ZELSUVMI™ net product revenue grew 28% Quarter over Quarter to
8,948 ZELSUVMI units prescribed by 2,712 unique prescribers for fiscal year 2025, with a 129% quarter over quarter increase in units dispensed, rising from 2,716 units in the third quarter of 2025 to 6,232 units in the fourth quarter of 2025.
Management will host a conference call today at
Recent and Full Year 2025 Highlights
- ZELSUVMI, the first at home FDA-approved treatment for molluscum contagiosum (“MC”), a highly contagious viral skin infection that largely afflicts children, was launched in
July 2025 and generated$16.2 million in net sales in the first two quarters of commercial operations, exceeding expectations. - From the launch of ZELSUVMI in
July 2025 throughDecember 31, 2025 , 8,948 units of ZELSUVMI were dispensed and were written by 2,712 unique prescribers. Quarter over quarter units of ZELSUVMI dispensed rose from 2,716 in the third quarter of 2025 to 6,232 in the fourth quarter of 2025, representing a 129% increase. - In
November 2025 , we completed the acquisition of XEPI®, which added a complementary dermatology product to our portfolio. XEPI is a novel FDA-approved topical treatment for impetigo that addresses a critical unmet need in antibiotic-resistant skin infections caused by staph and strep infections, most commonly affecting children. Impetigo affects approximately 3 million people in theU.S. every year and is among the most common bacterial skin infections seen in pediatric offices. - In
November 2025 , we closed an$18.0 million private convertible notes financing. This financing facilitated the purchase of and work to launch XEPI, accelerate the commercial rollout of ZELSUVMI and provided us with funds for general working capital purposes. - In
January 2026 , we announced the acquisition of XEGLYZE® (abametapir) fromHatchtech Pty Ltd. , an Australian biotech company. XEGLYZE is a novel, patent protected prescription medication indicated for the topical treatment of head lice infestation in patients 6 months of age and older. In theU.S. , infestation with head lice is most common among preschool- and elementary-school age children and their household members and caretakers. An estimated 6 to 12 million infestations occur each year in theU.S. among children. - In
January 2026 , we entered into a$50.0 million senior secured term loan facility, of which we drew$30.0 million at the close, with Horizon Technology Finance. The term loan provides us with the flexibility and resources to accelerate the commercialization of our portfolio and strengthens our balance sheet. - Our cash balance as of
December 31, 2025 was$18.0 million , which excludes the$30.0 million in term debt funding secured inJanuary 2026 , as set forth above. The cash balance is expected to support the current business plan, and the debt-based financing demonstrates the Company’s desire to be conscious of dilution and shareholder capital. - As of
December 31, 2025 , we had 8.9 million shares outstanding on an as converted basis, which includes unconverted Series A and Series C Convertible Preferred Stock and approximately 3.2 million shares of common stock. - We recently completed the previously announced expansion of the sales force, adding fourteen sales representatives in heretofore uncovered territories, bringing the nationwide total to 64 sales representatives.
Management Commentary
“In addition, the recent acquisition of XEPI and XEGLYZE have added two highly complementary products to our portfolio. FDA-approved XEPI and XEGLYZE each treat infectious skin conditions primarily impacting children, which aligns with the same target market as ZELSUVMI. This presents our sales reps and Pelthos with a synergistic opportunity to increase revenue by leveraging our current commercial relationships and infrastructure with de minimis additional SG&A. We believe we are well-positioned to capitalize on the large addressable markets and unmet needs presented by these three products and have the commercial infrastructure and experience to continue to grow ZELSUVMI and launch and grow XEPI and XEGLYZE.”
Fourth Quarter 2025 Financial Summary
- Our net product revenue for ZELSUVMI during the fourth quarter of 2025 was
$9.1 million , as compared to$7.1 million in the third quarter of 2025, representing an approximate 28% increase in product revenue quarter over quarter. - Our cost of goods sold was
$1.7 million for the fourth quarter of 2025 as compared to$2.3 million in the third quarter of 2025. Excluding fair value adjustments related to finished goods and API inventory on hand at the time of the merger, as well as the write-off of API related to one out of specification API batch and previously capitalized process validation expenses, cost of goods sold was$0.1 million in the fourth quarter of 2025 and$0.4 million in the third quarter of 2025. - Our SG&A expenses were
$18.5 million for the fourth quarter of 2025, as compared to$19.6 million for the third quarter of 2025, representing a decrease in SG&A expenses of approximately 6% quarter over quarter. Excluding non-cash items, non-capitalized transaction expenses and royalty expenses, our adjusted SG&A declined from approximately$14.2 million for the third quarter of 2025 to$13.5 million for the fourth quarter of 2025, representing an approximate decline in adjusted SG&A expenses of 5% quarter over quarter. - Our operating loss improved from a loss of approximately
$15.4 million in the third quarter of 2025 to a loss of approximately$12.0 million in the fourth quarter of 2025, representing a clear step towards reaching positive cash flow and net income. - Our adjusted EBITDA, netting out non-cash and non-capitalized transaction expenses, improved from a loss of approximately
$11.5 million in the third quarter of 2025 to approximately$9.0 million in the fourth quarter of 2025, representing an improvement of approximately 22% quarter over quarter. - Change in fair value of debt, related to the convertible note issued in
November 2026 , was$15.0 million in the fourth quarter of 2025. The Company analyzed the terms of the convertible notes and its embedded features concluding it appropriate to account for the convertible notes at fair value. Accordingly, the Company initially recognized the convertible notes at fair value and will subsequently measure the convertible notes at fair value with changes in fair value recorded in current period earnings. - Income tax benefit of
$6.9 million for the fourth quarter of 2025 related to the release of valuation allowance for historical deferred tax assets. - See additional detail within the Summary Financial Statement tables and Non-GAAP Financial Information below.
Webcast and Conference Call
Management will host a conference call today at
(877) 451-6152 (Domestic)
(201) 389-0879 (International)
Conference ID: 13758894
The live webcast will be accessible in the Investors section of the Company’s website or by following the direct link:
https://viavid.webcasts.com/starthere.jsp?ei=1753536&tp_key=4e91699655
For those who cannot listen to the live broadcast, an online replay will be available in the Investors section of Pelthos’ website.
About
Forward-Looking Statements
This press release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding Pelthos’ current expectations. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, references to our expectations regarding (i) our belief that our cash balance provides the runway to execute on our business plan; (ii) our belief that we will see continuing ZELSUVMI growth in 2026; (iii) the anticipated benefits of the acquisition of XEPI and that it will leverage our existing commercial and sales operations and provide additional opportunities to expand our revenue while benefiting from overhead cost synergies given XEPI’s complementary target market; (iv) our belief that Pelthos is well-positioned to capitalize on large addressable markets with ZELSUVMI, XEPI and XEGLYZE; (v) our belief that the exclusion of certain items in calculating Adjusted EBITDA and Adjusted COGs can provide a useful measure for period-to-period comparisons of our business; and (vi) our belief that Adjusted COGs provides useful information to investors in understanding and evaluating our operating results. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties related to there being no guarantee that the trading price of the combined company’s Common Stock will be indicative of the combined company’s value or that the combined company’s Common Stock will become an attractive investment in the future; we may rely on collaborative partners for milestone payments, royalties, materials revenue, contract payments and other revenue projections and may not receive expected revenue; we and our partners may not be able to timely or successfully advance any product(s) in our internal or partnered pipeline or receive regulatory approval and there may not be a market for the product(s) even if successfully developed and approved; and changes in general economic conditions, including as a result of war, conflict, epidemic diseases, the implementation of tariffs, and ongoing or future litigation could expose us to significant liabilities and have a material adverse effect on us. These and other risks and uncertainties are described more fully in our filings with the U.S. Securities and Exchange Commission. The information in this press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law.
Contacts
Investors:
mmoyer@lifesciadvisors.com
Media:
pelthos@kwmcommunications.com
(914) 315-6072
| Summary Financial Statements | ||||||
| Selected Condensed Consolidated Balance Sheet Data | ||||||
| (unaudited) | ||||||
| (in thousands) | ||||||
2025 | 2024 | |||||
| Cash and cash equivalents | $ | 17,973 | $ | 513 | ||
| Accounts receivable, net | 8,858 | — | ||||
| Inventory, net | 23,574 | — | ||||
| Total current assets | 53,410 | 1,369 | ||||
| Total assets | 130,397 | 1,369 | ||||
| Accounts payable | $ | 2,986 | $ | 1,897 | ||
| Accrued expenses | 15,364 | — | ||||
| Total current liabilities | 25,993 | 4,083 | ||||
| Total liabilities | 91,516 | 4,083 | ||||
| Total stockholders' equity (deficit) | 38,881 | (2,714 | ) | |||
| Total liabilities and stockholders' equity (deficit) | 130,397 | 1,369 | ||||
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (unaudited) | |||||||||||||||
| (in thousands except share and per share data) | |||||||||||||||
| Quarters Ended | Years Ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenue | |||||||||||||||
| Net product revenues | $ | 9,094 | $ | — | $ | 16,206 | $ | — | |||||||
| License and collaboration revenues | 295 | — | 589 | — | |||||||||||
| Total revenue | 9,389 | — | 16,795 | — | |||||||||||
| Operating expenses | |||||||||||||||
| Cost of goods sold | 1,672 | — | 3,988 | — | |||||||||||
| Selling, general and administrative | 18,469 | 1,539 | 42,453 | 6,392 | |||||||||||
| Research and development | 374 | 285 | 1,228 | 1,179 | |||||||||||
| Amortization of intangible assets | 877 | — | 1,556 | — | |||||||||||
| Total operating expenses | 21,392 | 1,824 | 49,225 | 7,571 | |||||||||||
| Operating loss | (12,003 | ) | (1,824 | ) | (32,430 | ) | (7,571 | ) | |||||||
| Other (expense) income | |||||||||||||||
| Interest expense | (1,314 | ) | (108 | ) | (3,012 | ) | (786 | ) | |||||||
| Impairment of intangible assets | (285 | ) | — | (285 | ) | — | |||||||||
| Change in fair value of convertible debt | (14,984 | ) | — | (14,984 | ) | — | |||||||||
| Interest income and other income | — | 6 | 5 | 402 | |||||||||||
| Total other (expense) income | (16,583 | ) | (102 | ) | (18,276 | ) | (384 | ) | |||||||
| Net loss before provision for income taxes | (28,586 | ) | (1,926 | ) | (50,706 | ) | (7,955 | ) | |||||||
| Provision for income taxes | (6,922 | ) | — | (7,387 | ) | — | |||||||||
| Net loss and comprehensive loss | $ | (21,664 | ) | $ | (1,926 | ) | $ | (43,319 | ) | $ | (7,955 | ) | |||
| Net loss per common share - basic and diluted | $ | (6.87 | ) | $ | (3.19 | ) | $ | (23.04 | ) | $ | (14.27 | ) | |||
| Weighted average number of common shares outstanding during the period - basic and diluted | 3,154,538 | 603,346 | 1,880,498 | 557,447 | |||||||||||
The table below sets forth the income statement for the third and fourth quarters of 2025. This table will be provided through the second quarter of 2026, after which this will be discontinued as the Company will have comparable year over year comparisons:
| Condensed Consolidated Statements of Operations | |||||||
| (unaudited) | |||||||
| (in thousands except share and per share data) | |||||||
| Quarters Ended | |||||||
| Revenue | |||||||
| Net product revenues | $ | 9,094 | $ | 7,112 | |||
| License and collaboration revenues | 295 | 294 | |||||
| Total revenue | 9,389 | 7,406 | |||||
| Operating expenses | |||||||
| Cost of goods sold | 1,672 | 2,316 | |||||
| Selling, general and administrative | 18,469 | 19,628 | |||||
| Research and development | 374 | 145 | |||||
| Amortization of intangible assets | 877 | 679 | |||||
| Total operating expenses | 21,392 | 22,768 | |||||
| Operating loss | (12,003 | ) | (15,362 | ) | |||
| Other (expense) income | |||||||
| Interest expense | (1,314 | ) | (1,346 | ) | |||
| Impairment of intangible assets | (285 | ) | — | ||||
| Change in fair value of convertible debt | (14,984 | ) | — | ||||
| Interest income and other income | — | 5 | |||||
| Total other (expense) income | (16,583 | ) | (1,341 | ) | |||
| Net loss before provision for income taxes | (28,586 | ) | (16,703 | ) | |||
| Provision for income taxes | (6,922 | ) | (465 | ) | |||
| Net loss and comprehensive loss | $ | (21,664 | ) | $ | (16,238 | ) | |
| Net loss per common share - basic and diluted | $ | (6.87 | ) | $ | (5.30 | ) | |
| Weighted average number of common shares outstanding during the period - basic and diluted | 3,154,538 | 3,061,488 | |||||
Non-GAAP Financial Information
Adjusted EBITDA
To provide investors with additional information regarding the Company’s financial results, we have provided within this press release Adjusted EBITDA, a non-GAAP financial measure. We define Adjusted EBITDA as net loss adjusted to eliminate (i) stock-based compensation expense, (ii) intangible asset impairment, (iii) change in fair value of convertible debt;(iv) interest expense, (v) interest and other income, (vi) amortization of intangible assets, (vii) depreciation expense, and (viii) the provision for income taxes. We have provided a reconciliation below of Net Loss and Comprehensive Loss, the most directly comparable GAAP financial measure, to Adjusted EBITDA.
We have included Adjusted EBITDA in this press release because it is a key measure used by our management to understand and evaluate our core operating performance and trends, to prepare and approve our annual budget and to develop short- and long-term operating plans. In particular, we believe the exclusion of certain items from net loss in calculating Adjusted EBITDA can provide a useful measure for period-to-period comparisons of our business.
Accordingly, we believe that Adjusted EBITDA provides useful information to investors in understanding and evaluating our operating results. Our use of Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP
The following table presents a reconciliation of Net Loss and Comprehensive Loss to Adjusted EBITDA for each of the periods indicated (in thousands):
| Quarters Ended | Years Ended | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Net loss and comprehensive loss | $ | (21,664 | ) | $ | (1,926 | ) | $ | (43,319 | ) | $ | (7,955 | ) | |||
| Adjustments: | |||||||||||||||
| Stock-based compensation | 1,799 | 450 | 5,461 | 1,560 | |||||||||||
| Impairment of intangible asset | 285 | — | 285 | — | |||||||||||
| Change in fair value of convertible debt | 14,984 | — | 14,984 | — | |||||||||||
| Interest expense | 1,314 | 108 | 3,012 | 786 | |||||||||||
| Interest and other income | — | (6 | ) | (5 | ) | (402 | ) | ||||||||
| Amortization of intangible assets | 877 | — | 1,556 | — | |||||||||||
| Depreciation | 340 | — | 729 | — | |||||||||||
| Provision for income taxes | (6,922 | ) | — | (7,387 | ) | — | |||||||||
| Adjusted EBITDA | $ | (8,987 | ) | $ | (1,374 | ) | $ | (24,684 | ) | $ | (6,011 | ) | |||
Adjusted Cost of Goods Sold (“COGs”)
To provide investors with additional information regarding the Company’s financial results, we have provided within this press release Adjusted COGs, a non-GAAP financial measure. We define Adjusted COGs as Cost of Goods Sold adjusted to eliminate (i) expense related to inventory write down as a result of excess, obsolescence or scrap, and (ii) the inventory valuation step-up recognized in connection with the
We have included Adjusted COGs in this press release because it is a key measure used by our management to understand and evaluate our core operating performance and trends, to prepare and approve our annual budget and to develop short- and long-term operating plans. In particular, we believe the exclusion of certain items from Cost of Goods Sold in calculating Adjusted COGs can provide a useful measure for period-to-period comparisons of our business.
The Company accounts for business acquisitions using the acquisition method of accounting in accordance with Accounting Standards Codification (“ASC”) 805, Business Combinations. ASC 805 requires, among other things, that assets acquired and liabilities assumed be recognized at their fair values, as determined in accordance with ASC 820, Fair Value Measurements (“ASC 820”), as of the acquisition date. As part of the
Accordingly, we believe that Adjusted COGs provides useful information to investors in understanding and evaluating our operating results. Our use of Adjusted COGs has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP.
The following table presents a reconciliation of Cost of Goods Sold to Adjusted COGs for each of the periods indicated (in thousands):
| Quarters Ended | Years Ended | ||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||
| Cost of goods sold | $ | 1,672 | $ | — | $ | 3,988 | $ | — | |||||
| Adjustments: | |||||||||||||
| Write-off of inventory | (121 | ) | — | (1,055 | ) | — | |||||||
| ASC 805 Basis Step-Up | (1,433 | ) | — | (2,502 | ) | — | |||||||
| Adjusted COGs | $ | 118 | $ | — | $ | 431 | $ | — | |||||
