Krystal Biotech Q4 Earnings Beat Estimates, Revenues Miss Mark

Core Insights - Krystal Biotech (KRYS) reported Q4 2025 earnings per share (EPS) of $1.70, exceeding the Zacks Consensus Estimate of $1.62, and up from $1.52 in the same quarter last year [1][7] - Revenues for the quarter were $107.1 million, a 17.5% increase year over year, but fell short of the Zacks Consensus Estimate of $109 million, with all revenues coming from Vyjuvek sales [1][6] - The FDA approved Vyjuvek, the first revocable gene therapy, for treating dystrophic epidermolysis bullosa (DEB) in patients aged six months and older, and for at-home administration [2] Financial Performance - For Q4 2025, product revenues from Vyjuvek were $107.1 million, up from $91.1 million in the previous year, driven by strong patient uptake, with a gross margin of 94% [6][7] - For the full year 2025, total product revenues reached $389.1 million, a 34% increase year over year, with net earnings of $6.84 per share compared to $3.00 in 2024 [10] Market Access and Demand - The company secured over 660 reimbursement approvals for Vyjuvek in the U.S., facilitating nationwide access, while international demand remains strong with over 90 patients prescribed the therapy in Germany, France, and Japan [3][7] Research and Development - R&D expenses for Q4 were approximately $14.8 million, a 9.36% increase year over year, while SG&A expenses totaled about $41.4 million, up 32.5% due to increased headcount and marketing costs [8] - Krystal Biotech is advancing multiple candidates, including KB407 and KB707, with several data readouts and studies planned for 2026 [7][12] Pipeline Updates - KB407 is being evaluated for cystic fibrosis, with successful data from a multicenter study announced in January, and a registrational study planned for 2026 [13][14] - KB707 is in development for solid lung tumors, with the FDA granting RMAT designation for advanced non-small cell lung cancer [18] - The company is also developing KB304 for aesthetic applications, with a mid-stage study expected to start in 2027 [19]