Core Viewpoint - Krystal Biotech announced positive interim clinical results for its cystic fibrosis program, KB407, highlighting the molecular confirmation of wild-type CFTR protein expression in patients' lungs [2]. Group 1: Clinical Update - The conference call was held to discuss the clinical update for the cystic fibrosis program, KB407 [2]. - The positive interim results were shared in a press release available on the company's website and filed as an 8-K with the SEC [2]. Group 2: Leadership and Participation - The call featured key executives including Krish Krishnan (Chairman and CEO), Suma Krishnan (President of Research and Development), Trevor Parry (Vice President of Product Development), David Sweet (Director of Clinical Development), and Dr. Jorge Lascano (Professor of Medicine and Director of the Cystic Fibrosis Therapeutics Development Center at the University of Florida) [2].

Krystal Biotech (NasdaqGS:KRYS) Update / Briefing January 08, 2026 04:30 PM ET Company ParticipantsKrish Krishnan - CEODavid Sweet - Director of Clinical DevelopmentJorge Lascano - Professor of MedicineSuma Krishnan - President of Research and DevelopmentTrevor Parry - VP of Product DevelopmentConference Call ParticipantsGautam Chukka - Research AnalystJoe Pantginis - Director of Research and Senior Healthcare AnalystRitu Baral - Managing Director and Senior Biotechnology AnalystRoger Song - Senior AnalystA ...

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 ...

Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations KB407 transduction confirmed in all six patients with successful bronchoscopies irrespective of modulator-status; percentage of conducting airway cells transduced in each patient ranged from 29.4% to 42.1% Registrational repeat dosing CORAL-3 study design submitted to FDA in late December; anticipating enrollment in study to start in 1H 2026 following alignment with the FDA Investor call to be he ...

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 ...

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 ...

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 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]