# EDGAR Filing Document

**Accession Number:** 0001858685
**File Stem:** 0001493152-26-001959
**Filing Date:** 2026-1
**Character Count:** 12404
**Document Hash:** c852c6f089045e3ef41a14f71a6a3c64
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-26-001959.hdr.sgml**: 20260113

**ACCESSION NUMBER**: 0001493152-26-001959

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20260113

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260113

**DATE AS OF CHANGE**: 20260113

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Biofrontera Inc.
- **CENTRAL INDEX KEY:** 0001858685
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 473765675
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40943
- **FILM NUMBER:** 26528528

**BUSINESS ADDRESS:**
- **STREET 1:** 120 PRESIDENTIAL WAY,
- **STREET 2:** SUITE 330
- **CITY:** WOBURN
- **STATE:** MA
- **ZIP:** 01801
- **BUSINESS PHONE:** 781-245-1325

**MAIL ADDRESS:**
- **STREET 1:** 120 PRESIDENTIAL WAY,
- **STREET 2:** SUITE 330
- **CITY:** WOBURN
- **STATE:** MA
- **ZIP:** 01801

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**PURSUANT TO SECTION 13 OR 15(D)**

**OF THE SECURITIES EXCHANGE ACT OF 1934**

**Date of Report (Date of earliest event reported): January 13, 2026**

**Biofrontera Inc.**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40943** | **47-3765675** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

---

| | |
|:---|:---|
| **660 Main Street**<br> **Woburn, Massachusetts** | **01801** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

**Registrant's telephone number, including area code: (781) 245-1325**

**Not Applicable**

**(Former name or former address, if changed since last report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

---

| | | |
|:---|:---|:---|
| **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** |
| **Preferred Stock Purchase Rights** | True | **The Nasdaq Stock Market LLC** |
| **Warrants to purchase common stock** | **BFRIW** | **The Nasdaq Stock Market LLC** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (the "Exchange Act") (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 2.02 Results of Operations and Financial Condition.**

On January 13, 2026 Biofrontera Inc. (the "Company") issued a press release announcing its preliminary unaudited revenues for the fourth quarter and full year ended December 31, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K (the "Form 8-K") and is incorporated herein by reference.

The information contained in this Item 2.02 in this Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

The financial information set forth in this Form 8-K reflects the Company's current preliminary revenue estimates, is subject to the completion of its review process, and is subject to change. The Company's fourth quarter results could differ materially from the preliminary estimates provided in this Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this Form 8-K. The Company undertakes no obligation to publicly release the results of any revision or update of the forward-looking statements, except as required by law.

**Item 9.01 Financial Statements and Exhibits.**

99.1 [Press Release dated January 13, 2026](ex99-1.htm) <br> 104 Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | |
|:---|:---|
| **January 13, 2026**<br> (Date) | **Biofrontera Inc.**<br> (Registrant) |
|  | */s/ E. Fred Leffler III* |
|  | E. Fred Leffler III |
|  | *Chief Financial Officer* |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Biofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year Growth**

● **Fourth quarter results represent highest quarterly revenue in Company's history** 

● **Q4 year-over-year growth of 35% to 39% driven by sales execution of Ameluz<sup>®</sup>** 

● **Full year 2025 revenues also expected to show double-digit growth of 11% to 13%** 

**WOBURN, Mass.** (January 13, 2026) – Biofrontera Inc. (Nasdaq: BFRI) ("Biofrontera" or the "Company"), a leader in photodynamic therapy (PDT) development and commercialization, today announced preliminary unaudited revenue results for the fourth quarter ended December 31, 2025. Fourth quarter revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company's history.

For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026.

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, commented "We are very pleased with our fourth quarter performance which was driven by strong execution across the business, continued growth of Ameluz<sup>®</sup> PDT and the pricing adjustment introduced in December. Customer adoption and engagement remained strong throughout the quarter, supporting record quarterly revenue performance, validating our strategic approach and setting us up for even stronger momentum throughout 2026.

Just as exciting, our recent transformational transaction with Biofrontera AG meaningfully improves our gross margin profile and further strengthens our financial foundation. We've never been more energized about the year ahead, and we're confident that our innovative products, operational excellence, and unwavering commitment to customers will drive continued, sustainable growth."

Results for the quarter and year ended December 31, 2025, have not been finalized and are subject to our financial statement closing procedures. As such, the preliminary unaudited figures described in this press release are subject to change, and actual results may differ. Biofrontera expects to report final, complete fourth quarter and full year financial results for 2025 in March 2026. Details concerning that announcement and conference call will be provided in the coming weeks.

Biofrontera management will present at the Lytham Partners Healthcare Investor Summit on January 15, 2026**.** 

**About Biofrontera Inc.**

Biofrontera is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED<sup>®</sup> lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers<sup>1</sup>. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit <u>www.biofrontera-us.com</u> and follow Biofrontera on <u>LinkedIn</u> and <u>X</u>.

1 <u>https://www.skincancer.org/skin-cancer-information/actinic-keratosis/</u>

**Forward-Looking Statements**

Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's preliminary financial results, revenue growth, commercial opportunities and the commercial success of its products, and other statements that are not historical facts. The words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential", "target", "goal", "assume", "would", "could" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz <sup>®</sup> in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's products; whether the market opportunity for Ameluz <sup>®</sup> in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the "SEC"), which can be obtained on the SEC's website at <u>www.sec.gov</u>. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

**Investor Relations**

Lytham Partners

Ben Shamsian

<u>shamsian@lythampartners.com</u>

646-829-9701