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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.
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
Historical Earnings Impact
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Avg. Return Before/After Earnings
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