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Pelthos Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Net product revenue for Zelsuvmi® was $15.2 million in Q3 2026, a 114% year-over-year increase from $7.1 million in Q3 2025, and a 1% quarter-over-quarter decrease from $15.4 million in Q2 2026.
    • Total revenue was $15.4 million in Q3 2026 compared to $7.4 million in Q3 2025.
    • Cost of goods sold was $1.7 million in Q3 2026, a 28% year-over-year reduction from $2.3 million in Q3 2025 and a 54% quarter-over-quarter reduction from $3.6 million in Q2 2026.
    • Selling, general and administrative (SG&A) expenses were $18.8 million in Q3 2026, a 3% year-over-year increase from $18.4 million in Q3 2025 and a 25% quarter-over-quarter reduction from $25.0 million in Q2 2026.
    • Net loss was $(7.9) million in Q3 2026, compared to $(16.2) million in Q3 2025 and $(23.4) million in Q2 2026.
    • Adjusted EBITDA was $(5.6) million in Q3 2026, compared to $(10.4) million in Q3 2025 and $(5.7) million in Q2 2026.
    • Cash balance was $17.7 million as of September 30, 2026.
    • Total liabilities were $135.0 million as of September 30, 2026, compared to $91.5 million as of December 31, 2025.
    • Total stockholders' deficit was $(6.2) million as of September 30, 2026, compared to $38.9 million as of December 31, 2025.
  • Guidance and Future Outlook:

    • Management targets the launch of Xepi® in the first quarter of 2027 and Xeglyze® in the third quarter of 2027.
    • The merger with Castle Creek is expected to close by the end of the first quarter of 2027, subject to customary closing conditions.
    • Pelthos expects a slight increase in gross-to-net deductions as new coverage is implemented, with net revenue per unit expected to improve over time.
    • An additional $10.0 million may be available from the Horizon Technology Finance facility prior to December 31, 2027, subject to achieving trailing twelve-month net revenue of at least $70.0 million.
  • Business Segments and Product Lines:

    • Zelsuvmi® units dispensed increased to 12,384 in Q3 2026, a 4% quarter-over-quarter increase and a 365% year-over-year increase.
    • Zelsuvmi® was dispensed by 4,942 unique prescribers during Q3 2026.
    • Formulary coverage for Zelsuvmi® reached 127 million commercially covered lives (69% of commercially covered lives) and over 70 million Medicaid covered lives (100% of covered lives).
    • New formulary coverage secured in Q3 2026 includes 24 million additional commercially covered lives via a major Pharmacy Benefit Manager and 3 million lives via a regional commercial health plan.
    • The combined company post-merger will leverage Pelthos' three FDA-approved products (Zelsuvmi®, Xepi®, Xeglyze®) alongside Castle Creek's lead candidate D-Fi.
  • Market and Competitive Landscape:

    • The merger with Castle Creek creates a diversified biotechnology company with a synergistic pediatric and dermatological focus targeting serious skin diseases.
    • Castle Creek's D-Fi is a redosable, gene-modified cell therapy for dystrophic epidermolysis bullosa (DEB) with Orphan Drug, Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy designations from the FDA.
    • The combined entity will possess multiple therapeutic modalities, integrating Castle Creek's fibroblast-based cell and gene therapy technology with Pelthos' Nitricil technical and manufacturing platform.
  • Risks and Challenges:

    • The merger closing is subject to customary conditions, including approval by Castle Creek's stockholders, which may not be satisfied or completed on a timely basis.
    • Future revenue depends on collaborative partners for milestone payments, royalties, and contract payments, which may not be received as projected.
    • There is no guarantee that the combined company's common stock will be indicative of value or become an attractive investment.
    • Risks include potential failure to advance pipeline products, lack of regulatory approval, or lack of market acceptance for new therapies.
    • Economic conditions, war, conflict, epidemics, tariffs, and litigation could materially adversely affect the company.
  • Management Commentary and Tone:

    • CEO Scott Plesha described Zelsuvmi's performance as a "solid quarter" and emphasized a focus on driving growth and building on success with upcoming product launches.
    • Management views the Castle Creek transaction as a "transformative" step creating a "stronger, more diversified biotechnology company" with "significant upside potential."
    • Management expressed confidence that the merger will create a portfolio spanning marketed, launch-stage, and late-stage assets providing multiple sources of growth.
  • Other Key Points:

    • On October 30, 2026, Pelthos entered into a definitive merger agreement to combine with Castle Creek Biosciences, Inc.
    • On October 30, 2026, Pelthos amended its Venture Loan and Security Agreement with Horizon Technology Finance, drawing an additional $10.0 million to bring total outstanding borrowings to $40.0 million under a facility of up to $50.0 million.
    • As of September 30, 2026, there were approximately 9.1 million shares outstanding on an as-converted basis.
    • Q2 2026 SG&A expenses included a $5.3 million one-time milestone expense, and Q2 2026 cost of goods sold included a $0.9 million write-off of work-in-process inventory.
    • A $4.1 million gain on the change in fair value of convertible debt was recorded in Q3 2026, compared to a $3.7 million loss in Q2 2026.
Company
PELTHOS THERAPEUTICS INC
Sector
Healthcare
Industry
Biotechnology