Acadia CEO Catherine Owen Adams appeared in a fireside chat at the Needham Healthcare Conference last night. Some points from that discussion:
Acadia is closely watching the Trump administration changes occurring at the FDA and NIH. To date, no impacts have been seen on clinical trials.
With respect to the potential impact of tariff changes, it was noted that Acadia has a couple of years’ inventory in the United States for both DayBue and Nuplazid. Trofinetide API is currently manufactured in Italy. There are alternative sources but any change in manufacturing location would take some time to effect. Trofinetide IP resides in the US.
Penetration into Rett Centres of Excellence is averaging ~50% with an average non-CEO setting penetration rate of ~25%.
Current boosting of the field force by 30% will allow for smaller rep territories thus enabling more frequent rep contact with physicians to support initial prescription and management of ongoing care. It will take a number of months to embed these new reps, hence growth through this initiative is not expected to be seen until the second half of the year.
As previously flagged, Q1 25 sales will be significantly lower, caused by similar factors to those that impacted Q1 sales last year. Approximately US$3.5m sales was pulled forward into Q4 2024 because of stocking up prior to January holidays. Seasonal centre closures also have negatively impacted sales and there has also been a small drop in net price due to increased rebates that commence on January 1.
Timing of EU approval of DayBue is still expected in Q1 next year.
Acadia has partnered with a third party to provide Managed Access support to anyone in Europe who wants to participate and lives in a country with a suitable Managed Access program. Examples provided of such countries are Germany, France and Italy.
No guidance was able to be given on pricing but proposal packages were said to be individualized for each country to maximise the case for robust pricing.
A full-time Acadia team based in Switzerland is managing the European entry of DayBue.
No mention of ACP-2591 development.
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(20min delay)