First Quarter 2025 Financial and Operating Results May 6, 2025 © Copyright 2025 Krystal Biotech, Inc. All rights reserved. Forward Looking Statements and Disclosures This presentation and the accompanying oral presentation contain forward-looking statements that involve substantial risks and uncertainties. Any statements about future expectations, plans, and prospects for Krystal Biotech, Inc. (together with its subsidiaries, the "Company"), including but not limited to statements about the Company's U.S. c ...

Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $1.20 per share, missing the Zacks Consensus Estimate of $1.38 per share. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -13.04%. A quarter ago, it was expected that this company would post earnings of $1.29 per share when it actually produced earnings of $1.52, delivering a surprise of 17.83%.Over the last four quarters, the c ...

Krystal Biotech (KRYS) Q1 2025 Earnings Call May 06, 2025 08:30 AM ET Company Participants Stéphane Paquette - VP - Business DevelopmentKrish Krishnan - Chairman & CEOJennifer McDonough - SVP of Patient Access, Analytics & OperationsChristine Wilson - Head of U.S. Sales & MarketingSuma Krishnan - President, Research & DevelopmentKathryn Romano - Executive VP & Chief Accounting OfficerAlec Stranahan - Vice President - Equity ResearchGavin Clark-Gartner - Director - Biotechnology Equity ResearchAndrea Newkirk ...

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 Biotech Announces First Quarter 2025 Financial and Operating Results VYJUVEK approved in Europe for the treatment of DEB patients from birth $88.2 million in 1Q VYJUVEK revenue and $429.4 million since launch in Q3 2023 Second ophthalmic program in clinic - KB801 for the treatment of neurotrophic keratitis Upcoming clinical readouts in 2025 - CF, AATD, ocular complications of DEB, and aesthetics Strong balance sheet, ending the quarter with $765.3 million in cash and investments PITTSBURGH, May 6, 2 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ FORM 10-Q _____________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 _____________ ...

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].

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 ...

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]

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 ...