We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. By pressing "Accept All" or closing out of this banner, you accept our Privacy Policy and Terms of Service, revised from time to time, and you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties. You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Why Is Krystal Biotech (KRYS) Up 6.6% Since Last Earnings Report?
Read MoreHide Full Article
A month has gone by since the last earnings report for Krystal Biotech, Inc. (KRYS - Free Report) . Shares have added about 6.6% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Krystal Biotech due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.
Krystal Q3 Earnings and Sales Top Estimates, Vyjuvek Gains Traction
Krystal Biotech reported third-quarter earnings per share of 91 cents, which beat the Zacks Consensus Estimate of 84 cents. In the year-ago quarter, the company incurred a loss of 67 cents per share.
Revenues totaled $83.8 million, which beat the Zacks Consensus Estimate of $83 million. Revenues came in solely from the sales of Vyjuvek. In the year-ago quarter, revenues amounted to $8.6 million.
Q3 Results in Detail
In May 2023, the FDA approved Vyjuvek, the first-ever revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB).
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1.
As of October, Krystal secured more than 460 reimbursement approvals for Vyjuvek in the United States. It also achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans.
Gross margin in the reported quarter was 92%.
Research and development expenses amounted to $13.5 million, up 27.1% year over year.
Selling, general, and administrative expenses totaled $28.7 million, up 21.1% from the year-ago level.
Cash, cash equivalents, and investments totaled $694.2 million as of Sept. 30, 2024.
Good Pipeline Progress
Vyjuvek is referred to as B-VEC outside the country. The European Medicines Agency’s (“EMA”) review of Marketing Authorization Application (“MAA”) for B-VEC for the treatment of DEB is ongoing.
Krystal expects an opinion from the Committee for Medicinal Products forHuman Use on the MAA before the end of the year based on its recent interactions with the EMA. Currently, Krytsal Biotech anticipates its first European launch in Germany in the first half of 2025.
In October, Krystal Biotech filed a new drug application with Japan’s Pharmaceuticals and Medical Devices Agency. A decision on the same is expected in the second half of 2025.
Krystal is also advancing a robust preclinical and clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics.
The company is evaluating KB407 for the treatment of cystic fibrosis. Krystal recently activated two additional clinical sites for its KB407 phase I CORAL-1 study and expects to report interim molecular data from the study in the first half of 2025. Dosing of the first patient in the third and final cohort in CORAL-1 is expected before the end of the year.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). In September, Krsytal Biotech amended the protocol for its phase I SERPENTINE-1 study on KB408 to include mandatory bronchoscopies in this cohort in an effort to measure alpha-1 antitrypsin expression. Dosing was initiated in Cohort 2. Krystal Biotech is on track to report interim molecular data from the study before the end of the year.
Krystal Biotech is also evaluating KB803 (B-VEC formulated as an eyedrop) for ocular complications of DEB. Patient enrollment is ongoing in a natural history study to prospectively collect data on the frequency of corneal abrasions in patients with DEB.
KB707 is being evaluated for the treatment of solid tumors of the lung. In August, KRYS progressed to dose expansion in KYANITE-1, the phase I open-label, multi-center, monotherapy, dose escalation and expansion study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung.
Krystal Biotech has also resumed the development of KB105 for the treatment of lamellar ichthyosis. It expects to commence the phase II portion of the JADE-1 trial in pediatric patients in the first half of 2025.
KB301 is being evaluated for the treatment of aesthetic indications. In August, Krystal’s wholly-owned subsidiary Jeune Aesthetics announced positive interim safety and efficacy results for KB301 in the treatment of lateral canthal lines at rest and dynamic wrinkles of the décolleté.
Based on the results from cohorts 3 and 4 of PEARL-1, Krystal Biotech has selected treatment of the dynamic wrinkles of the décolleté for advanced clinical development. The company expects to initiate a phase II study evaluating KB301 in this indication in 2025.
How Have Estimates Been Moving Since Then?
It turns out, fresh estimates have trended upward during the past month.
VGM Scores
At this time, Krystal Biotech has a great Growth Score of A, though it is lagging a bit on the Momentum Score front with a B. However, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for this investment strategy.
Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.
Outlook
Estimates have been broadly trending upward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Krystal Biotech has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Performance of an Industry Player
Krystal Biotech is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Insmed (INSM - Free Report) , a stock from the same industry, has gained 4.5%. The company reported its results for the quarter ended September 2024 more than a month ago.
Insmed reported revenues of $93.43 million in the last reported quarter, representing a year-over-year change of +18.2%. EPS of -$1.27 for the same period compares with -$1.10 a year ago.
Insmed is expected to post a loss of $1.17 per share for the current quarter, representing a year-over-year change of +8.6%. Over the last 30 days, the Zacks Consensus Estimate has changed -0.1%.
Insmed has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Why Is Krystal Biotech (KRYS) Up 6.6% Since Last Earnings Report?
A month has gone by since the last earnings report for Krystal Biotech, Inc. (KRYS - Free Report) . Shares have added about 6.6% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Krystal Biotech due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers.
Krystal Q3 Earnings and Sales Top Estimates, Vyjuvek Gains Traction
Krystal Biotech reported third-quarter earnings per share of 91 cents, which beat the Zacks Consensus Estimate of 84 cents. In the year-ago quarter, the company incurred a loss of 67 cents per share.
Revenues totaled $83.8 million, which beat the Zacks Consensus Estimate of $83 million. Revenues came in solely from the sales of Vyjuvek. In the year-ago quarter, revenues amounted to $8.6 million.
Q3 Results in Detail
In May 2023, the FDA approved Vyjuvek, the first-ever revocable gene therapy for treating patients aged six months or older with dystrophic epidermolysis bullosa (DEB).
DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1.
As of October, Krystal secured more than 460 reimbursement approvals for Vyjuvek in the United States. It also achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans.
Gross margin in the reported quarter was 92%.
Research and development expenses amounted to $13.5 million, up 27.1% year over year.
Selling, general, and administrative expenses totaled $28.7 million, up 21.1% from the year-ago level.
Cash, cash equivalents, and investments totaled $694.2 million as of Sept. 30, 2024.
Good Pipeline Progress
Vyjuvek is referred to as B-VEC outside the country. The European Medicines Agency’s (“EMA”) review of Marketing Authorization Application (“MAA”) for B-VEC for the treatment of DEB is ongoing.
Krystal expects an opinion from the Committee for Medicinal Products forHuman Use on the MAA before the end of the year based on its recent interactions with the EMA. Currently, Krytsal Biotech anticipates its first European launch in Germany in the first half of 2025.
In October, Krystal Biotech filed a new drug application with Japan’s Pharmaceuticals and Medical Devices Agency. A decision on the same is expected in the second half of 2025.
Krystal is also advancing a robust preclinical and clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics.
The company is evaluating KB407 for the treatment of cystic fibrosis. Krystal recently activated two additional clinical sites for its KB407 phase I CORAL-1 study and expects to report interim molecular data from the study in the first half of 2025. Dosing of the first patient in the third and final cohort in CORAL-1 is expected before the end of the year.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). In September, Krsytal Biotech amended the protocol for its phase I SERPENTINE-1 study on KB408 to include mandatory bronchoscopies in this cohort in an effort to measure alpha-1 antitrypsin expression. Dosing was initiated in Cohort 2. Krystal Biotech is on track to report interim molecular data from the study before the end of the year.
Krystal Biotech is also evaluating KB803 (B-VEC formulated as an eyedrop) for ocular complications of DEB. Patient enrollment is ongoing in a natural history study to prospectively collect data on the frequency of corneal abrasions in patients with DEB.
KB707 is being evaluated for the treatment of solid tumors of the lung. In August, KRYS progressed to dose expansion in KYANITE-1, the phase I open-label, multi-center, monotherapy, dose escalation and expansion study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung.
Krystal Biotech has also resumed the development of KB105 for the treatment of lamellar ichthyosis. It expects to commence the phase II portion of the JADE-1 trial in pediatric patients in the first half of 2025.
KB301 is being evaluated for the treatment of aesthetic indications. In August, Krystal’s wholly-owned subsidiary Jeune Aesthetics announced positive interim safety and efficacy results for KB301 in the treatment of lateral canthal lines at rest and dynamic wrinkles of the décolleté.
Based on the results from cohorts 3 and 4 of PEARL-1, Krystal Biotech has selected treatment of the dynamic wrinkles of the décolleté for advanced clinical development. The company expects to initiate a phase II study evaluating KB301 in this indication in 2025.
How Have Estimates Been Moving Since Then?
It turns out, fresh estimates have trended upward during the past month.
VGM Scores
At this time, Krystal Biotech has a great Growth Score of A, though it is lagging a bit on the Momentum Score front with a B. However, the stock was allocated a grade of D on the value side, putting it in the bottom 40% for this investment strategy.
Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.
Outlook
Estimates have been broadly trending upward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Krystal Biotech has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Performance of an Industry Player
Krystal Biotech is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Insmed (INSM - Free Report) , a stock from the same industry, has gained 4.5%. The company reported its results for the quarter ended September 2024 more than a month ago.
Insmed reported revenues of $93.43 million in the last reported quarter, representing a year-over-year change of +18.2%. EPS of -$1.27 for the same period compares with -$1.10 a year ago.
Insmed is expected to post a loss of $1.17 per share for the current quarter, representing a year-over-year change of +8.6%. Over the last 30 days, the Zacks Consensus Estimate has changed -0.1%.
Insmed has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F.