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: Yigal Nochomovitz - Citi Investment Research - Analyst
: Was literally thinking that, at peoples (inaudible)
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: Just give us a little bit of the background. What roles did you have in the company from the beginning through till now you're elected
to the CEO position?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: And then that sort of sets me up for my next question, which is, are you going to essentially continue to steer the ship in the same
direction with the same vision or is there a different or modified vision for the company now that you're the leader?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: Okay. Well, rather than talk about the INGREZZA growth trajectory right now, let's go with the thematic question. We know what
happened in the space with Cerevel -- AbbVie, Cerevel. Some criticisms of that of that study with respect -- not just them but just in
general in neuropsychiatric studies issues with the placebo effect issues with, quote-unquote, professional patients. You mentioned,
having very good stewardship of clinical trials. So maybe you can just talk about your thoughts on that competitive data point but
then just more generally how you solve for minimizing some of these risks, which are obviously more present in neuropsychiatry
than maybe in, what I do a lot of work in is, oncology, for example.
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: Well, you mentioned INGREZZA. So how much -- what's the growth expectation over the next -- over the near mid and long term?
How much more do you believe the brand could grow?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: What other strategies are you using to get exposure to that 85% where you don't have share right now, for example, using more
sophisticated newer methods, like maybe even AI or machine learning to look at electronic medical records and try to find patients
that may have symptoms that are consistent with TD? Obviously, social media campaigns. Some companies have leveraged influencers.
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: One thing I wanted to come back to on, 568. As far as the data that you showed there, so it's a plateau effect or it's a more of an
upside-down [U] response. Is that how to think about it? Which is more correct?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: And the other thing I've sort of gleaned from talking to some of the neuro experts, this aspect of the frequency of checking --
questioning the patient regarding their scores and that you don't want to do that too frequently because you can ramp up the
placebo effect if you're always interrogating the patient. Is -- do you buy into that thesis or not? And how does that impact how you
design your trials?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: Okay, let's -- in the last few minutes, let's just sort of expand the discussion to some macro topics, one sort of geopolitical actually
and the other regulatory. So starting -- this might be an easy one because I don't know the details of your supply chain. But where
is your manufacturing? Where do you do your API and your fill finish? And are there any risks associated to potential tariff --changes
in tariffs?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: Do you have contingency plans to do -- to build the US manufacturing plant or is that too far a field right now?
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: You're a lot in the same boat there. Yeah, for sure.
Question: Yigal Nochomovitz - Citi Investment Research - Analyst
: Okay. And then I mentioned regulatory. So in the last minute here, the potential changes in leadership at not only HHS but CMS,
FDA. To what extent may those impact or not impact your business?
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