Krystal(KRYS) - 2025 Q1 - Quarterly Results

Financial and Operating Highlights First Quarter 2025 Overview Krystal Biotech reported strong Q1 2025 results, with VYJUVEK European approval, $88.2 million revenue, and pipeline advancements Q1 2025 Key Metrics | Metric | Value | | :--- | :--- | | VYJUVEK Q1 Revenue | $88.2 million | | VYJUVEK Revenue Since Launch | $429.4 million | | Cash and Investments (End of Q1) | $765.3 million | - VYJUVEK received approval from the European Commission for the treatment of Dystrophic Epidermolysis Bullosa (DEB) patients from birth[1][3] - The company advanced its pipeline with a second ophthalmic program, KB801, entering clinical trials for neurotrophic keratitis[1][2] - Multiple clinical readouts are anticipated in 2025 across programs for cystic fibrosis (CF), alpha-1 antitrypsin deficiency (AATD), ocular complications of DEB, and aesthetics[1] Pipeline and Commercial Update VYJUVEK® for Dystrophic Epidermolysis Bullosa (DEB) VYJUVEK achieved significant Q1 2025 commercial and regulatory milestones, including $88.2 million revenue and European approval VYJUVEK Q1 2025 Performance | Metric | Value | | :--- | :--- | | Net Product Revenue | $88.2 million | | Gross Margin | 94% | | U.S. Reimbursement Approvals | >540 | | Patient Compliance Rate | 83% | - The European Commission approved VYJUVEK for DEB patients from birth; the first European launch is on track for Germany in mid-2025[3] - A decision on the Japan New Drug Application (JNDA) is anticipated from Japan's PMDA in the second half of 2025[3] Respiratory Pipeline The company is advancing its respiratory pipeline with ongoing enrollment for KB407 (CF) and KB408 (AATD) studies - KB407 (Cystic Fibrosis): Enrollment continues in Cohort 3 of the CORAL-1 study, with an interim molecular data readout anticipated in mid-2025[6] - KB408 (AATD): Enrollment is ongoing for Cohorts 2 and 3 of the SERPENTINE-1 study. Molecular results for these new patients are expected later in 2025[6] Ophthalmology Pipeline The ophthalmology pipeline expanded with KB801 IND clearance and anticipated first patient dosing for KB801 and KB803 in May 2025 - KB803 (Ocular DEB): The first patient is expected to be dosed in the registrational Phase 3 IOLITE study later in May 2025[8] - KB801 (Neurotrophic Keratitis): The FDA cleared the IND for this second ophthalmology program. KB801 is a gene therapy eye drop designed to deliver nerve growth factor (NGF)[8][9] - The first patient in the Phase 1/2 EMERALD-1 study for KB801 is expected to be dosed later in May 2025[13] Oncology Pipeline The oncology pipeline is advancing with ongoing enrollment for KB707 in two Phase 1/2 studies and a clinical update expected in June 2025 - Enrollment is ongoing in two Phase 1/2 studies for KB707: KYANITE-1 (inhaled for lung tumors) and OPAL-1 (intratumoral for solid tumors)[11][13] - A clinical update from the KYANITE-1 monotherapy cohort will be presented at the 2025 ASCO Annual Meeting in June[13] Aesthetics Pipeline Jeune Aesthetics is advancing its pipeline for wrinkles, with KB301 Phase 2 enrollment in Q4 2025 and KB304 top-line results in 2H 2025 - KB301 (Décolleté Wrinkles): A Phase 2 study is planned to begin enrollment in Q4 2025 after alignment with the FDA on a new clinical scale[14] - KB304 (Wrinkles): Enrollment is complete in the Phase 1 PEARL-2 study, with top-line results anticipated in 2H 2025[14] Dermatology Pipeline The dermatology pipeline includes KB105 Phase 2 initiation in 2026 and preclinical data for Hailey-Hailey and Darier diseases in 2025 - KB105 (Lamellar Ichthyosis): The Phase 2 portion of the JADE-1 trial in pediatric patients is expected to start in 2026[16] - Pipeline Expansion: Preclinical data for early-stage candidates targeting Hailey-Hailey and Darier diseases will be presented at the SID 2025 Annual Meeting[16] Financial Performance Q1 2025 Financial Results Krystal Biotech reported strong Q1 2025 financial results, with net product revenue of $88.2 million and net income of $35.7 million Q1 2025 vs Q1 2024 Financial Results (in millions, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product Revenue, net | $88.2 | $45.3 | | Cost of Goods Sold | $5.0 | $2.4 | | R&D Expenses | $14.3 | $11.0 | | SG&A Expenses | $32.7 | $26.1 | | Net Income | $35.7 | $0.9 | | Diluted EPS | $1.20 | $0.03 | | Cash & Investments | $765.3 | N/A | FY 2025 Financial Guidance The company projects full-year 2025 non-GAAP combined R&D and SG&A expenses between $150.0 million and $175.0 million - Full-year 2025 non-GAAP combined R&D and SG&A expense is projected to be between $150.0 million and $175.0 million[18] - This non-GAAP guidance excludes stock-based compensation expense, which cannot be confidently estimated at this time[18][31] Consolidated Financial Statements Condensed consolidated financial statements detail the company's financial position, including $1.07 billion in total assets and $35.7 million net income Condensed Consolidated Balance Sheet Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $308,770 | $344,865 | | Short-term investments | $308,076 | $252,652 | | Total assets | $1,074,416 | $1,055,838 | | Total liabilities | $89,742 | $109,458 | | Total stockholders' equity | $984,674 | $946,380 | Condensed Consolidated Statement of Operations Statement of Operations (in thousands, except per share data) | Account | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Product revenue, net | $88,183 | $45,250 | | Total operating expenses | $52,006 | $51,934 | | Income from operations | $36,177 | $(6,684) | | Net income | $35,733 | $932 | | Net income per common share (Diluted) | $1.20 | $0.03 | Corporate Information and Disclosures About VYJUVEK and Safety Information VYJUVEK is a topical gene therapy for DEB, approved in the U.S. and Europe, with common side effects and specific handling precautions - VYJUVEK is a topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene directly to DEB wounds[20] - The most common side effects observed (incidence >5%) were itching, chills, redness, rash, cough, and runny nose[22] - Precautions include application by a healthcare provider and careful handling of treated wounds and dressings for 24 hours to avoid accidental exposure[24][25] About Krystal Biotech and Jeune Aesthetics Krystal Biotech is a commercial-stage genetic medicines company, with Jeune Aesthetics as its subsidiary focusing on skin aging and damage - Krystal Biotech is a commercial-stage company focused on genetic medicines, headquartered in Pittsburgh, PA[27] - Jeune Aesthetics, a wholly-owned subsidiary, focuses on developing products to address the biology of aging and damaged skin using Krystal's gene delivery platform[28] Forward-Looking Statements and Non-GAAP Measures The report contains forward-looking statements subject to risks and includes non-GAAP financial guidance excluding stock-based compensation - The press release includes forward-looking statements concerning product launches, regulatory timelines, and clinical trial progress, which are subject to inherent risks[29][30] - The company uses a non-GAAP measure for its R&D and SG&A expense guidance, which excludes stock-based compensation, to better reflect ongoing operational performance[31]