Announcement • May 09
Biofrontera Inc. to Report Q1, 2026 Results on May 14, 2026 Biofrontera Inc. announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 14, 2026 Announcement • May 05
Biofrontera Inc., Annual General Meeting, Jun 11, 2026 Biofrontera Inc., Annual General Meeting, Jun 11, 2026. Location: meetnow.global/mvwjynq, United States New Risk • Mar 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$13m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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$13m free cash flow). Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Market cap is less than US$10m (US$9.45m market cap). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). Major Estimate Revision • Mar 23
Consensus estimates of losses per share improve by 70% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has improved. 2026 revenue forecast increased from US$45.7m to US$46.8m. EPS estimate increased from -US$0.115 per share to -US$0.035 per share. Pharmaceuticals industry in the US expected to see average net income decline 8.7% next year. Consensus price target of US$6.00 unchanged from last update. Share price fell 2.2% to US$0.87 over the past week. Reported Earnings • Mar 20
Full year 2025 earnings released: US$0.91 loss per share (vs US$3.22 loss in FY 2024) Full year 2025 results: US$0.91 loss per share (improved from US$3.22 loss in FY 2024). Revenue: US$41.7m (up 12% from FY 2024). Net loss: US$10.5m (loss narrowed 41% from FY 2024). Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 60% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Announcement • Feb 27
U.S. Patent Board Rules Sun Pharmaceutical Industries, Inc’s Patent Is Unpatentable After Biofrontera Challenge Biofrontera 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. Announcement • Feb 18
Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz®? for Actinic Keratoses on Trunk and Extendedities Biofrontera 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. Announcement • Feb 11
Biofrontera Inc. Announces U.S. Food and Drug Administration Filing Acceptance of Supplemental New Drug Application for Ameluz PDT in Superficial Basal Cell Carcinoma Biofrontera 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. Announcement • Feb 10
Biofrontera Announces Positive Results in Phase 3 Study of Ameluz PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint Biofrontera 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. Announcement • Jan 13
Biofrontera Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025 Biofrontera 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. New Risk • Jan 02
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$2.6m). Shareholders have been substantially diluted in the past year (50% increase in shares outstanding). Market cap is less than US$10m (US$6.64m market cap). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Dec 18
Biofrontera Inc. Completes Transfer of Ameluz®? and RhodoLED®? FDA Approval and Associated Intellectual Property Portfolio Biofrontera 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. Announcement • Dec 04
Last Patient Completes Biofrontera's Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities Biofrontera 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. Announcement • Dec 02
Biofrontera Inc. Announces Filing of Supplemental New Drug Application (Snda) for the Treatment of Superficial Basal Cell Carcinoma with Ameluz®?-Pdt Biofrontera 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. Reported Earnings • Nov 14
Third quarter 2025 earnings: EPS misses analyst expectations Third quarter 2025 results: US$0.62 loss per share. Revenue: US$6.99m (down 23% from 3Q 2024). Net loss: US$6.65m (loss widened 17% from 3Q 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 6.9%. Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 9.4% growth forecast for the Pharmaceuticals industry in the US. New Risk • Nov 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$17m Forecast net loss in 1 year: US$7.6m 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 Negative equity (-US$4.7m). Shareholders have been substantially diluted in the past year (63% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$7.6m net loss next year). Market cap is less than US$100m (US$10.4m market cap). New Risk • Nov 07
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$17m Forecast net loss in 1 year: US$7.2m 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 Negative equity (-US$4.7m). Shareholders have been substantially diluted in the past year (92% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$7.2m net loss next year). Market cap is less than US$100m (US$12.4m market cap). Announcement • Nov 07
Biofrontera Inc. to Report Q3, 2025 Results on Nov 12, 2025 Biofrontera Inc. announced that they will report Q3, 2025 results at 4:00 PM, US Eastern Standard Time on Nov 12, 2025 Breakeven Date Change • Oct 05
Forecast breakeven date pushed back to 2027 The 2 analysts covering Biofrontera previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 81% per year to 2026. The company is expected to make a profit of US$12.9m in 2027. Average annual earnings growth of 70% is required to achieve expected profit on schedule. Price Target Changed • Oct 03
Price target decreased by 7.7% to US$6.00 Down from US$6.50, the current price target is an average from 2 analysts. New target price is 461% above last closing price of US$1.07. Stock is up 11% over the past year. The company is forecast to post a net loss per share of US$1.42 next year compared to a net loss per share of US$3.22 last year. New Risk • Oct 03
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$17m Forecast net loss in 1 year: US$6.4m 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$9.4m free cash flow). Negative equity (-US$4.7m). Shareholders have been substantially diluted in the past year (92% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$6.4m net loss next year). Market cap is less than US$100m (US$10.9m market cap). Announcement • Sep 17
Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz Topical Gel Biofrontera 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. Announcement • Aug 26
Biofrontera Inc. Announces Last-Patient-Out in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris Biofrontera 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. Major Estimate Revision • Aug 20
Consensus EPS estimates fall by 33% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.995 to -US$1.33 per share. Revenue forecast unchanged at US$40.6m. Pharmaceuticals industry in the US expected to see average net income decline 0.3% next year. Consensus price target broadly unchanged at US$6.50. Share price fell 7.4% to US$0.88 over the past week. Reported Earnings • Aug 15
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$0.57 loss per share (further deteriorated from US$0.05 loss in 2Q 2024). Revenue: US$9.03m (up 15% from 2Q 2024). Net loss: US$5.32m (loss widened US$5.07m from 2Q 2024). Revenue exceeded analyst estimates by 8.8%. Earnings per share (EPS) missed analyst estimates by 36%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Pharmaceuticals industry in the US. Breakeven Date Change • Aug 15
No longer forecast to breakeven The 2 analysts covering Biofrontera no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$4.38m in 2027. New consensus forecast suggests the company will make a loss of US$14.0m in 2027. Announcement • Aug 12
Biofrontera Inc. Appoints George Jones as Chief Commercial Officer, Effective August 25, 2025 Biofrontera 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. Announcement • Aug 05
Biofrontera Inc. to Report Q2, 2025 Results on Aug 13, 2025 Biofrontera Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025 Major Estimate Revision • Jul 01
Consensus EPS estimates upgraded to US$0.99 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.13 to -US$0.995 per share. Revenue forecast unchanged from US$40.9m at last update. Pharmaceuticals industry in the US expected to see average net income growth of 4.1% next year. Consensus price target up from US$5.38 to US$6.38. Share price rose 7.3% to US$0.69 over the past week. Announcement • Jul 01
Biofrontera 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. New Risk • Jun 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. 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$11m free cash flow). Shareholders have been substantially diluted in the past year (86% increase in shares outstanding). Market cap is less than US$10m (US$6.28m market cap). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). Announcement • Jun 04
Biofrontera 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. Announcement • May 24
Biofrontera Receives A Non-Compliance Letter from the Nasdaq Stock Market On 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. Reported Earnings • May 17
First quarter 2025 earnings: EPS and revenues miss analyst expectations First quarter 2025 results: US$0.47 loss per share (improved from US$2.88 loss in 1Q 2024). Revenue: US$8.59m (up 8.5% from 1Q 2024). Net loss: US$4.20m (loss narrowed 60% from 1Q 2024). Revenue missed analyst estimates by 19%. Earnings per share (EPS) also missed analyst estimates by 119%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Pharmaceuticals industry in the US. Announcement • May 16
Biofrontera 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 Vulgaris Biofrontera 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. Announcement • May 15
Biofrontera Receives a Letter from the Listing Qualifications Department of the Nasdaq Stock Market On 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. Announcement • May 07
Biofrontera Inc. to Report Q1, 2025 Results on May 15, 2025 Biofrontera Inc. announced that they will report Q1, 2025 results After-Market on May 15, 2025 Announcement • Apr 21
Biofrontera Inc., Annual General Meeting, Jun 12, 2025 Biofrontera Inc., Annual General Meeting, Jun 12, 2025. Location: meetnow.global/m4t9rh6, United States Breakeven Date Change • Mar 25
Forecast breakeven date pushed back to 2027 The 2 analysts covering Biofrontera previously expected the company to break even in 2026. New consensus forecast suggests losses will reduce by 69% per year to 2026. The company is expected to make a profit of US$11.4m in 2027. Average annual earnings growth of 65% is required to achieve expected profit on schedule. New Risk • Mar 21
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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$10m free cash flow). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Market cap is less than US$10m (US$7.98m market cap). Reported Earnings • Mar 21
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: US$3.22 loss per share (improved from US$13.02 loss in FY 2023). Revenue: US$37.3m (up 9.5% from FY 2023). Net loss: US$17.8m (loss narrowed 12% from FY 2023). Revenue missed analyst estimates by 5.1%. Earnings per share (EPS) also missed analyst estimates by 6.1%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Pharmaceuticals industry in the US. Announcement • Mar 18
Biofrontera 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 Trunk Biofrontera 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. Announcement • Mar 11
Biofrontera Inc. to Report Q4, 2024 Results on Mar 21, 2025 Biofrontera Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 21, 2025 Announcement • Jan 08
Biofrontera 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. Announcement • Nov 23
Biofrontera Inc. announced that it has received $4.2 million in funding Biofrontera 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 15
Third quarter 2024 earnings: EPS and revenues miss analyst expectations 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 missed analyst estimates by 9.9%. Earnings per share (EPS) also missed analyst estimates by 17%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in the US. New Risk • Nov 14
New minor risk - Profitability The 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 (19% average weekly change). Shareholders have been substantially diluted in the past year (265% increase in shares outstanding). Market cap is less than US$10m (US$4.62m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year). Announcement • Nov 01
Biofrontera Inc. to Report Nine Months, 2024 Results on Nov 13, 2024 Biofrontera Inc. announced that they will report nine months, 2024 results on Nov 13, 2024 Announcement • Oct 31
Biofrontera 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%). Announcement • Oct 14
Biofrontera Inc. Announces Database Lock of Phase 3 Study of Ameluz-Photodynamic Therapy in Treatment of Superficial Basal Cell Carcinoma Biofrontera 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. Announcement • Oct 07
FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment Biofrontera 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®. Major Estimate Revision • Aug 21
Consensus EPS estimates fall by 17% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$2.74 to -US$3.22 per share. Revenue forecast unchanged at US$39.8m. Pharmaceuticals industry in the US expected to see average net income decline 0.1% next year. Consensus price target down from US$16.00 to US$11.50. Share price rose 6.1% to US$1.21 over the past week. Reported Earnings • Aug 16
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind 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 missed analyst estimates by 4.5%. Earnings per share (EPS) exceeded analyst estimates by 94%. Revenue is forecast to grow 22% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Pharmaceuticals industry in the US. Announcement • Aug 09
Biofrontera Inc. to Report Q2, 2024 Results on Aug 14, 2024 Biofrontera Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 14, 2024 Announcement • Jun 24
Biofrontera Announces the Launch of A New, FDA-Approved Red Light Source, the RhodoLED® XL Lamp Biofrontera 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. Major Estimate Revision • May 22
Consensus EPS estimates fall by 31% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$3.25 to -US$4.24 per share. Revenue forecast unchanged at US$41.0m. Pharmaceuticals industry in the US expected to see average net income growth of 3.3% next year. Consensus price target of US$16.00 unchanged from last update. Share price fell 14% to US$1.12 over the past week. Reported Earnings • May 17
First quarter 2024 earnings: EPS and revenues miss analyst expectations 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 missed analyst estimates by 27%. Earnings per share (EPS) also missed analyst estimates by 146%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 9.4% growth forecast for the Pharmaceuticals industry in the US. Announcement • May 08
Biofrontera Inc. to Report Q1, 2024 Results on May 15, 2024 Biofrontera Inc. announced that they will report Q1, 2024 results After-Market on May 15, 2024 Announcement • Mar 27
Biofrontera Inc., Annual General Meeting, Jun 12, 2024 Biofrontera Inc., Annual General Meeting, Jun 12, 2024. Major Estimate Revision • Mar 22
Consensus EPS estimates upgraded to US$3.25 loss, revenue downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$42.9m to US$40.7m. 2024 losses expected to reduce from -US$3.68 to -US$3.25 per share. Pharmaceuticals industry in the US expected to see average net income growth of 2.8% next year. Consensus price target of US$16.00 unchanged from last update. Share price fell 23% to US$1.20 over the past week. Breakeven Date Change • Mar 20
Forecast breakeven date pushed back to 2026 The 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 17
Full year 2023 earnings: EPS exceeds analyst expectations 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 was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 22%. Revenue is forecast to grow 21% p.a. on average during the next 3 years, compared to a 9.0% growth forecast for the Pharmaceuticals industry in the US. Announcement • Mar 09
Biofrontera Inc. to Report Q4, 2023 Results on Mar 15, 2024 Biofrontera Inc. announced that they will report Q4, 2023 results After-Market on Mar 15, 2024 Breakeven Date Change • Mar 01
Forecast to breakeven in 2025 The 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 29
New minor risk - Profitability The 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 Share price has been highly volatile over the past 3 months (23% average weekly change). Shareholders have been substantially diluted in the past year (281% increase in shares outstanding). Market cap is less than US$10m (US$4.14m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$14m net loss next year). Announcement • Feb 23
Biofrontera Inc. announced that it has received $8 million in funding On February 22, 2024, Biofrontera Inc., closed the transaction. Announcement • Feb 20
Biofrontera 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 Announcement • Feb 06
Biofrontera Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz(R) to Permit Up to Three Tubes Per Use Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "no filing review issues identified" letter regarding the sNDA (supplementary New Drug Application) submitted by its licensor Biofrontera Bioscience GmbH to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. FDA has completed its filing review and will begin its substantive review of Biofrontera's communication. The sNDA is supported by two clinical phase I studies investigating the safety of the application of three tubes of Ameluz®. The first study investigated the blood levels of 5-aminolevulinic acid, the active ingredient in Ameluz®, and its active metabolite protoporphyrine IX (PpIX), in 32 patients. Blood concentrations of these compounds were determined at 14 time points before and up to 10 hours after treatment in two groups of patients: 16 receiving photodynamic therapy (PDT) and three tubes of Ameluz on the face or scalp, and 16 receiving PDT and 3 tubes of Ameluz on other parts of the body. Further to a Type A meeting with the FDA in 2021, an additional safety trial with 100 patients receiving PDT with three tubes of Ameluz® was conducted. This data also formed part of the sNDA. The studies showed that after application of three tubes the blood concentrations of the active ingredient and the metabolite are transiently increased but they were several magnitudes below those at which side effects are known to occur. The systemic and application site adverse events were similar to those observed with one tube of Ameluz®, with patients frequently experiencing a transient inflammatory response at the application site and pain during illumination that was managed by a cooling air stream. New Risk • Feb 04
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 93% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (93% increase in shares outstanding). Market cap is less than US$10m (US$2.37m market cap). Announcement • Jan 26
Nasdaq Determines to Grant Biofrontera Inc. an Extension of 180 Calendar Days from November 22, 2023 to Regain Compliance Reference is made to the Current Report on Form 8-K filed by Biofrontera Inc. (the “Company”) with the Securities and Exchange Commission on November 29, 2023 regarding the notice received by the Company from The Nasdaq Stock Market (“Nasdaq”) on November 22, 2023 that the Company was no longer in compliance with certain of Nasdaq’s continued listing requirements. On January 8, 2024, the Company submitted to Nasdaq a plan to regain compliance with those requirements. On January 19, 2024, Nasdaq notified the Company that, based on the Company’s compliance plan, Nasdaq has determined to grant the Company an extension of 180 calendar days from November 22, 2023 (i.e., by May 20, 2024) to regain compliance. Announcement • Jan 17
Biofrontera Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million. Biofrontera Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 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$8.56m in 2026. Average annual earnings growth of 62% is required to achieve expected profit on schedule. New Risk • Dec 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% 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 Share price has been highly volatile over the past 3 months (16% average weekly change). Market cap is less than US$10m (US$5.84m market cap). Minor Risk Shareholders have been diluted in the past year (14% increase in shares outstanding). Announcement • Nov 30
Biofrontera Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with the Continued Listing Requirement Under Nasdaq Listing Rule 5550(b)(1) On November 22, 2023, Biofrontera Inc. (the ‘Company’) received a notice (the ‘Notice’) from the Listing Qualifications staff of 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 September 30, 2023 was $1,038,000, 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 November 22, 2023 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. Announcement • Nov 18
Biofrontera Inc., Annual General Meeting, Dec 20, 2023 Biofrontera Inc., Annual General Meeting, Dec 20, 2023, at 10:00 US Eastern Standard Time. Agenda: To elect two Class II directors to company's Board of Directors, to serve until the 2026 annual meeting of stockholders and until their successor has been duly elected and qualified, or until their earlier death, resignation or removal; to ratify the appointment of Marcum LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business as may properly come before the 2023 Annual Meeting or any adjournment or postponement thereof. New Risk • Nov 13
New minor risk - Profitability The 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 Risk Market cap is less than US$10m (US$5.78m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$14m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Announcement • Nov 12
Biofrontera Inc. Reaffirms Revenue Guidance for the Full Year 2023 Biofrontera Inc. reaffirmed revenue guidance for the full year 2023. The company affirms expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022. Announcement • Nov 04
Biofrontera Inc. to Report Q3, 2023 Results on Nov 09, 2023 Biofrontera Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 New Risk • Oct 13
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.09m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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$28m free cash flow). Market cap is less than US$10m (US$9.09m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$4.9m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). 