Biofrontera Inc. Reports First Quarter 2025 Financial Results and Provides a Business Update
- Revenue growth of 9% year-over-year to $8.6 million
- Net loss improved significantly from $10.4M to $4.2M
- Operating expenses reduced from $13.4M to $13.1M
- Patent protection for Ameluz® extended through 2043
- Cost of revenues decreased by 22.1% due to reduced cost structure
- Cash position declined significantly from $5.9M to $1.8M
- Still operating at a loss with negative EBITDA of $4.4M
- Legal expenses increased by $1.2M due to patent claims
- R&D expenses increased by $1.2M
Insights
Biofrontera reports 9% revenue growth but concerning cash burn with $4.1M quarterly decrease amid promising clinical milestones for Ameluz.
Biofrontera's Q1 2025 results present a mixed financial picture with some positive developments on the clinical front. The company reported
However, the most concerning aspect is the rapid cash burn rate - cash reserves declined from
The company still posted a net loss of
On the clinical development front, Biofrontera achieved several significant milestones including completing enrollment in their Phase 3 trial for treating actinic keratoses on extremities, neck and trunk, finishing the 1-year follow-up for their sBCC treatment study, and completing enrollment in their Phase 2b acne vulgaris trial. These developments could substantially expand Ameluz's market potential.
Particularly notable is the patent approval for a revised Ameluz formulation, extending protection until 2043 - a crucial development that secures the product's market exclusivity for nearly two more decades.
The reduced cost structure from the amended Ameluz license agreement (decreasing Transfer Price from 50% to 25%) helps offset increased R&D expenses from assuming clinical trial activities. However, the severely limited cash position means Biofrontera will likely need to secure additional financing in the very near term to maintain operations and capitalize on their clinical progress.
Conference call begins at 10:00 a.m. Eastern time on Friday, May 16, 2025
WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today reported financial results for the three months ended March 31, 2025 and provided a business update.
Highlights from the first quarter of 2025 and subsequent weeks included the following:
- Total revenues for the first quarter of 2025 were
$8.6 million , a9% increase from the same period of the prior year. - Cash and cash equivalents were
$1.8 million as of March 31, 2025, compared with$5.9 million on December 31, 2024. - Announced the enrollment of the final patient in the Phase 3 clinical trial evaluating Ameluz® (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses on the extremities, neck and trunk.
- Achieved a key milestone in the Phase 3 study of the use of Ameluz® and RhodoLED® photodynamic therapy (“PDT”) in the treatment of sBCC (ALA-BCC-CT013), with the last patient completing the 1-year follow-up visit in December 2024.
- Received patent approval for a revised formulation of Ameluz® which extends protection for the treatment through to December 2043.
- Completed patient enrollment in phase 2b study of Ameluz® Topical Gel,
10% for the treatment of moderate to severe acne vulgaris.
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated, "The beginning of 2025 has been a very encouraging and rewarding period for us, as we have improved our revenues by
"The enrollment of the final patient in the Phase 3 clinical trial evaluating Ameluz® for the treatment of mild to moderate actinic keratoses on the extremities, neck and trunk is something that we are excited about. Additionally, our past investments in PDT allow us to strategically plan and establish partnerships with dermatologists to future expansions of our label to the treatment of a cutaneous malignancy or moderate to severe acne,” concluded Mr. Luebbert.
First Quarter Financial Results
Total revenues for the three months ended March 31, 2025 were
Total operating expenses were
Cost of revenues, related party was
Selling, general and administrative expenses for the three months ended March 31, 2025 decreased by
Research and development (“R&D”) expenses for the three months ended March 31, 2025 increased by
The net loss for the first quarter of 2025 was
Adjusted EBITDA increased from (
Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the first quarters of 2025 and 2024.
Conference Call Details
Conference call: Friday, May 16, 2025 at 10:00 AM ET
Toll Free: 1-877-877-1275 (U.S. toll-free)
International: 1-412-858-5202
Webcast: First Quarter 2025 Financial Results and Business Update Conference Call
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz ® with the RhodoLED® lamp series for PDT of actinic keratoses, pre-cancerous skin lesions which may progress to invasive skin cancers. 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 www.biofrontera-us.com and follow Biofrontera on LinkedIn and X .
Contacts
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com
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, development and expansion of the Company's sales force and commercial infrastructure, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, educational outreach efforts, 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 ability to achieve and sustain profitability; our ability to compete effectively in selling our licensed products; our ability to compete effectively in selling our licensed products; our ability to expand, manage and maintain our direct sales and marketing organizations, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our Licensors; our Licensors’ ability to manufacture our licensed products; our Licensors’ ability to adequately protect their intellectual property and operate their business without infringing upon the intellectual property rights of others; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations in the healthcare industry; the willingness of healthcare providers to purchase our licensed products if coverage, reimbursement and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market, commercialize, achieve market acceptance for and sell our licensed products; any product quality issues, product defects, or product liability claims; our ability to comply with The Nasdaq Stock Market, LLC continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion of research, development and preclinical studies and clinical trials for our licensed products; our Licensors’ ability to obtain and maintain the regulatory approvals necessary for the marketing of our licensed products in the United States; 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 may be required by law.
(Tables follow)
BIOFRONTERA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)
| March 31, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,785 | $ | 5,905 | ||||
| Investment, related party | 7 | 7 | ||||||
| Accounts receivable, net | 4,031 | 5,315 | ||||||
| Inventories, net | 6,527 | 6,646 | ||||||
| Prepaid expenses and other current assets | 682 | 527 | ||||||
| Asset held for sale | 2,300 | 2,300 | ||||||
| Total current assets | 15,332 | 20,700 | ||||||
| Property and equipment, net | 59 | 80 | ||||||
| Operating lease right-of-use assets | 713 | 903 | ||||||
| Intangible assets, net | 31 | 35 | ||||||
| Other assets | 453 | 383 | ||||||
| Total assets | $ | 16,588 | $ | 22,101 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 3,300 | 1,856 | ||||||
| Accounts payable, related parties, net | 2,650 | 5,344 | ||||||
| Operating lease liabilities | 426 | 548 | ||||||
| Accrued expenses and other current liabilities | 4,583 | 4,273 | ||||||
| Total current liabilities | 10,959 | 12,021 | ||||||
| Long-term liabilities: | ||||||||
| Convertible notes payable, net | 4,217 | 4,098 | ||||||
| Warrant liabilities | 702 | 1,250 | ||||||
| Operating lease liabilities, non-current | 220 | 276 | ||||||
| Other liabilities | 21 | 23 | ||||||
| Total liabilities | 16,119 | 17,668 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred Stock, | - | - | ||||||
| Common Stock, | 9 | 9 | ||||||
| Additional paid-in capital | 122,072 | 121,833 | ||||||
| Accumulated deficit | (121,612 | ) | (117,409 | ) | ||||
| Total stockholders’ equity | 469 | 4,433 | ||||||
| Total liabilities and stockholders’ equity | $ | 16,588 | $ | 22,101 | ||||
BIOFRONTERA INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts and number of shares)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Product revenues, net | $ | 8,588 | $ | 7,901 | ||||
| Revenues, related party | - | 11 | ||||||
| Total revenues, net | 8,588 | 7,912 | ||||||
| Operating expenses | ||||||||
| Cost of revenues, related party | 3,075 | 3,946 | ||||||
| Cost of revenues, other | 193 | 170 | ||||||
| Selling, general and administrative | 8,653 | 9,250 | ||||||
| Selling, general and administrative, related party | 7 | (4 | ) | |||||
| Research and development | 1,207 | 17 | ||||||
| Total operating expenses | 13,135 | 13,379 | ||||||
| Loss from operations | (4,547 | ) | (5,467 | ) | ||||
| Other income (expense) | ||||||||
| Change in fair value of warrant liabilities | 548 | (3,429 | ) | |||||
| Change in fair value of investment, related party | - | 3 | ||||||
| Loss on debt extinguishment | - | (316 | ) | |||||
| Interest expense, net | (106 | ) | (1,407 | ) | ||||
| Other income (expense), net | (99 | ) | 180 | |||||
| Total other income (expense) | 343 | (4,969 | ) | |||||
| Loss before income taxes | (4,204 | ) | (10,436 | ) | ||||
| Income tax expense | (1 | ) | 1 | |||||
| Net loss | $ | (4,203 | ) | $ | (10,437 | ) | ||
| Loss per common share: | ||||||||
| Basic and diluted | $ | (0.47 | ) | $ | (2.88 | ) | ||
| Weighted-average common shares outstanding: | ||||||||
| Basic and diluted | 8,873,932 | 3,623,593 | ||||||
BIOFRONTERA INC.
GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIAITION
(In thousands, except per share amounts and number of shares)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net loss | $ | (4,203 | ) | $ | (10,437 | ) | ||
| Interest expense, net | 106 | 1,407 | ||||||
| Income tax expenses | (1 | ) | 1 | |||||
| Depreciation and amortization | 29 | 128 | ||||||
| EBITDA | (4,069 | ) | (8,901 | ) | ||||
| Loss on debt extinguishment | - | 316 | ||||||
| Change in fair value of warrant liabilities | (548 | ) | 3,429 | |||||
| Change in fair value of investment, related party | - | (3 | ) | |||||
| Stock based compensation | 239 | 228 | ||||||
| Expensed issuance costs | - | 354 | ||||||
| Adjusted EBITDA | $ | (4,378 | ) | $ | (4,577 | ) | ||
| Adjusted EBITDA margin | -51.0 | % | -57.9 | % | ||||
FAQ
What was Biofrontera's (BFRI) revenue growth in Q1 2025?
How much cash does Biofrontera (BFRI) have as of Q1 2025?
What was BFRI's net loss per share in Q1 2025?
What clinical trial developments did Biofrontera (BFRI) report in Q1 2025?
How did Biofrontera's (BFRI) operating expenses change in Q1 2025?
