Summary of Pelthos Therapeutics FY Conference Call (March 23, 2026) Company Overview - **Company**: Pelthos Therapeutics (NYSEAM:PTHS) - **Lead Product**: ZELSUVMI, a topical nitric oxide releasing product for treating molluscum contagiosum in patients aged one year and older [5][7] Key Points Company Background and Capitalization - Pelthos was formed from a merger with Channel Therapeutics on July 1, 2025, after raising $50 million through a PIPE [5] - The company trades on the NYSE under the ticker PTHS, with a current market cap of approximately $200 million [6] Product Information - **ZELSUVMI**: - First FDA-approved at-home treatment for molluscum contagiosum, allowing for daily application over 12 weeks [8] - Addresses a significant unmet need as traditional treatments involve painful procedures [7][10] Financial Performance - Prescription volume increased by 129% from Q3 to Q4, with net revenue rising from $7.1 million in Q3 to $9.1 million in Q4 [13][14] - The company has over 4,200 unique prescribers since the product launch [14] - Payer access is favorable, with 70% of prescriptions covered by commercial insurance and 99% by Medicaid [15][16] - Gross to net ratio improved from 25.3% in Q3 to 28.7% in Q4, with expectations to reach mid- to upper 30s% in 2026 [18] Sales Strategy and Market Access - The sales force is approximately 64 representatives, focusing on both dermatologists and pediatricians [19] - The company plans to leverage existing sales channels for new products, Xepi and Xeglyze, which target pediatric conditions [20][25] New Product Acquisitions - **Xepi**: - Targets impetigo, with a significant market need due to resistance to current treatments [21] - Expected to launch in early 2027 [24] - **Xeglyze**: - Aimed at treating head lice, with a unique dual-action formula [22] - Planned launch in the latter half of Q2 2027 [25] Future Outlook - Revenue guidance for ZELSUVMI is projected at $175 million by 2028, with a current consensus estimate of just over $60 million for the year [57] - The company is comfortable with its cash position, having raised $50 million in equity and additional funds through convertible debt [55][56] Intellectual Property and Market Exclusivity - ZELSUVMI has patent protection until 2035, with potential extensions into 2037 [40] - Xepi and Xeglyze have exclusivity until early 2032 and 2034, respectively [41] Strategic Focus - The primary focus remains on successfully launching ZELSUVMI, with plans to evaluate additional indications for the NITRICIL platform in the future [47][49] Additional Insights - The company emphasizes the importance of executing its current business plan before pursuing further acquisitions or expansions [47] - There is a noted prevalence of "super lice," which enhances the market potential for Xeglyze [22]

Financial Performance - Achieved record annual revenue of $41.7 million, driven by a 10% increase in Ameluz unit volumes and refined commercial targeting [5] - Improved gross margin profile significantly by replacing a 25-35% transfer pricing model with a 12-15% royalty-based earn-out structure [5] - Expects full-year 2026 gross profit margins to stabilize between 80% and 85% as the new cost structure applies to all sales volumes [5][7] Strategic Initiatives - Transformed the corporate structure by acquiring all U.S. rights, patents, and manufacturing contracts for Ameluz and RhodoLED from the former parent company [5] - Optimized sales operations by implementing a data-driven targeting approach and an inside sales pilot to capture previously underserved smaller accounts [5] - Divested the Xepi antibiotic cream license for $3 million in initial proceeds, with potential milestones up to $7 million to focus on core PDT assets [5] Clinical Development - Anticipates a PDUFA target action date of September 28, 2026, for the potential approval of Ameluz in treating superficial basal cell carcinoma [5] - Plans to file a supplemental NDA in 2026 to expand the Ameluz label for actinic keratosis on the extremities, neck, and trunk following positive Phase III results [5] - Intends to discuss the design of a Phase III program for moderate to severe acne vulgaris with the FDA in 2026 based on successful Phase II data [5] Operational Changes - Transitioned to full regulatory control in the U.S. following the formal FDA transfer of the NDA and IND in December 2025 [6] - Reduced customer churn to the lowest level since 2021 while successfully opening over 150 new accounts during the fiscal year [5] - Noted that legal expenses increased by $6.0 million in 2025 primarily due to ongoing patent litigation and defense costs [5]

Financial Data and Key Metrics Changes - Biofrontera achieved record annual revenues of $41.7 million in 2025, representing approximately 12% growth over the prior year [5][22] - Fourth quarter revenues reached $17.1 million, marking a 36% year-over-year increase and the highest quarterly revenue in the company's history [5][17] - Adjusted EBITDA for Q4 2025 was $4.9 million, a significant improvement from negative $1.4 million in Q4 2024 [21][27] - Net income for Q4 2025 was $5.6 million, compared to a net loss of $1.4 million in the same quarter of 2024 [21][26] Business Line Data and Key Metrics Changes - Ameluz unit volumes increased to approximately 121,000 tubes for the full year 2025, reflecting about 10% growth over 2024 [13] - Fourth quarter unit volumes were approximately 49,840 tubes, contributing to the strong revenue performance [13] - The installed base of RhodoLED lamps grew to approximately 745 across 686 dermatology offices by the end of 2025 [14] Market Data and Key Metrics Changes - The FDA accepted a supplemental new drug application for Ameluz in treating superficial basal cell carcinoma, with a PDUFA target action date of September 28, 2026 [9] - Positive phase 3 results were reported for actinic keratosis on the extremities, with plans to file a supplemental NDA in Q3 2026 [10] - The company anticipates a significant addressable market for treating extensive fields of actinic keratosis, affecting approximately 58 million American adults [10] Company Strategy and Development Direction - The completion of a strategic transaction with Biofrontera AG has fundamentally changed the business model, granting full control over U.S. assets and improving cost structure [7][40] - The new earn-out structure is expected to enhance gross margins, with projections of 80%-85% in 2026 [7][40] - The company is focused on expanding its clinical pipeline, with planned studies in squamous cell carcinoma and reduced pain PDT [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's trajectory, citing improved commercial execution and a strong pipeline of clinical developments [16][40] - The strategic transaction is expected to reduce cash consumption and advance towards cash flow breakeven [30][41] - Management highlighted the importance of institutional investors in supporting the company's strategic initiatives [30] Other Important Information - The company secured $11 million in funding through a private placement of Series C preferred stock [8] - A successful divestiture of the Xepi antibiotic cream license generated initial proceeds of $3 million, with potential additional milestone payments [8] Q&A Session Summary Question: Discussion on gross margin improvement for 2026 - Management expects gross profit margins to be between 80%-85%, starting from January 1, 2026, with potential fluctuations based on product mix [34][35]

Financial Data and Key Metrics Changes - Biofrontera achieved record annual revenues of $41.7 million in 2025, representing a 12% growth over the prior year, with Q4 revenues of $17.1 million, a 36% year-over-year increase [5][18] - Adjusted EBITDA for Q4 2025 was $4.9 million, a significant improvement from negative $1.4 million in Q4 2024, reflecting a margin improvement to 29% from negative 11% [21][28] - The net income for Q4 2025 was $5.6 million, compared to a net loss of $1.4 million in Q4 2024, driven by higher revenues and lower costs [21][27] Business Line Data and Key Metrics Changes - Ameluz unit volumes increased significantly, with Q4 2025 unit volumes at approximately 49,840 tubes, bringing the full year total to about 121,000 tubes, a 10% increase over 2024 [14] - The installed base of RhodoLED lamps grew to approximately 745 across 686 dermatology offices by the end of 2025, with 85 new lamps placed during the year [15] Market Data and Key Metrics Changes - The new royalty structure for Ameluz is set at 12% for annual U.S. net sales at or below $65 million and 15% for sales exceeding that threshold, improving gross margins significantly [8][19] - The FDA accepted a supplemental new drug application for Ameluz to treat superficial basal cell carcinoma, with a target action date of September 28, 2026, representing a new commercial opportunity [10] Company Strategy and Development Direction - The completion of the strategic transaction with Biofrontera AG has fundamentally changed the business model, allowing full control over U.S. assets, intellectual property, and regulatory approvals [41] - The company plans to expand its clinical pipeline, with studies in squamous cell carcinoma in situ and reduced pain PDT, while patent protection extends through 2043 [41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving gross profit margins between 80%-85% in 2026, driven by the new cost structure and improved operational efficiencies [35] - The company anticipates that the full annualized benefit of the new cost structure will be realized in 2026, contributing to a stronger financial trajectory [41] Other Important Information - Biofrontera secured $11 million in funding through a private placement of Series C preferred stock to support growth and the strategic transaction [9] - The company reported a significant reduction in related party cost of goods sold by 45% year-over-year, improving gross profit margins from 50% to 74% for the full year [24] Q&A Session Summary Question: Discussion on gross margin improvement for 2026 - Management expects gross profit margins to be between 80%-85% throughout 2026, starting at an 82% level [35] Question: Variability of gross margins over the year - Management indicated that while margins may fluctuate slightly based on product mix, they expect to maintain the target range consistently [36]

Corporate Presentation M A R C H 2 0 2 6 1 White 255 255 255 Background & Text Dark Grey 51 51 51 Pale Grey 225 225 225 Blue 0 61 166 Accents Blue 0 61 166 Sky Blue 0 154 222 Grey 137 138 141 Lime Green 164 203 95 Dark Teal 25 155 155 Title Case Headers Montserrat Bold Montserrat Legal Disclaimer This presentation of Pelthos Therapeutics Inc. ("we", "us", "our" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws ...

Summary of Pelthos Therapeutics FY Conference Call Company Overview - **Company Name**: Pelthos Therapeutics (NYSEAM:PTHS) - **Industry**: Biopharmaceuticals, specifically focused on pediatric cutaneous infectious diseases - **Ticker Symbol**: PTHS - **Market Capitalization**: Approximately $200 million [4] - **Shares Outstanding**: 8.9 million common shares [4] Key Products and Developments - **Lead Product**: ZELSUVMI, launched in July 2025, indicated for the treatment of molluscum contagiosum in patients aged 1 year and older [3][7] - **Recent Acquisitions**: - **Xepi**: Acquired in late 2025, expected launch in late 2026, treats impetigo [3][29] - **Xeglyze**: Acquired for $1.8 million, FDA-approved for head lice treatment, expected launch in mid-2027 [30][31] Financial Highlights - **Cash Position**: $14.2 million at Q3 close, raised an additional $18 million in a convertible note [4] - **Revenue Generation**: - Q3 2025: 2,700 units of ZELSUVMI dispensed, generating $7.1 million in net revenue [24] - Q4 2025: 129% growth in units quarter-over-quarter [24] - Anticipated gross-to-net (GTN) in Q4 expected to rise to the high 30% range [25] Market Strategy and Sales Performance - **Sales Force**: Initially launched with 50 representatives, expanded to 64 territories by March [21][22] - **Target Audience**: Focus on dermatologists, pediatric dermatologists, and pediatricians, covering approximately 10,000 top molluscum treaters [22] - **Digital Marketing**: Successful YouTube promotional video with over 3.5 million views [23] Clinical Insights and Product Efficacy - **ZELSUVMI Efficacy**: - B-SIMPLE4 trial showed about one-third of patients achieved complete clearance at 12 weeks [19] - 80% of parents found the treatment clinically meaningful even without complete clearance [20] - **Safety Profile**: Common side effects include mild application site pain (12%) and moderate pain (6%) [17] Market Challenges and Opportunities - **Molluscum Contagiosum**: High prevalence among children, with 73% of affected children going untreated [10] - **Treatment Landscape**: Traditional treatments often require multiple painful office visits; ZELSUVMI offers a home-based solution [16][17] - **Resistance Issues**: Concerns over mupirocin resistance in treating impetigo, presenting an opportunity for Xepi [30] Management Team and Experience - **CEO**: Over 30 years in the pharmaceutical industry, with a history of successful exits [5] - **Board Composition**: Includes experienced executives from various pharmaceutical companies, enhancing strategic direction [6] Future Outlook - **Product Pipeline**: Focus on maximizing ZELSUVMI's market potential before launching Xepi and Xeglyze [32] - **Potential Collaborations**: Opportunities to work with Ligand on clinical stage programs for the NITRICIL platform [37] - **Financial Position**: Strong capital position to support growth and potential acquisitions [36] Conclusion Pelthos Therapeutics is positioned for growth with its innovative product ZELSUVMI, a strong management team, and strategic acquisitions. The company is focused on addressing unmet needs in pediatric infectious diseases while navigating market challenges and leveraging digital marketing strategies for enhanced outreach.

As filed with the Securities and Exchange Commission on August 13, 2025. Registration No. 333-288717 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Delaware 2834 47-3765675 (I.R.S. Employer Identification No.) 120 Presidential Way, Suite 330 Woburn, MA 01801 Telephone: 781-245-1325 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) BI ...

As filed with the Securities and Exchange Commission on May 2, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) 120 Presidential Way, Suite 330 Woburn, MA 01801 Telephone: 781-245-1325 Washington, D.C. ...

As filed with the Securities and Exchange Commission on March 19, 2024. Registration No. 333-277811 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-3765675 (I.R.S. Employer Identification No.) 12 ...

As filed with the Securities and Exchange Commission on March 8, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 120 Presidential Way, Suite ...