|
|
|
(State or Other Jurisdiction of incorporation or Organization)
|
|
(I.R.S. Employer Identification No.)
|
|
|
|
(Address of principal executive offices)
|
|
(Zip code)
|
Title of Each Class
|
|
Trading Symbol(s)
|
|
Name Of Each Exchange On Which Registered
|
|
|
|
|
The
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|
Smaller reporting company
|
|
|
|
Emerging growth company
|
|
Page
|
|
Part I. |
FINANCIAL INFORMATION | |
Item 1. |
Financial Statements: |
|
|
1
|
|
|
2
|
|
|
3
|
|
|
4
|
|
|
5
|
|
Item 2. |
Management’s Discussion and Analysis
of Financial Condition and Results of Operations |
21 |
|
|
|
Item 3. |
29 | |
|
|
|
Item 4. |
29 | |
|
||
Part II. |
OTHER INFORMATION |
|
Item 1. |
Legal Proceedings |
30 |
|
|
|
Item 1A. |
Risk Factors |
30 |
|
|
|
Item 5. |
Other Information |
30 |
|
|
|
Item 6. |
Exhibits |
31 |
|
|
|
32
|
||
Certifications
|
|
March 31, 2025
|
December 31, 2024
|
|||||||
(unaudited) | ||||||||
Assets
|
|
|||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Restricted cash
|
||||||||
Accounts receivable, net of allowance for credit losses of $
|
|
|
||||||
Inventories
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Operating lease right-of-use assets
|
|
|
||||||
Intangible assets, net
|
|
|
||||||
Goodwill
|
|
|
||||||
Other assets
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
||||
Liabilities and Stockholders’ Equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses and other current liabilities
|
|
|
||||||
Deferred revenues
|
||||||||
Current portion of operating lease liabilities
|
|
|
||||||
Current portion of contingent consideration
|
|
|
||||||
Total current liabilities
|
|
|
||||||
Long-term debt, net
|
|
|
||||||
Deferred revenues and other liabilities |
||||||||
Operating lease liabilities, net of current portion
|
|
|
||||||
Contingent consideration, net of current portion |
|
|
||||||
Total liabilities
|
|
|
||||||
Commitments and contingencies (Note 13)
|
||||||||
Stockholders’ equity:
|
||||||||
Series C convertible preferred stock, $
|
||||||||
Common stock, $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ equity
|
|
|
||||||
Total liabilities and stockholders’ equity
|
$
|
|
$
|
|
Three Months Ended March 31,
|
||||||||
2025
|
2024
|
|||||||
Revenues, net
|
$
|
|
$
|
|
||||
Cost of revenues
|
|
|
||||||
Gross profit |
||||||||
Operating expenses: |
||||||||
Engineering and product development
|
|
|
||||||
Selling and marketing
|
|
|
||||||
General and administrative
|
|
|
||||||
Total operating expenses
|
|
|
||||||
Loss from operations
|
(
|
)
|
(
|
)
|
||||
Other income (expense): | ||||||||
Interest expense |
( |
) | ( |
) | ||||
Interest income |
||||||||
Total other expense
|
(
|
)
|
(
|
)
|
||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Net loss per share of common stock, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Weighted average shares of common stock outstanding, basic and diluted
|
|
|
Common Stock | ||||||||||||||||||||
Shares
|
Amount
|
Additional
Paid-in-Capital
|
Accumulated
Deficit
|
Total Stockholders’
Equity
|
||||||||||||||||
Balance at January 1, 2025
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock-based compensation expense
|
—
|
|
|
|
|
|||||||||||||||
Net loss
|
—
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at March 31, 2025
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Common Stock |
||||||||||||||||||||
Shares
|
Amount
|
Additional
Paid-in-Capital
|
Accumulated
Deficit
|
Total Stockholders’
Equity
|
||||||||||||||||
Balance at January 1, 2024
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Stock-based compensation expense
|
—
|
|
|
|
|
|||||||||||||||
Net loss
|
—
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Balance at March 31, 2024 |
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Three Months Ended March 31,
|
||||||||
2025
|
2024
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
|
|
||||||
Amortization of operating lease right-of-use assets
|
|
|
||||||
Amortization of deferred financing costs and debt discount | ||||||||
Provision for credit losses
|
|
|
||||||
Stock-based compensation expense
|
|
|
||||||
Loss on disposal of property and equipment
|
||||||||
Inventory write-off
|
||||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
|
|
||||||
Inventories
|
(
|
)
|
(
|
)
|
||||
Prepaid expenses and other assets
|
|
(
|
)
|
|||||
Accounts payable
|
|
|
||||||
Accrued expenses and other liabilities
|
|
(
|
)
|
|||||
Deferred revenues
|
(
|
)
|
|
|||||
Operating lease liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from investing activities: | ||||||||
Purchase of property and equipment
|
( |
) | ( |
) | ||||
Net cash used in investing activities
|
( |
) | ( |
) | ||||
Cash flows from financing activities: |
||||||||
Payment of contingent consideration
|
( |
) | ||||||
Net cash used in financing activities
|
( |
) | ||||||
Net decrease in cash, cash equivalents and restricted cash
|
(
|
)
|
(
|
)
|
||||
Cash, cash equivalents and restricted cash at beginning of period
|
|
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
|
$
|
|
||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Restricted cash
|
|
|
||||||
Total cash, cash equivalents and restricted cash
|
$
|
|
$
|
|
||||
Supplemental disclosure of cash flow information:
|
||||||||
Cash paid during the year for interest
|
$
|
|
$
|
|
||||
Supplemental schedule of non-cash operating, investing and financing activities:
|
||||||||
Operating lease right-of-use assets obtained in exchange for operating lease liabilities
|
$ | $ | ||||||
Transfer of property and equipment to inventories
|
$ | $ | ||||||
Accrued payment of
contingent consideration
|
$ | $ |
|
•
|
Level 1 – quoted market prices in active markets
for identical assets or liabilities.
|
|
•
|
Level 2 – observable inputs other than quoted
prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
|
|
•
|
Level 3 – inputs that are generally unobservable
and typically reflect the Company’s estimate of assumptions that market participants would use in pricing the asset or liability.
|
|
Three Months Ended March 31,
|
|||||||
|
2025
|
2024
|
||||||
Balance, beginning of period
|
$
|
|
$
|
|
||||
Additions
|
|
|
||||||
Expirations and claims satisfied
|
(
|
)
|
(
|
)
|
||||
Total
|
|
|
||||||
Less current portion within accrued expenses and other current liabilities
|
(
|
)
|
(
|
)
|
||||
Balance within deferred revenues and other liabilities
|
$
|
|
$
|
|
|
March 31,
|
||||||||
|
2025
|
2024
|
||||||
Stock options
|
||||||||
Common stock warrants | ||||||||
Restricted stock units
|
||||||||
|
•
|
identification of the contract, or contracts, with a customer;
|
|
•
|
identification of the performance obligations in the contract;
|
|
•
|
determination of the transaction price;
|
|
•
|
allocation of the transaction price to the performance obligations in the contract; and
|
|
•
|
recognition of revenue when, or as, performance obligations are satisfied.
|
(remaining) |
$ |
|
||
|
|
|||
|
|
|||
|
|
|||
|
$
|
|
March 31, 2025
|
December 31, 2024
|
|||||||
Raw materials and work-in-process
|
$
|
|
$
|
|
||||
Finished goods
|
|
|
||||||
|
$
|
|
$
|
|
March 31, 2025
|
December 31, 2024
|
|||||||
Lasers
placed-in-service
|
$
|
|
$
|
|
||||
Equipment,
computer hardware and software
|
|
|
||||||
Furniture and
fixtures
|
|
|
||||||
Leasehold
improvements
|
|
|
||||||
Lasers-in-process |
||||||||
|
|
|||||||
Less: accumulated depreciation and
amortization
|
(
|
)
|
(
|
)
|
||||
|
$
|
|
$
|
|
March 31, 2025
|
Gross Carrying
Value
|
Accumulated
Amortization
|
Net Book Value
|
|||||||||
Core technology
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Product technology
|
|
(
|
)
|
|
||||||||
Customer relationships
|
|
(
|
)
|
|
||||||||
Tradenames
|
|
(
|
)
|
|
||||||||
Pharos customer lists
|
|
(
|
)
|
|
||||||||
$
|
|
$
|
(
|
)
|
$
|
|
December 31, 2024
|
Gross Carrying
Value
|
Accumulated
Amortization
|
Net Book Value
|
|||||||||
Core technology
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Product technology
|
|
(
|
)
|
|
||||||||
Customer relationships
|
|
(
|
)
|
|
||||||||
Tradenames
|
|
(
|
)
|
|
||||||||
Pharos customer lists
|
|
(
|
)
|
|
||||||||
$
|
|
$
|
(
|
)
|
$
|
|
2025 (remaining)
|
$
|
|
||
2026
|
$ |
|
||
2027
|
$ |
|
||
2028
|
$ |
|
||
2029
|
$ |
|
March 31, 2025 | December 31, 2024 | |||||||
Warranty obligations
|
$
|
|
$
|
|
||||
Compensation and related benefits
|
||||||||
State sales, use and other taxes
|
|
|
||||||
Professional fees and other
|
|
|
||||||
|
$
|
|
$
|
|
2026
|
$
|
|
||
2027
|
||||
2028
|
||||
|
|
|
||
Exit fee
|
||||
|
||||
Less: unamortized debt discount
|
( |
) | ||
Long-term debt, net
|
$ |
Three Months Ended
March 31,
|
||||||||
2025 |
2024 |
|||||||
Selling and marketing*
|
$
|
|
$
|
(
|
)
|
|||
General and administrative
|
|
|
||||||
$
|
|
$
|
|
Number of Shares
Under Option Plan
|
Weighted-Average
Exercise Price per
Option
|
Weighted-Average
Remaining Contractual
Term (in years)
|
||||||||||
Outstanding at January 1, 2025
|
|
$
|
|
|||||||||
Granted
|
|
$
|
|
|||||||||
Forfeited and expired
|
|
$
|
|
|||||||||
Outstanding at March 31, 2025 | $ | |||||||||||
Exercisable at March 31, 2025 | $ | |||||||||||
Vested and expected to vest at March 31, 2025
|
$ |
Three Months Ended March 31, 2025 |
Dermatology
Recurring
Procedures
|
Dermatology
Procedures
Equipment
|
Total
|
|||||||||
Revenues, net
|
$
|
|
$
|
|
$
|
|
||||||
Cost of revenues | ||||||||||||
Gross profit
|
||||||||||||
Gross profit %
|
% | % | % | |||||||||
Allocated expenses:
|
||||||||||||
Engineering and product development
|
|
|
|
|||||||||
Selling and marketing
|
|
|
|
|||||||||
Unallocated expenses
|
|
|
|
|||||||||
Total allocated and unallocated expenses
|
|
|
|
|||||||||
Income (loss) from operations
|
|
|
(
|
)
|
||||||||
Interest expense
|
|
|
(
|
)
|
||||||||
Interest income | ||||||||||||
Net income (loss)
|
$
|
|
$
|
|
$
|
(
|
)
|
Three Months Ended March 31, 2024 |
Dermatology
Recurring
Procedures
|
Dermatology
Procedures
Equipment
|
Total
|
|||||||||
Revenues, net
|
$
|
|
$
|
|
$
|
|
||||||
Cost of revenues
|
||||||||||||
Gross profit
|
||||||||||||
Gross profit %
|
% | % | % | |||||||||
Allocated expenses:
|
||||||||||||
Engineering and product development
|
|
|
|
|||||||||
Selling and marketing
|
|
|
|
|||||||||
Unallocated expenses
|
|
|
|
|||||||||
Total allocated and unallocated expenses
|
|
|
|
|||||||||
(Loss) income from operations
|
(
|
)
|
|
(
|
)
|
|||||||
Interest expense
|
|
|
(
|
)
|
||||||||
Interest income |
||||||||||||
Net (loss) income
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
Three Months Ended March 31,
|
||||||||
|
2025
|
2024
|
||||||
Dermatology recurring procedures
|
$
|
|
$
|
|
||||
Dermatology procedures equipment
|
|
|
||||||
Unallocated expenses
|
|
|
||||||
Total
|
$
|
|
$
|
|
Three Months Ended March 31, 2025
|
Dermatology Recurring Procedures
|
Dermatology Procedures Equipment
|
Total
|
|||||||||
Domestic
|
$
|
|
$
|
|
$
|
|
||||||
China
|
|
|
|
|||||||||
Middle East
|
|
|
|
|||||||||
Other foreign
|
|
|
|
|||||||||
Total
|
$
|
|
$
|
|
$
|
|
Three Months Ended March 31, 2024
|
Dermatology Recurring Procedures
|
Dermatology Procedures Equipment
|
Total
|
|||||||||
Domestic
|
$
|
|
$
|
|
$
|
|
||||||
China
|
|
|
|
|||||||||
Middle East
|
|
|
|
|||||||||
Other foreign
|
|
|
|
|||||||||
Total
|
$
|
|
$
|
|
$
|
|
March 31, 2025
|
December 31, 2024
|
|||||||
Dermatology recurring procedures
|
$
|
|
$
|
|
||||
Dermatology procedures equipment
|
|
|
||||||
Other unallocated assets
|
|
|
||||||
Total
|
$
|
|
$
|
|
2025 (remaining)
|
$
|
|
||
2026
|
|
|||
2027 |
||||
2028 |
||||
2029 |
||||
Total remaining lease payments
|
|
|||
Less: imputed interest
|
(
|
)
|
||
Total lease liabilities
|
$
|
|
ITEM 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
• |
forecasts of future business performance, consumer trends and macro-economic conditions;
|
• |
descriptions of market, competitive conditions, and competitive product introductions;
|
• |
descriptions of plans or objectives of management for future operations, products or services;
|
• |
actions by the U.S. Food and Drug Administration (“FDA”) or other regulatory agencies with respect to our products or product candidates;
|
• |
changes to third-party reimbursement of laser treatments using our devices;
|
• |
our estimates regarding the sufficiency of our cash resources, expenses, capital requirements and needs for additional financing and our ability to obtain additional financing;
|
• |
our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
|
• |
anticipated results of existing or future litigation or government actions;
|
• |
health emergencies, the spread of infectious disease or pandemics; and
|
• |
descriptions or assumptions underlying or related to any of the above items.
|
• |
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.
|
• |
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 combines intense pulsed light with vacuum (suction) for the treatment of mild to
moderate inflammatory acne (including acne vulgaris), comedonal acne and pustular acne.
|
Three Months Ended March 31,
|
||||||||
2025
|
2024
|
|||||||
Dermatology recurring procedures
|
$
|
4,727
|
$
|
4,696
|
||||
Dermatology procedures equipment
|
2,085
|
2,058
|
||||||
Total revenues
|
$
|
6,812
|
$
|
6,754
|
Three Months Ended March 31,
|
||||||||
2025
|
2024
|
|||||||
Dermatology recurring procedures
|
$
|
2,049
|
$
|
2,195
|
||||
Dermatology procedures equipment
|
1,116
|
1,479
|
||||||
Total cost of revenues
|
$
|
3,165
|
$
|
3,674
|
Three Months Ended March 31,
|
||||||||
(in thousands, except percentages)
|
2025
|
2024
|
||||||
Revenues, net
|
$
|
6,812
|
$
|
6,754
|
||||
Cost of revenues
|
3,165
|
3,674
|
||||||
Gross profit
|
$
|
3,647
|
$
|
3,080
|
||||
Gross profit percentage
|
53.5
|
%
|
45.6
|
%
|
Three Months Ended March 31,
|
||||||||
(in thousands, except percentages)
|
2025
|
2024
|
||||||
Revenues, net
|
$
|
4,727
|
$
|
4,696
|
||||
Cost of revenues
|
2,049
|
2,195
|
||||||
Gross profit
|
$
|
2,678
|
$
|
2,501
|
||||
Gross profit percentage
|
56.7
|
%
|
53.3
|
%
|
Three Months Ended March 31,
|
||||||||
(in thousands, except percentages)
|
2025
|
2024
|
||||||
Revenues, net
|
$
|
2,085
|
$
|
2,058
|
||||
Cost of revenues
|
1,116
|
1,479
|
||||||
Gross profit
|
$
|
969
|
$
|
579
|
||||
Gross profit percentage
|
46.5
|
%
|
28.1
|
%
|
Three Months Ended March 31,
|
||||||||
2025
|
2024
|
|||||||
Net loss
|
$
|
(2,432
|
)
|
$
|
(3,368
|
)
|
||
Adjustments:
|
||||||||
Depreciation and amortization
|
1,220
|
1,249
|
||||||
Amortization of operating lease right-of-use assets
|
85
|
95
|
||||||
Loss on disposal of property and equipment
|
34
|
13
|
||||||
Interest expense, net
|
417
|
479
|
||||||
Non-GAAP EBITDA
|
(676
|
)
|
(1,532
|
)
|
||||
Stock-based compensation expense
|
129
|
112
|
||||||
Inventory write-off
|
—
|
141
|
||||||
Non-GAAP adjusted EBITDA
|
$
|
(547
|
)
|
$
|
(1,279
|
)
|
ITEM 3. |
Quantitative and Qualitative Disclosure about Market Risk
|
ITEM 4. |
Controls and Procedures
|
ITEM 1. |
Legal Proceedings
|
ITEM 1A. |
Risk Factors
|
ITEM 5. |
Other Information
|
ITEM 6. |
EXHIBITS
|
16.1
|
|
Rule 13a-14(a) Certificate of Chief Executive Officer
|
|
Rule 13a-14(a) Certificate of Chief Accounting Officer
|
|
Certifications of Chief Executive Officer and Chief Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
STRATA SKIN SCIENCES, INC.
|
||||
Date
|
May 14, 2025
|
By:
|
/s/ Dolev Rafaeli
|
|
Name:
|
Dolev Rafaeli
|
|||
Title:
|
President & Chief Executive Officer
|
|||
(Principal Executive Officer)
|
||||
Date
|
May 14, 2025
|
By:
|
/s/ John Gillings
|
|
Name:
|
John Gillings
|
|||
Title:
|
Chief Accounting Officer
|
|||
(Principal Financial Officer)
|