Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 08, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2023 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-40943 | |
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 Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Elected Not To Use the Extended Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 1,517,628 | |
Entity Information, Former Legal or Registered Name | Not Applicable | |
Common Stock [Member] | ||
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | BFRI | |
Security Exchange Name | NASDAQ | |
Warrant [Member] | ||
Title of 12(b) Security | Warrants to purchase common stock | |
Trading Symbol | BFRIW | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 3,422 | $ 17,208 |
Accounts receivable, net | 3,793 | 3,748 |
Inventories, net | 16,068 | 7,168 |
Prepaid expenses and other current assets | 274 | 810 |
Total current assets | 29,611 | 43,140 |
Property and equipment, net | 154 | 204 |
Operating lease right-of-use assets | 1,129 | 1,375 |
Intangible asset, net | 2,718 | 3,032 |
Other assets | 492 | 320 |
Total assets | 34,104 | 50,884 |
Current liabilities: | ||
Acquisition contract liabilities, net | 7,211 | 6,942 |
Operating lease liabilities | 555 | 498 |
Accrued expenses and other current liabilities | 11,039 | 10,864 |
Line of credit | 1,697 | |
Total current liabilities | 29,124 | 20,894 |
Long-term liabilities: | ||
Acquisition contract liabilities, net | 2,500 | 2,400 |
Warrant liabilities | 842 | 2,843 |
Operating lease liabilities, non-current | 562 | 848 |
Other liabilities | 38 | 21 |
Total liabilities | 33,066 | 27,006 |
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 |
Additional paid-in capital | 104,213 | 103,396 |
Accumulated deficit | (103,176) | (79,519) |
Total stockholders’ equity | 1,038 | 23,878 |
Total liabilities and stockholders’ equity | 34,104 | 50,884 |
Related Party [Member] | ||
Current assets: | ||
Investment, related party | 3,341 | 10,548 |
Other receivables, related party | 2,713 | 3,658 |
Other receivables long term, related party | 2,813 | |
Current liabilities: | ||
Accounts payable | 6,988 | 1,312 |
Nonrelated Party [Member] | ||
Current liabilities: | ||
Accounts payable | $ 1,634 | $ 1,278 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 15,000,000 | 15,000,000 |
Common stock, shares issued | 1,367,628 | 1,334,950 |
Common stock, shares outstanding | 1,367,628 | 1,334,950 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Product revenues, net | $ 8,879 | $ 4,290 | $ 23,423 | $ 18,467 |
Revenues, related party | 17 | 32 | 52 | 63 |
Total revenues, net | 8,896 | 4,322 | 23,475 | 18,530 |
Operating expenses | ||||
Cost of revenues, related party | 4,495 | 2,127 | 11,814 | 9,504 |
Cost of revenues, other | 95 | 98 | 262 | 425 |
Selling, general and administrative | 8,619 | 7,765 | 29,874 | 25,050 |
Selling, general and administrative, related party | 74 | 171 | 193 | 612 |
Research and development | 33 | 44 | ||
Change in fair value of contingent consideration | 200 | (2,200) | 100 | (4,100) |
Total operating expenses | 13,516 | 7,961 | 42,287 | 31,491 |
Loss from operations | (4,620) | (3,639) | (18,812) | (12,961) |
Other income (expense) | ||||
Change in fair value of warrant liabilities | 598 | 3,814 | 2,001 | 17,896 |
Warrant inducement expense | (2,629) | (2,629) | ||
Realized/Unrealized losses in investment, related party | (2,212) | (6,635) | ||
Interest expense, net | (142) | (89) | (256) | (160) |
Other income, net | 35 | (22) | 65 | 30 |
Total other income (expense) | (1,721) | 1,074 | (4,825) | 15,137 |
Income (loss) before income taxes | (6,341) | (2,565) | (23,637) | 2,176 |
Income tax expense | 1 | 1 | 20 | 31 |
Net income (loss) | $ (6,342) | $ (2,566) | $ (23,657) | $ 2,145 |
Income (loss) per common share: | ||||
Basic | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 |
Diluted | $ (4.64) | $ (2.26) | $ (17.57) | $ 2.19 |
Weighted-average common shares outstanding: | ||||
Basic | 1,366,842 | 1,136,291 | 1,346,264 | 978,018 |
Diluted | 1,366,842 | 1,136,291 | 1,346,264 | 980,251 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2021 | $ 1 | $ 90,216 | $ (78,879) | $ 11,338 |
Beginning balance, shares at Dec. 31, 2021 | 855,237 | |||
Stock based compensation | 1,469 | 1,469 | ||
Net income (loss) | 2,145 | 2,145 | ||
Issuance of shares for vested restricted stock units | $ 0 | |||
Issuance of shares for vested restricted stock units, shares | 8,504 | |||
Exercise of pre-funded warrants | $ 0 | 2,841 | 2,841 | |
Exercise of pre-funded warrants, shares | 78,450 | |||
Exercise of PIPE warrants | $ 0 | 4,686 | 4,686 | |
Exercise of PIPE warrants, shares | 142,857 | |||
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 | |||
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 Jun. 30, 2022 | $ 1 | 91,400 | (74,168) | 17,233 |
Beginning balance, shares at Jun. 30, 2022 | 950,573 | |||
Stock based compensation | 401 | 401 | ||
Net income (loss) | (2,566) | (2,566) | ||
Issuance of shares for vested restricted stock units | $ 0 | |||
Issuance of shares for vested restricted stock units, shares | 5,668 | |||
Exercise of pre-funded warrants | $ 0 | 2,841 | 2,841 | |
Exercise of pre-funded warrants, shares | 78,450 | |||
Exercise of PIPE warrants | $ 0 | 4,686 | 4,686 | |
Exercise of PIPE warrants, shares | 142,857 | |||
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 | |||
Issuance of shares in reverse stock split (for fractional shares) | $ 0 | |||
Issuance of shares in reverse stock split (for fractional shares), shares | 24,090 | |||
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 | |||
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 | |||
Issuance of shares in reverse stock split (for fractional shares) | $ 0 | |||
Issuance of shares in reverse stock split (for fractional shares), shares | 24,090 | |||
Stock based compensation | 207 | 207 | ||
Net income (loss) | (6,342) | (6,342) | ||
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 Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (23,657) | $ 2,145 |
Adjustments to reconcile net income (loss) to cash flows used in operations: | ||
Depreciation | 65 | 80 |
Amortization of right-of-use assets | 390 | |
Amortization of acquired intangible assets | 314 | 314 |
Realized/Unrealized losses in investment, related party | 6,635 | |
Change in fair value of contingent consideration | 100 | (4,100) |
Change in fair value of warrant liabilities | (2,001) | (17,896) |
Warrant inducement expense | 2,629 | |
Stock-based compensation | 817 | 1,469 |
Provision for inventory obsolescence | 100 | |
Provision for doubtful accounts | 158 | 111 |
Non-cash interest expense | 296 | 268 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (204) | 2,111 |
Other receivables, related party | 3,652 | 5,145 |
Prepaid expenses and other assets | 347 | 4,121 |
Inventories | (8,900) | (7,728) |
Accounts payable and related party payables | 6,137 | 3,519 |
Operating lease liabilities | (375) | |
Accrued expenses and other liabilities | 197 | (216) |
Cash flows used in operating activities | (16,029) | (7,928) |
Cash flows from investing activities | ||
Disbursement for loan receivable | (3,033) | |
Sales of equity investment, related party | 560 | |
Purchases of property and equipment | (14) | (37) |
Cash flows provided by (used) in investing activities | 546 | (3,070) |
Cash flows from financing activities | ||
Proceeds from line of credit | 13,546 | |
Proceeds from issuance of common stock and warrants in private placement, net of issuance costs | 9,391 | |
Proceeds from exercise of warrants | 4,630 | |
Repayment of line of credit | (11,849) | |
Cash flows provided by financing activities | 1,697 | 14,021 |
Net increase (decrease) in cash and cash equivalents | (13,786) | 3,023 |
Cash, cash equivalents and restricted cash, at the beginning of the period | 17,408 | 24,742 |
Cash, cash equivalents and restricted cash, at the end of the period | 3,622 | 27,765 |
Supplemental disclosure of cash flow information | ||
Interest paid | 31 | 10 |
Interest paid, related party | 22 | |
Income taxes paid, net | 21 | 30 |
Supplemental non-cash investing and financing activities | ||
Conversion of warrant liability to equity | 6,840 | |
Addition of right-of-use assets in exchange for operating lease liabilities | $ 147 |
Business Overview
Business Overview | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Acquisition Contract Liabilitie
Acquisition Contract Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Investment, Related Party
Investment, Related Party | 9 Months Ended |
Sep. 30, 2023 | |
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 ) $ - |
Accounts Receivable, net
Accounts Receivable, net | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Other Receivables, Related Part
Other Receivables, Related Party | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Intangible Asset, Net
Intangible Asset, Net | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Cash Balances and Statement of
Cash Balances and Statement of Cash Flows Reconciliation | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
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 |
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 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Stockholders_ Equity
Stockholders’ Equity | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Equity Incentive Plans and Shar
Equity Incentive Plans and Share-Based Payments | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Interest Expense, net
Interest Expense, net | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Net Earnings (Loss) per Share
Net Earnings (Loss) per Share | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
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. |
Retirement Plan
Retirement Plan | 9 Months Ended |
Sep. 30, 2023 | |
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. |
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 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
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. Capital Raise On October 30, 2023, the Company entered into a securities purchase agreement (“Purchase Agreement”) with an institutional investor for the purchase and sale, in a registered public offering by the Company (the “Public Offering”) of an aggregate of 1,205,000 shares of the Company’s Common Stock, or pre-funded warrants to purchase Common Stock in lieu thereof, each of which is coupled with a warrant to purchase one and one-half shares of Common Stock. Specifically, 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 Warrant Amendment As previously reported in a Current Report on Form 8-K filed with the SEC on May 20, 2022, the Company issued (i) a common stock purchase warrant, dated May 16, 2022 and exercisable until November 18, 2027 170,950 55.40 December 1, 2026 214,286 33.20 On October 30, 2023, in connection with the Purchase Agreement, the Company entered into an amendment to the Existing Warrants pursuant to which the Company agreed, effective November 2, 2023, to (i) revise the exercise price of the Existing Warrants to $ 3.55 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
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.: |
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. |
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. |
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. |
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 |
Acquisition Contract Liabilit_2
Acquisition Contract Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 |
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 |
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 % |
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 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Investment, Related Party (Tabl
Investment, Related Party (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, All Other Investments [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 ) $ - |
Intangible Asset, Net (Tables)
Intangible Asset, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Cash Balances and Statement o_2
Cash Balances and Statement of Cash Flows Reconciliation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 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 |
Sep. 30, 2023 | |
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 |
Equity Incentive Plans and Sh_2
Equity Incentive Plans and Share-Based Payments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 % |
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. |
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 |
Interest Expense, net (Tables)
Interest Expense, net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 ) |
Net Earnings (Loss) per Share (
Net Earnings (Loss) per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 |
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 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
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 % |
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 |
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 |
Business Overview (Details Narr
Business Overview (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Jul. 03, 2023 | Jun. 28, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Nov. 28, 2023 | Jun. 27, 2023 | Dec. 31, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | |||||||||
Reverse stock split | 1-for-20 | 1-for-20 | |||||||
Common stock par value | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Common stock shares authorized | 15,000,000 | 15,000,000 | 15,000,000 | 15,000,000 | 300,000,000 | 15,000,000 | |||
Exercise price per share | $ 100 | ||||||||
Cash and cash equivalents | $ 3,422 | $ 3,422 | $ 17,208 | ||||||
Operating Income (Loss) | 4,620 | $ 3,639 | 18,812 | $ 12,961 | |||||
Net Cash Provided by (Used in) Operating Activities | 16,029 | $ 7,928 | |||||||
Retained Earnings (Accumulated Deficit) | 103,176 | 103,176 | 79,519 | ||||||
Net capital | 4,100 | 4,100 | |||||||
Related Party [Member] | |||||||||
Defined Benefit Plan Disclosure [Line Items] | |||||||||
Investments in equity securities | $ 3,341 | $ 3,341 | $ 10,548 |
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 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||||
Contingent consideration | $ 2,500 | $ 2,400 | $ 2,100 | $ 6,200 |
Start-up cost financing | 7,300 | 7,300 | ||
Contract asset | (89) | (358) | ||
Acquisition contract liabilities, net | 7,211 | 6,942 | ||
Total acquisition contract liabilities, net | 9,711 | 9,342 | ||
Short-Term Debt [Member] | ||||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||||
Start-up cost financing | 7,300 | 7,300 | ||
Contract asset | (89) | (358) | ||
Acquisition contract liabilities, net | 7,211 | 6,942 | ||
Long-Term Debt [Member] | ||||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||||
Contingent consideration | $ 2,500 | $ 2,400 |
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 |
Business Acquisition [Line Items] | |||||
Contingent consideration | $ 2,500 | $ 2,400 | $ 2,100 | $ 6,200 | |
Long-Term Debt [Member] | |||||
Business Acquisition [Line Items] | |||||
Contingent consideration | 2,500 | $ 2,400 | |||
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% | ||||
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% |
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 |
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 | ||
Warrant liability – 2022 Purchase Warrants | 842 | 2,843 | $ 3,964 | $ 12,854 |
Fair Value, Inputs, Level 3 [Member] | 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 Warrants [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Warrant liability | $ 476 | $ 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 | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | ||||
Beginning balance, fair value of contingent consideration | $ 2,400 | $ 6,200 | ||
Change in fair value of contingent consideration | $ 200 | $ (2,200) | 100 | (4,100) |
Ending balance, fair value of contingent consideration | $ 2,500 | $ 2,100 | $ 2,500 | $ 2,100 |
Schedule of Fair Value Warrant
Schedule of Fair Value Warrant by Using Black-Scholes Pricing Model Assumptions (Details) - Fair Value, Inputs, Level 3 [Member] | Sep. 30, 2023 $ / shares | Dec. 31, 2022 $ / shares |
Measurement Input, Share Price [Member] | Purchase Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Stock price | $ 8.77 | $ 18.40 |
Measurement Input, Share Price [Member] | Inducement Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Stock price | $ 8.77 | $ 18.40 |
Measurement Input, Expected Term [Member] | Purchase Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Expiration term (in years) | 4 years 1 month 17 days | 4 years 10 months 17 days |
Measurement Input, Expected Term [Member] | Inducement Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Expiration term (in years) | 3 years 2 months 1 day | 3 years 11 months 1 day |
Measurement Input, Option Volatility [Member] | Purchase Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant outstanding, measurement input | 80 | 70 |
Measurement Input, Option Volatility [Member] | Inducement Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant outstanding, measurement input | 80 | 75 |
Measurement Input, Risk Free Interest Rate [Member] | Purchase Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant outstanding, measurement input | 4.63 | 3.96 |
Measurement Input, Risk Free Interest Rate [Member] | Inducement Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant outstanding, measurement input | 4.73 | 4.07 |
Measurement Input, Expected Dividend Payment [Member] | Purchase Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant outstanding, measurement input | 0 | 0 |
Measurement Input, Expected Dividend Payment [Member] | Inducement Warrants [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [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 | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Change in fair value of warrant liabilities | $ (598) | $ (3,814) | $ (2,001) | $ (17,896) |
Fair Value, Inputs, Level 3 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
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 | $ 842 | $ 3,964 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 | Jun. 28, 2023 | Jul. 26, 2022 | May 16, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
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 Activties (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | $ 82 | $ 246 |
Provision related to current period sales | 429 | 691 |
Credit or payments made during the period | (378) | (577) |
Ending Balance | 133 | 360 |
Returns [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 48 | 43 |
Provision related to current period sales | 4 | 8 |
Credit or payments made during the period | (5) | |
Ending Balance | 52 | 46 |
Co-pay Assistance Program [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 9 | 101 |
Provision related to current period sales | 156 | 503 |
Credit or payments made during the period | (145) | (400) |
Ending Balance | 20 | 204 |
Prompt Pay Discounts [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 5 | 48 |
Provision related to current period sales | 3 | 16 |
Credit or payments made during the period | (2) | (23) |
Ending Balance | 6 | 41 |
Government and Payor Rebates [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 20 | 54 |
Provision related to current period sales | 266 | 164 |
Credit or payments made during the period | (231) | (149) |
Ending Balance | $ 55 | $ 69 |
Schedule of Unrealized Gains an
Schedule of Unrealized Gains and Losses on Investments in Equity Securities (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Defined Benefit Plan Disclosure [Line Items] | ||||
Net losses recognized during the period on equity securities | $ (2,212,000) | $ (6,635,000) | ||
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 |
Investment, Related Party (Deta
Investment, Related Party (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Investments, All Other Investments [Abstract] | ||||
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 |
Accounts Receivable, net (Detai
Accounts Receivable, net (Details Narrative) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Credit Loss [Abstract] | ||
Allowance for doubtful accounts | $ 0.2 | $ 0.1 |
Other Receivables, Related Pa_2
Other Receivables, Related Party (Details Narrative) $ in Millions | Sep. 30, 2023 USD ($) |
Defined Benefit Plan Disclosure [Line Items] | |
Legal settlements receivable percentage | 50% |
Biofrontera Group [Member] | |
Defined Benefit Plan Disclosure [Line Items] | |
Accounts receivables | $ 2.7 |
Biofrontera AG [Member] | |
Defined Benefit Plan Disclosure [Line Items] | |
Legal settlements receivable percentage | 50% |
Interest rate percentage | 6% |
Schedule of Intangible Asset Ne
Schedule of Intangible Asset Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Xepi® license | $ 4,600 | $ 4,600 |
Less: Accumulated amortization | (1,882) | (1,568) |
Intangible asset, net | $ 2,718 | $ 3,032 |
Intangible Asset, Net (Details
Intangible Asset, Net (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||||
Finite lived license agreements gross | $ 4,600 | $ 4,600 | $ 4,600 | ||
Finite lived intangible asset useful life | 11 years | 11 years | |||
Amortization of intangible assets | $ 100 | $ 100 | $ 314 | $ 314 |
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 |
Cash and Cash Equivalents [Abstract] | ||
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 |
Cash Balances and Statement o_3
Cash Balances and Statement of Cash Flows Reconciliation (Details Narrative) | Sep. 30, 2023 USD ($) |
Cash and Cash Equivalents [Abstract] | |
Depositor | $ 250,000 |
Cash depositor | $ 3,000,000 |
Schedule of Accrued Expenses an
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
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 |
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% |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2023 | Dec. 31, 2022 | Oct. 08, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | |||||||
Accounts receivable, related parties | $ 3,793 | $ 3,748 | $ 3,793 | $ 3,793 | |||
Legal settlements receivable percentage | 50% | 50% | 50% | ||||
Interest Income, Operating | $ 1 | $ 110 | |||||
Number of shares in equity securities investment, shares | 5,745,678 | 6,446,946 | |||||
Biofrontera Pharma GmbH [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Interest Income, Operating | 100 | ||||||
Biofrontera AG [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Loss Contingency, Receivable | $ 2,800 | $ 6,400 | $ 2,800 | $ 2,800 | |||
Legal settlements receivable percentage | 50% | 50% | 50% | ||||
License and Supply Agreement [Member] | Biofrontera Pharma GmbH [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Related party costs | $ 5,100 | 5,200 | $ 18,800 | 16,600 | |||
Accounts payable related parties | $ 7,000 | 1,300 | 7,000 | 7,000 | |||
License and Supply Agreement [Member] | Fifty Percent of Anticipated Net Price [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenue from sales | $ 30,000 | ||||||
License and Supply Agreement [Member] | Forty Percent of Anticipated Net Price [Member] | Minimum [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenue from sales | 30,000 | ||||||
License and Supply Agreement [Member] | Forty Percent of Anticipated Net Price [Member] | Maximum [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenue from sales | 50,000 | ||||||
License and Supply Agreement [Member] | Thirty Percent of Anticipated Net Price [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenue from sales | $ 50,000 | ||||||
Service Agreements [Member] | Biofrontera AG [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Accounts payable related parties | 200 | 200 | 200 | 200 | |||
Expenses related to service | 100 | $ 200 | 200 | $ 600 | |||
Clinica Lamp Lease Agreement [Member] | Biofrontera Pharma GmbH [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Revenue from sales | 100 | 100 | |||||
Accounts receivable, related parties | $ 100 | $ 100 | $ 100 | 100 | |||
Share Purchase and Transfer Agreement [Member] | Maruho Co, Ltd. [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares in equity securities investment value | $ 3,300 | ||||||
Number of shares in equity securities investment, shares | 5,745,678 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - $ / shares | Jul. 03, 2023 | Jun. 28, 2023 | Sep. 30, 2023 | Jun. 27, 2023 | Dec. 31, 2022 |
Equity [Abstract] | |||||
Common Stock, Shares Authorized | 15,000,000 | 15,000,000 | 15,000,000 | 300,000,000 | 15,000,000 |
Preferred Stock, Shares Authorized | 20,000,000 | 20,000,000 | 20,000,000 | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | ||
Stockholders' Equity, Reverse Stock Split | 1-for-20 | 1-for-20 |
Schedule of Stock Options Assum
Schedule of Stock Options Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | |
Expected dividend yield | 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 | |
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 | |
Risk-free interest rate | 3.90% | 4.10% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 USD ($) $ / shares shares | ||
Share-Based Payment Arrangement [Abstract] | ||
Number of Shares Outstanding, Beginning Balance | shares | 86,951 | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 62.16 | |
Number of Shares Outstanding, Beginning Balance | shares | 22,477 | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 13.98 | |
Number of Shares Outstanding, Beginning Balance | shares | ||
Weighted Average Exercise Price, Beginning Balance | $ / shares | ||
Number of Shares Outstanding, Beginning Balance | shares | (31,480) | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 53.58 | |
Number of Shares Outstanding, Ending Balance | shares | 77,948 | |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 51.74 | |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 8 years 5 months 12 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Intrinsic Value | $ | $ 0 | [1] |
Number of Exercisable Shares Outstanding, Balance | shares | 24,210 | |
Weighted Average Exercise Price, Balance | $ / shares | $ 62.23 | |
Weighted Average Remaining Contractual Life (in Years), Exercisable | 7 years 9 months | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercisable, Intrinsic Value | $ | $ 0 | [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 September 30, 2023. |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares outstanding, beginning balance | shares | 17,176 |
Number of shares weighted average grant date fair value, beginning balance | $ / shares | $ 52.20 |
Number of shares outstanding, Awarded | shares | |
Number of shares weighted average grant date fair value, Awarded | $ / shares | |
Number of shares outstanding, Vested | shares | (8,588) |
Number of shares weighted average grant date fair value,Vested | $ / shares | $ 52.20 |
Number of shares outstanding, Canceled or expired | shares | (3,817) |
Weighted Average Remaining Contractual Life (in Years), Canceled or forfeited | 7 months 17 days |
Number of shares weighted average grant date fair value, Canceled or forfeited | $ / shares | |
Number of shares outstanding, ending balance | shares | 4,771 |
Weighted Average Remaining Contractual Life (in Years), Outstanding Ending Balance | 7 months 17 days |
Number of shares weighted average grant date fair value, outstanding ending balance | $ / shares | $ 52.20 |
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 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Unrecognized compensation cost | $ 1 | $ 1 | |||||
Compensation cost recognized, weighted average period | 1 year 9 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 | |||||
Compensation cost recognized, weighted average period | 7 months 6 days | ||||||
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 | |||
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 | |||
Omnibus Incentive Plan [Member] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | 163,362 | 163,362 | 137,500 | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Terms of Award | 10 years for stock options issued under the 2021 Plan. | ||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Period Increase (Decrease) | 266,990 | 129,490 |
Schedule of Interest Expense (D
Schedule of Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 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 (Details
Interest Expense, net (Details Narrative) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 |
Contract asset | $ (89) | $ (358) | |
Startup cost financing | $ 7,300 | $ 7,300 | |
Legal settlements receivable percentage | 50% | ||
Maruho Co, Ltd. [Member] | Cutanea Acquisition Agreement [Member] | |||
Contract asset | $ 1,700 | ||
Startup cost financing | $ 7,300 | ||
Debt instrument stated percentage | 6% | ||
Debt maturity date | Dec. 31, 2023 | ||
Biofrontera AG [Member] | |||
Legal settlements receivable percentage | 50% | ||
Biofrontera AG [Member] | Related Party [Member] | |||
Due from related party | $ 6,100 |
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 | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income (loss) per common share: | ||||
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 |
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 |
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 | |
Sep. 30, 2023 | Sep. 30, 2022 | |
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 |
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 |
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 |
Schedule of Components of Lease
Schedule of Components of Lease Expense and Other Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Amortization of ROU assets (operating lease cost) | $ 390 | |
Interest on lease liabilities | 54 | |
Total lease expense | 444 | |
Operational cash flow used for operating leases | $ 428 | |
Weighted -average remaining lease term (in years) | 2 years 3 days | |
Weighted -average discount rate | 6.75% |
Schedule of Future Commitments
Schedule of Future Commitments and Sublease Income (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
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 Lia
Schedule of Operating Lease Liability (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease liability, current | $ 555 | $ 498 |
Operating lease liability, non-current | 562 | $ 848 |
Total | $ 1,117 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) - USD ($) | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 | Nov. 29, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Product Liability Contingency [Line Items] | |||||
Lease option to extend | option to extend the term of the lease for one five (5) year period | ||||
Security deposit | $ 250,000 | $ 250,000 | |||
Start-up cost financing | 7,300,000 | 7,300,000 | $ 7,300,000 | ||
Settlement liability | $ 22,500,000 | ||||
Biofrontera AG [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Settlement liability | 6,000,000 | ||||
Loss contingency, receivable | 2,800,000 | 2,800,000 | 6,400,000 | ||
Licensing Agreement [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Licensing fee | 200,000 | ||||
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 | $ 4,000,000 | ||
Xepi LSA [Member] | Maximum [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Revenues | 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, 2023 [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Start-up cost financing | 3,700,000 | 3,700,000 | |||
Facility Leases [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Security deposit | $ 100,000 | $ 100,000 |
Retirement Plan (Details Narrat
Retirement Plan (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Retirement Benefits [Abstract] | ||||
Employee contributions description | 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 |
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 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - $ / shares | Oct. 30, 2023 | Jul. 26, 2022 | May 16, 2022 | Jun. 28, 2023 |
Subsequent Event [Line Items] | ||||
Warrant exercise price | $ 100 | |||
Date from warrant exercisable | Dec. 01, 2026 | Nov. 18, 2027 | ||
Warrant Amendment [Member] | ||||
Subsequent Event [Line Items] | ||||
Warrant exercise price | $ 33.20 | $ 55.40 | ||
Common Stock [Member] | Warrant Amendment [Member] | ||||
Subsequent Event [Line Items] | ||||
Shares issued for capital raise | 214,286 | 170,950 | ||
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] | Warrant [Member] | Securities Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Warrant expiry period | 5 years | |||
Warrant exercise price | $ 3.55 | |||
Subsequent Event [Member] | Prefunded Warrant [Member] | Securities Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Warrant expiry period | 5 years | |||
Warrant exercise price | $ 0.0001 | |||
Subsequent Event [Member] | IPO [Member] | Common Stock [Member] | Securities Purchase Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Shares issued for capital raise | 1,205,000 |