Krystal Biotech Reports Q1 2024 Financials and Business Updates

Krystal Biotech, Inc., a biotechnology company focused on genetic medicines for rare and serious diseases, announced significant progress and financial results for the first quarter ending March 31, 2024. The company achieved $45.3 million in net product revenue for VYJUVEK in the first quarter and has seen a total revenue of $95.9 million since August 2023. Krystal Biotech also has a strong balance sheet with $622.3 million in cash and investments.

Krish S. Krishnan, Chairman and CEO of Krystal Biotech, highlighted the company's progress in delivering genetic medicines, particularly through the successful U.S. launch of VYJUVEK, which has seen strong demand, rapid growth in reimbursement approvals, and high patient compliance. The company also completed a clinical study in Japan, setting the stage for another regulatory filing outside the U.S. by the end of the year. Moving forward, Krystal Biotech aims to expand VYJUVEK access globally and advance its clinical pipeline.

VYJUVEK, a treatment for Dystrophic Epidermolysis Bullosa (DEB), generated $45.3 million in net product revenue in the first quarter, with a gross margin of 95%. The company has secured over 330 reimbursement approvals in the U.S. and achieved positive access for 96% of lives covered under commercial and Medicaid plans. A permanent J-code for VYJUVEK was received in January, facilitating efficient billing and reimbursement.

The European Medicines Agency (EMA) completed inspections of Krystal Biotech's manufacturing facility in February as part of the review for the Marketing Authorization Application (MAA) for B-VEC, a treatment for DEB. The company expects a decision on the MAA and GMP certification in the second half of 2024. Additionally, Krystal Biotech is on track to file a New Drug Application in Japan in the second half of 2024, following the completion of the efficacy portion of the Japan open-label extension study of B-VEC.

In the respiratory field, Krystal Biotech made progress with KB407 for cystic fibrosis and KB408 for alpha-1 antitrypsin deficiency (AATD). The company completed dosing in Cohort 2 of the Phase 1 CORAL-1 study for KB407 and plans to start the final cohort in the second quarter of 2024. For KB408, the first patient was dosed in the Phase 1 SERPENTINE-1 study in February, and interim data is expected in the second half of 2024.

Krystal Biotech also explored the use of B-VEC eyedrops for ocular complications of DEB. The company aligned with the FDA on a single-arm, open-label study to enable approval of B-VEC eyedrops, which it plans to initiate in the second half of 2024. Additionally, the United States Patent and Trademark Office issued a patent covering methods of delivering human transgenes to the eye using replication-incompetent HSV-1.

In oncology, Krystal Biotech dosed the first patient in the inhaled KB707 study for solid tumors of the lung and received Fast Track Designation for both inhaled and intratumoral KB707. The company completed enrollment in Cohort 3 of the Phase 1 OPAL-1 study for intratumoral KB707 and expects to report interim data in the second half of 2024.

Jeune Aesthetics, a subsidiary of Krystal Biotech, initiated Cohort 4 of the Phase 1 PEARL-1 study to evaluate KB301 for dynamic wrinkles of the décolleté. The company expects to announce results from both Cohorts 3 and 4 in mid-2024.

Financial results for the first quarter of 2024 show a strong performance, with net income of $0.9 million, compared to a net loss of $45.3 million in the same quarter of 2023. Research and development expenses were $11.0 million, while selling, general, and administrative expenses totaled $26.1 million. The company continues to anticipate $150 million to $175 million in non-GAAP R&D and SG&A expenses for the year ending December 31, 2024.

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