Pelthos Therapeutics (NYSEAM:PTHS) FY Conference December 04, 2025 09:30 AM ET Company ParticipantsScott Plesha - CEOModeratorWelcome to Day Three of the Piper Sandler Healthcare Conference. This is David Amsellem from the Piper Biopharma Research Team. We're delighted to kick off today with Pelthos Therapeutics and CEO Scott Plesha. Thanks, Scott, for joining us. I'm going to dive right in. You had some favorable news on Zelzuvmi this morning on the payer front, so kind of hot off the presses. Maybe just g ...

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was reported at $14.3 million, a significant increase from a negative revenue of $1.8 million in Q3 2024 [21] - Net YCANTH revenue for Q3 2025 was $3.6 million, compared to negative $1.9 million in Q3 2024, reflecting improved demand and sales [21][22] - GAAP net loss for Q3 2025 was $0.2 million, or $0.03 per share, compared to a GAAP net loss of $22.9 million, or $4.88 per share in Q3 2024 [24] Business Line Data and Key Metrics Changes - Dispensed applicator units of YCANTH reached 14,093 in Q3 2025, representing approximately 5% sequential growth over the prior quarter [11] - Year-to-date dispensed applicator units increased to 37,642 for the nine months ended September 30, 2025, a 120% increase compared to the same period in 2024 [7] Market Data and Key Metrics Changes - The company received $18 million in cash milestone payments from Torii in 2025, with $10 million received in Q3 upon approval of YCANTH for molluscum in Japan [8] - Positive feedback from the European Medicines Agency indicated no further phase 3 studies are needed for YCANTH's approval for molluscum in the EU, with a filing anticipated in Q4 2026 [9][10] Company Strategy and Development Direction - The company aims to establish YCANTH as a leading therapy for multiple skin lesions, expanding beyond dermatology into pediatric and primary care [7][10] - The development of VP-315 for basal cell carcinoma is positioned as a potential standard of care, with plans for a phase 3 study design confirmed by the FDA [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of YCANTH and the potential for VP-315, highlighting a strong foundation for future growth [4][26] - The company is focused on optimizing its cost structure while advancing its clinical programs, with expectations for continued organic growth into 2026 [19][26] Other Important Information - The company has expanded its sales force to 45 representatives, with plans to increase to 50 in 2026 [15] - A new non-dispensing pharmacy, YCANTH Rx, is expected to launch in Q4 2025 to streamline prescription processes for healthcare providers [14][15] Q&A Session Summary Question: Can you further speak to the YCANTH demand that you're seeing in Q4? - Management noted that momentum from September has continued into Q4, with expectations for increased demand as the cold and flu season approaches [31] Question: What kind of counter-detailing are you seeing, and what has been the prescriber feedback on Zelsuvmi? - Management indicated that the largest competitor remains the "watch and wait" approach, but the launch of Zelsuvmi has positively influenced the market by promoting the need for treatment [32] Question: When do you expect sales force productivity to fully ramp? - Management expects new sales representatives to become productive in early 2026, as it typically takes a few months for new hires to ramp up [36] Question: Why is there a 12-month timeline for the EU filing despite no additional clinical trials required? - Management explained that the timeline includes necessary sequential steps, such as securing a pediatric waiver, which adds time to the process [38] Question: What feedback has been received regarding YCANTH Rx? - Feedback has been positive, with the new pharmacy model expected to simplify the prescription process for clinicians and improve patient access [45] Question: How should we think about seasonality impact in Q4 sales? - Management anticipates traditional slowdowns in November and December due to holidays but expects momentum to continue into early next year [50]

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was reported at $14.3 million, a significant increase from a negative revenue of $1.8 million in Q3 2024 [21] - Net YCANTH revenue for Q3 2025 was $3.6 million, compared to negative $1.9 million in Q3 2024, reflecting improved demand and sales [21][22] - GAAP net loss for Q3 2025 was $0.2 million, or $0.03 per share, compared to a GAAP net loss of $22.9 million, or $4.88 per share in Q3 2024 [24] Business Line Data and Key Metrics Changes - Dispensed applicator units of YCANTH reached 14,093 in Q3 2025, representing a 5% sequential growth from the previous quarter [11] - Year-to-date dispensed applicator units increased to 37,642 for the nine months ended September 30, 2025, a 120% increase compared to the same period in 2024 [7] Market Data and Key Metrics Changes - The company received $18 million in cash milestone payments from Torii in 2025, with $10 million received in Q3 upon approval of YCANTH for molluscum in Japan [8] - Positive feedback from the European Medicines Agency indicated no further phase III studies are needed for YCANTH's approval for molluscum in the EU, with a filing anticipated in Q4 2026 [9][10] Company Strategy and Development Direction - The company aims to establish YCANTH as a leading therapy for multiple skin lesions, expanding its use beyond dermatology into pediatric and primary care [7][10] - The development of VP-315 for basal cell carcinoma is positioned as a potential standard of care, with plans for a phase III study design confirmed by the FDA [11][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of YCANTH, citing a strong foundation for future growth and the potential for multiple approvals across major pharmaceutical markets [4][9] - The company is focused on maintaining a highly efficient operating model while exploring strategic partnerships to advance its pipeline [26][19] Other Important Information - The company plans to launch YCANTH Rx, a non-dispensing pharmacy, in Q4 2025 to streamline the prescription process for healthcare providers [15] - The sales force has expanded to 45 representatives, with plans to increase to 50 in 2026 [15] Q&A Session Summary Question: Can you further speak to the YCANTH demand that you're seeing in Q4? - Management noted that momentum from September has continued into Q4, with expectations of increased demand [31] Question: What kind of counter-detailing are you seeing, and what has been the prescriber feedback on Zilretc? - Management views the Zilretc launch positively, as it raises awareness about the need to treat molluscum, while YCANTH remains a best-in-class option [32] Question: When do you expect sales force productivity to fully ramp? - Management indicated that new sales representatives typically take a few months to ramp up, with expectations for productivity to increase in early 2026 [36] Question: Why is there a 12-month timeline for the EU filing despite no additional clinical trials required? - Management explained that sequential steps, including securing a pediatric waiver, are necessary for the EU filing, which adds time to the process [38] Question: What feedback have you received regarding YCANTH RX? - Feedback has been positive, with the new pharmacy model expected to simplify the prescription process for clinicians and patients [45] Question: How should we think about seasonality impact in Q4 sales? - Management expects traditional slowdowns in November and December but anticipates increased doctor visits in the cold and flu season could boost diagnoses of molluscum [50]

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was $14.3 million, a significant increase from negative revenue of $1.8 million in Q3 2024 [18] - Net YCANTH revenue for Q3 2025 was $3.6 million, compared to negative $1.9 million in Q3 2024, reflecting improved demand and sales [18][19] - GAAP net loss for Q3 2025 was $0.2 million, or $0.03 per share, compared to a GAAP net loss of $22.9 million, or $4.88 per share in Q3 2024 [21] - Non-GAAP net income for Q3 2025 was $1.2 million, or $0.13 per share, compared to a net loss of $20.2 million, or $4.30 per share in Q3 2024 [21] Business Line Data and Key Metrics Changes - Dispensed applicator units of YCANTH reached 14,093 in Q3 2025, representing approximately 5% sequential growth over the prior quarter [10] - Year-to-date dispensed applicator units increased to 37,642 for the nine months ended September 30, 2025, a 120% increase compared to the same period in 2024 [6] Market Data and Key Metrics Changes - The approval of YCANTH in Japan for molluscum is expected to lead to multiple approvals across major pharmaceutical markets, including the EU [8] - Feedback from the European Medicines Agency indicated no further phase III studies are needed for YCANTH's approval for molluscum, with a filing anticipated as early as Q4 2026 [8] Company Strategy and Development Direction - The company aims to establish YCANTH as a leading therapy for multiple types of skin lesions, leveraging its existing clinician relationships [6] - The development of VP-315 for basal cell carcinoma is positioned as a potential standard of care, with plans for a phase III study design confirmed by the FDA [10][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of YCANTH and the potential for VP-315, highlighting a strong foundation for future growth [4][17] - The company is focused on optimizing its cost structure while expanding its commercial strategy, which has led to reduced spending and increased product adoption [5][20] Other Important Information - The company received $18 million in cash milestone payments from Torii in 2025, with $10 million received in Q3 upon YCANTH's approval in Japan [7] - A new non-dispensing pharmacy, YCANTH Rx, is expected to launch in Q4 2025 to streamline the prescription process for healthcare providers [12][13] Q&A Session Summary Question: Can you further speak to the YCANTH demand that you're seeing in Q4? - Management noted that momentum from September has continued into Q4, with expectations for increased demand as the cold and flu season approaches [24][25] Question: What kind of counter-detailing are you seeing, and what has been the prescriber feedback on Zilretc? - Management views the Zilretc launch positively, as it raises awareness about the need to treat molluscum, while YCANTH remains a best-in-class option [25] Question: When do you expect sales force productivity to fully ramp? - It typically takes a few months for new sales representatives to become fully productive, with expectations for many to be effective early in 2026 [26][27] Question: Why is there a 12-month timeline for the EU filing despite no additional clinical trials required? - The timeline includes necessary sequential steps, such as securing a pediatric waiver, which adds time to the process [27][28] Question: What feedback has been received regarding YCANTH Rx? - Feedback has been positive, with the new pharmacy model expected to simplify the prescription process for clinicians and patients [29][30] Question: How should we think about seasonality impact in Q4 sales? - Traditional seasonal slowdowns are expected in November and December, but increased doctor visits during the cold and flu season may boost diagnoses of molluscum [32][33]

Group 1 - Verrica Pharmaceuticals held its Q1 2025 Corporate Update Conference Call on May 13, 2025, with key participants including the CEO, CFO, and COO [1][3] - The call included discussions on the commercialization of YCANTH for treating molluscum contagiosum in the U.S., revenue growth, regulatory developments, and the company's product candidates [4][5] - Management emphasized the importance of forward-looking statements regarding the company's business strategy and operations, highlighting potential risks and uncertainties [4][5]

Financial Data and Key Metrics Changes - In Q4 2024, total revenues were reported at $0.3 million, primarily from YCANTH revenue, with full-year revenues of $7.6 million compared to $5.1 million in the prior year [27][28] - Gross profit margins for the full year 2024 were 72%, with a cost of product revenue of $1.9 million, including $0.9 million of obsolete inventory costs [30] - GAAP net loss for Q4 2024 was $16.2 million or $0.24 per share, compared to a loss of $24.6 million or $0.53 per share in Q4 2023 [33] Business Line Data and Key Metrics Changes - YCANTH dispense applicator units increased to 8,654 in Q4 2024, a sequential growth of 12.3% from 7,706 units in the prior quarter, and a 44.8% increase from 5,975 units in Q2 2024 [15][28] - Research and development expenses decreased to $1.2 million in Q4 2024, down from $4.2 million in Q4 2023, primarily due to reduced clinical trial costs [31] Market Data and Key Metrics Changes - The company is focusing on territories with high prevalence of molluscum contagiosum and has established strong insurance coverage for YCANTH [13] - The pediatric market is showing growth, with an increasing percentage of pediatricians treating with YCANTH, although dermatologists remain the primary customer base [72] Company Strategy and Development Direction - The company is executing a turnaround plan with a focused commercialization strategy for YCANTH while reducing costs across the organization [7][8] - Plans to develop YCANTH for common warts are underway, with a Phase 3 clinical program expected to start as early as mid-2025 [19] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about the growth trajectory of YCANTH, noting good adoption and interest in the product [49][52] - The company aims to achieve cash-positive monthly operating results by year-end 2025, although specific revenue guidance was not provided [53][54] Other Important Information - The company raised approximately $42 million in an equity follow-on offering in November 2024, strengthening its balance sheet [26] - As of December 31, 2024, the company had cash and cash equivalents of $46.3 million, which may not be sufficient to fund operations for the next year without additional milestone payments [34] Q&A Session Summary Question: What is the patient demand for YCANTH and feedback from clinicians? - Management noted good adoption and interest in YCANTH across both pediatricians and dermatologists, with continued use of the product being reported [49][50] Question: What are the expectations for sales in 2025? - Management indicated that they are cautiously optimistic about growth and will maintain current guidance until more clarity is achieved [53][54] Question: What are the seasonal impacts on demand? - Management acknowledged that warmer weather could support growth and that they are prepared for potential seasonal changes [61][62] Question: What is the status of the IP protection for YCANTH? - The company has a robust IP portfolio and is addressing challenges from compounders while finding good adoption of the product [65][66] Question: What are the plans for advancing VP-315 into Phase 3 trials? - Management stated that the majority of expenses for the VP-315 program were incurred previously, and they will evaluate the program once they have the necessary data [75][76]