All right, we're gonna get started. Good afternoon, everyone. David Amsellem from the Piper Sandler pharma team, and welcome again to day two of the Piper Sandler Healthcare Conference. I should say 35th Annual Piper Sandler Healthcare Conference. Anniversary. Yeah, 30. It's a big one. Yeah, a big round number. And with us, we have Xeris and Paul Edick. Thanks so much for CEO Paul Edick. Thanks so much for joining us. And I'll just jump right into questions, if that's okay. Good. Uh- So I'll start off with, high level. You know, you've got Gvoke, you've got Keveyis, you've got Recorlev, and, we're moving towards, profitability. So I wanted to get your latest and greatest thoughts on, your profitability targets, when you expect to get there, and ultimately, talk to, how you're getting there. Is that continued Gvoke growth? Is it stability for Keveyis? Is it Recorlev growth? Is it a combination of all those things? Okay, you know, there's like six questions in there, right? That's how it is. Okay. Yeah. So the most important thing for me to clarify is our goal is sustainability. Mm-hmm. That, you know, we don't want to be in the market raising capital to run our business, and we don't anticipate, and we have no plans to. We have today a sustainable business based on what you just described. Mm-hmm. We will have, going forward, a sustainable business without having to raise capital. We've decreased our burn from $100+ million last year to $50-some million this year. It'll go down again next year. Net next year, will we have a modest burn? Maybe. Mm-hmm. It depends on how we invest in the business. Sure. Profitability is an important goal. We want to get there, but we want to get there in a way that we're continuing to fuel and foster growth in our business. As you know, we add sales force when it's opportunistic. We're potentially would like to bring a couple things through the pipeline into development. Gvoke, Recorlev, and Keveyis, to some degree, are going to continue to grow, Gvoke and Recorlev being the real drivers. Mm-hmm. But we've done an amazing job with Keveyis and grown it. In fact, triggered the CVR in the third quarter when it was a full year CVR. So the health of the commercial business, continuing to invest, driving our pipeline, and the partnership opportunity, I think is a, the potential future catalyst. Yep. I'll get to the partnership stuff sort of at the end. Want to talk about the your commercial portfolio. Let's cover Gvoke. So overall, glucagon rescue market growth, is it mainly been a Type 1 diabetes market? Are you getting more traction in Type 2 patients? Just help us understand the dynamics there that's driving that business forward. Almost all Type 1 at this point. All Type 1. Almost all. Okay. We're starting to get some traction in Type 2. As we increase our footprint and increase, you know, the breadth of our coverage, especially, we just added a few more of the inside salespeople- Mm-hmm ... to get to more of the primary care audience and working with the associations and next year with ADA, to try to take the message more to primary care. Mm-hmm. We're gonna start getting more Type 2, and the message, which ADA and others are starting to convey, is if you're on insulin or sulfonylureas, which is predominantly Type 2- Mm-hmm ... you should have a ready-to-use rescue glucagon on hand. And that population is easily 15 million people. Sure. Less than 1 million actually have a rescue glucagon today- Okay ... which is an important, you know, all the guidelines have changed because they recognize that's not a good thing. Mm-hmm. And ADA is very much behind that message at this point. And the market growth, we're driving it all right now. Hopefully, as competitors, you know, start driving it also, that market growth will get back to where it was pre-pandemic, which is in the 30% range. Yeah. Do you think the COVID dynamics really stalled the penetration in Type 2, or is there something else that's sort of proving to be a barrier to wider adoption among Type 2s? I think the barrier has always been a belief system that... Mm-hmm ... technology, better insulins, you know, better CGMs, et cetera, was going to solve the issue of severe hypo, and it really hasn't. The rates of severe hypo, hospitalizations, emergency room visits, deaths every year- Mm ... hasn't changed in decades. What really slowed the market growth, as it did for a lot of pharmaceutical categories- Mm ... was two and a half years of pandemic- Yeah ... and not being able to call on doctors. What you're seeing now is we're back to double-digit growth, mid-teens, mid to high teens. Mm-hmm. You know, both products, both of the ready-to-use products continue to grow. The market continues to grow. The legacy kits is down below 20% now. Mm-hmm. Even Novo has announced that they're gonna discontinue their kit. Mm-hmm. I think everything's moving in the right direction. Does Amphastar coming into the market and Lilly exiting on, on Baqsimi, is that a good thing or a net neutral or a negative? Or more... Or maybe I'll put it differently. Do you kind of want Lilly to be in the market just because they are, they are a diabetes leader? Well, we wanted more voice, period. Yeah. Right. So whether it's Lilly or whether it's Amphastar, the concern getting to those other 14 million people, you need more voice saying, "Hey, if you're on insulin, you're on sulfonylurea, you should absolutely have a rescue glucagon handy." So that's a positive. If it was Lilly and they were loud, that's an incremental positive- Mm-hmm. because they have a large position in the marketplace. What we're hoping is that Amphastar is going to be an aggressive commercial business behind Baqsimi. And that they're gonna focus on driving market growth, and if they do, everybody will benefit, especially the patients. Yep. I think you talked a little bit about sales force sizing. Mm-hmm. and you mentioned inside sales. What's your headcount right now? Do you expect more expansion down the road? And just remind us how many practitioners you're targeting. Well, the target in terms of number of practitioners we target changes every day. We've got 100 people on Gvoke in the field. Mm-hmm. We have 30 on Recorlev in the field. We have 20 on Keveyis in the field, with all the requisite support and marketing, et cetera, behind them. We've now upsized the inside sales group. Okay ... to about 50. And, you know, that's a group that we put in place during the pandemic. Because everybody was going virtual. You had to be virtual. Sure. We found it to be very efficient, very effective, and about a third of the cost. You know, when you have natural turnover in a field sales organization. Sure. The cost of that turnover is high. We use the inside sales group as a training ground to backfill our field sales, so the cost of replacing people who move or get promoted is a hell of a lot less. Yeah. Okay, that's helpful. And then just lastly, on Gvoke, the payer landscape. I mean, we haven't really talked about it much, but any changes, anything to think about there? No. It fluctuates, depending... But we've been as high as low 80% range- Mm-hmm. In terms of covered lives. I think we've settled in at around 70%-75% of covered lives when you look at commercial and Medicare. We don't have as much Medicaid. We just, we're not in the paid population as much. Sure. in any pharmaceutical category, over 70% of covered lives in commercial and Medicare is really good. Okay. So let's move on to Recorlev. Maybe talk to the overall patient mix here. I know there's a lot of, you know, different, you know, modalities and patients go on and off different agents, but are you, are you getting treatment-naive patients? Are you seeing patients who are on, who've been on previous therapies, including racemic ketoconazole? Just talk to what you're seeing in the field there. Yeah. Early on- Yeah ... predominantly, patients who did not do well on something or the churn, the patients that were changing therapies or physicians were changing therapies. We're actually starting to see more recently, drug naive, the patients who've not been on a previous therapy- Mm-hmm ... which is a really good sign because physicians who've tried Recorlev and got comfortable with getting the efficacy they want, seeing a very low incidence of side effects, beginning to use it first line, that's a really good thing. First-line use creates incremental barriers with payers- Mm-hmm. - because they hate that. Sure. So, you know, and what you'll see is you'll see some variability on a quarter-to-quarter basis in terms of the percentage of referrals that are converted to patients on drug. Referrals continue to grow very nicely, and it's like a linear curve. It's a lot of referrals. Mm-hmm. The time to convert that referral into a patient on drug varies. Mm-hmm. It sometimes takes longer, sometimes it's shorter. If we get a lot of those conversions early in the quarter, it's a really good quarter. Mm-hmm. If we get a lot of those conversions later in the quarter, it isn't. It's still growth, but it's not quite, quite the same. So you're seeing a little stair step. On average, how long does it take for a script to actually get in the hands of a patient? A referral to turn into- Referral to- - a patient on drug? Yeah. Could take a month. Mm-hmm. Could take three or four months. Mm-hmm. Because there's a series of tests they have to do. They have to get an EKG before the... Then we have to clear insurance. Yep. If it's a community-based endocrinologist, they might not have an EKG machine. You've got to schedule that. So, you know, that takes time. If you, you know, doctor's offices are full, you can't get an appointment the next day, so it's highly variable. Let's put it that way. So what does the payer landscape look like? I mean, in terms of, you know, ease of access and what different payers are requiring. Yeah, you're in rare disease. Yeah. Almost virtually, everybody's a prior authorization. Sure. So you have to go through the prior authorization process. The degree to which that prior authorization and the referral are filled out completely, you know, based on the physician, you're going to go to a payer, and you're gonna get a rejection for some reason. Then you've got to go through an appeal, and that all goes to the quality of the referral and the prior authorization coming out of the physician's office in the first place. Mm-hmm. Some do it really well, some don't do it so well. Yeah. So, you know, we've got case managers, patient assistance managers, and a specialty pharmacy all working with the offices to try to improve and increase the quality of the referral, the quality of the PA, in order to get faster reimbursement. That being said, on average, depending on the quarter, we're clearing 50%, sometimes as high as 60% of the referrals are cleared for insurance, which is pretty good if you think about the conversation we had about Gvoke. Sure. 70%-75% of covered lives is really good. To clear 50%-60% of referrals in a rare disease is excellent. In terms of the payer landscape, are you seeing payers want patients to have exposure to racemic ketoconazole? Has that happened in some cases? Not to the degree that people would have assumed we would. Okay. You know, bottom line is they you know, physicians recognize they'd rather use an approved drug that's got a clinical package and you know, has a label. Yeah. To some degree, are we still having to step through ketoconazole? Sure. Mm-hmm. It's been out there for a long time. Sure. A lot of patients have been on it. The good news is a lot of patients have already been on it. They've already failed it. So the step-through is almost a built-in. You know, if somebody asks us to step through Signifor, it's a harder hurdle. It's a higher hurdle- Right ... 'cause not that many people are on it. Right. So it's both a blessing and a curse all at the same time. So, I know it's early days. The product hasn't been on the market all that long, but do you have a good read on discontinuations or patient persistence? Discontinuations are very low. Okay. We've had, you know, a handful. These are sickly patients for the most part. Yeah, and your point, it's early days. We will have- Sure ...discontinuations because patients, they're—these are not well. They're sick people. Mm-hmm. They don't necessarily do well on everything. You know, we will. It's just we haven't seen many so far. So, from thinking about... I don't want to get too caught up on, you know, the near term in the fourth quarter, but if I'm hearing you correctly, you're getting these starts. Mm-hmm. You know, the cycle from referral to script is variable, so that's a big wild card. It's -- we're trying to handicap, you know, 4Q and going into 1Q. I mean, are there any other dynamics that we should be mindful of, you know, that might swing, you know, sales in the fourth quarter one way or another, you know? I don't think so. Okay. It's... It really is the dynamic that I described. Okay. If the referrals are pretty, remain very strong. If we convert a lot of those referrals to patients on drug early, like, in October, November- Mm-hmm ... it'll be a bigger quarter. If a lot of those patients get converted into drug in October or November, December, it'll be a good growth quarter, but maybe not quite as big. And that's why, you know, you saw a really big jump second to third, a nice jump, or first to second, and then a nice jump second to third, but not quite as big. Mm-hmm. That's just that stairstep that we're gonna go through. Right. That's gonna be a long term, and it's on a small end. Mm-hmm. If you draw a line through that, it's really nice continued growth. Okay, that's helpful. But let's move on to Keveyis. The product hung in there reasonably well, even with a generic. You don't see that very often. Yeah. So talk about the dynamics of that Keveyis that make it unique and might explain why it's been resilient. It's been more than resilient. Sure. It's remarkable. Yeah. And the fact that we have grown Keveyis significantly- Mm-hmm ... you know, materially, in the face of a generic for a year, I think is outstanding. What accounts for that is we surround every one of those patients. So we find the patients to begin with. Mm-hmm. We surround them with services, case managers to help them with insurance, patient managers to help them with their physician interactions and the pharmacy interactions, and mentors, so patients who are on Keveyis- Mm-hmm ... who've been through the process to help them kinda work their way through it. And remember, the process is, to some degree, reentering society. Sure. These are people who've become housebound. Mm-hmm. Because you can't go to dinner or drive a car not knowing when you suddenly would be paralyzed. Okay? Driving a car, paralyzed, bad. Okay? Yeah. Patients who've been through that experience as a mentor, you combine all of that, physicians are willing to fight for brand- Mm-hmm ... to be able to give patients the opportunity to have all that service. Patients that we've lost, that have had to go to generic, several of them have come back. Mm-hmm. Okay? And so it's that dynamic, which is unique to a drug like Keveyis, you can't do this in every category, has allowed us to not only maintain it, which we said when we bought Strongbridge, we believe we can maintain this business. Mm-hmm. We've grown it. How well we can maintain it in the future with one generic, we think we can still be able to do it well. Mm-hmm. We might lose some patients because of payers. If there's another generic, that changes the dynamic, but we believe that this is still gonna be a very positive contributor for years to come. Now, my understanding is the generic is changing hands, and that I don't know off the top of my head the company that's now taking it over, but I believe it's going to be more of a brand generic going forward, or at least that's what it seems like. Yeah. So how does that change things for you, or what are you hearing? Yeah. I don't know the specifics either, because- Yeah ... you know, people don't call us up and tell us that. Sure. Torrent is moving the product to more of a branded generic distributor to help them with the commercialization. Right. 'Cause obviously, it has not gone well. Mm-hmm. To some degree, I think you're right. It could be a very good thing because it is more of a branded generic player. Mm. It isn't a chase the price to the bottom kind of company- Right - which I think will be good. Whether they are going to participate in the identification of patients to grow the category, I think that's, the jury is still out on that. Yeah, and I guess that brings me to my next question, is how penetrated is Keveyis in primary periodic paralysis? And you know, what does the pace of new starts look like? I don't think, I don't think we really have a great handle on how penetrated it is. Yeah. We believe that there are several thousand of those, these patients out there. Mm-hmm. If you look at the historical, you know, how many patients have actually been on drug for at one time or another, it could be 2,000-3,000 patients. Mm-hmm. So I think there, there's still a great opportunity. You know, how well we can penetrate that in the future, I don't know. Okay. But there's... I mean, if I'm thinking about this the right way, there's, this is a market that can grow. I mean, is that a fair way to think about it? Well, it's a category of patients that is probably pretty stable. Okay. But the penetration can improve. Okay. Fair enough. So in the five minutes we have remaining, I wanted to touch on pipeline and partnerships and, you know, one product that you've been talking about is your injectable levothyroxine product. So just help us frame the value proposition here. I mean, this is a very big oral solid market. Mm-hmm. There's a number of generics here. So why does an injectable Levothyroxine... or what does an injectable Levothyroxine product add to the- Yeah to this, to this category? Yeah. What you're describing is very counterintuitive. Right. Right? You wouldn't expect you go, you know, you go from a liquid to a daily oral, right? Mm-hmm. But that daily oral, the population of people on levothyroxine is huge. Sure. It's over 100 million prescriptions a year, and there is a percentage of that population that either they have pretty serious gastrointestinal side effects or malabsorption, which creates a variability in blood levels, which we believe is better part of 25% of the population. Mm-hmm. Okay? Which, a drug this big, that's a lot of people. Sure. Evidence of that is in the phase II study we're currently doing. We're trying to finalize the dose conversion from oral to liquid. Mm-hmm. What we're finding is trying to do a study with stable Synthroid patients- Mm-hmm is incredibly hard because most of the screen failure of is through the roof. Right. For every 10 or 20 people we screen, we get one patient that actually goes on drug- Mm-hmm - which says there are a lot of patients that aren't doing very well on the oral. Right. If we can bypass the gut in a five-second subcutaneous injection- Mm-hmm - once a week, you capture that, a big percentage of those people. At today's price, today's generic Synthroid price- Mm-hmm If you multiply it by seven days, that percent, that slice of the market could be worth $2 billion-$3 billion. Okay, so I'll take a piece of that. Yep. Okay, and our market research, limited so far, we've yet to bump into a patient who's experiencing those problems who said, "I wouldn't want a once-weekly subQ injection. Okay, um- I think it's a great opportunity. You have your phase II. Mm-hmm. Can you just walk through quickly the design and the trial? It's pretty simple. Yeah. It's stable... people who are stable on Synthroid- Yep - to see what the conversion rate, the conversion is from oral to liquid. And in our modeling that we presented to the FDA on, non-drug taking patients- Mm-hmm No, you know, like, healthy volunteers, it was four-to-one. What we're trying to determine for the FDA, per, per their directive- Mm-hmm is do it on drug-taking patients. Mm-hmm - who are active, you know, Syn, and across more doses- Yeah - so that we can see that the conversion is the same at any dose. And if you, if you look at it, there's, like, 12 different doses of levothyroxine- Sure - out there, oral. Yep. It's to... And that will inform a phase III. Okay. What, what would a phase III look like? I mean, would it basically be also PK parameters? TSH, its endpoint of TSH is what the FDA wants. Okay. They haven't gotten that from a lot of sponsors historically. Right. We included that in the phase II because we know they're gonna want that. Mm-hmm. We could very easily argue, "You haven't done it, haven't made anybody else do that, but why should we?" But I think it's an endpoint that's worth doing. It's the correct endpoint, and, you know, that's where we should be in terms of helping the FDA further, what they're trying to do in terms of how they review these drugs. The question is going to be: How many patients? Sure. How long is that gonna take? Right. Is it all comers or people who are stable on... stable or unstable? So- Is it Synthroid, or is it anybody? I know that there's still a lot of questions outstanding, but, you know, what's a realistic case for when commercialization can happen? Is it 2027, 2028? Yeah. I mean, is that the right way to think about it? Probably late 2027, 2028. Okay. Part of the rate-limiting step is the dial-a-dose pen- Yep - that you have to be able to dial 12 different dosages. Okay. That's the development timeline for those devices is considerable. Okay. So this will be a patent? Oh, yeah. Nothing else but... Okay. Okay, that's helpful. And then we have about 30 seconds left. Just you've got the $6 million milestone on the subQ form of,- Yes - Tepezza. What are the next steps there? I know that's one partnership that- Well, yeah You know, we're- Amgen just closed their deal, and they're gonna review all of what's going on in Horizon. Mm-hmm. They'll make a decision on whether they want to continue clinical development of- Mm-hmm - the XeriJect Tepezza. Okay, what would your royalties be on that to the extent- Yeah that it's commercialized? We haven't disclosed value. Mm-hmm. until we get a license, it doesn't really make sense to de- Sure to talk about it. But with a license, we would get clinical milestones, regulatory milestones, commercial milestones, and royalties that one could argue, if you look at marketplace deals, market-sized deals- Mm-hmm - pretty substantial. One last one, I know we're out of time. Just real quick, any other partnerships that we should be keeping an eye on? I think the Regeneron platform deal is important. Yeah. They're gonna put a number of assets into our technology. We have successfully formulated for them multiple assets in the past. Right. I think that... and Regeneron is not a company that does third-party deals very often. Sure. I think that's an important one. All right. We'll keep an eye on it. Thanks, Paul. Thanks, everyone in the audience. Thank you. Okay.