Good morning, welcome to Day Two of the Barclays Global Healthcare Conference. My name is Carter Gould, Senior Biopharma Analyst here at Barclays. I am pleased to welcome Neurocrine Biosciences, recently celebrating their 30th anniversary. Joining us on stage, Kevin Gorman, CEO, and CFO, Matt Abernethy. Kevin's gonna make some opening comments. I will make. Thank you. I'll keep them brief. Wanna thank Barclays, wanna thank you, Carter, for the invitation here. We always love coming to this conference in Miami. I would also say that we are going to be making forward-looking statements, so I would refer you to our more recent SEC filings. As Carter said, Neurocrine just recently celebrated its 30th anniversary. We're a guide in the world neuroscience company. What does neuroscience mean to us? That means neurology, neuropsychiatry, and neuroendocrinology, and hopefully someday, neuroimmunology. We have a rapidly growing franchise in tardive dyskinesia with our drug INGREZZA. Also looking forward, knock on wood, that we have a PDUFA date for August 20th of this year to extend the indication base into Huntington's disease. We have a nice deep pipeline of 12, 13 compounds in there. 12 are mid- to late stage. Of those, five are registrational studies. We have data rich over the next 18-24 months. Just this year, we're going to be, as I said, looking forward to the August 20th PDUFA date for Huntington's disease. We're also looking forward to both of our phase III studies in congenital adrenal hyperplasia reading out second half of this year. A phase II study in focal onset seizures reading out in the second half. Also late in the year, a phase II study in anhedonia that is going to be reading out from our psychiatry portfolio. We are well capitalized. We have, as I said, a growing franchise, with INGREZZA. The drug is recognized by patients and prescribed to be highly effective, really easy to use. I'm gonna stop there. Okay. And- Perfect. Ton of questions to get to, but I wanted to toss one over to Matt just to start things off. Clearly been in the news today, or not today, over the past few days around SVB banking and exposure there. Maybe you could help kind of frame any exposure you may or may not have. Well, it's a pretty clear answer. We have no exposure. I'd say we feel fortunate even though the capital markets are a little bit volatile at the moment. We feel quite fortunate to have a growing franchise in INGREZZA that's generating a lot of cash, allowing us to make a lot of investments and, you know, from where does our cash sit perspective, very safe, high liquidity. We feel fortunate to be where we're at, Carter. Okay, great. Let's move on to the meat of this. Let's talk about INGREZZA first. Sure. Not surprised there. You guys gave guidance not that long ago. When you think about the drivers that are gonna, you know, drive that growth in 2023 and beyond, can you help frame some of those for us as well as kind of touch where you think long-term diagnosis rates can go? The guidance that we gave for INGREZZA, and it was only in TD, for 2023. We did not include anything potentially for HD in that because it's not an approved indication. It's gonna be happening very late in the quarter. Our guidance was $1.67 billion-$1.77 billion. The midpoint would be an increase of $300 million over last year's. Really doing quite well. There's a good amount of tailwinds that we have this year with INGREZZA is that, number one, I would say this was the first full year of having our expanded sales force. Last year on April 1, we had launched a 60% expansion of our sales force. Probably as important as the size of the expansion, for the first time, we split the sales force into three different units. The largest of which calls on psychiatrists and healthcare providers in psychiatry. The next largest is then focused on neurology. If you recall, that used to be our reps split those two. They were calling on both psychiatrists and neurologists about an 80/20 split, I would say that they did. Now we have them focused, two different sales force focused solely on those two areas. The third area, which is brand new for us, which we've been wanting to go into for some time now with the opportunity to do it's in the long-term care environment. That is like a completely new launch for us. We've not called on long-term care prior to this. That expanded sales force is one of the real nice tailwinds that we have. In addition, we have refreshed and launched a new DTC campaign in January of this year. We had our first DTC campaign full year was last year. We launched it was about 18 months back. For two years prior to that, we had an unbranded direct-to-consumer campaign that went on. These direct-to-consumer campaigns we found them to be very fruitful. All the metrics that you use to measure them, how much going to your website, length of time they spend on the website, number of clicks through the website, registering with us. All of those were well above our expectations and industry norms. Probably most important, when we finally contracted to have the ROI analysis done on the branded DTC, it came out quite positive, higher than industry standards. We've re-upped again for all of 2030, as I said, with a fresh campaign. We keep learning as we go along. That I'm very happy with. In addition, we've learned a lot on how to equip healthcare providers who are still very much in the telemedicine phase. I think we've learned how to deal with that. I think we continue to get better. We continue to develop more tools for those providers as time goes on, and I think that's going to be very important also for them. Did I leave... What I would say is that diagnosis rate is about 30% diagnosed. Long way to go. Yeah, we're not going to get to 100 diagnosed, but we're going to do a heck of a lot better than 30%. Of those 30% that are diagnosed, still half of them are not being treated with a VMAT2 modulator. That, you know, that means that when you add all that up, 85% of the patients are still suffering needlessly out there. This is, this is an unplowed field still to this day. There's a lot of blue sky out there for us to bring this treatment to patients. As we've been talking about our exclusivity based on intellectual property took us to 2029. We got two years of matchment. That takes us to 2031. Internal and external counsel now have told us that we can feel very comfortable with 20 Orange Book patents to be talking about exclusivity lasting mid-2030s. That's why you see us investing so much into INGREZZA, and for a portion of that, I'll call it valbenazine, into HD, into our sales force, into DTC. You also see us going into utilizing valbenazine in a phase three trial that'll read out next year in an adjunctive treatment of schizophrenia. You see us in, the dyskinesia associated with cerebral palsy, that we have a phase three study in. There's a lot of investment because we have a lot of runway with a highly effective, easy to use and, real nicely tolerated, drug that we have there. Perfect. You know, I think Kevin, and we get asked this question a lot, Carter, just about the investment and what's the financial return on that investment? Because when you think about the direct to consumer advertising campaign, it's around $100 million. The expanded sales force, are we seeing financial leverage? I think what you can see on our expense guidance this year within SG&A, it's going up around $100 million. Top line is growing around $300 million. We are showing about 300 basis points of operating leverage. It's just really a question of what do you do with the rest of that cash, which has been invested primarily into R&D. As Kevin said, with the growth that we expect this year and for the years to come, you're going to continue to see SG&A leverage as we look into the future. Okay. Wanted a couple of points to kind of dive in deeper there. First, on the LTC segment. Is this just going to be one of those things that's going to take time and it's going to take years of investment? Are there certain obstacles that you think you need to get past that will sort of unlock that opportunity? There have been years of investment leading up to it. We had planned on going into LTC back in about a 2019, 2020 timeframe. That got kiboshed. Sure. When we saw that the LTCs were opening back up again. We put the plan that we had in place but on the shelf into motion. The first part of it is actually not the sales force. One of the first obstacles that you have to go into is that there's certain pharmacies that dominate LTC. You first have to get on formulary of those. We did the work, we got onto those, so that was fine. Now we're launching at LTC and as I say, it's like a new launch in the LTC. LTC, we use that one term, but it describes such a wide range of different treatment environments, from group homes to inpatient psychiatric care to elder care to learning disabled facilities. We're in all of those. There's about 10%-15% we estimate of the TD population is in LTC right now. You have many different advocates within an LTC environment. They're different from LTC- to- LTC that your salesperson and your medical people need to go into to talk to educate, and then empower to diagnose and treat tardive dyskinesia. We're at the very beginning of that. I would say that it will. I would think that it's going to match somewhat the way that we saw it. When we went into community mental health centers, which is the first place that we went into. It takes a while to get going. You're going to start to see the ball really rolling. We haven't been in LTC before. Okay. You guys have been pretty straightforward in acknowledging the risk around IRA as well. Even more important than that, I think you've acknowledged the uncertainty r elative to some of your peers that, I think see this as a more firmed up than maybe it is at this point. Against that backdrop, how do you sort of, plan around the business around these potentially drastically different scenarios and more importantly, just the underlying uncertainty around what implementation may or may not look like? Yeah. It, it is something everyone hates uncertainty. We do, the markets do. Over the next 18 months to 2 years, at least through this, through 2024, you're not going to see anything, I think, done legislatively. It's all going to be through the administrative arm, CMS. How are they going to administer this, the rollout of it. The ones that are going to deal with it, the first are going to be the large pharmaceutical companies, and I think that's good. I would. They are more sophisticated in a better position, in a number of ways in order to lead the way here on how that on how that's going to roll. We're fortunate within biotech that we qualify for the two of the exemptions of the IRA, the small manufacturer and then the small biotech. Which means that the full effects of IRA phase into us from the Part D redesign from about 2025 to 2031 in that. Actually, the early years of that, it's a net advantage economically to us than how we take Part D right now. When it comes to drug price negotiation, I would say that if that, you know, as designed and sits here today, if it stays exactly the same, we'll start feeling the drug price negotiations in 2029 phased in over two years, so 2031 would be the first that we would feel it there. What I would say is that it changes really nothing about how we deal with INGREZZA. That's just an exceptional drug, and it's growing quite rapidly. Whatever impact that we're gonna have from price negotiations, it's gonna be off of a very, you know, successful drug as we think about, you know, eight to nine years from now. If that haircut does exist then, whatever that haircut that they're going to be put in place, it's gonna be off of a very successful drug that is valued by patients and customers, in at least, I would hope, two indications at that point, potentially more. When it comes to the rest of our business, we have been investing in our R&D in order to acknowledge where the science has gone in the last seven to 10 years. That means that whereas neuroscience and neurological disorders have mainly been addressed by symptomatic treatment, utilizing orally active small molecules, that's not going to be the case. By the end of this decade, you're going to see that there are gonna be neurological disorders that are going to be disease modified or potentially even curative, utilizing large molecules. We've been investing heavily at Neurocrine into that area of not only protein therapeutics, including antibodies, but also gene therapy. We've been doing that for several years, and we have all those capabilities just about concluded in-house. You're going to see coming from us probably our first large molecules coming out in 2025. You'll see multiple of them hitting the clinic from us each year after that, so that by the end of the decade, I look to Neurocrine to be one of the leaders in neurosciences, with if not disease modifying curative therapies. We'll still stick to our knitting when it comes to small molecules, because when it comes to neuropsychiatry, you just don't see that large molecules really have a place yet in psychiatry. That is still always going to be small molecules, at least out as far as we can look right now. It's a good segue as we think about business development. You clearly started off the year doing Voyager. I'd say there was certainly a knee-jerk reaction to that deal in the marketplace. Couple of things. One, can you just talk about you know, what gave you conviction to go back with Voyager sort of 2.0? Also maybe Matt can comment on what this means about, you know, sort of your firepower to still do deals and if Voyager rules in, rules out potential things going forward. Why don't you take the second half first, and then I'll pick it up. Yeah. Yeah. The second half is quite easy. It doesn't impact our financial capacity. If we wanted to invest in a larger transaction, we still have the firepower to be able to do that. It really comes down to making sure the asset That we would potentially acquire at scale. I think I've commented publicly $3 billion-$4 billion. You know, it would have to be something later stage or commercial that would really be transformative, in particular to our medium-term revenue growth profile. So the Voyager Therapeutics transaction is really an investment we're making, as Kevin Gorman said, to be positioned to be in a place to do to have the disease modifying or curative therapies tenured. We did the first deal with Voyager almost four years ago. Over that period of time, we worked with Voyager carefully. We built up a lot. What we always do with collaborations, whether we're the larger party or the smaller party, collaborations are more than just a drug-by-drug specific there to build up capabilities, expertise. We built quite a bit of expertise over the last four years in gene therapy in-house. Working closely with Voyager, what we were able to see, we have, we had three initial targets that we brought in, which we still have in that collaboration that we haven't disclosed that are targets that with the first generation capsids that they had, we are working on. One of them was Friedreich's ataxia, that has been disclosed. There are two others that have yet not. We were seeing Voyager making amazing progress, I would say industry-leading progress in designing that next and much, much better generation of capsids. What is better about them? Well, two things. Number one, is their ability to hone in on those areas that you want to deliver the payload to. For us, that's the CNS. You have CNS-tropic capsids. Now we don't have to deal with having to centrally administer the capsid. It can be given IV. Second is to be able to deliver the payload highly efficiently once it's in that area. They've made amazing progress there. Once we saw that kind of progress, and with their lead compound that they had internally, a gene GBA1 with Parkinson's and Gaucher's, we did that deal in order to be able to acquire that lead asset, plus again, three more. I think that what we have that we're working on with Voyager is seven gene therapy assets for the CNS. FA and GBA1 being the two that are furthest along in that. Having that leading technology, I'd put us up against just about anybody for CNS gene therapy right now. That's why we did the deal. It again, fits very nicely into our large molecule focus that we've developed internally. I know it sounds a little bit odd, but peptides, proteins, antibodies, gene therapy, they share one very fundamental aspect that goes across all of them, and that's protein engineering. It is all protein engineering. I think that we've built an amazing protein engineering group within Neurocrine. Again, proof is in the pudding. Starting in 2025, you're going to see the fruits of these investments. Okay. Got about two, three minutes left. Wanted to do a little bit of potentially speed dating as we know about some of these pipeline readouts coming up. Maybe first on focal onset. Can you talk at a high level around sort of the hurdle moving forward here? Clearly, you know Xenon asset just kinda set the bar, but seems like there's still room even if you don't match that efficacy. Is that a fair characterization? Yeah. That's a fair characterization. As you said, I think Xenon with their potassium channel compound had very nice results in phase II. They're in their phase IIIs. We collaborated with Xenon here with the sodium channel blocker that we have going after 1.6 specifically. We know that sodium channels are involved in focal onset seizure because there's very old, very dirty sodium channel blockers that have been on the market for decades. We're going at it with much more precision. Data's coming out second half of this year. As you and others are well aware of within the antiepileptic market, generally, patients are on a couple of antiepileptics. They cycle through them. To have real new mechanisms that can bring some real good efficacy and it... hopefully a much better side effect profile and tolerability, there's a lot of room in this market. Okay. A plug for our deep dive from last year on this topic. Maybe one follow-up there. Why do the study ex-U.S? Availability of patients. Great. I mean, moving on to crinecerfont, key data this year. Can you maybe help frame sort of, you know, the, you know, the level of steroid decrease that's, you know, that could be clinically relevant and the expectation we should get both these datasets together or please no? Yeah. We're gonna have to see how they close out. Both trials are fully enrolled. Enrollment is in both trials. If not at the same time, pretty close together. I would think at least amount, it really does depend on how the trials works out as we go through that process. You know, what is success? That's what everyone wants to look at, wants to know in advance. Success. The best I can say, and I said this for years leading up to unblinding our tardive dyskinesia data with INGREZZA and the AIMS, what is clinically significant? A half point change in AIMS, a one-point change, two, three, four-point changes. It really was, let's look at the data. Let's get stats on the data, and then we and the field will be able to say, "Is that important?" I give the same direction here. All the KOLs out there, the regulators, any decrease in glucocorticoids is important. Let's see statistical significance with it. Let's then look at it. Let's let the experts weigh in, and we'll be able to say that's important. Okay. Well, we're out of time. Kevin, Matt, thank you very much. Thank you. Todd Tushla in the crowd. If you have any follow-up questions as well. Thank you, guys. Thank you. Thanks, Carter.