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: Chris Shibutani - Goldman Sachs - Analyst
: Can you talk about anything, the learnings from INGREZZA that you reflect back and get ready to do this orderly transition over to Kyle, but in
particular?
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JUNE 13, 2024 / 2:40PM, NBIX.OQ - Neurocrine Biosciences Inc at Goldman Sachs Global Healthcare Conference
Question: Chris Shibutani - Goldman Sachs - Analyst
: This qualifies for de facto standing room moment here in the [Americano city, too], and Todd can testify to that. Good haircut, Todd.
Question: Chris Shibutani - Goldman Sachs - Analyst
: And it's interesting because the quarterly report, I think, about two years ago, there was a little bit of drama about the guidance and hitting and
missing. And Matt and his very [dower] voice would always say, like, I don't expect the first quarter to be a seasonally strong quarter probably.
And then they'd do well. And then the second quarter, this shouldn't have been thought of to rollover and stuff. There's Eeyore cadence from the
Winnie the Pooh series, always, with the way he's giving us a downtrodden kind of view.
Question: Chris Shibutani - Goldman Sachs - Analyst
: Okay, we'll go with that. So what are the -- are there other cards to play? I mean, I feel like we step into the print each quarter, and it's not that
controversial. And that's a relief because there's actually a lot of pipeline stuff that's very cool to talk about and think about there.
Before moving on from INGREZZA, are there other cards to turnover? Is there another channel, like long-term care part two or some other dimension
that can keep things going, as we -- we're in 2024. We still have a bunch of years left under Kyle, reading the prepared comments from Todd with
this.
Thoughts about other tricks up your sleeve, which sounds pejorative, but you know I mean. Just like, you've been creating, crafting, educating
doctors in the market. Is there something that you think, Dr. Gano?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Yeah. I'll say that as a -- given the scale of the revenues as a profitable company, no one's really running a PE multiple, per se. But the margin
progression is very important and that you guys are doing some very meaningful and significant investments, plus you're going to be launching
a product.
So when I hear you say you're going to put more hiring or -- on the SG&A aspect, specifically targeting INGREZZA -- I remember a couple of years
ago when you guys were talking about doing more of the branded direct to consumer. And there was a little bit of a groan that I heard across the
investor ecosystem in terms of, wow, this is a little bit late, not that any of us have ever manage these P&Ls or masterminded these.
And yet, you saw a return from that. I think when Eric has previously talked about adding feet on the street, so to speak, there were targeted, specific
ways where it was going down some of these channels. Can you provide a hint in terms of where the incremental headcount is going to be doing
what kind of musculature that that particular member of the sales force is going to be trying to emphasize?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Yeah. No, it's an important achievement. We're just the peanut gallery of skeptics. You have demonstrated and you have the credibility of having
made these investments before and watching these. And this has been a multi-year arc in the journey there, so I think that makes sense.
I opened with a question about learnings simply because we certainly don't understand. But then just the decision community didn't really
understand TD and the treatment and conditions. And we're seeing some elements metaphorically similar to that with crinecerfont and the
opportunity there.
Now you just came out of the Endo meeting in Boston, which was inconveniently overlapping with ASCO. And so we were all running around
dealing with all sorts of radiopharmaceutical BS. But with Endo -- and here we are again. How are you feeling in terms of the questions that the
Street is asking, the numbers that the analysts are forecasting?
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JUNE 13, 2024 / 2:40PM, NBIX.OQ - Neurocrine Biosciences Inc at Goldman Sachs Global Healthcare Conference
Are we just like all over the place and random? And two years from now, we're like, boy, did we get that wrong, i.e., when INGREZZA launched at
$500 million and we're talking $2 billion. Now, you're [5]? Give us a sense of maybe a better sense of true north with that from where we stand
now, recognizing just the risks.
Question: Chris Shibutani - Goldman Sachs - Analyst
: And at this stage of the game, if we came up to you and said, do you think there will be an AdCom, you would say --
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JUNE 13, 2024 / 2:40PM, NBIX.OQ - Neurocrine Biosciences Inc at Goldman Sachs Global Healthcare Conference
Question: Chris Shibutani - Goldman Sachs - Analyst
: And it's great to get a little bit nervous about documents and all the sort of stuff and write all these things and (inaudible) but then my original
question and the last on crinecerfont now, because there's some pipeline items I want to catch up on. How comfortable are you with how the
Street is attempting to sketch out numbers and the trajectory of that growth there?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Sounds good. Let's talk about muscarinic, hot mechanism. Is there a little bit of a Greek mythology thing going on? I mean, the previous schizophrenic
agents were actually responsible for tardive dyskinesia. And now, this next generation of pipeline asset is actually -- the profile is one where the
AE dimension of it is going to be quite different and almost solved for some of those things.
And so schizophrenia being the heterogeneous disease and what you've already articulated in terms of like the vastness of the patient population,
it's probably me being a little bit too zero-sum game. But certainly, it seems as if your approach includes a couple of different options.
You can talk about the biology, M1, M4, so activity waiting, et cetera. What's the lead steer in your mind? What's the top athlete that you want to
put forth in what is essentially a race? We have a PDUFA coming in September for KarXT.
We have Cerevel, some pretty important data coming up to them, hopefully, by the end of the year. Where are you guys? Which is the lead asset?
Just bring us up to speed.
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JUNE 13, 2024 / 2:40PM, NBIX.OQ - Neurocrine Biosciences Inc at Goldman Sachs Global Healthcare Conference
Question: Chris Shibutani - Goldman Sachs - Analyst
: Good general statement. What's your hypothesis in terms of where your mechanistic targets are emphasizing in terms of the ultimate clinical
manifestation of where that will benefit? Is there going to be a cognitive benefit M1, M4 versus more the symptoms associated with schizophrenia?
When we think about efficacy profiles and the slight variations on the theme, what's your hypothesis for your asset?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Yeah. Phase 2 data, 3Q '24 I think is, theoretically, timeline guidance there. Other things in the clinic. Is it your playbook to have several assets in
the clinic and ultimately conceive of, if they should all succeed, having multiple products, but with different profiles?
Or we often -- I mean, everybody has dual compounds. This is just a question of what the gating factor is to make the investment to throw them
into clinicals. And here, we have a sort of a tableau where there's so many different indications, subsets, even distinct patient populations. Alzheimer's
disease psychosis could be quite different from schizophrenia. Is it your thinking to keep on pressing forward with multiple assets?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Yeah. No, point taken. Obviously, I think we get a little obsessional about the muscarinic opportunity because it's like -- we love to be able to think
about some of these arenas there. But certainly, the bench has broadened considerably.
So just to touch upon some of the things you mentioned, with '845, any updates on the -- we've turned over some cards. It looks like we're able to
move forward. But when are the next gating factors talking to the FDA? Has that happened?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Great. We'll (multiple speakers)
Question: Chris Shibutani - Goldman Sachs - Analyst
: Luvadaxistat, you mentioned the data update. That's Phase 2 data, cognitive, 3Q as well. Another potential catalyst, correct?
Question: Chris Shibutani - Goldman Sachs - Analyst
: Okay. Great. Maybe in the closing moments here, Kyle, talk a little bit to your background. When you and I first started talking a bunch of years
back, I was impressed by your academic journey, how much time you spent, and the chops that you bring to bear into this role.
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JUNE 13, 2024 / 2:40PM, NBIX.OQ - Neurocrine Biosciences Inc at Goldman Sachs Global Healthcare Conference
And I'm a little bit curious because you've been Prime Minister of Business Development, and you have this portfolio now as a CEO. Will you continue
to have a hard time of removing that hat? The responsibilities are somewhat different, and then you'll have a Chairman as an overload and all these
other things happening. But tell us about you and give us a lens to begin to critique you by.
Question: Chris Shibutani - Goldman Sachs - Analyst
: Okay, terrific. We're at time. I really appreciate the two of you being up here. I had very low probability of success odds of getting you to break out
into a fight, which is -- I usually enjoy trying to get people to do. Too much gentlemanly behavior here.
But Kevin, much to appreciate through your tenure. It's been absolute pleasure working together with you. I know the shareholders and investment
community always believe that as well. And you will always have a seat at the Goldman Sachs Healthcare Conference. Probably in the back with
Todd, but you will always have a seat.
Question: Chris Shibutani - Goldman Sachs - Analyst
: Okay. Thanks, everybody.
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