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Date
Thursday, Nov. 6, 2025 at 8:30 a.m. ET
Call participants
Chief Executive Officer — John P. Shannon
Chief Financial Officer — Steven M. Pieper
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Takeaways
Total product revenue -- $74.1 million net product revenue for Q3 2025, increasing 40% year over year, driven by growth across all three products.
Recorlev net revenue -- $37 million net revenue for Recorlev in Q3 2025, representing a 109% year-over-year increase, primarily attributed to a 108% rise in the average number of patients on therapy.
Gvoke net revenue -- $25.2 million net revenue for Gvoke in Q3 2025, up approximately 10% year over year, propelled by a 5% increase in prescriptions and favorable gross-to-net adjustments.
KEVEYIS net revenue -- $11.9 million net revenue for KEVEYIS in Q3 2025, reflecting patient growth and ongoing franchise durability.
Gross margin -- 85% for the third quarter of 2025, driven by a favorable product mix.
Adjusted EBITDA -- Adjusted EBITDA for the third quarter of 2025 was $17.4 million, improved by more than $20 million compared to the third quarter of 2024.
Quarterly net income -- Achieved for the first time in company history, as confirmed by Steven M. Pieper, signaling "growing commercial strength and operational discipline."
Research and development expense -- $7.5 million for the third quarter of 2025, a $1.6 million increase versus the prior year, reflecting heightened pipeline and technology investment.
Selling, general, and administrative expense -- $46.5 million for the third quarter of 2025, an increase of approximately 3% compared to the prior year due to incremental personnel-related spending.
Full-year 2025 total revenue guidance -- Increased to a $285 million–$290 million range, with a 42% growth projected at the midpoint for 2025 over 2024.
Sales force expansion -- Sales and patient support teams will nearly double in size; new representatives are expected to be hired in January and reach optimal productivity after several quarters.
XP 8121 pipeline update -- XP 8121 remains on track for a phase 3 clinical trial initiation in 2026, with manufacturing scale-up and device validation progressing as planned.
Future expense trends -- Both SG&A and R&D are anticipated to rise starting in Q4 2025 as the company invests in commercial expansion and clinical development.
Summary
Xeris Biopharma Holdings (XERS 20.84%) reported record net product revenue of $74.1 million in Q3 2025, fueled by extraordinary growth in Recorlev prescriptions and ongoing expansion across the commercial portfolio. The company delivered its first-ever quarterly net income, citing operational leverage and gross margin improvement. Management raised full-year revenue guidance and disclosed substantial upcoming commercial and R&D investments to support continued topline and pipeline development.
Pieper stated, "we continue to prove the strength of our business model," by remaining adjusted EBITDA positive while increasing strategic investments.
The planned expansion of the field sales organization is explicitly tied to accelerating Recorlev's market penetration and supporting future scalable growth.
Management reinforced that Recorlev is on a multi-year trajectory toward "billion-dollar product" status, indicating ongoing scaling of infrastructure and investment.
XP 8121 development is advancing, with phase 3 preparations focused on manufacturing readiness and device finalization before study initiation in 2026.
KEVEYIS patient additions show no signs of deceleration, with management reiterating the brand's durability and ongoing weekly new patient starts.
Competition from Corcept's anticipated relacorilant launch was discussed, with Shannon noting, "we think relacorilant will help the market," and framing new entrants as market-expanding rather than defensive challenges.
Industry glossary
XeriSol: Proprietary platform enabling creation of subcutaneous injectable formulations for drugs with solubility or stability challenges.
Primary periodic paralysis (PPP): Rare neuromuscular disorder treated by KEVEYIS involving episodes of muscle weakness due to electrolyte channel dysfunction.
XeriJect: Proprietary Xeris formulation technology referenced in the company description, facilitating injectable drug delivery.
Full Conference Call Transcript
John P. Shannon: Thank you, Allison, and good morning, everyone. I am excited to share that Q3 marked another record-setting quarter for Xeris Biopharma Holdings, Inc. 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 to $290 million, a 42% increase at the midpoint.
Our performance was fueled by robust patient demand across all three of our products, reflecting the tremendous value our therapies are bringing to patients and the consistent and outstanding execution of our team. Recorlev has remained the primary growth engine, with revenue more than doubling versus the prior year. This momentum reflects a 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, they 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 hypercortisolism 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 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 three clinical trial in 2026. As we have stated before, we are 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.
Steven M. Pieper: Thank you, 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 nine months, we have 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 into 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 have 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. 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 the 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 of 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 three 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 will turn the call over to the operator for Q&A. Operator?
Operator: Thank you very much. When preparing to ask your question, please ensure your device is unmuted locally. Our first question comes from Dennis Ding from Jefferies. Your line is open, Dennis. Please go ahead.
Dennis Ding: Hi. Good morning. Thanks for the questions. I would like to ask about Recorlev. Can you just please talk about the impact of the expanded Salesforce that you guys have implemented last year? And if productivity has ramped up yet. And as you are thinking about further expansion, when do you think those reps will be fully trained to get the productivity? And then as a follow-up on a quarter, if 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? Thank you.
Steven M. Pieper: Yes. So the expansion last year, we added, we increased the size of the core 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. I would say that, you know, 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, you know, we will 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 are operating at optimal productivity. John, do you want to take the competition?
John P. Shannon: Yeah. I would say we did not 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, you know, the rest come from competition, all the same mix as we have seen in the past. So I would say, you know, nothing unusual. And everything is, you know, as status quo.
Dennis Ding: Okay. Thank you.
Steven M. Pieper: Thank you.
Operator: Our next question comes from Chase Knickerbocker from Craig Hallum. Your line is open, Chase. Please go ahead.
Chase Knickerbocker: Good morning. Thanks for taking the questions. Congrats on the quarter. Maybe just to start on some kind of under-the-covers stuff on Recorlev. Can you maybe just give us an update on what you are seeing from a persistency perspective? You know, any sort of help you can give us as far as current discontinuation rates? And how that has trended over the last couple of quarters?
John P. Shannon: Yeah. Chase, I think everything is, again, the same as what we have had in the past. Again, adding so many new patients that is really keeping all of those metrics in check right now. So we are getting, you know, the same amount of people started, the same time to get them started. You know, no real change in dropout rates, average dose. All those things. We are too new in our life cycle here to see any kind of real significant changes in there. Again, they are overwhelmed by the high level of new starts.
Chase Knickerbocker: Can you just remind us what kind of, you know, six or twelve-month discontinuation rates are, you know, either for the condition or, you know, specifically for Recorlev?
John P. Shannon: I do not 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 are seeing is as expected in the space, but we have not really disclosed any of that directly.
Chase Knickerbocker: Got it. And then maybe just as we look into 2026, you know, you have had pretty remarkable progress, particularly on the Recorlev front this year. Would you be willing to share any thoughts as we go into 2026? And start having, you know, some more impressive comps to deal with, obviously, as we look at the impressive Recorlev performance this year. I mean, any thoughts on how to set expectations as far as top-line growth either for Recorlev specifically or the business as a whole?
John P. Shannon: Yeah. I will try to take that on the context of Recorlev. As you heard, we are investing in more expansion around Recorlev. That is driven by a market that is ripe for expansion. There are more and more people being screened for hypercortisolism. We have, in my opinion, the best product for normalizing cortisol. And we are expanding into a market that is continuing to grow as we are expanding. So I see plenty of growth for Recorlev. You know, we said back in June, we think this is on pace to be a billion-dollar product. And this is all part of our plan to get to that billion dollars.
Chase Knickerbocker: 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 on the go forward. Any additional thoughts you would want to give us as far as when that cadence of R&D should be fully reflected from an enrollment perspective as it comes to the 8121 trial? I mean, should we ramp that up into mid-next year, and then that is kind of peak enrollment? Or, you know, just give us some thoughts on particularly the R&D line next year, but also, obviously, SG&A as we think about the Recorlev expansion?
Steven M. Pieper: Good to talk to you, Chase. As we think about, you know, I mentioned in my comments earlier, we are 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 2026. That is probably where it will peak off. Then in terms of the Recorlev investment, you know, we started to make some of these investments this quarter, late third quarter, but we are bringing on the reps starting in January. So that is where you are 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, you know, as we have said a number of times, even with these investments, we are committed to remaining adjusted EBITDA positive going forward. So that is a really important point here, even with the significant step up in spend over the next fifteen months, we will remain adjusted EBITDA positive.
Chase Knickerbocker: Got it. Thanks, John. Thanks, Steve.
Steven M. Pieper: Sure.
Operator: Our next question comes from Leland Gershell from Oppenheimer. Please go ahead.
Leland Gershell: Great. Thanks for taking the question. And 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 buildout to the Salesforce, or if you expect that you will be able to achieve those targets based on your current force. Thanks.
John P. Shannon: Thanks, Leland. We said that we are going to continue to invest over the several years on Recorlev. And we will need to do that to manage the patient load. So we will have to make investments in pharmacy, patient services, all the commercial footprint it takes to be successful in this space. We will also need to look to and 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, yeah, there will be investments all the way through to the end for this product. As you build a billion-dollar product, you continue to scale your investments with that growth level.
Leland Gershell: Got it. And I also wanted to ask, if you have 8121 coming through, obviously, you will have a bump in R&D over the next couple of years as it gets through its pivotal program. But then, you know, R&D should come back down unless we would be looking for maybe other candidates to be coming out of XeriSol or the company's platform to maybe fill in the early pipeline? Thank you.
John P. Shannon: That is a great question. And one of the beauties of the business here at Xeris Biopharma Holdings, Inc. 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 subcutaneous product that can really meet an unmet medical need. So, you know, in those time frames, sure. We are not fair 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, the capabilities we have, to continue to drive even more growth than we have already stated in our plan.
Leland Gershell: Alright. Thank you very much.
Operator: Thanks, Leland. Our next question comes from Brandon Folkes from H.C. Wainwright. Your line is open, Brandon. Please go ahead.
Brandon Folkes: Hi. Thanks for taking my questions, and congrats on the progress. Can you just remind me of the gating steps between now and the initiation of the 8121 trial? Then maybe just following on from similar questioning, you know, 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? Any comment there would be great. Thank you.
John P. Shannon: Let me answer the first one on 8121. So we have been really clear that we are planning and building a blockbuster here with 8121. And we are taking all the necessary steps before we start the phase three trial to basically make sure we have got the ready-to-go commercial product to take into that phase three trial. So we are 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 three trial so that we are not going back later on and dealing with delays because, you know, we were not able to do that. So we are going to do this very carefully, planfully, and we will 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.
Steven M. Pieper: The infrastructure and leverage for business development?
John P. Shannon: Yeah. Of course, the infrastructure, I mean, we are in such a growth mode right now. You know, the infrastructure is pretty much dedicated to the brands we are driving the growth with. But as we become a little more mature, yeah, sure, it makes sense to use that infrastructure to leverage even more opportunities and capabilities.
Brandon Folkes: Great. Thank you very much for taking my question.
Steven M. Pieper: Thanks, Brandon.
Operator: Our next question comes from David Amsellem from Piper Sandler. Your line is open, David. Please go ahead.
David Amsellem: Hi. Yes. Good morning. This is Alex on for David. Thank you for taking our question. 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 entrance 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 practice nurses? And I am sorry if I missed that earlier on the call. Thank you.
John P. Shannon: So, you know, yes, we anticipate relacorilant gets approved by the end of the year. We have said this in the past, and I will say it again, we think that this is a market where there is so much opportunity and so much potential that another player in this marketplace talking about screening, detection, and finding people with hypercortisolism is a good thing. So we think relacorilant will help the market. We know they are going to make great investments to drive that. And we see that as an opportunity as well. And then in terms of numbers on the expansion, I will let Steve maybe.
Steven M. Pieper: Yeah. I think the question was around targeting GPs. Are we going to be targeting GPs? Yeah. So we are approaching this with a 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 areas. Most of those GPs are endo-like. As we expand, of course, we will be moving into those spaces. High diabetologist, things like that. So, yes, to really go where the opportunity is.
Alex: Thank you.
Operator: Our next question comes from Roana Ruiz from Leerink Partners. Your line is open, Roana. Please go ahead.
Roana Ruiz: Great. Good morning, everyone. Thanks. So a follow-up question on Recorlev. Wanted to see if you could talk about how much momentum you are 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?
John P. Shannon: So, yes, we are seeing repeat prescribers and new prescribers come on. And, you know, we have momentum on both of those. You know, with a 108% increase in patients and prescriptions, you know, you are getting from both. So we are excited to see that momentum. We see that momentum is still very, very strong. And obviously, the reason why we are 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 would not say that is overly material for Recorlev.
We are not expecting it to be overly material, but that is something we pay attention to every year at the first of the year. So that would be the only potential seasonality impact for Recorlev that I would expect.
Roana Ruiz: Yep. That makes sense. And one other question I had was just if you could talk a bit more about the KEVEYIS franchise durability? 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?
John P. Shannon: Well, you know, we are always watching for more competition in this space, but I am like you, I am excited every time we talk about KEVEYIS because this is just a great model where what we do for patients is really important. 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 is why KEVEYIS continues to hang in there and remains to be a very durable asset for us.
We continue to bring on new patients to the brand every week, which is just really exciting in this space because we are really making an impact on those patients in the marketplace.
Roana Ruiz: Makes sense. Thanks.
Operator: We currently have no further questions. So I would like to hand back to John for some closing remarks.
John P. Shannon: I want to quickly thank everyone for their questions and continued interest in Xeris Biopharma Holdings, Inc. As we look ahead to the end of 2025, I could not be more proud of 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 are building for the future, with the foundation in place to initiate the XP 8121 phase three 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.
Operator: This concludes today's call. We thank everyone for joining. You may now disconnect your lines.