Krystal Biotech Reports $89.2 Million Net Income for 2024, Driven by VYJUVEK Sales

Krystal Biotech, Inc. reported net income of $89.2 million for the year ended December 31, 2024, a significant increase from the $10.9 million net income reported in 2023 and a substantial turnaround from the $140 million net loss in 2022. This improvement is largely attributed to the commercial success of VYJUVEK, their FDA-approved treatment for dystrophic epidermolysis bullosa (DEB), which generated $290.5 million in net product revenue in 2024, compared to $50.7 million in 2023. The company's gross margin for VYJUVEK was 93% in 2024. Cumulative net product revenue since VYJUVEK's launch in August 2023 reached $341.2 million by the end of 2024.

Significant changes compared to the previous fiscal year include a substantial increase in product revenue driven by VYJUVEK sales, along with increases in research and development expenses ($7.1 million increase) and selling, general, and administrative expenses ($15.3 million increase). The increase in research and development expenses reflects investments in multiple clinical-stage programs and the expansion of their pipeline. The rise in selling, general, and administrative expenses is linked to the commercial launch of VYJUVEK and the expansion of their commercial infrastructure. A $25 million increase in litigation settlement expense is also noted, related to a settlement with PeriphaGen.

Strategic developments during the year included the continued commercialization of VYJUVEK in the United States, with strong nationwide coverage secured across commercial and Medicaid lives (97% as of February 2025). The company also secured a permanent J-code for VYJUVEK from CMS in January 2024. Krystal Biotech is preparing for direct commercial launches of VYJUVEK in Europe and Japan in 2025, and has begun establishing distribution arrangements in other international markets. The company also advanced several pipeline programs, including initiating Phase 1 trials for KB407 (cystic fibrosis) and KB408 (alpha-1 antitrypsin deficiency), and reporting positive interim data from Phase 1/2 trials for inhaled KB707 (solid tumors). Jeune Aesthetics, their wholly-owned subsidiary, reported positive interim data for KB301 (décolleté wrinkles) and initiated a Phase 1 trial for KB304 (aesthetic skin conditions).

As of February 12, 2025, Krystal Biotech employed 275 full-time employees. The company's manufacturing capabilities include two commercial-scale CGMP facilities, ANCORIS (currently producing VYJUVEK) and ASTRA (completed and qualified in 2023). The company holds numerous patents and patent applications related to their technology platform and product candidates. The company's outlook includes continued commercialization of VYJUVEK, advancement of their pipeline programs, and preparations for international expansion. The 10-K filing also includes extensive discussion of various risk factors, including those related to competition, regulatory approvals, manufacturing, commercialization, intellectual property, and financial resources. The company anticipates continued significant expenses in the foreseeable future and may need to raise additional funding to support their operations and growth.