Following a launch last summer, Krystal Biotech’s topical gene therapy Vyjuvek is continuing to make waves in the dystrophic epidermolysis bullosa (DEB) disease space. During the most recent quarter, the med's sales growth accelerated as Krystal makes continued efforts to reach the estimated 3,000 DEB patients in the U.S.
After the med's growth tapered between the fourth quarter of last year and the first of this year, Vyjuvek quarterly sales have shot back up to $70.3 million, the company reported Monday. The second-quarter number was a 55% increase from $45.3 million in the first quarter of 2023.
The new figure brings the drug's total sales haul to more than $166 million since its May 2023 FDA approval and August 2023 launch.
The “rapid growth” in net product revenue reflects the “robust and sustained demand for Vyjuvek among the DEB patient community, the clinical benefits and correspondingly high compliance that come from a fundamentally corrective therapy, and strong execution by our commercial team,” Krystal’s CEO Krish Krishnan said in the company’s second-quarter earnings release.
So far, more than 400 reimbursement approvals for the therapy have been cleared across a range of payers, age groups and the two subtypes of the disease, according to Krystal’s earnings presentation.
The quarter marks a “transition point” in Vyjuvek’s launch, analysts at Evercore ISI wrote in a note to clients. While the analysts expect the drug's sales to keep growing, they cautioned of a potential slowdown in the third quarter and beyond as Krystal's initial commercial efforts shift to patient identification efforts.
The analysts expect 2025 U.S. sales to hit $425 million.
Krystal acknowledges that there's work to do on the patient identification front. The company estimates the U.S. DEB patient population is roughly 3,000, but only 1,200 patients were identified at the time of launch.
With that, the drugmaker is planning to boost its awareness and education efforts, which it aims to do through webinars, in-person programs, medical journal publications and a “growing” advocacy network. A social media campaign is already underway across major platforms.
Vyjuvek is the first FDA-approved topical gene therapy. The drug works by essentially binding skin together by delivering copies of the COL7A1 gene upon direct application to DEB wounds, a hallmark of the rare skin disease.
Aside from the U.S., Krystal is still working toward overseas expansions. The company has previously detailed a $1 billion global market opportunity for the product.
The European Medicines Agency validated Vyjuvek’s European application last November and inspected Krystal’s manufacturing facility in February, making the drug “on track” for a regulatory decision in the second half of this year. The company has targeted Germany for a launch after European approval.
The next market the company hopes to reach is Japan, where the therapy has an orphan drug designation. The company is currently eyeing a launch there in 2025.