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: Philip Nadeau - Cowen and Company LLC - Analyst
: Guys, first, I thought we'd start with maybe a brief overview of Neurocrine strategy for developing and commercializing drugs for neuropsychiatric
conditions. In particular, maybe which indications is Neurocrine most interested in? What types of targets will Neurocrine prioritize?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: On your latter point, CNS diseases are inherently higher risk and perhaps higher reward. How do you balance risk versus reward across the portfolio?
What's an optimal balance in Neurocrine's opinion?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: That's perfect. Moving to some of the specific programs, we expect Phase 2 data by the end of the year from '770 NMDA candidate. Can you maybe
start with discussing what the rationale is for using an NMDA, NAM in major depressive disorder? And how could '770 be differentiated from other
therapies for major depressive disorder?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: In terms of the data that we'll see at the end of this year or towards the end of this year, can you remind us of the design of the Phase 2 study? And
what results would Neurocrine consider proof of concept that would justify further development of '770 and suggest to you that you're on the
right path?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: What magnitude of change in MADRS is possible by day five? That seems like an incredibly short period of time.
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: And then what would be the next steps for '770 should the Phase 2 data be positive?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 17, 2025 / 4:40PM, NBIX.OQ - Neurocrine Biosciences Inc at TD Cowen Novel Mechanisms in
Neuropsychiatry & Epilepsy Summit
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Great. Moving on to osavampator, in April of last year, Neurocrine showed positive Phase 2 data from the Phase 2 SAVITRI study. And we'll get more
data this weekend.
I guess, maybe to set a background, can you give us a brief overview of the data that were disclosed in April of last year? Maybe discuss what we
expect to learn from this weekend's medical meeting presentation.
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: So on the data this weekend, I think the most controversial part of the initial disclosure was that it wasn't disclosed which dose was the one that
was statically significant. So we will see data from both doses --
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: That's great. Anything -- so I think investors will try to figure out how the doses compare and contrast. Anything else that we should be paying
attention to as we look through the scientific presentation?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: On the -- sorry, go ahead.
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: One of the questions we get on the Phase 3 trial design is why Neurocrine is looking at a 56-day MADRS in Phase 3, whereas Phase 2 had 28-day
primary endpoint. Is that because the efficacy increases over time? Do you think the day 56 results will be more impressive, more competitive?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Great. And just two more questions before moving on to '568, first, in terms of the Phase 3 data, what do you think -- what does the profile need
to be for osavampator to be competitive? What change in MADRS at day 56, what side effect profile do you think would position it to be a standard
therapy?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: That's perfect. Moving on to NBI-'568, in August of last year, you disclosed the data from the Phase 2 trial, evaluating it in the treatment of
schizophrenia. For those less familiar, can you briefly summarize the highlights of those data?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Perhaps the most controversial aspect of the data was the fact that the 20-milligram dose looked a bit better than the higher doses, at least in
terms of PANSS score. Is there a mechanistic rationale for why patients on a lower dose would do better? Do you think the difference between the
doses was real, or is it just within the noise of the measurement?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Perhaps, one of the most surprising developments in the muscarinic space over the last year was emraclidine's failure. Did Neurocrine learn anything
from that? Is there anything from that failure that informed the development plan for '568?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: In terms of the Phase 3 data, what do you think '568 needs to produce in order to be competitive, what magnitude of PANSS change? And is it
possible that '568 could compete simply on safety and tolerability and convenience even if the PANSS falls a little bit short of [COPE-M-FEE]?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Perfect. There are a number of early-stage candidates we didn't discuss specifically, including other muscarinics, a couple of new VMAT2 inhibitors,
and the selective NaV1.2, NaV1.6 inhibitor for epilepsy. Which one of those would you like to highlight for investors? Which should we start to dig
into?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
SEPTEMBER 17, 2025 / 4:40PM, NBIX.OQ - Neurocrine Biosciences Inc at TD Cowen Novel Mechanisms in
Neuropsychiatry & Epilepsy Summit
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Great. We're just about out of time, but one last question. Because this is a neuropsych day, we've focused our questions on the neuropsych
programs. But obviously, the commercialization of INGREZZA and CRENESSITY are key topics for investors. Any update or comment on either of
those you'd care to share as the third quarter approaches its end?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: That's perfect. With that, I think we are out of time. So Kyle, Sanjay, and Todd, thank you for joining us today. A very interesting discussion.
|