Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Management’s
discussion and analysis (“MD&A”) provides supplemental information, which sets forth the major factors that have affected
our financial condition and results of operations and should be read in conjunction with the Condensed Consolidated Financial Statements
and related notes. The following information should provide a better understanding of the major factors and trends that affect our earnings
performance and financial condition, and how our performance during the first quarter of 2026 compares with prior-year periods. Throughout
this section, Biofrontera Inc., including its wholly owned subsidiary, Biofrontera Discovery GmbH (“Discovery” or “subsidiary”),
is referred to as “Company,” “we,” “us,” or “our.” References to “ Former
Ameluz Licensor” refers to Biofrontera Pharma GmbH and references to the “Biofrontera
Group” refer to Biofrontera AG and its consolidated subsidiaries.
Trademarks,
Trade Names, and Service Marks
All
trademarks, trade names, and service marks appearing in this Form 10-Q are the property of their respective owners. Solely for convenience,
the trademarks and trade names in this Form 10-Q are referred to without the symbols ® and ™, but such references should not
be construed as any indication that their respective owners will not assert their rights thereto to the fullest extent under applicable
law. We do not intend to use or display other companies’ trademarks, trade names, or service marks to imply a relationship with,
or endorsement or sponsorship of us by, any other companies.
Forward-Looking
Statements
The Private Securities Litigation Reform Act of 1995 provides a “safe
harbor” for forward-looking statements. Certain statements in this Form 10-Q constitute “forward-looking statements”.
Such statements include estimates of our expenses, future revenue, capital requirements, our need for additional financing, statements
regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing licensed products
to market, the timeline for regulatory review and approval of our licensed products, and other statements that are not historical facts.
The words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential”, “target”, “goal”, “assume”, “would”, “could” or similar
words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
You should read this Form 10-Q and the documents that we have filed as exhibits completely and with the understanding that our actual
future results may be materially different from what we expect. While we have based these forward-looking statements on our current expectations
and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed in or implied by our
forward-looking statements, and you should not place undue reliance on our forward-looking statements. These forward-looking statements
are subject to risks, uncertainties and assumptions about us and accordingly, actual results or events could differ materially from the
plans, intentions and expectations disclosed in or implied by the forward-looking statements we make.
Factors that may cause such differences include, but are not limited to:
●
our
ability to achieve and sustain profitability;
●
our
ability to compete effectively in selling our products;
●
our
ability to expand, manage and maintain our direct sales and marketing efforts, including our ability to obtain the financing to develop
our marketing strategy, if needed;
●
changes
in our relationship with our manufacturing partners and the possible impact of tariffs;
●
our
ability to manufacture our products;
●
our
ability to adequately protect our intellectual property and operate the business without infringing upon the intellectual property
rights of others;
●
our
actual financial results may vary significantly from forecasts and from period to period;
●
our
estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing;
●
market
risks regarding consolidation and group purchasing organizations (“GPOs”) in the healthcare industry;
●
the
willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third-party payors for our
products, or procedures using our products significantly declines;
●
our
ability to market, commercialize, achieve market acceptance for and sell our products;
●
the
fact that product quality issues or product defects may harm our business;
●
any
claims brought against the Company, including but not limited to product liability claims, claims of patent infringement, or claims
challenging the validity of our intellectual property;
●
our
ability to maintain compliance with The Nasdaq Stock Market, LLC (“Nasdaq”) continued listing standards;
●
our
ability to comply with the requirements of being a public company;
●
the
progress, timing and completion of research, development and preclinical studies and clinical trials for our products;
●
our
ability to obtain and maintain the regulatory approvals necessary for the marketing of our products in the United States, and;
●
those
risks listed in the sections of our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Form 10-K”) entitled “Risk Factors”.
More detailed information about us and the risk factors that may affect
the realization of forward-looking statements, including the forward-looking statements in this Quarterly Report on Form 10-Q, is set
forth in our filings with the Securities and Exchange Commission (“SEC”), including the 2025 Form 10-K. We urge investors
and security holders to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly
update or revise our forward-looking statements as a result of new information, future events or otherwise, except as required by law.
21
Overview
Biofrontera
Inc. is a United States based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical
products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”). The Company’s
products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamp series (together, the “RhodoLED Lamps”), are
used for the treatment of actinic keratosis (“AK”), a common skin condition characterized by the growth of pre-cancerous
skin lesions (“AKs”). We generate revenue by selling our products, through our national commercial team, directly to dermatology
offices and groups in the United States.
We
conduct our clinical development activities and hold certain manufacturing-related assets through Discovery, our wholly owned German
subsidiary. Our research and development (“R&D”) programs are focused on label expansion for Ameluz and on enhancing
the RhodoLED Lamps to support adoption of PDT in the United States. See Note 1. Organization and Business Overview in our Notes to Condensed Consolidated Financial Statements in Part I,
Item 1 of this Form 10-Q for additional information about the Company and its subsidiary.
Recent
Key Developments
Strategic
Transaction with the Biofrontera Group. On October 20, 2025, we entered into (i) an Asset Purchase Agreement (the
“Transfer Agreement”) and (ii) an Earnout Agreement (together with the Transfer Agreement, the “Agreements”),
with the Biofrontera Group, pursuant to which the Company finalized the agreements to acquire all rights in the United States (the “U.S.
Rights”) to Ameluz and the RhodoLED Lamps (the “Strategic Transaction”). Pursuant to the terms of the Agreements, retroactive
to June 1, 2025, the Company will pay a monthly earnout of 12% of United States revenues of Ameluz in years when United States net sales
are $65.0 million or less and an earnout of 15% on all revenue in years when United States net sales of Ameluz exceed $65.0 million, continuing
until the expiration of patent protection on Ameluz allows for generic competition in the United States. The earnout replaces a transfer
pricing model under the Company’s Second Amended and Restated License and Supply Agreement (“Second A&R Ameluz LSA”)
by and among the Company and the Biofrontera Group, which has now been terminated pursuant to the Agreements. The new structure reduces
overall cost for the Company and is expected to accelerate the Company’s timeframe to reach break-even. The results of operations
for the three months ended March 31, 2026 reflect a full quarter under this revised cost structure, while the three months ended March
31, 2025 reflect the prior transfer-pricing model. Period-over-period comparisons of cost of revenues and related-party cost of revenues
are therefore affected by this change, as discussed further under “Results of Operations” below. See Note 12. Related Party
Transactions in our Notes to Condensed Consolidated Financial Statements in Part I, Item 1 of this Form 10-Q for additional information.
Compliance
with Nasdaq Listing Standards. On December 31, 2025, we received a letter from Nasdaq notifying us that
the listing of our common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “the Minimum Bid Price Requirement”).
On May 6, 2026, we received written notification from Nasdaq that we had regained compliance with the Minimum Bid Price Requirement and
that the matter was closed. There can be no assurance that we will maintain compliance with the Minimum Bid Price Requirement or other
continued listing standards in the future. See Note 18 . Subsequent Events in our Notes to Condensed Consolidated Financial
Statements in Part I, Item 1 of this Form 10-Q for additional information.
22
ITC Matter. On May
6, 2026, the International Trade Commission issued a Notice of Final Determination finding a violation of Section 337 of the Tariff Act of 1930 with respect to
two asserted patents involving certain components of our RhodoLED XL Lamps. The Commission issued a Limited Exclusion Order and Cease
and Desist Orders, with the orders relating to the ‘028 patent suspended pending further proceedings before the U.S. Patent Trial
and Appeal Board. See Note 16. Commitments and Contingencies for additional information
regarding this matter, which is referred to herein as the “ITC Matter.”
Geopolitical
Uncertainty and Tariffs. Recent actions by the U.S., including the imposition of significant tariffs on imports from certain countries,
have heightened uncertainty in the global trade environment. These tariffs, along with potential retaliatory measures by other countries,
may increase inflationary pressure and raise the costs of our products, which are exclusively imported from Europe. While several tariff
announcements have been followed by announcements of limited exemptions and temporary pauses, these actions have caused substantial uncertainty
and volatility in financial markets, and may result in further retaliatory measures. We may be unable to fully offset the impacts of
tariffs by adjusting the pricing of our products. We continue to monitor developments and assess the potential impact on our supply chain,
product cost, and pricing strategy.
Strategy
Our
principal objective is to improve patient outcomes through adoption and use of our products in the United States. The key elements
of our strategy include the following:
●
expanding
our sales in the United States of Ameluz in combination with the RhodoLED Lamps for the treatment
of minimally to moderately thick AKs of the face and scalp and positioning Ameluz to be the standard of care in the
United States by focusing on acquisition of new customers and growth of the therapy in our current customer base;
●
leveraging
the potential for future approvals and label extensions of our portfolio products that are in the pipeline for the United
States market with respect to Ameluz and furthering the clinical development of this product after taking over responsibility
for certain ongoing clinical trials since June 1, 2024; and
●
strategically
managing our portfolio, including opportunistically adding complementary products or services to our portfolio by acquiring
or licensing IP to further leverage our commercial infrastructure and customer relationships.
We
devote a substantial portion of our cash resources to the commercialization of Ameluz and the BF-RhodoLED Lamps.
We have financed our operating and capital expenditures through cash proceeds generated from our product sales, proceeds received from
convertible notes and equity financings.
We
believe that important measures of our results of operations include product revenue, operating income (loss) and adjusted earnings
before interest, taxes, depreciation and amortization (“EBITDA”; a non GAAP measure). Our sole source of product revenue
is sales of Ameluz and the BF-RhodoLED Lamps. Our long-term financial objectives include consistent revenue growth and expanding
operating margins. Accordingly, we are focused on product sales expansion to drive revenue growth and improve operating
efficiencies, including effective resource utilization, information technology leverage, and overhead cost management.
23
Key
Factor Affecting Our Performance
Because
traditional photodynamic therapy treatments using a lamp are performed more frequently during the winter, our revenue is subject to some
seasonality and has historically been higher during the first and fourth quarters than during the second and third quarters. As a result,
our historical results of operations may not be comparable to our results of operations in future periods, and our results of operations
may not be directly comparable from period to period.
Components
of Our Results of Operations
Product
Revenues, Net
We
generate product revenues through the sale of our products Ameluz and RhodoLED Lamps . Revenues from product sales are recorded
net of trade discounts and allowances and government rebates.
The
primary factors that determine our revenue derived from our products are:
●
the
level of orders generated by our sales force;
●
the
level of prescriptions and institutional demand for our products; and
●
unit
sales and average sales price.
Cost
of Revenues, Related Party
Cost
of revenues, related party, relating to inventory purchased before the Strategic Transaction, is comprised of purchase costs of our products,
Ameluz and RhodoLED Lamps, from Biofrontera Pharma GmbH and insignificant inventory adjustments due to scrapped, expiring and excess products.
Cost
of Revenues, Other
Cost
of revenues, other, is comprised of third-party logistics and distribution costs including packaging, freight, transportation, shipping
and handling costs.
24
Selling,
General and Administrative Expense
Selling,
general and administrative expenses consist principally of costs associated with our sales force, commercial support personnel, personnel
in executive and other administrative functions, as well as medical affairs professionals. Other selling, general and administrative
expenses include marketing, trade, and other commercial costs necessary to support the commercial and manufacturing operation of our
products and professional fees for legal, consulting and accounting services, product regulation, quality management, as well as depreciation
and amortization.
Selling,
General and Administrative Expenses, Related Party
Selling,
general and administrative expenses, related party, relate to the services provided by the Biofrontera Group, primarily for regulatory
support and pharmacovigilance. These expenses were charged to us based on costs incurred plus 6% in accordance with the Amended and Restated
Master Contact Services Agreement entered into in December 2021.
Research
and Development
Effective
June 1, 2024, we took control of all clinical trials for Ameluz in the United States, allowing for more effective cost management and
direct oversight of trial efficiency. Our R&D expenses include costs directly attributable to the clinical development of Ameluz,
including personnel-related expenses, the cost of services provided by outside contractors, including services related to the Company’s
clinical trial sites, facilities, depreciation, and other direct and allocated expenses. Along with our Ameluz clinical trials, our R&D
program also aims to improve the capabilities of our RhodoLED Lamps to better fulfill the needs of dermatologists and improve the effectiveness
of our commercial team by letting sales representatives carry approved devices with them, allowing for easier product demonstrations
and evaluations. All costs associated with R&D are expensed as incurred.
Change
in Fair Value of Warrant Liabilities
For
warrants that are classified as liabilities, the Company records the fair value of the warrants at each balance sheet date and records
changes in the estimated fair value as a non-cash gain or loss in the consolidated statements of operations until the warrants are exercised,
expire or other facts and circumstances lead the warrant liabilities to be reclassified to stockholders’ equity or deficit.
Interest
Income (Expense), net
Interest
expense, net, primarily consists of interest on our convertible notes and short-term debt, including amortization of deferred costs.
25
Other
Income (Expense), net
Other
income (expense), net primarily includes (i) gain on return of leased assets and (ii) gain (loss) on foreign currency transactions.
Income
Taxes
As
a result of the net losses we have incurred in each fiscal year since inception, we have recorded no provision for federal income taxes
during such periods. Income tax expense incurred relates to state income taxes.
Results
of Operations
Comparison
of the Three Months ended March 31, 2026 and 2025
The
following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:
( in thousands)
2026
2025
Change
Product revenues, net
$ 10,084
$ 8,588
$ 1,496
Operating expenses:
Cost of revenues, related party
1,831
3,075
(1,244 )
Cost of revenues, other
285
193
92
Selling, general and administrative
10,994
8,653
2,341
Selling, general and administrative, related party
2
7
(5 )
Patent remediation expense
392
-
392
Research and development
900
1,207
(307 )
Total operating expenses
14,404
13,135
1,269
Loss from operations
(4,320 )
(4,547 )
227
Other income (expense):
Change in fair value of warrant liabilities
(219 )
548
(767 )
Interest expense, net
(125 )
(106 )
(19 )
Other expense, net
(88 )
(99 )
11
Total other income (expense)
(432 )
343
(775 )
Loss before income taxes
(4,752 )
(4,204 )
(548 )
Income tax benefit
-
(1 )
1
Net loss
$ (4,752 )
$ (4,203 )
$ (549 )
Product
Revenues, net
Net
product revenue for the three months ended March 31, 2026 was $10.1 million, an increase of $1.5 million, or 17.4%, compared to the three
months ended March 31, 2025. The increase was primarily attributable to higher Ameluz® net sales, reflecting 15.9% growth in unit
volume, as well as the full period impact of a price increase implemented in the fourth quarter of 2025 that contributed approximately
$0.2 million revenue increase.
26
Operating
Expenses
Cost
of Revenues, Related Party
Cost
of revenues, related party for the three months ended March 31, 2026 decreased $1.2 million, or 40.5%, compared to the three months ended
March 31, 2025. The decrease was primarily driven by a reduction in the purchase price of Ameluz® resulting from the transition pursuant to the Strategic Transaction from
the transfer pricing model in place under the now-terminated Second A&R Ameluz LSA, which was 25% of net revenue, to
a significantly lower cost structure comprised only of Ameluz direct cost and the 12% earnout applied to
the net revenue.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses for the three months ended March 31, 2026 were $11.0 million, an increase of $2.3 million, or
27.1%, compared to the three months ended March 31, 2025. Selling and marketing expenses increased $0.8 million, reflecting the full
deployment of the direct sales team and higher sales activity levels, including sales meetings, conferences, and exhibits, in
support of improved commercial performance. General and administrative expenses increased $0.8 million, primarily due to legal
expenses associated with ongoing patent-related claims. Further, in connection with the Strategic Transaction, the Company
assumed responsibility for manufacturing operations beginning in the fourth quarter of 2025. Because we were in the process of
securing approvals and licenses to commence manufacturing later in 2026, manufacturing-related costs of $0.6 million are reflected
in selling, general and administrative expenses for the three months ended March 31, 2026.
Patent Remediation Expense
During the three months ended March 31, 2026, we recognized
a total charge of approximately $0.4 million reflecting the estimated cost to remediate the affected units of our RhodoLED XL Lamps in
response to ITC Matter. The total charge comprises (i) an inventory write-down of approximately $0.1 million
to reduce the carrying value of affected finished goods inventory and obsolete components in raw materials to net realizable
value in accordance with ASC 330-10-35, which were charged to cost of revenues, other, and (ii) an accrued remediation liability
of approximately $0.4 million for the future cost activities charged to patent remediation expense.
We expect to incur the cash component of these costs
over the twelve months following the 60-day Presidential Review period, concluding on July 6, 2026, as remediation activities are
executed. In addition, the remediation is expected to result in a modest, recurring increase in our per-unit cost of revenues
for affected products; this prospective impact is reflected in our cost of revenues as
units implementing the remediation are produced and sold. We do not expect the recurring per-unit cost increase to be material
to our overall cost of revenues.
Research
and Development Expense
Research
and development expenses for the three months ended March 31, 2026 decreased $0.3 million compared to the three months ended March 31,
2025. The decrease was primarily attributable to certain clinical trials reaching substantial completion ahead of their originally planned
timelines, resulting in lower trial-related expenditures in the current year period.
The
following table summarizes the major categories of our R&D expenses for the three months ended March 31, 2026 and 2025:
2026
2025
Actinic keratosis
$ 266
$ 554
Moderate to severe acne
28
141
Superficial basal cell carcinoma
109
127
Lamp Development
35
-
Personnel-related costs
462
379
Other research and development
-
6
$ 900
$ 1,207
Change
in Fair Value of Warrant Liabilities
The
change in fair value of warrant liabilities was ($0.2) million for three months ended March 31, 2026, as compared to $0.5 million for
the three months ended March 31, 2025. The increase in the fair value of warrant liabilities for the three months ended March 31, 2026
was driven primarily by an increase in the underlying value of the Company’s common stock while the decrease for the three months
ended March 31, 2025 was driven by a decrease in the underlying value of the Company’s common stock.
Net
Loss to Adjusted EBITDA Reconciliation for the Three Months Ended March 31, 2026 and 2025
We
define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other
non-operating items from our statements of operations as well as certain other items considered outside the normal course of our operations
specifically described below. Adjusted EBITDA is not a presentation made in accordance with GAAP. Our definition of adjusted EBITDA
may vary from the use of similarly-titled measures by others in our industry due to the potential inconsistencies in the method of calculation
and differences due to items subject to interpretation. Adjusted EBITDA should not be considered as an alternative to net income or loss,
operating income/(loss), cash flows from operating activities or any other performance measures derived in accordance with GAAP
as measures of operating performance or liquidity. Adjusted EBITDA has limitations as an analytical tool and should not be considered
in isolation or as a substitute for analysis of our results as reported under GAAP.
Change
in fair value of warrant liabilities: The warrants issued in conjunction with our private placement offerings and registered public
offerings were accounted for as liabilities in accordance with ASC 815-40. The warrant liabilities are measured at fair value at inception
and on a recurring basis, with changes in fair value presented within the consolidated statement of operations. We exclude the impact
of the change in fair value of warrant liabilities as this is non-cash.
Stock-Based
Compensation : To measure operating performance, we exclude the impact of costs relating to share-based compensation. Due to the subjective
assumptions and the variety of award types, we believe that the exclusion of share-based compensation expense, which is non-cash, allows
for more meaningful comparisons of our operating results to peer companies. Share-based compensation expense can vary significantly based
on the timing, size and nature of awards granted.
Patent Remediation
Expense : During the three months ended March 31, 2026, we recognized a total charge of approximately $0.4 million reflecting the
estimated cost to remediate the affected units of our RhodoLED XL Lamps in response to the ITC Matter.
The total charge comprises (i) an inventory write-down of approximately $0.1 million to reduce the carrying value of affected
finished goods inventory and obsolete components in raw materials to net realizable value in accordance with ASC
330-10-35, and (ii) an accrued remediation liability of approximately $0.4 million for the future cost activities required to
complete the remediation. We exclude these charges because they relate to a discrete adverse legal and regulatory matter that is
not indicative of the Company’s ongoing operating performance.
27
Adjusted
EBITDA margin is adjusted EBITDA for a particular period expressed as a percentage of revenues for that period.
We
use adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors. In addition
to adjusted EBITDA being a significant measure of performance for management purposes, we also believe that this presentation provides
useful information to investors regarding financial and business trends related to our results of operations and that when non GAAP
financial information is viewed with GAAP financial information, investors are provided with a more meaningful understanding of
our ongoing operating performance.
The
below table presents a reconciliation from net loss to Adjusted EBITDA for the three months ended March 31, 2026 and 2025:
Three Months Ended
March 31,
2026
2025
Net loss
$ (4,752 )
$ (4,203 )
Interest expense, net
125
106
Income tax benefit
-
(1 )
Depreciation and amortization
55
29
EBITDA
(4,572 )
(4,069 )
Change in fair value of warrant liabilities
219
(548 )
Patent Remediation - Inventory Write-down
58
-
Patent Remediation Expense
392
-
Stock-based compensation
342
239
Adjusted EBITDA
$ (3,561 )
$ (4,378 )
Adjusted EBITDA margin
-35.3 %
-51.0 %
Adjusted
EBITDA
Adjusted
EBITDA increased from ($4.4) million for the three months ended March 31, 2025 to ($3.6) million for the three months ended March 31,
2026, an improvement of approximately $0.8 million. The improvement was primarily driven by a $2.7 million increase in gross profit,
reflecting higher Ameluz unit volume and a significantly lower cost structure as described above. This improvement was partially offset
by a $2.3 million increase in selling, general and administrative expenses. Refer to the section above entitled “ Selling, General
and Administrative Expenses ” for additional details.
Liquidity
and Capital Resources
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the ordinary course of business. Since we commenced operations in 2015, we have generated significant losses. The Company
incurred net cash outflows from operations of $0.1 million and $4.1 million for the three months ended March 31, 2026 and 2025, respectively.
As of March 31, 2026, the Company’s accumulated deficit was $133 million. The Company’s primary sources of liquidity are
its cash collected from the sales of its products and cash flows from financing transactions. As of March 31, 2026, we had cash and cash
equivalents of $6.3 million, compared to $6.4 million as of December 31, 2025. The Company cannot provide assurance that it will ultimately
achieve profitable operations and become operating cash flow positive or raise additional debt or equity capital. Additionally, the current
capital resources are not adequate to continue operating and maintaining the business strategy for a period of twelve months from the
issuance date of this report. Management believes that these conditions raise substantial doubt about the Company’s ability to
continue as a going concern for at least twelve months from the issuance date of this Quarterly Report on Form 10-Q.
The
Company plans to address the conditions that raise substantial doubt regarding its ability to continue as a going concern by, among other
things, continuing to expand the commercialization of Ameluz in the United States while controlling expenses, pursuing the realization
of an additional $1.0 million in milestone payments from the sale of the Xepi intangible asset and, if necessary, securing additional
capital through equity or debt financings. However, there can be no assurance that the Company will be successful in obtaining sufficient
funding on acceptable terms, if at all. If the Company is unable to raise additional capital when needed, it will not have sufficient
cash resources and liquidity to fund its business operations and may be forced to delay or reduce continued commercialization efforts
or R&D programs which could have a material adverse effect on the Company and its financial statements.
The
condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets,
liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.
28
Cash
Flows
The
following table summarizes our cash provided by and (used in) operating, investing and financing activities:
Three Months Ended
March 31,
(in thousands)
2026
2025
Net cash used in operating activities
$ (70 )
$ (4,117 )
Net cash used in investing activities
(5 )
(3 )
Net (decrease) in cash and restricted cash
$ (75 )
$ (4,120 )
Operating
Activities
During
the three months ended March 31, 2026, operating activities used $0.1 million of cash, primarily resulting from our loss from operations
of $4.3 million, offset by changes in our operating assets and liabilities of $3.4 million. The net decrease in operating accounts was
attributable to the decrease in accounts receivable reflective of the seasonal sales of PDT procedures, with higher sales in the fourth
quarter, and collection in the first quarter of receivables outstanding at year-end.
During
the three months ended March 31, 2025, operating activities used $4.1 million of cash, primarily resulting from our loss from operations
of $4.2 million, plus the change in fair value of warrant liabilities of $0.5 million adjusted for non-cash expense of stock-based compensation
of $0.2 million, non-cash interest expense of $0.1 million, depreciation and amortization in the aggregate of $0.2 million, and net cash
used by changes in our operating assets and liabilities of $0.1 million.
Investing
Activities
During
the three months ended March 31, 2026 and 2025, net cash used in investing activities consisted of negligible fixed asset purchases.
29
Accounting
Policies and Significant Judgments and Estimates
Our
management’s discussion and analysis of our financial condition and results of operations are based on our financial statements,
which have been prepared in accordance with generally accepted accounting principles of the United States, or GAAP. The preparation of
the financial statements in accordance with GAAP requires the use of estimates and assumptions by management that affect the value
of assets and liabilities, as well as contingent assets and liabilities, as reported on the balance sheet date, and revenues and expenses
arising during the reporting period. The main areas in which assumptions, estimates and the exercising of a degree of judgment are appropriate
relate to contingent consideration, fair value measurements, valuation of intangible assets and impairment assessment, and stock compensation.
Estimates are based on historical experience and other assumptions that are considered appropriate in the circumstances. They are continuously
reviewed but may vary from the actual values.
Our
significant accounting policies are described in more detail in Note 2. Summary of Significant Accounting Policies , to our
consolidated financial statements included in Item 8. Financial Statements and Supplementary Data in the 2025 Form
10-K.
Critical
Accounting Estimates
A
summary of our critical accounting estimates is discussed in the section entitled “Critical Accounting Estimates” in Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in the 2025
Form 10-K. There were no material changes to our critical accounting estimates for the three months ended March 31, 2026 , other than as noted below .
Loss Contingency
for ITC Matter
With respect to the ITC Matter, our estimate of the loss is based on a
bottoms-up cost model encompassing component procurement, field service travel and labor, return-to-base rework, regulatory and quality
activities, and other costs. The estimate is sensitive to a number of assumptions that may change as remediation activities progress,
including, in particular, (a) the labor and the associated travel and lodging costs, (b) the unit cost of the remediation and
the foreign exchange rate at which it is procured, (c) the regulatory pathway determined for the remediation and (d) the timing
and outcome of the suspended limited exclusion order and cease and desist order as to the ‘028 patent. A change in any of these assumptions could result in a material
change in the recorded accrual, which would be recognized prospectively as a change in estimate in accordance with ASC 250-10-45-17.
Off-balance
Sheet Arrangements
Other
than those items reflected in Note 16. Commitments and Contingencies we did not have during the periods presented, and we do not
currently have, any other off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Emerging
Growth Company Status
The
Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended
transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise
apply to private companies. We have elected to take advantage of such extended transition period, which means that when an accounting
standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised
standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably
elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
As
a “smaller reporting company,” we are not required to provide the information required by this Item.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.