Krystal Biotech, Inc. Q1 FY2025 earnings call

VYJUVEK Global Expansion

• Positive EC decision with full approval in EU, planning to launch in Germany and France in Q3 2025; no post-approval efficacy study requirements in EU. Japan regulatory review progressing, manufacturing inspection complete, expected approval in Q3 2025 and patient treatment in Q4 2025.

1Q Results & U.S. Launch

• Net VYJUVEK revenue $88.2M; patients pausing after intensive induction, but long-term success stories driving growth. In U.S., reimbursement approvals exceed 540 as of April 2025, 97% treatments in home setting. Field sales team enhanced, VYJUVEK Voices program launching.

Clinical Pipeline

• Upcoming readouts in 2025 for CF Alpha-1, KB304 in aesthetics, KB803 in DEB eye lesions. New ophthalmic program KB801 for neurotrophic keratitis entering clinic.

Financials

• 1Q net income $35.7M, $1.24 per basic and $1.20 per diluted share. Well capitalized with $765.3M in cash plus investments.

Net VYJUVEK revenue for the quarter came in at $88.2 million. Gross margins and GTM were consistent with prior quarters. VYJUVEK revenue contributed significantly, with 1Q net revenue at $88.2M.

Global Launches

• Plan to launch VYJUVEK in Germany and France in Q3 2025, Japan expected approval in Q3 2025 and patient treatment in Q4 2025. ### Clinical Readouts
• Expect molecular readouts in CF this summer, AATD, KB803, KB304 by year-end. ### Business Diversification
• Aim to build global, geographically diversified business with VYJUVEK franchise.

Unpredictable Patient Patterns

• Patient pausing patterns are unpredictable quarter-to-quarter. ### Insurance & Reimbursement
• Insurance changes and time lags in reimbursement approvals. ### Competition & Subpoena
• Competition in rare disease market with differences in safety, efficacy, convenience; subpoena related to genetic testing with ongoing cooperation but no further details.

Q: On VYJUVEK sales in 1Q, impact of insurance changes and rebound in 2Q?

A: Krish Krishnan stated insurance changes had an impact, but expected to make up in 2Q.

Q: New reimbursement approvals slowing, natural shrinking of addressable population?

A: Krish mentioned total market opportunity remains, but longer time to get patient Start Forms, so increasing commercial effort.

Q: Long-term compliance rate, patients restarting VYJUVEK?

A: Jennifer McDonough said compliance heading to 50% long-term, patients pause and restart based on individualized wound behavior.

Q: EU launch cadence, patients stopping and restarting?

A: Krish noted EU launch faces time to first physician appointment, steps taken to mitigate; Suma Krishnan said small percentage of patients don't restart, mostly due to non-drug related complications.

Q: Competitor product approval, ASCO presentation?

A: Suma Krishnan said no competition due to safety, efficacy, and convenience differences; ASCO poster on inhaled KB707 shows novel cytokine delivery to lungs.

Q: Subpoena on genetic testing, compliance rate calculation?

A: Krish said cooperating with DOJ, Debjit Chattopadhyay was told compliance rate includes missed doses while on therapy.

Q: Japan market contribution, inspection outcome?

A: Yigal Nochomovitz was told Japan market attractive with ~500 identified patients, Suma Krishnan said manufacturing inspection went well with no findings.