Good morning and welcome once again to TD Cowen's 45th Annual Healthcare Conference. I'm Phil Nadeau, one of the biotech analysts here at Cowen. It's my pleasure to moderate a fireside chat with Neurocrine. We have with us Kyle Gano, the CEO; Eric Benevich, the Chief Commercial Officer; Matt Abernethy, CFO; and Todd Tushla, IR, is in the front row. With that, Kyle, I'll kick it to you. Can you give us a brief state of the company overview, biggest strengths, biggest challenges, and what does Neurocrine need to do to create shareholder value over the next year? Thanks, Phil, and thanks to TD Cowen for having us here. You know, I will be making forward-looking statements. I'd like to direct you to our latest SEC filings for the risk factors of the business. But beyond that, let me jump into Phil's question. You know, for those of you that are not familiar with the company, we're a fully integrated biotech company located in San Diego, California. We discover, develop, and commercialize, in whole and in part, four FDA-approved medicines. And all of those, when they are approved, were first in class. I think that speaks to what we focus on here at Neurocrine. And the reason why I start there is that we didn't get to these approved medicines without a pipeline. So that's where we're actually going to begin today, is talking a little bit about the pipeline. So in the current portfolio, we have 12 programs from phase I to phase III. And I'm going to tick down all the boxes here from late stage to earliest stage in phase I. So in phase III, we just initiated our MDD trial and program with osavampator. This is our AMPA PAM. And very shortly, we'll be kicking off the phase III program for our selective muscarinic M4 agonist. Part and parcel with that is a real interest in the muscarinic category as a whole. We have the largest, deepest muscarinic portfolio in the industry. So NBI-568, our program for schizophrenia, will be moving into a bipolar mania trial later this year. And then our M1, M4 muscarinic agonists will be moving into a schizophrenia program phase two later this year as well. We'll be able to compare for the first time an M1, M4 agonist directly with an M4 agonist. Beyond that, we have a number of programs that are in phase development and phase III development that we'll read out this year. Namely, in valbenazine, we have a phase III trial in the adjunctive treatment of schizophrenia that we'll read out, as well as dyskinesia and cerebral palsy. We have a phase II trial that we'll read out in major depressive disorder as well. That's NBI-770. Beyond that, we have a couple of phase 1 programs that we'll be entering the clinic very shortly. One is NBI 675, our VMAT2 follow-on to Ingrezza, as well as a dual Nav1.2/1.6 inhibitor that we'll be pushing forward in epilepsy. So a very full pipeline. I think it speaks to this idea that this year, it really is about execution and evolution. On the execution side of things, it's bringing forward all those new study starts that I just mentioned. It's also making sure that we close out those studies that are in flight right now to deliver top-line data throughout the course of this year. On the evolution side of things, it's launching and supporting a successful launch for CRENESSITY in congenital adrenal hyperplasia, which I'm hoping we are able to speak more about here today. And it's also the evolution of the pipeline. I didn't yet tell you all the things that are going on in the preclinical phases of development. We have a number of programs that will enter the clinic later this year in neuroendocrinology, in immunology, and in gene therapy that will expand the breadth and depth of what we can do at Neurocrine moving forward, so a lot of excitement there across the portfolio, and the reason why I started with the pipeline is that all this has been made possible because of Ingrezza. We spent a lot of time here talking about Ingrezza the past couple of weeks. It is our growing blockbuster to think that eight years in, we'd be talking about a medicine that we're guiding towards $2.5-$2.6 billion in revenue is amazing. I never thought we would be here at this point. That's a 10% growth from year- to -year at the midpoint, so a very exciting product there. Thinking about all the areas of differentiation that we have with Ingrezza that range from efficacy, not just on the movement disorder, for those of you that follow Neurocrine, you probably saw last week that we announced some really interesting data that showed statistical and clinically meaningful benefits on function and quality of life measures in patients with tardive dyskinesia. This is the first time that any company, any product has shown benefits on function and quality of life. We think combining that with benefits on the movement disorder as well is going to be quite differentiating for us to utilize with our physicians and patients moving forward. The efficacy is expanding in terms of our knowledge about Ingrezza and the benefits. We also see the lack of a need for titration, which is differentiating. The first dose is an efficacious dose. We also have a specialized formulation that allows patients with dysphagia, which is about 10% of TD patients, and patients with Huntington's chorea, which is the other patient population we have approval for, helps them utilize this medicine more efficiently, and last but not least, we have benefits and advantages in certain patient populations, in particular those with hepatic impairment, so there's a lot of things to like about Ingrezza, you overlay that with the fact that 90% of the patients with TD, 800,000 patients, are still not being treated with a VMAT2 inhibitor, and there's a tremendous amount of growth still ahead. It's important to flag that because we do have 13 more years of market life, market patent protection, so that's something that we will continue to invest in over time and grow this market. Now, the reason why I ordered things here today is that we have been spending a lot of time, Phil, thinking about questions, fielding questions from investors in the community about Q1 to 2025 guidance. So I would like to spend just a minute here on that. When it comes to Q1 dynamics, I mean, there's always growth impediments that we see here this time of year. And I think there are a number of things that are new, thinking about 2025, that we just wanted to flag to everyone to make sure that we're all on the same page. Q1 is typically a slow and challenging quarter for us, but there's extra factors here that I will be a little bit more descriptive on. So Q1 is typically the quarter that we're fighting through reauthorization. Any specialty product typically sees this type of situation play out during the course of the year. And basically, what it means is that new patient starts, whether you're a new patient to Ingrezza or you're getting a renewal of your prescription, have to go back through the authorization process to get your prescription that will be utilized throughout the course of the year. And the net effect of this challenge is that it pushes out prescriptions that would normally come closer to the time that your claim was approved, get pushed out to the end of the quarter. I think that's an important consideration here because when you think about either the dynamics around Q1 or your guidance, it's important to call out that the earlier you get prescriptions in Q1, because there's an accumulation effect of revenue for each patient throughout the course of the year, the higher your revenue will be at the end of the year. So Q1 has a lot of important considerations for us when we think about not just the number for Q1, but for your guidance throughout the year. So reauthorization, not new for Q1 for us and others with specialty products. But what's new is that this year we have one less ordering week. Now, what I just told you is that prescriptions are delayed from earlier in the quarter to later in the quarter. So weeks in Q1 from a revenue standpoint are not equal. So losing that last ordering week has an oversized effect on our performance for Q1. And the other item that I'd call out, and this is something that we shared at the earnings call, our 2024 earnings call, is that we saw last year, in particular in Q4, a decrease in our growth rate for new patient starts. And we lean on that to help give us good momentum going into the new year. So without that momentum, with one less ordering week, we're certainly going to be challenged here in Q1. But we do have a lot of initiatives that are ongoing here now that will help us recover in Q2 and see an acceleration of growth in the remainder of the year, second half of this year. And that's what variables played a role into the guidance that we gave you for $2.5-$2.6 billion. I'll just call out these things that will accelerate growth here, and then we can get into these further if you'd like in our Q&A. But number one, our sales force expansion. That was something that we executed in Q4. That's certainly a significantly scaled organization now that will be out there with new messaging this year. We have the ProConnect or ConnectPro data that I just mentioned, highlighting the new efficacy data that we have with Ingrezza on function and quality of life measures. We have optimization of access across formularies, plans, as well as the pharmacies to ensure greater efficiency of prescription fulfillment. And last but not least, just overall greater investment to support Ingrezza in the areas of DTC and education that will start rolling out in the month of April. A lot of things that we'll be leaning on this year, but Q1 will be noisy, no doubt. Q2 and the remainder of the year will be areas of growth for Ingrezza. I think that's the additional detail and description that we want to add here. Part and parcel with the business, that will be ebbs and flows. We've seen this before at Neurocrine. We were just talking here earlier about COVID and Cowen being associated with that event a number of years ago. It was a period of time at Neurocrine where Ingrezza had its own challenges, and we had to adapt the business for things like telemedicine. We did that through an initial slow growth year, but we rebounded with these investments, and we've seen significant growth since then. It feels an awful lot like that now, here in 2025. That's what I'd like to say about Ingrezza. I would like to turn it over to CRENESSITY. Eric is here to share some of his thoughts on the launch of CRENESSITY. But just let me say, a really exciting time here at the company. It's what we believe is our second blockbuster. It's the first medicine approved for CAH in over seven years. It's first in class, as I mentioned early on. That's a theme here at Neurocrine, and we do believe it's going to change the standard of care. With that, changing the standard of care often comes associated with that, a measured launch. That's what we see with CRENESSITY. But we do feel that once there's traction here and utilization with the product, we'll see an acceleration to market share peak, unlike what we see with Ingrezza, which is more steady. But overall, very exciting time here at Neurocrine with the medicine that we believe has patent protection now to the early 2040s. So with Ingrezza and CRENESSITY, real anchors to the organization moving forward to further grow the pipeline. But I think I'm going to stop there. I think I've said enough, and we can turn it back to you, Phil. Yeah, that was great. Maybe we will start with CRENESSITY. Eric, can you give us an update on how the first three months of launch have gone? How has the uptake, physician awareness, payer access track compared to your initial expectations? Yeah, so first of all, just really excited about the launch dynamics that we see unfolding. Very happy with how the launch is happening. And we're actually about two months now since the approval. So just to kind of recap here, CRENESSITY was a product that had breakthrough designation, had priority review. We had a PDUFA date set for the end of December, and we actually got approved in mid-December. So an early approval on top of an earlier approval timeline. Thankfully, we were prepared for that. And actually, we wanted to start to develop the market last year. One of the ways that we did it was to hire and deploy a field team, actually a sales force and a field medical team that were out visiting endocrinology practices. They were doing disease state education on CAH. They were profiling these accounts. They were scheduling appointments for the other side of the PDUFA date, and they were doing some patient finding activity. And we think that getting a team out there in advance has benefited us on the other side of the approval. As I mentioned, we got approved about two months ago. We were really happy with the labeling, a very broad label that enables a wide range of patients with classic CAH to be treated. And so far, the receptivity from the patient community and from the endocrinology community has been very positive. Our field teams have pivoted from talking about exclusively disease state. Now they're able to talk about the pivotal trial data in both pediatric and adult patients, and of course, the prescribing information and how to prescribe it. So we're well on our way in terms of the adoption curve. And I can share just a few, I guess, the tidbits and some color in terms of what that looks like for us. This is a condition that spans patients from birth all the way through their adult years. And certainly, we look at the market opportunity in terms of being able to benefit these pediatric patients. If you look at our label, anyone four years or older could be a candidate for treatment. If you look at the prescriber universe or the potential prescriber universe for CRENESSITY, the way to sort of break it down is the pediatric endocrinologists are caring for what we think is about a third or so of the CAH patient population. There's less than 1,000 pediatric endos out there. So it's a relatively compact prescriber base. And the good thing about these doctors is that for the most part, they're pretty comfortable and experienced in terms of managing CAH patients. Most of them, in fact, have one or more CAH patients currently in their practice. The second group of doctors to think about are those endocrinologists that are affiliated with Centers of Excellence. There's less than 10 Centers of Excellence out there that are accredited by the CARES Foundation, which is the patient advocacy group for CAH. And there's a similar number of Centers of Excellence that don't have accreditation but have most of the services. These are typically outpatient clinics that are affiliated with teaching hospitals. And those Centers of Excellence, we think, account for less than 15% of the total patient volume. Most of the patients that flow through those CoEs are pediatric patients. Once you get past the pediatric endocrinologists and the Centers of Excellence, now you're into the adult endocrinology community. And there's over 8,000 endocrinologists in the U.S. Many of these doctors don't have a CAH patient or have even treated a CAH patient. So that's sort of the, I'll call it the third wave of adoption, so to speak. So in terms of setting expectations of what uptake is going to look like, certainly we expect earlier and more rapid adoption amongst the pediatric population and through those pediatric endocrinologists. Also, the patients that are being cared for at those Centers of Excellence, we would expect more rapid adoption. And then over time, as we reach more of these adult endocrinologists and we continue to do that patient finding work, that's where we'll see the majority of the adult population get put on treatment. It's early days yet. The other element that I can share is sort of how things are sort of shaping up from a reimbursement perspective. CRENESSITY is a brand new medicine, as you know. It's a rare disease drug. It's a specialty drug. We've partnered with a rare disease pharmacy called PANTHERx Rare. They're an excellent pharmacy. We have been working with them over the years with Ingrezza, and they have delivered great service to our customers in the TD world, and now they're doing the same in the CAH world. When a doctor decides to prescribe CRENESSITY, the way that it works is they complete a treatment form that captures most of the information that we believe a health insurance plan would require to be able to adjudicate that claim. That gets sent into PANTHERx Rare. They start working that claim, and if after about a week they haven't gotten approval yet for reimbursement, they'll go ahead and ship the patient their first month's supply. We have a quick start program, which is free goods. So essentially, not delaying treatment initiation for these patients. We expect the majority of patients would get started initially under that quick start program while PANTHERx Rare continues to work with the insurance company to get that claim approved, so early in the launch, because it's a non-formulary product, essentially all of these initial prescriptions have to go through a formulary exceptions process, which can look a little bit different from health plan to health plan, and most of these patients are commercially insured, so that's really what's been happening here in the initial two months of this launch. The treatment forms are coming in. PANTHERx Rare receives them. They start working the claim, and what we have found is that, as expected, most of these patients are getting an initial product supply through that quick start program. But we have been pleased to see that there have been examples of patients that have not required that, that the health plan has approved their claim within that first week, and they're getting started initially right out of the gate on commercially reimbursed product. So that's an important factor for us to continue to track over time. The other thing that I'll say is that over time, we do expect these health plans will start to look at CRENESSITY, and they'll start to formulate coverage criteria. We have had a couple of plans publish their coverage criteria. In fact, one did their review only a week after CRENESSITY was approved. But we will see many of the plans kind of push that out into the second half of the year. Some will look at CRENESSITY and do a formal formulary review, and they'll publish their coverage criteria. Others will decide not to bother because it's a rare drug in a class of one, and so they'll continue to cover it on an exceptions basis, but I think the coverage criteria will sort of take shape over the second half of the year. In the meantime, though, we expect CRENESSITY will be very affordable. Most of these patients are commercially insured, and we're able to buy down their copay to zero, and the second largest insurance segment is Medicaid, and these patients for branded products have a copay of either $10 or $12 per month, so the vast majority of patients will pay less than $12 per month, so very affordable from that perspective, and we're very confident in our ability to get these claims approved, and like I said, we've had a great experience working together with PANTHERx Rare. So all in all, receptivity from the physician audience and from the patient community has been very positive. Obviously, there's a lot of people that we still need to reach and educate. We need to walk these endocrinologists through the data and through the labeling, but our team is making great progress in that regard, both the commercial sales team as well as the field medical team, and I started off by saying we were off to a great start, and I couldn't be more pleased, So maybe just to add a little bit to that, I mean, there's a lot of excitement, obviously, at Neurocrine launching a second medicine. It's one that we've been spending the better part of 30 years trying to discover and develop, so I think seeing that get over the finish line is very rewarding for the team. But just as an organization, beyond that, to have a second product that we believe will be a blockbuster, to add certainty on continued revenue growth for the organization, for investors, revenue diversification. And I'm hopeful that you get a hint, at a minimum, if not conviction, that we have a pipeline that's sustainable, that we can continuously bring out new medicines for patients. CRENESSITY is certainly going to help with that versus just looking at Ingrezza each quarter. So a lot of things to be excited about here in this milestone that CRENESSITY offers the organization. It's interesting. In a meeting earlier today, somebody asked Erick, how's the launch going? And in one word, he said, great. I can say as a finance guy, between having a $2.5 billion-plus medicine and something that's going to grow like CRENESSITY, the financial profile of our company and the flexibility that we're going to have to continue to invest and grow a company and build a leading neuroscience company, it's quite exciting. I'd be remiss not to call this out because somebody also asked me earlier, what should I expect in revenue for CRENESSITY? We've not given a guide yet. It took us four years for Ingrezza to give a guide. But I would say the number one metric that we want you to focus on coming out of the quarter is going to be enrollment forms. Enrollment forms are going to be a reflection of the new patients that have been prescribed medicine. And that's going to be able to show you the strength and the underlying demand for the product. So that's one aspect that I think I would just point you to. We'll, of course, provide information and insight into reimbursement and what we're seeing there. But enrollment forms are what matters most. And then the last comment that I'd make, it's going to be really cool to see in the second quarter when some of these new patients are seeing their biomarkers and getting blood draws and seeing what happens to their glucocorticoids. And you think about what causes the ultimate adoption to be higher, it's going to be if the drug works as advertised. And what we saw in the clinical trials was significant reductions in A4, significant reduction in glucocorticoid. We had over 90% of patients roll over into the open label extension study, and they're still on it today. So I think that everything that we have from a clinical perspective would point to a very durable, important medicine for the CAH patients. I would say we feel quite fortunate sitting here today, Phil. On the enrollments, there was controversy going into the Q4 report, exactly what was going to be reported. Are you going to report the Q1 enrollments on the Q1 call? As of what date will you give us this enrollment? It will be through the month of March. Through the end of March. Yeah. We'll be giving calendar quarter enrollments on a quarterly basis. We'll see how metrics evolve from there. There's not really a good analog that you could point to in terms of what you should assume around compliance and persistency and the rate of adoption. But I think as Kyle mentioned and Erick, we would expect this to be a medicine that is adopted in a much shorter path to peak than compared to Ingrezza. Yeah. Oh, I think it's worth clarifying when it comes to the enrollment forms for Q1. Like I mentioned, most of these patients initially will be on the free goods program. And so you think about the treatment forms or the enrollment forms as sort of the NRXs that are coming in the top of the funnel. And then net sales is what's coming out the bottom. And so someone started early in the quarter, most likely they're going to be on at least a month of free goods and then maybe a month or two of reimbursed product. And so there's a little bit of a shift time-wise between starting treatment and actually getting to reimbursed product. But I do think that as we get further into the launch, we'll see more alignment between treatment forms coming in and revenues. I'm sure it's only a matter of time until hedge fund calls me and asks, what is a good number of enrollment forms for Q1? So I'm going to ask you guys because I don't know what the answer to that question would be. Any thoughts on how we should frame expectations for Q1 enrollment forms? I think framing expectations for the overall market expectation here. You have over 20,000 patients. And this is CFO math I've been accused of. So you're going to have to give it an appropriate haircut. But you have over 20,000 patients with CAH. What we saw in the clinical trial, Dr. Auchus, the thought leader, says up to 80% of patients with CAH go in and out of control, and they may benefit from a medicine like CRENESSITY. So those are the two highest macro items in terms of the ultimate opportunity. The pace of adoption, I think you can look back and just say, well, gosh, these patients only go into the clinician's office one to two times per year. So there's going to be this natural phasing if you just straight line the patients coming in every six months or nine to 12 months. That's one aspect. Then the second question you would ask is then what percentage of prescribers are actually willing to treat those patients and at what rate? So no exact number for you, Phil. But I would just say that we're bullish over the medium and long term for CRENESSITY, just like we are for Ingrezza. Maybe one last question on CRENESSITY before a couple on Ingrezza. TD Cowen projects 2025 revenue for CRENESSITY of $55 million and $1 billion in 2030. Any feelings about those numbers? Do they provoke any emotions? The emotion that I would say is provoked is with our sales price, call it $400,000, only takes 2,500 patients to get to $1 billion. So I will be very disappointed in ERIC and team if by 2030 we're not at 2,500 patients. Our internal projections are higher than that. But on the flip side, it's up to us to help these patients. And I think if the patients are helped and benefit from the medicine with the tight-knit patient community, there's going to be a lot of adoption here. Perfect. I know we only have a couple of minutes left. On Ingrezza, Kyle, your opening remarks were very helpful in clarifying what happened or what is likely to happen in Q1. Two questions on that. First, Matt, I think in your prepared remarks on the earnings call, you talked about competitive pressure and things going on at payers. What happened in Q4? What were the dynamics around that? And how confident are you that you're now properly resourced to counter payer issues and the competitive issues? Well, it's probably good for Eric to answer part of that. But what I can say is that from an investment perspective, the number one investments that we've made over the last handful of years has been sales force expansion. We've found, by and large, call frequency, keeping tardive dyskinesia on the radar of a clinician largely leads to a new script getting written and ultimately filled. So from a share of voice perspective relative to our competitor, I'm very excited to see our new sales force in the field. Calls are going up in a significant way. Education is going up. And so we do expect that the market is going to develop in a very positive way. On the payer front, still pressures that, as you would anticipate with the overall environment associated with the IRA and those who participate in Medicare Part D coverage. Our goal is to ensure that if a script gets written, a patient ultimately ends up on Ingrezza, and these are new patients, so a lot of effort going on right now at payers associated with payers, associated with formularies, associated with ensuring a medicine can work through the exceptions process, and then at the pharmacy level, that they don't get worn out through this process, that payers might be taking them through to ensure pharmacies actually lead to fulfillment, so early days on some of these activities, but the leading indicators associated with their sales force, I would say, are positive, but back to Q1, just to make sure we address it, because it's probably the number one piece that buy side gives me feedback on relative to the sell side, is just to make sure that the sell side has fully factored in this phenomenon of one last order week. And just to be clear on what that means is that typically wholesalers order on a Monday, product gets delivered on a Tuesday, and that's when revenue is recognized. In the first quarter, you only have 12 Tuesdays. You have 13 Tuesdays in Q3, which would be a normal Q2, which would be a normal quarter of 14 in Q3, which is more than normal. And so you do have this phenomenon. So our main focus for Q1 is beyond the noise of what revenue you get reported, the focus is really on, did we ensure that patients stayed on therapy through the reauthorization process? And then the second key point that we'll be looking for is, did the pace of NRX pick up like what we would have anticipated in the second half of the quarter? Because that's really what sets you up for the rest of the year. Eric, do you want to talk about the sales force and how you're countering Teva a bit? Yeah, just to kind of build on what Matt was talking about. We have a competitor out there that's pretty aggressive. They did a, I would say, they increased the competitive pressure last year. They did a sizable expansion of their sales team in late 2023 and early 2024. They rolled out a reformulated version of their product that got them to once-a-day dosing. They fired up a DTC campaign. We started to feel the tangible effects of all that mostly in the second half of last year. Combine that with the payer dynamics that Matt was talking about from payers, making it a little bit more difficult for those new patient starts to get approved, sort of slowing down the approval process for NRX. Those two things combined led to a slower pace of new patient adds in the second half of last year and most acutely in Q4, and that's really that momentum that we were talking about coming from 2024 into 2025 as part of the calculus for our guidance, and I think that it's important to emphasize why new patient starts have such an impact on our business. New patients, NRX is actually just a single-digit percentage of total prescriptions in any given week, month, or quarter, so it's not a large magnitude. But the reality is every new patient start accounts for a handful of refills, and there is a cumulative effect. When you have a really good quarter from an NRX perspective, from a new patient start perspective, you really see the impact of that several quarters later. And so for us to have a slowdown in the second half of last year, we can predict that it's going to impact really most acutely the first half of this year. And then you layer on what I would call the disruption of scaling up, hiring, training, and deploying a new sales team. In the near term, that can affect the overall productivity of your sales force. And we've seen it in the past when we did expansions. It's a little bit of a distraction for the legacy team. They're kind of pulled away to help with recruiting and training. And then, of course, there's customer relationships. They get severed. New people, they get dropped into these realigned territories and so on. And so it takes some time for the new hires to get up to the same level of productivity as the legacy salespeople. And the way that we look at their productivity is based on their ability to generate new patient starts. And so in the near term, you see a dip in the productivity of the sales team. And then over time, as the new hires become more proficient and they reach the same level of productivity as the legacy team members, you see the full benefit of that and the value of the expansion. And as Matt said, we are seeing all the metrics trending in the right direction in terms of increased call activity, increased peer-to-peer programming, increased sampling activity, et cetera. So things are moving in the right direction. And we are still in the process of optimizing that team. But in Q1, it's sort of the post-expansion dip phase. Perfect. With that, I think we're out of time. Thanks, everyone. Thank you. Things are going great with CRENESSITY.