Krystal Biotech, Inc. Q4 FY2024 earnings call

• VYJUVEK U.S. launch has progressed well, with over 510 patients having reimbursement approvals as of February 2025, patient compliance at 85% in Q4, and growing prescriber base with over 65% new writers in Q4.
• Global expansion plans for 2025 include successful VYJUVEK launch in EU and Japan, translating early efficacy signs in CF and A1AT programs, and preparing for B-VEC launch to treat eye lesions in DEB patients.
• In aesthetics, Jeune Aesthetics has strong KB301 Phase 1 data and is building a seasoned management team.
• Respiratory programs: KB408 and KB407 are in clinical development with preclinical and early clinical data, and KB803 for ocular complications of DEB is progressing with a natural history study.

In the fourth quarter, Krystal's net VYJUVEK revenue was $91.1 million, bringing 2024 total revenue to $290.5 million. In aesthetics, Jeune Aesthetics reported strong KB301 Phase 1 data for decollete treatment and plans to start a Phase 2 study later in 2025. For the respiratory programs, KB408 and KB407 are progressing with preclinical and clinical data. In terms of financials, Q4 cost of goods sold was $4.9 million with a 95% gross margin, research and development expenses were $13.5 million, selling, general and administrative expenses were $31.3 million, and net income was $45.5 million, $1.58 per basic and $1.52 per diluted share.

• Expect successful VYJUVEK launches in EU and Japan in 2025, translate early efficacy signs in CF and A1AT programs, and prepare for B-VEC launch.
• Anticipate $150 million to $175 million in combined non-GAAP R&D and SG&A costs in 2025, driven by expanded commercial launches and pipeline programs.
• Conviction in VYJUVEK global peak sales estimate of over $1 billion has strengthened.

• Regulatory approval delays risk, such as potential delays in CHMP opinion on EU application.
• Market competition risk, as DEB commercial competition could emerge.
• Manufacturing process change risk, although a scaled-up manufacturing process for VYJUVEK has been approved by the FDA.
• Patient entry to treatment path delay risk, with turnaround time for patients and prescribers in the community still between 45-60 days.

Q: On VYJUVEK, any year-end stocking in 4Q and accounting for patient annual cap?

A: Nothing substantially different in Q4 vs other quarters, no change in stocking. Cap calculation is complex but no volatility in revenue expected.

Q: On CF study enrollment and CFF TDN sanctioning?

A: Enrollment in Cohort 3 has begun, TDN sanctioning is important with academic sites active and patients enrolled.

Q: Expectations from Europe in 2H 2025 and pricing?

A: Germany has ~600 identified patients, France ~400. Pricing in Germany to start at U.S. price and adjust later, France under AP2 program.

Q: Reimbursement approvals and compliance assumptions?

A: Percentage of dominant and recessive patients varies quarter-by-quarter, no material change expected in compliance assumptions.

Q: Regulatory process delay for CHMP and competition?

A: Delay was to iron out label details for favorable SMBC. Confident in maintaining market share despite potential competition.

Q: AATD expanded Cohort 2 and 3 data and molecular assessments?

A: Expanded Cohort 2 adds patients to confirm data, Cohort 3 is higher dose, looking for dose response and biomarker correlationship.