Xeris Biopharma Holdings, Inc. Q2 FY2025 earnings call

• Strong momentum from Q1 continued into Q2, with total revenue growing 49% to a quarterly record of almost $72 million. - Commercial product portfolio grew 46% to approximately $68 million in Q2, driven by increased patient demand for Recorlev, Gvoke, and Keveyis. - Recorlev grew 136% year-over-year to over $31 million, with patient count up over 122% year-over-year. - Gvoke had revenue of $23 million, a 17% increase, with steady prescription volume growth. - Keveyis had revenue over $11 million, with modest increase in patients and new starts. - First Analyst and Investor Day outlined long-term vision, including Recorlev and pipeline asset XP-8121. - XP-8121 is a novel once-weekly subcutaneous therapy for hypothyroidism with potential transformative impact, leveraging XeriSol technology.

Total revenue for Xeris Biopharma's Second Quarter 2025 was $71.5 million, a 49% year-over-year increase. Net product revenue was $67.7 million, up 46% year-over-year. Recorlev had net revenue of $31.4 million, a 136% year-over-year increase, contributing significantly to growth. Gvoke's net revenue was $23.5 million, a 17% increase year-over-year. Keveyis had net revenue of $11.5 million, with a modest increase in the average number of patients on therapy. Royalty contract and other revenue was $3.8 million, driven by a milestone payment from American Regent for Gvoke VialDx approval.

• Raised full-year 2025 revenue guidance to $280 million to $290 million from the previous range of $260 million to $275 million. - Anticipate modest improvement in gross margin compared to 2024. - Accelerating investments in Recorlev and XP-8121, leading to a low to mid-teens percentage increase in SG&A and R&D expenses compared to prior expectations of mid- to high single-digit increase. - Remain committed to delivering continued positive adjusted EBITDA.

No specific risks detailed in the transcript beyond general forward-looking statement disclaimers regarding risks that could cause actual results to differ from forward-looking statements.

Q: Congrats on the nice quarter here. Maybe just first on Gvoke. Can you talk about that gross to net benefit? Is that going to be something that's kind of onetime or something you can hold on to?

A: Yes, Chase, this is Steve. I'll just take that question. Yes, we anticipate that favorability to continue for the balance of the year.

Q: And so if I think about kind of the script growth that was seen in the quarter, is that kind of the way that we should think about the Gvoke franchise in the back half? Or just some general thoughts on Gvoke? And then I've got a follow-up on Recorlev.

A: Chase, on Gvoke, the third quarter is always a bigger growth quarter with the back-to-school movement. So definitely, you see a script growth that will increase in Q3 and then usually is consistent into Q4 like -- so I think you're going to see an increase coming up and then getting back to more kind of that -- I think it's in that high single-digit growth rate on a quarter-to-quarter basis.

Q: Helpful. And good to see the continued pretty impressive momentum, obviously, in Recorlev. Can you just kind of give us an update on kind of where your prescriptions are coming from, from a physician perspective? Is it still very much majority endo? And then any sort of update you'd be willing to give us just on kind of the average dosage per patient or kind of average, call it, WACC price per patient at this point?

A: Yes. It's pretty much endo. And at least half of our patients are new to therapy. So again -- and all of our growth is coming from new starts. So there's really no movement. That leads to virtually no movement in kind of the increase in dose. I think that's -- with the amount of people we're adding on new and the way they go low and titrate up, again, we don't think we're going to see real material movement in the dose range, at least for some time, I don't know, maybe it's next year or sometime, but it's definitely out -- it will be out for a while.

Q: There's a potential for an existing competitor to launch a new drug, obviously, around the end of the year. Can you just kind of refresh us on your thoughts on kind of how or if you think that changes the competitive environment in the hypercortisolism market towards the end of the year here?

A: Yes. I think, look, more voice in this market because it's growing so quickly, and there's so much attention on testing for cortisol in situations where things you're on today that should be working aren't working, specifically thinking about if you're on insulin and it's not working, what's going on, let's look for things like cortisol levels. And when you find elevated cortisol, that is really generating the market movement and the dynamics in this marketplace. So another player in this space brings more noise to that situation, and I think that's good for all of us.

Q: With the hypercortisolism market expanding, how are you envisioning long-term spend to support Recorlev? And do you foresee any headcount or promotional expansion in the near term? And then in that vein, do you have plans to call on general practitioners in the future?

A: Alex, we outlined in our Investor Day back in June that we would continue to invest into this space given the dynamics of the marketplace. And so yes, we anticipate -- and we said we will be increasing our commercial footprint. We've begun that process. We're working through that and making sure that we continue to expand to support the dynamic growth in this marketplace. So -- and we'll be making tremendous investments over the next several years as we continue to build the Recorlev brand because as I said in our comments on -- at Investor Day and again today, we think Recorlev is the right product at the right time coming into this marketplace. And so it's ripe for the investment, and we will be making those.

Q: Do you have any plans to generate further clinical data to further solidify Recorlev's value proposition beyond cortisol normalization, particularly in patients with secondary comorbidities like stubborn diabetes?

A: Long term, yes. I mean -- but even in our own existing data, things like diabetes, those comorbidities are resolved, and that we -- that exists in our current data sets when you treat the elevations in cortisol. So yes, and we'll continue to generate more and more data around that.

Q: It's Jason here on for Leland Gershell. A couple of questions on Gvoke. How do you see the treatment landscape evolving over the next 2 to 3 years, especially in regards to competitors? And could you provide any additional color on how the revenue might look in the next 2 to 3 years with the Gvoke VialDx collaboration with American Regent?

A: I'm going to try to break that down. The first question was with respect to Gvoke and the opportunity in patients with diabetes is the way I heard it. So as you know, and as we've talked a lot about, there are 15 million patients out there today that should have a ready- to-use rescue glucagon on hand just based on the medical guidelines. And from our estimates, probably only about 1 million of them actually have something on hand. So our job, along with our competitors is to find those patients who are not currently protected with a rescue med and get them protected. And that's a lot of work getting to the clinicians to basically help them understand the guidelines in some cases and then also assure that they're adhering to them in a way that their patients get protected. That's the process. That's what we're doing. That's what the competitors should be doing, and that's the long-term landscape. So there's a lot of runway there to continue to do that. As for the VialDx opportunity out there. More to come on that as we go. Our partner is going to launch by the end of the year. And as they get out there in the marketplace, we'll be able to give further guidance. For this year, there's not much impact, much more impact to our revenues than we've already seen. But in out years, we'll probably be in a better position in next year and beyond to really give some guidance on where that's going and how that's performing.