Neurocrine Biosciences, Inc.

during the question and answer session. Please note today's call will be recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead.

Thank you, Chloe. Welcome to Nurocrine Biosciences second quarter 2024 earnings call. With me are Kevin Gorman, our current Chief Executive Officer. Matt Abernathy, Chief Financial Officer.

Ivory Roberts, Chief Medical Officer. Eric Berger, Chief Financial Officer. Eric Berger, Chief Financial Officer.

during the question and answer session. Please note today's call will be recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead.

Thank you, Chloe. Welcome to Nurturing Biosciences' second quarter 2024 earnings call. With me are Kevin Gorman, our current Chief Executive Officer, Matt Abernathy, Chief Financial Officer, Irie Roberts, Chief Medical Officer, Eric Benevich, Chief Commercial Officer.

Todd Tushla, please go ahead.

Thank you, Floyd. Welcome to Nurocrine Biosciences' second quarter 2024 earnings call.

With me are Kevin Gorman, our current chief administrative officer, Matt Abernathy, chief financial officer, Airey Roberts, chief medical officer, Eric Benevich, chief commercial officer,

view of the medicine, and we are excited to get to the producer data at the end of the year.

The drug will change. The entire drug will change neuroscience in the world.

And this will become even more apparent next year as our biologics enter the clinic.

I'll shut up now and turn it over to Matt. We are also updating our GAAF SGNN.

financial guidance for 2025, I do want to highlight a few items for you to consider while you develop your operating expense expectations. For SG&A, over the past several years, our focus has been on generating top-line revenue growth, reaping the benefits of previous investments. Heading into 2025, our investment will increase with an incremental $125 million million to support our top priorities.

With this, we will be successful in delivering the growth.

Regarding R&D investments, although we are still waiting for important data cards to turn over this year, I want to emphasize our willingness to advance our position with financial flexibility to advance and potential medicines, like our AMPA program, through the clinic over the second half of this decade in a non-diluted manner. A lot of work ahead, but very exciting times here at Nuremberg.

With that, I'll hand the call over to Eric. Thanks, Matt.

The momentum we saw within resident Q1 certainly carried through into our performance last quarter. Q2 growth of over 30% versus the prior year is a testament to the strength of our underlying business across Tardive Dyskinesia and Huntington's Disease Korea. With sales approaching $1.1 billion in the first half of this year, we've raised and narrowed our full-year sales guidance, as Matt mentioned, to a range of $2.25 billion to $2.3 billion at the top end. At the midpoint, this range equals approximately 24% growth versus 2023. As Kevin noted from the podium of a CellSight conference in June, we've learned a lot about the TD market since the launch of Ingresa seven years ago. It's critically important that we continuously evolve our approach and appropriately invest in order to help even more patients that can benefit from Ingresa therapy. We've twice before increased the size of our sales team, the first time early in the launch by adding more sales specialists to the existing one-team structure, and the second time by splitting and creating dedicated teams for our key business segments in psychiatry, neurology, and now in long-term care. The TD market has grown substantially over time in terms of the number of HCPs diagnosing and treating people with TD, and we have seen that these HCPs are promotionally responsive. Each time we expanded Salesforce in the past, we saw a clear resulting increase in diagnosis and treatment with Ingresa, usually a couple of quarters after deployment of the new salespeople. Every year, we carefully evaluate the adequacy of our commercial footprint to meet the needs of our HCP customers and the patients they care for. We recognize that there remains much more opportunity to reach and educate HCPs that care for patients living with TD or HC Korea. and that we need to strategically and carefully adjust our commercial resources to meet their needs. With that as backdrop, as Kevin mentioned in June, we're increasing the size of our psychiatry and long-term care sales teams this year to help accelerate appropriate diagnosis and treatment with Ingresa. We plan to have the new team members in the field by the fourth quarter of this year. As with prior sales force increases, We expect contributions from the new salespeople once on board to be tangible a few quarters later. We continue to invest in Ingresa because we have strong conviction in the opportunity. In addition to investing in our team, we are investing in the brand. We're proud to have recently made available our new Ingresa sprinkle formulation. With this launch, only Ingresa offers the benefit of a sprinkle formulation that provides an alternative administration option for patients who experience dysphagia have difficulty swallowing or prefer not to swallow a pill. Our data tell us that upwards of 10% of people living with TD or HC-CREA experience dysphagia or difficulty swallowing. It's important for us to provide this new option to patients who want the benefit of treatment without the potential challenge of swallowing a pill. Congresa's sprinkle capsule is easy to open, and the granules can be sprinkled on soft food, such as applesauce, yogurt, or pudding, for oral administration. Congresa is the only VMAT2 inhibitor to offer one pill, once a day dosing, with no complex titration to reach an effective dose, offering both oral capsules and a sprinkle formulation to meet the diverse needs of people living with TD or HD chorea. And given the long runway of exclusivity for 14, more years out to 2038. Expanding our commercial footprint and investing in the brand gives us the opportunity to capitalize on the significant growth opportunities that remain ahead in the TD and AC Korea markets. Now, shifting to Kronesser Fund. Just as we've had a learning launch in TD with Ingresa, the same concept will apply to Kronesser Fund in congenital hyperplasia, or CAH. People suffering from CAH have had no new treatment options in over 70 years. Before the potential approval of Cronosurfant at year end, our rare endocrinology commercial team, which is now fully hired, is focused on a number of market development initiatives to better understand and inform the CAH community. In fact, we held a kickoff meeting for our endo-franchise team in July, and I was struck by their excitement and enthusiasm for really helping the CAH community. Because of the terrific clinical profile of Prenesophon that emerged, the clear unmet need in CAH, and our reputation as a great place to work, we've been fortunate to attract members to our endo team with, on average, more than 20 years of biopharma experience and more than 10 years focused on rare diseases. For the balance of this year, that team will focus primarily on delivering disease education to endocrinology healthcare providers, featuring our What's the CAH initiative. This unbranded educational resource aims to close the gap in CAH understanding and acknowledge the frustration and challenges experienced by members of the CAH community living with and managing this rare genetic endocrine condition. With priority review in hand, we'll be ready to bring Pranisapant to patients in the new year quickly after FDA approval. We've demonstrated with Ingresa that we can successfully launch into and build a new therapeutic category. We're committed and we're excited to do that all over again for Nessar Fund. So with that, I'll turn the call over to my colleague, Dr. Ivory Roberts, our Chief Medical Officer.

Thank you, Eric, and good morning to everyone on the call.

I'm pleased to share that we made substantial progress

price line in the last quarter, including delivery of several important chemical milestones.

I'll begin with NBI 845, a potent highly selective, potentially first in class, positive allosteric amphimodulator.

As a reminder, in April, we announced top-line results from the Savitri study in patients with major depressive disorder with inadequate response to the currently available treatment.

The primary endpoint in the study was achieved with NBI 845, which presented both the adult and pediatric Phase III capitalist study results at the ENDO meeting, with parallel publications results from both studies in the New England Journal of Medicine.

In July, the FDA accepted the Cronessa font filing and granted priority review, thus further recognising a potent, highly selective, potentially first-in-class positive allosteric AMPA modulator. As a reminder, in April, we announced top-line results from the Savitri study in patients with major depressive disorder with inadequate response to currently available treatment. The primary endpoint in the study was achieved with NBI 845, working towards an end-of-Phase II study meeting with the FDA later this year to support the initiation of registration studies for NBI 845 next year. Turning to Chronesophont, in June, we presented both the adult and pediatric Phase III catalyst study results at the ENDO meeting, with parallel publication of the results from both studies in the New England Journal of Medicine. In July, the FDA accepted the Kronessa-Font filing and granted priority review, thus further recognizing the seriousness of congenital... In the last quarter, two new Phase I molecules entered the clinic. NBI 986, a selective M4 RNA, and NBI567, an M1-preferring muscarinic agonist from our muscarinic agonist portfolio, which now totals four early-stage compounds in development. We'll provide more color on these programs and the remainder of the Phase 1 portfolio as they advance towards Phase 2. All in all, I'm pleased with the continued evolution of our portfolio, which reflects the deepest broadest pipeline in neurocognitive history. I look forward to continuing to advance and expand these efforts to provide meaningful new therapies for patients living with chronic debilitating diseases in the fields of neurology, neuropsychiatry, neuroendocrinology, and neuroimmunology. Our goal remains to deliver important improvements in clinical outcomes for Patients with great needs, but few options.

And for one last time, back to you, Kevin.

Thank you very much, Ari.

So you can't imagine how happy she is that it's one last time that she's getting the exact thing. We're ready for your questions this morning.

And we'll take our first question from Phil Nadeau with TD Cowan. Your line is open.

Good morning. Thanks for taking our question. Kevin, first, congrats to you on a tremendously successful career at Neurocrin. You've really built a biotech bellwether, and your efforts have helped countless patients.

So we hope you have a long, happy, and healthy, well-deserved retirement. Thank you very much, Bill. I have a question for you.

Could you review for us that data? What's known from Phase 1 in terms of muscular side effects, cardiovascular effects, the target, or any other information that's been released? Thanks.

Yeah, thanks, Phil. So, as I mentioned on the comments, we will, in this quarter, be delivering the data from our Phase 2 concept study in schizophrenia and kind of articulated what you can hope to see and plan to see as a result of that. You know, in terms of the... For that study, what I can say is that we had a broad range of both preclinical data and phase one information that made us very confident in terms of the safety and tolerability of the doses that we were choosing to take into the clinic.

And we saw, as expected, the range of muscarinic-related pharmacology.

some hints around the potential differentiation moving forward for this selective M4 agonist. This is a dose-finding study, and the doses that we took into the study reflect our confidence in terms of the range in which we anticipate seeing the pharmacology of interest. And so it's up to potentially four cohort studies. Each independent cohort is essentially chosen in this adaptive fashion on the basis of the tolerability seen in the previous slide.

And have you disclosed the adaptive rules?

By what rules are the patients shuffled between the arms?

We have not disclosed that. What I can say is there is an independent DMC that actually reviews tolerability data for each cohort as we go through the study and makes the recommendation or guides the dose for the next cohort. We do not know those doses in terms of what the total dose in the study is, but obviously it's not going to be very long for this quarter for us to get to those data.

And during our call-up that we're going to have here this quarter when we review the data, we will spend time going through the study design to make sure there's a lot of clarity around that.

That's very helpful. Thanks for taking our question, and Kevin, congrats again.

Thanks a lot, Bill. And as I was going through getting prepared for the day, I made the observation that probably You and I have worked together, I'll use that term, longer than any other pair of CEO and analysts. We both grew up together, says Bill.

We did. We did. I think it's been a couple decades.

Yes. Take care. Thanks. You too.

We'll move next to Paul Matisse with Stiefel. Your line is open.

Hey, thanks for taking my questions. Excuse me.

A lot of fun working with you and talking to you. I have another question on the muscarinic.

There's been a lot of conversation about

expectation is, whether that's kind of important to you.

And also just GDI side effects and whether you're expecting something from the mechanism here. So this is an M4 selective agonist. Thanks a lot, Bill. And as I was going through getting prepared for the day, I made the observation that probably you and I have worked together, I'll use that term, longer than any other... ... We did. We did. I think it's been a couple of decades. Yes. Thanks, you too.

Your line is open.

Hey, thanks for taking my questions. Excuse me, and Kevin, I'll echo Phil's congratulations. It's always been a lot of fun working with you and talking to you. I have another question on the muscarinic. There's been a lot of conversation.

or CEO or analyst that I can think of.

We both grew up together, says Bill. We did. We did. I think it's been a couple of decades. Yes.

Thank you. Thank you. Excuse me. And Kevin, congratulations. It's been a lot of fun working with you and talking to you. I have another question. There's been a lot of conversation. We did. We did. I think it's been a couple of decades. Yeah. Thanks. You too.

We'll move next to Paul Matisse with Stiefel. Your line is open.

Excuse me. I have another question on the Musker NX.

What your expectation is, whether that's kind of important to you, and also just GI side effects and whether you're expecting something that's more MRAC-like or CAR-like.

I have another question on the muscarinic. There's been a lot of conversation within a range of different that we have a review further studies should be in the sense that we. On the first I went back to it.

You know, Kevin's left quite a legacy here at NERC, and really I've been honored to work with him in the past 25 years.

Thank you, Jason. I've been here this morning.

You know, Kevin's left quite a legacy here at Nuremberg, and really I've been honored to work with him the past 25 years.

It's rare in this industry that Thank you. They have been honored to work with them the past almost 25 years. It's rare in this industry that you can really work still ahead, but also

You know, Kevin has left quite a lot of legacy here at NerveWorks, Brandon, and really I've been honored to work with him in the past. Well, almost 25 years. It's rare in this industry that you can bring to patients is a company that's in the strongest financial position that we've been here at NERC, and certainly in my time, $1.7 billion in cash.

There's a lot of things that we can do to add.

Thanks, Jay. You gave me probably the toughest question here this morning. You know, Kevin left us quite a legacy here at NERC, and really I've been honored to work with him the past almost 25 years.

It's rare in this industry that you can bring

This morning, you know, Kevin's left quite a legacy partner and really honored to work with him in the past.

Almost 25 years. It's rare. You can. Still ahead. Thanks, Shane. You gave me confidence.

The toughest question here this morning. You know, Kevin left a legacy here at Neurocrime and really I've been honored to work with him the past almost 25 years.

It's rare in this industry that you can't We're still ahead. Thanks, Jeff.

here at Neurocrime and really have been honored to work with them the past 25 years. It's rare in this industry that you can bring... Thanks, Jay. You gave me probably the toughest question here this morning. Kevin's left I have a legacy here at NERC, and really, I've been honored to work with them for almost 25 years.

I've been a part of the NERC industry for almost 25 years. Thanks, Jay, for giving me the opportunity to answer this question.

You know, Kevin's left a legacy here at Neurocrime and really has been a part of the work he's done in the past. Well, I'm