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]

Product Revenue and Sales - VYJUVEK generated net product revenue of $97.8 million for the three months ended September 30, 2025, and $623.2 million in cumulative net product revenue since launch[90]. - Product revenue, net increased to $97.8 million for the three months ended September 30, 2025, up 17% from $83.8 million in the same period of 2024, driven by higher VYJUVEK sales[128]. - For the nine months ended September 30, 2025, product revenue, net was $282.0 million, a 41% increase from $199.4 million in 2024[139]. Regulatory Approvals and Market Expansion - VYJUVEK was approved by the FDA in May 2023, making it the first redosable gene therapy for the treatment of dystrophic epidermolysis bullosa (DEB)[80]. - The European Commission granted marketing authorization to VYJUVEK in April 2025 for DEB patients starting from birth[82]. - VYJUVEK was launched in Germany in August 2025 and in France in October 2025, with pricing negotiations ongoing in both countries[85][86]. - The company is preparing regulatory filings for the United Kingdom and Switzerland, with plans for further market expansion in Western Europe[86]. Clinical Trials and Product Development - KB407 for cystic fibrosis has entered Phase 1 clinical trials, with the first patient dosed in July 2023[92]. - KB408 for alpha-1 antitrypsin deficiency lung disease has shown successful SERPINA1 delivery and AAT expression in clinical trials[93]. - KB803, a redosable eye drop formulation for ocular complications in DEB patients, has been applied under a compassionate use protocol with positive outcomes[95][96]. - The company initiated the IOLITE study in June 2025, expecting to enroll approximately 16 patients to evaluate KB803 for corneal abrasions in DEB patients[97]. - KB801, designed for Neurotrophic Keratitis, is expected to reduce treatment burden by maintaining consistent NGF levels with a dosing frequency of twice weekly[98]. - The EMERALD-1 study for KB801 began in July 2025, aiming to enroll up to 27 adult patients with Stage 2 or Stage 3 NK, with a primary focus on safety and tolerability[99]. - Inhaled KB707 for NSCLC showed a 36% objective response rate and a 54% disease control rate in a cohort of 11 heavily pre-treated patients[103]. - The FDA granted platform technology designation to the engineered HSV-1 viral vector used in KB801 in October 2025, facilitating drug development efficiencies[99]. - The company expects to report interim efficacy data from the KYANITE-1 study in the second half of 2026, following the opening of a new cohort for inhaled KB707[104]. - KB111 for Hailey-Hailey Disease received FDA clearance for clinical evaluation, with dosing expected in the first half of 2026[108]. - Jeune Aesthetics reported significant improvements in skin attributes from the KB304 treatment in the PEARL-2 study, with all adverse events being mild to moderate[111]. Financial Performance - Gross margin for the three months ended September 30, 2025, was 96%[90]. - Cost of goods sold decreased to $4.3 million for the three months ended September 30, 2025, down 36% from $6.7 million in 2024, due to manufacturing optimizations[129]. - Research and development expenses rose to $14.6 million for the three months ended September 30, 2025, an 8% increase from $13.5 million in 2024[132]. - Selling, general and administrative expenses increased by $8.9 million to $37.6 million for the three months ended September 30, 2025, a 31% rise compared to $28.7 million in 2024[133]. - Net income for the three months ended September 30, 2025, was $79.4 million, a 192% increase from $27.2 million in the same period of 2024[127]. - Total operating expenses for the nine months ended September 30, 2025, decreased to $165.0 million, down 6% from $175.0 million in 2024[138]. - Income from operations for the nine months ended September 30, 2025, was $117.0 million, a significant increase of 380% from $24.4 million in 2024[138]. - Income tax benefit for the three months ended September 30, 2025, was $31.4 million, compared to an expense of $2.6 million in 2024, reflecting a release of valuation allowance on deferred tax assets[137]. - Litigation settlement costs were zero for the three months ended September 30, 2025, compared to $12.5 million in 2024, indicating a significant reduction in legal expenses[135]. - Interest and other income, net for the nine months ended September 30, 2025 was $21.3 million, a decrease from $22.4 million in 2024[146]. - Income tax benefit for the nine months ended September 30, 2025 was $15.1 million, compared to an income tax expense of $3.1 million in 2024[147]. Cash Flow and Funding - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling approximately $731.1 million[148]. - The company reported net cash provided by operating activities of $123.4 million for the nine months ended September 30, 2025, up from $70.6 million in 2024[155][156]. - Net cash used in investing activities for the nine months ended September 30, 2025 was $69.6 million, compared to $79.7 million in 2024[158][159]. - Net cash used in financing activities for the nine months ended September 30, 2025 was $7.0 million, a decrease from net cash provided of $24.6 million in 2024[160][161]. - The accumulated deficit as of September 30, 2025 was $27.2 million[148]. - The company may require substantial additional funding to obtain regulatory approval and commercialize its product candidates[153]. Future Expectations - The company expects future revenue to fluctuate due to uncertain timing and amounts of product sales, particularly for VYJUVEK[150]. - The company anticipates a $3.6 million increase in marketing costs to support commercial sales of VYJUVEK[152]. - The company expects an increase in research and development expenses as it expands its product portfolio and manages clinical trials[120]. - Selling, general and administrative expenses are expected to rise due to commercialization efforts and the hiring of additional personnel[123].

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 Insights - Krystal Biotech, Inc. (KRYS) is expected to report a year-over-year increase in earnings and revenues for the quarter ended September 2025, with consensus estimates predicting earnings of $1.12 per share (+23.1%) and revenues of $91.5 million (+9.1%) [1][3] Earnings Expectations - The earnings report is scheduled for November 3, and the stock may rise if actual results exceed expectations, while a miss could lead to a decline [2] - The consensus EPS estimate has been revised 15.22% higher in the last 30 days, indicating a positive reassessment by analysts [4] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that the Most Accurate Estimate for Krystal Biotech is lower than the consensus estimate, resulting in an Earnings ESP of -1.18%, which indicates a bearish outlook [12] - The company currently holds a Zacks Rank of 3 (Hold), complicating predictions of an earnings beat [12] Historical Performance - In the last reported quarter, Krystal Biotech exceeded the consensus EPS estimate of $1.08 by delivering earnings of $1.29, resulting in a surprise of +19.44% [13] - Over the past four quarters, the company has beaten consensus EPS estimates three times [14] Industry Comparison - In the Zacks Medical - Biomedical and Genetics industry, Alnylam Pharmaceuticals (ALNY) is expected to post earnings of $1.67 per share for the same quarter, reflecting a significant year-over-year change of +434% and revenues of $1.02 billion (+104%) [18][19] - Alnylam's consensus EPS estimate has been revised 43.6% higher in the last 30 days, and it has an Earnings ESP of +25.79%, suggesting a likely earnings beat [19][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].

Longtime drug developer Suma Krishnan was 51 when she cofounded Krystal Biotech. Now the company has one gene therapy on the market and more in the works. https://t.co/4iMhKpwYT9 ...

Core Insights - The FDA granted platform technology designation to Krystal Biotech's genetically modified HSV-1 viral vector used in the gene therapy KB801 for neurotrophic keratitis [1][2][3] Group 1: FDA Designation and Implications - The platform technology designation is a significant milestone for Krystal Biotech, recognizing the reproducibility and scalability of their HSV-1 gene delivery platform [2] - This designation may provide development efficiencies, including early engagement with the FDA and the ability to leverage data from previously approved products like VYJUVEK [2][3] - The program aims to streamline drug development, manufacturing, and review processes for products utilizing designated platform technologies [3] Group 2: About KB801 - KB801 is a redosable eye drop gene therapy designed to enable sustained expression of nerve growth factor (NGF) for treating neurotrophic keratitis, a rare corneal disease [4] - The therapy aims to reduce the treatment burden on patients by allowing local production of NGF, addressing the limitations of current recombinant NGF eye drops that require frequent administration [4] - The safety and efficacy of KB801 are currently being evaluated in the EMERALD-1 Phase 1/2 study, which is a randomized, double-masked, multicenter, placebo-controlled trial [4] Group 3: Company Overview - Krystal Biotech is a global biotechnology company focused on developing genetic medicines for diseases with high unmet medical needs [5] - The company’s first commercial product, VYJUVEK, is the first redosable gene therapy approved in the U.S., Europe, and Japan for dystrophic epidermolysis bullosa [5] - Krystal Biotech is advancing a pipeline of investigational genetic medicines across various therapeutic areas, including respiratory, oncology, dermatology, ophthalmology, and aesthetics [5]

Group 1 - Krystal Biotech, Inc. specializes in gene therapy for rare diseases and shows the highest growth potential among its peers with a target price difference of 38.70% [1][4] - The current stock price of Krystal Biotech is $181.47, with a target price of $251.70, indicating a more optimistic outlook from analysts [1] - Mersana Therapeutics, Inc. focuses on developing antibody-drug conjugates for cancer treatment but has a negative target price difference, suggesting a less favorable outlook compared to Krystal Biotech [2][4] Group 2 - Overall, Krystal Biotech stands out in the biotechnology sector due to its promising position and significant target price difference [3]

Company Overview - Krystal Biotech 由 Suma Krishnan 在 51 岁时联合创立[1] - Krystal Biotech 目前已有一种基因疗法上市，并有更多疗法正在研发中[1]

Company Overview - Krystal Biotech 由 Suma Krishnan 在 51 岁时共同创立 [1] - Krystal Biotech 目前已有一种基因疗法上市，并有更多疗法正在研发中 [1] Drug Development - Krystal Biotech 是一家药物开发公司 [1] - Krystal Biotech 有基因疗法产品在市场上 [1]