Revance Therapeutics Inc (RVNC)

[soma2022]

with regard to CD and April 1st J code grant this week:

All initial trial patients enrolled with the first 20 neurologists are on their 2nd treatment now for CD. Started in September and all got retreated at approximately 3 months post first treatment. Dosing was 125 and 250U but hearing that some docs now up to 300 to 400U with no significant increase in AEs and signif improved duration over Botox with much less Dysphagia rates with Daxxify. This is consistent with less migration of Daxxify outside of the treated muscle and the theoretical MOA.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8648634/
Median duration of effect, as determined by time to loss of 80% peak treatment benefit, was 24.0 weeks for DAXI 125 U and 20.3 weeks for DAXI 250 U (Fig. ?(Fig.4),4), which is longer than the median effect duration of 12–14 weeks reported with onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA [4, 5, 47]. DAXI was generally safe and well tolerated, with dysphagia reported in 1.6% of subjects treated with DAXI 125 U and 3.8% of subjects treated with DAXI 250 U [13]. This is considerably lower than the incidence of dysphagia reported in registration trials of adults with cervical dystonia treated with onabotulinumtoxinA (19%), abobotulinumtoxinA (15%), and incobotulinumtoxinA (13–18%) [4, 5, 7]. The median duration of dysphagia events was 14 days, which is also substantially less than has been reported for other BoNTAs in cervical dystonia.

Expect they start the Prevu trial of around 200 CD injectors in May. These injectors will be able to buy and bill on April 1st, and although I don't expect any significant CD sales to materialize until late 2024/early 2025, the increased duration, less Dysphagia, and significantly lower price should help to get these CD docs to convert quickly from Botox to Daxi. Ethically, they will have a tough time explaining to their patients why they plan to keep them on Botox when it has less duration, costs more to the patient/insurance co, has higher copays, and higher dysphagia rates. Feel that word of mouth will spread quickly in CD discussion groups/message boards. There is no doubt that Allergan will have counter measures to blunt adoption/migration to Daxxify and likely why they guided conservatively on CD sales in 2024.