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KRYS Reports Preliminary Results for 2025, Outlines 2026 Objectives
ZACKS· 2026-01-12 20:10
Key Takeaways KRYS expects Q4 Vyjuvek revenues of $106-$107M on a preliminary basis, lifting full-year sales to $388-$389M.KRYS benefited from strong U.S. uptake and expanded Vyjuvek approvals across Europe and Japan.KRYS expects key 2026 catalysts, including top-line data from KB801 and KB803 registrational studies.Krystal Biotech, Inc. (KRYS) expects preliminary unaudited net product revenues of $106-$107 million from lead drug Vyjuvek in the fourth quarter of 2025, bringing full-year 2025 revenue forecas ...
Krystal Biotech (NasdaqGS:KRYS) FY Earnings Call Presentation
2026-01-12 15:30
This presentation and our discussion 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 our global VYJUVEK launch; selected preliminary 2025 unaudited results; our 2030 vision and the market potential of the product candidates that could be launched over the next four years; the development a ...
Krystal Biotech Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-11 18:00
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]
Krystal Biotech (NasdaqGS:KRYS) Earnings Call Presentation
2026-01-08 21:30
KB407 for Cystic Fibrosis CORAL-1 Clinical Data Update January 2026 © Copyright 2026 Krystal Biotech, Inc. All rights reserved. Forward Looking Statements and Disclosures This presentation and our discussion contain forward-looking statements that involve substantial risks and uncertainties. Any statements about future expectations, plans, and prospects for Krystal Biotech, Inc. (the "Company"), including but not limited to statements about the Company's investigational product candidate, KB407, and the COR ...
KRYS Stock Surges 57% in a Year: More Upside Potential in 2026?
ZACKS· 2026-01-08 15:45
Key Takeaways Krystal Biotech shares have climbed 57.2% in a year, far outperforming the biotech industry and sector.Vyjuvek uptake remains strong after FDA label expansion and approvals in the U.S., Japan and Europe.KRYS is advancing a broad pipeline across respiratory, ophthalmology, oncology, dermatology and aesthetics.Shares of Krystal Biotech (KRYS) have surged 57.2% in a year compared with the industry’s growth of 17.1%. The stock has also outperformed the industry and the sector in this time frame.Th ...
Krystal Biotech (KRYS) Up 8.5% Since Last Earnings Report: Can It Continue?
ZACKS· 2025-09-03 16:31
Core Viewpoint - Krystal Biotech, Inc. has shown a positive performance with an 8.5% increase in shares since the last earnings report, outperforming the S&P 500, but faces concerns regarding future revenue guidance [1][2]. Financial Performance - The company reported Q2 2025 earnings per share (EPS) of $1.29, exceeding the Zacks Consensus Estimate of $1.08, and up from $0.93 in the same quarter last year [3]. - Revenues reached $96 million, a 36.6% year-over-year increase, surpassing the Zacks Consensus Estimate of $91 million, with all revenues derived from Vyjuvek sales [3]. - Despite strong quarterly results, shares fell by 14% due to soft guidance for third-quarter revenues [4]. Product Developments - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in 2023 and has secured over 575 reimbursement approvals in the U.S. as of July [5]. - The European Commission approved Vyjuvek for treating DEB-related wounds, with launches planned in Germany and France in Q3 and Q4 respectively [7]. - Vyjuvek was also approved in Japan for DEB treatment, with a target launch before the end of 2025 [7]. Research and Development - Research and development expenses were $14.4 million, down 7.5% year-over-year, while selling, general, and administrative expenses rose to $35.2 million, a 27.2% increase from the previous year [6]. - The company is evaluating KB407 for cystic fibrosis, with four patients enrolled in a study, and expects interim data before year-end [8]. - KB408 is being assessed for alpha-1 antitrypsin deficiency, with positive results reported in a patient from a dose escalation study [9]. Pipeline Progress - Krystal Biotech is advancing multiple candidates, including KB801 for neurotrophic keratitis and KB707 for solid tumors, with ongoing enrollment in various studies [11][12]. - Jeune Aesthetics, a subsidiary, reported positive results for KB304 in treating décolleté wrinkles, leading to its progression into phase II studies [13][14]. Market Outlook - Since the earnings release, there has been a downward trend in estimates, with a consensus estimate shift of -16.13% [15]. - The stock has an average Growth Score of C, a Momentum Score of F, and a Value Score of D, resulting in an aggregate VGM Score of F [16]. - Krystal Biotech holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [17][18].
KRYS Q2 Earnings and Sales Top Estimates, Stock Down on Q3 Outlook
ZACKS· 2025-08-05 14:01
Core Insights - Krystal Biotech reported Q2 2025 EPS of $1.29, exceeding the Zacks Consensus Estimate of $1.08, and up from $0.93 in the same quarter last year [1][8] - Revenues reached $96 million, a 36.6% increase year over year, surpassing the Zacks Consensus Estimate of $91 million, driven solely by Vyjuvek sales [1][8] - Despite strong quarterly results, shares fell 14% due to soft guidance for Q3 revenues [2][17] Financial Performance - Gross margin for the reported quarter was 93% [5] - Research and development expenses were $14.4 million, down 7.5% year over year [5] - Selling, general and administrative expenses increased by 27.2% to $35.2 million, attributed to higher professional services fees [5] - As of June 30, 2025, cash, cash equivalents, and investments totaled $820.8 million, up from $765.3 million as of March 31, 2025 [6] Product Developments - Vyjuvek, the first revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in 2023 and has over 575 reimbursement approvals in the U.S. as of July [4][9] - The European Commission approved Vyjuvek for DEB treatment, with launches planned in Germany and France in Q3 and Q4 respectively [9] - Vyjuvek was also approved in Japan for DEB treatment, with a target launch before the end of 2025 [9] Pipeline Progress - Krystal Biotech is advancing multiple gene therapy candidates, including KB407 for cystic fibrosis and KB408 for alpha-1 antitrypsin deficiency, with ongoing clinical trials [10][11] - Enrollment is ongoing for various studies, including EMERALD-1 for KB801 and KYANITE-1 for inhaled KB707 [13][14] - Jeune Aesthetics, a subsidiary, is developing KB304 for aesthetic treatments, with positive results from the PEARL-2 study leading to progression into phase II [15][16] Market Outlook - Despite a strong Q2 performance, revenues are expected to decline in Q3 due to seasonal trends, but growth is anticipated to resume in Q4 [17]
Krystal(KRYS) - 2025 Q2 - Earnings Call Transcript
2025-08-04 13:32
Financial Data and Key Metrics Changes - Q2 net revenue was $96 million, marking a return to growth due to patients resuming treatment and ongoing sales team expansion [7][8] - Total net revenue for Visovac since launch exceeded $525 million [7] - Net income for the quarter was $38.3 million, representing $1.33 per basic and $1.29 per diluted share, compared to $15.6 million in the prior year's second quarter [30] Business Line Data and Key Metrics Changes - Gross margin remained consistent at 93% in Q2 [29] - Research and development expenses decreased to $14.4 million from $15.6 million in the prior year, while general and administrative expenses increased to $35.2 million from $27.6 million [29] Market Data and Key Metrics Changes - Compliance while on drug was reported at 82%, with expectations of a downward trend as the patient mix shifts [9] - The company secured over 575 reimbursement approvals for patients in the U.S. [8] Company Strategy and Development Direction - The company is focused on the successful launch of Visovac in Europe and Japan, with significant potential for growth in these markets [12][18] - The strategy includes expanding the sales force and enhancing patient support programs to drive adoption [10][15] Management's Comments on Operating Environment and Future Outlook - Management expects Q3 revenues to be below Q2 due to seasonal trends but anticipates a return to growth in Q4 [10] - The company is optimistic about the long-term growth trajectory driven by transformative patient outcomes and global expansion [11][18] Other Important Information - The approval of VYZUVAC in Japan is seen as a significant milestone, with plans for launch before year-end [12] - The company has established dedicated commercial teams in Germany and France for the European launch [14] Q&A Session Summary Question: Was the revenue growth for this quarter impacted by the Salesforce expansion? - Management clarified that part of the increase in Q2 was due to patients resuming treatment, and the full impact of the Salesforce expansion will be felt in the coming quarters [36] Question: Can you provide quantitative commentary on the magnitude of slower growth in the first few weeks of the quarter? - Management refrained from providing specific details, noting that summer vacations typically lead to increased treatment pauses [40] Question: What is the mix of RDEB versus DDEB patients in reimbursement approvals? - The mix was reported to be approximately 64% RDEB and 36% DDEB, with no significant changes noted [42] Question: How do drug holidays factor into the guidance for U.S. patients initiating VYJUVEC? - Management indicated that they are on track but may be a quarter or two behind the original timeline [46] Question: Will patients need to see a healthcare practitioner before initiating VYJUVEC in Japan? - Yes, the process is similar to Europe, requiring an initial visit to a physician [70] Question: What is the compliance rate among patients using different vial counts? - Compliance is defined based on the duration of drug use, with a range of 76% to 84% expected [101] Question: What are the timelines to capture the remaining patient base in the U.S. market? - Management emphasized that the goal is to target the entire 1,200 patient base, with ongoing efforts to reach the remaining patients [92]
Krystal(KRYS) - 2025 Q2 - Earnings Call Transcript
2025-08-04 13:30
Financial Data and Key Metrics Changes - Q2 net revenue was $96 million, marking a return to growth and bringing total net Visovac revenue since launch to over $525 million [6][27] - Net income for the quarter was $38.3 million, representing $1.33 per basic and $1.29 per diluted share, compared to $15.6 million in the prior year's second quarter [29] - Gross margin remained consistent at 93% in Q2 2025, with cost of goods sold at $7.2 million compared to $6 million in the prior year [28] Business Line Data and Key Metrics Changes - The return to growth in Q2 was attributed to patients resuming treatment and the ongoing expansion of the sales team [6] - Reimbursement approvals increased, with over 575 approvals secured by the end of Q2 [6] - Compliance while on drug was reported at 82%, although a decline is expected as the patient mix shifts [7] Market Data and Key Metrics Changes - The company is preparing for launches in Europe and Japan, with the European launch expected to begin this quarter [12][14] - Japan's Ministry of Health approved VYZUVAC, allowing for a broad label that includes all DEP patients from birth [11] - The identified patient pool in Germany and France exceeds 500 patients each, supported by expert centers [13] Company Strategy and Development Direction - The company aims for steady, multiyear growth in Europe and Japan, leveraging broad labels and flexible dosing options [16] - The focus remains on expanding the sales force and enhancing patient support to drive long-term sustainable growth [10] - The company is pursuing opportunities in other global markets through distributors and partners [17] Management's Comments on Operating Environment and Future Outlook - Management expects Q3 revenues to be below Q2 due to seasonal trends but anticipates a return to growth in Q4 [9] - The company is confident in the long-term growth trajectory, driven by a rich pipeline of clinical-stage programs [31] - Management highlighted the unpredictability of patient restarts and the need for ongoing monitoring of treatment patterns [8] Other Important Information - The company reported a strong balance sheet with over $820 million in cash and investments, positioning it well for upcoming launches and R&D objectives [30] - The R&D team is progressing with multiple clinical trials, including those in oncology and aesthetics [18][23] Q&A Session Summary Question: Was the revenue growth in Q2 impacted by the Salesforce expansion? - Management clarified that part of the increase was due to patients resuming treatment, and the full impact of new hires will be felt in the coming quarters [36] Question: Can you provide quantitative commentary on the slower start to Q3? - Management noted that it is early in the quarter and summer vacations typically lead to more treatment pauses, making it difficult to quantify [40] Question: How do drug holidays factor into the guidance for U.S. patients initiating VYJUVEC? - Management indicated they are on track but may be a quarter or two behind the original goal of reaching 720 patients [46] Question: What is the compliance rate among patients using different vial counts? - Management explained that compliance is defined based on the duration of drug use, with a range of 76-84% being consistent across calculations [102] Question: What are the timelines for capturing the remaining patient market in the U.S.? - Management emphasized that the goal is to target the entire 1,200 patient base, with a focus on achieving 60% market share within two years [92]
Krystal(KRYS) - 2025 Q2 - Earnings Call Presentation
2025-08-04 12:30
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]