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STRATA Skin Sciences to Participate in June Dermatology Conferences
GlobeNewswire News Room· 2024-06-04 12:00
HORSHAM, Penn., June 04, 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 its participation in two dermatology conferences in the month of June. On June 1, STRATA has participated in the inaugural Schweiger Symposium at the Jacob Javits Center in New York City. The Symposium brought together dermatology ...
STRATA Skin Sciences(SSKN) - 2024 Q1 - Earnings Call Transcript
2024-05-16 02:08
STRATA Skin Sciences, Inc. (NASDAQ:SSKN) Q1 2024 Results Conference Call May 2, 2024 4:30 PM ET Company Participants Dolev Rafaeli - Chief Executive Officer Chris Lesovitz - Chief Financial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann & Co. Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the STRATA Skin Sciences Inc. First Quarter of 2024 Financial Results and Corporate Update Conference Call. [Operator Instructions] A webcast replay of the ...
STRATA Skin Sciences(SSKN) - 2024 Q1 - Quarterly Report
2024-05-15 20:33
PART I. FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the three months ended March 31, 2024 and 2023 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | Change (vs. Dec 31, 2023) | | :-------------------------------- | :------------- | :---------------- | :------------------------ | | Cash and cash equivalents | $5,237 | $6,784 | -$1,547 | | Accounts receivable, net | $3,630 | $4,440 | -$810 | | Total current assets | $13,239 | $15,543 | -$2,304 | | Total assets | $40,048 | $42,016 | -$1,968 | | Accounts payable | $3,592 | $3,343 | +$249 | | Total current liabilities | $12,588 | $12,174 | +$414 | | Long-term debt, net | $15,075 | $15,044 | +$31 | | Total liabilities | $30,616 | $29,328 | +$1,288 | | Total stockholders' equity | $9,432 | $12,688 | -$3,256 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Revenues, net | $6,754 | $7,567 | -$813 | | Cost of revenues | $3,674 | $3,179 | +$495 | | Gross profit | $3,080 | $4,388 | -$1,308 | | Loss from operations | $(2,889) | $(2,586) | -$303 | | Net loss | $(3,368) | $(2,835) | -$533 | | Net loss per share, basic and diluted | $(0.10) | $(0.08) | -$0.02 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Changes in Stockholders' Equity (in thousands) | Metric | Balance at Jan 1, 2024 | Stock-based Compensation Expense | Net Loss | Balance at Mar 31, 2024 | | :------------------------ | :--------------------- | :------------------------------- | :------- | :---------------------- | | Total Stockholders' Equity | $12,688 | $112 | $(3,368) | $9,432 | - Stockholders' equity decreased by **$3,256 thousand** from January 1, 2024, to March 31, 2024, primarily due to a **net loss of $3,368 thousand**[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | $(804) | $(817) | +$13 | | Net cash used in investing activities | $(725) | $(1,792) | +$1,067 | | Net cash used in financing activities | $(18) | $0 | -$18 | | Net decrease in cash, cash equivalents and restricted cash | $(1,547) | $(2,609) | +$1,062 | | Cash, cash equivalents and restricted cash at end of period | $6,571 | $4,186 | +$2,385 | - The decrease in cash used in investing activities was primarily due to a **reduction in capital expenditures** after the launch of TheraClear in Q1 2023[153](index=153&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1: The Company – Background and Operations](index=7&type=section&id=Note%201%20The%20Company%3A%20Background) - STRATA Skin Sciences, Inc is a medical technology company specializing in dermatology, offering products like XTRAC® and Pharos® excimer lasers, VTRAC® lamp systems, and the TheraClear® X Acne Therapy System[22](index=22&type=chunk)[24](index=24&type=chunk)[115](index=115&type=chunk) - As of March 31, 2024, there were **907 XTRAC systems** placed in dermatologists' offices in the United States and **45 internationally** under a recurring revenue model[23](index=23&type=chunk)[117](index=117&type=chunk) - The company is transitioning its international distribution to a direct model, having signed distributor contracts in various countries since 2019[25](index=25&type=chunk) - The COVID-19 pandemic, Russia-Ukraine War, and Israel-Hamas conflict are noted as potential ongoing negative impacts on operations and financial performance[26](index=26&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) [Note 1: Basis of Presentation and Accounting Policies](index=8&type=section&id=Note%201%20Basis%20of%20presentation) - The condensed consolidated financial statements are unaudited and prepared in accordance with SEC rules for interim financial reporting[31](index=31&type=chunk) - No changes to significant accounting policies occurred during the three months ended March 31, 2024[33](index=33&type=chunk) - The company uses estimates and assumptions for revenue recognition, valuation allowances, goodwill impairment, and other financial metrics[34](index=34&type=chunk) - The fair values of cash, cash equivalents, restricted cash, and long-term debt approximate their carrying values[36](index=36&type=chunk) Warranty Accrual Activity (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Balance, beginning of period | $303 | $207 | | Additions | $39 | $27 | | Expirations and claims satisfied | $(64) | $(5) | | Total | $278 | $229 | [Note 1: Net Loss Per Share](index=9&type=section&id=Note%201%20Net%20Loss%20Per%20Share) - Diluted net loss per share is the same as basic net loss per share because potential dilutive securities are anti-dilutive when a net loss exists[39](index=39&type=chunk) Potentially Dilutive Securities Excluded from Diluted EPS (in thousands) | Security Type | March 31, 2024 | March 31, 2023 | | :-------------- | :------------- | :------------- | | Stock options | 5,391,069 | 4,464,714 | | Warrants | 800,000 | 373,626 | | RSUs | 22,654 | 119,597 | | Total | 6,213,723 | 4,957,937 | [Note 1: Recent Accounting Pronouncements](index=10&type=section&id=Note%201%20Recent%20Accounting%20Pronouncements) - The adoption of ASU 2020-06 (Accounting for Convertible Instruments) on January 1, 2024, had **no impact** on the financial statements[42](index=42&type=chunk) - The company is evaluating the effect of ASU 2023-07 (Segment Reporting) and ASU 2023-09 (Income Tax Disclosures)[43](index=43&type=chunk)[44](index=44&type=chunk) [Note 2: Liquidity](index=10&type=section&id=Note%202%20Liquidity) - The company believes current cash and anticipated revenues will be sufficient for the next 12 months despite a history of recurring losses[45](index=45&type=chunk)[151](index=151&type=chunk) - Market conditions, including geopolitical conflicts and supply chain disruptions, could interfere with the company's ability to access financing[45](index=45&type=chunk)[151](index=151&type=chunk) - In June 2023, the company amended its credit facility, refinancing an $8 million loan and borrowing an additional $7 million[45](index=45&type=chunk)[146](index=146&type=chunk) - As of March 31, 2024, **working capital was $651 thousand**, down from $3,369 thousand at December 31, 2023[145](index=145&type=chunk) [Note 3: Revenue Recognition](index=10&type=section&id=Note%203%20Revenue%20Recognition) - Revenues from dermatology recurring procedures are recognized over the estimated usage period[46](index=46&type=chunk) - Revenues from equipment sales are recognized when control is transferred to customers, typically upon shipment[49](index=49&type=chunk) - As of March 31, 2024, remaining performance obligations totaled **$628 thousand**, with $251 thousand expected to be recognized within one year[52](index=52&type=chunk) - The company recognized **$76 thousand** as revenue from deferred revenues for the three months ended March 31, 2024[53](index=53&type=chunk) Expected Future Undiscounted Fixed Treatment Code Payments (International) (in thousands) | Year | Amount | | :------------- | :----- | | Remaining 2024 | $1,064 | | 2025 | $934 | | 2026 | $716 | | 2027 | $445 | | 2028 | $19 | | Total | $3,178 | [Note 4: Inventories](index=13&type=section&id=Note%204%20Inventories) - The company wrote off **$141 thousand** of inventories during Q1 2024 due to the expiration of extended warranty service contracts[56](index=56&type=chunk) Inventories Breakdown (in thousands) | Category | March 31, 2024 | December 31, 2023 | | :------------------------ | :------------- | :---------------- | | Raw materials and work-in-process | $2,421 | $2,192 | | Finished goods | $274 | $481 | | Total | $2,695 | $2,673 | [Note 5: Property and Equipment, net](index=14&type=section&id=Note%205%20Property%20and%20Equipment%2C%20net) - Depreciation and amortization expense was **$755 thousand** for Q1 2024, up from $677 thousand in Q1 2023[58](index=58&type=chunk) Property and Equipment, net (in thousands) | Category | March 31, 2024 | December 31, 2023 | | :------------------------ | :------------- | :---------------- | | Lasers placed-in-service | $32,940 | $32,095 | | Lasers-in-process | $3,121 | $3,231 | | Total | $36,743 | $36,062 | | Less: accumulated depreciation and amortization | $(25,017) | $(24,284) | | Net | $11,726 | $11,778 | [Note 6: Intangible Assets, net](index=14&type=section&id=Note%206%20Intangible%20Assets%2C%20net) - Amortization expense for intangible assets was **$494 thousand** for Q1 2024, a decrease from $720 thousand in Q1 2023[59](index=59&type=chunk) - **No impairment charges** were recognized for intangible assets during Q1 2024 or Q1 2023[60](index=60&type=chunk) Intangible Assets, net (in thousands) | Category | March 31, 2024 Net Book Value | December 31, 2023 Net Book Value | | :------------------------ | :---------------------------- | :------------------------------- | | Core technology | $712 | $855 | | Product technology | $912 | $942 | | Customer relationships | $862 | $1,035 | | Tradenames | $187 | $225 | | Pharos customer lists | $4,152 | $4,262 | | Total | $6,825 | $7,319 | Estimated Future Amortization Expense for Intangible Assets (in thousands) | Year | Amount | | :------------- | :----- | | Remaining 2024 | $1,477 | | 2025 | $1,266 | | 2026 | $561 | | 2027 | $561 | | 2028 | $561 | [Note 7: Accrued Expenses and Other Current Liabilities](index=15&type=section&id=Note%207%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2024 | December 31, 2023 | | :------------------------ | :------------- | :---------------- | | Warranty obligations | $175 | $180 | | Compensation and related benefits | $1,667 | $1,679 | | State sales, use and other taxes | $4,290 | $4,316 | | Professional fees and other | $137 | $131 | | Total | $6,269 | $6,306 | [Note 8: Long-Term Debt](index=15&type=section&id=Note%208%20Long-Term%20Debt) - The company's Senior Term Facility provides for a **$20 million** senior secured term loan, with **$15 million drawn** as of March 31, 2024[68](index=68&type=chunk) - The facility bears interest at a variable rate, resulting in an effective interest rate of **13.94%** as of March 31, 2024[69](index=69&type=chunk) - The company is required to make interest-only payments through June 1, 2026, with a final maturity date of June 1, 2028[69](index=69&type=chunk) - The company was in compliance with its financial covenants as of March 31, 2024[71](index=71&type=chunk)[147](index=147&type=chunk) - Interest expense increased to **$524 thousand** in Q1 2024 from $286 thousand in Q1 2023[75](index=75&type=chunk)[142](index=142&type=chunk) Future Minimum Principal Payments at March 31, 2024 (in thousands) | Year | Amount | | :------------- | :----- | | 2026 | $3,750 | | 2027 | $7,500 | | 2028 | $3,750 | | Total | $15,000 | | Exit fee | $600 | | Less: unamortized debt discount | $(525) | | Long-term debt, net | $15,075 | [Note 9: Stock-Based Compensation](index=17&type=section&id=Note%209%20Stock-Based%20Compensation) - Stock-based compensation expense for Q1 2024 was **$112 thousand**, a decrease from $325 thousand in Q1 2023[79](index=79&type=chunk) - Selling and marketing expense for stock-based compensation was negative in Q1 2024 due to award forfeitures[79](index=79&type=chunk) - Unrecognized compensation expense for stock options was **$1,687 thousand**, expected to be recognized over approximately 2.9 years[80](index=80&type=chunk) Stock Option Activity for Three Months Ended March 31, 2024 | Metric | Number of Shares Under Option Plan | Weighted Average Exercise Price per Option | | :------------------------ | :------------------------------- | :--------------------------------------- | | Outstanding at Jan 1, 2024 | 7,728,721 | $1.11 | | Granted | 100,000 | $0.54 | | Forfeited and expired | (2,437,652) | $1.55 | | Outstanding at Mar 31, 2024 | 5,391,069 | $0.89 | | Exercisable at Mar 31, 2024 | 1,231,465 | $1.70 | Restricted Stock Unit Activity for Three Months Ended March 31, 2024 | Metric | Number of Units | Weighted Average Grant Date Fair Value | | :------------------------ | :-------------- | :------------------------------------- | | Unvested at Jan 1, 2024 | 22,654 | $1.03 | | Vested | (5,663) | $1.03 | | Unvested at Mar 31, 2024 | 16,991 | $1.03 | [Note 10: Income Taxes](index=19&type=section&id=Note%2010%20Income%20Taxes) - **No income tax expense** was incurred for the three months ended March 31, 2024 and 2023[85](index=85&type=chunk) [Note 11: Business and Geographical Reporting Segments](index=19&type=section&id=Note%2011%20Business%20and%20Geographical%20Reporting%20Segments) - The company operates in two segments: Dermatology Recurring Procedures and Dermatology Procedures Equipment[86](index=86&type=chunk) - Dermatology Recurring Procedures revenue **decreased by 9.9% YoY**, and gross profit percentage declined[88](index=88&type=chunk)[137](index=137&type=chunk) - Dermatology Procedures Equipment revenue **decreased by 12.7% YoY**, and gross profit percentage declined significantly[88](index=88&type=chunk)[133](index=133&type=chunk)[138](index=138&type=chunk) Segment Revenues and Gross Profit (in thousands) | Segment | Q1 2024 Revenue | Q1 2023 Revenue | Q1 2024 Gross Profit | Q1 2023 Gross Profit | Q1 2024 Gross Profit % | Q1 2023 Gross Profit % | | :-------------------------------- | :-------------- | :-------------- | :------------------- | :------------------- | :--------------------- | :--------------------- | | Dermatology Recurring Procedures | $4,696 | $5,209 | $2,501 | $3,189 | 53.3% | 61.2% | | Dermatology Procedures Equipment | $2,058 | $2,358 | $579 | $1,199 | 28.1% | 50.8% | | Total | $6,754 | $7,567 | $3,080 | $4,388 | 45.6% | 58.0% | Geographical Revenue Breakdown (in thousands) | Region | Q1 2024 Recurring | Q1 2024 Equipment | Q1 2024 Total | Q1 2023 Recurring | Q1 2023 Equipment | Q1 2023 Total | | :------- | :---------------- | :---------------- | :------------ | :---------------- | :---------------- | :------------ | | Domestic | $4,320 | $141 | $4,461 | $4,847 | $496 | $5,343 | | Foreign | $376 | $1,917 | $2,293 | $362 | $1,862 | $2,224 | | Total | $4,696 | $2,058 | $6,754 | $5,209 | $2,358 | $7,567 | [Note 12: Significant Customer Concentrations](index=21&type=section&id=Note%2012%20Significant%20Customer%20Concentrations) - For Q1 2024, one international distributor accounted for **16.3%** of total revenues[94](index=94&type=chunk) - One customer represented **12.5%** of net accounts receivable as of March 31, 2024[95](index=95&type=chunk) [Note 13: Commitments and Contingencies](index=21&type=section&id=Note%2013%20Commitments%20and%20Contingencies) - The company executed new five-year leases in March 2024, increasing ROU assets and operating lease liabilities by **$977 thousand**[97](index=97&type=chunk) - The company is appealing a New York State ruling that its XTRAC treatment codes are subject to sales tax, covering **$1.484 million** of a total $3.943 million in assessments[102](index=102&type=chunk)[103](index=103&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) - The company faces potential future earnout and royalty payments related to the 2022 acquisition of TheraClear devices[106](index=106&type=chunk)[148](index=148&type=chunk) - A PAGA class action lawsuit in California was settled for **$106 thousand**, with final approval granted on April 5, 2024[110](index=110&type=chunk)[163](index=163&type=chunk) Operating Lease Maturities as of March 31, 2024 (in thousands) | Year | Amount | | :------------- | :----- | | Remaining 2024 | $341 | | 2025 | $463 | | 2026 | $334 | | 2027 | $290 | | 2028 | $301 | | Thereafter | $231 | | Total remaining lease payments | $1,960 | | Less: imputed interest | $(494) | | Total lease liabilities | $1,466 | [Note 14: Subsequent Events](index=23&type=section&id=Note%2014%20Subsequent%20Events) - On April 26, 2024, the company announced a **1-for-10 reverse stock split** of its common stock, effective June 6, 2024[111](index=111&type=chunk)[125](index=125&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for Q1 2024 [Introduction, Outlook, Overview of Business Operations and Recent Developments](index=24&type=section&id=Introduction%2C%20Outlook%2C%20Overview%20of%20Business%20Operations%20and%20Recent%20Developments) - STRATA Skin Sciences is a medical technology company focused on dermatology, offering systems for various skin conditions[115](index=115&type=chunk) - The company's XTRAC system is widely recognized for treating psoriasis and vitiligo, with **907 systems** in the U.S. as of March 31, 2024[117](index=117&type=chunk)[123](index=123&type=chunk) - The TheraClear® X Acne Therapy System combines intense pulse light with vacuum for acne treatment, though insurance reimbursement is limited[118](index=118&type=chunk)[123](index=123&type=chunk) - Global events like COVID-19 and geopolitical conflicts continue to pose risks to business conditions and supply chains[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - A **1-for-10 reverse stock split** was announced, effective June 6, 2024, to meet Nasdaq's minimum bid price requirement[125](index=125&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) - Dermatology Recurring Procedures revenue decreased due to a reduction in direct-to-patient advertising and lower deferred revenue recognition[129](index=129&type=chunk)[130](index=130&type=chunk) - Dermatology Procedures Equipment revenue decreased primarily due to a reduction in Pharos service billings and discounts on international sales[133](index=133&type=chunk) - The decrease in overall gross profit percentage was driven by lower deferred revenue recognition, a **$141 thousand inventory write-off**, and higher depreciation costs[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - Selling and marketing expenses decreased primarily due to a reduction in sales force size and lower commissions[140](index=140&type=chunk) - General and administrative expenses decreased due to lower stock-based compensation, legal fees, and board fees[141](index=141&type=chunk) Revenue by Segment (in thousands) | Segment | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Dermatology recurring procedures | $4,696 | $5,209 | -$513 | | Dermatology procedures equipment | $2,058 | $2,358 | -$300 | | Total revenues, net | $6,754 | $7,567 | -$813 | Gross Profit Analysis (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Gross profit | $3,080 | $4,388 | -$1,308 | | Gross profit percentage | 45.6% | 58.0% | -12.4 pp | Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Engineering and product development | $241 | $315 | -$74 | | Selling and marketing | $3,018 | $3,742 | -$724 | | General and administrative | $2,710 | $2,917 | -$207 | | Interest expense | $524 | $286 | +$238 | [Non-GAAP Adjusted EBITDA](index=29&type=section&id=Non-GAAP%20adjusted%20EBITDA) - **Non-GAAP adjusted EBITDA worsened** to $(1,279) thousand in Q1 2024 from $(759) thousand in Q1 2023[144](index=144&type=chunk) Non-GAAP Adjusted EBITDA Reconciliation (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(3,368) | $(2,835) | | Depreciation and amortization | $1,249 | $1,397 | | Amortization of operating lease ROU assets | $95 | $105 | | Loss on disposal of property and equipment | $13 | $0 | | Interest expense, net | $479 | $249 | | Non-GAAP EBITDA | $(1,532) | $(1,084) | | Stock-based compensation expense | $112 | $325 | | Inventory write-off | $141 | $0 | | Non-GAAP adjusted EBITDA | $(1,279) | $(759) | [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - Working capital decreased to **$651 thousand** as of March 31, 2024, from $3,369 thousand at December 31, 2023[145](index=145&type=chunk) - Cash, cash equivalents, and restricted cash totaled **$6,571 thousand** as of March 31, 2024[145](index=145&type=chunk) - The company's credit facility was amended in June 2023, with an effective interest rate of **13.94%** as of March 31, 2024[69](index=69&type=chunk)[146](index=146&type=chunk) - The company believes its current cash and anticipated revenues will be sufficient to meet liquidity requirements for at least the next 12 months[151](index=151&type=chunk) - Net cash used in operating activities remained consistent at **$(804) thousand** in Q1 2024[152](index=152&type=chunk) - Net cash used in investing activities decreased to **$(725) thousand** in Q1 2024 from $(1,792) thousand in Q1 2023[153](index=153&type=chunk) [Commitments and Contingencies](index=31&type=section&id=Commitments%20and%20Contingencies) - No significant impacts on commitments and contingencies were noted beyond those discussed in the 2023 annual financial statements[155](index=155&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosure about Market Risk](index=31&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosure%20about%20Market%20Risk) This section states that there are no applicable quantitative and qualitative disclosures about market risk for the company - This item is not applicable to the company[156](index=156&type=chunk) [ITEM 4. Controls and Procedures](index=31&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024 - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2024[157](index=157&type=chunk) - Control systems provide **reasonable, not absolute, assurance** that objectives are met due to inherent limitations[159](index=159&type=chunk) - **No material changes** in internal control over financial reporting occurred during the most recent fiscal quarter[160](index=160&type=chunk) PART II. OTHER INFORMATION [ITEM 1. Legal Proceedings](index=32&type=section&id=ITEM%201.%20Legal%20Proceedings) This section updates on legal matters, including a class action settlement and ongoing state sales tax appeals - A proposed representative class action under California's PAGA was settled for **$0.1 million**, with final approval granted on April 5, 2024[163](index=163&type=chunk) - The company is appealing a New York State Appellate Division ruling that its XTRAC treatment codes are subject to sales tax[164](index=164&type=chunk)[165](index=165&type=chunk) - New York and California have assessed the company an aggregate of **$3.9 million** for sales and use tax[164](index=164&type=chunk)[166](index=166&type=chunk) - The company filed a motion for leave to appeal the New York State Appellate Division's decision on April 11, 2024[165](index=165&type=chunk) [ITEM 1A. Risk Factors](index=33&type=section&id=ITEM%201A.%20Risk%20Factors) This section refers to the comprehensive business risks detailed in the company's 2023 Annual Report on Form 10-K - A description of business risks is set forth in Item 1A of the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023[168](index=168&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds during the reporting period - None[169](index=169&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=33&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities during the reporting period - None[170](index=170&type=chunk) [ITEM 4. Mine Safety Disclosures](index=33&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures applicable to the company - None[171](index=171&type=chunk) [ITEM 5. Other Information](index=33&type=section&id=ITEM%205.%20Other%20Information) This section confirms no directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended March 31, 2024[172](index=172&type=chunk) [ITEM 6. Exhibits](index=33&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the report, including credit agreement amendments and officer certifications - Exhibits include amendments to the Credit and Security Agreement, a letter agreement, and Rule 13a-14(a) Certificates of the CEO and CFO[174](index=174&type=chunk) - Certifications pursuant to 18 U.S.C. Section 1350 are attached as Exhibit 32.1[174](index=174&type=chunk) [Signatures](index=34&type=section&id=Signatures) This section contains the required signatures of the registrant's authorized officers for the quarterly report - The report is signed by Dolev Rafaeli, President & Chief Executive Officer, and Christopher Lesovitz, Chief Financial Officer, on May 15, 2024[177](index=177&type=chunk)
STRATA Skin Sciences(SSKN) - 2024 Q1 - Quarterly Results
2024-05-15 20:30
Exhibit 99.1 STRATA Skin Sciences Reports First Quarter 2024 Financial Results and Provides a Corporate Update HORSHAM, Penn., May 15, 2024 – 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 ended March 31, 2024 and provides a corporate update. First Quarter 2024 Highlights • Revenue in the ...
STRATA Skin Sciences(SSKN) - 2023 Q4 - Earnings Call Transcript
2024-03-28 02:03
STRATA Skin Sciences, Inc. (NASDAQ:SSKN) Q4 2023 Earnings Conference Call March 27, 2024 4:30 PM ET Company Participants Rich Cockrell - Investor Relations Dolev Rafaeli - President & Chief Executive Officer Christopher Lesovitz - Chief Financial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Operator Greetings, and welcome to the STRATA Skin Sciences' Fourth Quarter 2023 Earnings Conference Call and Webcast. At this time, all participants are in a listen-only mode. A brief question ...
STRATA Skin Sciences(SSKN) - 2023 Q4 - Annual Report
2024-03-28 00:06
Technology and Product Efficacy - The XTRAC excimer laser technology is FDA-cleared and has been shown to have an 89% efficacy rate in treating psoriasis, with significant improvement in plaques and severity scores in as few as six to ten treatments [28]. - The XTRAC system has been cited in over 45 clinical studies, demonstrating its effectiveness and safety in treating various skin conditions [28]. - The TheraClear Acne Therapy System, acquired in January 2022, combines vacuum and broadband light for effective treatment of inflammatory acne, with treatments taking only 10 minutes [37]. - The XTRAC product line competes with pharmaceutical compounds and methodologies for treating skin conditions, with a focus on its clinical effect, minimal side effects, and cost-effectiveness [38]. - The XTRAC Momentum® 1.0, launched in February 2022, features higher power and a faster repetition rate compared to previous models, enhancing treatment efficiency [25]. Market Presence and Distribution - As of December 31, 2023, there are over 1,000 XTRAC lasers in use in the U.S., with 923 systems included in the dermatology recurring procedures revenue model [26]. - The company estimates that the target U.S. audience for XTRAC lasers comprises approximately 3,500 dermatologists who perform disease management [26]. - The company has transitioned its international sales to a direct distribution model, signing distributor contracts in multiple countries including Mexico and India in 2023 [27]. - The company has 923 partner clinics in the United States as of December 31, 2023, primarily in the dermatology procedures recurring revenue model [79]. Regulatory Compliance and Legal Matters - The XTRAC and TheraClear devices are classified as Class II medical devices, requiring FDA 510(k) clearance for marketing, which has been obtained for various skin conditions [48][51]. - The company has received FDA 510(k) clearance for the XTRAC Momentum Excimer Laser platform, enhancing its product offerings in dermatological treatments [49]. - The company is approved by the European Union to affix the CE mark to its XTRAC laser and VTRAC lamp systems, allowing marketing in the European Economic Area [54]. - The company is subject to various federal and state laws aimed at preventing fraud and abuse in healthcare programs, impacting its operational compliance [56]. - The False Claims Act imposes liability for knowingly presenting false claims, which could significantly affect the company's financial performance if violated [63]. - The company is subject to the U.S. Foreign Corrupt Practices Act and similar anti-bribery laws, impacting its international customer relationships [65]. - Compliance with HIPAA regulations entails significant costs for the company, despite not being classified as a covered entity [67]. - The Health Information Technology for Economic and Clinical Health (HITECH) Act has increased civil penalty amounts for HIPAA violations up to an annual maximum of $1.5 million for uncorrected violations [68]. - The California Consumer Privacy Act (CCPA) provides specific privacy protections for California residents, impacting how the company handles personal data [66]. Operational Challenges - The impact of the COVID-19 pandemic has led to significant disruptions in business operations, affecting financial performance and customer behavior [21]. - The ongoing Russia-Ukraine conflict has affected the supply and pricing of noble gases essential for the operation of the company's lasers [22]. - Third-party reimbursement for the company's products is challenged by payers who may deny reimbursement based on cost-effectiveness or alternative treatments [73]. - The company maintains third-party relationships for the manufacture and maintenance of its systems, ensuring sufficient capacity to meet demand [40]. Financial and Employment Overview - The company had 99 full-time employees as of December 31, 2023, including 2 executive officers and 35 sales and marketing staff [78]. - As of December 31, 2023, the national payment rates assigned by CMS for phototherapy treatments are $153 for areas less than 250 square centimeters, $168 for areas between 250 to 500 square centimeters, and $228 for areas over 500 square centimeters [77].
STRATA Skin Sciences(SSKN) - 2023 Q4 - Annual Results
2024-03-27 20:44
Exhibit 99.1 STRATA Skin Sciences Reports Fourth Quarter and Full-Year 2023 Earnings Company to host conference call and webcast today, March 27, 2024, at 4:30 PM ET HORSHAM, Pa., Mar. 27, 2024 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN) ("STRATA" or "the Company"), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced financial results for the fourth quarter and full-year ended ...
STRATA Skin Sciences(SSKN) - 2023 Q3 - Earnings Call Transcript
2023-11-15 02:24
STRATA Skin Sciences, Inc. (NASDAQ:SSKN) Q3 2023 Earnings Conference Call November 14, 2023 4:30 PM ET Company Participants Rich Cockrell – Investor Relations Dolev Rafaeli – President and Chief Executive Officer Chris Lesovitz – Chief Financial Officer Conference Call Participants Jeffrey Cohen – Ladenburg Thalmann Operator Greetings, and welcome to the STRATA Skin Sciences Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session ...
STRATA Skin Sciences(SSKN) - 2023 Q3 - Quarterly Report
2023-11-14 22:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to ___________ Commission File Number 0-51481 STRATA SKIN SCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other j ...
STRATA Skin Sciences(SSKN) - 2023 Q2 - Earnings Call Transcript
2023-08-10 01:24
STRATA Skin Sciences, Inc. (NASDAQ:SSKN) Q2 2023 Earnings Conference Call August 9, 2023 4:30 PM ET Company Participants Nicole Jones - IR Bob Moccia - CEO Chris Lesovitz - CFO Conference Call Participants Destiny Hance - Ladenburg Thalmann Operator Greetings. Welcome to STRATA Skin Sciences' 2Q 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is bein ...