Pelthos Therapeutics Signs Major Pharmacy Benefit Manager Agreement Expanding Patient Access to ZELSUVMI™ (berdazimer) Topical Gel, 10.3%

Rhea-AI Summary

Pelthos Therapeutics (NYSE American: PTHS) signed its first commercial agreement to expand patient access to ZELSUVMI™ (berdazimer) topical gel, 10.3%, an FDA‑approved at‑home treatment for molluscum contagiosum. The company entered a deal via a Group Purchasing Organization with a pharmacy benefit manager that covers more than 20 million lives; formulary inclusion updates began on December 1, 2025. ZELSUVMI launched in July 2025, is approved for patients aged one year and older, and received a Novel Drug designation from FDA in January 2024. Pelthos says the PBM partnership aims to improve coverage, distribution, and patient access to the once‑daily topical gel.

Positive

• Formulary inclusion began on December 1, 2025
• PBM manages more than 20 million covered lives
• ZELSUVMI launched commercially in July 2025
• ZELSUVMI received Novel Drug designation in January 2024

Negative

• None.

News Market Reaction

+0.61%

3 alerts

+0.61% News Effect

-12.9% Trough Tracked

+$524K Valuation Impact

$86M Market Cap

0.3x Rel. Volume

On the day this news was published, PTHS gained 0.61%, reflecting a mild positive market reaction. Argus tracked a trough of -12.9% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $524K to the company's valuation, bringing the market cap to $86M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Molluscum prevalence: 16.7 million people New U.S. cases: 6 million incidents/year PBM covered lives: More than 20 million +5 more

8 metrics

Molluscum prevalence 16.7 million people Estimated number affected by molluscum contagiosum in the U.S.

New U.S. cases 6 million incidents/year Estimated annual new molluscum contagiosum incidents in the United States

PBM covered lives More than 20 million Lives under prescription benefits managed by the PBM adding ZELSUVMI

Q3 2025 revenue $7.4 million Pelthos Q3 2025 revenue after ZELSUVMI launch

Q3 2025 net loss $16.2 million Net loss for quarter ended September 30, 2025

Cash balance $14.2 million Cash and cash equivalents as of September 30, 2025

Shares outstanding 3,061,681 shares Common shares outstanding as of November 7, 2025

Convertible note principal $9.0 million Senior secured convertible note issued November 6, 2025

Market Reality Check

Price: $24.69 Vol: Volume 25,123 is below it...

normal vol

$24.69 Last Close

Volume Volume 25,123 is below its 20-day average of 35,021 (relative volume 0.72). normal

Technical Shares at $23.94 are trading below the 200-day MA of $26.84 and about 55.9% under the 52-week high of $54.29.

Peers on Argus

Biotech peers showed mixed moves: HYFT +0.54%, MEIP +6.23%, ORMP +4.66%, PLRX +0...

Biotech peers showed mixed moves: HYFT +0.54%, MEIP +6.23%, ORMP +4.66%, PLRX +0.76%, while IFRX fell 5.56%. With PTHS down 1.15% ahead of this positive access news and no peers in the momentum scanner, trading looked more stock‑specific than a coordinated sector move.

Common Catalyst Only one peer (PLRX) had same-day clinical data news, suggesting no shared catalyst with PTHS’s PBM access announcement.

Historical Context

5 past events · Latest: Dec 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 04	PBM access deal	Positive	+0.6%	First PBM-linked commercial agreement to expand ZELSUVMI formulary access.
Dec 02	Conference appearance	Neutral	-5.0%	Announcement of CEO fireside chat at Piper Sandler healthcare conference.
Nov 13	Q3 2025 earnings	Negative	-7.3%	Q3 2025 results with net loss, ZELSUVMI launch revenues, going-concern language.
Nov 07	Acquisition & notes	Negative	-8.1%	Xepi acquisition funded by senior secured convertible notes and related financing.
Nov 05	Earnings preview	Neutral	+6.5%	Scheduling of Q3 2025 results release and conference call details.

Pattern Detected

Recent news often aligned with price direction: commercial and financing updates tending to see moves consistent with their tone, with several negative financing/earnings items followed by declines.

Recent Company History

Over the last two months, Pelthos reported several milestones around ZELSUVMI and corporate financing. A PBM access agreement on Dec 4, 2025 tied ZELSUVMI to a manager of over 20 million covered lives after its July 2025 launch. The company presented at the Piper Sandler conference and reported Q3 2025 results, including ZELSUVMI revenues and a going-concern warning. Pelthos also acquired Xepi and completed an $18 million senior secured convertible note financing. Today’s PBM agreement builds on this commercialization push for ZELSUVMI.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-09-19

The company has an active S-3/A shelf filed on 2025-09-19, currently marked as not effective with 0 recorded usages and an expiration date of 2028-09-19.

Market Pulse Summary

This announcement detailed Pelthos’s first commercial agreement linking ZELSUVMI to a major PBM that...

Analysis

This announcement detailed Pelthos’s first commercial agreement linking ZELSUVMI to a major PBM that manages prescription benefits for more than 20 million covered lives, building on its July 2025 launch. It reinforces the at-home positioning of the first FDA-approved topical nitric oxide-releasing gel for molluscum contagiosum. In context, investors may track how this expanded formulary access interacts with prior Q3 revenue of $7.4 million, ongoing net losses, recent convertible note financings, and the company’s existing S-3/A shelf filed in 2025.

Key Terms

pharmacy benefit manager, group purchasing organization, formulary, topical gel, +4 more

8 terms

pharmacy benefit manager financial

"partnering with a national pharmacy benefit manager is another important milestone"

A pharmacy benefit manager (PBM) is a company that manages prescription drug plans for health insurance providers, employers, and other organizations. They negotiate prices with drugmakers, decide which medicines are covered, and handle the distribution of prescriptions. For investors, PBMs are important because they influence healthcare costs and profit margins in the pharmacy industry.

group purchasing organization financial

"Pelthos has entered into an agreement with a Group Purchasing Organization that collaborates"

A group purchasing organization (GPO) is an entity that helps a group of buyers, such as healthcare providers or businesses, combine their purchasing power to buy goods or services at lower prices. By negotiating on behalf of its members, a GPO can secure better deals than individual buyers could on their own. This can lead to cost savings and operational efficiencies, making GPOs important players in industries where large-scale purchasing influences overall expenses and profitability.

formulary financial

"The PBM manages prescription drug benefits for more than 20 million covered lives, and the formulary inclusion updates"

A formulary is a list of prescription drugs that a health insurer, hospital system, or government program has approved for coverage and payment. Think of it like an approved menu or shopping list that determines which medicines patients can get with financial help. For investors, formulary placement affects a drug maker’s potential sales, pricing power and market access, so being included—or excluded—can materially change a company’s revenue outlook.

topical gel medical

"ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum"

A topical gel is a medicine or active formula delivered as a semi-solid, smooth substance applied directly to the skin or mucous membranes to treat local symptoms or deliver drugs through the skin. For investors, it matters because this delivery form affects manufacturing complexity, regulatory review, shelf life, and market appeal—think of it like choosing a spray versus a pill: the format influences cost, patient acceptance, and potential sales.

nitric oxide-releasing medical

"ZELSUVMI is a novel, topical nitric oxide-releasing gel for the treatment of molluscum"

A nitric oxide-releasing product is a drug, device, or material designed to deliver small amounts of nitric oxide (a naturally occurring signaling gas) at a controlled pace where it’s needed in the body. Investors care because this release mechanism can improve treatment effects—for example by widening blood vessels, killing microbes, or speeding healing—so it can differentiate a product, affect regulatory review, and influence market potential like a timed-release feature on a consumer product.

molluscum contagiosum medical

"treatment for molluscum contagiosum, a highly contagious viral skin condition"

Molluscum contagiosum is a common viral skin infection that causes small, painless bumps or lesions on the skin. While it primarily affects children and healthy adults, it can spread easily through skin contact. For investors, understanding health conditions like this highlights the importance of healthcare companies involved in treatments and the potential impact of infectious diseases on public health and economic stability.

novel drug designation regulatory

"ZELSUVMI received a Novel Drug designation from the U.S. Food and Drug Administration"

A novel drug designation is an official approval given to a new medicine that shows promise in treating serious or rare health conditions. This status can accelerate the development process and provide certain benefits, such as quicker review times or special protections, which may make the drug more attractive to investors. It signals that the drug is innovative and has potential to meet unmet medical needs.

prescription medication medical

"The once-daily prescription medication is effective, well-tolerated, and convenient"

Prescription medication is a drug that can only be dispensed with a licensed healthcare provider’s authorization and is intended to treat, manage, or prevent a specific medical condition; these drugs are developed, tested, and regulated to ensure they are safe and effective for their intended use. For investors, prescription medications matter because sales, patent protection, clinical trial results, regulatory approvals, and insurance reimbursement determine a drug’s market access and revenue potential — think of them as products that need both a safety stamp and a sales permit before they can earn money.

AI-generated analysis. Not financial advice.

ZELSUVMI is the first and only FDA-approved at-home treatment for molluscum contagiosum, a
highly contagious viral skin condition affecting an estimated 16.7 million people, with up to
6 million new incidents reported every year in the United States

DURHAM, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for unmet patient needs (“Pelthos”), today announced it has signed its first commercial agreement to expand patient access for ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older (“ZELSUVMI”).

Pelthos has entered into an agreement with a Group Purchasing Organization that collaborates with manufacturers on behalf of one of the largest Pharmacy Benefit Managers (“PBMs”) in the United States. The PBM manages prescription drug benefits for more than 20 million covered lives, and the formulary inclusion updates for ZELSUVMI started on December 1, 2025.

"Partnering with a national pharmacy benefit manager is another important milestone in our efforts to achieve increased commercial coverage for ZELSUVMI," said Scott Plesha, CEO of Pelthos. "This new partnership will allow an important treatment option to be included in more coverage and distribution networks, thereby improving access for patients and caregivers who are seeking an at-home treatment for molluscum contagiosum.”

Pelthos launched ZELSUVMI for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older in July 2025. ZELSUVMI is a novel, topical nitric oxide-releasing gel for the treatment of molluscum. The once-daily prescription medication is effective, well-tolerated, and convenient for at-home or on-the-go application and can be used to treat molluscum contagiosum infections on the body, including sensitive areas such as the face, groin, or underarms. ZELSUVMI received a Novel Drug designation from the U.S. Food and Drug Administration in January 2024 and is the first and only prescription therapy approved for use at home by patients, parents, and caregivers to treat molluscum infections.

“This PBM partnership supports our overall patient services plan for ZELSUVMI. We are committed to reducing barriers for patients and providing access to our novel medication ZELSUVMI for those patients suffering from molluscum,” said Sai Rangarao, Chief Commercial Officer at Pelthos.

About Molluscum Contagiosum
Molluscum is a poxvirus and one of the most common skin infections seen by dermatologists, pediatric dermatologists, and pediatricians. This highly contagious viral skin condition afflicts an estimated 16.7 million people, with up to 6 million new incidents reported every year in the United States, most of them in children.^1,2,3 Individuals with compromised immune systems are at an elevated risk of contracting molluscum, with the condition impacting approximately 20% of HIV patients.⁴ Molluscum infections spread to others through contact with infected persons or contaminated objects like towels, toys, furniture, swimming pools, and other surfaces. Molluscum infections present with raised, flesh-colored or red bumps that can appear anywhere on the body, including the face, hands, trunk, genitals, back of the knees, armpits, and other sensitive areas. People with molluscum may suffer discomfort from itching, secondary bacterial infections from scratching, or atopic dermatitis, as well as immense social stigma from having visible molluscum lesions that may persist for months to years. It is estimated that 30% of children will have lesions that persist beyond 18 months.⁵ Up to 73% of children with molluscum go untreated.

About ZELSUVMI (berdazimer) topical gel, 10.3%
ZELSUVMI (berdazimer) topical gel, 10.3% is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adults and pediatric patients one year of age and older. ZELSUVMI received a novel drug designation from the U.S. Food and Drug Administration in 2024 and is the first and only approved topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician’s office, or other medical setting to treat this highly contagious viral skin infection. The product was developed using the proprietary nitric oxide-based technology platform, NITRICIL™, now owned by Ligand Pharmaceuticals Incorporated. Complete prescribing information and important safety information is available at www.zelsuvmi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: None.

Warnings: Application site reactions, including, allergic contact dermatitis occurred. Discontinue ZELSUVMI and initiate appropriate therapy.

Adverse Reactions: The most commonly reported adverse reactions (1%) are application site reactions including pain such as burning or stinging sensations (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%).

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 the new pharmacy benefit manager agreement will expand patient access to ZELSUVMI, (ii) our plans for continued commercial growth and increased coverage for ZELSUVMI, and (iii) the Company’s future opportunities, strategy and plans in the market. 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 our reliance on third-party partners for market access and distribution; the possibility that ZELSUVMI may not achieve market acceptance or broad formulary coverage; our ability to maintain regulatory approvals; 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:
LifeSci Advisors, LLC
Mike Moyer, Managing Director
mmoyer@lifesciadvisors.com

Media:
KWM Communications
Kellie Walsh
pelthos@kwmcommunications.com
(914) 315-6072

_______________________________
¹ ZELSUVMI. Prescribing information. EPIH SPV, LLC. 2024.
² Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878
³ Han H, Smythe C, Yousefian F, Berman B. Molluscum contagiosum virus evasion of immune surveillance: a review. J Drugs Dermatol. 2023;22(2):182-189.
⁴ Neal Bhatia, Adelaide A Hebert, James Q Del Rosso. Comprehensive Management of Molluscum Contagiosum: Assessment of Clinical Associations, Comorbidities, and Management Principles. Journal of Clinical and Aesthetic Dermatology. 2023 Aug;16(8 Suppl 1):S12–S17
⁵ Olsen JR, Gallacher J, Finlay A, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15:190-195

FAQ

What did Pelthos announce about ZELSUVMI access on December 4, 2025?

Pelthos announced a commercial agreement via a GPO with a major PBM, with formulary updates for ZELSUVMI starting December 1, 2025.

How many covered lives does the PBM partner manage for PTHS ZELSUVMI coverage?

The PBM manages prescription benefits for more than 20 million covered lives.

When did Pelthos launch ZELSUVMI (berdazimer) for molluscum contagiosum?

Pelthos launched ZELSUVMI in July 2025 for adults and pediatric patients one year and older.

What makes ZELSUVMI notable among molluscum contagiosum treatments?

ZELSUVMI is the first and only FDA‑approved at‑home prescription therapy for molluscum contagiosum and is a once‑daily topical nitric oxide‑releasing gel.

Who at Pelthos commented on the PBM partnership and patient access?

CEO Scott Plesha and CCO Sai Rangarao commented that the partnership should improve coverage, distribution, and reduce patient access barriers.

What patient ages is ZELSUVMI approved to treat and what application sites are mentioned?

ZELSUVMI is approved for patients aged one year and older and may be used on body areas including the face, groin, and underarms.