Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 11, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
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 | 26,699,002 | |
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, each warrant exercisable for one share of common stock, each at an exercise price of $5.00 per share | |
Trading Symbol | BFRIW | |
Security Exchange Name | NASDAQ |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 13,505 | $ 17,208 |
Investment in equity securities | 7,596 | 10,548 |
Accounts receivable, net | 4,116 | 3,748 |
Other receivables, related party | $ 3,750 | $ 3,658 |
Other Receivable, after Allowance for Credit Loss, Current, Related and Nonrelated Party Status [Extensible Enumeration] | Related Party [Member] | Related Party [Member] |
Inventories | $ 6,670 | $ 7,168 |
Prepaid expenses and other current assets | 1,586 | 810 |
Total current assets | 37,223 | 43,140 |
Other receivables long term, related party | $ 2,813 | |
Other Receivable, after Allowance for Credit Loss, Noncurrent, Related and Nonrelated Party Status [Extensible Enumeration] | Related Party [Member] | Related Party [Member] |
Property and equipment, net | $ 197 | $ 204 |
Operating lease right-of-use assets | 1,234 | 1,375 |
Intangible asset, net | 2,927 | 3,032 |
Other assets | 384 | 320 |
Total assets | 41,965 | 50,884 |
Current liabilities: | ||
Accounts payable | 887 | 1,278 |
Accounts payable, related parties | 912 | 1,312 |
Acquisition contract liabilities, net | 7,032 | 6,942 |
Operating lease liabilities | 484 | 498 |
Accrued expenses and other current liabilities | 11,135 | 10,864 |
Total current liabilities | 20,450 | 20,894 |
Long-term liabilities: | ||
Acquisition contract liabilities, net | 2,200 | 2,400 |
Warrant liabilities | 1,815 | 2,843 |
Operating lease liabilities, non-current | 725 | 848 |
Other liabilities | 24 | 21 |
Total liabilities | 25,214 | 27,006 |
Commitments and contingencies (see Note 21) | ||
Stockholders’ equity: | ||
Preferred Stock, $0.001 par value, 20,000,000 shares authorized, zero shares issued and outstanding as of March 31, 2023 and December 31, 2022 | ||
Common Stock, $0.001 par value, 300,000,000 shares authorized; 26,699,002 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 27 | 27 |
Additional paid-in capital | 103,721 | 103,370 |
Accumulated deficit | (86,997) | (79,519) |
Total stockholders’ equity | 16,751 | 23,878 |
Total liabilities and stockholders’ equity | $ 41,965 | $ 50,884 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 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 | 300,000,000 | 300,000,000 |
Common stock, shares issued | 26,699,002 | 26,699,002 |
Common stock, shares outstanding | 26,699,002 | 26,699,002 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Statement [Abstract] | ||
Products revenues, net | $ 8,715 | $ 9,736 |
Revenues, related party | 18 | 15 |
Total revenues, net | 8,733 | 9,751 |
Operating expenses | ||
Cost of revenues, related party | 4,547 | 4,975 |
Cost of revenues, other | 51 | 175 |
Selling, general and administrative | 9,800 | 7,616 |
Selling, general and administrative, related party | 27 | 95 |
Change in fair value of contingent consideration | (200) | |
Total operating expenses | 14,225 | 12,861 |
Loss from operations | (5,492) | (3,110) |
Other income (expense) | ||
Change in fair value of warrant liabilities | 1,028 | 8,711 |
Change in fair value of investments | (2,941) | |
Interest expense, net | (35) | (33) |
Other income (expense), net | (33) | 23 |
Total other income (expense) | (1,981) | 8,701 |
Income (loss) before income taxes | (7,473) | 5,591 |
Income tax expense | 5 | 30 |
Net income (loss) | $ (7,478) | $ 5,561 |
Income (loss) per common share: | ||
Basic | $ (0.28) | $ 0.33 |
Diluted | $ (0.28) | $ 0.32 |
Weighted-average common shares outstanding: | ||
Basic | 26,699,002 | 17,104,749 |
Diluted | 26,699,002 | 17,133,218 |
Consolidated Statements of Stoc
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 | $ 17 | $ 90,200 | $ (78,879) | $ 11,338 |
Beginning balance, shares at Dec. 31, 2021 | 17,104,749 | |||
Stock based compensation | 517 | 517 | ||
Net income (loss) | 5,561 | 5,561 | ||
Ending balance, value at Mar. 31, 2022 | $ 17 | 90,717 | (73,318) | 17,416 |
Ending balance, shares at Mar. 31, 2022 | 17,104,749 | |||
Beginning balance, value at Dec. 31, 2022 | $ 27 | 103,370 | (79,519) | 23,878 |
Beginning balance, shares at Dec. 31, 2022 | 26,699,002 | |||
Stock based compensation | 351 | 351 | ||
Net income (loss) | (7,478) | (7,478) | ||
Ending balance, value at Mar. 31, 2023 | $ 27 | $ 103,721 | $ (86,997) | $ 16,751 |
Ending balance, shares at Mar. 31, 2023 | 26,699,002 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (7,478) | $ 5,561 |
Adjustments to reconcile net income (loss) to cash flows used in operations | ||
Depreciation | 22 | 26 |
Amortization of right-of-use assets | 139 | |
Amortization of acquired intangible assets | 105 | 105 |
Change in fair value of investment in equity securities | 2,941 | |
Change in fair value of contingent consideration | (200) | |
Change in fair value of warrant liabilities | (1,028) | (8,711) |
Stock-based compensation | 351 | 517 |
Provision for doubtful accounts | 14 | 42 |
Non-cash interest expense | 89 | 89 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (381) | (1,430) |
Other receivables, related party | 2,720 | (38) |
Prepaid expenses and other assets | (830) | 3,614 |
Inventories | 499 | (414) |
Accounts payable and related party payables | (792) | (366) |
Operating lease liabilities | (134) | |
Accrued expenses and other liabilities | 274 | (1,107) |
Cash flows used in operating activities | (3,689) | (2,112) |
Cash flows from investing activities | ||
Purchases of property and equipment | (14) | (5) |
Cash flows used in investing activities | (14) | (5) |
Net decrease in cash and cash equivalents | (3,703) | (2,117) |
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 | 13,705 | 22,625 |
Supplemental disclosure of cash flow information | ||
Interest paid | 4 | |
Income taxes paid, net | $ 22 | $ 30 |
Business Overview
Business Overview | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Overview | 1. Business Overview Biofrontera Inc (the “Company”). 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. Biofrontera Inc. includes its wholly owned subsidiary Bio-FRI GmbH, a limited liability company organized under the laws of Germany. Our subsidiary, Bioi-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 in our portfolio is Xepi® (ozenoxacin cream, 1%), a topical non-fluorinated quinolone that inhibits bacterial growth. Currently, no antibiotic resistance against Xepi® is known and it has been specifically approved by the FDA for the treatment of impetigo, a common skin infection, due to Staphylococcus aureus or Streptococcus pyogenes. It is approved for use in the United States in adults and children 2 months and older. We are currently selling Xepi® for this indication in the United States. under an exclusive license and supply agreement, as amended (“Xepi LSA”) with Ferrer Internacional S.A. (“Ferrer”) that was assumed by Biofrontera on March 25, 2019 through our acquisition of Cutanea Life Sciences, Inc.(“Cutanea”). Liquidity and Going Concern The Company’s primary sources of liquidity are its existing cash balances, cash collected from the sales of its products, and cash flows from equity financing transactions received in 2022. As of March 31, 2023, we had cash and cash equivalents of $ 13.5 17.2 Since we commenced operations in 2015, we have generated significant losses. For the three months ended March 31, 2023 and 2022, we incurred loss from operations of $ 5.5 3.1 . 3.7 2.1 87.0 The Company’s short-term material cash requirements include working capital needs and satisfaction of contractual commitments including facility and auto leases (see Note 21. Commitments and Contingencies 7.3 Note 3. Acquisition Contract Liabilities 2.5 (see Note 21. Commitments and Contingencies) Additionally, we expect to continue to incur operating losses due to significant discretionary sales and marketing , medical affairs, and dermatology community outreach These factors raise doubt about our ability to continue as a going concern, which we have determined are mitigated by the following plans. Based on current operating plans and financial forecasts, we expect that our revolving line of credit and expected proceeds from the sale of our investment in equity securities in addition to our current cash and cash equivalents will be sufficient to fund our operations for at least the next twelve months from the date of issuance of our financial statements. However, we expect to have to obtain either equity or additional debt financing to support our future long-term growth and to mitigate the risk of our operating costs significantly exceeding the amounts currently estimated. If our current operating plans or financial forecasts change, or we are unable to obtain additional financing, we may need to reduce the discretionary spend on promotional expenses, branding, marketing consulting and defer some hiring. While we expect to continue being flexible in our spending over the next twelve months, we do not consider there to be a need to significantly revise our operations currently. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 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 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 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 March 31, 2023, the Company’s operating results for the three months ended March 31, 2023 and 2022, and the Company’s cash flows for the three months ended March 31, 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 Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 13, 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. The Company’s significant accounting policies are discussed in Note 2—Summary of Significant Accounting Policies 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 | 3 Months Ended |
Mar. 31, 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 agreed to provide $ 7.3 In connection with this acquisition in 2019, we recorded the $ 7.3 1.7 6.5 Note 21. Commitment and contingencies – Cutanea payments) The contract asset related to the start-up cost financing is amortized on a straight-line basis using a 6.0 57 December 31, 2023 The contingent consideration was recorded at acquisition-date fair value using a Monte Carlo simulation with an assumed discount rate of approximately 6.0 Acquisition contract liabilities, net consist of the following: Schedule of Acquisition Contract Liabilities (in thousands) March 31, 2023 December 31, 2022 Short-term acquisition contract liabilities: Contingent consideration $ 2,200 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (268 ) (358 ) Acquisition contract liabilities, net $ 7,032 $ 6,942 Long-term acquisition contract liabilities: Contingent consideration $ 2,200 $ 2,400 Total acquisition contract liabilities: Contingent consideration $ 2,200 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (268 ) (358 ) Total acquisition contract liabilities, net $ 9,232 $ 9,342 |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 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 March 31, 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 March 31, 2023 December 31, 2022 Assets: Investment in equity securities 1 $ 7,596 $ 10,548 Liabilities: Contingent Consideration 3 $ 2,200 $ 2,400 Warrant liability – 2022 Purchase Warrants 3 $ 786 $ 1,129 Warrant liability - 2022 Inducement Warrants 3 $ 1,029 $ 1,714 Warrant liability 3 $ 1,029 $ 1,714 Investment in equity securities A s of March 31, 2023, the Company had an shares of Biofrontera AG is Contingent Consideration Contingent consideration, which relates to the estimated profits from the sale of Cutanea products to be shared equally with Maruho, is reflected at fair value within acquisition contract liabilities, net on the consolidated balance sheets. The fair value is based on significant inputs not observable in the market, which represent a Level 3 measurement within the fair value hierarchy. The valuation of the contingent consideration utilizes a scenario-based method under which a set of payoffs are calculated using the term of the earnout, projections, and an appropriate metric risk premium. These payoffs are then discounted back from the payment date to the valuation date using a payment discount rate. Finally, the discounted payments are summed together to arrive at the value of the contingent consideration. The scenario-based method incorporates the following key assumptions: (i) the forecasted product profit amounts, (ii) the remaining contractual term, (iii) a metric risk premium, and (iv) a payment discount rate. The Company re-measures contingent consideration and re-assesses the underlying assumptions and estimates at each reporting period. The following table provides a roll forward of the fair value of the contingent consideration: Schedule of Fair Value of Contingent Consideration (in thousands) Balance at December 31, 2021 $ 6,200 Change in fair value of contingent consideration - Balance at March 31, 2022 $ 6,200 Balance at December 31, 2022 $ 2,400 Change in fair value of contingent consideration (200 ) Balance at March 31, 2023 $ 2,200 Warrant Liabilities The warrant liabilities, comprised of warrants to purchase one share of common stock issued in a private placement on May 16, 2022, expiring five and one-half years after the issue date and with an exercise price of $ 2.77 warrants to purchase one share of common stock issued on July 26, 2022, expiring on December 1, 2026 with an exercise price of $ 1.66 statements 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 The fair value at March 31, 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 $ 0.61 $ 0.61 Expiration term (in years) 4.63 3.67 Volatility 85.0 % 85.0 % Risk-free Rate 3.61 % 3.71 % Dividend yield 0.0 % 0.0 % The following table presents the changes in the warrant liabilities measured at fair value (in thousands): Schedule of Changes in Fair Value Warrant Liabilities 2023 2022 Three Months Ended March 31, 2023 2022 Fair value at beginning of period $ 2,843 $ 12,854 Change in fair value of warrant liability (1,028 ) (8,711 ) Fair value at end of period $ 1,815 $ 4,143 |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 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 Biofrontera Bioscience GmbH (“Bioscience”) for BF-RhodoLED® leasing and installation service. Refer to Note 15, Related Party Transactions An analysis of the changes in product revenue allowances and reserves is summarized as follows: Schedule of Revenue Allowance and Accrual Activities (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 3 165 5 45 218 Credit or payments made during the period (5 ) (150 ) (17 ) (52 ) (224 ) Balance at March 31, 2022 $ 41 $ 116 $ 36 $ 47 $ 240 Balance at December 31, 2022 $ 48 $ 9 $ 5 $ 20 $ 82 Beginning Balance $ 48 $ 9 $ 5 $ 20 $ 82 Provision related to current period sales 1 62 3 33 99 Credit or payments made during the period - (71 ) (2 ) (39 ) (112 ) Balance at March 31, 2023 $ 49 - 6 14 69 Ending Balance $ 49 - 6 14 69 |
Accounts Receivable, net
Accounts Receivable, net | 3 Months Ended |
Mar. 31, 2023 | |
Credit Loss [Abstract] | |
Accounts Receivable, net | 6. Accounts Receivable, net Accounts receivables are mainly attributable to the sale of Ameluz ® ® The allowance for credit losses was $ 0.1 |
Other Receivables, Related Part
Other Receivables, Related Party | 3 Months Ended |
Mar. 31, 2023 | |
Receivables [Abstract] | |
Other Receivables, Related Party | 7. Other Receivables, Related Party As of March 31, 2023 the Company has a receivable of $ 3.8 million due from the Biofrontera Group of which $ 3.7 million is due from Biofrontera AG for its 50 % share of the balance of a legal settlement (see Note 21. 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 has been recorded as of March 31, 2023 or December 31, 2022. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | 8. Inventories Inventories are comprised of Ameluz ® ® In assessing the consumption of inventories, the sequence of consumption is assumed to be based on the first-in-first-out (FIFO) method. There was no |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
Prepaid Expenses and Other Current Assets | 9. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: Schedule of Prepaid Expenses and Other Current Assets (in thousands) March 31, 2023 December 31, 2022 Prepaid expenses $ 593 $ 240 Prepaid insurance 512 15 Prepaid licenses 423 317 Security deposits - 85 Other 58 153 Total $ 1,586 $ 810 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 10. Property and Equipment, Net Property and equipment, net consists of the following: Schedule of Property and Equipment (in thousands) March 31, 2023 December 31, 2022 Computer equipment $ 94 $ 89 Computer software 27 27 Furniture & fixtures 81 81 Leasehold improvement 368 368 Machinery & equipment 155 145 Property and equipment, gross 725 710 Less: Accumulated depreciation (528 ) (506 ) Property and equipment, net $ 197 $ 204 Depreciation expense for the three months ended March 31, 2023 and 2022 was negligible and was included in selling, general and administrative expense in the consolidated statements of operations. |
Intangible Asset, Net
Intangible Asset, Net | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Asset, Net | 11. Intangible Asset, Net Intangible asset, net consists of the following: Schedule of Intangible Asset Net (in thousands) March 31, 2023 December 31, 2022 Xepi® license $ 4,600 $ 4,600 Less: Accumulated amortization (1,673 ) (1,568 ) Intangible asset, net $ 2,927 $ 3,032 The Xepi® license intangible asset was recorded at acquisition-date fair value of $ 4.6 11 0.1 We review the Xepi ® The Company did not recognize any impairment charges during the three months ended March 31, 2023 or 2022. |
Statement of Cash Flows Reconci
Statement of Cash Flows Reconciliation | 3 Months Ended |
Mar. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Statement of Cash Flows Reconciliation | 12. Statement of Cash Flows Reconciliation The following table provides a reconciliation of cash, cash equivalents, and restricted cash that sum to the total shown in the consolidated statements of cash flows: Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (in thousands) March 31, 2023 December 31, 2022 Cash and cash equivalents $ 13,505 $ 17,208 Long-term restricted cash 200 200 Total cash, cash equivalent, and restricted cash shown on the consolidated statements of cash flows $ 13,705 $ 17,408 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 13. 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) March 31, 2023 December 31, 2022 Legal settlement (See note 21) $ 6,094 $ 6,207 Employee compensation and benefits 3,155 2,850 Professional fees 1,303 1,353 Product revenue allowances and reserves 69 82 Other 514 372 Total $ 11,135 $ 10,864 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes As a result of the net losses, we have incurred in each fiscal year since inception, we have recorded no no The Company continues to be in a cumulative loss position and as such, is maintaining a full valuation allowance. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as income tax expense in the accompanying consolidated statements of operations. As of March 31, 2023, and December 31, 2022, the Company has no accrued interest related to uncertain tax positions. Since the Company is in a loss carryforward position, it is generally subject to examination by the U.S. federal, state, and local income tax authorities for all tax years in which a loss carryforward is available. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 15. Related Party Transactions License and Supply Agreement On October 1, 2016, the Company executed an exclusive license and supply agreement with Biofrontera Pharma GmbH (“Pharma”), which was amended in July 2019 to increase the Ameluz ® 35.0% 50.0% ® 30% 50% ® ® Purchases of the licensed products during the three months ended March 31, 2023 and 2022 were $ 4.6 5.2 0.9 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 March 31, 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 negligible for the three months ended March 31, 2023 and $ 0.1 0.2 0.2 Clinical Lamp Lease Agreement On August 1, 2018, the Company executed a clinical lamp lease agreement with Biofrontera Bioscience GmbH (“Bioscience”) to provide lamps and associated services. Total revenue related to the clinical lamp lease agreement was minimal for the three months ended March 31, 2023 and 2022, respectively and was recorded as revenues, related party. Amounts due from Bioscience for clinical lamp and other reimbursements were approximately $ 0.2 0.1 Others The Company has recorded a receivable of $ 3.7 6.4 50 Refer to Note 7, Other Receivables, Related Party no 0.1 As of March 31, 2023, our investment in equity securities is valued at $ 7.6 million and consists of 6,466,946 common shares of Biofrontera AG, a significant shareholder of the Company. |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | 16. Stockholders’ Equity Under the Company’s amended and restated certificate of incorporation, dated December 21, 2020, the Company is authorized to issue 300,000,000 0.001 20,000,000 .001 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 | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Plans and Share-Based Payments | 17. 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, 2,750,000 10 years for stock options issued under the 2021 Plan. 2,589,800 5,339,800 2,946,988 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 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 Three Months Ended March 31, 2023 2022 Expected volatility 70 % 55 % Expected term (in years) 6.0 6.0 Risk-free interest rate 3.5 3.7 % 1.79 % Expected dividend yield 0.0 % 0.0 % Share-based compensation expense of approximately $ 0.3 0.1 Options outstanding and exercisable under the employee share option plan as of March 31, 2023 and a summary of option activity during the three 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 1,737,344 $ 3.11 Granted 200,692 $ 0.99 Exercised - $ - Canceled or forfeited (58,804 ) $ 2.42 Outstanding at March 31, 2023 1,879,232 $ 2.90 9.09 $ - Exercisable at March 31, 2023 251,496 $ 4.07 8.73 $ - (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 March 31, 2023. As of March 31, 2023, there was $ 2.0 2.1 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 0.4 As of March 31, 2023, there was $ 0.5 1.1 Schedule of Restricted Stock Units Shares Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Weighted Average Grant Date Fair Value Outstanding at December 31, 2022 343,512 $ $ 2.61 Awarded - $ $ - Vested - $ $ - Canceled or forfeited - $ $ - Outstanding at March 31, 2023 343,512 0.63 $ 210 $ 2.61 Expected to vest at March 31, 2023 343,512 0.63 $ 210 $ 2.61 |
Interest Expense, net
Interest Expense, net | 3 Months Ended |
Mar. 31, 2023 | |
Interest Expense, net | 18. Interest Expense, net Interest expense, net consists of the following: Schedule of Interest Expense Three Months Ended March 31, (in thousands) 2023 2022 Interest expense (2 ) (4 ) Contract asset interest expense (89 ) (89 ) Interest income 56 60 Interest expense, net $ (35 ) $ (33 ) Contract asset interest expense relates to the $ 1.7 7.3 6 December 31, 2023 |
Other Income (expense), net
Other Income (expense), net | 3 Months Ended |
Mar. 31, 2023 | |
Other Income and Expenses [Abstract] | |
Other Income (expense), net | 19. Other Income (expense), net Other income (expense), net primarily includes (i) gain (loss) on sale of leased assets and (ii) gain (loss) on foreign currency transactions. |
Net Earnings (Loss) per Share
Net Earnings (Loss) per Share | 3 Months Ended |
Mar. 31, 2023 | |
Income (loss) per common share: | |
Net Earnings (Loss) per Share | 20. Net Earnings (Loss) per Share Basic net earnings 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 by the diluted weighted average number of common shares outstanding during the period. The diluted shares include the dilutive effect of stock-based awards based on the treasury stock method. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. The following table sets forth the computation of the Company’s basic and diluted net loss per share attributable to common stockholders. (in thousands, except share and per share data): Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders 2023 2022 Three Months Ended March 31, 2023 2022 Net income (loss) $ (7,478 ) $ 5,561 Shares Basic weighted average common shares outstanding 26,699,002 17,104,749 Add: Effect of dilutive securities Stock options and restricted stock units - 28,469 Diluted weighted average common shares outstanding 26,699,002 17,133,218 Net earnings (loss) per share: Basic $ (0.28 ) $ 0.33 Diluted $ (0.28 ) $ 0.32 The following table sets forth securities that were anti-dilutive for diluted EPS for the periods presented but which could potentially dilute EPS in the future: Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share March 31, 2023 2022 Common stock warrants 9,197,109 4,349,537 Common stock options and RSUs 2,198,745 575,518 Unit Purchase Options 403,628 403,628 Anti-dilutive securities excluded from computation of earnings per share 403,628 403,628 Common stock warrants include Purchase Warrants, Inducement Warrants and warrants issued in the Initial Public Offering. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 21. 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 expiration dates ranging from February 2023 through September 2025. The components of lease expense for the three months ended March 31, 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) $ 139 Interest on lease liabilities 20 Total lease expense $ 159 Other Information Operational cash flow used for operating leases $ 154 ROU assets obtained in exchange for lease liabilities - Weighted -average remaining lease term (in years) 2.33 Weighted -average discount rate 6.31 % Future lease payments under non-cancelable leases as of March 31, 2023 were as follows (in thousands): Schedule of Future Commitments and Sublease Income Years ending December 31, Future lease commitments 2023 $ 409 2024 541 2025 349 Thereafter - Total future minimum lease payments 1,299 Less imputed interest (90 ) Total lease liability $ 1,209 Schedule of Operating Lease Liability Reported as: Operating lease liability, current $ 484 Operating lease liability, non-current 725 Total $ 1,209 Cutanea payments We have a contract in which we agreed to repay to Maruho $ 3.6 3.7 We have filed for arbitration against Maruho with the International Chamber of Commerce (“ICC”) regarding issues with Maruho’s contract manufacturer that were not disclosed at the time of the Agreement and therefore are 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 the undisclosed manufacturing issues and seeks damages as well as a declaration that we are not obligated to repay Maruho. We are also obligated to share product profits with Maruho equally from January 1, 2020 through October 30, 2030. Refer to Note 3, Acquisition Contract Liabilities Milestone payments with Ferrer Internacional S.A. Under the Xepi LSA, we are obligated to make payments to Ferrer upon the occurrence of certain milestones. Specifically, we must pay Ferrer i) $ 2,000,000 ® 25,000,000 4,000,000 ® 50,000,000 ® Contingent liability related to shares of Biofrontera AG acquired from Maruho through subscription rights Dependent on the outcome of the arbitration process between Biofrontera AG and Maruho, the Company may be liable for an additional payout of $ 0.9 Contingencies, Legal proceedings At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450, Contingencies On November 29, 2021, the Company entered into a settlement and release agreement with respect to a lawsuit filed March 23, 2018 in the United States District Court for the District of Massachusetts in which we were alleged to have infringed on certain patents and misappropriated certain trade secrets. In the settlement, the Company and Biofrontera AG together agreed to make an aggregate payment of $ 22.5 While Biofrontera AG has agreed to pay fifty percent of the settlement costs, we remain jointly and severally liable to DUSA for the full cash settlement amount, meaning that in the event Biofrontera AG does not pay all or a portion of the amount it owes under the Agreement, DUSA could compel us to pay Biofrontera AG’s share. If either we or Biofrontera AG violates the terms of the settlement agreement, we or Biofrontera AG may be liable for a greater amount. If we become liable for more than our agreed share of the aggregate settlement amount, either of these events could have a material adverse effect on our business, prospects, financial condition and/or results of operations. As of March 31, 2023, we have reflected a legal settlement liability in the amount of $ 6.1 3.7 |
Retirement Plan
Retirement Plan | 3 Months Ended |
Mar. 31, 2023 | |
Retirement Benefits [Abstract] | |
Retirement Plan | 22. Retirement Plan The Company has a defined-contribution plan under Section 401(k) of Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary. For the three months ended March 31, 2023 and 2022, matching contribution costs paid by the Company were $ 0.1 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 23. Subsequent Events We have completed an evaluation of subsequent events after the balance sheet date of March 31, 2023 through the date this Quarterly Report on Form 10-Q was submitted to the SEC. Settlement Agreement On April 11, 2023, Biofrontera Inc. and each member of its Board of Directors, in their individual capacities, entered into a settlement agreement (the “Settlement Agreement”) with Biofrontera AG, a significant stockholder of the Company. Pursuant to the terms of the Settlement Agreement, the major provisions are as follows: ● the Company and a member of its Board of Directors withdrew their challenges to the resolutions passed at the Biofrontera AG stockholder meeting on January 9, 2023 ● the Company will increase the Board of Directors from five to six members and appoint as a Class I Director a director nominated by Biofrontera AG to fill the vacancy, subject to certain restrictions as described in the Settlement Agreement; ● the Company will begin a search for an additional director candidate, who is fully independent, to be nominated for election as a Class II Director at the Company’s 2023 annual meeting of stockholders; at which point the Company will increase the size of the Board of Directors to seven members; ● the Board established a Related Party Transactions Committee to approve all contracts and transactions between the Company and Biofrontera AG, including any of its affiliates; ● the Company amended on April 26, 2023 that certain Stockholder Rights Agreement dated October 13, 2022, between the Company and Computershare Trust Company, N.A., as Rights Agent to increase the threshold of beneficial ownership before being deemed an Acquiring Person, solely with respect to Biofrontera AG, from 20% to 29.96%. Loan and Security Agreement On May 8, 2023, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with MidCap Business Credit LLC, providing us with a revolving line of credit in the aggregate principal amount of up to $ 6.5 million, subject to a borrowing base. The Loan Agreement allows the Company to request advances thereunder and to use the proceeds of such advances for working capital purposes until the maturity date of May 8, 2026. The Loan Agreement is secured by a lien on substantially all of the assets of the Company, subject to customary exceptions. Advances under the Loan Agreement shall bear interest at the 30-Day Adjusted Term SOFR Rate, set monthly on the first day of the month based on 30-Day Term SOFR plus a spread adjustment of 15 basis points and subject to a floor of 2.25 %, plus 4.00 % calculated and charged monthly in arrears. In the event of a called event of default, a default interest rate of 3.00 % percent shall be added to the aforementioned rate. Under the terms of the Loan Agreement, amounts available for advances would be subject to a borrowing base, which is a formula based on certain eligible receivables and inventory. The Loan Agreement also includes an Unused Line Fee Rate of 0.375 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis for Preparation of the Financial Statements | Basis for Preparation of the Financial Statements The accompanying unaudited interim 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 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 March 31, 2023, the Company’s operating results for the three months ended March 31, 2023 and 2022, and the Company’s cash flows for the three months ended March 31, 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 Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 13, 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. The Company’s significant accounting policies are discussed in Note 2—Summary of Significant Accounting Policies |
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) | 3 Months Ended |
Mar. 31, 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) March 31, 2023 December 31, 2022 Short-term acquisition contract liabilities: Contingent consideration $ 2,200 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (268 ) (358 ) Acquisition contract liabilities, net $ 7,032 $ 6,942 Long-term acquisition contract liabilities: Contingent consideration $ 2,200 $ 2,400 Total acquisition contract liabilities: Contingent consideration $ 2,200 $ 2,400 Start-up cost financing 7,300 7,300 Contract asset (268 ) (358 ) Total acquisition contract liabilities, net $ 9,232 $ 9,342 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 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 March 31, 2023 December 31, 2022 Assets: Investment in equity securities 1 $ 7,596 $ 10,548 Liabilities: Contingent Consideration 3 $ 2,200 $ 2,400 Warrant liability – 2022 Purchase Warrants 3 $ 786 $ 1,129 Warrant liability - 2022 Inducement Warrants 3 $ 1,029 $ 1,714 Warrant liability 3 $ 1,029 $ 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, 2021 $ 6,200 Change in fair value of contingent consideration - Balance at March 31, 2022 $ 6,200 Balance at December 31, 2022 $ 2,400 Change in fair value of contingent consideration (200 ) Balance at March 31, 2023 $ 2,200 |
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions | The fair value at March 31, 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 $ 0.61 $ 0.61 Expiration term (in years) 4.63 3.67 Volatility 85.0 % 85.0 % Risk-free Rate 3.61 % 3.71 % Dividend yield 0.0 % 0.0 % |
Schedule of Changes in Fair Value Warrant Liabilities | The following table presents the changes in the warrant liabilities measured at fair value (in thousands): Schedule of Changes in Fair Value Warrant Liabilities 2023 2022 Three Months Ended March 31, 2023 2022 Fair value at beginning of period $ 2,843 $ 12,854 Change in fair value of warrant liability (1,028 ) (8,711 ) Fair value at end of period $ 1,815 $ 4,143 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Revenue Allowance and Accrual Activities | An analysis of the changes in product revenue allowances and reserves is summarized as follows: Schedule of Revenue Allowance and Accrual Activities (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 3 165 5 45 218 Credit or payments made during the period (5 ) (150 ) (17 ) (52 ) (224 ) Balance at March 31, 2022 $ 41 $ 116 $ 36 $ 47 $ 240 Balance at December 31, 2022 $ 48 $ 9 $ 5 $ 20 $ 82 Beginning Balance $ 48 $ 9 $ 5 $ 20 $ 82 Provision related to current period sales 1 62 3 33 99 Credit or payments made during the period - (71 ) (2 ) (39 ) (112 ) Balance at March 31, 2023 $ 49 - 6 14 69 Ending Balance $ 49 - 6 14 69 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Prepaid Expenses And Other Current Assets | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: Schedule of Prepaid Expenses and Other Current Assets (in thousands) March 31, 2023 December 31, 2022 Prepaid expenses $ 593 $ 240 Prepaid insurance 512 15 Prepaid licenses 423 317 Security deposits - 85 Other 58 153 Total $ 1,586 $ 810 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consists of the following: Schedule of Property and Equipment (in thousands) March 31, 2023 December 31, 2022 Computer equipment $ 94 $ 89 Computer software 27 27 Furniture & fixtures 81 81 Leasehold improvement 368 368 Machinery & equipment 155 145 Property and equipment, gross 725 710 Less: Accumulated depreciation (528 ) (506 ) Property and equipment, net $ 197 $ 204 |
Intangible Asset, Net (Tables)
Intangible Asset, Net (Tables) | 3 Months Ended |
Mar. 31, 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) March 31, 2023 December 31, 2022 Xepi® license $ 4,600 $ 4,600 Less: Accumulated amortization (1,673 ) (1,568 ) Intangible asset, net $ 2,927 $ 3,032 |
Statement of Cash Flows Recon_2
Statement of Cash Flows Reconciliation (Tables) | 3 Months Ended |
Mar. 31, 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) March 31, 2023 December 31, 2022 Cash and cash equivalents $ 13,505 $ 17,208 Long-term restricted cash 200 200 Total cash, cash equivalent, and restricted cash shown on the consolidated statements of cash flows $ 13,705 $ 17,408 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 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) March 31, 2023 December 31, 2022 Legal settlement (See note 21) $ 6,094 $ 6,207 Employee compensation and benefits 3,155 2,850 Professional fees 1,303 1,353 Product revenue allowances and reserves 69 82 Other 514 372 Total $ 11,135 $ 10,864 |
Equity Incentive Plans and Sh_2
Equity Incentive Plans and Share-Based Payments (Tables) | 3 Months Ended |
Mar. 31, 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 Three Months Ended March 31, 2023 2022 Expected volatility 70 % 55 % Expected term (in years) 6.0 6.0 Risk-free interest rate 3.5 3.7 % 1.79 % Expected dividend yield 0.0 % 0.0 % |
Schedule of Stock Option Activity | Options outstanding and exercisable under the employee share option plan as of March 31, 2023 and a summary of option activity during the three 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 1,737,344 $ 3.11 Granted 200,692 $ 0.99 Exercised - $ - Canceled or forfeited (58,804 ) $ 2.42 Outstanding at March 31, 2023 1,879,232 $ 2.90 9.09 $ - Exercisable at March 31, 2023 251,496 $ 4.07 8.73 $ - |
Schedule of Restricted Stock Units | Schedule of Restricted Stock Units Shares Weighted Average Remaining Contractual Term Aggregate Intrinsic Value Weighted Average Grant Date Fair Value Outstanding at December 31, 2022 343,512 $ $ 2.61 Awarded - $ $ - Vested - $ $ - Canceled or forfeited - $ $ - Outstanding at March 31, 2023 343,512 0.63 $ 210 $ 2.61 Expected to vest at March 31, 2023 343,512 0.63 $ 210 $ 2.61 |
Interest Expense, net (Tables)
Interest Expense, net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Schedule of Interest Expense | Interest expense, net consists of the following: Schedule of Interest Expense Three Months Ended March 31, (in thousands) 2023 2022 Interest expense (2 ) (4 ) Contract asset interest expense (89 ) (89 ) Interest income 56 60 Interest expense, net $ (35 ) $ (33 ) |
Net Earnings (Loss) per Share (
Net Earnings (Loss) per Share (Tables) | 3 Months Ended |
Mar. 31, 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 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 Three Months Ended March 31, 2023 2022 Net income (loss) $ (7,478 ) $ 5,561 Shares Basic weighted average common shares outstanding 26,699,002 17,104,749 Add: Effect of dilutive securities Stock options and restricted stock units - 28,469 Diluted weighted average common shares outstanding 26,699,002 17,133,218 Net earnings (loss) per share: Basic $ (0.28 ) $ 0.33 Diluted $ (0.28 ) $ 0.32 |
Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share | The following table sets forth securities that were anti-dilutive for diluted EPS for the periods presented but which could potentially dilute EPS in the future: Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share March 31, 2023 2022 Common stock warrants 9,197,109 4,349,537 Common stock options and RSUs 2,198,745 575,518 Unit Purchase Options 403,628 403,628 Anti-dilutive securities excluded from computation of earnings per share 403,628 403,628 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Components of Lease Expense and Other Information | The components of lease expense for the three months ended March 31, 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) $ 139 Interest on lease liabilities 20 Total lease expense $ 159 Other Information Operational cash flow used for operating leases $ 154 ROU assets obtained in exchange for lease liabilities - Weighted -average remaining lease term (in years) 2.33 Weighted -average discount rate 6.31 % |
Schedule of Future Commitments and Sublease Income | Future lease payments under non-cancelable leases as of March 31, 2023 were as follows (in thousands): Schedule of Future Commitments and Sublease Income Years ending December 31, Future lease commitments 2023 $ 409 2024 541 2025 349 Thereafter - Total future minimum lease payments 1,299 Less imputed interest (90 ) Total lease liability $ 1,209 |
Schedule of Operating Lease Liability | Schedule of Operating Lease Liability Reported as: Operating lease liability, current $ 484 Operating lease liability, non-current 725 Total $ 1,209 |
Business Overview (Details Narr
Business Overview (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Cash and cash equivalents, at carrying value | $ 13,505 | $ 17,208 | |
Loss from operations | 5,492 | $ 3,110 | |
Net operating activities | 3,689 | $ 2,112 | |
Accumulated deficit | 86,997 | 79,519 | |
Business combination, contingent consideration, liability | 9,232 | $ 9,342 | |
Accrued liabilities and other liabilities | 2,500 | ||
Maruho Co. Ltd. [Member] | |||
Business combination, contingent consideration, liability | $ 7,300 |
Schedule of Acquisition Contrac
Schedule of Acquisition Contract Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||||
Contingent consideration | $ 2,200 | $ 2,400 | $ 6,200 | $ 6,200 |
Start-up cost financing | 7,300 | 7,300 | ||
Contract asset | (268) | (358) | ||
Acquisition contract liabilities, net | 7,032 | 6,942 | ||
Total acquisition contract liabilities, net | 9,232 | 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 | (268) | (358) | ||
Acquisition contract liabilities, net | 7,032 | 6,942 | ||
Long-Term Debt [Member] | ||||
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] | ||||
Contingent consideration | $ 2,200 | $ 2,400 |
Acquisition Contract Liabilit_3
Acquisition Contract Liabilities (Details Narrative) $ in Millions | Mar. 25, 2019 USD ($) |
Monte Carlo Simulation Model [Member] | Measurement Input, Discount Rate [Member] | |
Business Acquisition [Line Items] | |
Derivative liability measuremnet input | 6 |
Cutanea Life Sciences, Inc. [Member] | |
Business Acquisition [Line Items] | |
Equity interest in acquiree, percentage | 100% |
Non-interest bearing start-up cost financing | $ 1.7 |
Sale of equity estimated profits contingent consideration | 6.5 |
Cutanea Life Sciences, Inc. [Member] | Share Purchase Agreement [Member] | |
Business Acquisition [Line Items] | |
Start-up cost financing | $ 7.3 |
Biofrontera AG [Member] | |
Business Acquisition [Line Items] | |
Equity interest in acquiree, percentage | 29.90% |
Maruho Co, Ltd. [Member] | |
Business Acquisition [Line Items] | |
Start-up cost financing interest rate | 6% |
Start-up cost financing term | 57 months |
Start-up cost financing maturity date | Dec. 31, 2023 |
Schedule of Fair Value Hierarch
Schedule of Fair Value Hierarchy Valuation Inputs (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Warrant liability – 2022 Purchase Warrants | $ 1,815 | $ 2,843 | $ 4,143 | $ 12,854 |
Fair Value, Inputs, Level 1 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Investment in equity securities | 7,596 | 10,548 | ||
Fair Value, Inputs, Level 3 [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Contingent Consideration | 2,200 | 2,400 | ||
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 | 786 | 1,129 | ||
Fair Value, Inputs, Level 3 [Member] | Warrant Liability - 2022 July Common Warrant [Member] | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Warrant liability | $ 1,029 | $ 1,714 |
Schedule of Fair Value of Conti
Schedule of Fair Value of Contingent Consideration (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Beginning balance, fair value of contingent consideration | $ 2,400 | $ 6,200 |
Change in fair value of contingent consideration | (200) | |
Ending balance, fair value of contingent consideration | $ 2,200 | $ 6,200 |
Schedule of Fair value Warrant
Schedule of Fair value Warrant by Using Black-Scholes Pricing Model Assumptions (Details) | Mar. 31, 2023 $ / shares |
Measurement Input, Share Price [Member] | Purchase Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Stock price | $ 0.61 |
Measurement Input, Share Price [Member] | Inducement Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Stock price | $ 0.61 |
Measurement Input, Expected Term [Member] | Purchase Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Expiration term (in years) | 4 years 7 months 17 days |
Measurement Input, Expected Term [Member] | Inducement Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Expiration term (in years) | 3 years 8 months 1 day |
Measurement Input, Option Volatility [Member] | Purchase Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrant outstanding, measurement input | 85 |
Measurement Input, Option Volatility [Member] | Inducement Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrant outstanding, measurement input | 85 |
Measurement Input, Risk Free Interest Rate [Member] | Purchase Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrant outstanding, measurement input | 3.61 |
Measurement Input, Risk Free Interest Rate [Member] | Inducement Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrant outstanding, measurement input | 3.71 |
Measurement Input, Expected Dividend Payment [Member] | Purchase Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrant outstanding, measurement input | 0 |
Measurement Input, Expected Dividend Payment [Member] | Inducement Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Warrant outstanding, measurement input | 0 |
Schedule of Changes in Fair Val
Schedule of Changes in Fair Value Warrant Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Fair value at beginning of period | $ 2,843 | $ 12,854 |
Change in fair value of warrant liability | (1,028) | (8,711) |
Fair value at end of period | $ 1,815 | $ 4,143 |
Fair Value Measurements (Detail
Fair Value Measurements (Details Narrative) - $ / shares | Jul. 26, 2022 | May 16, 2022 |
Purchase Warrants [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Warrants exercise price | $ 2.77 | |
Inducement Warrants [Member] | ||
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] | ||
Warrants exercise price | $ 1.66 |
Schedule of Revenue Allowance a
Schedule of Revenue Allowance and Accrual Activities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | $ 82 | $ 246 |
Provision related to current period sales | 99 | 218 |
Credit or payments made during the period | (112) | (224) |
Ending Balance | 69 | 240 |
Returns [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 48 | 43 |
Provision related to current period sales | 1 | 3 |
Credit or payments made during the period | (5) | |
Ending Balance | 49 | 41 |
Co-pay Assistance Program [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 9 | 101 |
Provision related to current period sales | 62 | 165 |
Credit or payments made during the period | (71) | (150) |
Ending Balance | 116 | |
Prompt Pay Discounts [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 5 | 48 |
Provision related to current period sales | 3 | 5 |
Credit or payments made during the period | (2) | (17) |
Ending Balance | 6 | 36 |
Government and Payor Rebates [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Beginning Balance | 20 | 54 |
Provision related to current period sales | 33 | 45 |
Credit or payments made during the period | (39) | (52) |
Ending Balance | $ 14 | $ 47 |
Accounts Receivable, net (Detai
Accounts Receivable, net (Details Narrative) - USD ($) $ in Millions | Mar. 31, 2023 | Dec. 31, 2022 |
Credit Loss [Abstract] | ||
Allowance for doubtful accounts | $ 0.1 | $ 0.1 |
Other Receivables, Related Pa_2
Other Receivables, Related Party (Details Narrative) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Accounts Receivable, after Allowance for Credit Loss | $ 4,116 | $ 3,748 |
Legal settlements receivable percentage | 50% | |
Biofrontera AG [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 6% | |
Service Agreements [Member] | Related Party [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Accounts Receivable, after Allowance for Credit Loss | $ 3,800 | |
Other Receivables | $ 3,700 |
Inventories (Details Narrative)
Inventories (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | ||
Provision for inventories | $ 0 | $ 0 |
Schedule of Prepaid Expenses an
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid expenses | $ 593 | $ 240 |
Prepaid insurance | 512 | 15 |
Prepaid licenses | 423 | 317 |
Security deposits | 85 | |
Other | 58 | 153 |
Total | $ 1,586 | $ 810 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 725 | $ 710 |
Less: Accumulated depreciation | (528) | (506) |
Property and equipment, net | 197 | 204 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 94 | 89 |
Computer Software, Intangible Asset [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 27 | 27 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 81 | 81 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 368 | 368 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 155 | $ 145 |
Schedule of Intangible Asset Ne
Schedule of Intangible Asset Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Xepi® license | $ 4,600 | $ 4,600 |
Less: Accumulated amortization | (1,673) | (1,568) |
Intangible asset, net | $ 2,927 | $ 3,032 |
Intangible Asset, Net (Details
Intangible Asset, Net (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Finite lived license agreements gross | $ 4,600 | $ 4,600 | |
Finite lived intangible asset useful life | 11 years | ||
Amortization of intangible assets | $ 105 | $ 105 |
Schedule of Reconciliation of C
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Abstract] | ||
Cash and cash equivalents | $ 13,505 | $ 17,208 |
Long-term restricted cash | 200 | 200 |
Total cash, cash equivalent, and restricted cash shown on the consolidated statements of cash flows | $ 13,705 | $ 17,408 |
Schedule of Accrued Expenses an
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Legal settlement (See note 21) | $ 6,094 | $ 6,207 |
Employee compensation and benefits | 3,155 | 2,850 |
Professional fees | 1,303 | 1,353 |
Product revenue allowances and reserves | 69 | 82 |
Other | 514 | 372 |
Total | $ 11,135 | $ 10,864 |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |||
Provision for federal income taxes | $ 0 | $ 0 | |
Unrecognized tax benefits | $ 0 | $ 0 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |||||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Oct. 08, 2021 | Jul. 31, 2019 | Oct. 01, 2016 | |
Related Party Transaction [Line Items] | ||||||
Accounts receivable, related parties | $ 4,116 | $ 3,748 | ||||
Legal settlements receivable percentage | 50% | |||||
Biofrontera Pharma GmbH [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Interest income, related party | $ 100 | |||||
License and Supply Agreement [Member] | Biofrontera Pharma GmbH [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Related party costs | 4,600 | 5,200 | ||||
Accounts payable related parties | 900 | 1,300 | ||||
Service Agreements [Member] | Related Party [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Accounts receivable, related parties | 3,800 | |||||
Biofrontera Pharma GmbH [Member] | License and Supply Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Transfer price percentage | 50% | 35% | ||||
Biofrontera Pharma GmbH [Member] | Clinica Lamp Lease Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Accounts receivable, related parties | 200 | 100 | ||||
Biofrontera Pharma for Ameluz [Member] | Minimum [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Purchase price per unit percentage | 30% | |||||
Biofrontera Pharma for Ameluz [Member] | Maximum [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Purchase price per unit percentage | 50% | |||||
Biofrontera AG [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Loss contingency, receivable | 3,700 | 6,400 | ||||
Biofrontera AG [Member] | Service Agreements [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Accounts payable related parties | 200 | $ 200 | ||||
Biofrontera AG [Member] | Service Agreements [Member] | Related Party [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Expenses related to service | $ 100 | |||||
Maruho Co, Ltd. [Member] | Share Purchase and Transfer Agreement [Member] | ||||||
Related Party Transaction [Line Items] | ||||||
Investment ineEquity securities, value | $ 7,600 | |||||
Investment ineEquity securities, shares | 6,466,946 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 21, 2020 |
Equity [Abstract] | |||
Common stock, shares authorized | 300,000,000 | 300,000,000 | 300,000,000 |
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 |
Preferred stock designated | 20,000,000 | 20,000,000 | 20,000,000 |
Preferred stock, par value | $ 0.001 | $ 0.001 | $ 0.001 |
Schedule of Stock Options Assum
Schedule of Stock Options Assumptions (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected volatility | 70% | 55% |
Expected term (in years) | 6 years | 6 years |
Risk-free interest rate | 1.79% | |
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 3.50% | |
Maximum [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk-free interest rate, maximum | 3.70% |
Schedule of Stock Option Activi
Schedule of Stock Option Activity (Details) | 3 Months Ended | |
Mar. 31, 2023 USD ($) $ / shares shares | ||
Share-Based Payment Arrangement [Abstract] | ||
Number of Shares Outstanding, Beginning Balance | shares | 1,737,344 | |
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 3.11 | |
Number of Shares Outstanding, Granted | shares | 200,692 | |
Weighted Average Exercise Price, Granted | $ / shares | $ 0.99 | |
Number of Shares Outstanding, Exercised | shares | ||
Weighted Average Exercise Price, Exercised | $ / shares | ||
Number of Shares Outstanding, Canceled or forfeited | shares | (58,804) | |
Weighted Average Exercise Price, Canceled or forfeited | $ / shares | $ 2.42 | |
Number of Shares Outstanding, Ending Balance | shares | 1,879,232 | |
Weighted Average Exercise Price, Ending Balance | $ / shares | $ 2.90 | |
Weighted Average Remaining Contractual Life (in Years), Outstanding | 9 years 1 month 2 days | |
Aggregate Intrinsic Value, Outstanding, Ending Balance | $ | [1] | |
Number of Shares Execisable, Ending Balance | shares | 251,496,000 | |
Weighted Average Exercise Price Options Exercisable, Ending Balance | $ / shares | $ 4.07 | |
Weighted Average Remaining Contractual Life (in Years), Exercisable | 8 years 8 months 23 days | |
Aggregate Intrinsic Value, Exercisable, Ending Balance | $ | [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 March 31, 2023. |
Schedule of Restricted Stock Un
Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of shares outstanding, beginning balance | shares | 343,512 |
Number of shares weighted average grant date fair value, beginning balance | $ / shares | $ 2.61 |
Number of Shares Outstanding, Awarded | shares | |
Number of shares weighted average grant date fair value, awarded | $ / shares | |
Number of Shares Outstanding, Vested | shares | |
Number of shares weighted average grant date fair value,Vested | $ / shares | |
Number of Shares Outstanding, Canceled or expired | shares | |
Number of shares weighted average grant date fair value, canceled or forfeited | $ / shares | |
Share based compensation arrangement by share based payment award options vested and expected to vest outstanding number, ending balance | shares | 343,512 |
Weighted Average Remaining Contractual Life (in Years), Ending Balance | 7 months 17 days |
Total Intrinsic Value, Ending Balance | $ | $ 210 |
Number of shares weighted average grant date fair value, ending balance | $ / shares | $ 2.61 |
Share based compensation arrangement by share based payment award options vested and expected to vest outstanding number, ending balance | shares | 343,512 |
Weighted Average Remaining Contractual Term, Ending Balance | 7 months 17 days |
Total Intrinsic Value Exercisable, Ending Balance | $ | $ 210 |
Number of shares weighted average grant date fair value vest, ending balance | $ / shares | $ 2.61 |
Equity Incentive Plans and Sh_3
Equity Incentive Plans and Share-Based Payments (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Dec. 07, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Unrecognized compensation cost | $ 2 | |||
Compensation cost recognized, weighted average period | 2 years 1 month 6 days | |||
Restricted Stock Units (RSUs) [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Unrecognized compensation cost | $ 0.5 | |||
Compensation cost recognized, weighted average period | 1 year 1 month 6 days | |||
Selling, General and Administrative Expenses [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Share based compensation expenses | $ 0.3 | $ 0.1 | ||
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 | $ 0.4 | ||
Omnibus Incentive Plan [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Remain eligible for issuance shares | 2,750,000 | |||
Share-based payment award, terms of award | 10 years for stock options issued under the 2021 Plan. | |||
Number of shares available for future issuance | 2,946,988 | |||
Omnibus Incentive Plan [Member] | Minimum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Number of shares available for future awards, increased | 2,589,800 | |||
Omnibus Incentive Plan [Member] | Maximum [Member] | ||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||
Number of shares available for future awards, increased | 5,339,800 |
Schedule of Interest Expense (D
Schedule of Interest Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Interest expense | $ (2) | $ (4) |
Contract asset interest expense | (89) | (89) |
Interest income | 56 | 60 |
Interest expense, net | $ (35) | $ (33) |
Interest Expense, net (Details
Interest Expense, net (Details Narrative) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Contract asset | $ (268) | $ (358) |
Startup cost financing | 7,300 | $ 7,300 |
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 |
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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income (loss) per common share: | ||
Net income (loss) | $ (7,478) | $ 5,561 |
Shares | ||
Basic weighted average common shares outstanding | 26,699,002 | 17,104,749 |
Stock options and restricted stock units | 28,469 | |
Diluted weighted average common shares outstanding | 26,699,002 | 17,133,218 |
Net earnings (loss) per share: | ||
Basic | $ (0.28) | $ 0.33 |
Diluted | $ (0.28) | $ 0.32 |
Schedule of Anti-dilutive Secur
Schedule of Anti-dilutive Securities Excluded From Computation of Earnings Per Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 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 | 9,197,109 | 4,349,537 |
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 | 2,198,745 | 575,518 |
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 | 403,628 | 403,628 |
Schedule of Components of Lease
Schedule of Components of Lease Expense and Other Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Amortization of ROU assets (operating lease cost) | $ 139 | |
Interest on lease liabilities | 20 | |
Total lease expense | 159 | |
Operational cash flow used for operating leases | 154 | |
ROU assets obtained in exchange for lease liabilities | ||
Weighted -average remaining lease term (in years) | 2 years 3 months 29 days | |
Weighted -average discount rate | 6.31% |
Schedule of Future Commitments
Schedule of Future Commitments and Sublease Income (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2023 | $ 409 |
2024 | 541 |
2025 | 349 |
Thereafter | |
Total future minimum lease payments | 1,299 |
Less imputed interest | (90) |
Total lease liability | $ 1,209 |
Schedule of Operating Lease Lia
Schedule of Operating Lease Liability (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease liability, current | $ 484 | $ 498 |
Operating lease liability, non-current | 725 | $ 848 |
Total | $ 1,209 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | ||||
Mar. 31, 2023 | Nov. 29, 2021 | Mar. 31, 2023 | Mar. 31, 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 | ||||
Settlement liability | $ 22,500 | ||||
Biofrontera AG [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Settlement liability | $ 6,100 | ||||
Loss contingency, receivable | 3,700 | $ 3,700 | $ 6,400 | ||
Maruho Co, Ltd. [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Additional payout | 900 | ||||
Xepi LSA [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Contractual Obligation | 2,000 | 2,000 | $ 4,000 | ||
Xepi LSA [Member] | Maximum [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Revenues | 25,000 | $ 50,000 | |||
Maruho Co, Ltd. [Member] | December 31, 2022 [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Repayments of related party debt | 3,600 | ||||
Maruho Co, Ltd. [Member] | December 31, 2023 [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Repayments of related party debt | 3,700 | ||||
Facility Leases [Member] | |||||
Product Liability Contingency [Line Items] | |||||
Security deposit | $ 100 | $ 100 |
Retirement Plan (Details Narrat
Retirement Plan (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Employee contributions description | The Company matches 50% of employee contributions up to a maximum of 6% of employees’ salary. | |
Contribution cost | $ 0.1 | $ 0.1 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - Subsequent Event [Member] - USD ($) $ in Millions | Apr. 30, 2023 | Apr. 26, 2023 | May 08, 2023 |
Subsequent Event [Line Items] | |||
Shareholdes rights description | the Company amended on April 26, 2023 that certain Stockholder Rights Agreement dated October 13, 2022, between the Company and Computershare Trust Company, N.A., as Rights Agent to increase the threshold of beneficial ownership before being deemed an Acquiring Person, solely with respect to Biofrontera AG, from 20% to 29.96%. | ||
MidCap Business Credit LLC [Member] | |||
Subsequent Event [Line Items] | |||
Line of Credit Facility, Maximum Borrowing Capacity | $ 6.5 | ||
Debt Instrument, Interest Rate, Stated Percentage | 3% | ||
Unused line fee rate | 0.375% | ||
MidCap Business Credit LLC [Member] | Adjusted Secured Overnight Financing Floor Rate [Member] | |||
Subsequent Event [Line Items] | |||
Debt Instrument, Basis Spread on Variable Rate | 2.25% | ||
MidCap Business Credit LLC [Member] | Adjusted Secured Overnight Financing Rate [Member] | |||
Subsequent Event [Line Items] | |||
Debt Instrument, Basis Spread on Variable Rate | 4% |