Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG

Rhea-AI Summary

Biofrontera Inc. (Nasdaq: BFRI) closed its restructuring and asset purchase with former parent Biofrontera AG on October 23, 2025, acquiring all U.S. assets and rights to Ameluz and RhodoLED, including the NDA, IND, manufacturing contracts, intellectual property, and related personnel.

The deal replaces a perpetual transfer-pricing model with a capped monthly earnout of 12% on U.S. net sales up to $65 million and 15% above that threshold, with payments ending at patent expiry. The transaction was funded by an $11 million investment (with $8.5M earlier funded and $2.5M released at closing) led by Rosalind Advisors and AIGH Capital, and Biofrontera AG received a 10% post-money equity stake. The company expects full asset/personnel transfer by late Q4 2025 or early Q1 2026 and anticipates gross margin expansion starting Q4 2025.

Positive

• Earnout reduced to 12%–15% of U.S. net sales
• Transaction funded by $11 million investment
• 10% post-money equity granted to Biofrontera AG
• Acquired U.S. NDA, IND, IP, and manufacturing rights

Negative

• Assumes full U.S. manufacturing, regulatory, and pharmacovigilance responsibilities
• Asset/personnel transfer expected by late Q4 2025–early Q1 2026 (timing risk)

Insights

Corporate Finance and Commercialization Analyst

Acquiring full U.S. rights and an NDA, cutting ongoing payments, and closing final financing materially strengthens the company's path to profitability.

By taking ownership of the U.S. NDA, manufacturing contracts, personnel, and patents for Ameluz® and RhodoLED®, the company internalizes all commercial and regulatory control and removes the prior transfer-pricing reliance. The replacement of a perpetual 25%–35% per‑tube payment with a monthly earnout of 12% up to $65 million and 15% above that should meaningfully reduce unit economics pressure and improve gross margins beginning in Q4 2025.

Key dependencies and risks remain: successful operational transfer of manufacturing, quality, and pharmacovigilance responsibilities; completion of full asset/personnel transfers by late Q4 2025 or early Q1 2026; and the company’s ability to convert the new capital into sustainable cash flow. The transaction funding structure—$11 million total, with $8.5 million already funded and the closing releasing the final $2.5 million—reduces near-term liquidity risk but leaves future financing sensitivity if commercial uptake lags.

Monitor three concrete items over the next 6–12 months: integration milestones for manufacturing and quality systems, actual U.S. net sales relative to the $65 million threshold that changes the earnout rate, and quarterly cash-burn versus runway now supported by the $11 million financing. These observable metrics will show whether the structural cost reduction and capital infusion translate into the claim of accelerated path to break-even.

• Biofrontera Inc. acquires full U.S. rights to Ameluz^® and RhodoLED^®, including New Drug Application and associated patents, from former parent Biofrontera AG.
• New earnout structure reduces payment rate to 12%–15% of U.S. net sales from 25%–35%.
• Closing releases final $2.5 million of $11 million financing led by existing investors Rosalind Advisors and AIGH Capital Management, which is expected to fund Biofrontera Inc. to profitability.
  

WOBURN, Mass., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the closing of its restructuring and asset purchase agreement with its former parent company, Biofrontera AG. Under the transaction, Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz^® and RhodoLED^®, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights and contracts, all intellectual property, and related personnel.

As a result of the transaction, Biofrontera Inc. will now pay a monthly earnout of 12% in years where annual U.S. net sales of Ameluz^® are up to $65 million, and 15% in years where U.S. net sales are above that threshold. These payments will cease upon patent expiry. This replaces the prior transfer-pricing model under which the Company paid perpetual 25%–35% of net sales per tube, depending on timing and indication. The new structure reduces overall cost for Biofrontera Inc. and is expected to accelerate the Company’s timeframe to reach break-even.

With the completion of this agreement, Biofrontera Inc. now assumes full responsibility for manufacturing, regulatory, quality management, pharmacovigilance, and commercialization of Ameluz^® and the RhodoLED^® portfolio in the U.S. The Company expects the full transfer of assets and personnel to be completed by late Q4 2025 or early Q1 2026.

The transaction was funded through an $11 million investment led by existing investors Rosalind Advisors, Inc. and AIGH Capital Management LLC, $8.5 million of which was funded at the time of term-sheet execution. As part of the transaction, Biofrontera AG has received a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the two entities.

“This is a transformative transaction that strengthens Biofrontera’s financial and operational profile,” said Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. “The significantly reduced earnout structure is expected to drive meaningful gross margin expansion starting in the fourth quarter of 2025. Coupled with the new capital infusion, this positions us to accelerate Ameluz^® growth and advance label expansion into additional indications.”

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz^® with the RhodoLED^® lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X .

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, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, 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: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz^® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s products; whether the market opportunity for Ameluz^® in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Investor Relations Contact

Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

FAQ

What did Biofrontera Inc. (BFRI) acquire on October 23, 2025?

Biofrontera acquired all U.S. assets and rights to Ameluz and RhodoLED, including the NDA, IND, IP, manufacturing contracts, and related personnel.

How did the earnout change for Ameluz under Biofrontera Inc.'s deal (BFRI)?

The earnout was replaced with monthly payments of 12% on U.S. net sales up to $65M and 15% on sales above $65M, ending at patent expiry.

How was the Biofrontera Inc. purchase financed and what was the amount?

The transaction was funded by an $11 million investment led by Rosalind Advisors and AIGH Capital, with $8.5M funded earlier and $2.5M released at closing.

What equity stake did Biofrontera AG receive from Biofrontera Inc. (BFRI)?

Biofrontera AG received a 10% post-money equity stake in Biofrontera Inc.

When does Biofrontera Inc. expect the U.S. asset and personnel transfer to complete?

The company expects the full transfer by late Q4 2025 or early Q1 2026.

What near-term financial impact did Biofrontera Inc. (BFRI) highlight from the deal?

Management said the reduced earnout is expected to drive meaningful gross margin expansion starting Q4 2025 and help accelerate the path to break-even.