Krystal Biotech Inc

Latest Results (21.11.2025):

Krystal Biotech Inc — Third Quarter 2025: The company reported $97.8 million in VYJUVEK net product revenue for 3Q 2025 (96% gross margin) and $623.2 million in cumulative U.S. VYJUVEK revenue since launch. Krystal ended the quarter with $864.2 million in cash and investments and reported multiple commercial launches and regulatory updates that expand patient access. The company also highlighted several near-term clinical readouts and development milestones.

Revenue & margins

3Q 2025 VYJUVEK net product revenue: $97.8 million; quarter gross margin: 96%; cumulative U.S. VYJUVEK revenue since launch: $623.2 million.

Balance sheet

Strong cash position at quarter end: $864.2 million in cash and investments, providing runway to support ongoing development and commercialization activities.

Commercial expansion

First commercial launch outside the U.S. in Germany occurred in 3Q 2025; launches in France and Japan took place in 4Q 2025. The company reported >615 U.S. reimbursement approvals and is building a specialty distributor network for additional international markets.

Label update & patient access

FDA approved a VYJUVEK label update in September 2025 expanding the eligible DEB patient population to include patients from birth and permitting at‑home application by patients or caregivers, improving flexibility and potential uptake.

Pricing & reimbursement timing

Pricing negotiations ongoing in Germany (expected to continue through at least 2H 2026) and France (negotiations expected to continue for ~15 months), despite early reimbursed access and an ASMR III appraisal in France facilitating access discussions.

Near‑term clinical catalysts

Key upcoming readouts: interim data for KB407 (cystic fibrosis, CORAL‑1 cohort 3) expected in Q4 2025; KB408 (AATD) interim data expected 1H 2026; KB803 Phase 3 enrollment expected to complete before year end. Interim efficacy/readout plans for KB707 (inhaled oncology) expected in 2H 2026.

Regulatory/designation developments

FDA granted platform technology designation for Krystal’s genetically modified non‑replicating HSV‑1 viral vector (used in KB801 and VYJUVEK), which may offer development and regulatory efficiencies going forward.

Program adjustments

Intratumoral KB707 enrollment in OPAL‑1 is paused (patients continue to be followed); company may adjust development plans based on safety/efficacy data. Jeune Aesthetics and dermatology programs also progressing with planned Phase 2 starts and an IND clearance for KB111.