Nov 2, 2026 earnings call — VYJUVEK growth and pipeline progress
VYJUVEK revenue was $127.3 million in Q3, an increase of 30% from the same period last year.
Revenue $0.1B (est $0.1B) · EPS $2.05 (est $1.79)
Key quotes
"In the US, demand continues to grow as does the prescribing physician base. And internationally, we continue to translate physician interest into patient starts, across Germany, France, and Japan."
"As summarized in the table, on the left, over 80% of the assessed lesions regressed over the course of the study, and more than half of all lesions regressed by over 50%."
"Alongside these developments, our board authorized a share repurchase program of up to $400 million that we expect to deploy over the next 2 years."
Analyst Q&A 11
KB407 extra patients and Japan uptake
Q (Lachlan Hanbury-Brown · William Blair): Why add 3 more KB407 patients and will Japan adoption pick up after the first year restrictions?
A: The extra 3 KB407 patients are not about dose; they are on repeat dosing and tolerating it, and the slow enrollment was due to patient illnesses. Management expects the KB407 data by middle of next year. They said Japan’s prescription restriction should ease around November or December and that will speed adoption.
"That was 1 of the biggest questions we had to address with regarding to you know, safety, and, obviously, we are collecting FEV1." — Suma Krishnan (PRESIDENT)
KB408 and NK site expansion and screen failures
Q (Ritu Baral · TD Cowen): How many extra sites are you adding for KB408 and NK, and what is causing most screen failures?
A: They are adding another 10 to 15 US sites and are activating multiple sites across the EU and Eastern Europe to improve enrollment. Screen failures are driven by stringent inclusion/exclusion rules aiming to enroll persistent lesions only, so patients whose lesion size decreases between screens are not enrolled.
"So we are, you know, going pretty aggressively and getting multiple sites across the EU region and even Eastern Europe to get to actually, really improve our enrollments." — Suma Krishnan (PRESIDENT)
Capital use and R&D spending
Q (Yigal Nochomovitz · Citi): Would you increase R&D spend to speed trials, or is the buyback the right use of cash?
A: The buyback reflects confidence in VYJUVEK revenues and the ability to support the pipeline. They said they would increase investment where it would immediately speed enrollment or studies, and that a cash balance of $1.2 billion and $400 million gives them a cushion.
"If we the whole point of initiating a buyback is a high level of comfort that we have enough both in terms of the revenues from VYJUVEK and in terms of supporting our pipeline before we embark on such a thing as a cash buyback." — Krish S. Krishnan (CEO·CHAIR)
Why DEB patients withdrew and NK enrollment progress
Q (Gavin Clark-Gartner · Evercore): Why did patients withdraw from ocular DEB, and are NK trial completion rates as expected?
A: Two DEB patients dropped out because they were traveling and would not commit to weekly dosing; a third was added from natural history timing and a 1-year-old was enrolled for a specific clinical need. For NK, 21 sites are active but there were screen failures from stringent criteria; academic site delays from biosafety issues have been overcome and they are confident enrollment will get back on track.
"So it was truly because we wanted to get that patient in, and we thought even if we did not add these patients, we had enough powering for the study." — Suma Krishnan (PRESIDENT)
NK enrollment status and DEB timing
Q (RBC): How many NK patients are enrolled (are you halfway) and will ocular DEB read out before NK?
A: They will not disclose enrollment numbers now but are confident they can enroll NK patients and complete the study by 2027. For ocular DEB, there are 3 patients and the last patient exits end of February, with data expected to be announced in the first half of next year.
"We will once we have the last patient in, we should be shortly announcing data on KB408 first half of next year." — Suma Krishnan (PRESIDENT)
Which readout comes first: DEB or NK
Q (RBC): Confirm which program reports first: ocular DEB or NK?
A: The operator clarified that ocular DEB will come ahead of NK.
Hailey-Hailey early study goals
Q (Josh Schimmer · Cantor Fitzgerald): What will you look for in the first 5 Hailey-Hailey patients to move to a registrational study?
A: They developed and are validating an investigator-based scale; Part A validation is complete and Part B nearly done. They will show investigator-rated improvement from baseline after 3 months, collect baseline and end biopsies to show molecular correction and ATP2C1 expression, and provide before/after images.
"We will also be biopsying these patients at baseline and at the end of the treatment to show, you know, molecular correction." — Suma Krishnan (PRESIDENT)
Ex-US revenue and DEB filing readiness
Q (Roger Song · Jefferies): Will ex-US revenue stabilize after Germany and Italy pricing, and is anything outstanding before filing ocular DEB?
A: They said demand is growing and pricing in Germany and Italy is behind them, with more pricing/approvals to complete across Europe. From a filing view, CMC requirements are met and the BLA should be ready once the last patient is enrolled, the database is locked, and the data are analyzed.
"I think from a BLA, we should be ready to go." — Suma Krishnan (PRESIDENT)
France pricing and Gorlin study size
Q (Alec Stranahan · BofA): What are the France pricing timelines and what size and endpoint might a Gorlin pivotal study need?
A: In France, a two-step negotiation typically takes 13 months and they are 6 months into that process working through framework then granular pricing. For Gorlin, the 3-patient data showed responses in all 3 with histology confirming no BCCs; they expect a pivotal trial would be well under 100 patients based on observed response rates.
"I mean, as you can see from a 3 patient study where we looked at it, the data was pretty remarkable." — Suma Krishnan (PRESIDENT)
NK inclusion rules and OXERVATE washout
Q (Morgan Lamberti · Goldman Sachs): What are the NK inclusion rules about lesion changes and OXERVATE exposure, and would you change windows to speed accrual?
A: NK uses two screenings and is stratified by lesion surface area; it is strict so a 10 percent decrease between first and second screening disqualifies a patient. If patients used OXERVATE they must wash out for 30 days before enrolling, and they said it is too early to use recurrence or OXERVATE history to estimate TAM.
DEB ITT handling and NK vs OXERVATE criteria
Q (Kalpit Patel · Wolfe): Will the 2 withdrawn DEB patients be in the ITT and is your spontaneous-decrease criteria similar to OXERVATE studies?
A: Yes, the 2 withdrawn DEB patients will be included in the ITT and they will use sensitivity analyses and natural history data to handle crossover and potential carryover in the statistical plan. Regarding OXERVATE, they know OXERVATE had persistence criteria but do not know the specific levels used there.
"Yes. The 2 patients yes, they will meet the ITT because that is the definition of ITT." — Suma Krishnan (PRESIDENT)