• Net Income Per Share: $3.12 for 2024, up from $0.40 in 2023.
• Net VYJUVEK Revenue for Q4 2024: $91.1 million.
• Total Revenue for 2024: $290.5 million.
• Gross Margin for Q4 2024: 95%.
• Research and Development Expenses for Q4 2024: $13.5 million.
• Selling, General, and Administrative Expenses for Q4 2024: $31.3 million.
• Net Income for Q4 2024: $45.5 million.
• Cash on Hand at End of Q4 2024: $344.9 million.
• Total Cash and Investments at End of Q4 2024: $749.6 million.

• Warning! GuruFocus has detected 2 Warning Sign with KRYS.

Release Date: February 19, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Krystal Biotech Inc (NASDAQ:KRYS) reported a strong year in 2024 with significant progress in the VYJUVEK US launch, which is tracking in the top tier of rare disease launches.
• The company demonstrated the ability to safely and repeatedly deliver genes to the lung using a nebulizer, validating the lung as a second target tissue for their platform.
• Net income per share increased to $3.12 in 2024 from $0.40 in 2023, marking the sixth straight quarter of positive EPS and fourth straight quarter of sequential earnings growth.
• Krystal Biotech Inc (NASDAQ:KRYS) achieved $341 million in net revenue within 18 months of launch, with sequential revenue growth for six straight quarters.
• The company has a strong financial position with $749.6 million in total cash plus short-term and long-term investments, providing a solid foundation for future growth.

Negative Points

• The company faces challenges with the timing of patient treatment initiation, with an average turnaround time of 45 to 60 days from initial interest to starting treatment.
• There is a lag from prescription to approval due to the availability of genetic test results and prescriber familiarity with access pathways.
• Krystal Biotech Inc (NASDAQ:KRYS) anticipates increased operating expenses in 2025, driven by planned commercial launches outside the United States and expanded pipeline programs.
• The company is preparing for potential competition in the DEB market, which could impact market share and sales growth.
• The EU regulatory process experienced delays due to the need for additional documentation and training materials to support a favorable label for VYJUVEK.

Q & A Highlights

Q: Did Krystal Biotech experience any year-end stocking in Q4, and how does the patient annual cap affect the financial results? A: Krish Krishnan, CEO, stated that there was no significant change in stocking or inventory in Q4 compared to previous quarters. The company revisits the cap calculation at the end of each quarter to ensure no volatility in revenue, despite the complexity of the cap calculation at the payer level.

Q: How is enrollment progressing in the CF study, particularly in Cohort 3, and how does the CFF TDN sanctioning help? A: Krish Krishnan, CEO, mentioned that enrollment in Cohort 3 has begun, and the CFF TDN sanctioning is beneficial, although it just started. Suma Krishnan, President of R&D, added that several sites are active, and enrollment is going well.

Q: What are Krystal Biotech's expectations for the European market in the second half of the year, and how are they approaching pricing in Germany and France? A: Krish Krishnan, CEO, explained that Germany and France are more concentrated markets than the US, with about 600 patients in Germany and 400 in France. The initial pricing in Germany will match the US price for the first six months, with negotiations to follow. In France, pricing will be under the AP2 program, with expectations to finalize within 15-18 months.

Q: How does Krystal Biotech plan to maintain and expand market share in the face of potential DEB commercial competition? A: Krish Krishnan, CEO, emphasized the strong value proposition of VYJUVEK, particularly its home dosing convenience. The company is actively engaging with physicians and patients to reinforce its market position and remains confident in achieving its sales targets despite potential competition.

Q: What is the impact of the annual cap on VYJUVEK in 2024, and are there any changes planned for 2025? A: Christine Wilson, Head of US Sales and Marketing, noted that about 8% of commercial patients are consistently on the cap. Suma Krishnan, President of R&D, mentioned that the manufacturing process has been scaled up and approved by the FDA, which de-risks CMC for future products.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.