The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: Great. Thanks, Steve, and thanks for the introduction. And certainly, the area of focus being on that second pillar that you described on delivering
on the DRP opportunity.
But I thought before we get there, let's talk about that first pillar and the growth of NUPLAZID, alluded to some of the patterns that you saw coming
in the first part of this year. When would you expect some recovery of the COVID-19 impact on the various channels for PDP? That, of course,
includes the office-based setting as well as the long-term care. And how has that recovery momentum changed since what you had observed with
respect to improvement that was exiting the first quarter?
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: That's very helpful. And one of the questions that does come up is since the CRL was announced, any impact to NUPLAZID in PDP? And not just
off-label use based on script analyses, but just how, if there's any, perceptions or a change to how the market or how clinicians could be viewing
NUPLAZID in the marketplace with respect to some of the sNDA and regulatory proceedings?
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: That's very helpful, Steve. And yes, let's follow up on that with the latest on your regulatory interface. So based on your progress on preparing for
the briefing docs here, how should we think about some of those expectations around timing, around the Type A meeting? It sounds like disclosures
forthcoming with the minutes from when that meeting takes place, so that will be thereafter. What are those plans for the updates? And what's
the latest there?
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: That's very helpful, Steve. And certainly, numerous scenarios on which one can speculate, although we won't be doing that. But maybe just one
on one of the most common scenarios that comes up for investors is just about conducting another pivotal trial. And maybe the question there is
what is your level of commitment under such a scenario? Should a trial like that be needed for the registration of pimavanserin in DRP based on,
obviously, the momentum, all the factors about pimavanserin and the market, but also with your planned goals and resource allocation across the
company?
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: That makes sense. And just as a tack on to that, just your latest thinking, Steve, and perhaps for Serge, about just those additional indications and
maybe just walking us through the -- your mention of the schizophrenia negative symptom study, where we are there as far as that trial progressing
and how we should think about the ADVANCE-2 study now with the Phase III study there?
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: Thank you, Serge, for that context. And let's just continue on in the last few minutes that we have with what is in your growing pipeline. And
certainly, what's circled on the calendar is the LAVENDER trial and the top line readout for trofinetide in Rett syndrome. How is that recruitment
progressing? Maybe just in addition to putting potentially a finer point on the timing for enrollment completion, just how we should think about
a bar for success in population and with the trofinetide MOA?
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: Thank you, Serge.
And we certainly are at time and lots to talk about, didn't get to cover ACP-044 or 319 and in pain and cognition and schizophrenia. However,
maybe we can just close, Steve, by just allowing you to talk a little bit about BD, that last pillar, really key to the ACADIA strategy, maybe as those
programs typify your business development strategy and how that has and can evolve over the year.
Question: Gregory James Renza - RBC Capital Markets, Research Division - Analyst
: Well, that's great. I think we can leave it there. Steve, Serge, Elena, we appreciate you joining us today. We look forward to all the upcoming updates,
and have a great rest of the day. This concludes the session. Thank you very much.
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