UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D)
OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): October 3, 2023
Biofrontera
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40943 |
|
47-3765675 |
(State
or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
120
Presidential Way, Suite 330
Woburn,
Massachusetts |
|
01801 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (781) 245-1325
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange
on
which registered |
Common
stock, par value $0.001 per share |
|
BFRI |
|
The
Nasdaq Stock Market LLC |
Preferred
Stock Purchase Rights |
|
- |
|
The
Nasdaq Stock Market LLC |
Warrants
to purchase common stock |
|
BFRIW |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (the “Exchange Act”) (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Reaudited
Consolidated Financial Statements
As
previously reported, on June 16, 2023, Biofrontera Inc. (the “Company”) retained Marcum LLP (“Marcum”) as its
independent registered public accounting firm following the resignation of Grant Thornton LLP (“GT”), as was disclosed in
the Company’s Current Report on Form 8-K on June 16, 2023 and June 2, 2023, respectively. GT did not advise the Company that it
should not rely on its previously issued audit report related to the previously issued consolidated
financial statements for the fiscal years ended December 31, 2022 and 2021, as filed on March 13, 2023 with the Securities and Exchange
Commission as part of the Company’s Annual Report on Form 10-K for the year ending December 31, 2022 (the “2022 Annual Report”).
In
order to preserve flexibility with respect to plans to obtain additional financing to provide the opportunity for the Company to continue
as a going concern, Marcum was engaged to
reaudit the Company’s consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 (the “reaudited
Consolidated Financial Statements”), which had previously been audited by GT. The Company
also prepared a revised Management’s Discussion and Analysis of Financial Condition and Results of Operations for
the fiscal years ended December 31, 2022 and 2021 (the “revised MD&A”) to accompany the reaudited Consolidated Financial
Statements.
The
reaudited Consolidated Financial Statements and the revised MD&A are fundamentally identical to those corresponding items
included in the 2022 Annual Report other than (i) the inclusion of Marcum’s audit report which includes a “going concern”
paragraph and related disclosure in the Notes to the reaudited Consolidated Financial Statements and the MD&A, (ii) adjustments to
the number of shares of the Company’s common stock and related equity items as a result of the 1-for-20 reverse stock split that
was effective on July 3, 2023, (iii) increased detail in connection with the reporting of the Company’s warrant liabilities, including
breaking out the expenses of the warrant inducement in July 2022, and (iv) certain other updates to reflect events that occurred subsequent
to December 31, 2022 but prior to the completion of Marcum’s reaudit, including the legal claim described below. These adjustments
had no impact on the Company’s consolidated operating results, cash flows or equity (other than with respect to the reverse stock
split).
Attached
as Exhibits 99.1 and 99.2, respectively, are the reaudited Consolidated Financial Statements and the revised MD&A. This Form 8-K
is being filed only for the purposes described above, and all other information in the 2022 Annual Report remains unchanged. Except for
the matters noted above, Exhibits 99.1 and 99.2 to this Current Report do not reflect events occurring after the Company filed its 2022
Annual Report. Information contained in Exhibits 99.1 and 99.2 should be read in conjunction with and as a supplement to information
contained in the 2022 Annual Report.
Legal
Claim
On
September 13, 2023, Biofrontera was served with a complaint filed in United Stated District Court for the District of Massachusetts by
DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LTD (collectively “DUSA”
or “Plaintiffs”) in which DUSA alleges breach of contract, violation of the Lanham Act, and unfair trade practices. All claims
stem from allegations that Biofrontera has promoted its Ameluz product in a manner that is inconsistent with its approved FDA labeling.
The Company denies the Plaintiffs’ claims and intends to defend these matters vigorously.
Though
this complaint was originally filed in the U.S. District Court for the District of Massachusetts, this matter has been transferred by
agreement of the parties to the U.S. District Court for the District of New Jersey.
Forward-Looking
Statements
This
Current Report on Form 8-K contains forward-looking statements that involve risks and uncertainties. The Private Securities Litigation
Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Such statements include statements regarding
the timeline for regulatory review and approval of our products, the availability of funding sources for continued development of such
products, and other statements that are not historical facts, including statements which may be preceded by the words “intends,”
“may,” “will,” “plans,” “expects,” “anticipates,” “projects,”
“predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”
or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject
to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from
the expectations contained in the forward-looking statements.
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.
Item
9.01 |
Financial
Statements and Exhibits. |
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
October
3, 2023
(Date) |
Biofrontera
Inc.
(Registrant) |
|
|
|
/s/
E. Fred Leffler III |
|
E.
Fred Leffler III |
|
Chief
Financial Officer |
Exhibit
23.1
Independent
Registered Public Accounting Firm’s Consent
We
consent to the incorporation by reference in the Registration Statements of Biofrontera Inc. (the “Company”) on Forms S-1
(File No. 333-265467 and 333-268124) and S-8 (File No. 333-265463) of our report dated October 3, 2023, which includes an explanatory
paragraph as to the Company’s ability to continue as a going concern, with respect to our audits of the consolidated financial
statements of the Company as of December 31, 2022 and 2021 and for the years ended December 31, 2022 and 2021, which report is included
in this Current Report on Form 8-K of the Company.
/s/
Marcum llp
Marcum
llp
East
Hanover, NJ
October
3, 2023
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Exhibit 99.1
INDEX
TO FINANCIAL STATEMENTS
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and Board of Directors of Biofrontera, Inc.
Opinion on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Biofrontera, Inc. (the “Company”) as of December 31, 2022 and
December 31, 2021, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the two years
in the period ended December 31, 2022, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December
31, 2022 and December 31, 2021, and the results of its operations and its cash flows for each of the two years in the period ended December
31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Explanatory
Paragraph – Going Concern
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described
in Note 1, the Company has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in
regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
/s/
Marcum llp
Marcum
llp
We
have served as the Company’s auditor since 2023.
East
Hanover, New Jersey
October
3, 2023
Audited
Consolidated Financial Statements as of and for the Years Ended December 31, 2022 and 2021
BIOFRONTERA
INC.
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except par value and share amounts)
| |
2022 | | |
2021 | |
| |
December 31, | |
| |
2022 | | |
2021 | |
ASSETS | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 17,208 | | |
$ | 24,545 | |
Investment, related party | |
| 10,548 | | |
| - | |
Accounts receivable, net | |
| 3,748 | | |
| 3,784 | |
Other receivables, related party | |
| 3,658 | | |
| 8,647 | |
Inventories | |
| 7,168 | | |
| 4,458 | |
Prepaid expenses and other current assets | |
| 810 | | |
| 4,987 | |
| |
| | | |
| | |
Total current assets | |
| 43,140 | | |
| 46,421 | |
| |
| | | |
| | |
Other receivables long term, related party | |
| 2,813 | | |
| 2,813 | |
Property and equipment, net | |
| 204 | | |
| 267 | |
Operating lease right-of-use assets | |
| 1,375 | | |
| - | |
Intangible asset, net | |
| 3,032 | | |
| 3,450 | |
Other assets | |
| 320 | | |
| 268 | |
| |
| | | |
| | |
Total assets | |
$ | 50,884 | | |
$ | 53,219 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
| 1,278 | | |
| 658 | |
Accounts payable, related parties | |
| 1,312 | | |
| 282 | |
Accounts payable | |
| 1,278 | | |
| 658 | |
Acquisition contract liabilities, net | |
| 6,942 | | |
| 3,242 | |
Operating lease liabilities | |
| 498 | | |
| - | |
Accrued expenses and other current liabilities | |
| 10,864 | | |
| 9,654 | |
| |
| | | |
| | |
Total current liabilities | |
| 20,894 | | |
| 13,836 | |
| |
| | | |
| | |
Long-term liabilities: | |
| | | |
| | |
Acquisition contract liabilities, net | |
| 2,400 | | |
| 9,542 | |
Warrant liabilities | |
| 2,843 | | |
| 12,854 | |
Operating lease liabilities, non-current | |
| 848 | | |
| - | |
Other liabilities | |
| 21 | | |
| 5,649 | |
| |
| | | |
| | |
Total liabilities | |
| 27,006 | | |
| 41,881 | |
| |
| | | |
| | |
Commitments and contingencies (see Note 24) | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of December 31, 2022 and 2021 | |
| - | | |
| - | |
Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,334,950 and 855,237 shares issued and outstanding as of December 31, 2022 and 2021 | |
| 1 | | |
| 1 | |
Additional paid-in capital | |
| 103,396 | | |
| 90,216 | |
Accumulated deficit | |
| (79,519 | ) | |
| (78,879 | ) |
| |
| | | |
| | |
Total stockholders’ equity | |
| 23,878 | | |
| 11,338 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 50,884 | | |
$ | 53,219 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Audited
Consolidated Financial Statements as of and for the Years Ended December 31, 2022 and 2021
BIOFRONTERA
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(In
thousands, except per share amounts and number of shares)
| |
2022 | | |
2021 | |
| |
December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Products revenues, net | |
$ | 28,541 | | |
$ | 24,043 | |
Revenues, related party | |
| 133 | | |
| 57 | |
| |
| | | |
| | |
Total revenues, net | |
| 28,674 | | |
| 24,100 | |
| |
| | | |
| | |
Operating expenses | |
| | | |
| | |
Cost of revenues, related party | |
| 14,618 | | |
| 12,222 | |
Cost of revenues, other | |
| 567 | | |
| 520 | |
Cost of revenues | |
| 567 | | |
| 520 | |
Selling, general and administrative | |
| 35,137 | | |
| 36,512 | |
Selling, general and administrative, related party | |
| 733 | | |
| 697 | |
Selling, general and administrative | |
| 733 | | |
| 697 | |
Restructuring costs | |
| - | | |
| 752 | |
Change in fair value of contingent consideration | |
| (3,800 | ) | |
| (1,402 | ) |
| |
| | | |
| | |
Total operating expenses | |
| 47,255 | | |
| 49,301 | |
| |
| | | |
| | |
Loss from operations | |
| (18,581 | ) | |
| (25,201 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Change in fair value of warrant liabilities | |
| 19,017 | | |
| (12,801 | ) |
Warrant inducement expense | |
| (2,629 | ) | |
| - | |
Change in fair value of investment, related party | |
| 1,747 | | |
| - | |
Interest expense, net | |
| (195 | ) | |
| (344 | ) |
Other income, net | |
| 33 | | |
| 689 | |
| |
| | | |
| | |
Total other income (expense) | |
| 17,973 | | |
| (12,456 | ) |
| |
| | | |
| | |
Income tax expense | |
| 32 | | |
| 56 | |
| |
| | | |
| | |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) |
| |
| | | |
| | |
Loss per common share: | |
| | | |
| | |
Basic and diluted | |
$ | (0.61 | ) | |
$ | (85.63 | ) |
| |
| | | |
| | |
Weighted-average common shares outstanding: | |
| | | |
| | |
Basic and diluted | |
| 1,056,988 | | |
| 440,412 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Audited
Consolidated Financial Statements as of and for the Years Ended December 31, 2022 and 2021
BIOFRONTERA
INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
(In
thousands, except number of shares)
| |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Total | |
| |
Common Stock | | |
Additional Paid- | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
In Capital | | |
Deficit | | |
Total | |
| |
| | |
| | |
| | |
| | |
| |
Balance at December 31, 2020 | |
| 400,000 | | |
$ | 0 | | |
| 46,993 | | |
$ | (41,166 | ) | |
$ | 5,828 | |
Issuance of common stock and warrants under IPO, net of issuance costs of $3.1 million | |
| 180,000 | | |
| 0 | | |
| 14,943 | | |
| - | | |
| 14,943 | |
Issuance of common stock and warrants under private placement offering, net of issuance costs of $0.3 million | |
| 67,500 | | |
| 0 | | |
| 2,690 | | |
| - | | |
| 2,690 | |
Exercise of common stock warrants | |
| 132,380 | | |
| 0 | | |
| 13,238 | | |
| - | | |
| 13,238 | |
Exercise of pre-funded warrants | |
| 75,357 | | |
| 0 | | |
| 12,223 | | |
| - | | |
| 12,223 | |
Stock-based compensation | |
| | | |
| | | |
| 129 | | |
| | | |
| 129 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (37,713 | ) | |
| (37,713 | ) |
Balance at December 31, 2021 | |
| 855,237 | | |
$ | 1 | | |
$ | 90,216 | | |
$ | (78,879 | ) | |
$ | 11,338 | |
Issuance of common stock in exchange for investment, related party | |
| 157,402 | | |
| 0 | | |
| 3,683 | | |
| - | | |
| 3,683 | |
Issuance of common stock and warrants under private placement, net of negligible issuance costs | |
| 92,500 | | |
| 0 | | |
| 117 | | |
| - | | |
| 117 | |
Exercise of pre-funded warrants | |
| 78,450 | | |
| 0 | | |
| 2,842 | | |
| | | |
| 2,842 | |
Exercise of PIPE warrants | |
| 142,857 | | |
| 0 | | |
| 4,686 | | |
| - | | |
| 4,686 | |
Issuance of shares for vested restricted stock units | |
| 8,504 | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock-based compensation | |
| - | | |
| - | | |
| 1,852 | | |
| - | | |
| 1,852 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (640 | ) | |
| (640 | ) |
Balance at December 31, 2022 | |
| 1,334,950 | | |
$ | 1 | | |
$ | 103,396 | | |
$ | (79,519 | ) | |
$ | 23,878 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Audited
Consolidated Financial Statements as of and for the Years Ended December 31, 2022 and 2021
BIOFRONTERA
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
Thousands)
| |
2021 | | |
2021 | |
| |
Years ended December 31, | |
| |
2022 | | |
2021 | |
Cash Flows From Operating Activities: | |
| | | |
| | |
| |
| | | |
| | |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) |
| |
| | | |
| | |
Adjustments to reconcile net loss to cash flows used in operations | |
| | | |
| | |
| |
| | | |
| | |
Depreciation | |
| 101 | | |
| 122 | |
Amortization of right-of-use assets | |
| 653 | | |
| - | |
Amortization of acquired intangible assets | |
| 418 | | |
| 418 | |
Change in fair value of investment, related party | |
| (1,747 | ) | |
| - | |
Change in fair value of contingent consideration | |
| (3,800 | ) | |
| (1,402 | ) |
Change in fair value of warrant liabilities | |
| (19,017 | ) | |
| 12,801 | |
Warrant inducement expense | |
| 2,629 | | |
| - | |
Stock-based compensation | |
| 1,852 | | |
| 129 | |
Provision for inventory obsolescence | |
| 100 | | |
| 33 | |
Provision for doubtful accounts | |
| 106 | | |
| 44 | |
Non-cash interest expense | |
| 358 | | |
| 358 | |
| |
| | | |
| | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (70 | ) | |
| (612 | ) |
Other receivables, related party | |
| 4,990 | | |
| (11,387 | ) |
Prepaid expenses and other assets | |
| 4,154 | | |
| (3,809 | ) |
Inventories | |
| (2,810 | ) | |
| 2,592 | |
Accounts payable and related party payables | |
| 912 | | |
| (773 | ) |
Operating lease liabilities | |
| (781 | ) | |
| - | |
Accrued expenses and other liabilities | |
| (3,607 | ) | |
| 12,484 | |
| |
| | | |
| | |
Cash flows used in operating activities | |
| (16,199 | ) | |
| (26,715 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Purchases of investment, related party | |
| (5,118 | ) | |
| - | |
Purchases of property and equipment | |
| (38 | ) | |
| (11 | ) |
| |
| | | |
| | |
Cash flows used in investing activities | |
| (5,156 | ) | |
| (11 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from issuance of common stock and warrants upon initial public offering, net of issuance costs | |
| - | | |
| 14,943 | |
Proceeds from issuance of common stock and warrants in private placement, net of issuance costs | |
| 9,391 | | |
| 14,995 | |
Proceeds from exercise of warrants | |
| 4,630 | | |
| 13,253 | |
| |
| | | |
| | |
Cash flows provided by financing activities | |
| 14,021 | | |
| 43,191 | |
| |
| | | |
| | |
Net (decrease) increase in cash and cash equivalents | |
| (7,334 | ) | |
| 16,465 | |
Cash, cash equivalents and restricted cash, at the beginning of the year | |
| 24,742 | | |
| 8,277 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash, at the end of the year | |
$ | 17,408 | | |
$ | 24,742 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information | |
| | | |
| | |
Interest paid | |
$ | 1 | | |
$ | 2 | |
Income tax paid, net | |
$ | 32 | | |
$ | 56 | |
| |
| | | |
| | |
Supplemental non-cash investing and financing activities | |
| | | |
| | |
Conversion of warrant liability to equity in connection with exercise of warrants | |
$ | 6,840 | | |
$ | 12,208 | |
Issuance of common shares in exchange for investment, related party | |
$ | 3,683 | | |
$ | - | |
Addition of right-of-use assets in exchange for operating lease liabilities | |
$ | 234 | | |
$ | - | |
Issuance costs included in accrued expenses and other liabilities | |
$ | - | | |
$ | 44 | |
Non-cash purchase of fixed assets | |
$ | - | | |
$ | 8 | |
The
accompanying notes are an integral part of these consolidated financial statements.
Notes
to the Consolidated Financial Statements as of and for the Years Ended December 31, 2022 and 2021
1.
Organization and Business Overview
Biofrontera
Inc., a Delaware Corporation, (the “Company” or “ Biofrontera”) is a U.S.-based biopharmaceutical company commercializing a portfolio
of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”)
and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are
pre-cancerous skin lesions as well as
impetigo, a bacterial skin infection.
Our principal licensed product is Ameluz®, which is a prescription
drug approved for use in combination with the RhodoLED® lamp series, for PDT (when used together, “Ameluz®
PDT”). In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratoses
of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in the U.S. under
an exclusive license and supply agreement (“Ameluz LSA”) with Biofrontera Pharma (“Pharma”) GmbH and Biofrontera
Bioscience GmbH (together the “Ameluz Licensor”).
Our second prescription drug licensed product is Xepi® (ozenoxacin
cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi®
is known and it has been specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus
aureus or Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. We are currently
selling Xepi® for this indication in the United States under an exclusive license and supply agreement, as amended (“Xepi LSA”)
with Ferrer Internacional S.A. (“Ferrer”) that was assumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea
Life Sciences, Inc.(“Cutanea”). There has been limited revenue during the current reporting periods and recent developments
with the third-party manufacturer that was providing our supply of Xepi® have resulted in further delays of our commercialization
of the product. However, Ferrer is qualifying a new Contract manufacturer, Cambrex, which is expected to begin production early in 2024.
Once the new third-party manufacturer is qualified, we expect the supply of Xepi® will meet our future market demand.
Biofrontera Inc. includes its wholly owned subsidiary Bio-FRI GmbH (“Bio-FRI”), a limited liability company organized
under the laws of Germany. Our
subsidiary, Bio-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz
Licensor.
Liquidity
and Going Concern
The
Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, and cash
flows from financing transactions. During the year ended December 31, 2022, we received
proceeds of $9.4
million from the issuance of common stock and warrants in a private placement, net of issuance costs, and $4.6
million from the exercise of common stock warrants (See Note 19. Stockholders’ Equity). As of December 31, 2022,
we had cash and cash equivalents of $17.2
million, compared to $24.5
million as of December 31, 2021. Our unaudited estimated ending cash balance at September 30, 2023 was $3.1 million.
Since
we commenced operations in 2015, we have generated significant losses and have incurred net cash outflows from operations of $16.2
million and $26.7
million for the years ended December 31, 2022
and 2021. The Company had an accumulated deficit as of December 31, 2022 of $79.5
million.
The
Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments,
Maruho start-up payments of $7.3 million
(see Note 3. Acquisition Contract Liabilities), and legal settlement expenses after reimbursement from Biofrontera AG (see Note
24, Commitments and Contingencies).
Additionally,
we expect to continue to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology
community outreach efforts as we seek to expand the commercialization of our licensed products in the United States. We also expect to
incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel to support
our product commercialization efforts. In addition, we expect to incur costs to continue to comply with corporate governance, regulatory
reporting and other requirements applicable to us as a public company in the United States.
In connection with
our assessment of going concern considerations under applicable accounting standards, the Company’s management has determined that
substantial doubt exists about our ability to continue as a going concern for at least one year from the date these financial
statements were issued.
The future viability of the Company is dependent
on management’s plans to continue to execute its growth plan and raise additional capital or find alternative methods of financing to fund its
operations until cash flow from operations is sufficient. Management believes that actions presently being taken to obtain additional
funding and implement its strategic plans provide the opportunity for the Company to continue as a going concern. No assurance can be
given that the Company will be successful in these efforts. Accordingly, management has concluded that substantial doubt exists about the company’s ability to continue as a going concern for
a period of at least 12 months from the date of issuance of these financial statements.
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.
The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or
the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. There could be
a material adverse effect on the Company and its financial statements if management’s plans are not achieved on a timely
basis.
2.
Summary of Significant Accounting Policies
Basis
for Preparation of the Consolidated Financial Statements
The
accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“GAAP”). These consolidated financial statements include the accounts of our wholly owned
subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The information presented reflects the
application of significant accounting policies described below.
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.
Segment
Reporting
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision-maker in deciding how to allocate resources and assess performance. The Company’s chief operating decision maker
(determined to be the Chief Executive Officer) does not manage any part of the Company separately, and the allocation of resources and
assessment of performance are based on the Company’s operating results.
We
operate in a single reporting segment, the commercialization of pharmaceutical products for the treatment of dermatological conditions
and diseases within the U.S. All business operations focus on the products Ameluz®, including the complementary product
BF-RhodoLED®, and Xepi®. We monitor and manage our business operations across these products collectively
as one reporting segment.
Reverse Stock Split
On July 3, 2023 Biofrontera Inc. effected a 1-for-20
reverse stock split (the “Reverse Stock Split”) of the issued and outstanding shares of the Company’s common stock,
$0.001 par value (the “Common Stock”). The Common Stock began trading on the Nasdaq Capital Market on a post-split basis on
July 5, 2023.
All information included in these consolidated financial
statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock Split as if it had been effective from the beginning
of the earliest period presented, unless otherwise stated. All outstanding securities entitling their holders to purchase shares of Common
Stock or acquire shares of Common Stock, including stock options, restricted stock units, and warrants, were adjusted as a result of the
Reverse Stock Split, as required by the terms of those securities.
Use
of Estimates
The
preparation of the consolidated financial statements in accordance with U.S. 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 valuation allowances for receivables and inventory,
valuation of contingent consideration and warrant liabilities, realization of intangible and other long-lived assets, product sales allowances
and reserves, share-based payments and income taxes including deferred tax assets and liabilities. 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.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to
be cash equivalents.
The Company maintains its cash balances at financial institutions that
are insured by the Federal Deposit Insurance Corporation (“FDIC”). The FDIC provides coverage of up to $250,000 per depositor,
per financial institution. At December 31, 2022, approximately $16.8 million of the Company’s cash balances were in excess of FDIC
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.
Restricted
Cash
Restricted
cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards, in addition to
one deposit held for a sublease (see Note 13. Statement of Cash Flows Reconciliation).
Investment, Related Party
The
Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities (“ASC
321”). Equity securities, which are comprised of investments in common stock with a readily determinable fair value, are initially
recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and
losses reported in the Company’s consolidated statement of operations. As the fair value of the Company’s investments is
reported in a foreign currency, the change in fair value attributable to changes in foreign exchange rates is included in other income,
net in the consolidated statement of operations.
Accounts
Receivable
Accounts
receivables are reported at their net realizable value. Any value adjustments are booked directly against the relevant receivable. We
have standard payment terms that generally require payment within approximately 30 to 90 days. Management performs ongoing credit evaluations
of its customers. An allowance for potentially uncollectible accounts is provided based on history, economic conditions, and composition
of the accounts receivable aging. In some cases, the Company makes allowances for specific customers based on these and other factors.
Provisions for the allowance for doubtful accounts are recorded in selling, general and administrative expenses in the accompanying statements
of operations.
Concentration
of Credit Risk and Off-Balance Sheet Risk
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, accounts
receivable and other receivables, related party. The Company maintains all of its cash and cash equivalents at a single accredited financial
institution, in amounts that exceed federally insured limits. The Company has no significant off-balance sheet risk such as foreign exchange
contracts, option contracts, or other foreign hedging arrangements.
Concentrations
of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the wide variety of customers
using our products. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond
to changes in their credit profile. We continue to monitor these conditions and assess their possible impact on our business.
Other
receivables, related party consists of a receivable due from Biofrontera AG for its 50% share of a legal settlement and related
costs for which they are jointly and severally liable for the total settlement amount. The Company has a contractual right to
repayment of its share of the settlement payment from Biofrontera AG under the Settlement Allocation Agreement entered into on
December 9, 2021, which provided that the settlement payments would first be made by the Company and then reimbursed by Biofrontera
AG for its share. Although this receivable has credit risk, it is mitigated by the Settlement Allocation Agreement as amended on
March 31, 2022, which provides certain remedies to the Company, if Biofrontera AG fails to make timely reimbursements, which the
Company may implement in its sole discretion, including the ability to charge interest at a rate of 6.0% per annum for each day that
any reimbursement is past due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by
the Company (including amounts owed under the Company’s license and supply agreement for
Ameluz®).
We
are dependent on two suppliers, Biofrontera Pharma GmbH and Ferrer Internacional S.A., to supply drug products, including all underlying
components, for our commercial efforts. These efforts could be adversely affected by a significant interruption in the supply of our
finished products.
Inventories
Finished
goods consist of pharmaceutical products purchased for resale and are stated at the lower of cost or net realizable value. Cost is calculated
by applying the first-in-first-out method (FIFO). Inventory costs include the purchase price of finished goods and freight-in costs.
The Company regularly reviews inventory quantities on hand and writes down to its net realizable value any inventory that it believes
to be impaired. Management considers forecast demand in relation to the inventory on hand, competitiveness of product offerings, market
conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. Once inventory is written
down and a new cost basis is established, it is not written back up if demand increases.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is generally applied straight-line over the estimated
useful life of assets. Leasehold improvements are amortized over the shorter of the asset’s estimated useful life or the lease
term. The estimated useful lives of property and equipment are:
Schedule
of Estimated Useful Lives of Property, Plant and Equipment
| |
Estimated Useful Life in Years |
Computer equipment | |
3 years |
Computer software | |
3 years |
Furniture and fixtures | |
3-5 years |
Leasehold improvements | |
Shorter of estimated useful lives or the term of the lease |
Machinery & equipment | |
3-4 years |
The
cost and accumulated depreciation of assets retired or sold are removed from the respective asset category, and any gain or loss is recognized
in our statements of operations.
Intangible
Assets
Intangible
assets with finite lives are amortized over their estimated useful lives. Intangible assets with indefinite lives are not amortized.
Leases
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU
No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements.
The Company adopted the standard effective January 1, 2022. Using the optional transition method, prior period financial statements have
not been recast to reflect the new lease standard. The adoption of the new lease standard resulted in the addition of an operating lease
right-of-use asset and an operating lease liability in the amount of $1.8 million to the consolidated balance sheet as of January 1,
2022.
At
the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and
circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value
of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable.
As such, the Company utilizes its incremental borrowing rate (“IBR”), which is the rate incurred to borrow on a collateralized
basis over a similar term an amount equal to the lease payments in a similar economic environment. Given
the absence of an outstanding debt agreement, a synthetic credit rating analysis was used in estimating the Company’s IBR. Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for lease liabilities at inception and 8.5% for 2022 lease liabilities. No adjustments to the right-of-use
asset were required for items such as initial direct costs paid or incentives received.
The
Company has elected to adopt the practical expedient provided in ASC 842 and not reassess leases that existed prior to
the commencement date, 1). Whether any expired or existing contracts are or contain leases, 2). Lease classification, or 3).
Initial indirect costs for any existing leases. The Company has elected to combine lease and non-lease components as a single
component for certain asset classes, when applicable. Operating leases are recognized on the balance sheet as operating lease
right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The Company also
elected to utilize the short-term lease recognition exemption and for those leases that qualified, the Company did not recognize
right-of-use assets or lease liabilities. These leases are recognized on a straight-line basis over the expected term.
Impairment
of Long-Lived Assets
The
Company considers whether events or changes in facts and circumstances, both internally and externally, may indicate that an impairment
of long-lived assets held for use, including right-of-use assets, are present. To the extent indicators or impairment exist, the determination
of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition.
In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset, the assets are written
down to their estimated fair values and the loss is recognized in the statements of operations. Refer to Note 12. Intangible Asset, Net.
Contingent
Consideration
Contingent
consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition
date. For contingent consideration, management is responsible for determining the appropriate valuation model and estimated fair value,
and in doing so, considers a number of factors, including information provided by an outside valuation advisor. Contingent consideration
liabilities are reported at their estimated fair values based on probability-adjusted present values of the consideration expected to
be paid, using significant inputs and estimates. Key assumptions used in these estimates include probability assessments with respect
to the likelihood of achieving certain milestones and discount rates consistent with the level of risk of achievement. The fair value
of contingent consideration liabilities are remeasured each reporting period, with changes in the fair value included in current operations.
The remeasured liability amount could be significantly different from the amount at the acquisition date, resulting in material charges
or credits in future reporting periods.
Contingencies
Loss
contingency provisions are recorded if the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable,
and the amount can be reasonably estimated or a range of loss can be determined. These accruals represent management’s best estimate
of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible
that the amount of a loss will exceed the recorded provision. On a quarterly basis, we review the status of each significant matter and
assess its potential financial exposure. Significant judgment is required in both the determination of probability and as to whether
an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information
available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and
litigation and may change our estimates. Legal costs associated with legal proceedings are expensed when incurred.
Derivative
Instruments
The
Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of
the specific terms of the warrants and applicable authoritative guidance in FASB Accounting Standards Codification (“ASC”)
480, Distinguishing Liabilities from Equity (“ASC 480”) and Derivatives and Hedging (“ASC 815”). Warrants
classified as equity are recorded at fair value as of the date of issuance on the Company’s consolidated balance sheets and no
further adjustments to their valuation are made. Warrants classified as derivative liabilities that require separate accounting as liabilities
are recorded on the Company’s consolidated balance sheets at their fair value on the date of issuance and are revalued on each
subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods
recorded as other income or expense. Management estimates the fair value of these liabilities using the Black-Scholes-Merton (“BSM”)
model and assumptions that are based on the individual characteristics of the warrants or instruments on the valuation date, as well
as assumptions for future financings, expected volatility, expected life, yield, and risk-free interest rate.
At
their issuance date in October 2021, the IPO Warrants (see Note 19. Stockholders’ Equity) were
accounted for as equity as these instruments met all of the requirements for equity classification under ASC 815-40.
The
Purchase Warrants issued in connection with the private placement offerings completed on December 1, 2021 and May 16, 2022 as
well as the Inducement Warrants issued on July 26, 2022 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 consolidated statement of operations. Refer to Note 4. Fair Value
Measurements.
Fair
Value Measurements
The
Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs
used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures, or ASC 820, establishes a hierarchy
of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available. Observable inputs are those that market participants would use in pricing the asset
or liability based on market data obtained from sources independent of the Company. Unobservable inputs reflect the Company’s assumptions
about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information
available in the circumstances. The three levels of the fair value hierarchy are described below:
Level
1 – Quoted prices in active markets for identical assets or liabilities.
Level
2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or
indirectly.
Level
3 – Unobservable inputs using estimates or assumptions developed by the Company, which reflect those that a market participant
would use in pricing the asset or liability.
To
the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair
value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for
instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level
of any input that is significant to the fair value measurement.
Fair
Value of Financial Instruments
The
carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other receivables,
accounts payable and start-up cost financing included in acquisition contract liabilities
approximate their fair values, due to their short-term nature.
Revenue
Recognition
The
Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue
is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the
Company expects to be entitled in exchange for those goods or services. We recognize revenue when the customer obtains control of our
product, which occurs at a point in time, typically upon delivery to the customer.
To
determine revenue recognition, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance
obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction
price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We
only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods
or services we transfer to the customer is determined to be probable.
The
Company realizes its revenue primarily through the sales of its Ameluz® product which are made directly
to physicians, hospitals or other qualified healthcare providers. Sales are recognized, net of sales deductions, when ownership and control
are transferred to the customer, which is generally upon delivery. Sales deductions include expected trade discounts and allowances,
product returns, and government rebates. These discounts and allowances are estimated at the time of sale based on the amounts incurred
or expected to be received for the related sales.
Xepi®
is sold directly to specialty pharmacies. Sales are recognized net of sales deductions when ownership and control are transferred
to the customer, which is generally upon delivery. Sales deductions include expected returns, discounts and incentives such as payments
made under patient assistance programs. These rebates are estimated at the time of sale based on the amounts incurred or expected to
be received for the related sales.
The
payment terms for sales of our pharmaceutical products are generally short-term payment terms with the possibility of volume-based
discounts, co-pay assistance discounts, or other rebates.
BF
RhodoLED® is also sold directly to physicians, hospitals or other qualified healthcare providers through (i) direct sales
or (ii) an evaluation period up to six-month for a fee, after which a customer can decide to purchase or return the lamp. For direct
sales, revenue is recognized only after complete installation has taken place. As directed by the instruction manual, the lamp may only
be used by the customer once it has been professionally installed. A final decision to purchase the lamps that are within the evaluation
period does not need to be made until the end of the evaluation period. Lamps that are not returned at the end of the evaluation period
are converted into sales in accordance with the contract terms. The Company generates immaterial revenues from the monthly fees during
the evaluation period and from the sale of lamps at the end of the evaluation period.
Variable
Consideration
Revenues
from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which
sales reserves are established and which result from discounts, rebates and other incentives that are offered within contracts between
the Company and its customers. Components of variable consideration include trade discounts and allowances, product returns, government
rebates, and other incentives such as patient co-pay assistance. Variable consideration is recorded on the balance sheet as either a
reduction of accounts receivable, if expected to be claimed by a customer, or as a current liability, if expected to be payable to a
third party other than a customer. Where appropriate, these estimates take into consideration relevant factors such as the Company’s
historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted
customer buying and payment patterns. These reserves reflect the Company’s best estimates of the amount of consideration to which
it is entitled based on the terms of the contract. Actual amounts of consideration ultimately received may differ from the Company’s
estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, and record
any necessary adjustments in the period such variances become known.
Trade
Discounts and Allowances – The Company provides customers with trade discounts, rebates, allowances and/or other incentives.
The Company records estimates for these items as a reduction of revenue in the same period the revenue is recognized.
Government
and Payor Rebates – The Company contracts with, or is subject to arrangements with, certain third-party payors, including pharmacy
benefit managers and government agencies, for the payment of rebates with respect to utilization of its commercial products. The Company
is also subject to discount and rebate obligations under state and federal Medicaid programs and Medicare. The Company records estimates
for these discounts and rebates as a reduction of revenue in the same period the revenue is recognized.
Other
Incentives – The Company maintains a co-pay assistance program which is intended to provide financial assistance to qualified
patients with the cost of purchasing Xepi®. The Company estimates and records accruals for these incentives as a reduction
of revenue in the period the revenue is recognized. The Company estimates amounts for co-pay assistance based upon the number of claims
and the cost per claim that the Company expects to receive associated with products sold to customers but remaining in the distribution
channel at the end of each reporting period.
Royalties
For
arrangements that include sales-based royalties, the Company recognizes royalty expense at the later of (i) when the related sales occur,
or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Royalty expense is recognized as cost of revenues.
Product
Warranty
The
Company generally provides a 36-month warranty for sales of BF-RhodoLED® for which estimated contractual warranty obligations
are recorded as an expense at the time of installation. Customers do not have the option to purchase the warranty separately and the
warranty does not provide the customer with a service beyond the assurance that BF-RhodoLED® complies with agreed-upon
specifications. Therefore, the warranty is not considered to be a performance obligation. The lamps are subject to regulatory and quality
standards. Future warranty costs are estimated based on historical product performance rates and related costs to repair given products.
The accounting estimate related to product warranty expense involves judgment in determining future estimated warranty costs. Should
actual performance rates or repair costs differ from estimates, revisions to the estimated warranty liability would be required. Warranty
expenses incurred in 2022 and 2021 were negligible and are recognized as selling, general and administrative expenses.
Contract
Costs
Incremental
costs of obtaining a contract with a customer may be recorded as an asset if the costs are expected to be recovered. As a practical expedient,
we recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that we
otherwise would have recognized is one year or less. Sales commissions earned by the Company’s sales force are considered incremental
costs of obtaining a contract. To date, we have expensed sales commissions as these costs are generally attributed to periods shorter
than one year. Sales commissions are included in selling, general and administrative expenses.
Cost
of Revenues
Cost
of revenues is comprised of purchase costs of our products, third party logistics and distribution costs including packaging, freight,
transportation, shipping and handling costs, and inventory adjustment due to expiring products, as well as sales-based royalties. Logistics
and distribution costs totaled $0.5 million and $0.4 million for the years ended December 31, 2022 and 2021, respectively.
Share-Based
Compensation
The
Company measures and recognizes share-based compensation expense for equity awards based on fair value at the grant date. The Company
uses the Black-Scholes-Merton (“BSM”) option pricing model to calculate fair value of its stock option grants. The compensation
cost for restricted stock awards is based on the closing price of the Company’s common stock on the date of grant. Share-based
compensation expense recognized in the statements of operations is based on the period the services are performed and recognized as compensation
expense on a straight-line basis over the requisite service period. The Company accounts for forfeitures as they occur.
The
BSM option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility
of the value of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties
and the application of management’s judgment. If factors change and different assumptions are used, the share-based compensation
expense could be materially different in the future. These assumptions are estimated as follows:
Risk-Free
Interest Rate. The risk-free rate is based on the interest rate payable on United States Treasury securities in effect at the time of
grant for a period that is commensurate with the assumed expected term.
Expected
Volatility. The Company based the volatility assumption on a weighted average of the peer group re-levered equity volatility with 80%
weight and the warrant implied volatility with 20% weight. The peer group was developed based on companies in the biotechnology industry
whose shares are publicly traded. Due to our limited historical data and the long-term nature of the awards, the peer group volatility
was more heavily weighted.
Expected
Term. The expected term represents the period of time that options are expected to be outstanding. Due to the lack of historical exercise
data and given the plain vanilla nature of the options granted by the Company, the expected term is determined using the “simplified”
method, as prescribed in SEC Staff Accounting Bulletin (“SAB”) No. 107 (“SAB 107”), whereby the expected life
equals the average of the vesting term and the original contractual term.
Dividend
Yield. The dividend yield is 0% as the Company has never declared or paid, and for the foreseeable future does not expect to declare
or pay, a dividend on its common stock.
Foreign
Currency Transactions
Transactions
realized in currencies other than USD are reported using the exchange rate on the date of the transaction.
Selling,
General and Administrative Expense
Selling,
general and administrative expenses are primarily comprised of compensation and benefits 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, advertising, and other commercial costs to support the commercial operation of
our product and professional fees for legal, consulting, and other general and administrative costs.
Advertising
costs are expensed as incurred. For the years ended December 31, 2022 and 2021, advertising costs totaled $0.1 million and $0.5 million,
respectively.
Income
Taxes
The
Company accounts for income taxes using the asset and liability method in accordance with ASC 740, Income Taxes, which requires
the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in
the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial
reporting and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected
to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood
that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available
evidence, that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is
established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future
taxable profits expected and considering prudent and feasible tax planning strategies.
The
Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the
amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained
upon external examination by the taxing authorities. If the tax position is deemed more likely-than-not to be sustained, the tax position
is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized
is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes
includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related
net interest and penalties.
Net
Loss per Share
Basic
and diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted
average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing
the Company’s net income attributable to common stockholders by the weighted average number of common shares outstanding
and the impact of all dilutive potential common shares outstanding during the period, including stock options, restricted stock units,
and warrants, using the treasury stock method.
Recently
Issued Accounting Pronouncements
In
September 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard was
effective for us on January 1, 2023, and did not have a material effect on our consolidated financial statements.
3.
Acquisition Contract Liabilities
On
March 25, 2019, we entered into an agreement (as amended, the “Share Purchase Agreement”) with Maruho Co, Ltd. (“Maruho”)
to acquire 100% of the shares of Cutanea Life Sciences, Inc. (“Cutanea”). As of the date of the acquisition, Maruho Co, Ltd.
Owned approximately 29.9% of Biofrontera AG through its fully owned subsidiary Maruho Deutschland GmbH. Biofrontera AG is our former
parent, and currently a significant shareholder.
Pursuant
to the Share Purchase Agreement, Maruho agreed to provide $7.3 million in start-up cost financing for Cutanea’s redesigned business
activities (“start-up costs”). These start-up costs are to be paid back to Maruho by the end of 2023 in accordance with contractual
obligations related to an earn-out arrangement. In addition, as part of the earn-out arrangement with Maruho, the product profit amount
from the sale of Cutanea products as defined in the share purchase agreement will be shared equally between Maruho and Biofrontera until
2030 (“contingent consideration”).
In
connection with this acquisition in 2019, we recorded the $7.3
million in start-up cost financing (See Note 24, Commitments and Contingencies-
Cutanea payments), a $1.7
million contract asset related to the benefit associated with the non-interest bearing start-up cost financing and $6.5
million of contingent consideration related to the estimated profits from the sale of Cutanea products to be shared equally with
Maruho.
The
contract asset related to the start-up cost financing is amortized on a straight-line basis using a 6.0% interest rate over the 57-month
term of the financing arrangement, which ends on December 31, 2023. The contract asset is shown net of the related start-up cost financing
within acquisition contract liabilities, net.
The
contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of
6.0% over the applicable term. The contingent consideration is recorded within acquisition contract liabilities, net. The amount of contingent
consideration that could be payable is not subject to a cap under the agreement. The Company re-measures contingent consideration and
re-assesses the underlying assumptions and estimates at each reporting period utilizing a scenario-based method.
Acquisition
contract liabilities, net consist of the following:
Schedule of Acquisition Contract Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Short-term acquisition contract liabilities: | |
| | | |
| | |
Start-up cost financing | |
| 7,300 | | |
| 3,600 | |
Contract asset | |
| (358 | ) | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 6,942 | | |
$ | 3,242 | |
| |
| | | |
| | |
Long-term acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,400 | | |
$ | 6,200 | |
Start-up cost financing | |
| - | | |
| 3,700 | |
Contract asset | |
| - | | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 2,400 | | |
$ | 9,542 | |
| |
| | | |
| | |
Total acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,400 | | |
$ | 6,200 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (358 | ) | |
| (716 | ) |
Total acquisition contract liabilities, net | |
$ | 9,342 | | |
$ | 12,784 | |
4.
Fair Value Measurements
The
following table presents information about the Company’s assets that are measured at fair value on a recurring basis and indicates
the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
Schedule
of Fair Value Hierarchy Valuation Inputs
(in thousands) | |
Level | | |
December 31, 2022 | | |
December 31, 2021 | |
| |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | |
Investment, related party | |
| 1 | | |
$ | 10,548 | | |
$ | - | |
Liabilities: | |
| | | |
| | | |
| | |
Contingent Consideration | |
| 3 | | |
$ | 2,400 | | |
$ | 6,200 | |
Warrant liability – 2021 Purchase Warrants | |
| 3 | | |
$ | - | | |
$ | 12,854 | |
Warrant liability – 2022 Purchase Warrants | |
| 3 | | |
$ | 1,129 | | |
$ | - | |
Warrant liability - Purchase Warrants | |
| 3 | | |
$ | 1,129 | | |
$ | - | |
Warrant liability – 2022 Inducement Warrants | |
| 3 | | |
$ | 1,714 | | |
$ | - | |
Warrant liability | |
| 3 | | |
$ | 1,714 | | |
$ | - | |
Investment, related party
As
of December 31, 2022, the Company had investments in common stock of Biofrontera AG, a significant shareholder. The fair value of these investments was determined with Level 1
inputs through references to quoted market prices. See Notes 6 and 17.
Contingent
Consideration
Contingent
consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected
at fair value within acquisition contract liabilities, net on the consolidated balance sheets. The fair value is based on significant
inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent
consideration utilizes a scenario-based method under which a set of payoffs are calculated using the term of the earnout, projections,
and an appropriate metric risk premium. These payoffs are then discounted back from the payment date to the valuation date using a payment
discount rate. Finally, the discounted payments are summed together to arrive at the value of the contingent consideration. The scenario-based
method incorporates the following key assumptions: (i) the forecasted product profit amounts, (ii) the remaining contractual term, (iii)
a metric risk premium, and (iv) a payment discount rate. The Company re-measures contingent consideration and re-assesses the underlying
assumptions and estimates at each reporting period.
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule of Fair Value of Contingent Consideration
(in thousands) | |
| |
Balance at December 31, 2020 | |
$ | 7,602 | |
Change in fair value of contingent consideration | |
| (1,402 | ) |
Balance at December 31, 2021 | |
$ | 6,200 | |
Change in fair value of contingent consideration | |
| (3,800 | ) |
Balance at December 31, 2022 | |
$ | 2,400 | |
The decrease in fair value of the contingent consideration
in the amount of $(3.8) million and $(1.4) million during the years ended December 31, 2022 and 2021 was recorded in operating expenses
in the statements of operations.
Warrant
Liabilities
The
Purchase and Inducement Warrants were accounted for as liabilities in accordance with ASC 815-40 and are presented
within warrant liabilities in the accompanying consolidated balance sheets. 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.
Given the nominal strike price of
$0.001, the fair value of the Pre-funded Warrant was deemed to be equal to the market price of the underlying common stock at issuance
and at each reporting period and is considered a level 2 liability. The Pre-funded Warrant was issued and exercised within
the same year and therefore is not reflected in the ending balance.
The
Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Purchase and Inducement Warrants which is
considered a Level 3 fair value measurement. Certain inputs utilized in our Black-Scholes pricing 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 consolidated statement of operations.
The
fair value at issuance was estimated using a Black-Scholes pricing model based on the following assumptions at December 1, 2021 for
the 2021 Purchase Warrants, May 16, 2022 for the Purchase Warrants and July 26, 2022 for the Inducement Warrants:
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions
|
|
2021 Purchase | |
|
Purchase | | |
Inducement | |
Stock price |
|
$ |
86.60 | |
|
$ | 52.40 | | |
$ | 32.80 | |
Expiration term (in years) |
|
|
5 | |
|
| 5.50 | | |
| 4.34 | |
Volatility |
|
|
60.0 | % |
|
| 65.0 | % | |
| 70.0 | % |
Risk-free Rate |
|
|
1.15 | % |
|
| 2.83 | % | |
| 2.84 | % |
Dividend yield |
|
|
0.0 | % |
|
| 0.0 | % | |
| 0.0 | % |
The fair value was estimated using Black-Scholes pricing
model based on the following assumptions as of December 31, 2021:
|
|
2021 Purchase |
|
Stock price |
|
$ |
150.40 |
|
Expiration term (in years) |
|
|
4.92 |
|
Volatility |
|
|
60.0 |
% |
Risk-free Rate |
|
|
1.25 |
% |
Dividend yield |
|
|
0.0 |
% |
The
fair value was estimated using Black-Scholes pricing model based on the following assumptions as of December 31, 2022 (outstanding warrants were all issued during 2022):
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 18.40 | | |
$ | 18.40 | |
Expiration term (in years) | |
| 4.88 | | |
| 3.92 | |
Volatility | |
| 70 | % | |
| 75 | % |
Risk-free Rate | |
| 3.96 | % | |
| 4.07 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
following table presents the changes in the warrant liabilities measured at fair value (in thousands):
Schedule
of Changes in Fair Value Warrant Liabilities
| |
December 31, 2022 | |
|
December 31, 2021 | |
Fair value at beginning of year | |
$ | 12,854 | |
|
$ | - | |
Issuance of new warrants | |
| 13,217 | |
|
| 12,261 | |
Exercise of warrants | |
| (6,840 | ) |
|
| (12,208 | ) |
Change in fair value of warrant liability | |
| (19,017 | ) |
|
| 12,801 | |
Warrant inducement expense | |
| 2,629 | |
|
| - | |
Fair value at end of year | |
$ | 2,843 | |
|
| 12,854 | |
5.
Revenue
We
generate revenue primarily through the sales of our products Ameluz®, BF-RhodoLED® lamps and Xepi®.
Revenue from the sales of our BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with the
revenues generated through our sales of Ameluz®.
Related
party revenue relates to an agreement with Biofrontera Bioscience GmbH (“Bioscience”) for BF-RhodoLED® leasing
and installation service. Refer to Note 17, Related Party Transactions.
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule
of Revenue Allowance and Accrual Activities
| |
| | |
Co-pay | | |
Prompt | | |
Government | | |
| |
| |
| | |
assistance | | |
pay | | |
and payor | | |
| |
(in thousands): | |
Returns | | |
program | | |
discounts | | |
rebates | | |
Total | |
Balance at December 31, 2020 | |
$ | 217 | | |
$ | 52 | | |
$ | 15 | | |
$ | 43 | | |
$ | 327 | |
Provision related to current period sales | |
| 6 | | |
| 423 | | |
| 40 | | |
| 168 | | |
| 637 | |
Credit or payments made during the period | |
| (180 | ) | |
| (374 | ) | |
| (7 | ) | |
| (157 | ) | |
| (718 | ) |
Balance at December 31, 2021 | |
$ | 43 | | |
$ | 101 | | |
$ | 48 | | |
$ | 54 | | |
$ | 246 | |
Provision related to current period sales | |
| 10 | | |
| 574 | | |
| 19 | | |
| 210 | | |
| 813 | |
Credit or payments made during the period | |
| (5 | ) | |
| (666 | ) | |
| (62 | ) | |
| (244 | ) | |
| (977 | ) |
Balance at December 31, 2022 | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
6.
Investment, Related
Party
On
October 25, 2022, the Company entered into private exchange agreements with certain holders of options to acquire common shares,
nominal value €1.00 per
share, of Biofrontera AG (“AG Options), a German stock corporation and significant shareholder of the Company, pursuant to
which the parties agreed to a negotiated private exchange of 157,042 shares
of the Company’s common stock in exchange for the AG Options. There was no additional cost to exercise the AG Options. On
November 8, 2022, the Company exercised the AG options in full to acquire 2,623,365 shares
of Biofrontera AG. In addition, the Company purchased an additional 3,843,581 common
shares of Biofrontera AG for a total of 6,446,946 shares
or approximately 10%
of Biofrontera AG’s outstanding common shares as of December 31, 2022. These shares were not fully in our control to
vote or dispose of as they were note held in a brokerage account registered in our name, however, we are currently engaged with
advisors to transfer such share to our brokerage account.
Equity securities gains and losses include unrealized gains and losses from changes in fair
values during the period on equity securities we still own, as well as gains and losses on securities we sold during the period.
There were no proceeds from sales of equity securities during the twelve months ended December 31, 2022.
7.
Accounts Receivable, net
Accounts
receivable are mainly attributable to the sale of Ameluz®, the BF-RhodoLED® and Xepi®. It
is expected that all trade receivables will be settled within twelve months of the balance sheet date.
The
allowance for doubtful accounts was $0.1 million and negligible as of December 31, 2022 and 2021, respectively.
8.
Other Receivables, Related Party
As
of December 31, 2022, the Company has a receivable of $6.5 million
($3.7 short
term and $2.8 long-term)
due from the Biofrontera Group of which $6.4 million
is due from Biofrontera AG for its 50%
share of the balance of a legal settlement for which both parties are jointly and severally liable (refer to Note 24 Commitments and Contingencies). The Company’s receivable balance from Biofrontera AG related to the legal settlement as of December 31, 2021
was $11.3 million, with $2.8 million in long-term. The Company has a contractual
right to repayment of its share of the settlement payments, plus interest and other miscellaneous settlement costs, from Biofrontera
AG under the Settlement Allocation Agreement entered into on December 9, 2021 and as amended on March 31, 2022, which provides that
the settlement payments would first be made by the Company and then reimbursed by Biofrontera AG for its share. The March 31, 2022
Amended Settlement Allocation Agreement provides certain remedies to the Company, if
Biofrontera AG fails to make timely reimbursements, which the Company may implement in its sole discretion, including the ability to
charge interest at a rate of 6.0%
per annum for each day that any reimbursement is past due and the ability to offset any overdue reimbursement amounts against
payments owed to Biofrontera AG by the Company (including amounts owed under the Company’s license and supply agreement for
Ameluz®). As
such, no reserve for the receivable was deemed necessary as of December 31, 2022 or
December 31, 2021.
9.
Inventories
Inventories
are comprised of Ameluz®, Xepi® and the BF-RhodoLED® finished products.
The provision related to BF-RhodoLED® devices was $0.1
million for the year ended December 31, 2022,
and negligible for the year ended December 31, 2021. The provision for Xepi® inventory obsolescence was negligible for
the year ended December 31, 2022 and $0.3 million for the year ended December 31, 2021. There was no provision relating to Ameluz in either year.
10.
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Receivable for common stock warrants proceeds | |
$ | - | | |
$ | 3,258 | |
Prepaid expenses | |
| 439 | | |
$ | 824 | |
Security deposits | |
| 85 | | |
| 149 | |
Other | |
| 286 | | |
| 756 | |
Total | |
$ | 810 | | |
$ | 4,987 | |
11.
Property and Equipment, Net
Property
and equipment, net consists of the following:
Schedule of Property and Equipment
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Computer equipment | |
$ | 89 | | |
$ | 85 | |
Computer software | |
| 27 | | |
| 27 | |
Furniture & fixtures | |
| 81 | | |
| 81 | |
Leasehold improvement | |
| 368 | | |
| 368 | |
Machinery & equipment | |
| 146 | | |
| 112 | |
Property and equipment, gross | |
| 711 | | |
| 673 | |
Less: Accumulated depreciation | |
| (507 | ) | |
| (406 | ) |
Property and equipment, net | |
$ | 204 | | |
$ | 267 | |
Depreciation
expense was $0.1 million for each of the years ended December 31, 2022, and 2021, respectively, which was included in selling, general
and administrative expense on the consolidated statements of operations.
12.
Intangible Asset, Net
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Xepi® license | |
$ | 4,600 | | |
$ | 4,600 | |
Less: Accumulated amortization | |
| (1,568 | ) | |
| (1,150 | ) |
Intangible asset, net | |
$ | 3,032 | | |
$ | 3,450 | |
The
Xepi® license intangible asset was recorded at acquisition-date fair value of $4.6
million and is amortized on a straight-line basis
over the useful life of 11
years. Amortization expense was $0.4
million for each the years ended December 31,
2022 and 2021.
We
review the Xepi® license intangible asset for impairment whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be fully recoverable. In October 2022, upon receiving notification of third-party manufacturing
delays that impacted the timing of sales expansion and improved market positioning of the Xepi® product, we deemed it
necessary to assess the recoverability of our Xepi® asset group. Future cash flows were estimated over the expected remaining
useful life of the asset group and, on an undiscounted basis, the expected cash flows exceeded the carrying amount of
the asset group.
13.
Statement of Cash Flows Reconciliation
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Cash and cash equivalents | |
$ | 17,208 | | |
$ | 24,545 | |
Short-term restricted cash | |
| - | | |
| 47 | |
Long-term restricted cash | |
| 200 | | |
| 150 | |
Total cash and cash equivalent, and restricted cash shown on the statements of
cash flows | |
$ | 17,408 | | |
$ | 24,742 | |
Short-term and long-term restricted cash were recorded
in prepaid expenses and other current assets, and other assets, respectively, in the consolidated balance sheet.
14.
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Legal settlement (See Note 24) | |
$ | 6,207 | | |
$ | 5,625 | |
Employee compensation and benefits | |
| 2,850 | | |
| 2,384 | |
Professional fees | |
| 1,353 | | |
| 570 | |
Product revenue allowances and reserves | |
| 82 | | |
| 246 | |
Other | |
| 372 | | |
| 829 | |
Total | |
$ | 10,864 | | |
$ | 9,654 | |
15.
Other Long-Term Liabilities
Other
long-term liabilities consist of the following:
Schedule of Other Long Term Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Legal settlement – noncurrent (See Note 24) | |
$ | - | | |
$ | 5,625 | |
Other | |
| 21 | | |
| 24 | |
Total | |
$ | 21 | | |
$ | 5,649 | |
16.
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
for the years ended December 31, 2022 and December 31, 2021. Income tax expense incurred in 2022 and 2021 relates to state income taxes.
At December 31, 2022 and December 31, 2021, the Company had no unrecognized tax benefits.
A
reconciliation of the expected income tax (benefit) computed using the federal statutory income tax rate to the Company’s effective
income tax rate is as follows:
Schedule of Effective Income Tax Rate Reconciliation
| |
2022 | | |
2021 | |
| |
Year ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Income tax computed at federal statutory tax rate | |
| 21.00 | % | |
| 21.00 | % |
State taxes | |
| (5.85 | )% | |
| (0.09 | )% |
Permanent differences – non-deductible expenses | |
| (37.93 | )% | |
| (1.03 | )% |
Change in fair value of contingent consideration | |
| 133.62 | % | |
| 0.78 | % |
Change in fair value of warrant liabilities | |
| 576.27 | % | |
| (7.13 | )% |
True-ups | |
| (7.42 | )% | |
| - | |
Change in valuation allowance | |
| (685.54 | )% | |
| (13.62 | )% |
Effective income tax rate | |
| (5.85 | )% | |
| (0.09 | )% |
The
principal components of the Company’s deferred tax assets and liabilities consist of the following at December 31, 2022 and 2021:
Schedule
of Deferred Tax Assets and Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Deferred tax assets (liabilities): | |
| | | |
| | |
Net operating loss carryforwards | |
$ | 30,450 | | |
$ | 24,307 | |
Intangible assets | |
| 4,824 | | |
| 5,132 | |
Acquisition contract liabilities | |
| (96 | ) | |
| (187 | ) |
Property and equipment | |
| 123 | | |
| 103 | |
Accrued expenses and reserves | |
| 890 | | |
| 1,693 | |
Stock based compensation | |
| 449 | | |
| - | |
Lease liability | |
| 361 | | |
| - | |
Other | |
| - | | |
| 6 | |
ROU asset | |
| (369 | ) | |
| - | |
Investment revaluation | |
| (469 | ) | |
| - | |
Total deferred tax assets | |
| 36,163 | | |
| 31,054 | |
Less valuation allowance | |
| (36,163 | ) | |
| (31,054 | ) |
Net deferred taxes | |
$ | - | | |
$ | - | |
The
Company has had no federal income tax expense due to operating losses incurred since inception. The Company has evaluated the positive
and negative evidence bearing upon the realizability of its deferred tax assets. Based on this, the Company has provided a valuation
allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more
likely than not. During 2022, the valuation allowance increased by $5.1
million, primarily due to the increase in the
Company’s net operating loss carryforwards during the period.
As
of December 31, 2022, the Company had approximately $123.4 million and $89.2 million of Federal and state net operating loss carryforwards,
respectively. $113.8 million of the federal NOLs are not subject to expiration and the remaining NOLs begin to expire in 2036. These
loss carryforwards are available to reduce future federal taxable income, if any. These loss carryforwards are subject to review and
possible adjustment by the appropriate taxing authorities. The amount of loss carryforwards that may be utilized in any future period
may be limited based upon changes in the ownership of the Company’s shareholders.
The
Company follows the provisions of ASC 740-10, “Accounting for Uncertainty in Income Taxes,” which specifies how tax benefits
for uncertain tax positions are to be recognized, measured, and recorded in financial statements; requires certain disclosures of uncertain
tax matters; specifies how reserves for uncertain tax positions should be classified on the balance sheet; and provides transition and
interim period guidance, among other provisions. As of December 31, 2022, the Company has not recorded any amounts for uncertain tax
positions. The Company’s policy is to recognize interest and penalties accrued on any uncertain tax positions as a component of
income tax expense, if any, in its statements of operations. As of December 31, 2022 the Company had no reserves for uncertain tax positions.
For the year ended December 31, 2022 no estimated interest or penalties were recognized on uncertain tax positions.
The
Company’s tax returns 2019 through 2022 remain open and subject to examination by the Internal Revenue Service and state taxing
authorities. Net operating loss carryovers from earlier years are also subject to exam and adjustment.
17.
Related Party Transactions
License
and Supply Agreement
On October 8, 2021, we entered into an amendment to
the Ameluz LSA under which the price we pay per unit will be based upon our sales history. As a result of this amendment, the purchase
price we pay the Ameluz Licensor for Ameluz® will be determined in the following manner:
● |
fifty percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA); |
|
|
● |
forty percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the products we license from the Ameluz Licensor; and |
|
|
● |
thirty percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license from the Ameluz Licensor. |
Under the agreement, the Company obtained an exclusive,
non-transferable license to use Pharma’s technology to market and sell the licensed products, Ameluz® and BF-RhodoLED®
and must purchase the licensed products exclusively from Pharma. There was no consideration paid for the transfer of the license.
Purchases
of the licensed products from Pharma during the years ended December 31, 2022 and 2021 were $16.6
million and $9.4
million, respectively, and recorded in inventories in the consolidated balance sheets, and, when sold, in cost of revenues, related
party in the consolidated statements of operations. Amounts due and payable to Pharma as of December 31, 2022 and 2021 were $1.3
million and $0.3
million, respectively, which were recorded in accounts payable, related parties in the consolidated balance sheets.
Service
Agreements
In
December 2021, we entered into an Amended and Restated Master Contract Services Agreement, or “Services Agreement”, which
provides for the execution of statements of work that will replace the applicable provisions of our previous intercompany services agreement
dated January 1, 2016, or 2016 Services Agreement, by and among us, Biofrontera AG, Biofrontera Pharma and Biofrontera Bioscience, enabling
us to continue to use the IT resources of Biofrontera AG and its wholly owned subsidiaries (the “Biofrontera Group”) as well
as providing access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical affairs.
We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and investor relations
services, and are continuously assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will
be needed, and 2) whether they can or should be obtained from other third-party providers. Expenses related to the service agreement
were $0.7 million and $0.7 million for the years ended December 31, 2022 and 2021, which were recorded in selling, general and administrative,
related party. Amounts due to Biofrontera AG related to the service agreement were $0.2 million as of December
31, 2022 and 2021, which were recorded in accounts payable, related parties in the consolidated balance sheets.
Clinical
Lamp Lease Agreement
On
August 1, 2018, the Company executed a clinical lamp lease agreement with Biofrontera Bioscience GmbH (“Bioscience”) to provide
lamps and associated services.
Total
revenue related to the clinical lamp lease agreements was approximately $0.1 million for each of the years ended December 31, 2022 and
2021 and recorded as revenues, related party. Amounts due from Bioscience for clinical lamp and other reimbursements were approximately
$0.1 million for each of the years ended December 31, 2022 and 2021, which were recorded as accounts receivable, related party in the
consolidated balance sheets.
Reimbursements
from Maruho Related to Cutanea Acquisition
Pursuant
to the Cutanea acquisition share purchase agreement, we received start-up cost financing and reimbursements for certain costs. These
restructuring costs Maruho agreed to pay are referred to as “SPA costs” under the arrangement and are to be accounted
for as other income. There were no amounts
reimbursed relating to SPA costs for the year ended December 31, 2022. For the year ended December 31, 2021 the amounts reimbursed
relating to SPA costs were $0.5 million
and were recorded as other income in the consolidated statements of operations as the related expenses were incurred. There were no amounts
due from Maruho for the year ended December 31, 2022. The amounts due from Maruho, primarily relating to SPA cost reimbursements,
were $0.1 million
as of December 31, 2021 and were recorded in other receivables, related parties in the consolidated balance sheets.
Others
The
Company has recorded a receivable of $6.4
million and $11.3
million as of December 31, 2022 and December
31, 2021 due from Biofrontera AG for its 50%
share of the balance of a legal settlement for which both parties are jointly and severally liable as of December 31, 2022. Refer to Note 8, Other Receivables, Related Party. The Company has recognized $0.1
and $0.0
million of interest income for the years ended
December 31, 2022 and 2021, respectively in connection with this receivable.
As
of December 31, 2022, our investment, related party valued at $10.5
million consists of 6,466,949
common shares of Biofrontera AG, a significant
shareholder. See Note 6. In accordance with a Share Purchase and Transfer Agreement dated,
November 3, 2022, the Company purchased approximately 1,674,996
shares (of the total 6,466,946
shares) for $1.7
million from Maruho.
18.
Restructuring costs
We
restructured the business of Cutanea and incurred restructuring costs which are subsequently reimbursed by Maruho. Restructuring costs
primarily relate to the winding down of Cutanea’s operations. There were no
restructuring costs for the year ended December
31, 2022. For the year ended December 31, 2021, restructuring costs were incurred in the amount of $0.8
million, of which $0.5
million had been reimbursed in 2021.
19.
Stockholders’ Equity
Under
the Company’s amended and restated certificate of incorporation, dated December 21, 2020, the Company is authorized to issue 15,000,000
shares of common stock, par value $0.001
per share and 20,000,000
shares of preferred stock, par value $0.001
per share. See Note 2. Summary of Significant Accounting Policies and Note 26. Subsequent Events for information
and disclosures relating to adjustments related to the Reverse Stock Split.
The
holders of common stock are entitled to one vote for each share held. Common stockholders are not entitled to receive dividends, unless
declared by the Board of Directors. The Company has not declared dividends since inception. In the event of liquidation of the Company,
dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities.
The common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions
applicable to the common stock. The outstanding shares of common stock are fully paid and non-assessable.
Initial
Public Offering. On November 2, 2021, the Company completed its initial public offering (“IPO”) of 180,000
units (“Units”) each consisting of (i) one share of common stock of the Company, par value $0.001
per share and (ii) one warrant (the “IPO Warrants”). Every 20 warrants will be exercisable for one share of Common Stock
at an exercise price of $100.00
per share of Common Stock. The IPO Warrants are immediately exercisable upon issuance for a period of five
years after the issuance date. The common stock shares and Warrants were issued separately in the offering and may be
transferred separately immediately upon issuance. The Units were sold at a price of $100.00
per Unit, with gross proceeds from the IPO of approximately $18
million, offset by $3.1
million in offering costs.
At
the IPO date, the underwriters also exercised in full their option to purchase up to an additional 27,000 IPO Warrants at the purchase
price of $0.20 per Warrant to cover over-allotments.
In
connection with the IPO, the Company also issued to the underwriters Unit Purchase Options (“UPO”) to purchase, in the aggregate,
(a) 5,400
Units and (b) 810
Warrants (relating to the underwriters’
exercise of the over-allotment option in full, with respect to the Warrants). The UPOs have an exercise price of $125.00
if exercisable for Units and $0.25
if
exercisable for Warrants. The UPOs are exercisable at any time from October 28, 2021 (“Effective Date”) through the 5th
anniversary of the Effective Date.
The
UPOs issued to the underwriters were accounted for as equity under ASC 718, Compensation -Stock Compensation (“ASC
718”). The fair value of the UPOs, which were fully vested at the issuance date, was recognized as an offering cost against
the proceeds from the IPO. The estimated fair value of the UPO Units of $0.3 million
at the IPO date was determined using a Black-Scholes option pricing model with the following assumptions: fair value of the
underlying unit of $99,
expected volatility of 60.0%,
risk free rate of 1.15%,
remaining contractual term of 5 years
and a dividend yield of 0%.
The estimated fair value of the UPO Warrants of $21,000 at
the IPO date was determined using a Black-Scholes option pricing model with the following assumptions: fair value of the underlying
unit of $25.80,
expected volatility of 60.0%,
risk free rate of 1.15%,
remaining contractual term of 5 years
and a dividend yield of 0%.
Private
Placement – On December 1, 2021, the Company settled the private placement in connection with a securities purchase
agreement dated November 29, 2021 (“December 2021 PIPE”). In the December 2021 PIPE, the Company issued for the gross
cash receipts of $15,000,000
(i) 67,500
shares of the common stock, (ii) a warrant to purchase up to 142,857
shares of the common stock (“Purchase Warrant”) and (iii) a warrant to purchase up to 75,357
shares of the common stock (“Pre-Funded Warrant”). Each of the Purchase Warrant and the Pre-Funded Warrant is
exercisable immediately and has an exercise term of five years and an exercise price of: (a) $105.00
per share with respect to the Purchase Warrant and (b) a nominal exercise price of $0.002
per share with respect to the Pre-Funded Warrant. The shares of common stock and the accompanying warrants were issued separately
and were immediately separable upon issuance. The combined purchase price for one share of common stock and one Purchase Warrant was
$105.00
and the combined purchase price for one Pre-Funded Warrant and one common warrant was $104.80.
On
December 28, 2021, 75,357 common stock shares were issued from the exercise of the Pre-Funded Warrant at an exercise price of $0.002
per share of the Company’s common stock.
In
connection with the December 2021 PIPE, the Company, issued Unit Purchase Options (“PP-UPO”) to the placement agents to purchase,
in the aggregate, (a) 4,286 Units, consisting of one share of common stock and one warrant to purchase common stock. The PP-UPOs have
an exercise price of $131.20 and are exercisable at any time for the period of 5 years.
The
PP-UPOs issued to the underwriters were accounted for under ASC 718, Compensation -Stock Compensation (“ASC 718”). The
fair value of the PP-UPOs, which were fully vested at the issuance date, was recognized as an offering cost of the December 2021
PIPE and allocated between the issuance costs of warrants and issuance costs of common stock, based on the allocated proceeds. The
Company estimated the fair value of the unit purchase options to be approximately $0.3
million at December 1, 2021 of which $0.2
million was allocated to the issuance costs of warrants and immediately expensed in the consolidated statement of operations and
$0.1
million was allocated to the issuance costs of common stock and charged to equity. The fair value was determined using a
Black-Scholes option pricing model with the following assumptions: fair value of the underlying unit of $127.80,
expected volatility of 60.0%,
risk free rate of 1.15%,
remaining contractual term of 5 years
and a dividend yield of 0%.
Private
Placement – On May 16, 2022, the Company entered into a Securities Purchase Agreement (“May 2022 PIPE”). In the May 2022
PIPE, the Company issued for the gross cash receipts of $9.4 million (i) 92,500 shares of the common stock, (ii) a warrant to purchase
up to 170,950 shares of the common stock (“2022 Purchase Warrant”) and (iii) a warrant to purchase up to 78,450 shares
of the common stock (“2022 Pre-Funded Warrant”). The purchase price for one share of common stock (or common stock equivalent)
and a warrant to purchase one share of common stock was $55.00. The 2022 Purchase Warrant will be exercisable nine months after the issue
date, expires five and one-half years after the issue date and has an exercise price of: $55.40 per share. The Pre-Funded Warrant is exercisable
immediately and has a term of exercise equal to five (5) years with a nominal exercise price of $0.02 per share.
Because
the warrants are accounted for as liabilities, the May 2022 PIPE proceeds were
allocated between the fair value of the warrants with the remaining proceeds allocated to common stock and additional paid in
capital.
Exercise
of 2022 Pre-Funded Warrant - On July 14, 2022, an investor exercised the 2022 Pre-Funded Warrant and purchased a total of 78,450
shares of common stock at an exercise price of $0.02 per share, resulting in negligible net proceeds.
Exercise
of 2021 Purchase Warrant and Issuance of July 2022 Inducement Warrant - On July 26, 2022, the Company entered into the
Inducement Letter with the holder of the Company’s 2021 Purchase Warrants (the “Investor”). The 2021 Purchase
Warrants were originally issued on December 1, 2021 to purchase up to 142,858
shares of common stock, par value $0.001
per share. The Investor agreed to exercise for cash, the 2021 Purchase Warrants, in exchange
for the Company’s agreement to (i) lower the exercise price of the 2021 Purchase Warrants from $105.00
to $32.40
per share and (ii) issue a new warrant (the “Inducement Warrant”) to purchase up to 214,286
shares of common stock. The Company received proceeds of $4.6
million, from the exercise of the 2021 Purchase Warrants and expensed the related issuance costs of $0.3
million. The modification expense associated with the change in fair value due to
the repricing of the 2021 Purchase Warrants is recorded as inducement expense. The 2021 Purchase Warrant modification along with the fair
value of the inducement warrants of $2.6 million was expensed as warrant inducement expense in the accompanying consolidated statement
of operations for the year ended December 31, 2022.
The
Inducement Warrant is exercisable on or after January 27, 2023 at a price per share of $33.20 and expires on December 1, 2026.
Adoption
of a stockholder rights plan. On October 13, 2022 the Board of Directors (“Board”) authorized and declared a dividend
distribution of one Preferred Stock Purchase Right (a “Right”) for each outstanding share of common stock to stockholders
of record as of the close of business on October 24, 2022. In addition, one Right will automatically attach to each share of Common Stock
issued between the record date of the distribution and the earlier of the distribution date and the expiration date of the Rights. Each
Right entitles the registered holder to purchase from the Company a unit consisting of one ten-thousandth of a share (a “Unit”)
of Series A Junior Participating Cumulative Preferred Stock, par value $0.001 per share, of the Company at a cash exercise price of $5.00
per Unit, subject to adjustment, under certain conditions. The complete terms of the Rights are set forth in the Stockholder Rights Agreement,
dated October 13, 2022, between the Company and Computershare Trust Company, N.A, as Rights agent.
While
the stockholder rights plan described above (the “Rights Plan”) is effective immediately, the Rights would become exercisable
only if a person or group, or anyone acting in concert with such a person or group, acquires beneficial ownership, as defined in the
Rights Agreement, of 20% or more of the Company’s issued and outstanding common stock in a transaction not approved by the Company’s
Board of Directors. The Rights Plan will expire on October 13, 2023. Refer to Note 26. Subsequent Events
– Settlement Agreement.
Under
the Rights Plan, a person or group who beneficially owned 20% or more of the Company’s outstanding Common Stock prior to the first
public announcement of the Rights Plan on October 14, 2022 will not trigger the Rights so long as they do not acquire beneficial ownership
of any additional shares of Common Stock at a time when they still beneficially own 20% or more of such Common Stock.
Series
A Junior Participating Cumulative Preferred Stock. In connection with the adoption of the Rights Plan, the Board approved a Certificate
of Designations of Series A Junior Participating Cumulative Preferred Stock which designates the rights, preferences and privileges of
5,000 shares of Preferred Stock. The Certificate of Designations was filed with the Secretary of State of Delaware and became effective
on October 13, 2022.
Exchange
Agreement – On October 25, 2022, the Company entered into private exchange agreements with certain holders of options to acquire
ordinary shares, nominal value €1.00
per share, of Biofrontera AG, a German stock
corporation, pursuant to which the parties agreed to a negotiated private exchange, and closed on a series of private exchanges of 3,148,042
shares of the Company’s common stock in
exchange for the AG Options.
Warrants –
The following table summarizes information with regard to the IPO Warrants, and the PIPE
Warrants, which includes the Inducement and 2022 Pre-Funded Warrants (together, the “Warrants”) share activity
for the year ended December 31, 2022:
Schedule
of Warrants
| |
Warrant -
PIPE | | |
Warrant -
IPO* | | |
Total
Warrants | | |
Weighted Average Exercise Price | |
Balance, December 31, 2020 | |
| - | | |
| - | | |
| - | | |
$ | - | |
Issued | |
| 218,214 | | |
| 207,000 | | |
| 425,214 | | |
| 102.57 | |
Exercised | |
| (75,357 | ) | |
| (132,380 | ) | |
| (207,737 | ) | |
| 100.14 | |
Balance, December 31, 2021 | |
| 142,857 | | |
| 74,620 | | |
| 217,477 | | |
| 99.69 | |
Issued | |
| 463,686 | | |
| - | | |
| 463,686 | | |
| 35.77 | |
Exercised | |
| (221,307 | ) | |
| - | | |
| (221,307 | ) | |
| 20.92 | |
Balance, December 31, 2022 | |
| 385,236 | | |
| 74,620 | | |
| 459,856 | | |
$ | 52.29
| |
20.
Equity Incentive Plans and Share-Based Payments
2021
Omnibus Incentive Plan
In
2021, our Board of Directors adopted and our shareholders approved, the 2021 Omnibus Incentive Plan (“2021 Plan). Under the
original 2021 Plan, 137,500
shares are reserved and authorized for awards and the maximum contractual term is 10
years for stock options issued under the 2021 Plan. On December 12, 2022, the 2021 Plan was amended by our stockholders and
the number of shares authorized for awards under the 2021 Plan was increased by 129,490 to 266,990.
As of December 31, 2022, there were 154,359
shares available for future awards under the amended 2021 Plan.
Non-qualified
stock options
We
maintain the 2021 Plan for the benefit of our officers, directors and employees. Employee stock options granted under the 2021 Plan generally
vest in equal annual installments over three years and are exercisable for a period of up to ten years from the grant date. Non-employee
director options vest in equal monthly installments following the date of grant and will be fully vested on the one-year anniversary
of the date of grant. All stock options are exercisable at a price equal to the market value of the common shares underlying the option
on the grant date.
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 the Black-Scholes option pricing model,
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
fair value of each option was estimated on the date of the grant using the BSM option pricing model with the following assumptions:
Schedule of Stock Options Assumptions
|
|
2022 |
|
|
2021 |
|
Expected volatility |
|
|
55% -70 |
% |
|
|
55.0 |
% |
Expected term (in years) |
|
|
5.24 - 6.0 |
|
|
|
6.0 |
|
Risk-free interest rate |
|
|
1.34% - 4.10 |
% |
|
|
1.34 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
The weighted average grant-date fair value of options
granted during the years ended December 31, 2022 and 2021 was $29.28 and $49.55, respectively.
Share-based
compensation expense of approximately $0.8
million was recorded in selling, general and administrative expenses on the accompanying consolidated statement of operations for
the year ended December 31, 2022. There was negligible share-based compensation expense for the year ended December 31,
2021.
Options
outstanding and exercisable under the employee share option plan as of December 31, 2022 and December 2021, and a summary of option activity during
the year 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, 2020 | |
| - | | |
$ | - | | |
| | | |
| | |
Granted | |
| 30,942 | | |
$ | 95.40 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (205 | ) | |
$ | 95.40 | | |
| | | |
| | |
Outstanding at December 31, 2021 | |
| 30,737 | | |
$ | 95.40 | | |
| 9.94 | | |
$ | 1,691 | |
Granted | |
| 64,572 | | |
$ | 48.20 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (8,358 | ) | |
$ | 76.11 | | |
| | | |
| | |
Outstanding at December 31, 2022 | |
| 86,951 | | |
$ | 62.16 | | |
| 9.27 | | |
$ | 1 | |
Exercisable at December 31, 2022 | |
| 11,166 | | |
$ | 85.48 | | |
| 8.99 | | |
$ | - | |
As
of December 31, 2022, there was $2.2 million of unrecognized compensation cost related to unvested stock options held by employees and
directors, which is expected to be recognized over a weighted-average period of approximately 2.3 years.
Share-Based
Compensation (RSUs)
Restricted
Stock Units (“RSUs”) will vest annually over two years, subject to the recipient’s continued service with the Company
through the applicable vesting dates. The fair value of each RSU is estimated based on the closing market price of the Company’s
common stock on the grant date.
Share-based
compensation expense of $1.0 million
and $0.1 million for the RSUs was recorded in selling, general and administrative expenses in the accompanying consolidated
statement of operations for the years ended December 31, 2022 and 2021.
As
of December 31, 2022, there was $0.6 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized
over a weighted-average period of approximately 1.4 years. The total fair value of shares vested during the years ended December 31,
2022 and 2021 was $0.8 million and $0.0 million, respectively.
The
following table summarizes the activity for RSUs during the year ended December 31, 2022 and December 31, 2021:
Schedule
of Restricted Stock Units
| |
Shares | | |
Weighted Average Grant Date Fair Value | |
Outstanding balance at December 31, 2020 | |
| - | | |
$ | - | |
Granted | |
| 8,504 | | |
| 95.40 | |
Issued | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Outstanding balance at December 31, 2021 | |
| 8,504 | | |
$ | 95.40 | |
Awarded | |
| 17,176 | | |
| 52.20 | |
Issued | |
| (8,504 | ) | |
| 95.40 | |
Forfeited | |
| - | | |
| - | |
Outstanding balance at December 31, 2022 | |
| 17,176 | | |
$ | 52.20 | |
21.
Interest Expense, net
Interest
expense, net consists of the following:
Schedule of Interest Expense
| |
| | | |
| | |
| |
For years ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Interest expense | |
| (12 | ) | |
| (2 | ) |
Contract asset interest expense | |
| (358 | ) | |
| (358 | ) |
Interest income- related party | |
| 165 | | |
| - | |
Interest income – other | |
| 10 | | |
| 16 | |
Interest income | |
| 10 | | |
| 16 | |
Interest expense, net | |
$ | (195 | ) | |
$ | (344 | ) |
Contract
asset interest expense relates to the $1.7 million contract asset in connection with the $7.3 million start-up cost financing received
from Maruho under the Cutanea acquisition share purchase agreement. The contract asset is amortized on a straight-line basis using a
6% interest rate over the financing arrangement contract term, which ends on December 31, 2023.
Related
party interest income relates to the recorded receivable of $6.1 million from Biofrontera AG for its 50% share of the balance of a legal
settlement.
22.
Other Income, net
Other
income, net consists of the following:
Schedule of Other Income, Net
| |
| | | |
| | |
| |
For years ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Reimbursed SPA costs | |
$ | - | | |
$ | 539 | |
Other, net | |
| 33 | | |
| 150 | |
Other income, net | |
$ | 33 | | |
$ | 689 | |
Other,
net, primarily includes gain (loss) on foreign currency transactions and gain on termination of operating leases.
23.
Net Loss per Share
Basic
and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands, except share and per share
amounts):
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders
| |
| | | |
| | |
| |
For years ended December 31, | |
| |
2022 | | |
2021 | |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 1,056,988 | | |
| 440,412 | |
Net loss per share, basic and diluted | |
$ | (0.61 | ) | |
$ | (85.63 | ) |
The following table sets forth 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
| |
| | | |
| | |
December 31, | |
2022 | | |
2021 | |
Common stock warrants | |
| 459,856 | | |
| 217,477 | |
Common stock options and RSUs | |
| 104,127 | | |
| 39,241 | |
Unit Purchase Options | |
| 20,182 | | |
| 20,182 | |
Anti-dilutive securities excluded from computation of earnings per share | |
| 403,628 | | |
| 403,628 | |
24.
Commitments and Contingencies
Facility
Leases
The
Company leases its corporate headquarters under an operating lease that expires in August 2025. The Company has the option to extend
the term of the lease for one five (5) year period upon written notice to the landlord. The extension period has not been included
in the determination of the ROU asset or the lease liability as the Company concluded that it is not reasonably certain that it
would exercise this option. The Company provided the landlord with a security deposit in the amount of $0.1
million, which was recorded as other assets in the consolidated balance sheets.
The
Company has also entered into a master lease agreement for its vehicles. After an initial non-cancelable twelve-month period each
vehicle is leased on a month to month basis. Based on historical retention experience of approximately three
years, the vehicles have expiration dates ranging from February 2023 through September 2025.
In
calculating the present value of the lease payments, the Company has elected to utilize its incremental borrowing rate based on the original
lease term and not the remaining lease term. Given the absence of an outstanding debt agreement, a synthetic credit rating analysis
was used in estimating the Company’s IBR. Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for leased liabilities at inception and 8.5% for 2022 leased liabilities.
The
components of lease expense for the year ended December 31, 2022 was as follows (in thousands except lease term and discount rate):
Schedule
of Components of Lease Expense and Other Information
Lease expense | |
Operating Leases | |
Amortization of ROU assets (operating lease cost) | |
$ | 653 | |
Interest on lease liabilities | |
| 99 | |
Total lease expense | |
$ | 752 | |
Other Information | |
| |
Operational cash flow used for operating leases | |
$ | 781 | |
ROU assets obtained in exchange for lease liabilities | |
| 234 | |
Weighted -average remaining lease term (in years) | |
| 2.54 | |
Weighted -average discount rate | |
| 6.31 | % |
| |
| | |
Future
lease payments under non-cancelable leases as of December 31, 2022 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31, | |
Future lease commitments | |
2023 | |
| 565 | |
2024 | |
| 541 | |
2025 | |
| 349 | |
Thereafter | |
| - | |
Total future minimum lease payments | |
$ | 1,455 | |
Less imputed interest | |
$ | (109 | ) |
Total lease liability | |
$ | 1,346 | |
Schedule
of Operating Lease Liability
Reported as: | |
| |
Operating lease liability, current | |
$ | 498 | |
Operating lease liability, non-current | |
| 848 | |
Total | |
| 1,346 | |
Cutanea payments
We
have a contract in which we agreed to repay to Maruho $3.6
million on December 31, 2022 and $3.7
million on December 31, 2023 in start-up cost
financing paid to us in connection with the Cutanea acquisition.
We
have filed for arbitration against Maruho with the International Chamber of Commerce (“ICC”) regarding issues
with Maruho’s contract manufacturer that were not disclosed at the time of the Agreement and therefore are evaluating the repayment
of the $7.3
million of start-up costs. The arbitration notes
that Maruho breached the agreement with Cutanea due to the undisclosed manufacturing issues and seeks damages as well as a declaration
that we are not obligated to repay Maruho.
We
are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition
Contract Liabilities.
Milestone
payments with Ferrer Internacional S.A.
Under
the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer
i) $2,000,000
upon the first occasion when annual net sales
of Xepi® under the Xepi LSA exceed $25,000,000,
and ii) $4,000,000
upon the first occasion annual net sales of Xepi®
under the Xepi LSA exceed $50,000,000.
No payments were made in 2022 or 2021 related to Xepi® milestones.
Contingent
liability related to shares of Biofrontera AG acquired from Maruho through subscription rights
Dependent
on the outcome of legal proceedings between Biofrontera AG and Maruho, the Company may be liable for an additional payout of $0.9 million
in relation to the shares of Biofrontera AG acquired from Maruho through a subscription rights agreement. In accordance with ASC 450-20-50-3,
Contingencies, we have not accrued any liability associated with the subscription rights purchase, as the liability is not considered
probable. Refer to Note 26. Subsequent Events.
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 FASB ASC Topic 450, Contingencies. The Company expenses as incurred the legal
costs related to such legal proceedings.
On
November 29, 2021, the Company entered into a settlement and release agreement with respect to a lawsuit filed March 23, 2018 in the
United States District Court for the District of Massachusetts in which we were alleged to have infringed on certain patents and misappropriated
certain trade secrets. In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $22.5 million
and engage a forensic expert to destroy data at issue in the litigation to settle the claims in the litigation. The Company will be responsible for $11.25 million of the aggregate settlement
amount, plus interest accrued at a rate equal to the weekly average one-year constant maturity Treasury yield and agreed to pay in three
annual installments beginning with December 2021.
While
Biofrontera AG has agreed to pay fifty percent of the settlement costs, we remain jointly and severally liable to DUSA for the full
cash settlement amount, meaning that in the event Biofrontera AG does not pay all or a portion of the amount it owes under the
Agreement, DUSA could compel us to pay Biofrontera AG’s share. If either we or Biofrontera AG violates the terms of the
settlement agreement, we or Biofrontera AG may be liable for a greater amount. If we become liable for more than our agreed share of
the aggregate settlement amount, either of these events could have a material adverse effect on our business, prospects, financial
condition and/or results of operations. As of December 31, 2022, the remaining legal settlement liability accrued for was $6.2 million,
including the estimated remaining cost of the forensic expert. See Note 8, Other Receivables, Related Party for reimbursement
receivable and Note 26, Subsequent Events for additional DUSA claims.
25.
Retirement Plan
The
Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan
covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual
compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary.
For
each of the years ended December 31, 2022 and 2021, matching contribution costs paid by the Company were $0.2 million.
26.
Subsequent Events
Loan
and Security Agreement with MidCap.
On
May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC,
providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million, subject to a borrowing base. The
Loan Agreement allows the Company to request advances thereunder and to use the proceeds of such advances for working capital purposes
until the maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets of the Company, subject
to customary exceptions.
Advances
under the Loan Agreement shall bear interest at the 30-Day Adjusted Term SOFR Rate, set monthly on the first day of the month based on
30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%, plus 4.00% calculated and charged monthly
in arrears. In the event of a called event of default, a default interest rate of 3.00% percent shall be added to the aforementioned
rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to a borrowing base, which is a formula
based on certain eligible receivables and inventory. The Loan Agreement also includes an Unused Line Fee Rate of 0.375% of the Credit
Limit less all outstanding advances, which shall be paid on a monthly basis. Currently, our borrowing capacity is limited to our eligible
receivables, pending consent from Biofrontera AG to allow Midcap to obtain title to Biofrontera Inc.’s inventory in the event of
bankruptcy.
Settlement
Agreement. On April 11, 2023, Biofrontera Inc. and each member of its Board of Directors, in their individual capacities, entered
into a settlement agreement (the “Settlement Agreement”) with Biofrontera AG, a significant stockholder of the Company.
Pursuant
to the terms of the Settlement Agreement, the major provisions are as follows:
|
● |
the Company and a member of its Board of Directors withdrew
their challenges to the resolutions passed at the Biofrontera AG stockholder meeting on January 9, 2023 |
|
● |
the Company will increase the Board of Directors from five
to six members and appoint as a Class I Director a director nominated by Biofrontera AG to fill the vacancy, subject to certain restrictions
as described in the Settlement Agreement; |
|
● |
the Company will search for an additional director candidate,
who is fully independent, to be nominated for election as a Class II Director at the Company’s 2023 annual meeting of stockholders;
at which point the Company will increase the size of the Board of Directors to seven members; |
|
● |
the Board established a Related Party Transactions Committee
to approve all contracts and transactions between the Company and Biofrontera AG, including any of its affiliates; |
|
● |
the Company amended on April 26, 2023 that certain Stockholder
Rights Agreement dated October 13, 2022, between the Company and Computershare Trust Company, N.A., as Rights Agent to increase the threshold
of beneficial ownership before being deemed an Acquiring Person, solely with respect to Biofrontera AG, from 20% to 29.96%. |
|
● |
In addition, the Settlement Agreement contains provisions to
maintain Biofrontera AG’s representation on the Board of Directors as long as it holds at least 20% of the Company’s outstanding
common stock and to limit further increases in the size of the Board of Directors or changes to the Company’s stockholder rights
plan. Biofrontera AG also agrees, subject to certain conditions, to vote in support of the directors
nominated by, and the proposals recommended by, the Board of Directors. |
Reverse
Stock Split. On May 22, 2023, the Company held virtually a Special Meeting of Shareholders in which shareholders approved the amendment
to the Company’s Amended and Restated Certificate of Incorporation to (i) effect a reverse split at a ratio of not less than 1-for-5
and not greater than 1-for-25 and (ii) if and when the reverse stock split is effected, to decrease the number of authorized shares of
the Company’s common stock in the same ratio as is selected for the reverse stock split. The final decision of whether to proceed
with the Amendment shall be determined by our board of directors, in its discretion, at any time prior to August 23, 2023, the deadline
for regaining compliance with Nasdaq Listing Rule 5550(a)(2).
On
June 28, 2023, the Company, filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the “Amendment”)
with the Secretary of State of the State of Delaware to (i) effect the Reverse Stock Split of the Company’s Common Stock, and (ii)
effect a related proportional reduction in the number of the Company’s authorized shares of Common Stock from 300,000,000 to 15,000,000
(the “Authorized Share Reduction”).
Pursuant
to the Amendment, the Reverse Stock Split and Authorized Share Reduction was effective at 11:59 p.m. on July 3, 2023 (the “Split
Effective Time”), and the Common Stock began trading on the Nasdaq Capital Market on a post-split basis on July 5, 2023. The par
value and other terms of the Common Stock were not affected.
Licensing
Agreement with Optical Tools
On
December 2, 2022, the Company entered into the technology transfer agreement with Optical Tools LLC (“Optical Tools”), and
Stephen Tobin and Paul Sowyrda (the “Agreement”). The 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.
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 shall reimburse Optical Tools for all reasonable
out-of-pocket, material and labor costs per the agreement.
As
part of the 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 this Agreement.
New
Board Member
On
July 7, 2023, in connection with the Biofrontera AG settlement agreement disclosed above, the board of directors of the Company appointed
Heikki Lanckriet to the Board. Mr. Lanckriet will serve as a Class I Director to hold office for a term expiring at the annual meeting
of the Company’s stockholders for fiscal year 2025. Mr. Lanckriet’s term as director began upon his appointment at the July
7, 2023 meeting.
Mr.
Lanckriet was appointed to the Board upon the nomination of Biofrontera AG, a significant stockholder of the Company, pursuant to a settlement
agreement dated as of April 11, 2023, between the Company, each member of its Board of Directors at that time and Biofrontera AG.
Contingent
liability related to shares of Biofrontera AG acquired from Maruho through subscription rights relieved in 2023.
In
July 2023, AG and Maruho settled the dispute from which the contingent payment obligation of Biofrontera Inc. under the subscription
rights agreement could have arisen.
Legal
Claim
On
September 13, 2023, Biofrontera was served with a complaint filed in United Stated District Court for the District of Massachusetts by
DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LTD (collectively “DUSA”
or “Plaintiffs”) in which DUSA alleges breach of contract, violation of the Lanham Act, and unfair trade practices. 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 U.S. District Court for the District of Massachusetts, this matter has been transferred by
agreement of the parties to the U.S. District Court for the District of New Jersey.
The
Company denies the Plaintiffs’ claims and intends to defend these matters vigorously. Based on the Company’s assessment
of the facts underlying the above claims, the uncertainty of litigation and the preliminary stage of the case, 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.
Exhibit
99.2
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
The
following section contains statements that are not statements of historical fact and are forward-looking statements within the meaning
of the federal securities laws. These statements involve known and unknown risks, uncertainties, and other factors that may cause our
actual results, performance, or achievement to differ materially from anticipated results, performance, or achievement, expressed or
implied in such forward-looking statements. These statements reflect our current views with respect to future events, are based on assumptions,
and are subject to risks and uncertainties.
Forward-Looking
Statements
The
Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Such statements
include statements regarding the timeline for regulatory review and approval of our products, the availability of funding sources for
continued development of such products, and other statements that are not historical facts, including statements which may be preceded
by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions
and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ
materially from the expectations contained in the forward-looking statements.
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.
Overview
Biofrontera
Inc. (the “Company” or “Biofrontera”) includes its wholly owned subsidiary Bio-FRI GmbH (“Bio-FRI”
or “subsidiary”). Our subsidiary, Bio-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship
with Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH, our Ameluz Licensor.
We
are a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological
conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the
treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection.
Our
principal licensed product is Ameluz®, which is a prescription drug approved for use in combination with the BF-RhodoLED®
lamp series, for photodynamic therapy, or PDT (when used together, “Ameluz® PDT”). In the United States,
the PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratoses (“AK”) of mild-to-moderate
severity on the face and scalp. AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell
carcinoma) if left untreated. International treatment guidelines list photodynamic therapy as the “gold standard” for treating
AK, especially multiple AK and the surrounding photodamaged skin.1We are currently selling Ameluz® for this
indication in the U.S. under the Ameluz License and Supply Agreement (“LSA”).
Our
second prescription drug licensed product in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated
quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been
specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or
Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. We are currently
selling Xepi® for this indication in the United States under an exclusive license and supply agreement, as amended
(“Xepi LSA”), with Ferrer that was assumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life
Sciences, Inc. (“Cutanea”).
1
Werner
RN, Stockfleth E, Connolly SM, et al. Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International
League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version. J Eur Acad Dermatol Venereol.
2015;29(11):2069-2079. doi:10.1111/jdv.13180.
Our
principal objective is to increase the sales of our licensed 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 BF-RhodoLED® lamp for the treatment
of minimally to moderately thick actinic keratoses of the face and scalp and positioning Ameluz® to be the standard
of care in the United States by growing our dedicated sales and marketing infrastructure in the United States; |
|
|
● |
leveraging
the potential for future approvals and label extensions of our portfolio products that are in the pipeline for the U.S. market through
the LSAs with our Licensors; and |
|
|
● |
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 our licensed products, Ameluz® and the
BF-RhodoLED® lamp series. We have financed our operating and capital expenditures through cash proceeds
generated from our product sales, our line of credit, and proceeds received in equity financings.
We
believe that important measures of our results of operations include product revenue, operating income (loss) and adjusted EBITDA (a
non-GAAP measure as defined below). Our sole source of product revenue is sales of products that we license from certain related and
unrelated companies. Our long-term financial objectives include consistent revenue growth and expanding operating margins. Accordingly,
we are focused on licensed product sales expansion to drive revenue growth and improve operating efficiencies, including effective resource
utilization, information technology leverage, and overhead cost management.
Key
factors affecting our performance
As
a result of a number of factors, 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. Set forth below is a brief discussion of the key
factors impacting our results of operations.
Seasonality
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.
COVID-19
The
COVID-19 global pandemic still affects our business and presents challenges particularly regarding our supply chain. Although, we are
optimistic that our business will continue to thrive throughout 2023 and beyond, the ultimate extent of the impact of any epidemic, pandemic,
outbreak, or other public health crisis on our business, financial condition and results of operations will depend on future developments,
which are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of such epidemic,
pandemic, outbreak, or other public health crisis and actions taken to contain or prevent the further spread, including the effectiveness
of vaccination and booster vaccination campaigns, among others. Accordingly, we cannot predict the extent to which our business, financial
condition and results of operations will continue to be affected. We remain focused on maintaining a strong balance sheet, liquidity
and financial flexibility and continue to monitor developments as we deal with the disruptions and uncertainties from a business and
financial perspective relating to COVID-19 and variants thereof.
Supply
Chain
While
our Licensors take reasonable precautions to ensure the successful production of our commercially licensed products, their contract manufacturers
may experience a myriad of business difficulties (i.e., workforce instability, supply chain issues, erosion of customer base, etc.) that
could impact their financial solvency. In December 2021, we were notified by Ferrer of third-party manufacturing delays for the Xepi®
product. Although we have inventory of Xepi® on hand, we expect a delay in further shipments of Xepi® for
the next 3 to 6 months. Despite these delays, our total revenues will not be significantly impacted since the majority of
our revenues are from sales of Ameluz®. We continue to monitor the impacts of the supply chain on our business and are
focused on ensuring the stability of the supply chains for Ameluz® and BF-RhodoLED®.
Components
of Our Results of Operations
Product
Revenue, net
We
generate product revenues through the third-party sales of our licensed products Ameluz®, BF-RhodoLED®
lamps and Xepi® covered by our exclusive LSAs with our Licensors. Revenues from product sales are recorded net
of discounts, rebates and other incentives, including trade discounts and allowances, product returns, government rebates, and other
incentives such as patient co-pay assistance. Revenue from the sales of our BF-RhodoLED® lamp and Xepi® are
relatively insignificant compared with revenues generated through our sales of Ameluz®.
The
primary factors that determine our revenue derived from our licensed products are:
● |
the
level of orders generated by our sales force; |
|
|
● |
the
level of prescriptions and institutional demand for our licensed products; and |
|
|
● |
unit
sales prices. |
Related
Party Revenues
We
also generate insignificant related party revenue in connection with an agreement with Biofrontera Bioscience GmbH to provide BF-RhodoLED®
lamps, associated services for the clinical trials performed by Biofrontera Bioscience GmbH and accounting services provided to
Biofrontera AG.
Cost
of Revenues, Related Party
Cost
of revenues, related party, is comprised of purchase costs of our licensed products, Ameluz® and BF-RhodoLED®
lamps from Biofrontera Pharma GmbH and insignificant inventory adjustments due to scrapped, expiring and excess products.
On
October 8, 2021, we entered into an amendment to the Ameluz LSA under which the price we pay per unit will be based upon our sales history.
As a result of this amendment, the purchase price we pay the Ameluz Licensor for Ameluz® will be determined in the following
manner:
● |
fifty
percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from
the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA); |
|
|
● |
forty
percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the
products we license from the Ameluz Licensor; and |
|
|
● |
thirty
percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license
from the Ameluz Licensor. |
Cost
of Revenues, Other
Cost
of revenues, other, is comprised of purchase costs of our licensed product, Xepi®, third-party logistics and distribution
costs including packaging, freight, transportation, shipping and handling costs, inventory adjustment due to expiring Xepi®
products, as well as sales-based Xepi® royalties.
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 operation of our licensed products
and professional fees for legal, consulting and accounting services. Selling, general and administrative expenses also include the amortization
of our intangible asset and our legal settlement expenses.
Selling,
General and Administrative Expenses, Related Party
Selling,
general and administrative expenses, related party, primarily relate to the services provided by our significant stockholder, Biofrontera
AG, for accounting consolidation, IT support, and pharmacovigilance. These expenses were charged to us based on costs incurred plus 6%
in accordance with the 2016 Services Agreement. During 2021, we entered into the Services Agreement which provides for the execution
of statements of work that supersede the applicable provisions of the 2016 Services Agreement. The Services Agreement enables us to continue
relying on Biofrontera AG and its subsidiaries for various services it has historically provided to us, including IT and pharmacovigilance
support for as long as we deem necessary. We currently have statements of work in place regarding IT, regulatory affairs, medical affairs,
pharmacovigilance, and Investor Relations services, and are continuously assessing the other services historically provided to us by
Biofrontera AG to determine 1) if they will be needed, and 2) whether they can or should be obtained from other third-party providers.
During 2022, we hired additional IT personnel and developed our IT infrastructure, enabling us to commence work on our IT separation
from Biofrontera AG. During 2023, we have migrated most of our significant IT services from Biofrontera AG to third party providers.
Restructuring
Costs
We
restructured the business of Cutanea and incurred restructuring costs through 2021, which were subsequently reimbursed by Maruho Co.,
Ltd, (“Maruho”). Restructuring costs primarily relate to Aktipak® discontinuation, and personnel costs related
to the termination of certain Cutanea employees.
Change
in Fair Value of Contingent Consideration
In
connection with the Cutanea acquisition, we recorded contingent consideration related to the estimated profits from the sale of Cutanea
products to be shared equally with Maruho. The fair value of such contingent consideration was determined to be $6.5 million on the acquisition
date of March 25, 2019 and is re-measured at each reporting date until the contingency is resolved.
Change
in Fair Value of Warrant Liabilities
Common
stock warrants issued in conjunction with private placement financing transactions are accounted for as liabilities in accordance with
ASC 815-40.
The
warrant liability is measured at fair value at inception and on a recurring basis, with changes in fair value presented within the consolidated
statements of operations.
Warrant
Inducement Expense
The
warrant inducement expense represents the accounting fair value of consideration issued to induce conversion of the 2021 Purchase Warrant.
On July 26, 2022, the Company entered into the Inducement Letter, in which the Company agreed to lower the exercise price of the 2021
Purchase Warrant and issue a new warrant (the “Inducement Warrant”) in exchange for $4.6 million in proceeds (see Note
19 Stockholders’ Equity within our consolidated financial statements for details).
The
warrant inducement expense was determined using the Black-Scholes option pricing model and was calculated as the difference between the
fair value of the 2021 Purchase Warrant prior to, and immediately after, the reduction in the exercise price on the date of repricing
in addition to the fair value of the Inducement Warrant issued.
Change
in Fair Value of Investment, Related Party
Our
investments are comprised of equity securities in shares of Biofrontera AG, which are initially recorded at cost, plus transaction costs,
and subsequently measured at fair value, based on quoted market prices, with the gains and losses reported in the Company’s consolidated
statement of operations. For the investments held in foreign currencies, the change in fair value attributable to changes in foreign
exchange rates is included in gains and losses in the consolidated statement of operations.
The
Company may sell its equity securities in response to changes in interest rates, risk/reward characteristics, liquidity needs or other
factors.
Interest
Expense, net
Interest
expense, net, primarily consists of amortization of the contract asset related to the start-up cost financing from Maruho under the Share
Purchase and Transfer Agreement dated March 25, 2019 (as amended, the “Share Purchase Agreement”) offset by interest income
of 6% per annum for each day that any reimbursement is past due related to the Amended Settlement Allocation Agreement with Biofrontera
AG, and immaterial amounts of interest income earned on our financing of customer purchases of BF-RhodoLED® lamps.
Other
Income, net
Other
income, net primarily includes (i) gain on sale 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 Years Ended December 31, 2022 and December 31, 2021
The
following table summarizes our results of operations for the years ended December 31, 2022 and December 31, 2021:
| |
For the Year Ended December 31, | |
(in thousands) | |
2022 | | |
2021 | | |
Change | | |
%Change | |
| |
| | |
| | |
| | |
| |
Product revenues, net | |
$ | 28,541 | | |
$ | 24,043 | | |
$ | 4,498 | | |
| 18.7 | % |
Related party revenues | |
| 133 | | |
| 57 | | |
| 76 | | |
| 132.5 | % |
Revenues, net | |
| 28,674 | | |
$ | 24,100 | | |
| 4,574 | | |
| 19.0 | % |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenues, related party | |
| 14,618 | | |
| 12,222 | | |
| 2,396 | | |
| 19.6 | % |
Cost of revenues, other | |
| 567 | | |
| 520 | | |
| 47 | | |
| 9.1 | % |
Selling, general and administrative | |
| 35,137 | | |
| 36,512 | | |
| (1,375 | ) | |
| -3.8 | % |
Selling, general and administrative, related party | |
| 733 | | |
| 697 | | |
| 36 | | |
| 5.1 | % |
Restructuring costs | |
| - | | |
| 752 | | |
| (752 | ) | |
| -100.0 | % |
Change in fair value of contingent consideration | |
| (3,800 | ) | |
| (1,402 | ) | |
| (2,398 | ) | |
| 171.0 | % |
Total operating expenses | |
| 47,255 | | |
| 49,301 | | |
| (2,046 | ) | |
| -4.1 | % |
Loss from operations | |
| (18,581 | ) | |
| (25,201 | ) | |
| 6,620 | | |
| -26.3 | % |
Change in fair value of warrant liabilities | |
| 19,017 | | |
| (12,801 | ) | |
| 31,818 | | |
| -248.6 | % |
Warrant inducement expense | |
| (2,629 | ) | |
| - | | |
| (2,629 | ) | |
| n/a | |
Change in fair value of investment, related party | |
| 1,747 | | |
| - | | |
| 1,747 | | |
| n/a | |
Interest expense, net | |
| (195 | ) | |
| (344 | ) | |
| 149 | | |
| -43.3 | % |
Other income, net | |
| 33 | | |
| 689 | | |
| (656 | ) | |
| -95.2 | % |
Loss before income taxes | |
| (608 | ) | |
| (37,657 | ) | |
| 37,049 | | |
| -98.4 | % |
Income tax expenses | |
| 32 | | |
| 56 | | |
| (24 | ) | |
| -42.9 | % |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) | |
$ | 37,073 | | |
| -98.3 | % |
Revenues,
net
Our
net revenue was $28.7 million and $24.1 million 2022 and 2021, respectively, an increase of $4.6 million, or 19.0%. Net product revenue
was $28.5 million and $24.0 million for 2022 and 2021, respectively, an increase of $4.5 million, or 18.7%. The increase was primarily
driven by: (i) higher volume of Ameluz® orders, which resulted in an increase in Ameluz® revenue of $3.7
million, and (ii) an increase in the price of Ameluz®, which further increased Ameluz® revenue by $0.6
million.
Operating
Expenses
Cost
of Revenues, Related Party
Cost
of revenues, related party was $14.6 million and $12.2 million for 2022 and 2021, respectively, an increase of $2.4 million, or 19.6%.
The increase was primarily driven by the increase in Ameluz® product revenue. Cost of Ameluz® is directly
correlated to the selling price under the Ameluz LSA.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses were $35.1 million and $36.5 million for 2022 and 2021, respectively, a decrease of $1.4 million,
or 3.8%. This decrease was driven by a legal settlement expense, net of reimbursement from AG, of $11.3 million recognized
in 2021. This decrease was offset by an increase in headcount costs as a result of resumed hiring in 2022 and a broad increase in the
costs to comply with corporate governance, such as regulatory reporting, risk management and other requirements applicable to us as a
public company, as well as external legal costs.
Restructuring
Costs
There
were no restructuring costs for the twelve months ended December 31, 2022. Restructuring costs were $0.8 million for the twelve months
ended December 31, 2021, all of which related to facility exit costs.
Change
in Fair Value of Contingent Consideration
The
change in fair value of contingent consideration was a decrease of $3.8 million and a decrease of $1.4 million for 2022 and 2021, respectively.
The change in fair value of contingent consideration is driven by the estimated profit share the Company is required to pay under the
Share Purchase Agreement. During 2022, the estimated profit share was reduced in response to supply chain delays experienced by the supplier
and its impact on expected demand.
Change
in Fair Value of Warrant Liabilities
The
change in fair value of warrant liabilities was a decrease of $31.8 million and an increase of $12.8 million for 2022 and 2021, respectively.
The change was driven by changes in the underlying value of the Company’s common stock.
Warrant
Inducement Expense
The
warrant inducement expense was an increase of $2.6 million for 2022. The change was driven by changes in the underlying value of the
common stock, related to the modification and exercise of the 2021 Purchase Warrant.
Change
in fair value of investment, related party
The
change in fair value of investment, related party of $1.7 million was driven by changes in the quoted market price of the common stock
of Biofrontera AG.
Other
Income, net
Other
income, net was negligible and $0.7 million in 2022 and 2021, respectively, a decrease of $0.7 million or 95.2%. The decrease is primarily
related to the decrease in reimbursed costs under the Share Purchase Agreement with Maruho of $0.5 million.
Net
Income to Adjusted EBITDA Reconciliation for years ended December 31, 2022 and 2021
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 contingent consideration: Pursuant to the Share Purchase Agreement, the profits from the sale of Cutanea products
will be shared equally between Maruho and Biofrontera until 2030. The fair value of the contingent consideration was determined to be
$6.5 million on the acquisition date and is re-measured at each reporting date. We exclude the impact of the change in fair value of
contingent consideration as this is non-cash.
Change
in fair value of warrant liabilities: The Warrants issued in conjunction with our private placement 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.
Warrant
inducement expense: The warrant inducement expense was determined using the Black-Scholes option pricing model and was calculated
as the difference between the fair value of the 2021 Purchase Warrant prior to, and immediately after, the reduction in the exercise
price on the date of repricing in addition to the fair value of the Inducement Warrant issued and is presented within the statement of
operations. We exclude the impact of the change in fair value of the warrant modification as this is non-cash.
Change
in fair value of investment, related party: The Company accounts for its investment, related party in accordance with ASC 321, Investments
— Equity Securities (“ASC 321”). Equity securities, which are comprised of investments in common stock, are initially
recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and
losses reported in the Company’s consolidated statement of operations. For the investments held in foreign currencies, the change
in fair value attributable to changes in foreign exchange rates is included in gains and losses in the consolidated statement of operations.
We exclude the impact of the change in fair value of investments as this is non-cash.
Legal
settlement expenses: To measure operating performance, we exclude legal settlement expenses. We do not expect to incur these types
of legal expenses on a recurring basis and believe the exclusion of such amounts allows management and the users of the financial statements
to better understand our financial results.
Stock
Based Compensation: To measure operating performance, we exclude the impact of costs relating to share-based compensation. Due to
the subjective assumptions and a variety of award types, we believe that the exclusion of share-based compensation expense, which is
typically 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.
Expensed
issuance costs: To measure operating performance, we exclude the portion of issuance costs allocated to our warrant liabilities.
We do not expect to incur this type of expense on a recurring basis and believe the exclusion of these costs allows management and the
users of the financial statements to better understand our financial results.
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 years ended December 31, 2022 and 2021:
| |
Years ended December 31, | |
| |
2022 | | |
2021 | |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) |
Interest expense, net | |
| 195 | | |
| 344 | |
Income tax expenses | |
| 32 | | |
| 56 | |
Depreciation and amortization | |
| 519 | | |
| 540 | |
EBITDA | |
| 106 | | |
| (36,773 | ) |
| |
| | | |
| | |
Change in fair value of contingent consideration | |
| (3,800 | ) | |
| (1,402 | ) |
Change in fair value of warrant liabilities | |
| (19,017 | ) | |
| 12,801 | |
Warrant inducement expense | |
| 2,629 | | |
| - | |
Change in fair value of investment, related party | |
| (1,747 | ) | |
| - | |
Legal settlement expenses | |
| 870 | | |
| 11,250 | |
Stock based compensation | |
| 1,852 | | |
| 129 | |
Expensed issuance costs | |
| 1,045 | | |
| 1,383 | |
Adjusted EBITDA | |
$ | (18,062 | ) | |
$ | (12,612 | ) |
Adjusted EBITDA margin | |
| -63.0 | % | |
| -52.3 | % |
Adjusted
EBITDA
Adjusted
EBITDA decreased from ($12.7) million for the year ended December 31, 2021 to ($18.1) million for the year ended December 31, 2022. The
decrease was primarily driven by an increase in Selling, general, and administrative expenses (excluding legal settlement expenses) due
to increased headcount and compliance costs. Our adjusted EBITDA margin decreased from (52.8%) for the year ended December 31, 2021 to
(63.0%) for the year ended December 31, 2022, as the decline in our Adjusted EBITDA outpaced our increase in revenues.
Liquidity
and Capital Resources
The
Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, and cash
flows from financing transactions. During the year ended December 31, 2022, we received proceeds of $9.4 million from the issuance of
common stock and warrants in private placement, net of issuance costs, and $4.6 million from the exercise of common stock warrants (See
Note 19. Stockholders’ Equity within our consolidated financial statements). As of December 31, 2022, we had cash and cash
equivalents of $17.2 million, compared to $24.5 million as of December 31, 2021.
Since
we commenced operations in 2015, we have generated significant losses. For the years ended December 31, 2022 and 2021, we incurred net
losses of $0.6 million and $37.7 million, respectively. We incurred net cash outflows from operations of $16.2 million and $26.7 million,
for the same periods, respectively. We had an accumulated deficit as of December 31, 2022 of $79.5 million.
The
Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments, Maruho
start-up payments of $7.3 million (see Note 3. Acquisition Contract Liabilities), and legal settlement expenses after reimbursement
from Biofrontera AG (see Note 24, Commitments and Contingencies within our consolidated financial statements).
Additionally,
we expect to continue to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology
community outreach efforts as we seek to expand the commercialization of our licensed products in the United States. We also expect to
incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel to support
our product commercialization efforts. In addition, we expect to incur costs to continue to comply with corporate governance, regulatory
reporting and other requirements applicable to us as a public company in the United States.
In
connection with our assessment of going concern considerations under applicable accounting standards, the Company’s management
has determined that substantial doubt exists about our ability to continue as a going concern for at least one year from the date these
financial statements were issued.
The
future viability of the Company is dependent on its ability to continue to execute its growth plan and raise additional capital or find
alternative methods of financing to fund its operations until cash flow from operations is sufficient. Management believes that actions
presently being taken to obtain additional funding and implement its strategic plans provide the opportunity for the Company to continue
as a going concern. No assurance can be given that the Company will be successful in these efforts on a timely basis. There can be no
guarantee that the actions presently being taken by the Company will be successful in raising additional capital or finding alternative
methods of financing. If the Company is not successful in these endeavors, it would likely have a material adverse effect on the Company’s
business, results of operations and financial condition.
Cash
Flows
The
following table summarizes our cash provided by and (used in) operating, investing and financing activities:
| |
For the Year Ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Net cash used in operating activities | |
$ | (16,199 | ) | |
$ | (26,715 | ) |
Net cash used in investing activities | |
| (5,156 | ) | |
| (11 | ) |
Net cash provided by financing activities | |
| 14,021 | | |
| 43,191 | |
Net increase in cash and restricted cash | |
$ | (7,334 | ) | |
$ | 16,465 | |
Operating
Activities
During
the year ended December 31, 2022, operating activities used $16.2 million of cash, primarily resulting from our net loss of $0.6 million,
adjusted for the add back of non-cash income of $18.3 million and offset by net cash provided by changes in our operating assets and
liabilities of $2.7 million. Non-cash items include warrant inducement expense of $2.6 million, stock-based compensation of $1.9 million,
non-cash interest expense of $0.4 million, and depreciation and amortization in the aggregate of $1.2 million, netted against a change
in fair value of i warrant liabilities of $19.0 million, change in fair value of contingent consideration of $3.8 million, and change
in fair value of equity securities of $1.7 million.
Investing
Activities
During
the year ended December 31, 2022, investing activities used $5.2 million, primarily resulting from the purchase of shares of Biofrontera
AG (See Note 4. Fair Value Measurements and Note 6. Investment, related party within our consolidated financial statements)
Financing
Activities
During
the years ended December 31, 2022 and 2021, net cash provided by financing activities was $14.0 million and $43.2 million, respectively.
Financing activities during year ended December 31, 2022 consisted of proceeds of $9.4 million from the issuance of common stock and
warrants in private placement, net of issuance costs, and $4.6 million from the exercise of common stock warrants. Financing activities
during year ended December 31, 2021 consisted of proceeds from the issuance of common stock upon an initial public offering of $14.9
million, issuance of common stock in private placement of $15.0 million, and the exercise of warrants of $13.2 million.
On
May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC,
providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million, subject to a borrowing base. The
Loan Agreement allows the Company to request advances thereunder and to use the proceeds of such advances for working capital purposes
until the maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets of the Company, subject
to customary exceptions. For additional details see Note 26. Subsequent Events – Loan and Security Agreement with MidCap, within
our consolidated financial statements.
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.
Critical
Accounting Estimates
We
believe that the following accounting policies are those that are most critical to the judgments and estimates used in the preparation
of our financial statements.
Contingent
Consideration
We
record contingent consideration resulting from a business combination at its fair value on the acquisition date. Each reporting period
thereafter, we revalue the remaining obligations and record increases or decreases in their fair value as an adjustment to contingent
consideration expense in our statements of operations. We considered a number of factors, including information provided by an outside
valuation advisor in performing the valuation. Contingent consideration is reported at the estimated fair values based on the probability-adjusted
present value of the consideration expected to be paid, using significant inputs and estimates. Changes in the fair value of our contingent
consideration obligations can result from changes to one or multiple inputs, including forecasted product profit amounts, metric risk
premium and discount rates consistent with the level of risk of achievement as further discussed in Note 4, Fair Value Measurements
to the audited financial statements as of and for the years ended December 31, 2022 and 2021 as included in this Form 10-K. The fair
value of the contingent consideration is remeasured each reporting period, with changes in the fair value included in current operations.
These fair value measurements represent Level 3 measurements as they are based on significant inputs not observable in the market.
Significant
judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period.
Accordingly, changes in assumptions described above, could have a material impact on the amount of contingent consideration expense we
record in any given period.
Intangible
Assets and Impairment Assessment
The
Company regularly reviews the carrying amount of its long-lived assets to determine whether indicators of impairment may exist, which
warrant adjustments to carrying values or estimated useful lives. In connection with this review, assets are grouped at the lowest level
at which identifiable cash flows are largely independent of other asset groupings. If indications of impairment exist, projected future
undiscounted cash flows associated with the asset grouping are compared to the carrying amount to determine whether the asset’s
value is recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the
use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the
impaired asset group over its fair value, determined based on discounted cash flows.
In
determining future cash flows, we take various factors into account, including the remaining useful life of each asset group, forecasted
growth rates, pricing, working capital, capital expenditures, and other cash needs specific to the asset group. Additional considerations
when assessing impairment include changes in our strategic operational and financial decisions, economic conditions, demand for our product
and other corporate initiatives which may eliminate or significantly decrease the realization of future benefits from our long-lived
assets. Since the determination of future cash flows is an estimate of future performance, future impairments may arise in the event
that future cash flows do not meet expectations.
We
perform an impairment assessment in accordance with FASB ASC Topic 360-10-S99, Impairment or Disposal of Long-Lived Assets. Management’s
review for the presence of indicators of impairment include events or changes in circumstances that indicate the carrying amount of an
asset may not be recoverable. In October 2022, upon receiving notification of further third-party manufacturing delays that impacted
the timing of sales expansion and improved market positioning of the Xepi® product, we deemed it necessary to assess the
recoverability of our Xepi® asset group. As of the date of notification, future undiscounted cash flows were estimated
over the expected remaining useful life using revenue and operating expense growth rates. Also, the expected cash flows were based on
the assumption that sales levels would grow considerably for the first two years after resolution of the manufacturing delays as a result
of expanding the sales force and marketing efforts related to the asset group. While we believe these assumptions were reasonable, the
level of future sales may vary significantly from the levels assumed. Also, the timeframe over which activity levels grow is highly uncertain.
Potential events that could affect our assumptions are affected by factors such as those described in “Risks Related to Our
Business and Strategy”. After the assessment we performed, we determined that, on an undiscounted basis, expected cash flows
exceeded the carrying amount of the asset group. For additional information on our impairment assessment, refer Note 12, “Intangible
Assets, Net”, to our financial statements included in this Form 10-K.
Fair
Value – Warrant Liability
The
Warrants issued in conjunction with our private placement offerings were accounted for as liabilities in accordance with ASC 815-40 and
are presented within warrant liabilities in the accompanying consolidated balance sheet. 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.
The
Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Warrants which is considered a Level 3 fair value
measurement. The Black-Scholes option-pricing model considers several variables and assumptions in estimating the fair value of financial
instruments, including the per-share fair value of the underlying common stock, exercise price, expected term, risk-free interest rate,
expected stock price volatility over the expected term, and expected annual dividend yield. Certain inputs utilized in our Black-Scholes
pricing 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
liability which could also result in material non-cash gain or loss being reported in our consolidated statement of operations.
Recently
issued accounting pronouncements
A
description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations
is disclosed in Note 2, Summary of Significant Accounting Policies—Recently Issued Accounting Pronouncements Not Yet Effective.
Off-balance
Sheet Arrangements
Besides
the contractual obligations and commitments as discussed in the Liquidity and Capital Resources, 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.
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Biofrontera
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v3.23.3
Consolidated Balance Sheets - USD ($) $ in Thousands |
Dec. 31, 2022 |
Dec. 31, 2021 |
Current assets: |
|
|
Cash and cash equivalents |
$ 17,208
|
$ 24,545
|
Accounts receivable, net |
3,748
|
3,784
|
Inventories |
7,168
|
4,458
|
Prepaid expenses and other current assets |
810
|
4,987
|
Total current assets |
43,140
|
46,421
|
Property and equipment, net |
204
|
267
|
Operating lease right-of-use assets |
1,375
|
|
Intangible asset, net |
3,032
|
3,450
|
Other assets |
320
|
268
|
Total assets |
50,884
|
53,219
|
Current liabilities: |
|
|
Acquisition contract liabilities, net |
6,942
|
3,242
|
Operating lease liabilities |
498
|
|
Accrued expenses and other current liabilities |
10,864
|
9,654
|
Total current liabilities |
20,894
|
13,836
|
Long-term liabilities: |
|
|
Acquisition contract liabilities, net |
2,400
|
9,542
|
Warrant liabilities |
2,843
|
12,854
|
Operating lease liabilities, non-current |
848
|
|
Other liabilities |
21
|
5,649
|
Total liabilities |
27,006
|
41,881
|
Commitments and contingencies (see Note 24) |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of December 31, 2022 and 2021 |
|
|
Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,334,950 and 855,237 shares issued and outstanding as of December 31, 2022 and 2021 |
1
|
1
|
Additional paid-in capital |
103,396
|
90,216
|
Accumulated deficit |
(79,519)
|
(78,879)
|
Total stockholders’ equity |
23,878
|
11,338
|
Total liabilities and stockholders’ equity |
50,884
|
53,219
|
Related Party [Member] |
|
|
Current assets: |
|
|
Investment, related party |
10,548
|
|
Other receivables, related party |
3,658
|
8,647
|
Other receivables long term, related party |
2,813
|
2,813
|
Current liabilities: |
|
|
Accounts payable |
1,312
|
282
|
Nonrelated Party [Member] |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 1,278
|
$ 658
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v3.23.3
Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Dec. 31, 2022 |
Dec. 31, 2021 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
15,000,000
|
15,000,000
|
Common stock, shares issued |
1,334,950
|
855,237
|
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1,334,950
|
855,237
|
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v3.23.3
Consolidated Statements of Operations - USD ($) $ in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
Products revenues, net |
$ 28,541
|
$ 24,043
|
Revenues, related party |
133
|
57
|
Total revenues, net |
28,674
|
24,100
|
Operating expenses |
|
|
Restructuring costs |
|
752
|
Change in fair value of contingent consideration |
(3,800)
|
(1,402)
|
Total operating expenses |
47,255
|
49,301
|
Loss from operations |
(18,581)
|
(25,201)
|
Other income (expense) |
|
|
Change in fair value of warrant liabilities |
19,017
|
(12,801)
|
Warrant inducement expense |
(2,629)
|
|
Change in fair value of investment, related party |
1,747
|
|
Interest expense, net |
(195)
|
(344)
|
Other income, net |
33
|
689
|
Total other income (expense) |
17,973
|
(12,456)
|
Loss before income taxes |
(608)
|
(37,657)
|
Income tax expense |
32
|
56
|
Net loss |
$ (640)
|
$ (37,713)
|
Loss per common share: |
|
|
Basic and diluted |
$ (0.61)
|
$ (85.63)
|
Weighted-average common shares outstanding: |
|
|
Basic and diluted |
1,056,988
|
440,412
|
Related Party [Member] |
|
|
Operating expenses |
|
|
Cost of revenues |
$ 14,618
|
$ 12,222
|
Selling, general and administrative |
733
|
697
|
Nonrelated Party [Member] |
|
|
Operating expenses |
|
|
Cost of revenues |
567
|
520
|
Selling, general and administrative |
$ 35,137
|
$ 36,512
|
X |
- DefinitionWarrant inducement cost experience.
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v3.23.3
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2020 |
$ 0
|
$ 46,993
|
$ (41,166)
|
$ 5,828
|
Beginning balance, shares at Dec. 31, 2020 |
400,000
|
|
|
|
Issuance of common stock in exchange for investment, related party |
$ 0
|
14,943
|
|
14,943
|
Issuance of common stock in exchange for investments in equity securities, shares |
180,000
|
|
|
|
Issuance of common stock and warrants under private placement, net of negligible issuance costs |
$ 0
|
2,690
|
|
2,690
|
Issuance of common stock and warrants under private placement, net of issuance costs, shares |
67,500
|
|
|
|
Exercise of common stock warrants |
$ 0
|
13,238
|
|
$ 13,238
|
Exercise of common stock warrants, shares |
132,380
|
|
|
|
Exercise of pre-funded warrants |
$ 0
|
12,223
|
|
$ 12,223
|
Exercise of pre-funded warrants, shares |
75,357
|
|
|
|
Stock-based compensation |
|
129
|
|
129
|
Net loss |
|
|
(37,713)
|
(37,713)
|
Ending balance, value at Dec. 31, 2021 |
$ 1
|
90,216
|
(78,879)
|
11,338
|
Ending balance, shares at Dec. 31, 2021 |
855,237
|
|
|
|
Issuance of common stock in exchange for investment, related party |
$ 0
|
3,683
|
|
3,683
|
Issuance of common stock in exchange for investments in equity securities, shares |
157,402
|
|
|
|
Issuance of common stock and warrants under private placement, net of negligible issuance costs |
$ 0
|
117
|
|
$ 117
|
Issuance of common stock and warrants under private placement, net of issuance costs, shares |
92,500
|
|
|
|
Exercise of common stock warrants, shares |
|
|
|
|
Exercise of pre-funded warrants |
$ 0
|
2,842
|
|
$ 2,842
|
Exercise of pre-funded warrants, shares |
78,450
|
|
|
|
Stock-based compensation |
|
1,852
|
|
1,852
|
Net loss |
|
|
(640)
|
(640)
|
Exercise of PIPE warrants |
$ 0
|
4,686
|
|
4,686
|
Exercise of PIPE warrants, shares |
142,857
|
|
|
|
Issuance of shares for vested restricted stock units |
|
|
|
|
Issuance of shares for vested restricted stock units, shares |
8,504
|
|
|
|
Ending balance, value at Dec. 31, 2022 |
$ 1
|
$ 103,396
|
$ (79,519)
|
$ 23,878
|
Ending balance, shares at Dec. 31, 2022 |
1,334,950
|
|
|
|
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v3.23.3
Consolidated Statements of Cash Flows - USD ($) $ in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Cash Flows From Operating Activities: |
|
|
Net loss |
$ (640)
|
$ (37,713)
|
Adjustments to reconcile net loss to cash flows used in operations |
|
|
Depreciation |
101
|
122
|
Amortization of right-of-use assets |
653
|
|
Amortization of acquired intangible assets |
418
|
418
|
Change in fair value of investment, related party |
(1,747)
|
|
Change in fair value of contingent consideration |
(3,800)
|
(1,402)
|
Change in fair value of warrant liabilities |
(19,017)
|
12,801
|
Warrant inducement expense |
2,629
|
|
Stock-based compensation |
1,852
|
129
|
Provision for inventory obsolescence |
100
|
33
|
Provision for doubtful accounts |
106
|
44
|
Non-cash interest expense |
358
|
358
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(70)
|
(612)
|
Other receivables, related party |
4,990
|
(11,387)
|
Prepaid expenses and other assets |
4,154
|
(3,809)
|
Inventories |
(2,810)
|
2,592
|
Accounts payable and related party payables |
912
|
(773)
|
Operating lease liabilities |
(781)
|
|
Accrued expenses and other liabilities |
(3,607)
|
12,484
|
Cash flows used in operating activities |
(16,199)
|
(26,715)
|
Cash flows from investing activities |
|
|
Purchases of investment, related party |
(5,118)
|
|
Purchases of property and equipment |
(38)
|
(11)
|
Cash flows used in investing activities |
(5,156)
|
(11)
|
Cash flows from financing activities |
|
|
Proceeds from issuance of common stock and warrants upon initial public offering, net of issuance costs |
|
14,943
|
Proceeds from issuance of common stock and warrants in private placement, net of issuance costs |
9,391
|
14,995
|
Proceeds from exercise of warrants |
4,630
|
13,253
|
Cash flows provided by financing activities |
14,021
|
43,191
|
Net (decrease) increase in cash and cash equivalents |
(7,334)
|
16,465
|
Cash, cash equivalents and restricted cash, at the beginning of the year |
24,742
|
8,277
|
Cash, cash equivalents and restricted cash, at the end of the year |
17,408
|
24,742
|
Supplemental disclosure of cash flow information |
|
|
Interest paid |
1
|
2
|
Income tax paid, net |
32
|
56
|
Supplemental non-cash investing and financing activities |
|
|
Conversion of warrant liability to equity in connection with exercise of warrants |
6,840
|
12,208
|
Issuance of common shares in exchange for investment, related party |
3,683
|
|
Addition of right-of-use assets in exchange for operating lease liabilities |
234
|
|
Issuance costs included in accrued expenses and other liabilities |
|
44
|
Non-cash purchase of fixed assets |
|
$ 8
|
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v3.23.3
Organization and Business Overview
|
12 Months Ended |
Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Business Overview |
1.
Organization and Business Overview
Biofrontera
Inc., a Delaware Corporation, (the “Company” or “ Biofrontera”) is a U.S.-based biopharmaceutical company commercializing a portfolio
of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”)
and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are
pre-cancerous skin lesions as well as
impetigo, a bacterial skin infection.
Our principal licensed product is Ameluz®, which is a prescription
drug approved for use in combination with the RhodoLED® lamp series, for PDT (when used together, “Ameluz®
PDT”). In the United States, the PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratoses
of mild-to-moderate severity on the face and scalp. We are currently selling Ameluz® for this indication in the U.S. under
an exclusive license and supply agreement (“Ameluz LSA”) with Biofrontera Pharma (“Pharma”) GmbH and Biofrontera
Bioscience GmbH (together the “Ameluz Licensor”).
Our second prescription drug licensed product is Xepi® (ozenoxacin
cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi®
is known and it has been specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus
aureus or Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. We are currently
selling Xepi® for this indication in the United States under an exclusive license and supply agreement, as amended (“Xepi LSA”)
with Ferrer Internacional S.A. (“Ferrer”) that was assumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea
Life Sciences, Inc.(“Cutanea”). There has been limited revenue during the current reporting periods and recent developments
with the third-party manufacturer that was providing our supply of Xepi® have resulted in further delays of our commercialization
of the product. However, Ferrer is qualifying a new Contract manufacturer, Cambrex, which is expected to begin production early in 2024.
Once the new third-party manufacturer is qualified, we expect the supply of Xepi® will meet our future market demand.
Biofrontera Inc. includes its wholly owned subsidiary Bio-FRI GmbH (“Bio-FRI”), a limited liability company organized
under the laws of Germany. Our
subsidiary, Bio-FRI was formed on February 9, 2022, as a German presence to facilitate our relationship with the Ameluz
Licensor.
Liquidity
and Going Concern
The
Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, and cash
flows from financing transactions. During the year ended December 31, 2022, we received
proceeds of $9.4
million from the issuance of common stock and warrants in a private placement, net of issuance costs, and $4.6
million from the exercise of common stock warrants (See Note 19. Stockholders’ Equity). As of December 31, 2022,
we had cash and cash equivalents of $17.2
million, compared to $24.5
million as of December 31, 2021. Our unaudited estimated ending cash balance at September 30, 2023 was $3.1 million.
Since
we commenced operations in 2015, we have generated significant losses and have incurred net cash outflows from operations of $16.2
million and $26.7
million for the years ended December 31, 2022
and 2021. The Company had an accumulated deficit as of December 31, 2022 of $79.5
million.
The
Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments,
Maruho start-up payments of $7.3 million
(see Note 3. Acquisition Contract Liabilities), and legal settlement expenses after reimbursement from Biofrontera AG (see Note
24, Commitments and Contingencies).
Additionally,
we expect to continue to incur operating losses due to significant discretionary sales and marketing, medical affairs, and dermatology
community outreach efforts as we seek to expand the commercialization of our licensed products in the United States. We also expect to
incur additional expenses to add and improve operational, financial and information systems and personnel, including personnel to support
our product commercialization efforts. In addition, we expect to incur costs to continue to comply with corporate governance, regulatory
reporting and other requirements applicable to us as a public company in the United States.
In connection with
our assessment of going concern considerations under applicable accounting standards, the Company’s management has determined that
substantial doubt exists about our ability to continue as a going concern for at least one year from the date these financial
statements were issued.
The future viability of the Company is dependent
on management’s plans to continue to execute its growth plan and raise additional capital or find alternative methods of financing to fund its
operations until cash flow from operations is sufficient. Management believes that actions presently being taken to obtain additional
funding and implement its strategic plans provide the opportunity for the Company to continue as a going concern. No assurance can be
given that the Company will be successful in these efforts. Accordingly, management has concluded that substantial doubt exists about the company’s ability to continue as a going concern for
a period of at least 12 months from the date of issuance of these financial statements.
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.
The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or
the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. There could be
a material adverse effect on the Company and its financial statements if management’s plans are not achieved on a timely
basis.
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- DefinitionThe entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
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v3.23.3
Summary of Significant Accounting Policies
|
12 Months Ended |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
Basis
for Preparation of the Consolidated Financial Statements
The
accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“GAAP”). These consolidated financial statements include the accounts of our wholly owned
subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The information presented reflects the
application of significant accounting policies described below.
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.
Segment
Reporting
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision-maker in deciding how to allocate resources and assess performance. The Company’s chief operating decision maker
(determined to be the Chief Executive Officer) does not manage any part of the Company separately, and the allocation of resources and
assessment of performance are based on the Company’s operating results.
We
operate in a single reporting segment, the commercialization of pharmaceutical products for the treatment of dermatological conditions
and diseases within the U.S. All business operations focus on the products Ameluz®, including the complementary product
BF-RhodoLED®, and Xepi®. We monitor and manage our business operations across these products collectively
as one reporting segment.
Reverse Stock Split
On July 3, 2023 Biofrontera Inc. effected a 1-for-20
reverse stock split (the “Reverse Stock Split”) of the issued and outstanding shares of the Company’s common stock,
$0.001 par value (the “Common Stock”). The Common Stock began trading on the Nasdaq Capital Market on a post-split basis on
July 5, 2023.
All information included in these consolidated financial
statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock Split as if it had been effective from the beginning
of the earliest period presented, unless otherwise stated. All outstanding securities entitling their holders to purchase shares of Common
Stock or acquire shares of Common Stock, including stock options, restricted stock units, and warrants, were adjusted as a result of the
Reverse Stock Split, as required by the terms of those securities.
Use
of Estimates
The
preparation of the consolidated financial statements in accordance with U.S. 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 valuation allowances for receivables and inventory,
valuation of contingent consideration and warrant liabilities, realization of intangible and other long-lived assets, product sales allowances
and reserves, share-based payments and income taxes including deferred tax assets and liabilities. 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.
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to
be cash equivalents.
The Company maintains its cash balances at financial institutions that
are insured by the Federal Deposit Insurance Corporation (“FDIC”). The FDIC provides coverage of up to $250,000 per depositor,
per financial institution. At December 31, 2022, approximately $16.8 million of the Company’s cash balances were in excess of FDIC
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.
Restricted
Cash
Restricted
cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards, in addition to
one deposit held for a sublease (see Note 13. Statement of Cash Flows Reconciliation).
Investment, Related Party
The
Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities (“ASC
321”). Equity securities, which are comprised of investments in common stock with a readily determinable fair value, are initially
recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and
losses reported in the Company’s consolidated statement of operations. As the fair value of the Company’s investments is
reported in a foreign currency, the change in fair value attributable to changes in foreign exchange rates is included in other income,
net in the consolidated statement of operations.
Accounts
Receivable
Accounts
receivables are reported at their net realizable value. Any value adjustments are booked directly against the relevant receivable. We
have standard payment terms that generally require payment within approximately 30 to 90 days. Management performs ongoing credit evaluations
of its customers. An allowance for potentially uncollectible accounts is provided based on history, economic conditions, and composition
of the accounts receivable aging. In some cases, the Company makes allowances for specific customers based on these and other factors.
Provisions for the allowance for doubtful accounts are recorded in selling, general and administrative expenses in the accompanying statements
of operations.
Concentration
of Credit Risk and Off-Balance Sheet Risk
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, accounts
receivable and other receivables, related party. The Company maintains all of its cash and cash equivalents at a single accredited financial
institution, in amounts that exceed federally insured limits. The Company has no significant off-balance sheet risk such as foreign exchange
contracts, option contracts, or other foreign hedging arrangements.
Concentrations
of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the wide variety of customers
using our products. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond
to changes in their credit profile. We continue to monitor these conditions and assess their possible impact on our business.
Other
receivables, related party consists of a receivable due from Biofrontera AG for its 50% share of a legal settlement and related
costs for which they are jointly and severally liable for the total settlement amount. The Company has a contractual right to
repayment of its share of the settlement payment from Biofrontera AG under the Settlement Allocation Agreement entered into on
December 9, 2021, which provided that the settlement payments would first be made by the Company and then reimbursed by Biofrontera
AG for its share. Although this receivable has credit risk, it is mitigated by the Settlement Allocation Agreement as amended on
March 31, 2022, which provides certain remedies to the Company, if Biofrontera AG fails to make timely reimbursements, which the
Company may implement in its sole discretion, including the ability to charge interest at a rate of 6.0% per annum for each day that
any reimbursement is past due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by
the Company (including amounts owed under the Company’s license and supply agreement for
Ameluz®).
We
are dependent on two suppliers, Biofrontera Pharma GmbH and Ferrer Internacional S.A., to supply drug products, including all underlying
components, for our commercial efforts. These efforts could be adversely affected by a significant interruption in the supply of our
finished products.
Inventories
Finished
goods consist of pharmaceutical products purchased for resale and are stated at the lower of cost or net realizable value. Cost is calculated
by applying the first-in-first-out method (FIFO). Inventory costs include the purchase price of finished goods and freight-in costs.
The Company regularly reviews inventory quantities on hand and writes down to its net realizable value any inventory that it believes
to be impaired. Management considers forecast demand in relation to the inventory on hand, competitiveness of product offerings, market
conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. Once inventory is written
down and a new cost basis is established, it is not written back up if demand increases.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is generally applied straight-line over the estimated
useful life of assets. Leasehold improvements are amortized over the shorter of the asset’s estimated useful life or the lease
term. The estimated useful lives of property and equipment are:
Schedule
of Estimated Useful Lives of Property, Plant and Equipment
| |
Estimated Useful Life in Years |
Computer equipment | |
3 years |
Computer software | |
3 years |
Furniture and fixtures | |
3-5 years |
Leasehold improvements | |
Shorter of estimated useful lives or the term of the lease |
Machinery & equipment | |
3-4 years |
The
cost and accumulated depreciation of assets retired or sold are removed from the respective asset category, and any gain or loss is recognized
in our statements of operations.
Intangible
Assets
Intangible
assets with finite lives are amortized over their estimated useful lives. Intangible assets with indefinite lives are not amortized.
Leases
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU
No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements.
The Company adopted the standard effective January 1, 2022. Using the optional transition method, prior period financial statements have
not been recast to reflect the new lease standard. The adoption of the new lease standard resulted in the addition of an operating lease
right-of-use asset and an operating lease liability in the amount of $1.8 million to the consolidated balance sheet as of January 1,
2022.
At
the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and
circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value
of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable.
As such, the Company utilizes its incremental borrowing rate (“IBR”), which is the rate incurred to borrow on a collateralized
basis over a similar term an amount equal to the lease payments in a similar economic environment. Given
the absence of an outstanding debt agreement, a synthetic credit rating analysis was used in estimating the Company’s IBR. Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for lease liabilities at inception and 8.5% for 2022 lease liabilities. No adjustments to the right-of-use
asset were required for items such as initial direct costs paid or incentives received.
The
Company has elected to adopt the practical expedient provided in ASC 842 and not reassess leases that existed prior to
the commencement date, 1). Whether any expired or existing contracts are or contain leases, 2). Lease classification, or 3).
Initial indirect costs for any existing leases. The Company has elected to combine lease and non-lease components as a single
component for certain asset classes, when applicable. Operating leases are recognized on the balance sheet as operating lease
right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The Company also
elected to utilize the short-term lease recognition exemption and for those leases that qualified, the Company did not recognize
right-of-use assets or lease liabilities. These leases are recognized on a straight-line basis over the expected term.
Impairment
of Long-Lived Assets
The
Company considers whether events or changes in facts and circumstances, both internally and externally, may indicate that an impairment
of long-lived assets held for use, including right-of-use assets, are present. To the extent indicators or impairment exist, the determination
of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition.
In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset, the assets are written
down to their estimated fair values and the loss is recognized in the statements of operations. Refer to Note 12. Intangible Asset, Net.
Contingent
Consideration
Contingent
consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition
date. For contingent consideration, management is responsible for determining the appropriate valuation model and estimated fair value,
and in doing so, considers a number of factors, including information provided by an outside valuation advisor. Contingent consideration
liabilities are reported at their estimated fair values based on probability-adjusted present values of the consideration expected to
be paid, using significant inputs and estimates. Key assumptions used in these estimates include probability assessments with respect
to the likelihood of achieving certain milestones and discount rates consistent with the level of risk of achievement. The fair value
of contingent consideration liabilities are remeasured each reporting period, with changes in the fair value included in current operations.
The remeasured liability amount could be significantly different from the amount at the acquisition date, resulting in material charges
or credits in future reporting periods.
Contingencies
Loss
contingency provisions are recorded if the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable,
and the amount can be reasonably estimated or a range of loss can be determined. These accruals represent management’s best estimate
of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible
that the amount of a loss will exceed the recorded provision. On a quarterly basis, we review the status of each significant matter and
assess its potential financial exposure. Significant judgment is required in both the determination of probability and as to whether
an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information
available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and
litigation and may change our estimates. Legal costs associated with legal proceedings are expensed when incurred.
Derivative
Instruments
The
Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of
the specific terms of the warrants and applicable authoritative guidance in FASB Accounting Standards Codification (“ASC”)
480, Distinguishing Liabilities from Equity (“ASC 480”) and Derivatives and Hedging (“ASC 815”). Warrants
classified as equity are recorded at fair value as of the date of issuance on the Company’s consolidated balance sheets and no
further adjustments to their valuation are made. Warrants classified as derivative liabilities that require separate accounting as liabilities
are recorded on the Company’s consolidated balance sheets at their fair value on the date of issuance and are revalued on each
subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods
recorded as other income or expense. Management estimates the fair value of these liabilities using the Black-Scholes-Merton (“BSM”)
model and assumptions that are based on the individual characteristics of the warrants or instruments on the valuation date, as well
as assumptions for future financings, expected volatility, expected life, yield, and risk-free interest rate.
At
their issuance date in October 2021, the IPO Warrants (see Note 19. Stockholders’ Equity) were
accounted for as equity as these instruments met all of the requirements for equity classification under ASC 815-40.
The
Purchase Warrants issued in connection with the private placement offerings completed on December 1, 2021 and May 16, 2022 as
well as the Inducement Warrants issued on July 26, 2022 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 consolidated statement of operations. Refer to Note 4. Fair Value
Measurements.
Fair
Value Measurements
The
Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs
used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures, or ASC 820, establishes a hierarchy
of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available. Observable inputs are those that market participants would use in pricing the asset
or liability based on market data obtained from sources independent of the Company. Unobservable inputs reflect the Company’s assumptions
about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information
available in the circumstances. The three levels of the fair value hierarchy are described below:
Level
1 – Quoted prices in active markets for identical assets or liabilities.
Level
2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or
indirectly.
Level
3 – Unobservable inputs using estimates or assumptions developed by the Company, which reflect those that a market participant
would use in pricing the asset or liability.
To
the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair
value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for
instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level
of any input that is significant to the fair value measurement.
Fair
Value of Financial Instruments
The
carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other receivables,
accounts payable and start-up cost financing included in acquisition contract liabilities
approximate their fair values, due to their short-term nature.
Revenue
Recognition
The
Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue
is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the
Company expects to be entitled in exchange for those goods or services. We recognize revenue when the customer obtains control of our
product, which occurs at a point in time, typically upon delivery to the customer.
To
determine revenue recognition, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance
obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction
price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We
only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods
or services we transfer to the customer is determined to be probable.
The
Company realizes its revenue primarily through the sales of its Ameluz® product which are made directly
to physicians, hospitals or other qualified healthcare providers. Sales are recognized, net of sales deductions, when ownership and control
are transferred to the customer, which is generally upon delivery. Sales deductions include expected trade discounts and allowances,
product returns, and government rebates. These discounts and allowances are estimated at the time of sale based on the amounts incurred
or expected to be received for the related sales.
Xepi®
is sold directly to specialty pharmacies. Sales are recognized net of sales deductions when ownership and control are transferred
to the customer, which is generally upon delivery. Sales deductions include expected returns, discounts and incentives such as payments
made under patient assistance programs. These rebates are estimated at the time of sale based on the amounts incurred or expected to
be received for the related sales.
The
payment terms for sales of our pharmaceutical products are generally short-term payment terms with the possibility of volume-based
discounts, co-pay assistance discounts, or other rebates.
BF
RhodoLED® is also sold directly to physicians, hospitals or other qualified healthcare providers through (i) direct sales
or (ii) an evaluation period up to six-month for a fee, after which a customer can decide to purchase or return the lamp. For direct
sales, revenue is recognized only after complete installation has taken place. As directed by the instruction manual, the lamp may only
be used by the customer once it has been professionally installed. A final decision to purchase the lamps that are within the evaluation
period does not need to be made until the end of the evaluation period. Lamps that are not returned at the end of the evaluation period
are converted into sales in accordance with the contract terms. The Company generates immaterial revenues from the monthly fees during
the evaluation period and from the sale of lamps at the end of the evaluation period.
Variable
Consideration
Revenues
from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which
sales reserves are established and which result from discounts, rebates and other incentives that are offered within contracts between
the Company and its customers. Components of variable consideration include trade discounts and allowances, product returns, government
rebates, and other incentives such as patient co-pay assistance. Variable consideration is recorded on the balance sheet as either a
reduction of accounts receivable, if expected to be claimed by a customer, or as a current liability, if expected to be payable to a
third party other than a customer. Where appropriate, these estimates take into consideration relevant factors such as the Company’s
historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted
customer buying and payment patterns. These reserves reflect the Company’s best estimates of the amount of consideration to which
it is entitled based on the terms of the contract. Actual amounts of consideration ultimately received may differ from the Company’s
estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, and record
any necessary adjustments in the period such variances become known.
Trade
Discounts and Allowances – The Company provides customers with trade discounts, rebates, allowances and/or other incentives.
The Company records estimates for these items as a reduction of revenue in the same period the revenue is recognized.
Government
and Payor Rebates – The Company contracts with, or is subject to arrangements with, certain third-party payors, including pharmacy
benefit managers and government agencies, for the payment of rebates with respect to utilization of its commercial products. The Company
is also subject to discount and rebate obligations under state and federal Medicaid programs and Medicare. The Company records estimates
for these discounts and rebates as a reduction of revenue in the same period the revenue is recognized.
Other
Incentives – The Company maintains a co-pay assistance program which is intended to provide financial assistance to qualified
patients with the cost of purchasing Xepi®. The Company estimates and records accruals for these incentives as a reduction
of revenue in the period the revenue is recognized. The Company estimates amounts for co-pay assistance based upon the number of claims
and the cost per claim that the Company expects to receive associated with products sold to customers but remaining in the distribution
channel at the end of each reporting period.
Royalties
For
arrangements that include sales-based royalties, the Company recognizes royalty expense at the later of (i) when the related sales occur,
or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Royalty expense is recognized as cost of revenues.
Product
Warranty
The
Company generally provides a 36-month warranty for sales of BF-RhodoLED® for which estimated contractual warranty obligations
are recorded as an expense at the time of installation. Customers do not have the option to purchase the warranty separately and the
warranty does not provide the customer with a service beyond the assurance that BF-RhodoLED® complies with agreed-upon
specifications. Therefore, the warranty is not considered to be a performance obligation. The lamps are subject to regulatory and quality
standards. Future warranty costs are estimated based on historical product performance rates and related costs to repair given products.
The accounting estimate related to product warranty expense involves judgment in determining future estimated warranty costs. Should
actual performance rates or repair costs differ from estimates, revisions to the estimated warranty liability would be required. Warranty
expenses incurred in 2022 and 2021 were negligible and are recognized as selling, general and administrative expenses.
Contract
Costs
Incremental
costs of obtaining a contract with a customer may be recorded as an asset if the costs are expected to be recovered. As a practical expedient,
we recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that we
otherwise would have recognized is one year or less. Sales commissions earned by the Company’s sales force are considered incremental
costs of obtaining a contract. To date, we have expensed sales commissions as these costs are generally attributed to periods shorter
than one year. Sales commissions are included in selling, general and administrative expenses.
Cost
of Revenues
Cost
of revenues is comprised of purchase costs of our products, third party logistics and distribution costs including packaging, freight,
transportation, shipping and handling costs, and inventory adjustment due to expiring products, as well as sales-based royalties. Logistics
and distribution costs totaled $0.5 million and $0.4 million for the years ended December 31, 2022 and 2021, respectively.
Share-Based
Compensation
The
Company measures and recognizes share-based compensation expense for equity awards based on fair value at the grant date. The Company
uses the Black-Scholes-Merton (“BSM”) option pricing model to calculate fair value of its stock option grants. The compensation
cost for restricted stock awards is based on the closing price of the Company’s common stock on the date of grant. Share-based
compensation expense recognized in the statements of operations is based on the period the services are performed and recognized as compensation
expense on a straight-line basis over the requisite service period. The Company accounts for forfeitures as they occur.
The
BSM option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility
of the value of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties
and the application of management’s judgment. If factors change and different assumptions are used, the share-based compensation
expense could be materially different in the future. These assumptions are estimated as follows:
Risk-Free
Interest Rate. The risk-free rate is based on the interest rate payable on United States Treasury securities in effect at the time of
grant for a period that is commensurate with the assumed expected term.
Expected
Volatility. The Company based the volatility assumption on a weighted average of the peer group re-levered equity volatility with 80%
weight and the warrant implied volatility with 20% weight. The peer group was developed based on companies in the biotechnology industry
whose shares are publicly traded. Due to our limited historical data and the long-term nature of the awards, the peer group volatility
was more heavily weighted.
Expected
Term. The expected term represents the period of time that options are expected to be outstanding. Due to the lack of historical exercise
data and given the plain vanilla nature of the options granted by the Company, the expected term is determined using the “simplified”
method, as prescribed in SEC Staff Accounting Bulletin (“SAB”) No. 107 (“SAB 107”), whereby the expected life
equals the average of the vesting term and the original contractual term.
Dividend
Yield. The dividend yield is 0% as the Company has never declared or paid, and for the foreseeable future does not expect to declare
or pay, a dividend on its common stock.
Foreign
Currency Transactions
Transactions
realized in currencies other than USD are reported using the exchange rate on the date of the transaction.
Selling,
General and Administrative Expense
Selling,
general and administrative expenses are primarily comprised of compensation and benefits 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, advertising, and other commercial costs to support the commercial operation of
our product and professional fees for legal, consulting, and other general and administrative costs.
Advertising
costs are expensed as incurred. For the years ended December 31, 2022 and 2021, advertising costs totaled $0.1 million and $0.5 million,
respectively.
Income
Taxes
The
Company accounts for income taxes using the asset and liability method in accordance with ASC 740, Income Taxes, which requires
the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in
the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial
reporting and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected
to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood
that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available
evidence, that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is
established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future
taxable profits expected and considering prudent and feasible tax planning strategies.
The
Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the
amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained
upon external examination by the taxing authorities. If the tax position is deemed more likely-than-not to be sustained, the tax position
is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized
is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes
includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related
net interest and penalties.
Net
Loss per Share
Basic
and diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted
average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing
the Company’s net income attributable to common stockholders by the weighted average number of common shares outstanding
and the impact of all dilutive potential common shares outstanding during the period, including stock options, restricted stock units,
and warrants, using the treasury stock method.
Recently
Issued Accounting Pronouncements
In
September 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard was
effective for us on January 1, 2023, and did not have a material effect on our consolidated financial statements.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.3
Acquisition Contract Liabilities
|
12 Months Ended |
Dec. 31, 2022 |
Business Combination and Asset Acquisition [Abstract] |
|
Acquisition Contract Liabilities |
3.
Acquisition Contract Liabilities
On
March 25, 2019, we entered into an agreement (as amended, the “Share Purchase Agreement”) with Maruho Co, Ltd. (“Maruho”)
to acquire 100% of the shares of Cutanea Life Sciences, Inc. (“Cutanea”). As of the date of the acquisition, Maruho Co, Ltd.
Owned approximately 29.9% of Biofrontera AG through its fully owned subsidiary Maruho Deutschland GmbH. Biofrontera AG is our former
parent, and currently a significant shareholder.
Pursuant
to the Share Purchase Agreement, Maruho agreed to provide $7.3 million in start-up cost financing for Cutanea’s redesigned business
activities (“start-up costs”). These start-up costs are to be paid back to Maruho by the end of 2023 in accordance with contractual
obligations related to an earn-out arrangement. In addition, as part of the earn-out arrangement with Maruho, the product profit amount
from the sale of Cutanea products as defined in the share purchase agreement will be shared equally between Maruho and Biofrontera until
2030 (“contingent consideration”).
In
connection with this acquisition in 2019, we recorded the $7.3
million in start-up cost financing (See Note 24, Commitments and Contingencies-
Cutanea payments), a $1.7
million contract asset related to the benefit associated with the non-interest bearing start-up cost financing and $6.5
million of contingent consideration related to the estimated profits from the sale of Cutanea products to be shared equally with
Maruho.
The
contract asset related to the start-up cost financing is amortized on a straight-line basis using a 6.0% interest rate over the 57-month
term of the financing arrangement, which ends on December 31, 2023. The contract asset is shown net of the related start-up cost financing
within acquisition contract liabilities, net.
The
contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of
6.0% over the applicable term. The contingent consideration is recorded within acquisition contract liabilities, net. The amount of contingent
consideration that could be payable is not subject to a cap under the agreement. The Company re-measures contingent consideration and
re-assesses the underlying assumptions and estimates at each reporting period utilizing a scenario-based method.
Acquisition
contract liabilities, net consist of the following:
Schedule of Acquisition Contract Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Short-term acquisition contract liabilities: | |
| | | |
| | |
Start-up cost financing | |
| 7,300 | | |
| 3,600 | |
Contract asset | |
| (358 | ) | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 6,942 | | |
$ | 3,242 | |
| |
| | | |
| | |
Long-term acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,400 | | |
$ | 6,200 | |
Start-up cost financing | |
| - | | |
| 3,700 | |
Contract asset | |
| - | | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 2,400 | | |
$ | 9,542 | |
| |
| | | |
| | |
Total acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,400 | | |
$ | 6,200 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (358 | ) | |
| (716 | ) |
Total acquisition contract liabilities, net | |
$ | 9,342 | | |
$ | 12,784 | |
|
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v3.23.3
Fair Value Measurements
|
12 Months Ended |
Dec. 31, 2022 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
4.
Fair Value Measurements
The
following table presents information about the Company’s assets that are measured at fair value on a recurring basis and indicates
the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
Schedule
of Fair Value Hierarchy Valuation Inputs
(in thousands) | |
Level | | |
December 31, 2022 | | |
December 31, 2021 | |
| |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | |
Investment, related party | |
| 1 | | |
$ | 10,548 | | |
$ | - | |
Liabilities: | |
| | | |
| | | |
| | |
Contingent Consideration | |
| 3 | | |
$ | 2,400 | | |
$ | 6,200 | |
Warrant liability – 2021 Purchase Warrants | |
| 3 | | |
$ | - | | |
$ | 12,854 | |
Warrant liability – 2022 Purchase Warrants | |
| 3 | | |
$ | 1,129 | | |
$ | - | |
Warrant liability - Purchase Warrants | |
| 3 | | |
$ | 1,129 | | |
$ | - | |
Warrant liability – 2022 Inducement Warrants | |
| 3 | | |
$ | 1,714 | | |
$ | - | |
Warrant liability | |
| 3 | | |
$ | 1,714 | | |
$ | - | |
Investment, related party
As
of December 31, 2022, the Company had investments in common stock of Biofrontera AG, a significant shareholder. The fair value of these investments was determined with Level 1
inputs through references to quoted market prices. See Notes 6 and 17.
Contingent
Consideration
Contingent
consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected
at fair value within acquisition contract liabilities, net on the consolidated balance sheets. The fair value is based on significant
inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent
consideration utilizes a scenario-based method under which a set of payoffs are calculated using the term of the earnout, projections,
and an appropriate metric risk premium. These payoffs are then discounted back from the payment date to the valuation date using a payment
discount rate. Finally, the discounted payments are summed together to arrive at the value of the contingent consideration. The scenario-based
method incorporates the following key assumptions: (i) the forecasted product profit amounts, (ii) the remaining contractual term, (iii)
a metric risk premium, and (iv) a payment discount rate. The Company re-measures contingent consideration and re-assesses the underlying
assumptions and estimates at each reporting period.
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule of Fair Value of Contingent Consideration
(in thousands) | |
| |
Balance at December 31, 2020 | |
$ | 7,602 | |
Change in fair value of contingent consideration | |
| (1,402 | ) |
Balance at December 31, 2021 | |
$ | 6,200 | |
Change in fair value of contingent consideration | |
| (3,800 | ) |
Balance at December 31, 2022 | |
$ | 2,400 | |
The decrease in fair value of the contingent consideration
in the amount of $(3.8) million and $(1.4) million during the years ended December 31, 2022 and 2021 was recorded in operating expenses
in the statements of operations.
Warrant
Liabilities
The
Purchase and Inducement Warrants were accounted for as liabilities in accordance with ASC 815-40 and are presented
within warrant liabilities in the accompanying consolidated balance sheets. 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.
Given the nominal strike price of
$0.001, the fair value of the Pre-funded Warrant was deemed to be equal to the market price of the underlying common stock at issuance
and at each reporting period and is considered a level 2 liability. The Pre-funded Warrant was issued and exercised within
the same year and therefore is not reflected in the ending balance.
The
Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Purchase and Inducement Warrants which is
considered a Level 3 fair value measurement. Certain inputs utilized in our Black-Scholes pricing 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 consolidated statement of operations.
The
fair value at issuance was estimated using a Black-Scholes pricing model based on the following assumptions at December 1, 2021 for
the 2021 Purchase Warrants, May 16, 2022 for the Purchase Warrants and July 26, 2022 for the Inducement Warrants:
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions
|
|
2021 Purchase | |
|
Purchase | | |
Inducement | |
Stock price |
|
$ |
86.60 | |
|
$ | 52.40 | | |
$ | 32.80 | |
Expiration term (in years) |
|
|
5 | |
|
| 5.50 | | |
| 4.34 | |
Volatility |
|
|
60.0 | % |
|
| 65.0 | % | |
| 70.0 | % |
Risk-free Rate |
|
|
1.15 | % |
|
| 2.83 | % | |
| 2.84 | % |
Dividend yield |
|
|
0.0 | % |
|
| 0.0 | % | |
| 0.0 | % |
The fair value was estimated using Black-Scholes pricing
model based on the following assumptions as of December 31, 2021:
|
|
2021 Purchase |
|
Stock price |
|
$ |
150.40 |
|
Expiration term (in years) |
|
|
4.92 |
|
Volatility |
|
|
60.0 |
% |
Risk-free Rate |
|
|
1.25 |
% |
Dividend yield |
|
|
0.0 |
% |
The
fair value was estimated using Black-Scholes pricing model based on the following assumptions as of December 31, 2022 (outstanding warrants were all issued during 2022):
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 18.40 | | |
$ | 18.40 | |
Expiration term (in years) | |
| 4.88 | | |
| 3.92 | |
Volatility | |
| 70 | % | |
| 75 | % |
Risk-free Rate | |
| 3.96 | % | |
| 4.07 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
The
following table presents the changes in the warrant liabilities measured at fair value (in thousands):
Schedule
of Changes in Fair Value Warrant Liabilities
| |
December 31, 2022 | |
|
December 31, 2021 | |
Fair value at beginning of year | |
$ | 12,854 | |
|
$ | - | |
Issuance of new warrants | |
| 13,217 | |
|
| 12,261 | |
Exercise of warrants | |
| (6,840 | ) |
|
| (12,208 | ) |
Change in fair value of warrant liability | |
| (19,017 | ) |
|
| 12,801 | |
Warrant inducement expense | |
| 2,629 | |
|
| - | |
Fair value at end of year | |
$ | 2,843 | |
|
| 12,854 | |
|
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v3.23.3
Revenue
|
12 Months Ended |
Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] |
|
Revenue |
5.
Revenue
We
generate revenue primarily through the sales of our products Ameluz®, BF-RhodoLED® lamps and Xepi®.
Revenue from the sales of our BF-RhodoLED® lamp and Xepi® are relatively insignificant compared with the
revenues generated through our sales of Ameluz®.
Related
party revenue relates to an agreement with Biofrontera Bioscience GmbH (“Bioscience”) for BF-RhodoLED® leasing
and installation service. Refer to Note 17, Related Party Transactions.
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule
of Revenue Allowance and Accrual Activities
| |
| | |
Co-pay | | |
Prompt | | |
Government | | |
| |
| |
| | |
assistance | | |
pay | | |
and payor | | |
| |
(in thousands): | |
Returns | | |
program | | |
discounts | | |
rebates | | |
Total | |
Balance at December 31, 2020 | |
$ | 217 | | |
$ | 52 | | |
$ | 15 | | |
$ | 43 | | |
$ | 327 | |
Provision related to current period sales | |
| 6 | | |
| 423 | | |
| 40 | | |
| 168 | | |
| 637 | |
Credit or payments made during the period | |
| (180 | ) | |
| (374 | ) | |
| (7 | ) | |
| (157 | ) | |
| (718 | ) |
Balance at December 31, 2021 | |
$ | 43 | | |
$ | 101 | | |
$ | 48 | | |
$ | 54 | | |
$ | 246 | |
Provision related to current period sales | |
| 10 | | |
| 574 | | |
| 19 | | |
| 210 | | |
| 813 | |
Credit or payments made during the period | |
| (5 | ) | |
| (666 | ) | |
| (62 | ) | |
| (244 | ) | |
| (977 | ) |
Balance at December 31, 2022 | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
|
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v3.23.3
Investment,
|
12 Months Ended |
Dec. 31, 2022 |
Investments, All Other Investments [Abstract] |
|
Investment, |
6.
Investment, Related
Party
On
October 25, 2022, the Company entered into private exchange agreements with certain holders of options to acquire common shares,
nominal value €1.00 per
share, of Biofrontera AG (“AG Options), a German stock corporation and significant shareholder of the Company, pursuant to
which the parties agreed to a negotiated private exchange of 157,042 shares
of the Company’s common stock in exchange for the AG Options. There was no additional cost to exercise the AG Options. On
November 8, 2022, the Company exercised the AG options in full to acquire 2,623,365 shares
of Biofrontera AG. In addition, the Company purchased an additional 3,843,581 common
shares of Biofrontera AG for a total of 6,446,946 shares
or approximately 10%
of Biofrontera AG’s outstanding common shares as of December 31, 2022. These shares were not fully in our control to
vote or dispose of as they were note held in a brokerage account registered in our name, however, we are currently engaged with
advisors to transfer such share to our brokerage account.
Equity securities gains and losses include unrealized gains and losses from changes in fair
values during the period on equity securities we still own, as well as gains and losses on securities we sold during the period.
There were no proceeds from sales of equity securities during the twelve months ended December 31, 2022.
|
X |
- DefinitionThe entire disclosure for investment.
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v3.23.3
Accounts Receivable, net
|
12 Months Ended |
Dec. 31, 2022 |
Credit Loss [Abstract] |
|
Accounts Receivable, net |
7.
Accounts Receivable, net
Accounts
receivable are mainly attributable to the sale of Ameluz®, the BF-RhodoLED® and Xepi®. It
is expected that all trade receivables will be settled within twelve months of the balance sheet date.
The
allowance for doubtful accounts was $0.1 million and negligible as of December 31, 2022 and 2021, respectively.
|
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- DefinitionThe entire disclosure for accounts receivable, contract receivable, receivable held-for-sale, and nontrade receivable.
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v3.23.3
Other Receivables, Related Party
|
12 Months Ended |
Dec. 31, 2022 |
Receivables [Abstract] |
|
Other Receivables, Related Party |
8.
Other Receivables, Related Party
As
of December 31, 2022, the Company has a receivable of $6.5 million
($3.7 short
term and $2.8 long-term)
due from the Biofrontera Group of which $6.4 million
is due from Biofrontera AG for its 50%
share of the balance of a legal settlement for which both parties are jointly and severally liable (refer to Note 24 Commitments and Contingencies). The Company’s receivable balance from Biofrontera AG related to the legal settlement as of December 31, 2021
was $11.3 million, with $2.8 million in long-term. The Company has a contractual
right to repayment of its share of the settlement payments, plus interest and other miscellaneous settlement costs, from Biofrontera
AG under the Settlement Allocation Agreement entered into on December 9, 2021 and as amended on March 31, 2022, which provides that
the settlement payments would first be made by the Company and then reimbursed by Biofrontera AG for its share. The March 31, 2022
Amended Settlement Allocation Agreement provides certain remedies to the Company, if
Biofrontera AG fails to make timely reimbursements, which the Company may implement in its sole discretion, including the ability to
charge interest at a rate of 6.0%
per annum for each day that any reimbursement is past due and the ability to offset any overdue reimbursement amounts against
payments owed to Biofrontera AG by the Company (including amounts owed under the Company’s license and supply agreement for
Ameluz®). As
such, no reserve for the receivable was deemed necessary as of December 31, 2022 or
December 31, 2021.
|
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v3.23.3
Inventories
|
12 Months Ended |
Dec. 31, 2022 |
Inventory Disclosure [Abstract] |
|
Inventories |
9.
Inventories
Inventories
are comprised of Ameluz®, Xepi® and the BF-RhodoLED® finished products.
The provision related to BF-RhodoLED® devices was $0.1
million for the year ended December 31, 2022,
and negligible for the year ended December 31, 2021. The provision for Xepi® inventory obsolescence was negligible for
the year ended December 31, 2022 and $0.3 million for the year ended December 31, 2021. There was no provision relating to Ameluz in either year.
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- DefinitionThe entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory.
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v3.23.3
Prepaid Expenses and Other Current Assets
|
12 Months Ended |
Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets |
|
Prepaid Expenses and Other Current Assets |
10.
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Receivable for common stock warrants proceeds | |
$ | - | | |
$ | 3,258 | |
Prepaid expenses | |
| 439 | | |
$ | 824 | |
Security deposits | |
| 85 | | |
| 149 | |
Other | |
| 286 | | |
| 756 | |
Total | |
$ | 810 | | |
$ | 4,987 | |
|
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v3.23.3
Property and Equipment, Net
|
12 Months Ended |
Dec. 31, 2022 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
11.
Property and Equipment, Net
Property
and equipment, net consists of the following:
Schedule of Property and Equipment
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Computer equipment | |
$ | 89 | | |
$ | 85 | |
Computer software | |
| 27 | | |
| 27 | |
Furniture & fixtures | |
| 81 | | |
| 81 | |
Leasehold improvement | |
| 368 | | |
| 368 | |
Machinery & equipment | |
| 146 | | |
| 112 | |
Property and equipment, gross | |
| 711 | | |
| 673 | |
Less: Accumulated depreciation | |
| (507 | ) | |
| (406 | ) |
Property and equipment, net | |
$ | 204 | | |
$ | 267 | |
Depreciation
expense was $0.1 million for each of the years ended December 31, 2022, and 2021, respectively, which was included in selling, general
and administrative expense on the consolidated statements of operations.
|
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.3
Intangible Asset, Net
|
12 Months Ended |
Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Asset, Net |
12.
Intangible Asset, Net
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Xepi® license | |
$ | 4,600 | | |
$ | 4,600 | |
Less: Accumulated amortization | |
| (1,568 | ) | |
| (1,150 | ) |
Intangible asset, net | |
$ | 3,032 | | |
$ | 3,450 | |
The
Xepi® license intangible asset was recorded at acquisition-date fair value of $4.6
million and is amortized on a straight-line basis
over the useful life of 11
years. Amortization expense was $0.4
million for each the years ended December 31,
2022 and 2021.
We
review the Xepi® license intangible asset for impairment whenever events or changes in circumstances indicate that the
carrying amount of the assets may not be fully recoverable. In October 2022, upon receiving notification of third-party manufacturing
delays that impacted the timing of sales expansion and improved market positioning of the Xepi® product, we deemed it
necessary to assess the recoverability of our Xepi® asset group. Future cash flows were estimated over the expected remaining
useful life of the asset group and, on an undiscounted basis, the expected cash flows exceeded the carrying amount of
the asset group.
|
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v3.23.3
Statement of Cash Flows Reconciliation
|
12 Months Ended |
Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] |
|
Statement of Cash Flows Reconciliation |
13.
Statement of Cash Flows Reconciliation
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Cash and cash equivalents | |
$ | 17,208 | | |
$ | 24,545 | |
Short-term restricted cash | |
| - | | |
| 47 | |
Long-term restricted cash | |
| 200 | | |
| 150 | |
Total cash and cash equivalent, and restricted cash shown on the statements of
cash flows | |
$ | 17,408 | | |
$ | 24,742 | |
Short-term and long-term restricted cash were recorded
in prepaid expenses and other current assets, and other assets, respectively, in the consolidated balance sheet.
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- DefinitionThe entire disclosure for cash and cash equivalent footnotes, which may include the types of deposits and money market instruments, applicable carrying amounts, restricted amounts and compensating balance arrangements. Cash and equivalents include: (1) currency on hand (2) demand deposits with banks or financial institutions (3) other kinds of accounts that have the general characteristics of demand deposits (4) short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Generally, only investments maturing within three months from the date of acquisition qualify.
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v3.23.3
Accrued Expenses and Other Current Liabilities
|
12 Months Ended |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
14.
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Legal settlement (See Note 24) | |
$ | 6,207 | | |
$ | 5,625 | |
Employee compensation and benefits | |
| 2,850 | | |
| 2,384 | |
Professional fees | |
| 1,353 | | |
| 570 | |
Product revenue allowances and reserves | |
| 82 | | |
| 246 | |
Other | |
| 372 | | |
| 829 | |
Total | |
$ | 10,864 | | |
$ | 9,654 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.23.3
Other Long-Term Liabilities
|
12 Months Ended |
Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] |
|
Other Long-Term Liabilities |
15.
Other Long-Term Liabilities
Other
long-term liabilities consist of the following:
Schedule of Other Long Term Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Legal settlement – noncurrent (See Note 24) | |
$ | - | | |
$ | 5,625 | |
Other | |
| 21 | | |
| 24 | |
Total | |
$ | 21 | | |
$ | 5,649 | |
|
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v3.23.3
Income Taxes
|
12 Months Ended |
Dec. 31, 2022 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
16.
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
for the years ended December 31, 2022 and December 31, 2021. Income tax expense incurred in 2022 and 2021 relates to state income taxes.
At December 31, 2022 and December 31, 2021, the Company had no unrecognized tax benefits.
A
reconciliation of the expected income tax (benefit) computed using the federal statutory income tax rate to the Company’s effective
income tax rate is as follows:
Schedule of Effective Income Tax Rate Reconciliation
| |
2022 | | |
2021 | |
| |
Year ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Income tax computed at federal statutory tax rate | |
| 21.00 | % | |
| 21.00 | % |
State taxes | |
| (5.85 | )% | |
| (0.09 | )% |
Permanent differences – non-deductible expenses | |
| (37.93 | )% | |
| (1.03 | )% |
Change in fair value of contingent consideration | |
| 133.62 | % | |
| 0.78 | % |
Change in fair value of warrant liabilities | |
| 576.27 | % | |
| (7.13 | )% |
True-ups | |
| (7.42 | )% | |
| - | |
Change in valuation allowance | |
| (685.54 | )% | |
| (13.62 | )% |
Effective income tax rate | |
| (5.85 | )% | |
| (0.09 | )% |
The
principal components of the Company’s deferred tax assets and liabilities consist of the following at December 31, 2022 and 2021:
Schedule
of Deferred Tax Assets and Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Deferred tax assets (liabilities): | |
| | | |
| | |
Net operating loss carryforwards | |
$ | 30,450 | | |
$ | 24,307 | |
Intangible assets | |
| 4,824 | | |
| 5,132 | |
Acquisition contract liabilities | |
| (96 | ) | |
| (187 | ) |
Property and equipment | |
| 123 | | |
| 103 | |
Accrued expenses and reserves | |
| 890 | | |
| 1,693 | |
Stock based compensation | |
| 449 | | |
| - | |
Lease liability | |
| 361 | | |
| - | |
Other | |
| - | | |
| 6 | |
ROU asset | |
| (369 | ) | |
| - | |
Investment revaluation | |
| (469 | ) | |
| - | |
Total deferred tax assets | |
| 36,163 | | |
| 31,054 | |
Less valuation allowance | |
| (36,163 | ) | |
| (31,054 | ) |
Net deferred taxes | |
$ | - | | |
$ | - | |
The
Company has had no federal income tax expense due to operating losses incurred since inception. The Company has evaluated the positive
and negative evidence bearing upon the realizability of its deferred tax assets. Based on this, the Company has provided a valuation
allowance for the full amount of the net deferred tax assets as the realization of the deferred tax assets is not determined to be more
likely than not. During 2022, the valuation allowance increased by $5.1
million, primarily due to the increase in the
Company’s net operating loss carryforwards during the period.
As
of December 31, 2022, the Company had approximately $123.4 million and $89.2 million of Federal and state net operating loss carryforwards,
respectively. $113.8 million of the federal NOLs are not subject to expiration and the remaining NOLs begin to expire in 2036. These
loss carryforwards are available to reduce future federal taxable income, if any. These loss carryforwards are subject to review and
possible adjustment by the appropriate taxing authorities. The amount of loss carryforwards that may be utilized in any future period
may be limited based upon changes in the ownership of the Company’s shareholders.
The
Company follows the provisions of ASC 740-10, “Accounting for Uncertainty in Income Taxes,” which specifies how tax benefits
for uncertain tax positions are to be recognized, measured, and recorded in financial statements; requires certain disclosures of uncertain
tax matters; specifies how reserves for uncertain tax positions should be classified on the balance sheet; and provides transition and
interim period guidance, among other provisions. As of December 31, 2022, the Company has not recorded any amounts for uncertain tax
positions. The Company’s policy is to recognize interest and penalties accrued on any uncertain tax positions as a component of
income tax expense, if any, in its statements of operations. As of December 31, 2022 the Company had no reserves for uncertain tax positions.
For the year ended December 31, 2022 no estimated interest or penalties were recognized on uncertain tax positions.
The
Company’s tax returns 2019 through 2022 remain open and subject to examination by the Internal Revenue Service and state taxing
authorities. Net operating loss carryovers from earlier years are also subject to exam and adjustment.
|
X |
- DefinitionThe entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.
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v3.23.3
Related Party Transactions
|
12 Months Ended |
Dec. 31, 2022 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
17.
Related Party Transactions
License
and Supply Agreement
On October 8, 2021, we entered into an amendment to
the Ameluz LSA under which the price we pay per unit will be based upon our sales history. As a result of this amendment, the purchase
price we pay the Ameluz Licensor for Ameluz® will be determined in the following manner:
● |
fifty percent of the anticipated net price per unit until we generate $30 million in revenue from sales of the products we license from the Ameluz Licensor during a given Commercial Year (as defined in the Ameluz LSA); |
|
|
● |
forty percent of the anticipated net price per unit for all revenues we generate between $30 million and $50 million from sales of the products we license from the Ameluz Licensor; and |
|
|
● |
thirty percent of the anticipated net price per unit for all revenues we generate above $50 million from sales of the products we license from the Ameluz Licensor. |
Under the agreement, the Company obtained an exclusive,
non-transferable license to use Pharma’s technology to market and sell the licensed products, Ameluz® and BF-RhodoLED®
and must purchase the licensed products exclusively from Pharma. There was no consideration paid for the transfer of the license.
Purchases
of the licensed products from Pharma during the years ended December 31, 2022 and 2021 were $16.6
million and $9.4
million, respectively, and recorded in inventories in the consolidated balance sheets, and, when sold, in cost of revenues, related
party in the consolidated statements of operations. Amounts due and payable to Pharma as of December 31, 2022 and 2021 were $1.3
million and $0.3
million, respectively, which were recorded in accounts payable, related parties in the consolidated balance sheets.
Service
Agreements
In
December 2021, we entered into an Amended and Restated Master Contract Services Agreement, or “Services Agreement”, which
provides for the execution of statements of work that will replace the applicable provisions of our previous intercompany services agreement
dated January 1, 2016, or 2016 Services Agreement, by and among us, Biofrontera AG, Biofrontera Pharma and Biofrontera Bioscience, enabling
us to continue to use the IT resources of Biofrontera AG and its wholly owned subsidiaries (the “Biofrontera Group”) as well
as providing access to the Biofrontera Group’s resources with respect to quality management, regulatory affairs and medical affairs.
We currently have statements of work in place regarding IT, regulatory affairs, medical affairs, pharmacovigilance, and investor relations
services, and are continuously assessing the other services historically provided to us by Biofrontera AG to determine 1) if they will
be needed, and 2) whether they can or should be obtained from other third-party providers. Expenses related to the service agreement
were $0.7 million and $0.7 million for the years ended December 31, 2022 and 2021, which were recorded in selling, general and administrative,
related party. Amounts due to Biofrontera AG related to the service agreement were $0.2 million as of December
31, 2022 and 2021, which were recorded in accounts payable, related parties in the consolidated balance sheets.
Clinical
Lamp Lease Agreement
On
August 1, 2018, the Company executed a clinical lamp lease agreement with Biofrontera Bioscience GmbH (“Bioscience”) to provide
lamps and associated services.
Total
revenue related to the clinical lamp lease agreements was approximately $0.1 million for each of the years ended December 31, 2022 and
2021 and recorded as revenues, related party. Amounts due from Bioscience for clinical lamp and other reimbursements were approximately
$0.1 million for each of the years ended December 31, 2022 and 2021, which were recorded as accounts receivable, related party in the
consolidated balance sheets.
Reimbursements
from Maruho Related to Cutanea Acquisition
Pursuant
to the Cutanea acquisition share purchase agreement, we received start-up cost financing and reimbursements for certain costs. These
restructuring costs Maruho agreed to pay are referred to as “SPA costs” under the arrangement and are to be accounted
for as other income. There were no amounts
reimbursed relating to SPA costs for the year ended December 31, 2022. For the year ended December 31, 2021 the amounts reimbursed
relating to SPA costs were $0.5 million
and were recorded as other income in the consolidated statements of operations as the related expenses were incurred. There were no amounts
due from Maruho for the year ended December 31, 2022. The amounts due from Maruho, primarily relating to SPA cost reimbursements,
were $0.1 million
as of December 31, 2021 and were recorded in other receivables, related parties in the consolidated balance sheets.
Others
The
Company has recorded a receivable of $6.4
million and $11.3
million as of December 31, 2022 and December
31, 2021 due from Biofrontera AG for its 50%
share of the balance of a legal settlement for which both parties are jointly and severally liable as of December 31, 2022. Refer to Note 8, Other Receivables, Related Party. The Company has recognized $0.1
and $0.0
million of interest income for the years ended
December 31, 2022 and 2021, respectively in connection with this receivable.
As
of December 31, 2022, our investment, related party valued at $10.5
million consists of 6,466,949
common shares of Biofrontera AG, a significant
shareholder. See Note 6. In accordance with a Share Purchase and Transfer Agreement dated,
November 3, 2022, the Company purchased approximately 1,674,996
shares (of the total 6,466,946
shares) for $1.7
million from Maruho.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
Restructuring costs
|
12 Months Ended |
Dec. 31, 2022 |
Restructuring and Related Activities [Abstract] |
|
Restructuring costs |
18.
Restructuring costs
We
restructured the business of Cutanea and incurred restructuring costs which are subsequently reimbursed by Maruho. Restructuring costs
primarily relate to the winding down of Cutanea’s operations. There were no
restructuring costs for the year ended December
31, 2022. For the year ended December 31, 2021, restructuring costs were incurred in the amount of $0.8
million, of which $0.5
million had been reimbursed in 2021.
|
X |
- DefinitionThe entire disclosure for restructuring and related activities. Description of restructuring activities such as exit and disposal activities, include facts and circumstances leading to the plan, the expected plan completion date, the major types of costs associated with the plan activities, total expected costs, the accrual balance at the end of the period, and the periods over which the remaining accrual will be settled.
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v3.23.3
Stockholders’ Equity
|
12 Months Ended |
Dec. 31, 2022 |
Equity [Abstract] |
|
Stockholders’ Equity |
19.
Stockholders’ Equity
Under
the Company’s amended and restated certificate of incorporation, dated December 21, 2020, the Company is authorized to issue 15,000,000
shares of common stock, par value $0.001
per share and 20,000,000
shares of preferred stock, par value $0.001
per share. See Note 2. Summary of Significant Accounting Policies and Note 26. Subsequent Events for information
and disclosures relating to adjustments related to the Reverse Stock Split.
The
holders of common stock are entitled to one vote for each share held. Common stockholders are not entitled to receive dividends, unless
declared by the Board of Directors. The Company has not declared dividends since inception. In the event of liquidation of the Company,
dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities.
The common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions
applicable to the common stock. The outstanding shares of common stock are fully paid and non-assessable.
Initial
Public Offering. On November 2, 2021, the Company completed its initial public offering (“IPO”) of 180,000
units (“Units”) each consisting of (i) one share of common stock of the Company, par value $0.001
per share and (ii) one warrant (the “IPO Warrants”). Every 20 warrants will be exercisable for one share of Common Stock
at an exercise price of $100.00
per share of Common Stock. The IPO Warrants are immediately exercisable upon issuance for a period of five
years after the issuance date. The common stock shares and Warrants were issued separately in the offering and may be
transferred separately immediately upon issuance. The Units were sold at a price of $100.00
per Unit, with gross proceeds from the IPO of approximately $18
million, offset by $3.1
million in offering costs.
At
the IPO date, the underwriters also exercised in full their option to purchase up to an additional 27,000 IPO Warrants at the purchase
price of $0.20 per Warrant to cover over-allotments.
In
connection with the IPO, the Company also issued to the underwriters Unit Purchase Options (“UPO”) to purchase, in the aggregate,
(a) 5,400
Units and (b) 810
Warrants (relating to the underwriters’
exercise of the over-allotment option in full, with respect to the Warrants). The UPOs have an exercise price of $125.00
if exercisable for Units and $0.25
if
exercisable for Warrants. The UPOs are exercisable at any time from October 28, 2021 (“Effective Date”) through the 5th
anniversary of the Effective Date.
The
UPOs issued to the underwriters were accounted for as equity under ASC 718, Compensation -Stock Compensation (“ASC
718”). The fair value of the UPOs, which were fully vested at the issuance date, was recognized as an offering cost against
the proceeds from the IPO. The estimated fair value of the UPO Units of $0.3 million
at the IPO date was determined using a Black-Scholes option pricing model with the following assumptions: fair value of the
underlying unit of $99,
expected volatility of 60.0%,
risk free rate of 1.15%,
remaining contractual term of 5 years
and a dividend yield of 0%.
The estimated fair value of the UPO Warrants of $21,000 at
the IPO date was determined using a Black-Scholes option pricing model with the following assumptions: fair value of the underlying
unit of $25.80,
expected volatility of 60.0%,
risk free rate of 1.15%,
remaining contractual term of 5 years
and a dividend yield of 0%.
Private
Placement – On December 1, 2021, the Company settled the private placement in connection with a securities purchase
agreement dated November 29, 2021 (“December 2021 PIPE”). In the December 2021 PIPE, the Company issued for the gross
cash receipts of $15,000,000
(i) 67,500
shares of the common stock, (ii) a warrant to purchase up to 142,857
shares of the common stock (“Purchase Warrant”) and (iii) a warrant to purchase up to 75,357
shares of the common stock (“Pre-Funded Warrant”). Each of the Purchase Warrant and the Pre-Funded Warrant is
exercisable immediately and has an exercise term of five years and an exercise price of: (a) $105.00
per share with respect to the Purchase Warrant and (b) a nominal exercise price of $0.002
per share with respect to the Pre-Funded Warrant. The shares of common stock and the accompanying warrants were issued separately
and were immediately separable upon issuance. The combined purchase price for one share of common stock and one Purchase Warrant was
$105.00
and the combined purchase price for one Pre-Funded Warrant and one common warrant was $104.80.
On
December 28, 2021, 75,357 common stock shares were issued from the exercise of the Pre-Funded Warrant at an exercise price of $0.002
per share of the Company’s common stock.
In
connection with the December 2021 PIPE, the Company, issued Unit Purchase Options (“PP-UPO”) to the placement agents to purchase,
in the aggregate, (a) 4,286 Units, consisting of one share of common stock and one warrant to purchase common stock. The PP-UPOs have
an exercise price of $131.20 and are exercisable at any time for the period of 5 years.
The
PP-UPOs issued to the underwriters were accounted for under ASC 718, Compensation -Stock Compensation (“ASC 718”). The
fair value of the PP-UPOs, which were fully vested at the issuance date, was recognized as an offering cost of the December 2021
PIPE and allocated between the issuance costs of warrants and issuance costs of common stock, based on the allocated proceeds. The
Company estimated the fair value of the unit purchase options to be approximately $0.3
million at December 1, 2021 of which $0.2
million was allocated to the issuance costs of warrants and immediately expensed in the consolidated statement of operations and
$0.1
million was allocated to the issuance costs of common stock and charged to equity. The fair value was determined using a
Black-Scholes option pricing model with the following assumptions: fair value of the underlying unit of $127.80,
expected volatility of 60.0%,
risk free rate of 1.15%,
remaining contractual term of 5 years
and a dividend yield of 0%.
Private
Placement – On May 16, 2022, the Company entered into a Securities Purchase Agreement (“May 2022 PIPE”). In the May 2022
PIPE, the Company issued for the gross cash receipts of $9.4 million (i) 92,500 shares of the common stock, (ii) a warrant to purchase
up to 170,950 shares of the common stock (“2022 Purchase Warrant”) and (iii) a warrant to purchase up to 78,450 shares
of the common stock (“2022 Pre-Funded Warrant”). The purchase price for one share of common stock (or common stock equivalent)
and a warrant to purchase one share of common stock was $55.00. The 2022 Purchase Warrant will be exercisable nine months after the issue
date, expires five and one-half years after the issue date and has an exercise price of: $55.40 per share. The Pre-Funded Warrant is exercisable
immediately and has a term of exercise equal to five (5) years with a nominal exercise price of $0.02 per share.
Because
the warrants are accounted for as liabilities, the May 2022 PIPE proceeds were
allocated between the fair value of the warrants with the remaining proceeds allocated to common stock and additional paid in
capital.
Exercise
of 2022 Pre-Funded Warrant - On July 14, 2022, an investor exercised the 2022 Pre-Funded Warrant and purchased a total of 78,450
shares of common stock at an exercise price of $0.02 per share, resulting in negligible net proceeds.
Exercise
of 2021 Purchase Warrant and Issuance of July 2022 Inducement Warrant - On July 26, 2022, the Company entered into the
Inducement Letter with the holder of the Company’s 2021 Purchase Warrants (the “Investor”). The 2021 Purchase
Warrants were originally issued on December 1, 2021 to purchase up to 142,858
shares of common stock, par value $0.001
per share. The Investor agreed to exercise for cash, the 2021 Purchase Warrants, in exchange
for the Company’s agreement to (i) lower the exercise price of the 2021 Purchase Warrants from $105.00
to $32.40
per share and (ii) issue a new warrant (the “Inducement Warrant”) to purchase up to 214,286
shares of common stock. The Company received proceeds of $4.6
million, from the exercise of the 2021 Purchase Warrants and expensed the related issuance costs of $0.3
million. The modification expense associated with the change in fair value due to
the repricing of the 2021 Purchase Warrants is recorded as inducement expense. The 2021 Purchase Warrant modification along with the fair
value of the inducement warrants of $2.6 million was expensed as warrant inducement expense in the accompanying consolidated statement
of operations for the year ended December 31, 2022.
The
Inducement Warrant is exercisable on or after January 27, 2023 at a price per share of $33.20 and expires on December 1, 2026.
Adoption
of a stockholder rights plan. On October 13, 2022 the Board of Directors (“Board”) authorized and declared a dividend
distribution of one Preferred Stock Purchase Right (a “Right”) for each outstanding share of common stock to stockholders
of record as of the close of business on October 24, 2022. In addition, one Right will automatically attach to each share of Common Stock
issued between the record date of the distribution and the earlier of the distribution date and the expiration date of the Rights. Each
Right entitles the registered holder to purchase from the Company a unit consisting of one ten-thousandth of a share (a “Unit”)
of Series A Junior Participating Cumulative Preferred Stock, par value $0.001 per share, of the Company at a cash exercise price of $5.00
per Unit, subject to adjustment, under certain conditions. The complete terms of the Rights are set forth in the Stockholder Rights Agreement,
dated October 13, 2022, between the Company and Computershare Trust Company, N.A, as Rights agent.
While
the stockholder rights plan described above (the “Rights Plan”) is effective immediately, the Rights would become exercisable
only if a person or group, or anyone acting in concert with such a person or group, acquires beneficial ownership, as defined in the
Rights Agreement, of 20% or more of the Company’s issued and outstanding common stock in a transaction not approved by the Company’s
Board of Directors. The Rights Plan will expire on October 13, 2023. Refer to Note 26. Subsequent Events
– Settlement Agreement.
Under
the Rights Plan, a person or group who beneficially owned 20% or more of the Company’s outstanding Common Stock prior to the first
public announcement of the Rights Plan on October 14, 2022 will not trigger the Rights so long as they do not acquire beneficial ownership
of any additional shares of Common Stock at a time when they still beneficially own 20% or more of such Common Stock.
Series
A Junior Participating Cumulative Preferred Stock. In connection with the adoption of the Rights Plan, the Board approved a Certificate
of Designations of Series A Junior Participating Cumulative Preferred Stock which designates the rights, preferences and privileges of
5,000 shares of Preferred Stock. The Certificate of Designations was filed with the Secretary of State of Delaware and became effective
on October 13, 2022.
Exchange
Agreement – On October 25, 2022, the Company entered into private exchange agreements with certain holders of options to acquire
ordinary shares, nominal value €1.00
per share, of Biofrontera AG, a German stock
corporation, pursuant to which the parties agreed to a negotiated private exchange, and closed on a series of private exchanges of 3,148,042
shares of the Company’s common stock in
exchange for the AG Options.
Warrants –
The following table summarizes information with regard to the IPO Warrants, and the PIPE
Warrants, which includes the Inducement and 2022 Pre-Funded Warrants (together, the “Warrants”) share activity
for the year ended December 31, 2022:
Schedule
of Warrants
| |
Warrant -
PIPE | | |
Warrant -
IPO* | | |
Total
Warrants | | |
Weighted Average Exercise Price | |
Balance, December 31, 2020 | |
| - | | |
| - | | |
| - | | |
$ | - | |
Issued | |
| 218,214 | | |
| 207,000 | | |
| 425,214 | | |
| 102.57 | |
Exercised | |
| (75,357 | ) | |
| (132,380 | ) | |
| (207,737 | ) | |
| 100.14 | |
Balance, December 31, 2021 | |
| 142,857 | | |
| 74,620 | | |
| 217,477 | | |
| 99.69 | |
Issued | |
| 463,686 | | |
| - | | |
| 463,686 | | |
| 35.77 | |
Exercised | |
| (221,307 | ) | |
| - | | |
| (221,307 | ) | |
| 20.92 | |
Balance, December 31, 2022 | |
| 385,236 | | |
| 74,620 | | |
| 459,856 | | |
$ | 52.29
| |
|
* |
Every 20 IPO warrants are exercisable for one share of Common Stock at
an exercise price of $100.00 per share of Common Stock. For financial statement purposes, the warrant shares have been decreased by a
factor of 20 to effectively reflect the 1-for-20 reverse stock split. Refer to Note 26. Subsequent Events – Reverse Stock
Split. However, prices reflected on The Nasdaq Stock Market, for ticker BRIW warrants are the presplit price. |
|
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- DefinitionThe entire disclosure for equity.
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v3.23.3
Equity Incentive Plans and Share-Based Payments
|
12 Months Ended |
Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] |
|
Equity Incentive Plans and Share-Based Payments |
20.
Equity Incentive Plans and Share-Based Payments
2021
Omnibus Incentive Plan
In
2021, our Board of Directors adopted and our shareholders approved, the 2021 Omnibus Incentive Plan (“2021 Plan). Under the
original 2021 Plan, 137,500
shares are reserved and authorized for awards and the maximum contractual term is 10
years for stock options issued under the 2021 Plan. On December 12, 2022, the 2021 Plan was amended by our stockholders and
the number of shares authorized for awards under the 2021 Plan was increased by 129,490 to 266,990.
As of December 31, 2022, there were 154,359
shares available for future awards under the amended 2021 Plan.
Non-qualified
stock options
We
maintain the 2021 Plan for the benefit of our officers, directors and employees. Employee stock options granted under the 2021 Plan generally
vest in equal annual installments over three years and are exercisable for a period of up to ten years from the grant date. Non-employee
director options vest in equal monthly installments following the date of grant and will be fully vested on the one-year anniversary
of the date of grant. All stock options are exercisable at a price equal to the market value of the common shares underlying the option
on the grant date.
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 the Black-Scholes option pricing model,
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
fair value of each option was estimated on the date of the grant using the BSM option pricing model with the following assumptions:
Schedule of Stock Options Assumptions
|
|
2022 |
|
|
2021 |
|
Expected volatility |
|
|
55% -70 |
% |
|
|
55.0 |
% |
Expected term (in years) |
|
|
5.24 - 6.0 |
|
|
|
6.0 |
|
Risk-free interest rate |
|
|
1.34% - 4.10 |
% |
|
|
1.34 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
The weighted average grant-date fair value of options
granted during the years ended December 31, 2022 and 2021 was $29.28 and $49.55, respectively.
Share-based
compensation expense of approximately $0.8
million was recorded in selling, general and administrative expenses on the accompanying consolidated statement of operations for
the year ended December 31, 2022. There was negligible share-based compensation expense for the year ended December 31,
2021.
Options
outstanding and exercisable under the employee share option plan as of December 31, 2022 and December 2021, and a summary of option activity during
the year 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, 2020 | |
| - | | |
$ | - | | |
| | | |
| | |
Granted | |
| 30,942 | | |
$ | 95.40 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (205 | ) | |
$ | 95.40 | | |
| | | |
| | |
Outstanding at December 31, 2021 | |
| 30,737 | | |
$ | 95.40 | | |
| 9.94 | | |
$ | 1,691 | |
Granted | |
| 64,572 | | |
$ | 48.20 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (8,358 | ) | |
$ | 76.11 | | |
| | | |
| | |
Outstanding at December 31, 2022 | |
| 86,951 | | |
$ | 62.16 | | |
| 9.27 | | |
$ | 1 | |
Exercisable at December 31, 2022 | |
| 11,166 | | |
$ | 85.48 | | |
| 8.99 | | |
$ | - | |
|
(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 December 31, 2022 and December 31, 2021. |
As
of December 31, 2022, there was $2.2 million of unrecognized compensation cost related to unvested stock options held by employees and
directors, which is expected to be recognized over a weighted-average period of approximately 2.3 years.
Share-Based
Compensation (RSUs)
Restricted
Stock Units (“RSUs”) will vest annually over two years, subject to the recipient’s continued service with the Company
through the applicable vesting dates. The fair value of each RSU is estimated based on the closing market price of the Company’s
common stock on the grant date.
Share-based
compensation expense of $1.0 million
and $0.1 million for the RSUs was recorded in selling, general and administrative expenses in the accompanying consolidated
statement of operations for the years ended December 31, 2022 and 2021.
As
of December 31, 2022, there was $0.6 million of unrecognized compensation cost related to unvested RSUs, which is expected to be recognized
over a weighted-average period of approximately 1.4 years. The total fair value of shares vested during the years ended December 31,
2022 and 2021 was $0.8 million and $0.0 million, respectively.
The
following table summarizes the activity for RSUs during the year ended December 31, 2022 and December 31, 2021:
Schedule
of Restricted Stock Units
| |
Shares | | |
Weighted Average Grant Date Fair Value | |
Outstanding balance at December 31, 2020 | |
| - | | |
$ | - | |
Granted | |
| 8,504 | | |
| 95.40 | |
Issued | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Outstanding balance at December 31, 2021 | |
| 8,504 | | |
$ | 95.40 | |
Awarded | |
| 17,176 | | |
| 52.20 | |
Issued | |
| (8,504 | ) | |
| 95.40 | |
Forfeited | |
| - | | |
| - | |
Outstanding balance at December 31, 2022 | |
| 17,176 | | |
$ | 52.20 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Interest Expense, net
|
12 Months Ended |
Dec. 31, 2022 |
Interest Expense, net |
21.
Interest Expense, net
Interest
expense, net consists of the following:
Schedule of Interest Expense
| |
| | | |
| | |
| |
For years ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Interest expense | |
| (12 | ) | |
| (2 | ) |
Contract asset interest expense | |
| (358 | ) | |
| (358 | ) |
Interest income- related party | |
| 165 | | |
| - | |
Interest income – other | |
| 10 | | |
| 16 | |
Interest income | |
| 10 | | |
| 16 | |
Interest expense, net | |
$ | (195 | ) | |
$ | (344 | ) |
Contract
asset interest expense relates to the $1.7 million contract asset in connection with the $7.3 million start-up cost financing received
from Maruho under the Cutanea acquisition share purchase agreement. The contract asset is amortized on a straight-line basis using a
6% interest rate over the financing arrangement contract term, which ends on December 31, 2023.
Related
party interest income relates to the recorded receivable of $6.1 million from Biofrontera AG for its 50% share of the balance of a legal
settlement.
|
X |
- DefinitionThe entire disclosure for interest income and interest expense for enterprises that derive a significant portion of their revenue from interest collected on investments, loans, and securities.
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v3.23.3
Other Income, net
|
12 Months Ended |
Dec. 31, 2022 |
Other Income and Expenses [Abstract] |
|
Other Income, net |
22.
Other Income, net
Other
income, net consists of the following:
Schedule of Other Income, Net
| |
| | | |
| | |
| |
For years ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Reimbursed SPA costs | |
$ | - | | |
$ | 539 | |
Other, net | |
| 33 | | |
| 150 | |
Other income, net | |
$ | 33 | | |
$ | 689 | |
Other,
net, primarily includes gain (loss) on foreign currency transactions and gain on termination of operating leases.
|
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v3.23.3
Net Loss per Share
|
12 Months Ended |
Dec. 31, 2022 |
Loss per common share: |
|
Net Loss per Share |
23.
Net Loss per Share
Basic
and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands, except share and per share
amounts):
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders
| |
| | | |
| | |
| |
For years ended December 31, | |
| |
2022 | | |
2021 | |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 1,056,988 | | |
| 440,412 | |
Net loss per share, basic and diluted | |
$ | (0.61 | ) | |
$ | (85.63 | ) |
The following table sets forth 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
| |
| | | |
| | |
December 31, | |
2022 | | |
2021 | |
Common stock warrants | |
| 459,856 | | |
| 217,477 | |
Common stock options and RSUs | |
| 104,127 | | |
| 39,241 | |
Unit Purchase Options | |
| 20,182 | | |
| 20,182 | |
Anti-dilutive securities excluded from computation of earnings per share | |
| 403,628 | | |
| 403,628 | |
|
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v3.23.3
Commitments and Contingencies
|
12 Months Ended |
Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
24.
Commitments and Contingencies
Facility
Leases
The
Company leases its corporate headquarters under an operating lease that expires in August 2025. The Company has the option to extend
the term of the lease for one five (5) year period upon written notice to the landlord. The extension period has not been included
in the determination of the ROU asset or the lease liability as the Company concluded that it is not reasonably certain that it
would exercise this option. The Company provided the landlord with a security deposit in the amount of $0.1
million, which was recorded as other assets in the consolidated balance sheets.
The
Company has also entered into a master lease agreement for its vehicles. After an initial non-cancelable twelve-month period each
vehicle is leased on a month to month basis. Based on historical retention experience of approximately three
years, the vehicles have expiration dates ranging from February 2023 through September 2025.
In
calculating the present value of the lease payments, the Company has elected to utilize its incremental borrowing rate based on the original
lease term and not the remaining lease term. Given the absence of an outstanding debt agreement, a synthetic credit rating analysis
was used in estimating the Company’s IBR. Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for leased liabilities at inception and 8.5% for 2022 leased liabilities.
The
components of lease expense for the year ended December 31, 2022 was as follows (in thousands except lease term and discount rate):
Schedule
of Components of Lease Expense and Other Information
Lease expense | |
Operating Leases | |
Amortization of ROU assets (operating lease cost) | |
$ | 653 | |
Interest on lease liabilities | |
| 99 | |
Total lease expense | |
$ | 752 | |
Other Information | |
| |
Operational cash flow used for operating leases | |
$ | 781 | |
ROU assets obtained in exchange for lease liabilities | |
| 234 | |
Weighted -average remaining lease term (in years) | |
| 2.54 | |
Weighted -average discount rate | |
| 6.31 | % |
| |
| | |
Future
lease payments under non-cancelable leases as of December 31, 2022 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31, | |
Future lease commitments | |
2023 | |
| 565 | |
2024 | |
| 541 | |
2025 | |
| 349 | |
Thereafter | |
| - | |
Total future minimum lease payments | |
$ | 1,455 | |
Less imputed interest | |
$ | (109 | ) |
Total lease liability | |
$ | 1,346 | |
Schedule
of Operating Lease Liability
Reported as: | |
| |
Operating lease liability, current | |
$ | 498 | |
Operating lease liability, non-current | |
| 848 | |
Total | |
| 1,346 | |
Cutanea payments
We
have a contract in which we agreed to repay to Maruho $3.6
million on December 31, 2022 and $3.7
million on December 31, 2023 in start-up cost
financing paid to us in connection with the Cutanea acquisition.
We
have filed for arbitration against Maruho with the International Chamber of Commerce (“ICC”) regarding issues
with Maruho’s contract manufacturer that were not disclosed at the time of the Agreement and therefore are evaluating the repayment
of the $7.3
million of start-up costs. The arbitration notes
that Maruho breached the agreement with Cutanea due to the undisclosed manufacturing issues and seeks damages as well as a declaration
that we are not obligated to repay Maruho.
We
are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition
Contract Liabilities.
Milestone
payments with Ferrer Internacional S.A.
Under
the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer
i) $2,000,000
upon the first occasion when annual net sales
of Xepi® under the Xepi LSA exceed $25,000,000,
and ii) $4,000,000
upon the first occasion annual net sales of Xepi®
under the Xepi LSA exceed $50,000,000.
No payments were made in 2022 or 2021 related to Xepi® milestones.
Contingent
liability related to shares of Biofrontera AG acquired from Maruho through subscription rights
Dependent
on the outcome of legal proceedings between Biofrontera AG and Maruho, the Company may be liable for an additional payout of $0.9 million
in relation to the shares of Biofrontera AG acquired from Maruho through a subscription rights agreement. In accordance with ASC 450-20-50-3,
Contingencies, we have not accrued any liability associated with the subscription rights purchase, as the liability is not considered
probable. Refer to Note 26. Subsequent Events.
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 FASB ASC Topic 450, Contingencies. The Company expenses as incurred the legal
costs related to such legal proceedings.
On
November 29, 2021, the Company entered into a settlement and release agreement with respect to a lawsuit filed March 23, 2018 in the
United States District Court for the District of Massachusetts in which we were alleged to have infringed on certain patents and misappropriated
certain trade secrets. In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $22.5 million
and engage a forensic expert to destroy data at issue in the litigation to settle the claims in the litigation. The Company will be responsible for $11.25 million of the aggregate settlement
amount, plus interest accrued at a rate equal to the weekly average one-year constant maturity Treasury yield and agreed to pay in three
annual installments beginning with December 2021.
While
Biofrontera AG has agreed to pay fifty percent of the settlement costs, we remain jointly and severally liable to DUSA for the full
cash settlement amount, meaning that in the event Biofrontera AG does not pay all or a portion of the amount it owes under the
Agreement, DUSA could compel us to pay Biofrontera AG’s share. If either we or Biofrontera AG violates the terms of the
settlement agreement, we or Biofrontera AG may be liable for a greater amount. If we become liable for more than our agreed share of
the aggregate settlement amount, either of these events could have a material adverse effect on our business, prospects, financial
condition and/or results of operations. As of December 31, 2022, the remaining legal settlement liability accrued for was $6.2 million,
including the estimated remaining cost of the forensic expert. See Note 8, Other Receivables, Related Party for reimbursement
receivable and Note 26, Subsequent Events for additional DUSA claims.
|
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v3.23.3
Retirement Plan
|
12 Months Ended |
Dec. 31, 2022 |
Retirement Benefits [Abstract] |
|
Retirement Plan |
25.
Retirement Plan
The
Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan
covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual
compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary.
For
each of the years ended December 31, 2022 and 2021, matching contribution costs paid by the Company were $0.2 million.
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v3.23.3
Subsequent Events
|
12 Months Ended |
Dec. 31, 2022 |
Subsequent Events [Abstract] |
|
Subsequent Events |
26.
Subsequent Events
Loan
and Security Agreement with MidCap.
On
May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC,
providing us with a revolving line of credit in the aggregate principal amount of up to $6.5 million, subject to a borrowing base. The
Loan Agreement allows the Company to request advances thereunder and to use the proceeds of such advances for working capital purposes
until the maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets of the Company, subject
to customary exceptions.
Advances
under the Loan Agreement shall bear interest at the 30-Day Adjusted Term SOFR Rate, set monthly on the first day of the month based on
30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25%, plus 4.00% calculated and charged monthly
in arrears. In the event of a called event of default, a default interest rate of 3.00% percent shall be added to the aforementioned
rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to a borrowing base, which is a formula
based on certain eligible receivables and inventory. The Loan Agreement also includes an Unused Line Fee Rate of 0.375% of the Credit
Limit less all outstanding advances, which shall be paid on a monthly basis. Currently, our borrowing capacity is limited to our eligible
receivables, pending consent from Biofrontera AG to allow Midcap to obtain title to Biofrontera Inc.’s inventory in the event of
bankruptcy.
Settlement
Agreement. On April 11, 2023, Biofrontera Inc. and each member of its Board of Directors, in their individual capacities, entered
into a settlement agreement (the “Settlement Agreement”) with Biofrontera AG, a significant stockholder of the Company.
Pursuant
to the terms of the Settlement Agreement, the major provisions are as follows:
|
● |
the Company and a member of its Board of Directors withdrew
their challenges to the resolutions passed at the Biofrontera AG stockholder meeting on January 9, 2023 |
|
● |
the Company will increase the Board of Directors from five
to six members and appoint as a Class I Director a director nominated by Biofrontera AG to fill the vacancy, subject to certain restrictions
as described in the Settlement Agreement; |
|
● |
the Company will search for an additional director candidate,
who is fully independent, to be nominated for election as a Class II Director at the Company’s 2023 annual meeting of stockholders;
at which point the Company will increase the size of the Board of Directors to seven members; |
|
● |
the Board established a Related Party Transactions Committee
to approve all contracts and transactions between the Company and Biofrontera AG, including any of its affiliates; |
|
● |
the Company amended on April 26, 2023 that certain Stockholder
Rights Agreement dated October 13, 2022, between the Company and Computershare Trust Company, N.A., as Rights Agent to increase the threshold
of beneficial ownership before being deemed an Acquiring Person, solely with respect to Biofrontera AG, from 20% to 29.96%. |
|
● |
In addition, the Settlement Agreement contains provisions to
maintain Biofrontera AG’s representation on the Board of Directors as long as it holds at least 20% of the Company’s outstanding
common stock and to limit further increases in the size of the Board of Directors or changes to the Company’s stockholder rights
plan. Biofrontera AG also agrees, subject to certain conditions, to vote in support of the directors
nominated by, and the proposals recommended by, the Board of Directors. |
Reverse
Stock Split. On May 22, 2023, the Company held virtually a Special Meeting of Shareholders in which shareholders approved the amendment
to the Company’s Amended and Restated Certificate of Incorporation to (i) effect a reverse split at a ratio of not less than 1-for-5
and not greater than 1-for-25 and (ii) if and when the reverse stock split is effected, to decrease the number of authorized shares of
the Company’s common stock in the same ratio as is selected for the reverse stock split. The final decision of whether to proceed
with the Amendment shall be determined by our board of directors, in its discretion, at any time prior to August 23, 2023, the deadline
for regaining compliance with Nasdaq Listing Rule 5550(a)(2).
On
June 28, 2023, the Company, filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the “Amendment”)
with the Secretary of State of the State of Delaware to (i) effect the Reverse Stock Split of the Company’s Common Stock, and (ii)
effect a related proportional reduction in the number of the Company’s authorized shares of Common Stock from 300,000,000 to 15,000,000
(the “Authorized Share Reduction”).
Pursuant
to the Amendment, the Reverse Stock Split and Authorized Share Reduction was effective at 11:59 p.m. on July 3, 2023 (the “Split
Effective Time”), and the Common Stock began trading on the Nasdaq Capital Market on a post-split basis on July 5, 2023. The par
value and other terms of the Common Stock were not affected.
Licensing
Agreement with Optical Tools
On
December 2, 2022, the Company entered into the technology transfer agreement with Optical Tools LLC (“Optical Tools”), and
Stephen Tobin and Paul Sowyrda (the “Agreement”). The 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.
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 shall reimburse Optical Tools for all reasonable
out-of-pocket, material and labor costs per the agreement.
As
part of the 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 this Agreement.
New
Board Member
On
July 7, 2023, in connection with the Biofrontera AG settlement agreement disclosed above, the board of directors of the Company appointed
Heikki Lanckriet to the Board. Mr. Lanckriet will serve as a Class I Director to hold office for a term expiring at the annual meeting
of the Company’s stockholders for fiscal year 2025. Mr. Lanckriet’s term as director began upon his appointment at the July
7, 2023 meeting.
Mr.
Lanckriet was appointed to the Board upon the nomination of Biofrontera AG, a significant stockholder of the Company, pursuant to a settlement
agreement dated as of April 11, 2023, between the Company, each member of its Board of Directors at that time and Biofrontera AG.
Contingent
liability related to shares of Biofrontera AG acquired from Maruho through subscription rights relieved in 2023.
In
July 2023, AG and Maruho settled the dispute from which the contingent payment obligation of Biofrontera Inc. under the subscription
rights agreement could have arisen.
Legal
Claim
On
September 13, 2023, Biofrontera was served with a complaint filed in United Stated District Court for the District of Massachusetts by
DUSA Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries LTD (collectively “DUSA”
or “Plaintiffs”) in which DUSA alleges breach of contract, violation of the Lanham Act, and unfair trade practices. 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 U.S. District Court for the District of Massachusetts, this matter has been transferred by
agreement of the parties to the U.S. District Court for the District of New Jersey.
The
Company denies the Plaintiffs’ claims and intends to defend these matters vigorously. Based on the Company’s assessment
of the facts underlying the above claims, the uncertainty of litigation and the preliminary stage of the case, 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.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
12 Months Ended |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
Basis for Preparation of the Consolidated Financial Statements |
Basis
for Preparation of the Consolidated Financial Statements
The
accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“GAAP”). These consolidated financial statements include the accounts of our wholly owned
subsidiary. All intercompany balances and transactions have been eliminated in consolidation. The information presented reflects the
application of significant accounting policies described below.
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.
|
Segment Reporting |
Segment
Reporting
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision-maker in deciding how to allocate resources and assess performance. The Company’s chief operating decision maker
(determined to be the Chief Executive Officer) does not manage any part of the Company separately, and the allocation of resources and
assessment of performance are based on the Company’s operating results.
We
operate in a single reporting segment, the commercialization of pharmaceutical products for the treatment of dermatological conditions
and diseases within the U.S. All business operations focus on the products Ameluz®, including the complementary product
BF-RhodoLED®, and Xepi®. We monitor and manage our business operations across these products collectively
as one reporting segment.
|
Reverse Stock Split |
Reverse Stock Split
On July 3, 2023 Biofrontera Inc. effected a 1-for-20
reverse stock split (the “Reverse Stock Split”) of the issued and outstanding shares of the Company’s common stock,
$0.001 par value (the “Common Stock”). The Common Stock began trading on the Nasdaq Capital Market on a post-split basis on
July 5, 2023.
All information included in these consolidated financial
statements has been adjusted, on a retrospective basis, to reflect the Reverse Stock Split as if it had been effective from the beginning
of the earliest period presented, unless otherwise stated. All outstanding securities entitling their holders to purchase shares of Common
Stock or acquire shares of Common Stock, including stock options, restricted stock units, and warrants, were adjusted as a result of the
Reverse Stock Split, as required by the terms of those securities.
|
Use of Estimates |
Use
of Estimates
The
preparation of the consolidated financial statements in accordance with U.S. 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 valuation allowances for receivables and inventory,
valuation of contingent consideration and warrant liabilities, realization of intangible and other long-lived assets, product sales allowances
and reserves, share-based payments and income taxes including deferred tax assets and liabilities. 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.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to
be cash equivalents.
The Company maintains its cash balances at financial institutions that
are insured by the Federal Deposit Insurance Corporation (“FDIC”). The FDIC provides coverage of up to $250,000 per depositor,
per financial institution. At December 31, 2022, approximately $16.8 million of the Company’s cash balances were in excess of FDIC
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.
|
Restricted Cash |
Restricted
Cash
Restricted
cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards, in addition to
one deposit held for a sublease (see Note 13. Statement of Cash Flows Reconciliation).
|
Investment, Related Party |
Investment, Related Party
The
Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities (“ASC
321”). Equity securities, which are comprised of investments in common stock with a readily determinable fair value, are initially
recorded at cost, plus transaction costs, and subsequently measured at fair value, based on quoted market prices, with the gains and
losses reported in the Company’s consolidated statement of operations. As the fair value of the Company’s investments is
reported in a foreign currency, the change in fair value attributable to changes in foreign exchange rates is included in other income,
net in the consolidated statement of operations.
|
Accounts Receivable |
Accounts
Receivable
Accounts
receivables are reported at their net realizable value. Any value adjustments are booked directly against the relevant receivable. We
have standard payment terms that generally require payment within approximately 30 to 90 days. Management performs ongoing credit evaluations
of its customers. An allowance for potentially uncollectible accounts is provided based on history, economic conditions, and composition
of the accounts receivable aging. In some cases, the Company makes allowances for specific customers based on these and other factors.
Provisions for the allowance for doubtful accounts are recorded in selling, general and administrative expenses in the accompanying statements
of operations.
|
Concentration of Credit Risk and Off-Balance Sheet Risk |
Concentration
of Credit Risk and Off-Balance Sheet Risk
Financial
instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents, accounts
receivable and other receivables, related party. The Company maintains all of its cash and cash equivalents at a single accredited financial
institution, in amounts that exceed federally insured limits. The Company has no significant off-balance sheet risk such as foreign exchange
contracts, option contracts, or other foreign hedging arrangements.
Concentrations
of credit risk with respect to receivables, which are typically unsecured, are somewhat mitigated due to the wide variety of customers
using our products. We monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond
to changes in their credit profile. We continue to monitor these conditions and assess their possible impact on our business.
Other
receivables, related party consists of a receivable due from Biofrontera AG for its 50% share of a legal settlement and related
costs for which they are jointly and severally liable for the total settlement amount. The Company has a contractual right to
repayment of its share of the settlement payment from Biofrontera AG under the Settlement Allocation Agreement entered into on
December 9, 2021, which provided that the settlement payments would first be made by the Company and then reimbursed by Biofrontera
AG for its share. Although this receivable has credit risk, it is mitigated by the Settlement Allocation Agreement as amended on
March 31, 2022, which provides certain remedies to the Company, if Biofrontera AG fails to make timely reimbursements, which the
Company may implement in its sole discretion, including the ability to charge interest at a rate of 6.0% per annum for each day that
any reimbursement is past due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by
the Company (including amounts owed under the Company’s license and supply agreement for
Ameluz®).
We
are dependent on two suppliers, Biofrontera Pharma GmbH and Ferrer Internacional S.A., to supply drug products, including all underlying
components, for our commercial efforts. These efforts could be adversely affected by a significant interruption in the supply of our
finished products.
|
Inventories |
Inventories
Finished
goods consist of pharmaceutical products purchased for resale and are stated at the lower of cost or net realizable value. Cost is calculated
by applying the first-in-first-out method (FIFO). Inventory costs include the purchase price of finished goods and freight-in costs.
The Company regularly reviews inventory quantities on hand and writes down to its net realizable value any inventory that it believes
to be impaired. Management considers forecast demand in relation to the inventory on hand, competitiveness of product offerings, market
conditions and product life cycles when determining excess and obsolescence and net realizable value adjustments. Once inventory is written
down and a new cost basis is established, it is not written back up if demand increases.
|
Property and Equipment |
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is generally applied straight-line over the estimated
useful life of assets. Leasehold improvements are amortized over the shorter of the asset’s estimated useful life or the lease
term. The estimated useful lives of property and equipment are:
Schedule
of Estimated Useful Lives of Property, Plant and Equipment
| |
Estimated Useful Life in Years |
Computer equipment | |
3 years |
Computer software | |
3 years |
Furniture and fixtures | |
3-5 years |
Leasehold improvements | |
Shorter of estimated useful lives or the term of the lease |
Machinery & equipment | |
3-4 years |
The
cost and accumulated depreciation of assets retired or sold are removed from the respective asset category, and any gain or loss is recognized
in our statements of operations.
|
Intangible Assets |
Intangible
Assets
Intangible
assets with finite lives are amortized over their estimated useful lives. Intangible assets with indefinite lives are not amortized.
|
Leases |
Leases
In
February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU
No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements.
The Company adopted the standard effective January 1, 2022. Using the optional transition method, prior period financial statements have
not been recast to reflect the new lease standard. The adoption of the new lease standard resulted in the addition of an operating lease
right-of-use asset and an operating lease liability in the amount of $1.8 million to the consolidated balance sheet as of January 1,
2022.
At
the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and
circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value
of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable.
As such, the Company utilizes its incremental borrowing rate (“IBR”), which is the rate incurred to borrow on a collateralized
basis over a similar term an amount equal to the lease payments in a similar economic environment. Given
the absence of an outstanding debt agreement, a synthetic credit rating analysis was used in estimating the Company’s IBR. Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for lease liabilities at inception and 8.5% for 2022 lease liabilities. No adjustments to the right-of-use
asset were required for items such as initial direct costs paid or incentives received.
The
Company has elected to adopt the practical expedient provided in ASC 842 and not reassess leases that existed prior to
the commencement date, 1). Whether any expired or existing contracts are or contain leases, 2). Lease classification, or 3).
Initial indirect costs for any existing leases. The Company has elected to combine lease and non-lease components as a single
component for certain asset classes, when applicable. Operating leases are recognized on the balance sheet as operating lease
right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. The Company also
elected to utilize the short-term lease recognition exemption and for those leases that qualified, the Company did not recognize
right-of-use assets or lease liabilities. These leases are recognized on a straight-line basis over the expected term.
|
Impairment of Long-Lived Assets |
Impairment
of Long-Lived Assets
The
Company considers whether events or changes in facts and circumstances, both internally and externally, may indicate that an impairment
of long-lived assets held for use, including right-of-use assets, are present. To the extent indicators or impairment exist, the determination
of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition.
In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset, the assets are written
down to their estimated fair values and the loss is recognized in the statements of operations. Refer to Note 12. Intangible Asset, Net.
|
Contingent Consideration |
Contingent
Consideration
Contingent
consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition
date. For contingent consideration, management is responsible for determining the appropriate valuation model and estimated fair value,
and in doing so, considers a number of factors, including information provided by an outside valuation advisor. Contingent consideration
liabilities are reported at their estimated fair values based on probability-adjusted present values of the consideration expected to
be paid, using significant inputs and estimates. Key assumptions used in these estimates include probability assessments with respect
to the likelihood of achieving certain milestones and discount rates consistent with the level of risk of achievement. The fair value
of contingent consideration liabilities are remeasured each reporting period, with changes in the fair value included in current operations.
The remeasured liability amount could be significantly different from the amount at the acquisition date, resulting in material charges
or credits in future reporting periods.
|
Contingencies |
Contingencies
Loss
contingency provisions are recorded if the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable,
and the amount can be reasonably estimated or a range of loss can be determined. These accruals represent management’s best estimate
of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible
that the amount of a loss will exceed the recorded provision. On a quarterly basis, we review the status of each significant matter and
assess its potential financial exposure. Significant judgment is required in both the determination of probability and as to whether
an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information
available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and
litigation and may change our estimates. Legal costs associated with legal proceedings are expensed when incurred.
|
Derivative Instruments |
Derivative
Instruments
The
Company accounts for common stock warrants as either equity-classified or liability-classified instruments based on an assessment of
the specific terms of the warrants and applicable authoritative guidance in FASB Accounting Standards Codification (“ASC”)
480, Distinguishing Liabilities from Equity (“ASC 480”) and Derivatives and Hedging (“ASC 815”). Warrants
classified as equity are recorded at fair value as of the date of issuance on the Company’s consolidated balance sheets and no
further adjustments to their valuation are made. Warrants classified as derivative liabilities that require separate accounting as liabilities
are recorded on the Company’s consolidated balance sheets at their fair value on the date of issuance and are revalued on each
subsequent balance sheet date until such instruments are exercised or expire, with any changes in the fair value between reporting periods
recorded as other income or expense. Management estimates the fair value of these liabilities using the Black-Scholes-Merton (“BSM”)
model and assumptions that are based on the individual characteristics of the warrants or instruments on the valuation date, as well
as assumptions for future financings, expected volatility, expected life, yield, and risk-free interest rate.
At
their issuance date in October 2021, the IPO Warrants (see Note 19. Stockholders’ Equity) were
accounted for as equity as these instruments met all of the requirements for equity classification under ASC 815-40.
The
Purchase Warrants issued in connection with the private placement offerings completed on December 1, 2021 and May 16, 2022 as
well as the Inducement Warrants issued on July 26, 2022 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 consolidated statement of operations. Refer to Note 4. Fair Value
Measurements.
|
Fair Value Measurements |
Fair
Value Measurements
The
Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs
used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures, or ASC 820, establishes a hierarchy
of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available. Observable inputs are those that market participants would use in pricing the asset
or liability based on market data obtained from sources independent of the Company. Unobservable inputs reflect the Company’s assumptions
about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information
available in the circumstances. The three levels of the fair value hierarchy are described below:
Level
1 – Quoted prices in active markets for identical assets or liabilities.
Level
2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or
indirectly.
Level
3 – Unobservable inputs using estimates or assumptions developed by the Company, which reflect those that a market participant
would use in pricing the asset or liability.
To
the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair
value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for
instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level
of any input that is significant to the fair value measurement.
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
The
carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, accounts receivable, other receivables,
accounts payable and start-up cost financing included in acquisition contract liabilities
approximate their fair values, due to their short-term nature.
|
Revenue Recognition |
Revenue
Recognition
The
Company accounts for revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue
is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the
Company expects to be entitled in exchange for those goods or services. We recognize revenue when the customer obtains control of our
product, which occurs at a point in time, typically upon delivery to the customer.
To
determine revenue recognition, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance
obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction
price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We
only apply the five-step model to contracts when collectability of the consideration to which we are entitled in exchange for the goods
or services we transfer to the customer is determined to be probable.
The
Company realizes its revenue primarily through the sales of its Ameluz® product which are made directly
to physicians, hospitals or other qualified healthcare providers. Sales are recognized, net of sales deductions, when ownership and control
are transferred to the customer, which is generally upon delivery. Sales deductions include expected trade discounts and allowances,
product returns, and government rebates. These discounts and allowances are estimated at the time of sale based on the amounts incurred
or expected to be received for the related sales.
Xepi®
is sold directly to specialty pharmacies. Sales are recognized net of sales deductions when ownership and control are transferred
to the customer, which is generally upon delivery. Sales deductions include expected returns, discounts and incentives such as payments
made under patient assistance programs. These rebates are estimated at the time of sale based on the amounts incurred or expected to
be received for the related sales.
The
payment terms for sales of our pharmaceutical products are generally short-term payment terms with the possibility of volume-based
discounts, co-pay assistance discounts, or other rebates.
BF
RhodoLED® is also sold directly to physicians, hospitals or other qualified healthcare providers through (i) direct sales
or (ii) an evaluation period up to six-month for a fee, after which a customer can decide to purchase or return the lamp. For direct
sales, revenue is recognized only after complete installation has taken place. As directed by the instruction manual, the lamp may only
be used by the customer once it has been professionally installed. A final decision to purchase the lamps that are within the evaluation
period does not need to be made until the end of the evaluation period. Lamps that are not returned at the end of the evaluation period
are converted into sales in accordance with the contract terms. The Company generates immaterial revenues from the monthly fees during
the evaluation period and from the sale of lamps at the end of the evaluation period.
Variable
Consideration
Revenues
from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which
sales reserves are established and which result from discounts, rebates and other incentives that are offered within contracts between
the Company and its customers. Components of variable consideration include trade discounts and allowances, product returns, government
rebates, and other incentives such as patient co-pay assistance. Variable consideration is recorded on the balance sheet as either a
reduction of accounts receivable, if expected to be claimed by a customer, or as a current liability, if expected to be payable to a
third party other than a customer. Where appropriate, these estimates take into consideration relevant factors such as the Company’s
historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted
customer buying and payment patterns. These reserves reflect the Company’s best estimates of the amount of consideration to which
it is entitled based on the terms of the contract. Actual amounts of consideration ultimately received may differ from the Company’s
estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, and record
any necessary adjustments in the period such variances become known.
Trade
Discounts and Allowances – The Company provides customers with trade discounts, rebates, allowances and/or other incentives.
The Company records estimates for these items as a reduction of revenue in the same period the revenue is recognized.
Government
and Payor Rebates – The Company contracts with, or is subject to arrangements with, certain third-party payors, including pharmacy
benefit managers and government agencies, for the payment of rebates with respect to utilization of its commercial products. The Company
is also subject to discount and rebate obligations under state and federal Medicaid programs and Medicare. The Company records estimates
for these discounts and rebates as a reduction of revenue in the same period the revenue is recognized.
Other
Incentives – The Company maintains a co-pay assistance program which is intended to provide financial assistance to qualified
patients with the cost of purchasing Xepi®. The Company estimates and records accruals for these incentives as a reduction
of revenue in the period the revenue is recognized. The Company estimates amounts for co-pay assistance based upon the number of claims
and the cost per claim that the Company expects to receive associated with products sold to customers but remaining in the distribution
channel at the end of each reporting period.
Royalties
For
arrangements that include sales-based royalties, the Company recognizes royalty expense at the later of (i) when the related sales occur,
or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Royalty expense is recognized as cost of revenues.
Product
Warranty
The
Company generally provides a 36-month warranty for sales of BF-RhodoLED® for which estimated contractual warranty obligations
are recorded as an expense at the time of installation. Customers do not have the option to purchase the warranty separately and the
warranty does not provide the customer with a service beyond the assurance that BF-RhodoLED® complies with agreed-upon
specifications. Therefore, the warranty is not considered to be a performance obligation. The lamps are subject to regulatory and quality
standards. Future warranty costs are estimated based on historical product performance rates and related costs to repair given products.
The accounting estimate related to product warranty expense involves judgment in determining future estimated warranty costs. Should
actual performance rates or repair costs differ from estimates, revisions to the estimated warranty liability would be required. Warranty
expenses incurred in 2022 and 2021 were negligible and are recognized as selling, general and administrative expenses.
Contract
Costs
Incremental
costs of obtaining a contract with a customer may be recorded as an asset if the costs are expected to be recovered. As a practical expedient,
we recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that we
otherwise would have recognized is one year or less. Sales commissions earned by the Company’s sales force are considered incremental
costs of obtaining a contract. To date, we have expensed sales commissions as these costs are generally attributed to periods shorter
than one year. Sales commissions are included in selling, general and administrative expenses.
|
Cost of Revenues |
Cost
of Revenues
Cost
of revenues is comprised of purchase costs of our products, third party logistics and distribution costs including packaging, freight,
transportation, shipping and handling costs, and inventory adjustment due to expiring products, as well as sales-based royalties. Logistics
and distribution costs totaled $0.5 million and $0.4 million for the years ended December 31, 2022 and 2021, respectively.
|
Share-Based Compensation |
Share-Based
Compensation
The
Company measures and recognizes share-based compensation expense for equity awards based on fair value at the grant date. The Company
uses the Black-Scholes-Merton (“BSM”) option pricing model to calculate fair value of its stock option grants. The compensation
cost for restricted stock awards is based on the closing price of the Company’s common stock on the date of grant. Share-based
compensation expense recognized in the statements of operations is based on the period the services are performed and recognized as compensation
expense on a straight-line basis over the requisite service period. The Company accounts for forfeitures as they occur.
The
BSM option pricing model requires the input of subjective assumptions, including the risk-free interest rate, the expected volatility
of the value of the Company’s common stock, and the expected term of the option. These estimates involve inherent uncertainties
and the application of management’s judgment. If factors change and different assumptions are used, the share-based compensation
expense could be materially different in the future. These assumptions are estimated as follows:
Risk-Free
Interest Rate. The risk-free rate is based on the interest rate payable on United States Treasury securities in effect at the time of
grant for a period that is commensurate with the assumed expected term.
Expected
Volatility. The Company based the volatility assumption on a weighted average of the peer group re-levered equity volatility with 80%
weight and the warrant implied volatility with 20% weight. The peer group was developed based on companies in the biotechnology industry
whose shares are publicly traded. Due to our limited historical data and the long-term nature of the awards, the peer group volatility
was more heavily weighted.
Expected
Term. The expected term represents the period of time that options are expected to be outstanding. Due to the lack of historical exercise
data and given the plain vanilla nature of the options granted by the Company, the expected term is determined using the “simplified”
method, as prescribed in SEC Staff Accounting Bulletin (“SAB”) No. 107 (“SAB 107”), whereby the expected life
equals the average of the vesting term and the original contractual term.
Dividend
Yield. The dividend yield is 0% as the Company has never declared or paid, and for the foreseeable future does not expect to declare
or pay, a dividend on its common stock.
|
Foreign Currency Transactions |
Foreign
Currency Transactions
Transactions
realized in currencies other than USD are reported using the exchange rate on the date of the transaction.
|
Selling, General and Administrative Expense |
Selling,
General and Administrative Expense
Selling,
general and administrative expenses are primarily comprised of compensation and benefits 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, advertising, and other commercial costs to support the commercial operation of
our product and professional fees for legal, consulting, and other general and administrative costs.
Advertising
costs are expensed as incurred. For the years ended December 31, 2022 and 2021, advertising costs totaled $0.1 million and $0.5 million,
respectively.
|
Income Taxes |
Income
Taxes
The
Company accounts for income taxes using the asset and liability method in accordance with ASC 740, Income Taxes, which requires
the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in
the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial
reporting and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected
to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood
that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available
evidence, that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is
established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future
taxable profits expected and considering prudent and feasible tax planning strategies.
The
Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the
amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained
upon external examination by the taxing authorities. If the tax position is deemed more likely-than-not to be sustained, the tax position
is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized
is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes
includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related
net interest and penalties.
|
Net Loss per Share |
Net
Loss per Share
Basic
and diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted
average number of common shares outstanding. When the effects are not anti-dilutive, diluted earnings per share is computed by dividing
the Company’s net income attributable to common stockholders by the weighted average number of common shares outstanding
and the impact of all dilutive potential common shares outstanding during the period, including stock options, restricted stock units,
and warrants, using the treasury stock method.
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
In
September 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires entities to record expected credit losses for certain financial instruments, including trade receivables,
as an allowance that reflects the entity’s current estimate of credit losses expected to be incurred. The new standard was
effective for us on January 1, 2023, and did not have a material effect on our consolidated financial statements.
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v3.23.3
Acquisition Contract Liabilities (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Business Combination and Asset Acquisition [Abstract] |
|
Schedule of Acquisition Contract Liabilities |
Acquisition
contract liabilities, net consist of the following:
Schedule of Acquisition Contract Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Short-term acquisition contract liabilities: | |
| | | |
| | |
Start-up cost financing | |
| 7,300 | | |
| 3,600 | |
Contract asset | |
| (358 | ) | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 6,942 | | |
$ | 3,242 | |
| |
| | | |
| | |
Long-term acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,400 | | |
$ | 6,200 | |
Start-up cost financing | |
| - | | |
| 3,700 | |
Contract asset | |
| - | | |
| (358 | ) |
Acquisition contract liabilities, net | |
$ | 2,400 | | |
$ | 9,542 | |
| |
| | | |
| | |
Total acquisition contract liabilities: | |
| | | |
| | |
Contingent consideration | |
$ | 2,400 | | |
$ | 6,200 | |
Start-up cost financing | |
| 7,300 | | |
| 7,300 | |
Contract asset | |
| (358 | ) | |
| (716 | ) |
Total acquisition contract liabilities, net | |
$ | 9,342 | | |
$ | 12,784 | |
|
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v3.23.3
Fair Value Measurements (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value Hierarchy Valuation Inputs |
The
following table presents information about the Company’s assets that are measured at fair value on a recurring basis and indicates
the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
Schedule
of Fair Value Hierarchy Valuation Inputs
(in thousands) | |
Level | | |
December 31, 2022 | | |
December 31, 2021 | |
| |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | |
Investment, related party | |
| 1 | | |
$ | 10,548 | | |
$ | - | |
Liabilities: | |
| | | |
| | | |
| | |
Contingent Consideration | |
| 3 | | |
$ | 2,400 | | |
$ | 6,200 | |
Warrant liability – 2021 Purchase Warrants | |
| 3 | | |
$ | - | | |
$ | 12,854 | |
Warrant liability – 2022 Purchase Warrants | |
| 3 | | |
$ | 1,129 | | |
$ | - | |
Warrant liability - Purchase Warrants | |
| 3 | | |
$ | 1,129 | | |
$ | - | |
Warrant liability – 2022 Inducement Warrants | |
| 3 | | |
$ | 1,714 | | |
$ | - | |
Warrant liability | |
| 3 | | |
$ | 1,714 | | |
$ | - | |
|
Schedule of Fair Value of Contingent Consideration |
The
following table provides a roll forward of the fair value of the contingent consideration:
Schedule of Fair Value of Contingent Consideration
(in thousands) | |
| |
Balance at December 31, 2020 | |
$ | 7,602 | |
Change in fair value of contingent consideration | |
| (1,402 | ) |
Balance at December 31, 2021 | |
$ | 6,200 | |
Change in fair value of contingent consideration | |
| (3,800 | ) |
Balance at December 31, 2022 | |
$ | 2,400 | |
|
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions |
The
fair value at issuance was estimated using a Black-Scholes pricing model based on the following assumptions at December 1, 2021 for
the 2021 Purchase Warrants, May 16, 2022 for the Purchase Warrants and July 26, 2022 for the Inducement Warrants:
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions
|
|
2021 Purchase | |
|
Purchase | | |
Inducement | |
Stock price |
|
$ |
86.60 | |
|
$ | 52.40 | | |
$ | 32.80 | |
Expiration term (in years) |
|
|
5 | |
|
| 5.50 | | |
| 4.34 | |
Volatility |
|
|
60.0 | % |
|
| 65.0 | % | |
| 70.0 | % |
Risk-free Rate |
|
|
1.15 | % |
|
| 2.83 | % | |
| 2.84 | % |
Dividend yield |
|
|
0.0 | % |
|
| 0.0 | % | |
| 0.0 | % |
The fair value was estimated using Black-Scholes pricing
model based on the following assumptions as of December 31, 2021:
|
|
2021 Purchase |
|
Stock price |
|
$ |
150.40 |
|
Expiration term (in years) |
|
|
4.92 |
|
Volatility |
|
|
60.0 |
% |
Risk-free Rate |
|
|
1.25 |
% |
Dividend yield |
|
|
0.0 |
% |
The
fair value was estimated using Black-Scholes pricing model based on the following assumptions as of December 31, 2022 (outstanding warrants were all issued during 2022):
| |
Purchase | | |
Inducement | |
Stock price | |
$ | 18.40 | | |
$ | 18.40 | |
Expiration term (in years) | |
| 4.88 | | |
| 3.92 | |
Volatility | |
| 70 | % | |
| 75 | % |
Risk-free Rate | |
| 3.96 | % | |
| 4.07 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
Dividend yield | |
| 0.0 | % | |
| 0.0 | % |
|
Schedule of Changes in Fair Value Warrant Liabilities |
The
following table presents the changes in the warrant liabilities measured at fair value (in thousands):
Schedule
of Changes in Fair Value Warrant Liabilities
| |
December 31, 2022 | |
|
December 31, 2021 | |
Fair value at beginning of year | |
$ | 12,854 | |
|
$ | - | |
Issuance of new warrants | |
| 13,217 | |
|
| 12,261 | |
Exercise of warrants | |
| (6,840 | ) |
|
| (12,208 | ) |
Change in fair value of warrant liability | |
| (19,017 | ) |
|
| 12,801 | |
Warrant inducement expense | |
| 2,629 | |
|
| - | |
Fair value at end of year | |
$ | 2,843 | |
|
| 12,854 | |
|
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v3.23.3
Revenue (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Revenue Allowance and Accrual Activities |
An
analysis of the changes in product revenue allowances and reserves is summarized as follows:
Schedule
of Revenue Allowance and Accrual Activities
| |
| | |
Co-pay | | |
Prompt | | |
Government | | |
| |
| |
| | |
assistance | | |
pay | | |
and payor | | |
| |
(in thousands): | |
Returns | | |
program | | |
discounts | | |
rebates | | |
Total | |
Balance at December 31, 2020 | |
$ | 217 | | |
$ | 52 | | |
$ | 15 | | |
$ | 43 | | |
$ | 327 | |
Provision related to current period sales | |
| 6 | | |
| 423 | | |
| 40 | | |
| 168 | | |
| 637 | |
Credit or payments made during the period | |
| (180 | ) | |
| (374 | ) | |
| (7 | ) | |
| (157 | ) | |
| (718 | ) |
Balance at December 31, 2021 | |
$ | 43 | | |
$ | 101 | | |
$ | 48 | | |
$ | 54 | | |
$ | 246 | |
Provision related to current period sales | |
| 10 | | |
| 574 | | |
| 19 | | |
| 210 | | |
| 813 | |
Credit or payments made during the period | |
| (5 | ) | |
| (666 | ) | |
| (62 | ) | |
| (244 | ) | |
| (977 | ) |
Balance at December 31, 2022 | |
$ | 48 | | |
$ | 9 | | |
$ | 5 | | |
$ | 20 | | |
$ | 82 | |
|
X |
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v3.23.3
Prepaid Expenses and Other Current Assets (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets |
|
Schedule of 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) | |
December 31,
2022 | | |
December 31,
2021 | |
Receivable for common stock warrants proceeds | |
$ | - | | |
$ | 3,258 | |
Prepaid expenses | |
| 439 | | |
$ | 824 | |
Security deposits | |
| 85 | | |
| 149 | |
Other | |
| 286 | | |
| 756 | |
Total | |
$ | 810 | | |
$ | 4,987 | |
|
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v3.23.3
Property and Equipment, Net (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Property
and equipment, net consists of the following:
Schedule of Property and Equipment
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Computer equipment | |
$ | 89 | | |
$ | 85 | |
Computer software | |
| 27 | | |
| 27 | |
Furniture & fixtures | |
| 81 | | |
| 81 | |
Leasehold improvement | |
| 368 | | |
| 368 | |
Machinery & equipment | |
| 146 | | |
| 112 | |
Property and equipment, gross | |
| 711 | | |
| 673 | |
Less: Accumulated depreciation | |
| (507 | ) | |
| (406 | ) |
Property and equipment, net | |
$ | 204 | | |
$ | 267 | |
|
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v3.23.3
Intangible Asset, Net (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Asset Net |
Intangible
asset, net consists of the following:
Schedule of Intangible Asset Net
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Xepi® license | |
$ | 4,600 | | |
$ | 4,600 | |
Less: Accumulated amortization | |
| (1,568 | ) | |
| (1,150 | ) |
Intangible asset, net | |
$ | 3,032 | | |
$ | 3,450 | |
|
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v3.23.3
Statement of Cash Flows Reconciliation (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash |
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) | |
December 31,
2022 | | |
December 31,
2021 | |
Cash and cash equivalents | |
$ | 17,208 | | |
$ | 24,545 | |
Short-term restricted cash | |
| - | | |
| 47 | |
Long-term restricted cash | |
| 200 | | |
| 150 | |
Total cash and cash equivalent, and restricted cash shown on the statements of
cash flows | |
$ | 17,408 | | |
$ | 24,742 | |
|
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v3.23.3
Accrued Expenses and Other Current Liabilities (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
Schedule of 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) | |
December 31,
2022 | | |
December 31,
2021 | |
Legal settlement (See Note 24) | |
$ | 6,207 | | |
$ | 5,625 | |
Employee compensation and benefits | |
| 2,850 | | |
| 2,384 | |
Professional fees | |
| 1,353 | | |
| 570 | |
Product revenue allowances and reserves | |
| 82 | | |
| 246 | |
Other | |
| 372 | | |
| 829 | |
Total | |
$ | 10,864 | | |
$ | 9,654 | |
|
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v3.23.3
Income Taxes (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Income Tax Disclosure [Abstract] |
|
Schedule of Effective Income Tax Rate Reconciliation |
A
reconciliation of the expected income tax (benefit) computed using the federal statutory income tax rate to the Company’s effective
income tax rate is as follows:
Schedule of Effective Income Tax Rate Reconciliation
| |
2022 | | |
2021 | |
| |
Year ended December 31, | |
| |
2022 | | |
2021 | |
| |
| | |
| |
Income tax computed at federal statutory tax rate | |
| 21.00 | % | |
| 21.00 | % |
State taxes | |
| (5.85 | )% | |
| (0.09 | )% |
Permanent differences – non-deductible expenses | |
| (37.93 | )% | |
| (1.03 | )% |
Change in fair value of contingent consideration | |
| 133.62 | % | |
| 0.78 | % |
Change in fair value of warrant liabilities | |
| 576.27 | % | |
| (7.13 | )% |
True-ups | |
| (7.42 | )% | |
| - | |
Change in valuation allowance | |
| (685.54 | )% | |
| (13.62 | )% |
Effective income tax rate | |
| (5.85 | )% | |
| (0.09 | )% |
|
Schedule of Deferred Tax Assets and Liabilities |
The
principal components of the Company’s deferred tax assets and liabilities consist of the following at December 31, 2022 and 2021:
Schedule
of Deferred Tax Assets and Liabilities
(in thousands) | |
December 31,
2022 | | |
December 31,
2021 | |
Deferred tax assets (liabilities): | |
| | | |
| | |
Net operating loss carryforwards | |
$ | 30,450 | | |
$ | 24,307 | |
Intangible assets | |
| 4,824 | | |
| 5,132 | |
Acquisition contract liabilities | |
| (96 | ) | |
| (187 | ) |
Property and equipment | |
| 123 | | |
| 103 | |
Accrued expenses and reserves | |
| 890 | | |
| 1,693 | |
Stock based compensation | |
| 449 | | |
| - | |
Lease liability | |
| 361 | | |
| - | |
Other | |
| - | | |
| 6 | |
ROU asset | |
| (369 | ) | |
| - | |
Investment revaluation | |
| (469 | ) | |
| - | |
Total deferred tax assets | |
| 36,163 | | |
| 31,054 | |
Less valuation allowance | |
| (36,163 | ) | |
| (31,054 | ) |
Net deferred taxes | |
$ | - | | |
$ | - | |
|
X |
- DefinitionTabular disclosure of the components of net deferred tax asset or liability recognized in an entity's statement of financial position, including the following: the total of all deferred tax liabilities, the total of all deferred tax assets, the total valuation allowance recognized for deferred tax assets.
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v3.23.3
Stockholders’ Equity (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Equity [Abstract] |
|
Schedule of Warrants |
Warrants –
The following table summarizes information with regard to the IPO Warrants, and the PIPE
Warrants, which includes the Inducement and 2022 Pre-Funded Warrants (together, the “Warrants”) share activity
for the year ended December 31, 2022:
Schedule
of Warrants
| |
Warrant -
PIPE | | |
Warrant -
IPO* | | |
Total
Warrants | | |
Weighted Average Exercise Price | |
Balance, December 31, 2020 | |
| - | | |
| - | | |
| - | | |
$ | - | |
Issued | |
| 218,214 | | |
| 207,000 | | |
| 425,214 | | |
| 102.57 | |
Exercised | |
| (75,357 | ) | |
| (132,380 | ) | |
| (207,737 | ) | |
| 100.14 | |
Balance, December 31, 2021 | |
| 142,857 | | |
| 74,620 | | |
| 217,477 | | |
| 99.69 | |
Issued | |
| 463,686 | | |
| - | | |
| 463,686 | | |
| 35.77 | |
Exercised | |
| (221,307 | ) | |
| - | | |
| (221,307 | ) | |
| 20.92 | |
Balance, December 31, 2022 | |
| 385,236 | | |
| 74,620 | | |
| 459,856 | | |
$ | 52.29
| |
|
* |
Every 20 IPO warrants are exercisable for one share of Common Stock at
an exercise price of $100.00 per share of Common Stock. For financial statement purposes, the warrant shares have been decreased by a
factor of 20 to effectively reflect the 1-for-20 reverse stock split. Refer to Note 26. Subsequent Events – Reverse Stock
Split. However, prices reflected on The Nasdaq Stock Market, for ticker BRIW warrants are the presplit price. |
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v3.23.3
Equity Incentive Plans and Share-Based Payments (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Options Assumptions |
The
fair value of each option was estimated on the date of the grant using the BSM option pricing model with the following assumptions:
Schedule of Stock Options Assumptions
|
|
2022 |
|
|
2021 |
|
Expected volatility |
|
|
55% -70 |
% |
|
|
55.0 |
% |
Expected term (in years) |
|
|
5.24 - 6.0 |
|
|
|
6.0 |
|
Risk-free interest rate |
|
|
1.34% - 4.10 |
% |
|
|
1.34 |
% |
Expected dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
Schedule of Stock Option Activity |
Options
outstanding and exercisable under the employee share option plan as of December 31, 2022 and December 2021, and a summary of option activity during
the year 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, 2020 | |
| - | | |
$ | - | | |
| | | |
| | |
Granted | |
| 30,942 | | |
$ | 95.40 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (205 | ) | |
$ | 95.40 | | |
| | | |
| | |
Outstanding at December 31, 2021 | |
| 30,737 | | |
$ | 95.40 | | |
| 9.94 | | |
$ | 1,691 | |
Granted | |
| 64,572 | | |
$ | 48.20 | | |
| | | |
| | |
Exercised | |
| - | | |
$ | - | | |
| | | |
| | |
Canceled or forfeited | |
| (8,358 | ) | |
$ | 76.11 | | |
| | | |
| | |
Outstanding at December 31, 2022 | |
| 86,951 | | |
$ | 62.16 | | |
| 9.27 | | |
$ | 1 | |
Exercisable at December 31, 2022 | |
| 11,166 | | |
$ | 85.48 | | |
| 8.99 | | |
$ | - | |
|
(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 December 31, 2022 and December 31, 2021. |
|
Schedule of Restricted Stock Units |
The
following table summarizes the activity for RSUs during the year ended December 31, 2022 and December 31, 2021:
Schedule
of Restricted Stock Units
| |
Shares | | |
Weighted Average Grant Date Fair Value | |
Outstanding balance at December 31, 2020 | |
| - | | |
$ | - | |
Granted | |
| 8,504 | | |
| 95.40 | |
Issued | |
| - | | |
| - | |
Forfeited | |
| - | | |
| - | |
Outstanding balance at December 31, 2021 | |
| 8,504 | | |
$ | 95.40 | |
Awarded | |
| 17,176 | | |
| 52.20 | |
Issued | |
| (8,504 | ) | |
| 95.40 | |
Forfeited | |
| - | | |
| - | |
Outstanding balance at December 31, 2022 | |
| 17,176 | | |
$ | 52.20 | |
|
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v3.23.3
Interest Expense, net (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Schedule of Interest Expense |
Interest
expense, net consists of the following:
Schedule of Interest Expense
| |
| | | |
| | |
| |
For years ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Interest expense | |
| (12 | ) | |
| (2 | ) |
Contract asset interest expense | |
| (358 | ) | |
| (358 | ) |
Interest income- related party | |
| 165 | | |
| - | |
Interest income – other | |
| 10 | | |
| 16 | |
Interest income | |
| 10 | | |
| 16 | |
Interest expense, net | |
$ | (195 | ) | |
$ | (344 | ) |
|
X |
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v3.23.3
Other Income, net (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Other Income and Expenses [Abstract] |
|
Schedule of Other Income, Net |
Other
income, net consists of the following:
Schedule of Other Income, Net
| |
| | | |
| | |
| |
For years ended December 31, | |
(in thousands) | |
2022 | | |
2021 | |
Reimbursed SPA costs | |
$ | - | | |
$ | 539 | |
Other, net | |
| 33 | | |
| 150 | |
Other income, net | |
$ | 33 | | |
$ | 689 | |
|
X |
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v3.23.3
Net Loss per Share (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Loss per common share: |
|
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders |
Basic
and diluted net loss per share attributable to common stockholders is calculated as follows (in thousands, except share and per share
amounts):
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders
| |
| | | |
| | |
| |
For years ended December 31, | |
| |
2022 | | |
2021 | |
Net loss | |
$ | (640 | ) | |
$ | (37,713 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 1,056,988 | | |
| 440,412 | |
Net loss per share, basic and diluted | |
$ | (0.61 | ) | |
$ | (85.63 | ) |
|
Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share |
The following table sets forth 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
| |
| | | |
| | |
December 31, | |
2022 | | |
2021 | |
Common stock warrants | |
| 459,856 | | |
| 217,477 | |
Common stock options and RSUs | |
| 104,127 | | |
| 39,241 | |
Unit Purchase Options | |
| 20,182 | | |
| 20,182 | |
Anti-dilutive securities excluded from computation of earnings per share | |
| 403,628 | | |
| 403,628 | |
|
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v3.23.3
Commitments and Contingencies (Tables)
|
12 Months Ended |
Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of Components of Lease Expense and Other Information |
The
components of lease expense for the year ended December 31, 2022 was as follows (in thousands except lease term and discount rate):
Schedule
of Components of Lease Expense and Other Information
Lease expense | |
Operating Leases | |
Amortization of ROU assets (operating lease cost) | |
$ | 653 | |
Interest on lease liabilities | |
| 99 | |
Total lease expense | |
$ | 752 | |
Other Information | |
| |
Operational cash flow used for operating leases | |
$ | 781 | |
ROU assets obtained in exchange for lease liabilities | |
| 234 | |
Weighted -average remaining lease term (in years) | |
| 2.54 | |
Weighted -average discount rate | |
| 6.31 | % |
| |
| | |
|
Schedule of Future Commitments and Sublease Income |
Future
lease payments under non-cancelable leases as of December 31, 2022 were as follows (in thousands):
Schedule of Future Commitments and Sublease Income
Years ending December 31, | |
Future lease commitments | |
2023 | |
| 565 | |
2024 | |
| 541 | |
2025 | |
| 349 | |
Thereafter | |
| - | |
Total future minimum lease payments | |
$ | 1,455 | |
Less imputed interest | |
$ | (109 | ) |
Total lease liability | |
$ | 1,346 | |
|
Schedule of Operating Lease Liability |
Schedule
of Operating Lease Liability
Reported as: | |
| |
Operating lease liability, current | |
$ | 498 | |
Operating lease liability, non-current | |
| 848 | |
Total | |
| 1,346 | |
|
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v3.23.3
Organization and Business Overview (Details Narrative) - USD ($) $ in Thousands |
12 Months Ended |
|
Dec. 31, 2022 |
Dec. 31, 2021 |
Sep. 30, 2023 |
Proceeds from issuance of common stock and warrants in private placement |
$ 9,391
|
$ 14,995
|
|
Proceeds from stock issuance |
|
14,943
|
|
Cash and cash equivalents, at carrying value |
17,208
|
24,545
|
|
Cash |
16,800
|
|
$ 3,100
|
Net Cash Provided by (Used in) Operating Activities |
16,199
|
26,715
|
|
Retained Earnings (Accumulated Deficit) |
79,519
|
78,879
|
|
Business Combination, Contingent Consideration, Liability |
9,342
|
$ 12,784
|
|
Maruho Co. Ltd. [Member] |
|
|
|
Business Combination, Contingent Consideration, Liability |
7,300
|
|
|
Common Stock [Member] |
|
|
|
Proceeds from stock issuance |
$ 4,600
|
|
|
X |
- DefinitionAmount of liability recognized arising from contingent consideration in a business combination.
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v3.23.3
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
|
|
12 Months Ended |
|
|
|
Jul. 03, 2023 |
Jan. 01, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Sep. 30, 2023 |
Dec. 01, 2021 |
Dec. 21, 2020 |
Product Information [Line Items] |
|
|
|
|
|
|
|
Stock split |
1-for-20
|
|
|
|
|
|
|
Stock price |
$ 0.001
|
|
$ 0.001
|
$ 0.001
|
|
$ 0.001
|
$ 0.001
|
Cash FDIC insured amount |
|
|
$ 250,000
|
|
|
|
|
Cash |
|
|
$ 16,800,000
|
|
$ 3,100,000
|
|
|
Concentration risk license, descriptions |
|
|
Other
receivables, related party consists of a receivable due from Biofrontera AG for its 50% share of a legal settlement and related
costs for which they are jointly and severally liable for the total settlement amount. The Company has a contractual right to
repayment of its share of the settlement payment from Biofrontera AG under the Settlement Allocation Agreement entered into on
December 9, 2021, which provided that the settlement payments would first be made by the Company and then reimbursed by Biofrontera
AG for its share. Although this receivable has credit risk, it is mitigated by the Settlement Allocation Agreement as amended on
March 31, 2022, which provides certain remedies to the Company, if Biofrontera AG fails to make timely reimbursements, which the
Company may implement in its sole discretion, including the ability to charge interest at a rate of 6.0% per annum for each day that
any reimbursement is past due and the ability to offset any overdue reimbursement amounts against payments owed to Biofrontera AG by
the Company
|
|
|
|
|
Operating lease right of use asset |
|
$ 1,800,000
|
$ 1,375,000
|
|
|
|
|
Operating lease liability |
|
$ 1,800,000
|
$ 1,346,000
|
|
|
|
|
Credit rating description |
|
Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for lease liabilities at inception and 8.5% for 2022 lease liabilities
|
Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for leased liabilities at inception and 8.5% for 2022 leased liabilities
|
|
|
|
|
Weighting of volatility rate input |
|
|
|
55.00%
|
|
|
|
Dividend rate |
|
|
0.00%
|
0.00%
|
|
|
|
Advertising costs |
|
|
$ 100,000
|
$ 500,000
|
|
|
|
Re-Levered Equity [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Weighting of volatility rate input |
|
|
80.00%
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Weighting of volatility rate input |
|
|
20.00%
|
|
|
|
|
Logistics and Distribution [Member] |
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
Logistics and distribution costs |
|
|
$ 500,000
|
$ 400,000
|
|
|
|
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v3.23.3
Schedule of Acquisition Contract Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Start-up cost financing |
$ 7,300
|
$ 7,300
|
|
Contract asset |
(358)
|
(716)
|
|
Acquisition contract liabilities, net |
6,942
|
3,242
|
|
Contingent consideration |
2,400
|
6,200
|
$ 7,602
|
Acquisition contract liabilities, net |
2,400
|
9,542
|
|
Total acquisition contract liabilities, net |
9,342
|
12,784
|
|
Short-Term Debt [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Start-up cost financing |
7,300
|
3,600
|
|
Contract asset |
(358)
|
(358)
|
|
Acquisition contract liabilities, net |
6,942
|
3,242
|
|
Long-Term Debt [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Start-up cost financing |
|
3,700
|
|
Contract asset |
|
(358)
|
|
Contingent consideration |
2,400
|
6,200
|
|
Acquisition contract liabilities, net |
$ 2,400
|
$ 9,542
|
|
X |
- DefinitionAmount of liability recognized from contingent consideration in asset acquisition.
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v3.23.3
Schedule of Fair Value Hierarchy Valuation Inputs (Details) - USD ($) $ in Thousands |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Warrant liability - Purchase Warrants |
$ 2,843
|
$ 12,854
|
|
Fair Value, Inputs, Level 1 [Member] | Related Party [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Investment, related party |
10,548
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Contingent Consideration |
2,400
|
6,200
|
|
Fair Value, Inputs, Level 3 [Member] | Warrant Liability - 2021 Common Warrant [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Warrant liability - Purchase Warrants |
|
12,854
|
|
Fair Value, Inputs, Level 3 [Member] | Warrant Liability - 2022 Common Warrant [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Warrant liability - Purchase Warrants |
1,129
|
|
|
Fair Value, Inputs, Level 3 [Member] | Two Thousand Twenty Two Inducement Warrant [Member] |
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
Warrant liability |
$ 1,714
|
|
|
X |
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v3.23.3
Schedule of Fair Value of Contingent Consideration (Details) - USD ($) $ in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Fair Value Disclosures [Abstract] |
|
|
Beginning balance, fair value of contingent consideration |
$ 6,200
|
$ 7,602
|
Change in fair value of contingent consideration |
(3,800)
|
(1,402)
|
Ending balance, fair value of contingent consideration |
$ 2,400
|
$ 6,200
|
X |
- DefinitionAmount of liability recognized from contingent consideration in asset acquisition.
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v3.23.3
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions (Details)
|
Dec. 31, 2022
$ / shares
|
Jul. 26, 2022
$ / shares
|
May 16, 2022
$ / shares
|
Dec. 31, 2021
$ / shares
|
Dec. 01, 2021
$ / shares
|
Measurement Input, Share Price [Member] | Twenty Twenty One Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Stock price |
|
|
|
$ 150.40
|
$ 86.60
|
Measurement Input, Share Price [Member] | Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Stock price |
$ 18.40
|
|
$ 52.40
|
|
|
Measurement Input, Share Price [Member] | Inducement Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Stock price |
$ 18.40
|
$ 32.80
|
|
|
|
Measurement Input, Expected Term [Member] | Twenty Twenty One Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Expiration term (in years) |
|
|
|
4 years 11 months 1 day
|
5 years
|
Measurement Input, Expected Term [Member] | Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Expiration term (in years) |
4 years 10 months 17 days
|
|
5 years 6 months
|
|
|
Measurement Input, Expected Term [Member] | Inducement Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Expiration term (in years) |
3 years 11 months 1 day
|
4 years 4 months 2 days
|
|
|
|
Measurement Input, Option Volatility [Member] | Twenty Twenty One Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
|
|
|
60.0
|
60.0
|
Measurement Input, Option Volatility [Member] | Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
70
|
|
65.0
|
|
|
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|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
75
|
70.0
|
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | Twenty Twenty One Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
|
|
|
1.25
|
1.15
|
Measurement Input, Risk Free Interest Rate [Member] | Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
3.96
|
|
2.83
|
|
|
Measurement Input, Risk Free Interest Rate [Member] | Inducement Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
4.07
|
2.84
|
|
|
|
Measurement Input, Expected Dividend Payment [Member] | Twenty Twenty One Purchase Warrants [Member] |
|
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
|
Warrant outstanding, measurement input |
|
|
|
0.0
|
0.0
|
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|
|
|
|
|
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|
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0.0
|
|
0.0
|
|
|
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|
|
|
|
|
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|
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|
|
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0.0
|
0.0
|
|
|
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v3.23.3
Schedule of Changes in Fair Value Warrant Liabilities (Details) - USD ($) $ in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Fair Value Disclosures [Abstract] |
|
|
Fair value at beginning of year |
$ 12,854
|
|
Issuance of new warrants |
13,217
|
12,261
|
Exercise of warrants |
(6,840)
|
(12,208)
|
Change in fair value of warrant liability |
(19,017)
|
12,801
|
Warrant inducement expense |
2,629
|
|
Fair value at end of year |
$ 2,843
|
$ 12,854
|
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v3.23.3
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- DefinitionAmount of increase (decrease) in the value of a contingent consideration liability, including, but not limited to, differences arising upon settlement.
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v3.23.3
Schedule of Revenue Allowance and Accrual Activities (Details) - USD ($) $ in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Disaggregation of Revenue [Line Items] |
|
|
Balance at December 31, 2021 |
$ 246
|
$ 327
|
Provision related to current period sales |
813
|
637
|
Credit or payments made during the period |
(977)
|
(718)
|
Balance at December 31, 2022 |
82
|
246
|
Returns [Member] |
|
|
Disaggregation of Revenue [Line Items] |
|
|
Balance at December 31, 2021 |
43
|
217
|
Provision related to current period sales |
10
|
6
|
Credit or payments made during the period |
(5)
|
(180)
|
Balance at December 31, 2022 |
48
|
43
|
Co-pay Assistance Program [Member] |
|
|
Disaggregation of Revenue [Line Items] |
|
|
Balance at December 31, 2021 |
101
|
52
|
Provision related to current period sales |
574
|
423
|
Credit or payments made during the period |
(666)
|
(374)
|
Balance at December 31, 2022 |
9
|
101
|
Prompt Pay Discounts [Member] |
|
|
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|
|
Balance at December 31, 2021 |
48
|
15
|
Provision related to current period sales |
19
|
40
|
Credit or payments made during the period |
(62)
|
(7)
|
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5
|
48
|
Government and Payor Rebates [Member] |
|
|
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|
|
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54
|
43
|
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210
|
168
|
Credit or payments made during the period |
(244)
|
(157)
|
Balance at December 31, 2022 |
$ 20
|
$ 54
|
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v3.23.3
Investment, (Details Narrative) - Private Exchange Agreement [Member] - € / shares
|
Dec. 31, 2022 |
Nov. 08, 2022 |
Oct. 25, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Share Price |
|
|
€ 1.00
|
Conversion of Stock, Shares Issued |
|
|
157,042
|
[custom:StockIssuedDuringPeriodSharesPurchasedThroughExerciseOfOptions] |
6,446,946
|
2,623,365
|
|
[custom:AdditionalNumberOfSharesPurchasedThroughExerciseOfOptions] |
3,843,581
|
|
|
[custom:OutstandingSharesPercent-0] |
10.00%
|
|
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v3.23.3
Other Receivables, Related Party (Details Narrative) - USD ($) $ in Thousands |
|
12 Months Ended |
|
Nov. 29, 2021 |
Dec. 31, 2021 |
Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Other receivables related party, short term |
|
$ 3,784
|
$ 3,748
|
Legal settlements receivable percentage |
|
|
50.00%
|
Legal settlements |
$ 22,500
|
|
|
Biofrontera AG [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Other receivables related party, short term |
|
|
$ 3,700
|
Other receivables related party, long term |
|
|
2,800
|
Due from related party |
|
|
$ 6,100
|
Debt Instrument, Interest Rate, Stated Percentage |
|
|
6.00%
|
Service Agreements [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Other receivables related party |
|
|
$ 6,500
|
Due from related party |
|
|
$ 6,400
|
Legal settlements |
|
11,300
|
|
Legal settlements in short-term |
|
$ 2,800
|
|
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v3.23.3
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Dec. 31, 2022 |
Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 711
|
$ 673
|
Less: Accumulated depreciation |
(507)
|
(406)
|
Property and equipment, net |
204
|
267
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
89
|
85
|
Computer Software, Intangible Asset [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
27
|
27
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
81
|
81
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
368
|
368
|
Machinery and Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 146
|
$ 112
|
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v3.23.3
v3.23.3
Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands |
Dec. 31, 2022 |
Dec. 31, 2021 |
Income Tax Disclosure [Abstract] |
|
|
Net operating loss carryforwards |
$ 30,450
|
$ 24,307
|
Intangible assets |
4,824
|
5,132
|
Acquisition contract liabilities |
(96)
|
(187)
|
Property and equipment |
123
|
103
|
Accrued expenses and reserves |
890
|
1,693
|
Stock based compensation |
449
|
|
Lease liability |
361
|
|
Other |
|
6
|
ROU asset |
(369)
|
|
Investment revaluation |
(469)
|
|
Total deferred tax assets |
36,163
|
31,054
|
Less valuation allowance |
(36,163)
|
(31,054)
|
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|
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v3.23.3
Income Taxes (Details Narrative) - USD ($)
|
24 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Operating Loss Carryforwards [Line Items] |
|
|
Provision for federal income taxes |
$ 0
|
$ 0
|
Unrecognized tax benefits |
0
|
0
|
Operating Loss Carryforwards, Valuation Allowance |
5,100,000
|
|
Domestic Tax Authority [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Operating loss carryforward |
123,400,000
|
|
Operating loss carryforward not subject to expiration |
|
$ 113,800,000
|
State and Local Jurisdiction [Member] |
|
|
Operating Loss Carryforwards [Line Items] |
|
|
Operating loss carryforward |
$ 89,200,000
|
|
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v3.23.3
Related Party Transactions (Details Narrative) - USD ($)
|
|
|
12 Months Ended |
Nov. 03, 2022 |
Oct. 08, 2021 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Related Party Transaction [Line Items] |
|
|
|
|
Revenue from sales |
|
|
$ 28,674,000
|
$ 24,100,000
|
Other Operating Income |
|
|
|
500,000
|
Loss Contingency, Receivable |
|
|
$ 6,200,000
|
|
Legal settlements receivable percentage |
|
|
50.00%
|
|
Biofrontera AG [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Other Receivables |
|
|
$ 6,100,000
|
|
Loss Contingency, Receivable |
|
|
6,400,000
|
11,300,000
|
Interest Income, Operating |
|
|
100,000
|
0.0
|
License and Supply Agreement [Member] | Biofrontera Pharma GmbH [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Related party costs |
|
|
16,600,000
|
9,400,000
|
Accounts payable related parties |
|
|
1,300,000
|
300,000
|
License and Supply Agreement [Member] | Fifty Percent Of Anticipated Net Price [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Revenue from sales |
|
$ 30,000,000
|
|
|
License and Supply Agreement [Member] | Forty Percent Of Anticipated Net Price [Member] | Minimum [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Revenue from sales |
|
30,000,000
|
|
|
License and Supply Agreement [Member] | Forty Percent Of Anticipated Net Price [Member] | Maximum [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Revenue from sales |
|
50,000,000
|
|
|
License and Supply Agreement [Member] | Thirty Percent Of Anticipated Net Price [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Revenue from sales |
|
$ 50,000,000
|
|
|
Service Agreements [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Accounts Receivable, after Allowance for Credit Loss |
|
|
6,500,000
|
|
Other Receivables |
|
|
6,400,000
|
|
Service Agreements [Member] | Biofrontera AG [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Accounts payable related parties |
|
|
200,000
|
200,000
|
Expenses related to service |
|
|
700,000
|
700,000
|
Clinica Lamp Lease Agreement [Member] | Biofrontera Pharma GmbH [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Revenue from sales |
|
|
100,000
|
100,000
|
Accounts Receivable, after Allowance for Credit Loss |
|
|
100,000
|
100,000
|
Cutanea Acquisition Agreement [Member] | Maruho Co, Ltd. [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Accounts Receivable, after Allowance for Credit Loss |
|
|
|
$ 100,000
|
Other Receivables |
|
|
0
|
|
Share Purchase and Transfer Agreement [Member] | Maruho Co, Ltd. [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
[custom:StockIssuedDuringPeriodValuesInvestmentInEquitySecurities] |
|
|
$ 10,500,000
|
|
[custom:StockIssuedDuringPeriodSharesInvestmentInEquitySecurities] |
|
|
6,466,949
|
|
[custom:StockIssuedDuringPeriodSharesPurchase] |
1,674,996
|
|
|
|
[custom:TotalNumberOfSharesPurchased] |
6,466,946
|
|
|
|
[custom:StockIssuedDuringPeriodValuesPurchase] |
$ 1,700,000
|
|
|
|
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- DefinitionAmount of other expenses associated with exit or disposal activities pursuant to an authorized plan. Excludes expenses associated with a discontinued operation or an asset retirement obligation.
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v3.23.3
Schedule of Warrants (Details) - $ / shares
|
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Balance |
|
217,477
|
|
Weighted Average Exercise Price Balance |
|
$ 99.69
|
|
Warrants issued |
|
463,686
|
425,214
|
Weighted Average Exercise Price of Warrants issued |
|
$ 35.77
|
$ 102.57
|
Warrants exercised |
|
(221,307)
|
(207,737)
|
Weighted Average Exercise Price of Warrants exercised |
|
$ 20.92
|
$ 100.14
|
Balance |
|
459,856
|
217,477
|
Weighted Average Exercise Price Balance |
|
$ 52.29
|
$ 99.69
|
PIPE [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Balance |
|
142,857
|
|
Warrants issued |
|
463,686
|
218,214
|
Warrants exercised |
|
(221,307)
|
(75,357)
|
Balance |
|
385,236
|
142,857
|
IPO [Member] |
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
Balance |
[1] |
74,620
|
|
Warrants issued |
[1] |
|
207,000
|
Warrants exercised |
[1] |
|
(132,380)
|
Balance |
[1] |
74,620
|
74,620
|
|
|
X |
- DefinitionWeighted average price at which grantees can acquire the shares reserved for issuance under the stock non-option equity plan.
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v3.23.3
Stockholders’ Equity (Details Narrative)
|
|
|
|
|
|
1 Months Ended |
12 Months Ended |
|
|
|
|
|
|
Oct. 25, 2022
€ / shares
shares
|
Jul. 26, 2022
USD ($)
$ / shares
shares
|
Dec. 31, 2021
USD ($)
$ / shares
shares
|
Dec. 02, 2021
USD ($)
$ / shares
shares
|
Nov. 02, 2021
USD ($)
$ / shares
shares
|
May 16, 2022
USD ($)
$ / shares
shares
|
Dec. 31, 2022
USD ($)
$ / shares
shares
|
Dec. 31, 2021
USD ($)
$ / shares
shares
|
Jul. 03, 2023
$ / shares
|
Oct. 13, 2022
$ / shares
shares
|
Jul. 14, 2022
$ / shares
shares
|
Dec. 28, 2021
$ / shares
shares
|
Dec. 01, 2021
$ / shares
|
Dec. 21, 2020
$ / shares
shares
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock shares authorized | shares |
|
|
15,000,000
|
|
|
|
15,000,000
|
15,000,000
|
|
|
|
|
|
15,000,000
|
Common stock, par or stated value per share |
|
|
$ 0.001
|
|
|
|
$ 0.001
|
$ 0.001
|
$ 0.001
|
|
|
|
$ 0.001
|
$ 0.001
|
Preferred stock designated | shares |
|
|
20,000,000
|
|
|
|
20,000,000
|
20,000,000
|
|
|
|
|
|
20,000,000
|
Preferred stock par value |
|
|
$ 0.001
|
|
|
|
$ 0.001
|
$ 0.001
|
|
$ 0.001
|
|
|
|
$ 0.001
|
Stock issued during period, shares, new issues | shares |
|
214,286
|
|
|
|
|
|
|
|
|
|
|
|
|
Share exercise price |
|
|
|
|
|
|
|
|
|
$ 5.00
|
|
|
|
|
Expected volatility |
|
|
|
|
|
|
|
55.00%
|
|
|
|
|
|
|
Risk free rate |
|
|
|
|
|
|
|
1.34%
|
|
|
|
|
|
|
Contractual term |
|
|
|
|
|
|
|
6 years
|
|
|
|
|
|
|
Dividend yield |
|
|
|
|
|
|
0.00%
|
0.00%
|
|
|
|
|
|
|
Proceeds from issuance of private placement | $ |
|
|
|
|
|
|
$ 9,391,000
|
$ 14,995,000
|
|
|
|
|
|
|
Common stock shares isued | shares |
|
|
855,237
|
|
|
|
1,334,950
|
855,237
|
|
|
|
|
|
|
Class of warrant or right, number of securities called by each warrant or right | shares |
|
142,858
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from warrant exercises | $ |
|
$ 4,600,000
|
|
|
|
|
$ 4,630,000
|
$ 13,253,000
|
|
|
|
|
|
|
Warrant inducement expense | $ |
|
|
|
|
|
|
$ 2,629,000
|
|
|
|
|
|
|
|
Senior A Junior Participating Cumulative Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock designated | shares |
|
|
|
|
|
|
|
|
|
5,000
|
|
|
|
|
Investor [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance costs | $ |
|
$ 300,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
$ 105.00
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual term |
|
|
|
|
|
|
6 years
|
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
32.40
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual term |
|
|
|
|
|
|
5 years 2 months 26 days
|
|
|
|
|
|
|
|
2022 Pre-Funded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant term |
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
|
|
$ 55.40
|
|
|
|
|
|
|
|
|
Warrant purchase, common stock | shares |
|
|
|
|
|
78,450
|
|
|
|
|
|
|
|
|
Prefunded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
|
|
$ 0.02
|
|
|
|
|
|
|
|
|
May 2022 PIPE [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of private placement | $ |
|
|
|
|
|
$ 9,400,000
|
|
|
|
|
|
|
|
|
Private Exchange Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price | € / shares |
€ 1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Stock, Shares Issued | shares |
157,042
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant term |
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
Expected volatility |
|
|
|
|
|
|
20.00%
|
|
|
|
|
|
|
|
Warrant [Member] | Inducement Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price per shares |
|
$ 33.20
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants rights exercisable date |
|
Jan. 27, 2023
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant expiration date |
|
Dec. 01, 2026
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues | shares |
|
|
|
|
|
|
157,402
|
180,000
|
|
|
|
|
|
|
Common Stock [Member] | 2022 Pre-Funded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price per shares |
|
|
|
|
|
|
|
|
|
|
$ 0.02
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
|
|
$ 55.00
|
|
|
|
|
|
|
|
|
Common stock shares isued | shares |
|
|
|
|
|
|
|
|
|
|
78,450
|
|
|
|
Common Stock [Member] | Private Exchange Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Stock, Shares Issued | shares |
3,148,042
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant purchase, common stock | shares |
|
|
|
|
|
|
|
|
|
|
|
4,286
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock, par or stated value per share |
|
|
|
|
$ 0.001
|
|
|
|
|
|
|
|
|
|
Number of shares sold | shares |
|
|
|
|
180,000
|
|
|
|
|
|
|
|
|
|
Share price per shares |
|
|
|
|
$ 100.00
|
|
|
|
|
|
|
|
|
|
Proceeds from IPO | $ |
|
|
|
|
$ 18,000,000
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance costs | $ |
|
|
$ 3,100,000
|
|
|
|
|
$ 3,100,000
|
|
|
|
|
|
|
IPO [Member] | Black Scholes Option Pricing Model [Member] | UPO Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants and Rights Outstanding | $ |
|
|
|
|
|
|
$ 21,000
|
|
|
|
|
|
|
|
IPO [Member] | Black Schole Option Pricing Model [Member] | UPO Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share fair value of share-based payment award |
|
|
|
|
|
|
$ 25.80
|
|
|
|
|
|
|
|
Expected volatility |
|
|
|
|
|
|
60.00%
|
|
|
|
|
|
|
|
Risk free rate |
|
|
|
|
|
|
1.15%
|
|
|
|
|
|
|
|
Contractual term |
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
Dividend yield |
|
|
|
|
|
|
0.00%
|
|
|
|
|
|
|
|
IPO [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
|
$ 100.00
|
|
|
|
|
|
|
|
|
|
Over-Allotment Option [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
|
$ 0.20
|
|
|
|
|
|
|
|
|
|
Warrant purchase, common stock | shares |
|
|
|
|
27,000
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues | shares |
|
|
|
|
810
|
|
|
|
|
|
|
|
|
|
Share exercise price |
|
|
|
|
$ 0.25
|
|
|
|
|
|
|
|
|
|
Over-Allotment Option [Member] | Unit Purchase Options [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues | shares |
|
|
|
|
5,400
|
|
|
|
|
|
|
|
|
|
Share exercise price |
|
|
|
|
$ 125.00
|
|
|
|
|
|
|
|
|
|
UPO [Member] | Black Scholes Option Pricing Model [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity, Fair Value Disclosure | $ |
|
|
|
|
|
|
$ 300,000
|
|
|
|
|
|
|
|
UPO [Member] | Black Schole Option Pricing Model [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share fair value of share-based payment award |
|
|
|
|
|
|
$ 99
|
|
|
|
|
|
|
|
Expected volatility |
|
|
|
|
|
|
60.00%
|
|
|
|
|
|
|
|
Risk free rate |
|
|
|
|
|
|
1.15%
|
|
|
|
|
|
|
|
Contractual term |
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
Dividend yield |
|
|
|
|
|
|
0.00%
|
|
|
|
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance costs | $ |
|
|
|
|
|
|
|
$ 300,000
|
|
|
|
|
|
|
Proceeds from issuance of private placement | $ |
|
|
|
$ 15,000,000
|
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] | 2022 Purchase Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant purchase, common stock | shares |
|
|
|
|
|
170,950
|
|
|
|
|
|
|
|
|
Private Placement [Member] | Purchase Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
$ 105.00
|
|
|
|
|
|
|
|
|
|
|
Warrant purchase, common stock | shares |
|
|
|
142,857
|
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] | Prefunded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
|
$ 0.002
|
|
|
|
|
|
|
|
$ 0.002
|
|
|
Warrant purchase, common stock | shares |
|
|
|
75,357
|
|
|
|
|
|
|
|
75,357
|
|
|
Sale of stock price per share |
|
|
|
$ 104.80
|
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class of warrant or right, exercise price of warrants or rights |
|
|
$ 131.20
|
|
|
|
|
$ 131.20
|
|
|
|
|
|
|
Private Placement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant term |
|
|
5 years
|
|
|
|
|
5 years
|
|
|
|
|
|
|
Private Placement [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues | shares |
|
|
|
67,500
|
|
|
|
|
|
|
|
|
|
|
Private Placement [Member] | Common Stock [Member] | May 2022 PIPE [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues | shares |
|
|
|
|
|
92,500
|
|
|
|
|
|
|
|
|
PP UPO [Member] | Black Scholes Option Pricing Model [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of options vested | $ |
|
|
|
$ 300,000
|
|
|
|
|
|
|
|
|
|
|
PP UPO [Member] | Black Schole Option Pricing Model [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share fair value of share-based payment award |
|
|
$ 127.80
|
|
|
|
|
$ 127.80
|
|
|
|
|
|
|
Expected volatility |
|
|
|
|
|
|
|
60.00%
|
|
|
|
|
|
|
Risk free rate |
|
|
|
|
|
|
|
1.15%
|
|
|
|
|
|
|
Contractual term |
|
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
Dividend yield |
|
|
|
|
|
|
|
0.00%
|
|
|
|
|
|
|
PP UPO [Member] | Warrant [Member] | Black Scholes Option Pricing Model [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of options vested | $ |
|
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
PP UPO [Member] | Common Stock [Member] | Black Scholes Option Pricing Model [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of options vested | $ |
|
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
|
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v3.23.3
Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Share-Based Payment Arrangement [Abstract] |
|
|
|
Number of Shares Outstanding, Beginning Balance |
|
30,737
|
|
Weighted Average Exercise Price, Beginning Balance |
|
$ 95.40
|
|
Number of Shares Outstanding, Granted |
|
64,572
|
30,942
|
Weighted Average Exercise Price, Granted |
|
$ 48.20
|
$ 95.40
|
Number of Shares Outstanding, Exercised |
|
|
|
Weighted Average Exercise Price, Exercised |
|
|
|
Number of Shares Outstanding, Canceled or forfeited |
|
(8,358)
|
(205)
|
Weighted Average Exercise Price, Canceled or forfeited |
|
$ 76.11
|
$ 95.40
|
Weighted Average Remaining Contractual Life (in Years), Outstanding |
|
9 years 11 months 8 days
|
|
Aggregate Intrinsic Value, Outstanding, Beginning Balance |
[1] |
$ 1,691
|
|
Number of Shares Outstanding, Ending Balance |
|
86,951
|
30,737
|
Weighted Average Exercise Price, Ending Balance |
|
$ 62.16
|
$ 95.40
|
Weighted Average Remaining Contractual Life (in Years), Outstanding |
|
9 years 3 months 7 days
|
|
Aggregate Intrinsic Value, Outstanding, Ending Balance |
[1] |
$ 1
|
$ 1,691
|
Number of Shares Execisable, Ending Balance |
|
11,166
|
|
Weighted Average Exercise Price Options Exercisable, Ending Balance |
|
$ 85.48
|
|
Weighted Average Remaining Contractual Life (in Years), Exercisable |
|
8 years 11 months 26 days
|
|
Aggregate Intrinsic Value, Exercisable, Ending Balance |
[1] |
|
|
|
|
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v3.23.3
Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares
|
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number of shares outstanding, beginning balance |
8,504
|
|
Number of shares weighted average grant date fair value, beginning balance |
$ 95.40
|
|
Number of Shares Outstanding, Awarded/Granted |
17,176
|
8,504
|
Number of shares weighted average grant date fair value, awarded/granted |
$ 52.20
|
$ 95.40
|
Number of Shares Outstanding, Number of Shares Outstanding, Issued |
(8,504)
|
|
Number of shares weighted average grant date fair value, Number of Shares Outstanding, Issued |
$ 95.40
|
|
Number of Shares Outstanding, Forfeited |
|
|
Number of shares weighted average grant date fair value forfeited |
|
|
Number of shares outstanding, ending balance |
17,176
|
8,504
|
Number of shares weighted average grant date fair value, ending balance |
$ 52.20
|
$ 95.40
|
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v3.23.3
Equity Incentive Plans and Share-Based Payments (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
|
12 Months Ended |
Dec. 12, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Grant fair value |
|
$ 29.28
|
$ 49.55
|
Unrecognized compensation cost |
|
$ 2.2
|
|
Compensation cost recognized, weighted average period |
|
2 years 3 months 18 days
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Unrecognized compensation cost |
|
$ 0.6
|
|
Compensation cost recognized, weighted average period |
|
1 year 4 months 24 days
|
|
Share based compensation vested in period, fair value |
|
$ 0.8
|
$ 0.0
|
Selling, General and Administrative Expenses [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Share based compensation expenses |
|
0.8
|
0.8
|
Selling, General and Administrative Expenses [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Share based compensation expenses |
|
$ 1.0
|
$ 0.1
|
Two Thousand Twenty One Omnibus Incentive Plan [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Remain eligible for issuance shares |
|
|
137,500
|
Share-based payment award, terms of award |
|
|
10
years for stock options issued under the 2021 Plan
|
Number of shares available for future issuance |
|
154,359
|
|
Two Thousand Twenty One Omnibus Incentive Plan [Member] | Minimum [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of shares available for future awards, increased |
129,490
|
|
|
Two Thousand Twenty One Omnibus Incentive Plan [Member] | Maximum [Member] |
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
Number of shares available for future awards, increased |
266,990
|
|
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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Dec. 31, 2022 |
Dec. 31, 2021 |
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v3.23.3
Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share (Details) - shares shares in Thousands |
12 Months Ended |
Dec. 31, 2022 |
Dec. 31, 2021 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities excluded from computation of earnings per share |
403,628
|
403,628
|
Common Stock Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities excluded from computation of earnings per share |
459,856
|
217,477
|
Common Stock Options and Restricted Stock Units [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities excluded from computation of earnings per share |
104,127
|
39,241
|
Unit Purchase Options [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities excluded from computation of earnings per share |
20,182
|
20,182
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v3.23.3
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands |
|
|
12 Months Ended |
Jan. 01, 2022 |
Nov. 29, 2021 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Product Liability Contingency [Line Items] |
|
|
|
|
Lease option to extend |
|
|
option to extend
the term of the lease for one five (5) year period
|
|
Credit rating description |
Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for lease liabilities at inception and 8.5% for 2022 lease liabilities
|
|
Based on a synthetic credit rating of Ba3 and a term of 3.33 to six years, the IBR was determined to be 6% for leased liabilities at inception and 8.5% for 2022 leased liabilities
|
|
Revenues |
|
|
$ 28,674
|
$ 24,100
|
Settlements |
|
$ 11,250
|
|
|
Legal proceedings aggregate payment |
|
$ 22,500
|
|
|
Loss contingency receivable |
|
|
6,200
|
|
Maruho Co, Ltd. [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Settlements |
|
|
900
|
|
Xepi LSA [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Contractual Obligation |
|
|
2,000
|
4,000
|
Xepi LSA [Member] | Maximum [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Revenues |
|
|
25,000
|
$ 50,000
|
Maruho Co, Ltd. [Member] | December 31, 2022 [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Repayments of Related Party Debt |
|
|
3,600
|
|
Maruho Co, Ltd. [Member] | December 31, 2023 [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Repayments of Related Party Debt |
|
|
3,700
|
|
Maruho Contract Manufacturer [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Repayments of Related Party Debt |
|
|
7,300
|
|
Facility Leases [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Security deposit |
|
|
$ 100
|
|
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v3.23.3
Subsequent Events (Details Narrative) - USD ($) $ in Millions |
Jul. 03, 2023 |
May 28, 2023 |
May 22, 2023 |
May 08, 2023 |
Apr. 26, 2023 |
Jun. 28, 2023 |
Jun. 27, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Dec. 21, 2020 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock split |
1-for-20
|
|
|
|
|
|
|
|
|
|
Shares authorised |
|
|
|
|
|
|
|
15,000,000
|
15,000,000
|
15,000,000
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Stock split |
|
|
(i) effect a reverse split at a ratio of not less than 1-for-5
and not greater than 1-for-25 and (ii) if and when the reverse stock split is effected, to decrease the number of authorized shares of
the Company’s common stock in the same ratio as is selected for the reverse stock split. The final decision of whether to proceed
with the Amendment shall be determined by our board of directors, in its discretion, at any time prior to August 23, 2023, the deadline
for regaining compliance with Nasdaq Listing Rule 5550(a)
|
|
|
|
|
|
|
|
Shares authorised |
|
|
|
|
|
150,000
|
3,000,000
|
|
|
|
Subsequent Event [Member] | Licensing Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Royalty expense |
|
$ 1.0
|
|
|
|
|
|
|
|
|
Royalty percentage |
|
3.00%
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Computershare Trust Company [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Beneficial ownership description |
|
|
|
|
beneficial ownership before being deemed an Acquiring Person, solely with respect to Biofrontera AG, from 20% to 29.96%
|
|
|
|
|
|
Subsequent Event [Member] | MidCap Business Credit LLC [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Line of Credit Facility, Maximum Borrowing Capacity |
|
|
|
$ 6.5
|
|
|
|
|
|
|
Basis points |
|
|
|
15.00%
|
|
|
|
|
|
|
Interest rate |
|
|
|
2.25%
|
|
|
|
|
|
|
Floor Interest rate |
|
|
|
4.00%
|
|
|
|
|
|
|
Interest rate |
|
|
|
3.00%
|
|
|
|
|
|
|
Unused line fee rate |
|
|
|
0.375%
|
|
|
|
|
|
|
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