Xeris Biopharma Q4 2025 Earnings Call Transcript

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Provided by Quartr
March 2, 2026

Key Takeaways

  • Positive Sentiment: Financial self-sustainability achieved — Xeris reported full-year net income and ~$59.4M adjusted EBITDA in 2025 and guided 2026 revenue of $375–$390M while expecting to remain adjusted EBITDA positive.
  • Positive Sentiment: Recorlev is the primary growth engine, ending 2025 at ~700 patients (nearly double year‑over‑year) with FY revenue of $139.3M, and the company nearly doubled its commercial team in January to accelerate adoption with impacts expected notably in H2 2026.
  • Neutral Sentiment: Xeris filed a patent infringement lawsuit against two ANDA filers to defend Recorlev and points to four Orange Book‑listed patents through March 2040 and orphan exclusivity to end of 2028, but litigation timelines are uncertain and could create a multi‑year overhang.
  • Positive Sentiment: The pipeline priority XP‑8121 (once‑weekly subcutaneous levothyroxine) is planned to start Phase 3 in H2 2026, targets an estimated 3–5M patients with absorption issues, and is modeled for potential peak sales of $1–$3B, with R&D budget to increase by about $25M to support the program.
  • Positive Sentiment: The commercial portfolio is durable — Gvoke and Keveyis delivered steady contributions, gross margin improved to ~85% for 2025 (87% in Q4), and management expects further margin improvement and continued operating leverage despite planned SG&A investments (~$45M) to scale Recorlev.
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Earnings Conference Call
Xeris Biopharma Q4 2025
00:00 / 00:00

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Operator

Hello, everyone. Thank you for joining us, and welcome to the Xeris Biopharma Fourth Quarter 2025 Earnings Conference Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again. I will now hand the call over to Allison Wey, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.

Allison Wey
Allison Wey
SVP of Corporate Communications and Investor Relations at Xeris Biopharma

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'll 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's 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.

Allison Wey
Allison Wey
SVP of Corporate Communications and Investor Relations at Xeris Biopharma

For 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, 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

Thanks, Allison. 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. 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

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. 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 three 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. 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

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 three 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 healthcare provider and patient interactions.

John Shannon
John Shannon
CEO at Xeris Biopharma

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 two 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 four 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

Our expectation shared during our Investor Day last June of $1 billion in 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

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.

John Shannon
John Shannon
CEO at Xeris Biopharma

Of those 20 million patients, we believe there are 3 million-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 three 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

We believe XP-8121 has the opportunity to become our next blockbuster, potentially generating $1 billion-$3 billion in peak revenue. As we prepare 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

We will continue to be Adjusted EBITDA positive, even as we significantly step up our R&D and commercial investments. 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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

This growth was driven by robust demand across all three 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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

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 healthcare 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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

We also delivered another period of net income in the fourth quarter. 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. Lastly, maintaining disciplined investment prioritization as we continue to enhance operating leverage. We believe this balanced approach positions us well for 2026 and beyond.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

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-$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.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

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 remainAdjusted EBITDA positive moving forward. 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. 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

We will now begin the question-and-answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again. Please pick up your handset when asking a question. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of David Amsellem with Piper Sandler. Your line is open. Please go ahead.

David Amsellem
David Amsellem
Managing Director and Senior Research Analyst at Piper Sandler

Hey, thanks. Just a couple for me. Helpful color on the spend this year. 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? 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? That's number one.

David Amsellem
David Amsellem
Managing Director and Senior Research Analyst at Piper Sandler

Number two is, as you think about the IP litigation, and I realize this is gonna 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. Thank you.

John Shannon
John Shannon
CEO at Xeris Biopharma

Thanks, David. It's John. Let's start with the expansion. We just doubled our commercial footprint as of the 1st of January. 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 onto therapy. We see that, you know, as, you know, 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.

John Shannon
John Shannon
CEO at Xeris Biopharma

We see that as continuing and continuing based on scale and how we grow there. We're also making, you know, additional investments in data studies, things like that. We'll see that over time as well. We see a, you know, 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 gonna do. We think we know we can get this thing to $1 billion by 2035.

John Shannon
John Shannon
CEO at Xeris Biopharma

Those investments will again, continue to come on a scaled approach so that we can, you know, again, manage the growth that we're driving. 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.

Operator

Your next question comes from the line of Brandon Folkes with H.C. Wainwright. Your line is open. Please go ahead.

Brandon Folkes
Brandon Folkes
Managing Director at H.C. Wainwright

Hi. Thanks for taking my questions, and congratulations on another very good quarter. Maybe just following on from the earlier line of questioning, can you just help us think about the evolution of capital deployment beyond 2026? You know, as you realize there's 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 XP-8121 comes to market to just sort of hedge the new product concentration risk? Secondly, maybe I'll just ask this 'cause maybe it goes in. Can you just talk about the evolution of gross margin here longer term?

Brandon Folkes
Brandon Folkes
Managing Director at H.C. Wainwright

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? Thank you.

John Shannon
John Shannon
CEO at Xeris Biopharma

Let me try to start this, Brandon. I don't know that we got all those questions in there. We'll try to answer them all. You know, 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, you know, whatever is in front of us, specifically XP-8121 and Recorlev growth. You know, as it relates to the IP, again, nothing's changed. It's unchanged. We weren't surprised by these lawsuits. We knew this was coming. We saw this coming.

John Shannon
John Shannon
CEO at Xeris Biopharma

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. We see all of that in front of us, and now that we're at this point where we're, you know, forever, you know, have situations where as long as we continue to grow, we'll be able to continue to leverage that into future growth. I'll let Steve cover any of the...

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

Yeah, I'll just add on to John's comments around operating leverage and some of the questions that have come up. I mean, yeah, 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, you know, the balance sheet is as strong as ever, and it will continue to improve, and our operating leverage will continue to improve. 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 an asset in the pipeline, a blockbuster, in the wings. Certainly, opens up capacity to do other things.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

We'll continue to be disciplined about business development and evaluating those things. Touching on your question around gross margin and gross to nets. Yeah, our gross to net, you know, we benefited on Gvoke specifically this year. I would say gross to nets on balance have kind of steadied out. We're not expecting any material movement either way in 2026 on the gross to net front. From a gross margin perspective, as we've noted over the last, you know, year and a half, 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, you know, approaching kind of best in class gross margin profiles for a company that looks like us.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

Hopefully that addresses your questions, Brandon.

Brandon Folkes
Brandon Folkes
Managing Director at H.C. Wainwright

It does. You got all of them, so I appreciate that and appreciate the color. Congrats again.

Operator

Your next question comes from the line of Chase Knickerbocker with Craig-Hallum. Your line is open. Please go ahead.

Chase Knickerbocker
Chase Knickerbocker
Senior Equity Research Analyst at Craig-Hallum

Good morning. Congrats on all the progress here and thanks for taking the questions. Maybe just first to start out a little bit more color on guidance would be helpful. Can you just kinda 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, you know, being driven by Recorlev, but any sort of thoughts, you know, kind of down the product portfolio would be helpful.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

Good morning, Chase. Yeah, I'll take this one. On the revenue, I think, you know, maybe we'll start with the easiest one is Keveyis. You know, we see that Keveyis is kind of, you know, been a steady contributor over the last, you know, five, six quarters in terms of its revenue contribution. It's kind of, you know, flattening out, so to speak. I think that's a fair assumption moving forward. On Gvoke, I think what we've talked about, you know, over the last year is that we see that again being a steady contributor in that high single-digit, low double-digit growth. I would anticipate that we're gonna see that play out in 2026 that way.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

For Recorlev, that is, you know, the growth driver. You can kind of back into the math there in terms of the contribution there. That's, that's on balance what we're expecting. We did, you know, we do expect some contribution from, you know, our partnerships, other revenue. Historically, it's been in that 5-10 range. I think that's a fair assumption, for 2026.

Chase Knickerbocker
Chase Knickerbocker
Senior Equity Research Analyst at Craig-Hallum

Helpful. Maybe just specifically on Recorlev, you know, obviously, you know, very strong implied guide. Can you maybe talk to us about kind of what you've seen so far in Q1, even kind of-

John Shannon
John Shannon
CEO at Xeris Biopharma

Mm-hmm

Chase Knickerbocker
Chase Knickerbocker
Senior Equity Research Analyst at Craig-Hallum

... that sales force expansion, you know, benefit that you will get here? You know, 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 that is kind of now unwound and kind of come to your benefit? Just some thoughts there would be helpful.

John Shannon
John Shannon
CEO at Xeris Biopharma

Chase, it's John. I, you know, I think the first quarter is as we expected. It's pretty typical. You know, we get a lot of, you know, payer resets and co-pay resets and things like that slow down the quarter early on in January. We see that it's another typical year. You know, that's all kind of starting to rebound pretty aggressively in February and usually does so in March. We're seeing that standard. In terms of, you know, 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. That momentum continues in the marketplace.

John Shannon
John Shannon
CEO at Xeris Biopharma

You know, and now with our expanded team in there, we're in a good, great position to capture more of it. We don't see any of that slowing down, you know, in our, in our organization or as well as with any of our competitors.

Chase Knickerbocker
Chase Knickerbocker
Senior Equity Research Analyst at Craig-Hallum

Helpful, guys. Thank you.

Operator

Your next question comes from the line of Dennis Ding with Jefferies. Your line is open. Please go ahead.

Dennis Ding
Dennis Ding
VP and Equity Research Analyst at Jefferies

Hi. Good morning. Thanks for taking our questions. We have two on Recorlev. Number one, it's been a few years since the launch, I guess what is holding you back from issuing Recorlev guidance? I guess what additional data do you need to make an informed approach to guidance? Number two, do you have any updated thoughts on how you're thinking about the market if Teva indeed is able to secure a specialty pharmacy to distribute generic Korlym, and if you think that's a risk at all? Many thanks.

John Shannon
John Shannon
CEO at Xeris Biopharma

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

Dennis Ding
Dennis Ding
VP and Equity Research Analyst at Jefferies

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

John Shannon
John Shannon
CEO at Xeris Biopharma

Yeah. 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 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 to in order to get to Recorlev, and that's a very different approach than what Korlym does.

Dennis Ding
Dennis Ding
VP and Equity Research Analyst at Jefferies

Okay. Thank you.

Operator

Your next question comes from the line of Roanna Ruiz with Leerink Partners. Your line is open. Please go ahead.

Analyst at Leerink Partners

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

John Shannon
John Shannon
CEO at Xeris Biopharma

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 wanna enter that phase III trial with the actual go-to-market device and formulation scale-up for commercial scale-up. 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, you know, 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. That's what's really the gating item, and that's what we're working on.

Analyst at Leerink Partners

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

John Shannon
John Shannon
CEO at Xeris Biopharma

You know, that's a, 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 a, an outstanding opportunity for ourselves. You know, from that perspective, we don't need to, but it doesn't mean that if the right situation came along that we wouldn't consider that.

Steve Pieper
Steve Pieper
CFO at Xeris Biopharma

That would drive incremental value.

John Shannon
John Shannon
CEO at Xeris Biopharma

Yeah.

Analyst at Leerink Partners

Great. Thank you.

Operator

Your next question comes from the line of Jason Dorr with Opco. Your line is open. Please go ahead.

Jason Dorr
Jason Dorr
Associate Analyst at Oppenheimer

Hey, good morning. Jason on for [audio distortion], congrats on the strong quarter.

John Shannon
John Shannon
CEO at Xeris Biopharma

Thanks.

Jason Dorr
Jason Dorr
Associate Analyst at Oppenheimer

Understanding you're early in the process, could the team provide any guidance on the patent infringement lawsuit for Recorlev against the ANDA filers? You know, maybe what might the timelines be, and what does a favorable outcome look like for the Xeris team? Thank you.

John Shannon
John Shannon
CEO at Xeris Biopharma

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

Jason Dorr
Jason Dorr
Associate Analyst at Oppenheimer

Appreciate the color there. Looking forward to following. Thank you.

John Shannon
John Shannon
CEO at Xeris Biopharma

Mm-hmm.

Operator

Your next question comes from the line of Jenna Davidner with Barclays. Your line is open. Please go ahead.

Jenna Davidner
Jenna Davidner
VP of Equity Research at Barclays

Hi. Thank you for taking my question. 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 timeframe, 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. Thank you.

John Shannon
John Shannon
CEO at Xeris Biopharma

Yeah, thanks for the question, Jenna. I clearly can't comment on, you know, legal strategy, and litigation strategy, so, but I do appreciate the question.

Operator

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

John Shannon
John Shannon
CEO at Xeris Biopharma

Thanks. 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, and 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. Thank you.

Operator

This concludes today's call. Thank you for attending. You may now disconnect.

Executives
    • Allison Wey
      Allison Wey
      SVP of Corporate Communications and Investor Relations
    • John Shannon
      John Shannon
      CEO
    • Steve Pieper
      Steve Pieper
      CFO
Analysts
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