Krystal Biotech, Inc. (NASDAQ: KRYS) has reported its financial results and key business updates for the fourth quarter and full year ending December 31, 2023. The company recorded net product revenue of $42.1 million in the fourth quarter and $50.7 million for the full year 2023. Notably, it closed the year with a strong balance sheet, holding $594.1 million in cash and investments.
Vyjuvek, the company's FDA-approved therapy for dystrophic epidermolysis bullosa (DEB), has seen substantial success in the market. The U.S. net product revenue for Vyjuvek reached $42.1 million in the fourth quarter, with a gross margin of 93%. As of February 2024, the company had secured 35% of the 1,200 identified patient base in patient start forms and 228 reimbursement approvals for Vyjuvek. Additionally, patient compliance with the once-weekly treatment while on the drug was reported at 96% at the end of December 2023.
In terms of regulatory progress, the European Medicines Agency validated Krystal Biotech's marketing authorization application for B-VEC for the treatment of DEB, with a decision anticipated in the second half of 2024. Moreover, in December 2023, B-VEC was granted orphan drug designation status for the treatment of DEB by the Japan Ministry of Health, Labour and Welfare.
The company has also made significant advancements in its clinical pipeline. In January 2024, Krystal Biotech initiated dosing in cohort 2 of the phase 1 Coral-1 study for the treatment of cystic fibrosis (CF) with KB407, and in February 2024, the first patient was dosed in the KB408 phase 1 Serpentine-1 study for the treatment of alpha-1 antitrypsin deficiency (AATD).
Financially, the company's cash, cash equivalents, and investments totaled $594.1 million as of December 31, 2023. Net income for the fourth quarter of 2023 was $8.7 million, a significant improvement from the net loss of $(32.1) million in the same period of 2022, with net product revenue from Vyjuvek contributing to this positive change.
For the full year 2023, Krystal Biotech recorded net product revenue of $50.7 million from Vyjuvek sales, marking a successful year since the therapy's FDA approval. The company also reported a gain of $100.0 million from the sale of the rare pediatric disease priority review voucher.
In the coming year, the company expects non-GAAP research and development and selling, general and administrative expenses to range between $150.0 million and $175.0 million.
Today the company's shares have moved 41.0% to a price of $157.0. If you want to know more, read the company's complete 8-K report here.
