Aminolevulinic Acid Hydrochloride

Woburn, MA, May 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three months ended March 31, 2026 and provided a business update. First Quarter Financial Highlights Revenues for Q1 2026 were $10.1 million, a ~17% increase compared to $8.6 million for the same period in 2025. Gross margins were about 80%, an 18 percentage points increase compared to approximately 62% in Q1 2025, reflecting the first full quarter under the new earnout structure following the closing of the strategic transaction with Biofrontera AG in October 2025 (the “Strategic Transaction”). Operating loss was $4.3 million in Q1 2026 compared to a loss of $4.5 million in Q1 2025. Adjusted EBITDA improved to $(3.6) million from $(4.4) million in Q1 2025, an improvement of approximately $0.8 million reflecting expanded gross margins under the new earnout structure. With $70 thousand used in operations, we largely maintained the operating cash balance we had at the end of Q4 2025, with $6.3 million as of March 31, 2026, compared to $1.8 million in Q1 2025. Recent Operational Highlights Announced FDA's completion of its filing review and filing acceptance of the Company's supplemental New Drug Application (sNDA) for Ameluz ® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026. Announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz ® PDT for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk, meeting the primary endpoint. Announced database lock of Phase 1 pharmacokinetics study required for FDA filing on treatment field on extremities, neck and trunk with a treatment area of up to 240 cm². Announced positive results of its Phase 2b clinical trial for the treatment of moderate to severe acne vulgaris (AV), with a 58% reduction in inflammatory lesions in the 3-hour incubation protocol with Ameluz ® PDT, compared to 37% with vehicle PDT (PPS). Regained compliance with the Nasdaq Minimum Bid Price Requirement as confirmed by Nasdaq on May 6, 2026. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated: "The first quarter of 2026 marks the first full quarter under our new cost structure following the Strategic Transaction, and the results speak clearly. Revenue grew 17% year over year, gross margins expanded to approximately 80%, and our cash consumption was near zero—a dramatic improvement from $4.1 million of cash consumption in the prior-year quarter. Our results were further driven by continued commercial momentum leading to significant uptake of the Ameluz PDT platform by dermatologists and their patients. At the same time, our clinical pipeline continues to advance at an accelerated pace. With a PDUFA date for sBCC in September 2026, positive Phase 3 results in AK on neck/trunk and extremities, and encouraging Phase 2b data in acne, we have multiple near-term catalysts that could meaningfully expand the commercial opportunity for the Ameluz platform. We remain focused on our goal of reaching sustained profitability and cash-flow breakeven while setting the foundation for medium to long-term growth, and I believe we are well positioned to help our customers and their patients and build long-term value for our shareholders." First Quarter Financial Results Total revenues for the first quarter of 2026 were $10.1 million compared with $8.6 million for the first quarter of 2025. The 17% year-over-year growth was primarily driven by approximately 16% growth in the number of Ameluz units sold and a price increase implemented in the fourth quarter of 2025. Gross profit margin in the first quarter of 2026 was approximately 80% compared to approximately 62% in Q1 2025. Cost of revenues, related party decreased by approximately 40% year over year, driven by the transition from the transfer pricing model under the prior license and supply agreement to the significantly lower earnout structure in place following the Strategic Transaction. The Company recognized $1.2 million in earnout expense during the quarter. Total operating expenses were $14.4 million for the first quarter of 2026 compared with $13.1 million for the first quarter of 2025. Selling, general and administrative expenses were $11.0 million for the first quarter of 2026 compared with $8.7 million for the first quarter of 2025. The increase was primarily driven by higher selling and marketing costs reflecting lower sales team turnover during the period leading to the full deployment of the direct sales team, increased legal expenses associated with ongoing patent-related claims, and manufacturing-related costs of $0.6 million assumed in connection with the Strategic Transaction. Research and development expenses were $0.9 million for the first quarter of 2026 compared with $1.2 million for the first quarter of 2025. The decrease was primarily attributable to certain clinical trials reaching substantial completion. The net loss for the first quarter of 2026 was $4.8 million, or $0.41 per share, compared with a net loss of $4.2 million, or $0.47 per share, for the prior-year quarter. The net loss comparison was impacted by a $0.8 million swing in the non-cash change in fair value of warrant liabilities. Adjusted EBITDA for the first quarter of 2026 was $(3.6) million compared with $(4.4) million for the first quarter of 2025, an improvement of approximately $0.8 million. Adjusted EBITDA margin improved to (35.3)% from (51.0)% in the prior-year quarter. We look at Adjusted EBITDA, a non-GAAP financial measure, as an indication of ongoing operations, defined as net income or loss excluding interest income and expense, income taxes, depreciation and amortization, and certain other non-recurring or non-cash items. Please refer to the table below which presents a GAAP to non-GAAP reconciliation of Adjusted EBITDA for the first quarters of 2026 and 2025. Conference Call Details Conference call: Thursday, May 14, 2026 at 11:00 AM ET Conference Call: 1-877-877-1275 (U.S./Canada) 1-412-858-5202 (international) Webcast: Webcast – Biofrontera Inc. 1Q26 Results Conference Call About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with photodynamic therapy (PDT). The Company's products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and in development for additional indications. For more information, visit and follow Biofrontera on LinkedIn and X. Contacts Investor Relations Ben Shamsian Lytham Partners 646-829-9701 shamsian@lythampartners.com Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, in this press release, including statements regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words "believe", "anticipate", "intend", "expect", "target", "goal", "estimate", "plan", "assume", "may", "will", "predict", "project", "would", "could" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. You should read this press release and any documents referenced herein completely and with the understanding that our actual future results may be materially different from what we expect. While we have based these forward-looking statements on our current expectations and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed in or implied by our forward-looking statements, and you should not place undue reliance on our forward-looking statements. These forward-looking statements are subject to risks, uncertainties and assumptions about us and accordingly, actual results or events could differ materially from the plans, intentions and expectations disclosed in or implied by the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: our ability to achieve and sustain profitability; our ability to compete effectively in selling our products; our ability to expand, manage and maintain our direct sales and marketing efforts, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our manufacturing partners and the possible impact of tariffs; our ability to manufacture our products; our ability to adequately protect our intellectual property and operate the business without infringing upon the intellectual property rights of others; our actual financial results may vary significantly from forecasts and from period to period; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations ("GPOs") in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market, commercialize, achieve market acceptance for and sell our products; the fact that product quality issues or product defects may harm our business; any claims brought against the Company, including but not limited to product liability claims, claims of patent infringement, or claims challenging the validity of our intellectual property; our ability to maintain compliance with The Nasdaq Stock Market, LLC continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion of research, development and preclinical studies and clinical trials for our products; our ability to obtain and maintain the regulatory approvals necessary for the marketing of our products in the United States; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC website at . Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. (Tables follow) BIOFRONTERA INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except par value and share amounts) March 31, 2026 (Unaudited) December 31, 2025 ASSETS Current assets: Cash and cash equivalents $ 6,317 $ 6,392 Investment, related party 9 9 Accounts receivable, net 3,879 7,291 Inventories 1,231 1,426 Prepaid expenses and other current assets 1,062 2,279 Other assets, related party 661 686 Total current assets 13,159 18,083 Inventories, long term 3,591 3,729 Property and equipment, net 2,175 2,158 Operating lease right-of-use assets 2,895 1,584 Intangible assets, net 2,609 2,650 Other assets 358 360 Total assets $ 24,787 $ 28,564 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 3,634 $ 1,855 Accounts payable, related parties, net 1,315 4,811 Operating lease liabilities 506 332 Accrued expenses and other current liabilities 5,468 4,897 Total current liabilities 10,923 11,895 Long-term liabilities: Convertible notes payable, net 4,719 4,589 Warrant liabilities 570 351 Operating lease liabilities, non-current 2,499 1,240 Other liabilities 6 9 Total liabilities 18,717 18,084 Total stockholders' equity 6,070 10,480 Total liabilities and stockholders' equity $ 24,787 $ 28,564 BIOFRONTERA INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts and number of shares) Three Months Ended March 31, 2026 (Unaudited) Three Months Ended March 31, 2025 (Unaudited) Product revenues, net $ 10,084 $ 8,588 Operating expenses Cost of revenues, related party 1,831 3,075 Cost of revenues, other 285 193 Selling, general and administrative 10,994 8,653 Selling, general and administrative, related party 2 7 Patent remediation expense 392 — Research and development 900 1,207 Total operating expenses 14,404 13,135 Loss from operations (4,320 ) (4,547 ) Other income (expense) Change in fair value of warrant liabilities (219 ) 548 Interest expense, net (125 ) (106 ) Other expense, net (88 ) (99 ) Total other income (expense) (432 ) 343 Loss before income taxes (4,752 ) (4,204 ) Income tax benefit — (1 ) Net loss $ (4,752 ) $ (4,203 ) Loss per common share: Basic and diluted $ (0.41 ) $ (0.47 ) Weighted-average common shares outstanding: Basic and diluted 11,683,323 8,873,932 BIOFRONTERA INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) Three Months Ended March 31, 2026 (Unaudited) Three Months Ended March 31, 2025 (Unaudited) Cash flows from operating activities: Net loss $ (4,752 ) $ (4,203 ) Adjustments to reconcile net loss to cash flows used in operations: Depreciation and amortization 55 29 Reduction in the carrying amount of right-of-use assets 132 190 Stock-based compensation 342 239 Non-cash interest expense 130 119 Allowance for credit losses (1 ) (46 ) Change in fair value of warrant liabilities 219 (548 ) Loss from termination of operating leases 1 — Changes in operating assets and liabilities: Accounts receivable 3,413 1,330 Other receivables, related party 1 - Prepaid expenses and other assets 1,219 (224 ) Other assets, related party 25 — Inventories 307 119 Accounts payable 1,780 1,444 Accounts payable, related parties, net (3,497 ) (2,694 ) Operating lease liabilities (10 ) (179 ) Accrued expenses and other liabilities 566 307 Cash flows used in operating activities (70 ) (4,117 ) Cash flows from investing activities Purchases of property and equipment (5 ) (3 ) Cash flows used in investing activities (5 ) (3 ) Net decrease in cash and cash equivalents (75 ) (4,120 ) Cash, cash equivalents and restricted cash, at beginning of period 6,592 6,105 Cash, cash equivalents and restricted cash, at end of period $ 6,517 $ 1,985 BIOFRONTERA INC. GAAP TO NON-GAAP ADJUSTED EBITDA RECONCILIATION (In thousands) Three Months Ended March 31, 2026 (Unaudited) Three Months Ended March 31, 2025 (Unaudited) Net loss $ (4,752 ) $ (4,203 ) Interest expense, net 125 106 Income tax expense — (1 ) Depreciation and amortization 55 29 EBITDA (4,572 ) (4,069 ) Change in fair value of warrant liabilities 219 (548 ) Stock-based compensation 342 239 Patent remediation - inventory write-down 58 — Patent remediation expense 392 — Adjusted EBITDA $ (3,561 ) $ (4,378 ) Adjusted EBITDA margin (35.3 )% (51.0 )%

当前，细胞与基因治疗正引领着生物医药的第三次革命。而在此浪潮之下，如何利用生命最基本的单元——“细胞”，作为高效、绿色的生产平台，创造出满足未来健康需求的新材料与新成分，已成为合成生物学赋能大健康产业的关键命题。 如何将CGT领域对细胞机制的深刻理解，转化为更高效的生物制造策略？ 合成生物学创造的“细胞工厂”，如何为细胞治疗、基因治疗本身提供更优的培养基、细胞因子等关键上游原料？ 在“818政策”带来的新机遇下，生物制造如何与细胞治疗产业协同发展，共同打造大湾区世界级的生物医药创新生态？  “细胞工厂” 并非传统的细胞治疗概念，而是指通过先进的合成生物学技术，对微生物细胞进行理性设计与工程化改造，使其成为高效生产特定高价值功能成分的“活体工厂”。这一技术路径，完美契合了本次论坛推动产业高质量发展的精神，为细胞提供了更优质的“燃料”，也为开发更安全、更有效、更具成本优势的大健康产品提供了全新的底层解决方案。 深圳汉和生命科学有限公司为深圳市2025年首批“引进重点创新型企业”，认证为“深圳市合成生物学企业”，依托南宁母公司工信部生物制造中试能力建设平台（四星级），致力于打造高效可靠的“细胞工厂”。 深圳汉和承担前端菌株设计、工艺优化与高端产品开发职能，推动实验室成果向规模化生产高效转化，已成功将多项实验室突破性技术转化为具备全球竞争力的工业化产品，标志着其在打通科技成果转化“最后一公里”的道路上取得了决定性进展，让“细胞工厂”生产健康原料从概念走向现实。 01 技术突破，合成生物学引领大健康原料新纪元 合成生物学作为21世纪最具潜力的前沿技术之一，正在重塑大健康产业的技术基础。深圳汉和并非行业的初入者，而是一位厚积薄发的“革新者”，母公司汉和生物是广西规模最大的民营合成生物生产企业，单独承建农业农村部重点实验室，获批工信部首批生物制造中试建设能力平台（四星级单位），入选工信部首批生物制造标志性产品名单（γ-氨基丁酸）。  汉和生物凭借其在基因编辑、微生物发酵等领域的深度积累，实现了从“跟跑”到“领跑”的转变，通过17代迭代改造，汉和生物成功掌握构建高效工程菌株的技术，解除了代谢抑制、平衡了辅因子，显著提升了目标产物的转化率。 技术突破的背后是汉和生物坚实的研发投入。公司拥有3个研发中心，总占地13,200平米，深圳汉和生命研发中心1,200+平米，研发团队总人数112人，菌种保藏库33,000株，高端仪器设备240+台，完备的中试放大平台，研发总投入超过2亿元。  此外，深圳汉和深度践行“产学研”融合之道。与江南大学、南京农业大学、中国科学院天津工业生物技术研究所、湘湖实验室等顶尖科研机构建立了长期战略合作。 02 产品矩阵，构建全方位健康解决方案 基于合成生物学技术平台，汉和生物已构建了涵盖功能性寡糖、功能性氨基酸、益生菌、大型真菌液体发酵培养物等多元化的产品矩阵。 汉和生物推出了七大核心功能原料：α-酮戊二酸及其钙盐（AKG钙）、γ-氨基丁酸（GABA）、5-氨基乙酰丙酸（5-ALA）、褐藻寡糖（AOS）、嗜黏蛋白阿克曼菌（Akk菌）、L-茶氨酸、药食用大型真菌液体发酵培养物。 α-酮戊二酸及钙盐（AKG/Ca-AKG）：抗衰老、增肌壮骨、提高运动表现、防脱生发 AKG钙作为汉和生物的拳头产品，拥有年产3000吨的规模优势，是全球抗衰和运动营养领域的热门原料。研究表明，AKG钙在健康老龄化、运动营养等方面具有独特价值。 γ-氨基丁酸（GABA）：助睡眠、抗焦虑、促长高、促进乙醇代谢、降血压 γ-氨基丁酸（GABA）是汉和生物的又一明星产品，已入选工信部首批“生物制造标志性产品名单”，全国仅36项，是广西唯一入选产品。汉和生物不仅是GABA行业标准《QB/T 5633.7-2022》的副组长起草单位，而且《一种利用希氏乳杆菌生产γ-氨基丁酸的方法和应用》获得国家发明专利授权。 5-氨基乙酰丙酸（5-ALA）：抗病毒、降血糖、补血活血、提高免疫力 汉和生物将5-ALA发酵含量提升至全球最高的60g/L，纯度达99.9%以上，并建成了全球首条千吨级生产线，使原料成本断崖式下降，这一突破打破了日本科斯莫石油公司等国际巨头的技术垄断，使5-ALA从昂贵的医药原料转变为可大规模应用于多领域的平价原料。目前海外市场火爆，大批量出口欧美日韩地区。 褐藻寡糖（AOS）：调节肠道菌群、治疗便秘、缓解阿尔茨海默病、调血糖 汉和生物与中国科学院天津工业生物技术研究所合作开发、生产褐藻寡糖，获“天津市科学技术进步奖三等奖”。是国内唯一一款治疗阿尔茨海默病药物（九期一甘露特纳）的核心成分。 嗜黏蛋白阿克曼菌（AKK）：增强肠道健康、减脂减重、改善非酒精性脂肪肝 Akk是一种定殖于黏膜层的肠内共生菌，是哺乳动物肠道中最丰富的微生物之一，其代谢产物与肠道屏障相互作用，是下一代益生菌，同时也被海外各种专家媒体称为“长寿菌”、“瘦子菌”。目前汉和 L-茶氨酸：镇静助眠、抗抑郁、抗焦虑、戒烟瘾 L-茶氨酸是一种主要存在于茶叶中的独特的非蛋白质氨基酸，具有多种生理作用，包括放松、增强认知和潜在的神经保护，抗氧化、抗炎和护肝活性等特性 药食用大型真菌液体发酵培养物：灵芝、桑黄、羊肚菌、猴头菇、蝙蝠蛾拟青霉等发酵液及其提取物 产品线的丰富背后是汉和生物强大的菌种资源库。公司拥有22,000株菌株库、三个现代化细胞工厂、合成生物学概念验证中心，形成了从菌种筛选到产品转化的完整研发体系。 03 产业协同，构建大健康生态系统 公司战略布局也极具前瞻性：将研发中心设立于深圳光明科学城，充分利用大湾区的人才、信息与技术高地优势；同时，将规模化生产基地扎根于南宁高新技术产业园区，形成了“深圳创新，南宁转化”的高效协同模式，高度契合区内“北上广研发，广西集成，面向世界”的发展战略。 合作模式也颇具创新性。汉和生物采取“开放式创新”模式，为科学家和研发团队提供免费试验场所及大部分仪器设备，做到“仪器设备等人，不让科学家等仪器设备”。 这种开放合作的模式有助于推动整个行业的创新发展。通过与产业链各环节的优秀企业合作，汉和生物正在构建一个覆盖研发、生产、销售的大健康生态系统。 04 未来愿景，打造全球大健康原料引领者 面向未来，深圳汉和生物确立了清晰的发展路径：将持续深化合成生物学与智能制造的融合，拓展更多高价值化合物品类；加速推进国际化战略，布局海外市场与认证体系；致力于建设面向未来的全流程数字化工厂，最终实现从“生物制造”到“生物智造”的升级，成为全球大健康品牌值得信赖的核心原料供应商。 国际化是汉和生物未来发展的重要方向。公司已取得清真、犹太、FDA备案等多项国际认证，具备高活性原料的全球交付能力。未来，汉和生物将继续拓展海外市场与国际认证体系，助推更多原料“走出去”。 我们的愿景，是让更多源自中国的合成生物学创新成果，以稳定、高效、高性价比的方式走向世界，成为全球大健康产业的基石。我们不仅是原料的生产者，更是与合作伙伴共同成长的“创新引擎”！ 科学与科学家的汉和生物 深圳汉和生命科学有限公司 销售甘经理：17777336673 销售卢经理：18775827828 销售陈经理：19101434031 产品经理韦经理：17878899809 产品经理李经理：18178286655 研发中心曾主任：13620901605 研发中心余老师：15994301191