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Krystal(KRYS) - 2025 Q1 - Earnings Call Transcript
2025-05-06 13:32
Financial Data and Key Metrics Changes - The net product revenue for the first quarter of 2025 was $88.2 million, representing a 95% increase from the first quarter of 2024 [49] - Cost of goods sold was $5 million, up from $2.4 million in the prior year's first quarter, with gross margin remaining consistent at 94% [49] - Research and development expenses increased to $14.3 million from $11 million in the prior year, primarily due to personnel-related expenses and clinical development costs [49] - General and administrative expenses rose to $32.7 million from $26.1 million in the prior year, driven by personnel-related expenses and increased professional service expenses [49] - Net income for the quarter was $35.7 million, equating to $1.24 per basic share and $1.20 per diluted share [49] - The company ended Q1 with $765.3 million in total cash plus investments, indicating strong financial health for upcoming launches and clinical programs [49] Business Line Data and Key Metrics Changes - The U.S. patient access to VYJUVEC exceeded 540 patients with reimbursement approvals as of April 2025, maintaining strong nationwide commercial and Medicaid coverage [23] - The company observed a slowdown in reimbursement approvals in Q1, attributed to the pace of patient start forms received [32] - The treatment success of VYJUVEC is leading to meaningful treatment pauses and maintenance treatment, which is expected to drive long-term growth [25][26] Market Data and Key Metrics Changes - The company plans to launch VYJUVEC in Germany and France in Q3 2025, with expectations that the opportunity in the EU could exceed current market anticipations [10] - The regulatory review in Japan is progressing well, with approval expected in Q3 2025 [10] Company Strategy and Development Direction - The company aims to build a geographically diversified business to limit exposure to regulatory or trade dynamics in any single market [22] - The focus is on establishing VYJUVEC as a lifelong first-line therapy for wound management, with ongoing efforts to enhance patient experience [15][22] - The clinical pipeline includes upcoming readouts for CF, AATD, aesthetic skin conditions, and ocular lesions in DEB, with optimism surrounding molecular data updates [16][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential driven by patient outcomes and the effectiveness of VYJUVEC therapy [52] - The company is insulated from external turbulence due to all commercial and pipeline products being manufactured in the U.S. [20] - Management acknowledged the challenges in patient start forms but remains optimistic about the total market opportunity and long-term profitability [59] Other Important Information - The company has had seven consecutive quarters of profitable EPS, indicating strong financial management [21] - The upcoming ASCO presentation will showcase efficacy and safety data from inhaled KB707, highlighting the company's commitment to innovative therapies [47] Q&A Session Summary Question: Impact of insurance changes on VYJUVEC sales in Q1 - Management acknowledged that insurance changes had an impact but noted it was less prominent than in the previous year due to existing contracts [57] Question: Slowing reimbursement approvals and addressable population - Management clarified that while reimbursement approvals have slowed, the total market opportunity remains robust, with approximately 1,200 identified patients in the U.S. [59] Question: Long-term compliance rates and patient restart experiences - Management indicated that compliance rates are ahead of expectations, with patients pausing and restarting treatment based on individual needs [65][66] Question: Trajectory of the German launch compared to the U.S. - Management expects the German launch to have a strong trajectory due to lower patient identification issues and existing demand [70] Question: Increase in salesforce headcount and its purpose - Management confirmed that the increase in salesforce is aimed at enhancing educational efforts in the community rather than responding to competitive pressures [74][76] Question: Utilization of VYJUVEC in light of competitor products - Management does not view the newly approved competitor product as a direct threat due to significant differences in safety and efficacy [103][104]
Krystal(KRYS) - 2025 Q1 - Earnings Call Transcript
2025-05-06 12:30
Financial Data and Key Metrics Changes - The net product revenue for the first quarter of 2025 was $88.2 million, representing a 95% increase from the first quarter of 2024 [46] - Cost of goods sold was $5 million, up from $2.4 million in the prior year's first quarter, with gross margin remaining consistent at 94% [46] - Research and development expenses increased to $14.3 million from $11 million, primarily due to higher personnel-related expenses and clinical development costs [46] - General and administrative expenses rose to $32.7 million from $26.1 million, driven by increased personnel-related expenses and charitable contributions [46] - Net income for the quarter was $35.7 million, translating to $1.24 per basic share and $1.20 per diluted share [46] - The company ended Q1 with $765.3 million in total cash and investments, indicating strong financial stability [46] Business Line Data and Key Metrics Changes - The U.S. patient access to VYJUVEC continued to grow, with reimbursement approvals exceeding 540 as of April 2025 [21] - The access landscape in the U.S. remains strong, with full nationwide commercial and Medicaid coverage [21] - Treatment success on VYJUVEC is leading to meaningful treatment pauses and maintenance treatment, which is expected to drive long-term growth [23][24] Market Data and Key Metrics Changes - The company plans to launch VYJUVEC in Germany and France in Q3 2025, with expectations that the opportunity in the EU could be larger than currently anticipated [7] - Regulatory review in Japan is progressing well, with approval expected in Q3 2025 [7] Company Strategy and Development Direction - The company is focused on establishing VYJUVEC as a lifelong first-line therapy for wound management and is enhancing patient experience through various support initiatives [12][24] - Upcoming clinical readouts for CF, AATD, aesthetic skin conditions, and ocular lesions are anticipated in 2025, with optimism surrounding the clinical pipeline [13][38] - The company aims to build a geographically diversified business to limit exposure to regulatory or trade dynamics in any single market [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential driven by patient outcomes and the upcoming launches in Europe [49] - The company is insulated from external turbulence due to all commercial and pipeline products being manufactured in the U.S. [17] - Management acknowledged the unpredictability of patient pausing patterns but remains optimistic about long-term growth [11] Other Important Information - The company has had seven consecutive quarters of profitable EPS, indicating strong financial management [18] - The launch of VYJUVEC in the U.S. has been characterized by strong patient outcomes, which are expected to support long-term market adoption [50] Q&A Session Summary Question: Impact of insurance changes on VYJUVEC sales in Q1 - Management noted that while there was an impact from insurance changes, it was less prominent than in previous years due to an established JCORD [55] Question: Slowing new reimbursement approvals - Management clarified that the slowing approvals are due to longer interaction times with physicians as the company reaches deeper into communities [57] Question: Long-term compliance rate expectations - Management indicated that compliance is ahead of expectations, with a target of 50% compliance in the long term [62] Question: Trajectory of the German launch compared to the U.S. - Management expects the German launch to have a similar growth target of achieving 60% market share in two years, with existing demand already noted [66] Question: Increase in Salesforce headcount - Management confirmed that the increase in headcount is focused on enhancing field sales efforts to engage more effectively with healthcare providers [70] Question: Compliance tracking on a quarterly basis - Management stated that while compliance has been consistent since launch, quarterly behavior may vary due to patient-specific factors [80] Question: EU launch and patient start cadence - Management acknowledged that the time to secure the first appointment with a physician may be a gating factor but is actively addressing this issue [90] Question: Coexistence with competitor products - Management emphasized that they do not consider the newly approved competitor product as direct competition due to significant differences in safety and efficacy [96]
Krystal(KRYS) - 2025 Q1 - Quarterly Results
2025-05-06 12:09
[Financial and Operating Highlights](index=1&type=section&id=Financial%20and%20Operating%20Highlights) [First Quarter 2025 Overview](index=1&type=section&id=First%20Quarter%202025%20Overview) 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](index=1&type=chunk)[3](index=3&type=chunk) - The company advanced its pipeline with a second ophthalmic program, KB801, entering clinical trials for neurotrophic keratitis[1](index=1&type=chunk)[2](index=2&type=chunk) - 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](index=1&type=chunk) [Pipeline and Commercial Update](index=1&type=section&id=Pipeline%20and%20Commercial%20Update) [VYJUVEK® for Dystrophic Epidermolysis Bullosa (DEB)](index=1&type=section&id=VYJUVEK%C2%AE%20for%20Dystrophic%20Epidermolysis%20Bullosa%20%28DEB%29) 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](index=3&type=chunk) - A decision on the Japan New Drug Application (JNDA) is anticipated from Japan's PMDA in the second half of 2025[3](index=3&type=chunk) [Respiratory Pipeline](index=2&type=section&id=Respiratory%20Pipeline) 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](index=6&type=chunk) - **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](index=6&type=chunk) [Ophthalmology Pipeline](index=2&type=section&id=Ophthalmology%20Pipeline) 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](index=8&type=chunk) - **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](index=8&type=chunk)[9](index=9&type=chunk) - The first patient in the Phase 1/2 EMERALD-1 study for KB801 is expected to be dosed later in May 2025[13](index=13&type=chunk) [Oncology Pipeline](index=3&type=section&id=Oncology%20Pipeline) 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](index=11&type=chunk)[13](index=13&type=chunk) - A clinical update from the KYANITE-1 monotherapy cohort will be presented at the 2025 ASCO Annual Meeting in June[13](index=13&type=chunk) [Aesthetics Pipeline](index=3&type=section&id=Aesthetics%20Pipeline) 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](index=14&type=chunk) - **KB304 (Wrinkles):** Enrollment is complete in the Phase 1 PEARL-2 study, with top-line results anticipated in 2H 2025[14](index=14&type=chunk) [Dermatology Pipeline](index=4&type=section&id=Dermatology%20Pipeline) 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](index=16&type=chunk) - **Pipeline Expansion:** Preclinical data for early-stage candidates targeting Hailey-Hailey and Darier diseases will be presented at the SID 2025 Annual Meeting[16](index=16&type=chunk) [Financial Performance](index=4&type=section&id=Financial%20Performance) [Q1 2025 Financial Results](index=4&type=section&id=Q1%202025%20Financial%20Results) 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](index=5&type=section&id=FY%202025%20Financial%20Guidance) 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](index=18&type=chunk) - This non-GAAP guidance excludes stock-based compensation expense, which cannot be confidently estimated at this time[18](index=18&type=chunk)[31](index=31&type=chunk) [Consolidated Financial Statements](index=9&type=section&id=Consolidated%20Financial%20Statements) 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](index=9&type=section&id=Condensed%20Consolidated%20Balance%20Sheet) 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](index=9&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) 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](index=5&type=section&id=Corporate%20Information%20and%20Disclosures) [About VYJUVEK and Safety Information](index=5&type=section&id=About%20VYJUVEK%20and%20Safety%20Information) 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](index=20&type=chunk) - The most common side effects observed (incidence >5%) were itching, chills, redness, rash, cough, and runny nose[22](index=22&type=chunk) - Precautions include application by a healthcare provider and careful handling of treated wounds and dressings for 24 hours to avoid accidental exposure[24](index=24&type=chunk)[25](index=25&type=chunk) [About Krystal Biotech and Jeune Aesthetics](index=6&type=section&id=About%20Krystal%20Biotech%20and%20Jeune%20Aesthetics) 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](index=27&type=chunk) - 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](index=28&type=chunk) [Forward-Looking Statements and Non-GAAP Measures](index=6&type=section&id=Forward-Looking%20Statements%20and%20Non-GAAP%20Measures) 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](index=29&type=chunk)[30](index=30&type=chunk) - 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](index=31&type=chunk)
Krystal(KRYS) - 2025 Q1 - Quarterly Report
2025-05-06 12:08
PART I. FINANCIAL INFORMATION This section presents the Company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Krystal Biotech, Inc., including the balance sheets, statements of operations and comprehensive income (loss), statements of stockholders' equity, and statements of cash flows, along with their accompanying notes, for the periods ended March 31, 2025, and December 31, 2024 (for balance sheet) or March 31, 2024 (for income statement, equity, and cash flows) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the Company's financial position at specific dates, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | (in thousands) | March 31, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $308,770 | $344,865 | $(36,095) | | Short-term investments | $308,076 | $252,652 | $55,424 | | Accounts receivable, net | $103,260 | $104,746 | $(1,486) | | Inventory | $29,942 | $26,508 | $3,434 | | Total current assets | $766,798 | $742,045 | $24,753 | | Total assets | $1,074,416 | $1,055,838 | $18,578 | | **Liabilities and Stockholders' Equity** | | | | | Accounts payable | $2,672 | $4,985 | $(2,313) | | Accrued rebates | $47,405 | $36,804 | $10,601 | | Accrued expenses and other current liabilities | $28,050 | $58,989 | $(30,939) | | Total current liabilities | $79,489 | $101,995 | $(22,506) | | Total liabilities | $89,742 | $109,458 | $(19,716) | | Total stockholders' equity | $984,674 | $946,380 | $38,294 | | Total liabilities and stockholders' equity | $1,074,416 | $1,055,838 | $18,578 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) This section outlines the Company's financial performance over specific periods, including revenues, expenses, and net income or loss Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $88,183 | $45,250 | $42,933 | | Cost of goods sold | $5,028 | $2,419 | $2,609 | | Research and development | $14,255 | $10,957 | $3,298 | | Selling, general and administrative | $32,723 | $26,058 | $6,665 | | Litigation settlement | $0 | $12,500 | $(12,500) | | Total operating expenses | $52,006 | $51,934 | $72 | | Income (loss) from operations | $36,177 | $(6,684) | $42,861 | | Interest and other income, net | $7,420 | $7,616 | $(196) | | Income before income taxes | $43,597 | $932 | $42,665 | | Income tax expense | $(7,864) | $0 | $(7,864) | | Net income | $35,733 | $932 | $34,801 | | Comprehensive income (loss) | $36,313 | $(5) | $36,318 | | Net income per common share: Basic | $1.24 | $0.03 | $1.21 | | Net income per common share: Diluted | $1.20 | $0.03 | $1.17 | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section details changes in the Company's equity accounts over specific periods, reflecting net income, stock-based compensation, and other equity transactions - Total stockholders' equity increased from **$946.4 million** as of January 1, 2025, to **$984.7 million** as of March 31, 2025, primarily driven by net income of **$35.7 million** and stock-based compensation of **$14.4 million**, partially offset by tax withholdings related to restricted stock units and awards[13](index=13&type=chunk) - For the three months ended March 31, 2025, **17 thousand shares** were issued upon exercise of stock options, and **98 thousand shares** vested from restricted stock units, net of shares withheld for taxes[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the Company's cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Net cash provided by operating activities | $30,969 | $15,888 | $15,081 | | Net cash (used in) investing activities | $(54,769) | $(25,980) | $(28,789) | | Net cash (used in) provided by financing activities | $(12,466) | $10,583 | $(23,049) | | Net (decrease) increase in cash and cash equivalents | $(36,095) | $678 | $(36,773) | | Cash and cash equivalents at end of period | $308,770 | $359,006 | $(50,236) | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Organization](index=7&type=section&id=1.%20Organization) This note describes Krystal Biotech, Inc.'s business, focus on genetic medicines, and global commercialization strategy - Krystal Biotech, Inc. is a fully integrated, commercial-stage, global biotechnology company focused on genetic medicines, utilizing an engineered herpes simplex virus-1 (HSV-1) platform for non-invasive or minimally invasive administration[19](index=19&type=chunk) - The company has established wholly-owned subsidiaries in Switzerland, Netherlands, France, Germany, Japan, Italy, and Spain for the commercialization of VYJUVEK and its product pipeline in Europe and Japan[19](index=19&type=chunk) - As of March 31, 2025, the Company had an accumulated deficit of **$144.9 million** but believes its cash, cash equivalents, and short-term investments of approximately **$616.8 million** are sufficient to fund operations for at least the next 12 months[20](index=20&type=chunk)[21](index=21&type=chunk) [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the accounting principles and policies used in preparing the financial statements, including recent accounting pronouncements - The financial statements are prepared in conformity with GAAP, and there were no material changes to the Company's significant accounting policies during the three months ended March 31, 2025[22](index=22&type=chunk)[26](index=26&type=chunk) - The Company is assessing the potential impact of recently issued FASB ASUs 2023-09 (Income Tax Disclosures, effective after Dec 15, 2024) and 2024-03 (Expense Disaggregation Disclosures, effective after Dec 15, 2026) on its financial statement disclosures[28](index=28&type=chunk)[29](index=29&type=chunk) [3. Product Revenue, Accounts Receivable and Reserves for Product Sales](index=8&type=section&id=3.%20Product%20Revenue,%20Accounts%20Receivable%20and%20Reserves%20for%20Product%20Sales) This note details the recognition of product revenue, accounts receivable balances, and changes in allowances and discounts related to product sales Product Revenue, Net (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product revenue, net | $88,183 | $45,250 | Accounts Receivable, Net (in thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accounts receivable, net | $103,260 | $104,746 | - Customer A accounted for **82%** of accounts receivable, net as of March 31, 2025, down from **100%** as of March 31, 2024[31](index=31&type=chunk) Changes in Allowances and Discounts (in thousands) | (in thousands) | Rebates | Prompt Pay | Other Accruals | Total | | :--- | :--- | :--- | :--- | :--- | | Balance as of December 31, 2024 | $38,223 | $2,570 | $326 | $41,119 | | Provisions | $15,375 | $2,626 | $98 | $18,099 | | Payments/Credits | $(4,240) | $(2,592) | $(105) | $(6,937) | | Balance as of March 31, 2025 | $49,358 | $2,604 | $319 | $52,281 | [4. Net Income Per Share Attributable to Common Stockholders](index=9&type=section&id=4.%20Net%20Income%20Per%20Share%20Attributable%20to%20Common%20Stockholders) This note provides the calculation of basic and diluted net income per common share, including factors affecting share counts Net Income Per Common Share | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net income (in thousands) | $35,733 | $932 | | Weighted-average basic common shares (in thousands) | 28,815 | 28,295 | | Weighted-average diluted common shares (in thousands) | 29,871 | 29,291 | | Net income per common share—basic | $1.24 | $0.03 | | Net income per common share—diluted | $1.20 | $0.03 | - Common stock equivalents totaling **413 thousand** (stock options) and **48 thousand** (unvested restricted stock) were excluded from diluted EPS calculation for Q1 2025 as their effect would be anti-dilutive[34](index=34&type=chunk) [5. Fair Value Instruments](index=9&type=section&id=5.%20Fair%20Value%20Instruments) This note presents information on the fair value of the Company's financial instruments, particularly cash, cash equivalents, and marketable securities Cash, Cash Equivalents and Available-for-Sale Securities (March 31, 2025, in thousands) | (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized (Losses) | Aggregate Fair Value | Cash and Cash Equivalents | Short-term Marketable Securities | Long-term Marketable Securities | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $308,770 | $0 | $0 | $308,770 | $308,770 | $0 | $0 | | Commercial paper | $10,213 | $7 | $0 | $10,220 | $0 | $10,219 | $0 | | Corporate bonds | $228,713 | $516 | $(94) | $229,135 | $0 | $124,423 | $104,713 | | U.S. government agency securities | $216,939 | $343 | $(89) | $217,193 | $0 | $173,434 | $43,759 | | Total | $764,635 | $866 | $(183) | $765,318 | $308,770 | $308,076 | $148,472 | - Total cash, cash equivalents, and marketable securities increased from **$749.6 million** at December 31, 2024, to **$765.3 million** at March 31, 2025[36](index=36&type=chunk)[39](index=39&type=chunk) [6. Balance Sheet Components](index=10&type=section&id=6.%20Balance%20Sheet%20Components) This note provides a detailed breakdown of specific balance sheet accounts, including inventory and accrued expenses Inventory (in thousands) | (in thousands) | March 31, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Raw materials | $15,139 | $13,639 | +11.0% | | Work-in-process | $8,905 | $10,743 | -17.2% | | Finished goods | $5,898 | $2,126 | +177.4% | | Total Inventory | $29,942 | $26,508 | +13.3% | Accrued Expenses and Other Current Liabilities (in thousands) | (in thousands) | March 31, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Accrued taxes | $11,429 | $4,288 | +166.5% | | Accrued payroll and benefits | $3,487 | $9,558 | -63.5% | | Accrued litigation settlement | $0 | $31,250 | -100% | | Total Accrued expenses and other current liabilities | $28,050 | $58,989 | -52.5% | - The Company fully paid the **$75.0 million** litigation settlement with PeriphaGen, Inc. during the three months ended March 31, 2025, with a **$31.25 million** payment, resulting in zero accrued litigation settlement at period end[43](index=43&type=chunk)[44](index=44&type=chunk) [7. Commitments and Contingencies](index=11&type=section&id=7.%20Commitments%20and%20Contingencies) This note discloses the Company's contractual commitments and potential liabilities from legal proceedings or other contingent events - Estimated remaining commitments under CMO/CRO agreements as of March 31, 2025, were approximately **$414 thousand**, with R&D expenses related to these commitments at **$2.2 million** for Q1 2025 (up from **$1.5 million** in Q1 2024)[45](index=45&type=chunk) - The Company received subpoenas from the U.S. Department of Justice in Q1 2025 regarding its sponsored genetic testing program for VYJUVEK and related commercial practices, and is cooperating with the inquiry, though the potential loss cannot be estimated[47](index=47&type=chunk) [8. Leases](index=12&type=section&id=8.%20Leases) This note details the Company's operating lease arrangements, including future minimum payments and lease expenses Future Minimum Operating Lease Commitments (in thousands) | (in thousands) | Operating Leases | | :--- | :--- | | 2025 (remaining nine months) | $1,127 | | 2026 | $1,884 | | 2027 | $1,919 | | 2028 | $1,954 | | 2029 | $1,990 | | Thereafter | $9,226 | | Total Future minimum operating lease payments | $18,100 | | Less: Interest | $(8,438) | | Present value of lease liability | $9,662 | Total Lease Expense (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total lease expense | $490 | $339 | [9. Stock-Based Compensation](index=12&type=section&id=9.%20Stock-Based%20Compensation) This note describes the Company's stock-based compensation plans and the related expense recognized in the financial statements - Shares available for grant under the 2017 IPO Stock Incentive Plan were **2.0 million** as of March 31, 2025[51](index=51&type=chunk) Stock-Based Compensation Expense, Net (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $2,469 | $1,868 | +32.2% | | Selling, general and administrative | $11,009 | $7,431 | +48.1% | | Total stock-based compensation | $13,478 | $9,299 | +44.9% | - Unrecognized stock-based compensation expense totaled **$76.1 million** for options (over 2.9 years), **$51.8 million** for RSUs (over 3.3 years), and **$8.2 million** for PSUs (over 0.9 years) as of March 31, 2025[55](index=55&type=chunk)[57](index=57&type=chunk)[59](index=59&type=chunk) [10. Income Taxes](index=15&type=section&id=10.%20Income%20Taxes) This note provides information on the Company's income tax expense, deferred taxes, and effective tax rates Income Tax Expense (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Income tax expense | $7,864 | $0 | - The Company recorded an income tax provision of **$7.9 million** for Q1 2025, primarily due to state, federal, and foreign income taxes, compared to no provision in Q1 2024 due to sufficient tax losses[61](index=61&type=chunk) [11. Segment Information](index=15&type=section&id=11.%20Segment%20Information) This note clarifies the Company's operating segments and provides selected financial information by segment - The Company operates as a single operating segment focused on genetic medicines, with the CEO using consolidated financial information to manage resources and assess performance[62](index=62&type=chunk) Selected Financial Information by Operating Segment (in thousands) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Product revenue, net | $88,183 | $45,250 | | Cost of goods sold | $5,028 | $2,419 | | Gross margin | 94% | 95% | | Total research and development | $14,255 | $10,957 | | Selling, general and administrative | $32,723 | $26,058 | | Litigation settlement | $0 | $12,500 | | Income (loss) from operations | $36,177 | $(6,684) | | Net income | $35,733 | $932 | [12. Subsequent Events](index=16&type=section&id=12.%20Subsequent%20Events) This note discloses any significant events that occurred after the balance sheet date but before the financial statements were issued - No subsequent events requiring recognition or disclosure in the condensed consolidated financial statements have occurred between March 31, 2025, and the issuance date of the report[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and results of operations for the three months ended March 31, 2025, compared to the same period in 2024. It covers key financial metrics, operational highlights, pipeline developments, and an assessment of liquidity and capital resources, emphasizing the commercialization of VYJUVEK and the progress of its gene therapy product candidates [Overview](index=18&type=section&id=Overview) This section provides a high-level summary of Krystal Biotech's business, key product VYJUVEK's commercialization, and pipeline developments - Krystal Biotech is a commercial-stage global biotechnology company focused on genetic medicines using an HSV-1 gene therapy platform, supported by two in-house CGMP manufacturing facilities[72](index=72&type=chunk) - VYJUVEK, approved by the FDA (May 2023) and EMA (April 2025) for dystrophic epidermolysis bullosa (DEB), generated **$88.2 million** in net product revenue for Q1 2025, with cumulative net product revenue of **$429.4 million** since launch[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[78](index=78&type=chunk) - The Company is preparing for direct commercial launch of VYJUVEK in key European markets and Japan in 2025, starting with Germany in mid-2025, and has secured over **97%** commercial and Medicaid coverage in the U.S.[77](index=77&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - Key pipeline developments include positive interim safety data for KB407 (Cystic Fibrosis) and KB408 (AATD Lung Disease), preparation to initiate a registrational Phase 3 study for KB803 (Ocular DEB) in May 2025, FDA clearance for KB801 (Neurotrophic Keratitis) Phase 1/2 study in April 2025, and early evidence of monotherapy activity for inhaled KB707 (Solid Tumors) in Phase 1/2 KYANITE-1 study[83](index=83&type=chunk)[84](index=84&type=chunk)[88](index=88&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) [Financial Overview](index=22&type=section&id=Financial%20Overview) This section provides an overview of the Company's key financial statement line items and their accounting treatment - Product revenue, net, is recognized from VYJUVEK sales post-FDA approval (May 2023), including estimates for variable consideration like discounts and rebates[104](index=104&type=chunk) - Cost of goods sold includes direct and indirect manufacturing costs for VYJUVEK, personnel, facility, and overhead costs, and may include period costs and inventory adjustments[105](index=105&type=chunk) - Research and development expenses are expensed as incurred, covering preclinical and clinical candidates, manufacturing materials, facility costs, and payroll, and are expected to increase with pipeline expansion[106](index=106&type=chunk)[107](index=107&type=chunk) - Selling, general and administrative expenses include personnel costs, professional fees, and commercialization efforts, anticipated to increase with global VYJUVEK commercialization and product candidate development[108](index=108&type=chunk)[109](index=109&type=chunk) [Critical Accounting Policies, Significant Judgments and Estimates](index=23&type=section&id=Critical%20Accounting%20Policies,%20Significant%20Judgments%20and%20Estimates) This section confirms the consistency of critical accounting policies and estimates during the reporting period - There have been no significant changes to the Company's critical accounting policies, significant judgments, and estimates during the three months ended March 31, 2025, as disclosed in its 2024 Form 10-K[112](index=112&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) This section analyzes the Company's financial performance by comparing key revenue and expense items between periods Key Financial Results (Three Months Ended March 31, 2025 vs 2024, in thousands) | (in thousands) | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $88,183 | $45,250 | $42,933 | 95% | | Cost of goods sold | $5,028 | $2,419 | $2,609 | 108% | | Research and development | $14,255 | $10,957 | $3,298 | 30% | | Selling, general and administrative | $32,723 | $26,058 | $6,665 | 26% | | Litigation settlement | $0 | $12,500 | $(12,500) | (100)% | | Income (loss) from operations | $36,177 | $(6,684) | $42,861 | (641)% | | Net income | $35,733 | $932 | $34,801 | 3734% | - The **95%** increase in product revenue was driven by higher VYJUVEK sales, leading to a **108%** increase in cost of goods sold[115](index=115&type=chunk)[116](index=116&type=chunk) - R&D expenses increased by **$3.3 million (30%)**, primarily due to a **$1.8 million** increase in payroll and stock-based compensation, **$813 thousand** in clinical development, and **$331 thousand** in manufacturing expenses for product candidates, partially offset by capitalization of overhead costs for VYJUVEK[117](index=117&type=chunk)[118](index=118&type=chunk) - SG&A expenses rose by **$6.7 million (26%)**, mainly from a **$4.4 million** increase in payroll and stock-based compensation, **$2.0 million** in other G&A costs (including charitable contributions), and **$1.2 million** in professional services, partially offset by a **$1.0 million** decrease in patient access program costs[123](index=123&type=chunk)[130](index=130&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the Company's ability to meet its financial obligations and fund future operations through available cash and capital sources - As of March 31, 2025, the Company had **$616.8 million** in cash, cash equivalents, and short-term investments, deemed sufficient to fund operations for at least the next 12 months[127](index=127&type=chunk) - Future operations will be funded through existing cash, VYJUVEK sales revenue, equity sales, and potentially strategic partnerships or debt financings, with significant costs expected for regulatory compliance, clinical trials, and commercialization[128](index=128&type=chunk)[129](index=129&type=chunk) Sources and Uses of Cash (Three Months Ended March 31, 2025 vs 2024, in thousands) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $30,969 | $15,888 | | Net cash (used in) investing activities | $(54,769) | $(25,980) | | Net cash (used in) provided by financing activities | $(12,466) | $10,583 | | Net (decrease) increase in cash | $(36,095) | $678 | - Operating activities provided **$31.0 million** in cash for Q1 2025, primarily from net income adjusted for non-cash items, while investing activities used **$54.8 million** due to investment purchases and property/equipment, and financing activities used **$12.5 million** mainly for employee tax withholdings[137](index=137&type=chunk)[139](index=139&type=chunk)[141](index=141&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the Company's exposure to market risks, primarily interest rate risk on its investment portfolio and foreign currency exchange rate risk from international operations, and outlines strategies to mitigate these risks - The Company's **$616.8 million** in cash, cash equivalents, and short-term investments are subject to interest rate risk, but a **10%** immediate change in interest rates is not expected to materially affect results[143](index=143&type=chunk)[144](index=144&type=chunk) - Foreign exchange rate risk exists due to operations in Europe and Japan holding Swiss Francs, Euros, and Japanese Yen, but foreign operations are not currently material, and a **10%** immediate change in exchange rates is not expected to materially affect results[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the Company's disclosure controls and procedures and reports no material changes in internal control over financial reporting during the first quarter of 2025 - The CEO and Chief Accounting Officer concluded that the Company's disclosure controls and procedures were effective as of March 31, 2025[147](index=147&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended March 31, 2025[148](index=148&type=chunk) PART II. OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and other disclosures [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) This section details the final settlement of litigation with PeriphaGen, Inc. and notes that the Company is not currently a party to any other material legal proceedings, while acknowledging potential future claims - The Company fully paid the **$75.0 million** litigation settlement with PeriphaGen, Inc. during Q1 2025, with a **$31.25 million** payment, resolving allegations of breach of contract and misappropriation of trade secrets[149](index=149&type=chunk)[150](index=150&type=chunk) - The Company is not currently a party to any material legal proceedings but may face various claims in the ordinary course of business, which could be costly and impact financial results or reputation[151](index=151&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could adversely affect the Company's business, prospects, operating results, and financial condition, categorized into risks related to business and industry, product development and regulatory approval, manufacturing, commercialization, intellectual property, financial position, and common stock ownership - The Company's near-term prospects are substantially dependent on the commercial success of VYJUVEK, with risks including failure to obtain regulatory approval in other jurisdictions and challenges in commercialization[153](index=153&type=chunk)[154](index=154&type=chunk) - Significant competition exists from other companies developing gene therapies, with many competitors having greater financial and technical resources, potentially leading to market share loss or obsolescence of the Company's products[162](index=162&type=chunk)[164](index=164&type=chunk) - Product liability lawsuits, negative public opinion on gene therapy, and increased regulatory scrutiny could lead to substantial liabilities, decreased demand, and delays in regulatory approvals[167](index=167&type=chunk)[170](index=170&type=chunk)[172](index=172&type=chunk) - The development and commercialization of product candidates are subject to uncertainties, including delays in clinical trials, failure to demonstrate safety and efficacy, and the complex, lengthy, and expensive regulatory approval process for novel gene therapies[229](index=229&type=chunk)[232](index=232&type=chunk)[240](index=240&type=chunk) - Manufacturing risks include delays in regulatory approvals for processes and facilities, reliance on limited third-party suppliers, potential contamination, and challenges in scaling up production, which could disrupt supply[278](index=278&type=chunk)[281](index=281&type=chunk)[285](index=285&type=chunk)[287](index=287&type=chunk) - Commercialization risks include limited experience as a commercial company, challenges in expanding sales and marketing capabilities, and the uncertainty of market acceptance and adequate reimbursement for VYJUVEK and other product candidates[294](index=294&type=chunk)[299](index=299&type=chunk)[304](index=304&type=chunk)[308](index=308&type=chunk)[312](index=312&type=chunk) - Intellectual property risks involve the inability to obtain and maintain adequate patent protection, potential infringement claims from third parties, and the high costs and distractions associated with intellectual property litigation[325](index=325&type=chunk)[332](index=332&type=chunk)[336](index=336&type=chunk) - Financial risks include past net losses, the need for additional funding to sustain operations and commercialization, potential dilution from future equity offerings, and the volatility of the common stock price[346](index=346&type=chunk)[351](index=351&type=chunk)[361](index=361&type=chunk)[365](index=365&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds during the reporting period - No unregistered sales of equity securities or use of proceeds occurred during the three months ended March 31, 2025[375](index=375&type=chunk) [Item 3. Defaults Upon Senior Securities](index=69&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities occurred during the three months ended March 31, 2025[376](index=376&type=chunk) [Item 4. Mine Safety Disclosures](index=69&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the Company - Mine safety disclosures are not applicable to Krystal Biotech, Inc.[377](index=377&type=chunk) [Item 5. Other Information](index=69&type=section&id=Item%205.%20Other%20Information) This section reports that no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the first quarter of 2025 - No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended March 31, 2025[378](index=378&type=chunk) [Item 6. Exhibits](index=69&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including certifications, XBRL data, and the cover page interactive data file - Exhibits include certifications by the CEO and Chief Accounting Officer (31.1, 31.2, 32.1) and Inline XBRL data (101, 104) for the financial statements[379](index=379&type=chunk) SIGNATURES This section contains the required signatures for the financial report, certifying its accuracy and completeness
Krystal Biotech Announces First Quarter 2025 Financial and Operating Results
Globenewswire· 2025-05-06 12:00
Core Insights - VYJUVEK has been approved in Europe for treating dystrophic epidermolysis bullosa (DEB) patients from birth, with a revenue of $88.2 million in Q1 2025 and a total of $429.4 million since its launch in Q3 2023 [1][6][20] - The company is advancing its pipeline with a second ophthalmic program, KB801, for neurotrophic keratitis, and expects significant clinical readouts in 2025 for various product candidates [2][11] - The company reported a strong financial position with $765.3 million in cash and investments at the end of Q1 2025 [1][18] Product Development - VYJUVEK is a topical gene therapy designed to treat DEB by delivering two copies of the COL7A1 gene directly to wounds [20][21] - The company is on track for its first European launch in Germany in mid-2025 and has secured over 540 reimbursement approvals for VYJUVEK in the U.S. [6][18] - KB407 is currently in a multi-center, dose escalation study for cystic fibrosis, with an interim data readout expected in mid-2025 [5][18] - KB408 is in an open-label study for alpha-1 antitrypsin deficiency, with results anticipated later this year [7][18] - KB801 is designed to treat neurotrophic keratitis and is expected to begin patient dosing in a Phase 1/2 study soon [11][18] Financial Performance - The company reported net income of $35.7 million for Q1 2025, a significant increase from $0.9 million in Q1 2024 [18][34] - Product revenue increased by 95% from $45.3 million in Q1 2024 to $88.2 million in Q1 2025 [18][34] - Research and development expenses rose to $14.3 million in Q1 2025 from $11.0 million in Q1 2024, reflecting ongoing investment in product development [18][34] Market Position - The company maintains strong access to VYJUVEK with positive access determinations for 97% of lives covered under commercial and Medicaid plans in the U.S. [6][18] - High patient compliance with the treatment remains at 83% as of the end of Q1 2025 [6][18] - The company is expanding its pipeline to include treatments for various conditions in respiratory, oncology, dermatology, ophthalmology, and aesthetics [28]
Krystal Biotech Announces European Commission Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
Globenewswire· 2025-04-28 11:00
Core Viewpoint - The European Commission has granted marketing authorization for VYJUVEK, a gene therapy for treating dystrophic epidermolysis bullosa (DEB) from birth, marking a significant milestone for Krystal Biotech and patients in need of this therapy [2][4][5]. Group 1: Product Approval and Features - VYJUVEK (beremagene geperpavec-svdt) is approved for patients with DEB who have mutations in the COL7A1 gene, aiming to provide wound healing through the delivery of functional copies of the gene [2][6]. - The therapy can be administered at home or in healthcare settings, with the option for patient or caregiver administration if deemed appropriate by healthcare professionals [2][3]. - This approval allows for the marketing of VYJUVEK across all EU member states, as well as Iceland, Norway, and Liechtenstein, with the first launch planned in Germany by mid-2025 [3][4]. Group 2: Clinical Evidence and Development - The approval was based on positive recommendations from the European Medicines Agency and comprehensive clinical data from Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, demonstrating successful gene delivery and durable wound closure [4][5]. - VYJUVEK is the first corrective medicine approved in Europe for DEB, highlighting its significance in addressing a high unmet medical need [2][5][7]. Group 3: Company Overview and Future Plans - Krystal Biotech is a global biotechnology company focused on developing genetic medicines for diseases with high unmet medical needs, with VYJUVEK being its first commercial product [7][8]. - The company is also pursuing approval for VYJUVEK in Japan, with a decision expected in the second half of 2025 [5].
副省长方伟来镇检查节前安全生产工作
Zhen Jiang Ri Bao· 2025-04-27 23:42
4月27日,副省长方伟赴镇江检查安全生产工作。省政府副秘书长徐华勤参加检查。市委常委、常 务副市长张克陪同检查。 在江苏金斯瑞生物科技有限公司,方伟深入企业生产和研发一线,详细了解企业安全管理体系建设 和安全生产责任制落实情况。得知企业建立了EHS基本安全准则,成立了安全生产委员会,配备专职安 全管理机构EHS部门,方伟给予肯定。他指出,生物科技行业技术密集、工艺复杂,安全风险点多、管 理要求高,企业必须树牢底线思维,强化安全管理,持续完善安全生产各项制度,提升本质安全水平, 切实将安全责任落实到每一个岗位、每一名员工。 随后,方伟来到镇江信缘康米山颐养院,实地检查消防控制室、消防设施设备运行状况以及疏散通 道设置情况,仔细询问火灾防控、应急预案制定、日常巡查制度和员工安全培训等工作落实情况。在认 真听取养老机构负责人介绍后,方伟指出,养老机构入住人员多为高龄老人,行动不便、应急反应能力 弱,消防安全责任重大。要深刻吸取近期各地火灾事故教训,进一步压实安全管理责任,全面开展风险 隐患排查整治,完善应急处置预案,加强员工技能培训和演练,做到早发现、早处置,确保遇到突发情 况能够及时组织有效应对,切实守护入住老人 ...
Krystal Biotech to Present at Upcoming Scientific Conferences
Newsfilter· 2025-04-24 12:00
Core Insights - Krystal Biotech, Inc. will present multiple programs related to lung, eye, and skin at scientific conferences in May and June 2025 [1] Conference Presentations - The company will participate in the following conferences: - American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting: Invited Oral Presentation [2] - 2025 American Society of Clinical Oncology (ASCO) Annual Meeting: Poster Presentation [2] - Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting: Poster Presentation [2] - Society for Investigative Dermatology (SID) 2025 Annual Meeting: Poster Presentation [3] Company Overview - Krystal Biotech, Inc. is a global biotechnology company focused on genetic medicines for diseases with high unmet medical needs [4] - The company's first commercial product, VYJUVEK®, is the first-ever redosable gene therapy approved by the FDA for dystrophic epidermolysis bullosa [4] - The company is advancing a pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [4]
Krystal Biotech to Report First Quarter 2025 Financial Results on May 6, 2025
Globenewswire· 2025-04-17 12:00
PITTSBURGH, April 17, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that it will report its first quarter 2025 financial results on Tuesday, May 6, 2025, prior to the open of U.S. markets. The Company’s management will also host a conference call and webcast at 8:30 am ET on Tuesday, May 6, 2025, to discuss the financial results and provide a business update. Investors and the general public can access the live webcas ...
Jeune Aesthetics Appoints Marc Forth as Chief Executive Officer
Newsfilter· 2025-04-07 20:30
PITTSBURGH, April 07, 2025 (GLOBE NEWSWIRE) -- Jeune Aesthetics, Inc. ("Jeune"), a wholly owned subsidiary of Krystal Biotech, Inc. ("Krystal") (NASDAQ:KRYS) leveraging Krystal's clinically validated gene-delivery platform to fundamentally address and reverse the biology of aging skin, announced today the appointment of Marc Forth as Chief Executive Officer (CEO), effective today. A veteran of the healthcare industry, Mr. Forth has over 30 years of commercial and executive leadership experience, with an ext ...