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Mar 31, 2023
Krystal Biotech Q1 2023 Earnings Report
Krystal Biotech reported financial results and operational progress for Q1 2023.
Key Takeaways
Krystal Biotech reported a net loss of $45.3 million for the first quarter of 2023. The company's cash, cash equivalents, and investments totaled $355.5 million as of March 31, 2023. Significant progress was made in commercial preparation activities for B-VEC and advancements across the pipeline.
PDUFA date of May 19, 2023, for B-VEC.
Presented clinical data at ARVO on topical application of B-VEC to treat ocular complications in a patient with recessive dystrophic epidermolysis bullosa under Compassionate Use Program.
Strong balance sheet with $355.5 million in cash, cash equivalents, and investments at the end of the quarter.
Initiated Phase 2 cohort of its KB105-02 (JADE-1) trial in the first half of 2023.
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech anticipates several milestones in the near future, including potential FDA approval of B-VEC, initiation of clinical trials, and regulatory submissions. However, these plans are subject to various risks and uncertainties.
Positive Outlook
- Potential FDA approval of B-VEC later this month.
- Plans to start an open label extension study of B-VEC in Japan in 2023 with an approval in Japan expected in early 2025.
- Plans to initiate the Phase 2 cohort of the KB105-02 (JADE-1) trial in the first half of 2023.
- Plans to file an IND for KB104 in 2023.
- Plans to initiate a Phase 1 clinical trial of KB408 for the treatment of AATD in the second half of 2023.
Challenges Ahead
- Uncertainties associated with regulatory review of clinical trials and applications for marketing approvals.
- The availability or commercial potential of product candidates including B-VEC.
- The sufficiency of cash resources and need for additional financing.
- Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors.
- Timing of submission of the European Medicines Agency’s marketing authorization application for B-VEC and approval in the EU is uncertain.