Biofrontera(BFRI)

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Biofrontera(BFRI) - 2022 Q2 - Quarterly Report
2022-08-11 16:00
Filing Information This section provides details on Biofrontera Inc.'s Form 10-Q filing, including its registration status and filer classifications [Form 10-Q Details](index=1&type=section&id=Form%2010-Q%20Details) This document is a Quarterly Report on Form 10-Q for Biofrontera Inc. for the period ended June 30, 2022. The company is registered on The Nasdaq Stock Market LLC under the trading symbol BFRI and is classified as a non-accelerated filer and an emerging growth company - Biofrontera Inc., a Delaware corporation, filed a Quarterly Report on Form 10-Q for the period ended June 30, 2022[1](index=1&type=chunk) Securities Information | Securities Information | | :--------------------- | | Trading Symbol | BFRI | | Exchange | The Nasdaq Stock Market LLC | Filer Status | Filer Status | | :-------------------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☒ | - As of August 11, 2022, there were **23,550,960 shares of common stock** outstanding[4](index=4&type=chunk) PART I. FINANCIAL INFORMATION This part presents the company's unaudited interim financial statements, including balance sheets, statements of operations, cash flows, and comprehensive notes, along with management's discussion and analysis [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited interim financial statements of Biofrontera Inc., including the Balance Sheets, Statements of Operations, Statements of Stockholders' Equity, and Statements of Cash Flows, along with comprehensive notes detailing the company's accounting policies, financial instruments, revenue, and various assets and liabilities [Balance Sheets](index=4&type=section&id=Balance%20Sheets) This section details the company's financial position, showing assets, liabilities, and stockholders' equity at specific points in time Balance Sheet Summary | (In thousands) | June 30, 2022 (Unaudited) | December 31, 2021 | | :----------------------------------- | :-------------------------- | :------------------ | | **ASSETS** | | | | Cash and cash equivalents | $31,913 | $24,545 | | Total current assets | 46,981 | 46,421 | | Total assets | $53,626 | $53,219 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | 14,876 | 13,836 | | Warrant liability | 8,046 | 12,854 | | Total liabilities | $36,393 | $41,881 | | Total stockholders' equity | 17,233 | 11,338 | | Total liabilities and stockholders' equity | $53,626 | $53,219 | - Cash and cash equivalents **increased by $7.368 million** from December 31, 2021, to June 30, 2022[6](index=6&type=chunk)[11](index=11&type=chunk) - Total stockholders' equity **increased from $11.338 million to $17.233 million** from December 31, 2021, to June 30, 2022[6](index=6&type=chunk) [Statements of Operations](index=5&type=section&id=Statements%20of%20Operations) This section outlines the company's revenues, expenses, and net income or loss over specific reporting periods Statements of Operations Summary | (In thousands, except per share amounts) | Three months ended June 30, 2022 | Three months ended June 30, 2021 | Six months ended June 30, 2022 | Six months ended June 30, 2021 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues, net | $4,457 | $5,855 | $14,208 | $10,599 | | Total operating expenses | 10,669 | 9,542 | 23,530 | 17,814 | | Loss from operations | (6,212) | (3,687) | (9,322) | (7,215) | | Change in fair value of warrants | 5,371 | - | 14,082 | - | | Net income (loss) | $(850) | $(3,661) | $4,711 | $(7,195) | | Basic EPS | $(0.05) | $(0.46) | $0.26 | $(0.90) | | Diluted EPS | $(0.05) | $(0.46) | $0.26 | $(0.90) | - Net income for the six months ended June 30, 2022, was **$4.711 million**, a significant improvement from a net loss of $7.195 million in the prior year, primarily due to a **$14.082 million gain** from the change in fair value of warrants[7](index=7&type=chunk) - Total revenues for the six months ended June 30, 2022, **increased by 34.1% to $14.208 million** compared to $10.599 million in the same period of 2021[7](index=7&type=chunk) [Statements of Stockholders' Equity](index=6&type=section&id=Statements%20of%20Stockholders'%20Equity) This section presents changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit Statements of Stockholders' Equity Summary | (In thousands, except number of shares) | Common Shares | Common Stock Amount | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity | | :-------------------------------------- | :------------ | :------------------ | :------------------------- | :------------------ | :------------------------- | | Balance, December 31, 2021 | 17,104,749 | $17 | $90,200 | $(78,879) | $11,338 | | Issuance of common stock and warrants under private placement, net of issuance costs | 1,850,000 | 2 | 114 | - | 116 | | Stock based compensation | - | - | 1,068 | - | 1,068 | | Net income | - | - | - | 4,711 | 4,711 | | Balance, June 30, 2022 | 19,011,438 | $19 | $91,382 | $(74,168) | $17,233 | - Total stockholders' equity **increased from $11.338 million to $17.233 million** from December 31, 2021, to June 30, 2022, driven by net income and proceeds from private placement[8](index=8&type=chunk) - Common shares outstanding **increased by 1,906,689 shares** from December 31, 2021, to June 30, 2022, primarily due to a private placement[8](index=8&type=chunk) [Statements of Cash Flows](index=7&type=section&id=Statements%20of%20Cash%20Flows) This section reports the cash generated and used by the company across its operating, investing, and financing activities Statements of Cash Flows Summary | (In Thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net income (loss) | $4,711 | $(7,195) | | Cash flows used in operating activities | $(1,987) | $(4,508) | | Cash flows used in investing activities | $(36) | $(3) | | Cash flows provided by (used) in financing activities | $9,391 | $(517) | | Net increase (decrease) in cash and cash equivalents | $7,368 | $(5,028) | | Cash, cash equivalents and restricted cash, at the end of the period | $32,110 | $3,249 | - Net cash used in operating activities **used $2.0 million of cash in H1 2022**, a decrease from $4.5 million used in H1 2021[11](index=11&type=chunk) - Financing activities **provided $9.391 million in cash** during H1 2022, primarily from the issuance of common stock and warrants in a private placement[11](index=11&type=chunk) [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) This section provides detailed explanations and additional information regarding the figures presented in the financial statements [Note 1. Business Overview](index=8&type=section&id=Note%201.%20Business%20Overview) Biofrontera Inc. is a biopharmaceutical company focused on dermatological products, primarily Ameluz® for actinic keratoses and Xepi® for impetigo. The company reported significant losses since 2015 but expects current cash and recent warrant exercise proceeds to fund operations for at least the next twelve months - The company specializes in commercializing pharmaceutical products for dermatological conditions, with principal licensed products **Ameluz® for actinic keratoses** and **Xepi® for impetigo**[13](index=13&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) - As of June 30, 2022, cash and cash equivalents were **$31.9 million**, up from $24.5 million at December 31, 2021, bolstered by **$9.4 million** from a May 2022 private placement[16](index=16&type=chunk) - The company incurred operating losses of **$9.3 million** and **$7.2 million** for the six months ended June 30, 2022 and 2021, respectively, with an accumulated deficit of **$74.2 million** as of June 30, 2022[17](index=17&type=chunk) - Expected cash requirements include working capital, Maruho start-up payments (**$7.3 million**), and legal settlement expenses (**$5.6 million** after reimbursement)[18](index=18&type=chunk) - Subsequent to June 30, 2022, an investor exercised warrants for **$4.6 million gross proceeds**, which, combined with existing cash, is expected to fund operations for at least the next twelve months[20](index=20&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) The unaudited interim financial statements are prepared in accordance with SEC rules and U.S. GAAP, using estimates and assumptions for various financial items. The company is evaluating the impact of recently issued accounting pronouncements, ASU 2016-02 (Leases) and ASU 2016-13 (Credit Losses), which will be effective for the company in fiscal years beginning after December 15, 2022, and January 1, 2023, respectively - The financial statements are prepared under **U.S. GAAP**, with certain information condensed or omitted per SEC interim reporting rules[21](index=21&type=chunk) - Key estimates and assumptions are made for valuation allowances, contingent consideration, warrant liabilities, intangible assets, product sales allowances, share-based payments, and income taxes[23](index=23&type=chunk) - The company is evaluating the impact of **ASU 2016-02 (Leases)**, effective for fiscal years beginning after December 15, 2022, and **ASU 2016-13 (Credit Losses)**, effective January 1, 2023[24](index=24&type=chunk)[25](index=25&type=chunk) [Note 3. Acquisition Contract Liabilities](index=10&type=section&id=Note%203.%20Acquisition%20Contract%20Liabilities) Acquisition contract liabilities primarily stem from the 2019 acquisition of Cutanea Life Sciences, Inc. from Maruho, including $7.3 million in start-up cost financing repayable by the end of 2023 and contingent consideration for profit sharing until 2030. The contingent consideration's fair value decreased from $6.2 million at December 31, 2021, to $4.3 million at June 30, 2022 - The company acquired Cutanea Life Sciences, Inc. from Maruho in 2019, which included **$7.3 million in start-up cost financing** repayable by the end of 2023[26](index=26&type=chunk)[27](index=27&type=chunk) - An earn-out arrangement requires equal sharing of product profit from Cutanea products with Maruho until 2030, recorded as contingent consideration[27](index=27&type=chunk) Acquisition Contract Liabilities Summary | (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :------------ | :---------------- | | Contingent consideration (total) | $4,300 | $6,200 | | Start-up cost financing (total) | 7,300 | 7,300 | | Contract asset (total) | (537) | (716) | | Total acquisition contract liabilities, net | $11,063 | $12,784 | [Note 4. Fair Value Measurements](index=11&type=section&id=Note%204.%20Fair%20Value%20Measurements) The company measures contingent consideration and warrant liabilities at fair value on a recurring basis. Contingent consideration, related to Cutanea product profits, is a Level 3 measurement, valued using a scenario-based method. Warrant liabilities, including 2021 and 2022 Purchase Warrants, are also Level 3, valued using a Black-Scholes model, while 2022 Pre-funded Warrants are Level 2 Fair Value Measurements Summary | (in thousands) | Level | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :---- | :------------ | :---------------- | | Contingent Consideration | 3 | $4,300 | $6,200 | | Warrant liability – 2021 Common warrant | 3 | $1,743 | $12,854 | | Warrant liability - 2022 Common warrant | 3 | $3,385 | $ - | | Warrant liability- 2022 Common warrant (Pre-funded) | 2 | $2,918 | $ - | - Contingent consideration **decreased by $1.9 million** from December 31, 2021, to June 30, 2022, reflecting changes in estimated product profits[34](index=34&type=chunk) - Warrant liability **decreased from $12.854 million to $8.046 million** from December 31, 2021, to June 30, 2022, despite the issuance of new liabilities, due to a **$14.082 million change in fair value**[38](index=38&type=chunk) [Note 5. Revenue](index=13&type=section&id=Note%205.%20Revenue) Revenue is primarily generated from sales of Ameluz®, BF-RhodoLED® lamps, and Xepi®, with Ameluz® being the most significant contributor. Related party revenue is minimal and comes from a clinical lamp lease agreement. Product revenue allowances and reserves increased to $331,000 at June 30, 2022, from $246,000 at December 31, 2021 - Primary revenue sources are **Ameluz®, BF-RhodoLED® lamps, and Xepi®**, with Ameluz® sales being the most significant[40](index=40&type=chunk) - Related party revenue is generated from an agreement with Biofrontera Bioscience GmbH for BF-RhodoLED® leasing and installation services[40](index=40&type=chunk) Product Revenue Allowances and Reserves | (in thousands) | Balance at December 31, 2021 | Provision related to current period sales | Credit or payments made during the period | Balance at June 30, 2022 | | :------------------------------------ | :--------------------------- | :---------------------------------------- | :---------------------------------------- | :----------------------- | | Returns | $43 | $5 | $(5) | $43 | | Co-pay assistance program | $101 | $380 | $(300) | $181 | | Prompt pay discounts | $48 | $11 | $(20) | $39 | | Government payor rebates | $54 | $129 | $(115) | $68 | | Total | $246 | $517 | $(440) | $331 | [Note 6. Accounts Receivable, net](index=13&type=section&id=Note%206.%20Accounts%20Receivable%2C%20net) Accounts receivables primarily arise from sales of Ameluz, BF-RhodoLED, and Xepi, with all expected to be settled within twelve months. The allowance for doubtful accounts increased significantly to $126,000 as of June 30, 2022, from $18,000 at December 31, 2021 - Accounts receivables are mainly from sales of **Ameluz, BF-RhodoLED, and Xepi**, with expected settlement within twelve months[42](index=42&type=chunk) Allowance for Doubtful Accounts | Date | Amount (USD) | | :------------------------------ | :------------------------------ | | June 30, 2022 | $126,000 | | December 31, 2021 | $18,000 | [Note 7. Other Receivables, Related Party](index=13&type=section&id=Note%207.%20Other%20Receivables%2C%20Related%20Party) The company holds a $5.6 million receivable from Biofrontera AG for its share of a legal settlement, with a contractual right to repayment and remedies for late payments. An additional $0.3 million in related party receivables pertains to service agreements and chargebacks - A **$5.6 million receivable** is due from Biofrontera AG for its 50% share of a legal settlement, with repayment rights and remedies for late payments[43](index=43&type=chunk) - The remaining **$0.3 million in other receivables** from related parties relates to service agreements and chargebacks[45](index=45&type=chunk) [Note 8. Inventories](index=14&type=section&id=Note%208.%20Inventories) Inventories consist of Ameluz, Xepi®, and BF-RhodoLED finished products, valued using the FIFO method. A provision for inventory obsolescence of $0.1 million was recorded for BF-RhodoLED devices for the three and six months ended June 30, 2022 - Inventories include **Ameluz, Xepi®, and BF-RhodoLED finished products**, with consumption assumed by the FIFO method[46](index=46&type=chunk) - A **$0.1 million provision for BF-RhodoLED device obsolescence** was recorded for the three and six months ended June 30, 2022[46](index=46&type=chunk) [Note 9. Prepaid Expenses and Other Current Assets](index=14&type=section&id=Note%209.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets decreased significantly from $4.987 million at December 31, 2021, to $1.214 million at June 30, 2022, primarily due to the absence of a receivable for common stock warrants proceeds Prepaid Expenses and Other Current Assets Summary | (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :------------ | :---------------- | | Receivable for common stock warrants proceeds | $ - | $3,258 | | Prepaid expenses | 599 | $824 | | Security deposits | 128 | 149 | | Other | 487 | 756 | | Total | $1,214 | $4,987 | [Note 10. Property and Equipment, Net](index=14&type=section&id=Note%2010.%20Property%20and%20Equipment%2C%20Net) Property and equipment, net, decreased slightly from $267,000 at December 31, 2021, to $248,000 at June 30, 2022. Depreciation expense for the six months ended June 30, 2022, was $54,000 Property and Equipment, Net Summary | (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :------------ | :---------------- | | Property and equipment, gross | $708 | $673 | | Less: Accumulated depreciation | (460) | (406) | | Property and equipment, net | $248 | $267 | - Depreciation expense for the six months ended June 30, 2022, was **$54,000**, included in selling, general and administrative expense[48](index=48&type=chunk) [Note 11. Intangible Asset, Net](index=14&type=section&id=Note%2011.%20Intangible%20Asset%2C%20Net) The Xepi® license, recorded at an acquisition-date fair value of $4.6 million, is amortized over 11 years. The net intangible asset decreased to $3.241 million at June 30, 2022, from $3.450 million at December 31, 2021, due to amortization. No impairment charges were recognized Intangible Asset, Net Summary | (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :------------ | :---------------- | | Xepi® license | $4,600 | $4,600 | | Less: Accumulated amortization | (1,359) | (1,150) | | Intangible asset, net | $3,241 | $3,450 | - Amortization expense for the six months ended June 30, 2022, was **$0.2 million**[50](index=50&type=chunk) - No impairment charges were recognized for the Xepi® license during the three or six months ended June 30, 2022 or 2021[51](index=51&type=chunk) [Note 12. Statement of Cash Flows Reconciliation](index=15&type=section&id=Note%2012.%20Statement%20of%20Cash%20Flows%20Reconciliation) The total cash, cash equivalents, and restricted cash increased to $32.110 million at June 30, 2022, from $24.742 million at December 31, 2021, with restricted cash remaining stable Cash, Cash Equivalents, and Restricted Cash Reconciliation | (in thousands) | June 30, 2022 | December 31, 2021 | | :----------------------------------------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $31,913 | $24,545 | | Short-term restricted cash | 47 | 47 | | Long-term restricted cash | 150 | 150 | | Total cash, cash equivalent, and restricted cash shown on the statements of cash flows | $32,110 | $24,742 | [Note 13. Accrued Expenses and Other Current Liabilities](index=15&type=section&id=Note%2013.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued expenses and other current liabilities slightly decreased to $9.413 million at June 30, 2022, from $9.654 million at December 31, 2021. The largest component remains the legal settlement liability of $5.625 million Accrued Expenses and Other Current Liabilities Summary | (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :------------ | :---------------- | | Legal settlement | $5,625 | $5,625 | | Employee compensation and benefits | 2,302 | 2,384 | | Professional fees | 659 | 570 | | Product revenue allowances and reserves | 331 | 246 | | Other | 496 | 829 | | Total | $9,413 | $9,654 | [Note 14. Other Long-Term Liabilities](index=15&type=section&id=Note%2014.%20Other%20Long-Term%20Liabilities) Other long-term liabilities remained stable at $5.650 million at June 30, 2022, primarily consisting of the noncurrent portion of the legal settlement liability Other Long-Term Liabilities Summary | (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------------------------ | :------------ | :---------------- | | Legal settlement – noncurrent | $5,625 | $5,625 | | Other | 25 | 24 | | Total | $5,650 | $5,649 | [Note 15. Income Taxes](index=15&type=section&id=Note%2015.%20Income%20Taxes) Due to cumulative net losses since inception, Biofrontera Inc. has recorded no federal income tax provision. The company maintains a full valuation allowance and has no unrecognized tax benefits or accrued interest related to uncertain tax positions - **No federal income tax provision** has been recorded due to net losses incurred since inception[55](index=55&type=chunk) - The company maintains a full valuation allowance due to its cumulative loss position[56](index=56&type=chunk) - Income tax expense for the periods ended June 30, 2022 and 2021, relates solely to state income taxes[55](index=55&type=chunk) [Note 16. Related Party Transactions](index=16&type=section&id=Note%2016.%20Related%20Party%20Transactions) Related party transactions include an exclusive license and supply agreement for Ameluz® with Biofrontera Pharma GmbH, service agreements with Biofrontera AG for IT and other support, and a clinical lamp lease agreement with Biofrontera Bioscience GmbH. The company also has a $5.6 million receivable from Biofrontera AG for a legal settlement - Purchases of licensed products (Ameluz and RhodoLED lamps) from Biofrontera Pharma GmbH were **$11.5 million** for the six months ended June 30, 2022, up from $3.9 million in the prior year[59](index=59&type=chunk) - Expenses for services from Biofrontera AG (IT, regulatory, medical affairs, pharmacovigilance, investor relations) were **$0.4 million** for the six months ended June 30, 2022[60](index=60&type=chunk) - The company recognized **$0.1 million in interest income** for the six months ended June 30, 2022, related to the $5.6 million receivable from Biofrontera AG for a legal settlement[66](index=66&type=chunk) [Note 17. Restructuring costs](index=17&type=section&id=Note%2017.%20Restructuring%20costs) No restructuring costs were incurred for the three and six months ended June 30, 2022. In contrast, $0.5 million in restructuring costs were incurred for the six months ended June 30, 2021, primarily related to winding down Cutanea's operations, which were subsequently reimbursed by Maruho - **No restructuring costs** were incurred for the three and six months ended June 30, 2022[67](index=67&type=chunk) - Restructuring costs of **$0.5 million** were incurred for the six months ended June 30, 2021, related to winding down Cutanea's operations and were reimbursed by Maruho[67](index=67&type=chunk) [Note 18. Stockholders' Equity](index=17&type=section&id=Note%2018.%20Stockholders'%20Equity) The company is authorized to issue 300 million common shares and 20 million preferred shares. In May 2022, a private placement generated $9.4 million gross proceeds from the issuance of 1,850,000 common shares and associated warrants. Common stockholders are not entitled to dividends and have no preemptive or conversion rights - The company is authorized to issue **300,000,000 shares of common stock** and **20,000,000 shares of preferred stock**[68](index=68&type=chunk) - In May 2022, a private placement generated **$9.4 million gross cash receipts** from the issuance of **1,850,000 common shares and warrants**[70](index=70&type=chunk) - Common stockholders are entitled to one vote per share, not entitled to dividends, and have no preemptive or conversion rights[69](index=69&type=chunk) [Note 19. Equity Incentive Plans and Share-Based Payments](index=17&type=section&id=Note%2019.%20Equity%20Incentive%20Plans%20and%20Share-Based%20Payments) The 2021 Omnibus Incentive Plan authorizes 2,750,000 shares for awards. During H1 2022, the company granted 1,081,812 non-qualified stock options and 343,512 Restricted Stock Units (RSUs), resulting in $1.1 million in share-based compensation expense for the six months ended June 30, 2022. Unrecognized compensation cost for options and RSUs totals $3.5 million - The 2021 Omnibus Incentive Plan authorizes **2,750,000 shares for awards**, with **2,693,311 shares** remaining eligible as of June 30, 2022[71](index=71&type=chunk) - During H1 2022, **1,081,812 non-qualified stock options** were granted with a weighted average exercise price of **$2.62**[79](index=79&type=chunk) - **343,512 Restricted Stock Units (RSUs)** were awarded in Q2 2022 with a grant-date fair value of **$0.9 million**[77](index=77&type=chunk)[81](index=81&type=chunk) - Share-based compensation expense for the six months ended June 30, 2022, was **$1.1 million** ($0.3 million for options, $0.8 million for RSUs)[75](index=75&type=chunk)[78](index=78&type=chunk) [Note 20. Interest Expense, net](index=20&type=section&id=Note%2020.%20Interest%20Expense%2C%20net) Net interest expense for the six months ended June 30, 2022, was $(71,000), a decrease from $(169,000) in the prior year. This includes contract asset interest expense related to the Cutanea acquisition and interest income from a related party receivable Interest Expense, Net Data | (in thousands) | For three months ended June 30, 2022 | For three months ended June 30, 2021 | For six months ended June 30, 2022 | For six months ended June 30, 2021 | | :------------------------------------ | :----------------------------------- | :----------------------------------- | :--------------------------------- | :--------------------------------- | | Interest expense | $(3) | $ - | $(7) | $ - | | Contract asset interest expense | $(89) | $(89) | $(179) | $(179) | | Interest income – related party | 53 | - | 110 | - | | Interest income – other | 1 | 4 | 5 | 10 | | Interest expense, net | $(38) | $(85) | $(71) | $(169) | - Contract asset interest expense of **$179,000** for the six months ended June 30, 2022, relates to the **$1.7 million contract asset** from Maruho's start-up cost financing[82](index=82&type=chunk) - Interest income from a related party was **$110,000** for the six months ended June 30, 2022[82](index=82&type=chunk) [Note 21. Other Income, net](index=20&type=section&id=Note%2021.%20Other%20Income%2C%20net) Other income, net, for the six months ended June 30, 2022, was $52,000, a decrease from $234,000 in the prior year. This change is primarily due to no reimbursed Share Purchase Agreement (SPA) costs in 2022, compared to $284,000 in 2021 Other Income, Net Data | (in thousands) | For three months ended June 30, 2022 | For three months ended June 30, 2021 | For six months ended June 30, 2022 | For six months ended June 30, 2021 | | :------------------------------------ | :----------------------------------- | :----------------------------------- | :--------------------------------- | :--------------------------------- | | Reimbursed SPA costs | $ - | $185 | $ - | $284 | | Other, net | 29 | (30) | 52 | (50) | | Other income, net | $29 | $155 | $52 | $234 | - Other, net, primarily includes gain (loss) on foreign currency transactions and gain on termination of operating leases[83](index=83&type=chunk) [Note 22. Net Earnings per Share](index=20&type=section&id=Note%2022.%20Net%20Earnings%20per%20Share) Basic and diluted net earnings per share for the six months ended June 30, 2022, were $0.26, a significant improvement from a loss of $(0.90) in the prior year. This was based on weighted-average common shares outstanding of 17,968,870 (basic) and 18,044,174 (diluted) Net Earnings Per Share Data | (in thousands, except share and per share data) | Three Months June 30, 2022 | Three Months June 30, 2021 | Six Months June 30, 2022 | Six Months June 30, 2021 | | :---------------------------------------------- | :------------------------- | :------------------------- | :----------------------- | :----------------------- | | Net income (loss) | $(850) | $(3,661) | $4,711 | $(7,195) | | Basic weighted average common shares outstanding | 18,823,497 | 8,000,000 | 17,968,870 | 8,000,000 | | Diluted weighted average common shares outstanding | 18,823,497 | 8,000,000 | 18,044,174 | 8,000,000 | | Basic EPS | $(0.05) | $(0.46) | $0.26 | $(0.90) | | Diluted EPS | $(0.05) | $(0.46) | $0.26 | $(0.90) | - Common stock warrants (**7,768,537**) and common stock options (**848,550**) were anti-dilutive for the six months ended June 30, 2022, and thus excluded from diluted EPS calculation[87](index=87&type=chunk) [Note 23. Commitments and Contingencies](index=22&type=section&id=Note%2023.%20Commitments%20and%20Contingencies) The company has lease commitments totaling $1.849 million through 2025 for its corporate headquarters and field sales force autos. It is obligated to repay $7.3 million in start-up cost financing to Maruho by December 31, 2023, and share product profits until 2030. Potential milestone payments to Ferrer for Xepi® could reach $6 million. A legal settlement liability of $11.3 million remains, with $5.6 million due from Biofrontera AG Future Lease Commitments | (in thousands) | Future lease commitments | | :------------------------------------ | :----------------------- | | Remainder of 2022 | $414 | | 2023 | 609 | | 2024 | 474 | | 2025 | 352 | | Total | $1,849 | - The company is obligated to repay Maruho **$3.6 million by December 31, 2022**, and **$3.7 million by December 31, 2023**, for start-up cost financing[91](index=91&type=chunk) - Potential milestone payments to Ferrer for Xepi® could total **$6 million** if annual net sales exceed $25 million and $50 million, respectively[93](index=93&type=chunk) - A legal settlement liability of **$11.3 million** remains, with **$5.6 million** reflected as a receivable from Biofrontera AG, though both parties are jointly and severally liable[96](index=96&type=chunk) [Note 24. Retirement Plan](index=23&type=section&id=Note%2024.%20Retirement%20Plan) The company offers a 401(k) Plan with a 50% matching contribution up to 6% of employees' salary. Matching contribution costs for the six months ended June 30, 2022, were $0.1 million - The company's 401(k) Plan includes a **50% matching contribution** on employee contributions, up to a maximum of **6% of salary**[97](index=97&type=chunk) - Matching contribution costs for the six months ended June 30, 2022, were **$0.1 million**[98](index=98&type=chunk) [Note 25. Subsequent Events](index=23&type=section&id=Note%2025.%20Subsequent%20Events) Subsequent to June 30, 2022, the company received $1,569 from the exercise of 2022 Pre-funded warrants on July 14, 2022. On July 26, 2022, an investor exercised 2021 Purchase Warrants for approximately $4.3 million net proceeds, in exchange for a reduced exercise price and the issuance of new Inducement Warrants to purchase up to 4,285,715 shares - On July 14, 2022, 2022 Pre-funded warrants were exercised, generating **$1,569 in net proceeds**[99](index=99&type=chunk) - On July 26, 2022, an investor exercised 2021 Purchase Warrants for approximately **$4.3 million net proceeds**, after the exercise price was lowered from $5.25 to $1.62 per share[100](index=100&type=chunk) - In connection with the warrant exercise, the company issued new Inducement Warrants to purchase up to **4,285,715 shares of common stock**, exercisable from January 27, 2023, at **$1.66 per share**[100](index=100&type=chunk)[101](index=101&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Biofrontera Inc.'s financial condition and results of operations, including forward-looking statements, business overview, key performance factors, detailed analysis of revenue and expenses, reconciliation to Adjusted EBITDA, and discussion of liquidity and capital resources [Forward-Looking Statements](index=24&type=section&id=Forward-Looking%20Statements) This section highlights statements about future expectations and events, along with factors that could cause actual results to differ materially - The report contains forward-looking statements regarding expenses, future revenue, capital requirements, financing needs, product efficacy, market timelines, and regulatory approvals[102](index=102&type=chunk) - Factors that may cause actual results to differ include reliance on licensed product sales, competitor success, supply chain issues, COVID-19 impact, insurance coverage, regulatory changes, competition, profitability, and ability to obtain additional financing[103](index=103&type=chunk) [Overview](index=26&type=section&id=Overview) This section provides a general description of Biofrontera Inc.'s business, its strategic objectives, and key performance measures - Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing dermatological products, primarily **Ameluz® for actinic keratoses** and **Xepi® for impetigo**[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) - Strategic objectives include expanding sales of Ameluz and Xepi in the U.S., leveraging future approvals, and pursuing strategic investments or acquisitions to grow the product and business portfolio[110](index=110&type=chunk)[112](index=112&type=chunk) - Key performance measures include product revenue, operating income (loss), and adjusted EBITDA, with long-term objectives of consistent revenue growth and expanding operating margins[114](index=114&type=chunk) [Key factors affecting our performance](index=27&type=section&id=Key%20factors%20affecting%20our%20performance) This section discusses significant internal and external factors influencing the company's financial results, including seasonality, market conditions, and supply chain issues - Revenue is subject to seasonality, historically higher in the first and fourth quarters due to traditional photodynamic therapy treatments being more frequent in winter[115](index=115&type=chunk) - The COVID-19 pandemic caused a significant decline in demand for licensed products, though sales showed a recovery in Q4 2021 and Q1 2022[116](index=116&type=chunk) - Supply chain issues, particularly manufacturing delays for Xepi® due to a supplier's bankruptcy, are expected to delay Xepi shipments for **18 months**, though the impact on total revenues is not expected to be significant as Ameluz sales are the majority[117](index=117&type=chunk) [Components of Our Results of Operations](index=28&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section describes the primary categories of revenue and expenses that constitute the company's financial performance - Product revenue, net, is generated from third-party sales of **Ameluz, RhodoLED lamps, and Xepi**, recorded net of discounts, rebates, and other incentives[118](index=118&type=chunk) - Cost of revenues, related party, includes purchase costs of Ameluz and RhodoLED lamps from Biofrontera Pharma GmbH[121](index=121&type=chunk) - Selling, general and administrative expenses include sales force costs, commercial support, marketing, professional fees, and amortization of intangible assets[122](index=122&type=chunk) - Changes in fair value of contingent consideration (related to Cutanea acquisition) and warrant liabilities (from private placements) are non-cash items presented in the statements of operations[125](index=125&type=chunk)[126](index=126&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance for the reported periods, detailing changes in revenues, expenses, and net income or loss [Comparison of the Three Months ended June 30, 2022 and 2021](index=30&type=section&id=Comparison%20of%20the%20Three%20Months%20ended%20June%2030%2C%202022%20and%202021) This section compares the company's financial performance for the three-month periods ended June 30, 2022, and 2021, highlighting key changes in revenue and expenses Three Months Ended June 30 Comparative Data | (in thousands) | 2022 | 2021 | Change | | :--------------------------------------- | :--- | :--- | :----- | | Product revenues, net | $4,441 | $5,840 | $(1,399) | | Revenues, net | $4,457 | $5,855 | $(1,398) | | Total operating expenses | 10,699 | 9,542 | 1,127 | | Loss from operations | $(6,212) | $(3,687) | $(2,525) | | Change in fair value of warrant liabilities | 5,371 | - | 5,371 | | Net loss | $(850) | $(3,661) | $2,811 | - Net product revenue **decreased by $1.4 million (23.9%)** due to lower Ameluz orders, partially offset by a price increase[132](index=132&type=chunk) - Selling, general and administrative expenses **increased by $4.1 million (74.2%)** due to higher legal expenses, private placement issuance costs, business insurance, headcount costs, stock compensation, consulting, and travel[134](index=134&type=chunk)[135](index=135&type=chunk) - A **$5.4 million decrease in the fair value of warrant liabilities** contributed to a reduced net loss compared to the prior year[138](index=138&type=chunk) [Comparison of the Six Months ended June 30, 2022 and 2021](index=31&type=section&id=Comparison%20of%20the%20Six%20Months%20ended%20June%2030%2C%202022%20and%202021) This section compares the company's financial performance for the six-month periods ended June 30, 2022, and 2021, detailing significant shifts in revenue and profitability Six Months Ended June 30 Comparative Data | (in thousands) | 2022 | 2021 | Change | | :--------------------------------------- | :--- | :--- | :----- | | Product revenues, net | $14,177 | $10,571 | $3,606 | | Revenues, net | $14,208 | $10,599 | $3,609 | | Total operating expenses | 23,530 | 17,814 | 5,716 | | Loss from operations | $(9,322) | $(7,215) | $(2,107) | | Change in fair value of warrant liabilities | 14,082 | - | 14,082 | | Net loss | $4,711 | $(7,195) | $11,906 | - Net product revenue **increased by $3.6 million (34.1%)** due to higher Ameluz order volume and a price increase[139](index=139&type=chunk) - Selling, general and administrative expenses **increased by $7.0 million (67.7%)** driven by legal expenses, business insurance, headcount costs, stock compensation, private placement issuance costs, consulting, and travel[143](index=143&type=chunk)[144](index=144&type=chunk) - A **$14.1 million decrease in the fair value of warrant liabilities** resulted in a net income of **$4.711 million** for H1 2022, compared to a net loss of $7.195 million in H1 2021[148](index=148&type=chunk) [Net Income (Loss) to Adjusted EBITDA Reconciliation](index=34&type=section&id=Net%20Income%20(Loss)%20to%20Adjusted%20EBITDA%20Reconciliation) This section reconciles net income or loss to Adjusted EBITDA, a non-GAAP measure, providing insights into operational performance excluding certain non-cash and non-recurring items - Adjusted EBITDA is a non-GAAP measure used to assess performance, excluding interest, taxes, depreciation, amortization, and non-operating items like changes in fair value of contingent consideration and warrant liabilities[150](index=150&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk)[154](index=154&type=chunk) Adjusted EBITDA Reconciliation | (in thousands) | Three Months June 30, 2022 | Three Months June 30, 2021 | Six Months June 30, 2022 | Six Months June 30, 2021 | | :--------------------------------------- | :------------------------- | :------------------------- | :----------------------- | :----------------------- | | Net income (loss) | $(850) | $(3,661) | $4,711 | $(7,195) | | EBITDA | $(680) | $(3,394) | $5,075 | $(6,706) | | Change in fair value of contingent consideration | $(1,900) | 500 | $(1,900) | 998 | | Change in fair value of warrant liabilities | $(5,371) | - | $(14,082) | - | | Adjusted EBITDA | $(7,951) | $(2,894) | $(11,257) | $(5,708) | | Adjusted EBITDA margin | -178.4% | -49.4% | -78.6% | -53.9% | - Adjusted EBITDA **decreased significantly** for both the three and six months ended June 30, 2022, primarily due to the negative impact of changes in fair value of contingent consideration and warrant liabilities[156](index=156&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its short-term and long-term financial obligations, including sources and uses of cash - Primary liquidity sources are existing cash balances and equity financing, with cash and cash equivalents at **$31.9 million** at June 30, 2022, up from $24.5 million at December 31, 2021[157](index=157&type=chunk) - The company has generated significant losses since 2015, with an accumulated deficit of **$74.2 million** as of June 30, 2022[158](index=158&type=chunk) - Current cash and proceeds from a July 2022 warrant exercise (**$4.6 million gross**) are expected to fund operations for at least the next twelve months[161](index=161&type=chunk) - Future cash requirements include working capital, contractual commitments (auto leases, **Maruho start-up payments of $7.3 million**, **legal settlement expenses of $5.6 million**), and potential milestone payments to Ferrer[159](index=159&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) This section analyzes the company's cash inflows and outflows from operating, investing, and financing activities for the reported periods Cash Flows Summary | (In Thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(1,987) | $(4,508) | | Net cash used in investing activities | $(36) | $(3) | | Net cash provided by (used) in financing activities | $9,391 | $(517) | | Net increase (decrease) in cash and restricted cash | $7,368 | $(5,028) | - Operating activities **used $2.0 million of cash in H1 2022**, a decrease from $4.5 million used in H1 2021[166](index=166&type=chunk)[167](index=167&type=chunk) - Financing activities **provided $9.4 million in cash** during H1 2022, primarily from the sale of common stock and warrants in a private placement[168](index=168&type=chunk) [Accounting Policies and Significant Judgments and Estimates](index=37&type=section&id=Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section outlines the critical accounting policies and significant management judgments and estimates used in preparing the financial statements - Financial statements are prepared in accordance with **U.S. GAAP**, requiring management to use estimates and assumptions for assets, liabilities, revenues, and expenses[172](index=172&type=chunk) - Critical accounting estimates include fair value measurements of contingent consideration, warrant liabilities, and stock compensation[172](index=172&type=chunk) - No material changes to critical accounting estimates were made for the six months ended June 30, 2022[174](index=174&type=chunk) [Off-balance Sheet Arrangements](index=38&type=section&id=Off-balance%20Sheet%20Arrangements) This section discloses any material off-balance sheet arrangements that could impact the company's financial condition or results of operations - The company did not have any off-balance sheet arrangements during the periods presented[176](index=176&type=chunk) [Emerging Growth Company Status](index=38&type=section&id=Emerging%20Growth%20Company%20Status) This section explains the company's status as an emerging growth company and its implications for regulatory compliance and accounting standards - As an 'emerging growth company,' Biofrontera Inc. has elected to use the extended transition period for complying with new or revised accounting standards[177](index=177&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Biofrontera Inc. is not required to provide quantitative and qualitative disclosures about market risk in this Form 10-Q - The company is not required to provide disclosures about market risk as it is a 'smaller reporting company'[178](index=178&type=chunk) [ITEM 4. Controls and Procedures](index=38&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of June 30, 2022, due to an un-remediated material weakness in internal control over financial reporting. This weakness pertains to insufficient management review over work performed by third-party service providers, specifically regarding valuation errors for an intangible asset - Disclosure controls and procedures were deemed **not effective** at the reasonable assurance level as of June 30, 2022[178](index=178&type=chunk) - A **material weakness in internal control over financial reporting** was identified, related to insufficient management review control over information produced by third-party service providers, specifically computational and information errors in the valuation of the Xepi intangible asset[180](index=180&type=chunk) - Remediation efforts, including formalized reviews and additional steps for engaging specialists, are in process but the material weakness was not fully remediated as of June 30, 2022[181](index=181&type=chunk)[182](index=182&type=chunk)[184](index=184&type=chunk) PART II. OTHER INFORMATION This part includes disclosures on legal proceedings, risk factors, equity sales, and other miscellaneous information not covered in the financial statements [ITEM 1. Legal Proceedings](index=39&type=section&id=ITEM%201.%20Legal%20Proceedings) Information regarding legal proceedings is incorporated by reference from Note 23, 'Commitments and Contingencies,' in the Notes to Financial Statements - Information on legal proceedings is detailed in **Note 23 - Commitments and Contingencies**[186](index=186&type=chunk) [ITEM 1A. Risk Factors](index=39&type=section&id=ITEM%201A.%20Risk%20Factors) As a smaller reporting company, Biofrontera Inc. is not required to provide risk factor disclosures in this Form 10-Q, but directs readers to the 'Risk Factors' section in its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 - As a smaller reporting company, the registrant is not required to provide risk factor disclosure in this Form 10-Q[187](index=187&type=chunk) - Readers are advised to refer to the 'Risk Factors' in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[187](index=187&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Proceeds from the company's Initial Public Offering (IPO) on October 28, 2021, were used for working capital and general corporate purposes, with no material change in the planned use of proceeds - Proceeds from the IPO on October 28, 2021, were used for working capital and general corporate purposes[188](index=188&type=chunk) - There has been no material change in the planned use of IPO proceeds[188](index=188&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=39&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There are no defaults upon senior securities[188](index=188&type=chunk) [ITEM 4. Mine Safety Disclosures](index=39&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Biofrontera Inc - Mine Safety Disclosures are not applicable to the registrant[189](index=189&type=chunk) [ITEM 5. Other Information](index=39&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information for this period - No other information is reported[189](index=189&type=chunk) [ITEM 6. Exhibits](index=39&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including various warrant forms, an employment agreement amendment, a securities purchase agreement, a registration rights agreement, and certifications - The exhibits include forms of Common Stock Purchase Warrant and Pre-Funded Common Stock Purchase Warrant issued in connection with the May 2022 PIPE[190](index=190&type=chunk) - An Amendment to Employment Agreement for Erica Monaco, a Form of Securities Purchase Agreement, and a Form of Registration Rights Agreement for May 2022 PIPE are also filed[190](index=190&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are included[190](index=190&type=chunk) SIGNATURES This section contains the official signatures certifying the accuracy and completeness of the quarterly report [Signature of Authorized Officer](index=41&type=section&id=Signature%20of%20Authorized%20Officer) The report is duly signed on August 12, 2022, by Erica Monaco, Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) of Biofrontera Inc - The report was signed on **August 12, 2022**[193](index=193&type=chunk) - Erica Monaco, Chief Executive Officer (Principal Executive Officer and Principal Financial Officer), signed on behalf of Biofrontera Inc[193](index=193&type=chunk)
Biofrontera(BFRI) - 2022 Q1 - Earnings Call Transcript
2022-05-13 16:53
Biofrontera, Inc. (NASDAQ:BFRI) Q1 2022 Results Conference Call May 13, 2022 11:00 AM ET Company Participants Tirth Patel - LHA IR Hermann Lubbert - Executive Chairman Erica Monaco - CEO Operator Good morning and welcome to the Biofrontera Inc’s First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Tirth Patel with LHA Investor Relations. ...
Biofrontera(BFRI) - 2022 Q1 - Quarterly Report
2022-05-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-40943 Biofrontera Inc. (Exact name of registrant as specified in its charter) Delaware 47-3765675 (State or other jurisdiction o ...
Biofrontera(BFRI) - 2021 Q4 - Annual Report
2022-04-10 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | |-------------------------------------------------------------------------------------------| | | | FOR THE TRANSITION PERIOD FROM _________TO__________ | | COMMISSION FILE NUMBER 001-40 ...
Biofrontera(BFRI) - 2021 Q4 - Earnings Call Transcript
2022-04-08 18:35
Biofrontera Inc. (NASDAQ:BFRI) Q4 2021 Earnings Conference Call April 8, 2022 11:00 AM ET Company Participants Tirth Patel - LHA IR Hermann Lubbert - Executive Chairman Erica Monaco - CEO Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Bruce Jackson - The Benchmark Company Operator Welcome to the Biofrontera Inc. Fourth Quarter and Full Year 2021 Financial Results Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference ...
Biofrontera(BFRI) - 2021 Q3 - Earnings Call Transcript
2021-12-01 01:35
Biofrontera Inc. (NASDAQ:BFRI) Q3 2021 Earnings Conference Call November 30, 2021 4:30 PM ET Company Participants Pamela Keck – Head-Investor Relations Hermann Lübbert – Executive Chairman and Chief Executive Officer-Biofrontera AG Erica Monaco – Chief Executive Officer Conference Call Participants Bruce Jackson – The Benchmark Company Jonathan Aschoff – ROTH Capital Partners Thomas Flaten – Lake Street Capital Markets Operator Welcome to the Biofrontera Inc. Third Quarter Earnings Conference Call. [Operato ...
Biofrontera(BFRI) - 2021 Q3 - Quarterly Report
2021-11-29 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, par value $0.001 per share BFRI The Nasdaq Stock Market LLC Warrants, each warrant exercisable for one share of common stock, each at an exercise price of $5.00 per share BFRIW The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended ...