View ValuationBiofrontera 将来の成長Future 基準チェック /56Biofronteraは、61.3%と22.4%でそれぞれ年率61.3%で利益と収益が成長すると予測される一方、EPSはgrowで65.5%年率。主要情報61.3%収益成長率65.52%EPS成長率Pharmaceuticals 収益成長23.4%収益成長率22.4%将来の株主資本利益率n/aアナリストカバレッジLow最終更新日25 Nov 2024今後の成長に関する最新情報お知らせ • Jan 13Biofrontera Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025Biofrontera Inc. provided earnings guidance for the fourth quarter and full year ended December 31, 2025. For the quarter, revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history. For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026.Breakeven Date Change • Mar 20Forecast breakeven date pushed back to 2026The 2 analysts covering Biofrontera previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 61% per year to 2025. The company is expected to make a profit of US$6.69m in 2026. Average annual earnings growth of 66% is required to achieve expected profit on schedule.Breakeven Date Change • Mar 01Forecast to breakeven in 2025The 2 analysts covering Biofrontera expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$23.0k in 2025. Average annual earnings growth of 62% is required to achieve expected profit on schedule.すべての更新を表示Recent updatesお知らせ • May 09Biofrontera Inc. to Report Q1, 2026 Results on May 14, 2026Biofrontera Inc. announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 14, 2026お知らせ • May 05Biofrontera Inc., Annual General Meeting, Jun 11, 2026Biofrontera Inc., Annual General Meeting, Jun 11, 2026. Location: meetnow.global/mvwjynq, United Statesお知らせ • Mar 10+ 1 more updateBiofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development Of Ameluz Photodynamic Therapy For Moderate To Severe Acne VulgarisBiofrontera Inc. announced results of its Phase 2b clinical trial evaluating Ameluz (aminolevulinic acid HCL) topical gel, 10% PDT for the treatment of moderate to severe acne vulgaris (AV). The multicenter, randomized, double-blind study compared Ameluz and vehicle gel using two incubation times (1 hour and 3 hours) prior to illumination with the BF-RhodoLED lamp. Participants received one tube of Ameluz or vehicle gel applied to the entire face, followed by incubation and illumination with the red light. Up to three PDT treatments were administered at one-month intervals, and patients were followed up for two months after receiving the final PDT treatment. The study had co-primary endpoints, one of which looked at the relative reduction in inflammatory lesion counts. The other required an improvement of at least two grades on a 5-point modified Investigator Global Assessment (mIGA) scale and that the patient was rated “clear” or “almost clear” (score 0 or 1). Greater improvements in both inflammatory lesion counts and mIGA scores were observed with Ameluz vs. vehicle with the 3-hour incubation regimen, identifying this as the most promising protocol for further clinical investigation in acne vulgaris. In the 3-hour per-protocol population, the Ameluz group achieved a 57.97% reduction in inflammatory lesions (n=20), compared with 36.51% (n=14) in the corresponding vehicle group. For the mIGA analysis, 25% of the Ameluz treated patients met this co-primary endpoint with 21.4% of the vehicle patients achieving the same outcome. Reductions in absolute lesion counts further supported the efficacy of the 3-hour regimen. The values for inflammatory, non-inflammatory and total lesion reductions were 19.7, 23.1 and 42.7 with Ameluz vs. 15.4, 16.5 and 31.9 with vehicle. Ameluz PDT demonstrated a favorable safety profile consistent with previously reported photodynamic therapy experience. The most frequently reported treatment-related adverse events were burning sensation and pruritus, both of which were generally mild to moderate in severity. In addition, the average pain scores during the 3-hour incubation PDT treatments were modest, with the values in the Ameluz group ranging from 3.4 to 3.8, and from 2.0 to 2.1 with vehicle on an 11-point scale. Participants reported high overall satisfaction with PDT treatment. Of the patients who underwent the 3-hour Ameluz incubation, 85.7% said they would choose PDT again and 71.4% of them rated their esthetic outcome as “good” or “very good”. Acne vulgaris is one of the most common dermatologic conditions in the US, affecting millions of patients and representing a large treatment market. It may lead to permanent scarring and can carry a significant psychosocial burden, including reduced self-esteem and depression. Current treatment options include topical therapies requiring long-term daily treatment, and systemic antibiotic and oral isotretinoin which may have significant safety considerations. Additionally, increasing antibiotic resistance continues to drive interest in alternative treatment approaches. As an in-office physician-administered procedure, photodynamic therapy may offer dermatologists an alternative treatment option with a high rate of compliance and that avoids patients having to undergo chronic systemic exposure. The Company plans to present these Phase 2b data to the U.S. Food and Drug Administration (FDA) in Third Quarter 2026 to discuss potential next steps to develop Ameluz PDT for the treatment of acne vulgaris.お知らせ • Feb 27U.S. Patent Board Rules Sun Pharmaceutical Industries, Inc’s Patent Is Unpatentable After Biofrontera ChallengeBiofrontera Inc. announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries Inc.’s U.S. Patent No. 11,697,028 to be unpatentable. As previously disclosed in Biofrontera’s filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of the ‘028 Patent and a related patent, U.S. Patent No. 11,446,512 (the “’512 Patent”). In response to these proceedings, Biofrontera challenged the validity of Sun Pharma’s asserted claims by filing petitions for Inter Partes Review with the Board. The Board has now agreed with Biofrontera on all challenged claims of the ‘028 Patent. Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit. The decision does not affect the petition filed by the Company relating to the ‘512 patent, which was denied review by the Patent Office on administrative, rather than substantive, grounds.お知らせ • Feb 18Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz®? for Actinic Keratoses on Trunk and ExtendeditiesBiofrontera Inc. announced that the database of its Phase 1 PK study evaluating Ameluz®? (aminolevulinic acid hydrochloride) topical gel for the treatment of mild to moderate actinic keratoses (AKs) on neck, trunk and trunk and trunk was locked on February 11, 2026. The Phase 1, non-randomized, open-label study assessed systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during photodynamic therapy (PDT) with Ameluz®? in combination with the red-light BF-RhodoLED®? XL lamp. The study was designed to investigate the pharmacokinetics of 5-aminolevulinIC acid (ALA) and protoporphyrin IX ("PpIX") under maximal use conditions during and after treatment with 3 entire tubes of Ameluz®? applied to an approximately 240 cm2 treatment field. Seventeen patients received a single PDT treatment with Ameluz®?. Plasma concentrations of ALA and PpIX were then measured for a 10-hour period following application. Together with the Company's previously announced positive Phase 3 clinical results evaluating Ameluz®? PDT for mild to moderate AKs on the extremities, neck and trunk, the PK data are intended to support a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for expansion of the current label. This submission is expected in the third quarter of 2026 and aims at extending the label from the currently approved indication of an up to 60 cm2 treatment field with AK on the face and scalp to an AK treatment field of up to 240 cm2 on other body parts.お知らせ • Feb 11Biofrontera Inc. Announces U.S. Food and Drug Administration Filing Acceptance of Supplemental New Drug Application for Ameluz PDT in Superficial Basal Cell CarcinomaBiofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Company's supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED®? red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026. If approved, this new indication would represent a significant clinical expansion of the Ameluz®? PDT platform beyond its existing FDA approval for treatment of actinic keratosis. It would also further validate Biofrontera's PDT approach, which combines Ameluz®?'s nanoemulsion technology with red-light illumination designed to penetrate deeper into tissue compared with shorter wavelengths of light such as green and blue, enabling treatment of lesions extending into deeper skin layers. Basal cell carcinoma is the most common cancer in the U.S., with approximately 3.6 million cases diagnosed annually, and published estimates suggest that 10-25% of these cases are of the superficial subtype2,3,4. If approved, Ameluz®? PDT for the treatment of SBCC would offer dermatology providers and their patients a non-invasive treatment option aligned with real-world practice needs. 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 cancers5. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements make. These risks and uncertainties, many of which are beyond the 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 sustainability; whether 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 coverage, reimbursement and pricing for procedures using the Company's products; whether the market opportunity for Ameluz®? in addition with BF-Rhodo LED®? 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 will be available for the Company's financial resources and need for additional financing.お知らせ • Feb 10Biofrontera Announces Positive Results in Phase 3 Study of Ameluz PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary EndpointBiofrontera Inc. announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz®? PDT with the red-light LED (RhodoLED) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. The multicenter, randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy and tolerability of field-directed Ameluz PDT compared with vehicle PDT in patients with AKs located on the extremities, neck., and trunk. The study enrolled 172 patients, randomized 4:1 to receive Ameluz gel or vehicle gel, respectively. Based on these positive Phase 3 results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026.お知らせ • Jan 13Biofrontera Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025Biofrontera Inc. provided earnings guidance for the fourth quarter and full year ended December 31, 2025. For the quarter, revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history. For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026.お知らせ • Jan 08+ 1 more updateBiofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory MilestonesBiofrontera Inc. announced the successful database lock of two clinical studies evaluating Ameluz®? PDT, marking an important milestone ahead of several anticipated data and regulatory events in 2026. The databases for the treatment phase of the Company's Phase 3 clinical study evaluating Ameluz®?PD for the treatment of actinic keratosis (AK) on the extremities, neck and trunk as well as its Phase 2 clinical study evaluating the treatment of moderate to severe acne vulgaris were successfully locked on January 5, 2026. All data from participants that is collected throughout each study is captured in a specific database. Locking the database enables unblinding and statistical analysis of the study results in accordance with the pre-specified study endpoints. Biofrontera expects data for both studies to be available in February of this year. Pending positive outcomes of the Phase 3 AK study, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in Summer of 2026 to expand the approved use of Ameluz®? PDT for AK beyond the face and scalp. Results from the Phase 2 acne vulgaris study are expected to be presented to the FDA in early Third Quarter 2026 and are intended to provide the basis of a future Phase 3 program, with the goal of achieving approval for Ameluz®? PDT in this indication. Together with the submission in December 2025 of the Company's sNDA for the treatment of superficial Basal Cell Cell Canceroma (sBCC) with Ameluz®? PST, these milestones support Biofrontera's strategy to expand the clinical utility of its PDT platform and advance additional growth opportunities. The 1-year follow-up phase of the phase III study on AK is still ongoing, but not required for FDA approval of the indication.お知らせ • Dec 18Biofrontera Inc. Completes Transfer of Ameluz®? and RhodoLED®? FDA Approval and Associated Intellectual Property PortfolioBiofrontera Inc. announced the completion of the transfer of the FDA approvals for Ameluz and the RhodoLED Lamp Series, including the NDA and the Investigational New Drug Application (IND), to Biofrontera. In addition, the Company has completed all necessary filings to transfer all US and some international intellectual property associated with Ameluz and the RhodiLED Lamp Series, including 11 granted US patents, 10 US patent applications, and 19 patent filings or registered designs outside of the US. The registration of the assignment to Biofrontera of all associated trademarks has also been initiated. These asset transfers were secured, in part, by an $11.0 million investment recently reported by the Company.お知らせ • Dec 04Last Patient Completes Biofrontera's Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and ExtremitiesBiofrontera Inc. announced the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas). The last patient visit took place on 24 November 2025. Data from this study, together with results from Biofrontera's recently completed Phase 3 clinical trial, will form the basis of a planned supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the Ameluz® label to include the treatment of AKs on all peripheral body areas. Actinic Keratoses commonly occur on sun-exposed areas across the body and may progress to squamous cell carcinoma if left untreated. Expanding Ameluz®'s current FDA approval for use beyond the face and scalp would address a critical unmet need in dermatology. This open-label Phase 1 study assessed the PK profile of 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during Ameluz®-PDT of the upper extremities, neck or trunk using the BF-RhodoLED® XL lamp. Pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (s NDA) to the Food and Drug Administration ("FDA") in the Summer of 2026.お知らせ • Dec 02Biofrontera Inc. Announces Filing of Supplemental New Drug Application (Snda) for the Treatment of Superficial Basal Cell Carcinoma with Ameluz®?-PdtBiofrontera Inc. announced the submission of an sNDA to the FDA, seeking approval of Ameluz-PDT for the treatment of sBCC. The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera's U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz label to include treatment of sBCC treatment with PDT using its BF-RhodoLED or RhodoLED XL red light lamps. Participants received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart. If required, a second treatment cycle was repeated at three months. The study's primary endpoint was a composite measure of complete clinical and histological clearance of one preselected "main target lesion" (MTL) at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), a highly significant statistical difference (p(JAAD) summarized "The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in the publication reinforce the value of Ameluz-PD T for the treatment of sBC C. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.お知らせ • Nov 07Biofrontera Inc. to Report Q3, 2025 Results on Nov 12, 2025Biofrontera Inc. announced that they will report Q3, 2025 results at 4:00 PM, US Eastern Standard Time on Nov 12, 2025お知らせ • Oct 24+ 1 more updateBiofrontera Inc. (NasdaqCM:BFRI) completed the acquisition of US Assets related to Ameluz and RhodoLED of Biofrontera AG.Biofrontera Inc. (NasdaqCM:BFRI) signed an agreement to acquire US Assets related to Ameluz and RhodoLED of Biofrontera AG on June 30, 2025. The transaction coupled with an $11 million financing led by existing investors, Rosalind Advisors and AIGH Capital Management LLC, funded the acquisition and transfer costs. Upon completion, Biofrontera Inc. will pay a monthly Ameluz® royalty of 12% in years where Ameluz® revenue in the US is less than $65 million, and 15% in years when revenue exceeds that threshold. The new royalty replaces the former transfer pricing model which required payment of 25% to 35% of the net sales price per tube depending on timing and indication. As part of the agreement, Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the entities. Biofrontera Inc. (NasdaqCM:BFRI) completed the acquisition of US Assets related to Ameluz and RhodoLED of Biofrontera AG on October 23, 2025. On completion, 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.お知らせ • Sep 17Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz Topical GelBiofrontera Inc. announced that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz®? (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Second Quarter 2026. Actinic keratosis is a common precancerous skin condition found on sun-exposed areas of the body: 58 million US adults have at least one AK lesion1. In total, 172 subjects were enrolled in the study. The 12-month follow-up Phase 3 study is expected to be completed by Second Quarter 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter.お知らせ • Aug 26Biofrontera Inc. Announces Last-Patient-Out in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne VulgarisBiofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz®? (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025. Acne vulgaris is a common skin condition characterized by inflammatory and non-inflammatory lesions that frequently lead to permanent scarring. Beyond the physical burden, AV often has a significant psychological impact, including reduced self-esteem and depression. Many of these patients continue to rely on regimens that carry significant treatment burdens including cost, adverse effects and the necessity for prolonged treatments. Expanding the use of Ameluz®? to treat acne would be a valuable advancement for both physicians and patients. The company look forward to the study results with great anticipation. Pending positive results, the Company intends to present the findings to the U.S. Food Drug Administration (FDA) in early Third Quarter 2026 as the basis for a future Phase III program, with the goal of achieving approval for Ameluz®? PDT for the treatment of acne vulgaris.お知らせ • Aug 12Biofrontera Inc. Appoints George Jones as Chief Commercial Officer, Effective August 25, 2025Biofrontera Inc. announced the appointment of George Jones as Chief Commercial Officer (CCO), starting August 25, 2025. In this role, Mr. Jones will oversee the Company’s commercial functions, including sales, marketing, and market access. He will report directly to CEO Dr. Hermann Luebbert. Hiring a CCO in this transformational situation will further strengthen the Company’s unparalleled commercial and clinical efforts in the PDT field. Mr. Jones brings over 25 years of extensive commercial leadership experience within the specialty pharmaceutical and biotech sectors. Mr. Jones' career is marked by a demonstrated ability to build and lead commercial organizations. At Currax Pharmaceuticals, as Vice President Global Marketing and Commercial Operations and one of the earliest employees following the company's restructuring, he was instrumental in the build out of the commercial organization, including supporting the establishment of the marketing department, sales force and training functions. He guided the young company through a period of rapid growth while simultaneously navigating the early stages of the global pandemic. While at Currax Mr. Jones also led the development of a first-in-market digital ecosystem, driving direct patient demand via social media linked to telemedicine. Prior to Currax, at Pernix Therapeutics, Mr. Jones was promoted to Vice President of Sales and Marketing and implemented an efficient and focused sales strategy that supported rapid growth while lowering the cost structure. Earlier in his career, at Depomed Inc. while a Senior Director of Marketing, his efforts supported the company’s inorganic growth strategy successfully leading the marketing integration and re-launch of five product acquisitions. Most recently, Mr. Jones served as Chief Operating Officer at UpScriptHealth. He was appointed to drive change and support the evolution of the leading telehealth technology platform. Under his guidance, UpScriptHealth achieved substantial growth, including a more than threefold increase in partnership revenues. This experience underscores his expertise in leveraging innovative channels to enhance patient access to therapies.お知らせ • Aug 05Biofrontera Inc. to Report Q2, 2025 Results on Aug 13, 2025Biofrontera Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025お知らせ • Jul 01Biofrontera Inc. announced that it expects to receive $11 million in funding from Aigh Capital Management, LLC, Rosalind Advisors, Inc.Biofrontera Inc. announced a private placement of preferred shares for gross proceeds of $11,000,000 on June 30, 2025. The preferred shares are convertible to common shares at the price of $0.6249 per share. The transaction will include participation from new investors Aigh Capital Management, LLC, Rosalind Advisors, Inc. On the same day, the company raised $8,500,000 in its first tranche. The second tranche of $2,500,000 will be funded upon finalization of a detailed asset transfer agreement, which is expected by September 30, 2025.お知らせ • Jun 04Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic Acid HCI)Biofrontera Inc. announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulations of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz®® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, 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.お知らせ • May 24Biofrontera Receives A Non-Compliance Letter from the Nasdaq Stock MarketOn May 21, 2025, Biofrontera Inc. received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying the Company that, because the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended March 31, 2025 was $469,000, the Company is no longer in compliance with the continued listing requirement under Nasdaq Listing Rule 5550(b)(1), which requires that a listed company’s stockholders’ equity be at least $2,500,000. Additionally, as of the date of the Notice, the Company did not meet either of the alternative requirements of maintaining a market value of listed securities of $35 million or achieving a net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years. As a result, as of the date of this Report, the Company does not satisfy Nasdaq Marketplace Rule 5550(b). The Notice has no immediate effect on the listing or trading of the Company’s securities on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the Notice to submit a plan to regain compliance with the Nasdaq Listing Rules. The Company intends to evaluate available options to regain compliance and timely submit a compliance plan to Nasdaq. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from May 21, 2025 to evidence compliance. If the plan is not accepted, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel.お知らせ • May 16Biofrontera Inc. Announces New Patent Protection on Ameluz®? until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne VulgarisBiofrontera Inc. received confirmation that the updated formulation of the Ameluz nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz against generic competition, Biofrontera announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods --1 hour and 3 hours. The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. It marks a significant step in expanding the indications for Ameluz®?PD over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp.お知らせ • May 15Biofrontera Receives a Letter from the Listing Qualifications Department of the Nasdaq Stock MarketOn May 8, 2025, Biofrontera Inc. received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market, as the closing bid price of the Company’s common stock was less than $1.00 per share for the previous 33 consecutive business days. The notice has no present impact on the listing or trading of the Company’s securities on The Nasdaq Capital Market. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until November 5, 2025, to regain compliance with the rule referred to in this paragraph. To regain compliance, during this 180-day compliance period, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days. In the event that the Company does not regain compliance with the Nasdaq Listing Rules prior to the expiration of the 180-day compliance period ending on November 5, 2025, the Company may be eligible for additional time to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii) by meeting the continued listing requirement for market value of publicly held shares and all other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and providing written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. Should the Nasdaq staff conclude that the Company will not be able to cure the deficiency, or if the Company does not meet other listing standards, Nasdaq could provide notice that the Company’s securities will be subject to delisting. At such time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of its common stock and, as appropriate, will consider available options to resolve the deficiency and regain compliance with the Nasdaq Listing Rules. There can be no assurance that the Company will be able to regain compliance with Rule 5550(a)(2) or maintain compliance with the other listing requirements of the Nasdaq Capital Market.お知らせ • May 07Biofrontera Inc. to Report Q1, 2025 Results on May 15, 2025Biofrontera Inc. announced that they will report Q1, 2025 results After-Market on May 15, 2025お知らせ • Apr 21Biofrontera Inc., Annual General Meeting, Jun 12, 2025Biofrontera Inc., Annual General Meeting, Jun 12, 2025. Location: meetnow.global/m4t9rh6, United Statesお知らせ • Mar 18Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz®? Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and TrunkBiofrontera Inc. announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz®? (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk. Actinic keratosis is a common skin condition found on sun-exposed areas of the body, and if left untreated, may progress to squamous cell carcinoma. This trial is a multicenter, randomized, double-blind study comparing Ameluz®? with vehicle in the field-directed treatment of actinic keratosing (AK) located on the extremities, neck & trunk with PDT using a RhodoLED lamp (BF-RhodoLED®? XL or BF-RhodoLED™?). It is designed to assess the safety and efficacy of Ameluz®? PDT following the application of 1-3 tubes of product over a surface area (continuous or in patches) of approximately 80, 160 or 240cm2. Patients receive one PDT treatment with either Ameluz®? or vehicle gel, and a second one at 12 weeks if at least one AK lesion remains. With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by second quarter 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026.お知らせ • Mar 11Biofrontera Inc. to Report Q4, 2024 Results on Mar 21, 2025Biofrontera Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 21, 2025お知らせ • Jan 08Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)Biofrontera Inc. announced that a key milestone in its Phase 3 study of the use of Ameluz and RhodoLED PDT in the treatment of sBCC (ALA-BCC-CT013) was met with the last patient completing the 1 year follow-up visit in December of 2024. The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz® -PDT or placebo-PDT) 1-2 weeks apart. Lesions that were not completely resolved after 3 months were retreated. The FDA has advised Biofrontera to submit the sNDA with one-year follow-up data. While 1-year data will support the FDA submission, the superficial BCC lesions will in total be followed up for five years. Long-term follow-up studies are often required by the FDA for dermatology product submissions, in particular for skin cancers, and they are important in trials enrolling sBCC patients due to the risk of local recurrence, or subsequent additional skin cancer development.お知らせ • Nov 23Biofrontera Inc. announced that it has received $4.2 million in fundingBiofrontera Inc. announced that it has completed private placement of a $4.2 million senior secured convertible note on November 22, 2024. The Note matures on November 22, 2027, bears a paid in kind interest of 10% per annum and is secured by the Company’s assetsReported Earnings • Nov 15Third quarter 2024 earnings released: US$0.98 loss per share (vs US$4.64 loss in 3Q 2023)Third quarter 2024 results: US$0.98 loss per share (improved from US$4.64 loss in 3Q 2023). Revenue: US$9.01m (up 1.3% from 3Q 2023). Net loss: US$5.67m (loss narrowed 11% from 3Q 2023). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany.New Risk • Nov 14New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$14m Forecast net loss in 1 year: US$12m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (265% increase in shares outstanding). Market cap is less than US$10m (€4.37m market cap, or US$4.62m). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year).お知らせ • Nov 01Biofrontera Inc. to Report Nine Months, 2024 Results on Nov 13, 2024Biofrontera Inc. announced that they will report nine months, 2024 results on Nov 13, 2024お知らせ • Oct 31Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC)Biofrontera Inc. announced top-line results in its Phase 3 study of the use of Ameluz with the BF-RhodoLED lamp in the treatment of sBCC (study ALA-BCC-CT013). The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart, repeated after three months, if required. The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. Ameluz-PDT achieved 65.5% success (95/145 subjects) in this rigorous target, compared to 4.8% success (2/42 subjects) achieved with placebo-PDT (p<0.0001). Complete histological clearance was seen in 75.9% (110/145) of these lesions in the Ameluz arm, compared to 19.0% (8/42) with placebo. Complete clinical clearance was achieved in 83.4% (121/145) of patients treated with Ameluz compared to 21.4% (8/42) with placebo. The results for all other secondary efficacy parameters were equally highly significant (p<0.0001) with, for instance, 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT. Most patients who received Ameluz-PDT rated the overall treatment satisfaction and esthetic outcome as very good (64.3%) or good (22.2%).お知らせ • Oct 14Biofrontera Inc. Announces Database Lock of Phase 3 Study of Ameluz-Photodynamic Therapy in Treatment of Superficial Basal Cell CarcinomaBiofrontera Inc. announced that the database for the treatment phase of study ALA-BCC-CT013 has been locked. The database lock is an important milestone in the lifecycle of a clinical trial, marking the end of data collection and the point at which no further changes can be made to the trial database. The clinical data are now ready for final analysis. This Phase 3 trial is to evaluate the safety and efficacy of Ameluz-PDT in combination with the BF-RhodoLED lamp for the treatment of sBCC. It is a double-blind, randomized, placebo-controlled multi-center study involving 186 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart, repeated after three months if required. The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were evaluated. In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for First Quarter 2025.お知らせ • Oct 07FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One TreatmentBiofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients. The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz® were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz®.New Risk • Sep 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (305% increase in shares outstanding). Market cap is less than US$10m (€6.61m market cap, or US$7.32m).Reported Earnings • Aug 16Second quarter 2024 earnings released: US$0.05 loss per share (vs US$7.23 loss in 2Q 2023)Second quarter 2024 results: US$0.05 loss per share (improved from US$7.23 loss in 2Q 2023). Revenue: US$7.84m (up 34% from 2Q 2023). Net loss: US$257.0k (loss narrowed 97% from 2Q 2023). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany.New Risk • Aug 15New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$23m Forecast net loss in 1 year: US$13m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$25m free cash flow). Negative equity (-US$1.8m). Shareholders have been substantially diluted in the past year (272% increase in shares outstanding). Market cap is less than US$10m (€5.28m market cap, or US$5.80m). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$13m net loss next year). Share price has been volatile over the past 3 months (10.0% average weekly change).お知らせ • Aug 09Biofrontera Inc. to Report Q2, 2024 Results on Aug 14, 2024Biofrontera Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 14, 2024お知らせ • Jun 24Biofrontera Announces the Launch of A New, FDA-Approved Red Light Source, the RhodoLED® XL LampBiofrontera Inc. announced the launch of its FDA-approved RhodoLED XL, a red light emitting LED lamp. Biofrontera RhodoLED XL®?: This innovative device represents a significant advancement in the treatment of PDT with engineering, robust but sleek construction and an intuitive user interface. It is designed to be simple to manage and able to accommodate various patient treatment positions in order to optimize ease of use. Biofrontera's PDT drug, Ameluz®?, is approved by the FDA in combination with either member of the RhodoLED lamp family. The introduction of the RhodoLED XL provides the option to illuminate a larger area in a single on-label Ameluz PDT treatment. In comparison to Biofrontera's existing lamp, the RhodoLED XL offers a larger illumination area with five panels compared to one, and additional features such as positioning sensors to ensure the patient receives the optimal energy delivery from the LED array. Cleaver Dermatology, a renowned practice with offices in Missouri and Georgia, was the first to have the RhodoLED XL lamp installed.Reported Earnings • May 17First quarter 2024 earnings released: US$2.88 loss per share (vs US$5.60 loss in 1Q 2023)First quarter 2024 results: US$2.88 loss per share. Revenue: US$7.91m (down 9.4% from 1Q 2023). Net loss: US$10.4m (loss widened 40% from 1Q 2023). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany.お知らせ • May 08Biofrontera Inc. to Report Q1, 2024 Results on May 15, 2024Biofrontera Inc. announced that they will report Q1, 2024 results After-Market on May 15, 2024お知らせ • Mar 27Biofrontera Inc., Annual General Meeting, Jun 12, 2024Biofrontera Inc., Annual General Meeting, Jun 12, 2024.Breakeven Date Change • Mar 20Forecast breakeven date pushed back to 2026The 2 analysts covering Biofrontera previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 61% per year to 2025. The company is expected to make a profit of US$6.69m in 2026. Average annual earnings growth of 66% is required to achieve expected profit on schedule.Reported Earnings • Mar 17Full year 2023 earnings released: US$13.02 loss per share (vs US$0.60 loss in FY 2022)Full year 2023 results: US$13.02 loss per share (further deteriorated from US$0.60 loss in FY 2022). Revenue: US$34.1m (up 19% from FY 2022). Net loss: US$20.1m (loss widened US$19.5m from FY 2022). Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany.お知らせ • Mar 09Biofrontera Inc. to Report Q4, 2023 Results on Mar 15, 2024Biofrontera Inc. announced that they will report Q4, 2023 results After-Market on Mar 15, 2024Breakeven Date Change • Mar 01Forecast to breakeven in 2025The 2 analysts covering Biofrontera expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$23.0k in 2025. Average annual earnings growth of 62% is required to achieve expected profit on schedule.New Risk • Feb 29New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$26m Forecast net loss in 1 year: US$14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Shareholders have been substantially diluted in the past year (281% increase in shares outstanding). Market cap is less than US$10m (€3.83m market cap, or US$4.14m). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$14m net loss next year).お知らせ • Feb 23Biofrontera Inc. announced that it has received $8 million in fundingOn February 22, 2024, Biofrontera Inc., closed the transaction.お知らせ • Feb 20Biofrontera Inc. has withdrawn its Follow-on Equity Offering in the amount of $5.5 million.Biofrontera Inc. has withdrawn its Follow-on Equity Offering in the amount of $5.5 million. Security Name: Common Stock Security Type: Common Stock Price\Range: $1.51 Discount Per Security: $0.1057 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 3,300,000 Security Name: Pre-Funded Warrants Security Type: Equity WarrantBoard Change • Feb 19High number of new and inexperienced directorsThere are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. No experienced directors. 1 highly experienced director. CEO, President & Executive Chairman Hermann Luebbert is the most experienced director on the board, commencing their role in 2015. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model.業績と収益の成長予測MUN:AI10 - アナリストの将来予測と過去の財務データ ( )USD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20277610N/AN/A112/31/2026601N/AN/A112/31/202547-7N/A-8212/31/202439-16N/A-329/30/202435-13-18-18N/A6/30/202435-14-19-19N/A3/31/202433-23-25-25N/A12/31/202334-20-25-25N/A9/30/202334-26-24-24N/A6/30/202329-23-28-28N/A3/31/202328-14-18-18N/A12/31/202229-1-16-16N/A9/30/202228-12-29-29N/A6/30/202228-26-24-24N/A3/31/202229-29-25-25N/A12/31/202124-38-27-27N/A9/30/202124-23-6-6N/A6/30/202122-10-6-6N/A3/31/202119-10-9-9N/A12/31/202019-11-12-12N/A12/31/201926-11-38-38N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: AI10は今後 3 年間で収益性が向上すると予測されており、これは 貯蓄率 ( 1% ) よりも高い成長率であると考えられます。収益対市場: AI10今後 3 年間で収益性が向上すると予想されており、これは市場平均を上回る成長と考えられます。高成長収益: AI10今後 3 年以内に収益を上げることが予想されます。収益対市場: AI10の収益 ( 22.4% ) German市場 ( 6.8% ) よりも速いペースで成長すると予測されています。高い収益成長: AI10の収益 ( 22.4% ) 20%よりも速いペースで成長すると予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: AI10の 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2025/01/28 01:39終値2024/10/31 00:00収益2024/09/30年間収益2023/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Biofrontera Inc. 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Bruce JacksonBenchmark CompanyJonathan AschoffRoth Capital Partners
お知らせ • Jan 13Biofrontera Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025Biofrontera Inc. provided earnings guidance for the fourth quarter and full year ended December 31, 2025. For the quarter, revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history. For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026.
Breakeven Date Change • Mar 20Forecast breakeven date pushed back to 2026The 2 analysts covering Biofrontera previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 61% per year to 2025. The company is expected to make a profit of US$6.69m in 2026. Average annual earnings growth of 66% is required to achieve expected profit on schedule.
Breakeven Date Change • Mar 01Forecast to breakeven in 2025The 2 analysts covering Biofrontera expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$23.0k in 2025. Average annual earnings growth of 62% is required to achieve expected profit on schedule.
お知らせ • May 09Biofrontera Inc. to Report Q1, 2026 Results on May 14, 2026Biofrontera Inc. announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 14, 2026
お知らせ • May 05Biofrontera Inc., Annual General Meeting, Jun 11, 2026Biofrontera Inc., Annual General Meeting, Jun 11, 2026. Location: meetnow.global/mvwjynq, United States
お知らせ • Mar 10+ 1 more updateBiofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development Of Ameluz Photodynamic Therapy For Moderate To Severe Acne VulgarisBiofrontera Inc. announced results of its Phase 2b clinical trial evaluating Ameluz (aminolevulinic acid HCL) topical gel, 10% PDT for the treatment of moderate to severe acne vulgaris (AV). The multicenter, randomized, double-blind study compared Ameluz and vehicle gel using two incubation times (1 hour and 3 hours) prior to illumination with the BF-RhodoLED lamp. Participants received one tube of Ameluz or vehicle gel applied to the entire face, followed by incubation and illumination with the red light. Up to three PDT treatments were administered at one-month intervals, and patients were followed up for two months after receiving the final PDT treatment. The study had co-primary endpoints, one of which looked at the relative reduction in inflammatory lesion counts. The other required an improvement of at least two grades on a 5-point modified Investigator Global Assessment (mIGA) scale and that the patient was rated “clear” or “almost clear” (score 0 or 1). Greater improvements in both inflammatory lesion counts and mIGA scores were observed with Ameluz vs. vehicle with the 3-hour incubation regimen, identifying this as the most promising protocol for further clinical investigation in acne vulgaris. In the 3-hour per-protocol population, the Ameluz group achieved a 57.97% reduction in inflammatory lesions (n=20), compared with 36.51% (n=14) in the corresponding vehicle group. For the mIGA analysis, 25% of the Ameluz treated patients met this co-primary endpoint with 21.4% of the vehicle patients achieving the same outcome. Reductions in absolute lesion counts further supported the efficacy of the 3-hour regimen. The values for inflammatory, non-inflammatory and total lesion reductions were 19.7, 23.1 and 42.7 with Ameluz vs. 15.4, 16.5 and 31.9 with vehicle. Ameluz PDT demonstrated a favorable safety profile consistent with previously reported photodynamic therapy experience. The most frequently reported treatment-related adverse events were burning sensation and pruritus, both of which were generally mild to moderate in severity. In addition, the average pain scores during the 3-hour incubation PDT treatments were modest, with the values in the Ameluz group ranging from 3.4 to 3.8, and from 2.0 to 2.1 with vehicle on an 11-point scale. Participants reported high overall satisfaction with PDT treatment. Of the patients who underwent the 3-hour Ameluz incubation, 85.7% said they would choose PDT again and 71.4% of them rated their esthetic outcome as “good” or “very good”. Acne vulgaris is one of the most common dermatologic conditions in the US, affecting millions of patients and representing a large treatment market. It may lead to permanent scarring and can carry a significant psychosocial burden, including reduced self-esteem and depression. Current treatment options include topical therapies requiring long-term daily treatment, and systemic antibiotic and oral isotretinoin which may have significant safety considerations. Additionally, increasing antibiotic resistance continues to drive interest in alternative treatment approaches. As an in-office physician-administered procedure, photodynamic therapy may offer dermatologists an alternative treatment option with a high rate of compliance and that avoids patients having to undergo chronic systemic exposure. The Company plans to present these Phase 2b data to the U.S. Food and Drug Administration (FDA) in Third Quarter 2026 to discuss potential next steps to develop Ameluz PDT for the treatment of acne vulgaris.
お知らせ • Feb 27U.S. Patent Board Rules Sun Pharmaceutical Industries, Inc’s Patent Is Unpatentable After Biofrontera ChallengeBiofrontera Inc. announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries Inc.’s U.S. Patent No. 11,697,028 to be unpatentable. As previously disclosed in Biofrontera’s filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of the ‘028 Patent and a related patent, U.S. Patent No. 11,446,512 (the “’512 Patent”). In response to these proceedings, Biofrontera challenged the validity of Sun Pharma’s asserted claims by filing petitions for Inter Partes Review with the Board. The Board has now agreed with Biofrontera on all challenged claims of the ‘028 Patent. Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit. The decision does not affect the petition filed by the Company relating to the ‘512 patent, which was denied review by the Patent Office on administrative, rather than substantive, grounds.
お知らせ • Feb 18Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz®? for Actinic Keratoses on Trunk and ExtendeditiesBiofrontera Inc. announced that the database of its Phase 1 PK study evaluating Ameluz®? (aminolevulinic acid hydrochloride) topical gel for the treatment of mild to moderate actinic keratoses (AKs) on neck, trunk and trunk and trunk was locked on February 11, 2026. The Phase 1, non-randomized, open-label study assessed systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during photodynamic therapy (PDT) with Ameluz®? in combination with the red-light BF-RhodoLED®? XL lamp. The study was designed to investigate the pharmacokinetics of 5-aminolevulinIC acid (ALA) and protoporphyrin IX ("PpIX") under maximal use conditions during and after treatment with 3 entire tubes of Ameluz®? applied to an approximately 240 cm2 treatment field. Seventeen patients received a single PDT treatment with Ameluz®?. Plasma concentrations of ALA and PpIX were then measured for a 10-hour period following application. Together with the Company's previously announced positive Phase 3 clinical results evaluating Ameluz®? PDT for mild to moderate AKs on the extremities, neck and trunk, the PK data are intended to support a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for expansion of the current label. This submission is expected in the third quarter of 2026 and aims at extending the label from the currently approved indication of an up to 60 cm2 treatment field with AK on the face and scalp to an AK treatment field of up to 240 cm2 on other body parts.
お知らせ • Feb 11Biofrontera Inc. Announces U.S. Food and Drug Administration Filing Acceptance of Supplemental New Drug Application for Ameluz PDT in Superficial Basal Cell CarcinomaBiofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Company's supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED®? red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026. If approved, this new indication would represent a significant clinical expansion of the Ameluz®? PDT platform beyond its existing FDA approval for treatment of actinic keratosis. It would also further validate Biofrontera's PDT approach, which combines Ameluz®?'s nanoemulsion technology with red-light illumination designed to penetrate deeper into tissue compared with shorter wavelengths of light such as green and blue, enabling treatment of lesions extending into deeper skin layers. Basal cell carcinoma is the most common cancer in the U.S., with approximately 3.6 million cases diagnosed annually, and published estimates suggest that 10-25% of these cases are of the superficial subtype2,3,4. If approved, Ameluz®? PDT for the treatment of SBCC would offer dermatology providers and their patients a non-invasive treatment option aligned with real-world practice needs. 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 cancers5. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements make. These risks and uncertainties, many of which are beyond the 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 sustainability; whether 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 coverage, reimbursement and pricing for procedures using the Company's products; whether the market opportunity for Ameluz®? in addition with BF-Rhodo LED®? 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 will be available for the Company's financial resources and need for additional financing.
お知らせ • Feb 10Biofrontera Announces Positive Results in Phase 3 Study of Ameluz PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary EndpointBiofrontera Inc. announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz®? PDT with the red-light LED (RhodoLED) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. The multicenter, randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy and tolerability of field-directed Ameluz PDT compared with vehicle PDT in patients with AKs located on the extremities, neck., and trunk. The study enrolled 172 patients, randomized 4:1 to receive Ameluz gel or vehicle gel, respectively. Based on these positive Phase 3 results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026.
お知らせ • Jan 13Biofrontera Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025Biofrontera Inc. provided earnings guidance for the fourth quarter and full year ended December 31, 2025. For the quarter, revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history. For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026.
お知らせ • Jan 08+ 1 more updateBiofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory MilestonesBiofrontera Inc. announced the successful database lock of two clinical studies evaluating Ameluz®? PDT, marking an important milestone ahead of several anticipated data and regulatory events in 2026. The databases for the treatment phase of the Company's Phase 3 clinical study evaluating Ameluz®?PD for the treatment of actinic keratosis (AK) on the extremities, neck and trunk as well as its Phase 2 clinical study evaluating the treatment of moderate to severe acne vulgaris were successfully locked on January 5, 2026. All data from participants that is collected throughout each study is captured in a specific database. Locking the database enables unblinding and statistical analysis of the study results in accordance with the pre-specified study endpoints. Biofrontera expects data for both studies to be available in February of this year. Pending positive outcomes of the Phase 3 AK study, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in Summer of 2026 to expand the approved use of Ameluz®? PDT for AK beyond the face and scalp. Results from the Phase 2 acne vulgaris study are expected to be presented to the FDA in early Third Quarter 2026 and are intended to provide the basis of a future Phase 3 program, with the goal of achieving approval for Ameluz®? PDT in this indication. Together with the submission in December 2025 of the Company's sNDA for the treatment of superficial Basal Cell Cell Canceroma (sBCC) with Ameluz®? PST, these milestones support Biofrontera's strategy to expand the clinical utility of its PDT platform and advance additional growth opportunities. The 1-year follow-up phase of the phase III study on AK is still ongoing, but not required for FDA approval of the indication.
お知らせ • Dec 18Biofrontera Inc. Completes Transfer of Ameluz®? and RhodoLED®? FDA Approval and Associated Intellectual Property PortfolioBiofrontera Inc. announced the completion of the transfer of the FDA approvals for Ameluz and the RhodoLED Lamp Series, including the NDA and the Investigational New Drug Application (IND), to Biofrontera. In addition, the Company has completed all necessary filings to transfer all US and some international intellectual property associated with Ameluz and the RhodiLED Lamp Series, including 11 granted US patents, 10 US patent applications, and 19 patent filings or registered designs outside of the US. The registration of the assignment to Biofrontera of all associated trademarks has also been initiated. These asset transfers were secured, in part, by an $11.0 million investment recently reported by the Company.
お知らせ • Dec 04Last Patient Completes Biofrontera's Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and ExtremitiesBiofrontera Inc. announced the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas). The last patient visit took place on 24 November 2025. Data from this study, together with results from Biofrontera's recently completed Phase 3 clinical trial, will form the basis of a planned supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the Ameluz® label to include the treatment of AKs on all peripheral body areas. Actinic Keratoses commonly occur on sun-exposed areas across the body and may progress to squamous cell carcinoma if left untreated. Expanding Ameluz®'s current FDA approval for use beyond the face and scalp would address a critical unmet need in dermatology. This open-label Phase 1 study assessed the PK profile of 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during Ameluz®-PDT of the upper extremities, neck or trunk using the BF-RhodoLED® XL lamp. Pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (s NDA) to the Food and Drug Administration ("FDA") in the Summer of 2026.
お知らせ • Dec 02Biofrontera Inc. Announces Filing of Supplemental New Drug Application (Snda) for the Treatment of Superficial Basal Cell Carcinoma with Ameluz®?-PdtBiofrontera Inc. announced the submission of an sNDA to the FDA, seeking approval of Ameluz-PDT for the treatment of sBCC. The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera's U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz label to include treatment of sBCC treatment with PDT using its BF-RhodoLED or RhodoLED XL red light lamps. Participants received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart. If required, a second treatment cycle was repeated at three months. The study's primary endpoint was a composite measure of complete clinical and histological clearance of one preselected "main target lesion" (MTL) at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), a highly significant statistical difference (p(JAAD) summarized "The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in the publication reinforce the value of Ameluz-PD T for the treatment of sBC C. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.
お知らせ • Nov 07Biofrontera Inc. to Report Q3, 2025 Results on Nov 12, 2025Biofrontera Inc. announced that they will report Q3, 2025 results at 4:00 PM, US Eastern Standard Time on Nov 12, 2025
お知らせ • Oct 24+ 1 more updateBiofrontera Inc. (NasdaqCM:BFRI) completed the acquisition of US Assets related to Ameluz and RhodoLED of Biofrontera AG.Biofrontera Inc. (NasdaqCM:BFRI) signed an agreement to acquire US Assets related to Ameluz and RhodoLED of Biofrontera AG on June 30, 2025. The transaction coupled with an $11 million financing led by existing investors, Rosalind Advisors and AIGH Capital Management LLC, funded the acquisition and transfer costs. Upon completion, Biofrontera Inc. will pay a monthly Ameluz® royalty of 12% in years where Ameluz® revenue in the US is less than $65 million, and 15% in years when revenue exceeds that threshold. The new royalty replaces the former transfer pricing model which required payment of 25% to 35% of the net sales price per tube depending on timing and indication. As part of the agreement, Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the entities. Biofrontera Inc. (NasdaqCM:BFRI) completed the acquisition of US Assets related to Ameluz and RhodoLED of Biofrontera AG on October 23, 2025. On completion, 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.
お知らせ • Sep 17Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz Topical GelBiofrontera Inc. announced that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz®? (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Second Quarter 2026. Actinic keratosis is a common precancerous skin condition found on sun-exposed areas of the body: 58 million US adults have at least one AK lesion1. In total, 172 subjects were enrolled in the study. The 12-month follow-up Phase 3 study is expected to be completed by Second Quarter 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter.
お知らせ • Aug 26Biofrontera Inc. Announces Last-Patient-Out in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne VulgarisBiofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz®? (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025. Acne vulgaris is a common skin condition characterized by inflammatory and non-inflammatory lesions that frequently lead to permanent scarring. Beyond the physical burden, AV often has a significant psychological impact, including reduced self-esteem and depression. Many of these patients continue to rely on regimens that carry significant treatment burdens including cost, adverse effects and the necessity for prolonged treatments. Expanding the use of Ameluz®? to treat acne would be a valuable advancement for both physicians and patients. The company look forward to the study results with great anticipation. Pending positive results, the Company intends to present the findings to the U.S. Food Drug Administration (FDA) in early Third Quarter 2026 as the basis for a future Phase III program, with the goal of achieving approval for Ameluz®? PDT for the treatment of acne vulgaris.
お知らせ • Aug 12Biofrontera Inc. Appoints George Jones as Chief Commercial Officer, Effective August 25, 2025Biofrontera Inc. announced the appointment of George Jones as Chief Commercial Officer (CCO), starting August 25, 2025. In this role, Mr. Jones will oversee the Company’s commercial functions, including sales, marketing, and market access. He will report directly to CEO Dr. Hermann Luebbert. Hiring a CCO in this transformational situation will further strengthen the Company’s unparalleled commercial and clinical efforts in the PDT field. Mr. Jones brings over 25 years of extensive commercial leadership experience within the specialty pharmaceutical and biotech sectors. Mr. Jones' career is marked by a demonstrated ability to build and lead commercial organizations. At Currax Pharmaceuticals, as Vice President Global Marketing and Commercial Operations and one of the earliest employees following the company's restructuring, he was instrumental in the build out of the commercial organization, including supporting the establishment of the marketing department, sales force and training functions. He guided the young company through a period of rapid growth while simultaneously navigating the early stages of the global pandemic. While at Currax Mr. Jones also led the development of a first-in-market digital ecosystem, driving direct patient demand via social media linked to telemedicine. Prior to Currax, at Pernix Therapeutics, Mr. Jones was promoted to Vice President of Sales and Marketing and implemented an efficient and focused sales strategy that supported rapid growth while lowering the cost structure. Earlier in his career, at Depomed Inc. while a Senior Director of Marketing, his efforts supported the company’s inorganic growth strategy successfully leading the marketing integration and re-launch of five product acquisitions. Most recently, Mr. Jones served as Chief Operating Officer at UpScriptHealth. He was appointed to drive change and support the evolution of the leading telehealth technology platform. Under his guidance, UpScriptHealth achieved substantial growth, including a more than threefold increase in partnership revenues. This experience underscores his expertise in leveraging innovative channels to enhance patient access to therapies.
お知らせ • Aug 05Biofrontera Inc. to Report Q2, 2025 Results on Aug 13, 2025Biofrontera Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025
お知らせ • Jul 01Biofrontera Inc. announced that it expects to receive $11 million in funding from Aigh Capital Management, LLC, Rosalind Advisors, Inc.Biofrontera Inc. announced a private placement of preferred shares for gross proceeds of $11,000,000 on June 30, 2025. The preferred shares are convertible to common shares at the price of $0.6249 per share. The transaction will include participation from new investors Aigh Capital Management, LLC, Rosalind Advisors, Inc. On the same day, the company raised $8,500,000 in its first tranche. The second tranche of $2,500,000 will be funded upon finalization of a detailed asset transfer agreement, which is expected by September 30, 2025.
お知らせ • Jun 04Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic Acid HCI)Biofrontera Inc. announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulations of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz®® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, 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.
お知らせ • May 24Biofrontera Receives A Non-Compliance Letter from the Nasdaq Stock MarketOn May 21, 2025, Biofrontera Inc. received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying the Company that, because the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended March 31, 2025 was $469,000, the Company is no longer in compliance with the continued listing requirement under Nasdaq Listing Rule 5550(b)(1), which requires that a listed company’s stockholders’ equity be at least $2,500,000. Additionally, as of the date of the Notice, the Company did not meet either of the alternative requirements of maintaining a market value of listed securities of $35 million or achieving a net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years. As a result, as of the date of this Report, the Company does not satisfy Nasdaq Marketplace Rule 5550(b). The Notice has no immediate effect on the listing or trading of the Company’s securities on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the Notice to submit a plan to regain compliance with the Nasdaq Listing Rules. The Company intends to evaluate available options to regain compliance and timely submit a compliance plan to Nasdaq. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from May 21, 2025 to evidence compliance. If the plan is not accepted, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel.
お知らせ • May 16Biofrontera Inc. Announces New Patent Protection on Ameluz®? until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne VulgarisBiofrontera Inc. received confirmation that the updated formulation of the Ameluz nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz against generic competition, Biofrontera announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods --1 hour and 3 hours. The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. It marks a significant step in expanding the indications for Ameluz®?PD over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp.
お知らせ • May 15Biofrontera Receives a Letter from the Listing Qualifications Department of the Nasdaq Stock MarketOn May 8, 2025, Biofrontera Inc. received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market, as the closing bid price of the Company’s common stock was less than $1.00 per share for the previous 33 consecutive business days. The notice has no present impact on the listing or trading of the Company’s securities on The Nasdaq Capital Market. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until November 5, 2025, to regain compliance with the rule referred to in this paragraph. To regain compliance, during this 180-day compliance period, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days. In the event that the Company does not regain compliance with the Nasdaq Listing Rules prior to the expiration of the 180-day compliance period ending on November 5, 2025, the Company may be eligible for additional time to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii) by meeting the continued listing requirement for market value of publicly held shares and all other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and providing written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. Should the Nasdaq staff conclude that the Company will not be able to cure the deficiency, or if the Company does not meet other listing standards, Nasdaq could provide notice that the Company’s securities will be subject to delisting. At such time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of its common stock and, as appropriate, will consider available options to resolve the deficiency and regain compliance with the Nasdaq Listing Rules. There can be no assurance that the Company will be able to regain compliance with Rule 5550(a)(2) or maintain compliance with the other listing requirements of the Nasdaq Capital Market.
お知らせ • May 07Biofrontera Inc. to Report Q1, 2025 Results on May 15, 2025Biofrontera Inc. announced that they will report Q1, 2025 results After-Market on May 15, 2025
お知らせ • Apr 21Biofrontera Inc., Annual General Meeting, Jun 12, 2025Biofrontera Inc., Annual General Meeting, Jun 12, 2025. Location: meetnow.global/m4t9rh6, United States
お知らせ • Mar 18Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz®? Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and TrunkBiofrontera Inc. announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz®? (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk. Actinic keratosis is a common skin condition found on sun-exposed areas of the body, and if left untreated, may progress to squamous cell carcinoma. This trial is a multicenter, randomized, double-blind study comparing Ameluz®? with vehicle in the field-directed treatment of actinic keratosing (AK) located on the extremities, neck & trunk with PDT using a RhodoLED lamp (BF-RhodoLED®? XL or BF-RhodoLED™?). It is designed to assess the safety and efficacy of Ameluz®? PDT following the application of 1-3 tubes of product over a surface area (continuous or in patches) of approximately 80, 160 or 240cm2. Patients receive one PDT treatment with either Ameluz®? or vehicle gel, and a second one at 12 weeks if at least one AK lesion remains. With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by second quarter 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026.
お知らせ • Mar 11Biofrontera Inc. to Report Q4, 2024 Results on Mar 21, 2025Biofrontera Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 21, 2025
お知らせ • Jan 08Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)Biofrontera Inc. announced that a key milestone in its Phase 3 study of the use of Ameluz and RhodoLED PDT in the treatment of sBCC (ALA-BCC-CT013) was met with the last patient completing the 1 year follow-up visit in December of 2024. The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz® -PDT or placebo-PDT) 1-2 weeks apart. Lesions that were not completely resolved after 3 months were retreated. The FDA has advised Biofrontera to submit the sNDA with one-year follow-up data. While 1-year data will support the FDA submission, the superficial BCC lesions will in total be followed up for five years. Long-term follow-up studies are often required by the FDA for dermatology product submissions, in particular for skin cancers, and they are important in trials enrolling sBCC patients due to the risk of local recurrence, or subsequent additional skin cancer development.
お知らせ • Nov 23Biofrontera Inc. announced that it has received $4.2 million in fundingBiofrontera Inc. announced that it has completed private placement of a $4.2 million senior secured convertible note on November 22, 2024. The Note matures on November 22, 2027, bears a paid in kind interest of 10% per annum and is secured by the Company’s assets
Reported Earnings • Nov 15Third quarter 2024 earnings released: US$0.98 loss per share (vs US$4.64 loss in 3Q 2023)Third quarter 2024 results: US$0.98 loss per share (improved from US$4.64 loss in 3Q 2023). Revenue: US$9.01m (up 1.3% from 3Q 2023). Net loss: US$5.67m (loss narrowed 11% from 3Q 2023). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany.
New Risk • Nov 14New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$14m Forecast net loss in 1 year: US$12m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (265% increase in shares outstanding). Market cap is less than US$10m (€4.37m market cap, or US$4.62m). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year).
お知らせ • Nov 01Biofrontera Inc. to Report Nine Months, 2024 Results on Nov 13, 2024Biofrontera Inc. announced that they will report nine months, 2024 results on Nov 13, 2024
お知らせ • Oct 31Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC)Biofrontera Inc. announced top-line results in its Phase 3 study of the use of Ameluz with the BF-RhodoLED lamp in the treatment of sBCC (study ALA-BCC-CT013). The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart, repeated after three months, if required. The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. Ameluz-PDT achieved 65.5% success (95/145 subjects) in this rigorous target, compared to 4.8% success (2/42 subjects) achieved with placebo-PDT (p<0.0001). Complete histological clearance was seen in 75.9% (110/145) of these lesions in the Ameluz arm, compared to 19.0% (8/42) with placebo. Complete clinical clearance was achieved in 83.4% (121/145) of patients treated with Ameluz compared to 21.4% (8/42) with placebo. The results for all other secondary efficacy parameters were equally highly significant (p<0.0001) with, for instance, 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT. Most patients who received Ameluz-PDT rated the overall treatment satisfaction and esthetic outcome as very good (64.3%) or good (22.2%).
お知らせ • Oct 14Biofrontera Inc. Announces Database Lock of Phase 3 Study of Ameluz-Photodynamic Therapy in Treatment of Superficial Basal Cell CarcinomaBiofrontera Inc. announced that the database for the treatment phase of study ALA-BCC-CT013 has been locked. The database lock is an important milestone in the lifecycle of a clinical trial, marking the end of data collection and the point at which no further changes can be made to the trial database. The clinical data are now ready for final analysis. This Phase 3 trial is to evaluate the safety and efficacy of Ameluz-PDT in combination with the BF-RhodoLED lamp for the treatment of sBCC. It is a double-blind, randomized, placebo-controlled multi-center study involving 186 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart, repeated after three months if required. The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were evaluated. In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for First Quarter 2025.
お知らせ • Oct 07FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One TreatmentBiofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients. The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz® were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz®.
New Risk • Sep 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (305% increase in shares outstanding). Market cap is less than US$10m (€6.61m market cap, or US$7.32m).
Reported Earnings • Aug 16Second quarter 2024 earnings released: US$0.05 loss per share (vs US$7.23 loss in 2Q 2023)Second quarter 2024 results: US$0.05 loss per share (improved from US$7.23 loss in 2Q 2023). Revenue: US$7.84m (up 34% from 2Q 2023). Net loss: US$257.0k (loss narrowed 97% from 2Q 2023). Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany.
New Risk • Aug 15New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$23m Forecast net loss in 1 year: US$13m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$25m free cash flow). Negative equity (-US$1.8m). Shareholders have been substantially diluted in the past year (272% increase in shares outstanding). Market cap is less than US$10m (€5.28m market cap, or US$5.80m). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$13m net loss next year). Share price has been volatile over the past 3 months (10.0% average weekly change).
お知らせ • Aug 09Biofrontera Inc. to Report Q2, 2024 Results on Aug 14, 2024Biofrontera Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 14, 2024
お知らせ • Jun 24Biofrontera Announces the Launch of A New, FDA-Approved Red Light Source, the RhodoLED® XL LampBiofrontera Inc. announced the launch of its FDA-approved RhodoLED XL, a red light emitting LED lamp. Biofrontera RhodoLED XL®?: This innovative device represents a significant advancement in the treatment of PDT with engineering, robust but sleek construction and an intuitive user interface. It is designed to be simple to manage and able to accommodate various patient treatment positions in order to optimize ease of use. Biofrontera's PDT drug, Ameluz®?, is approved by the FDA in combination with either member of the RhodoLED lamp family. The introduction of the RhodoLED XL provides the option to illuminate a larger area in a single on-label Ameluz PDT treatment. In comparison to Biofrontera's existing lamp, the RhodoLED XL offers a larger illumination area with five panels compared to one, and additional features such as positioning sensors to ensure the patient receives the optimal energy delivery from the LED array. Cleaver Dermatology, a renowned practice with offices in Missouri and Georgia, was the first to have the RhodoLED XL lamp installed.
Reported Earnings • May 17First quarter 2024 earnings released: US$2.88 loss per share (vs US$5.60 loss in 1Q 2023)First quarter 2024 results: US$2.88 loss per share. Revenue: US$7.91m (down 9.4% from 1Q 2023). Net loss: US$10.4m (loss widened 40% from 1Q 2023). Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany.
お知らせ • May 08Biofrontera Inc. to Report Q1, 2024 Results on May 15, 2024Biofrontera Inc. announced that they will report Q1, 2024 results After-Market on May 15, 2024
お知らせ • Mar 27Biofrontera Inc., Annual General Meeting, Jun 12, 2024Biofrontera Inc., Annual General Meeting, Jun 12, 2024.
Breakeven Date Change • Mar 20Forecast breakeven date pushed back to 2026The 2 analysts covering Biofrontera previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 61% per year to 2025. The company is expected to make a profit of US$6.69m in 2026. Average annual earnings growth of 66% is required to achieve expected profit on schedule.
Reported Earnings • Mar 17Full year 2023 earnings released: US$13.02 loss per share (vs US$0.60 loss in FY 2022)Full year 2023 results: US$13.02 loss per share (further deteriorated from US$0.60 loss in FY 2022). Revenue: US$34.1m (up 19% from FY 2022). Net loss: US$20.1m (loss widened US$19.5m from FY 2022). Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany.
お知らせ • Mar 09Biofrontera Inc. to Report Q4, 2023 Results on Mar 15, 2024Biofrontera Inc. announced that they will report Q4, 2023 results After-Market on Mar 15, 2024
Breakeven Date Change • Mar 01Forecast to breakeven in 2025The 2 analysts covering Biofrontera expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$23.0k in 2025. Average annual earnings growth of 62% is required to achieve expected profit on schedule.
New Risk • Feb 29New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$26m Forecast net loss in 1 year: US$14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Shareholders have been substantially diluted in the past year (281% increase in shares outstanding). Market cap is less than US$10m (€3.83m market cap, or US$4.14m). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$14m net loss next year).
お知らせ • Feb 23Biofrontera Inc. announced that it has received $8 million in fundingOn February 22, 2024, Biofrontera Inc., closed the transaction.
お知らせ • Feb 20Biofrontera Inc. has withdrawn its Follow-on Equity Offering in the amount of $5.5 million.Biofrontera Inc. has withdrawn its Follow-on Equity Offering in the amount of $5.5 million. Security Name: Common Stock Security Type: Common Stock Price\Range: $1.51 Discount Per Security: $0.1057 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 3,300,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant
Board Change • Feb 19High number of new and inexperienced directorsThere are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. No experienced directors. 1 highly experienced director. CEO, President & Executive Chairman Hermann Luebbert is the most experienced director on the board, commencing their role in 2015. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model.