UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ FORM 10-Q _____________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 ______________ ...

Krystal Biotech Announces Second Quarter 2024 Financial Results and Provides Business Updates Net product revenue of $70.3 million in 2Q and $166.2 million since launch in August 2023 On track to deliver three clinical readouts in 2H 2024 Jeune Aesthetics' KB301 Phase 1 PEARL-1 study (Cohorts 3 and 4) in 3Q 2024; KB408 Phase 1 SERPENTINE-1 study for the treatment of AATD in 4Q 2024; and KB707 Phase 1 OPAL-1 study for the treatment of injectable solid tumors in 4Q 2024 Strong balance sheet, ending the quarte ...

Net product revenue of $70.3 million in 2Q and $166.2 million since launch in August 2023 On track to deliver three clinical readouts in 2H 2024 Jeune Aesthetics' KB301 Phase 1 PEARL-1 study (Cohorts 3 and 4) in 3Q 2024; KB408 Phase 1 SERPENTINE-1 study for the treatment of AATD in 4Q 2024; and KB707 Phase 1 OPAL-1 study for the treatment of injectable solid tumors in 4Q 2024 Strong balance sheet, ending the quarter with $628.9 million in cash and investments PITTSBURGH, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Kr ...

We Arc Krystal Biotech's Vyjuvek: A Topical Triumph Driving Gains Krystal Biotech's (NASDAQ:KRYS) stock has risen another 25.6% since my previous "strong buy" recommendation in February. 100 Analyst's Rating History on KRYS ● Strong Buy ● Buy ● Hold ● Soll ● Strong Sell Jan '24 Oct "23 Apr "24 Jul '24 50 250 200 150 Seeking Alpha Back then, I wrote about their Q4 earnings report, which showed strong sales and high patient compliance for Vyjuvek, Krystal Biotech's dystrophic epidermolysis bullosa (DEB) topic ...

PITTSBURGH, July 26, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that it will report its second quarter 2024 financial results on Monday, August 5, 2024, prior to the open of U.S. markets. The Company's management will also host a conference call and webcast at 8:30 am ET on Monday, August 5, 2024, to discuss the financial results and provide a business update. Investors and the general public can access the live we ...

A solid price increase over a period of 12 weeks reflects investors' continued willingness to pay more for the potential upside in a stock. KRYS is quite a good fit in this regard, gaining 30.3% over this period. Moreover, KRYS is currently trading at 93.7% of its 52-week High-Low Range, hinting that it can be on the verge of a breakout. The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Za ...

Krystal Biotech, Inc. (KRYS) appears an attractive pick given a noticeable improvement in the company's earnings outlook. The stock has been a strong performer lately, and the momentum might continue with analysts still raising their earnings estimates for the company. Analysts' growing optimism on the earnings prospects of this company is driving estimates higher, which should get reflected in its stock price. After all, empirical research shows a strong correlation between trends in earnings estimate revi ...

Shares of the commercial-stage biotechnology company, Krystal Biotech, Inc. (KRYS) , surged 36.5% year to date against the industry's decline of 4.3%. This was due to the strong uptake of its newly approved drug Vyjuvek and encouraging pipeline progress. Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). Krystal dosed the first patient in phase I SERPENTINE-1 study in adult patients with AATD. Recruitment is ongoing and the company remains on track to re ...

Title: Murine Toxicology Study of Repeat-Dose Inhaled KB408, an HSV-1-Based Vector for the Treatment of Alpha-1 Antitrypsin Deficiency Presenter: Sara Artusi, PhD Date and Time: May 20, 2024 from 11:30AM to 1:15PM PT Poster Session: B70: COPD in the Spotlight: Insights into Disease Pathogenesis Poster Number: P659 Title: Evaluation of KB407, an HSV-1-Based Gene Therapy Vector for the Treatment of Cystic Fibrosis, in Healthy and Patient-Derived Airway Cells Including an Apical-out Diseased Airway Organoid Mo ...

Financial Data and Key Metrics Changes - Net VYJUVEK revenues for the quarter were $45.3 million, with total net revenues exceeding $95 million since launch, indicating strong growth despite a one-time headwind from the permanent J-code switch [99][100] - Gross margins were reported at 95%, up 2 percentage points from the previous quarter, with expectations to maintain margins above 90% in the coming quarters [36][145] - The net income for the quarter was $932,000, representing $0.03 per basic and diluted share [146] Business Line Data and Key Metrics Changes - Research and development expenses for the quarter were $11 million, down from $12.3 million in the prior year's first quarter, primarily due to decreased VYJUVEK manufacturing costs now recorded as inventory [13] - Selling, general, and administrative expenses increased to $26.1 million from $24 million in the prior year, driven by higher selling expenses related to the VYJUVEK launch [119] Market Data and Key Metrics Changes - The company has secured over 330 patient reimbursement approvals as of April, with a strong focus on expanding access across all ages [113][101] - Compliance rates for weekly treatments remain above 90%, with 97% of treatments occurring at home, reflecting high patient satisfaction and engagement [101][150] Company Strategy and Development Direction - The company is focused on expanding VYJUVEK's market presence in Europe and Japan, with plans for commercial launches in both regions by 2025 [110][143] - The strategy includes enhancing patient access through analytics and education, aiming to establish VYJUVEK as the standard of care for Dystrophic Epidermolysis Bullosa (DEB) [116][142] - The company is also advancing its clinical pipeline, with multiple active trials and a focus on inhaled therapies for solid tumors [98][144] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting or exceeding 2024 net revenue projections despite challenges faced in Q1 due to the J-code transition [87][99] - The management highlighted the importance of patient experience and compliance, noting that positive patient outcomes are driving demand for VYJUVEK [150][116] Other Important Information - The company recorded a litigation settlement expense of $12.5 million due to anticipated milestone payments related to a settlement [43] - The EMA's review of the marketing authorization application is ongoing, with expectations for a decision by the end of the year [11] Q&A Session Summary Question: Can you talk about patient compliance and feedback from the field? - Management reported high patient compliance, with 91% of patients receiving weekly treatments, and emphasized the importance of maintaining treatment schedules for effective wound healing [72][150] Question: What impact did the Change Healthcare hack have on reimbursement approvals? - The disruption from the hack resulted in a delay of one to two weeks in reimbursement approvals, but the situation has since normalized [33][139] Question: What are the current conversion times to commercial treatment? - Conversion times are currently longer than expected, with ongoing efforts to streamline the process and reduce it to under a month [131][85] Question: Can you provide updates on the European and Japanese regulatory processes? - The company is on track for regulatory submissions in both regions, with successful inspections completed and promising data from ongoing studies [158][110]