The CEO, John Shannon, and on the line, we have Steve Pieper, the CFO. Thank you guys for joining and, you know, welcome to the conference. Thanks for having us. Maybe just to level set the conversation, John, can you just give investors that are less familiar- Mm-hmm. A brief overview of the company and your current product portfolio?
Yeah. I'll just go really high level because I know we're going to dig into some of this. Xeris is a fast-growing commercial biopharma company. We have three commercial products on the market. Gvoke for hypoglycemia. It's a rescue pen for hypoglycemia, basically an EpiPen for diabetics. KEVEYIS. KEVEYIS is for primary periodic paralysis, which is an ultra-rare hereditary genetic disorder. We can talk a little bit about that asset in a little bit. RECORLEV. RECORLEV is for hypercortisolemia and Cushing's syndrome, which is our big grower in the business. On top of that, we have XP-8121, which is our next potential blockbuster, and that's a once-weekly SubQ levothyroxine for hypothyroidism. That's phase III-ready. We're gonna get that phase III started this year. It's really set us up to really develop, and we're on this journey to build this multi-billion-dollar biopharmaceutical company. That's what I really want people to hear today as we talk about the brands.
Awesome. Before we dive into the products and guidance, 2025 was a really big year for the company. You transitioned to positive EBITDA. RECORLEV became the number one product. Maybe just looking back over the course of the year, can you talk about the trends and things that maybe went even better than you expected?
Yeah.
through 2025?
As you pointed out, it was a transformational year for us. We delivered $292 million in revenue, which was above the high end of our range for the year. That's 44% revenue growth for the year. The most exciting things about that was we then delivered $60 million of adjusted EBITDA. On top of that, we had net income for the full year, which really allowed us to transition to and really prove once and for all for people that we could fund our strategy, we could self-fund our strategy, our pipeline, and our future.
Switching over to RECORLEV, this product has grown over 100% for the past two years. It's still pretty early in the launch. Can you just talk about the launch trajectory from the beginning? Because it really started to inflect towards the end of 2024. With that, just the drivers, whether patient demand and also along the way, you've made some incremental investments in sales.
Mm-hmm.
If you can, as you're walking through this trajectory, remind us of where you've made those incremental sales investments and where we stand today.
Yeah. RECORLEV's a great story. We saw going out just before 2024, that there was a real dynamic changing in the marketplace. In this marketplace of hypercortisolemia and Cushing's syndrome, more and more patients were being screened and diagnosed with cortisol levels, you know, 1.82x above the upper limit of normal. They had these other conditions, which were resistant to drugs that should normally be working. This dynamic was starting to happen and so at that timeframe, we took our sales organization from 28- 42 people in order to take advantage of that dynamic in the marketplace, of more people coming in, right? The growing population of people coming in, being diagnosed. As we expanded into that, we saw that coming.
We made that first expansion a year and a half ago, maybe a little more than that in front of that. We were able to capture. That's why you see the acceleration in our growth as we find those patients and then get them onto RECORLEV. Seeing that trend and where it's going has really allowed us to make incremental and additional investments, which is what we did this year. We already have doubled our sales organization, our whole commercial footprint, 'cause it's not just salespeople, it's the patient services, reimbursement services, pharmacy services, all the things it takes to be able to get these patients on therapy, keep them on therapy, and really help them get through this normalization of cortisol.
Awesome. We're gonna go back.
Okay.
to RECORLEV, but let's talk about-
Yeah.
Gvoke and KEVEYIS. Gvoke, can you talk about maybe the overall revenue growth in the most recent quarter and the dynamics between unit volumes and pricing? You know, on the ready-to-use side, there's another key competitor, and they've talked about focusing more on unit growth as opposed to pricing. I'm just maybe curious for an update on the market and how penetration into that opportunity is going and maybe how you're thinking about it for next year. This year.
I would start with Gvoke has been a very steady growing asset for us, since we launched it seven years ago. I think it's seven. And that product itself is all about getting the patients today that should be protected that are not protected. And when I talk about that, people on insulin, sulfonylureas, there's about 15 million of them, they should have. Based on the guidelines, they should have a ready-to-use rescue just in case. They don't. There's only about 1 million people out there. So all of our efforts have been getting more and more people on therapy. That's what's allowed us to grow, is bringing on more people on therapy. You mentioned the pricing.
The pricing, you know, was a little bit of a difference this year because we've been also doing things to, you know, kind of improve that Gross to Net along the way during this process. Those things were showing up in our revenue numbers, as well. The game here is really to grow this thing. We see this growing, you know, in the high single digits percentage to low double digits percentage for a very long time with so many patients out there that still need to be protected.
Awesome. KEVEYIS has obviously turned generic, with some competitors on the market. In the fourth quarter, the product actually returned to growth after the first three quarters of some expected decline in 2025. Just can you talk about the outlook on the competitive landscape and maybe how we should think about the trajectory of that product?
Yeah.
Yeah. Here we go.
Yeah. Just, you know, this is an asset that we're really proud of in its performance and how it's been, you know, so resilient since generic competition came in three, four years ago, and really hasn't made a dent. And as you mentioned, we actually saw growth from an overall patient perspective on the full year in 2025. Obviously there's always pricing dynamics when you have generic competition, but those have been on balance with the patient growth, kind of been neutralized. We see KEVEYIS continuing to be a steady contributor to our business.
It's not just the product itself, all of the services that we put around the patient to support them on their journey has really made that product really resilient for us from a contribution perspective.
Awesome. Tying these three products together into your recent 2026 guidance that you gave, which came in well ahead of what people thought. You know, we talked about the trends in KEVEYIS, high single-digit growth from Gvoke. That leaves RECORLEV. I'm just curious, given the very strong 100%, almost 120% growth the past two years prior, just can you help us understand, you know, the low end to the high end of that range? What gives you confidence if there's any layer of conservatism, just given how strong RECORLEV has been performing?
Steve, I'll let you take that one too.
Yeah. I'll take that one. No, we're really confident in our guidance. You know, I think we've established a track record of meeting or beating guidance over the last couple of years. We put out numbers that we feel like we can meet or beat. To your point, I think, you know, you're seeing that the growth is really coming from RECORLEV. Majority of the growth we're expecting in 2026 is coming from RECORLEV. As John mentioned, we doubled down on our commercial footprint for RECORLEV this year, and so we're gonna start to see the tailwinds of that really start to accelerate in the back half of the year. This is our third expansion with RECORLEV, so we have a history of how these expansions perform. This was our most significant expansion. We're really expecting to see the tailwinds from that expansion kind of, you know, in Q3 and beyond.
Awesome. Just as for people listening that might not be familiar, quickly on RECORLEV with guidance, is there any part of the guidance that included, you know, there was a competitive product that it received a CRL towards the end of 2025? Like, did that impact your guidance at all?
Not at all.
Yeah.
Not at all.
Just sticking on that point is the way you think about the competitive landscape. Like, how do you view another player entering the market and maybe having more resources out there talking about it? We're gonna review the differentiated nature of RECORLEV. I'm just curious if having more people marketing a product can, you know, be a rising tide that lifts all boats.
Yeah, that's exactly how we think about it, is more and more products coming into this space, finding patients, screening them, diagnosing them with hypercortisolemia and Cushing's syndrome, allows for a greater opportunity here. That's really what's going on in this marketplace, is everybody is out there finding new patients. More than 60% of our patients today are naive to therapy, coming onto drugs. That would suggest a couple things. One is we're becoming more and more first line, as the last guy into the marketplace. Number two is that that's what we're all doing is finding those patients so we can treat them. We see that as, you know, this market is very early in kind of evolving and growing. You know, we're looking at all these metabolic disorders where drugs that should be working are not working.
Mm-hmm.
If you go and look and find cortisol as the culprit, that's certainly how the clinician knows what to treat.
Yeah.
So-
Thinking about the products that are on the market and even one has, there's now a generic player involved and just the traditional therapies and with Cushing's, sometimes the issue has been side effect profile as well as treating more of the symptoms rather than the underlying condition. Can you help frame RECORLEV from that perspective and just how it's been different?
Yeah.
on those fronts relative
Sure.
to what's approved?
The way RECORLEV works is it normalizes and brings down cortisol levels by going after the source of synthesis of cortisol. It does it by hitting it at three enzymatic places in that design. By slowing it down and bringing the cortisol into normal levels, the clinician can track that, and you can see the progress to all the comorbidities that comes with bringing cortisol back in the normal range. Some of the, you know, other products will block the cortisol at the receptor level. The cortisol is still being produced, it's running around, it's just not having an effect on certain things, right? That's how we're very different in that respect. Our conversation with clinicians is like, if you want to go after the source and we want to bring cortisol back into range, let's talk about our product. Which is very different than, you know, at least some of the competitors on the marketplace.
Awesome. You know, you hosted an analyst day earlier last year, and you laid out some peak sales estimates for RECORLEV and your pipeline, which we'll get to. Just considering where we are today, 2025 was around $140 million. The peak sales target is $1 billion. I think it just emphasizes how much of a runway there still is. Sometimes the question we get now that this one product is in such high focus and for good reason, but I think we should talk about that peak sales, which is still about 10 years or so relative to when you gave it. That's a long runway of growth. Just maybe talk about some of the assumptions behind that and maybe how you see this playing out over time.
Yeah. The main assumptions behind that are that we'll continue to see these dynamics in the marketplace where more and more people are screened and diagnosed. This is one of those things where it's going to take time, and it'll move up, and you'll have to scale along with it, right? That's why, you know, we say by 2035, we'll get this to $1 billion. I'll tell you, sitting here today, just a year into it, we're on pace. I mean, we're at where we want to be. The other thing we want to be really clear on with everybody is it will take investment on the way there.
Mm.
Like we laid out this year, a doubling of our commercial footprint to be able to get to have the reach and frequency to get at those patients. Then all the resources you need to bring those patients on. There will be additional investments that'll need to be made over the next several years to continue to keep that growth rate going and stay on the curve. In addition to that, we are also looking at and doing work around what other data generation, other things we can do to basically bring even more value into this space.
Awesome. We're going to touch back on profitability.
Yeah.
I'll wait until we talk about the phase III trial. The recent Paragraph IV lawsuit, I just wanted to go touch on that.
Yeah.
Just maybe help people better appreciate the nature of these ANDA filers and the timing on when the window can open for them to file and how maybe that, you know, impacted you and, like, whether or not you expected this and just kind of talk us through that?
Yeah. We expected it. We were not surprised by this. We anticipated it. It was almost on the day that we anticipated it. The first day that they could file would have been technically the first of the year, which gets them to where they all ended up. We had and we were ready for it.
Mm.
You know, we filed the lawsuits within 10 days, because we knew it was coming. We were prepared, and we feel so strongly. We have such great IP going all the way out to the four patents that everybody's challenging. There's four of them, and they go out to 2040.
Yep.
They're related to methods of use on things that is very common, utilized with people with hypercortisolemia Cushing's. We feel really strongly that we can defend those patents. We knew that even when we put out that $1 billion back in July of last year, June of last year. I'll say it every single time I'm out here, our strategy has not changed.
Yeah.
We have this product on a path to $1 billion. I don't see any scenario that takes us off that path.
Awesome. You mentioned it, but it's just worth probably talking about again because obviously you gave the peak sales. You expected that this was coming. It's clearly contemplated in that forecast. I just wanted to double highlight that because based on the market reaction, maybe if people haven't been following as closely, it's almost like you react first and then figure it out later. It's just good to hear that, you know, this is as expected, you know, it doesn't change anything.
Yeah.
I'm assuming that's all fair to say.
That's all fair to say.
Awesome.
Yeah. I couldn't reiterate that as much as I could. I mean, we're making significant investments, and we'll continue to do that to drive that $1 billion of value.
Perfect. Speaking of investments in the long term, you have an asset in phase III now. You know, you turned into EBITDA profitability last year. You have some step-ups from investments, R&D to fund the trial. Can you talk about the profitability outlook this year and what you expect just for 2026?
Thanks for the question, Jenna. Yeah, we guided to this year, you know, starting at the top, 30% growth at the midpoint, revenue in that.
Allows us to fund these additional investments, both from an R&D perspective as well as SG&A. We've guided to increasing SG&A $45 million this year and $25 million incrementally for R&D to support XP-8121. We'll continue to invest incrementally in those two assets beyond 2026. The good news is that's powered by the growth that we're seeing on the top line. Importantly, I think it's worth noting, you know, we finished the year with 85% Gross Margin. We also guided to our Gross Margin modestly improving this year as well. That, again, those two factors really allow us to kinda reinvest back into the business.
Yeah. You know, as RECORLEV progresses towards that peak sales, and as you mentioned along the way, there will be incremental investments. It's probably too early because you just gave guidance for this year, but the way you think about the path to $1 billion, is there like a timeframe on when you might or certain milestones or metrics that would determine when we might see these incremental investments? Is it a step up every year with new sales force addition or just anything to help us think about the longer term profitability?
I'll try.
Yeah. Yeah
this one. Yeah, I think we've been pretty opportunistic. This is our third expansion.
Yeah
with RECORLEV. As the market conditions warrant, we'll make those investments, and we have capacity to now invest incrementally.
Yeah
a set time, but, you know, we're expecting we will continue to invest incrementally behind those assets.
It's all about scaling it.
Yeah
at the right pace so that you can really keep up and make sure not only are you filling the top of the funnel with referrals, but being able to pull those patients through on drug and then also keep them on drug.
Awesome.
Really important.
Now we'll talk about the pipeline. Maybe just walk us through this asset.
Yeah.
What makes you so excited?
Yeah.
I mean, the peak sales is three times what you gave for RECORLEV, so that's very interesting. You know, the timeline of when we might expect any data readouts and milestones and things like that.
Yeah. We're, as you pointed out, we're really excited about XP-8121. Starting with it was formulated, and it's made possible by our own formulation technology. It's homegrown, developed inside, and it fits right into everything we do, from drug device combo to endocrinology and our sales teams and commercial teams. It's like the perfect fit for us going forward. As we've got it to this point, we're about ready to start the phase III. We can see that there's a real unmet medical need in the marketplace. This is hypothyroidism. There's 20 million people out there on replacement therapy, daily orals. Somewhere between three-five million of them cannot come into range or the clinicians can't even get them into range because of GI absorption issues. This bypasses the GI, right?
Doing a once weekly SubQ can really solve a problem not only for the patients, for the clinicians. These are really challenging patients to manage. We are going about this as it's a blockbuster. We're taking our time to do all the things right before you even start the clinical trial, and making sure that we can, you know, successfully navigate that. We'll give a lot more about the trial design, endpoints, and all the things everybody wants to know probably later this summer or early fall.
Mm-hmm
right before we start that trial.
Awesome. Maybe we'll touch on the balance sheet as well, Steve. Just we talked earlier about transitioning to profitability and, you know, being able to really fund the commercial products as well as the pipeline, and just give us maybe a balance sheet update and any thoughts that you're willing to share on capital allocation priorities.
Yeah. As you mentioned, our balance sheet continues to improve. It's never been stronger. We ended the year with over $110 million in cash. Given our guidance, you know, we expect that to continue to grow. The capital allocation priorities right now are RECORLEV and XP-8121 and funding their futures. Beyond that, there are, you know, things that we can do, inorganic things from a balance sheet perspective with regard to our debt. A lot of options open up to us as our balance sheet continues to improve.
Awesome. In review, 2025 milestone year, RECORLEV top product, EBITDA profitable. You gave preliminary strong 4Q. You reiterated those results and also then guided ahead of The Street. These updates have been incrementally positive. Just if we take a step back and think about just how the stock has traded, and I mean, I think we kinda discussed the answer to this, but I just wanted to give you the last word on what you're thinking is the most dislocated between what's going on at the company and all these positive trends and outlook versus maybe how the stock has responded to some of the news that we've seen this year.
Yeah. I think, you know, our position on this is, you know, we're just gonna keep executing. That's what we do. At some point, there'll be more rational movements in the markets, and that, you know, and then when we'll see that. If we continue to do exactly what we said, which we've been doing, there's no reason that the stock wouldn't just, you know, follow the right, you know, kind of trajectory up, as it was following just a few months ago.
Awesome. I think we're out of time, so this will be a good place to stop. Thank you so much.
Thank you. Thank you.
Thank you, John.