KRYS Reports Preliminary Results for 2025, Outlines 2026 Objectives

Core Insights - Krystal Biotech, Inc. (KRYS) anticipates preliminary unaudited net product revenues of $106-$107 million from its lead drug Vyjuvek in Q4 2025, raising the full-year 2025 revenue forecast to $388-$389 million, driven by strong uptake in the U.S. and successful launches in Europe and Japan [1][11] Financial Performance - At the end of 2025, Krystal reported approximately $955 million in cash, cash equivalents, and investments, providing substantial financial flexibility for clinical programs [2] - For 2026, the company expects combined non-GAAP R&D and SG&A expenses to be between $175-$195 million [2] Pipeline Development - Krystal is advancing several rare disease programs utilizing its redosable HSV-1 gene therapy platform, targeting high-turnover tissues such as skin, lung, and eye [3] - Key pipeline candidates include KB803 for ocular complications of DEB, KB801 for neurotrophic keratitis, KB407 for cystic fibrosis, and KB111 for Hailey-Hailey disease [3] Clinical Trials and Updates - Enrollment in the registrational KB801 study has increased to 60 patients, indicating potential for expedited development, with a detailed update expected in February 2026 [4] - Top-line data from the KB801 and KB803 registrational studies are anticipated in 2026, serving as important near-term catalysts [6] - Other targets for 2026 include initiating and completing enrollment in a registrational repeat dose study for KB407 and starting a double-blind, placebo-controlled study for KB111 [7] Vyjuvek Developments - Vyjuvek received FDA approval in May 2023 as the first revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB) [8] - In September 2025, a label update expanded the treatment-eligible population to include DEB patients from birth and allowed for greater dosing flexibility [9][12] Long-term Strategy - The company aims to have at least four marketed rare disease therapies by 2030, targeting over 10,000 patients globally while maintaining profitability [5] - Krystal continues to invest in earlier-stage programs for larger indications, including KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer, which could provide long-term growth potential [5] Stock Performance - Shares of KRYS increased by 5% on January 9, with a notable 73.9% rise over the past year compared to the industry growth of 19.6% [16]