Krystal Biotech, a commercial-stage biotechnology company, has recently released its 10-Q report. The company focuses on discovering, developing, and commercializing genetic medicines for patients with rare diseases in the United States. Its commercialized product, VYJUVEK (beremagene geperpavec-svdt, or B-VEC), is used for the treatment of dystrophic epidermolysis bullosa (DEB). Krystal Biotech also has a pipeline of other product candidates in various stages of development, including KB105, KB104, KB407, KB707, KB408, and KB301.
In the 10-Q report, Krystal Biotech reported net VYJUVEK product revenue of $70.3 million for the three months ended June 30, 2024, and $166.2 million in cumulative net product revenue since its launch in August 2023. The company achieved a gross margin of 91% for the same period.
The report also highlighted the company's progress in securing access and reimbursement for VYJUVEK, with positive access determinations achieved for 97% of lives covered under commercial and Medicaid plans as of July 2024. Krystal Biotech has secured over 400 reimbursement approvals for VYJUVEK in the U.S.
Furthermore, the company is actively preparing for a direct commercial launch of VYJUVEK in Europe and Japan. It submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for B-VEC for the treatment of DEB, with expectations of an EMA decision in the second half of 2024. Additionally, it anticipates filing a Japan New Drug Application with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2024, potentially leading to authorization in 2025.
Krystal Biotech's pipeline highlights include progress in the development of respiratory and ophthalmology treatments, as well as oncology therapies. The company has initiated clinical studies and presented preclinical data for various product candidates, such as KB407, KB408, KB707, and ophthalmic B-VEC, demonstrating its commitment to advancing treatments for a range of rare diseases.
Following these announcements, the company's shares moved -7.2%, and are now trading at a price of $178.16. For the full picture, make sure to review Krystal Biotech's 10-Q report.