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.

Insights

Commercial Access Analyst

Agreement with a large PBM network expands formulary access for ZELSUVMI and should materially improve patient reach.

Signing a commercial agreement via a Group Purchasing Organization places ZELSUVMI onto the formularies managed by a Pharmacy Benefit Manager covering more than 20 million lives, with inclusion updates effective December 1, 2025. This directly links the marketed product to payer networks and likely eases prescribing and reimbursement friction for the once-daily topical gel.

Key dependencies include continued formulary placement, tiering and any utilization management policies the PBM applies. If the PBM assigns restrictive prior authorization or high patient cost share, real access gains could be muted. The company cites its patient services plan as a mitigation, but implementation details remain unspecified.

Watch formulary tier, prior‑authorization rules, and real-world uptake over the next 3–6 months, and monitor any announcements about additional PBM or payer coverage expansions and specific patient cost-sharing measures. The agreement coincides with the product launch in July 2025 and the FDA Novel Drug recognition in January 2024, which frame near-term commercial milestones.

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.