Hi again,My key takeaways (not exhaustive) from Acadia’s just...

Hi again,
My key takeaways (not exhaustive) from Acadia’s just finished presentation at the 42nd JP Morgan Healthcare Conference:

Steve Davis presented and his prepared remarks once again commenced with a focus on Daybue for Rett Syndrome which is now closing in on 9 months of sales since launch.

The rollout continues to go as planned and the early surge of patients from COE’s and High Volume Institutions is morphing into a steadier, more incremental flow from High Volume Institutions and Community Treatment.

No guidance updates re Q4 sales figures or number of patients on Daybue; stuck with Q3 figures already known to market (US$170-$177.5 million/800 patients). Payor coverage still as per previously published figures of 80% of covered lives.

Real world persistency rates for Daybue are tracking better than the clinical trial (76% versus 68%) and dose compliance is sitting at 75-80%.

ROW updates for Daybue - Acadia will lodge their submission to Canadian health authorities in the next few months and are hoping for approval around the end of the year! Also engaging with European authorities in Q1, 2024 but won’t lodge submission until early 2025. Will also commence negotiations with Japanese authorities this year.

Prader-Willi trial (Hyperphagia only) has commenced using ACP-101 (aka Carbetocin - not a NEU molecule). There are 8,000-10,000 patients in the US and the primary endpoint being used is the HQ-CT.

Acadia was asked if they will switch to providing annual guidance for Daybue (as they do with Nuplazid) at the Feb earnings call. The response was fairly coy, affirming that the switch from forward quarter to annual guidance will occur but they still haven’t decided when this will occur.

Asked about capital allocation and business development, Steve Davis said that this was one of their most important activities, they have a “war chest” and an appetite to do more in future.

There was nothing earth shattering in this preso for me but I am thankful that the US Daybue rollout continues to go so well without any major hiccups thus far (touch wood). The best takeaway for me was the potential for Canadian regulatory approval of Daybue at the end of this year - now that would make a fantastic Christmas present for a lot of patients and their loved ones.

So we have about 6 weeks to wait until Acadia’s Q4 earnings call towards the end of February. But for me it’s back to sleep here in Perth - it’s just about 3am