Krystal Biotech (KRYS – Free Report) reported fourth-quarter earnings per share of $1.52, which beat the Zacks Consensus Estimate of $1.29 as Vyjuvek gains traction in the U.S. market. In the year-ago quarter, the company reported earnings of 30 cents per share.
See the Zacks Earnings Calendar to stay ahead of market-making news.
However, revenues totaled $91.1 million, which missed the Zacks Consensus Estimate of $97 million. Revenues came in solely from the sales of Vyjuvek. In the year-ago quarter, revenues amounted to $42.1 million.
KRYS’ Q4 Results in Details
In 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 February 2025, KRYS secured more than 510 reimbursement approvals for Vyjuvek in the United States. It also achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans. The gross margin in the reported quarter was 95%. Additionally, patient adherence to weekly treatment while on the drug remained high at 85% as of the end of 2024.
Despite the mixed nature of earnings results in the fourth quarter of 2024, Krystal Biotech’s shares gained 12.4% yesterday, likely due to record revenue growth from Vyjuvek sales.
In the past three months, shares of KRYS have lost 3.4% against the industry’s 0.8% growth.
Image Source: Zacks Investment Research
Research and development expenses amounted to $13.5 million, up 19% year over year. Selling, general and administrative expenses totaled $31.3 million, up 26% from the year-ago level.
Cash, cash equivalents and investments totaled $749.6 million as of Dec. 31, 2024, compared with $694.2 million as of Sept. 30, 2024.
KRYS’ Full-Year 2024 Results
In 2024, Krystal Biotech recorded total revenues of $290.5 million which fell short of the Zacks Consensus Estimate of $292.1 million. In 2023, the company’s total revenues amounted to $50.7 million.
For the full year, KRYS recorded earnings per share of $3, which surpassed the Zacks Consensus Estimate of $2.9. In the previous year, the company recorded earnings of 39 cents per share.
KRYS Makes Good Pipeline Progress
Vyjuvek is referred to as B-VEC outside the country. The European Medicines Agency’s review of the Marketing Authorization Application (“MAA”) for B-VEC for the treatment of DEB is ongoing.
KRYS expects an opinion from the Committee for Medicinal Products for Human Use on the MAA in the first quarter 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.
KRYS is also advancing a robust preclinical and clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics.
Krystal Biotech is evaluating KB407 for the treatment of cystic fibrosis. In December 2024, the company announced that dosing with the candidate was safe and well-tolerated by patients in both Cohort 1 and Cohort 2 of the ongoing KB407 phase I CORAL-1 study. Interim molecular data for Cohort 3 patients of the study is expected to be reported in mid-2025.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency. During the reported quarter, Krystal Biotech reported successful SERPINA1 gene delivery and functional alpha-1 antitrypsin expression at therapeutic levels in Cohorts 1 and Cohorts 2 of its ongoing KB408 phase I SERPENTINE-1 study. Inhaled KB408 was safe and well-tolerated at both tested doses. Based on these findings, Cohort 2 was expanded and Cohort 3 was opened for further molecular assessments. Results from both cohorts are expected in the second half of 2025.
The company is also evaluating KB803 (B-VEC formulated as an eyedrop) for ocular complications of DEB. Patient enrollment has been completed in a natural history study to prospectively collect data on the frequency of corneal abrasions in patients with DEB. This will allow KRYS to screen eligible patients for its registrational phase III IOLITE study, which will evaluate the effect of KB803 on corneal abrasions of DEB. The late-stage study is expected to begin in the first half of 2025.
In December 2024, KRYS provided an initial clinical update from the phase I/II KYANITE-1 study, evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung. Enrollment in KYANITE-1 is ongoing.
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 study in pediatric patients in 2026.
KRYS’ wholly-owned subsidiary, Jeune Aesthetics, previously announced positive interim safety and efficacy results from the PEARL-1 study of KB301 in the treatment of dynamic wrinkles of the décolleté. Based on such data, Jeune Aesthetics is currently gearing up to initiate a phase II study of the candidate for the same indication in the second half of 2025.
During the reported quarter, Jeune Aesthetics also began dosing patients in a phase I PEARL-2 study, evaluating its second clinical-stage investigational aesthetic product, KB304, for the treatment of wrinkles. Top-line data is expected in the second half of 2025.
Krystal Biotech, Inc. Price, Consensus and EPS Surprise
Krystal Biotech, Inc. price-consensus-eps-surprise-chart | Krystal Biotech, Inc. Quote
KRYS’ Zacks Rank and Stocks to Consider
Krystal carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks from the sector are Castle Biosciences (CSTL – Free Report) , BioMarin Pharmaceutical (BMRN – Free Report) and Amicus Therapeutics (FOLD – Free Report) , carrying a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 45 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $1.51. In the past three months, shares of Castle Biosciences have plunged 5.9%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have increased from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.02 to $4.01 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 3.4%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
In the past 30 days, the estimate for Amicus Therapeutics’ 2024 earnings per share has remained constant at 23 cents. The estimate for 2025 earnings per share has deteriorated from 44 cents to 43 cents. In the past three months, shares of Amicus Therapeutics have gained 0.6%.
FOLD’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 27.09%.
Financial Market Newsflash
No financial news published today. Check back later.
