Krystal Biotech Q2 2023 Earnings Report
Key Takeaways
Krystal Biotech announced positive Q2 2023 results, highlighted by the FDA approval of VYJUVEK, a topical gene therapy for dystrophic epidermolysis bullosa, and its subsequent commercial launch. The company also reported progress in its cystic fibrosis and oncology programs, with a strong balance sheet including $505.9 million in cash, cash equivalents, and investments.
VYJUVEK approved in the U.S. as the first and only topical redosable gene therapy for dystrophic epidermolysis bullosa.
Received 121 Patient Start Forms in the first six weeks of VYJUVEK launch.
First cystic fibrosis patient dosed in Phase 1 Clinical Trial of KB407.
IND for KB707, Krystal’s oncology candidate for solid tumors, accepted by FDA and granted Fast Track Designation.
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech anticipates continued momentum for the rest of the year, with plans to submit a market authorization application to the EMA in the second half of 2023 and a potential EU launch in the second half of 2024. The company also expects to announce data from the Phase 1 study of KB407 in 2024 and dose the first patient with KB707 in the second half of 2023.
Positive Outlook
- Plans to submit a market authorization application to the EMA in the second half of 2023 and anticipates a potential launch of B-VEC in the EU in the second half of 2024.
- Plans for an open label extension study of B-VEC in Japan in the second half of 2023, filing for approval in Japan in 2024.
- Expectation to announce data from the Phase 1 study of KB407 in 2024.
- Intends to file an IND application with the FDA and initiate a Phase 1 clinical trial of KB408 for the treatment of AATD in the second half of 2023.
- Expects to dose the first patient with KB707 in the second half of 2023.
Challenges Ahead
- Uncertainties associated with regulatory review of clinical trials and applications for marketing approvals.
- Availability or commercial potential of product candidates including VYJUVEK.
- Sufficiency of cash resources and need for additional financing.
- Plans to initiate the Phase 2 cohort of the KB105-02 (JADE-1) trial in 2024.
- Plans to file an IND application and initiate a clinical trial of KB104 in late 2024.