STOCK TITAN

Biofrontera Q3 2026 net loss narrows to $6.4M

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(High)

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.

Form Type
8-K

Rhea-AI Filing Summary

Biofrontera Inc. (BFRI) reported third-quarter 2026 net product revenue of $9.1 million, up 29.8% from $7.0 million a year earlier. Gross margin was 74.4%, versus 70.7%; net loss was $6.4 million versus $6.6 million, and adjusted EBITDA was negative $5.5 million versus negative $6.0 million. For the first nine months, revenue rose 26.6% to $31.2 million; net loss was $11.8 million versus $16.2 million, and adjusted EBITDA was negative $9.3 million versus negative $15.5 million.

The FDA approved Ameluz for superficial basal cell carcinoma (sBCC) on September 9, 2026, making Ameluz plus red light the first PDT approved in the U.S. for a cancerous skin tumor. On September 14, 2026, U.S. Customs and Border Protection ruled that redesigned RhodoLED XL-C lamps were not subject to the ITC exclusion order and could be imported.

Cash and cash equivalents were $3.2 million as of September 30, 2026, versus $6.4 million as of December 31, 2025. Cash used in operating activities for the first nine months of 2026 was $3.2 million, compared with $11.0 million in the prior-year period. Convertible notes, net, totaled $4.7 million and mature in November 2027.

5 points · 1 major

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.

0 major · 0 points

How the balance works

Positive

  • Major pointFDA approved Ameluz for sBCC on September 9, 2026.
  • Moderate point26.6% nine-month revenue growth brought product revenue to $31.2 million.
  • Moderate pointCBP’s September 14 ruling said redesigned XL-C lamps could be imported.
  • Moderate pointNine-month net loss fell to $11.8 million from $16.2 million.
  • Moderate pointNine-month adjusted EBITDA loss narrowed to $9.3 million from $15.5 million.

Negative

  • None.

Filing Explained

As of September 30, 2026, the reported common-share count was 17,949,000 versus 11,648,323 at December 31, 2025, diluting holders whose share counts stayed constant.

The 8-K furnishes Biofrontera’s third-quarter results; the attached balance sheet reports 17,949,000 common shares issued and outstanding on September 30, 2026, versus 11,648,323 on December 31, 2025, so holders with unchanged share counts own a smaller fraction of the larger share base.

The release also revises the stock-based-compensation amount in the nine-month 2025 adjusted EBITDA reconciliation from $0.4 million to $0.7 million; the company says this affects only that non-GAAP measure, not its condensed consolidated financial statements.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Third-quarter net product revenue $9.1 million Three months ended September 30, 2026; up 29.8% from $7.0 million in 2025.
Nine-month net product revenue $31.2 million Nine months ended September 30, 2026; up 26.6% from $24.6 million in 2025.
Third-quarter gross margin 74.4% Three months ended September 30, 2026, compared with 70.7% in 2025.
Third-quarter net loss $6.4 million net loss Three months ended September 30, 2026, compared with $6.6 million in 2025.
Nine-month net loss $11.8 million net loss Nine months ended September 30, 2026, compared with $16.2 million in 2025.
Nine-month Adjusted EBITDA $(9.3) million Non-GAAP measure for the nine months ended September 30, 2026, compared with $(15.5) million in 2025.
Cash and cash equivalents $3.2 million As of September 30, 2026, compared with $6.4 million as of December 31, 2025.
Cash used in operating activities $3.2 million Nine months ended September 30, 2026, compared with $11.0 million in the prior-year period.
Adjusted EBITDA financial
"Adjusted EBITDA was $(5.5) million"
Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.
12% earnout financial
"Ameluz direct cost plus a 12% earnout on net revenue"
photodynamic therapy (PDT) medical
"commercialization of photodynamic therapy (PDT) in dermatology"
Photodynamic therapy (PDT) is a medical treatment that uses special light-sensitive drugs and a light source to target and destroy abnormal or cancerous cells. It works like a precise spotlight, activating the drug only in the affected area to minimize damage to surrounding tissue. While primarily a health care method, its development and adoption can influence biotech and pharmaceutical markets, making it relevant for investors tracking advancements in medical technology.
superficial basal cell carcinoma (sBCC) medical
"treatment of superficial basal cell carcinoma (sBCC)"
A superficial basal cell carcinoma (sBCC) is a common, slow-growing form of skin cancer that stays near the surface of the skin, often appearing as a scaly or reddish patch rather than a deep lump. Investors care because its high prevalence and tendency to be treated with topical drugs, minor procedures or recurring therapy creates steady demand, clinical trial opportunities and regulatory milestones that can materially affect companies focused on dermatology treatments.
supplemental New Drug Application regulatory
"submitted a supplemental New Drug Application"
A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.
limited exclusion order regulatory
"limited exclusion order and cease and desist order issued by the U.S. International Trade Commission"
A limited exclusion order is a trade-agency ruling that bars specific foreign manufacturers or importers from bringing particular products into the country because those products violate a patent, trademark or trade rule. Think of it like customs refusing entry to a named brand’s shipment while allowing other similar goods; for investors, it can quickly reduce competition or disrupt supply chains and therefore affect sales, profit outlooks and stock values.
Third-quarter net product revenue $9.1 million Up 29.8% from $7.0 million
Third-quarter gross margin 74.4% Compared with 70.7%
Third-quarter net loss $6.4 million Compared with $6.6 million
Third-quarter Adjusted EBITDA (non-GAAP) $(5.5) million Compared with $(6.0) million
Nine-month net product revenue $31.2 million Up 26.6% from $24.6 million
Nine-month net loss $11.8 million Compared with $16.2 million
Nine-month Adjusted EBITDA (non-GAAP) $(9.3) million Compared with $(15.5) million

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What drove BFRI’s third-quarter 2026 revenue growth?

Net product revenue rose 29.8% to $9.1 million. Ameluz unit volume increased 23.3%, contributing $1.6 million, while price and mix contributed $0.3 million; the balance reflected higher device sales. Biofrontera said early-July accelerated orders ahead of potential supply restrictions partly drove volume, and it believed this affected order timing rather than total demand.

When did Biofrontera expect to begin commercializing Ameluz for sBCC?

Biofrontera said it was preparing to begin commercializing Ameluz for sBCC later in the fourth quarter of 2026 and into the first quarter of 2027.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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): November 13, 2026

 

Biofrontera Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40943   47-3765675

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

660 Main Street, First Floor

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
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 November 13, 2026, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results for the three and nine months ended September 30, 2026. 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 November 13, 2026
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.

 

November 13, 2026   Biofrontera Inc.
(Date)   (Registrant)
     
    /s/ E. Fred Leffler III
    E. Fred Leffler, III
    Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

Biofrontera Inc. Reports Strong Third Quarter 2026 Financial Results Driven by 30% Year-Over-Year Revenue Growth

 

WOBURN, Mass., November 13, 2026 — 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 of 29.8% compared to $7.0 million in the prior-year period.
●Gross margin of 74.4%, compared to 70.7% 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 of 26.6% from $24.6 million in the prior-year period.
●Gross margin of 78.0%, compared to 67.7% 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 30% in the quarter and 27% for the first nine months, and our gross margin continues to reflect the lower cost structure we put in place with the Strategic Transaction. The quarter also carried the legal and remediation costs of the ITC Matter, and with the XL-C now cleared our attention is on execution. We are preparing to begin commercializing Ameluz® for sBCC later in the fourth quarter and into the first quarter of 2027, and in October we submitted a supplemental New Drug Application to expand the Ameluz® label for actinic keratosis to the extremities, neck and trunk. Each of these indications is served by the lamps and the sales force we already have in place.”

 

Third Quarter 2026 Financial Results

 

Net product revenue for the third quarter of 2026 was $9.1 million, an increase of $2.1 million, or 29.8%, from $7.0 million in the third quarter of 2025. The increase was primarily attributable to a 23.3% increase in Ameluz® unit volume resulting in an increase of $1.6 million and $0.3 million due to price and mix increase, with the balance reflecting higher device sales. The increase in unit volume was partially driven by accelerated order timing from certain customers in early July 2026 in anticipation of potential supply restrictions resulting from the limited exclusion order and cease and desist order issued by the U.S. International Trade Commission (“ITC”) related to our RhodoLED® XL lamp, which took effect on July 6, 2026 (the “ITC Matter”) and importantly, commercial execution where we have focused on increasing utilization with key accounts and bringing Ameluz to new dermatology customers. We believe that the accelerated ordering impacted the timing of orders rather than total demand. On September 14, 2026, U.S. Customs and Border Protection (“CBP”) issued a ruling finding that our redesigned RhodoLED® XL-C is not subject to the exclusion order, and we began placing XL-C lamps during the 3rd quarter, enabling these customers to again purchase Ameluz®.

 

 
 

 

Cost of revenues was $2.3 million, compared to $2.0 million in the prior-year period, producing gross profit of $6.7 million and a gross margin of 74.4%, compared to gross profit of $4.9 million and a gross margin of 70.7% in the third quarter of 2025. The improvement was driven principally by the transition from the prior transfer pricing arrangement to a cost structure comprising Ameluz® direct cost plus a 12% earnout on net revenue, which reduced cost of Ameluz® despite a 23.3% increase in unit volume. This was partially offset by a $0.4 million increase in lamp and device costs, including $0.3 million of ITC Matter-related inventory write-downs.

 

Selling, general and administrative (“SG&A”) expenses, including SG&A, related party, were $12.5 million, compared to $10.4 million in the prior-year quarter, an increase of $2.1 million, driven primarily by a $0.9 million increase in legal fees related to the ITC Matter, $0.7 million of combined costs from lamp manufacturing and regulatory and product affairs, and a $0.5 million increase in direct sales expenses, mainly commissions on higher Ameluz® sales volume.

 

Research and development expenses were $0.5 million, compared to $0.9 million in the prior-year quarter, reflecting the substantial completion of clinical trials.

 

Patent remediation expense related to the ITC Matter was $0.3 million, compared to none in the prior-year quarter, reflecting a $0.2 million increase in the estimated remediation cost following the September 14, 2026 CBP ruling and a $0.1 million write-down of loaner and RhodoLED® XL lamps used in the remediation program.

 

Net loss for the third quarter was $6.4 million, or $(0.42) per share, compared to a net loss of $6.6 million, or $(0.62) per share, for the prior-year quarter. Adjusted EBITDA, a non-GAAP measure reconciled below, was $(5.5) million, compared to $(6.0) million in the prior-year period.

 

Nine Months Ended September 30, 2026 Financial Results

 

Net product revenue for the nine months ended September 30, 2026 was $31.2 million, an increase of $6.6 million, or 26.6%, from $24.6 million in the first nine months of 2025. The increase reflects Ameluz® unit volume growth of $5.5 million and a price impact of approximately $0.7 million and the remainder generally attributable to increases in device sales.

 

Cost of revenues was $6.8 million, compared to $8.0 million in the prior-year period, producing gross profit of $24.3 million and gross margin of 78.0%, compared to gross profit of $16.7 million and gross margin of 67.7% in the prior-year period. The improvement was driven principally by the same transition in Ameluz® cost structure described above.

 

SG&A expenses, including SG&A related party, were $33.2 million, compared to $29.6 million in the prior-year period, an increase of $3.5 million. The increase was primarily driven by $1.8 million of combined costs from manufacturing and regulatory and product affairs; $1.2 million of higher direct sales expenses, mainly sales commissions reflecting Ameluz® sales volume growth; and $0.8 million of higher sales support expenses, reflecting increased commercial activity. Other SG&A expenses, including stock-based compensation, depreciation and amortization, and bad debt, increased $0.3 million. These increases were partially offset by a $0.3 million decrease in selling, general and administrative expenses, related party, and a $0.2 million decrease in general and administrative costs.

 

Research and development expenses were $1.8 million, compared to $2.9 million, reflecting the substantial completion of clinical trials.

 

Patent remediation expense related to the ITC Matter was $0.7 million, compared to none in the prior-year period. Including inventory write-downs recorded in cost of revenues, the Company has recognized total charges of $1.1 million related to the ITC Matter through September 30, 2026, consisting of $0.6 million of accrued remediation costs and $0.5 million of inventory write-downs to net realizable value. Of the accrued remediation costs, $0.2 million was settled with inventory used in the remediation program and the remaining $0.4 million is paid or payable in cash.

 

Net loss was $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 was $(9.3) million, compared to $(15.5) million in the prior-year period.

 

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 $3.2 million as of September 30, 2026, compared to $6.4 million as of December 31, 2025. Cash used in operating activities for the nine months ended September 30, 2026 was $3.2 million, compared to $11.0 million in the prior-year period.

 

Total liabilities were $21.7 million as of September 30, 2026, compared to $18.1 million at December 31, 2025. The Company’s outstanding indebtedness as of September 30, 2026 consisted of $4.7 million of convertible notes, net, maturing in November 2027. The Company has no bank or other term debt.

 

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, $0.001 par value, 20,000,000 shares authorized; 759 and 2,050 Series B-2; 6,498 and 6,593 Series B-3; 8,390 and 10,719 Series C; and 3,019 and 3,019 Series D shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively   -    - 
Common stock, $0.001 par value, 70,000,000 shares authorized; 17,949,000 and 11,648,323 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively   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 $0.4 million, as previously reported, to $0.7 million to correct the amount presented in the prior-period reconciliation. The revision affects only this non-GAAP measure and had no effect on the Company’s condensed consolidated financial statements.

 

 

 

 

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