Okay, let's get started. Good afternoon, everyone, and welcome again to the 37th Annual Piper Sandler Healthcare Conference. David Amsellem here from the Biopharma Research Team. We have Xeris with us. It's been an exciting year for the company. We have CEO John Shannon and CFO Steve Pieper here. Thanks, gentlemen, for joining us. Before we go into questions, and I know there's a lot to cover, I just wanted to kick it over to you guys for just quick introductory remarks. I think that would be appropriate just given what a transformative year it's been for the company. I'm going to turn it over to you. Thanks for coming, and I'd love to get your thoughts. Thanks for having us, David. Yeah, we've been meeting a lot of new investors that are kind of new to the Xeris story. Just high level, we're a fast-growing commercial biopharmaceutical company. We have three products on the market: Gvoke HypoPen, Keveyis, and Recorlev. I know we're going to talk a lot about Recorlev. That's our growth engine. We've had a great year, as you just pointed out. We have been growing this business very significantly. We've raised our guidance again in the last quarter to now we're at $285 million-$290 million. That's 42% growth at the midpoint. Again, that fast growing. We have great biopharma margins, 85% gross margins, and improving. This has really allowed us to do two things: one, really invest in Recorlev and the growth of our business, as well as our next product in the pipeline, XP-8121. We're at a point where we went adjusted EBITDA positive a year ago in the fourth quarter, and we said we're never going back. We'll stay positive. Last quarter was exciting. We actually had net income for the first time. We're really at a point where we're generating, but reinvesting back in everything we do. Okay. Let's start with Recorlev. That's the topic that I think a lot of people want to spend time on. This is a transforming space. With that in mind, talk to what you're seeing in the field in terms of greater screening of hypercortisolism on the part of endocrinologists, particularly in their patients with uncontrolled type 2 diabetes, poorly controlled hypertension. Just want to get a better sense of the kinds of patients that are getting started on Recorlev and ultimately what's driving this significant expansion of the footprint of the product. Sure. There's tremendous awareness going on and greater and greater screening. That's being driven by a lot of education that's happening throughout the community around endocrinology and specifically around hypercortisolemia and Cushing's syndrome. There's a lot of talk and discussion around when drugs that normally work aren't working, let's figure out what's going on. The first place people went to was diabetes. Insulin works. When insulin's not working, we should be looking at what's causing the problem that this insulin isn't working. This is true of GLP-1s when people don't lose weight, hypertension when hypertensive meds. It's driving a lot more awareness and screening, and the clinicians are doing a lot more testing of cortisol. When they find those cortisol levels, that's where we step in and helping them kind of normalize those cortisol levels. The types of patients we get for Recorlev specifically all have hypercortisolemia. They all have measures of 1.8 or higher times normal levels of cortisol. They have some other underlying condition which caused them to get screened in the first place, whether that's diabetes, hypertension, dyslipidemia, you name it, and/or obesity. All of those things they have as well, and that's what's driving. Those are our patients. It could be any of those, not any one specific, but any one of them. What are you hearing in the field and what are you seeing in terms of endocrinologist awareness and essentially keying in on this idea that, "Okay, I need to look at cortisol." This is something that's, I think, a fairly recent phenomenon, but we're seeing an impact on Recorlev sales. We've seen it with Korlym. The market is evolving. Can you talk to endocrinologist behavior and what you're seeing? Yeah. The awareness has come up dramatically by having three branded players in there talking about this in a lot of different ways, both from an education standpoint as well as getting into physicians' offices. Yeah, that's what's driving it right now. That's why we've expanded our commercial footprint. That's why Recordati has. That's why Corcept has. Yeah. I want to talk about your commercial infrastructure supporting Recorlev specifically. How large is the current and expanded sales force? Talk about how many prescribers you're targeting now. Yeah. We kind of saw this phenomenon happening a year or so ago, and we added 50% to our sales force in August of 2024. We went up to 42 reps at that time point. We have been building all the infrastructure around as we scaled up, and it has been driving our growth. We have now announced doubling that group. We will be prepared and in the field in the 1st January with that team. We have already expanded all the infrastructure it takes to support that organization, as well as this is a very complex patient group to manage. You have to also scale up your patient services, your reimbursement services, your pharmacy services, all the things that are critical to serving the patient and the clinicians there. That is all happening. We will be ready by the first of the year. We are pretty much ready. That'll take us from about 6,000 target physicians today with our 42 to about 12,000. Those physicians are still community endo-like. I call them endo-like. They're high divertology, high GLP-1 writers, all those areas that are treating complex, pretty significant patient groups. That's where we fit. That's where the patients are. Right? We're kind of expanding right into where that is with Recorlev. Can you talk to how many current prescribers there are of Recorlev and a portion of those that are repeat writers? I don't know that exact number of how many are writers, but I can tell you every quarter, especially in the third quarter of this year, we've increased the number of new writers as well as we're seeing repeat writers. It is depth and breadth of where we're at. This will really help us get to more new writers as we kind of expand our territory. Is the sales force, the expanded sales force, is it right-sized? Do you expect additional expansion? I mean, you think about diabetologists. I mean, that's a fairly sizable call audience. You can make an argument that maybe as the market continues to evolve, you might want to expand the sales force again down the road. How do you think about that? Yeah. I think I'll let you talk. Yeah. Yeah. Yeah. Yeah. Thanks, John. I think we feel good about the expansion doubling in January to meet the kind of near-term and mid-term opportunity for Recorlev. Really, this expansion is focused on deepening penetration with high-value prescribers. We're not ruling out future adds down the road, but there's no immediate need to expand further. Longer term, to get to a billion-dollar opportunity for Recorlev, it's going to take incremental investment, no matter when. We'll approach that in a pretty disciplined manner. What does payer access look like these days? This whole space is all about prior authorizations, improving medical necessity. It is really not about payer access. It is about, can you demonstrate that this person has hypercortisolemia at a certain level and they have some comorbid condition that you are trying to treat? You can make the argument with the payers. That is where we are at. We continue to make those arguments. Our teams help the clinicians make those arguments so we can get patients on. It is really just about working through that process. It starts with collecting the right clinical information on the referral form and then getting it to a point where you can get the patient started. I mean, are you seeing any cases where patients have to have prior exposure to ketoconazole? In many cases, the payers will try to run through step-throughs across all the brands, including us and ketoconazole. The ketoconazole one was something we thought about years ago, but it really isn't that big of an issue because the physician can easily ask for a peer review and say, "Okay, there's no label here. There's no dosing. There's no drug-drug interaction. I have nothing on how to manage this patient from the ketoconazole label or even what's available in the literature. I can't use this. I need to use the product that is approved for this condition." That's an easier one to win, but you still got to get through those in some cases. Yep. Makes sense. Looking further ahead, there's a PDUFA for Corcept's relacorilant before the end of the year. How are you thinking about competitive impact, if any, on Recorlev? I know mechanistically it's a very different product, but how are you thinking about that? That's exactly how we think about it. Mechanistically, it's very different. Them coming into the market with another product with more resources, talking about finding the people that are in uncontrolled situations and treating that uncontrolled condition is good for all players in this marketplace and good for patients at the end of the day. We sit very nicely because, like you said, we're a very different product. If the clinician wants to normalize the cortisol, that's what we do. We have a mechanism of action that hits the synthesis of cortisol in three places. It actually nicely slows down the cortisol and brings it into normal range. When you do that, the clinician can A, track that, and B, see the symptom improvement. It is a good value proposition talking to the clinician if they want to bring down and normalize the cortisol in a nice even manner. That is how we position Recorlev. Yeah. You do not see any sort of disruption. I know the pie is growing. I do not look at it as a zero-sum game, but anytime you have a new launch, there is certain awareness, but there is also the potential for some dislocation, at least temporarily. You do not see that being an issue? Not terribly because, again, you're going to bring a lot of awareness in this and get a lot more patients screened and tested. You also have it in the first quarter when payer resets kick in. This is one seasonality of this space. We're also expanding. There is a lot of stuff going on that Q1 might see a little bit, but I'm so confident in the way the market is growing and the number of patients that are being screened and detected that I think at the end of the day, all the three players will play right through any disruption. Yeah. I want to switch gears and ask you about your IP position on Recorlev. Just talk about the patent estate, where you see the strongest claims, and I guess the question about when we'll start to see paragraph IV filers on the product. Yeah. We feel really strongly about the position we're in. We have multiple Orange Book-listed patents, four of which go out to 2040. All of those relate to drug-drug interactions. All of them read to the label. We will be really strong arguments for why we should be able to protect that brand from generic competition. On top of that, the composition of matter goes out till the end, to 2027. The soonest anybody could file, which was your last question, would be sometime in 2026, as early as 2026. I also remind you that we also have orphan exclusivity that goes to the end of 2028. Of course, we will protect this brand with rigor. The important thing is we wouldn't have put out our projections of we think this is a billion-dollar brand by 2035 if we didn't feel so confident in where our patent situation and our patent protection comes with Recorlev. One thing I do see with DDI patents sometimes is generic companies trying to get a little creative and trying to carve out a label around that. I mean, and we've seen this before, and I haven't really seen it go anywhere. Just can you talk to that and how you feel about that as a potential avenue for generics to get—I don't want to call it get cute, but ways to try to get around the DDI patent? I think they're going to have a hard time on this one because the patents cover things that people with hypercortisolemia are on. Metformin is a great example. I mean, so that would be a challenge. Okay. All right. That's helpful. Last question on Recorlev before we go into Gvoke, Keveyis, and levothyroxine. Just talk about life cycle management strategies on Recorlev. Any color there? Yeah. Our immediate and near-term focus is on driving our commercial footprint to really get more patients on and starting to generate more and more data that supports all the cases and uses of this product and people in uncontrolled conditions. We'll continue to do that. Long term, we will look to add to this. We can look at other indications. We can look at label changes. We can—all of those things. When you're building a billion-dollar brand, you do all those. We're in a great position to do that. Yeah. Gvoke. Let's talk about the growth drivers here. Is it mainly type 1 diabetes? I've heard that in the past. I'm not sure how accurate that is. Are you pulling in type 2 diabetes patients as well? Maybe a broader question. Why do you think penetration of ready-to-use glucagon is still pretty low? Wow, that's a great question. I'll tell you, it's primarily driven by a lack of awareness of the guidelines. The medical guidelines are really clear here that you should have—if you're on insulin or sulfonylurea, you should have a ready-to-use glucagon just in case, just in case. You should be protected. A big part of our job is to educate a lot of clinicians on that's what the guidelines say. Number two is get them more compliant with the guidelines. Right? There are still 270,000 patients that end up in the every year because they don't have hypoglycemia. There are 25,000 deaths that still happen because of hypoglycemia. These could be prevented if we were just stronger at getting all the patients to have a ready-to-use glucagon just in case. Yeah, it's taken time. It's taken effort. All of that growth is in the adult population as well. The pediatric segments are saturated in terms of pretty much everybody has a glucagon. I guess, is this sort of a classic case of blocking and tackling where you just got to continue to get in front of the endos and there's a certain level of promotion intensity associated with the product? I mean, is that a right way to think about it? Trying to really change and get it as part of their practice. Yeah. In terms of the commercial resources behind Gvoke, just dig again. I mean, how do you think about the extent to which you're going to need further investment in the product? Because I mean, Recorlev is the big growth driver, but where does Gvoke fit in terms of further investment? Yeah. I think at this point, we feel that our Gvoke infrastructure is scaled appropriately to continue to deliver consistent, reliable growth for the brand. We evaluate market dynamics all the time. If data presents itself that says we should make further investments, we'll do that. At this point, we feel good about our commercial infrastructure behind Gvoke. What about payer access for Gvoke? I mean, I think when you launched, it was quite good. I mean, it still is. Still is very good. Yeah. We're probably over 80% access. It's there. That's really not the issue. It's really getting clinicians kind of in the mindset of, "Oh, they're on insulin. Do you have glucagon with you? Do you have it?" Getting them to that point when they got so many other things to worry about is really the work we're doing. Making the standard of care the standard of practice. Yeah. Yeah. Do you feel like there's any competitive dynamics with Baqsimi that might be problematic, or is it kind of a market that can readily accommodate these two different modalities? It readily can accommodate. I don't see a real competitive dynamic. You should have one or the other, honestly. I don't care which one you have. I know which one I would choose. I take Gvoke ibuprofen every day. Last question on Gvoke, just can you talk to the gross to net and where net pricing is on that product? Yeah. It's been pretty stable for the last couple of years. Given our strong payer access, I don't anticipate that changing at all. Okay. Wanted to sneak in a quick one on Keveyis. Kind of hangs in there, which is a good thing because not that long ago, there was a generic launch. Just give us some thoughts on the trajectory of that product and how you see that evolving given the presence of a generic. Yeah. You can get me excited when you talk about Keveyis because I think it's one of those areas where you really are making a difference in the patient, and it goes beyond just the medicine you deliver. It's everything you do. What we do for Keveyis in this space of PPP is we help the clinicians diagnose these people for the first time ever. We help them get started on drug. We help them eliminate and get rid of these episodes with patient services, with pharmacy, everything we do around this. It's as important, probably more important than the drug itself. That's what's allowed it to, despite generic competition, continue to maintain. We still find new patients every week and get them on the brand. We get patients coming back after going to a generic. They come back because they need all that service. They don't want to have breakthrough episodes, and they want to have all the support that's necessary. It's been solid. It's been holding on right around pretty flat at $11 million a quarter, and we see that continuing. You do not have any visibility into additional competitive entrants from a generic? We assume there will be. As we see them, we'll see if it impacts. Having two out there now that are having virtually no impact makes us feel pretty good. We'll see. Okay. 8121. I want to spend a few minutes on that. Can you talk to the underlying dynamics of the levothyroxine space that make it well-suited to a long-acting injectable modality, even with generics of oral levothyroxine pretty well established? Yeah. This is one of the biggest drug categories in terms of number of patients. There's 20 million patients on daily orals of levothyroxine. Our product is a once-weekly subcutaneous injection of levothyroxine. Somewhere between 20%-40% or 3 million-5 million people today cannot be brought into normal ranges because of GI absorption issues. That is really where the market opportunity and the potential for this is, in those 3 million-5 million people that, due to some either physical reason of their GI or they're on certain drugs or proton pump inhibitors or things that get in the way of the absorption and the constant daily fluctuations of taking a daily oral, this is where it comes in. This is where 8121 fits. What's really interesting to us is what a hassle managing these patients are for the clinicians. They're constantly measuring TSH. They're constantly adjusting dose, and they don't need to with a product like 8121. That sort of brings me to my next question, which is the target patient groups that you think are most appropriate for 8121. Is it those frequent dose adjusters, those frequent what I call switchers? They go from different generic products to try to find the sort of the Goldilocks product, if you will. I mean, is that the right way to think about it? Exactly. What portion of that market is it? I think it's like—we think it's 3million- 5 million. 3million- 5 million. To patients, people. Right? And then some of the data would suggest it's higher than that, but just stay in that area. This is a very large drug. That's why we went out and said we think it's a $1 billion-$3 billion opportunity in that segment. Can you walk us through the design of the phase III for 8121 and also just how to think about timing of data? Yeah. We put out there—and we'll talk more about this. We're going to launch the phase three trial later in the second half of 2026. It'll be about 1,000 patients. It's going to be a year-long study. We will show therapeutic equivalence to the daily orals. That's kind of what we need to do from a regulatory pathway standpoint. The significance of that is all of the daily orals have been—they're pre-DESI drugs and then PK back to the pre-DESI drugs. They've never been tested clinically with things like measuring TSH and T4, things like that. There's none of that data. We'll be establishing all that for the first time. That's why it's like about 1,000-patient study. We want to design it so that we assure our probability of success because we know levothyroxine works. We want to do it with the right formulation and the commercial presentation, so to speak, when we start that trial. Okay. What is the extent to which you can leverage your existing commercial infrastructure to support the product? Highly leverageable, yeah, with our endofocused commercial infrastructure for Gvoke and Recorlev. That is something that we'll tap into. We're very familiar with the prescriber base already. Our patient services and patient access capabilities that we have built in-house for Recorlev and Keveyis are directly transferable. It also leverages our formulation capabilities, our drug-device combo capabilities. These are all things that we have in-house that we are leveraging for this pipeline product. In the half a minute we have left, just you're profitable. You've got a commercial infrastructure that you can leverage. That sort of begs the question, what's your willingness to acquire an asset or assets that you can plug into your existing commercial infrastructure? How big of a priority is that? Yeah. What we said is that's why we laid out a target of $750 million by 2030. We can do that with our existing products, with Gvoke, Keveyis, and Recorlev. As we look at BD, we don't need to do BD for those reasons. We are looking at things that could fit in and tuck in and leverage all the capabilities we have. If we find one of those, we'll certainly move at it. It would be very leverageable to what we already do. All right. Terrific. Lots of progress. I'm sure more to come. Thanks, John. Thanks, Steve. Thanks, everyone at the event. Thanks.