Conference call will be held today,
Fourth Quarter Financial Highlights
- Revenues for 4Q25 were a record
$17.1 million , a 36% increase compared to$12.6 million for the same period in 2024. - Gross margins were 82.4%, a roughly 2,400 basis point year over year increase compared to 58.0% in 4Q24, reflecting the transition away from the transfer pricing model under the prior license and supply agreement.
- Operating income was
$4.6 million in 4Q25 compared to a loss of$1.7 million in 4Q24. - Cash balance was
$6.4 million as ofDecember 31, 2025 .
Recent Operational Highlights
- Announced positive results of its Phase 2b clinical trial evaluating Ameluz® topical gel, 10% used in combination with the RhodoLED® red-light lamp series for the treatment of moderate to severe acne vulgaris (AV).
- Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz® Photodynamic Therapy (PDT) for the treatment of superficial basal cell carcinoma (sBCC).
- Announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz® PDT with the red-light LED (RhodoLED®) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.
- Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk of up to 240 cm2.
- Closed the purchase of all Ameluz and RhodoLED US Assets from Biofrontera AG. New earnout structure reduces payment rate from 25%–35% to 12%–15% of
U.S. net sales. - Received the final
$2.5 million of$11 million financing led by existing investors in October. - In November, announced the divestiture of its Xepi antibiotic cream to
Pelthos Pharmaceuticals for$3 million at closing,$1 million upon commercial availability, and up to$6 million in milestone payments tied to revenue thresholds of$10 million and$15 million .
The completion of our strategic transaction with Biofrontera AG marks a fundamental inflection point for the Company. With full ownership and control of our
At the same time, our clinical pipeline is advancing with strong momentum, highlighted by a PDUFA date for sBCC in
Importantly, the combination of accelerating revenue growth, structurally lower cost of goods, and disciplined expense management drove profitability in the fourth quarter—the first full quarter reflecting our new cost structure. We believe this marks the beginning of a meaningful shift in our financial trajectory as we move toward sustained profitability and cash flow breakeven in 2026.”
Fourth Quarter Financial Results
Total revenues for the fourth quarter of 2025 were a record
Gross profit margin in the fourth quarter of 2025 was 82.4% compared to 58.0% in 4Q24. Cost of goods sold related party decreased 45% year over year, driven by the transition from the pricing model under the prior license and supply agreement to the significantly lower earnout structure under the strategic transaction that took place in 2025.
Total operating expenses were $12.5 million for the fourth quarter of 2025 compared with $14.3 million for the fourth quarter of 2024.
Selling, general and administrative expenses were $8.7 million for the fourth quarter of 2025 compared with $8.2 million for the fourth quarter of 2024. The increase was mainly driven by legal costs.
Net income for the fourth quarter of 2025 was $5.6 million, compared with a net loss of $1.4 million for the prior-year quarter. This improvement was driven by higher revenues and materially lower cost of revenues resulting from the strategic transaction with Biofrontera AG, partially offset by higher legal and R&D expenses.
Adjusted EBITDA for the fourth quarter of 2025 was
Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the fourth quarters of 2025 and 2024.
Full Year 2025 Financial Results
Total revenues for full year 2025 increased 12% to $41.7 million compared with $37.3 million for the full year 2024.
Gross profit margin for the full year 2025 was 73.7% compared to 50.1% for the prior year. Cost of goods sold related party decreased 43% year over year, driven by the transition from the pricing model under the prior license and supply agreement to the significantly lower earnout structure under the strategic transaction that took place in 2025.
Total operating expenses were $53.1 million for the full year 2025 compared with $54.5 million for the same period in 2024. Increased legal expense was offset by reduced operational cost.
Net loss for the full year 2025 was
Adjusted EBITDA was
Conference Call Details
Conference call: Thursday, March 19, 2026 at 10:00 AM ET
Toll Free: 1-888-222-5806 (U.S. toll-free) International: 1-412-902-6516
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=XTq1cPRZ
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 photodynamic therapy (PDT). The Company's products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and in development for additional indications. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.
Contacts Investor Relations
646-829-9701
shamsian@lythampartners.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. All statements, other than statements of historical facts, in this press release, including statements regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words “believe”, “anticipate”, “intend”, “expect”, “target”, “goal”, “estimate”, “plan”, “assume”, “may”, “will”, “predict”, “project”, “would”, “could” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. You should read this press release and any documents referenced herein completely and with the understanding that our actual future results may be materially different from what we expect. While we have based these forward-looking statements on our current expectations and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed in or implied by our forward-looking statements, and you should not place undue reliance on our forward-looking statements.
These forward-looking statements are subject to risks, uncertainties and assumptions about us and accordingly, 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 products; our ability to expand, manage and maintain our direct sales and marketing efforts, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our manufacturing partners and the possible impact of tariffs; our ability to manufacture our products; our ability to adequately protect our intellectual property and operate the business without infringing upon the intellectual property rights of others; our actual financial results may vary significantly from forecasts and from period to period; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations (“GPOs”) in the healthcare industry; the willingness of healthcare providers to purchase our 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 products; the fact that product quality issues or product defects may harm our business; any claims brough against the Company, including but not limited to product liability claims, claims of patent infringement, or claims challenging the validity of our intellectual property; our ability to maintain compliance with
(Tables follow)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,392 | $ | 5,905 | ||||
| Investment, related party | 9 | 7 | ||||||
| Accounts receivable, net | 7,291 | 5,315 | ||||||
| Inventories | 1,426 | 6,646 | ||||||
| Prepaid expenses and other current assets | 2,279 | 527 | ||||||
| Asset held for sale | - | 2,300 | ||||||
| Other assets, related party | 686 | - | ||||||
| Total current assets | 18,083 | 20,700 | ||||||
| Inventories, long term | 3,729 | - | ||||||
| Property and equipment, net | 2,158 | 80 | ||||||
| Operating lease right-of-use assets | 1,584 | 903 | ||||||
| Intangible assets, net | 2,650 | 35 | ||||||
| Other assets | 360 | 383 | ||||||
| Total assets | $ | 28,564 | $ | 22,101 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 1,855 | 1,856 | ||||||
| Accounts payable, related parties, net | 4,811 | 5,344 | ||||||
| Operating lease liabilities | 332 | 548 | ||||||
| Accrued expenses and other current liabilities | 4,897 | 4,273 | ||||||
| Total current liabilities | 11,895 | 12,021 | ||||||
| Long-term liabilities: | ||||||||
| Convertible notes payable | 4,589 | 4,098 | ||||||
| Warrant liabilities | 351 | 1,250 | ||||||
| Operating lease liabilities, non-current | 1,240 | 276 | ||||||
| Other liabilities | 9 | 23 | ||||||
| Total liabilities | 18,084 | 17,668 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Convertible Preferred Stock, | - | - | ||||||
| Common Stock, | 12 | 9 | ||||||
| Additional paid-in capital | 138,413 | 121,833 | ||||||
| Accumulated deficit | (127,945 | ) | (117,409 | ) | ||||
| Total stockholders’ equity | 10,480 | 4,433 | ||||||
| Total liabilities and stockholders’ equity | $ | 28,564 | $ | 22,101 | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts and number of shares)
| Three Months Ended | Year Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product revenues, net | $ | 17,100 | $ | 12,560 | $ | 41,705 | $ | 37,303 | ||||||||
| Revenues, related party | - | - | - | 18 | ||||||||||||
| Total revenues, net | 17,100 | 12,560 | 41,705 | 37,321 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues, related party | 2,734 | 5,016 | 10,111 | 17,855 | ||||||||||||
| Cost of revenues, other | 275 | 256 | 853 | 752 | ||||||||||||
| Selling, general and administrative | 8,523 | 8,192 | 37,751 | 33,793 | ||||||||||||
| Selling, general and administrative, related party | 223 | 12 | 619 | 42 | ||||||||||||
| Research and development | 787 | 796 | 3,719 | 2,089 | ||||||||||||
| Total operating expenses | 12,542 | 14,272 | 53,053 | 54,531 | ||||||||||||
| Income (Loss) from operations | 4,558 | (1,712 | ) | (11,348 | ) | (17,210 | ) | |||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of warrant liabilities | 482 | 351 | 899 | 1,680 | ||||||||||||
| Change in fair value of investment, related party | (1 | ) | (1 | ) | 2 | (14 | ) | |||||||||
| Loss on debt extinguishment | - | - | - | (316 | ) | |||||||||||
| Interest expense, net | (120 | ) | (40 | ) | (452 | ) | (2,035 | ) | ||||||||
| Other income (expense), net | 721 | 4 | 388 | 158 | ||||||||||||
| Total other income (expense) | 1,082 | 314 | 837 | (527 | ) | |||||||||||
| Income (loss) before income taxes | 5,640 | (1,398 | ) | (10,511 | ) | (17,737 | ) | |||||||||
| Income tax expense | - | (2 | ) | 25 | 22 | |||||||||||
| Net income (loss) | $ | 5,640 | $ | (1,396 | ) | $ | (10,536 | ) | $ | (17,759 | ) | |||||
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
| Years ended | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (10,536 | ) | $ | (17,759 | ) | ||
| Adjustments to reconcile net loss to cash flows used in operations | ||||||||
| Depreciation and amortization | 138 | 421 | ||||||
| Reduction in the carrying amount of right-of-use assets | 730 | 728 | ||||||
| Stock-based compensation | 951 | 1,019 | ||||||
| Non-cash interest expense | 491 | 297 | ||||||
| Allowance for credit losses | (69 | ) | 162 | |||||
| Change in fair value of warrant liabilities | (899 | ) | (1,680 | ) | ||||
| Gain on sale of asset held for sale | (700 | ) | - | |||||
| Loss from termination of operating leases | 19 | - | ||||||
| Realized/unrealized loss in investment, related party | (2 | ) | 14 | |||||
| Loss on debt extinguishment | - | 316 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | (1,907 | ) | (315 | ) | ||||
| Other receivables, related party | - | 2 | ||||||
| Prepaid expenses and other assets | (1,728 | ) | (141 | ) | ||||
| Other assets, related party | (686 | ) | 5,159 | |||||
| Inventories | 1,445 | 4,233 | ||||||
| Accounts payable | (2 | ) | (1,452 | ) | ||||
| Accounts payable, related parties, net | (533 | ) | (355 | ) | ||||
| Operating lease liabilities | (683 | ) | (689 | ) | ||||
| Accrued expenses and other liabilities | 610 | (230 | ) | |||||
| Cash flows used in operating activities | (13,361 | ) | (10,270 | ) | ||||
| Cash flows from investing activities | ||||||||
| Proceeds from sale of asset held for sale | 3,000 | - | ||||||
| Sales of investment, related party | - | 57 | ||||||
| Purchase of intangible assets | - | (50 | ) | |||||
| Purchases of property and equipment | (2 | ) | (10 | ) | ||||
| Cash flows provided by (used in) investing activities | 2,998 | (3 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of Series C preferred stock, net of offering costs | 10,850 | - | ||||||
| Proceeds from issuance of Series B-1 preferred stock and warrants to purchase series B-3 preferred stock, net of issuance costs | - | 7,662 | ||||||
| Proceeds from issuance of Series B-3 preferred stock from exercise of warrants | - | 7,438 | ||||||
| Proceeds from issuance of convertible notes, net of issuance costs | 4,050 | |||||||
| Payment of principal short-term debt | - | (4,315 | ) | |||||
| Cash flows provided by financing activities | 10,850 | 14,835 | ||||||
| Net increase in cash and cash equivalents | 487 | 4,562 | ||||||
| Cash, cash equivalents and restricted cash, at the beginning of the year | 6,105 | 1,543 | ||||||
| Cash, cash equivalents and restricted cash, at the end of the year | $ | 6,592 | $ | 6,105 | ||||
| Supplemental disclosure of cash flow information | ||||||||
| Interest paid | $ | 6 | $ | 1,728 | ||||
| Income tax paid, net | $ | 25 | $ | 24 | ||||
| Supplemental non-cash investing and financing activities | ||||||||
| Preferred stock issued as consideration in asset purchase acquisition (See Note 3. Asset Acquisition) | $ | 4,782 | $ | - | ||||
| Property, plant and equipment acquired | 2,126 | - | ||||||
| Intangible asset acquired | 2,656 | - | ||||||
| Addition of right-of-use assets in exchange for operating lease liabilities | $ | 1,371 | $ | 55 | ||||
GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION
(In thousands, except per share amounts and number of shares)
| Three Months Ended | Year Ended | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net income (loss) | $ | 5,640 | $ | (1,396 | ) | $ | (10,536 | ) | $ | (17,759 | ) | |||||
| Interest expense, net | 121 | 40 | 452 | 2,035 | ||||||||||||
| Income tax expense | - | (3 | ) | 25 | 22 | |||||||||||
| Depreciation and amortization | 62 | 34 | 138 | 421 | ||||||||||||
| EBITDA | 5,823 | (1,325 | ) | (9,921 | ) | (15,281 | ) | |||||||||
| Gain on sale of asset held for sale | (700 | ) | - | (700 | ) | - | ||||||||||
| Change in fair value of warrant liabilities | (482 | ) | (351 | ) | (899 | ) | (1,680 | ) | ||||||||
| Change in fair value of investment, related party | 1 | 2 | (2 | ) | 14 | |||||||||||
| Loss on debt extinguishment | - | - | - | 316 | ||||||||||||
| Stock based compensation | 289 | 299 | 951 | 1,019 | ||||||||||||
| Expensed issuance costs | - | - | - | 354 | ||||||||||||
| Adjusted EBITDA | $ | 4,931 | $ | (1,375 | ) | $ | (10,571 | ) | $ | (15,258 | ) | |||||
| Adjusted EBITDA margin | 28.8 | % | -10.9 | % | -25.4 | % | -40.9 | % | ||||||||
