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For 20 years, Botox — short for the neurotoxic protein botulinum toxin — has reigned supreme as the most popular cosmetic procedure. Even as Evolus managed to score an FDA approval for a rival product named Jeuveau, its 2021 sales of almost $100 million were no match for the $2.2 billion revenue AbbVie reported for Botox Cosmetic alone.
But that could change by the end of this year.
Revance, the Nashville, TN-based biotech developing DaxibotulinumtoxinA injection for moderate to severe glabellar lines — a fancy term for frown lines or wrinkles — said the FDA has accepted its BLA resubmission six months after a rejection, which it had blamed on manufacturing issues. It’s given a PDUFA date of Sept. 8.
According to Cowen’s Ken Cacciatore, an approval here could shake up the landscape for this corner of the cosmetic world.
While AbbVie’s Botox has retained ~70% share despite multiple entrants, our proprietary clinician survey indicates that Revance’s longer-duration neurotoxin DAXI could be the first truly differentiated competitor that could disrupt – while still help grow – this very lucrative market.
By his analysis, Botox remains relatively unchallenged because other neurotoxin products are “undifferentiated” — and therefore unable to penetrate the market despite price discounts.
DAXI, on the other hand, promises to last for six months compared to Botox’s three to four months.
Our updated proprietary expert survey indicates that dermatologists expect ~30% of their neurotoxin patients to be using DAXI in the next three years, given DAXI’s 24-week duration of efficacy,with some key thought leaders indicating the potential for the majority of their neurotoxin practice will convert to DAXI.
Other analysts, though, have previously expressed doubts that a one- or two-month extension would make a big difference.
In addition to the cosmetic use, Revance is also pursuing therapeutic applications of its drug for indications like cervical dystonia and adult upper limb spasticity.
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