Filing Flows › Krystal Biotech (KRYS) › Guidance & outlook
Krystal Biotech (KRYS) guidance and outlook
Krystal Biotech's 10-Q filed Nov 2, 2026 makes 31 forward-looking statements.
Guidance and outlook
Forward-looking statements, 10-Q filed Nov 2, 2026
- • the design, initiation, enrollment, timing, progress, and results of clinical trials for our product candidates, as well as expected timing of regulatory filings, interactions with regulatory authorities, and reporting of data readouts from our clinical trials;
- • our expectations regarding future fluctuations in revenue and anticipated increases in certain expenses;
- In October 2026, we successfully completed pricing negotiations with Italian authorities and now expect to launch VYJUVEK in Italy in early 2027.
- We also expect a pricing decision in Spain before the end of the year.
- We also expect to submit a marketing authorization application in Switzerland before the end of the year.
- We expect to report HALITE-1 interim study results before the end of the year.
- We expect to meet with the FDA in the first quarter of 2027, following completion of scale validation, to discuss HALITE-1 study results, the HHD-specific severity scale, and study designs to enable a registrational study start later in 2027.
- We expect to provide an update on our development plans following alignment with the FDA.
- After reaching the initial IOLITE enrollment target of 16 patients in April 2026, we enrolled three additional patients to replace two patients who withdrew for reasons unrelated to safety and to generate additional evidence to support the potential treatment of corneal abrasions in DEB patients from birth.
- We expect the last patient visit for IOLITE in February 2027 with top-line results reported shortly thereafter.
- Under the updated protocol, we expect to enroll approximately 60 adult patients with Stage 2 or Stage 3 NK, as defined by the Mackie criteria, randomized 1:1 to receive either KB801 or placebo.
- We now expect to complete enrollment and report top-line results in 2027.
Krystal Biotech's latest quarter
Krystal Biotech, Q3 2026: revenue $127M (+30% year over year), operating margin 55.9%, net earnings $63.1M, operating cash flow $91.2M. The chart follows the revenue to costs, profit and cash.
Questions
What does Krystal Biotech expect?
• the design, initiation, enrollment, timing, progress, and results of clinical trials for our product candidates, as well as expected timing of regulatory filings, interactions with regulatory authorities, and reporting of data readouts from our clinical trials; • our expectations regarding future fluctuations in revenue and anticipated increases in certain expenses; In October 2026, we successfully completed pricing negotiations with Italian authorities and now expect to launch VYJUVEK in Italy in early 2027.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.