for 2024 was $10,086,000, a decrease from a net loss of $10,830,000 in 2023, resulting in a net loss per share of $2.65 compared to $3.10 in the previous year[31] Cash and Liquidity - Cash and cash equivalents at December 31, 2024, were $8.6 million[10] - Cash and cash equivalents at the end of 2024 were $7,261,000, up from $6,784,000 in 2023, indicating improved liquidity[29] Assets and Liabilities - Total current assets increased to $16,595,000 in 2024 from $15,543,000 in 2023, primarily driven by an increase in accounts receivable[29] - Total liabilities rose to $31,185,000 in 2024, compared to $29,328,000 in 2023, with current liabilities increasing significantly due to accrued expenses[29] Impairment and Challenges - The company reported an impairment of goodwill of $3,861,000 in 2024, compared to $2,284,000 in 2023, reflecting challenges in asset valuation[31] Cash Flow from Operations - The company generated net cash provided by operating activities of $188,000 in 2024, a recovery from a net cash used of $519,000 in 2023[33] Future Plans - The company plans to focus on developing social media marketing campaigns and expanding its dermatology and aesthetics franchise, although specific financial projections were not provided[26]
STRATA Skin Sciences(SSKN) - 2024 4 - Earnings Call Transcript
2025-03-27 20:30
Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $9.6 million, an increase of 10% compared to $8.7 million in Q4 2023 [19] - Gross profit increased to $5.8 million in Q4 2024, up from $4.8 million in the year-ago quarter [21] - Gross margins improved to 60.1% from 55.3% over the same period in 2023 [22] - Operating loss adjusted for non-cash impairment charges improved by 68% compared to Q4 2023 [12] Business Line Data and Key Metrics Changes - Average net revenue per device increased by 11% over the previous quarter and 6% over the prior year period [10] - Equipment revenue was $3.8 million in Q4 2024, up from $3.1 million in Q4 2023, driven by strong capital sales in international markets [21] - Gross domestic revenue billings in Q4 were $4.9 million, marking the third consecutive quarter of sequential increase [13] Market Data and Key Metrics Changes - International sales reached $4.1 million in Q4 2024, up 27% over Q3 2024 and up 41% over Q4 2023 [15] - The installed base of TheraClear X devices in the U.S. increased to 144 at the end of Q4 2024, up from 92 devices at the end of 2023 [14] - The company secured preauthorization for over 3,700 patients with acne in partner clinics year to date [15] Company Strategy and Development Direction - The company is focusing on improving the utilization of its machines by migrating accounts to non-cash insurance reimbursed accounts [9] - The strategy includes removing underperforming units while assisting higher volume customers to better utilize extract devices [10] - The company aims to enhance in-clinic processes and identify partner clinics with the greatest opportunities for growth [13] Management's Comments on Operating Environment and Future Outlook - Management noted a strong seasonal effect between Q4 and Q1, with Q4 typically being the strongest quarter [17] - The company is committed to executing its strategic goals for 2025, supported by its current financial position [23] - Management highlighted the importance of understanding the operational dynamics within clinics to improve device utilization [59] Other Important Information - Direct-to-consumer advertising ramped up significantly, generating approximately 2,800 patient appointments [12] - The company is experiencing strong growth in international markets, particularly in Japan, China, South Korea, and the Middle East [39][40] Q&A Session Summary Question: Clarification on the number of TheraClear devices - Management confirmed that 108 of the 144 TheraClear devices are in accounts that are now billing insurance [29] Question: Types of practices and geographical presence for new accounts - Initial uptake of insurance reimbursed accounts started in the Northeast, primarily among small to medium-sized groups [35] Question: Strength of international markets - The strongest international markets are Japan, China, South Korea, and the Middle East, with significant growth driven by technology appreciation and economic changes [39][40] Question: Identifying underutilized accounts and new clinic placements - Management explained the process of identifying underutilized accounts and emphasized the importance of historical patient numbers and clinic staffing for new placements [52][63]
STRATA Skin Sciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides a Corporate Update
Globenewswire· 2025-03-27 20:05
HORSHAM, Pa., March 27, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces its financial results for the quarter and year ended December 31, 2024, and provides a corporate update. Fourth Quarter and Full-Year 2024 Financial Highlights Revenue in the fourth quarter of 2024 was $9.6 million, up 10% from $8. ...
STRATA Skin Sciences to Report Fourth Quarter and Year End 2024 Financial Results on March 27, 2025 and Provide Corporate Update
Newsfilter· 2025-03-21 17:43
HORSHAM, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. ("STRATA" or the "Company") (NASDAQ:SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces that it will report fourth quarter and year end 2024 financial results on Thursday, March 27, 2025 after the market close. STRATA management will host a conference call at 4:30 p.m. ET on Thursday, March 27, 2025 to review financial ...
STRATA Skin Sciences to Report Fourth Quarter and Year End 2024 Financial Results on March 27, 2025 and Provide Corporate Update
Globenewswire· 2025-03-21 17:43
HORSHAM, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces that it will report fourth quarter and year end 2024 financial results on Thursday, March 27, 2025 after the market close. STRATA management will host a conference call at 4:30 p.m. ET on Thursday, March 27, 2025 to review financia ...
STRATA Skin Sciences Highlights New Clinical Study from Japan Demonstrating Superiority of Narrow Band Excimer Laser Over Non Narrow Band UVB-Source Like Excimer Light
Globenewswire· 2025-03-20 12:25
HORSHAM, Pa., March 20, 2025 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces the results of a newly published study in Japan that further validates the technological advantages of high repetition rate, high dose, coherent collimated narrow band Excimer Laser technology over other sources of UVB light that a ...
Why Fast-paced Mover Strata Skin Sciences (SSKN) Is a Great Choice for Value Investors
ZACKS· 2025-01-06 14:56
Momentum investing is essentially an exception to the idea of "buying low and selling high." Investors following this style of investing are usually not interested in betting on cheap stocks and waiting long for them to recover. Instead, they believe that "buying high and selling higher" is the way to make far more money in lesser time.Who doesn't like betting on fast-moving trending stocks? But determining the right entry point isn't easy. Often, these stocks lose momentum once their valuation moves ahead ...
STRATA Skin Sciences to Participate in the Benchmark Company 13th Annual Discovery Investor Conference
GlobeNewswire News Room· 2024-12-05 13:15
HORSHAM, Pa., Dec. 05, 2024 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces that President and Chief Executive Officer Dr. Dolev Rafaeli will participate in the Benchmark Company 13th Annual Discovery Investor Conference that is being held on Wednesday, December 11, 2024, at the New York Athletic Club in Ne ...
STRATA Skin Sciences(SSKN) - 2024 Q3 - Earnings Call Transcript
2024-11-14 01:05
STRATA Skin Sciences, Inc. (NASDAQ:SSKN) Q3 2024 Results Conference Call November 13, 2024 4:30 PM ET Company Participants Joey Delahoussaye - Investor Relations Dolev Rafaeli - Chief Executive Officer John Gillings - V.P. Finance Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the STRATA Skin Sciences, Inc. Third Quarter 2024 Financial Results and Corporate Update Conference Call. [Operator Instructions]. Participants of this call are advised that the audio of this ...