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Dec 31, 2023
Krystal Biotech Q4 2023 Earnings Report
Reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.
Key Takeaways
Krystal Biotech reported Q4 net product revenue of $42.1 million from VYJUVEK sales and a net income of $8.7 million. The company closed the year with a strong balance sheet, holding $594.1 million in cash and investments.
Net product revenue reached $42.1 million in Q4 and $50.7 million for the year.
New England Journal of Medicine published data on the use of B-VEC eyedrop formulation.
Alignment with FDA was reached to enable approval of B-VEC eyedrop formulation for treating lesions in the eye of DEB patients.
First patient dosed in Phase 1 KB408 trial for AATD treatment, with five active clinical trials planned for 2024.
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech provided financial guidance for the full year 2024.
Positive Outlook
- Expects to expand VYJUVEK access in the U.S. and globally.
- Anticipates potential B-VEC approval for DEB treatment in the EU in 2H 2024.
- Intends to file a Japanese New Drug Application for B-VEC in 2H 2024.
- Plans to announce interim data from its Phase 1 study of KB408 in 2H 2024.
- Plans to initiate a study in 2H 2024 of B-VEC eyedrops for treating lesions in the eye of DEB patients.
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.
- The sufficiency of cash resources and need for additional financing.
- Combined R&D and SG&A expense guidance does not include stock-based compensation.
- The company is unable to confidently estimate Full Year 2024 stock-based compensation expense.