Good morning, and welcome to the Xeris Biopharma Fourth Quarter and Full Year 2024 Financial Results. My name is Harry and I'll be your operator today. All lines are currently in listen-only mode and there'll be an opportunity for Q&A after management's prepared remarks. [Operator Instructions] I would now like to hand the call over to Allison Wey, Senior Vice President of Investor Relations and Corporate Communications. Thank you, you may proceed.

Thank you, Harry. Good morning, everyone. We appreciate you joining our call today. I'm joined by John Shannon, our CEO; and Steve Pieper, our CFO. This morning we issued a press release with our detailed results which can be found on our website. After our prepared remarks, we will open the line for questions. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, prospects and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements. For more information on such risks, please refer to our Earnings Release and Risk Factors included in our SEC filing. Any forward-looking statements in this call represent our views only as the date of this call and subject to applicable laws. We disclaim any obligations to update such statements. Please note some metrics we will discuss today are presented in a non-GAAP basis. We've reconciled the comparable GAAP and non-GAAP figures in our earnings release. Let me pass the call over to John for opening remarks.

Thanks Allison, and good morning everyone. 2024 was an unprecedented year of exceptional commercial execution, focused pipeline development and disciplined capital management. I want to thank our employees, the healthcare community and the patients we serve for helping us to meet or exceed all of our goals consistent with our journey to become a fast growing, self-sustaining biopharmaceutical company. Our focus, execution and performance in 2024 has positioned Xeris perfectly for what I will call a transformational year in 2025. Let me start with the highlights for 2024. I will cover the full year results at a high level and Steve will provide more detail on Q4 and full year in his remarks. I'm proud to report that we exceeded our full year guidance with total revenue of over $203 million, growing 24% versus last year led by strong demand for Recorlev and Gvoke and continuing durability of the Keveyis brand. Across all three products, the commercial team continued to execute our plans resulting in 28% product revenue growth for the full year 2024 versus 2023. Looking specifically at each of our products, let's start with Recorlev which is rapidly becoming our flagship brand. We saw a record number of referrals and new patient starts, especially in the back half of the year, representing more than $64 million in total revenue in 2024 and an impressive 118% growth versus '23. Our focused and targeted investments in Recorlev are paying off and we see this momentum continuing as we enter 2025. Turning now to Gvoke. What a great year. This product continues to deliver steady, predictable growth. On a full year basis, Gvoke achieved nearly $83 million in revenue, an increase of 24% versus 2023. We saw the same increase in prescriptions totaling 265,000 coming from an increase in new prescribers…

Thanks, John, and good morning, everyone. Our fourth quarter 2024 performance marked the end of a very successful year. And I can say that Xeris has never been financially stronger. This quarter, we ended with net product revenue of $57 million and total revenue of $60.1 million, increasing by approximately 34% and 35% compared to prior year. This is the 13th consecutive quarter with greater than 20% product revenue growth. On a full year basis, net product revenue was $196.6 million and total revenue was $203.1 million, increasing by approximately 28% and 24% compared to prior year. Recorlev net revenue in the fourth quarter was $22.6 million, a 131% increase compared to the same period in 2023, this growth was driven by the average number of patients on Recorlev, increasing 123% from the same period in 2023. For the year ending 2024, Recorlev net revenue was $64.3 million, a 118% increase compared to 2023. On a sequential basis, Recorlev net revenue increased by a record $5 million in the fourth quarter. The strategic investments we made in the Recorlev commercial organization in mid-2024, coupled with favorable and evolving market dynamics helped drive the accelerated revenue gains we saw in the back half of 2024. Gvoke net revenue was $23.3 million for the quarter and $82.8 million for the year, representing a 25% and 24% increase compared to the same period last year. This growth was primarily driven by an increase in total Gvoke prescriptions growing 18% and 23% compared to prior year. Keveyis net revenue for the quarter and year-to-date was $11.1 million and $49.5 million. In the fourth quarter, we saw average patients on Keveyis, hold relatively steady compared to the third quarter. We also generated $3.1 million in other revenue in the fourth quarter and for the year,…

Thank you. [Operator Instructions] Our first question today will be from the line of Chase Knickerbocker with Craig-Hallum. Please go ahead. Your line is open.

Good morning. Thanks for taking the questions, and congrats on a record quarter here. First kind of just on the Recorlev strength, just help us better characterize, I guess, specifically kind of the strength there, of prescribers who are already writing, what kind of growth are you seeing from them and then, what kind of growth in overall writers are you seeing? Basically, how much of this growth is going deeper with existing writers, and kind of benefiting from their growth in prescriptions, as people have kind of just a better appreciation of this disease state, versus you guys successfully expanding your writer base?

Hi Chase, it's John. It's both like we continue to expand our writer base, but you also are getting more and more writers, writing more patients. So as they get comfortable in utilizing Recorlev, they begin to add more patients. So we have both happening, and with the expansion of the sales force, that's also allowing us to get to new patients. So it's coming from all places.

Do you get a sense of kind of what the increase in year-over-year kind of prescriptions in kind of hypercortisolism is in the market? Do you have any kind of sense?

We don't. I mean, as you know that these. There's no data out there that supports exactly where all these patients are. And so it's hard to, kind of figure that out. But obviously that's why you have people in the field, so that you can find these patients.

Yes, got it. And obviously, what you're seeing so far on Q1, kind of gives you the confidence for, what's a really strong guide here, anything else you can give us just from deeper than the kind of record, kind of pipeline and kind of incrementally, what you're seeing even better than Q4, that sort of thing. And then, just lastly from me on Keveyis, how should we think about it on a year-over-year basis in '25, should we be thinking about kind of the same decline, as what we saw in '24, or should we be kind of annualizing what we saw in Q4? Thanks.

I think, to your first question. We're trying to really point, what we saw in the back half of 2024. We anticipate we're going to see for all of 2025. We're seeing this acceleration and growth of our business that, we're confident we're going to be able to do in 2025. And even better than we did, on a full year basis for '24. So it's, a lot of the same stuff that we've been executing on. And then for Keveyis, I think Keveyis may have found, maybe its bottom, but we - so we don't know exactly what's going to happen, but it looks like we're really holding our own, especially as we hold on to patients.

Great. Thanks.

Our next question will be from the line of Oren Livnat with H.C. Wainwright. Please go ahead. Your line is open.

Thanks for taking the questions. Just first, I want to just clarify that last commentary on Recorlev growth. Just so we understand, when you talk about growth rates consistent, or better than what we saw in the latter part of 2024. Are you talking about year-over-year patient's ad rates? I mean, that was in the mid 125% range. Is that what we're talking about, or are we just talking about sort of sequential average quarterly revenue growth?

Yes, probably not on a, on a growth rate percentage, right. Because it's off of a higher end now, right. So, but I think - like an absolute, from an absolute perspective, I think what we saw in the back half should, we expect will continue throughout 2025, that we're. We've reached kind of a new trajectory, and this thing isn't slowing down, Oren. So I would think about it more from the underlying number of patient ads, rather than a growth percentage.

Okay. Makes sense. And in general, have there been any changes to access in that market? Obviously the market itself is growing, but is there anything changing within it with regards to, off-label prescribing or lack thereof, changes in managed care positioning within that space? And also, how are you doing on the sort of post initiation interaction, with patients and offices with, as we think about patients, tight training up over time. Is that something you guys are proactively interacting with offices and patients, to sort of push them to continue to check levels and optimize therapy? And I have one follow-up?

So on the first part of your question, no changes in reimbursement. Everything's pretty much the same. Obviously there's a great opportunity and once a patient is on, is to help them and keep them on. And we continue to, invest in that and work on that, as an important aspect of helping to drive our growth.

Okay. And just lastly, obviously you guys are really excited about 8121, and we've all been sort of waiting for a while to get that clarity. So it sounds like, you're still planning to give us more midyear. Pardon me, are you able to talk about now, like maybe if there's anything still TBD on that front, between now and midyear updates, or is it just about preparing how you want to roll out the reveal there, so to speak?

We're still having a dialogue with the agency and as we planned, this is all part of our plan here, was how we go to the agency, how do we work out the clinical, the device. And the path to regulatory approval, was a process that we've been running. And we'll be prepared to talk more about exactly, where that all lands by midyear.

All right, appreciate it. Great quarter on guidance. Thanks.

Thanks, Oren.

Thanks, Oren.

The next question today will be from the line of Glen Santangelo with Jefferies. Please go ahead. Your line is open.

Yes, thanks for taking my questions. Just a couple of quick financial ones. Steve, I think you said that gross margin was 84% in the fourth quarter, and that was up 100 basis points, recognizing sort of what happened in the third quarter. When we look at that, that margin - that gross margin expansion in 4Q. Is that the right way to think about, 2025, based on the mix assumptions that you sort of making for '25?

Yes, I think that's a good starting assumption right there, Glen moving forward, plus or minus.

All right, but then, then moving on to your expenses, I mean it seems like, I think you use the word that you expect your operating expenses to be up only modestly when looking at R&D was flat in 4Q and SG&A was up about 7%. So how should we think about that term? Sort of up modestly, because it starts to seem like a lot of leverage in the model, obviously, which but just sort of help us put those operating expenses into context? Thanks.

Yes, I think, I think you hit the nail on the head, Glen that we are creating some leverage in the P&L, with our operating expenses. We continue to invest in Recorlev, and we had some adds to SG&A in the second half as a result of the Recorlev expansion. So you'll get the full year effect of that in, in 2025. And then I think we'll invest incrementally in 8121. The real spend though. It's, it's worth pointing out the real bolus of spend, when you start talking about clinical spend will be more of a 2026 phenomenon.

Okay. Thanks, Steve.

Sure.

The next question will be from the line of David Amsellem with Piper Sandler. Please go ahead. Your line is open.

Thanks. So just a couple from me. Number one, is looking at one of your competitors with Korlym. There's significant growth in sales and marketing spend for that company, and a lot of it of course is supporting this expanded market, and expanded understanding of the prevalence of hypercortisolism. So I guess that sort of begs the question, how are you thinking about the long-term spend to support for Recorlev. And do you expect significant headcount expansion in terms of the sales force. Do you expect significant overall promotional - growth and promotional spend to support the product? Just help us understand that as our understanding of the market evolves, and we have greater clarity on the extent to, which this is a much bigger market, compared to our understanding of it historically. So that's number one. And then number two, can you just remind us how we should think about the durability, and exclusivity runway for Recorlev that would be helpful? Thank you.

Wow. A lot to unpack there. We see the expansions both of Corcept and Recordati in this space, as is really adding to the opportunity raising awareness, raising testing will get more and more people identified and treated. We see that all as positive, and adding to the tailwinds that we're all enjoying in this space. I think that's important that that continues and it's helping all of us, really find these patients, and get them on therapy. So that that's all, the positive and adding to the positive momentum in the space. And then what was the second part, somebody?

Exclusivity on Recorlev…

Oh, exclusivity on Recorlev, I think our patents are - on the Recorlev goes to 2040, and we have orphan exclusivity through '29 in '28.

And to '28.

So again a lot of runway here. A lot of opportunity to continue to, advance this market. And the other piece of this is we have Recorlev. We think Recorlev is, as I said in my remarks, the right product at the right time. So I think we have the best-in-class in terms of normalizing the synthesis of cortisol, which is a very important aspect to treating these patients. So I think it's just perfect timing for us.

And headcount expansion, what's your expectation longer term?

Longer term investments in Recorlev will continue, as we see the opportunity and we will continue to advance our investments in here, because like we said, we have plenty of runway and a really accelerating market that says yes, to invest. How we invest. I'm not going to talk about exactly, how that works out over the next several months, but we definitely are, see that as one of our key priorities of investment.

All right, thanks.

The next question will be from the line of Leland Gershell with Oppenheimer. Please go ahead. Your line is open.

Great. Good morning. Great to see the positive investment EBITDA and thanks for taking our questions. Just two from us. Just first, John, just wanted to ask with respect to Gvoke given the updated guidelines, if you could just maybe go into some detail on maybe how you're leveraging that update, with respect to growing the product? And then also wanted to ask on - 8121 as we look forward to the unveiling of the broader plan midyear, would you be able to say that you at least intend to enter the candidate into Phase 3 potentially by the end of the year? Thank you.

Yes. Let me start with Gvoke and the guidelines. The guidelines are pretty clear. And our job and our team is really focused on not only raising awareness of the guidelines, but also helping clinicians offices, become more compliant with the guidelines, so that we can get the 14 million people today that are not protected, they're unprotected and should be protected based on the guidelines. So our focus in those offices every day is to help those offices advance their practice in a way that can get these people protected. And our Gvoke team is doing that on a day - everyday basis. We see that as a long-term opportunity. It's going to take effort, and we continue to invest in that effort. 8121 I think, as Steve pointed out, yes, we're making investments this year. They're not super large investments. They're more Phase 3 readiness, so that we can get started in the clinic, probably our thinking is sometime in '26. But yes, it's more Phase 3 readiness this year.

Got it. Thanks very much.

The next question will be from the line of Mazahir Alimohamed with Leerink Partners. Please go ahead. Your line is open.

This is Mazi on for Roanna Ruiz. Just a couple from us. I guess, firstly, as we think about the expansion with Recorlev, how -- and the recent sales expansion, is there any thoughts in terms of 2025, of increasing the sales force or any changes to the commercial strategy?

So I think sitting here today, we feel pretty confident with what we have in terms of our commercial footprint for Recorlev. That being said, we've had 2 expansions over the last 15 months. So we'll be opportunistic as the market dynamics unfold. And if we see an opportunity to invest incrementally in Recorlev this year, we'll do that. But right now, sitting here today, no, we don't have any firm plans for an expansion.

Great. Thanks. And then last one from me. On 8121 as we think about kind of moving through the trials, and into a potential commercialization phase for that. How would the synergies of your current existing products play a role in that? And is that something that you guys, could build upon as you think about commercial, are you kind of taking advantage of your already strong footprint, within the endocrine space?

That's exactly it. That's why we're - another reason why we're so excited about 8121, is it fits perfectly with our endocrinology footprint across Gvoke and Recorlev for that matter. And we have all the capabilities from patient support to channel to and pharmacy. So we - it's a perfect fit for us. And we'll be able to slide it right into our existing footprint. So another exciting reason. The other thing that's exciting about it, it's our own organic development program. It's XeriSol technology, which we know - how to use, we know how to work with and proven in our Gvoke products. So again, it's - those are two things that really are, get us excited about our ability to get this to market, and be successful once we get there.

Great. Makes a lot of sense. Thanks for the time.

[Operator Instructions] Our next question will be from the line of Oren Livnat with H.C. Wainwright. Please go ahead. Your line is open.

Hi, thanks for the follow-ups. I just wanted to clarify on the guidance. You talked about sort of sustained positive EBITDA. Are you able to put a stake in the ground right now, and say that for the full year or before year-end, that you'll be cash flow breakeven this year. And on Recorlev, just wanted to check on seasonality. Obviously, work on drugs are subject to pretty material growth to net changes in Q1 typically. Obviously, you're talking about really strong patient growth, and overall revenue growth there. Can you just talk about the cadence, and whether we should expect sequential growth quarter-over-quarter in net revenue, you think, in Q1? Or like most competitors should we see maybe a divot, before we accelerate into the year? Thanks.

Oren, let me take the Recorlev one, and then I'll throw Steve the first question you asked. Like every company that's in - especially in the rare disease space, there are resets and things that go on in the first quarter. So you see a little bit of slowdown in the first - January, February time frame, and that starts to rebound towards the end of the quarter. So Q1 is always a little bit slower, and then it picks back up. So - and we - it's I don't really call it a seasonality. It's just - it's all about the payer resets. And we see that across all of our products, but specifically more importantly, Recorlev and Keveyis probably feel it the most.

So Oren, on your cash question, I think you probably picked up on the fact that we're not really guiding on cash going forward. So let me just start with one, we have plenty of cash to operate the business moving forward. And hopefully, clear from the guidance we provided this morning that the company is on really solid financial ground, with a really promising outlook for '25, right? 30% revenue growth at the midpoint of our guidance, healthy, already healthy and improving gross margins and modest operating expense growth, and obviously, adjusted EBITDA moving forward, positive moving forward. So I think what we're doing - what we're saying here is we're transitioning from a kind of cash burn story that we have been historically. And we want to focus investors on the growing strength of our P&L, and the operations of the business. So that's kind of answering your question, without answering it. But I think what's important, is that we feel really good about where this business is heading, particularly in '25.

All right, thanks so much.

Thank you. This concludes Q&A. I will now hand the call back to John Shannon for closing remarks.

Thank you, and thank you, everyone, for your questions. As you just heard, the continued momentum of our commercial business, our exciting pipeline, along with our unrelenting focus on execution, will create even more value for our patients and our shareholders, and set Xeris up for a transformational 2025. Thank you.

Thank you. This concludes the Xeris Biopharma fourth quarter and full year 2024 financial results. You may now disconnect your lines.