Item 1. Financial Statements
Item
1. Financial Statements
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
( In
thousands, except par value and share amounts )
June 30,
2026
December 31,
2025
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$ 4,659
$ 6,392
Investment, related party
8
9
Accounts receivable, net
5,545
7,291
Inventories
1,097
1,426
Prepaid expenses and other current assets
892
2,279
Other assets, related party
234
686
Total current assets
12,435
18,083
Inventories, long term
3,658
3,729
Property and equipment, net
2,139
2,158
Operating lease right-of-use assets
2,813
1,584
Intangible assets, net
2,568
2,650
Other assets
451
360
Total assets
$ 24,064
$ 28,564
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
4,315
1,855
Accounts payable, related parties, net
1,044
4,811
Accounts payable
1,044
4,811
Operating lease liabilities
472
332
Accrued expenses and other current liabilities
4,710
4,897
Total current liabilities
10,541
11,895
Long-term liabilities:
Convertible notes payable, net
4,620
4,589
Warrant liabilities
526
351
Operating lease liabilities, non-current
2,412
1,240
Other liabilities
9
9
Total liabilities
18,108
18,084
Commitments and contingencies (see Note 17)
-
-
Stockholders’ equity:
Convertible Preferred Stock, $ 0.001 par value, 20,000,000 shares authorized; no Series B-1; 1,850 and 2,050 Series B-2; 6,498 and 6,593 Series B-3; 9,707 and 10,719 Series C; and 3,019 Series D shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively
-
-
Common stock, $ 0.001 par value, 70,000,000 shares authorized; 14,206,126 and 11,648,323 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively
14
12
Additional paid-in capital
139,243
138,413
Accumulated deficit
( 133,301 )
( 127,945 )
Total stockholders’ equity
5,956
10,480
Total liabilities and stockholders’ equity
$ 24,064
$ 28,564
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
( In
thousands, except per share amounts and number of shares )
(Unaudited)
2026
2025
2026
2025
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Product revenues, net
$ 12,003
$ 9,030
$ 22,087
$ 17,617
Operating expenses
Cost of revenues, related party
2,185
2,380
4,016
5,455
Cost of revenues, other
225
262
510
455
Cost of revenues
225
262
510
455
Selling, general and administrative
9,628
10,528
20,623
19,183
Selling, general and administrative, related party
41
69
42
76
Patent remediation expense
-
-
392
-
Research and development
448
870
1,348
2,077
Total operating expenses
12,527
14,109
26,931
27,246
Loss from operations
( 524 )
( 5,079 )
( 4,844 )
( 9,629 )
Other income (expense)
Change in fair value of warrant liabilities
44
153
( 175 )
702
Change in fair value of investment, related party
( 1 )
2
( 1 )
2
Interest expense, net
( 126 )
( 115 )
( 251 )
( 220 )
Other income (expense), net
26
( 264 )
( 62 )
( 363 )
Total other income (expense)
( 57 )
( 224 )
( 489 )
121
Loss before income taxes
( 581 )
( 5,303 )
( 5,333 )
( 9,508 )
Income tax expense
23
21
23
19
Net loss
$ ( 604 )
$ ( 5,324 )
$ ( 5,356 )
$ ( 9,527 )
Loss per common share:
Basic and diluted
$ ( 0.05 )
$ ( 0.57 )
$ ( 0.44 )
$ ( 1.05 )
Weighted-average common shares outstanding:
Basic and diluted
12,923,710
9,351,557
12,306,944
9,108,091
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In
thousands, except number of shares)
(Unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Three and Six Months Ended June 30, 2026
Preferred Stock
Common Stock
Additional Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance, April 1, 2026
22,381
$ -
11,873,323
$ 12
$ 138,755
$ ( 132,697 )
$ 6,070
Conversion of Series B-2 Preferred into Common
( 200 )
-
282,600
-
-
-
-
Conversion of Series B-3 Preferred into Common
( 95 )
-
134,235
-
-
-
-
Conversion of Series C Preferred into Common
( 1,012 )
-
1,619,463
2
( 2 )
-
-
Conversion of convertible notes into Common
-
-
296,505
-
227
-
227
Stock-based compensation
-
-
-
-
263
-
263
Net loss
-
-
-
-
-
( 604 )
( 604 )
Balance, June 30, 2026
21,074
-
14,206,126
14
139,243
( 133,301 )
5,956
Balance, January 1, 2026
22,381
$ -
11,648,323
$ 12
$ 138,413
$ ( 127,945 )
$ 10,480
Conversion of Series B-2 Preferred into Common
( 200 )
-
282,600
-
-
-
-
Conversion of Series B-3 Preferred into Common
( 95 )
-
134,235
-
-
-
-
Conversion of Series C Preferred into Common
( 1,012 )
-
1,619,463
2
( 2 )
-
-
Conversion of convertible notes into Common
-
-
296,505
-
227
-
227
Issuance of shares for restricted stock units
-
-
225,000
-
-
-
-
Stock-based compensation
-
-
-
-
605
-
605
Net loss
-
-
-
-
-
( 5,356 )
( 5,356 )
Balance, June 30, 2026
21,074
$ -
14,206,126
$ 14
$ 139,243
$ ( 133,301 )
$ 5,956
Three and Six Months Ended June 30, 2025
Preferred Stock
Common Stock
Additional Paid-in
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance, April 1, 2025
10,129
-
8,873,932
9
122,072
( 121,612 )
469
Conversion of Series B-2 Preferred into Common
( 725 )
-
1,024,425
-
-
-
Conversion of Series B-3 Preferred into Common
( 170 )
-
240,210
-
-
-
Stock based compensation
-
187
187
Net loss
-
-
-
( 5,324 )
( 5,324 )
Balance, June 30, 2025
9,234
-
10,138,567
9
122,259
( 126,936 )
( 4,668 )
Balance, January 1, 2025
10,129
-
8,873,932
9
121,833
( 117,409 )
4,433
Balance
10,129
-
8,873,932
9
121,833
( 117,409 )
4,433
Conversion of Series B-2 Preferred into Common
( 725 )
-
1,024,425
-
-
-
-
Conversion of Series B-3 Preferred into Common
( 170 )
-
240,210
-
-
-
-
Stock based compensation
-
-
-
426
-
426
Net loss
-
-
-
-
( 9,527 )
( 9,527 )
Balance, June 30, 2025
9,234
-
10,138,567
9
122,259
( 126,936 )
( 4,668 )
Balance
9,234
-
10,138,567
9
122,259
( 126,936 )
( 4,668 )
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
BIOFRONTERA
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
2026
2025
Six Months Ended June 30,
2026
2025
Cash flows from operating activities:
Net loss
$ ( 5,356 )
$ ( 9,527 )
Adjustments to reconcile net loss to cash flows used in operations:
Depreciation and amortization
120
55
Reduction in the carrying amount of right-of-use assets
263
386
Stock-based compensation
605
426
Non-cash interest expense
259
240
Allowance for credit losses
40
( 57 )
Change in fair value of warrant liabilities
175
( 702 )
Realized/unrealized (gain)/ loss in investment, related party
1
( 2 )
Loss from termination of operating leases
4
-
Changes in operating assets and liabilities:
Accounts receivable
1,706
1,418
Other receivables, related party
( 54 )
-
Prepaid expenses and other assets
1,296
45
Other assets, related party
452
( 953 )
Inventories
386
2,618
Accounts payable
2,461
2,412
Accounts payable, related parties, net
( 3,714 )
( 4,674 )
Operating lease liabilities
( 184 )
( 371 )
Accrued expenses and other liabilities
( 188 )
1,524
Cash flows used in operating activities
( 1,728 )
( 7,162 )
Cash flows from investing activities
Purchases of property and equipment
( 5 )
( 4 )
Cash flows used in investing activities
( 5 )
( 4 )
Cash flows from financing activities
Proceeds from stockholder advances
-
8,500
Cash flows provided by financing activities
-
8,500
Net change in cash, cash equivalents
( 1,733 )
1,334
Cash, cash equivalents and restricted cash, at the beginning of the period
6,592
6,105
Cash, cash equivalents and restricted cash, at the end of the period
$ 4,859
$ 7,439
Supplemental disclosure of cash flow information
Interest paid
-
3
Income taxes paid, net
21
21
Supplemental non-cash financing activities
Addition of right-of-use assets in exchange for operating lease liabilities
$ 1,529
$ 98
Conversion of convertible note payable and PIK interest into common stock
$ 227
-
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
Biofrontera
Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
1.
Organization and Business Overview
Biofrontera
Inc., a Delaware corporation (the “Company,” “we,” “us,” “our,” or “Biofrontera”),
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 (or “AKs”). With our national commercial team, we
generate revenue by selling our products directly to dermatology offices and groups.
We
conduct all clinical trials relating to Ameluz ® in the United States through Biofrontera Discovery GmbH (“Discovery”),
our wholly owned subsidiary organized under the laws of Germany and formed in February 2022. Our research and development (“R&D”)
programs are focused on label expansion for Ameluz ® as well as supporting PDT growth by improving the capabilities of
the RhodoLED ® Lamps to better fulfill the needs of dermatologists.
On
October 20, 2025, the Company entered into (i) an Asset Purchase Agreement (the “Transfer Agreement”) and (ii) an Earnout
Agreement (together with the Transfer Agreement, the “Agreements”) with Biofrontera AG and its consolidated subsidiaries
(the “Biofrontera Group”), pursuant to which the Company acquired all rights in the United States (the “U.S. Rights”)
to Ameluz ® and RhodoLED ® (the “Strategic Transaction”). In exchange for the U.S. Rights, and
in addition to a monthly earnout payable to the Biofrontera Group and the Company’s assumption of all costs associated with the
U.S. business, Biofrontera AG received 3,019
shares of Series D Convertible Preferred Stock, par value $ 0.001
per share (the “Series D Preferred Stock”). The
Strategic Transaction was funded through an $ 11.0
million investment by existing investors. See Note 13. Related
Party Transactions for additional information.
On
November 6, 2025, the Company completed the sale of the long-lived intangible asset relating to its Xepi product line. The Company
received fixed consideration in the amount of $ 3.0 million
and may receive up to $ 7.0 million
of variable consideration contingent upon the buyer’s future activities. See Note 10. Asset Held for Sale , to our
consolidated financial statements included in Item 8. Financial Statements and Supplementary Data in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Form 10-K”) for additional
information.
On
May 6, 2026, the U.S. International Trade Commission (the “Commission”) issued a Limited Exclusion Order (“LEO”)
and cease and desist order (“CDO”) prohibiting the Company from importing and/or selling the RhodoLED ® XL in
the United States and restricting the Company from selling Ameluz ® for use with the RhodoLED ® XL (the “ITC
Matter”). See Note 17. Commitments and Contingencies for additional information.
Liquidity
and Going Concern
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 $ 1.7 million and $ 7.2 million for the six months ended June 30, 2026 and 2025, respectively.
As of June 30, 2026, the Company’s accumulated deficit was $ 133.3 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 June 30, 2026, we had cash and cash
equivalents of $ 4.7 million, compared to $ 6.4 million as of December 31, 2025.
As
discussed above and in Note 17. Commitments and Contingencies, in connection with the ITC Matter, the Company has recorded an
estimated remediation cost of $0.5 million and expects related cash disbursements to occur over the twelve months following July 6, 2026;
these disbursements are reflected in the Company's cash flow forecasts used in this assessment. Based on currently available information,
management does not expect this matter to materially impair the Company's core Ameluz ® revenue base.
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; drawing
on a working capital line of credit; pursuing the realization of an additional $ 1.0
million in milestone payments from the sale of the Xepi intangible
asset expected in December 2026; and, if necessary, securing additional capital through equity or debt financings to support commercial
expansion and R&D programs. 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.
7
2.
Summary of Significant Accounting Policies
Basis
for Preparation of the Financial Statements
The
accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared pursuant to the rules and
regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information and footnote
disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted accounting principles
(“GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the Company’s opinion, the unaudited
condensed consolidated financial statements include all material adjustments, all of which are of a normal and recurring nature, necessary
to present fairly the Company’s financial position as of June 30, 2026, the Company’s operating results for the three and
six months ended June 30, 2026 and 2025, and the Company’s cash flows for the six months ended June 30, 2026 and 2025. The accompanying
financial information as of December 31, 2025 is derived from audited financial statements. Interim results are not necessarily indicative
of results for a full year. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the 2025 Form 10-K.
All
amounts shown in these financial statements and tables are in thousands and amounts in the notes are in millions, except percentages
and per share and share amounts.
With
the exception of the accounting policies below, there have been no new or material changes to the significant accounting policies discussed
in the 2025 Form 10-K.
Reclassification
of Prior Year Presentation
Certain
prior period amounts have been reclassified for consistency with the current period presentation. Depreciation expense and amortization
expense previously presented separately in the condensed consolidated statements of cash flows have been combined into a single line
item. The reclassification was limited to the condensed consolidated statements of cash flows and had no impact on the reported results
of operations.
The
Nasdaq Stock Market, LLC (“Nasdaq”) Compliance
On
December 31, 2025, the Company received a letter from Nasdaq notifying the Company that the listing of the Common Stock was not in compliance
with Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”) as the closing bid price of the Common Stock was
less than $ 1.00 per share for the previous 34 consecutive business days. The notice had no impact on the listing or trading of the Company’s
securities on Nasdaq. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company had a period of 180 calendar days, or until June 30, 2026,
to regain compliance with the rule referred to in this paragraph.
On
May 6, 2026, we received written notification from Nasdaq, with confirmation that for the last 10 consecutive business days, from April
22, 2026 to May 6, 2026, the closing bid price of the Company’s Common Stock had been at $ 1.00 per share or greater. Accordingly,
the Company 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.
Use
of Estimates
The
preparation of the condensed consolidated financial statements in accordance with GAAP requires the use of estimates and assumptions
by management that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities,
as reported on the balance sheet date, and the reported amounts of revenues and expenses arising during the reporting period. The main
areas in which assumptions, estimates and the exercising of judgment are appropriate relate to realization and valuation of receivables
and inventory, valuation of warrant liabilities, impairment assessment of intangibles and other long-lived assets, share-based payments,
deferred tax asset valuations, and contingent liability recognition. 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.
Recently
Adopted or Issued Accounting Pronouncements
We
evaluate Accounting Standard Updates (“ASUs”) issued by the Financial Accounting Standards Board (“FASB”). ASUs
not included in our disclosures were assessed and determined to either be not applicable or are not expected to have a significant impact
on our financial statements.
In
November 2024, the FASB issued ASU 2024-04, Debt with Conversion and Other Options (Subtopic 470-20); Induced Conversions of Convertible
Debt. This ASU clarifies requirements for determining whether certain settlements of convertible debt instruments, including convertible
debt instruments with cash conversion features or convertible debt instruments that are not currently convertible, should be accounted
for as an induced conversion. It is effective for all entities for annual reporting periods beginning after December 15, 2025, and interim
reporting periods within those annual reporting periods. Early adoption is permitted. The Company adopted this ASU on January 1, 2026,
and the adoption did not have a material impact on its condensed consolidated financial statements and related disclosures.
8
In
July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts
Receivable and Contract Assets , which provides a practical expedient for estimating expected credit losses on current trade receivables
and contract assets arising from revenue transactions. This ASU is effective for public business entities for annual reporting periods
beginning after December 15, 2025, with early adoption permitted, and must be applied prospectively. The
Company adopted this ASU on January 1, 2026, and the adoption did not have a material impact on its condensed consolidated financial
statements and related disclosures.
In
November 2024, the FASB issued ASU
2024-03, I ncome Statement—Reporting Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expense . The
new guidance requires disaggregated information about certain income statement expense line items on an annual and interim basis. This
ASU is effective for public business entities for annual reporting periods beginning after December 15, 2026, and interim reporting periods
beginning after December 15, 2027. The new standard permits early adoption and can be applied prospectively or retrospectively. We are
evaluating the effect that this guidance will have on our consolidated financial statements and related disclosures.
In
September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic
606) , which provides updates to refine the scope of the guidance on derivatives in Accounting
Standards Codification (“ASC”) 815 and clarify the guidance on share-based noncash payments from customers in ASC
606. The derivative scope refinement excludes non-exchange-traded contracts with derivative accounting apart from variables based on
market rates, prices and indices, variables based on the price or performance of a financial asset or liability of one of the parties
to a contract, contracts involving the issuer’s own equity evaluated under ASC 815-40 and call or put options on debt instruments.
The amendments in ASU 2025-07 are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods
within those annual reporting periods and should be applied either prospectively or on a modified retrospective basis. We are currently
evaluating the effect of adopting ASU 2025-07 on our consolidated financial statements and related disclosures.
In
December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements , which clarifies
interim disclosure requirements. The guidance is effective for the Company’s interim reporting periods within annual reporting
periods beginning after December 15, 2027. Early adoption is permitted. We are evaluating the effect that this guidance will have on
our consolidated financial statements and related disclosures.
In
December 2025, the FASB issued ASU 2025-12, Codification Improvements , which addresses 33 issues, representing amendments to ASC
topics that clarify, correct errors or make minor improvements. The amendments in ASU 2025-12 are effective for annual reporting periods
beginning after December 15, 2026, and interim reporting periods within those annual reporting periods. Early adoption is permitted in
both interim and annual periods in which financial statements have not yet been issued or made available for issuance. If an entity adopts
the amendments in this ASU in an interim period, it must adopt them as of the beginning of the annual period that includes that interim
period. An entity may elect to early adopt the amendments on an issue-by-issue basis. We are currently evaluating the effect of adopting
ASU 2025-12 on our consolidated financial statements and related disclosures.
3.
Fair Value Measurements
The
following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring
basis at June 30, 2026 and December 31, 2025 and indicates the fair value hierarchy of the valuation inputs the Company utilized to
determine such fair value:
Schedule of Assets Measured at Fair Value On Recurring Basis
(in thousands)
Level
June 30,
2026
December 31,
2025
Assets:
Investment, related party
1
$ 8
$ 9
Liabilities:
Warrant liability – 2023 Purchase Warrants
3
$ 434
$ 289
Warrant liability - 2022 Purchase Warrants
3
$ 41
$ 28
Warrant liability – 2022 Inducement Warrants
3
$ 51
$ 34
Total Liabilities
$ 526
$ 351
Investment,
related party
As
of June 30, 2026 and December 31, 2025, the Company owned 3,019 common shares of Biofrontera AG. The fair value of this investment was
determined with Level 1 inputs through references to quoted market prices.
9
Warrant
Liabilities
The
warrant liabilities are comprised of (i) outstanding warrants to purchase 170,950 shares of the common stock, originally issued in a
private placement on May 16, 2022, as amended on November 2, 2023 to extend the expiration date until November 2, 2028 and revise the
exercise price to $ 3.55 per share (the “2022 Purchase Warrants”); (ii) warrants to purchase 214,286 shares of common stock
issued on July 26, 2022, as amended on November 2, 2023 to extend the expiration date until November 2, 2028 and revise the exercise
price to $ 3.55 per share (the “2022 Inducement Warrants”); and (iii) warrants to purchase 1,807,500 shares of common stock
issued on November 2, 2023 expiring five years following the date of issuance and with an exercise price of $ 3.55 per share (the “2023
Purchase Warrants”). See Note 14. Stockholders’ Equity for additional details.
The
2023 Purchase Warrants, the 2022 Inducement Warrants and the 2022 Purchase Warrants were accounted for as liabilities as these warrants
provide for a redemption right in the case of a fundamental transaction which fails the requirement of the indexation guidance under
ASC 815-40. The resulting warrant liabilities are re-measured at each balance sheet date until their exercise or expiration, and any
change in fair value is recognized in the Company’s condensed consolidated statements of operations. The warrant liabilities are
measured at fair value at inception and on a recurring basis, with changes in fair value presented within the condensed consolidated
statements of operations.
The
Company utilizes a Black-Scholes-Merton (“BSM”) model to estimate the fair value of the warrant liabilities which is considered
a Level 3 fair value measurement. Certain inputs utilized in our BSM model may fluctuate in future periods based upon factors which are
outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value
may cause a significant change to the fair value of our warrant liabilities which could also result in material non-cash gain or loss
being reported in our condensed consolidated statements of operations.
The
fair value for the Level 3 warrants at June 30, 2026 and December 31, 2025 was estimated using a BSM model based on the following assumptions
at each measurement date:
Schedule
of Fair Value of Warrant Estimated by Using Black-Scholes Pricing Model Assumptions
June 30,
2026
December 31,
2025
Stock price
$ 0.95
$ 0.57
Expiration term (in years)
2.34
2.84
Volatility
95 %
105 %
Risk-free Rate
4.1 %
3.51 %
Dividend yield
0.0 %
0.0 %
The
following table presents the changes in the Level 3 warrant liabilities measured at fair value (in thousands):
Schedule
of Changes in Fair Value of Warrant Liabilities
2026
2025
Six Months Ended
June 30,
2026
2025
Fair value at beginning of period
$ 351
$ 1,250
Change in fair value of warrant liabilities
175
( 702 )
Fair value at end of period
$ 526
$ 548
10
4.
Revenue
We
generate revenue primarily through the sales of our products, Ameluz ® and the RhodoLED ® Lamps. Traditional
PDT treatments using a lamp are performed more frequently during the winter. As such, 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.
5.
Cash Balances and Statements of Cash Flows Reconciliation
The
Company maintains its cash balances at financial institutions that are insured by the Federal Deposit Insurance Corporation, which at
times may exceed federally insured limits. The Company has not experienced any losses on these accounts and management does not believe
that the Company is exposed to any significant risks with respect to these accounts.
Restricted
cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards. Long-term restricted
cash was recorded in other assets in the condensed consolidated balance sheet.
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the statements
of cash flows:
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
(in thousands)
June 30,
2026
December 31,
2025
Cash and cash equivalents
$ 4,659
$ 6,392
Long-term restricted cash
200
200
Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows
$ 4,859
$ 6,592
Long-term
restricted cash was recorded in other assets in the condensed consolidated balance sheet.
6.
Accounts Receivable, net
Accounts
receivable are mainly attributable to the sale of Ameluz ® in the United States and are expected to be collected within
twelve months of the balance sheet date. Trade accounts receivable are stated at their net realizable value. The allowance for credit
losses reflects our best estimate of expected credit losses of the receivables determined on the basis of historical experience and current
information. In developing the estimate for expected credit losses, trade accounts receivable are segmented into pools of assets depending
primarily on delinquency status, and reserve percentages are established for each pool of trade accounts receivable.
In
determining the reserve percentages for each pool of trade accounts receivable, we considered our historical experience with certain
customers, regulatory and legal environments and other relevant current and future forecasted macroeconomic factors. If we become aware
of any customer-specific factors that impact credit risk, specific allowances for these known troubled accounts are recorded.
The
allowance for credit losses was $ 0.2 million and $ 0.1 million as of June 30, 2026 and December 31, 2025, respectively.
11
7.
Inventories
Inventories
are comprised of the following:
Schedule of Inventories
(in thousands)
June 30,
2026
December 31,
2025
Inventory, short-term:
Finished product
$ 862
$ 1,426
Work in process
67
-
Raw materials
168
-
Total inventory, short-term
$ 1,097
$ 1,426
Inventory, long term
Finished product
$ 741
$ 1,102
Work in process
1,017
649
Raw materials
1,900
1,978
Total inventory, long-term
$ 3,658
$ 3,729
Total inventories
$ 4,755
$ 5,155
Our
long-term inventory balance relates to the RhodoLED ® Lamps. During the six months ended June 30, 2026, the Company
recognized an inventory write-down of $ 0.1
million in connection with the U.S. International Trade Commission’s May 6, 2026 Notice of Final Determination (See Note
17. Commitments and Contingencies ). The write-down was recognized to reduce the carrying value of the affected inventory to its
net realizable value in accordance with ASC 330-10-35 and is presented within cost of revenues, other in the condensed consolidated
statements of operations. Other than the write-down noted above, no
inventory write-downs or obsolescence reserves were recognized during the three and six months ended June 30, 2026 and 2025 that
were material to the condensed consolidated financial statements.
8.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the following:
Schedule of Prepaid Expenses and Other Current Assets
(in thousands)
June 30,
2026
December 31,
2025
Value-added tax receivable
$ 80
$ 1,218
Licenses
267
403
Clinical trials
50
171
Insurance
105
151
Inventory
233
-
Other
157
336
Total
$ 892
$ 2,279
9.
Property and Equipment, Net
Property
and equipment, net consists of the following:
Schedule of Property and Equipment, Net
(in thousands)
June 30,
2026
December 31,
2025
Manufacturing equipment
$ 2,166
$ 2,126
Machinery & equipment
126
116
Computer equipment
54
102
Furniture & fixtures
58
81
Leasehold Improvements
7
-
Property and equipment, gross
2,411
2,425
Less: Accumulated depreciation
( 272 )
( 267 )
Property and equipment, net
$ 2,139
$ 2,158
Depreciation
expense was no t material to the condensed consolidated statements of operations for the three and six months ended June 30, 2026 and
2025 and was recorded in the condensed consolidated statements of operations within cost of revenues or selling, general and administrative
expense, depending on the nature and use of the underlying asset. As of June 30, 2026 and December 31, 2025, $ 1.8 million
of manufacturing equipment acquired in connection with the Strategic Transaction had not yet been placed in service and is therefore
not being depreciated. The Company will commence depreciation of these assets over their estimated useful lives upon being placed in
service.
12
10.
Intangible Assets, Net
Intangible
assets, net are comprised of the following:
Schedule of Intangible Assets, Net
(in thousands)
June 30,
2026
December 31,
2025
Intellectual property
$ 2,656
$ 2,656
Accumulated amortization
( 98 )
( 24 )
Intellectual property, net
2,558
2,632
Software
50
50
Intangible assets
50
50
Accumulated amortization
( 40 )
( 32 )
Software, net
10
18
Intangible assets, net
$ 2,568
$ 2,650
Intangible
assets consist primarily of intellectual property acquired in the Strategic Transaction, which was recorded at an acquisition-date fair
value of $ 2.7 million and is being amortized on a straight-line basis over an estimated useful life of 18 years. Internal use software
is amortized over three years .
Amortization
expense was negligible and $ 0.1 million for the three and six months ended June 30, 2026, respectively, and negligible for the three and six months
ended June 30, 2025. Amortization expense is recorded in the condensed consolidated statements of operations within cost of revenues
or selling, general and administrative expense depending on the nature and use of the underlying intangible asset. No impairment losses
were recognized for intangible assets during the three and six months ended June 30, 2026 and 2025.
Estimated
future amortization expense as of June 30, 2026 is as follows:
Schedule of Estimated Future Amortization Expense
Year
(in thousands)
Amount
July
– December 2026
$
81
2027
148
2028
146
2029
146
2030
146
Thereafter
1,901
Total
$
2,568
13
11.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consist of the following:
Schedule of Accrued Expenses and Other Current Liabilities
(in thousands)
June 30,
2026
December 31,
2025
Employee compensation and benefits
$ 2,225
$ 2,805
Professional fees
1,517
1,305
Patent remediation expense (See Note 17. Commitments and Contingencies – Legal Proceedings)
365
-
Research and development
332
410
Product revenue allowances and reserves
54
57
Other
217
320
Total
$ 4,710
$ 4,897
12.
Debt
Convertible
Notes Payable
On
November 22, 2024, the Company issued $ 4.2 million in an aggregate principal amount of the Company’s Senior Secured Convertible
Notes (the “Notes”) pursuant to a Securities Purchase Agreement entered into on November 21, 2024 with its principal stockholders.
The
Notes bear interest at 10.0 % per annum, payable in-kind (“PIK”) through the issuance of additional principal on
a quarterly basis. In the Event of Default (as defined in the Notes), the interest will increase to 15 % per annum from the date of written
notice from the holder. The Notes may be converted at any time into shares of the Company’s common stock at a conversion price
of $ 0.78 per share subject to customary adjustments for stock splits, stock dividends and recapitalizations, as described in the Notes.
The
Notes mature on November 22, 2027, unless earlier converted or repurchased. The Company may not redeem the Notes at its option prior
to maturity. Upon maturity, the Company will pay to the holders of the Notes an amount in cash representing all of the outstanding aggregate
principal amount of the Notes, together with any accrued and unpaid interest. Alternatively, the entire amount of the Notes will be automatically
converted to shares of common stock if the 10-day volume weighted average price of a share of the Company’s common stock on Nasdaq
is greater than 250 % of the conversion price, and certain other conditions are met.
The
Notes provide for customary events of default and contain conversion limitations, providing that no conversion may be made if the aggregate
number of shares of common stock beneficially owned by the holder would exceed 9.99 % immediately after conversion. There were no events
of default at June 30, 2026.
The
Notes are secured by substantially all property of the Company, including but not limited to the Company’s assets, inventory, intellectual
property and accounts.
The
Notes were accounted for as a liability under ASC 470 and the embedded conversion option has been assessed under ASC 815. Based on the
Company’s evaluation, there were no embedded features that required bifurcation as a derivative liability.
In
connection with the issuance of the Notes, the Company incurred $ 0.2 million of debt issuance costs, consisting of legal fees.
On
May 11, 2026, one of the Note holders exercised its right to convert its $ 0.2 million aggregate principal amount of Notes, together with
a negligible amount of accrued PIK interest, into 296,505 shares of the Company’s common stock at the conversion price of $ 0.78
per share. The carrying value of the converted Notes, net of allocable unamortized debt issuance costs, was reclassified to stockholders’
equity, and no gain or loss was recognized on the conversion in accordance with ASC 470. No other conversions have occurred since issuance.
During
the three and six months ended June 30, 2026, the Company recognized interest expense of $ 0.1
million and $ 0.2
million, respectively, and minimal discount amortization. During the three and six months ended June 30, 2025 the Company recognized
interest expense of $ 0.1 million and $ 0.2 million, respectively, and minimal discount amortization. As of June 30, 2026
and December 31, 2025, the outstanding balance of the Notes was $ 4.6
million, which is shown net of the remaining unamortized issuance cost of $ 0.1
million.
13.
Related Party Transactions
We
consider Biofrontera Group to be a related party, as prior to the Strategic Transaction, we relied on the Biofrontera Group as the sole
supplier of Ameluz ® and the RhodoLED ® Lamps, and following the Strategic Transaction, it holds all 3,019
shares of our Series D Preferred Stock.
License
and Supply Agreement
Under
the Second Amended and Restated License and Supply Agreement (“Second A&R Ameluz LSA”), which was applicable for any
tubes purchased through May 31, 2025, the Company had an exclusive, non-transferable license to market and sell its previously licensed
products, Ameluz ® and RhodoLED ® Lamps, in the United States and was required to purchase the previously
licensed products exclusively from Biofrontera Pharma GmbH (the “Former Ameluz Licensor”). Pursuant to the Second A&R
Ameluz LSA, the price paid was set at twenty-five percent of the anticipated net selling price per unit through 2025 (the “Transfer
Price”), which covered the cost of goods, royalties on sales, and services, including all regulatory efforts, agency fees, pharmacovigilance,
and patent administration.
14
The
Second A&R Ameluz LSA provided for the transfer of responsibilities for clinical trials relating to Ameluz ® in the
US on June 1, 2024, including the Company assuming related contracts and transferring key personnel from the Former Ameluz Licensor to
the Company.
The
Company entered into a Release of Claims with the Former Ameluz Licensor, dated February 13, 2024, pursuant to which the Company agreed
to release the Former Ameluz Licensor from all claims and liabilities arising out of or relating to any failure by the Former Ameluz
Licensor to perform certain obligations under the Second A&R Ameluz LSA with respect to clinical trials for which the Company assumed
responsibility.
Strategic
Transaction with Biofrontera Group
The
Company entered into the Strategic Transaction on October 20, 2025. See Note 1. Organization and Business Overview for more information.
Pursuant
to the terms of the Agreements, retroactive to June 1, 2025, the Company will pay an earnout of 12 %
in years where Ameluz ® revenues in the United States are less than $ 65.0
million and an earnout of 15 %
in years when Ameluz ® revenues in the United States exceed $ 65.0
million, continuing until the expiration of patent protection
on Ameluz ® . The earnout replaces a transfer pricing model under the now terminated Second A&R Ameluz LSA. At the acquisition
date, the Company evaluated the terms of the earnout arrangement and concluded that the amount of contingent consideration was not reasonably
estimable due to the significant uncertainty associated with the timing and magnitude of future net sales. Accordingly, no amount related
to the earnout was included in the initial measurement of the cost of the acquired assets. The Company has elected to account for contingent
consideration in an asset acquisition as the contingency is resolved (earned and payable). No contingent consideration liability is recognized
for amounts not yet earned.
The
Company also agreed to assume the defense of co-defendant Biofrontera Group and all costs associated therewith in connection with certain
legal actions pending in the United States which will be paid directly to the legal advisors by the Company. Details of the legal claims
are disclosed in Note 17. Commitments and Contingencies – Legal Proceedings.
Effective
as of the date of the Strategic Transaction and for the following three years, as long as Biofrontera AG holds any shares of Series D
Preferred Stock (or shares of common stock that were converted from Series D Preferred Stock), Biofrontera AG shall have the right to
appoint (i) one individual to the Company’s board of directors if the board consists of seven or fewer members; or (ii) two individuals
to the Company’s board of directors if the board consists of eight or more directors.
If
the Company does not achieve the Minimum Order Amount as defined in Note 17. Commitments and Contingencies for two consecutive
calendar years starting on January 1, 2026, then the Biofrontera Group will have the right to terminate the Agreements and recover all
assets transferred to the Company.
Amounts
Due and Payable
Amounts
due and payable to the Biofrontera Group as of June 30, 2026 and December 31, 2025 were $ 1.0 million and $ 4.8 million, respectively,
and were recorded in accounts payable, related parties and when applicable, net of accounts receivable, in the condensed consolidated
balance sheets. Amounts due from the Biofrontera Group as of June 30, 2026 and December 31, 2025 were $ 0.2 million and $ 0.7 million,
respectively, and recorded as other assets, related party.
Inventory
Purchases
Purchases
from the Biofrontera Group of the previously licensed products (inclusive of estimated and actual purchase price adjustments) were $ 0.4
million and $ 0.8 million during the three and six months ended June 30, 2026, respectively. There were no inventory purchases from the
Biofrontera Group for the three months ended June 30, 2025 and purchases of $ 3.0 million were made during the six months
ended June 30, 2025. These purchases were recorded in inventories in the condensed consolidated balance sheets, and, when sold, in cost
of revenues, related party in the condensed consolidated statements of operations.
Earnout
For
the three and six months ended June 30, 2026, the Company expensed $ 1.4 million and $ 2.6 million, respectively, in earnouts in connection
with the Strategic Transaction. The earnout was recorded in cost of revenues, related party in the condensed consolidated statements
of operations. There were no earnout payments for the three and six months ended June 30, 2025.
Other
In
November 2024, the Company issued $ 4.2 million in aggregate principal amount of Notes to certain stockholders. For each of the periods
ended June 30, 2026 and December 31, 2025, the outstanding balance of the Notes was $ 4.6 million, including PIK interest. See Note
12. Debt-Convertible Notes Payable .
15
14.
Stockholders’ Equity
Under
the Company’s Certificate of Third Amendment to the Amended and Restated Certificate of Incorporation, filed June 16, 2025,
the Company is authorized to issue 70,000,000 shares
of common stock, and 20,000,000 shares
of preferred stock, par value $ 0.001 per
share. The rights and preferences of the Company’s common stock and preferred stock are described in Note 17.
Stockholders’ Equity , to our consolidated financial statements included in Item 8. Financial Statements and
Supplementary Data of the Company’s 2025 Form 10-K and are unchanged as of June 30, 2026.
Common
Stock:
The
holders of common stock are entitled to one vote for each share held. The Company has not declared any dividends since inception.
During
the six months ended June 30, 2026, the Company issued 225,000
shares of common stock upon the vesting of restricted stock units (“RSUs”) under the 2021 Omnibus Incentive Plan
(“2021 Plan”) (see Note 15. Equity Incentive Plans and Share-Based Payments ). No shares of common stock were
issued for RSUs during the three months ended June 30, 2026.
During
the three months ended June 30, 2026, the Company issued an aggregate of 2,332,803
shares of common stock in connection with conversions of outstanding securities, consisting of
(i) 282,600 shares issued upon the conversion of 200 shares of Series B-2 Convertible Preferred Stock, par value $0.001 per share
(the “Series B-2 Preferred Stock”) at a conversion ratio of 1,413-to-one, (ii) 134,235 shares issued upon the conversion
of 95 shares of Series B-3 Convertible Preferred Stock, par value $0.001 per share (the “Series B-3 Preferred Stock”) at
a conversion ratio of 1,413-to-one, (iii) 1,619,463 shares issued upon the conversion of 1,012 shares of Series C Convertible
Preferred Stock, par value $0.001 per share (the “Series C Preferred Stock”) at a conversion ratio of 1,600.26-to-one,
and (iv) 296,505
shares issued upon the conversion of $231,274 aggregate principal amount and accrued PIK interest of the Company’s Notes
(consisting of $200,000 of principal and $31,274 of accrued PIK interest) at a conversion price of $ 0.78
per share. No shares of common stock were issued upon the exercise of warrants during the three or six months ended June 30,
2026.
Warrants
As
of June 30, 2026, the Company had outstanding warrants to purchase an aggregate of 2,269,356 shares of common stock with an exercise
price range of $ 3.55 to $ 100.00 per share and expiration dates ranging from November 2026 to November 2028. No warrants were issued,
exercised, expired, forfeited or otherwise modified during the three or six months ended June 30, 2026. The Company’s outstanding
warrants as of June 30, 2026 were as follows:
Schedule of Warrants Outstanding
Warrants
Number of
Shares
Exercise
Price
Expiration
Date
Liability classified (See Note 3. Fair Value Measurements )
2,192,736
$ 3.55
11/02/2028
Equity classified
76,620
100.00
11/02/2026
The
liability-classified warrants are remeasured to fair value at each reporting date, with changes in fair value recognized in the condensed
consolidated statements of operations. See Note 3. Fair Value Measurements for the change in fair value recognized during the
six months ended June 30, 2026.
Preferred
Stock:
During
the three months ended June 30, 2026, 200 shares of Series B-2 Preferred Stock, 95 shares of Series B-3 Preferred Stock and 1,012 shares
of Series C Preferred Stock were converted into shares of common stock as described above under Common Stock. There were no other changes
in any series of preferred stock during the three and six months ended June 30, 2026.
Shares
of preferred stock issued and outstanding at June 30, 2026 and December 31, 2025 were as follows:
Schedule of Preferred Stock Issued and Outstanding
June 30,
2026
December 31,
2025
Conversion
Price
Series B-2 Convertible Preferred Stock
1,850
2,050
$ 0.7074
Series B-3 Convertible Preferred Stock
6,498
6,593
$ 0.7074
Series C Convertible Preferred Stock
9,707
10,719
$ 0.6249
Series D Convertible Preferred Stock
3,019
3,019
$ 0.6249
All
series of preferred stock outstanding as of June 30, 2026 are classified as permanent equity on the Company’s condensed consolidated
balance sheets. The Series C Preferred Stock and Series D Preferred Stock were reclassified from mezzanine equity to permanent equity
following the Company’s September 16, 2025 special meeting of stockholders, in accordance with the limited exception under ASC
480-10-S99-3A(3)(f).
16
Convertible
Debt
The
Notes issued in November 2024 originally allowed for up to 5,384,615 shares
of common stock to be issued upon conversion of principal, plus additional shares issuable upon conversion of accrued PIK interest.
During the three and six months ended June 30, 2026, a portion of the Notes representing $ 0.2
million of aggregate principal amount and accrued
PIK interest was converted into 296,505 shares
of common stock at a conversion price of $ 0.78 per
share. No other conversions have occurred since issuance. As of June 30, 2026, the remaining $ 4.0
million of principal was convertible into 5,128,205
shares of common stock, exclusive of additional shares issuable upon conversion of accrued and unpaid PIK interest. The remaining
unconverted portion of the Notes outstanding as of June 30, 2026, is detailed in Note 12. Debt – Convertible Notes
Payable .
15.
Equity Incentive Plans and Share-Based Payments
2021
Omnibus Incentive Plan
In
July 2021, the Board adopted, and our stockholders approved, the 2021 Plan, under which the maximum contractual term for stock
options is 10
years. In June 2026, our stockholders approved the amendment and restatement of the 2021 Plan,
including to increase the total number of shares of common stock authorized from 3,750,000
to 8,750,000 .
As of June 30, 2026, there were 5,178,852
shares available for future awards under the amended 2021 Plan.
Non-qualified
stock options
The
Company recognizes the grant-date fair value of share-based awards granted as compensation expense on a straight-line basis over the
requisite service period. The fair value of stock options is estimated at the time of grant using either a binomial lattice pricing model,
or the BSM model for ‘plain vanilla’ options, each of which requires the use of inputs and assumptions such as the fair value
of the underlying stock, exercise price of the option, expected term, risk-free interest rate, expected volatility and dividend yield.
The Company elects to account for forfeitures as they occur.
The
assumptions and key inputs used in the BSM model for the stock options granted during the six months ended June 30, 2026 were as follows:
exercise price of $ 0.78 to $ 0.90 , risk-free rate of 3.7 % to 3.8 %, volatility of 100 %, a dividend yield of 0.0 % and expected term of 5.27
years to 6 years. There were no equity grants awarded during the six months ended June 30, 2025.
Share-based
compensation expense of $ 0.2 million and $ 0.4 million for the three and six months ended June 30, 2026, respectively, and $ 0.1 million
and $ 0.3 million for the three and six months ended June 30, 2025, respectively, was recorded in selling, general and administrative
expenses, with a negligible amount recorded in research and development in the accompanying condensed consolidated statements of operations.
17
Options
outstanding and exercisable under the employee share option plan as of June 30, 2026 and a summary of option activity during the six
months then ended is presented below.
Schedule of Stock Option Activity
Shares
Weighted
Average
Exercise Price
Weighted
Average
Remaining
Contractual Term
Aggregate
Intrinsic
Value (1)
Outstanding at December 31, 2025
1,886,718
$ 2.70
7.46
-
Granted
815,088
$ 0.89
-
-
Exercised
-
$ -
-
-
Canceled or forfeited
( 31,338 )
$ 2.49
-
-
Outstanding at June 30, 2026
2,670,468
$ 2.15
7.75
$ 46
Exercisable at June 30, 2026
712,097
$ 5.06
6.41
$ 1
(1)
The
aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value
of the common stock for the options that were in the money at June 30, 2026.
As
of June 30, 2026, there was $ 0.8
million of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a
weighted-average period of 1.30
years.
Share-Based
Compensation (RSUs)
RSU-related share-based compensation expense of $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2026, respectively,
and $ 0.1 million for both the three and six months ended June 30, 2025 was recorded in selling, general and administrative expenses in
the accompanying condensed consolidated statements of operations.
Schedule of Restricted Stock Units
Shares
Weighted
Average
Remaining
Contractual Term
Weighted
Average
Grant Date
Fair Value
Unvested balance at December 31, 2025
412,500
-
$ 0.99
Awarded
237,500
-
$ 0.90
Issued
( 225,000 )
-
$ 1.06
Forfeited
-
-
$ -
Unvested balance at June 30, 2026
425,000
0.91
$ 0.90
As
of June 30, 2026, there was $ 0.3
million of unrecognized compensation related to unvested RSUs, which is expected to be recognized over a period of 1.41
years.
16.
Net Loss per Share
Basic
net loss per common share is calculated by dividing net loss by the weighted average number of common shares outstanding during the period.
Diluted net loss per common share is calculated by dividing net loss by the diluted weighted average number of common shares outstanding
during the period. The diluted shares include the dilutive effect of stock-based awards based on the treasury stock method. In periods
where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive.
The
following table sets forth the computation of the Company’s basic and diluted net loss per share attributable to common stockholders
(in thousands, except share and per share data):
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders
2026
2025
2026
2025
Three Months Ended
Six Months Ended
June 30,
June 30,
2026
2025
2026
2025
Net loss
$ ( 604 )
$ ( 5,324 )
$ ( 5,356 )
$ ( 9,527 )
Weighted average common shares outstanding, basic and diluted
12,923,710
9,351,557
12,306,944
9,108,091
Net loss per share, basic and diluted
$ ( 0.05 )
$ ( 0.57 )
$ ( 0.44 )
$ ( 1.05 )
18
The
following table sets forth the securities that were anti-dilutive for diluted EPS for the periods presented but which could potentially
dilute EPS in the future:
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share
2026
2025
June 30,
2026
2025
Common stock warrants
2,269,356
2,269,356
Common stock options and RSUs
3,095,468
1,740,679
Unit Purchase Options
20,182
20,182
Series B convertible preferred stock
11,795,724
13,047,642
Series C convertible preferred stock
15,533,724
-
Series D convertible preferred stock
4,831,185
-
Convertible notes
6,009,921
5,716,926
Total
43,555,560
22,794,785
Anti-dilutive securities
43,555,560
22,794,785
17.
Commitments and Contingencies
Leases
The
Company leases office space, warehouse space and vehicles. The Company has elected the short-term lease exemption under ASC 842-20-25-2
for leases with an initial term of twelve months or less. For its office, warehouse and vehicle leases, the Company has not elected the
practical expedient in ASC 842-10-15-37 and therefore does not combine lease components with associated non-lease components.
The
lease for our office space at 120 Presidential Way, Woburn, MA expired in November 2025. The Company elected to not renew the lease and
has no remaining commitments under this agreement. Lease expense was recognized through the expiration date, and the ROU asset and related
lease liability were derecognized.
The
Company’s corporate headquarters is located at 660 Main Street, Woburn, MA, under a 63-month operating lease that commenced on
December 1, 2025 and expires on February 28, 2031. Under the terms of the agreement, the Company was entitled to a rent-free period for
the first three months of the lease and reduced rent payments for months four through nine, followed by periodic escalated payments thereafter.
The Company provided the landlord with a security deposit in the amount of $ 0.2 million, which was recorded as other assets in the condensed
consolidated balance sheets.
The
Company also leases office and warehouse space at Hemmelrather Weg 201, 51377 Leverkusen, Germany under an operating lease agreement
commencing on January 1, 2026, with a lease term of 10 years with automatic twelve-month renewal periods thereafter unless terminated
by either party upon twelve months’ prior written notice. The Company has not included any of the automatic twelve-month renewal
periods in the lease term used to measure the operating lease liability, as the Company is not reasonably certain to exercise these renewal
options at lease commencement. The new lease arrangement resulted in $ 1.3 million of right-of-use-assets obtained in exchange for new
operating lease liabilities. The lease includes an initial rent-free period of three months, with the base rent subject to adjustment
if the German consumer price index moves by ten percent or more from the lease commencement date or most recent adjustment. In connection
with the lease, the Company provided a security deposit in the amount of $ 0.1 million.
The
Company leases vehicles under a master agreement, pursuant to which each vehicle is leased for an initial non-cancelable term of twelve
months, and thereafter on a month-to-month basis. Based on historical retention experience of approximately three years, the vehicles
have varying expiration dates through August 2029.
19
Operating
lease cost was $ 0.2 million and $ 0.4 million for the three and six months ended June 30, 2026, respectively, and $ 0.2 million and $ 0.4
million for the three and six months ended June 30, 2025, respectively. Cash paid for amounts included in the measurement of operating lease liabilities
was $ 0.3 million and $ 0.4 million for the six months ended June 30, 2026 and 2025, respectively. At June 30, 2026, the weighted-average
remaining lease term for the Company’s operating leases was 6.5 years and the weighted-average discount rate was 9.9 %.
Future
lease payments under non-cancelable leases as of June 30, 2026 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31,
Future lease
commitments
July – December 2026
389
2027
663
2028
630
2029
591
2030
558
Thereafter
1,095
Total future minimum lease payments
$ 3,926
Less imputed interest
$ ( 1,042 )
Total lease liability
$ 2,884
Minimum
Sales or Minimum Order
Until
the earlier to occur of (i) the Company manufactures orders meeting one million tubes of Ameluz ® during the period from
June 1, 2025 through May 31, 2031, or (ii) the expiration of patent protection, which is expected to occur in December 2043 (the “Asset
Reversion Term”), starting January 1, 2026 and continuing until the end of the Asset Reversion Term, the Company shall be required
to manufacture or order from suppliers at least 80,000 tubes of Ameluz ® per year (the “Minimum Order Amount”).
The Company is on track to meet the annual Minimum Order Amount by the end of the year.
Supply
Agreement
On
December 12, 2025, Discovery entered into a Supply Agreement (“Supply Agreement”) with Midas Pharma GmbH (“Midas”).
Among other things, the Supply Agreement provides that Midas will supply Discovery or its contract manufacturers, in the aggregate, 100
kg of the active pharmaceutical ingredient (“API”) 5-Aminolevulinic acid Hydrochloride through the second quarter of 2028.
Under the terms of the Supply Agreement, Discovery will provide Midas with a twenty-four (24) month non-binding rolling forecast, which
shall 1) indicate the anticipated quantity of API required by the company and 2) be updated every twelve (12) months during the term
of the agreement.
Licensing
Agreement with Optical Tools
On
December 2, 2022, the Company entered into the technology transfer agreement with Optical Tools LLC (“Optical Tools”), Stephen
Tobin and Paul Sowyrda (the “OT Agreement”). The OT Agreement allowed for the transfer of the assigned patents and trademarks,
and upon notification by the Company to Optical Tools, the research and development of certain prototypes. The Company paid a licensing
fee of $ 0.2 million which was expensed during the year ended December 31, 2022.
On
May 28, 2023, the Company authorized Optical Tools to design, develop, manufacture, and deliver at least two portable photodynamic therapy
lamp prototypes (“PDT Device”) using the technology in the assigned patents. The PDT Device provides illumination, based
on different light profiles, to the external skin surface of the human body. The Company is to reimburse Optical Tools for all reasonable
out-of-pocket, material and labor costs per the OT Agreement.
20
As
part of the OT Agreement, Optical Tools will be eligible to receive regulatory and sales milestone payments totaling up to $ 1.0 million,
and royalties of up to 3 % of net revenue of certain products developed under the OT Agreement.
The
Company did not make any milestone or royalty payments or accruals for such payments during the three and six months ended June 30,
2026 or 2025.
Legal
proceedings
At
each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably
estimable under the provisions of ASC 450, Contingencies . The Company expenses as incurred the legal costs related to such
legal proceedings.
Legal
Proceedings
On
September 13, 2023, Biofrontera was served with a complaint filed by DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc.,
and Sun Pharmaceutical Industries LTD (collectively, “SUN”) in which SUN alleges (i) breach of contract, (ii) violation of
the Lanham Act, and (iii) unfair trade practices under Massachusetts law. All claims stem from allegations that Biofrontera has promoted
its Ameluz ® product in a manner that is inconsistent with its approved FDA labeling. Though this complaint was originally
filed in the United States District Court for the District of Massachusetts, this matter has been transferred by agreement of the parties
to the United States District Court for the District of New Jersey. In March 2024, Biofrontera filed a partial motion to dismiss the
Lanham Act and Massachusetts statutory claims, which was denied on October 15, 2024. Biofrontera subsequently answered SUN’s complaint
and filed counterclaims on October 30, 2024 alleging (i) violation of the Lanham Act, (ii) deceptive trade practices under Georgia law,
and (iii) trade libel/product disparagement, which SUN answered on December 17, 2024. On March 11, 2025, Biofrontera received an additional
notice alleging breach of contract through unlawful marketing practices which makes reference to similar previous communications sent
by SUN to Biofrontera on February 4, 2022 and September 9, 2022. SUN has since amended its complaint to include the allegations contained
therein with its existing claims.
Discovery
is ongoing in the above-referenced matters. The Company denies the claims brought by SUN and intends to defend them vigorously. Based
on the Company’s assessment of the facts underlying the above claims and the uncertainty of litigation, the Company cannot estimate
the possibility of a material loss, nor the potential range of loss that may result from this action. If the final resolution of the
matter is adverse to the Company, it could have a material impact on the Company’s financial position, results of operations, or
cash flows.
Separately,
on June 26, 2024 and June 27, 2024, SUN filed two complaints against Biofrontera, Biofrontera AG, Biofrontera Pharma, and
Biofrontera Bioscience with the United States District Court for the District of Massachusetts (the “Massachusetts District
Court”) and the Commission, both alleging that the RhodoLED ® XL infringes either/both of two patents held
by SUN (individually, the “‘028 Patent” and the “‘512 Patent,” and collectively the “SUN
Patents”). The complaint filed in the Massaschusetts District Court has been held in abeyance
pending the completion of the investigation before the Commission and any subsequent appeals.
In
the Commission proceeding, a hearing was held in front of an administrative law judge (“ALJ”) between June 30, 2025 and July
3, 2025, and on September 30, 2025, the ALJ issued an Initial Determination (“ID”) finding the SUN Patents to be valid and
infringed, and that importation of Biofrontera’s RhodoLED ® XL violates Section 337 of the Tariff Act of 1930. Following
review by the Commission (during which time the ID had no immediate effect), on May 6, 2026, the Commission adopted the ID in its Final
Determination (“FD”) and issued a LEO and corresponding cease and desist order (“CDO”), prohibiting the Company
from importing and/or selling the RhodoLED ® XL in the United States and restricting the Company from importing or selling
Ameluz ® for use with the RhodoLED ® XL. Importation and sale of Ameluz for use with the BF-RhodoLED is not
affected. The LEO and CDO were both subject to a 60-day Presidential Review period that concluded on July 6, 2026, prior to which time
the Company was permitted to continue to import and sell the RhodoLED ® XL (and Ameluz ® for use with the
RhodoLED ® XL) and after which the Company has implemented measures to comply with the CDO and LEO, including but not limited
to ceasing importation and sales of the RhodoLED ® XL (and Ameluz ® for use with the RhodoLED ®
XL).
Separately, Biofrontera challenged the validity of the SUN Patents by filing separate petitions for inter partes
review (“IPR”) at the United States Patent Trial and Appeal Board (“PTAB”) for each of the SUN Patents. The IPR
filed in relation to the ‘512 Patent was discretionarily denied by the PTAB on July 2, 2025 for administrative reasons. However,
the IPR filed in relation to the ‘028 Patent was instituted in February 2025, and the PTAB issued a final written decision on February
23, 2026 (the “FWD”) finding all challenged claims in the ‘028 Patent to be unpatentable. On March 25, 2026, SUN requested
that the Director of the United States Patent and Trademark Office (“USPTO”) review the FWD and either reverse and vacate
the PTAB’s FWD, or vacate the PTAB’s FWD and de-institute the IPR, which the Company opposed. On July 29, 2026, the USPTO
Director granted SUN’s request, vacating the PTAB’s FWD and dismissing the IPR concerning the ‘028 Patent.
The
Company may appeal both the Commission’s determination and the USPTO Director’s decision to the U.S. Court of Appeals
for the Federal Circuit. In addition, on June 4, 2026, the Company submitted a ruling request to U.S. Customs and Border Protection regarding a redesigned version of the RhodoLED ® XL that the Company contends falls outside the purview
of the LEO and CDO. No ruling has been issued and a response is expected in September or October 2026.
The
Company evaluated this matter and concluded that a loss is probable and reasonably estimable as of the balance sheet date. As such, the
total estimated remediation cost of $ 0.5 million, representing management’s best estimate within a range of $ 0.4 million to $ 0.6 million, has been recognized as a $ 0.4 million charge to operating expenses within patent remediation expense and
a $ 0.1 million charge to cost of revenues, other on the condensed consolidated statements of operations for the six months
ended June 30, 2026, offset with an inventory write-down of $ 0.1 million, presented as a reduction of inventories on the
condensed consolidated balance sheets, in accordance with ASC 330-10-35; and an accrued remediation liability of $ 0.4 million,
presented within accrued expenses and other current liabilities on the condensed consolidated balance sheets.
The Company continues to deny SUN's infringement allegations and disagrees with the Commission's Final Determination.
The Company is complying, and intends to continue to comply, with the LEO and CDO for so long as they remain in effect. While there can
be no assurance that any appeal will be successful or that the orders will be modified, rescinded, or stayed, the Company intends to continue
to defend the remaining above-referenced matters vigorously.
21
Based
on the Company’s assessment of the facts underlying the above-referenced patent matters, as well as the uncertainty of
litigation, except as stated above, the Company cannot estimate the possibility of a material loss, nor the potential range of loss
that may result from either action. Money damages are not available to SUN based on the ruling by the Commission or any related appeals. If the final
resolution of the case before the Massachusetts District Court is adverse to the Company, it could have a material impact on the
Company’s financial position, results of operations, or cash flows.
18.
Segment Reporting
The
Company operates as one
operating segment
that derives revenue primarily from our principal product,
Ameluz ® , which is a prescription drug approved for use in PDT using our RhodoLED ® Lamps, for the treatment
of AKs. We are currently selling Ameluz ® for this indication in the United States. Ameluz ® (including the
RhodoLED ® Lamps) accounts for substantially all of our revenue.
The
Company’s chief operating decision maker (“CODM”) is its Chief Executive Officer, who reviews financial information
presented on a consolidated basis. The CODM uses consolidated net loss to allocate resources and assesses financial performance by
comparing actual results to historical results and previously forecasted financial information.
The
following table presents selected financial information with respect to the Company’s single operating segment :
Schedule of Operating Segment
(in thousands)
2026
2025
2026
2025
Three Months Ended
June 30,
Six Months Ended
June 30,
(in thousands)
2026
2025
2026
2025
Revenues, net
$ 12,003
$ 9,030
$ 22,087
$ 17,617
Operating expenses:
Cost of revenues
2,410
2,642
4,526
5,910
Direct sales
2,131
1,774
4,271
3,576
Sales support
2,267
2,100
4,816
4,196
General and administrative
4,397
6,464
9,732
11,011
Manufacturing related
135
-
629
-
Regulatory and product affairs
368
-
479
-
Patent remediation expense
-
-
392
-
Research and development
448
870
1,348
2,077
Other operating expenses
371
259
738
476
Total operating expenses
12,527
14,109
26,931
27,246
Loss from operations
( 524 )
( 5,079 )
( 4,844 )
( 9,629 )
Other income (expense), net
( 57 )
( 224 )
( 489 )
121
Loss before income taxes
( 581 )
( 5,303 )
( 5,333 )
( 9,508 )
Income tax expense
23
21
23
19
Net loss
$ ( 604 )
$ ( 5,324 )
$ ( 5,356 )
$ ( 9,527 )
19.
Subsequent Events
We
have completed an evaluation of subsequent events after the balance sheet date of June 30, 2026 through the date this Quarterly Report
on Form 10-Q was submitted to the Securities and Exchange Commission and identified the following material subsequent event.
On July 8, 2026 391 shares of Series B-2 Convertible Preferred Stock were converted into 552,483 shares of the Company's
common stock, at the 1,413-to-one conversion ratio described in Note 13. Stockholders' Equity .
The conversion did not involve the payment or receipt of cash, and no gain or loss was recognized.
22
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.