What factors drove the changes in Krystal Biotech's revenue and profit?

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What does Krystal Biotech do and what are its main business segments?

What were the key takeaways from Krystal Biotech’s earnings call?

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Did Krystal Biotech beat or miss consensus estimates last quarter?

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What were the key takeaways from Krystal Biotech's earnings call?

- **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

- **VYJUVEK Growth**: $96M Q2 revenue, 93% gross margin. 3Q 2025 U.S. revenue expected below Q2 due to summer pauses, resuming growth in 4Q. 
- **Global Expansion**: Europe launch Q3 2025 (Germany/France), Japan approval with ~200 DEB patients. 
- **Pipeline Momentum**: 
  - KB707 NSCLC: 36% ORR in late-line patients. 
  - KB408 AATD: Repeat dosing study to assess durability. 
  - KB304 aesthetics: Phase II décolleté study planned for H1 2026. 
- **Financial Strength**: $820M+ cash, 2+ years of positive EPS. 
- **Strategic Moves**: Jeune subsidiary spin-out planned for end 2026.

**【CEO Summary Section】**
- Q2 2025 net VYJUVEK revenue: $96 million, cumulative $525 million since launch. U.S. growth driven by patient restarts and sales force expansion (still underway). 
- Gross margin: 93%, consistent with prior quarters. 
- Compliance rate: 82% (Q2), expected to trend down as moderate/mild patients increase. 
- Global expansion: Europe launch in Germany/France Q3 2025, Japan approval with ~200 DEB patients. 
- 2025 guidance: 3Q revenue below Q2 due to summer pauses, 4Q growth resumption. 
- Financial health: 2+ years of positive EPS, $1.29 diluted share Q2. 

**【CFO Financial Commentary】**
- Q2 2025: 
  - Net income: $38.3M ($1.33 basic, $1.29 diluted) vs $15.6M (Q2 2024). 
  - R&D: $14.4M (-8% YoY) due to manufacturing timing. 
  - G&A: $35.2M (+28% YoY) for global commercialization. 
  - Cash: $820M+ (up from $750M Q1). 
- Key metrics: 
  - COGS: $7.2M (93% gross margin). 
  - Stock-based comp: $14.1M (up 7% YoY). 

**【Pipeline Update】**
- **Oncology (KB707)**: 
  - NSCLC Phase I/II: 36% ORR (n=11), median PFS/DoR not reached. 
  - Combination cohorts open, safety/tolerability maintained. 
- **AATD (KB408)**: 
  - Cohort 2B: Repeat dosing study to assess durability. 
  - Cohort 2: 30-40% transduction, AAT expression in 3/3 patients. 
- **Aesthetics (KB304)**: 
  - Phase II décolleté study planned for H1 2026. 
  - PEARL-2: 82% subjects reported aesthetic improvement vs 38% placebo. 
- **Ophthalmology**: 
  - KB803 (corneal abrasions): Phase III IOLITE启动. 
  - KB801 (neurotrophic keratitis): Phase I/II EMERALD-1启动. 

**【Q&A Highlights】**
- **Sales Force Impact**: Full impact of 2025 hires expected in 2026. Q3 2025 U.S. revenue down YoY due to summer pauses. 
- **Europe Pricing**: Germany: 12-month free pricing post-launch. France: Accès Précoce continuity expected. 
- **CF Progress**: TDN site delays pushed Cohort 3 data to late 2025. 3 null mutation patients in Cohort 3. 
- **Jeune Spin-out**: Phase II décolleté start H1 2026, spin-out by end 2026. 
- **Japan Launch**: Payer discussions ongoing, launch before year-end. 
- **Pipeline Risk**: Patient variability in DEB, clinical trial enrollment delays.

Krystal Biotech, Inc. (KRYS) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: Q1 2025 VYJUVEK revenue up 95% YoY to $88.2M, driven by U.S. adoption and patient success.
- **Global Expansion**: Europe launch Q3 2025 targeting 60% market share; Japan approval expected Q3 2025.
- **Financial Strength**: $765M cash, 94% gross margin, and $35.7M net income support global growth.
- **Pipeline Momentum**: Ophthalmology program KB801 enters Phase 1-2; CF and AATD molecular data readouts Q3 2025.
- **Competitive Edge**: VYJUVEK's 100% wound closure rate vs. 50% for autologous grafts reinforces first-line therapy status.

**【CEO Opening Remarks】**
- Q1 2025 revenue for VYJUVEK reached $88.2 million, up 95% YoY, driven by strong U.S. adoption and patient success stories.
- Europe launch in Q3 2025 targeting Germany and France, with potential for larger EU opportunity due to lower genetic confirmation barriers.
- Japan regulatory review complete; anticipate approval in Q3 2025 and patient access in Q4 2025.
- Global DEB patient opportunity estimated at ~3,000 in U.S. and ~500 in Japan, with VYJUVEK as first-line therapy for chronic wound management.

**【CFO Financial Highlights】**
- Gross margin maintained at 94%, with COGS of $5 million (vs. $2.4M prior year).
- R&D expenses: $14.3 million (up 30% YoY) due to clinical trial costs and manufacturing.
- G&A expenses: $32.7 million (up 25% YoY) driven by stock comp and professional services.
- Net income: $35.7 million ($1.24 EPS), with $765M cash on hand for global expansion.

**【Q&A Key Takeaways】**
- **Patient Compliance**: 83% compliance rate since launch, with individualized pausing patterns due to wound healing success.
- **Competitor Response**: Krystal's VYJUVEK differentiated by home administration, 100% wound closure rate vs. 50% for autologous grafts.
- **Europe Launch**: Germany/France launches in Q3, targeting 60% market share in 2 years, similar to U.S. trajectory.
- **Japan Pricing**: Expected to be mid-tier between U.S. and Europe, leveraging rare disease pricing frameworks.
- **Clinical Pipeline**: Ophthalmology program KB801 for neurotrophic keratitis set to dose first patient in May, with Phase 1-2 readout by year-end.

Krystal Biotech, Inc. (KRYS) Q1 2025 Earnings Call Transcript

- **Revenue & Margin Strength**: Q4 2024 revenue up 150% YoY to $91.1 million, with 95% gross margin.
- **Global Launch Momentum**: 510+ U.S. approvals, 1,000+ European patients targeted, and Japan regulatory decision pending.
- **Pipeline Breakthroughs**: Lung gene delivery validated in AATD/CF, with KB803 Phase 3 expected in 2025.
- **Financial Resilience**: $345 million cash, supporting $150-175 million 2025 operating expenses.

**【CEO Summary Section】**
- **Revenue Growth**: Q4 2024 net revenue of $91.1 million, up 49 million year-over-year. Full-year 2024 revenue reached $290.5 million, with 95% gross margin.
- **VYJUVEK Launch Momentum**: 510+ reimbursement approvals in the U.S., 97% home administration compliance, and sequential revenue growth despite seasonal challenges.
- **Global Expansion**: Targeting EU (Germany, France) and Japan launches in 2025, with 1,000+ identified DEB patients in Europe and strong pricing discussions.
- **Pipeline Progress**: KB803 (ocular DEB) Phase 3 expected H2 2025, KB408 (AATD) showing safe gene delivery in lungs, and KB407 (CF) entering dose escalation.

**【CFO Financial Commentary】**
- **Net Income**: $45.5 million ($1.58 EPS) in Q4, driven by VYJUVEK sales and cost management.
- **Expense Growth**: R&D up 18% YoY to $13.5 million, SG&A up 26% to $31.3 million, reflecting global launch investments.
- **Cash Position**: $344.9 million in cash, supporting 2025 operating expenses of $150-175 million.

**【Q&A Highlights】**
- **Stocking & Pricing**: No Q4 stocking; Europe pricing to be negotiated post-launch, with U.S. price maintained for first 6 months in Germany.
- **Competition**: Confident in VYJUVEK's home dosing convenience and efficacy against potential competitors.
- **Manufacturing**: Scale-up process approved, enabling pipeline scalability.
- **Patient Compliance**: 85% compliance in Q4, with some patients pausing treatment due to durable wound closure.

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