Krystal Biotech heads into earnings with Vyjuvek growth and pipeline milestones in focus

Krystal Biotech will report fourth-quarter results before the bell Tuesday, with investors eager to see whether the gene therapy company’s commercial momentum can match the growing excitement around its clinical pipeline. Analysts expect earnings of $1.58 a share on revenue of $106.16 million for the quarter ended December. Vyjuvek is now approved in the United States, Europe, and Japan.

The rare-disease treatment has been a commercial success since its U.S. launch. In 2023, Vyjuvek became the first topical genetic therapy and first treatment approved by the Food and Drug Administration for dystrophic epidermolysis bullosa. Krystal recently released preliminary numbers pointing to annual sales of $388 million to $389 million, which would be a 34% increase at the midpoint.

In November, Krystal posted third-quarter earnings of $2.66 a share versus the $1.09 consensus. The expected decline to $1.58 in the current quarter likely reflects normalization rather than weakness. EPS estimates have remained flat over the past 60 days, while revenue estimates have edged down slightly by 0.79% over the same period.

Attention is also on pipeline expansion. Three registrational programs could result in product launches in 2028: KB803 for ocular DEB, KB801 for neurotrophic keratitis, and KB407 for cystic fibrosis. Top-line data for KB801 is expected before year-end 2026.

Interim Phase 1/2 data for KB407 in cystic fibrosis showed robust 29%+ transduction after dosing. The company is planning to align with the FDA on a potentially expedited registrational trial design in the first quarter, and enrollment is expected to begin in the second quarter.

Krystal’s KB707 candidate is intended to be a treatment for advanced or metastatic non-small cell lung cancer. The FDA gave KB707 a Regenerative Medicine Advanced Therapy designation, which could speed up its development and approval.

The company called 2025 a standout year with successful launches in Europe and Japan. Management has set a goal of bringing at least four marketed rare-disease medicines to over 10,000 patients worldwide by the end of 2030.