Krystal Biotech, Inc. Q3 FY2025 earnings call

• VYJUVEK launch continued to gain momentum, with the updated U.S. label strengthening the long-term outlook. It was launched in Germany, France, and Japan, and pricing was successfully negotiated in Japan.
• Pipeline progress: Anticipates a readout this quarter for the cystic fibrosis program KB407, accelerating enrollment across the pipeline including KB801 for NK, and initiating a new clinical program for Hailey-Hailey disease.
• Financials: Strong, with net VYJUVEK revenue at $97.8 million, gross margin at 96%. Over 40 new reimbursement approvals in the U.S. brought the total to over 615. The field force is fully hired and deploying.
• Europe update: Launch in Germany is off to a good start with over 20 patients prescribed and broad prescribing across centers. France had early access approval and ASMR III designation, and VYJUVEK was granted the Prix Galien in Italy.
• Pipeline details: FDA platform therapy designation for KB801, KB407 CF program near study completion, KB408 AATD program in repeat dosing, progress in ophthalmology and oncology pipelines, and a new Hailey-Hailey disease program with cleared IND.

In the third quarter, VYJUVEK net product revenue was $97.8 million. Total net VYJUVEK revenues since launch are over $623 million. Gross margin for the quarter was 96%. The VYJUVEK segment is the primary contributor, with revenue growth driven by U.S. and European launches.

• Expect a readout in CF before year-end.
• Aim for readouts in KB801 for NK and KB803 for eye lesions in DEB patients by midyear.
• No full-year revenue guidance for VYJUVEK in 2026 yet due to ongoing launches.
• Will continue to invest in pipeline programs with operational discipline before entering partnerships.

Forward-looking statements are subject to risks and uncertainties as detailed in SEC filings, which may cause actual results to differ from projections.

Q: On the ex U.S. launch, whether focus is on expanding breadth or depth of prescribers?

A: Krish Krishnan mentioned focus on accelerating getting patients to meet physicians, starting with centers of excellence and spreading to community. On optimized process, moving to larger bioreactor approved in U.S., working towards Europe approval.

Q: Expectation on ex U.S. vs U.S. revenue contribution and pricing?

A: Krish said EU launch expected to be steady, pricing country-specific, based on ASMR rating and disease efficacy.

Q: On NK timing, gating aspects, enrollment, and CF data?

A: Suma Krishnan mentioned started enrolling patients in NK study, adding sites globally, and for CF, looking at minimum 3 null patients with molecular correction focus.

Q: On NK dose confidence, safety, and ocular DEB study?

A: Suma said dose confidence from animal studies, single efficacy trial expected, no adverse events of concern in ocular DEB study.

Q: On VYJUVEK revenue guidance and KB408?

A: Krish said no full-year revenue guidance for 2026, and for KB408, expecting uptick in AAT with repeat dosing, with few sites capable of bronchoscopy and lavage.