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Sep 30, 2024
Krystal Biotech Q3 2024 Earnings Report
Krystal Biotech's financial performance surged in Q3 2024, driven by strong VYJUVEK sales and strategic advancements.
Key Takeaways
Krystal Biotech reported a net product revenue of $83.8 million for Q3 2024 and $250.1 million since the launch of VYJUVEK in August 2023. The company is progressing with its B-VEC filings in Japan and Europe, with commercial launches expected in 2025. A strong cash position of $694.2 million was maintained at the end of the quarter.
Net product revenue reached $83.8 million in Q3 2024.
JNDA for B-VEC was filed, targeting commercial launches in Japan and Europe in 2025.
French health authority approved early reimbursed access for B-VEC in France.
Cash and investments ended the quarter at $694.2 million.
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech anticipates non-GAAP R&D and SG&A expenses to be between $115 million and $125 million for the full year ending December 31, 2024.
Positive Outlook
- Advancing Jeune Aesthetics’ KB301 to Phase 2 after positive results in Phase 1
- Expect Committee for Medicinal Products for Human Use (CHMP) opinion on the MAA before year end
- Anticipates its first European launch in Germany in 1H 2025
- Registrational IOLITE study is a single arm, open-label study that is expected to commence in 1H 2025.
- The Company expects to report detailed results of PEARL-1 Cohorts 3 and 4, including redosing, at future scientific conference(s).
Challenges Ahead
- Uncertainties associated with regulatory review of clinical trials and applications for marketing approvals
- The availability or commercial potential of VYJUVEK or product candidates
- Non-GAAP combined R&D and SG&A expense guidance does not include stock-based compensation
- The Company has not provided a quantitative reconciliation of forecasted non-GAAP combined R&D and SG&A expense to forecasted GAAP combined R&D and SG&A expense because the Company is unable, without making unreasonable efforts, to calculate the reconciling item, stock-based compensation expenses, with confidence
- This item, which could materially affect the computation of forward-looking GAAP combined R&D and SG&A expense, is inherently uncertain and depends on various factors, some of which are outside of the Company’s control.