Krystal Biotech (KRYS) Gains EC Approval for VYJUVEK in DEB Treatment | KRYS Stock News

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Krystal Biotech (KRYS, Financial) has achieved a significant milestone with the European Commission's (EC) approval of VYJUVEK, a groundbreaking treatment for dystrophic epidermolysis bullosa (DEB). Officially authorized on April 23, 2025, VYJUVEK targets patients from birth who possess mutations in the collagen type VII alpha 1 chain gene, helping to facilitate wound healing.

VYJUVEK operates by delivering functional copies of the human COL7A1 gene, addressing the genetic basis of DEB and promoting sustained production of type VII collagen. As the first therapy approved in Europe specifically for DEB, it represents a significant advancement in the treatment landscape.

This approval provides flexibility in administration, allowing VYJUVEK to be dosed either at home or within healthcare settings. Under professional guidance, administration by patients or caregivers is also an option, offering a tailored approach to care. This development marks a new era in the management of DEB, offering hope for enhanced patient outcomes and quality of life.

Wall Street Analysts Forecast

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Based on the one-year price targets offered by 10 analysts, the average target price for Krystal Biotech Inc (KRYS, Financial) is $215.20 with a high estimate of $245.00 and a low estimate of $195.00. The average target implies an upside of 28.05% from the current price of $168.06. More detailed estimate data can be found on the Krystal Biotech Inc (KRYS) Forecast page.

Based on the consensus recommendation from 11 brokerage firms, Krystal Biotech Inc's (KRYS, Financial) average brokerage recommendation is currently 1.7, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

KRYS Key Business Developments

Release Date: February 19, 2025

  • 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.

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

Positive Points

  • Krystal Biotech Inc (KRYS, Financial) 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 (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 (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.

Disclosures

I/We may personally own shares in some of the companies mentioned above. However, those positions are not material to either the company or to my/our portfolios.