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, 2022. 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 number of shares, prices per treatment, number of treatments and number of devices.
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 Pharos® excimer lasers and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo, and various other skin conditions, as well as the TheraClear® X Acne Therapy System utilized in the treatment of acne-related skin conditions.
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 September 30, 2023, there were 929 XTRAC systems placed in dermatologists’ offices in the United States under our dermatology recurring procedures model, an increase from 909 as of December 31, 2022. 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. The Pharos excimer laser system holds FDA clearance to treat chronic skin diseases, including psoriasis, vitiligo, atopic dermatitis, and leukoderma. We believe there are approximately 8 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 TheraClear® X Acne Therapy 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. The TheraClear device was cleared by the FDA through the 510(k) process. Currently, there is little insurance reimbursement coverage for acne treatments, such as those provided by TheraClear.
Our non-U.S. business focuses on a direct distribution model for equipment sales and recurring revenue, and we have distribution agreements in place in the Mid-East, Asia, and Mexico.
In late 2019, there was an outbreak of a new strain of coronavirus (“COVID-19”) which became a global pandemic. Since March 2020, the COVID-19 pandemic has negatively impacted business conditions in the industry in which we operate, disrupted global supply chains, constrained workforce participation, and created significant volatility and disruption of financial markets. 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 most offices have reopened, some physician practices closed and never reopened, and the impact of the 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, but not limited to, impact on supply chains and transport, and governmental and customer responses, including staffing issues, all of which are uncertain and cannot be predicted.
Prior to the outbreak of the Russia-Ukraine War, Ukraine was the largest exporter of noble gases including neon, krypton, and xenon. Historically, Ukraine has been the source of a significant amount of gas supplied to us by our contract suppliers. Neon gas is essential to the proper functioning of our lasers. Our suppliers have been resourceful in continuing to supply gases to us but cannot assure us that the supply will not remain uninterrupted. The reduced supply and ongoing conflict have raised the price of gas significantly worldwide. Additionally, the Creating Helpful Incentives to Produce Semiconductors and Science Act of 2022 has led to a further tightening of rare gas supplies as chip manufacturers reconfigure their supply chains to address the need to secure their own supplies of rare gases for use in the manufacture of computer chips.
Key Technologies
| • | 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 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. 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 Momentum® 1.0. |
| • | 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® X Acne Treatment Device. The TheraClear® Acne Therapy System was cleared by the FDA through the 510(k) process and combines intense pulse light with vacuum (suction) for the treatment of mild to moderate inflammatory acne (including acne vulgaris), comedonal acne and pustular acne. |
Recent Developments
On October 26, 2023, our stockholders approved a proposal authorizing a reverse stock split of our common stock at a ratio of not less than 1 for 5 and no greater than 1 for 25, with the exact ratio, if effected at all, to be set within that range approved at the discretion of our board of directors and publicly announced by April 26, 2024 without further approval or authorization of our stockholders.
On October 26, 2023, the board of directors authorized the execution of two agreements related to a change in management of the Company and the execution of a third agreement related to compensation of an executive officer.
The three agreements are as follows:
| • | Effective October 30, 2023, (a) Robert Moccia stepped down as our President and Chief Executive Officer and as a member of our board of directors; and (b) the Company and Christopher Lesovitz, our Chief Financial Officer, entered into a retention agreement, pursuant to which, in accordance with the terms and conditions of such agreement, Mr. Lesovitz will receive an aggregate cash bonus equal to $143. |
| • | On October 31, 2023, Dr. Dolev Rafaeli was appointed as our Vice-Chairman, President and Chief Executive Officer and as a member of our board of directors. In connection with such appointment, on October 31, 2023, we issued Dr. Rafaeli an option to purchase 1,745,569 shares of common stock, with a strike price of $0.53 per share, vesting over a three-year period. |
Critical Accounting Policies and Estimates
There have been no changes to our critical accounting policies in the nine months ended September 30, 2023. 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 and Estimates” 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, 2022 of our Annual Report on Form 10-K as filed with the SEC on March 31, 2023.
Results of Operations
Revenues
The following tables present revenues from our segments for the periods indicated below:
| | For the Three Months Ended September 30, | |
| | 2023 | | | 2022 | |
Dermatology recurring procedures | | $ | 5,280 | | | $ | 5,847 | |
Dermatology procedures equipment | | | 3,572 | | | | 3,566 | |
Total revenues | | $ | 8,852 | | | $ | 9,413 | |
| | For the Nine Months Ended September 30, | |
| | 2023 | | | 2022 | |
Dermatology recurring procedures | | $ | 15,945 | | | $ | 16,496 | |
Dermatology procedures equipment | | | 8,724 | | | | 9,063 | |
Total revenues | | $ | 24,669 | | | $ | 25,559 | |
Dermatology Recurring Procedures
Recognized recurring treatment revenue for the three months ended September 30, 2023 was $5,280, which we estimate is approximately 70,000 XTRAC treatments with prices between $65 to $95 per treatment, compared to recognized recurring treatment revenue for the three months ended September 30, 2022 of $5,847, which we estimate is approximately 80,000 XTRAC treatments, with prices between $65 to $95 per treatment. Recognized recurring treatment revenue for the nine months ended September 30, 2023 was $15,945, which we estimate is approximately 210,000 XTRAC treatments with prices between $65 to $95 per treatment, compared to recognized recurring treatment revenue for the nine months ended September 30, 2022 of $16,496, which we estimate is approximately 236,000 XTRAC treatments, with prices between $65 to $95 per treatment. In connection with the launch of the TheraClear Acne Therapy System, there were 76 TheraClear devices placed in dermatologists’ offices in the United States under our recurring procedures model as of September 30, 2023, which includes devices placed during the soft launch in the fourth quarter of 2022. Nominal revenue was earned from these devices during the three and nine months ended September 30, 2023.
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.
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 September 30, 2023 and 2022, we deferred net revenues of $1,947 and $2,310, respectively, which will be recognized as revenue over the remaining usage period for domestic placements. Lower deferred revenue from the second quarter of 2023 negatively impacted the third quarter of 2023 as compared to the same period in 2022.
Dermatology Procedures Equipment
For the three and nine months ended September 30, 2023, dermatology procedures equipment revenues were $3,572 and $8,724, respectively. Internationally, we sold 21 systems (19 XTRAC and 2 VTRAC) and 51 systems (44 XTRAC and 7 VTRAC), respectively, during the three and nine months ended September 30, 2023. Domestically, there were 6 and 20 systems sold, respectively, during the three and nine months ended September 30, 2023. In addition to equipment sales, we recognized approximately $45 and $185 of previously deferred service revenue associated with assumed service contracts from Ra Medical during the three and nine months ended September 30, 2023, respectively.
For the three and nine months ended September 30, 2022, dermatology procedures equipment revenues were $3,566 and $9,063, respectively. Internationally, we sold 27 systems (25 XTRAC and 2 VTRAC) and 76 systems (66 XTRAC and 10 VTRAC), respectively, during the three and nine months ended September 30, 2022. Domestically, there were 2 and 3 XTRAC systems sold during the three and nine months ended September 30, 2022, respectively. In addition to equipment sales, we recognized approximately $152 and $772, respectively, of deferred service revenue associated with assumed service contracts from Ra Medical during the three and nine months ended September 30, 2022.
Cost of Revenues
The following tables illustrate cost of revenues from our two business segments for the periods listed below:
| | For the Three Months Ended September 30, | |
| | 2023 | | | 2022 | |
Dermatology recurring procedures | | $ | 2,229 | | | $ | 2,057 | |
Dermatology procedures equipment | | | 1,669 | | | | 1,557 | |
Total cost of revenues | | $ | 3,898 | | | $ | 3,614 | |
| | For the Nine Months Ended September 30, | |
| | 2023 | | | 2022 | |
Dermatology recurring procedures | | $ | 6,454 | | | $ | 6,387 | |
Dermatology procedures equipment | | | 4,555 | | | | 4,252 | |
Total cost of revenues | | $ | 11,009 | | | $ | 10,639 | |
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 September 30, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 8,852 | | | $ | 9,413 | |
Cost of revenues | | | 3,898 | | | | 3,614 | |
Gross profit | | $ | 4,954 | | | $ | 5,799 | |
Gross profit percentage | | | 56.0 | % | | | 61.6 | % |
| | For the Nine Months Ended September 30, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 24,669 | | | $ | 25,559 | |
Cost of revenues | | | 11,009 | | | | 10,639 | |
Gross profit | | $ | 13,660 | | | $ | 14,920 | |
Gross profit percentage | | | 55.4 | % | | | 58.4 | % |
Gross profit decreased to $4,954 for the three months ended September 30, 2023 from $5,799 during the same period in 2022. As a percentage of revenues, the gross profit was 56.0% for the three months ended September 30, 2023, as compared to 61.6% for the same period in 2022. The decrease in gross profit percentage was primarily the result of higher depreciation due to more XTRAC lasers and new TheraClear devices placed into service, higher material costs, and a change in product mix with higher sales of dermatology procedures equipment, which has a lower margin than dermatology recurring procedures, during the three months ended September 30, 2023.
Gross profit decreased to $13,660 for the nine months ended September 30, 2023 from $14,920 during the same period in 2022. As a percentage of revenues, the gross profit was 55.4% for the nine months ended September 30, 2023, as compared to 58.4% for the same period in 2022. The decrease in gross profit percentage was primarily the result of higher depreciation due to more XTRAC lasers and new TheraClear devices placed into service, higher material costs, and lower recognition of previously deferred service revenue associated with assumed service contracts from Ra Medical during the nine months ended September 30, 2023.
The following tables present changes in our gross profit, by segment, for the periods presented below:
Dermatology Recurring Procedures
| | For the Three Months Ended September 30, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 5,280 | | | $ | 5,847 | |
Cost of revenues | | | 2,229 | | | | 2,057 | |
Gross profit | | $ | 3,051 | | | $ | 3,790 | |
Gross profit percentage | | | 57.8 | % | | | 64.8 | % |
| | For the Nine Months Ended September 30, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 15,945 | | | $ | 16,496 | |
Cost of revenues | | | 6,454 | | | | 6,387 | |
Gross profit | | $ | 9,491 | | | $ | 10,109 | |
Gross profit percentage | | | 59.5 | % | | | 61.3 | % |
Gross profit decreased to $3,051 for the three months ended September 30, 2023 from $3,790 during the same period in 2022. As a percentage of revenues, the gross profit was 57.8% for the three months ended September 30, 2023, as compared to 64.8% for the same period in 2022. The primary reason that gross profit percentage decreased for the three months ended September 30, 2023 as compared to the same period in 2022 was a reduction in sales and higher depreciation costs due to more XTRAC lasers and new TheraClear devices placed into service.
Gross profit decreased to $9,491 for the nine months ended September 30, 2023 from $10,109 during the same period in 2022. As a percentage of revenues, the gross profit was 59.5% for the nine months ended September 30, 2023, as compared to 61.3% for the same period in 2022. The primary reason that gross profit percentage decreased for the nine months ended September 30, 2023 as compared to the same period in 2022 was higher depreciation costs due to more XTRAC lasers and new TheraClear devices placed into service, offset by higher absorption of overhead costs and a reduction in training and other startup costs for outsourced field service technicians.
Dermatology Procedures Equipment
| | For the Three Months Ended September 30, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 3,572 | | | $ | 3,566 | |
Cost of revenues | | | 1,669 | | | | 1,557 | |
Gross profit | | $ | 1,903 | | | $ | 2,009 | |
Gross profit percentage | | | 53.3 | % | | | 56.3 | % |
| | For the Nine Months Ended September 30, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 8,724 | | | $ | 9,063 | |
Cost of revenues | | | 4,555 | | | | 4,252 | |
Gross profit | | $ | 4,169 | | | $ | 4,811 | |
Gross profit percentage | | | 47.8 | % | | | 53.1 | % |
Gross profit decreased to $1,903 for the three months ended September 30, 2023 from $2,009 during the same period in 2022. As a percent of revenues, the gross profit was 53.3% for the three months ended September 30, 2023, as compared to 56.3% for the same period in 2022. The primary reason for the decrease in gross profit percentage for the three months ended September 30, 2023 as compared to the same period in 2022 was lower recognition of previously deferred service revenue associated with assumed service contracts from Ra Medical, which is decreasing as the related service contracts expire.
Gross profit decreased to $4,169 for the nine months ended September 30, 2023 from $4,811 during the same period in 2022. As a percent of revenues, the gross profit was 47.8% for the nine months ended September 30, 2023, as compared to 53.1% for the same period in 2022. The primary reason for the decrease in gross profit percentage for the nine months ended September 30, 2023 as compared to the same period in 2022 was lower recognition of previously deferred service revenue associated with assumed service contracts from Ra Medical, which is decreasing as the related service contracts expire, and an increase in domestic sales with longer warranty periods, leading to a greater amount of deferred revenue for those sales.
Engineering and Product Development
For the three months ended September 30, 2023, engineering and product development expenses were $248 as compared to $216 for the three months ended September 30, 2022. For the nine months ended September 30, 2023, engineering and product development expenses were $937 as compared to $588 for the nine months ended September 30, 2022. Engineering and product development costs during the three- and nine-month periods in 2023 were higher primarily as a result of an increase in consulting expenses related to future enhancements of our devices.
Selling and Marketing Expenses
For the three months ended September 30, 2023, selling and marketing expenses were $3,038 as compared to $3,754 for the three months ended September 30, 2022. Selling and marketing expenses for the three months ended September 30, 2023 were lower as compared to the same period in 2022 primarily due to a reduction in salaries and commissions.
For the nine months ended September 30, 2023, selling and marketing expenses were $10,196 as compared to $11,516 for the nine months ended September 30, 2022. Selling and marketing expenses for the nine months ended September 30, 2023 were lower as compared to the same period in 2022 primarily due to a reduction in advertising costs, salaries and commissions.
General and Administrative Expenses
For the three months ended September 30, 2023, general and administrative expenses decreased to $2,283 as compared to $2,615 for the three months ended September 30, 2022. General and administrative expenses were lower for the three months ended September 30, 2023 as compared to the same period in 2022 primarily due to a decrease in employee-related expenses, such as salaries and stock-based compensation expense, and lower computer-related costs.
For the nine months ended September 30, 2023, general and administrative expenses increased to $7,690 as compared to $7,599 for the nine months ended September 30, 2022. General and administrative expenses were higher for the nine months ended September 30, 2023 as compared to the same period in 2022 primarily due to higher legal and accounting costs associated with the 2022 financial statement audit and the adoption of a new accounting standard, offset by a decrease in employee-related expenses, such as salaries and stock-based compensation expense.
Loss on Debt Extinguishment
During the second quarter of 2023, we refinanced our Senior Term Facility with MidCap (see Note 9, Long-term Debt to the Notes to Unaudited Condensed Consolidated Financial Statements). The new loan is considered substantially different from the original loan and, as such, we recorded a loss on debt extinguishment of $909 during the nine months ended September 30, 2023. There was no such financing event or debt extinguishment during the three and nine months ended September 30, 2022.
Interest Expense
Interest expense is primarily attributable to our debt obligations. Interest expense increased to $528 for the three months ended September 30, 2023 from $244 for the three months ended September 30, 2022. Interest expense increased to $1,112 for the nine months ended September 30, 2023 from $651 for the nine months ended September 30, 2022. The increase was primarily the result of a higher interest rate on our variable rate Senior Term Facility entered into in September 2021 and the additional $7,000 borrowed under our Senior Term Facility on June 30, 2023.
Non-GAAP adjusted EBITDA
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 September 30, | |
| | 2023 | | | 2022 | |
Gross profit | | $ | 4,954 | | | $ | 5,799 | |
Amortization of acquired intangible assets | | | 507 | | | | 507 | |
Non-GAAP gross profit | | $ | 5,461 | | | $ | 6,306 | |
Gross profit percentage | | | 56.0 | % | | | 61.6 | % |
Non-GAAP gross profit percentage | | | 61.7 | % | | | 67.0 | % |
| | For the Nine Months Ended September 30, | |
| | 2023 | | | 2022 | |
Gross profit | | $ | 13,660 | | | $ | 14,920 | |
Amortization of acquired intangible assets | | | 1,523 | | | | 1,523 | |
Non-GAAP gross profit | | $ | 15,183 | | | $ | 16,443 | |
Gross profit percentage | | | 55.4 | % | | | 58.4 | % |
Non-GAAP gross profit percentage | | | 61.5 | % | | | 64.3 | % |
| | For the Three Months Ended September 30, | |
| | 2023 | | | 2022 | |
Net loss | | $ | (1,053 | )
| | $ | (995 | ) |
| | | | | | | | |
Adjustments: | | | | | | | | |
Depreciation and amortization | | | 1,449 | | | | 1,311 | |
Amortization of operating lease right-of-use assets | | | 89 | | | | 67 | |
Loss on disposal of property and equipment | | | 31 | | | | 17 | |
Interest expense, net | | | 438 | | | | 209 | |
Non-GAAP EBITDA | | | 954 | | | | 609 | |
Stock-based compensation expense | | | 337 | | | | 455 | |
Non-GAAP adjusted EBITDA | | $ | 1,291 | | | $ | 1,064 | |
| | | For the Nine Months Ended September 30, | |
| | | 2023 | | | | 2022 | |
Net loss |
| $ | (7,036 | )
| | $ | (5,389 | ) |
|
|
|
| | |
|
|
|
Adjustments: |
|
|
| | |
|
|
|
Depreciation and amortization |
|
| 4,274 | | |
| 3,971 |
|
Amortization of operating lease right-of-use assets |
|
| 257 | | |
| 248 |
|
Loss on disposal of property and equipment |
|
| 55 | | |
| 52 |
|
Interest expense, net |
|
| 964 | | |
| 606 |
|
Non-GAAP EBITDA |
|
| (1,486 | ) | |
| (512 | ) |
Stock-based compensation expense |
|
| 1,014 | | |
| 1,275 |
|
Loss on debt extinguishment |
|
| 909 | | |
| — |
|
Non-GAAP adjusted EBITDA |
| $ | 437 | | | $ | 763 |
|
Liquidity and Capital Resources
As of September 30, 2023, we had $7,697 of working capital compared to $4,078 as of December 31, 2022. The change in working capital was primarily the result of an increase in cash and cash equivalents from additional proceeds received upon the refinancing of the Senior Term Facility on June 30, 2023, offset by an increase in capital expenditures for lasers and TheraClear devices. Cash, cash equivalents and restricted cash were $8,465 as of September 30, 2023, as compared to $6,795 as of December 31, 2022.
In September 2021, we entered into a credit and security agreement with MidCap, 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 bore interest at LIBOR (with a LIBOR floor rate of 0.50%) plus 7.50% per year and matured on September 1, 2026, unless terminated earlier. All borrowings are secured by substantially all of our assets. In September 2022, we amended the facility to transition, upon the cessation of LIBOR, to one-month Secured Overnight Financing Rate (“SOFR”), or such other applicable period, plus 0.10%, with a floor of 0.50%. On June 30, 2023, we amended our credit facility with MidCap to: (i) refinance our existing $8,000 term loan, (ii) borrow an additional $7,000, and (iii) provide for an additional $5,000 tranche that can be drawn under certain conditions in 2024. The facility matures on June 1, 2028. Borrowings under the Senior Term Facility bear interest at a rate per annum equal to the sum of (a) the greater of (i) the sum of (A) 30-day forward-looking term rate of one month SOFR, as published by CME Group Benchmark Administration Limited, from time to time, plus (B) 0.10%, and (ii) the applicable floor rate of 3.50%, with such sum reset monthly, and (b) 7.50%. The senior term loan provides for monthly interest only-payments until June 1, 2026, and monthly straight-line amortization of principal plus interest for the remaining term. We also amended and restated the existing warrant to allow MidCap to purchase 800,000 shares of our common stock at an exercise price of $0.88 per share for a 10-year period ending June 30, 2033. We agreed to register the shares underlying this warrant for resale.
In January 2022, we acquired certain assets related to the TheraClear devices from Theravant Corporation (“Theravant”). Theravant 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 $500 in future milestone payments upon the achievement of certain development and commercialization related targets. In September 2023, we paid Theravant $42 based on gross profit from domestic and international sales during the nine months ended September 30, 2023.
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 September 30, 2023.
We cannot predict our revenues and expenses in the short term as a result of the COVID-19 pandemic, the ongoing Russia-Ukraine war, supply chain disruptions, rising interest rates, and related responses by our customers and our ultimate consumers as a result thereof. 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 and operating expense management, will be sufficient to satisfy our working capital needs, capital asset purchases, outstanding commitments and other liquidity requirements associated with our 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 used in operating activities was $2,025 for the nine months ended September 30, 2023, compared to net cash used in operating activities of $1,103 for the nine months ended September 30, 2022. The increase in cash flows used in operating activities for the nine months ended September 30, 2023 was primarily the result of an increase in the net loss and a decrease in accounts payable, net of inventories, as we had increased our inventories during 2022 to avoid supply chain disruptions.
Net cash used in investing activities was $3,166 for the nine months ended September 30, 2023, compared to net cash used in investing activities of $2,668 for the nine months ended September 30, 2022. The increase is primarily the result of an increase in capital assets as a result of the launch of the TheraClear Acne Therapy System, offset by the cash paid to acquire the TheraClear devices in the first half of 2022.
Net cash provided by financing activities was $6,861 for the nine months ended September 30, 2023 compared to net cash provided by financing activities of $0 for the nine months ended September 30, 2022. The increase is a result of the refinancing of the Senior Term Facility, pursuant to which we borrowed an additional $6,903, net of financing costs.
Commitments and Contingencies
There were no items that significantly impacted our commitments and contingencies as discussed in the notes to our 2022 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 September 30, 2023. 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 us with temporary employees. The complaint alleges various violations of the California Labor Code, including California’s wage and hour laws, relating to certain of our current and former non-exempt employees. 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 us 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 through mediation. The mediation was held on February 23, 2023, and the matter was settled on terms agreeable to us. The settlement, which requires us to pay $0.1 million, is subject to the right of individual class members to reject the settlement and proceed on their own.
In the ordinary course of business, we are, 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 us are subject to sales and use tax rather than exempt from tax under applicable law. Several states have assessed us an aggregate of $2.4 million including penalties and interest for the period from March 2014 through April 2020. We received notification that an administrative state judge issued an opinion finding in favor of us 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, we received a written decision from the State of New York Appeals Tribunal (“Tribunal”) overturning the favorable sales tax determination of the administrative law judge. We filed an appeal of the Tribunal’s decision, and posted the required appellate bond requiring posting cash collateral, with the New York State Appellate Division, and are awaiting for the appellate court to set a schedule for oral argument.
We are also in another jurisdiction’s administrative process of appeal with respect to the remaining $0.9 million of assessments, and the timing of the process has been impacted by the COVID-19 pandemic. If there is a determination that the true object of our recurring revenue model is not exempt from sales taxes and is not a prescription medicine, or we do not have other defenses where we prevail, we may be subject to sales taxes in those particular states for previous years and in the future, plus potential interest and penalties.
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.
Except as set forth below and in our Quarterly Report on Form 10-Q for the period ended June 30, 2023, 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, 2022 and filed with the SEC on March 31, 2023.
If we are not able to maintain the requirements for listing on the Nasdaq Capital Market, we could be delisted, which could have a material adverse effect on our ability to raise additional funds as well as the price and liquidity of our common stock.
Our common stock is currently listed on the Nasdaq Capital Market. To maintain the listing of our common stock on the Nasdaq Capital Market, we are required to meet certain listing requirements, including, among others, (i) a minimum closing bid price of $1.00 per share, (ii) a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $1 million and (iii) either: (x) stockholders’ equity of at least $2.5 million; or (y) a total market value of listed securities of at least $35 million.
On June 29, 2023, we received a notification from the Listing Department of Nasdaq indicating that during the preceding 30 consecutive business day period, the closing price of our common stock was below $1.00 per share. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days, or until December 26, 2023, to regain compliance. To regain compliance, the closing bid price of our common stock must be at least $1.00 per share for a minimum of ten consecutive business days. If we do not regain compliance by December 26, 2023, we may be eligible for a second 180-calendar-day period, provided that we meet the continued listing requirement for market value of publicly held shares and all other initial listing requirements for Nasdaq, other than the minimum bid price requirement, and we provide written notice to Nasdaq of our intention to cure the deficiency during the second compliance period. In order to regain compliance, we proposed, and, on October 26, 2023, our stockholders approved a proposal to effect a reverse stock split of our common stock at a ratio of not less than 1 for 5 and no greater than 1 for 25, with the exact ratio, if effected at all, to be set within that range approved at the discretion of our board of directors and publicly announced by April 26, 2024 without further approval or authorization of our stockholders. At this time, we expect to apply for a second 180-calendar day period within which to regain compliance. There can be no guarantee or assurance that a second compliance period will be granted by Nasdaq.
Even if a reverse stock split is effected, there can be no assurance that the market price per share of our common stock will remain in excess of the $1.00 minimum bid price for a sustained period of time. The continuing effect of a reverse stock split on the market price of our common stock cannot be predicted with any certainty, and the history of similar stock split combinations for companies in like circumstances is varied. It is possible that the per share price of our common stock after a reverse stock split will not rise in proportion to the reduction in the number of shares of common stock outstanding resulting from a reverse stock split, effectively reducing our market capitalization, and there can be no assurance that the market price per post-reverse split share will either exceed or remain in excess of the $1.00 minimum bid price for a sustained period of time. The market price of our common stock may vary based on other factors that are unrelated to the number of shares outstanding, including our future performance.
The delisting of our common stock from a national exchange could impair the liquidity and market price of the common stock. It could also materially, adversely affect our access to the capital markets, and any limitation on market liquidity or reduction in the price of the common stock as a result of that delisting could adversely affect our ability to raise capital on terms acceptable to us, or at all.
If we do not meet the minimum stockholders’ equity, minimum closing bid price requirements, or any other listing requirements, we would be subject to delisting from the Nasdaq Capital Market.
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.
During the quarter ended September 30, 2023, none of our directors or officers (as defined in Section 16 of the Securities Exchange Act of 1934, as amended) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (each as defined in Item 408(a) and (c) of Regulation S-K).
3.1
| | Fifth Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference to Exhibit 3.1 contained in our Registration Statement on Form S-3 (File No. 333-258814), as filed on August 13, 2021). |
3.2
| | Fourth Amended and Restated Bylaws of the Company (Incorporated by reference to Exhibit 3.2 contained in our Form 8-K current report as filed on January 8, 2016). |
|
| 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. |
SIGNATURES
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 November 14, 2023 | By: | /s/ Dolev Rafaeli |
|
| | Name: Dolev Rafaeli |
|
| | Title: President & Chief Executive Officer |
|
Date November 14, 2023 | By: | /s/ Christopher Lesovitz |
|
|
| Name: Christopher Lesovitz |
|
|
| Title: Chief Financial Officer |
|
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