Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 15

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 15
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 one year of age and older that can administered by patients, parents and caregivers. As a prescription, ZELSUVMI will generally be covered under patients’ pharmacy benefit, differentiating it from procedural reimbursement for cantharidin and cryotherapy. Pediatricians, pediatric dermatologists, dermatologists and infectious disease specialists will be the target prescribers.

Pediatricians diagnose the majority of molluscum contagiosum infections, and the Company believes many patients have not been treated due, in part, to a lack of FDA approved prescription treatment options that can be administered outside of medical settings. The Company believes that pediatricians will be key to expanding the market, increasing peak sales, and sales and marketing efficiency. The Company will seek to position ZELSUVMI as the preferred first line therapy among pediatricians. The Company believes ZELSUVMI will enhance and complement current non-prescription treatment options and referral patterns. Based on the Company’s interactions with healthcare professionals (“HCPs”) to date, the Company believes HCPs would welcome this positioning of ZELSUVMI.

The Company believes
that ZELSUVMI fills a medical need in the market as the first safe and efficacious prescription medication for molluscum contagiosum
that can be administered outside of medical settings. Based on 2023 data from Veeva Compass, on an annual basis, greater than 390,000
unique patients are affected by molluscum contagiosum and greater than 100,000 unique HCPs are treating the disease in the United
States. However, we believe this number underestimates the true number of cases due to a lack of treatment options.

Sales and Distribution Strategy

The Company plans to
market ZELSUVMI primarily to physicians with personal promotion and direct sales efforts with a dedicated sales force supported
by a product management team and critical support staff. The sales and marketing effort will focus on increasing awareness, trial,
adoption and usage of ZELSUVMI to targeted pediatricians, pediatric dermatologists and dermatologists. The Company plans to distribute
ZELSUVMI via standard retail pharmacy chains, mail order and Amazon pharmacy utilizing a third-party logistics provider. Based
on the Company’s conversations with HCPs, the Company believes these distribution channels are the most preferred by patients
and HCPs. Critical to the launch of ZELSUVMI will be co-pay assistance and managing co-pay and patient out-of-pocket costs as well
as prescription “pull-through” strategies and tactics to ensure patient access and