Krystal Biotech (KRYS) Q3 2024 earnings summary

Executive summary

• VYJUVEK net product revenue reached $83.8 million in Q3 2024 and $250.1 million since launch in August 2023, with over 460 U.S. reimbursement approvals and 97% positive access for covered lives.

• Net income for Q3 2024 was $27.2 million ($0.95 basic, $0.91 diluted EPS), up from $0.54 EPS in Q2 2024, but down from $80.7 million in Q3 2023, which included a $100 million one-time gain from a priority review voucher sale.

• European and Japanese launches are on track for 2025, with regulatory filings under review, early reimbursed access approved in France, and EMA GMP certification granted.

• Pipeline advances include positive KB301 data in aesthetics, ongoing KB408 and KB707 studies, and preparations for the IOLITE ophthalmic trial, with multiple clinical milestones expected by year-end.

• Ended Q3 with $694.2 million in cash and investments, supporting ongoing pipeline and commercial expansion.

Financial highlights

• Q3 2024 net product revenue was $83.8 million, up from $8.6 million in Q3 2023, with gross margin at 92% and cost of goods sold at $6.7 million.

• Net income for Q3 2024 was $27.2 million; EPS was $0.95 basic and $0.91 diluted.

• Nine-month net product revenue was $199.4 million (2024) vs. $8.6 million (2023); net income $43.7 million (2024) vs. $2.2 million (2023).

• Cash and investments totaled $694.2 million as of September 30, 2024.

• $12.5 million litigation expense accrued in Q3, finalizing all litigation accruals.

Outlook and guidance

• Non-GAAP R&D and SG&A expense guidance for full year 2024 is $115–$125 million, excluding stock-based compensation.

• EMA decision and first ex-U.S. launch in Germany expected in 1H 2025; Japan launch anticipated in 2H 2025, with pricing negotiations ongoing.

• Interim data from KB408 (AATD) and KB707 (oncology) expected before year-end; KB407 (CF) data in 1H 2025.

• On track for 720 reimbursement approvals (60% penetration) within two years of launch.

• Revenue guidance for 2025 pending further clarity on ex-U.S. launches.