As filed with the Securities and Exchange Commission on May 2, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) 120 Presidential Way, Suite 330 Woburn, MA 01801 Telephone: 781-245-1325 Washington, D.C. ...

As filed with the Securities and Exchange Commission on March 19, 2024. Registration No. 333-277811 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-3765675 (I.R.S. Employer Identification No.) 12 ...

Financial Data and Key Metrics Changes - Total revenues for 2023 were $34.4 million, a growth of approximately 19% compared to $28.7 million for 2022, primarily driven by higher Ameluz sales volume and a restructured discount program [53][45] - Adjusted EBITDA for the fourth quarter of 2023 was negative $3.2 million, an improvement from negative $4.4 million for the fourth quarter of 2022, reflecting higher revenues partially offset by increased SG&A costs [35] - Net income for the fourth quarter of 2023 was $3.5 million or $1.65 per share, compared to a net loss of $2.8 million or a loss of $2.16 per share for the prior-year quarter [52] Business Line Data and Key Metrics Changes - The company placed 123 BF-RhodoLED lamps at physician offices during 2023, an increase of 86% from 66 in 2022, indicating strong adoption of Ameluz PDT [45] - Cost of revenues increased to $17.4 million for 2023 from $15.2 million in 2022, primarily driven by increased Ameluz volume [36] Market Data and Key Metrics Changes - The company expects to achieve two-digit growth in revenue compared to 2023 and anticipates being cash flow positive within approximately 12 to 18 months [62] - The company has secured financing of $8 million and expects another tranche of $8 million in Q2 2024 to support ongoing commercial activities and clinical development [28] Company Strategy and Development Direction - The company is optimizing its customer-facing teams and shifting resources from a sales force-focused organization to invest in marketing and support functions [46] - The company plans to launch the larger RhodoLED XL lamp in Q2 2024, which will allow treatment of larger skin areas, crucial for future growth [30] Management Comments on Operating Environment and Future Outlook - Management highlighted transformational changes in 2023 that have improved the company's status and future outlook compared to the previous year [76] - The company expects to maintain a growth trajectory similar to the past couple of years, with a compound annual growth rate (CAGR) of 22% since 2020 [73] Other Important Information - The company settled arbitration regarding the acquisition of the Xepi asset, removing significant liabilities from its balance sheet [29] - The U.S. Patent and Trademark Office granted a new patent related to a less painful PDT protocol, extending product protection until 2040 [47] Q&A Session Summary Question: What is the enrollment status for the acne trial? - Approximately 50% to 60% of patients are currently enrolled, with completion expected by the end of the year and data available in the middle of next year [38] Question: What about the peripheral AK study? - The enrollment is similar, with data expected slightly after the acne trial due to longer patient duration in the trial [64] Question: Any changes to the sales force and turnover? - The sales force has been slightly reduced to focus on growing other service functions, with current turnover being below the industry average [11][19] Question: What are the expectations for sales growth this year? - A reasonable target for sales growth is around 19%, consistent with the growth seen over the past couple of years [73]

Our principal licensed product is Ameluz, which is a prescription drug approved for use in combination with the RhodoLEDlamp series, for PDT (when used together, "Ameluz PDT"). In the United States, the PDT treatment is used for the lesion-directed and fielddirected treatment of actinic keratoses ("AK") of mild-to-moderate severity on the face and scalp. AKs are premalignant lesions of the skin that can potentially develop into skin cancer (squamous cell carcinoma) if left untreated.International treatment ...

As filed with the Securities and Exchange Commission on March 8, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 120 Presidential Way, Suite ...

As filed with the Securities and Exchange Commission on January 29, 2024. Registration No. 333-276535 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-3765675 (I.R.S. Employer Identification No.) ...

As filed with the Securities and Exchange Commission on January 16, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 120 Presidential Way, Sui ...

Biofrontera Inc. (NASDAQ:BFRI) Q3 2023 Earnings Conference Call November 10, 2023 10:00 AM ET Company Participants Tirth Patel - IR Hermann Luebbert - Chairman, CEO and Founder Fred Leffler - CFO Conference Call Participants Jonathan Aschoff - ROTH Bruce Jackson - The Benchmark Company Operator Good day, and welcome to the Biofrontera Inc. Third Quarter 2023 Financial Results and Business Update Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the c ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended September 30, 2023, show a significant decrease in total assets from $50.9 million at the end of 2022 to $34.1 million, with total liabilities increasing and stockholders' equity substantially reducing, alongside a net loss of $23.7 million and a going concern warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, the company's total assets decreased to $34.1 million from $50.9 million, while total liabilities increased to $33.1 million from $27.0 million, resulting in a sharp fall in stockholders' equity to $1.0 million from $23.9 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,422 | $17,208 | | Total current assets | $29,611 | $43,140 | | Total assets | $34,104 | $50,884 | | Total current liabilities | $29,124 | $20,894 | | Total liabilities | $33,066 | $27,006 | | Total stockholders' equity | $1,038 | $23,878 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2023, total revenues more than doubled to $8.9 million, but operating expenses led to a higher loss from operations of $4.6 million, with the net loss widening to $6.3 million, and for the nine-month period, the company swung from a net income of $2.1 million to a net loss of $23.7 million Statement of Operations Summary (in thousands) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenues, net | $8,896 | $4,322 | $23,475 | $18,530 | | Loss from operations | $(4,620) | $(3,639) | $(18,812) | $(12,961) | | Net income (loss) | $(6,342) | $(2,566) | $(23,657) | $2,145 | | Basic EPS | $(4.64) | $(2.26) | $(17.57) | $2.19 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities significantly increased to $16.0 million, leading to an overall decrease in cash, cash equivalents, and restricted cash by $13.8 million, ending at $3.6 million Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,029) | $(7,928) | | Net cash provided by (used in) investing activities | $546 | $(3,070) | | Net cash provided by financing activities | $1,697 | $14,021 | | Net increase (decrease) in cash | $(13,786) | $3,023 | | Cash at end of period | $3,622 | $27,765 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on dermatological products like **Ameluz**, a 1-for-20 reverse stock split in July 2023, significant liquidity challenges leading to a **going concern** warning, and specifics on acquisition liabilities, fair value measurements, related-party transactions, and legal settlements - The company is a U.S.-based biopharmaceutical firm focused on commercializing products for dermatological conditions, primarily photodynamic therapy (PDT) with its main product, **Ameluz**[13](index=13&type=chunk)[37](index=37&type=chunk) - A 1-for-20 reverse stock split was **effective** on July 3, 2023, and all share and per-share amounts in the financial statements have been retrospectively adjusted[15](index=15&type=chunk)[38](index=38&type=chunk)[320](index=320&type=chunk) - Management has determined that **substantial doubt** exists about the Company's ability to continue as a **going concern** due to significant losses, negative cash flows, and the need to raise additional capital to fund operations into 2024[17](index=17&type=chunk)[41](index=41&type=chunk)[322](index=322&type=chunk) - The company has an ongoing legal settlement with DUSA Pharmaceuticals Inc., with a remaining liability of **$6.0 million** as of September 30, 2023. Biofrontera AG is responsible for **50%** of the settlement costs[136](index=136&type=chunk)[157](index=157&type=chunk) - Subsequent to the quarter end, on October 30, 2023, the company entered into a securities purchase agreement for a registered public offering, raising gross proceeds of approximately **$4.5 million**[164](index=164&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, highlighting a **107%** increase in product revenue for Q3 2023, but a widened net loss due to increased operating expenses and a **$6.6 million** unrealized loss on investment, with critical liquidity challenges leading to **substantial doubt** about its **going concern** ability, mitigated by a recent **$4.1 million** net capital raise [Results of Operations](index=25&type=section&id=Results%20of%20Operations) For Q3 2023, product revenue surged **107%** to **$8.9 million** year-over-year, primarily from increased **Ameluz** sales volume, though loss from operations grew to **$4.6 million**, and for the nine months, product revenue increased **26.8%** to **$23.4 million**, resulting in a net loss of **$23.7 million** compared to a net income of **$2.1 million** in the prior year Comparison of Three Months Ended September 30 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $8,879 | $4,290 | $4,589 (107.0%) | | Loss from operations | $(4,620) | $(3,639) | $(981) | | Net loss | $(6,342) | $(2,566) | $(3,776) | Comparison of Nine Months Ended September 30 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $23,423 | $18,467 | $4,956 (26.8%) | | Loss from operations | $(18,812) | $(12,961) | $(5,851) | | Net Income (loss) | $(23,657) | $2,145 | $(25,802) | - The increase in SG&A expenses for the nine-month period was primarily driven by **$2.9 million** in personnel-related costs, **$1.2 million** in legal settlement expenses, and **$1.2 million** in other non-recurring legal costs[219](index=219&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity challenges with cash and equivalents at **$3.4 million**, leading management to conclude **substantial doubt** about its **going concern** ability, with primary liquidity sources including product sales and a revolving line of credit, and a recent **$4.1 million** net capital raise aimed at funding operations - The company has generated significant losses since inception, with a loss from operations of **$18.8 million** and **net cash outflows** from operations of **$16.0 million** for the nine months ended September 30, 2023[251](index=251&type=chunk) - Management has determined that **substantial doubt** exists about the company's ability to continue as a **going concern**[233](index=233&type=chunk) - Primary sources of liquidity are existing cash (**$3.4M**), an investment in a related party (**$3.3M**), and a revolving line of credit[271](index=271&type=chunk) - Management believes a recent **net capital raise** of **$4.1 million** and plans to improve working capital will provide the opportunity for the company to continue as a **going concern**, though no assurance can be given[272](index=272&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Biofrontera Inc. is **not required** to provide the information for this item - The company is **not required** to provide information for this item as it qualifies as a "smaller reporting company"[280](index=280&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were **effective** as of September 30, 2023, with **no material changes** in internal control over financial reporting during the quarter - Based on an evaluation as of the end of the period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective**[281](index=281&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[282](index=282&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=31&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in legal proceedings, notably with DUSA Pharmaceuticals, Inc., with a remaining settlement liability of **$6.0 million**, and a new complaint filed in September 2023 alleging breach of contract and unfair trade practices related to **Ameluz** promotion, which the company denies and intends to defend vigorously - On September 13, 2023, DUSA Pharmaceuticals filed a new complaint against Biofrontera, alleging breach of contract and unfair trade practices related to the promotion of its **Ameluz** product[138](index=138&type=chunk) - The company denies the claims and intends to defend the matter vigorously, but cannot currently estimate the possibility or range of a material loss[159](index=159&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=ITEM%201A.%20Risk%20Factors) There have been **no material changes** to the risk factors disclosed in the Annual Report on Form 10-K, except for highlighting specific risks including the uncertainty of research and development efforts and **substantial doubt** about the company's ability to continue as a **going concern** due to its financial condition and need for additional capital - A key risk factor is the **substantial doubt** about the company's ability to continue as a "**going concern**" due to its need to raise additional capital to fund its growth plans and operations[262](index=262&type=chunk)[285](index=285&type=chunk) - The company notes that the results of its research and development efforts are uncertain and may not be technologically successful or achieve market acceptance[261](index=261&type=chunk)[284](index=284&type=chunk)[299](index=299&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) **None** - **None**[264](index=264&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) **None** - **None**[287](index=287&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) **Not Applicable** - **Not Applicable**[265](index=265&type=chunk) [Item 5. Other Information](index=31&type=section&id=ITEM%205.%20Other%20Information) **None** - **None**[266](index=266&type=chunk) [Item 6. Exhibits](index=32&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the report, including various agreements related to a **securities purchase**, **warrant amendments**, and **officer certifications** as required by the Sarbanes-Oxley Act - Exhibits filed include the **Securities Purchase Agreement**, **Placement Agency Agreement**, and amendments to **Common Stock Purchase Warrants**, all dated October 30, 2023[293](index=293&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 as exhibits[268](index=268&type=chunk)[300](index=300&type=chunk)

As filed with the Securities and Exchange Commission on October 26, 2023. Registration No. 333-274871 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 Delaware 2834 47-3765675 (I.R.S. Employer Identification No.) 120 Presidential Way, Suite 330 Woburn, MA 01801 Telephone: 781-245-1325 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Prof. Dr. Hermann Luebbert Chairman and Chief Executive O ...