Short answer
Krystal Biotech, Inc. (KRYS) filed its fiscal 2025 10-K annual report with the SEC on Feb 17, 2026. It reported revenue of $389M (+33.9% year over year) and net income of $205M.
- Top risk flagged: Regulatory risk from Biologics Price Competition and Innovation Act (BPCIA) allowing biosimilar competition after 12 years exclusivity on VYJUVEK
FY2025 key financial metrics · XBRL
- Revenue
- $389M
- +33.9% YoY
- Net income
- $205M
- +129.7% YoY
- Operating margin
- 41.5%
- +18.8 pp YoY
- EPS (diluted)
- $6.84
- +128.0% YoY
- ROE
- 16.8%
- +7.4 pp YoY
- Operating cash flow
- $201M
- +62.7% YoY
Source: XBRL data from the Krystal Biotech, Inc. (KRYS) FY2025 10-K on SEC EDGAR. USD.
Krystal Biotech, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: commercializing gene therapies targeting rare monogenic diseases, led by approved topical VYJUVEK for dystrophic epidermolysis bullosa (DEB)
- New emphasis on diverse clinical pipeline including KB407 (cystic fibrosis), KB408 (AAT deficiency), ophthalmic KB803 & KB801, dermatology KB111, oncology KB707, and aesthetics via Jeune Aesthetics
- Strategic broadened focus from dermatology to respiratory, ophthalmology, oncology, and aesthetic segments, with ongoing regulatory and reimbursement expansions in Europe and Japan
- VYJUVEK net product revenue $389.1M in 2025, gross margin 94%; quarterly launches in Germany, France, Japan plus pipeline clinical progress in Phase 1-3 for multiple candidates
- Noteworthy: FDA granted platform technology designation to HSV-1 vector for KB801 in October 2025, underscoring innovation in ocular gene therapy delivery
Management Discussion & Analysis
- No capital allocation details such as buybacks, dividends, or capex provided
- No management outlook, guidance, or emerging risks described in text provided
Risk Factors
- Regulatory risk from Biologics Price Competition and Innovation Act (BPCIA) allowing biosimilar competition after 12 years exclusivity on VYJUVEK
- Geopolitical risk from uncertain regulatory approval of VYJUVEK outside U.S., EU, Japan limiting international revenue
- Operational risk in scaling manufacturing process for VYJUVEK, subject to risks and uncertainties with demand fluctuations
- Competitive risk from companies developing advanced gene therapies or biosimilars, potentially rendering VYJUVEK obsolete
- Financial risk of IRA drug pricing reforms including Medicare price negotiations, inflation rebates, and new $2,000 out-of-pocket cap effective 2025
Generated from the filing text; verify against the original. How to read a 10-K
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