Krystal Biotech Q1 2025 Earnings Report
Key Takeaways
Krystal Biotech reported strong first-quarter 2025 results driven by VYJUVEK revenue, achieving $88.2 million in product sales and a net income of $35.7 million. The company also secured European approval for VYJUVEK and advanced its pipeline with a new ophthalmic program and upcoming clinical readouts.
VYJUVEK approved in Europe for the treatment of DEB patients from birth
$88.2 million in 1Q VYJUVEK revenue and $429.4 million since launch in Q3 2023
Second ophthalmic program in clinic - KB801 for the treatment of neurotrophic keratitis
Upcoming clinical readouts in 2025 - CF, AATD, ocular complications of DEB, and aesthetics
Krystal Biotech
Krystal Biotech
Forward Guidance
The company provided guidance for full-year 2025 non-GAAP combined R&D and SG&A expenses, expecting them to be between $150 million and $175 million, excluding stock-based compensation.
Positive Outlook
- First European launch of VYJUVEK in Germany expected in mid-2025.
- Potential expansion to Japan later in the year with a PMDA decision expected in 2H 2025.
- Near-term initiation of registrational study in DEB patients with eye lesions (KB803 Phase 3 IOLITE).
- Dosing the first patient in the KB801 Phase 1/2 EMERALD-1 study expected later this month.
- Upcoming clinical readouts in 2025 for CF (KB407), AATD (KB408), ocular complications of DEB (KB803), and aesthetics (KB304).
Challenges Ahead
- Non-GAAP R&D and SG&A expense guidance excludes stock-based compensation, which is difficult to estimate.
- GAAP R&D and SG&A expense guidance is not provided due to the uncertainty of stock-based compensation.
- Uncertainties exist regarding regulatory review timelines and outcomes for clinical trials and marketing approvals.
- The availability or commercial potential of VYJUVEK or other product candidates is uncertain.
- Future results may differ materially from forward-looking statements due to various factors.