Latest news with #Biofrontera
Associated Press
4 days ago
- Business
- Associated Press
Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today 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 formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. 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. 'We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz® RhodoLED PDT.' References: About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of 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. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; 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; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact: Investor Relations Andrew Barwicki 1-516-662-9461 [email protected]
Yahoo
4 days ago
- Business
- Yahoo
Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
Biofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043. The Orange Book is published by the U.S. Food and Drug Administration (FDA) and lists all approved prescription drug products, along with patent and exclusivity information. Inclusion signifies FDA recognition of the revised formulation's approved status and its intellectual property protection. WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today 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 formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. 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. 'We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz® RhodoLED PDT.' References: Jacob SE, et al. 'Contact Allergy to Propylene Glycol: A Review.' Dermatitis. 2008;19(3):157–163. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of 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. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; 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; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-05-2025
- Business
- Yahoo
Biofrontera Inc (BFRI) Q1 2025 Earnings Call Highlights: Revenue Growth and Strategic ...
Total Revenue: $8.6 million for Q1 2025, a 9% increase from the same period in 2024. Ameluz Sales Increase: $0.5 million increase due to higher unit price and RotoLED XL lamp launch. Total Operating Expenses: $13.1 million for Q1 2025, down from $13.4 million in Q1 2024. Cost of Revenues: $3.1 million for Q1 2025, a 22.1% decrease from the prior year. SG&A Expenses: Decreased by $0.6 million or 6.5% compared to Q1 2024. R&D Expenses: Increased by $1.2 million due to assumption of clinical trial activities for Ameluz. Net Loss: $4.2 million or $0.47 per share for Q1 2025, compared to $10.4 million or $2.88 per share in Q1 2024. Adjusted EBITDA: Increased to $4.4 million for Q1 2025 from $4.6 million in Q1 2024. Cash and Cash Equivalents: $1.8 million as of March 31, 2025, down from $5.9 million as of December 31, 2024. Inventory: $6.5 million as of March 31, 2025, compared to $6.6 million as of December 31, 2024. Warning! GuruFocus has detected 5 Warning Signs with BFRI. Release Date: May 16, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Biofrontera Inc (NASDAQ:BFRI) reported a 9% increase in total revenues for the first quarter of 2025, reaching $8.6 million. The company successfully reduced its cost of revenue and operating costs compared to the same period in the previous year. A new formulation of Ameluz, free from the allergen propylene glycol, has been granted a patent, providing protection until December 2043. Biofrontera Inc (NASDAQ:BFRI) achieved key milestones in clinical trials, including the final patient enrollment for a Phase 3 trial of Ameluz for actinic keratosis and completion of a one-year follow-up for basal cell carcinoma treatment. The company increased its EBITDA and gross profit, supporting its goal of reaching breakeven quickly. Biofrontera Inc (NASDAQ:BFRI) reported a net loss of $4.2 million for the first quarter of 2025, although this was an improvement from the previous year's loss. The company experienced a decrease in cash and cash equivalents, dropping to $1.8 million as of March 31, 2025, from $5.9 million at the end of 2024. Research and development expenses increased by $1.2 million compared to the previous year, driven by the assumption of all clinical trial activities for Ameluz in the United States. Legal expenses increased by $1.2 million due to patent claims, partially offsetting savings in other areas. The sales force experienced some turnover, and the company is working on restructuring its commercial team to improve efficiency. Q: Over the first quarter of 2025, how many lamp units did Biofrontera sell, both the original and the XL? A: Herman Louvert, CEO, stated that Biofrontera placed 18 XL lamps during the first quarter. Clyde Lefler, CFO, mentioned that he would need to double-check the number of original lamps sold as he did not have that information readily available. Q: Is there any sales force attrition, and what is the current sales force headcount compared to the end of the year? A: Clyde Lefler, CFO, explained that Biofrontera is restructuring its commercial team, bringing in more junior representatives with lower salaries. There has been some turnover, but the company is committed to reorganizing the team to be as efficient as possible. Q: How will the change in transfer pricing affect gross margins for the rest of the year? A: Clyde Lefler, CFO, noted that all current inventory is at the 25% transfer price, which will be consistent for the rest of the year. However, gross margins may fluctuate based on the number of lamps sold, as the margin on lamps is lower. Q: What is the status of reimbursement for the three-tube indication? A: Herman Louvert, CEO, confirmed that after approval, Biofrontera focused on ensuring Medicare coverage and informed private payers. There have been no reported cases of reimbursement refusal for using more than one tube, indicating the issue is resolved. Q: Can you provide an update on the financial performance and strategic goals for the first quarter of 2025? A: Herman Louvert, CEO, highlighted that Biofrontera achieved a 9% revenue increase to $8.6 million, reduced costs, and improved EBITDA and gross profit. The company aims to reach breakeven quickly and continues to explore new applications for Ameluz, including treatments for superficial basal cell carcinoma and moderate to severe acne. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
17-05-2025
- Business
- Yahoo
Q1 2025 Biofrontera Inc Earnings Call
Operator Good day and welcome to the Biofrontera's First Quarter of 2025 Financial Results and business update conference call. All participants will be in listen-only mode. (Operator Instructions) I would now like to turn the conference over to Andrew Barwicki. Please go ahead. Good morning and welcome to Biofrontera Incorporates First Quarter Fiscal year 2025 Financial results and business update conference call. Please note that certain information discussed during today's call by management is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that Biofrontera's management will be making forward-looking statements and that actual results may differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. All risks and uncertainty are detailed in and are qualified by the cautionary statements contained in Biofrontera's press releases and SEC filings. Also, this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 16, 2025. BioFronter undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, there will be references to certain non-GAAP financial measures. Biofrontera believes that these measures provide useful information for investors yet should not be considered as a substitute for GAAP, nor should they be viewed as a substitute for operating results determined in accordance with GAAP. A reconciliation of Non-GAAP to GAAP results is included in this, in the press release that was issued yesterday. More specifically, management will be referencing adjusted EBITDA, a Non-GAAP financial measure defined as net income or loss excluding interest, income and expense, income taxes, depreciation and amortization, and certain other non-recurring or non-cash items. With that being said, I would now like to turn the call over to Herman Louvert, CEO, Chairman and founder of Biofrontera. Herman. Yeah, thank you and my thanks to everyone joining us this morning. On today's call, I will provide an overview of our business during the first quarter. Clyde Lefler, our CFO, will follow with a discussion on financial results, and then both of us will be happy to answer questions after our prepared remarks. Starting with the business update, our first quarter was a busy and exciting period for us. We continued our revenue growth while keeping our costs under control. Total revenues for the first quarter of 2025 were $8.6 million and 9% increase from the same period of the prior year. Both our cost of revenue and our operating costs were lower than in the same period of the previous year, as Fred will explain in much more detail. We strongly believe our past investments, execution, and tremendous efforts to increase the effectiveness of our sales force will allow us to achieve record revenues in 2025 without increasing our costs. On top of the positive financial development. We achieved several more milestones. An important development for our long-term future is the recent granting of a patent on the new formulation of Ameluz. This new formulation, which lacks the potential allergen propylene glycol, have already been approved by the FDA and is in use since last year. Having no patent protection on this Ameluz formulation until December 2043 gives us another eighteen point five years of protection from generic competition. We announced the enrolment of the final patient in the Phase three clinical trial evaluating Ameluz for the treatment of mild to moderate actinic keratosis on the extremities, neck and trunk. Currently, label is restricted to treatments of AK on the face and scalp. The goal of this study is to extend the label to the entire body. This represents another important cornerstone in our overall strategy, complementing the use of free tubes and the availability of the larger lab both launched in 2024. As the last building block for this label extension, FDA has requested a Phase one pharmacokinetic study with 16 patients, which started in January and is currently recruiting. Furthermore, we reached a key milestone in the Phase three study for the use of Ameluz and Autoled PTC in the treatment of superficial basal cell carcinoma. The last patient completed the one-year follow-up visit, which is required for FDA approval in December 2024. We believe Ameluz has additional applications other than actinic keratosis and we are committed to explore these opportunities. So, our next goal is approval for superficial basal cell carcinoma. I can tell you that being able to treat actinic keratosis, which are precancerous lesions that may progress to squamous cell carcinoma is a wonderful feeling, but to expand beyond that to treating certain skin tumors is very encouraging and exciting for all of us here at Biofrontera. We expect to submit the new data to the FDA in the second half of this year. Following the approvals for AK on the entire body and for superficial basal cell carcinoma, we are aiming to at getting Ameluz approved for the treatment of moderate to severe acne. Acne is the most frequent indication seen by dermatologists and the treatment options available for the more severely affected patients suffer from very considerable side effects. This creates a significant medical need for these patients. Our ongoing Phase two study in this indication is close to completing patient or it has completed patient recruitment, and data will be available towards the end of the year. The further development plan will be discussed with the FDA once the data of this study become available. As I look back on the first quarter, in addition to the achievements and milestones, we were able to lower the cost of revenues, total operating expenses and SG and A. We continue to monitor and be very prudent in all aspects of our business and operations. Additionally, we increased EBITDA and gross profit, all of which support our goal of reaching breakeven as quickly as possible. We believe we have built the foundation with the sales team and back end support to continue to improve our results on a consistent basis. With that, I'll turn the call over to Clyde to walk through the financial details of the second quarter. Clyde? Thank you, Herman Pleasure talking with everyone again and I'll cover our first quarter, 2025 results. Total revenues for the first three months ended March 30, 2025, for $8.6 million, an increase of $0.7 million or 8.7% as compared to the three months ended March 30, 2024. This increase was driven by a $0.5 million dollar increase in Ameluz sales due to an increased unit price and the launch of our RotoLED XL lamp which resulted in sales of the XL lamp of $0.2 million. Total operating expenses were $13.1 million for the first quarter of 2025 compared with $13.4 million for the first quarter of 2024. Cost of revenues related party were $3.1 million. For the first quarter of 2025 compared with $4.0 million for the prior year quarter, this decrease of $0.9 million or 22.1% compared to last year was due to the reduced cost structure under the last amendment of the EU's license and supply agreement. Selling general and administrative expenses for the three months ended March 31, 2025, decreased by $0.6 million or 6.5% as compared to the three months ended March 31, 2024. Selling and marketing expenses decreased by $0.8 million with a $0.3 million decrease coming from direct sales team personnel expenses due to headcount fluctuation and a $0.5 million decrease driven by reduced general marketing activity and spend on conferences. These decreases were partially offset by an increase in legal expenses of $1.2 million due to patent claims, which was partially offset by savings of $0.8 million in personnel and financing expenses. Research and development R&D expenses for the first three months of 2025 increased by $1.2 million as compared to the first three months of 2024. The increase is attributed to our assumption of all clinical trial activities for Ameluz in the United States effective as of June 1, 2024, which allows for more effective cost management and direct oversight of trial efficiency. These increases in R&D expense were and will continue to be offset by a reduction in the transfer price of Ameluz from 50% to 25% for inventory purchases made through 2025. The net loss for the first quarter of 2025 was $4.2 million or $0.47 per share compared with a net loss of $10.4 million or $2.88 per share for the prior year quarter. The change in net loss reflects a decrease in the non-cash change in the fair value of warrant liabilities driven by a decrease in the outstanding. Population, a decrease in interest expense due to the payoff of high interest debt in 2024 and the aforementioned decreases in cost of revenues related party and selling general administrative expenses partially offset by increased R&D spending. Adjusted EBITDA increased from $4.6 million for the first three months ended March 31, 2024, to 4.4 or as compared to $4.4 million for the three months ended March 31, 2025. The improvement was driven by an increase in gross profit of $1.5 million offset by $1.2 million increases in R&D expenses. These changes were driven by the reduced cost structure under the latest amendment of the Emmalou license agreement and the assumption of all clinical activities for Ameluz in the United States. I'll refer you to the table in the news release we issued yesterday for a reconciliation of GAAP to Non-GAAP financial measures. According to our balance sheet as of March 31st, 2025, we had cash and cash equivalents of $1.8 million compared with $5.9 million as of December 31st, 2024. Finally, we have $6.5 million of inventory on hand as compared to $6.6 million of inventory as of December 31, 2024. With that overview of our business and recent financial performance, Herman and I are now ready to take questions from our covering analysts. Operator We will now begin the question-and-answer session. (Operator Instructions) Our first question will come from Jonathan Aschoff with Roth capital. Please go ahead. Thank you. Good morning. I was curious over 1Q '25, how many lamp units did you sell both the original and the XL? Yes, hey, Jonathan right here sorry as on mute, so, placements as of a Q1 were, let me just. 18, we placed 18 of the XL lamps. And that's just in the first quarter. That's in the first, yes, exactly. Okay, and how about the original one? The original ones. I will have to double check on that one. I don't have the original right at my fingertips. That's fine. My second and last question is, any sales force attrition just the comment in the press release, savings of $800,000 in personnel and financing expenses. And I'm curious, what is the current sales force headcount, say, versus the end of the year? Is there any attrition there that explains that drop in expense? Yes, Herman, do you want me to take that one? No. Well, we are looking at how we're structuring our commercial team and what types of roles are a good fit for the larger territories and some things like that. So, we're working on bringing in some more what we call like a more junior rep that's like ready to be on the road. Some of that comes with bit lower salary and then some of it has been some turnover but we're committed to replacing that and reorganizing the territories and the team to be as efficient as possible to finish up the year strong. All right, thank you very much. Operator The next question will come from Bruce Jackson with the Benchmark Company. Please go ahead. Hi, good morning and thank you for taking my questions. Wanted to take a moment to look at the gross margins. So, you've got the change in the transfer pricing, which gave you a little bit of a boost in the first quarter. How is that going to play out over the rest of the year? Yes. So, in the first quarter, we did burn off a bit of Ameluz inventory that was still under the prior LSA cost structure. So that should that's all gone. So, we have all of the inventory we have now is at the 25% transfer price and that's what we will see for the rest of the year. It might be offset. So, if that was the only thing we sold then cost of goods would be 25%. However, there's going to be some fluctuation in that, based on how many lamps we sell because the margin there is lower. Okay. Okay. And then a question on the three tube indication. Sometimes it takes time for the payers to get the reimbursement information into their databases. Can you just kind of give us an update on the status of the reimbursement for the three-tube indication and is that all systems go now for you? Yes, we paid a lot of attention to that when after we got approval and focused initially on Medicare, making sure that Medicare actually covers this and then send all the information to all the private payers. So from what we hear so far, I mean, we have to rely on feedback from the market. We are not aware of a single case where a doctor has been refused payment because of using more than one tube. So, this seems to be completely solved. Okay, great. That's it for me. Thank you. Operator Thank you. This will conclude our question-and-answer session. I would like to turn the conference back over to Herman Louvert r for any closing remarks. Yes. Well, thank you, operator. As you heard, the first quarter has been a very exciting time for us and we look forward to the rest of the year. Each day our sales team gets new clients, which is a victory for the customer facing strategy that we have implemented. I would like to thank everyone for participating in this call and we look forward to speaking with you again when we report our second quarter results. Thank you and have a nice day. Operator The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Sign in to access your portfolio
Yahoo
15-05-2025
- Business
- Yahoo
Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris
Biofrontera has received patent approval for the revised formulation of Ameluz®, which extends patent protection through to December 2043 Ameluz PDT offers the potential for effective treatment of moderate to severe acne without the side effects associated with some systemic therapies4 Approximately 50 million people in the US are suffering from acne vulgaris, including both adolescents and adults1,2 The US acne treatment market was valued at $5.7 billion in 2024 and is growing annually5 WOBURN, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), 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 today 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. One tube of Ameluz® or vehicle gel is applied to the entire face, followed by illumination for 10 minutes after the specified incubation period has taken place. Patients received up to three PDT sessions spaced one month apart and will receive follow-up consultations for two months following their final treatment. A total of 120 patients has been enrolled. The Company anticipates last-patient-out in Q3 2025, marking a key milestone in the clinical development of Ameluz® for a potential new dermatological indication. Dr. Mitchel P. Goldman, MD, FAAD, the coordinating investigator of the study and Medical Director of Cosmetic Laser Dermatology and Platinum Dermatology Partners, expressed enthusiasm about its potential impact. 'We see many patients who suffer from inflammatory acne. The possibility of expanding the indication for Ameluz® PDT to treat this disorder would be welcomed by physicians and our patients. I look forward to seeing the final results of the study.' 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. Notably, over 55% of total market spending is attributed to oral antibiotics and isotretinoin, the primary treatments for moderate to severe inflammatory acne6. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. 'We are thrilled to reach this pivotal stage in our clinical program,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'The successful enrollment of our last patient in this important Phase 2b study brings us closer to offering an effective treatment option for patients with moderate to severe acne. It marks a significant step in expanding the indications for Ameluz® PDT over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Together with our patent protection now lasting to December 2043, extensions of the Ameluz approved indications position our company for future growth.' About Acne vulgaris Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people annually1. While often associated with adolescence, studies have shown that acne affects approximately 40% of the adult population2. It can range from mild (blackheads and whiteheads) to more severe forms, including inflammatory pimples, nodules, and cysts. If not treated effectively, acne may lead to permanent scarring and can significantly affect a person's mental health and self-esteem3. According to U.S. clinical guidelines, treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin which may have serious side effects4. As a result, there is a growing need for effective alternatives. References: American Academy of Dermatology Association. Acne: Overview. ↩ Collier CN et al. 'The prevalence of acne in adults 20 years and older.' J Am Acad Dermatol. 2008;58(1):56–59. ↩ Tan JK, Bhate K. 'A global perspective on the epidemiology of acne.' Br J Dermatol. 2015;172 Suppl 1:3–12. ↩ Zaenglein AL et al. 'Guidelines of care for the management of acne vulgaris.' J Am Acad Dermatol. 2016;74(5):945–973.e33. ↩ Fortune Business Insights. Acne Treatment Market Size, Share & Trends Report, 2024–2032. ↩ IQVIA Institute Report, U.S. Dermatology Market Analysis, 2023. (Note: Replace with actual IQVIA data if available or request specific spending data from your market access team.) About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of 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. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@
