8-K
Biofrontera Inc. (BFRI)
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
Dateof Report (Date of earliest event reported): May 14, 2026
BiofronteraInc.
(Exactname of registrant as specified in its charter)
| Delaware | 001-40943 | 47-3765675 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
| 660 Main Street, First Floor<br><br> <br>Woburn, Massachusetts | 01801 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’stelephone number, including area code: (781) 245-1325
NotApplicable
(Formername 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<br> pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant<br> to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications<br> 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. ☐
Item2.02 Results of Operations and Financial Condition.
On 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.
Item9.01 Financial Statements and Exhibits.
| 99.1 | Press release dated May 14, 2026 |
|---|---|
| 104 | Cover Page Interactive<br> 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 |
Exhibit 99.1
BiofronteraInc. 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<br> for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period<br> in 2025. |
|---|---|
| ● | Gross<br> margins were about 80%, an 18 percentage points increase compared to approximately 62% in<br> Q1 2025, reflecting the first full quarter under the new earnout structure following the<br> closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic<br> Transaction”). |
| ● | Operating<br> loss was $4.3 million in Q1 2026 compared to a loss of $4.5 million in Q1 2025. |
| ● | Adjusted<br> EBITDA improved to $(3.6) million from $(4.4) million in Q1 2025, an improvement of approximately<br> $0.8 million reflecting expanded gross margins under the new earnout structure. |
| ● | With<br> $70 thousand used in operations, we largely maintained the operating cash balance we had at the end<br> of Q4 2025, with $6.3 million as of March 31, 2026, compared to $1.8 million in Q1 2025. |
Recent Operational Highlights
| ● | Announced<br> FDA’s completion of its filing review and filing acceptance of the Company’s<br> supplemental New Drug Application (sNDA) for Ameluz^®^ PDT for the treatment<br> of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September<br> 28, 2026. |
|---|---|
| ● | Announced<br> positive and statistically significant top-line results from its Phase 3 clinical trial evaluating<br> Ameluz^®^ PDT for the treatment of mild to moderate actinic keratoses (AKs)<br> on the extremities, neck, and trunk, meeting the primary endpoint. |
| ● | Announced<br> database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field<br> on extremities, neck and trunk with a treatment area of up to 240 cm². |
| ● | Announced<br> positive results of its Phase 2b clinical trial for the treatment of moderate to severe acne<br> vulgaris (AV), with a 58% reduction in inflammatory lesions in the 3-hour incubation protocol<br> with Ameluz^®^ PDT, compared to 37% with vehicle PDT (PPS). |
| ● | Regained<br> compliance with the Nasdaq Minimum Bid Price Requirement as confirmed by Nasdaq on May 6,<br> 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<br> (U.S./Canada)<br><br> <br>1-412-858-5202<br> (international) |
|---|---|
| Webcast: | Webcast<br> – Biofrontera Inc. 1Q26 Results Conference Call<br><br> <br>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<br> (Unaudited) | December 31, 2025 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ | 6,317 | $ | 6,392 |
| Investment, related party | 9 | 9 | ||
| 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 | 6 | 9 | ||
| 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<br> March 31, 2026<br> (Unaudited) | Three Months Ended<br> March 31, 2025<br> (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 | 2 | 7 | ||||
| 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<br> March 31, 2026<br> (Unaudited) | Three Months Ended<br> March 31, 2025<br> (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 | 55 | 29 | ||||
| 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 | 1 | — | ||||
| Changes in operating assets and liabilities: | ||||||
| Accounts receivable | 3,413 | 1,330 | ||||
| Other receivables, related party | 1 | - | ||||
| Prepaid expenses and other assets | 1,219 | (224 | ) | |||
| Other assets, related party | 25 | — | ||||
| 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<br> <br>(Unaudited) | Three Months Ended March 31, 2025<br> <br>(Unaudited) | |||||
|---|---|---|---|---|---|---|
| Net loss | $ | (4,752 | ) | $ | (4,203 | ) |
| Interest expense, net | 125 | 106 | ||||
| Income tax expense | — | (1 | ) | |||
| Depreciation and amortization | 55 | 29 | ||||
| EBITDA | (4,572 | ) | (4,069 | ) | ||
| Change in fair value of warrant liabilities | 219 | (548 | ) | |||
| Stock-based compensation | 342 | 239 | ||||
| Patent remediation - inventory write-down | 58 | — | ||||
| Patent remediation expense | 392 | — | ||||
| Adjusted EBITDA | $ | (3,561 | ) | $ | (4,378 | ) |
| Adjusted EBITDA margin | (35.3 | )% | (51.0 | )% |