What happened?
- Acadia presented at the BofA Healthcare conference this morning, answered questions on the outlook for DAYBUE and impactions of Most Favoured Nation (MFN) policy and changes to FDA.
- No immediate impact from MFN on Acadia.
- ~18 months of breathing room before they have to make “differential decisions” according to where MFN lands.
- New CEO working to get DAYBUE growth curve “back to steepness they saw initially” with 3Q flagged as potential “inflection point” as they expect to see impact from sales force really kicking in.
- Expecting new patient growth for DAYBUE throughout the year in the next few quarters.
E&P comments
Acadia largely reiterated the sentiment from their 1Q25 result call and continued to play a straight bat regarding the implication of MFN, noting it wasn’t a new idea given it was proposed before, in the first administration. Acadia reaffirmed its position that it doesn’t sell outside the US thus, no immediate impact. We note they are targeting 3Q25 for DAYBUE sales in Canada and 1Q26 for EU but once approved, it then takes several months to years to get each product reimbursed in each individual member state of the EU. That said, first country they can launch is Germany which they have free pricing for the first 6 months. Acadia flagged ~18 months of breathing room before they have to make “differential decisions” according to where it lands.
On the FDA, added there are “no clear immediate impacts to Acadia” with feedback and communication in line with what they usually expect in the timelines that they expect (dealing with the same people still). That aside, we are aware of reports of some companies having had delays in their interactions as well as harsher views of what’s going on at the FDA in terms of resourcing.
On DAYBUE, they felt salesforce was underpowered with 2H25 to see the impact from its increased sales force as it targets patients outside of key centres of excellence (21 in US for Rett). Suggested that the “tail” of the population outside of those CoE would become the strength of the numbers (65% of Rett patients are outside CoE). The positive thing for NEU is that they receive all the benefit of this increased investment (30% lift in sales force) while bearing none of the cost. This however isn’t not new information for the narrative. Acadia again talked up the number of new writers prescribing DAYBUE, typically, they each need ~4-5 touch points before they write a script for DAYBUE, which was difficult with the smaller sales force. 3Q flagged as a potential “inflection point” as they expect to see impact from sales force really kicking in.
(20min delay)