Krystal Biotech (KRYS) Q1 FY26 earnings call: guidance and Q&A

How should we think about US growth for the rest of 2026 and the continuation of strong ex-US trends? Also, what are the endpoints for CF 24-week data and the decision process for the pivotal study?

Management expects overall positive US growth despite Q-by-Q fluctuations due to start-stop treatment. Ex-US growth is strong and expected to continue. For CF, the 24-week study focuses on repeat dose safety, with FEV1 and PRO scales as exploratory endpoints. The registrational trial design is being finalized with FDA and CFF, aiming for an innovative approach.

“I know we've previously said there's maybe about 1,200 identified patients and we're steadily marching towards that and even hope to get to that $720 million number by next quarter, right? So we're at 60% market share.”

asked by Jiale Song · answered by Krish Krishnan

Assuming positive KB803 data, how will its launch trajectory compare to VYJUVEK, considering prescriber/patient overlap and reimbursement? Why was the Hailey-Hailey registrational study pushed to 2027?

KB803 launch is expected to be positive due to established infrastructure from VYJUVEK and identified patient populations. For Hailey-Hailey, the delay is due to the need to validate a new patient-reported outcome scale and conduct a small Phase 1 study to establish safety, dosing, and scale robustness before initiating the registrational trial in 2027.

“It affects about 50% of the RD population according to publications, and maybe 10% to 15% of the dominant population, and there are evidences of many more patients having lesions in the eye, but it is positioned as somewhat like a prophylactic, and so we expect the launch to be really good.”

asked by Unknown Analyst · answered by Krish Krishnan

Can you elaborate on key education steps needed for ex-US doctors versus US, and any other negotiation points besides pricing that differ from the US launch?

Physician education in Europe and Japan is easier due to awareness of VYJUVEK's US success. Negotiations involve political factors and rare disease budgets, but the compelling clinical benefits are strong. Germany and Italy will provide early benchmarks for European pricing.

“In terms of bringing them up to speed, teaching them about the disease, the benefits of VYJUVEK and how it works and the application, it's been a lot easier relative to the U.S. in terms of physician education and getting them up to speed, and that's true in Japan, too.”

asked by Joseph Pantginis · answered by Krish Krishnan

Are there insurance frictions around VYJUVEK's stop-start drug holidays, specifically regarding reauthorization and documentation? For CF, are there prescribed definitions for modulator intolerance, and can functional data be obtained from 4-week patients ahead of pivotal?

There have been no issues with access, reimbursement, or reauthorization for VYJUVEK's stop-start treatment. For CF, patients ineligible for or intolerant to modulators are enrolled. The current 5-patient study focuses on repeat dose safety, with FEV1 and PRO scales as exploratory measures, but no functional data from prior 4-day dosing.

“I mean, from since the launch, we've had no issues with access to date, whether that's in terms of reimbursement, reauthorization, start and stop effect. The start and stop decisions are obviously made by the patient in consultation with their physician. But once they're ready to start, we've had no delays with respect to getting them back on drug at all.”

asked by Ritu Baral · answered by Krish Krishnan

Has Germany entered the second 6 months of accrual? Will Spain and Italy use a pricing-first model or an accrual model? How are KB803 natural history run-in data tracking, and what about compliance with blinded symptom diaries?

Germany has entered the second 6 months of accrual. Italy and Spain are expected to have definitive reimbursement (pricing-first) rather than an accrual model. For KB803, the natural history data extensively informs patient selection for the trial, and patients are experienced with the diary, which is managed by a blinded system with CRO support for compliance.

“In our case, we have over 100 patients in this natural is very prospectively collected, which simulates exactly what they're going to do in the clinical. So I think we can leverage that data to -- in the analysis as we move forward.”

asked by Yigal Nochomovitz · answered by Christine Wilson

How conservative is the 25% reduction in symptom days powering for KB803, and how much does the delta matter for commercialization? What is the current capital allocation strategy?

Any improvement in DDEB patients with corneal abrasions is a benefit due to the debilitating nature of the disease. The natural history data allowed selection of patients where a drug effect should be evident, and the crossover design increases statistical power. For capital allocation, the focus is on growth (commercial and pipeline). Share buybacks will be considered once there is more visibility into the future of the pipeline and the launch of the next drug.

“So once we have visibility into the future of our pipeline, especially on the drugs that address large markets, KB408, the oncology, the aesthetics, and then when we have some visibility into the launch of our next drug, that would be a great timing to think about share buyback.”

asked by Bill Maughan · answered by Krish Krishnan

What has been the impact of home administration on US VYJUVEK, specifically on start-stop dynamics or new patient adds? For ex-US, will Spain's pricing be similar to other European territories, and how many patients are estimated in Spain?

Home administration has been well-received, offering flexibility and choice, leading to some patients initiating therapy who previously wouldn't, and supporting the stop-start dynamic. For Spain, pricing is expected to be within the established value corridor, and patient prevalence is estimated to be equivalent to other European countries.

“We do have a pricing corridor reflecting the value of Vivek. And so we do expect Spain to be within this pricing corridor. But of course, negotiations are ongoing. So difficult to speculate at this stage. And the number of patients in Spain, we would think, we would look at it as an equivalent prevalence to the other European countries.”

asked by Unknown Analyst · answered by Laurent Goux