XERS - NASDAQ

Hello, everyone. Thank you for joining us, and welcome to the Xeris Biopharma Fourth Quarter 2025 Earnings Conference Call. [Operator Instructions] I will now hand the call over to Allison Wey, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.

Thank you, Warren. Good morning, and welcome to the Xeris Biopharma 2025 Full Year Financial Results Conference Call. Earlier this morning, we issued a press release detailing our 2025 financial and operating results and financial guidance for 2026. This press release is available on our website. Joining me on the call today is John Shannon, our CEO; and Steve Pieper, our CFO. Following our prepared remarks, we will open the call for questions. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements regarding Xeris' future expectations, plans, strategies, objectives and financial performance. These forward-looking statements are based on management's current assumptions and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied. For a discussion of these risks and uncertainties, please refer to the risk factors described in our filings with the SEC. Any forward-looking statements made on this call speak only as of today's date and except as required by law, the company undertakes no obligation to update or revise these statements. In addition, during today's call, we will reference certain financial measures that are presented on a non-GAAP basis. A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our earnings release. With that, I will now turn the call over to John for his opening remarks.

Thanks, Allison, and good morning, everyone. We expected 2025 to be a transformational year for Xeris and it was. Our performance extended well beyond our incredible fourth quarter and full year revenue growth. Across the organization, we executed with discipline and focus, advancing our strategic priorities and driving measurable progress throughout the business. Most importantly, we reached a defining milestone, financial self-sustainability. Our progress across the entire business has enabled us to forever put behind us the question of our ability to self-fund our strategy, our pipeline and our future. Now as we enter 2026, we do so with clear momentum positioned to drive rapid revenue growth, execute on our advanced pipeline and thoughtfully prepare for even greater opportunities ahead. I'm excited and confident that our long-term strategy is firmly on track. Before diving into the details, I want to recognize and thank the entire Xeris team. The performance you delivered in 2025 and the strength of our outlook for 2026 is a direct result of your extraordinary commitment, focus and disciplined execution across every part of our enterprise. Now to the results. Fourth quarter total revenue grew 43% year-over-year to nearly $86 million. This outstanding quarterly result was driven by strong demand across all 3 products. For the full year, total revenue increased by an incredible 44% to $292 million. This performance was broad-based and strengthened as the year unfolded. Most importantly, it fueled our ability to deliver nearly $60 million in adjusted EBITDA and for the first time, net income on a full year basis. The exceptional performance we delivered in the fourth quarter was no aberration. It reflects consistent progress throughout the year as we executed with increasing discipline and effectiveness. As a result, we exited 2025 with strong momentum, increased confidence in our strategy and a significantly stronger operating platform. With that, let me walk you through performance across our 3 commercial products. First, Recorlev. Recorlev remained the primary growth engine for Xeris in 2025 and delivered another strong quarter in Q4. Recorlev's growth was driven by continued expansion of the patient base, ending the year at approximately 700 patients nearly doubling the number of patients on therapy from a year-end 2024. This growth reflects expanding prescriber awareness in a very dynamic market coupled with increasing confidence in Recorlev's differentiated clinical profile. Turning to this year. In January, we nearly doubled our Recorlev commercial team significantly expanding our sales and patient support organizations to increase the quantity and quality of our health care provider and patient interactions. This expanded commercial footprint is expected to further escalate awareness and adoption, and we expect to see the impact of this expansion, most notably in the second half of this year and continuing well into the future. We believe Recorlev is still in the early stages of realizing its full commercial potential. Last week, we filed a patent infringement lawsuit against 2 ANDA filers to vigorously enforce our rights and defend Recorlev. We are very confident in the quality and strength of our intellectual property, our legal position and our long-term outlook for Recorlev. We have built a strong IP foundation for Recorlev with 4 Orange Book-listed patents that run until March 2040 and orphan drug exclusivity, which runs through the end of 2028. Our Recorlev strategy is unchanged. Recorlev is and will continue to be on an exciting journey for many years to come. And our expectation shared during our Investor Day last June of $1 billion of peak sales by 2035 remains securely intact. Moving to Gvoke. Gvoke delivered steady, reliable growth in 2025 reinforcing its role as a durable and predictable contributor to our portfolio. On a full year basis, revenue grew 14%, supported by broad access, strong prescriber awareness and continued alignment with treatment guidelines. Gvoke remains a potentially life-saving rescue product that should be in the hands of every person with diabetes at risk of having their blood sugar go too low. Keveyis. Keveyis continues to outperform expectations, and 2025 was no exception. The brand's strength and durability have only become more evident given that we were able to end the year with an increase in the number of patients on therapy versus 2024. As we highlighted throughout 2025, success with Keveyis reflects not only the product itself, but the comprehensive support we provide to patients living with primary periodic paralysis. Importantly, Keveyis represents our long-standing commitment to serving a small, highly underserved patient community, and it remains deeply aligned with our mission to make a meaningful difference in the lives of patients with rare diseases. Turning to our pipeline. XP-8121 continues to advance according to plan. The anticipated initiation of Phase III in the second half of 2026 marks a significant value creation inflection point for the program and underscores our conviction in its blockbuster commercial potential. XP-8121 addresses a significant unmet medical need. There are over 20 million patients with hypothyroidism on daily oral replacement therapy today. Of those 20 million patients, we believe there are 3 million to 5 million patients who are unable to achieve and sustain normal range due to GI absorption issues. XP-8121 is a once-weekly subcutaneous levothyroxine injection that potentially solves this problem for many patients. As we look ahead to Phase III, the program is entering a pivotal stage, one where execution, milestones and value creation become increasingly tangible and visible. We believe XP-8121 has the attributes to become a differentiated high-impact therapy for patients and a meaningful growth driver for Xeris. Building on our strong commercial momentum, we are entering 2026 with 3 clear priorities. First, we remain focused on driving rapid revenue growth and are making targeted investments across our sales, patient support and commercial infrastructure. Second, we will continue to advance XP-8121, our once-weekly subcutaneous levothyroxine for hypothyroidism. We believe XP-8121 has the opportunity to become our next blockbuster potentially generating $1 billion to $3 billion in peak revenue. As we have prepared to initiate our Phase III program in the second half of 2026, we intend to significantly step up our R&D investments marking a critical milestone for both the asset and the company. Third, we remain committed to maintaining a strong balance sheet with disciplined operating execution. This approach preserves our flexibility to make ongoing prioritized investments in our business. Together, these priorities position Xeris perfectly to drive sustained performance over the near, medium and long-term. With that momentum as context, before turning the call over to Steve, I'd like to briefly share our outlook for 2026. For the full year, we are expecting total revenue between $375 million and $390 million, representing more than 30% growth at the midpoint compared to 2025. We will continue to be adjusted EBITDA positive even as we significantly step up our R&D and commercial investments. Now with that, I'll turn the call over to Steve, who will take you through our financial results in greater detail and review our guidance for 2026.

Thanks, John. The results we are reviewing today are the product of a year defined by discipline, focus and strong execution across the organization. I, too, want to thank our employees for your dedication, accountability and relentless focus on delivering against our priorities. Your efforts continue to strengthen our operational foundation and position us for sustained success. Turning now to the fourth quarter and full year results. Total revenue for the fourth quarter was $85.8 million, representing 43% growth year-over-year. The strong performance reflects continued underlying demand across our portfolio. Importantly, this performance reinforces the momentum we carried through the end of the year as we enter 2026 with a solid foundation for continued growth. For the full year, total revenue was $291.8 million, an increase of 44% compared to 2024. This growth was driven by robust demand across all 3 commercial products, Recorlev, Gvoke and Keveyis. Looking at our performance from a product level. Recorlev revenue was $45.3 million in the fourth quarter and $139.3 million for the full year. This reflects growth of more than 100% both for the fourth quarter and the full year and was driven almost entirely by a continued expansion of the patient base, reflecting strong underlying demand and increasing prescriber confidence. Gvoke delivered revenue of $24.6 million in the fourth quarter and $94.1 million for the full year. Performance reflected steady prescription growth, broad access and favorable gross to net dynamics. Gvoke continues to serve as a stable and predictable contributor to our revenue base. Keveyis generated revenue of $12.8 million in the fourth quarter and $47.6 million for the year, supported by an increase in the average number of patients on therapy. Our performance continues to benefit from our focused approach to ongoing health care provider and patient support. Overall, the breadth of contribution across our portfolio reinforces the durability of our revenue base and the focus of our team to meet and exceed goals. Gross margin for the fourth quarter was 87% and for the full year was 85%, reflecting steady improvement relative to prior year, driven by favorability from product mix. R&D expenses were $7.9 million for the quarter and $31.2 million for the year. The 22% increase year-over-year primarily reflects our continued disciplined investment in advancing our pipeline including increased spend to support our preparation for the upcoming Phase III clinical trial, XP-8121. SG&A expenses were $47.5 million for the quarter, representing an increase of approximately 18% compared to prior year. For the full year, SG&A expenses were $182.4 million, an increase of approximately 12% driven by incremental personnel-related investments to support the rising demand for our commercial products. Adjusted EBITDA for the fourth quarter was $25.1 million an improvement of $16.8 million compared to last year. For the full year, adjusted EBITDA was $59.4 million. The improved results reflect continued operating leverage and underscores our ability to scale revenue while maintaining a disciplined approach to expense management. We also delivered another period of net income in the fourth quarter and as a result, we reported net income on a full year basis for 2025. Importantly, our 2025 performance resulted in an improved balance sheet which provides us with the flexibility to fund continued revenue growth, advance XP-8121 and operate the business from a position of financial strength. As John outlined, we have entered 2026 guided by a clear set of priorities that underpin our decision-making. These priorities include: one, driving continued rapid revenue growth; two, initiating the Phase III study for XP-8121, a significant milestone for the company. And lastly, maintaining disciplined investment prioritization as we continue to enhance operating leverage. We believe this balanced approach positions us well for 2026 and beyond. Turning to our outlook for 2026. We expect total revenue to be between $375 million and $390 million for the full year, representing over 30% growth at the midpoint. This outlook reflects expanding patient demand across our products. Our revenue growth is also expected to drive a modest improvement in gross margin as we continue to benefit from a favorable product mix. Moving to R&D. As we plan to initiate our Phase III study for XP-8121 in the second half of the year, we expect R&D to increase by approximately $25 million. This step-up reflects a deliberate and disciplined allocation of capital to advance XP-8121 and is critical to unlocking its significant long-term value and future potential which we believe is $1 billion to $3 billion in peak sales. Looking at SG&A, we continue to invest and scale our commercial enterprise to support Recorlev on its own journey to $1 billion in peak sales by 2035. As such, we plan to increase SG&A by approximately $45 million in 2026 primarily due to the expansion we recently completed. This deliberate material step-up in investment will drive significant revenue growth, resulting in improved operating leverage across the business. As we committed to in 2025, we expect to remain adjusted EBITDA positive moving forward. And specific to 2026, we expect adjusted EBITDA will grow on an absolute dollars basis compared to 2025. Our business has never been on more solid financial ground. The sales growth momentum is enabling our reinvestment strategy and every dollar we deploy is aimed at expanding our capabilities and positioning Xeris for sustained long-term growth. With that, I'll turn the call over to the operator for Q&A.

[Operator Instructions] Your first question comes from the line of David Amsellem with Piper Sandler.

So just a couple for me. Helpful color on the spend this year. I was wondering, though, as you think about the expansion of Recorlev and the widening of the addressable market that you've seen and certainly your competitors have seen. Can you talk about the extent of additional operating leverage that you think you're going to be able to realize longer-term? And specifically interested in further sales force expansion? Or I guess we've seen, for instance, your competitor expand the sales force a few times. Is that a good way to think about what you're going to need to do to adequately support Recorlev. So that's #1. And then #2, as you think about the IP litigation, and I realize this is going to play out over the long-term, but just help us understand how that's playing into your sense of urgency regarding the potential acquisition of an asset where you can leverage your now expanded commercial organization. That would be helpful color as well.

Thanks, David. It's John. Let's start with the expansion. And we just doubled our commercial footprint as of the first of January. And when I say that, it's not only our salespeople, but all the patient support, medical affairs, pharmacy services, all of those things that it takes to manage this very complex patient as you bring them on to therapy. So we see that as a significant move that we need to do in order to continue to drive the growth we're driving and get those patients on therapy and keep them on therapy. As we continue to expand into outer years, we'll need to add more resources in that capacity. It just takes more to, again, manage the patient loads. So we see that as continuing and continuing based on scale and how we grow there. We're also making additional investments in data, studies, things like that. So we'll see that over time as well. And we -- so we see a constant and consistent increase in expense and investment on Recorlev for the next several years. As it relates to your question, I think, around IP litigation and how does that change anything? Well, as I said in my opening comments, our strategy is unchanged on Recorlev. We will continue to do exactly what we said we were going to do. We think -- we know we can get this thing to $1 billion by 2035. Those investments will again continue to come on a scaled approach so that we can, again, manage the growth that we're driving. So we see that as longer-term, and we feel strongly that we'll continue to do that, and we'll be able to get this to a $1 billion product by 2035.

Your next question comes from the line of Brandon Folkes with H.C. Wainwright.

Congratulations on another very good quarter. So maybe just following on from the earlier line of questioning. Can you just help us think about the evolution of capital deployment beyond 2026. As you realize this operating leverage in the business, what's your updated thinking about sort of internal allocations that you've laid out today on the call versus perhaps external business development. Does the emergence of this IP litigation change your appetite to perhaps sort of bring in something between sort of now and when 8121 comes to market to just sort of hedge the product concentration risk. And then secondly, maybe I'll just ask this because maybe it goes in. Can you just talk about the evolution of gross margin here longer-term? How should we think about gross to net in 2026 across your portfolio as we think about the evolution just with regards to product mix?

Let me try to start this, Brandon, and I don't know that we got all those questions in there, so we'll try to answer them all. So as you heard in our comments, we're in a position where we're self-sustainable in terms of the amount of leverage we're getting from the business and our ability to support whatever is in front of us, specifically 8121 and Recorlev growth. And as it relates to the IP, again, nothing's changed. It's unchanged. We weren't surprised by these lawsuits. So we knew this was coming. We saw this coming. We're prepared for it. And we still see a future where we have lots of opportunities in front of us with respect to our own existing technology and capabilities to drive growth for a long time as well as external. So we see all of that in front of us. And now that we're at this point, where we're forever have situations where as long as we continue to grow, we'll be able to continue to leverage that in the future growth. So -- and then I'll let Steve cover any of the kind of...

Yes, I'll just add on to John's comments around operating leverage and some of the questions that have come up. I mean, I think when you start to do the math on our growth trajectory and look at even with the step-up in investment, it's becoming clear that the balance sheet is as strong as ever, and it will continue to improve, and our operating leverage will continue to improve and so that opens up capacity to do other things. The good news is we don't have to do other things. We've got great assets both commercial assets and asset in the pipeline, a blockbuster in the wings, but certainly opens up capacity to do other things. We'll continue to be disciplined about business development and evaluating those things. Touching on your question around gross margin and gross to nets. Yes, gross to net, we benefited on Gvoke specifically this year. I would say gross to nets on balance have kind of steadied out. So we're not expecting any material movement either way in '26 on the gross to net front. From a gross margin perspective, as we've noted over the last 1.5 years, we've seen a nice steady increase in our gross margin really benefiting from product mix. We see that continuing for the foreseeable future and approaching kind of best-in-class gross margin profile for a company that looks like us. So hopefully, that addresses your questions, Brandon.

Your next question comes from the line of Chase Knickerbocker with Craig-Hallum.

Congrats on all the progress here. Maybe just first to start out a little bit more color on guidance would be helpful. Can you just kind of walk us through maybe with kind of some rough outlines how you're kind of thinking about the top line by product in 2026, obviously, largely being driven by Recorlev, but any sort of thoughts kind of down the product portfolio would be helpful.

Chase. Yes, I'll take this one. So on the revenue, I think maybe I'll start with the easiest one is Keveyis. We see that Keveyis kind of been a steady contributor over the last 5, 6 quarters in terms of its revenue contribution and it's kind of flattening out, so to speak. So I think that's a fair assumption moving forward. On Gvoke, I think what we've talked about over the last year is that we see that, again, being a steady contributor in that high single-digit, low double-digit growth. And I would anticipate that we're going to see that play out in 2026 that way. And then for Recorlev, that is the growth driver. So you can kind of back into the math there in terms of the contribution there. But that's on balance what we're expecting. And we do expect some contribution from our partnerships other revenue. Historically, it's been in that 5% to 10% range. I think that's a fair assumption for 2026.

Helpful. And maybe just specifically on Recorlev. Obviously, very strong implied guide. Can you maybe talk to us about kind of what you've seen so far in Q1 even kind of before that sales force expansion benefit that you will get here and there was a competitive product that was kind of expected in the market in 2026. I mean any kind of anticipation that you sensed in the market from that is kind of now unwound and kind of come to your benefit? Just some thoughts there would be helpful.

Yes, Chase, it's John. I think the first quarter is as we expected, it's pretty typical. We get a lot of payer resets and co-pay resets and things like that, that slowed down the quarter early on in January. We see that it's another typical year. But that's all kind of starting to revolve pretty aggressively in February and going into it usually does so in March. So we're seeing that standard. In terms of a lack of a new competitor, I don't think that's really changed much. The market dynamic is still very strong towards finding and diagnosing people with hypercortisolemia and getting them treated. So that is -- that momentum continues in the marketplace. And now with our expanded team in there, we're in a great position to capture more of it. And we don't see any of that slowing down in our organization as well as with any of our competitors.

Your next question comes from the line of Dennis Ding with Jefferies.

We have 2 on Recorlev. So #1, it's been a few years since the launch. So I guess what is holding you back from issuing Recorlev guidance? And I guess, what additional data do you need to make in an informed approach to guidance? And then #2, do you have any updated thoughts on how you're thinking about the market if Teva indeed is able to secure specialty pharmacy to distribute generic Korlym. And if you think that's a risk at all.

Yes. Dennis, the first one is we don't give specific product guidance, and we haven't. And so we just give a total revenue guidance and try to give the color Steve just gave. So there's no hesitation there. It's just -- that's what we do. And then I don't know I understood or could even hear your last question. So maybe you could repeat that.

Yes. Maybe I'll just repeat that. Yes, I was just wondering if you have any updated thoughts on how you're thinking about the Cushing's market and for Recorlev specifically if Teva is indeed able to secure a specialty pharmacy to distribute generic Korlym, if you think that is a risk at all for your business moving forward?

Yes. We don't see that as a risk at all for our business with respect to generic Korlym. We haven't seen that for the last couple of years. We don't see that going forward. This is a scenario where a clinician will have to write a referral for someone to normalize cortisol in order to get to Recorlev, and that's a very different approach than what Korlym does.

Your next question comes from the line of Roanna Ruiz with Leerink Partners.

This is Michael Ahn for Roanna Ruiz at Leerink Partners. Congrats on your great quarter. We have some questions about XP-8121. Could you provide more color on your interactions with the FDA regarding the upcoming initiation of the Phase III program? And are there any remaining gating items or regulatory dependencies that needs to be handled before the initiation.

So we've had all the interactions with the agency. We're very much aligned on everything we need to do. So no regulatory gating. The gating that we're going through right now is we want to enter that Phase III trial with the actual go-to-market device and formulation scale up for commercial scale-up. So we're going through all the steps before we start that Phase III to get all that work done and enter that Phase III with the actual go-to-market device, scaled up at commercial scale, which is really important when you're going into kind of a narrow therapeutic window area with a lot of range of doses. We want to make sure we take the time now so that we don't create delays later in the approval process. So that's what's really the gating item, and that's what we're working on.

Got it. Great. And are you thinking about any partnership optionality for 8121 at all?

That's a great question. We don't need to do a partnership. We have what we need to get this to market. We think it's an outstanding opportunity for ourselves. And from that perspective, we don't need to, but it doesn't mean that the right situation came along that we wouldn't consider that.

That would drive incremental value.

Your next question comes from the line of Jason Dorr with OpCo.

Jason on for Leland Gershell. Congrats on the strong quarter. Understanding you're in the process, could the team provide any guidance on the patent infringement lawsuit for Recorlev against the ANDA filers? Maybe what might the time lines be? And what does a favorable outcome look like for the Xeris team?

Well, as you can tell, we're very early in. We just filed on Thursday, the lawsuit. Timing-wise, I don't know, years, months. So more to come on that. We feel really strongly in our 4 Orange Book patents that run until 2040. So that's really important that we kind of make sure we defend and stay behind those.

Your next question comes from the line of Jenna Davidner with Barclays.

I was just curious on the Recorlev litigation, what your openness or appetite for a settlement could be appreciating your confidence in the 2040 patent time frame, but also maybe the balance between removing any potential overhang that could, in theory, last several years versus settling for a couple of years prior to 2040. I'm just curious what your thought process there is.

Thanks for the question, Jenna. I clearly can't comment on legal strategy and litigation strategy. So -- but I do appreciate the question.

There are no further questions at this time. I will now turn the call back to John Shannon, CEO, for closing remarks.

Thanks, and thanks, everyone, for your questions. In closing, 2025 was a defining year for Xeris. We exited the year with strong momentum, a more durable operating foundation and tremendous confidence in our strategy. We believe our commercial portfolio is well positioned to drive continued rapid revenue growth in our pipeline, specifically XP-8121, adds extended meaningful longer-term value as we look ahead. As we enter 2026, our priorities are clear. We believe the immediate and long-term opportunities for Xeris are increasingly exciting, and we remain committed to translating our continued success and momentum into long-lasting value for the patients we serve and our shareholders. We appreciate your time and your continued support, and thank you.