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