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- **Revenue Growth**: Q3 Vyjuvek revenue $97.8M, up 15% QoQ, with 615 U.S. reimbursement approvals and 450+ prescribers.
- **Gross Margin Boost**: 96% gross margin (vs 93% Q2) from U.S. manufacturing efficiencies; ex-U.S. margins to normalize as process awaits EU approval.
- **Pipeline Momentum**: 4 CF null patient molecular data readout by year-end; NK trial enrollment underway; new HHD program IND cleared.
- **Global Expansion**: Launched in Germany, France, Japan; distributor network expanding to CEE, ME.

**【CEO Summary Section】**
- Vyjuvek net revenue reached $97.8 million in Q3, driven by U.S. growth and early European launches (Germany, France) and Japan. 
- U.S. reimbursement approvals expanded to 615, up 40 from Q2, with 450+ prescribers and 80%+ patient compliance.
- Global expansion via regional distributors in CEE, Turkey, and ME; Japan launch with favorable pricing.
- New clinical programs: KB111 for Hailey-Hailey disease (IND cleared), CF interim data expected by year-end, and NK trial enrollment underway.

**【CFO Financial Commentary】**
- Q3 gross margin 96% (vs 93% Q2) due to U.S. manufacturing process optimizations; ex-U.S. margins to normalize as optimized process awaits EU approval.
- R&D expenses $14.6M, G&A $37.6M; revised full-year non-GAAP guidance narrowed to $145-155M.
- Strong cash position ($864M) supports global launches and pipeline.

**【R&D Pipeline Update】**
- KB407 (CF): 3 null patient molecular data readout expected by year-end; repeat dosing study planned for 2026 FEV1 data.
- KB408 (AATD): Repeat dosing study ongoing; interim data in H1 2026.
- KB801 (NK): Global sites opening; interim data mid-2026.
- KB111 (HHD): IND cleared; Phase 1/2 study to start H1 2026.

**【Q&A Highlights】**
- Ex-U.S. sales: Germany launched in August with ~20 patients; France ASMR 3 rating signals potential EU pricing upside.
- NK trial: Enrollment underway globally; targeting mid-2026 interim data.
- CF: 3 null patients biopsied for full-length CFTR expression; success defined as ≥5% CFTR expression.
- Pricing: Japan negotiations favorable; U.S. MFN policy applies to ex-U.S. markets.
- 2026 guidance: No Vyjuvek revenue guidance due to global launch variability.

Krystal Biotech, Inc. (KRYS) Q3 2025 Earnings Call Transcript

Revenue

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KRYS

KRYS fundamentals

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