Form 8-K

8-K — Biofrontera Inc.

Accession: 0001493152-26-022875

Filed: 2026-05-14

Period: 2026-05-14

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): May 14, 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.

May 14, 2026, Biofrontera Inc. (the “Company”) issued a press release announcing its financial and operational results for

the three months ended March, 31, 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 May 14, 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.

May 14, 2026

Biofrontera

Inc.

(Date)

(Registrant)

/s/

E. Fred Leffler III

E. Fred Leffler, III

Chief Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Biofrontera

Inc. Reports First Quarter 2026 Financial Results and Provides a Business Update

Woburn,

MA (May 14, 2026) (GLOBE NEWSWIRE) — Biofrontera Inc. (NASDAQ: BFRI) (the “Company”), a biopharmaceutical company specializing

in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three

months ended March 31, 2026 and provided a business update.

First

Quarter Financial Highlights

● Revenues

for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period

in 2025.

● Gross

margins were about 80%, an 18 percentage points increase compared to approximately 62% in

Q1 2025, reflecting the first full quarter under the new earnout structure following the

closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic

Transaction”).

● Operating

loss was $4.3 million in Q1 2026 compared to a loss of $4.5 million in Q1 2025.

● Adjusted

EBITDA improved to $(3.6) million from $(4.4) million in Q1 2025, an improvement of approximately

$0.8 million reflecting expanded gross margins under the new earnout structure.

● With

$70 thousand used in operations, we largely maintained the operating cash balance we had at the end

of Q4 2025, with $6.3 million as of March 31, 2026, compared to $1.8 million in Q1 2025.

Recent

Operational Highlights

● Announced

FDA’s completion of its filing review and filing acceptance of the Company’s

supplemental New Drug Application (sNDA) for Ameluz® PDT for the treatment

of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September

28, 2026.

● Announced

positive and statistically significant top-line results from its Phase 3 clinical trial evaluating

Ameluz® PDT for the treatment of mild to moderate actinic keratoses (AKs)

on the extremities, neck, and trunk, meeting the primary endpoint.

● Announced

database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field

on extremities, neck and trunk with a treatment area of up to 240 cm².

● Announced

positive results of its Phase 2b clinical trial for the treatment of moderate to severe acne

vulgaris (AV), with a 58% reduction in inflammatory lesions in the 3-hour incubation protocol

with Ameluz® PDT, compared to 37% with vehicle PDT (PPS).

● Regained

compliance with the Nasdaq Minimum Bid Price Requirement as confirmed by Nasdaq on May 6,

2026.

Hermann

Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated: “The first quarter of 2026 marks the first full quarter

under our new cost structure following the Strategic Transaction, and the results speak clearly. Revenue grew 17% year over year, gross

margins expanded to approximately 80%, and our cash consumption was near zero—a dramatic improvement from $4.1 million of cash

consumption in the prior-year quarter. Our results were further driven by continued commercial momentum leading to significant uptake

of the Ameluz PDT platform by dermatologists and their patients.

At the same time, our clinical pipeline continues to advance at an accelerated pace. With a PDUFA date for sBCC in September 2026, positive

Phase 3 results in AK on neck/trunk and extremities, and encouraging Phase 2b data in acne, we have multiple near-term catalysts that

could meaningfully expand the commercial opportunity for the Ameluz platform.

We remain focused on our goal of reaching sustained profitability and cash-flow breakeven while setting the foundation for medium to

long-term growth, and I believe we are well positioned to help our customers and their patients and build long-term value for our shareholders.”

First

Quarter Financial Results

Total

revenues for the first quarter of 2026 were $10.1 million compared with $8.6 million for the first quarter of 2025. The 17% year-over-year

growth was primarily driven by approximately 16% growth in the number of Ameluz units sold and a price increase implemented in the fourth

quarter of 2025.

Gross

profit margin in the first quarter of 2026 was approximately 80% compared to approximately 62% in Q1 2025. Cost of revenues, related

party decreased by approximately 40% year over year, driven by the transition from the transfer pricing model under the prior license

and supply agreement to the significantly lower earnout structure in place following the Strategic Transaction. The Company recognized

$1.2 million in earnout expense during the quarter.

Total

operating expenses were $14.4 million for the first quarter of 2026 compared with $13.1 million for the first quarter of 2025.

Selling,

general and administrative expenses were $11.0 million for the first quarter of 2026 compared with $8.7 million for the first quarter

of 2025. The increase was primarily driven by higher selling and marketing costs reflecting lower sales team turnover during the period

leading to the full deployment of the direct sales team, increased legal expenses associated with ongoing patent-related claims, and

manufacturing-related costs of $0.6 million assumed in connection with the Strategic Transaction.

Research

and development expenses were $0.9 million for the first quarter of 2026 compared with $1.2 million for the first quarter of 2025. The

decrease was primarily attributable to certain clinical trials reaching substantial completion.

The

net loss for the first quarter of 2026 was $4.8 million, or $0.41 per share, compared with a net loss of $4.2 million, or $0.47 per share,

for the prior-year quarter. The net loss comparison was impacted by a $0.8 million swing in the non-cash change in fair value

of warrant liabilities.

Adjusted

EBITDA for the first quarter of 2026 was $(3.6) million compared with $(4.4) million for the first quarter of 2025, an improvement of

approximately $0.8 million. Adjusted EBITDA margin improved to (35.3)% from (51.0)% in the prior-year quarter. We look at Adjusted EBITDA,

a non-GAAP financial measure, as an indication of ongoing operations, defined as net income or loss excluding interest income and expense,

income taxes, depreciation and amortization, and certain other non-recurring or non-cash items.

Please

refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the first quarters of 2026 and 2025.

Conference

Call Details

Conference

call: Thursday, May 14, 2026 at 11:00 AM ET

Conference

Call:

1-877-877-1275

(U.S./Canada)

1-412-858-5202

(international)

Webcast:

Webcast

– Biofrontera Inc. 1Q26 Results Conference Call

https://event.choruscall.com/mediaframe/webcast.html?webcastid=Re1hZKm0

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.

Contacts

Investor Relations

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.

(Tables

follow)

BIOFRONTERA

INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share amounts)

March 31, 2026

(Unaudited)

December 31, 2025

ASSETS

Current assets:

Cash and cash equivalents

$ 6,317

$ 6,392

Investment, related party

Accounts receivable, net

3,879

7,291

Inventories

1,231

1,426

Prepaid expenses and other current assets

1,062

2,279

Other assets, related party

661

686

Total current assets

13,159

18,083

Inventories, long term

3,591

3,729

Property and equipment, net

2,175

2,158

Operating lease right-of-use assets

2,895

1,584

Intangible assets, net

2,609

2,650

Other assets

358

360

Total assets

$ 24,787

$ 28,564

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 3,634

$ 1,855

Accounts payable, related parties, net

1,315

4,811

Operating lease liabilities

506

332

Accrued expenses and other current liabilities

5,468

4,897

Total current liabilities

10,923

11,895

Long-term liabilities:

Convertible notes payable, net

4,719

4,589

Warrant liabilities

570

351

Operating lease liabilities, non-current

2,499

1,240

Other liabilities

Total liabilities

18,717

18,084

Total stockholders’ equity

6,070

10,480

Total liabilities and stockholders’ equity

$ 24,787

$ 28,564

BIOFRONTERA

INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts and number of shares)

Three Months Ended

March 31, 2026

(Unaudited)

Three Months Ended

March 31, 2025

(Unaudited)

Product revenues, net

$ 10,084

$ 8,588

Operating expenses

Cost of revenues, related party

1,831

3,075

Cost of revenues, other

285

193

Selling, general and administrative

10,994

8,653

Selling, general and administrative, related party

Patent remediation expense

392

—

Research and development

900

1,207

Total operating expenses

14,404

13,135

Loss from operations

(4,320 )

(4,547 )

Other income (expense)

Change in fair value of warrant liabilities

(219 )

548

Interest expense, net

(125 )

(106 )

Other expense, net

(88 )

(99 )

Total other income (expense)

(432 )

343

Loss before income taxes

(4,752 )

(4,204 )

Income tax benefit

—

(1 )

Net loss

$ (4,752 )

$ (4,203 )

Loss per common share:

Basic and diluted

$ (0.41 )

$ (0.47 )

Weighted-average common shares outstanding:

Basic and diluted

11,683,323

8,873,932

BIOFRONTERA

INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In Thousands)

Three Months Ended

March 31, 2026

(Unaudited)

Three Months Ended

March 31, 2025

(Unaudited)

Cash flows from operating activities:

Net loss

$ (4,752 )

$ (4,203 )

Adjustments to reconcile net loss to cash flows used in operations:

Depreciation and amortization

Reduction in the carrying amount of right-of-use assets

132

190

Stock-based compensation

342

239

Non-cash interest expense

130

119

Allowance for credit losses

(1 )

(46 )

Change in fair value of warrant liabilities

219

(548 )

Loss from termination of operating leases

—

Changes in operating assets and liabilities:

Accounts receivable

3,413

1,330

Other receivables, related party

Prepaid expenses and other assets

1,219

(224 )

Other assets, related party

—

Inventories

307

119

Accounts payable

1,780

1,444

Accounts payable, related parties, net

(3,497 )

(2,694 )

Operating lease liabilities

(10 )

(179 )

Accrued expenses and other liabilities

566

307

Cash flows used in operating activities

(70 )

(4,117 )

Cash flows from investing activities

Purchases of property and equipment

(5 )

(3 )

Cash flows used in investing activities

(5 )

(3 )

Net decrease in cash and cash equivalents

(75 )

(4,120 )

Cash, cash equivalents and restricted cash, at beginning of period

6,592

6,105

Cash, cash equivalents and restricted cash, at end of period

$ 6,517

$ 1,985

BIOFRONTERA

INC.

GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION

(In thousands)

Three Months Ended

March 31, 2026

(Unaudited)

Three Months Ended

March 31, 2025

(Unaudited)

Net loss

$ (4,752 )

$ (4,203 )

Interest expense, net

125

106

Income tax expense

—

(1 )

Depreciation and amortization

EBITDA

(4,572 )

(4,069 )

Change in fair value of warrant liabilities

219

(548 )

Stock-based compensation

342

239

Patent remediation - inventory write-down

—

Patent remediation expense

392

—

Adjusted EBITDA

$ (3,561 )

$ (4,378 )

Adjusted EBITDA margin

(35.3 )%

(51.0 )%

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Local phone number for entity.

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No definition available.

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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

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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

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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

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-Section 12

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- Definition

Name of the Exchange on which a security is registered.

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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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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

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-Section 14a

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Trading symbol of an instrument as listed on an exchange.

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No definition available.

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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

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-Section 425

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