XERS - NASDAQ

Hello, everyone, and thank you for joining us today for the Xeris Biopharma Q3 2025 Earnings Conference Call. My name is Sami, and I'll be coordinating your call today. [Operator Instructions] I'd now like to hand over to your host, Allison Wey, Senior Vice President of Investor Relations and Corporate Communications, to begin. Please go ahead, Allison.

Thank you, Sami. Good morning, and welcome, everyone, to the Xeris Biopharma Third Quarter 2025 Earnings Call. You can find this morning's earnings release and our detailed financial results on the Investor Relations section of our website. Today, I'm joined by John Shannon, CEO; and Steve Pieper, our CFO. After our prepared remarks, we will open the line for questions. Before we begin, I'd like to remind you that this call will contain certain forward-looking statements concerning the company's future expectations, plans, projects 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 our risks, please refer to our earnings release and risk factors included in our SEC filings. Any forward-looking statements in this call represent our views only as of the date of this call and subject to certain applicable laws. We disclaim any obligation to update such statements. Please note that some metrics we will discuss today are presented on a non-GAAP basis. We have reconciled the comparable GAAP and non-GAAP figures in our earnings release. I'll now turn the call over to John for opening remarks.

Thanks, Allison, and good morning, everyone. I'm excited to share that Q3 marked another record-setting quarter for Xeris. Total product revenue exceeded $74 million, representing a 40% increase year-over-year. As highlighted in this morning's press release, the strength of our year-to-date results gives us the confidence to raise the lower end of our full year total revenue guidance. We now expect total revenue for the year to be in the range of $285 million and $290 million, a 42% increase at the midpoint. Our performance was fueled by robust patient demand across all 3 of our products, reflecting the tremendous value our therapies are bringing to patients and the consistent and outstanding execution of our team. RECORLEV remained the primary growth engine with revenue more than doubling versus the prior year. This momentum reflects the continuing expansion of new patients and prescribers. Gvoke delivered another quarter of steady, reliable growth, demonstrating the effectiveness of our efforts to expand awareness and reinforce adherence to established medical guidelines. KEVEYIS outperformed our expectations, supported by new patient additions, which drove an increase in the average number of patients on therapy. Let's take a closer look at each product, starting with RECORLEV. RECORLEV generated revenue of $37 million in the quarter, a year-over-year increase of 109%. We continue to expand our prescriber breadth and depth as more clinicians gain experience with RECORLEV and recognize the important clinical benefits. The average number of patients on therapy grew by 108% versus the same period last year, reinforcing our confidence in RECORLEV's position in the growing hypercortisolemia and Cushing's syndrome marketplace. Turning to Gvoke. Gvoke delivered another solid quarter with revenue of more than $25 million, up nearly 10% from the same period last year. As we continue to educate patients and providers, we see considerable potential to reach more individuals who could benefit from having a ready-to-use glucagon on hand. Moving to KEVEYIS. KEVEYIS continues to serve a critical need for patients living with primary periodic paralysis. Quarterly revenue was approximately $12 million, driven by growth in the average number of patients on therapy. These results underscore what we know to be true, that effective treatment of PPP requires more than just delivering a product. It requires a sustained, holistic commitment to supporting patients throughout their journey. Our continued strong commercial performance this year has enabled us to accelerate our strategic priorities. As previewed during our August call, the third quarter marked the initiation of our next commercial expansion, a key milestone in laying the foundation for future scalable growth. This initiative is centered on expanding our commercial footprint to capture the significant opportunity ahead for RECORLEV while simultaneously strengthening the operational backbone required to scale efficiently in 2026 and beyond. This strategic expansion, nearly doubling our sales and patient support teams will enhance our ability to reach more clinicians and serve more patients and allows us to capitalize on the significant market opportunity ahead. Let's turn now to our pipeline in XP-8121, our once-weekly subcutaneous form of levothyroxine for primary hypothyroidism. XP-8121 continues to advance according to plan. Leveraging our proprietary XeriSol technology and drug device development capabilities, we are creating a novel formulation and a high-precision delivery system that will enable the administration across a wide array of doses. Important drug manufacturing and device validation work is in process, and we remain on track to initiate our Phase III clinical trial in the second half of 2026. As we've stated before, we're really excited about this product and the unmet medical need it can address. While at the recent American Thyroid Association's Annual Meeting, we enjoyed a large number of enthusiastic discussions with key opinion leaders who further reinforced our conviction in XP-8121's blockbuster potential. Before I turn the call over to Steve to walk through the details of our exceptional quarter, I want to leave you with this. We are focused. Our ability to deliver remarkable performance quarter after quarter highlights the value of our commercial product portfolio, the effectiveness of our strategy and most importantly, our dedication to serving patients. With that, let me hand the call over to Steve.

Thanks, John, and good morning, everyone. Before diving into our financial performance, I want to highlight the considerable progress our company has made this year. Over the past 9 months, we've generated outstanding revenue growth, fueled by both robust demand for our therapies and a high-performing commercial organization. At the same time, our gross margin has continued to improve, underscoring the strength of our operations. In the third quarter, we generated significant positive cash flow as well as net income for the first time in the company's history. We also delivered strong adjusted EBITDA growth, further demonstrating the scalability of our business and reinforcing our ability to translate consistent top line performance and bottom line results. These results are a clear testament to the discipline, focus and execution across the organization, and they reinforce the solid foundation we've established for sustainable growth well into the future. Turning to our third quarter results. On a year-over-year basis, net product revenue increased 40% to $74.1 million with total revenue of $74.4 million. RECORLEV delivered another record quarter with net revenue of $37 million. Compared to the prior year, net revenue once again more than doubled, increasing approximately 109%, driven almost entirely by patient growth of 108%. Gvoke net revenue was $25.2 million, an increase of approximately 10% compared to the same period last year. This growth was driven by a 5% increase in total Gvoke prescriptions as well as some favorability in our gross to net. KEVEYIS net revenue was $11.9 million. We saw a modest increase in the average number of patients on therapy in the third quarter, and we continue to see a healthy pace of new patient starts, underscoring the durability of this franchise. Turning to gross margin. We delivered a significant improvement this quarter with gross margin growing to 85%, driven primarily by improved product mix. Research and development expenses were $7.5 million for the quarter, a $1.6 million increase versus last year. This increase primarily reflects our continued investment in our pipeline and technology platforms. Selling, general and administrative expenses were $46.5 million in the quarter, an increase of approximately 3% compared to prior year. The increase in SG&A primarily reflects incremental personnel-related expenses. Adjusted EBITDA for the quarter was $17.4 million, improving more than $20 million compared to the third quarter 2024. This impressive result underscores the strength of our operating model and validates the actions we have taken to drive long-term value creation. As I mentioned earlier, for the first time since the company's inception, we reported quarterly net income. This achievement highlights our growing commercial strength and operational discipline. As we continue to make targeted investments across a range of growth opportunities, we do expect some variability in quarterly EPS results going forward. And to be clear, we remain committed to maintaining positive adjusted EBITDA even as we make these incremental investments. Moving to our near-term outlook and guidance. As John highlighted, our strong performance year-to-date, coupled with the momentum we are seeing in the fourth quarter, gives us the confidence to raise our full year 2025 guidance for total revenue. We are raising the low end of our previous range, which, as a reminder, was $280 million to $290 million, to $285 million to $290 million. The new range represents growth of 42% at the midpoint compared to 2024. Additionally, as we make incremental investments in our RECORLEV commercial organization and as we prepare for our Phase III clinical study start for XP-8121 in 2026, we expect an increase in both SG&A and R&D spend starting in the fourth quarter. These investments are aligned with our strategic priorities of supporting near and long-term growth. Before we move to Q&A, I want to reiterate my earlier comments and emphasize our considerable progress this year. We delivered strong top line growth once again reflecting robust ongoing demand for our therapies. With gross margins around 85%, strong cash generation and significantly positive adjusted EBITDA, we continue to prove the strength of our business model. Overall, this has been a year defined by exceptional execution and transformational progress. With that, I'll turn the call over to the operator for Q&A.

[Operator Instructions] Our first question comes from Dennis Ding from Jefferies.

I'd like to ask on RECORLEV. Can you just please talk about the impact of the expanded sales force that you guys have implemented last year and if productivity has ramped up yet? And as you're thinking about further expansion, when do you think those reps will be fully trained and get to productivity? And then as a follow-up on RECORLEV, your competitor continues to have supply issues with its specialty pharmacy. Just curious, were you able to capitalize on that in Q3? Or should we see more of a tailwind from that in Q4?

Steve, do you want to?

Yes. So the expansion last year, we increased the size of the RECORLEV commercial team by 50%. So we were at around 42 reps starting in the third quarter of last year. And as you know, it takes a little bit of time to ramp up productivity. But I would say that starting in the first quarter, second quarter this year, those reps were operating at optimal productivity. Looking ahead, we expect more of the same in terms of productivity from our next expansion. And the timing of that would be, we'll bring those reps on board in January, take some time to train them up, get them out in the field, get a couple of quarters under their belt before they're operating at optimal productivity. John, do you want to take the competition?

Yes. I would say we didn't see anything unusual in Q3 as it relates to where our patients were coming from. We continue to see the majority of our patients are new to therapy for RECORLEV and the rest come from competition, all the same mix as we've seen in the past. So I would say nothing unusual and everything is as status quo.

Our next question comes from Chase Knickerbocker from Craig-Hallum.

Congrats on the quarter. Maybe just to start on some kind of under-the-cover stuff on RECORLEV. Can you maybe just give us an update on kind of what you're seeing from a persistency perspective? Any sort of help you can give us as far as kind of the current discontinuation rates and how that's trended over the last couple of quarters?

Yes, Chase, I think everything is, again, same as what we've had in the past. We're again adding so many new patients that that's really keeping all of those metrics in check right now. So we're getting the same amount of people started, the same time to get them started. No real change in dropout rates, average dose, all those things. We're too new in our life cycle here to see any kind of real significant changes in there. And again, they're overwhelmed by the high level of new starts.

Can you just remind us what kind of 6 or 12 months discontinuation rates are either for the condition or specifically for RECORLEV?

I don't know exactly what they are for the condition. I would tell you, RECORLEV is pretty typical to a specialty product like this in a complex disease state. I think what we're seeing is as expected in the space, but we haven't really disclosed any of that directly.

Got it. And then maybe just as we kind of look into 2026, you've had pretty remarkable progress, particularly on the RECORLEV front this year. Would you be willing to share kind of any thoughts as we go into 2026 and start having some more impressive comps to deal with, obviously, as we look at the impressive RECORLEV performance this year? I mean any thoughts on kind of how to set expectations as far as top line growth, either for RECORLEV specifically or the business as a whole?

Yes, I'll try to take that on the context of RECORLEV. As you heard, we're investing on more expansion around RECORLEV. That's driven by a market that is ripe for expansion. There's more and more people being screened for hypercortisolemia. We have, in my opinion, the best product for normalizing cortisol. And we're expanding into a market that's continuing to grow as we're expanding. So I see plenty of growth for RECORLEV. We said back in June, we think this is on pace to be a $1 billion product. And this is all part of our plan to get to that $1 billion.

Maybe just last one for me. Steve, I hear your comments as far as some variability on the bottom line as far as we think about expenses in the go forward. Any additional thoughts you'd be willing to give us as far as kind of when that cadence of R&D should be fully reflected from enrollment perspective as it comes to the 8121 trial? I mean, should we ramp that up into mid next year and then that's kind of peak enrollment? Or just kind of give us some thoughts on particularly the R&D line next year, but also obviously, SG&A as we think about the RECORLEV expansion?

Yes. Good to talk to you, Chase. As we think about -- in my comments earlier, we're going to start to see some of those investments for both RECORLEV and 8121 stepping up in the fourth quarter. John highlighted in his prepared remarks that we plan to start the trial in the second half of next year. So I think that's when you'll really start to see the spend start to ramp up and then obviously well into '27. That's probably where it will peak off. And then in terms of the RECORLEV investment, we started to make some of these investments this quarter, late third quarter, but we're bringing on the reps starting in January. So that's where you're going to see another step-up in SG&A spend. But again, all things under the umbrella of supporting growth in our strategic priorities. And as we've said a number of times, even with these investments, we are committed to remaining adjusted EBITDA positive going forward. So that's a really important point here is even with the significant step-up in spend, over the next 15 months, we will remain adjusted EBITDA positive.

Our next question comes from Leland Gershell from Oppenheimer.

Congrats on the continued progress. Just a question with regard to your longer-term sales guidance for RECORLEV. Just wondering if that anticipates any further build-out of the sales force or if you expect that you'll be able to achieve those targets based on your current force?

Thanks, Leland. We said that we're going to continue to invest over the next several years on RECORLEV. And we'll need to do that to manage the patient load, so we'll have to make investments in pharmacy, patient services, all the commercial footprint it takes to be successful in this space. We'll also need to and look to start investing even more in data and other things that can help drive more growth in this space and position us to really capture that growth. So yes, there will be investments all the way through to the end for this product. As you build a $1 billion product, you continue to scale your investments with that growth level.

Got it. And I also wanted to ask, we have 8121 coming through and we still have a bump in R&D over the next couple of years as it gets through its pivotal program. But then R&D should come back down unless that we'll be looking for maybe other candidates to be coming out of XeriSol or the company's platform to maybe fill in, in the early pipeline.

That's a great question. One of the beauties of the business here at Xeris is we continuously find great ways to invest in our technology, using our technology for new opportunities. 8121 is a perfect example of that to be able to create using our XeriSol technology, a once-weekly subcu product that can really meet an unmet medical need. So in those time frames, sure, we're not prepared to say what those would be now, but we see it as an opportunity for us always to make incremental investments with the platforms we have and the capabilities we have to continue to drive even more growth than we've already stated in our plans.

Our next question comes from Brandon Folkes from H.C. Wainwright.

Congrats on the progress. Can you just remind me of the gating steps between now and the initiation of 8121 trial? And then maybe just following on from some of the questioning. As you make these multiyear investments in the infrastructure behind these products, does that infrastructure ever get large enough where it makes sense to bring in additional products? Just any comment there would be great.

Let me answer the first one on 8121. So we've been really clear that we're planning and building a blockbuster here with 8121. And we're taking all the necessary steps before we start the Phase III trial to basically make sure we've got the ready-to-go commercial product to take into that Phase III trial. So we're right now in the middle of manufacturing scale-up, device verification and design that device verification and making sure that what we go into the clinical trial with can deliver the wide range of doses that are necessary in this space. And we just need to make sure that we get that done before we start the Phase III trial so that we're not going back later on and dealing with delays because we weren't able to do that. So we're going to do this very carefully, planfully, and we'll start that trial when all that work is done, and we can go into it with the commercial presentation. Remind me on the second question.

The infrastructure and leverage for business development.

Yes. Of course, yes, the infrastructure -- I mean, we're in such a growth mode right now, the infrastructure is pretty much dedicated to the brands we're driving the growth with. But as we get a little more mature, yes, sure, it makes sense to use that infrastructure to kind of leverage even more opportunities and capabilities.

Our next question comes from David Amsellem from Piper Sandler.

This is Alex on for David. My first question is, how are you thinking about competitive dynamics for RECORLEV to the extent that Corcept's relacorilant gains approval by the end of the year? And what are your base case scenarios for the impact of that potential entrant on RECORLEV? And then maybe also a second question just on the headcount for RECORLEV. Do you have any plans in the future to call on general practitioners? And I'm sorry if I missed that earlier on the call.

So yes, we anticipate relacorilant gets approved by the end of the year. We've said this in the past, and I'll say it again, is we think that this is a market where there's so much opportunity and so much potential that another player in this marketplace talking about screening, detection and finding people with hypercortisolemia is a good thing. So we think relacorilant will help the market. We know they're going to make great -- and they're already making great investments to drive that. And we see that as opportunity as well. And then in terms of numbers on the expansion, I'll let Steve maybe.

Yes, I think the question was around targeting GPs. Are we going to be targeting GPs?

Yes. So we're approaching this data-driven kind of approach to expansion and focus. And where the patients are is where we will go with our commercial footprint. And that leads you into some GP area. Most of those GPs are endo-like, high diabetologists, things like that. So yes, as we expand, of course, we'll be moving into those spaces to really go where the opportunity is.

[Operator Instructions] Our next question comes from Roanna Ruiz from Leerink Partners.

So a follow-up question on RECORLEV. I wanted to see if you could talk about how much momentum you're seeing across new and repeat prescribers. And just thinking ahead to 2026, any seasonality trends or volume growth drivers we should consider for RECORLEV going forward?

So yes, we're seeing repeat prescribers and new prescribers come on. And we have momentum on both of those with 108% increase in patients and prescriptions, you're getting from both. So we're excited to see that momentum. We see that momentum is still very, very strong, and obviously, the reason why we're expanding into that opportunity.

In terms of seasonality for RECORLEV, maybe a little bit with deductibles that get reset in the first quarter, and you see that across all of our products really. But I wouldn't say that that's overly material for RECORLEV. We're not expecting it to be overly material, but that's something we pay attention to every year at the first of the year. So that would be the only potential seasonality impact, Roanna, that I would expect for RECORLEV.

Yes. That makes sense. And one other question I had was just could you talk a bit more about the KEVEYIS franchise durability? It seems to be continuing pretty steadily. Do you expect that to persist into next year? And have you been hearing anything else about competition to KEVEYIS?

Well, we're always watching for more competition in this space. But like you, I'm excited every time we talk about KEVEYIS because this is just a great model where what we do for patients is really important. And starting with finding the patients, helping them get diagnosed for the first time, working them through treatment and helping them stay and remain on treatment. All of those things really, really matter in this space, and that's why KEVEYIS continues to hang in there, and it remains to be a very durable asset for us. We continue to bring on new patients to brand every week, which is just really exciting in this space because we're really making an impact on those patients in the marketplace.

We currently have no further questions, so I'd like to hand it back to John for some closing remarks.

I want to quickly thank everyone for their questions and continued interest in Xeris. As we look ahead to the end of 2025, I couldn't be more proud with how our team delivered this year. We are finishing the year from a position of real strength, evidenced by our strong commercial and financial performance. At the same time, we're building for the future with the foundation in place to initiate the XP-8121 Phase III clinical study next year and continue advancing our broader strategic priorities. We believe these efforts position Xeris exceptionally well heading into 2026, a year where our operational momentum will continue to translate into outstanding revenue growth, profitability and long-term value creation. Thanks again for joining us today and for your continued support.