BFRI 8-K
Biofrontera Inc. (BFRI)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Item 2.02 Results of Operations and Financial Condition.
On August 13, 2025, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results for the three and six months ended June 30, 2025. A copy of the press release is being furnished as Exhibit 99.1 attached hereto to this Current Report on Form 8-K.
The Company’s press release contains non-GAAP financial measures. Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with United States generally accepted accounting principles, or GAAP. Pursuant to the requirements of Regulation G, the Company has provided within the press release quantitative reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures.
The information contained in this Item 2.02 in the Current Report on 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.
Item 9.01 Financial Statements and Exhibits.
| 99.1 | Press Release Dated August 13, 2025 | |
| 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.
| August 13, 2025 | Biofrontera Inc. |
| (Date) | (Registrant) |
| /s/ E. Fred Leffler III | |
| E. Fred Leffler, III | |
| Chief Financial Officer |
Exhibit 99.1
Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update
Woburn, MA, Aug. 13, 2025 (GLOBE NEWSWIRE) — Biofrontera Inc. (NASDAQ:BFRI) (the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy in dermatology, today reported financial results for the three and six months ended June 30, 2025 and provided a business update.
Highlights from the first six months of 2025 included the following:
| ● | Total revenues for the second quarter of 2025 were $9.0 million, a 15% increase from the same period of the prior year | |
| ● | For the first six months of 2025, revenue was $17.7 million, a 12% increase from the comparable period in 2024 | |
| ● | Cash and cash equivalents were $7.2 million as of June 30, 2025, compared with $5.9 million at December 31, 2024 | |
| ● | Agreed to major restructuring of relationship with Biofrontera AG, including acquisition of United States Intellectual Property (IP) and New Drug Applications (NDA) and control of manufacturing, supported by an addition $11 million in funding for the company | |
| ● | US patent on revised formulation of Ameluz® granted, extending patent protection through to December 2043 | |
| ● | Announced last patient completing 1 year follow-up in superficial basal cell carcinoma (sBCC) Phase 3 study | |
| ● | Completed patient enrollment in Phase 3 study with Ameluz® for mild to moderate actinic keratosis (AK) on the entire body and in Phase 2b study for the treatment of moderate to severe acne vulgaris |
Hermann Luebbert, Chief Executive Officer and Chairman of the Company, stated, “We have changed our approach to our business in 2025 by transforming our customer segmentation, focusing our strategy and using extended data analysis to support our sales team effectiveness. This led to two very gratifying quarters for us driven by customer growth and disciplined execution resulting in increased sales volume and higher revenues. In addition to Ameluz® treating pre-cancerous skin lesions on the face and scalp, we are very encouraged about the potential for Ameluz® to be used more broadly to treat AK on the entire body, and the potential label extension to basal cell carcinoma and acne vulgaris.”
“In addition, we recently announced a fundamental change in our agreement with Biofrontera AG which includes acquiring all the rights, approvals and patents to Ameluz® and RhodoLED® in the United States. This has been a long process that began June 1, 2024 when we assumed control of all clinical studies relating to Ameluz® in the United States, a move that has given us direct oversight of trial efficiency and more effective cost management. We are now in the process of transferring the US IP, NDA, and manufacturing capabilities for Ameluz® and the RhodoLED® lamps. We will pay a monthly Ameluz® royalty of 12% in years where Ameluz® revenue in the US is less than $65 million, and 15% in years when revenue exceeds that threshold. The royalty replaces the former transfer pricing model — which required payment of 25% to 35% of the net sales price per tube depending on timing and indication. This will give us further savings on our cost of goods above those already generated by the earlier renegotiation of the transfer pricing model.”
Prof. Luebbert concluded by saying “The $11 million investment we secured, the fundamental restructuring in our agreement with Biofrontera AG and the improvements we have made this year in our promotional strategy and sales effectiveness have led to significant increases in volume and revenue in the first half of 2025 and have positioned us strongly for the rest of the year and beyond”.
Second Quarter Financial Results
Total revenues for the second quarter of 2025 were $9.0 million compared with $7.8 million for the second quarter of 2024. This increase was driven by both a 5% higher unit sales price and a 9.5% increase in sales volume of Ameluz® in the second quarter of 2025. The higher sales volume of Ameluz® was due to improvements in direct sales team effectiveness.
Total operating expenses were $14.1 million for the second quarter of 2025 compared with $12.9 million for the second quarter of 2024. Cost of revenues decreased by $1.7 million, or 41.8% as compared to the three months ended June 30, 2024. This was primarily due to the reduced Ameluz® cost agreed upon with Biofrontera AG in relation to taking over clinical trial costs.
Selling, general and administrative expenses were $10.5 million for the second quarter of 2025 compared with $7.9 million for the second quarter of 2024. The increase was primarily driven by a $3.4 million increase in legal costs, partially offset by $0.5 million in personnel savings within both the direct sales team and general and administrative staff and a $0.3 million decrease in miscellaneous general and administrative expenses.
The net loss for the second quarter of 2025 was $5.3 million, compared with a net loss of $0.3 million for the prior-year quarter. The increase in the net loss is attributed to the $5.4 million non-cash fluctuation in the change in fair value of warrants of in 2024.
Adjusted EBITDA for the second quarter of 2025 was negative $5.1 million compared with negative $4.7 million for the second quarter of 2024, driven by higher legal costs offset by lower cost of goods sold. We look at Adjusted EBITDA, a non-GAAP financial measure, as a better indication of ongoing operations and this measurement is defined as net income or loss excluding interest income and expense, income taxes, depreciation and amortization, and certain other non-recurring or non-cash items.
Please refer to the table below which presents a GAAP to non- GAAP reconciliation of Adjusted EBITDA for the second quarters of 2025 and 2024.
Six Month Financial Results
Total revenues were $17.6 million for the first half of 2025 compared with $15.8 million for the first half of 2024. This 12% increase was driven by a higher unit sales price contributing $0.6 million and increased sales volume of Ameluz® contributing $1.0 million, as well as a $0.3 million increase in sales of the RhodoLED® Lamps. The higher sales volume of Ameluz® was due to improvements in direct sales team effectiveness.
Total operating expenses were $27.2 million for the first half of 2025 compared with $26.3 million for the first half of 2024. Increased legal expense was offset by reduced operational cost. Cost of revenues decreased from the prior year to $5.5 million for the first six months of 2025 compared to $8.0 million for the first half of 2024 due to the reduced transfer price agreed upon with Biofrontera AG in February 2024 in relation to taking over clinical development costs.
Selling, general and administrative expenses increased to $19.2 million compared to $17.2 million in the prior year. The increase was primarily attributable to a $4.4 million increase in legal expenses. The increased legal expenses were partially offset by savings in personnel expenses of $0.9 million due to headcount fluctuations in our direct sales and administrative teams, as well as a decrease of $0.5 million in expenses relating to sales support functions and a decrease of $0.4 million in issuance costs.
Adjusted EBITDA was negative $9.5 million for the first half of 2024 compared with negative $9.3 million for the first half of 2024.
Conference Call Details
Conference call: Thursday, August 14, 2025 at 10:00 AM ET
Toll Free: 1-877-877-1275 (U.S. toll-free) International: 1-412-858-5202
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=eaQgqzXL
About Biofrontera Inc.
Biofrontera Inc. 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.. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.
Contacts Investor Relations
Andrew Barwicki
1-516-662-9461
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. These statements include, but are not limited to, statements relating to the Company’s revenue guidance, business and marketing strategy, revenue growth, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, 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, our reliance on sales of products we currently license from other companies as our sole source of revenue; the success of our competitors in developing generic topical dermatological products that successfully compete with our licensed products; the success of our principal licensed product, Ameluz®; the ability of the Company’s licensors to establish and maintain relationships with contract manufacturers that are able to supply the Company with enough of our products to meet our demand; the ability of our licensors or their manufacturing partners to supply the licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully comply with current good manufacturing practice or other applicable manufacturing regulations; the ability of our licensors to successfully defend or enforce patents related to our licensed products; the availability of insurance coverage and medical expense reimbursement for our licensed products; the impact of legislative and regulatory changes; competition from other pharmaceutical and medical device companies and existing treatments, such as simple curettage and cryotherapy; the Company’s ability to achieve and sustain profitability; the Company’s ability to obtain additional financing as needed to implement its growth strategy; the Company’s ability to retain and hire key personnel; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (“SEC”), which can be obtained on the SEC website at www.sec.gov. 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 undertake 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.
(Tables follow)
BIOFRONTERA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,239 | $ | 5,905 | ||||
| Investment, related party | 9 | 7 | ||||||
| Accounts receivable, net | 3,955 | 5,315 | ||||||
| Inventories, net | 4,028 | 6,646 | ||||||
| Prepaid expenses and other current assets | 331 | 527 | ||||||
| Asset held for sale | 2,300 | 2,300 | ||||||
| Other assets, related party | 953 | - | ||||||
| Total current assets | 18,815 | 20,700 | ||||||
| Property and equipment, net | 37 | 80 | ||||||
| Operating lease right-of-use assets | 729 | 903 | ||||||
| Intangible assets, net | 26 | 35 | ||||||
| Other assets | 535 | 383 | ||||||
| Total assets | $ | 20,142 | $ | 22,101 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 4,268 | 1,856 | ||||||
| Accounts payable, related parties, net | 670 | 5,344 | ||||||
| Operating lease liabilities | 443 | 548 | ||||||
| Advance from Stockholders | 8,500 | - | ||||||
| Accrued expenses and other current liabilities | 5,806 | 4,273 | ||||||
| Total current liabilities | 19,687 | 12,021 | ||||||
| Long-term liabilities: | ||||||||
| Convertible notes payable, net | 4,338 | 4,098 | ||||||
| Warrant liabilities | 548 | 1,250 | ||||||
| Operating lease liabilities, non-current | 223 | 276 | ||||||
| Other liabilities | 14 | 23 | ||||||
| Total liabilities | 24,810 | 17,668 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ (deficit) equity: | ||||||||
| Preferred Stock $0.001 par value; 20,000,000 shares authorized; no Series B-1 issued; 2,641 and 3,366 Series B-2; 6,593 and 6,763 Series B-3 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | - | - | ||||||
| Common Stock $0.001 par value; 70,000,000 shares authorized; 10,138,567 and 8,873,932 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 9 | 9 | ||||||
| Additional paid-in capital | 122,259 | 121,833 | ||||||
| Accumulated deficit | (126,936 | ) | (117,409 | ) | ||||
| Total stockholders’ (deficit) equity | (4,668 | ) | 4,433 | |||||
| Total liabilities and stockholders’ equity | $ | 20,142 | $ | 22,101 | ||||
BIOFRONTERA INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts and number of shares)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product revenues, net | $ | 9,030 | $ | 7,831 | $ | 17,617 | $ | 15,732 | ||||||||
| Revenues, related party | - | 8 | - | 18 | ||||||||||||
| Total revenues, net | 9,030 | 7,839 | 17,617 | 15,750 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues, related party | 2,380 | 4,092 | 5,455 | 8,038 | ||||||||||||
| Cost of revenues, other | 262 | 250 | 455 | 421 | ||||||||||||
| Selling, general and administrative | 10,528 | 7,915 | 19,183 | 17,163 | ||||||||||||
| Selling, general and administrative, related party | 69 | 32 | 76 | 29 | ||||||||||||
| Research and development | 870 | 621 | 2,077 | 637 | ||||||||||||
| Total operating expenses | 14,109 | 12,910 | 27,246 | 26,288 | ||||||||||||
| Loss from operations | (5,079 | ) | (5,071 | ) | (9,629 | ) | (10,538 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of warrants | 153 | 5,438 | 702 | 2,009 | ||||||||||||
| Change in fair value of investment, related party | 2 | (14 | ) | 2 | (11 | ) | ||||||||||
| Loss on debt extinguishment | - | - | - | (316 | ) | |||||||||||
| Interest expense, net | (115 | ) | (596 | ) | (220 | ) | (2,003 | ) | ||||||||
| Other income, net | (264 | ) | 6 | (363 | ) | 186 | ||||||||||
| Total other income (expense) | (224 | ) | 4,834 | 121 | (135 | ) | ||||||||||
| Loss before income taxes | (5,303 | ) | (237 | ) | (9,508 | ) | (10,673 | ) | ||||||||
| Income tax expense | 21 | 20 | 19 | 21 | ||||||||||||
| Net loss | $ | (5,324 | ) | $ | (257 | ) | $ | (9,527 | ) | $ | (10,694 | ) | ||||
| Loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (0.57 | ) | $ | (0.05 | ) | $ | (1.05 | ) | $ | (2.45 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 9,351,557 | 5,091,353 | 9,108,091 | 4,357,474 | ||||||||||||
BIOFRONTERA INC.
GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION
(In thousands, except per share amounts and number of shares)
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss | $ | (5,324 | ) | $ | (257 | ) | $ | (9,527 | ) | $ | (10,694 | ) | ||||
| Interest expense, net | 115 | 596 | 220 | 2,003 | ||||||||||||
| Income tax expenses | 21 | 20 | 19 | 21 | ||||||||||||
| Depreciation and amortization | 22 | 130 | 46 | 258 | ||||||||||||
| EBITDA | (5,166 | ) | 489 | (9,242 | ) | (8,412 | ) | |||||||||
| Loss on debt extinguishment | - | - | - | 316 | ||||||||||||
| Change in fair value of warrant liabilities | (153 | ) | (5,438 | ) | (702 | ) | (2,009 | ) | ||||||||
| Change in fair value of investment, related party | (2 | ) | 14 | (2 | ) | 11 | ||||||||||
| Stock based compensation | 187 | 204 | 426 | 432 | ||||||||||||
| Expensed issuance costs | - | - | - | 354 | ||||||||||||
| Adjusted EBITDA | $ | (5,135 | ) | $ | (4,731 | ) | $ | (9,520 | ) | $ | (9,308 | ) | ||||
| Adjusted EBITDA margin | -56.9 | % | -60.3 | % | -54.0 | % | -59.1 | % | ||||||||