Core Insights - Krystal Biotech, Inc. reported preliminary unaudited net product revenue for VYJUVEK® of $106 million to $107 million for Q4 2025, and $388 million to $389 million for the full year 2025, indicating strong financial performance [3][4] - The company aims to establish itself as a global leader in rare diseases, leveraging its HSV-1 platform to develop differentiated genetic medicines [2][5] - A robust clinical pipeline is in place, with multiple potential blockbuster launches anticipated in the next four years, positioning the company for sustained growth [2][5] Financial Performance - Preliminary net product revenue for VYJUVEK is projected to be between $106 million and $107 million for Q4 2025, and between $388 million and $389 million for the full year 2025 [3] - As of December 31, 2025, the company had approximately $955 million in cash, cash equivalents, and investments, indicating a strong balance sheet [3] Strategic Vision - The company’s strategic vision includes having at least four marketed rare disease medicines by the end of 2030, aiming to treat over 10,000 patients globally [7] - The company plans to accelerate clinical development for its rare disease pipeline, including increasing enrollment targets for ongoing studies [6][8] Corporate Objectives for 2026 - Key objectives include launching VYJUVEK in additional major European markets, expanding the specialty distributor network to over 40 countries, and reporting top-line results from various registrational studies [14] - The company expects combined non-GAAP R&D and SG&A expenses for 2026 to be between $175 million and $195 million [9]

Investor call to be held January 8 at 4:30 pm ET to discuss data update and next stepsPITTSBURGH, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that it will host an investor conference call and webcast tomorrow, Thursday, January 8, 2026, at 4:30 pm ET, to disclose an interim clinical update from CORAL-1, the Company’s multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis. The interim clinical update will focus ...

PITTSBURGH, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco. Krish S. Krishnan, Chairman and Chief Executive Officer, is scheduled to give a presentation at 10:30 am ET / 7:30 am PT and host investor meetings throughout the day. A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, J ...

Core Insights - Krystal Biotech, Inc. (NASDAQ:KRYS) is recognized as a leading gene-editing stock, with a Buy rating reaffirmed by Evercore ISI and a price target set at $218 [1][2]. Financial Performance - In Q3 2025, Krystal reported an EPS of $2.66 per diluted share, significantly exceeding the anticipated $1.09 [2]. - Revenue for the quarter reached $97.8 million from the VYJUVEK product, contributing to a total revenue of over $623 million since its US launch [2]. - The net income for the quarter was $79.4 million, attributed to manufacturing efficiencies and a one-time non-cash tax benefit [2]. - Gross margin improved to 96%, up from 93% in the previous quarter, due to optimizations in US product manufacturing [2]. - The company ended the quarter with over $864 million in cash and investments [2]. Operational Developments - Management highlighted ongoing expansion efforts into Germany, France, and Japan, along with partnerships in the Middle East, Turkey, and Central and Eastern Europe [3]. - The company is focused on increasing patient access for the treatment of Dystrophic Epidermolysis Bullosa (DEB) and expanding its global market presence [3]. Company Overview - Krystal Biotech, Inc. is a biotechnology company that develops and commercializes redosable gene therapies for rare and serious genetic diseases [4]. - Its first approved product, VYJUVEK, is the only FDA-approved redosable gene therapy for DEB, a severe skin disorder [4].

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VYJUVEK Launch and Revenue - Since launch, VYJUVEK has generated over $623 million in net revenue[10] - Q3 2025 VYJUVEK product revenue reached $97.8 million, compared to $83.8 million in Q3 2024[35] - The company has secured over 615 reimbursement approvals for VYJUVEK in the U S[14] European and Japanese Expansion - VYJUVEK launched in Germany in late August, with over 10 prescribing centers and prescriptions for an estimated 20 DEB patients[15] - VYJUVEK launched in Japan in October, targeting over 500 estimated DEB patients[17, 18] - The company is building a specialty distributor partner network to reach thousands of potential DEB patients in rest-of-world markets[20] Pipeline Development - The FDA granted Platform Technology Designation for KB801, potentially accelerating its path to market[21] - The company expects to report molecular data from the KB407 Phase 1 trial for Cystic Fibrosis by year-end[28] - KB111 is entering clinical trials for the treatment of Hailey-Hailey disease, targeting an estimated 10,000-15,000 patients in the U S and Europe[34] Financial Performance - The company's cash and investments totaled $864.2 million as of September 30, 2025[35] - Net income for Q3 2025 was $79.4 million, compared to $27.2 million in Q3 2024[35] - Non-GAAP R&D and SG&A expense guidance for full year 2025 is updated to $145 million to $155 million[36]

Financial Performance - The company reported $97.8 million in net product revenue for VYJUVEK in Q3 2025, an increase from $83.8 million in Q3 2024, reflecting a growth of approximately 16.7% year-over-year [3][23][37] - Gross margin for the quarter was 96%, indicating strong profitability from product sales [3] - Net income for Q3 2025 was $79.4 million, or $2.74 per common share (basic), compared to $27.2 million, or $0.95 per common share (basic) in Q3 2024, representing a significant increase [23][36] Product Development and Market Expansion - VYJUVEK was launched in Germany in Q3 2025, with approximately 20 patients prescribed the therapy across over 10 centers [3] - The product was also launched in France and Japan in Q4 2025, following successful pricing negotiations [3][4] - The FDA approved a label update for VYJUVEK, expanding the eligible patient population to include DEB patients from birth and allowing for home application by patients or caregivers [3][24] Pipeline and Future Prospects - The company is advancing its pipeline with multiple near-term readouts, including interim results for cystic fibrosis expected in Q4 2025 [2][6] - The company is preparing regulatory filings for the UK and Switzerland and is initiating pricing discussions in other key Western European markets [3][4] - The company continues to enroll in clinical trials for KB407 and KB408, with interim data readouts expected in late 2025 and early 2026 [6][11] Financial Guidance - The company provided guidance for FY 2025, estimating non-GAAP combined R&D and SG&A expenses to be between $145 million and $155 million [20]

Core Viewpoint - Krystal Biotech, Inc. is set to report its third quarter 2025 financial results on November 3, 2025, and will host a conference call to discuss these results and provide a business update [1]. Company Overview - Krystal Biotech, Inc. is a fully integrated, commercial-stage global biotechnology company focused on the discovery, development, and commercialization of genetic medicines for diseases with high unmet medical needs [3]. - The company's first commercial product, VYJUVEK, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa [3]. - The company is advancing a robust pipeline of investigational genetic medicines across various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3].

Core Viewpoint - Krystal Biotech, Inc. is advancing the development of KB707, a redosable immunotherapy targeting non-small cell lung cancer (NSCLC), with promising early efficacy data leading to an End of Phase 2 meeting with the FDA to discuss registration pathways [1][2][3] Group 1: Development Plans and Efficacy - The company has observed a 36% objective response rate in heavily pre-treated NSCLC patients as of April 15, 2025, with no Grade 4 or 5 adverse events reported, indicating a favorable safety profile [3] - Enrollment is ongoing in the KYANITE-1 study, a Phase 1/2 trial evaluating inhaled KB707 in patients with locally advanced or metastatic lung tumors [4] - The company has paused enrollment in the OPAL-1 study, which evaluates intratumoral KB707, to prioritize inhaled KB707, while continuing to monitor patients in OPAL-1 [5] Group 2: Company Overview - Krystal Biotech is a commercial-stage biotechnology company focused on genetic medicines for diseases with high unmet medical needs, with its first product, VYJUVEK, being the first redosable gene therapy approved in multiple regions [6]

Financial Performance & VYJUVEK Launch - VYJUVEK revenue since launch exceeds $525 million[8] - Second quarter 2025 product revenue reached $96 million, compared to $70.3 million in the second quarter of 2024[43] - Gross margin in the second quarter was 93%[10, 43] - Gross to net in the second quarter was 17%[10] VYJUVEK Expansion & Approvals - VYJUVEK received approval in Japan for DEB patients from birth, with launch expected in the fourth quarter of 2025[11, 14] - Over 575 reimbursement approvals in the U S[10] - U S compliance to weekly therapy while on drug at 82% as of end of 2Q 2025[10] - European launch is on track for later this quarter, with over 575 identified DEB patients in Germany and France[15, 16] Pipeline Development - 36% objective response rate was observed with KB707 monotherapy in advanced NSCLC patients[22] - 40% AAT positive cells after KB408[26] - Functional AAT delivery to the lungs was confirmed in the third patient dosed with KB408, showing a 79.3% reduction in free neutrophil elastase in ELF after a single dose[25, 26] Financial Guidance - Non-GAAP R&D and SG&A expense guidance for the full year 2025 is $150 million to $175 million[44]