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: Ash Verma - UBS - Analyst
: Yeah, absolutely. I mean, there is a lot to unpack here.
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NOVEMBER 12, 2024 / 9:15PM, NBIX.OQ - Neurocrine Biosciences Inc at UBS Global Healthcare Conference
Unidentified Company Representative
Kyle, maybe it would be interesting just for the audience just to get a little bit of background on you and how things have transpired.
Even over the last seven years as a company, we've gone from not revenue generating to revenue generating.
And I think Kyle is just heritage with the company. I think it would be a good perspective. If you don't mind sharing a bit, Kyle.
Question: Ash Verma - UBS - Analyst
: Excellent. That's great. Great start. So yeah, I wanted to sort of talk about some of the recent developments that have happened in
this story, and just this field in general for muscarinic. So as you might have seen some data coming out from (inaudible)your
competitor program to the extent that it has any kind of like a read across to you. I wanted to understand that.
So in terms of like this (inaudible) data yesterday, not only did it like surprise negatively on such a high placebo response, but also
their own like efficacy was much lower versus what they showed in their earlier Phase 1b trial. So I wanted to understand like what
are the implications of that for you, because you are effectively like starting a new study in this domain. And if from a trial conduct
perspective, like are there some learnings that you identified that might be relevant for your program?
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NOVEMBER 12, 2024 / 9:15PM, NBIX.OQ - Neurocrine Biosciences Inc at UBS Global Healthcare Conference
Question: Ash Verma - UBS - Analyst
: Just like a quick question or follow-up on this. So I think as companies like similar to you, like trying to do like a Phase 2 meeting --
end of Phase 2 meeting with the FDA, right? Is there a possibility that you are either AbbVie, and this is I'm just asking you your
assumption, either AbbVie or you might be asked by the FDA that mechanistically or from -- how much of a placebo response we
are seeing, it might not make sense to continue development.
Question: Ash Verma - UBS - Analyst
: Great. So maybe just like a switching topics. So you have this potential upcoming launch of crinecerfont, maybe let's talk about that
a little bit. I know on the third quarter conference call, you mentioned that like you still positive or upbeat about like patient adds.
But in terms of like the revenue realization, it might be a little bit slower because of like the how the commercial insurance is going
to work out. Can you elaborate on that dynamic a little bit? And I guess like the most important one thing for me is that would you
be providing like patient numbers to the street on where you are?
Unidentified Company Representative
I mean, that's a lot in that question. But yeah, absolutely, there's going to be a lot that we learn in this launch. I mean, this is the first
medicine in this entire patient population that's been launched in 70 years. So we don't have it all figured out.
But what we do know is that there's a lot of patient demand at the moment. But given that 60% to 70% of these patients are actually
commercial patients. There's more to like there's more than likely going to be some form of a block on that new medicine.
And as a result of that, there's going to be a delay in reimbursed scripts. So early on, there may be patients taking the medication
that is not reimbursed. And so that's where your question comes into. Would we be willing to provide patient numbers who are on
therapy?
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NOVEMBER 12, 2024 / 9:15PM, NBIX.OQ - Neurocrine Biosciences Inc at UBS Global Healthcare Conference
That's something that we're still trying to think through from a disclosure perspective. The other aspect that we think about that
might impair ultimate adoption. And the recent reality of the space is that these patients by and large only see their clinician one to
two times per year.
So when you think about the just natural flow of them seeing their clinicians, there's not going to be a bolus effect of patients that
are knocking on the door from day one that will get this prescribed. It will be prescribed as they come in, as clinicians get experience
with this medication, how do they down titrate any of the glucocorticoid.
So there's still a lot to be learned in the commercial market. But all the feedback that we're getting, whether it's from patients, whether
it's from clinicians, people can't wait to get their hands on the medicine to see how it can start helping these patients with congenital
adrenal hyperplasia.
Question: Ash Verma - UBS - Analyst
: I know you've previously talked about these like 8,000 patients in the CARES foundation, which are kind of like activated patients
right, out of the 30,000 total prevalence. Is that still the assumption that like those to your point that like they would they be early
adopters and might be in active care and physician that that's like the low hanging fruit that you might get a quick ramp in.
Unidentified Company Representative
Well, I just say for any parent or anybody with the age, it's like a four letter word. You don't understand what it truly is, and how it
wreaks havoc, and the burden of taking really high dose steroids three or four times a day, and the ramifications it has on the life.
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NOVEMBER 12, 2024 / 9:15PM, NBIX.OQ - Neurocrine Biosciences Inc at UBS Global Healthcare Conference
And I would just say the CARES Foundation was established, I don't know, 15 or 20 years ago, and their whole focus has been just
on creating some network for these patients. Some establishment of clinicians who actually specialize or care about treating patients
with CAH, because up until the 1960s, all of these patients died, because they couldn't produce cortisol.
And as a result, they would have this huge surge of androgens and ultimately would pass away. So at the advent of the hydrocortisone,
that's really where things have started. So over the last 15 years, 20 years, education awareness, patient advocacy has really ramped
up in CARES has been a huge help in this regard.
So when you ask who could be the earliest adopters, I think that kids in particular are going to be those who are going to be the
most motivated to seek treatment. However, any kid or any parent, if they ask a clinician and they're going to listen to the clinician.
And so I think getting clinician expertise, getting their insight. Many of them participated in the trials, these parents or these patients
are ultimately going to rely on what the clinicians say. So we do have a motivated patient population.
We do have the defined patients that are part of the CARES Foundation. But I really think the adoption is going to ultimately come
down to the clinicians. How comfortable are they prescribing the medicine? What types of patients are they going to try this on first?
But as Kyle said, with the rich data that we saw in both efficacy, and there's very little downside from what we saw in terms of safety.
Our sense is that up to 80% of patients would be typical candidates for this type of medication. So we're enthusiastic about the long
term potential. It may take a little while for this to convert to revenue, but would expect this to be a quicker ramp to peak than per
se as compared to the tardive dyskinesia market.
Question: Ash Verma - UBS - Analyst
: Got it. Great. So I guess the other thing that I wanted to ask about the pricing. So Matt, going back to your comment at the conference
call, and on the third quarter, I think you mentioned that you expect on a year over year basis like pricing per script to be flat year
over year.
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NOVEMBER 12, 2024 / 9:15PM, NBIX.OQ - Neurocrine Biosciences Inc at UBS Global Healthcare Conference
Just like if you can talk about quickly on the pushes and pulls. I know you have the Medicare Part D redesign, any kind of like price
increase and contracting, anything that you would highlight on those factors.
Question: Ash Verma - UBS - Analyst
: So just one last question on INGREZZA. So I think there's an increasingly like investors are trying to understand, like let's say 10
(inaudible) of stero ends up on the list for 2027. What is the sort of the if there is any indirect impact of that to you? And I understand
that you have the small by the exception, so that takes about the impact too further away. But just in terms of the competitive indirect
pricing impact.
Question: Ash Verma - UBS - Analyst
: Great. Just one last quick question for me and we can wrap it up. So I guess positively surprised by the ASR that you're now $300
million, it's becoming a little bit more common in the biotech land to see that -- for you, do you think that this is sort of like a one-time
rest or can buy backs become more prominent part of your capital allocation strategy going forward?
Unidentified Company Representative
This was clearly opportunistic. We're buyers of our stock at this level for sure. And I was thankful the Board was supportive of wanting
to move forward with a direct shot like this in retiring the shares. We know, I think most of biotech knows that long term shareholder
value is going to be driven by revenue growth and advance in and expanding our pipeline.
And so looking forward, Ash, the large majority of our capital is still going to be invested behind R&D potential business development
into the future. But of course, this will always be on the radar if we do have excess capital in our stock price, feels very dislocated.
I think our Board will continue to be supportive, but with that as a backdrop, knowing that investing as a growth company is the
utmost priority for us as a company.
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NOVEMBER 12, 2024 / 9:15PM, NBIX.OQ - Neurocrine Biosciences Inc at UBS Global Healthcare Conference
Question: Ash Verma - UBS - Analyst
: Excellent. Thanks a lot for your insights. Thanks for taking the time to participate in this fireside chat. I'm very happy that we have
you here, and looking forward to more interaction like this.
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