Krystal Biotech, Inc. (NASDAQ:KRYS) is one of the 10 best NASDAQ growth stocks to buy for the next 10 years. Andrea Tan, an analyst at Goldman Sachs, raised the firm’s price target on Krystal Biotech, Inc. (NASDAQ:KRYS) from $206 to $327 on January 30 while keeping a Buy rating. The firm’s revised price target implies an additional 16.7% upside from current levels. The company is positioning itself for short-term growth through three registrational programs. These programs include KB801, KB803, and KB407. ...

Core Insights - Krystal Biotech, Inc. (KRYS) anticipates preliminary unaudited net product revenues of $106-$107 million from its lead drug Vyjuvek in Q4 2025, raising the full-year 2025 revenue forecast to $388-$389 million, driven by strong uptake in the U.S. and successful launches in Europe and Japan [1][11] Financial Performance - At the end of 2025, Krystal reported approximately $955 million in cash, cash equivalents, and investments, providing substantial financial flexibility for clinical programs [2] - For 2026, the company expects combined non-GAAP R&D and SG&A expenses to be between $175-$195 million [2] Pipeline Development - Krystal is advancing several rare disease programs utilizing its redosable HSV-1 gene therapy platform, targeting high-turnover tissues such as skin, lung, and eye [3] - Key pipeline candidates include KB803 for ocular complications of DEB, KB801 for neurotrophic keratitis, KB407 for cystic fibrosis, and KB111 for Hailey-Hailey disease [3] Clinical Trials and Updates - Enrollment in the registrational KB801 study has increased to 60 patients, indicating potential for expedited development, with a detailed update expected in February 2026 [4] - Top-line data from the KB801 and KB803 registrational studies are anticipated in 2026, serving as important near-term catalysts [6] - Other targets for 2026 include initiating and completing enrollment in a registrational repeat dose study for KB407 and starting a double-blind, placebo-controlled study for KB111 [7] Vyjuvek Developments - Vyjuvek received FDA approval in May 2023 as the first revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB) [8] - In September 2025, a label update expanded the treatment-eligible population to include DEB patients from birth and allowed for greater dosing flexibility [9][12] Long-term Strategy - The company aims to have at least four marketed rare disease therapies by 2030, targeting over 10,000 patients globally while maintaining profitability [5] - Krystal continues to invest in earlier-stage programs for larger indications, including KB408 for alpha-1 antitrypsin deficiency and KB707 for non-small cell lung cancer, which could provide long-term growth potential [5] Stock Performance - Shares of KRYS increased by 5% on January 9, with a notable 73.9% rise over the past year compared to the industry growth of 19.6% [16]

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 ...

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]

Core Insights - Krystal Biotech (KRYS) shares have increased by 57.2% over the past year, significantly outperforming the biotech industry growth of 17.1% [1][9] - The stock's strong performance is attributed to the successful uptake of Vyjuvek and positive developments in its pipeline [1][9] Vyjuvek Performance - Vyjuvek, the first-ever revocable gene therapy for dystrophic epidermolysis bullosa (DEB), received FDA approval in May 2023 [4] - In September 2025, the FDA updated Vyjuvek's label to expand the treatment-eligible population to include DEB patients from birth and allowed for greater dosing flexibility [5] - As of November 3, 2025, Krystal secured over 615 reimbursement approvals for Vyjuvek in the U.S., ensuring strong nationwide access [6][9] - The therapy has also been approved in Japan and Europe, making it the first corrective therapy for DEB in those markets [6] Pipeline Progress - Krystal Biotech is advancing a diverse pipeline, including candidates for respiratory, ophthalmology, oncology, dermatology, and aesthetics [9] - KB407 is being evaluated for cystic fibrosis, with ongoing enrollment in a multi-center trial [10] - KB408 targets alpha-1 antitrypsin deficiency lung disease, with interim results expected in the first half of 2026 [10] - In ophthalmology, KB803 is in a phase III study for corneal abrasions in DEB patients, with enrollment expected to complete soon [11] - KB801 is under evaluation for neurotrophic keratitis, with a phase II trial currently enrolling [12] - KB707 is being developed for non-small cell lung cancer (NSCLC), with plans for a phase III trial based on FDA feedback [13][14][15] - The aesthetics division is developing KB304 for wrinkles, with a phase II study set to begin in the first half of 2026 [16] Financial Outlook - KRYS shares currently trade at a price/earnings ratio of 29.39x forward earnings, higher than its historical mean but lower than the biotech industry average [18] - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen to $6.45 from $6.18 over the past 60 days, indicating positive earnings momentum [20] - The company had a cash balance of $864.2 million as of September 30, 2025, positioning it well for pipeline development [22] Investment Recommendation - Given the strong performance of Vyjuvek and the promising pipeline, Krystal Biotech is viewed as having significant growth potential, making it an attractive investment opportunity [1][22]

Financial Data and Key Metrics Changes - The company reported net Vyjuvek revenue of $97.8 million for Q3 2025, reflecting sustained growth compared to the previous quarter, including early sales from the German launch [9][26] - Gross margin improved to 96% for the quarter, up from 93% in the prior quarter, due to manufacturing process optimizations in the U.S. [26] - Net income for the quarter was $79.4 million, translating to $2.74 per basic share and $2.66 per diluted share, influenced by one-time benefits from tax adjustments [28][29] Business Line Data and Key Metrics Changes - Vyjuvek's total net revenues since launch exceeded $623 million, with significant contributions from the U.S. and early traction in Europe [9][10] - The company added over 40 new reimbursement approvals in the U.S., bringing the total to over 615, indicating a strong acceleration in reimbursement approvals [10][26] Market Data and Key Metrics Changes - The launch of Vyjuvek in Germany has seen approximately 20 patients prescribed since late August, with broad prescribing patterns across over 10 centers [12] - In France, Vyjuvek received early access approval and was launched, with the potential for pricing discussions following its ASMR 3 designation [13][14] Company Strategy and Development Direction - The company is focused on expanding its global footprint with Vyjuvek, having launched in Germany, France, and Japan, and is also contracting with regional specialty distributors for broader market access [16][17] - The strategic emphasis is on accelerating patient access to therapy and expanding the prescriber network, with over 450 prescribers now in the U.S. [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth trajectory of Vyjuvek, anticipating continued revenue growth and successful clinical pipeline advancements [30] - The company is optimistic about upcoming readouts in cystic fibrosis and other pipeline programs, indicating a robust clinical development strategy [30][31] Other Important Information - The company revised its full-year non-GAAP R&D and SG&A guidance to $145-$155 million, reflecting improved performance and confidence in execution [27] - The FDA granted a platform therapy designation for the HSV-1 gene delivery platform, which could expedite the approval process for related programs [18][19] Q&A Session Summary Question: What is the focus for the ex-U.S. launch? - The company aims to accelerate patient access by expanding the breadth of prescribers while also deepening relationships with existing prescribers [34] Question: What optimizations led to better gross margins? - The optimization involved moving to a larger bioreactor, with plans to apply for approval in Europe based on U.S. data [34][36] Question: What are the expectations for ex-U.S. revenue contributions? - The company anticipates steady growth in ex-U.S. markets, with Germany showing promising early results [39] Question: How is the NK trial progressing? - Enrollment has started, with a focus on adding sites globally to facilitate patient recruitment [44] Question: What are the expectations for the CF program? - The company plans to report on a minimum of three null patients, focusing on molecular correction as a success metric [48] Question: Will there be revenue guidance for Vyjuvek in 2026? - The company will not provide revenue guidance for 2026 due to the complexity of multiple launches [57] Question: Can you provide a breakdown of U.S. and ex-U.S. sales for Vyjuvek? - The company did not break down sales this quarter but plans to do so in 2026 as contributions grow [59]

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]

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]

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].

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]