Operator: Good morning, and welcome to the Xeris Biopharma Q1 ’26 Earnings Conference Call. [Operator Instructions] I will now pass the call over to Allison Wey for opening remarks. Please go ahead.

Allison Wey: Thank you, Sarah. Good morning, everyone, and welcome to Xeris’ First Quarter Financial Results Conference Call. Earlier this morning, we issued a press release detailing our first quarter 2026 financial and operating results. This press release can be found on our website. Joining me today is John Shannon, our Chief Executive Officer; and Steve Pieper, our Chief Financial Officer. Following our prepared remarks, we will open the call for your 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 represented on a non-GAAP basis. A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our press release. With that, I will now turn the call over to John for his opening remarks.

John Shannon: Thank you, and good morning, everyone. We are off to an amazing start in 2026. First quarter net product revenue grew an impressive 43% to more than $82 million, driven by Recorlev, which nearly doubled with 95% growth, while Keveyis increased 4% and Gvoke remained flat year-over-year. Given the strong start to the year and the positive demand trends we are seeing overall, especially for Recorlev, we are raising the bottom end of our revenue guidance. We now expect full year revenue of $380 million to $390 million, representing more than 30% revenue growth. Turning now to each product, starting with Recorlev. As I said, Recorlev revenue nearly doubled to $50 million, representing a $24 million increase compared to last year.

This was driven by both record referrals and record new patient starts. Importantly, coming out of the typical Q1 payer resets, we saw a significant increase in new patients, especially in March, which is fueling our optimism for another outstanding year. I’m also pleased to share that our commercial expansion was completed exactly as planned, significantly expanding our sales force and patient support teams. This enhanced infrastructure will allow us to increase both the quantity and quality of our interactions with health care providers and patients, driving even greater awareness of Recorlev’s value proposition in treating hypercortisolemia and Cushing’s syndrome. We anticipate the impact of this commercial expansion to begin contributing incrementally in the second half of this year and continue to deliver sustained benefits well into the future.

The trajectory we are seeing reinforces our conviction that Recorlev is well positioned to realize its full commercial potential. It remains solidly on path for significant continued growth and is well on its way to achieving $1 billion in revenue by 2035. Turning to Gvoke. Gvoke generated revenue of nearly $21 million in the first quarter. While we anticipated some seasonal headwinds from typical payer resets, Gvoke’s performance was slightly below our internal expectations. This was primarily due to Medicare policy and plan changes, which impacted patients’ coverage, deductibles and most importantly, out-of-pocket costs, resulting in a reduction in the number of patients getting their prescriptions filled. We expect Gvoke to recover from its first quarter challenges, and it’s already beginning to see an increase in prescription demand.

Importantly, Gvoke’s growth potential remains well intact and untapped since the vast majority of the 15 million patients who should have a ready-to-use glucagon rescue therapy still do not have one. Finally, Keveyis. Keveyis once again delivered exceptional performance in the first quarter with revenue of approximately $12 million, representing a 4% increase year-over-year. This is the second consecutive quarter of year-over-year growth and demonstrates the remarkable brand strength and durability of Keveyis in this ultra-rare market. This performance not only highlights the inherent clinical value of Keveyis itself, but also the importance of the comprehensive patient-centered support infrastructure we have built to serve individuals living with primary periodic paralysis.

Turning to our pipeline. XP-8121 is progressing well, and we are on track to begin Phase III later this year. Millions of hypothyroid patients still struggle to achieve stable hormone levels due to GI absorption issues, and XP-81 is designed to address this important unmet medical need. XP-8121 will also enable us to leverage a tremendous amount of existing capability. First, it requires our XeriSol formulation technology, the same technology inside of Gvoke. It will also leverage our drug device combination expertise, our deep connections with the endocrinology community and our extensive commercial infrastructure. From a medical communication standpoint, XP-8121 is receiving significant attention this year as the medical conference season gets underway.

This quarter alone, we’re presenting 4 separate abstracts, each carefully designed to advance the understanding of hypothyroidism management while highlighting the persistent clinical challenges that prevent many patients from achieving and maintaining stable control. Building on this momentum, we’ll plan to host a comprehensive program review later this fall, where we will share additional details of our Phase III trial design. Before I turn the call over to Steve, I want to briefly recap the strong progress we have made against the 3 priorities I outlined in March. First, we remain clearly focused on driving rapid revenue growth. Our first quarter performance and upward revised full year outlook gives us tremendous confidence that our business is on track.

Second, we remain focused on advancing our pipeline with key deliverables on track and XP-8121’s Phase III start anticipated later this year. And third, we remain committed to disciplined financial management and to maintaining a strong balance sheet, which is driving much of the outstanding performance that Steve will highlight in more detail. With that, I’ll turn the call over to Steve.

Steven Pieper: Good morning, everyone. As John highlighted, we are off to a strong start in 2026. Our results reflect solid execution and growing confidence in the performance of our business. Total revenue reached $83.1 million in the first quarter, representing growth of 38% year-over-year. This performance demonstrates the strength of our commercial execution and the traction Recorlev continues to generate as we drive rapid and sustained revenue growth. Net product revenue grew 43% year-over-year to $82.5 million, an increase of nearly $25 million compared to Q1 of last year. Recorlev generated net revenue of $49.8 million, representing growth of 95% year-over-year, an increase of $24.2 million, reflecting continued expansion of our patient base with momentum gaining in March and continuing into April.

Gvoke generated net revenue of $20.8 million in the first quarter, flat year-over-year with soft prescription demand partially offset by favorable net pricing. As John mentioned, Gvoke’s soft start to the year reflects lower total prescription volume, which was primarily driven by a decline in the Medicare channel, resulting from higher-than-normal out-of-pocket costs and a reduction in patients getting their prescriptions filled. Even with this soft start, we still expect modest growth from Gvoke this year, and we are confident it will return to being a steady growth contributor for years to come. Keveyis delivered strong financial results in the first quarter, generating net revenue of $11.9 million. The year-over-year growth of 4% reflects modest improvements in both net pricing and the number of patients on therapy compared to the first quarter of 2025.

Turning to gross margin. Our gross margin for the first quarter was 87%, an increase of 2% versus last year. This improvement was primarily driven by favorable product mix dynamics. R&D expenses totaled $8.8 million in the first quarter, representing an increase of 13% compared to the prior year period. This increase reflects higher personnel costs related to incremental investments in our XP-8121 program as we advance towards Phase III initiation later this year. SG&A expenses were $53.1 million for the quarter, reflecting growth of 21% year-over-year. This increase was primarily related to our strategic commercial expansion activities associated with the nearly doubling of our Recorlev commercial team. These incremental investments in both R&D and our commercial organization represent our disciplined approach to scaling the organization in alignment with our growth trajectory, ensuring we have the infrastructure necessary to maximize the potential of both our current commercial portfolio and our Phase III-ready asset.

Adjusted EBITDA for the first quarter was $15.1 million, an improvement of $10.7 million versus last year, demonstrating our continued commitment to profitable growth. Underscoring the progress we have made in our profitability journey, we delivered net income of $2.2 million in the first quarter, a significant improvement of more than $11 million compared to last year. Together, these metrics reflect the operating leverage we are generating as we scale our business and validate our disciplined approach to balancing growth investments with financial performance. Moving to our revised 2026 guidance and outlook. As John mentioned earlier, the overall growth of our diversified portfolio is ahead of our initial expectations and the strong performance of both Recorlev and Keveyis are more than offsetting early softness from Gvoke.

We expect our overall strong performance to continue as we move throughout the balance of 2026. As such, we are raising the low end of our total revenue guidance to a range of $380 million to $390 million compared to our prior range of $375 million to $390 million. This upward revision reflects the outstanding results we delivered in the first quarter and our confidence that this momentum will continue throughout the year, especially as incremental contributions from Recorlev’s expanded commercial infrastructure begin to yield more meaningful results in the second half of the year. On R&D, we continue to expect an increase of approximately $25 million year-over-year, driven by the planned Phase III initiation of XP-8121 later this year, a deliberate and disciplined investment to unlock what we believe is a $1 billion to $3 billion peak sales opportunity.

On SG&A, we continue to assume an increase of approximately $45 million, reflecting primarily the full year cost of the Recorlev commercial expansion. Finally, we remain committed to delivering positive adjusted EBITDA in 2026, growing on an absolute dollar basis versus 2025. Our financial story this quarter is one of solid execution and confidence. We are driving exceptional top line growth, improving already strong gross margins and investing deliberately in the commercial and pipeline initiatives that will grow Xeris for years to come. With that, I will now hand the call over to the operator for Q&A.

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Operator: [Operator Instructions] Your first question comes from the line of Chase Knickerbocker with Craig-Hallum.

Chase Knickerbocker: Congrats on a nice quarter here. Can you maybe just help us understand a little bit more on the Gvoke dynamics? Were there any actual formulary changes in the quarter? Or are these strictly kind of redesign dynamics? And then if it’s the latter, can you just give us some thoughts on why you guys might be getting a little bit more impacted than some other assets, particularly your competitor in the ready-to-use space?

John Shannon: Thanks, Chase. So a couple of things there. One is there’s always payer change resets that happen in the first quarter. There’s probably a couple of small changes that are in there, nothing really big. It’s primarily the Medicare resets. And as I said, that really impacted deductibles and mostly out-of-pocket costs in — especially in the first quarter for Gvoke. And we saw that pretty standard in the first part of the quarter, and then it started to creep back up a little bit in March, but not quite as much as we would expect, and we can see that it was primarily in Medicare. So we’re confident we know where it’s at and what’s going on there. And then in terms of did it affect BAQSIMI? In Medicare, yes, it did.

We can see that in the data. But overall, BAQSIMI probably has a very much — a very different split of their channel mix than we do. We are — we’ve always done very well in the Medicare space, and I think this hit us particularly harder than our competitors.

Chase Knickerbocker: And just a follow-up there and then one on Recorlev. So just on another one there on — with the redesign dynamics, I mean, would you expect a pretty significant recovery in the second half then as some of these beneficiaries hit catastrophic? And then second, just on Recorlev, can you help us understand if you’re seeing any benefit yet from the commercial team expansion? Maybe discuss the top of the funnel a little bit if there are some early indicators on some benefit from those new reps.

John Shannon: Yes. So back to Gvoke, yes, we expect it to recover. We feel good about that. And there’s 15 million people out there, again, that don’t have a ready-to-use rescue med, and we need to get it in their hands. So there’s plenty of opportunity. We’ll continue to drive that, and we feel good about the long-term potential of Gvoke. With Recorlev, yes, I mean, it’s — we saw an unbelievable start to the quarter and driven by record new starts, record referrals at the top of the funnel, as you indicated. But understand this, we don’t really think we’ll see the real kind of drive and expansion until later in the year. We know from prior experience, this takes 6 to 9 months for them to really fully hit stride. And so that real push will come more in the back half of the year.

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

Georgia Bank: This is Georgia Bank on the line for Dennis Ding. Two from me. One, despite some Q1 payer resets and any winter-related disruption, Recorlev showed strong sequential growth. Maybe you can help unpack what’s driving that underlying momentum a little bit more and what you’re seeing in terms of any recovery from seasonal dynamics as you move through March and April into May? And then given the raised low end of guidance, how much contribution from the January commercial expansion is already assumed in your outlook versus what still represents upside as the team ramps through the year?

John Shannon: Let me start with kind of the payer resets. I think we saw typical resets, specifically around Recorlev. And then as March kicked in, we continue to grow. And that growth really comes into play with the market dynamics. There are still — there’s lots and lots of people with — that are being tested and screened and diagnosed with hypercortisolemia. And we’re in a perfect position now with our expanded field organization to capture more and more of those patients and get them on drug. So — and we see that will continue to progress throughout the year. Steve, do you want to…

Steven Pieper: Yes, I’ll take the — yes, I’ll take the second question on the guidance. So I think based on our prepared remarks, Recorlev performed better than our initial expectations, and that’s part of the reason why we raised the bottom end of our guidance. The contribution from the expanded commercial footprint was already embedded in our original guidance. And that’s predicated on history, our experience with these expansions. So I think that’s what’s already assumed in our guidance of $380 million to $390 million.

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

Brandon Folkes: Congratulations on a very good quarter. Maybe just 2 for me. I’ll switch gears a little bit. Can you just update us on your latest capital allocation thinking, especially as things track better than anticipated? And then secondly, can you just update us on the gating factors between now and starting the 8121 trial that needs to be done?

Steven Pieper: Do you want to start with 8121?

John Shannon: Yes. Why don’t I start with 8121. As I said, we’re on track. We’re hitting our milestones this year. We’re on track to start this trial by the start of the year. But what I’ve also said is that we’re not going to start this trial until we have kind of the go-to-market commercial presentation ready. It’s really important that we start this trial with the go-to-market presentation. So what we’re doing now and what we’ve been doing over the last several months is really scaling up all of that, the device, the formulation, the commercial scale formulation and then putting those 2 things together before we put — start the trial. So we’re going to get all that stuff done prior, and we’re on track to do that. And we’ll stay on pace and we’ll share more about that later this year as we kind of do a full kind of program review later in the fall.

Steven Pieper: And then, Brandon, from a capital allocation perspective, yes, certainly, the performance of the business is driving towards a healthy and — healthier balance sheet that gives us a lot of optionality with our business. I would say, first and foremost, we’re focused on reinvesting in the business for growth. So that’s kind of the primary lens by which we’re deciding on where to invest our next dollar. And then obviously, we have options around what we can do with our balance sheet and our capital structure in terms of debt. That’s always — it’s always an option for us. But I’d say primarily, we’re focused on things that are going to drive additional growth.

Operator: Your next question comes from the line of Jason Dorr with Oppenheimer.

Jason Dorr: It’s Jason on for Leland. Congrats on the quarter. To what degree is there appetite to expand the pipeline beyond 8121? And if there’s appetite there, would that involve bringing in external innovation, something to tune for Recorlev? Or would that be more on the end of developing new molecules with the XeriSol, XeriJect technologies?

John Shannon: Thanks, Jason. You just heard Steve talk about our flexibility around our capital and the fact that we’re — our performance is driving our ability to do more things. And we’ll focus those things on growth. So things that can drive growth will be the areas we’ll spend that capital on. And if that’s future pipeline, yes, if it’s external inorganic things, yes, especially if they fit in and allow us to leverage our capabilities, both from an R&D perspective as well as from a commercial perspective. So we’re looking at all those things with an eye on growth, additional growth.

Operator: Your next question comes from David Amsellem with Piper Sandler & Company.

Alexandra von Riesemann: This is Alex von Riesemann on for David. So firstly, looking at Recorlev, can you help give us a better sense of what kinds of patients are getting the product? And how are you thinking about other subgroups of patients beyond uncontrolled hypertension and uncontrolled type 2 diabetes? And then secondly, regarding the expansion of the sales force, can you remind us how many reps you have in the field, how many doctors they’re targeting and the audience breakdown?

John Shannon: Thanks, Alex. Well, our patients are coming — our patients are, I think, I’ve said this before, and they continue on the same path. About 60% of our patients are new to therapy, naive to drug. So most of them are first diagnosed and coming into Recorlev. And then the rest are coming from probably switches and from the various other products on the market. In terms of what your next question was around?

Steven Pieper: Number of reps.

John Shannon: Number of reps.

Steven Pieper: And targets.

John Shannon: Yes. I think we raised our targets from about 7,000, 8,000 to somewhere in the 12,000 range. So we probably added about 6,000 targets out there with the expansion. We’re up to around 80 reps. And then we’ve also expanded our patient services, reimbursement services and capabilities around pharmacy. So all of those things support the revenue growth that we’re seeing and are anticipating. I think you also asked another question around subgroups of patients. I think the thing to think about our patients are all of these patients have hypercortisolemia. They have cortisol levels at 1.8 above the upper limit of normal or even higher. And all of them have other comorbidities that really constitute Cushing’s syndrome. And it’s across the board. I think obviously, there’s probably some skew towards diabetes, resistant diabetes, but it’s really across the board, all the various comorbidities. So…

Operator: We have reached the end of the Q&A session. I will now turn the call over to John Shannon for closing remarks.

John Shannon: As you just heard, Q1 marked another strong quarter for Xeris and an exceptional start for the year, underscoring sustained commercial momentum and disciplined execution against our strategic priorities. We remain focused on delivering impressive revenue growth while continuing to operate with financial discipline. Our performance to date reinforces the confidence we have in achieving our updated full year guidance. We are encouraged by underlying demand trends and the meaningful progress our teams are making to expand market penetration and strengthen long-term value creation. Thank you for joining us today.

Operator: This concludes today’s call. Thank you for attending. You may now disconnect.

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XERIS BIOPHARMA HOLDINGS INC

Q1 2026

Earnings Transcript

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