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.