Form 8-K

8-K — Biofrontera Inc.

Accession: 0001493152-26-037610

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0001858685

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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)

THE SECURITIES EXCHANGE ACT OF 1934

Date

of Report (Date of earliest event reported): August 13, 2026

Biofrontera

Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-40943

47-3765675

(State

or other jurisdiction

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 ☒

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.

August 13, 2026, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results

for the three and six months ended June 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 August 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.

August

13, 2026

Biofrontera

Inc.

(Date)

(Registrant)

/s/

E. Fred Leffler III

Fred Leffler, III

Chief

Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Biofrontera

Inc. Reports Strong Second Quarter 2026 Financial Results Driven by 33% Revenue Growth

WOBURN,

Mass., August 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 June 30, 2026.

Second

Quarter 2026 Highlights

● Net

product revenue of $12.0 million, an increase of 32.9% compared to $9.0 million in the prior-year

period.

● Gross

margin of 80%, compared to 71% in the prior-year period, an improvement of approximately

920 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”).

● Net

loss of $0.6 million, or $(0.05) per share, compared to a net loss of $5.3 million, or $(0.57)

per share, in the prior-year period.

● Adjusted

EBITDA of $(0.2) million, compared to $(5.1) million in the prior-year period, an improvement

of approximately $5.0 million.

First

Half 2026 Highlights

● Net

product revenue of $22.1 million, an increase of 25.4%, from $17.6 million in the prior-year

period.

● Gross

margin of 80%, compared to 67% in the prior-year period.

● Net

loss of $5.4 million, or $(0.44) per share, compared to a net loss of $9.5 million, or $(1.05)

per share, in the prior-year period.

● Adjusted

EBITDA of $(3.7) million, compared to $(9.5) million in the prior-year period.

● Cash

used in operating activities of $1.7 million, compared to $7.2 million in the prior-year

period, a reduction of approximately 76%.

Hermann

Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: “This was the strongest operating Q2 and H1 in the Company’s

history as a standalone business, and it reflects work that has been underway for more than a year - a restructured cost base, a more

disciplined commercial organization, and steady growth in Ameluz® demand. We are seeing the pace of reorders accelerate, which reflects

strength of underlying demand. We also continue to be encouraged by the new indications advancing in our development pipeline, including

superficial basal cell carcinoma (sBCC), for which we have a PDUFA date in late September of this year and expect to launch in Q1 of

2027. If approved for sBCC, Ameluz will be the first PDT in the United States approved for the treatment of cancerous tumors. Our clinical

pipeline also includes recent positive Phase III results in AK on the extremities/neck/trunk and encouraging Phase 2B data in acne that

we believe can expand the reach of our PDT platform in the years ahead.”

“We

see positive effects from the Strategic Transaction and our overall cost management, the impacts of which are now visible in the Q2 results,”

said Fred Leffler, Chief Financial Officer. “Gross margin improved roughly 920 basis points year over year, operating expenses

declined 11%, and we brought Adjusted EBITDA to within $0.2 million of breakeven. Operating cash used in the first half of 2026 was $1.7

million, down from $7.2 million a year ago. That figure includes a $3.7 million paydown of related party payables connected to the Strategic

Transaction. Excluding that item, changes in working capital would have been a net source of cash in the first half. We continue

to make progress towards cash flow breakeven in 2026.”

Second

Quarter 2026 Financial Results

Net

product revenue for the second quarter of 2026 was $12.0 million, an increase of $3.0 million, or 32.9%, from $9.0 million in the second

quarter of 2025. While the revenue increase was partly due a price increase, unit volume grew, which was partly driven by the impact

of order timing from certain customers in anticipation of potential supply restrictions resulting from an exclusion order by the International

Trade Commission (ITC) related to our RhodoLED XL lamp that took effect on July 7, 2026, impacting the timing of orders rather than total

demand. We are pursuing a remediation plan to allow us to begin selling a modified version of our XL lamp. Because the substantial majority

of our installed lamp base is unaffected by the ITC order, any shift in orders to the second quarter from the second half of the year

is not expected to impact our full-year 2026 revenue goals.

Cost

of revenues was $2.4 million, compared to $2.6 million in the prior-year period, producing gross profit of $9.6 million and a gross margin

of 80%, compared to gross profit of $6.4 million and a gross margin of 71% in the second 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.

Selling,

general and administrative expenses were $9.7 million, compared to $10.6 million in the prior-year quarter, a decrease of $0.9 million,

driven primarily by a $2.1 million reduction in litigation-related legal fees, partially offset by planned investment in the commercial

organization and costs associated with the manufacturing and regulatory functions established following the Strategic Transaction.

Research

and development expenses were $0.4 million, compared to $0.9 million in the prior-year quarter, reflecting the substantial completion

of clinical trials.

Net

loss for the second quarter was $0.6 million, or $(0.05) per share, compared to a net loss of $5.3 million, or $(0.57) per share, for

the prior-year quarter. Adjusted EBITDA, a non-GAAP measure reconciled below, was $(0.2) million, compared to $(5.1) million in the prior-year

period.

First

Half 2026 Financial Results

Net

product revenue for the six months ended June 30, 2026 was $22.1 million, an increase of $4.5 million, or 25.4%, from $17.6 million in

the first six months of 2025. The increase reflects Ameluz® unit volume growth and the full-period effect of the list price increase

implemented in the fourth quarter of 2025.

Cost

of revenues was $4.5 million, compared to $5.9 million in the prior-year period, producing gross profit of $17.6 million and gross margin

of 80%, compared to gross profit of $11.7 million and gross margin of 67% in the prior-year period. The improvement was driven principally

by the same transition in Ameluz® cost structure described above.

Selling,

general and administrative expenses were $20.7 million, compared to $19.3 million in the prior-year period, an increase of $1.4 million,

driven primarily by planned investment and lower turnover in the commercial organization and costs associated with the manufacturing

and regulatory functions established following the Strategic Transaction, partially offset by lower litigation-related legal fees.

Research

and development expenses were $1.3 million, compared to $2.1 million, reflecting the substantial completion of clinical trials.

Net

loss was $5.4 million, or $(0.44) per share, compared to a net loss of $9.5 million, or $(1.05) per share, in the prior-year period.

Adjusted EBITDA was $(3.7) million, compared to $(9.5) 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 second quarters and first haves

of 2026 and 2025.

Balance

Sheet and Cash Flow

Cash

and cash equivalents were $4.7 million as of June 30, 2026, compared to $6.4 million as of December 31, 2025. Cash used in operating

activities for the six months ended June 30, 2026 was $1.7 million, compared to $7.2 million in the prior-year period.

Total

liabilities were $18.1 million as of June 30, 2026, essentially unchanged from $18.1 million at December 31, 2025. The Company’s

outstanding indebtedness as of June 30, 2026 consisted of $4.6 million of convertible notes, net, maturing in November 2027. The Company

has no bank or other term debt. Total stockholders’ equity was $6.0 million as of June 30, 2026, compared to $10.5 million at

December 31, 2025.

Conference

Call

Biofrontera

will host a conference call and webcast on Thursday, August 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 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

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.

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. We do not assume any obligation to update any forward-looking statements, whether as a result of new

information, future events or otherwise, except as required by law. 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)

June 30,

2026

December 31,

2025

(Unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$ 4,659

$ 6,392

Investment, related party

Accounts receivable, net

5,545

7,291

Inventories

1,097

1,426

Prepaid expenses and other current assets

892

2,279

Other assets, related party

234

686

Total current assets

12,435

18,083

Inventories, long term

3,658

3,729

Property and equipment, net

2,139

2,158

Operating lease right-of-use assets

2,813

1,584

Intangible assets, net

2,568

2,650

Other assets

451

360

Total assets

$ 24,064

$ 28,564

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

4,315

1,855

Accounts payable, related parties, net

1,044

4,811

Operating lease liabilities

472

332

Accrued expenses and other current liabilities

4,710

4,897

Total current liabilities

10,541

11,895

Long-term liabilities:

Convertible notes payable, net

4,620

4,589

Warrant liabilities

526

351

Operating lease liabilities, non-current

2,412

1,240

Other liabilities

Total liabilities

18,108

18,084

Stockholders’ equity:

Convertible Preferred Stock, $0.001 par value, 20,000,000 shares authorized; no Series B-1; 1,850 and 2,050 Series B-2; 6,498 and 6,593 Series B-3; 9,707 and 10,719 Series C; and 3,019 Series D shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Common stock, $0.001 par value, 70,000,000 shares authorized; 14,206,126 and 11,648,323 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

139,243

138,413

Accumulated deficit

(133,301 )

(127,945 )

Total stockholders’ equity

5,956

10,480

Total liabilities and stockholders’ equity

$ 24,064

$ 28,564

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,

2026

2025

2026

2025

Product revenues, net

$ 12,003

$ 9,030

$ 22,087

$ 17,617

Operating expenses

Cost of revenues, related party

2,185

2,380

4,016

5,455

Cost of revenues, other

225

262

510

455

Selling, general and administrative

9,628

10,528

20,623

19,183

Selling, general and administrative, related party

Patent remediation expense

392

Research and development

448

870

1,348

2,077

Total operating expenses

12,527

14,109

26,931

27,246

Loss from operations

(524 )

(5,079 )

(4,844 )

(9,629 )

Other income (expense)

Change in fair value of warrant liabilities

153

(175 )

702

Change in fair value of investment, related party

(1 )

Interest expense, net

(126 )

(115 )

(251 )

(220 )

Other income (expense), net

(264 )

(62 )

(363 )

Total other income (expense)

(57 )

(224 )

(489 )

121

Loss before income taxes

(581 )

(5,303 )

(5,333 )

(9,508 )

Income tax expense

Net loss

$ (604 )

$ (5,324 )

$ (5,356 )

$ (9,527 )

Loss per common share:

Basic and diluted

$ (0.05 )

$ (0.57 )

$ (0.44 )

$ (1.05 )

Weighted-average common shares outstanding:

Basic and diluted

12,923,710

9,351,557

12,306,944

9,108,091

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,

2026

2025

2026

2025

Net loss

$ (604 )

$ (5,324 )

$ (5,356 )

$ (9,527 )

Interest expense, net

126

115

251

220

Income tax expense

Depreciation and amortization

120

EBITDA

(390 )

(5,167 )

(4,962 )

(9,242 )

Change in fair value of warrant liabilities

(44 )

(153 )

175

(702 )

Change in fair value of investment, related party

(2 )

Patent remediation – inventory write-down

Patent remediation expense

392

Stock-based compensation

263

187

605

426

Adjusted EBITDA

$ (170 )

$ (5,135 )

$ (3,731 )

$ (9,520 )

Adjusted EBITDA margin

-1.4 %

-56.9 %

-16.9 %

-54.0 %

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- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

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- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

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- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

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- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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Name:

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- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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- Definition

Local phone number for entity.

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No definition available.

+ Details

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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Namespace Prefix:

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- Definition

Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Name:

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Namespace Prefix:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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Namespace Prefix:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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