Company Participants Alec Stranahan - Bank of America Tim Lugo - William Blair Ritu Baral - TD Cowen Benazir Ali - Stifel Andrea Tan - Goldman Sachs Gavin Clark-Gartner - Evercore ISI Yigal Nochomovitz - Citigroup Stéphane Paquette With that, I will turn the call over to Krish. As real-world experiences with VYJUVEK grows, it has been immensely rewarding to hear and see the improvements that patients have made while on therapy. As you will hear this morning, our US Commercial We also continue to build out o ...

Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.20 per share. This compares to loss of $1.76 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -85%. A quarter ago, it was expected that this company would post a loss of $0.52 per share when it actually produced earnings of $0.30, delivering a surprise of 157.69%.Over the last four quarters, the company h ...

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 March 31, 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 _____________ ...

Exhibit 99.1 Krystal Biotech Announces First Quarter 2024 Financial Results and Provides Business Updates Net product revenue of $45.3 million in 1Q and $95.9 million since August First patient dosed in inhaled KB707 study for locally advanced or metastatic tumors of the lung Received Fast Track Designations for both inhaled and intratumoral KB707 Strong balance sheet with $622.3 million in cash and investments PITTSBURGH, May 6, 2024 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), ...

• Received Fast Track Designations for both inhaled and intratumoral KB707 PITTSBURGH, April 22, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the "Company") (NASDAQ:KRYS), a commercial-stage biotechnology company, announced today that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and interleukin-2 (IL-2) to the lung, for the treatment of patients with locally adva ...

While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock aliv ...

Krystal Biotech, Inc. (NASDAQ:KRYS) Q4 2023 Earnings Call Transcript February 26, 2024 8:30 AM ET Conference Call Participants Thank you for standing by and welcome to the Krystal Biotech Fourth Quarter and Full Year 2023 Earnings Conference Call. At this time, all participants are on a lesson-only mode. After the speakers' presentations, there will be a question-and-answer session. As a reminder, today's conference is being recorded. Good morning, and thank you all for joining today's call. Earlier today, ...

Exhibit 99.1 Krystal Biotech Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates • Net product revenue of $42.1M in 4Q and $50.7M for the year PITTSBURGH, February 26, 2024 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS), a commercial-stage biotechnology company, today reported financial results and key business updates for the fourth quarter and year ending December 31, 2023. "2023 was an inflection point for Krystal with the approval and laun ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________________________________ FORM 10-K ______________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO C ...

Financial Data and Key Metrics - Net product revenue for Q3 2023 was $8 6 million, representing approximately two full revenue months following the FDA approval of VYJUVEK in May 2023 [39] - The company reported a one-time gain of $100 million from the sale of its rare pediatric disease Priority Review Voucher, which was the primary driver of net income and positive EPS for the quarter [67] - Cash, cash equivalents, and investments totaled $598 6 million as of September 30, 2023, providing sufficient funding for planned activities for the next several quarters [47] Business Line Data and Key Metrics - VYJUVEK launch progress: 284 start forms received in Q3 2023, with an estimated 85% conversion rate to patients on drug, resulting in a 20% penetration of the identified patient base [35][36] - 45% of patient start forms were from commercial insurance plans, with over 80% already eligible for reimbursement, while 55% were from government insurance, with 74% eligible for reimbursement [37] - 33% of start forms were from patients aged 10 years or younger, indicating potential for longer induction phases and higher annual consumption of VYJUVEK [36] Market Data and Key Metrics - The company expects Medicaid coverage to increase starting October 2023, with the permanent J code becoming available in January 2024, which will further improve reimbursement eligibility [4][37] - The company has filed a marketing authorization application with the European Medicines Agency and anticipates EU approval in the second half of 2024, with a launch expected in 2025 [41] - In Japan, the company initiated an open-label extension study and dosed five patients, with plans to file a Japanese New Drug Application in the first half of 2024 [41] Company Strategy and Industry Competition - The company aims to reduce the conversion cycle from patient start forms to paid revenue to two to three weeks by early 2024, down from the initial six to seven weeks [12] - The company is focusing on home dosing, with 88% of patient start forms received by the end of September 2023 for home dosing, leading to a high adherence rate of 96% [59] - The company is advancing its pipeline, including KB407 for cystic fibrosis, KB408 for Alpha-1 Antitrypsin deficiency, and KB707 for oncology, with data expected in 2024 [42][43][64] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for VYJUVEK, with continued momentum expected into Q4 2023 and beyond [35][60] - The company is working to expand the number of patients treated with VYJUVEK globally, with a focus on the EU and Japan [41][60] - Management highlighted the importance of patient experience and adherence, with efforts to ensure smooth and timely access to VYJUVEK [38][58] Other Important Information - Research and Development expenses for Q3 2023 were $10 6 million, a decrease of $887,000 compared to Q3 2022, primarily due to costs related to VYJUVEK manufacturing being recorded to inventory post-FDA approval [46] - Selling, General, and Administrative expenses increased by $3 8 million in Q3 2023, largely due to costs incurred related to the VYJUVEK launch [67] Q&A Session Summary Question: Update on the progress of identifying patients outside the initial 1200 identified patients [30] - The company is in the process of identifying more patients and expects to have a new Chief Commercial Officer in place by early 2024 [31] Question: Reimbursement process and any surprises with insurance policies [18] - The reimbursement process has been smooth, with no unexpected issues, and the company expects the J code to be finalized in January 2024 [19] Question: Cadence of start forms and impact of the holiday season [23] - The pace of start forms has been good, but the impact of the holiday season is uncertain, with no guidance provided on potential slowdowns [24] Question: Conversion rate from start forms to patients on drug [85] - The company estimates an 85% conversion rate, with expectations for this to increase as insurance coverage improves [85] Question: Reasons for rejected start forms [96] - The most frequent reason for rejected start forms is genotyping issues [97] Question: Trends in buy-and-bill and clinic availability at Centers of Excellence [101] - Buy-and-bill has been minimal, with most patients being dosed at home, and Centers of Excellence are not adding clinic days or availability for appointments [102]