XERS - NASDAQ

Hello, everyone, and thank you for joining the Xeris Biopharma Second Quarter 2025 Earnings Conference Call. My name is Sami, and I'll be coordinating your call today. [Operator Instructions] I'll now hand over to your host, Allison Wey, Senior Vice President of Investor Relations and Corporate Communications, to begin. Please go ahead, Allison.

Thank you, Sami. Good morning, everyone, and thank you for joining our call today. I'm joined with John Shannon, our CEO; and Steve Pieper, our CFO. Earlier this morning, we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we will open the line for questions. Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, projects and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements. For more information on our risks, please refer to our earnings release and the risk factors included in our SEC filings. Any forward-looking statements in this call represent our views only as of the date of this call and subject to applicable laws, we disclaim any obligation to update such statements. Please note, some metrics we will discuss today are represented in a non-GAAP basis. We've reconciled the comparable GAAP and non-GAAP figures in our press release. Please let me pass the call over to John for his opening remarks.

Thanks, Allison, and good morning, everyone. I'm excited to report that the strong momentum we established in the first quarter continued into the second quarter, driving another period of incredible performance and positioning us to outperform our original expectations for 2025. Our total revenue grew 49% to a quarterly record of almost $72 million. This success is being fueled by the strength of our commercial product portfolio, which grew 46% to approximately $68 million in Q2. Our exceptional performance was driven by increased patient demand across all 3 products. Recorlev continues to lead our growth with very strong demand driven by its differentiation as a much-needed treatment for patients with hypercortisolemia and endogenous Cushing's syndrome. Gvoke once again delivered consistent steady growth, supported by our efforts to increase awareness and reinforce adherence to medical guidelines. And at the same time, Keveyis remains strong as we continue to add new patients, which led to an increase in the average number of patients on therapy in Q2. Building on this strong foundation and the exceptional results from both Q1 and Q2, we are raising our full year revenue guidance to reflect the very positive trajectory we see ahead. Our revised outlook anticipates total revenue in the range of $280 million to $290 million, surpassing the high end of our previous guidance and representing year-over-year growth of 40% at the midpoint. This significant upward revision reflects our confidence in the growing demand for our commercial products and our operational discipline as we execute against our strategic priorities. Now let's turn to a more detailed review of performance by product, beginning with Recorlev. In the second quarter, Recorlev grew an impressive 136% year-over-year, reaching over $31 million of revenue in the quarter. The average number of patients on therapy grew by more than 122% year-over-year, reinforcing our confidence that Recorlev is solidifying its position as an important treatment option for patients with Cushing's syndrome. As we outlined during our June Analyst Day, Recorlev is the right product at the right time. It's uniquely positioned to capitalize on the fast-growing hypercortisolemia and Cushing's syndrome market, we are making deliberate and strategic investments to drive sustained growth for Recorlev over the near and long term. These efforts are focused on a deepening engagement with health care professionals to accelerate patient identification while simultaneously strengthening our support model for patients as they navigate their therapeutic journey. Turning to Gvoke. Gvoke posted another great quarter with revenue of $23 million, a 17% increase compared to the second quarter of last year. Prescription volume continued its steady upward trend driven both -- driven by both growth in prescribers and increased adoption among existing ones. We expect Gvoke to remain a strong and dependable driver of our overall performance throughout the remainder of the year. Given the extensive number of people with diabetes that don't yet carry ready-to-use glucagon, Gvoke is well positioned for steady long-term growth for many years to come. Now let's turn to Keveyis. Keveyis continues to demonstrate its importance in the treatment of patients with primary periodic paralysis. With revenue of more than $11 million in the second quarter, we saw a modest increase in the average number of patients on therapy, along with growth in new patient starts, underscoring the strength of the Keveyis brand and our team's focus on execution. In fact, today is the 10-year anniversary of Keveyis' FDA approval. And Keveyis remains an important part of our portfolio, consistently serving patients with PPP and reinforcing our commitment to addressing the needs of this ultra-rare community with a dependable and proven therapy. In addition to strong commercial execution, as I mentioned earlier, the second quarter was also defined by an important strategic milestone, our first ever Analyst and Investor Day. This event was a pivotal moment for us as we outlined our long-term vision and key growth drivers, most notably Recorlev and our lead pipeline asset, XP-8121. The engagement we received from the investment community underscores the excitement we feel about the opportunities ahead. As many of you heard on Investor Day, we believe that XP-8121, our novel once-weekly subcutaneous therapy in development for the treatment of hypothyroidism is a very special product in the making. Of all the patients with primary hypothyroidism in the U.S., we estimate that 3 million to 5 million of them are ideal candidates for this therapy because of their inability to achieve control with daily oral levothyroxine due to gastrointestinal absorption issues. We believe XP-8121 represents a transformative opportunity in a space that has seen little to no meaningful innovation for decades despite there being a significant unmet medical need. This is not for lack of trying, but because of the technical challenges are substantial. We've invested the time and resources to solve for those challenges, leveraging our proprietary XeriSol technology to develop a novel formulation and a high-precision delivery system capable of reliably administering a wide array of doses. Our clinical program will also generate a wealth of meaningful data, including regular thyroid hormone monitoring and quality of life assessments, which we believe can improve patient care, enhance our regulatory submission and potentially support differentiated claims. Before I turn the call to Steve, I want to reiterate that our strong performance in the first half of the year further reinforces our confidence in the strength of our business and growth opportunities ahead of us. The increase in our 2025 revenue guidance reflects the momentum we've built by remaining focused on our strategic priorities, executing with discipline and delivering value for patients, providers and shareholders. With that, I will now turn the call over to Steve, who will provide a comprehensive review of our financial performance for the quarter and provide detail around our updated guidance and outlook.

Thanks, John, and good morning, everyone. We had another record-breaking quarter. On a year-over-year basis, total revenue grew 49% to $71.5 million, while net product revenue increased 46% to $67.7 million. Recorlev net revenue was $31.4 million, representing a 136% increase year-over-year. Sequentially, revenue grew by a record $5.9 million. This performance was primarily driven by a higher average number of patients on Recorlev, which increased 122% compared to the prior year and 24% compared to the prior quarter. Recorlev has continued its strong momentum into August with no signs of slowing down. Gvoke net revenue was $23.5 million, increasing 17% versus last year. This increase was attributable to total Gvoke prescriptions growing 5%, coupled with some favorability in our gross to net. Keveyis net revenue was $11.5 million, a slight uptick compared to the first quarter 2025. The average number of patients on therapy modestly increased, and we continue to capture a healthy number of new patient starts. Royalty contract and other revenue generated in the quarter was $3.8 million. As we announced in March, Xeris received FDA approval for Gvoke VialDx, which triggered a onetime milestone payment from our commercial partner, American Regent, that accounted for the majority of other revenue in the quarter. Turning to gross margin. Gross margin in the quarter was 82%, slightly below the first quarter due to expenses associated with Gvoke capacity expansion efforts that were nonroutine. On a year-to-date basis, gross margin was 84%. Research and development expenses were $8.1 million for the quarter, a $2.2 million increase versus last year. This increase primarily reflects our continued investment in our pipeline, namely XP-8121 and our products. Selling, general and administrative expenses were $44.4 million in the quarter, an increase of 11% compared to prior year. The increase in SG&A expenses primarily reflects the impact from the Q3 2024 Recorlev commercial expansion as well as other personnel-related costs. On a sequential basis, SG&A expenses were flat. Turning to adjusted EBITDA. I'm pleased to report that adjusted EBITDA in the quarter was a positive $12.5 million. Compared to prior year, this reflects an improvement of nearly $13 million. This further demonstrates our ability to translate strong top line performance into meaningful bottom line results. That operational efficiency empowers us to reinvest strategically in high-impact organic growth opportunities. Before moving to our near-term outlook and guidance, I want to reiterate that our strong financial position gives us the flexibility to execute on our strategic priorities with confidence. We are taking deliberate value-driven actions to advance Xeris to its next phase of growth. By leveraging our operational and financial strengths, we are well positioned to realize the full potential of our portfolio and pipeline. Our focus remains clear: to drive meaningful, durable growth and deliver lasting value for our shareholders. Turning to our near-term outlook and guidance. We are revising our full year 2025 outlook to account for the strong year-to-date performance. We are raising our total revenue guidance to $280 million to $290 million from the previous range of $260 million to $275 million. This new range represents year-over-year growth of 40% at the midpoint and reflects our confidence in the growing demand for our products, particularly the continued acceleration and adoption of Recorlev. From a gross margin perspective, we continue to expect a modest improvement in gross margin compared to 2024. As we highlighted during Investor Day, we will continue to make incremental value-driven investments. Given the outperformance of our commercial products this year, we are accelerating investments in both Recorlev and XP-8121. This will result in a modest year-over-year increase in total SG&A and R&D expenses. We now anticipate a low to mid-teens percentage increase year-over-year compared to our prior expectations of a mid- to high single-digit increase. This reflects continued investment in further expanding our Recorlev commercial footprint and ensures we remain on track to initiate patient dosing in our pivotal Phase III trial for XP-8121 in 2026. It is important to note that with our raised revenue guidance and deliberate incremental value-driven investments, we remain committed to delivering continued positive adjusted EBITDA going forward. With that, I'll now hand the call over to the operator for Q&A. Operator?

[Operator Instructions] Our first question comes from Chase Knickerbocker from Craig-Hallum.

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?

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

Got it. 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.

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.

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?

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.

And then last thing for me, John. 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?

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.

Our next question comes from David Amsellem from Piper Sandler.

This is Alex on for David. Just one from us. 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?

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.

Our next question comes from Christian Clark from Leerink Partners.

This is Chris Clark on for Roanna Ruiz. I just have one question. 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?

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.

Our next question comes from Jason Dorr from Oppenheimer.

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?

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.

We currently have no further questions. So I'd now like to hand back to John Shannon for some closing remarks.