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Krystal Biotech Q1 Earnings and Sales Miss Estimates, Stock Down
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Krystal Biotech (KRYS - Free Report) reported first-quarter 2025 earnings per share (EPS) of $1.20, which missed the Zacks Consensus Estimate of $1.38. Nonetheless, the reported EPS was up from 3 cents posted in the year-ago quarter. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
Revenues of $88.1 million surged 95% year over year but missed the Zacks Consensus Estimate of $95 million. Revenues came in solely from the sales of Vyjuvek.
Shares of the company are trading down in response to the disappointing results.
Shares of KRYS have risen 3.6% year to date against the industry’s 2.2% decline.
Image Source: Zacks Investment Research
KRYS’ Q1 Results in Detail
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 April, Krystal secured more than 540 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 94%.
Research and development expenses amounted to $14.2 million, up 30.1% year over year. Selling, general and administrative expenses totaled $32.7 million, up 25.6% from the year-ago level.
Cash, cash equivalents, and investments totaled $765.3 million as of March 31, 2025.
Krystal Biotech, Inc. Price, Consensus and EPS Surprise
Last month, the European Commission approved Vyjuvek for the treatment of wounds in patients with DEB who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. KRYS is on track to launch the drug in Germany in mid-2025.
Krystal Biotech has also 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. Enrollment is ongoing in cohort 3 of CORAL-1, a multi-center, dose escalation study evaluating KB407 in patients with CF, regardless of their underlying genotype.
KRYS received full sanctioning of the study protocol by the Cystic Fibrosis Foundation Therapeutic Development Network in January and remains on track for an interim molecular data readout for cohort 3 patients in mid-2025.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency. Enrollment is ongoing in cohort 2 and is working to enroll in Cohort 3 of SERPENTINE-1, an open-label, single-dose escalation study in adult patients with AATD.
Vyjuvek is referred to as B-VEC outside the country. The company is also evaluating KB803 (B-VEC formulated as an eyedrop) for ocular complications of DEB. Enroll is ongoing in its ongoing 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 ocular complications of DEB. Krystal Biotech expects to dose the first patient in the registrational phase III IOLITE study on KB803 later this month.
In April, the FDA cleared the company’s investigational new drug application to evaluate KB801. This is the company’s second clinical-stage ophthalmology program for the treatment of neurotrophic keratitis (NK).
KRYS expects to dose the first patient in EMERALD-1, a randomized, double-blind, placebo-controlled, multi-center Phase 1/2 study evaluating KB801 in moderate-to-severe NK patients, later this month.
Enrollment is ongoing in KYANITE-1, a phase I/II open-label, multi-center, dose escalation and expansion study evaluating inhaled KB707, as monotherapy or in combination, in patients with locally advanced or metastatic solid tumors of the lung.
KRYS’ wholly-owned subsidiary, Jeune Aesthetics, is currently developing a décolleté-specific photo numeric scale for advanced clinical development of KB301. This subsidiary expects to align with the FDA on the scale and enroll the first subject in a multi-center, randomized, placebo-controlled phase II study evaluating KB301 for the treatment of dynamic wrinkles of the décolleté in the fourth quarter.
In February, Jeune Aesthetics completed enrolment in PEARL-2, an ongoing, randomized and placebo-controlled phase I study evaluating KB304 for the treatment of wrinkles. Top-line results from the study are expected in the second half.
KRYS also expects to initiate the phase II portion of its phase I/II JADE-1 trial evaluating KB105 for the treatment of TGM1-deficient lamellar ichthyosis in pediatric patients in 2026.
KRYS’ Zacks Rank and Stocks to Consider
Krystal carries a Zacks Rank #3 (Hold) at present.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.22 for 2025. During the same time, earnings per share have increased from $1.23 to $1.31 for 2026. Year to date, shares of BAYRY have rallied 40.3%.
In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 36.6%.
ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.
In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.45 to $4.27 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.94 to $4.80.
BEAM’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.92%.
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Krystal Biotech Q1 Earnings and Sales Miss Estimates, Stock Down
Krystal Biotech (KRYS - Free Report) reported first-quarter 2025 earnings per share (EPS) of $1.20, which missed the Zacks Consensus Estimate of $1.38. Nonetheless, the reported EPS was up from 3 cents posted in the year-ago quarter. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)
Revenues of $88.1 million surged 95% year over year but missed the Zacks Consensus Estimate of $95 million. Revenues came in solely from the sales of Vyjuvek.
Shares of the company are trading down in response to the disappointing results.
Shares of KRYS have risen 3.6% year to date against the industry’s 2.2% decline.
Image Source: Zacks Investment Research
KRYS’ Q1 Results in Detail
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 April, Krystal secured more than 540 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 94%.
Research and development expenses amounted to $14.2 million, up 30.1% year over year. Selling, general and administrative expenses totaled $32.7 million, up 25.6% from the year-ago level.
Cash, cash equivalents, and investments totaled $765.3 million as of March 31, 2025.
Krystal Biotech, Inc. Price, Consensus and EPS Surprise
Krystal Biotech, Inc. price-consensus-eps-surprise-chart | Krystal Biotech, Inc. Quote
KRYS Makes Good Pipeline Progress
Last month, the European Commission approved Vyjuvek for the treatment of wounds in patients with DEB who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, starting from birth. KRYS is on track to launch the drug in Germany in mid-2025.
Krystal Biotech has also 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. Enrollment is ongoing in cohort 3 of CORAL-1, a multi-center, dose escalation study evaluating KB407 in patients with CF, regardless of their underlying genotype.
KRYS received full sanctioning of the study protocol by the Cystic Fibrosis Foundation Therapeutic Development Network in January and remains on track for an interim molecular data readout for cohort 3 patients in mid-2025.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency. Enrollment is ongoing in cohort 2 and is working to enroll in Cohort 3 of SERPENTINE-1, an open-label, single-dose escalation study in adult patients with AATD.
Vyjuvek is referred to as B-VEC outside the country. The company is also evaluating KB803 (B-VEC formulated as an eyedrop) for ocular complications of DEB. Enroll is ongoing in its ongoing 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 ocular complications of DEB. Krystal Biotech expects to dose the first patient in the registrational phase III IOLITE study on KB803 later this month.
In April, the FDA cleared the company’s investigational new drug application to evaluate KB801. This is the company’s second clinical-stage ophthalmology program for the treatment of neurotrophic keratitis (NK).
KRYS expects to dose the first patient in EMERALD-1, a randomized, double-blind, placebo-controlled, multi-center Phase 1/2 study evaluating KB801 in moderate-to-severe NK patients, later this month.
Enrollment is ongoing in KYANITE-1, a phase I/II open-label, multi-center, dose escalation and expansion study evaluating inhaled KB707, as monotherapy or in combination, in patients with locally advanced or metastatic solid tumors of the lung.
KRYS’ wholly-owned subsidiary, Jeune Aesthetics, is currently developing a décolleté-specific photo numeric scale for advanced clinical development of KB301. This subsidiary expects to align with the FDA on the scale and enroll the first subject in a multi-center, randomized, placebo-controlled phase II study evaluating KB301 for the treatment of dynamic wrinkles of the décolleté in the fourth quarter.
In February, Jeune Aesthetics completed enrolment in PEARL-2, an ongoing, randomized and placebo-controlled phase I study evaluating KB304 for the treatment of wrinkles. Top-line results from the study are expected in the second half.
KRYS also expects to initiate the phase II portion of its phase I/II JADE-1 trial evaluating KB105 for the treatment of TGM1-deficient lamellar ichthyosis in pediatric patients in 2026.
KRYS’ Zacks Rank and Stocks to Consider
Krystal carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the pharma/biotech sector are Bayer (BAYRY - Free Report) , ADMA Biologics Inc. (ADMA - Free Report) and Beam Therapeutics Inc. (BEAM - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.22 for 2025. During the same time, earnings per share have increased from $1.23 to $1.31 for 2026. Year to date, shares of BAYRY have rallied 40.3%.
In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have rallied 36.6%.
ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.
In the past 60 days, estimates for Beam Therapeutics' loss per share have narrowed from $4.45 to $4.27 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.94 to $4.80.
BEAM’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.92%.