At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter can be attributed to its recent sale of an FDA priority review voucher (PRV) for $100 million.
It shouldn’t be long before the eight-year-old Pittsburgh biotech can chalk its positive earnings up to drug sales, however, after launching Vyjuvek, the world’s first-ever topical gene therapy. The drug was approved by the FDA in May to treat certain patients with dystrophic epidermolysis bullosa (DEB).
While the Wall Street consensus projects Vyjuvek’s sales will come in at $163 million next year, Evercore ISI has boosted its own estimate to $273 million based on launch metrics the company provided 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 wrote in a note to clients.
In its third-quarter update, the company said it finished the quarter with 284 start forms for the treatment, with demand continuing to be strong. Krystal projects an 85% conversion rate in turning those requests into prescriptions.
A third of the start forms are for patients between the ages of six months and 10 years, who typically have a longer induction phase, leading to potentially more consumption of Vyjuvek, the company said.
One advantage favoring strong uptake is that Vyjuvek can be taken at home. Of the patient start forms received, 88% were for those who wanted to take the drug at home. Though it’s very early, that has helped drive a 96% rate of adherence, according to the company.
“We believe we have a strong launch in our hands,” Krishnan said during the call. “We see really good demand from both recessive and dominant patients, access coverage has been relatively smooth, and home health visits are pointing to a high patient compliance. We expect this momentum to continue going forward.”
Krystal reported revenue of $8.6 million in the third quarter for Vyjuvek, with the company adding that the figure accounts for less than two months of sales because the first commercial patient did not receive treatment until early August.
Last month, Krystal filed for approval of Vyjuvek in Europe, with the company anticipating approval there in the second half of 2024, it said. The company has kicked off an open label extension study of the drug in Japan and expects to file for approval there in early 2024.
Krystal sold its PRV to an undisclosed company in August. It was obtained when the FDA signed off on Vyjuvek under the Rare Pediatric Disease Priority Review Voucher Program.
DEB is a genetic condition that causes blisters that can lead—in its most severe form—to vision loss and disfigurement. Those with DEB lack a gene that adheres the inner and outer layers of the skin, leaving it vulnerable to even the slightest friction. After application of the topical gel to wounds, Vyjuvek helps bind the layers together.