Neurocrine Biosciences Inc 12th Annual Cantor Fitzgerald Global Healthcare Conference

Well, first of all, thanks for hosting us. Always good to be with you, and good to see your name is spelled Joshua and I am Matthew, so we got our formal names going on Yes.

today, so that is always a good thing. We will be making forward-looking statements and so we direct you to our SEC filing. We have a lot of great things going on at the company. It is amazing to think just two years ago, we were a single product company. Now we are a multi-product company. Going from one product with INGREZZA to now INGREZZA, CRENESSITY, and VYKAT XR. Last quarter, we had about $1 billion in sales. And we pinch ourselves and find ourselves quite fortunate to have three growing brands, three brands that are helping many patients. And I would just say kudos to the teams that have been involved in that, and being able to help so many patients across these different therapeutic areas. In addition to that, if you just rewind three to five years ago, we probably had three pipeline programs. Now we have close to 20.

You think about where is our pipeline, and you stack that up against anybody else in the industry. I do not know if there is anybody that has a broader, bigger pipeline from phase I to phase III than what Neurocrine has. And I think that is reflective of the strategy that the team has laid out in terms of investing in early-stage research, that is now allowing us to put new programs into the clinic. And that spans psychiatry, that is our later-stage programs, neurology, immunology, which we will touch on more later this year, and then also endocrinology. A lot of great things going on in the pipeline. Of course, the headline are there are two major phase III programs that we are going to have next year. One of them is osavampator, which is an AMPA potentiator that is being studied in major depressive disorder.

And then we also have direclidine, which is a muscarinic program that is focused initially in schizophrenia. That data will read out in 2027 and 2028. Those are transformational programs for our company. We are looking forward to executing those trials and getting to that data. Then lastly, strong financial position that gives us a lot of flexibility. I think you mentioned what are investors missing or maybe might be overlooked, and I know today it is important we will get into nuances of each of our brands. We will get into nuances of our pipeline program, and it is important for investors to understand those nuances. But I also would encourage folks to take a step back and look at Neurocrine.

In the elevator after our meeting earlier this morning, I was riding up and somebody says to me, "Wow, I have been an investor 15, 20 years ago in Neurocrine." And he says, "Now you are a big, real company." And I think that is an appropriate perspective. We have three products. We have durable top-line growth, durable cash flow, and we are working to have a durable, sustainable R&D engine. And I think those allow itself to have us valued in the long run as an enterprise, not as a single product company, not as a binary outcome from a data readout, but we are a company striving to help as many patients as possible, and that is the mission that we are on today. We are looking forward to being here, and we will take your questions however you want to go, Josh.

Yeah, I guess I will take a crack at that. Hi, everyone. I am Eric, and that is my full name. For those of you that may be a little bit less familiar with INGREZZA, when we think about INGREZZA, we primarily think about the tardive dyskinesia indication. That is the vast majority of our business. It has been on the market for nine plus years now, and Josh, as you were saying, it keeps delivering robust growth. In fact, in Q2 of this year, we reported a record NRX or new patient starts. We also reported record TRX, which is unusual for a product this far into its life cycle. Though I will say that it has a long runway ahead with exclusivity out to 2038. So if this was a baseball game, I would say we are in the fourth inning or fifth inning maybe.

But bottom line is that this is still a rapidly growing category, the tardive dyskinesia market. We're on a pace this year for growth in the mid-teens. We expect to be able to continue to deliver robust growth going forward. You were talking about 2027 and beyond. One of the investments that we recently made was an expansion of our field sales team, and that was completed at the end of Q1, and the expanded team rolled out in Q2 of this year, so it's relatively fresh. I would say that the expanded sales force is a contributor to the momentum that we've seen, but certainly not the only investment that's delivering these results. This is the most recent expansion, and as we were chatting about earlier, over the years, we've expanded our field sales team four times.

I think that's really in response to the growth of the category, the growth of the prescriber base for VMAT2 inhibitors. At the time that we announced this most recent expansion last fall, we said that the base of VMAT2 writers had grown by 30% over the prior two years. In some ways, every time we expand our team, it's to keep up with the growth of the category to make sure that we're calling on the prescribers that are treating these patients with diagnosed or non-diagnosed tardive dyskinesia. We estimate today that the size of the prevalent population is at least 800,000 in the U.S. Roughly half of those folks have been given a diagnosis to explain their uncontrolled abnormal movements. Yet only about 10% of TD sufferers are currently being treated with one of the two approved VMAT2 inhibitors.

So there's a lot of headroom from an organic growth perspective. Certainly, the investments that we make, whether it's in sales force or whether it's in branded DTC, medical education, omni-channel marketing, they all work together to continue to drive recognition, diagnosis, and treatment with INGREZZA. So, we feel really good about the first nine years of the launch. Our aspiration is to continue to drive diagnosis and treatment with INGREZZA because there's a whole lot of people still that could be benefiting from treatment.

Yeah. I would say, based on our historical experience, it does take a couple of quarters to, I would say, have the sort of tangible full benefit of a sales force expansion. The TD market's a little bit different than other categories within psychiatry or behavioral health. Our folks, they have a little bit of a broader scope of role than maybe what you see in antidepressants or antipsychotics. They do a lot of disease state education. They really help educate the providers, especially those that are earlier in career or newer in behavioral health, to understand drug-induced movement disorders, to distinguish TD from other hyperkinetic or hypokinetic movement disorders. Certainly educating them on VMAT2 inhibitors and INGREZZA in particular. So it takes a little bit longer to get up to speed when you're coming into this therapeutic area.

I do think that some of the momentum that we saw in Q2 was due to the expanded sales team. I also believe that we'll see the full impact of the expansion as we exit this year. So ultimately, our learnings as we go forward is each time we do an expansion, I think we get a little bit better at telescoping that time from onboarding to effectiveness. The way that we look at the impact of the expanded team is their ability to drive new patient starts. So it's really about NRX. Ultimately, that's one of the reasons that we have a lot of confidence going into next year.