Pelthos Therapeutics (NYSEAMERICAN:PTHS) reported fourth-quarter and full-year 2025 results on its earnings call, highlighting rapid early demand for its lead product ZELSUVMI, two newly acquired FDA-approved dermatology products, and financing transactions that management said strengthened the balance sheet while narrowing operating losses.
ZELSUVMI prescriptions and revenue rose in Q4
Chief Executive Officer Scott Plesha said the company’s fourth quarter was driven by “substantial demand-generated revenue growth” for ZELSUVMI following its third-quarter 2025 launch. ZELSUVMI is a topical nitric oxide-releasing product indicated for molluscum contagiosum (MC) in patients one year of age or older for up to 12 weeks, and management emphasized its at-home administration as a differentiator versus in-office procedures.
Chief Commercial Officer Sai Rangarao said the launch was progressing “better than expected,” with both shipments and prescriptions ahead of internal expectations, prompting the company to raise its internal outlook for 2026. Rangarao also said the fourth quarter is historically the weakest quarter for MC claims, but prescriptions still grew significantly. He cited average monthly MC claims of roughly 33,700 in Q4 2025 compared with about 45,100 per month from March through October 2025.
Management also shared early 2026 prescription trends. From Jan. 1, 2026 through the week ending March 6, 2026, the company recorded 5,297 prescribed units, and recently reached an all-time high of 695 prescribed units in a single week. Plesha added that the company was approaching 4,000 unique prescribers through March 6.
Market access expansion and gross-to-net outlook
Rangarao said Pelthos launched ZELSUVMI initially without commercial contracts using a selective contracting approach, but entered into a PBM commercial contract during Q4 covering approximately 20 million lives. He said the contract, which began in early December, “removed friction on access” quickly and was structured at a contract rate that does not affect the company’s Medicaid rate while allowing annual price increases.
As of the call, management reported a 59% coverage rate for commercial insurance plans and a 99% Medicaid coverage rate. Rangarao noted that some larger Medicaid states, including New York, do not require prior authorization, and in many other states prior authorization is written to label.
On gross-to-net (GTN), Rangarao said Q4 2025 GTN was 28.7%, which he described as favorable and in line with expectations. Both he and Chief Financial Officer Frank Knuettel said the company expects GTNs to rise into the mid- to high-30% range over time, driven by the PBM contract, co-pay card usage, and a higher-than-forecast mix of Medicaid business. In response to analyst questions, Knuettel reiterated that the primary GTN drivers were the PBM contract, co-pay cards, and Medicaid utilization.
Sales force expansion and marketing initiatives
Rangarao said the company launched with 50 territory managers placed based on ICD-10 prevalence data and added 14 more representatives in previously uncovered metropolitan areas such as Seattle, Minneapolis, San Francisco, and Salt Lake City. He said early data suggests the expansion was advantageous, with prescriptions in some territories increasing enough that new reps were “already covering the cost of their sales efforts” quickly.
In marketing, Rangarao cited continued efforts including the “Moms Against Molluscum” initiative, conference engagement, social media campaigns, and the company’s first YouTube commercial launched in Q4, which he said generated more than 4.5 million views and led patients and caregivers to ask healthcare providers about ZELSUVMI. He also noted the company planned full promotional and medical engagement activities at the American Academy of Dermatology meeting later in the month.
On prescriber mix, Rangarao said adoption was strongest in dermatology, including pediatric dermatologists and NP/PA providers, while uptake among pediatricians had been “better than expected.” Management said some pediatricians historically took a “wait and see” approach or used treatments that did not address the virus, and the company is working to build comfort with treatment now that an at-home FDA-approved option is available.
Two FDA-approved product acquisitions: Xepi and Xeglyze
Plesha said Pelthos acquired U.S. rights to Xepi in November. He described Xepi as a topical treatment for impetigo that addresses antibiotic-resistant skin infections caused by staph and strep and is most common in children. Management said impetigo affects roughly 3 million patients diagnosed annually and that Xepi is complementary because it targets the same prescriber base as ZELSUVMI, allowing the company to leverage its existing commercial infrastructure.
Pelthos said it is establishing manufacturing and building launch inventory for Xepi, expects to stock the product by the end of Q4 2026, and plans to launch it in January 2027. Plesha added that the company had received “very positive feedback” from key opinion leaders at recent dermatology meetings, citing rising resistance to current treatments.
In December, Pelthos acquired Xeglyze, an FDA-approved product for head lice. Plesha said Xeglyze is also highly complementary and would require minimal incremental overhead to bring to market. He emphasized that resistance to current treatments is growing and that Xeglyze requires only one application. Management expects to bring Xeglyze to market in late Q2 2027.
Financial results, balance sheet, and path to cash flow
Knuettel reported that cost of goods sold totaled $1.7 million for Q4 2025 and $4.0 million for the year. He attributed a quarter-over-quarter decline in cost of goods to a Q3 write-off of an out-of-specification API batch. He also said cost of goods includes fair value step-up of inventory on hand when the merger closed, with the company expecting to run through stepped-up finished goods inventory by late summer 2026 and stepped-up API inventory roughly 12 to 15 months later. After that, he said cost of goods should be a mid-single-digit percentage of wholesale acquisition cost.
SG&A expenses in Q4 were $18.5 million, including approximately $2.1 million of non-cash charges (equity compensation and depreciation), about $1.2 million in one-time items related to financing that could not be capitalized, and a $1.6 million royalty obligation. Knuettel said “steady-state” cash SG&A was $13.5 million for the quarter and down about 5% from Q3, reflecting tight expense management. He said SG&A is expected to rise in 2026 with a larger sales team and launch preparations for Xepi and Xeglyze, with incremental costs of roughly $1 million per quarter for additional personnel and low single-digit millions for each product’s launch preparation over the course of 2026.
Pelthos reported that quarterly net operating loss improved to $12.0 million in Q4 from $15.4 million in Q3, while adjusted EBITDA loss improved to $9.0 million from $11.5 million. The company ended 2025 with $18.0 million in cash and $8.9 million in accounts receivable, compared with $14.2 million in cash and $8.0 million in receivables at the end of Q3.
Management said it bolstered liquidity through an $18 million convertible note issued in November and a $50 million term debt facility with Horizon in January 2026, drawing $30 million. Knuettel said the loan has a five-year term with three years of interest-only payments and carries an interest rate of prime plus 3.75% (10.5% at the time of the call). He said additional capital is available upon milestones, but the company does not expect to draw more based on its current plan.
Knuettel also described a non-cash $15.0 million expense related to fair value assessment of the November convertible notes, tied largely to valuation of future royalty streams and a beneficial conversion feature. He said note holders are entitled to royalties on future Xepi sales and revenue from the Japanese license for ZELSUVMI.
On profitability timing, Knuettel said that, assuming no changes to the current business plan or outlook, the company expects “toward the end of the year” to cross into profitability. Plesha reiterated that the company has not provided discrete revenue or EPS guidance given it remains early in the launch, but said management remains confident in the revenue growth trajectory and views current cash as sufficient runway to execute the plan.
About Pelthos Therapeutics (NYSEAMERICAN:PTHS)
We are a clinical-stage biotech company focused on developing and commercializing new therapeutics to alleviate pain. Our clinical focus is to selectively target the sodium ion-channel known as “NaV1.7”, as well as other receptors in the NaV family. NaV1.7 has been genetically validated as a pain receptor in human physiology. Genetic studies have shown that families with a certain inherited NaV1.7 modulation consistently show a pathology of not feeling pain. A NaV1.7 blocker is a chemical entity that modulates the structure of the sodium-channel in a way to prevent the transmission of pain perception to the central nervous system (“CNS”).
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