Biofrontera Inc. Reports Second Quarter 2025 Financial Results and Provides a Business Update
Biofrontera Inc. (NASDAQ:BFRI) reported strong Q2 2025 financial results with total revenues of $9.0 million, marking a 15% increase year-over-year. The company achieved significant milestones, including a major restructuring of its relationship with Biofrontera AG, acquiring U.S. IP rights and NDAs for Ameluz® and RhodoLED®.
Key financial highlights include H1 2025 revenue of $17.7 million (up 12% YoY) and cash position of $7.2 million. The company secured an additional $11 million in funding and negotiated a new royalty structure of 12-15% with Biofrontera AG, replacing the previous 25-35% transfer pricing model.
Clinical progress includes completion of patient follow-up in sBCC Phase 3 study and enrollment completion in Phase 3 study for AK treatment and Phase 2b acne vulgaris study. A new U.S. patent extends Ameluz® protection through 2043.
Biofrontera Inc. (NASDAQ:BFRI) ha riportato solidi risultati finanziari nel secondo trimestre 2025 con ricavi totali di 9,0 milioni di dollari, segnando un aumento del 15% su base annua. La società ha raggiunto importanti traguardi, inclusa una ristrutturazione significativa del rapporto con Biofrontera AG, acquisendo i diritti di proprietà intellettuale negli USA e gli NDA per Ameluz® e RhodoLED®.
I principali indicatori finanziari includono ricavi del 1° semestre 2025 pari a 17,7 milioni di dollari (in crescita del 12% anno su anno) e una posizione di cassa di 7,2 milioni di dollari. L'azienda ha ottenuto un ulteriore finanziamento di 11 milioni di dollari e ha negoziato una nuova struttura di royalty del 12-15% con Biofrontera AG, sostituendo il precedente modello di transfer pricing del 25-35%.
I progressi clinici comprendono il completamento del follow-up dei pazienti nello studio di fase 3 per sBCC e il completamento dell'arruolamento nello studio di fase 3 per il trattamento delle AK (cheratosi attiniche) e nello studio di fase 2b sull'acne vulgaris. Un nuovo brevetto statunitense estende la protezione di Ameluz® fino al 2043.
Biofrontera Inc. (NASDAQ:BFRI) presentó sólidos resultados financieros del 2T 2025 con ingresos totales de 9,0 millones de dólares, un aumento del 15% interanual. La compañía alcanzó hitos importantes, incluida una reestructuración mayor de su relación con Biofrontera AG, adquiriendo los derechos de propiedad intelectual en EE. UU. y los NDA para Ameluz® y RhodoLED®.
Los aspectos financieros clave incluyen ingresos del 1S 2025 de 17,7 millones de dólares (subida del 12% interanual) y una posición de caja de 7,2 millones de dólares. La empresa aseguró 11 millones de dólares adicionales de financiación y negoció una nueva estructura de royalties del 12-15% con Biofrontera AG, reemplazando el anterior modelo de transfer pricing del 25-35%.
En materia clínica, se completó el seguimiento de pacientes en el ensayo de fase 3 para sBCC y el reclutamiento en el ensayo de fase 3 para el tratamiento de AK (queratosis actínica) y en el estudio de fase 2b para acné vulgar se dio por finalizado. Una nueva patente en EE. UU. extiende la protección de Ameluz® hasta 2043.
Biofrontera Inc. (NASDAQ:BFRI)는 2025년 2분기 강력한 실적을 발표했으며 총매출 900만 달러로 전년 동기 대비 15% 증가했습니다. 회사는 Biofrontera AG와의 관계를 대대적으로 재구성하여 Ameluz® 및 RhodoLED®에 대한 미국 내 지식재산권과 NDA를 취득하는 등 중요한 이정표를 달성했습니다.
주요 재무 하이라이트로는 2025년 상반기 매출 1,770만 달러(전년 대비 12% 증가)와 720만 달러의 현금 보유액이 있습니다. 회사는 추가로 1,100만 달러의 자금을 확보했으며 Biofrontera AG와의 기존 25-35% 이전가격(transfer pricing) 모델을 대체하는 12-15%의 새로운 로열티 구조를 협상했습니다.
임상 진행 상황으로는 sBCC 대상 3상 연구의 환자 추적 관찰이 완료되었고 AK(광화성 각화증) 치료를 위한 3상 연구와 중증도 2b 여드름 연구의 등록이 완료되었습니다. 미국 신규 특허로 Ameluz®의 보호 기간이 2043년까지 연장됩니다.
Biofrontera Inc. (NASDAQ:BFRI) a publié de solides résultats pour le T2 2025 avec un chiffre d'affaires total de 9,0 millions de dollars, soit une hausse de 15% sur un an. La société a atteint des étapes importantes, notamment une restructuration majeure de sa relation avec Biofrontera AG, acquérant les droits de PI aux États-Unis et les NDA pour Ameluz® et RhodoLED®.
Les points financiers clés comprennent des revenus du 1er semestre 2025 de 17,7 millions de dollars (en hausse de 12% en glissement annuel) et une position de trésorerie de 7,2 millions de dollars. L'entreprise a obtenu un financement supplémentaire de 11 millions de dollars et négocié une nouvelle structure de redevances de 12-15% avec Biofrontera AG, remplaçant l'ancien modèle de transfert de prix de 25-35%.
Les avancées cliniques incluent l'achèvement du suivi des patients dans l'étude de phase 3 sur sBCC et la fin du recrutement dans l'étude de phase 3 pour le traitement des AK (kératoses actiniques) ainsi que dans l'étude de phase 2b sur l'acné vulgaire. Un nouveau brevet américain prolonge la protection d'Ameluz® jusqu'en 2043.
Biofrontera Inc. (NASDAQ:BFRI) meldete starke Finanzergebnisse für das 2. Quartal 2025 mit Gesamtumsatz von 9,0 Mio. USD, was einem Anstieg von 15% gegenüber dem Vorjahr entspricht. Das Unternehmen erzielte wichtige Meilensteine, darunter eine wesentliche Umstrukturierung der Beziehung zu Biofrontera AG und die Übernahme der US-IP-Rechte sowie der NDA für Ameluz® und RhodoLED®.
Zentrale finanzielle Eckdaten sind Umsatz für H1 2025 von 17,7 Mio. USD (plus 12% im Jahresvergleich) und eine Barposition von 7,2 Mio. USD. Das Unternehmen sicherte sich zusätzliche 11 Mio. USD an Finanzmitteln und verhandelte mit Biofrontera AG eine neue Lizenzgebührenstruktur von 12–15%, die das bisherige Transferpreismodell von 25–35% ersetzt.
Der klinische Fortschritt umfasst den Abschluss der Nachbeobachtung der Patienten in der Phase‑3‑Studie zu sBCC sowie den Abschluss der Rekrutierung in der Phase‑3‑Studie zur AK‑Behandlung und in der Phase‑2b‑Studie zur Akne vulgaris. Ein neues US‑Patent verlängert den Schutz für Ameluz® bis 2043.
- Revenue growth of 15% YoY to $9.0 million in Q2 2025
- Secured additional $11 million in funding
- Reduced cost of goods through new royalty structure (12-15% vs previous 25-35%)
- Extended patent protection for Ameluz® through 2043
- Completed enrollment in multiple clinical trials expanding potential indications
- Increased sales volume by 9.5% for Ameluz®
- Net loss increased to $5.3 million in Q2 2025 from $0.3 million in Q2 2024
- Legal costs increased by $3.4 million
- Adjusted EBITDA remained negative at -$5.1 million in Q2 2025
- Total operating expenses increased to $14.1 million from $12.9 million YoY
Insights
Biofrontera shows 15% Q2 revenue growth and strategic restructuring, but widening losses amid higher legal costs.
Biofrontera's Q2 2025 results reveal a 15% year-over-year revenue increase to
The most significant strategic development is Biofrontera's restructured relationship with Biofrontera AG, which includes acquiring US intellectual property rights, NDAs, and manufacturing control for Ameluz® and RhodoLED®. This fundamental change reduces their royalty obligations from
However, despite the revenue growth and improved gross margins, Biofrontera's net loss widened to
Cash position improved to
The extended US patent protection for Ameluz® through 2043 significantly strengthens Biofrontera's long-term competitive positioning. While the company is making strategic progress and growing revenues, the substantial legal expenses and negative EBITDA indicate ongoing financial challenges that will require continued sales growth and cost management to overcome.
Woburn, MA, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy in dermatology, today reported financial results for the three and six months ended June 30, 2025 and provided a business update.
Highlights from the first six months of 2025 included the following:
- Total revenues for the second quarter of 2025 were
$9.0 million , a15% increase from the same period of the prior year - For the first six months of 2025, revenue was
$17.7 million , a12% increase from the comparable period in 2024 - Cash and cash equivalents were
$7.2 million as of June 30, 2025, compared with$5.9 million at December 31, 2024 - Agreed to major restructuring of relationship with Biofrontera AG, including acquisition of United States Intellectual Property (IP) and New Drug Applications (NDA) and control of manufacturing, supported by an addition
$11 million in funding for the company - US patent on revised formulation of Ameluz® granted, extending patent protection through to December 2043
- Announced last patient completing 1 year follow-up in superficial basal cell carcinoma (sBCC) Phase 3 study
- Completed patient enrollment in Phase 3 study with Ameluz® for mild to moderate actinic keratosis (AK) on the entire body and in Phase 2b study for the treatment of moderate to severe acne vulgaris
Hermann Luebbert, Chief Executive Officer and Chairman of the Company, stated, "We have changed our approach to our business in 2025 by transforming our customer segmentation, focusing our strategy and using extended data analysis to support our sales team effectiveness. This led to two very gratifying quarters for us driven by customer growth and disciplined execution resulting in increased sales volume and higher revenues. In addition to Ameluz® treating pre-cancerous skin lesions on the face and scalp, we are very encouraged about the potential for Ameluz® to be used more broadly to treat AK on the entire body, and the potential label extension to basal cell carcinoma and acne vulgaris.”
“In addition, we recently announced a fundamental change in our agreement with Biofrontera AG which includes acquiring all the rights, approvals and patents to Ameluz® and RhodoLED® in the United States. This has been a long process that began June 1, 2024 when we assumed control of all clinical studies relating to Ameluz® in the United States, a move that has given us direct oversight of trial efficiency and more effective cost management. We are now in the process of transferring the US IP, NDA, and manufacturing capabilities for Ameluz® and the RhodoLED® lamps. We will pay a monthly Ameluz® royalty of
Prof. Luebbert concluded by saying “The
Second Quarter Financial Results
Total revenues for the second quarter of 2025 were
Total operating expenses were
Selling, general and administrative expenses were
The net loss for the second quarter of 2025 was
Adjusted EBITDA for the second quarter of 2025 was negative
Please refer to the table below which presents a GAAP to non- GAAP reconciliation of Adjusted EBITDA for the second quarters of 2025 and 2024.
Six Month Financial Results
Total revenues were
Total operating expenses were
Selling, general and administrative expenses increased to
Adjusted EBITDA was negative
Conference Call Details
Conference call: Thursday, August 14, 2025 at 10:00 AM ET
Toll Free: 1-877-877-1275 (U.S. toll-free) International: 1-412-858-5202
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=eaQgqzXL
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 a focus on photodynamic therapy (PDT) and topical antibiotics. The Company's licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions.. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.
Contacts Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.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. These statements include, but are not limited to, statements relating to the Company's revenue guidance, business and marketing strategy, revenue growth, sales force productivity, growth strategy, liquidity and cash flow, potential to expand the label of Ameluz®, available market opportunities for Ameluz®, ongoing clinical trials, and other statements that are not historical facts. The words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential", "target", "goal", "assume", "would", "could" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. 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, our reliance on sales of products we currently license from other companies as our sole source of revenue; the success of our competitors in developing generic topical dermatological products that successfully compete with our licensed products; the success of our principal licensed product, Ameluz®; the ability of the Company's licensors to establish and maintain relationships with contract manufacturers that are able to supply the Company with enough of our products to meet our demand; the ability of our licensors or their manufacturing partners to supply the licensed products that we market in sufficient quantities and at acceptable quality and cost levels, and to fully comply with current good manufacturing practice or other applicable manufacturing regulations; the ability of our licensors to successfully defend or enforce patents related to our licensed products; the availability of insurance coverage and medical expense reimbursement for our licensed products; the impact of legislative and regulatory changes; competition from other pharmaceutical and medical device companies and existing treatments, such as simple curettage and cryotherapy; the Company's ability to achieve and sustain profitability; the Company's ability to obtain additional financing as needed to implement its growth strategy; the Company's ability to retain and hire key personnel; 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. 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 undertake 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.
(Tables follow)
BIOFRONTERA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value and share amounts)
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,239 | $ | 5,905 | ||||
| Investment, related party | 9 | 7 | ||||||
| Accounts receivable, net | 3,955 | 5,315 | ||||||
| Inventories, net | 4,028 | 6,646 | ||||||
| Prepaid expenses and other current assets | 331 | 527 | ||||||
| Asset held for sale | 2,300 | 2,300 | ||||||
| Other assets, related party | 953 | - | ||||||
| Total current assets | 18,815 | 20,700 | ||||||
| Property and equipment, net | 37 | 80 | ||||||
| Operating lease right-of-use assets | 729 | 903 | ||||||
| Intangible assets, net | 26 | 35 | ||||||
| Other assets | 535 | 383 | ||||||
| Total assets | $ | 20,142 | $ | 22,101 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 4,268 | 1,856 | ||||||
| Accounts payable, related parties, net | 670 | 5,344 | ||||||
| Operating lease liabilities | 443 | 548 | ||||||
| Advance from Stockholders | 8,500 | - | ||||||
| Accrued expenses and other current liabilities | 5,806 | 4,273 | ||||||
| Total current liabilities | 19,687 | 12,021 | ||||||
| Long-term liabilities: | ||||||||
| Convertible notes payable, net | 4,338 | 4,098 | ||||||
| Warrant liabilities | 548 | 1,250 | ||||||
| Operating lease liabilities, non-current | 223 | 276 | ||||||
| Other liabilities | 14 | 23 | ||||||
| Total liabilities | 24,810 | 17,668 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ (deficit) equity: | ||||||||
| Preferred Stock | - | - | ||||||
| Common Stock | 9 | 9 | ||||||
| Additional paid-in capital | 122,259 | 121,833 | ||||||
| Accumulated deficit | (126,936 | ) | (117,409 | ) | ||||
| Total stockholders’ (deficit) equity | (4,668 | ) | 4,433 | |||||
| Total liabilities and stockholders’ equity | $ | 20,142 | $ | 22,101 | ||||
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, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product revenues, net | $ | 9,030 | $ | 7,831 | $ | 17,617 | $ | 15,732 | ||||||||
| Revenues, related party | - | 8 | - | 18 | ||||||||||||
| Total revenues, net | 9,030 | 7,839 | 17,617 | 15,750 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenues, related party | 2,380 | 4,092 | 5,455 | 8,038 | ||||||||||||
| Cost of revenues, other | 262 | 250 | 455 | 421 | ||||||||||||
| Selling, general and administrative | 10,528 | 7,915 | 19,183 | 17,163 | ||||||||||||
| Selling, general and administrative, related party | 69 | 32 | 76 | 29 | ||||||||||||
| Research and development | 870 | 621 | 2,077 | 637 | ||||||||||||
| Total operating expenses | 14,109 | 12,910 | 27,246 | 26,288 | ||||||||||||
| Loss from operations | (5,079 | ) | (5,071 | ) | (9,629 | ) | (10,538 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Change in fair value of warrants | 153 | 5,438 | 702 | 2,009 | ||||||||||||
| Change in fair value of investment, related party | 2 | (14 | ) | 2 | (11 | ) | ||||||||||
| Loss on debt extinguishment | - | - | - | (316 | ) | |||||||||||
| Interest expense, net | (115 | ) | (596 | ) | (220 | ) | (2,003 | ) | ||||||||
| Other income, net | (264 | ) | 6 | (363 | ) | 186 | ||||||||||
| Total other income (expense) | (224 | ) | 4,834 | 121 | (135 | ) | ||||||||||
| Loss before income taxes | (5,303 | ) | (237 | ) | (9,508 | ) | (10,673 | ) | ||||||||
| Income tax expense | 21 | 20 | 19 | 21 | ||||||||||||
| Net loss | $ | (5,324 | ) | $ | (257 | ) | $ | (9,527 | ) | $ | (10,694 | ) | ||||
| Loss per common share: | ||||||||||||||||
| Basic and diluted | $ | (0.57 | ) | $ | (0.05 | ) | $ | (1.05 | ) | $ | (2.45 | ) | ||||
| Weighted-average common shares outstanding: | ||||||||||||||||
| Basic and diluted | 9,351,557 | 5,091,353 | 9,108,091 | 4,357,474 | ||||||||||||
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, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss | $ | (5,324 | ) | $ | (257 | ) | $ | (9,527 | ) | $ | (10,694 | ) | ||||
| Interest expense, net | 115 | 596 | 220 | 2,003 | ||||||||||||
| Income tax expenses | 21 | 20 | 19 | 21 | ||||||||||||
| Depreciation and amortization | 22 | 130 | 46 | 258 | ||||||||||||
| EBITDA | (5,166 | ) | 489 | (9,242 | ) | (8,412 | ) | |||||||||
| Loss on debt extinguishment | - | - | - | 316 | ||||||||||||
| Change in fair value of warrant liabilities | (153 | ) | (5,438 | ) | (702 | ) | (2,009 | ) | ||||||||
| Change in fair value of investment, related party | (2 | ) | 14 | (2 | ) | 11 | ||||||||||
| Stock based compensation | 187 | 204 | 426 | 432 | ||||||||||||
| Expensed issuance costs | - | - | - | 354 | ||||||||||||
| Adjusted EBITDA | $ | (5,135 | ) | $ | (4,731 | ) | $ | (9,520 | ) | $ | (9,308 | ) | ||||
| Adjusted EBITDA margin | -56.9 | % | -60.3 | % | -54.0 | % | -59.1 | % | ||||||||
FAQ
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