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Sep 30, 2022
Krystal Biotech Q3 2022 Earnings Report
Reported financial results for the third quarter ended September 30, 2022.
Key Takeaways
Krystal Biotech reported a net loss of $29.9 million for the third quarter of 2022. The company's cash, cash equivalents, and investments totaled $407.0 million as of September 30, 2022. The company is preparing for the potential launch of B-VEC in the US and EU in 2023.
Received FDA filing acceptance of B-VEC BLA with Priority Review designation, PDUFA target action date of February 17, 2023.
FDA does not plan on holding an Advisory Committee meeting for the B-VEC application.
Received positive opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC.
Closed the quarter with $407.0 million in cash, cash equivalents and investments.
Krystal Biotech
Krystal Biotech
Forward Guidance
Krystal Biotech is focused on advancing its pipeline of gene therapies and preparing for the potential commercialization of B-VEC.
Positive Outlook
- Initiate dosing in KB407 clinical trials
- Initiate dosing in KB105 clinical trials
- Initiate dosing in KB301 clinical trials
- Submit a marketing authorization application in fourth quarter of 2022
- Company plans to initiate the trial in the fourth quarter of 2022.
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
- Timing of announcement of results from the durability trial of KB301
- Commencement of a Phase 2 study of KB301