Krystal Biotech (KRYS Quick QuoteKRYS - Free Report) 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.

Shares of Krystal have surged 37.8% year to date against the industry’s decline of 3.8%.

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KRYS’ 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, KRYS 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.

KRYS Makes 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.

KRYS expects an opinion from the Committee for Medicinal Products for Human 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. KRYS 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, KRYS 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, KRYS 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.

Our Take on KRYS’ Q3 Performance

The uptake of Vyjuvek is encouraging and should gain further traction. Vyjuvek is the first FDA-approved gene therapy treatment for DEB. The successful development of other pipeline candidates should also bode well.

With a cash balance of $694.2 million as of Sept.  30, 2024, the company seems to be in a good position to develop its pipeline candidates.

KRYS’ Zacks Rank and Stocks to Consider

Krystal carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks in the biotech sector are Amicus Therapeutics (FOLD Quick QuoteFOLD - Free Report) , Exelixis (EXEL Quick QuoteEXEL - Free Report) and Amarin (AMRN Quick QuoteAMRN - Free Report) . While FOLD carries a Zacks #1 Rank (Strong Buy) at present, both TEVA and AMRN carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 90 days, estimates for Amicus Therapeutics’ 2024 earnings per share (EPS) have moved up from 20 to 22 cents. EPS estimates for 2025 have remained stable at 53 cents during the same period. FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 23.96%.

Estimates for EXEL’s 2024 EPS have increased 30 cents to $1.83 in the past 90 days. Shares of EXEL have risen 43% year to date.

In the past 90 days, the 2024 loss per share estimate for Amarin has narrowed 2 cents. AMRN’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 118.75%.