Shares of Krystal Biotech KRYS have gained 15.8% in the past month compared with the industry’s growth of 4%. The stock has also outperformed the industry and the sector in this timeframe.
Last month, KRYS reported fourth-quarter 2024 results. While earnings beat estimates, sales missed the same. Nonetheless, shares surged post the quarterly release, mostly due to the strong uptake of Vyjuvek and encouraging pipeline progress.
KRYS Outperforms Industry, Sector & S&P 500
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Strong Uptake of KRYS’ Vyjuvek
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.
Vyjuvek is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds.
Krystal recorded Vyjuvek sales of $290.5 million, up from $50.7 million in 2023. It has made steady progress, securing access and reimbursement for Vyjuvek since its launch in the United States.
As of February 2025, Krystal secured more than 510 reimbursement approvals for Vyjuvek in the United States and continues to maintain strong access nationwide, including positive access determinations for 97% of lives covered under commercial and Medicaid plans.
Krystal is looking to get Vyjuvek approved in other geographies as well.
The European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of Vyjuvek (beremagene geperpavec-svdt, or B-VEC) for the treatment of wounds in patients with DEB.
In October, Krystal Biotech filed a new drug application with Japan’s Pharmaceuticals and Medical Devices Agency. A decision is expected in the second half of 2025.
Krystal’s Makes Encouraging Pipeline Progress
The company is also advancing a robust preclinical and clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics.
It is evaluating KB407 for the treatment of cystic fibrosis. In December 2024, Krystal reported that single and repeat dosing of KB407 was safe and well-tolerated by patients in Cohorts 1 and 2 of the ongoing CORAL-1 study. Krystal expects to report interim molecular data for Cohort 3 patients in mid-2025.
Another candidate, KB408, is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD). In December, Krystal reported successful SERPINA1 gene delivery and functional alpha-1 antitrypsin expression reaching therapeutic levels as part of an interim clinical update for Cohorts 1 and 2 of its ongoing 1 SERPENTINE-1 study. Inhaled KB408 was safe and well-tolerated at both tested dose levels.
Consequently, based on this promising initial data, Krystal has simultaneously expanded Cohort 2 and opened Cohort 3 of SERPENTINE-1 for more comprehensive molecular assessments at both dose levels and expects to report results from the cohorts in the second half of 2025.
KB707 is being evaluated for the treatment of solid tumors of the lung. Enrollment in KYANITE-1 is ongoing.
Enrollment is ongoing in OPAL-1, a phase I/II open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707, either as monotherapy or in combination, in patients with locally advanced or metastatic solid tumor malignancies.
KB301 is being evaluated for the treatment of dynamic wrinkles of the décolleté. The company’s 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.
In November 2024, Jeune Aesthetics dosed the first subject in an ongoing, randomized and placebo-controlled phase I study PEARL-2 evaluating its second clinical-stage investigational aesthetic product KB304 for the treatment of wrinkles.
KRYS’s Valuation and Estimate Movement
Going by the price/sales ratio, KRYS’ shares currently trade at 10.58x forward sales, lower than its mean of 22.83x but higher than 1.63x for the drug industry.
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The Zacks Consensus Estimate for 2025 earnings per share (EPS) has increased to $7.07 from $5.40 over the past 30 days. The EPS estimate for 2025 has also increased to $11.03 from $9.15 over the past 30 days.
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Invest in KRYS Stock
Large biotech companies are generally considered safe havens for investors interested in this sector. KRYS is a good stock to buy now, considering its good fundamentals and growth prospects.
The prospects for Krystal look strong as Vyjuvek is the first FDA-approved gene therapy treatment for DEB. Approval in additional geographies will further boost sales. The successful development of other pipeline candidates should bode well too.
With a cash balance of $749.6 million as of Dec. 31, 2024, the company seems to be in a good position to develop its pipeline candidates.
Krystal’s Zacks Rank & Other Stocks to Consider
Krystal carries a Zacks Rank #2 (Buy) at present.
A couple of top-ranked stocks in the biotech sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead Sciences
In the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.60 to $7.87. During the same timeframe, the figure for 2026 has increased to $8.27 from $7.92.
GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.
BioMarin Pharmaceutical
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 EPS have increased from $4.01 to $4.24. Estimate for 2026 EPS has increased to $5.25 from $5.20 during the same timeframe. BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.
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