ITEM 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
The following discussion of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and notes to condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q (this “Report”). This discussion contains forward-looking statements that involve risks and uncertainties. These forward-looking statements include, but are not limited to, statements about the plans, objectives, expectations and intentions of STRATA Skin Sciences, Inc., a Delaware corporation (referred to in this Report as “we,” “us,” “our,” “STRATA,” “STRATA Skin Sciences” or “registrant”) and other statements contained in this Report that are not historical facts. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that characterize our business including the scope and duration of the COVID-19 outbreak and its impact on global economic systems. In particular, we encourage you to review the risks and uncertainties described in Part II-Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021. These risks and uncertainties could cause actual results to differ materially from those projected in forward-looking statements contained in this Report or implied by past results and trends. Forward-looking statements are statements that attempt to forecast or anticipate future developments in our business, financial condition or results of operations and statements These statements, like all statements in this Report, speak only as of their date (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.
The following financial data, in this narrative, are expressed in thousands, except for the earnings per share and prices per treatment.
Introduction, Outlook, Overview of Business Operations and Recent Developments
STRATA Skin Sciences, Inc. is a medical technology company in dermatology dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions. Its products include the XTRAC® and now Pharos® excimer lasers and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions. Its products also include the TheraClear® Acne Clearing System utilized in the treatment of mild to moderate inflammatory, comedonal and pustular acne.
The XTRAC ultraviolet light excimer laser system is utilized to treat psoriasis, vitiligo and other skin diseases. The XTRAC excimer laser system received clearance from the United States Food and Drug Administration in 2000 and has since become a widely recognized treatment among dermatologists. The system delivers targeted 308nm ultraviolet light to affected areas of skin, leading to psoriasis clearing and vitiligo repigmentation, following a series of treatments. As of June 30, 2022, there were 915 XTRAC systems placed in dermatologists’ offices in the United States under our dermatology recurring procedures model, an increase from 890 at the end of December 31, 2021. Under the dermatology recurring procedures model, the XTRAC system is placed in a physician’s office and fees are charged on a per procedure basis or a fee is charged on a periodic basis not to exceed an agreed upon number of procedures. The XTRAC system’s use for psoriasis is covered by nearly all major insurance companies, including Medicare. The VTRAC Excimer Lamp system, offered internationally in addition to the XTRAC, provides targeted therapeutic efficacy demonstrated by excimer technology with the simplicity of design and reliability of a lamp system. We believe there are approximately 7.5 million people in the United States and up to 125 million people worldwide suffering from psoriasis, and 1% to 2% of the world’s population suffers from vitiligo.
The Pharos excimer laser system holds FDA clearance to treat chronic skin diseases, including psoriasis, vitiligo, atopic dermatitis and leukoderma.
The TheraClear® Acne Clearing System combines intense pulse light with vacuum (suction) for the treatment of mild to moderate inflammatory acne (including acne vulgaris), comedonal acne and pustular acne.
In late 2019, there was an outbreak of a new strain of coronavirus (“COVID-19”) which became a global pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and created significant volatility and disruption of financial markets. In addition, the pandemic led to the suspension of elective procedures in the U.S. and to the temporary closure of many physician practices which are our primary customers. While many offices have reopened, some physician practices closed and never reopened, and the impact of the ongoing COVID-19 pandemic and its variants on our operational and financial performance, including our ability to execute our business strategies and initiatives in the expected time frames, will depend on future developments, including the duration and ongoing spread of the COVID-19 outbreak and its variants, continued or renewed restrictions on business operations and transportation, any governmental and societal responses thereto, including legislative or regulatory as well as the percentage of the populace vaccinated and effectiveness of COVID-19 vaccines and the continued impact on worldwide economic and geopolitical conditions and inflation, all of which are uncertain and cannot be predicted.
Domestically, as the procedures in which our devices are used are elective in nature and as social distancing, travel restrictions, and other restrictions became prevalent in the United States, this had a negative impact on our recurring revenue model and our financial position and cash flow. The virus has disrupted the supply chains world-wide that we depend upon to provide a steady source of components to manufacture and repair our devices. To mitigate the impact of COVID-19, we have taken a variety of measures to ensure the availability and functioning of our critical infrastructure by implementing business continuity plans to promote the safety and security of our employees, while complying with various government mandates, including work-from-home arrangements and social-distancing initiatives to reduce the transmission of COVID-19, and complying with federal and local regulations at our facilities. The Company implemented a policy whereby all Company employees are required to be vaccinated or complete weekly COVID-19 testing. In addition, we created and executed programs utilizing our direct-to-consumer advertising and call center to contact patients and partner clinics to restart our partners’ businesses.
In the event our own employees are impacted through direct or ancillary contact with a person who has the virus, we may need to devise other methods of transacting business in our offices by working from home and or potentially ceasing operations for a period of time. Supply chain disruptions which began during the pandemic have continued and may continue for the foreseeable future. While the Company’s operations have not been materially impacted by the general trends in supply chain problems, the Company continues to monitor and assess potential risks.
The ongoing COVID-19 pandemic has had a negative impact on our results of operations and financial performance through the second quarter of fiscal 2022. We experienced a significant number of cases of a COVID-19 variant among our employees in January 2022 and some physician offices continue to experience staffing issues, and we believe these shortages of trained personnel have negatively impacted our business. Accordingly, current results and financial conditions discussed herein may not be indicative of future operating results and trends.
In August 2021, we acquired certain assets and assumed certain liabilities related to the Pharos U.S. dermatology business of Ra Medical Systems, Inc. (“Ra Medical”) for an upfront cash payment of $3,700. The Pharos asset acquisition provides us with the opportunity to market our full business solutions to Ra Medical’s existing customer base of 400 dermatology practices and increase our recurring revenue base. The Pharos transaction also provides a potentially synergistic path to gain additional placements for our XTRAC excimer laser system.
In January 2022, we acquired certain assets of TheraClear Devices from Theravant Corporation (“Theravant”). The TheraClear asset acquisition will allow us to further develop, commercialize and market the TheraClear Devices that are used for acne treatment, as well as advance the TheraClear technology into multiple other devices that can be used to treat a range of additional indications. We made an upfront cash payment of $500 in connection with the asset acquisition. In addition, Theravant received 358,367 shares of our common stock with an aggregate value of $500 as of the closing date and is eligible to receive up to $3,000 in future earnout payments upon the achievement of certain annual net revenue milestones, up to $20,000 in future royalty payments based upon a percentage of gross profit from future domestic sales ranging from 10-20%, 25% of gross profit from international sales over the subsequent four-year period, and up to $1,000 in future milestone payments upon the achievement of certain development and commercialization related targets.
In January 2022, we entered into a Development Agreement (the “Development Agreement”) with Theravant. Under the Development Agreement, the Company will reimburse Theravant for costs incurred in further developing certain TheraClear technology and other healthcare products and methods for the medical aesthetic marketplace. In connection with the development of three devices, Theravant is eligible to receive $500 upon FDA clearance for each device and $500 upon achievement of certain net revenue targets for each device, aggregating to $3,000 of potential future milestone payments under the Development Agreement. The Development Agreement has a three-year term, unless terminated sooner by either party.
Key Technology
| • | XTRAC® Excimer Laser. XTRAC received FDA clearance in 2000 and has since become a widely recognized treatment among dermatologists for psoriasis and other skin diseases. The XTRAC System delivers ultra-narrowband ultraviolet B (“UVB”) light to affected areas of skin. Following a series of treatments typically performed twice weekly, psoriasis remission can be achieved, and vitiligo patches can be re-pigmented. XTRAC is endorsed by the National Psoriasis Foundation, and its use for psoriasis is covered by nearly all major insurance companies, including Medicare. We estimate that more than half of all major insurance companies now offer reimbursement for vitiligo as well, a figure that is increasing. In February 2022, we announced the commercial launch, with the first installation in the U.S. market, of our next generation excimer laser system, XTRAC MomentumTM 1.0 |
| • | In the third quarter of 2018, we announced the FDA granted clearance for our Multi Micro Dose (MMD) tip for our XTRAC excimer laser. The MMD Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the Narrow Band UVB (“NB-UVB”) light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient. |
| • | In January 2020, we announced the FDA granted clearance of our XTRAC Momentum Excimer Laser Platform. |
| • | VTRAC® Lamp. VTRAC received FDA clearance in 2005 and provides targeted therapeutic efficacy demonstrated by excimer technology with the simplicity of design and reliability of a lamp system. |
| • | TheraClear Acne Treatment Device. The TheraClear® Acne Clearing System combines intense pulse light with vacuum (suction) for the treatment of mild to moderate inflammatory acne (including acne vulgaris), comedonal acne and pustular acne. |
Critical Accounting Policies and Estimates
There have been no changes to our critical accounting policies in the six months ended June 30, 2022 except for contingent consideration as described below. Critical accounting policies and the significant estimates made in accordance with such policies are regularly discussed with our Audit Committee. Those policies are discussed under “Critical Accounting Policies” in our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in Item 7, as well as in our consolidated financial statements and the footnotes thereto for the fiscal year ended December 31, 2021 of our Annual Report on Form 10-K as filed with the SEC on March 21, 2022.
Contingent Consideration
The purchase price for certain assets acquired related to TheraClear Devices during January 2022 includes earnout payments, or contingent consideration. Estimates that involve a significant level of estimation uncertainty include the valuation of contingent consideration, which was determined using forecasted financial information available at the acquisition date, a discount rate and various other assumptions as described in more detail in Note 4 to our condensed consolidated financial statements. Due to uncertainties associated with the development of a new product line and the use of estimates and assumptions to determine the fair value of the contingent consideration, the amount ultimately paid in connection with the earnout may differ from the estimated fair value at the acquisition date. A revaluation of the contingent consideration would only be required if there is a significant change to the underlying valuation assumptions. The contingent consideration will be adjusted when the contingency is resolved and the consideration is paid or becomes payable. Any difference between the cash payment and the amount accrued for contingent consideration will result in an adjustment to the technology intangible asset.
Results of Operations
Revenues
The following table presents revenues from our segments for the periods indicated below:
| | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
Dermatology Recurring Procedures | | $ | 5,582 | | | $ | 5,452 | |
Dermatology Procedures Equipment | | | 3,523 | | | | 1,930 | |
Total Revenues | | $ | 9,105 | | | $ | 7,382 | |
| | For the Six Months Ended June 30, | |
| | 2022 | | | 2021 | |
Dermatology Recurring Procedures | | $ | 10,649 | | | $ | 10,131 | |
Dermatology Procedures Equipment | | $ | 5,497 | | | | 3,078 | |
Total Revenues | | $ | 16,146 | | | $ | 13,209 | |
Dermatology Recurring Procedures
The ongoing COVID-19 pandemic had a negative impact on our results during 2021 and through the first quarter of 2022 Recognized recurring treatment revenue for the three months ended June 30, 2022 was $5,582, which we estimate is approximately 86,000 treatments with prices between $65 to $95 per treatment, compared to recognized recurring treatment revenue for the three months ended June 30, 2021 of $5,452, which we estimate is approximately 78,000 treatments, with prices between $65 to $95 per treatment. Recognized recurring treatment revenue for the six months ended June 30, 2022 was $10,649, which we estimate is approximately 157,000 treatments with prices between $65 to $95 per treatment, compared to recognized recurring treatment revenue for the six months ended June 30, 2021 of $10,131, which we estimate is approximately 145,000 treatments, with prices between $65 to $95 per treatment.
Increases in procedures are dependent upon building market acceptance through marketing programs with our physician partners and their patients to show that the XTRAC procedures will be of clinical benefit and will be generally reimbursed by insurers. We believe that several factors have an impact on the prescribed use of XTRAC treatments for psoriasis and vitiligo patients. Specifically, we believe that there is a lack of awareness of the positive effects of XTRAC treatments among both sufferers and providers; and the treatment regimen, which can sometimes require up to 12 or more treatments, has limited XTRAC use to certain patient populations. Therefore, our strategy is to continue to execute a direct-to-patient program for XTRAC advertising in the United States, targeting psoriasis and vitiligo patients through a variety of media including television and radio; and through our use of social media such as Facebook and Twitter. We monitor the results of our advertising expenditures in this area to reach the more than 10 million patients in the United States we believe are afflicted with these diseases. Furthermore, we increased our presence at trade shows throughout the United States during the first and second quarters of 2022, and we held our national sales meeting for the first time since the onset of the COVID-19 pandemic during the second quarter of 2022.
Revenues from dermatology recurring procedures are recognized over the estimated usage period of the agreed upon number of treatments, as the treatments are being used. As of June 30, 2022 and 2021, we deferred net revenues of $2,501 and $1,897 respectively, which will be recognized as revenue over the remaining usage period for domestic placements. Higher deferred revenue from the fourth quarter of 2021 favorably impacted the first half of 2022 as compared to the first half of 2021, when lower deferred revenue from the fourth quarter of 2020 negatively impacted that period.
Dermatology Procedures Equipment
For the three and six months ended June 30, 2022, dermatology procedures equipment revenues were $3,523 and $5,497, respectively. Internationally, we sold 35 systems (30 XTRAC and 5 VTRAC) and 49 systems (41 XTRAC and 8 VTRAC), respectively, during the three and six months ended June 30, 2022. Domestically, there was one XTRAC system sold during the three and six months ended June 30, 2022. In addition to equipment sales, we recognized approximately $220 and $620, respectively, of deferred service revenue associated with assumed service contracts from Ra Medical during the three and six months ended June 30, 2022.
For the three and six months ended June 30, 2021, dermatology procedures equipment revenues were $1,930 and $3,078, respectively. Internationally, we sold 14 and 16 XTRAC systems, respectively, during the three and six months ended June 30, 2021. Domestically, there were five XTRAC systems sold during the three and six months ended June 30, 2021.
Cost of Revenues
The following table illustrates cost of revenues from our two business segments for the periods listed below:
| | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
Dermatology Recurring Procedures | | $ | | | | $ | 1,635 | |
Dermatology Procedures Equipment | | | | | | | 986 | |
Total Cost of Revenues | | $ | 4,112 | | | $ | 2,621 | |
| | For the Six Months Ended June 30, | |
| | 2022 | | | 2021 | |
Dermatology Recurring Procedures | | $ | | | | $ | 3,136 | |
Dermatology Procedures Equipment | | | | | | | 1,599 | |
Total Cost of Revenues | | $ | 7,025 | | | $ | 4,735 | |
Gross Profit Analysis
The following tables present changes in our gross profit for the periods presented below:
Company Profit Analysis | | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
Revenues | | $ | 9,105 | | | $ | 7,382 | |
Cost of revenues | | | 4,112 | | | | 2,621 | |
Gross profit | | $ | 4,993 | | | $ | 4,761 | |
Gross profit percentage | | | 54.8 | % | | | 64.5 | % |
Company Profit Analysis | | For the Six Months Ended June 30, | |
| | | 2022 | | | | 2021 | |
Revenues | | $ | 16,146 | | | $ | 13,209 | |
Cost of revenues | | | 7,025 | | | | 4,735 | |
Gross profit | | $ | 9,121 | | | $ | 8,474 | |
Gross profit percentage | | | 56.5 | % | | | 64.2 | % |
Gross profit increased to $4,993 for the three months ended June 30, 2022 from $4,761 during the same period in 2021. As a percent of revenues, the gross profit was 54.8% for the three months ended June 30, 2022, as compared to 64.5% for the same period in 2021. The decrease in gross profit percentage was primarily the result of an increase in amortization of intangible assets due to the Pharos and TheraClear asset acquisitions and a change in product mix with higher sales of dermatology procedures equipment, which has a lower margin than dermatology recurring procedures.
Gross profit increased to $9,121 for the six months ended June 30, 2022 from $8,474 during the same period in 2021. As a percent of revenues, the gross profit was 56.5% for the six months ended June 30, 2022, as compared to 64.2% for the same period in 2021. The decrease in gross profit percentage was primarily the result of an increase in amortization of intangible assets due to the Pharos and TheraClear asset acquisitions and a change in product mix with higher sales of dermatology procedures equipment, which has a lower margin than dermatology recurring procedures.
The following tables present changes in our gross profit, by segment, for the periods presented below:
Dermatology Recurring Procedures | | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
Revenues | | $ | 5,582 | | | $ | 5,452 | |
Cost of revenues | | | | | | | 1,635 | |
Gross profit | | $ | | | | $ | 3,817 | |
Gross profit percentage | | | | % | | | 70.0 | % |
Dermatology Recurring Procedures | | For the Six Months Ended June 30, | |
| | 2022 | | | 2021 | |
Revenues | | $ | 10,649 | | | $ | 10,131 | |
Cost of revenues | | | | | | | 3,136 | |
Gross profit | | $ | | | | $ | 6,995 | |
Gross profit percentage | | | | % | | | 69.0 | % |
The primary reasons that gross profit percentage decreased for the three months ended June 30, 2022 as compared to the same period in 2021 were higher amortization of intangible assets due to the Pharos and TheraClear asset acquisitions and higher depreciation expenses and labor costs in 2022 compared to the same period of 2021, partially offset by higher recurring procedures sales.
The primary reasons that gross profit percentage decreased for the six months ended June 30, 2022 as compared to the same period in 2021 were higher amortization of intangible assets due to the Pharos and TheraClear asset acquisitions and higher depreciation expenses and labor costs in 2022 compared to the same period of 2021, partially offset by higher recurring procedures sales.
Dermatology Procedures Equipment | | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
Revenues | | $ | 3,523 | | | $ | 1,930 | |
Cost of revenues | | | | | | | 986 | |
Gross profit | | $ | | | | $ | 944 | |
Gross profit percentage | | | | % | | | 48.9 | % |
Dermatology Procedures Equipment | | For the Six Months Ended June 30, | |
| | 2022 | | | 2021 | |
Revenues | | $ | 5,497 | | | $ | 3,078 | |
Cost of revenues | | | | | | | 1,599 | |
Gross profit | | $ | | | | $ | 1,479 | |
Gross profit percentage | | | | % | | | 48.1 | % |
The primary reasons for the decrease in gross profit percentage for the three months ended June 30, 2022 as compared to the same period in 2021 were higher amortization of intangible assets due to the Pharos and TheraClear asset acquisitions, partially offset by a change in product mix resulting in greater sales of equipment with higher sales margins and the recognition of deferred service revenue associated with assumed service contracts from Ra Medical.
The primary reasons for the increase in gross profit percentage for the six months ended June 30, 2022 as compared to the same period in 2021 were a change in product mix resulting in greater sales of equipment with higher sales margins and the absorption of acquired inventories and recognition of deferred service revenue associated with assumed service contracts from Ra Medical, partially offset by higher amortization of intangible assets due to the Pharos and TheraClear asset acquisitions.
Engineering and Product Development
For the three months ended June 30, 2022, engineering and product development expenses were $209 as compared to $403 for the three months ended June 30, 2021. For the six months ended June 30, 2022, engineering and product development expenses were $372 as compared to $787 for the six months ended June 30, 2021. Engineering and product development costs during the three and six-month periods in 2022 were lower primarily as a result of reduction of costs incurred in connection with developing XTRAC MomentumTM 1.0, our next generation excimer laser system that was commercially launched in February 2022.
Selling and Marketing Expenses
For the three months ended June 30, 2022, selling and marketing expenses were $4,146 as compared to $3,160 for the three months ended June 30, 2021. Sales and marketing expenses for the three months ended June 30, 2022 were higher as compared to the same period in 2021 primarily due to investments we made in sales and marketing and direct-to-consumer and dermatologists advertising, as well as increased head count and employee-related expenses in the first half of 2022. Increased spending in the second quarter of 2022 compared to the same period in 2021 also consisted of our national sales meeting and increased attendance at trade shows.
For the six months ended June 30, 2022, selling and marketing expenses were $7,762 as compared to $6,092 for the six months ended June 30, 2021. Sales and marketing expenses for the six months ended June 30, 2022 were higher as compared to the same period in 2021 primarily due to investments we made in sales and marketing and direct-to-consumer and dermatologists advertising, as well as increased head count and employee-related expenses, in the first quarter of 2022. Increased spending in the first half of 2022 compared to the same period in 2021 also consisted of our national sales meeting, held in the second quarter of 2022, and increased attendance at trade shows.
General and Administrative Expenses
For the three months ended June 30, 2022, general and administrative expenses increased to $2,332 from $2,121 for the three months ended June 30, 2021. General and administrative expenses were higher for the three months ended June 30, 2022 as compared to the same period in 2021, primarily due to higher accounting and legal fees.
For the six months ended June 30, 2022, general and administrative expenses increased to $4,984 from $4,910 for the six months ended June 30, 2021. General and administrative expenses were consistent with the six months ended June 30, 2022 as compared to the same period in 2021, primarily due to higher compensation, severance and recruiting expenses incurred in the first quarter of 2021 as a result of the CEO transition, offset by higher accounting and legal fees in the first half of 2022.
Gain on Debt Extinguishment
During the second quarter of 2021, we received notification that our PPP loan had been forgiven and we recorded a gain on debt extinguishment of $2,028 for the three and six months ended June 30, 2021.
Interest Expense
Interest expense is primarily attributable to our debt obligations. Interest expense increased to $208 for the three months ended June 30, 2022 from $26 for the three months ended June 30, 2021. Interest expense increased to $407 for the six months ended June 30, 2022 from $56 for the six months ended June 30, 2021. The increases were primarily the result of a higher interest rate on the Senior Term Facility entered into in September 2021.
Non-GAAP Financial Measures
We have determined to supplement our condensed consolidated financial statements, prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), presented elsewhere within this Report, with certain non-GAAP measures of financial performance. These non-GAAP measures include non-GAAP gross profit, which excludes the non-cash expense of amortization of acquired intangible assets classified as cost of revenues, and non-GAAP adjusted EBITDA, “Earnings Before Interest, Taxes, Depreciation, and Amortization.”
These non-GAAP disclosures have limitations as an analytical tool, should not be viewed as a substitute for Gross Profit or Net Earnings (Loss) determined in accordance with U.S. GAAP, and should not be considered in isolation or as a substitute for analysis of the Company’s results as reported under U.S. GAAP, nor are they necessarily comparable to non-GAAP performance measures that may be presented by other companies. We consider these non-GAAP measures in addition to our results prepared under current accounting standards, but they are not a substitute for, nor superior to, U.S. GAAP measures. These non-GAAP measures are provided to enhance readers’ overall understanding of our current financial performance and to provide further information for comparative purposes. This supplemental presentation should not be construed as an inference that the Company’s future results will be unaffected by similar adjustments to Gross Profit or Net Earnings (Loss) determined in accordance with U.S. GAAP. Specifically, we believe the non-GAAP measures provide useful information to management and investors by isolating certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. In addition, we believe non-GAAP measures enhance the comparability of results against prior periods. Reconciliation to the most directly comparable U.S. GAAP measure of all non-GAAP measures included in this Report is as follows:
| | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
| | | | | | |
Gross profit | | $ | 4,993 | | | $ | 4,761 | |
Amortization of acquired intangible assets | | | 532 | | | | 138 | |
Non-GAAP gross profit | | $ | 5,525 | | | $ | 4,899 | |
Gross profit percentage | | | 54.8 | % | | | 64.5 | % |
Non-GAAP gross profit percentage | | | 60.7 | % | | | 66.4 | % |
| | For the Six Months Ended June 30, | |
| | 2022 | | | 2021 | |
| | | | | | |
Gross profit | | $ | 9,121 | | | $ | 8,474 | |
Amortization of acquired intangible assets | | | 1,016 | | | | 284 | |
Non-GAAP gross profit | | $ | 10,137 | | | $ | 8,758 | |
Gross profit percentage | | | 56.5 | % | | | 64.2 | % |
Non-GAAP gross profit percentage | | | 62.8 | % | | | 66.3 | % |
| | For the Three Months Ended June 30, | |
| | 2022 | | | 2021 | |
| | | | | | |
Net (loss) income | | $ | (1,892 | ) | | $ | 1,082 | |
| | | | | | | | |
Adjustments: | | | | | | | | |
Depreciation and amortization | | | 1,339 | | | | 873 | |
Amortization of right-of-use asset | | | 92 | | | | 88 | |
Loss on disposal of property and equipment | | | 18 | | | | 63 | |
Income tax expense | | | - | | | | 4 | |
Gain on debt extinguishment | | | - | | | | (2,028 | ) |
Interest expense, net | | | 198 | | | | 19 | |
Non-GAAP EBITDA | | | (245 | ) | | | 101 | |
Stock-based compensation | | | 452 | | | | 581 | |
Non-GAAP adjusted EBITDA | | $ | 207 | | | $ | 682 | |
| | For the Six Months Ended June 30, | |
| | 2022 | | | 2021 | |
| | | | | | |
Net loss | | $ | (4,394 | ) | | $ | (1,336 | ) |
| | | | | | | | |
Adjustments: | | | | | | | | |
Depreciation and amortization | | | 2,660 | | | | 1,706 | |
Amortization of right-of-use asset | | | 181 | | | | 174 | |
Loss on disposal of property and equipment | | | 35 | | | | 63 | |
Income tax expense | | | - | | | | 8 | |
Gain on debt extinguishment | | | - | | | | (2,028 | ) |
Interest expense, net | | | 397 | | | | 41 | |
Non-GAAP EBITDA | | | (1,121 | ) | | | (1,372 | ) |
Stock-based compensation | | | 820 | | | | 1,243 | |
Non-GAAP adjusted EBITDA | | $ | (301 | ) | | $ | (129 | ) |
Liquidity and Capital Resources
As of June 30, 2022, we had $4,266 of working capital compared to $7,168 as of December 31, 2021. The change in working capital was primarily the result of decreases in cash and cash equivalents and accounts receivable and an increase in accounts payable, offset by an increase in inventories, as we invested in capital assets, completed the asset acquisition of TheraClear, and bolstered inventories to avoid supply chain disruptions. Cash and cash equivalents were $10,036 as of June 30, 2022, as compared to $12,586 as of December 31, 2021.
In September 2021, we entered into a credit and security agreement with MidCap Financial Trust, also acting as the administrative agent, and the lenders identified therein and borrowed $8,000 in the form of a senior term loan. The term loan bears interest at LIBOR (with a LIBOR floor rate of 0.50%) plus 7.50% per year and matures on September 1, 2026, unless terminated earlier. We are obligated to make monthly interest-only payments through September 30, 2024. From October 1, 2024 to the date of maturity, we will make 24 equal monthly principal payments plus interest, and all borrowings are secured by substantially all of our assets.
In October 2021, we entered into an equity distribution agreement with an investment bank under which we may sell up to $11,000 of our shares of common stock in registered “at-the-market” offerings. The shares will be offered at prevailing market prices, and we will pay commissions of up to 3.00% of the gross proceeds from the sale of shares sold through our agent, which may act as an agent and/or principal. We have no obligation to sell any shares under this agreement and may, at any time, suspend solicitations under this agreement. No shares of our common stock have been sold under this distribution agreement through June 30, 2022.
We cannot predict our revenues and expenses in the short term as a result of the COVID-19 pandemic and related governmental responses. Based on our current business plan, we believe that our cash and cash equivalents, combined with the anticipated revenues from the sale or use of our products, will be sufficient to satisfy our working capital needs, capital asset purchases, outstanding commitments and other liquidity requirements associated with its existing operations for at least the next 12 months following the date of the issuance of these unaudited interim condensed consolidated financial statements. However, if these sources are insufficient to satisfy our liquidity requirements, we may seek to sell additional debt or equity securities or enter into a new credit facility or another form of third-party funding or seek other debt financing. If we raise additional funds by issuing equity or equity-linked securities, our stockholders would experience dilution and any new equity securities could have rights, preferences and privileges superior to those of holders of our common stock. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. We cannot be assured that additional equity, equity-linked or debt financing will be available on terms favorable to us or our stockholders, or at all. It is also possible that we may allocate significant amounts of capital towards products or technologies for which market demand is lower than expected and, as a result, abandon such efforts. If we are unable to maintain our current financing or obtain adequate additional financing when we require it, or if we obtain financing on terms which are not favorable to us, or if we expend capital on products or technologies that are unsuccessful, our ability to continue to support our business growth and to respond to business challenges could be significantly limited, or we may be required to delay the development, commercialization and marketing of our products.
Net cash and cash equivalents and restricted cash used in operating activities was $409 for the six months ended June 30, 2022, compared to net cash provided by operating activities of $387 for the six months ended June 30, 2021. The decrease in cash flows provided by operating activities for the six months ended June 30, 2022 was primarily the result of no gain on debt extinguishment, an increase in net loss, a reduction in stock-based compensation related to the CEO transition in the first quarter of 2021 and net movements in asset and liability accounts, offset by increased depreciation and amortization expense primarily related to intangible assets acquired through the Ra Medical and TheraClear asset acquisitions. The decrease in cash flows from asset and liability accounts was primarily driven by an increase in inventories to avoid supply chain disruptions, a decrease in accrued compensation and the recognition of deferred service revenue associated with assumed service contracts from Ra Medical, offset by an increase in accounts payable.
Net cash and cash equivalents and restricted cash used in investing activities was $2,141 for the six months ended June 30, 2022, compared to net cash used in investing activities of $1,466 for the six months ended June 30, 2021. The increase is primarily the result of the asset purchase of TheraClear.
There were no cash flows from financing activities for the six months ended June 30, 2022 and 2021.
Commitments and Contingencies
There were no items, except as described above with respect to the potential future earnout payments related to the TheraClear asset acquisition and Development Agreement, that significantly impacted our commitments and contingencies as discussed in the notes to our 2021 annual financial statements included in our Annual Report on Form 10-K.
ITEM 3. | Quantitative and Qualitative Disclosure about Market Risk |
Not applicable.
ITEM 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”)), as of June 30, 2022. Based on that evaluation, management has concluded that, as of such date, our disclosure controls and procedures were effective.
Limitations on the Effectiveness of Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within an organization have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our Chief Executive Officer and Chief Financial Officer have concluded, based on their evaluation as of the end of the period covered by this Report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting in our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - Other Information
On April 1, 2022, a proposed representative class action under California’s Private Attorneys General Act (“PAGA”) was filed in Superior Court of California, County of San Diego against the Company and an employment agency (“Co-Defendant”) which provided the Company with temporary employees. The complaint alleges various violations of the California Labor Code, including California’s wage and hour laws, relating to current and former non-exempt employees of the Company. The complaint seeks class status and payments for allegedly unpaid compensation and attorney’s fees. In a related matter, the attorneys in this matter and the proposed class representative, in a letter dated March 12, 2022, to the California Labor & Workforce Development Agency made nearly identical claims seeking the right to pursue a PAGA action against the Company and the employment agency. On or about May 16, 2022, the plaintiff filed a First Amended Complaint adding a PAGA claim to the action. On or about June 2, 2022, the plaintiff filed an Application to Dismiss Class and Individual Claim without prejudice, in an attempt to pursue a PAGA only complaint. On or about June 30, 2022, the parties entered into a stipulation to allow the plaintiff to file a Second Amended Complaint to clarify the PAGA claim and to stay the pending action to allow an attempt at resolution at a mediation scheduled for February 23, 2023. On July 7, 2022, the Company and the Co-Defendant each filed its respective Notice of Appearance that each intended to defend against the claims.
In the ordinary course of business, the Company is, from time to time, subject to audits performed by state taxing authorities. These actions and proceedings are generally based on the position that the arrangements entered into by the Company are subject to sales and use tax rather than exempt from tax under applicable law. Several states have assessed the Company an aggregate of $2.4 million including penalties and interest for the period from March 2014 through April 2020. An administrative state judge in the State of New York issued an opinion in January 2021 finding in favor of the Company that the sale of XTRAC treatment codes was not taxable as sales tax with respect to that state’s first assessment. This ruling covers $1.5 million of the total $2.4 million of assessments. The relevant taxing authority filed an appeal of the administrative law judge’s finding and, following the submission of legal briefs by both sides and oral argument held in January 2022, on May 6, 2022, the Company received a written decision from the State of New York Tax Appeals Tribunal (“Tribunal”) overturning the favorable sales tax determination of the administrative law judge. The Company has until September 6, 2022 to file an appeal of the Tribunal’s decision.
Additionally, from time to time in the ordinary course of our business, we may be a party to certain legal proceedings, incidental to the normal course of our business. These may include controversies relating to contract claims and employment related matters, some of which claims may be material, in which case, we will make separate disclosure as required.
A description of the risks associated with our business, financial conditions and results of operations is set forth in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and filed with the SEC on March 21, 2022.
ITEM 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
None
ITEM 3. | Defaults Upon Senior Securities. |
None.
ITEM 4. | Mine Safety Disclosures |
None.
None.
| Rule 13a-14(a) Certificate of Chief Executive Officer (attached hereto) |
| Rule 13a-14(a) Certificate of Chief Financial Officer (attached hereto) |
| Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (attached hereto) |
101.INS | XBRL Instance Document |
101.SCH | XBRL Taxonomy Schema |
101.CAL | XBRL Taxonomy Calculation Linkbase |
101.DEF | XBRL Taxonomy Definition Linkbase |
101.LAB | XBRL Taxonomy Label Linkbase |
101.PRE | XBRL Taxonomy Presentation Linkbase |
* | The certifications attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. |
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
| STRATA SKIN SCIENCES, INC. | |
Date August 10, 2022 | By: | /s/ Robert J. Moccia | |
| | Name
| Robert J. Moccia | |
| | Title
| President & Chief Executive Officer | |
Date August 10, 2022 | By: | /s/ Christopher Lesovitz | |
| | Name
| Christopher Lesovitz | |
| | Title
| Chief Financial Officer | |
35