Well, Acadia’s new CEO, along with Jon Pilcher, seems to have become a bit of a kicking bag for some.
What Catherine Owen Adams said is that growth in new product starts for DayBue had plateaued in the last few months. Her stated aim is to kickstart new growth in DayBue patient commencements.
That patient starts have significantly slowed is not new news. It is both consistent with the figures that have been supplied by Acadia to date and consistent with what Catherine Owen Adams has said previously. The figures show that after 12 months on the market (end of Q1 2024), ~1300 patients had initiated treatment. By August, that number had grown to ~1500 and the current figure is ~1600 patients.
As for Q4 sales, no new guidance was given. For DayBue sales in 2024, the last guidance given (in early November) was US$340 - $350m, which would equate with sales of US$88.3m - $98.3m in the final quarter.
However there was new news, and it was all positive.
Acadia has filed for EU approval of DayBue. Despite the scepticism of some, Ms Owen Adams said this submission would be filed in this quarter and she has already delivered by mid-January.
Implementation of a Managed Access Program in select European countries while waiting for EU approval was unexpected. This means the potential for additional new patient growth and revenue from as early as Q2 this year.
Boosting the US DayBue field team by 30% (at zero cost to Neuren) will assist with tapping into the HCPs of the 70% of Rett patients in the US who are not treated at Centres of Excellence. It will also allow closer management of patients during the crucial first few months when titration and diarrhoea management are key factors in whether patients persist with treatment.
The number of identified patients with Rett syndrome has been increasing. When DayBue was approved in March 2023, there were 4,500 diagnosed patients in the US. As predicted by Acadia, the approval of a treatment has led to a growing awareness of the condition and an increased rate of diagnosis. The US patient pool has now grown to 5500+ diagnosed patients. That’s almost 4,000 diagnosed patients in the US yet to try DayBue.
Persistency rates for DayBue seem to be improving. The rate at 10 months now stands at 66% and was said to be holding at 12 months. In May last year, Acadia reported a persistency rate of 58% at 9 months.
Acadia is working to further increase awareness of both Rett syndrome and DayBue through omnichannel strategies including a direct to consumer campaign. As an example of one of these strategies, this week Acadia launched a youtube Daybue channel. https://www.youtube.com/channel/UCNqP32wyKupOe_E6n8RUQ5Q
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