Good afternoon, everyone. Day one, Jefferies Healthcare Conference. As I was mentioning to Kevin, this room is a lot colder, which I enjoy. I have been dying in some of these meetings. But it also means that there's a lot of people attending, and that's always great to see. I have the pleasure of hosting the Neurocrine management team. Joining us is Kevin Gorman, CEO; Matt Abernethy, CFO; Kyle Gano, Chief Head of BD and Strategy; and then Eric Benevich, CCO. So we've got you know, the entire gamut here. It's quite exciting. I will start off with maybe just some opening questions 'cause I know we're running a little behind. So I wanna I wanna give you guys some credit. I saw Teva settle on Ingrezza, and I'm like: Ah, you know, it, they have Austedo. They have a reason to settle. Then Lupin settles. Now, everyone has seemingly settled for your multi-billion dollar drug, Ingrezza, and you seemingly have patent life out to 2038. Really, really well done. The market has not necessarily given you credit, and I think part of that might be, t here's just this question of, like: Okay, so how do we think about products that get, you know, impacted by the IRA, and, you know, what does that do for pricing potential? And I'd love to start off with, A, in terms of the IP settlement, how important is that for you? What does that open up strategically now that your lead product actually is protected out for, you know, and well over a decade? And then, number two, as you think about IRA-impacted products, but, you know, you still have patent life, should the Street think that, you know, price is gonna continue to go down every single year? Or are we gonna get to some run rate stability, where you guys can feel comfortable forecasting on a go-forward basis? That's a simple and easy question. Simple, simple and easy question. So first off, thank you very much for the opportunity to be here, and we will be making forward-looking statements, so I direct you to our recent SEC filings. It's very important for us to have been able to resolve the ANDA litigation. I think we did it in a very timely fashion, and it worked out really well for us that we do have patent protection out to... or exclusivity, I should say, out to March of 2038. So approximately 14 more years that we have patent protection on our lead asset here, Ingrezza. You know, we could spend the entire time here talking about IRA, and then you guys, you would all glaze over with that. I'm gonna start out by saying the same thing I said, the day that the IRA was passed, and I said that, you know, it is not going to remain the way that it is. It's not gonna change for at least two years after it was passed. That's probably the soonest one could ever start seeing any changes to IRA, more probably like 2.5 years, if you use precedents for exceptionally large legislation like that. So I still believe that. Nothing has changed to date. IRA looks exactly the same as it did, you know, a bit over a year ago. So let's just take it as it sits today, what IRA looks like. Neurocrine, best guess that we have, looking at how they're rolling it out, Neurocrine would be listed for negotiation in 2027. We'd be negotiated between 2027 and 2029. 2029, the negotiated price would then be set, and it would roll in between incrementally over 2029 to 2031. Okay? So that's how the price part works. The key feature here is the least amount that they can reduce, how far can they take our price down from whatever it is in 2027, that's gonna be the reference price of which the negotiations start, is 25%. So the legislation says that they can take you down 25% from that price. They can't take you down any more than 34%, so you have a maximum deduction. And I'm talking about... for those companies that have the small biotech exception. That's one thing. There's a second part to IRA. That second part is the redesign of Part D. And I know for a lot of my European colleagues, this is all completely gibberish. So I apologize. And that is one where we will. We believe we qualify for the small manufacturers exemption, so that'll be staged in for us from 2025- 2031 also. And that's where no longer do we fill up the donut hole, but we will then be picking up, in the catastrophic phase of Medicare coverage, up to 20% of that. Again, many years, starts out low, 1%, 2%. 1% for the first year, 2% for the second, grows like that. That, in the first couple of years, that's actually a tailwind. We will be paying less into Medicare Part D than what we currently pay for today. Once you are negotiated, wherever you are in that going up to 20%, that goes away. You no longer pay into Part D, 'cause you're a negotiated price at that point in time. So when you start looking at that and seeing how all that works out, there are people who immediately came to the conclusion: "Oh, my god, when you are negotiated, they'll negotiate you like you're a generic. You're just gonna be a generic drug. Right. Not even close. Yeah. I mean, not even close. We're going to have a much greater number of patients that'll be on our drug between now and 2029, when the negotiated drug goes in place. We take very careful, cautious, no more than inflation price increases when we take them, so we will have a higher price that will be negotiated off of in 2027. And so it's, it is, it is not good. I, I want, you know, for our industry, for the patients in the United States, most of the things are not going to be good in the long term for the IRA from IRA. But it is not as draconian or devastating as I think many people have thought of in the past. So I'm gonna, that's wonky enough for right now. No, that's incredibly helpful. And actually, I you said something there that I just wanted to press on a bit. There is this view that, you know, the IRA, it's like First Amendment challenges, like you got your Takings Clause, you got your first, you know, freedom of speech, and like either it's gonna get killed or it's not. And that's not what we're seeing in terms of some of the legal challenges, right? Like AstraZeneca is talking about, you know, bona fide marketing. There's this question about excessive fines, right? And I to me, when I look at the industry, A, it's a really a play on the Supreme Court, to your point. But number two, it's even if this idea, we just want a negotiation, right? Like even if it's a real negotiation, we would be okay with th And I think part of that is the excessive fines component, right? Where if you look at the CBO bill, they literally modeled no one opting out 'cause they said it would literally just, you know, destroy every single company. So when you talk... You know, you mentioned, things that could change from an IRA. Outside of like, let's say, a constitutional challenge and the entire bill getting killed, what are some other modifications do you think that maybe investors aren't paying enough attention to right now? Well, I mean, there are certain things that right off the bat don't seem to make sense, and I'll just pick one. It's the difference between small molecules and biologics. So you can't be negotiated earlier than nine years if you're a small molecule. You can't be negotiated earlier than 13 years on the market as a biologic. If I were to ask any of you, in whatever country you're from, what is one of the greatest healthcare crises that is going on? You would say mental health. If I were to ask you what's number two, you would probably say substance abuse. Both of those are only treated with small molecules, and... none of us are smart enough to see a way that there will ever be, in the next 10 years, will there be a target to treat mental health or substance abuse that's a biologic. Why would you handicap the development of those important medicines that are some of the biggest—treating some disorders, diseases that are the biggest scourge that we have today? And I could go on and on. The other one is, what we normally see when you have an Orphan Drug approval, is that's usually only your first Orphan Drug approval with that drug. You then go on, and you invest, you know, hundreds of millions to get a second and a third orphan population involved there. There's a disincentive to ever do that because the clock starts on your losing your exclusivity right from that first approval. Why would you go off and then try to do that? Even sometimes, people get an orphan approval to get proof of concept, foot in the door, then they go after maybe larger indications. You would never do that. Your exclusivity clock starts at that first indication. There's a couple of things that you can say. There's also a massive amount of gray area where there is no guidance on what happens within this legislation. So massive legislation affecting one of the largest industries that we have in the world, and who's going to make those determinations? Well, then that's unelected officials, bureaucrats, that are beholden to no one. Those are real serious problems with the legislation. There are, mind you, there are good things in the IRA. There are things that, biotech and pharma have fought for, for years, and they wanted to protect, elderly patients. They wanted to have protections for the out-of-pocket costs. That has been capped at $2,000. That's two big thumbs up. That was great that they did that. The legislation maybe took away some of the protections, but left most intact that we care about as our most vulnerable, is the elderly, who are poor, and they are still protected within the legislation. That is good. There are some good things, but clearly on balance, the word innovation is thrown about a lot. I would say, for life-changing medications, there will be fewer of them if it stays in place the way that it is. Understood. That's really, really interesting. Now, I do wanna maybe kinda step back. You saw, Jazz talk about, you know, like well, there was a headline that Jazz is looking at alternative options. Obviously, they're not commenting on, you know, these type of rumors. But there is this kind of question of consolidation in CNS companies and, you know, leveraging OpEx that's been built out and getting kind of plug-and-play assets there, right? And, you know, it seems like you guys are very well positioned to do that with some of the footprint and the success you've had with Ingrezza and now crinecerfont. Now that you also have, you know, IP for your lead asset for, as you mentioned, 14 years, how does that change, A, what you guys are willing to do from a BD perspective? You've guys have talked about kind of a $3 billion-$4 billion, you know, potential deal, but at the same time, I look at your company, you guys are gonna generate $10 billion in EBITDA, you know, over the next decade. I mean, you could do far more than that. Yes. So- No, you're absolutely right. It's the smirk was- Yeah, exactly ... a nod to Matt, but- It's a nice problem for us to have. Yeah. Let's go on to the question. Sure. So, I guess, well, Kevin, the question is really, well, why put out that kind of $3 billion-$4 billion in terms of a range, and why not look more aggressively in terms of consolidating in the space? So what I'm gonna start out with first is not gonna directly answer to your question, because he's gonna answer it- Right here. What I'm first going to say is, you know, we have, not so long ago, just a couple of years ago, we had fabulous phase III data in Huntington's disease with Ingrezza. Very shortly thereafter, that led to an approval for Huntington's disease. So now Eric and his team are both are marketing Ingrezza, both for tardive dyskinesia and the chorea associated with Huntington's. So, and as you said, that's a very important drug, and it's selling well. We just came out, in the last three months, just in the last quarter, two phase III trials in congenital adrenal hyperplasia, an orphan disease, that we had high hopes and expectations, far exceeded it. I mean, we knew we had a great drug there. We didn't realize how great a drug we had because no one has developed a drug for CAH since glucocorticoids in 1964, when they were approved. This will change how these patients are treated, and it is a disease that suffer from from birth all throughout your life. So we have just some fabulous drugs here, and that is gonna be a great one for, again, knock on wood, we're going to be filing the NDAs next year. NDAs, meaning one for pediatric and one for adults, and we did a worldwide development program, so we're going to be filing here in Europe, and we're going to be marketing it ourselves, both in the U.S. and Europe. And we have a wonderful pipeline that's going to grow every year. You're going to see several compounds from our own internal research efforts, both more small molecules, large molecules, gene therapies that are going to be coming out of Neurocrine. So you're going to see all that. So we have a great internal engine, but that is not to say that BD will still remain a high priority. Yeah, I think I'll just add a little bit to that. You know, we work with great urgency within our team, and we cover the universe across our therapeutic areas, which neurology, neuropsychiatry, neuroendocrinology are the ones that we focus on. I think that building off what Kevin said, what we really see over the next, you know, near to midterm, are growth opportunities, revenue legs of the company being in crinecerfont and CAH, and then looking at all the investments we're making now in the muscarinic as a validated target. That's something that could be a new product for us by the end of the decade. So you can see an evolution of new products coming to market. We spent the past couple years working with our new CSO, Jude Onyia, to help him accelerate some of the programs and interests from his team, and you're gonna start seeing that paying off here this year, in the next year, and that would only accumulate over time. So as we see the future, then a lot of the programs that will fill the pipeline will be coming internally. And business development, while we work with great urgency, we don't feel like there is a great need to do something right now. We look for the right deal. If it makes sense, we have the opportunity to do a license or something that's more on the acquisition at a fairly significant scale, but it really has to be the right deal for us and has to fit into what we're doing here as a company. So I think I would probably stop there and see if there's anything else. But I'm not gonna disagree- Yeah. I'm not just going to disagree with your thesis there. There's a lot of companies out there. Actually, many of them were well-capitalized. There is a lot of money, three years ago, four years ago, when many of these companies were formed. Science, obviously, most of the time doesn't work, so many of those companies are struggling. It doesn't necessarily mean they're out of cash, but a lot of them are trading less than their, their cash value. That seems to be a, you know, shampoo, rinse, repeat, in our industry. That, that happens. We see that cycle over and over again. We also see that the discussion, it would really make sense if there were more of a consolidation. Why doesn't the big oncology companies roll up the smaller oncology? Why doesn't the big, you know, neuroscience company, Biogen, should have owned the world by now, by that logic. It's, but it rarely happens. Yeah. You don't see that whole roll-up thing happen, and there's a lot of reasons for that. One of which I would say that investors do a real good job. Those companies that are public are valued where they are because you do a real good job. The companies that you really like, they're doing well. The companies that you don't like, they're not doing real well. We like the same ones you like. So there, it's not like there are abundant deals out there where you missed it. All right? Those don't come along that often. You do a good job of figuring out where you're gonna put your money. So, just- Yeah ... to comment on the financial front, I think we had mentioned a few years ago, I did $3 billion-$4 billion type of range. I would say that I would describe our capacity as very flexible. Yeah. We can go up or down from there. I mean, we are generating a significant amount of cash, as you mentioned, earlier. But as Kevin said and Kyle said, we're gonna be patient. Understood. Makes sense. Okay, so, going on crinecerfont, which, Kevin, you're absolutely right, the data in both populations is very impressive. If we back out the P values, I'm waiting for the full data sets. But, you know, I think the question I get most often from investors is, you know, like, okay, pediatric seems like there's the highest unmet need. It's a smaller population, but maybe there's bigger ramp-up, and then at the same time, you have very impressive data in adults, where I think we're backing out, like, 30% reduction in at, you know, steroid doses, and then you're getting a lot of these patients, much more importantly, to that kind of responder endpoint, where they're getting, you know, more normalized levels of, steroid use on a background. Now that you have both data sets, right? How do you think about the size of the pediatric population versus the adult population? And if you were to think about the cadence of uptake, right, this is more of a 2025 launch, but, the cadence of uptake in both of those populations, you know, which one could we perhaps get a bolus out of the gate in terms of demand? I'll answer your question. I'm gonna take one quick step back for those of you who aren't as familiar with what we're talking about here. So congenital adrenal hyperplasia, which is CAH, it is a situation where the child is born with a genetic lesion such that it cannot make hydrocortisone or cortisol, I should say. Cannot make cortisol. In the pathway then, if you can't make cortisol, you're shunted down those precursors that would have gone on to cortisol, would have gone on to the sex steroids, particularly androgens. Now it all goes dumping into the androgens. In addition, the feedback loop that cortisol would have to tamp down the accelerated, it keeps making try to make more cortisol, that there's no brake on that any longer. So it's one, can't make cortisol. All of those babies died until about 1964, when hydrocortisone was invented. For inflammation, mainly, it was immediately used by the endocrinologist to give these children that so that they would live. You give replacement doses so that they would have a synthetic cortisol like we have in this room, that's great. You live, but you have a problem. You have done nothing to this massive shunting into making huge amounts of the androgens, because hydrocortisone isn't nearly as effective as natural cortisol to go back up to the hypothalamus and at the pituitary and tone the system down. So now you have to give massive doses of the hydrocortisone in order to do that. Endocrinologists, for the last 60 years, have had two really bad choices on their hands. Mind you, we're talking about from birth, your entire life. They have a teeter-totter here, and they constantly shift between it. "I'll let the androgens fly out of control, so I don't have to give such high doses of hydrocortisone." Androgens, high levels of androgens cause all sorts of problems, especially for kids, because it leads to rapid bone maturation, shortened stature, and all of the problems that... And then later in life, they're suffering from bone loss and being osteopenic and osteoporotic at 30 years old. They also have testicular tumors because of having it. Well, then, what they try to do is they try to, at times, okay, they're not tolerating these high levels of androgens. Now I'm going to hit them with, you know, for months at a time or years, with high levels of cortisol, hydrocortisone. Now they have all the problems with that. As anyone in this room knows, when your doctor puts you on a usually, it's like an eight-day course, and they want you the hell off of steroids because of all the metabolic problems, again, all the bone problems, cardiovascular problems that come with that, eye problems that come with that. So they are just in this horrible seesaw throughout a patient's life, very difficult to try to deal with. What does our drug do? Our drug takes care of that basic aspect of the system. We bring the androgens down to normal levels. You no longer need the hydrocortisone or prednisone, whatever the synthetic glucocorticoid is being used. You no longer have to give it in high, high doses. You can bring it down to that normal level, replacement level, and you fundamentally now change the entire course of the disease. No more excessive androgens, no more excessive glucocorticoids. The data that we reported out only gives a glimpse of how good it is, and that was outstanding. It is even better than that. Now you ask, where's it most important? Where's the low-hanging fruit? Pediatrics, you're right. It's about a third of the population. Parents want this disease arrested as early in their child's life, cease the damage as early as you can. So there's the first that you would go into. Second, when you're talking about an adult population, who is harmed more by having high, high levels of testosterone, that is really obvious? Well, it's women. It affects fertility, it affects appearance with hair growth. But the mistake is saying men, adult men, are not going to take this up, not as rapidly as the first two, but gives them the same benefit because amongst all of them, the problem with high levels of androgens and/or high levels of glucocorticoids is the same. The metabolic disease, the cardiovascular disease, everything else, the bone disease that they go through is exactly the same. So it actually is important for all three groups, if you will. Uptake, I would say, is first in pedes, second in women, third in males. That is an awesome answer. I know we're out of time. Thank you so much. Thank you. This is a great discussion. I really appreciate it.