Biofrontera Inc. Reports Strong Third Quarter 2026 Financial Results Driven by 30% Year-Over-Year Revenue Growth
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Biofrontera (NASDAQ: BFRI) reported third-quarter net product revenue of $9.1 million, up 29.8% from the prior-year quarter. Gross margin rose to 74.4% from 70.7%, while net loss narrowed to $6.4 million, or $(0.42) per share, from $6.6 million, or $(0.62). Biofrontera believes accelerated customer ordering changed order timing rather than total demand.
Nine-month revenue rose 26.6% to $31.2 million; net loss narrowed to $11.8 million from $16.2 million. September 30 cash was $3.2 million, versus $6.4 million at year-end. FDA approved Ameluz for superficial basal cell carcinoma on September 9. Biofrontera plans commercialization later in the fourth quarter and into early 2027. Customs cleared the redesigned RhodoLED XL-C lamp on September 14, and placements began during the quarter. An October application seeks to expand Ameluz treatment of precancerous actinic keratosis lesions to the extremities, neck and trunk.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointAmeluz received FDA approval September 9, 2026 for superficial basal cell carcinoma.
- Moderate pointThird-quarter net product revenue increased 29.8% to $9.1 million from $7.0 million a year earlier.
- Moderate pointThird-quarter gross margin improved to 74.4% from 70.7% a year earlier.
- Moderate pointNine-month net loss narrowed to $11.8 million, or $(0.89) per share, from $16.2 million, or $(1.67).
- Moderate pointNine-month adjusted EBITDA improved to $(9.3) million from $(15.5) million a year earlier.
- Moderate pointNine-month operating cash use decreased to $3.2 million from $11.0 million a year earlier.
11 minor points
- Minor pointThird-quarter Ameluz unit volume increased 23.3%, contributing $1.6 million of revenue growth.
- Minor pointThird-quarter price and mix contributed $0.3 million of revenue growth.
- Minor pointThird-quarter net loss narrowed to $6.4 million, or $(0.42) per share, from $6.6 million, or $(0.62).
- Minor pointThird-quarter adjusted EBITDA improved to $(5.5) million from $(6.0) million a year earlier.
- Minor pointThird-quarter research and development expense fell to $0.5 million from $0.9 million as clinical trials substantially completed.
- Minor pointNine-month net product revenue increased 26.6% to $31.2 million from $24.6 million a year earlier.
- Minor pointNine-month gross margin improved to 78.0% from 67.7% a year earlier.
- Minor pointNine-month research and development expense fell to $1.8 million from $2.9 million as clinical trials substantially completed.
- Minor point. Forward-looking: it has not happened yet and may not happen.Biofrontera plans Ameluz commercialization for superficial basal cell carcinoma later in Q4 and into Q1 2027.
- Minor pointRedesigned RhodoLED XL-C received Customs clearance September 14, 2026; lamp placements began during the third quarter.
- Minor pointOctober supplemental application seeks Ameluz label expansion for actinic keratosis on the extremities, neck and trunk.
Negative
- Major pointCommon shares outstanding increased to 17,949,000 at September 30, 2026, from 11,648,323 at year-end, diluting holders.
- Moderate pointCash fell to $3.2 million at September 30, 2026 from $6.4 million at December 31, 2025.
- Moderate pointStockholders’ equity became a $243,000 deficit at September 30, versus $10.480 million equity at year-end.
- Moderate pointTotal liabilities rose to $21.7 million at September 30, 2026 from $18.1 million at year-end.
- Moderate pointOutstanding convertible notes totaled $4.7 million, net at September 30, 2026, maturing in November 2027. 34% of market cap
- Moderate pointThird-quarter selling, general and administrative expenses rose to $12.5 million from $10.4 million a year earlier.
- Moderate pointITC-related remediation and inventory charges totaled $1.1 million through September 30, 2026. 8% of market cap
- Minor pointNine-month selling, general and administrative expenses rose to $33.2 million from $29.6 million a year earlier.
News Explained
In reporting third-quarter results, Biofrontera disclosed 17,949,000 common shares outstanding at
Key Figures
- Quarterly net product revenue
- $9.1 million; increase of 29.8%
- Third quarter 2026 versus third quarter 2025
- Quarterly gross margin
- 74.4%
- Third quarter 2026; compared with 70.7% in the prior-year period
- Quarterly net loss
- $6.4 million
- Third quarter 2026; compared with $6.6 million in the prior-year period
- Quarterly Adjusted EBITDA
- $(5.5) million
- Third quarter 2026; compared with $(6.0) million in the prior-year period
- Nine-month net product revenue
- $31.2 million; increase of 26.6%
- Nine months ended September 30, 2026 versus the prior-year period
- Nine-month gross margin
- 78.0%
- Nine months ended September 30, 2026; compared with 67.7% in the prior-year period
- Nine-month net loss
- $11.8 million
- Nine months ended September 30, 2026; compared with $16.2 million in the prior-year period
- Cash and cash equivalents
- $3.2 million
- As of September 30, 2026; compared with $6.4 million as of December 31, 2025
Previous Earnings Reports
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Revenue grew year over year and gross margin rose; reported 24-hour reaction was positive.
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Revenue growth, higher gross margin, and narrower net loss; reported 24-hour reaction was positive.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
photodynamic therapy medical
supplemental new drug application regulatory
convertible notes financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
WOBURN, Mass., Nov. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the quarter ended September 30, 2026.
Third Quarter 2026 Highlights
- Net product revenue of
$9.1 million , an increase of29.8% compared to$7.0 million in the prior-year period. - Gross margin of
74.4% , compared to70.7% in the prior-year period, an improvement of approximately 370 basis points, reflecting the lower Ameluz® cost structure established following the closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic Transaction”), partially offset by ITC Matter-related inventory write-downs and higher lamp and device costs. - Net loss of
$6.4 million , or$(0.42) per share, compared to a net loss of$6.6 million , or$(0.62) per share, in the prior-year period. - Adjusted EBITDA of
$(5.5) million , compared to$(6.0) million in the prior-year period. - On September 9, 2026 FDA Approval of Ameluz on September for the treatment of Superficial Basal Cell Carcinoma (sBCC), making Ameluz plus Red-Light the first and only PDT approved for the treatment of cancerous skin tumors.
- US Customs and Border Protection ruled that the re-designed XL-C lamp did not violate the ITC order and could be imported for use in the US market.
Nine Months Ended September 30, 2026 Highlights
- Net product revenue of
$31.2 million , an increase of26.6% from$24.6 million in the prior-year period. - Gross margin of
78.0% , compared to67.7% in the prior-year period. - Net loss of
$11.8 million , or$(0.89) per share, compared to a net loss of$16.2 million , or$(1.67) per share, in the prior-year period. - Adjusted EBITDA of
$(9.3) million , compared to$(15.5) million in the prior-year period.
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "The third quarter was a pivotal one for Biofrontera. On September 9, the FDA approved Ameluz® PDT for the treatment of superficial basal cell carcinoma (sBCC), making it the first PDT approved in the United States for a cancerous skin tumor. Five days later, U.S. Customs and Border Protection ruled that our redesigned RhodoLED® XL-C is not subject to the ITC exclusion order, which allows us to again serve the customers who rely on our large-field lamp. Revenue grew
Third Quarter 2026 Financial Results
Net product revenue for the third quarter of 2026 was
Cost of revenues was
Selling, general and administrative (“SG&A”) expenses, including SG&A, related party, were
Research and development expenses were
Patent remediation expense related to the ITC Matter was
Net loss for the third quarter was
Nine Months Ended September 30, 2026 Financial Results
Net product revenue for the nine months ended September 30, 2026 was
Cost of revenues was
SG&A expenses, including SG&A related party, were
Research and development expenses were
Patent remediation expense related to the ITC Matter was
Net loss was
Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the third quarters and first nine months of 2026 and 2025.
Balance Sheet and Cash Flow
Cash and cash equivalents were
Total liabilities were
Conference Call
Biofrontera will host a conference call and webcast on Friday, November 13, 2026 at 10:00 a.m., Eastern Time. Participants may dial 1-877-877-1275 (U.S./Canada toll-free), 1-866-605-3852 (Canada toll-free), or 1-412-858-5202 (international).
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, following FDA approval in September 2026, superficial basal cell carcinoma, and are in development for additional indications. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.
Use of Non-GAAP Financial Measures
We define adjusted EBITDA as net income or loss before interest income and expense, income taxes, depreciation and amortization, and other non-operating items from our statements of operations as well as certain other items considered outside the normal course of our operations specifically described below. Adjusted EBITDA is not a presentation made in accordance with GAAP. Our definition of adjusted EBITDA may vary from the use of similarly titled measures by others in our industry due to the potential inconsistencies in the method of calculation and differences due to items subject to interpretation. Adjusted EBITDA should not be considered as an alternative to net income or loss, operating income/(loss), cash flows from operating activities or any other performance measures derived in accordance with GAAP as measures of operating performance or liquidity. Adjusted EBITDA has limitations as an analytical tool and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP.
We exclude the change in fair value of warrant liabilities and the change in fair value of investment, related party, because these items are non-cash. We exclude patent remediation expense and ITC-related inventory write-downs because they relate to a discrete adverse legal and regulatory matter that is not indicative of the Company's ongoing operating performance. We exclude stock-based compensation, which is non-cash, because the subjective assumptions and variety of award types involved can cause this expense to vary significantly, and its exclusion allows for more meaningful comparisons of our operating results to peer companies.
Adjusted EBITDA margin is Adjusted EBITDA for a particular period expressed as a percentage of revenues for that period. We use Adjusted EBITDA to measure our performance from period to period and to compare our results to those of our competitors, and we believe that, when viewed with GAAP financial information, this presentation provides investors with useful information regarding financial and business trends related to our results of operations and a more meaningful understanding of our ongoing operating performance.
Investor Contact
Ben Shamsian
Lytham Partners
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 brought 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 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 products; our ability to obtain and maintain the regulatory approvals necessary for the marketing of our 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. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors.
BIOFRONTERA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)
| September 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,218 | $ | 6,392 | ||||
| Investment, related party | 12 | 9 | ||||||
| Accounts receivable, net | 4,787 | 7,291 | ||||||
| Inventories | 1,733 | 1,426 | ||||||
| Prepaid expenses and other current assets | 1,111 | 2,279 | ||||||
| Other assets, related party | 242 | 686 | ||||||
| Total current assets | 11,103 | 18,083 | ||||||
| Inventories, long term | 2,565 | 3,729 | ||||||
| Property and equipment, net | 2,112 | 2,158 | ||||||
| Operating lease right-of-use assets | 2,707 | 1,584 | ||||||
| Intangible assets, net | 2,528 | 2,650 | ||||||
| Other assets | 451 | 360 | ||||||
| Total assets | $ | 21,466 | $ | 28,564 | ||||
| LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 6,896 | 1,855 | ||||||
| Accounts payable, related parties, net | 731 | 4,811 | ||||||
| Operating lease liabilities | 463 | 332 | ||||||
| Accrued expenses and other current liabilities | 6,147 | 4,897 | ||||||
| Total current liabilities | 14,237 | 11,895 | ||||||
| Long-term liabilities: | ||||||||
| Convertible notes payable, net | 4,749 | 4,589 | ||||||
| Warrant liabilities | 395 | 351 | ||||||
| Operating lease liabilities, non-current | 2,322 | 1,240 | ||||||
| Other liabilities | 6 | 9 | ||||||
| Total liabilities | 21,709 | 18,084 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ (deficit) equity: | ||||||||
| Convertible Preferred Stock, | - | - | ||||||
| Common stock, | 18 | 12 | ||||||
| Additional paid-in capital | 139,463 | 138,413 | ||||||
| Accumulated deficit | (139,724 | ) | (127,945 | ) | ||||
| Total stockholders’ (deficit) equity | (243 | ) | 10,480 | |||||
| Total liabilities and stockholders’ (deficit) equity | $ | 21,466 | $ | 28,564 | ||||
BIOFRONTERA INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts and number of shares)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Product revenues, net | $ | 9,070 | $ | 6,988 | $ | 31,157 | $ | 24,605 | ||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues, related party | 2,164 | 1,922 | 6,180 | 7,377 | ||||||||||||
| Cost of revenues, other | 157 | 123 | 667 | 578 | ||||||||||||
| Selling, general and administrative | 12,461 | 10,047 | 33,083 | 29,229 | ||||||||||||
| Selling, general and administrative, related party | 29 | 320 | 72 | 396 | ||||||||||||
| Patent remediation expense | 306 | - | 698 | - | ||||||||||||
| Research and development | 450 | 854 | 1,798 | 2,932 | ||||||||||||
| Total operating expenses | 15,567 | 13,266 | 42,498 | 40,512 | ||||||||||||
| Loss from operations | (6,497 | ) | (6,278 | ) | (11,341 | ) | (15,907 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of warrant liabilities | 132 | (285 | ) | (44 | ) | 417 | ||||||||||
| Change in fair value of investment, related party | 4 | 1 | 4 | 3 | ||||||||||||
| Interest expense, net | (128 | ) | (111 | ) | (379 | ) | (331 | ) | ||||||||
| Other income (expense), net | 70 | 30 | 8 | (333 | ) | |||||||||||
| Total other income (expense) | 78 | (365 | ) | (411 | ) | (244 | ) | |||||||||
| Loss before income taxes | (6,419 | ) | (6,643 | ) | (11,752 | ) | (16,151 | ) | ||||||||
| Income tax expense | 4 | 6 | 27 | 25 | ||||||||||||
| Net loss | $ | (6,423 | ) | $ | (6,649 | ) | $ | (11,779 | ) | $ | (16,176 | ) | ||||
| Loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (0.42 | ) | $ | (0.62 | ) | $ | (0.89 | ) | $ | (1.67 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 15,280,526 | 10,776,739 | 13,309,031 | 9,674,378 | ||||||||||||
BIOFRONTERA INC.
GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION
(In thousands, except per share amounts and number of shares)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Net loss | $ | (6,423 | ) | $ | (6,649 | ) | $ | (11,779 | ) | $ | (16,176 | ) | ||||
| Interest expense, net | 128 | 111 | 379 | 331 | ||||||||||||
| Income tax expense | 4 | 6 | 27 | 25 | ||||||||||||
| Depreciation and amortization | 59 | 25 | 179 | 76 | ||||||||||||
| EBITDA | (6,232 | ) | (6,507 | ) | (11,194 | ) | (15,744 | ) | ||||||||
| Change in fair value of warrant liabilities | (132 | ) | 285 | 44 | (417 | ) | ||||||||||
| Change in fair value of investment, related party | (4 | ) | (1 | ) | (4 | ) | (3 | ) | ||||||||
| ITC-related inventory write-downs | 317 | - | 375 | - | ||||||||||||
| Patent remediation expense | 306 | - | 698 | - | ||||||||||||
| Stock-based compensation | 224 | 236 | 829 | 662 | (1) | |||||||||||
| Adjusted EBITDA | $ | (5,521 | ) | $ | (5,987 | ) | $ | (9,252 | ) | $ | (15,502 | ) | ||||
| Adjusted EBITDA margin | -60.9 | % | -85.7 | % | -29.7 | % | -63.0 | % | ||||||||
(1) Stock-based compensation for the nine months ended September 30, 2025 included in the Adjusted EBITDA reconciliation above has been revised from
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Biofrontera's third-quarter 2026 revenue and earnings results?
Biofrontera reported $9.1 million in net product revenue, up 29.8% year over year, and a net loss of $6.4 million, or $(0.42) per share. The prior-year quarter had revenue of $7.0 million and a net loss of $6.6 million, or $(0.62) per share.
When did Biofrontera's Ameluz receive approval for superficial basal cell carcinoma, and when is commercialization planned?
Ameluz received FDA approval for superficial basal cell carcinoma on September 9, 2026, and Biofrontera plans commercialization later in the fourth quarter and into the first quarter of 2027.
What cost structure helped improve Biofrontera's Ameluz gross margin?
The Ameluz cost structure changed from the prior transfer pricing arrangement to direct cost plus a 12% earnout on net revenue. This reduced Ameluz costs despite a 23.3% increase in third-quarter unit volume, although higher lamp and device costs partially offset the improvement.