Krystal’s Vyjuvek Gene Therapy Gains FDA Approval, Spurs Sales Projections

Krystal's Vyjuvek Gene Therapy Receives FDA Approval, Boosts Sales Forecast

Krystal Biotech’s CEO, Krish Krishnan, was quick to highlight in the company’s inaugural conference call to present its quarterly results that their positive earnings for the third quarter can be attributed to the recent sale of an FDA priority review voucher (PRV) for $100 million.

Nevertheless, it won’t be long before the eight-year-old biotech based in Pittsburgh can attribute its favorable earnings to drug sales. They recently launched Vyjuvek, the world’s first topical gene therapy, which received FDA approval in May for treating specific patients with dystrophic epidermolysis bullosa (DEB).

While the Wall Street consensus predicts Vyjuvek’s sales to reach $163 million next year, Evercore ISI has raised its estimate to $273 million based on launch metrics provided by the company on Monday.

“We expect revenue to come in very strong over the next six months, driving Krystal to reach GAAP profitability by the middle of next year.” 

– Evercore ISI analysts Gavin Clark-Gartner and Yesha Patel 

Also Read: Krystal Biotech Secures $100 Million In Sale Of Priority Review Voucher

In its third-quarter update, Krystal reported 284 start forms for the treatment and strong demand. The company anticipates an 85% conversion rate for turning these requests into prescriptions. A third of the start forms are for patients between six months and ten years of age, who typically have a more extended induction phase, potentially leading to greater consumption of Vyjuvek.

Vyjuvek’s at-home administration is one advantage contributing to its robust adoption. Of the patient start forms received, 88% were from individuals wishing to take the drug at home, and early data suggests a 96% adherence rate.

“We believe we have a strong launch in our hands. We see really good demand from both recessive and dominant patients, access coverage has been relatively smooth, and home health visits are pointing to high patient compliance. We expect this momentum to continue going forward.”

– Krish Krishnan, CEO

In the third quarter, Krystal reported $8.6 million in revenue for Vyjuvek, considering that this amount only reflects less than two months of sales since the first commercial patient received treatment in early August.

Krystal has also applied for approval of Vyjuvek in Europe, with expectations for approval in the second half of 2024. They have initiated an open-label extension study of the drug in Japan and plan to seek approval there in early 2024.

Also Read: LifeArc’s Project For Rare Diseases Will Spend £100 Million On Patient Care

It’s worth noting that Krystal sold its PRV to an undisclosed company in August, which they obtained when the FDA approved Vyjuvek under the Rare Pediatric Disease Priority Review Voucher Program.

DEB is a genetic condition that causes blisters and, in its most severe form, can lead to vision loss and disfigurement. Individuals with DEB lack a gene that binds the inner and outer layers of the skin, making it vulnerable to even minor friction. Vyjuvek, a topical gel applied to wounds, helps secure these layers together.

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