Cover
Cover | 9 Months Ended |
Sep. 30, 2023 | |
Entity Addresses [Line Items] | |
Document Type | S-1 |
Amendment Flag | false |
Entity Registrant Name | BIOFRONTERA INC. |
Entity Central Index Key | 0001858685 |
Entity Tax Identification Number | 47-3765675 |
Entity Incorporation, State or Country Code | DE |
Entity Address, Address Line One | 120 Presidential Way |
Entity Address, Address Line Two | Suite 330 |
Entity Address, City or Town | Woburn |
Entity Address, State or Province | MA |
Entity Address, Postal Zip Code | 01801 |
City Area Code | 781 |
Local Phone Number | 245-1325 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | true |
Elected Not To Use the Extended Transition Period | false |
Business Contact [Member] | |
Entity Addresses [Line Items] | |
Entity Address, Address Line One | Biofrontera Inc. |
Entity Address, Address Line Two | 120 Presidential Way |
Entity Address, Address Line Three | Suite 330 |
Entity Address, City or Town | Woburn |
Entity Address, State or Province | MA |
Entity Address, Postal Zip Code | 01801 |
City Area Code | 781 |
Local Phone Number | 245-1325 |
Contact Personnel Name | Prof. Dr. Hermann Luebbert |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | |||
Cash and cash equivalents | $ 3,422 | $ 17,208 | $ 24,545 |
Investment, related party | 10,548 | ||
Accounts receivable, net | 3,793 | 3,748 | 3,784 |
Inventories, net | 16,068 | 7,168 | 4,458 |
Prepaid expenses and other current assets | 274 | 810 | 4,987 |
Total current assets | 29,611 | 43,140 | 46,421 |
Property and equipment, net | 154 | 204 | 267 |
Operating lease right-of-use assets | 1,129 | 1,375 | |
Intangible asset, net | 2,718 | 3,032 | 3,450 |
Other assets | 492 | 320 | 268 |
Total assets | 34,104 | 50,884 | 53,219 |
Current liabilities: | |||
Acquisition contract liabilities, net | 7,211 | 6,942 | 3,242 |
Operating lease liabilities | 555 | 498 | |
Accrued expenses and other current liabilities | 11,039 | 10,864 | 9,654 |
Line of credit | 1,697 | ||
Total current liabilities | 29,124 | 20,894 | 13,836 |
Long-term liabilities: | |||
Acquisition contract liabilities, net | 2,500 | 2,400 | 9,542 |
Warrant liabilities | 842 | 2,843 | 12,854 |
Operating lease liabilities, non-current | 562 | 848 | |
Other liabilities | 38 | 21 | 5,649 |
Total liabilities | 33,066 | 27,006 | 41,881 |
Commitments and contingencies (Note 18) | |||
Stockholders’ equity: | |||
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of September 30, 2023 and December 31, 2022 | |||
Common Stock, $0.001 par value, 15,000,000 shares authorized; 1,367,628 and 1,334,950 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | 1 | 1 | 1 |
Additional paid-in capital | 104,213 | 103,396 | 90,216 |
Accumulated deficit | (103,176) | (79,519) | (78,879) |
Total stockholders’ equity | 1,038 | 23,878 | 11,338 |
Total liabilities and stockholders’ equity | 34,104 | 50,884 | 53,219 |
Related Party [Member] | |||
Current assets: | |||
Investment, related party | 3,341 | 10,548 | |
Other receivables, related party | 2,713 | 3,658 | 8,647 |
Other receivables long term, related party | 2,813 | 2,813 | |
Current liabilities: | |||
Accounts payable | 6,988 | 1,312 | 282 |
Nonrelated Party [Member] | |||
Current liabilities: | |||
Accounts payable | $ 1,634 | $ 1,278 | $ 658 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | |||
Preferred stock par value | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 | 0 |
Common stock par value | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 15,000,000 | 15,000,000 | 15,000,000 |
Common stock, shares issued | 1,367,628 | 1,334,950 | 855,237 |
Common stock, shares outstanding | 1,367,628 | 1,334,950 | 855,237 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||||||
Product revenues, net | $ 8,879 | $ 4,290 | $ 23,423 | $ 18,467 | $ 28,541 | $ 24,043 |
Revenues, related party | 17 | 32 | 52 | 63 | 133 | 57 |
Total revenues, net | 8,896 | 4,322 | 23,475 | 18,530 | 28,674 | 24,100 |
Operating expenses | ||||||
Cost of revenues, related party | 4,495 | 2,127 | 11,814 | 9,504 | 14,618 | 12,222 |
Cost of revenues, other | 95 | 98 | 262 | 425 | 567 | 520 |
Selling, general and administrative | 8,619 | 7,765 | 29,874 | 25,050 | 35,137 | 36,512 |
Selling, general and administrative, related party | 74 | 171 | 193 | 612 | 733 | 697 |
Research and development | 33 | 44 | ||||
Restructuring costs | 752 | |||||
Change in fair value of contingent consideration | 200 | (2,200) | 100 | (4,100) | (3,800) | (1,402) |
Total operating expenses | 13,516 | 7,961 | 42,287 | 31,491 | 47,255 | 49,301 |
Loss from operations | (4,620) | (3,639) | (18,812) | (12,961) | (18,581) | (25,201) |
Other income (expense) | ||||||
Change in fair value of warrant liabilities | 598 | 3,814 | 2,001 | 17,896 | 19,017 | (12,801) |
Warrant inducement expense | (2,629) | (2,629) | (2,629) | |||
Realized/Unrealized losses in investment, related party | (2,212) | (6,635) | 1,747 | |||
Interest expense, net | (142) | (89) | (256) | (160) | (195) | (344) |
Other income, net | 35 | (22) | 65 | 30 | 33 | 689 |
Total other income (expense) | (1,721) | 1,074 | (4,825) | 15,137 | 17,973 | (12,456) |
Income (loss) before income taxes | (6,341) | (2,565) | (23,637) | 2,176 | (608) | (37,657) |
Income tax expense | 1 | 1 | 20 | 31 | 32 | 56 |
Net income (loss) | $ (6,342) | $ (2,566) | $ (23,657) | $ 2,145 | $ (640) | $ (37,713) |
Income (loss) per common share: | ||||||
Basic | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 | $ (0.61) | $ (85.63) |
Diluted | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 | $ (0.61) | $ (85.63) |
Weighted-average common shares outstanding: | ||||||
Basic | 1,366,842 | 1,136,291 | 1,346,264 | 978,018 | 1,056,988,000 | 440,412,000 |
Diluted | 1,366,842 | 1,136,291 | 1,346,264 | 980,251 | 1,056,988,000 | 440,412,000 |
Condensed Consolidated Statem_2
Condensed 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 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 income (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 and warrants under private placement, net of issuance costs | $ 0 | 116 | 116 | |
Issuance of common stock and warrants under private placement, net of issuance costs, shares | 92,500 | |||
Exercise of pre-funded warrants | $ 0 | 2,841 | 2,841 | |
Exercise of pre-funded warrants, shares | 78,450 | |||
Stock based compensation | 1,469 | 1,469 | ||
Net income (loss) | 2,145 | 2,145 | ||
Exercise of PIPE warrants | $ 0 | 4,686 | 4,686 | |
Exercise of PIPE warrants, shares | 142,857 | |||
Issuance of shares for vested restricted stock units | $ 0 | |||
Issuance of shares for vested restricted stock units, shares | 8,504 | |||
Ending balance, value at Sep. 30, 2022 | $ 1 | 99,328 | (76,734) | 22,595 |
Ending balance, shares at Sep. 30, 2022 | 1,177,548 | |||
Beginning balance, value at Dec. 31, 2021 | $ 1 | 90,216 | (78,879) | 11,338 |
Beginning 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 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 income (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 | |||
Beginning balance, value at Jun. 30, 2022 | $ 1 | 91,400 | (74,168) | 17,233 |
Beginning balance, shares at Jun. 30, 2022 | 950,573 | |||
Exercise of pre-funded warrants | $ 0 | 2,841 | 2,841 | |
Exercise of pre-funded warrants, shares | 78,450 | |||
Stock based compensation | 401 | 401 | ||
Net income (loss) | (2,566) | (2,566) | ||
Exercise of PIPE warrants | $ 0 | 4,686 | 4,686 | |
Exercise of PIPE warrants, shares | 142,857 | |||
Issuance of shares for vested restricted stock units | $ 0 | |||
Issuance of shares for vested restricted stock units, shares | 5,668 | |||
Ending balance, value at Sep. 30, 2022 | $ 1 | 99,328 | (76,734) | 22,595 |
Ending balance, shares at Sep. 30, 2022 | 1,177,548 | |||
Beginning balance, value at Dec. 31, 2022 | $ 1 | 103,396 | (79,519) | $ 23,878 |
Beginning balance, shares at Dec. 31, 2022 | 1,334,950 | |||
Exercise of common stock warrants, shares | ||||
Stock based compensation | 817 | $ 817 | ||
Net income (loss) | (23,657) | (23,657) | ||
Issuance of shares for vested restricted stock units | $ 0 | |||
Issuance of shares for vested restricted stock units, shares | 8,588 | |||
Issuance of shares in reverse stock split (for fractional shares) | $ 0 | |||
Issuance of shares in reverse stock split (for fractional shares), shares | 24,090 | |||
Ending balance, value at Sep. 30, 2023 | $ 1 | 104,213 | (103,176) | 1,038 |
Ending balance, shares at Sep. 30, 2023 | 1,367,628 | |||
Beginning balance, value at Jun. 30, 2023 | $ 1 | 104,006 | (96,834) | 7,173 |
Beginning balance, shares at Jun. 30, 2023 | 1,343,538 | |||
Stock based compensation | 207 | 207 | ||
Net income (loss) | (6,342) | (6,342) | ||
Issuance of shares in reverse stock split (for fractional shares) | $ 0 | |||
Issuance of shares in reverse stock split (for fractional shares), shares | 24,090 | |||
Ending balance, value at Sep. 30, 2023 | $ 1 | $ 104,213 | $ (103,176) | $ 1,038 |
Ending balance, shares at Sep. 30, 2023 | 1,367,628 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | |
Nov. 02, 2021 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||
IPO Net issuance cost | $ 3.1 | |
IPO [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
IPO Net issuance cost | $ 3.1 | |
Private Placement [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
IPO Net issuance cost | $ 0.3 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||||
Net income (loss) | $ (23,657) | $ 2,145 | $ (640) | $ (37,713) |
Adjustments to reconcile net income (loss) to cash flows used in operations: | ||||
Depreciation | 65 | 80 | 101 | 122 |
Amortization of right-of-use assets | 390 | 653 | ||
Amortization of acquired intangible assets | 314 | 314 | 418 | 418 |
Realized/Unrealized losses in investment, related party | 6,635 | (1,747) | ||
Change in fair value of contingent consideration | 100 | (4,100) | (3,800) | (1,402) |
Change in fair value of warrant liabilities | (2,001) | (17,896) | (19,017) | 12,801 |
Warrant inducement expense | 2,629 | 2,629 | ||
Stock-based compensation | 817 | 1,469 | 1,852 | 129 |
Provision for inventory obsolescence | 100 | 100 | 33 | |
Provision for doubtful accounts | 158 | 111 | 106 | 44 |
Non-cash interest expense | 296 | 268 | 358 | 358 |
Changes in operating assets and liabilities: | ||||
Accounts receivable | (204) | 2,111 | (70) | (612) |
Other receivables, related party | 3,652 | 5,145 | 4,990 | (11,387) |
Prepaid expenses and other assets | 347 | 4,121 | 4,154 | (3,809) |
Inventories | (8,900) | (7,728) | (2,810) | 2,592 |
Accounts payable and related party payables | 6,137 | 3,519 | 912 | (773) |
Operating lease liabilities | (375) | (781) | ||
Accrued expenses and other liabilities | 197 | (216) | (3,607) | 12,484 |
Cash flows used in operating activities | (16,029) | (7,928) | (16,199) | (26,715) |
Cash flows from investing activities | ||||
Purchases of investment, related party | (5,118) | |||
Disbursement for loan receivable | (3,033) | |||
Sales of equity investment, related party | 560 | |||
Purchases of property and equipment | (14) | (37) | (38) | (11) |
Cash flows provided by (used) in investing activities | 546 | (3,070) | (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 line of credit | 13,546 | |||
Proceeds from issuance of common stock and warrants in private placement, net of issuance costs | 9,391 | 9,391 | 14,995 | |
Proceeds from exercise of warrants | 4,630 | 4,630 | 13,253 | |
Repayment of line of credit | (11,849) | |||
Cash flows provided by financing activities | 1,697 | 14,021 | 14,021 | 43,191 |
Net increase (decrease) in cash and cash equivalents | (13,786) | 3,023 | (7,334) | 16,465 |
Cash, cash equivalents and restricted cash, at the beginning of the period | 17,408 | 24,742 | 24,742 | 8,277 |
Cash, cash equivalents and restricted cash, at the end of the period | 3,622 | 27,765 | 17,408 | 24,742 |
Supplemental disclosure of cash flow information | ||||
Interest paid | 31 | 10 | 1 | 2 |
Interest paid, related party | 22 | |||
Income taxes paid, net | 21 | 30 | 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 | 147 | 234 | ||
Conversion of warrant liability to equity | $ 6,840 | |||
Issuance costs included in accrued expenses and other liabilities | 44 | |||
Non-cash purchase of fixed assets | $ 8 |
Business Overview
Business Overview | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Business Overview | 1. Business Overview Biofrontera Inc. (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. In May 2023, the Company began research and development (“R&D”) activities to support PDT growth and will continue to opportunistically invest in these activities going forward. Our research and development program currently aims to improve the capabilities of our BF-RhodoLED ® Biofrontera 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. Our principal licensed product is Ameluz ® ® ® Our second prescription drug licensed product is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. 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 in 2024. Reverse Stock Split 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 a 1-for-20 0.001 300,000,000 15,000,000 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. Following the Split Effective Time, every 20 shares of Biofrontera Common Stock issued and outstanding were automatically combined and reclassified into one share of Common Stock. Outstanding equity-based awards, warrants and other equity rights were proportionately adjusted pursuant to their terms and the number of shares authorized and reserved for issuance upon vesting of restricted stock units or exercise of stock options and warrants were reduced proportionately. No fractional shares were issued as a result of the Reverse Stock Split. Stockholders who would otherwise hold a fractional share as a result of the Reverse Stock Split received an additional share of Common Stock. Under the terms of the applicable warrant agreement, the number of shares of Common Stock issuable on exercise of each warrant will be proportionately decreased. Specifically, following effectiveness of the Reverse Stock Split, every 20 shares of Common Stock that may be purchased pursuant to the exercise of public warrants now represents one share of Common Stock that may be purchased pursuant to such warrants. Accordingly, for the Company’s warrants trading under the symbol “BFRIW”, every 20 warrants will be exercisable for one share of Common Stock at an exercise price of $ 100.00 The Reverse Stock Split affected all stockholders uniformly and did not alter any stockholder’s percentage interest in the Company’s equity (other than as a result of the rounding up of fractional shares). Liquidity and Going Concern The Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, proceeds from the sale of our investment, related party, and cash flows from a revolving line of credit. As of September 30, 2023, we had cash and cash equivalents of $ 3.4 3.3 17.2 10.5 Since we commenced operations in 2015, we have generated significant losses. For the nine months ended September 30, 2023 and 2022, we incurred loss from operations of $ 18.8 million and $ 13.0 million, respectively. We incurred net cash outflows from operations of $ 16.0 million and $ 7.9 million, for the same periods, respectively. We had an accumulated deficit as of September 30, 2023 of $ 103.2 million. 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 the unaudited condensed consolidated 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 during the first half of 2024, and until cash flow from operations is sufficient, if ever. We have implemented plans to improve our working capital position, particularly around inventory levels, and do not expect to need a delivery until sometime in Q3 2024, depending on actual sales until then. Management believes that the anticipated implementation of such plans, together with the recent net capital raise of $ 4.1 Subsequent Events 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. | 1. Organization and Business Overview 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 ® ® ® ® 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 4.6 Note 19. Stockholders’ Equity 17.2 24.5 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 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis for Preparation of the Financial Statements The accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the Company’s opinion, the unaudited condensed consolidated financial statements include all material adjustments, all of which are of a normal and recurring nature, necessary to present fairly the Company’s financial position as of September 30, 2023, the Company’s operating results for the three and nine months ended September 30, 2023 and 2022, and the Company’s cash flows for the nine months ended September 30, 2023 and 2022. The accompanying financial information as of December 31, 2022 is derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s reaudited consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 (“reaudited Consolidated Financial Statements”), and the revised Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal years ended December 31, 2022 and December 31, 2021 (“revised MD&A”), filed in a Current Report on From 8-K with the SEC on October 3, 2023. All amounts shown in these financial statements and tables are in thousands and amounts in the notes are in millions, except percentages and per share and share amounts. With the exception of the accounting policies below, there have been no new or material changes to the significant accounting policies discussed in the Company’s reaudited Consolidated Financial Statements.: Reverse Stock Split 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. Research and Development Costs Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct research and development activities, and other operational costs related to the Company’s research and development activities. Use of Estimates The preparation of the 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. Recently Adopted Accounting Pronouncements In September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments | 2. Summary of Significant Accounting Policies Basis for Preparation of the Consolidated Financial Statements Basis for Preparation of the 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 ® ® ® 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 T he Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities 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 ® 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 Computer software 3 Furniture and fixtures 3 5 Leasehold improvements Shorter of estimated useful lives or the term of the lease Machinery & equipment 3 4 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 (“ 1.8 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. 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 , 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 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 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 ® Xepi ® 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 ® 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 Government and Payor Rebates Other Incentives ® 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 ® ® 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 0.4 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 20 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 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 0.5 Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with ASC 740, Income Taxes 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 |
Acquisition Contract Liabilitie
Acquisition Contract Liabilities | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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 29.9 Pursuant to the Share Purchase Agreement, Maruho provided $ 7.3 The contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of approximately 6.0 2.5 Acquisition contract liabilities, net consist of the following: Schedule of Acquisition Contract Liabilities (in thousands) September 30, 2023 December 31, 2022 Short-term acquisition contract liabilities: Contingent consideration $ 2,500 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (89 ) (358 ) Acquisition contract liabilities, net $ 7,211 $ 6,942 Long-term acquisition contract liabilities: Contingent consideration $ 2,500 $ 2,400 Total acquisition contract liabilities: Contingent consideration $ 2,500 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (89 ) (358 ) Total acquisition contract liabilities, net $ 9,711 $ 9,342 | 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 29.9 Pursuant to the Share Purchase Agreement, Maruho agreed to provide $ 7.3 In connection with this acquisition in 2019, we recorded the $ 7.3 Commitments and Contingencies- Cutanea payments 1.7 6.5 The contract asset related to the start-up cost financing is amortized on a straight-line basis using a 6.0 57 December 31, 2023 The contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of 6.0 Acquisition contract liabilities, net consist of the following: Schedule of Acquisition Contract Liabilities (in thousands) December 31, December 31, 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 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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 at September 30, 2023 and December 31, 2022 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 September 30, 2023 December 31, 2022 Assets: Investment, related party 1 $ 3,341 $ 10,548 Liabilities: Contingent Consideration 3 $ 2,500 $ 2,400 Warrant liability – 2022 Purchase Warrants 3 $ 366 $ 1,129 Warrant liability - 2022 Inducement Warrants 3 $ 476 $ 1,714 Warrant liability 3 $ 476 $ 1,714 Investment, related party A s of September 30, 2023 and December 31, 2022, the Company has an investment in 5,745,678 6,446,946 company traded on the Frankfurt Stock Exchange Note 6. Investment Related Party and Note 13. Related Party Transactions. 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. 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, 2022 $ 2,400 Change in fair value of contingent consideration 100 Balance at September 30, 2023 $ 2,500 Balance at December 31, 2021 $ 6,200 Change in fair value of contingent consideration (4,100 ) Balance at September 30, 2022 $ 2,100 Warrant Liabilities The warrant liabilities are comprised of (i) currently outstanding 170,950 55.40 214,286 33.20 The Company utilizes a Black-Scholes option pricing model to estimate the fair value of the Purchase Warrants 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 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 statements of operations. The fair value for the Level 3 warrants at September 30, 2023 was estimated using a Black-Scholes pricing model based on the following assumptions: Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions Purchase Inducement Stock price $ 8.77 $ 8.77 Expiration term (in years) 4.13 3.17 Volatility 80.0 % 80 % Risk-free Rate 4.63 % 4.73 % Dividend yield 0.0 % 0.0 % The fair value for the Level 3 warrants at December 31, 2022 was estimated using a Black-Scholes pricing model based on the following assumptions: Purchase Inducement Stock price $ 18.40 $ 18.40 Expiration term (in years) 4.88 3.92 Volatility 70.0 % 75 % Risk-free Rate 3.96 % 4.07 % Dividend yield 0.0 % 0.0 % The following table presents the changes in the Level 3 warrant liabilities measured at fair value (in thousands): Schedule of Changes in Level 3 Warrant Liabilities 2023 2022 Nine Months Ended September 30, 2023 2022 Fair value at beginning of period $ 2,843 $ 12,854 Issuance of new warrants - 13,217 Exercise of warrants - (6,840 ) Change in fair value of warrant liabilities (2,001 ) (15,267 ) Fair value at end of period $ 842 $ 3,964 | 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 A s 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. 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) (1.4) 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 |
Revenue
Revenue | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Revenue | 5. Revenue We generate revenue primarily through the sales of our licensed 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 Bioscience for BF-RhodoLED® leasing and installation service. Refer to Note 13, Related Party Transactions An analysis of the changes in product revenue allowances and reserves is summarized as follows: Schedule of Revenue Allowance and Accrual Activties (in thousands): Returns Co-pay assistance program Prompt pay discounts Government and payor rebates Total Balance at December 31, 2021 $ 43 $ 101 $ 48 $ 54 $ 246 Provision related to current period sales 8 503 16 164 691 Credit or payments made during the period (5 ) (400 ) (23 ) (149 ) (577 ) Balance at September 30, 2022 $ 46 $ 204 $ 41 $ 69 $ 360 Balance at December 31, 2022 $ 48 $ 9 $ 5 $ 20 $ 82 Beginning Balance $ 48 $ 9 $ 5 $ 20 $ 82 Provision related to current period sales 4 156 3 266 429 Credit or payments made during the period - (145 ) (2 ) (231 ) (378 ) Balance at September 30, 2023 $ 52 20 6 55 133 Ending Balance $ 52 20 6 55 133 | 5. Revenue We generate revenue primarily through the sales of our products Ameluz ® ® ® ® ® ® Related party revenue relates to an agreement with Biofrontera Bioscience GmbH (“Bioscience”) for BF-RhodoLED ® 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 |
Investment, Related Party
Investment, Related Party | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Investments, All Other Investments [Abstract] | ||
Investment, Related Party | 6. Investment, Related Party A s of September 30, 2023 and December 31, 2022, our investment in equity securities consisted solely of 5,745,678 6,446,946 Note 13. Related Party Transactions 3,377,346 0.6 Unrealized losses on investment, related party were $ 1.9 6.2 no Schedule of Unrealized Gains and Losses on Investments in Equity Securities (in thousands) 2023 2022 2023 2022 Three months ended Nine months ended (in thousands) 2023 2022 2023 2022 Net losses recognized during the period on equity securities $ (2,212 ) $ - $ (6,635 ) $ - Less: Net realized losses on equity securities sold 345 - 420 - Unrealized losses recognized during the reporting period on equity securities still held at the reporting date $ (1,867 ) $ - $ (6,215 ) $ - | 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 € 1.00 157,042 2,623,365 3,843,581 6,446,946 10 uity 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. |
Accounts Receivable, net
Accounts Receivable, net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Credit Loss [Abstract] | ||
Accounts Receivable, net | 7. Accounts Receivable, net Accounts receivables are mainly attributable to the sale of Ameluz ® In determining the reserve percentages for each pool of trade accounts receivables, we considered our historical experience with certain customers, regulatory and legal environments and other relevant current and future forecasted macroeconomic factors. If we become aware of any customer-specific factors that impact credit risk, specific allowances for these known troubled accounts are recorded. The allowance for credit losses was $ 0.2 0.1 | 7. Accounts Receivable, net Accounts receivable are mainly attributable to the sale of Ameluz ® ® ® The allowance for doubtful accounts was $ 0.1 |
Other Receivables, Related Part
Other Receivables, Related Party | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Receivables [Abstract] | ||
Other Receivables, Related Party | 8. Other Receivables, Related Party As of September 30, 2023 the Company has a receivable, related party of $ 2.7 50 Note 18. Commitments and Contingencies – Legal proceedings 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 ® s such no reserve for the receivable was deemed necessary as of September 30, 2023 or December 31, 2022. | 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 Settlement 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 ® A s such no reserve for the receivable was deemed necessary as of December 31, 2022 or December 31, 2021. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventories | 9. Inventories Inventories are comprised of Ameluz ® ® ® The provision related to BF-RhodoLED ® 0.1 million for the year ended December 31, 2022, and negligible for the year ended December 31, 2021. The provision for Xepi ® |
Prepaid Expenses and Other Curr
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, December 31, Receivable for common stock warrants proceeds $ - $ 3,258 Prepaid expenses 439 $ 824 Security deposits 85 149 Other 286 756 Total $ 810 $ 4,987 |
Property and Equipment, Net
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, December 31, 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 |
Intangible Asset, Net
Intangible Asset, Net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Intangible Asset, Net | 9. Intangible Asset, Net Intangible asset, net consists of the following: Schedule of Intangible Asset Net (in thousands) September 30, 2023 December 31, 2022 Xepi® license $ 4,600 $ 4,600 Less: Accumulated amortization (1,882 ) (1,568 ) Intangible asset, net $ 2,718 $ 3,032 The Xepi® license intangible asset was recorded at acquisition-date fair value of $ 4.6 11 0.1 0.3 We review the Xepi ® The Company performed an impairment analysis because of this situation and determined no impairment charges were deemed necessary during the three and nine months ended September 30, 2023. | 12. Intangible Asset, Net Intangible asset, net consists of the following: Schedule of Intangible Asset Net (in thousands) December 31, December 31, Xepi ® $ 4,600 $ 4,600 Less: Accumulated amortization (1,568 ) (1,150 ) Intangible asset, net $ 3,032 $ 3,450 The Xepi ® 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 ® ® ® |
Cash Balances and Statement of
Cash Balances and Statement of Cash Flows Reconciliation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | ||
Cash Balances and Statement of Cash Flows Reconciliation | 10. Cash Balances and Statement of Cash Flows Reconciliation 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 3.0 Restricted cash consists primarily of deposits of cash collateral held in accordance with the terms of our corporate credit cards. Long-term restricted cash was recorded in other assets in the consolidated balance sheet. The following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the consolidated statements of cash flows: Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (in thousands) September 30, 2023 December 31, 2022 Cash and cash equivalents $ 3,422 $ 17,208 Long-term restricted cash 200 200 Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows $ 3,622 $ 17,408 | 13. Statement of Cash Flows Reconciliation Cash Balances and 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, December 31, 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. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Payables and Accruals [Abstract] | ||
Accrued Expenses and Other Current Liabilities | 11. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities (in thousands) September 30, 2023 December 31, 2022 Legal settlement (See note 18) $ 6,028 $ 6,207 Employee compensation and benefits 2,948 2,850 Professional fees 1,253 1,353 Product revenue allowances and reserves 134 82 Other 676 372 Total $ 11,039 $ 10,864 | 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, December 31, 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 |
Other Long-Term Liabilities
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, December 31, Legal settlement – noncurrent (See Note 24) $ - $ 5,625 Other 21 24 Total $ 21 $ 5,649 |
Income Taxes
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 no 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, December 31, 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 As of December 31, 2022, the Company had approximately $ 123.4 89.2 113.8 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. |
Related Party Transactions
Related Party Transactions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Related Party Transactions [Abstract] | ||
Related Party Transactions | 13. 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. 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. As a result of this amendment, the purchase price we pay the Ameluz Licensor for Ameluz ® ● fifty percent of the anticipated net price per unit until we generate $ 30 ● forty percent of the anticipated net price per unit for all revenues we generate between $ 30 50 ● thirty percent of the anticipated net price per unit for all revenues we generate above $ 50 Purchases of the licensed products during the three and nine months ended September 30, 2023 were $ 5.1 18.8 5.2 16.6 7.0 1.3 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, and pharmacovigilance, 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. As of September 30, 2023, we have migrated away from Biofrontera AG to third party providers for most of our significant IT services. Expenses related to the service agreement were $ 0.1 0.2 0.2 0.6 0.2 0.2 Clinical Lamp Lease Agreement On August 1, 2018, the Company executed a clinical lamp lease agreement with Bioscience to provide lamps and associated services. Total revenue related to the clinical lamp lease agreement was minimal and $ 0.1 0.1 Others The Company has recorded a receivable of $ 2.8 million and $ 6.4 million as of September 30, 2023 and December 31, 2022, respectively, due from Biofrontera AG for its 50 % share of the balance of a legal settlement for which both parties are jointly and severally liable. (See Note 8. Other Receivables, Related Party ) no interest income recognized for the nine months ended September 30, 2023 and $ 0.1 million of interest income for the nine months ended September 30, 2022, in connection with this receivable. As of September 30, 2023, our investment, related party is valued at $ 3.3 5,745,678 See Note 6. Investment, Related Party. | 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 ® ● 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 ® ® Purchases of the licensed products from Pharma during the years ended December 31, 2022 and 2021 were $ 16.6 9.4 1.3 0.3 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 0.7 0.2 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 0.1 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 0.5 no 0.1 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 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. 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. |
Restructuring costs
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 0.8 |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Equity [Abstract] | ||
Stockholders’ Equity | 14. Stockholders’ Equity Under the Company’s Certificate of Amendment to the Amended and Restated Certificate of incorporation, effective July 3, 2023, the Company is authorized to issue 15,000,000 shares of Common Stock and 20,000,000 shares of preferred stock, par value $ .001 per share. See Note 1. Reverse Stock Split 1-for-20 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. | 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 Note 2. Summary of Significant Accounting Policies Note 26. Subsequent Events 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. 180,000 0.001 100.00 five years 100.00 18 3.1 At the IPO date, the underwriters also exercised in full their option to purchase up to an additional 27,000 0.20 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 Warrants. The UPOs are exercisable at any time from October 28, 2021 (“Effective Date”) through the 5 th 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 99 60.0 1.15 5 0 21,000 25.80 60.0 1.15 5 0 Private Placement - 15,000,000 67,500 142,857 75,357 105.00 0.002 105.00 104.80 On December 28, 2021, 75,357 0.002 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) 4,286 131.20 5 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 0.2 0.1 127.80 60.0 1.15 5 0 Private Placement - 9.4 92,500 170,950 78,450 55.00 55.40 5 0.02 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 - 78,450 0.02 Exercise of 2021 Purchase Warrant and Issuance of July 2022 Inducement Warrant - 142,858 0.001 exchange for the 105.00 32.40 214,286 4.6 0.3 The Inducement Warrant is exercisable on or after January 27, 2023 33.20 December 1, 2026 Adoption of a stockholder rights plan. 0.001 5.00 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. 5,000 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 3,148,042 Warrants the IPO Warrants, and the PIPE Warrants, which includes the Inducement and 2022 Pre-Funded Warrants (together, the “ Schedule of Warrants Warrant - Warrant - Total 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 |
Equity Incentive Plans and Shar
Equity Incentive Plans and Share-Based Payments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Equity Incentive Plans and Share-Based Payments | 15. 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 10 years for stock options issued under the 2021 Plan. 129,490 266,990 163,362 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 as set by the Company at the time of the grant but shall not be less than 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 (“BSM”) 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 Nine Months Ended September 30, 2023 2022 Expected volatility 70 95 % 55 70 % Expected term (in years) 6.0 5.24 6.0 Risk-free interest rate 3.5 3.9 % 1.34 4.10 % Expected dividend yield 0.0 % 0.0 % Share-based compensation expense of approximately $ 0.1 0.5 0.3 0.6 Options outstanding and exercisable under the employee share option plan as of September 30, 2023 and a summary of option activity during the nine months then ended is presented below. Schedule of Stock Option Activity Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (1) Outstanding at December 31, 2022 86,951 $ 62.16 Granted 22,477 $ 13.98 Exercised - $ - Canceled or forfeited (31,480 ) $ 53.58 Outstanding at September 30, 2023 77,948 $ 51.74 8.45 $ 0 Exercisable at September 30, 2023 24,210 $ 62.23 7.75 $ 0 (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 September 30, 2023. As of September 30, 2023, there was $ 1.0 1.8 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 $ 0.1 0.3 0.1 0.9 Schedule of Restricted Stock Units Shares Weighted Average Remaining Contractual Term Weighted Average Grant Date Fair Value Outstanding at December 31, 2022 17,176 $ 52.20 Awarded - $ - Vested (8,588 ) $ 52.20 Canceled or forfeited (3,817 ) 0.63 $ - Outstanding at September 30, 2023 4,771 0.63 $ 52.20 As of September 30, 2023, there was $ 0.2 0.6 | 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, 137,500 129,490 266,990 154,359 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 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 2.3 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 0.1 As of December 31, 2022, there was $ 0.6 1.4 0.8 0.0 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 |
Interest Expense, net
Interest Expense, net | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Interest Expense, net | 16. Interest Expense, net Interest expense, net consists of the following: Schedule of Interest Expense (in thousands) 2023 2022 2023 2022 For three months ended For nine months ended (in thousands) 2023 2022 2023 2022 Interest expense $ (43 ) $ (3 ) $ (77 ) $ (10 ) Interest expense, related party $ (22 ) $ - $ (22 ) $ - Contract asset interest expense (90 ) (89 ) (268 ) (268 ) Interest income – related party - 1 - 110 Interest income – other 13 2 111 8 Interest expense, net $ (142 ) $ (89 ) $ (256 ) $ (160 ) Interest expense is comprised primarily of interest on our Loan and Security Agreement with MidCap Business Credit LLC. Contract asset interest expense relates to the $ 1.7 7.3 6 December 31, 2023 Interest income - related party interest income relates to default interest on the recorded receivable of $ 6.1 50 | 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 expense, net $ (195 ) $ (344 ) Contract asset interest expense relates to the $ 1.7 7.3 6 December 31, 2023 Related party interest income relates to the recorded receivable of $ 6.1 50 |
Other Income, net
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. |
Net Earnings (Loss) per Share
Net Earnings (Loss) per Share | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income (loss) per common share: | ||
Net Earnings (Loss) per Share | 17. Net Earnings (Loss) per Share Basic net earnings (loss) per common share are calculated by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net earnings per common share are calculated by dividing net income (loss) by the diluted weighted average number of common shares outstanding during the period. The diluted shares include the dilutive effect of stock-based awards based on the treasury stock method. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. The following table sets forth the computation of the Company’s basic and diluted net earnings (loss) per share attributable to common stockholders (in thousands, except share and per share data): Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders 2023 2022 2023 2022 Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net income (loss) $ (6,342 ) $ (2,566 ) $ (23,657 ) $ 2,145 Shares: Basic weighted average common shares outstanding 1,366,842 1,136,291 1,346,264 978,018 Add: Effect of dilutive securities Stock options and restricted stock units - - - 2,233 Diluted weighted average common shares outstanding 1,366,842 1,136,291 1,346,264 980,251 Net earnings (loss) per share: Basic $ (4.64 ) $ (2.26 ) $ (17.57 ) $ 2.19 Diluted $ (4.64 ) $ (2.26 ) $ (17.57 ) $ 2.19 The following table sets forth the securities that were anti-dilutive for diluted EPS for the periods presented but which could potentially dilute EPS in the future: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share Nine Months Ended September 30, 2023 2022 Common stock warrants 459,856 459,856 Common stock options and RSUs 82,719 55,620 Unit Purchase Options 20,182 20,182 Anti-dilutive securities excluded from computation of earnings per share 20,182 20,182 Common Stock warrants include Purchase Warrants, Inducement Warrants and warrants issued in the Initial Public Offering. | 23. Net Loss per Share Net Earnings (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 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Commitments and Contingencies | 18. Commitments and Contingencies 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 0.1 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 varying expiration dates through January 2027. The components of lease expense for the three and nine months ended September 30, 2023 were 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) $ 390 Interest on lease liabilities 54 Total lease expense $ 444 Other Information Operational cash flow used for operating leases $ 428 Weighted -average remaining lease term (in years) 2.01 Weighted -average discount rate 6.75 % Future lease payments under non-cancelable leases as of September 30, 2023 were as follows (in thousands): Schedule of Future Commitments and Sublease Income Years ending December 31, Future lease commitments 2023 $ 171 2024 584 2025 393 2026 44 2027 1 Total future minimum lease payments 1,193 Less imputed interest (76 ) Total lease liability $ 1,117 Schedule of Operating Lease Liability Reported as: Operating lease liability, current $ 555 Operating lease liability, non-current 562 Total $ 1,117 Cutanea payments We have a contract in which we agreed to repay to Maruho $ 3.6 3.7 We have filed for arbitration against Maruho with the International Chamber of Commerce regarding issues with Maruho’s contract manufacturer that were not disclosed at the time of the Share Purchase Agreement and therefore are withholding the repayment of the start-up cost financing until a decision is reached through the arbitration process. The arbitration notes that Maruho breached the agreement with Cutanea due to undisclosed manufacturing issues and seeks damages as well as a declaration that we are not obligated to repay Maruho. As such, the required contractual payments noted above have not been made as of the financial statement filing date. 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 ® 25,000,000 4,000,000 ® 50,000,000 ® 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. The Company paid a licensing fee of $ 0.2 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 3 The Company did not make any milestone or royalty payments during the three or nine months ended September 30, 2023. 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 Settlement Agreement with DUSA Pharmaceuticals Inc. 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 While Biofrontera AG has agreed to pay fifty percent of the settlement costs, we remain jointly and severally liable to DUSA Pharmaceuticals Inc. (“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 settlement agreement, DUSA could compel us to pay Biofrontera AG’s share. As of September 30, 2023, we have reflected a legal settlement liability in the amount of $ 6.0 2.8 Settlement Agreement with Biofrontera AG Pursuant to the terms of that certain Settlement Agreement, dated as of April 11, 2023, among the Company, Biofrontera AG and certain current and former directors of the Company (the “Settlement Agreement”), the Company has taken or committed, among other things, to take the following actions: ● On July 7, 2023, in connection with the Biofrontera AG settlement agreement, 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. ● The Company will begin a search, pursuant to the conditions set forth in the Settlement Agreement including a strike right granted to the aforementioned director nominated by Biofrontera AG, for an additional director candidate, who is fully independent from Biofrontera AG, Deutsche Balaton Aktiengesellschaft (“DB”) and any of their respective affiliates, to be nominated for election as a Class II Director at the Company’s 2024 annual meeting of stockholders. ● The Board will increase its size to seven members, including the two directors appointed and elected pursuant to the Settlement Agreement as noted above. 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. Under the Settlement Agreement, 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. 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. | 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 0.1 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. 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 3.7 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 ® 25,000,000 , and ii) $ 4,000,000 upon the first occasion annual net sales of Xepi ® 50,000,000 . No payments were made in 2022 or 2021 related to Xepi ® 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 Contingencies, 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 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 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 Subsequent Events |
Retirement Plan
Retirement Plan | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Retirement Plan | 19. 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. Matching contribution costs paid by the Company for the three and nine months ended September 30, 2023 were $ 0.1 0.2 0.1 million and $ 0.2 million for the three and nine months ended September 30, 2022, respectively. | 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. |
Subsequent Events
Subsequent Events | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Subsequent Events [Abstract] | ||
Subsequent Events | 21. Subsequent Events We have completed an evaluation of subsequent events after the balance sheet date of September 30, 2023 through the date this Quarterly Report on Form 10-Q was submitted to the SEC. Registered Public Offering On October 30, 2023, the Company entered into a placement agency agreement with Roth Capital Partners, LLC and a securities purchase agreement (“Purchase Agreement”) with an institutional investor for the purchase and sale, in a registered public offering by the Company of an aggregate of 1,205,000 shares of the Company’s common stock, par value $ 0.001 the Company agreed to issue and sell to the institutional investor: (i) 150,000 shares of Common Stock at a combined offering price of $3.74, (ii) 1,055,000 pre-funded warrants to purchase up to 1,055,000 shares of Common Stock (the “Pre-Funded Warrants”) at a combined offering price of $3.7399 and (iii) 1,205,000 warrants to purchase up to 1,807,500 shares of Common Stock (the “Common Warrants”), resulting in gross proceeds of approximately $4.5 million. The Public Offering closed on November 2, 2023 . The Common Warrants are exercisable upon issuance, will expire five 3.55 five 0.0001 Each of the Placement Agency Agreement and Purchase Agreement contains representations, warranties and covenants made by the Company that are customary for transactions of this type. In addition, pursuant to the terms of the Purchase Agreement, the Company and its executive officers and directors have agreed not to, subject to limited exceptions, offer, sell, transfer or otherwise dispose of the Company’s securities for a period of 90 days following the date of closing of the Public Offering. As compensation in connection with the Public Offering, the Company paid the Placement Agent a cash fee of 7% Warrant Amendment As previously reported in a Current Report on Form 8-K filed with the Commission on May 20, 2022, the Company issued (i) a common stock purchase warrant, dated May 16, 2022 and exercisable until November 18, 2027 , to purchase up to 170,950 shares of Common Stock, at an exercise price of $ 55.40 and (ii) a common stock purchase warrant, dated July 26, 2022 and exercisable until December 1, 2026 , to purchase up to 214,286 shares of Common Stock at an exercise price of $ 33.20 (collectively, the “Existing Warrants”) to an institutional investor. On October 30, 2023, in connection with the Purchase Agreement discussed above, the Company entered into an amendment to the Existing Warrants as described above pursuant to which the Company agreed, effective November 2, 2023, to (i) revise the exercise price of the Existing Warrants to $ 3.55 and (ii) extend the date until which the Existing Warrants can be exercised until November 2, 2028. No other terms of the Existing Warrants were revised or changed. Amendment to Ameluz LSA On December 12, 2023, we entered into an addendum (the “Addendum”) to the Ameluz LSA. The Addendum provides, among other things, for a schedule of payments in relation to various financial obligations among the Company, Pharma, Bioscience, and Biofrontera AG (the parent company of Pharma and Bioscience), including updated terms relating to payments by the Company to Pharma for purchases of Licensed Products (as that term is defined in the LSA) under the LSA through the end of 2024. Annual Shareholder’s Meeting On December 20, 2023, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”) in which stockholders voted on two proposals. The matters voted on were the election of Class II Directors Beth J. Hoffman, Ph.D. and Kevin D. Weber both of whom were elected for another term and the ratification of Marcum LLP as our public accounting firm which also passed. As a result, Marcum LLP is the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2023. Details of the proposals are described in a proxy statement filed with the Securities and Exchange Commission on November 17, 2023. At the record date for the Annual Meeting, 1,517,628 58.2% Debt Financing On December 21, 2023, the Company entered into (a) a Business Loan and Security Agreement (the “Agreement A”) pursuant to which the lender (“Lender A”) has made a term loan to the Company in the principal amount of $ 2,000,000 2,000,000 Each of the Loans requires the Company to make weekly payments of principal and interest in the amount of approximately $ 102,857 880,000 5.0% Each of the Loan Agreements includes limitations on the Company’s ability to sell, lease, transfer, or otherwise dispose of its assets outside the ordinary course of its business; or to create, incur, allow or suffer to exist any lien on any of its assets other than liens in favor of Lender A and Lender B and certain other permitted liens. Each of the Loan Agreements also contains customary representations and warranties and customary events of default, upon the occurrence of which, after any applicable grace period, the applicable lender would have the ability to accelerate its loan and exercise remedies with respect to the Collateral. Maruho Settlement On December 29, 2023, we entered into a Confidential Settlement Agreement and Mutual Release (the “Release”), dated as of December 27, 2023 and effective as of December 22, 2023, with Maruho Co. Ltd. (“Maruho”), and a Share Transfer Agreement (the “STA” and, together with the Release, the “Settlement Agreement”), dated as of December 27, 2023 and effective as of December 22, 2023, by and among us, Maruho, and Maruho Deutschland GmbH. The Settlement Agreement resolves an arbitration proceeding initiated by us against Maruho in the International Chamber of Commerce (the “Arbitration”) in which we alleged certain claims against Maruho concerning the Share Purchase and Transfer Agreement (the “SPA”), dated as of March 25, 2019, referred to in the Settlement Agreement. In the Arbitration, we sought, in part, a declaration that we are not obligated to repay $ 7.3 The Settlement Agreement contains a mutual release whereby each of Maruho and us agreed to release and discharge the other party from any and all claims, actions, causes of action, suits, debts, dues, sums of money, accounts, reckonings, bonds, bills, specialties, covenants, contracts, controversies, agreements, promises, variances, trespasses, damages, judgments, extents, executions, claims, and demands whatsoever, in law, admiralty, equity, arbitration or otherwise, against the other arising from or in connection with or in any manner relating to the SPA, including but not limited to any claims that were or could have been asserted in the Arbitration. Under the Settlement Agreement, our obligations to i) repay the $ 7.3 5,451,016 2.4 Midcap Termination On January 3, 2024, the Company voluntarily terminated the revolving line of credit between the Company and MidCap Business Credit LLC that provided for maximum borrowings of $ 6.5 194,000 150,000 Nasdaq Notification On November 22, 2023, the Company received a notice from the Listing Qualifications staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that, because the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended September 30, 2023 was $ 1,038,000 2,500,000 35 500,000 On January 8, 2024, the Company submit a compliance plan to Nasdaq. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from November 22, 2023 to evidence compliance. If the plan is not accepted, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. | 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 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 4.00 3.00 0.375 Settlement Agreement. 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 (Amended to be nominated for election in connection with the 2024 meeting);; ● 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. (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. 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 15,000,000 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 3 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. |
Line of Credit
Line of Credit | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Line of Credit | 12. Line of Credit 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 Advances under the Loan Agreement bear interest at the 30-Day Adjusted Term Secured Overnight Financing Rate (“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. 650,000 1.0 1.0 0.375 The interest rate as of September 30, 2023 was 5.48 0.2 |
Reclassification of Prior Year
Reclassification of Prior Year Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Reclassification of Prior Year Presentation | 20. Reclassification of Prior Year Presentation Certain prior year amounts have been reclassified to their own line items within the Consolidated Statement of Operations and Consolidated Statements of Cash Flow. Specifically, warrant inducement expense of $ 2.6 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Basis for Preparation of the Financial Statements | Basis for Preparation of the Financial Statements The accompanying unaudited interim condensed consolidated financial statements of the Company have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. In the Company’s opinion, the unaudited condensed consolidated financial statements include all material adjustments, all of which are of a normal and recurring nature, necessary to present fairly the Company’s financial position as of September 30, 2023, the Company’s operating results for the three and nine months ended September 30, 2023 and 2022, and the Company’s cash flows for the nine months ended September 30, 2023 and 2022. The accompanying financial information as of December 31, 2022 is derived from audited financial statements. Interim results are not necessarily indicative of results for a full year. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s reaudited consolidated financial statements for the fiscal years ended December 31, 2022 and 2021 (“reaudited Consolidated Financial Statements”), and the revised Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fiscal years ended December 31, 2022 and December 31, 2021 (“revised MD&A”), filed in a Current Report on From 8-K with the SEC on October 3, 2023. All amounts shown in these financial statements and tables are in thousands and amounts in the notes are in millions, except percentages and per share and share amounts. With the exception of the accounting policies below, there have been no new or material changes to the significant accounting policies discussed in the Company’s reaudited Consolidated Financial Statements.: | Basis for Preparation of the Consolidated Financial Statements Basis for Preparation of the 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 ® ® ® | |
Reverse Stock Split | Reverse Stock Split 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. | 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 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. | 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 T he Company accounts for its investment, related party in accordance with ASC 321, Investments — Equity Securities | |
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 ® 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 Computer software 3 Furniture and fixtures 3 5 Leasehold improvements Shorter of estimated useful lives or the term of the lease Machinery & equipment 3 4 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 (“ 1.8 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. | |
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 , 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 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 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 ® Xepi ® 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 ® 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 Government and Payor Rebates Other Incentives ® 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 ® ® 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 0.4 | |
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 20 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 | |
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 0.5 | |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method in accordance with ASC 740, Income Taxes 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 Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In September 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments | 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 |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development costs include external costs of outside vendors engaged to conduct research and development activities, and other operational costs related to the Company’s research and development activities. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Property, Plant and Equipment | Schedule of Estimated Useful Lives of Property, Plant and Equipment Estimated Useful Life in Years Computer equipment 3 Computer software 3 Furniture and fixtures 3 5 Leasehold improvements Shorter of estimated useful lives or the term of the lease Machinery & equipment 3 4 |
Acquisition Contract Liabilit_2
Acquisition Contract Liabilities (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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) September 30, 2023 December 31, 2022 Short-term acquisition contract liabilities: Contingent consideration $ 2,500 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (89 ) (358 ) Acquisition contract liabilities, net $ 7,211 $ 6,942 Long-term acquisition contract liabilities: Contingent consideration $ 2,500 $ 2,400 Total acquisition contract liabilities: Contingent consideration $ 2,500 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (89 ) (358 ) Total acquisition contract liabilities, net $ 9,711 $ 9,342 | Acquisition contract liabilities, net consist of the following: Schedule of Acquisition Contract Liabilities (in thousands) December 31, December 31, 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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 at September 30, 2023 and December 31, 2022 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 September 30, 2023 December 31, 2022 Assets: Investment, related party 1 $ 3,341 $ 10,548 Liabilities: Contingent Consideration 3 $ 2,500 $ 2,400 Warrant liability – 2022 Purchase Warrants 3 $ 366 $ 1,129 Warrant liability - 2022 Inducement Warrants 3 $ 476 $ 1,714 Warrant liability 3 $ 476 $ 1,714 | 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, 2022 $ 2,400 Change in fair value of contingent consideration 100 Balance at September 30, 2023 $ 2,500 Balance at December 31, 2021 $ 6,200 Change in fair value of contingent consideration (4,100 ) Balance at September 30, 2022 $ 2,100 | 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 for the Level 3 warrants at September 30, 2023 was estimated using a Black-Scholes pricing model based on the following assumptions: Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions Purchase Inducement Stock price $ 8.77 $ 8.77 Expiration term (in years) 4.13 3.17 Volatility 80.0 % 80 % Risk-free Rate 4.63 % 4.73 % Dividend yield 0.0 % 0.0 % The fair value for the Level 3 warrants at December 31, 2022 was estimated using a Black-Scholes pricing model based on the following assumptions: Purchase Inducement Stock price $ 18.40 $ 18.40 Expiration term (in years) 4.88 3.92 Volatility 70.0 % 75 % Risk-free Rate 3.96 % 4.07 % Dividend yield 0.0 % 0.0 % | 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 Level 3 Warrant Liabilities | The following table presents the changes in the Level 3 warrant liabilities measured at fair value (in thousands): Schedule of Changes in Level 3 Warrant Liabilities 2023 2022 Nine Months Ended September 30, 2023 2022 Fair value at beginning of period $ 2,843 $ 12,854 Issuance of new warrants - 13,217 Exercise of warrants - (6,840 ) Change in fair value of warrant liabilities (2,001 ) (15,267 ) Fair value at end of period $ 842 $ 3,964 | 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 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | ||
Schedule of Revenue Allowance and Accrual Activties | An analysis of the changes in product revenue allowances and reserves is summarized as follows: Schedule of Revenue Allowance and Accrual Activties (in thousands): Returns Co-pay assistance program Prompt pay discounts Government and payor rebates Total Balance at December 31, 2021 $ 43 $ 101 $ 48 $ 54 $ 246 Provision related to current period sales 8 503 16 164 691 Credit or payments made during the period (5 ) (400 ) (23 ) (149 ) (577 ) Balance at September 30, 2022 $ 46 $ 204 $ 41 $ 69 $ 360 Balance at December 31, 2022 $ 48 $ 9 $ 5 $ 20 $ 82 Beginning Balance $ 48 $ 9 $ 5 $ 20 $ 82 Provision related to current period sales 4 156 3 266 429 Credit or payments made during the period - (145 ) (2 ) (231 ) (378 ) Balance at September 30, 2023 $ 52 20 6 55 133 Ending Balance $ 52 20 6 55 133 | 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 |
Prepaid Expenses and Other Cu_2
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, December 31, Receivable for common stock warrants proceeds $ - $ 3,258 Prepaid expenses 439 $ 824 Security deposits 85 149 Other 286 756 Total $ 810 $ 4,987 |
Property and Equipment, Net (Ta
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, December 31, 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 |
Intangible Asset, Net (Tables)
Intangible Asset, Net (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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) September 30, 2023 December 31, 2022 Xepi® license $ 4,600 $ 4,600 Less: Accumulated amortization (1,882 ) (1,568 ) Intangible asset, net $ 2,718 $ 3,032 | Intangible asset, net consists of the following: Schedule of Intangible Asset Net (in thousands) December 31, December 31, Xepi ® $ 4,600 $ 4,600 Less: Accumulated amortization (1,568 ) (1,150 ) Intangible asset, net $ 3,032 $ 3,450 |
Cash Balances and Statement o_2
Cash Balances and Statement of Cash Flows Reconciliation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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, December 31, 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 | |
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 consolidated statements of cash flows: Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (in thousands) September 30, 2023 December 31, 2022 Cash and cash equivalents $ 3,422 $ 17,208 Long-term restricted cash 200 200 Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows $ 3,622 $ 17,408 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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) September 30, 2023 December 31, 2022 Legal settlement (See note 18) $ 6,028 $ 6,207 Employee compensation and benefits 2,948 2,850 Professional fees 1,253 1,353 Product revenue allowances and reserves 134 82 Other 676 372 Total $ 11,039 $ 10,864 | Accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities (in thousands) December 31, December 31, 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 |
Other Long-Term Liabilities (Ta
Other Long-Term Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Other Long Term Liabilities | Other long-term liabilities consist of the following: Schedule of Other Long Term Liabilities (in thousands) December 31, December 31, Legal settlement – noncurrent (See Note 24) $ - $ 5,625 Other 21 24 Total $ 21 $ 5,649 |
Income Taxes (Tables)
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, December 31, 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 $ - $ - |
Stockholders_ Equity (Tables)
Stockholders’ Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of Warrants | Warrants the IPO Warrants, and the PIPE Warrants, which includes the Inducement and 2022 Pre-Funded Warrants (together, the “ Schedule of Warrants Warrant - Warrant - Total 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 |
Equity Incentive Plans and Sh_2
Equity Incentive Plans and Share-Based Payments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | 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 Nine Months Ended September 30, 2023 2022 Expected volatility 70 95 % 55 70 % Expected term (in years) 6.0 5.24 6.0 Risk-free interest rate 3.5 3.9 % 1.34 4.10 % Expected dividend yield 0.0 % 0.0 % | 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 September 30, 2023 and a summary of option activity during the nine months then ended is presented below. Schedule of Stock Option Activity Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (1) Outstanding at December 31, 2022 86,951 $ 62.16 Granted 22,477 $ 13.98 Exercised - $ - Canceled or forfeited (31,480 ) $ 53.58 Outstanding at September 30, 2023 77,948 $ 51.74 8.45 $ 0 Exercisable at September 30, 2023 24,210 $ 62.23 7.75 $ 0 (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 September 30, 2023. | 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 | Schedule of Restricted Stock Units Shares Weighted Average Remaining Contractual Term Weighted Average Grant Date Fair Value Outstanding at December 31, 2022 17,176 $ 52.20 Awarded - $ - Vested (8,588 ) $ 52.20 Canceled or forfeited (3,817 ) 0.63 $ - Outstanding at September 30, 2023 4,771 0.63 $ 52.20 | 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 |
Interest Expense, net (Tables)
Interest Expense, net (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Schedule of Interest Expense | Interest expense, net consists of the following: Schedule of Interest Expense (in thousands) 2023 2022 2023 2022 For three months ended For nine months ended (in thousands) 2023 2022 2023 2022 Interest expense $ (43 ) $ (3 ) $ (77 ) $ (10 ) Interest expense, related party $ (22 ) $ - $ (22 ) $ - Contract asset interest expense (90 ) (89 ) (268 ) (268 ) Interest income – related party - 1 - 110 Interest income – other 13 2 111 8 Interest expense, net $ (142 ) $ (89 ) $ (256 ) $ (160 ) | 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 expense, net $ (195 ) $ (344 ) |
Other Income, net (Tables)
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 |
Net Earnings (Loss) per Share (
Net Earnings (Loss) per Share (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Income (loss) per common share: | ||
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | The following table sets forth the computation of the Company’s basic and diluted net earnings (loss) per share attributable to common stockholders (in thousands, except share and per share data): Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders 2023 2022 2023 2022 Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net income (loss) $ (6,342 ) $ (2,566 ) $ (23,657 ) $ 2,145 Shares: Basic weighted average common shares outstanding 1,366,842 1,136,291 1,346,264 978,018 Add: Effect of dilutive securities Stock options and restricted stock units - - - 2,233 Diluted weighted average common shares outstanding 1,366,842 1,136,291 1,346,264 980,251 Net earnings (loss) per share: Basic $ (4.64 ) $ (2.26 ) $ (17.57 ) $ 2.19 Diluted $ (4.64 ) $ (2.26 ) $ (17.57 ) $ 2.19 | 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 the securities that were anti-dilutive for diluted EPS for the periods presented but which could potentially dilute EPS in the future: Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share Nine Months Ended September 30, 2023 2022 Common stock warrants 459,856 459,856 Common stock options and RSUs 82,719 55,620 Unit Purchase Options 20,182 20,182 Anti-dilutive securities excluded from computation of earnings per share 20,182 20,182 | 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 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Schedule of Components of Lease Expense and Other Information | The components of lease expense for the three and nine months ended September 30, 2023 were 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) $ 390 Interest on lease liabilities 54 Total lease expense $ 444 Other Information Operational cash flow used for operating leases $ 428 Weighted -average remaining lease term (in years) 2.01 Weighted -average discount rate 6.75 % | 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 September 30, 2023 were as follows (in thousands): Schedule of Future Commitments and Sublease Income Years ending December 31, Future lease commitments 2023 $ 171 2024 584 2025 393 2026 44 2027 1 Total future minimum lease payments 1,193 Less imputed interest (76 ) Total lease liability $ 1,117 | 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 $ 555 Operating lease liability, non-current 562 Total $ 1,117 | Schedule of Operating Lease Liability Reported as: Operating lease liability, current $ 498 Operating lease liability, non-current 848 Total 1,346 |
Subsequent Events (Tables)
Subsequent Events (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Schedule of Unrealized Gains and Losses on Investments in Equity Securities | Unrealized losses on investment, related party were $ 1.9 6.2 no Schedule of Unrealized Gains and Losses on Investments in Equity Securities (in thousands) 2023 2022 2023 2022 Three months ended Nine months ended (in thousands) 2023 2022 2023 2022 Net losses recognized during the period on equity securities $ (2,212 ) $ - $ (6,635 ) $ - Less: Net realized losses on equity securities sold 345 - 420 - Unrealized losses recognized during the reporting period on equity securities still held at the reporting date $ (1,867 ) $ - $ (6,215 ) $ - |
Business Overview (Details Narr
Business Overview (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Jul. 03, 2023 | Jun. 28, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Nov. 28, 2023 | Jun. 27, 2023 | Jul. 26, 2022 | Dec. 21, 2020 | |
Proceeds from issuance of common stock and warrants in private placement | $ 9,391 | $ 9,391 | $ 14,995 | |||||||||
Proceeds from stock issuance | 14,943 | |||||||||||
Cash and cash equivalents | $ 3,422 | 3,422 | 17,208 | 24,545 | ||||||||
Net Cash Provided by (Used in) Operating Activities | 16,029 | 7,928 | 16,199 | 26,715 | ||||||||
Retained Earnings (Accumulated Deficit) | 103,176 | 103,176 | 79,519 | 78,879 | ||||||||
Business Combination, Contingent Consideration, Liability | $ 9,711 | $ 9,711 | $ 9,342 | $ 12,784 | ||||||||
Reverse stock split | 1-for-20 | 1-for-20 | ||||||||||
Common stock par value | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Common stock shares authorized | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | 300,000,000 | 15,000,000 | ||||
Exercise price per share | $ 100 | |||||||||||
Investments in equity securities | $ 10,548 | |||||||||||
Operating Income (Loss) | $ 4,620 | $ 3,639 | $ 18,812 | $ 12,961 | 18,581 | $ 25,201 | ||||||
Net capital | 4,100 | 4,100 | ||||||||||
Related Party [Member] | ||||||||||||
Investments in equity securities | $ 3,341 | $ 3,341 | 10,548 | |||||||||
Maruho Co. Ltd. [Member] | ||||||||||||
Business Combination, Contingent Consideration, Liability | 7,300 | |||||||||||
Common Stock [Member] | ||||||||||||
Proceeds from stock issuance | $ 4,600 |
Schedule of Estimated Useful Li
Schedule of Estimated Useful Lives of Property, Plant and Equipment (Details) | Dec. 31, 2022 |
Computer Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life in Years | 3 years |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life in Years | 3 years |
Furniture and Fixtures [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life in Years | 3 years |
Furniture and Fixtures [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life in Years | 5 years |
Machinery and Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life in Years | 3 years |
Machinery and Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life in Years | 4 years |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2022 | |
Product Information [Line Items] | |||||
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 | $ 1,129 | $ 1,375 | $ 1,800 | ||
Operating lease liability | $ 1,117 | $ 1,346 | $ 1,800 | ||
Dividend rate | 0% | 0% | 0% | 0% | |
Advertising costs | $ 100 | $ 500 | |||
Re-Levered Equity [Member] | |||||
Product Information [Line Items] | |||||
Weighting of volatility rate input | 80% | ||||
Warrant [Member] | |||||
Product Information [Line Items] | |||||
Weighting of volatility rate input | 20% | ||||
Logistics and Distribution [Member] | |||||
Product Information [Line Items] | |||||
Logistics and distribution costs | $ 500 | $ 400 |
Schedule of Acquisition Contrac
Schedule of Acquisition Contract Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 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 | $ 7,300 | ||
Contract asset | (89) | (358) | (716) | ||
Acquisition contract liabilities, net | 7,211 | 6,942 | 3,242 | ||
Contingent consideration | 2,500 | 2,400 | $ 2,100 | 6,200 | $ 7,602 |
Acquisition contract liabilities, net | 2,500 | 2,400 | 9,542 | ||
Total acquisition contract liabilities, net | 9,711 | 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 | 7,300 | 3,600 | ||
Contract asset | (89) | (358) | (358) | ||
Acquisition contract liabilities, net | 7,211 | 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 | $ 2,500 | 2,400 | 6,200 | ||
Acquisition contract liabilities, net | $ 2,400 | $ 9,542 |
Acquisition Contract Liabilit_3
Acquisition Contract Liabilities (Details Narrative) - USD ($) $ in Thousands | Mar. 25, 2019 | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Business Acquisition [Line Items] | ||||||
Contingent consideration | $ 2,500 | $ 2,400 | $ 2,100 | $ 6,200 | $ 7,602 | |
Long-Term Debt [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Contingent consideration | 2,500 | $ 2,400 | $ 6,200 | |||
Monte Carlo Simulation Model [Member] | Long-Term Debt [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Contingent consideration | $ 2,500 | |||||
Monte Carlo Simulation Model [Member] | Measurement Input, Discount Rate [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Derivative liability measuremnet input | 6 | |||||
Cutanea Life Sciences, Inc. [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Equity interest in acquiree, percentage | 100% | |||||
Non-interest bearing start-up cost financing | $ 1,700 | |||||
Sale of equity estimated profits contingent consideration | 6,500 | |||||
Cutanea Life Sciences, Inc. [Member] | Share Purchase Agreement [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Start-up cost financing | $ 7,300 | |||||
Biofrontera AG [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Equity interest in acquiree, percentage | 29.90% | |||||
Maruho Co, Ltd. [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Start-up cost financing interest rate | 6% | |||||
Start-up cost financing term | 57 months | |||||
Start-up cost financing maturity date | Dec. 31, 2023 |
Schedule of Fair Value Hierarch
Schedule of Fair Value Hierarchy Valuation Inputs (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Warrant liability – 2022 Purchase Warrants | $ 2,843 | $ 12,854 | |||
Fair Value, Inputs, Level 1 [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Investment, related party | 10,548 | ||||
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 | $ 3,341 | 10,548 | |||
Fair Value, Inputs, Level 3 [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Contingent Consideration | 2,500 | 2,400 | 6,200 | ||
Warrant liability – 2022 Purchase Warrants | 842 | 2,843 | $ 3,964 | 12,854 | |
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 – 2022 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 – 2022 Purchase Warrants | 366 | 1,129 | |||
Fair Value, Inputs, Level 3 [Member] | 2022 Inducement Warrant [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Warrant liability | $ 476 | 1,714 | |||
Fair Value, Inputs, Level 2 [Member] | Two Thousand Twenty Two July Common Warrant [Member] | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Warrant liability | $ 1,714 |
Schedule of Fair Value of Conti
Schedule of Fair Value of Contingent Consideration (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | ||||||
Beginning balance, fair value of contingent consideration | $ 2,400 | $ 6,200 | $ 6,200 | $ 7,602 | ||
Change in fair value of contingent consideration | $ 200 | $ (2,200) | 100 | (4,100) | (3,800) | (1,402) |
Ending balance, fair value of contingent consideration | $ 2,500 | $ 2,100 | $ 2,500 | $ 2,100 | $ 2,400 | $ 6,200 |
Schedule of Fair value Warrant
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 |
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] | 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] | Purchase Warrants [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrant outstanding, measurement input | 70 | 65 | |
Measurement Input, Option Volatility [Member] | Inducement Warrants [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrant outstanding, measurement input | 75 | 70 | |
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] | Purchase Warrants [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrant outstanding, measurement input | 0 | 0 | |
Measurement Input, Expected Dividend Payment [Member] | Inducement Warrants [Member] | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Warrant outstanding, measurement input | 0 | 0 |
Schedule of Changes in Fair Val
Schedule of Changes in Fair Value Warrant Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | ||||||
Fair value at beginning of year | $ 2,843 | $ 12,854 | $ 12,854 | |||
Issuance of new warrants | 13,217 | 12,261 | ||||
Exercise of warrants | (6,840) | (12,208) | ||||
Change in fair value of warrant liability | $ (598) | $ (3,814) | $ (2,001) | $ (17,896) | (19,017) | 12,801 |
Fair value at end of year | $ 2,843 | $ 12,854 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jun. 28, 2023 | Jul. 26, 2022 | May 16, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Fair value of contingent consideration | $ 200 | $ (2,200) | $ 100 | $ (4,100) | $ (3,800) | $ (1,402) | |||||
Investment in equity securities, shares | 5,745,678 | 6,446,946 | |||||||||
Class of warrant or right, exercise price of warrants or rights | $ 100 | ||||||||||
Fair Value, Inputs, Level 3 [Member] | Purchase Warrants [Member] | |||||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 55.40 | ||||||||||
Fair Value, Inputs, Level 3 [Member] | Inducement Warrants [Member] | |||||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Class of warrant or right, number of securities called by warrants or rights | 214,286 | ||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 33.20 | ||||||||||
Fair Value, Inputs, Level 3 [Member] | Private Placement [Member] | |||||||||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||||||||
Class of warrant or right, number of securities called by warrants or rights | 170,950 |
Schedule of Revenue Allowance a
Schedule of Revenue Allowance and Accrual Activities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Balance at December 31, 2021 | $ 82 | $ 246 | $ 246 | $ 327 |
Provision related to current period sales | 429 | 691 | 813 | 637 |
Credit or payments made during the period | (378) | (577) | (977) | (718) |
Balance at December 31, 2022 | 133 | 360 | 82 | 246 |
Returns [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Balance at December 31, 2021 | 48 | 43 | 43 | 217 |
Provision related to current period sales | 4 | 8 | 10 | 6 |
Credit or payments made during the period | (5) | (5) | (180) | |
Balance at December 31, 2022 | 52 | 46 | 48 | 43 |
Co-pay Assistance Program [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Balance at December 31, 2021 | 9 | 101 | 101 | 52 |
Provision related to current period sales | 156 | 503 | 574 | 423 |
Credit or payments made during the period | (145) | (400) | (666) | (374) |
Balance at December 31, 2022 | 20 | 204 | 9 | 101 |
Prompt Pay Discounts [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Balance at December 31, 2021 | 5 | 48 | 48 | 15 |
Provision related to current period sales | 3 | 16 | 19 | 40 |
Credit or payments made during the period | (2) | (23) | (62) | (7) |
Balance at December 31, 2022 | 6 | 41 | 5 | 48 |
Government and Payor Rebates [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Balance at December 31, 2021 | 20 | 54 | 54 | 43 |
Provision related to current period sales | 266 | 164 | 210 | 168 |
Credit or payments made during the period | (231) | (149) | (244) | (157) |
Balance at December 31, 2022 | $ 55 | $ 69 | $ 20 | $ 54 |
Investment, Related Party (Deta
Investment, Related Party (Details Narrative) $ in Thousands | 9 Months Ended | |||||
Sep. 30, 2023 shares | Dec. 31, 2022 shares | Nov. 08, 2022 shares | Oct. 25, 2022 € / shares shares | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Investment in equity securities, shares | 5,745,678 | 6,446,946 | ||||
Investment in equity securities additional information | 3,377,346 | |||||
Proceeds from sale of equity securities | $ | $ 560 | |||||
Private Exchange Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Share price | € / shares | € 1 | |||||
Exchange of shares issued | 3,148,042 | |||||
Number of shares purchased through the exercise of options | 6,446,946 | 2,623,365 | ||||
Number of shares purchased through the exercise of options | 3,843,581 | |||||
Outstanding shares, percent | 10% | |||||
Private Exchange Agreement [Member] | Related Party [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Exchange of shares issued | 157,042 |
Accounts Receivable, net (Detai
Accounts Receivable, net (Details Narrative) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Credit Loss [Abstract] | |||
Allowance for doubtful accounts | $ 0.2 | $ 0.1 | $ 0.1 |
Other Receivables, Related Pa_2
Other Receivables, Related Party (Details Narrative) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Other receivables related party | $ 3,793 | $ 3,748 | $ 3,784 |
Legal settlements receivable percentage | 50% | 50% | |
Biofrontera AG [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Accounts receivables | $ 3,700 | ||
Other receivables related party, long term | $ 2,800 | ||
Legal settlements receivable percentage | 50% | ||
Interest rate percentage | 6% | 6% | |
Biofrontera Group [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Accounts receivables | $ 2,700 | ||
Service Agreements [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Other receivables related party | $ 6,500 | ||
Service Agreements [Member] | Biofrontera AG [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Accounts receivables | $ 6,400 |
Inventories (Details Narrative)
Inventories (Details Narrative) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
BF-RhodoLED [Member] | |
[custom:ProvisionForInventories] | $ 0.1 |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses And Other Current Assets | |||
Receivable for common stock warrants proceeds | $ 3,258 | ||
Prepaid expenses | 439 | 824 | |
Security deposits | 85 | 149 | |
Other | 286 | 756 | |
Total | $ 274 | $ 810 | $ 4,987 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | 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 | $ 154 | 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 |
Property and Equipment, Net (De
Property and Equipment, Net (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 65 | $ 80 | $ 101 | $ 122 |
Schedule of Intangible Asset Ne
Schedule of Intangible Asset Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Xepi® license | $ 4,600 | $ 4,600 | $ 4,600 |
Less: Accumulated amortization | (1,882) | (1,568) | (1,150) |
Intangible asset, net | $ 2,718 | $ 3,032 | $ 3,450 |
Intangible Asset, Net (Details
Intangible Asset, Net (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||||||
Finite lived license agreements gross | $ 4,600 | $ 4,600 | $ 4,600 | $ 4,600 | ||
Finite lived intangible asset useful life | 11 years | 11 years | 11 years | |||
Amortization of intangible assets | $ 100 | $ 100 | $ 314 | $ 314 | $ 418 | $ 418 |
Schedule of Reconciliation of C
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] | |||
Cash and cash equivalents | $ 3,422 | $ 17,208 | $ 24,545 |
Short-term restricted cash | 47 | ||
Long-term restricted cash | 200 | 200 | 150 |
Total cash, cash equivalents, and restricted cash shown on the consolidated statements of cash flows | $ 3,622 | $ 17,408 | $ 24,742 |
Schedule of Accrued Expenses an
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | |||
Legal settlement (See note 18) | $ 6,028 | $ 6,207 | $ 5,625 |
Employee compensation and benefits | 2,948 | 2,850 | 2,384 |
Professional fees | 1,253 | 1,353 | 570 |
Product revenue allowances and reserves | 134 | 82 | 246 |
Other | 676 | 372 | 829 |
Total | $ 11,039 | $ 10,864 | $ 9,654 |
Schedule of Other Long Term Lia
Schedule of Other Long Term Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Legal settlement – noncurrent (See Note 24) | $ 5,625 | |
Other | 21 | 24 |
Total | $ 21 | $ 5,649 |
Schedule of Effective Income Ta
Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income tax computed at federal statutory tax rate | 21% | 21% |
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
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) |
Net deferred taxes |
Income Taxes (Details Narrative
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 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2023 | Dec. 31, 2022 | Nov. 03, 2022 | Oct. 08, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | ||||||||||
Accounts receivable, related parties | $ 3,793,000 | $ 3,748,000 | $ 3,793,000 | $ 3,793,000 | $ 3,748,000 | $ 3,784,000 | ||||
Expenses related to service | 500,000 | |||||||||
Legal settlements receivable percentage | 50% | 50% | 50% | 50% | 50% | |||||
Interest Income, Operating | $ 1,000 | $ 110,000 | $ 165,000 | |||||||
[custom:StockIssuedDuringPeriodSharesInvestmentInEquitySecurities] | 5,745,678 | 6,446,946 | ||||||||
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, related parties | $ 6,500,000 | 6,500,000 | ||||||||
Share Purchase Agreement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Start-up cost financing and reimbursements | 0 | |||||||||
Biofrontera Pharma GmbH [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Interest Income, Operating | 100,000 | |||||||||
Biofrontera Pharma GmbH [Member] | License and Supply Agreement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Related party costs | 5,100,000 | 5,200,000 | 18,800,000 | 16,600,000 | 16,600,000 | 9,400,000 | ||||
Accounts payable related parties | $ 7,000,000 | 1,300,000 | 7,000,000 | 7,000,000 | 1,300,000 | 300,000 | ||||
Biofrontera Pharma GmbH [Member] | Clinica Lamp Lease Agreement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Revenue from sales | 100,000 | 100,000 | 100,000 | 100,000 | ||||||
Accounts receivable, related parties | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | 100,000 | ||||
Biofrontera AG [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Due from related parties | 3,700,000 | 3,700,000 | ||||||||
Loss Contingency, Receivable | $ 2,800,000 | 6,400,000 | $ 2,800,000 | $ 2,800,000 | 6,400,000 | 11,300,000 | ||||
Legal settlements receivable percentage | 50% | 50% | 50% | |||||||
Interest Income, Operating | 100,000 | 0 | ||||||||
Biofrontera AG [Member] | Service Agreements [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Accounts payable related parties | $ 200,000 | 200,000 | $ 200,000 | $ 200,000 | 200,000 | 200,000 | ||||
Expenses related to service | 700,000 | 700,000 | ||||||||
Expenses related to service | $ 100,000 | $ 200,000 | 200,000 | $ 600,000 | ||||||
Due from related parties | $ 6,400,000 | 6,400,000 | ||||||||
Maruho Co, Ltd. [Member] | Cutanea Acquisition Agreement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
Accounts receivable, related parties | 100,000 | |||||||||
Due from related parties | $ 0 | |||||||||
Maruho Co, Ltd. [Member] | Share Purchase and Transfer Agreement [Member] | ||||||||||
Related Party Transaction [Line Items] | ||||||||||
[custom:StockIssuedDuringPeriodValuesInvestmentInEquitySecurities] | $ 3,300,000 | $ 10,500,000 | ||||||||
[custom:StockIssuedDuringPeriodSharesInvestmentInEquitySecurities] | 5,745,678 | 6,466,949 | ||||||||
[custom:StockIssuedDuringPeriodSharesPurchase] | 1,674,996 | |||||||||
[custom:TotalNumberOfSharesPurchased] | 6,466,946 | |||||||||
[custom:StockIssuedDuringPeriodValuesPurchase] | $ 1,700,000 |
Restructuring costs (Details Na
Restructuring costs (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | ||
Restructuring costs | $ 0 | $ 800,000 |
Schedule of Warrants (Details)
Schedule of Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||
Beginning balance | 217,477 | |
Weighted Average Exercise Price Balance, Beginning 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 |
Ending balance | 459,856 | 217,477 |
Weighted Average Exercise Price Balance, Ending balance | $ 52.29 | $ 99.69 |
PIPE [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Beginning balance | 142,857 | |
Warrants issued | 463,686 | 218,214 |
Warrants exercised | (221,307) | (75,357) |
Ending balance | 385,236 | 142,857 |
IPO [Member] | ||
Subsidiary, Sale of Stock [Line Items] | ||
Beginning balance | 74,620 | |
Warrants issued | 207,000 | |
Warrants exercised | (132,380) | |
Ending balance | 74,620 | 74,620 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||||||||
Jul. 03, 2023 $ / shares shares | Jun. 28, 2023 $ / shares shares | Oct. 25, 2022 € / shares shares | Jul. 26, 2022 USD ($) $ / shares shares | Jul. 26, 2022 $ / shares shares | May 16, 2022 $ / shares shares | Dec. 02, 2021 USD ($) $ / shares shares | Nov. 02, 2021 USD ($) $ / shares shares | Nov. 02, 2021 $ / shares shares | May 16, 2022 USD ($) $ / shares shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Nov. 28, 2023 $ / shares | Jun. 27, 2023 shares | Oct. 13, 2022 $ / shares shares | Jul. 14, 2022 $ / shares shares | Dec. 28, 2021 $ / shares 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 | 15,000,000 | 300,000,000 | 15,000,000 | |||||||||||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||||
Preferred stock designated | shares | 20,000,000 | 20,000,000 | 20,000,000 | 20,000,000 | 20,000,000 | |||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 100 | |||||||||||||||||||
Proceeds from issuance costs | $ | $ 3,100,000 | |||||||||||||||||||
Stock issued during period, shares, new issues | shares | 214,286 | |||||||||||||||||||
Share exercise price | $ 5 | |||||||||||||||||||
Expected volatility | 55% | |||||||||||||||||||
Risk free rate | 1.34% | |||||||||||||||||||
Contractual term | 6 years | 6 years | ||||||||||||||||||
Dividend yield | 0% | 0% | 0% | 0% | ||||||||||||||||
Proceeds from issuance of private placement | $ | $ 9,391,000 | $ 9,391,000 | $ 14,995,000 | |||||||||||||||||
Common stock shares isued | shares | 1,367,628 | 1,334,950 | 855,237 | |||||||||||||||||
Class of warrant or right, number of securities called by each warrant or right | shares | 142,858 | 142,858 | ||||||||||||||||||
Proceeds from warrant exercises | $ | $ 4,600,000 | |||||||||||||||||||
Warrants rights exercisable date | Dec. 01, 2026 | Nov. 18, 2027 | ||||||||||||||||||
Preferred stock par value | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-20 | 1-for-20 | ||||||||||||||||||
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 | $ 105 | ||||||||||||||||||
Expected volatility | 95% | 70% | ||||||||||||||||||
Risk free rate | 3.90% | 4.10% | ||||||||||||||||||
Contractual term | 6 years | 6 years | ||||||||||||||||||
Minimum [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | 32.40 | 32.40 | ||||||||||||||||||
Expected volatility | 70% | 55% | ||||||||||||||||||
Risk free rate | 3.50% | 1.34% | ||||||||||||||||||
Contractual term | 5 years 2 months 26 days | 5 years 2 months 26 days | ||||||||||||||||||
2022 Pre-Funded Warrant [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Warrant term | 5 years | 5 years | ||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 55.40 | $ 55.40 | ||||||||||||||||||
Warrant purchase, common stock | shares | 78,450 | 78,450 | ||||||||||||||||||
Prefunded Warrant [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.02 | $ 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 | |||||||||||||||||||
Exchange of shares issued | shares | 3,148,042 | |||||||||||||||||||
Warrant [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Warrant term | 5 years | 5 years | ||||||||||||||||||
Warrant [Member] | Inducement Warrant [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Share price per shares | $ 33.20 | $ 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 | $ 55 | ||||||||||||||||||
Common stock shares isued | shares | 78,450 | |||||||||||||||||||
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 | $ 0.001 | ||||||||||||||||||
Number of shares sold | shares | 180,000 | |||||||||||||||||||
Share price per shares | $ 100 | 100 | ||||||||||||||||||
Proceeds from IPO | $ | $ 18,000,000 | |||||||||||||||||||
Proceeds from issuance costs | $ | $ 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% | |||||||||||||||||||
Risk free rate | 1.15% | |||||||||||||||||||
Contractual term | 5 years | |||||||||||||||||||
Dividend yield | 0% | |||||||||||||||||||
IPO [Member] | Warrant [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 100 | 100 | ||||||||||||||||||
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 | $ 0.20 | ||||||||||||||||||
Warrant purchase, common stock | shares | 27,000 | 27,000 | ||||||||||||||||||
Stock issued during period, shares, new issues | shares | 810 | |||||||||||||||||||
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 | $ 125 | ||||||||||||||||||
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% | |||||||||||||||||||
Risk free rate | 1.15% | |||||||||||||||||||
Contractual term | 5 years | |||||||||||||||||||
Dividend yield | 0% | |||||||||||||||||||
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 | 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 | |||||||||||||||||||
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 | |||||||||||||||||||
Private Placement [Member] | Warrant [Member] | ||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||||||
Warrant term | 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 | |||||||||||||||||||
Expected volatility | 60% | |||||||||||||||||||
Risk free rate | 1.15% | |||||||||||||||||||
Contractual term | 5 years | |||||||||||||||||||
Dividend yield | 0% | |||||||||||||||||||
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 |
Schedule of Stock Options Assum
Schedule of Stock Options Assumptions (Details) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected Volatility, minimum | 55% | |||
Expected volatility, maximum | 70% | |||
Expected volatility | 55% | |||
Expected term (in years) | 6 years | 6 years | ||
Risk-free interest rate, minimum | 1.34% | |||
Risk-free interest rate, maximum | 4.10% | |||
Risk-free interest rate | 1.34% | |||
Expected dividend yield | 0% | 0% | 0% | 0% |
Minimum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected volatility | 70% | 55% | ||
Expected term (in years) | 5 years 2 months 26 days | 5 years 2 months 26 days | ||
Risk-free interest rate | 3.50% | 1.34% | ||
Maximum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Expected volatility | 95% | 70% | ||
Expected term (in years) | 6 years | 6 years | ||
Risk-free interest rate | 3.90% | 4.10% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |||||
Share-Based Payment Arrangement [Abstract] | |||||||
Number of Shares Outstanding, Beginning Balance | 86,951 | 30,737 | |||||
Weighted Average Exercise Price, Beginning Balance | $ 62.16 | $ 95.40 | |||||
Number of Shares Outstanding, Beginning Balance | 22,477 | 64,572 | 30,942 | ||||
Weighted Average Exercise Price, Beginning Balance | $ 13.98 | $ 48.20 | $ 95.40 | ||||
Number of Shares Outstanding, Beginning Balance | |||||||
Weighted Average Exercise Price, Beginning Balance | |||||||
Number of Shares Outstanding, Beginning Balance | (31,480) | (8,358) | (205) | ||||
Weighted Average Exercise Price, Beginning Balance | $ 53.58 | $ 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 | $ 1,691 | ||||
Number of Shares Outstanding, Ending Balance | 77,948 | 86,951 | 30,737 | ||||
Weighted Average Exercise Price, Ending Balance | $ 51.74 | $ 62.16 | $ 95.40 | ||||
Weighted Average Remaining Contractual Life (in Years), Outstanding | 8 years 5 months 12 days | 9 years 3 months 7 days | |||||
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ 0 | [2] | $ 1 | [1] | $ 1,691 | [1] | |
Number of Exercisable Shares Outstanding, Balance | 24,210 | 11,166,000 | |||||
Weighted Average Exercise Price, Balance | $ 62.23 | $ 85.48 | |||||
Weighted Average Remaining Contractual Life (in Years), Exercisable | 7 years 9 months | 8 years 11 months 26 days | |||||
Aggregate Intrinsic Value, Exercisable, Ending Balance | $ 0 | [2] | [1] | ||||
[1]The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the common stock for the options that were in the money at December 31, 2022 and December 31, 2021.[2]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 September 30, 2023. |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||
Number of shares outstanding, beginning balance | 17,176 | 8,504 | |
Number of shares weighted average grant date fair value, beginning balance | $ 52.20 | $ 95.40 | |
Number of shares outstanding, Awarded | 17,176 | 8,504 | |
Number of shares weighted average grant date fair value, Awarded | $ 52.20 | $ 95.40 | |
Number of shares outstanding, Vested | (8,588) | (8,504) | |
Number of shares weighted average grant date fair value,Vested | $ 52.20 | $ 95.40 | |
Number of Shares Outstanding, Forfeited | 3,817 | ||
Number of shares weighted average grant date fair value, Canceled or forfeited | |||
Number of shares outstanding, ending balance | 4,771 | 17,176 | 8,504 |
Number of shares weighted average grant date fair value, outstanding ending balance | $ 52.20 | $ 52.20 | $ 95.40 |
Number of shares outstanding, Canceled or expired | (3,817) | ||
Weighted Average Remaining Contractual Life (in Years), Canceled or forfeited | 7 months 17 days | ||
Weighted Average Remaining Contractual Life (in Years), Outstanding Ending Balance | 7 months 17 days |
Equity Incentive Plans and Sh_3
Equity Incentive Plans and Share-Based Payments (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Dec. 12, 2022 | Dec. 11, 2022 | Dec. 07, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Unrecognized compensation cost | $ 1 | $ 1 | $ 2.2 | ||||||
Compensation cost recognized, weighted average period | 1 year 9 months 18 days | 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 | 0.2 | $ 0.2 | $ 0.6 | ||||||
Compensation cost recognized, weighted average period | 7 months 6 days | 1 year 4 months 24 days | |||||||
Share based compensation vested in period, fair value | $ 0.8 | $ 0 | |||||||
Selling, General and Administrative Expenses [Member] | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Share based compensation expenses | 0.1 | $ 0.3 | $ 0.5 | $ 0.6 | 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 | $ 0.1 | $ 0.1 | $ 0.3 | $ 0.9 | $ 1 | $ 0.1 | |||
Omnibus Incentive Plan [Member] | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Remain eligible for issuance shares | 163,362 | 163,362 | 137,500 | ||||||
Number of shares available for future awards, increased | 266,990 | 129,490 | |||||||
Number of shares available for future issuance | 154,359 | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Terms of Award | 10 years for stock options issued under the 2021 Plan. | ||||||||
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 | ||||||||
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 |
Schedule of Interest Expense (D
Schedule of Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Interest expense | $ (43) | $ (3) | $ (77) | $ (10) | $ (12) | $ (2) |
Contract asset interest expense | (90) | (89) | (268) | (268) | (358) | (358) |
Interest income – related party | 1 | 110 | 165 | |||
Interest income – other | 13 | 2 | 111 | 8 | 10 | 16 |
Interest expense, net | (142) | (89) | (256) | (160) | $ (195) | $ (344) |
Interest expense, related party | $ (22) | $ (22) |
Interest Expense, net (Details
Interest Expense, net (Details Narrative) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Contract asset | $ (89) | $ (358) | $ (716) | |
Startup cost financing | $ 7,300 | $ 7,300 | $ 7,300 | |
Legal settlements receivable percentage | 50% | 50% | ||
Maruho Co, Ltd. [Member] | Cutanea Acquisition Agreement [Member] | ||||
Contract asset | $ 1,700 | $ 1,700 | ||
Startup cost financing | $ 7,300 | $ 7,300 | ||
Debt instrument stated percentage | 6% | 6% | ||
Debt maturity date | Dec. 31, 2023 | Dec. 31, 2023 | ||
Biofrontera AG [Member] | ||||
Legal settlements receivable percentage | 50% | 50% | ||
Biofrontera AG [Member] | Related Party [Member] | ||||
Due from related party | $ 6,100 | $ 6,100 |
Schedule of Other Income, Net (
Schedule of Other Income, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Other Income and Expenses [Abstract] | ||||||
Reimbursed SPA costs | $ 539 | |||||
Other, net | 33 | 150 | ||||
Other income, net | $ 35 | $ (22) | $ 65 | $ 30 | $ 33 | $ 689 |
Schedule of Basic and Diluted N
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income (loss) per common share: | ||||||
Net loss | $ (6,342) | $ (2,566) | $ (23,657) | $ 2,145 | $ (640) | $ (37,713) |
Weighted average common shares outstanding, basic and diluted | 1,366,842 | 1,136,291 | 1,346,264 | 978,018 | 1,056,988,000 | 440,412,000 |
Net loss per share, basic and diluted | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 | $ (0.61) | $ (85.63) |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share (Details) - shares shares in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | 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 | 459,856 | 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 | 82,719 | 55,620 | 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 | 20,182 | 20,182 |
Schedule of Components of Lease
Schedule of Components of Lease Expense and Other Information (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Amortization of ROU assets (operating lease cost) | $ 390 | $ 653 | ||
Interest on lease liabilities | 54 | 99 | ||
Total lease expense | 444 | 752 | ||
Operational cash flow used for operating leases | $ 428 | 781 | ||
ROU assets obtained in exchange for lease liabilities | $ 234 | |||
Weighted -average remaining lease term (in years) | 2 years 3 days | 2 years 6 months 14 days | ||
Weighted -average discount rate | 6.75% | 6.31% |
Schedule of Future Commitments
Schedule of Future Commitments and Sublease Income (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Jan. 01, 2022 |
Commitments and Contingencies Disclosure [Abstract] | |||
2024 | $ 584 | $ 565 | |
2025 | 393 | 541 | |
2026 | 44 | 349 | |
Thereafter | |||
Total future minimum lease payments | 1,193 | 1,455 | |
Less imputed interest | (76) | (109) | |
Total lease liability | 1,117 | $ 1,346 | $ 1,800 |
2023 | 171 | ||
2027 | $ 1 |
Schedule of Operating Lease Lia
Schedule of Operating Lease Liability (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Jan. 01, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease liability, current | $ 555 | $ 498 | ||
Operating lease liability, non-current | 562 | 848 | ||
Total | $ 1,117 | $ 1,346 | $ 1,800 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | |||||
Sep. 30, 2023 | Dec. 31, 2022 | Nov. 29, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | 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 | option to extend the term of the lease for one five (5) year period | |||||
Security deposit | $ 250,000 | $ 250,000 | |||||
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 leased liabilities at inception and 8.5% for 2022 leased liabilities. | ||||||
Settlement liability | $ 22,500,000 | ||||||
Start-up cost financing | 7,300,000 | $ 7,300,000 | 7,300,000 | $ 7,300,000 | $ 7,300,000 | ||
Licensing Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Licensing fee | 200,000 | ||||||
Biofrontera AG [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Settlement liability | 6,000,000 | 6,200,000 | |||||
Loss contingency, receivable | 2,800,000 | 6,400,000 | 2,800,000 | 6,400,000 | 11,300,000 | ||
Maruho Co, Ltd. [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Additional payout | 900,000 | ||||||
Maximum [Member] | Licensing Agreement [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Sales milestone payments | $ 1,000,000 | $ 1,000,000 | |||||
Royalties percentage related to royalties | 3% | 3% | |||||
Xepi LSA [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Contractual Obligation | $ 2,000,000 | 2,000,000 | $ 2,000,000 | $ 4,000,000 | 2,000,000 | 4,000,000 | |
Xepi LSA [Member] | Maximum [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Revenues | 25,000,000 | $ 50,000,000 | 25,000,000 | $ 50,000,000 | |||
Maruho Co, Ltd. [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Repayments of related party debt | 3,600,000 | ||||||
Maruho Co, Ltd. [Member] | December 31, 2022 [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Repayments of related party debt | 3,600,000 | ||||||
Maruho Co, Ltd. [Member] | December 31, 2023 [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Repayments of related party debt | 3,700,000 | ||||||
Start-up cost financing | 3,700,000 | 3,700,000 | |||||
Maruho Contract Manufacturer [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Repayments of related party debt | 7,300,000 | ||||||
Facility Leases [Member] | |||||||
Product Liability Contingency [Line Items] | |||||||
Security deposit | $ 100,000 | $ 100,000 | $ 100,000 | $ 100,000 |
Retirement Plan (Details Narrat
Retirement Plan (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||||||
Employee contributions description | The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary. | The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary | ||||
Defined Contribution Plan, Cost | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 | $ 0.2 |
Schedule of Fair Value Warran_2
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions (Details) | Sep. 30, 2023 $ / shares | Dec. 31, 2022 $ / shares | Jul. 26, 2022 $ / shares | May 16, 2022 $ / shares |
Measurement Input, Share Price [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Stock price | $ 18.40 | $ 52.40 | ||
Measurement Input, Share Price [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Stock price | $ 18.40 | $ 32.80 | ||
Measurement Input, Expected Term [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Expiration term (in years) | 4 years 10 months 17 days | 5 years 6 months | ||
Measurement Input, Expected Term [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Expiration term (in years) | 3 years 11 months 1 day | 4 years 4 months 2 days | ||
Measurement Input, Option Volatility [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 70 | 65 | ||
Measurement Input, Option Volatility [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 75 | 70 | ||
Measurement Input, Risk Free Interest Rate [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 3.96 | 2.83 | ||
Measurement Input, Risk Free Interest Rate [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 4.07 | 2.84 | ||
Measurement Input, Expected Dividend Payment [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 0 | 0 | ||
Measurement Input, Expected Dividend Payment [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 0 | 0 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Share Price [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Stock price | $ 8.77 | $ 18.40 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Share Price [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Stock price | $ 8.77 | $ 18.40 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Term [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Expiration term (in years) | 4 years 1 month 17 days | 4 years 10 months 17 days | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Term [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Expiration term (in years) | 3 years 2 months 1 day | 3 years 11 months 1 day | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Option Volatility [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 80 | 70 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Option Volatility [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 80 | 75 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Risk Free Interest Rate [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 4.63 | 3.96 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Risk Free Interest Rate [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 4.73 | 4.07 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Dividend Payment [Member] | Purchase Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 0 | 0 | ||
Fair Value, Inputs, Level 3 [Member] | Measurement Input, Expected Dividend Payment [Member] | Inducement Warrants [Member] | ||||
Platform Operator, Crypto-Asset [Line Items] | ||||
Warrant outstanding, measurement input | 0 | 0 |
Schedule of Changes in Level 3
Schedule of Changes in Level 3 Warrant Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Platform Operator, Crypto-Asset [Line Items] | ||||||
Fair value at beginning of year | $ 2,843 | $ 12,854 | $ 12,854 | |||
Issuance of new warrants | 13,217 | 12,261 | ||||
Exercise of warrants | (6,840) | (12,208) | ||||
Change in fair value of warrant liabilities | $ (598) | $ (3,814) | (2,001) | (17,896) | (19,017) | 12,801 |
Fair value at end of year | 2,843 | 12,854 | ||||
Fair Value, Inputs, Level 3 [Member] | ||||||
Platform Operator, Crypto-Asset [Line Items] | ||||||
Fair value at beginning of year | 2,843 | 12,854 | 12,854 | |||
Issuance of new warrants | 13,217 | |||||
Exercise of warrants | (6,840) | |||||
Change in fair value of warrant liabilities | (2,001) | (15,267) | ||||
Fair value at end of year | $ 842 | $ 3,964 | $ 842 | $ 3,964 | $ 2,843 | $ 12,854 |
Schedule of Revenue Allowance_2
Schedule of Revenue Allowance and Accrual Activties (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Balance at December 31, 2021 | $ 82 | $ 246 | $ 246 | $ 327 |
Provision related to current period sales | 429 | 691 | 813 | 637 |
Credit or payments made during the period | (378) | (577) | (977) | (718) |
Balance at December 31, 2022 | 133 | 360 | 82 | 246 |
Returns [Member] | ||||
Balance at December 31, 2021 | 48 | 43 | 43 | 217 |
Provision related to current period sales | 4 | 8 | 10 | 6 |
Credit or payments made during the period | (5) | (5) | (180) | |
Balance at December 31, 2022 | 52 | 46 | 48 | 43 |
Co-pay Assistance Program [Member] | ||||
Balance at December 31, 2021 | 9 | 101 | 101 | 52 |
Provision related to current period sales | 156 | 503 | 574 | 423 |
Credit or payments made during the period | (145) | (400) | (666) | (374) |
Balance at December 31, 2022 | 20 | 204 | 9 | 101 |
Prompt Pay Discounts [Member] | ||||
Balance at December 31, 2021 | 5 | 48 | 48 | 15 |
Provision related to current period sales | 3 | 16 | 19 | 40 |
Credit or payments made during the period | (2) | (23) | (62) | (7) |
Balance at December 31, 2022 | 6 | 41 | 5 | 48 |
Government and Payor Rebates [Member] | ||||
Balance at December 31, 2021 | 20 | 54 | 54 | 43 |
Provision related to current period sales | 266 | 164 | 210 | 168 |
Credit or payments made during the period | (231) | (149) | (244) | (157) |
Balance at December 31, 2022 | $ 55 | $ 69 | $ 20 | $ 54 |
Schedule of Unrealized Gains an
Schedule of Unrealized Gains and Losses on Investments in Equity Securities (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Benefit Plan Disclosure [Line Items] | ||||||
Net losses recognized during the period on equity securities | $ (2,212,000) | $ (6,635,000) | $ 1,747,000 | |||
Less: Net realized losses on equity securities sold | 345,000 | 420,000 | ||||
Unrealized losses recognized during the reporting period on equity securities still held at the reporting date | (1,867,000) | (6,215,000) | ||||
Related Party [Member] | ||||||
Defined Benefit Plan Disclosure [Line Items] | ||||||
Unrealized gain loss on investments | $ 1,900,000 | $ 0 | $ 6,200,000 | $ 0 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | ||||||||||||||||||||||||
Jan. 03, 2024 | Dec. 29, 2023 | Dec. 21, 2023 | Dec. 21, 2023 | Dec. 20, 2023 | Nov. 22, 2023 | Oct. 30, 2023 | Oct. 30, 2023 | Jul. 03, 2023 | Jun. 28, 2023 | May 28, 2023 | May 22, 2023 | May 08, 2023 | Apr. 26, 2023 | Mar. 09, 2023 | Jul. 26, 2022 | Jul. 26, 2022 | May 16, 2022 | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 23, 2024 | Nov. 28, 2023 | Jun. 27, 2023 | Nov. 02, 2021 | Dec. 21, 2020 | |
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Stockholders' Equity, Reverse Stock Split | 1-for-20 | 1-for-20 | ||||||||||||||||||||||||
Common Stock, Shares Authorized | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | 300,000,000 | 15,000,000 | |||||||||||||||||||
Stock issued during period, shares, new issues | 214,286 | |||||||||||||||||||||||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 100 | |||||||||||||||||||||||||
Class of warrant or right, date from which warrants or rights exercisable | Dec. 01, 2026 | Nov. 18, 2027 | ||||||||||||||||||||||||
Interest rate percentage | 5.48% | |||||||||||||||||||||||||
Line of credit facility, annual principal payment | $ 650,000 | |||||||||||||||||||||||||
Stock issued during period, value, new issues | $ 3,683,000 | $ 14,943,000 | ||||||||||||||||||||||||
Depositor | 250,000 | |||||||||||||||||||||||||
Cash depositor | $ 3,000,000 | |||||||||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Stock issued during period, shares, new issues | 157,402 | 180,000 | ||||||||||||||||||||||||
Stock issued during period, value, new issues | $ 0 | $ 0 | ||||||||||||||||||||||||
IPO [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Common stock, par or stated value per share | $ 0.001 | |||||||||||||||||||||||||
IPO [Member] | Warrant [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 100 | |||||||||||||||||||||||||
Warrant Amendment [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 33.20 | $ 33.20 | $ 55.40 | |||||||||||||||||||||||
Warrant Amendment [Member] | Common Stock [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Stock issued during period, shares, new issues | 214,286 | 170,950 | ||||||||||||||||||||||||
Subsequent Event [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Stockholders' Equity, Reverse 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. | |||||||||||||||||||||||||
Common Stock, Shares Authorized | 150,000 | 3,000,000 | ||||||||||||||||||||||||
Stock issued during period, shares, new issues | 1,517,628 | |||||||||||||||||||||||||
Common stock, par or stated value per share | $ 0.001 | $ 0.001 | ||||||||||||||||||||||||
Placement agent a cash fee | 7% | |||||||||||||||||||||||||
Annual meeting, constituting | 58.20% | |||||||||||||||||||||||||
Other borrowings | $ 6,500,000 | |||||||||||||||||||||||||
Line of credit facility, annual principal payment | $ 194,000 | |||||||||||||||||||||||||
Termination fees | $ 150,000 | |||||||||||||||||||||||||
Stock issued during period, value, new issues | $ 1,038,000 | |||||||||||||||||||||||||
Stockholders' equity, period increase (decrease) | 2,500,000 | |||||||||||||||||||||||||
Assets sold under agreements to repurchase, market value | 35,000,000 | |||||||||||||||||||||||||
Income from continuing operations | $ 500,000 | |||||||||||||||||||||||||
Subsequent Event [Member] | Licensing Agreement [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Royalty Expense | $ 1,000,000 | |||||||||||||||||||||||||
[custom:RoyaltyPercentage] | 3% | |||||||||||||||||||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Sale of stock, description of transaction | the Company agreed to issue and sell to the institutional investor: (i) 150,000 shares of Common Stock at a combined offering price of $3.74, (ii) 1,055,000 pre-funded warrants to purchase up to 1,055,000 shares of Common Stock (the “Pre-Funded Warrants”) at a combined offering price of $3.7399 and (iii) 1,205,000 warrants to purchase up to 1,807,500 shares of Common Stock (the “Common Warrants”), resulting in gross proceeds of approximately $4.5 million. The Public Offering closed on November 2, 2023 | |||||||||||||||||||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Warrant [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Warrant expiry period | 5 years | |||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 3.55 | $ 3.55 | ||||||||||||||||||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | Prefunded Warrant [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Warrant expiry period | 5 years | |||||||||||||||||||||||||
Class of warrant or right, exercise price of warrants or rights | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||
Subsequent Event [Member] | Securities Purchase Agreement [Member] | IPO [Member] | Common Stock [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Stock issued during period, shares, new issues | 1,205,000 | |||||||||||||||||||||||||
Subsequent Event [Member] | Debt Financing [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Debt instrument, periodic payment | $ 102,857 | $ 880,000 | ||||||||||||||||||||||||
Interest rate percentage | 5% | 5% | ||||||||||||||||||||||||
Subsequent Event [Member] | Debt Financing [Member] | Loan A [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Debt instrument, face amount | $ 2,000,000 | $ 2,000,000 | ||||||||||||||||||||||||
Subsequent Event [Member] | Debt Financing [Member] | Loan B [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Debt instrument, face amount | $ 2,000,000 | $ 2,000,000 | ||||||||||||||||||||||||
Subsequent Event [Member] | Maruho Settlement [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Repayments of secured debt | $ 7,300,000 | |||||||||||||||||||||||||
Repayments of settlement agreement | $ 7,300,000 | |||||||||||||||||||||||||
Shares, issued | 5,451,016 | |||||||||||||||||||||||||
Transferor's interests in transferred financial assets, fair value | $ 2,400,000 | |||||||||||||||||||||||||
Subsequent Event [Member] | Computer Share Trust Company [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
[custom:BeneficialOwnershipDescription] | 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] | ||||||||||||||||||||||||||
Aggregate principal amount | $ 6,500,000 | |||||||||||||||||||||||||
Default interest rate | 300% | |||||||||||||||||||||||||
Line of Credit Facility, Unused Capacity, Commitment Fee Percentage | 0.375% | |||||||||||||||||||||||||
Subsequent Event [Member] | MidCap Business Credit LLC [Member] | Adjusted Secured Overnight Financing Floor Rate [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Interest rate | 225% | |||||||||||||||||||||||||
Subsequent Event [Member] | MidCap Business Credit LLC [Member] | Adjusted Secured Overnight Financing Rate [Member] | ||||||||||||||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||||||||||||||
Interest rate | 400% |
Schedule of Basic and Diluted_2
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Disclosure [Abstract] | ||||||
Net income (loss) | $ (6,342) | $ (2,566) | $ (23,657) | $ 2,145 | $ (640) | $ (37,713) |
Shares: | ||||||
Basic weighted average common shares outstanding | 1,366,842 | 1,136,291 | 1,346,264 | 978,018 | 1,056,988,000 | 440,412,000 |
Stock options and restricted stock units | 2,233 | |||||
Diluted weighted average common shares outstanding | 1,366,842 | 1,136,291 | 1,346,264 | 980,251 | 1,056,988,000 | 440,412,000 |
Net earnings (loss) per share: | ||||||
Basic | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 | $ (0.61) | $ (85.63) |
Diluted | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 | $ (0.61) | $ (85.63) |
Schedule of Anti-dilutive Sec_2
Schedule of Anti-dilutive Securities Excluded from Computation of Earnings per Share (Details) - shares shares in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | 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 | 459,856 | 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 | 82,719 | 55,620 | 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 | 20,182 | 20,182 |
Line of Credit (Details Narrati
Line of Credit (Details Narrative) - USD ($) | 9 Months Ended | |
May 08, 2023 | Sep. 30, 2023 | |
Line of Credit Facility [Line Items] | ||
Debt instrument term amount | $ 650,000 | |
Interest rate percentage | 5.48% | |
Line of credit value | $ 200,000 | |
Loan Agreement [Member] | ||
Line of Credit Facility [Line Items] | ||
Line of credit maximum borrowing capacity | $ 1,000,000 | |
Debt instrument term amount | $ 1,000,000 | |
Revolving Credit Facility [Member] | Loan Agreement [Member] | ||
Line of Credit Facility [Line Items] | ||
Line of credit maximum borrowing capacity | $ 6,500,000 | |
Debt instrument, interest rate terms | Advances under the Loan Agreement bear interest at the 30-Day Adjusted Term Secured Overnight Financing Rate (“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. | |
Unused line fee rate | 0.375% |
Reclassification of Prior Yea_2
Reclassification of Prior Year Presentation (Details Narrative) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Inducement expense | $ 2.6 |