Krystal Biotech Reports Q2 2024 Financials and Business Updates

Krystal Biotech, Inc., a leading commercial-stage biotechnology company, has announced its financial results for the second quarter ending June 30, 2024, along with key business updates. The company, listed on NASDAQ under the ticker KRYS, reported significant growth in its VYJUVEK U.S. commercial launch as well as advancements in its clinical-stage pipeline.

Net product revenue for the second quarter reached $70.3 million, reflecting a 55.3% increase from the first quarter. Since the launch of VYJUVEK in August 2023, the company has accumulated $166.2 million in revenue. The company also boasts a strong balance sheet, ending the quarter with $628.9 million in cash and investments.

Krystal Biotech has been focusing on expanding VYJUVEK's reach. In the U.S., the company has secured over 400 reimbursement approvals, with coverage for 97% of lives under commercial and Medicaid plans. High patient compliance with weekly treatment stands at 90%. The company's manufacturing facility, ANCORIS, received GMP certification from the European Medicines Agency (EMA) in May. The EMA is reviewing the company’s Marketing Authorization Application (MAA) for B-VEC for treating Dystrophic Epidermolysis Bullosa (DEB), with a decision expected in the second half of 2024. The company is also on track to file a Japan New Drug Application in the second half of 2024, with potential authorization anticipated in 2025.

In respiratory medicine, Krystal Biotech is advancing KB407 for treating cystic fibrosis (CF). The company has cleared Cohort 2 of the Phase 1 CORAL-1 study and expects to initiate the third and final cohort in the second half of 2024. Additionally, preclinical data presented at the American Thoracic Society's 2024 International Conference demonstrated KB407's effectiveness in transducing patient airway epithelial cell-derived organoids.

For alpha-1 antitrypsin deficiency (AATD) lung disease, the company is progressing with the KB408 Phase 1 SERPENTINE-1 study. The first cohort has been cleared, and enrollment for Cohort 2 is ongoing. Interim data from this study is expected in the fourth quarter of 2024.

In ophthalmology, the company launched a natural history study in August to collect data on DEB patients, serving as a precursor to a registrational study for B-VEC eyedrops, expected to commence in the fourth quarter of 2024. Preclinical data presented at the Association for Research in Vision & Ophthalmology 2024 Annual Meeting highlighted the potential of the company’s HSV-1-based gene delivery platform for ocular treatments.

Oncology efforts include the inhaled KB707 for treating lung tumors. The company has cleared the first dose escalation cohort in the Phase 1 KYANITE-1 clinical study, with enrollment for the second cohort underway. For treating injectable solid tumors, KB707’s Phase 1 OPAL-1 study has cleared its third and final dose escalation cohort, with interim data expected in the fourth quarter of 2024. The FDA has granted Rare Pediatric Disease Designation to intratumoral KB707 for treating osteosarcoma.

Jeune Aesthetics, a subsidiary of Krystal Biotech, completed enrollment for Cohorts 3 and 4 of the Phase 1 PEARL-1 study in April, evaluating KB301 for aesthetic indications. Results are expected in the third quarter of 2024. The company also resumed efforts for KB105 for treating lamellar ichthyosis, planning to commence the Phase 2 portion of the JADE-1 trial in pediatric patients in the first half of 2025.

Financially, the company reported a net income of $15.6 million for the second quarter, compared to a net loss of $33.2 million in the same period the previous year. For the first six months of 2024, net income was $16.5 million, a significant turnaround from the $78.5 million net loss in the same period of 2023.

Krystal Biotech is poised for continued growth, with expectations to drive further VYJUVEK expansion both in the U.S. and internationally, while advancing its diverse pipeline of genetic medicines.