Xeris Biopharma Holdings Inc (XERS) 2025 Q3 法說會逐字稿

Hello everyone, and thank you for joining us today for the Xeris Biopharma Q3 2025 earnings conference call. (Operator Instruction). I'd now like to hand over to your host, Allison Wey, Senior Vice President of Investor Relations and Corporate Communications to begin. Allison.

Thank you, (Inaudible). Good morning and welcome everyone to the Xeris Biopharma Third quarter 2025 earnings call. You can find this morning's earnings release on our and our detailed financial results on the investor relations section of our website. Today, I'm joined by John Shannon, CEO, and Steve Pieper, our CFO. After our prepared remarks, we'll open a line for questions.

Before we begin, I'd like to remind you that this call will contain certain forward-looking statements concerning the company's future expectations, plans, projects, and financial performance. Forward-looking statements are subject to risks and uncertainty that could cause actual results to differ materially from those forward.

For more information on our risks, please refer to our earnings relief and risk factors included in our SEC filing.

Any forward-looking statements in this call represent our views only as to the date of this call and subject to certain applicable laws. We disclaim any obligation to update such statements.

Please note that some metrics we will discuss today are presented on a non-GAAP basis.

We have reconciled the comparable GAAP in non-GAAP figures in our earnings release.

Well now turn the call over to John for opening remarks.

Thanks Allison, and good morning everyone.

I'm excited to share that Q3 marked another record setting quarter for Xeris.

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 $285million and $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.

Rekorolev 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.

Well, let's take a closer look at each product, starting with Recola.

Recola generated revenue of $37 million in the quarter, year over year increase of 109%.

We continue to expand our prescriber breadth and depth as more clinicians gain experience with Rekorli and 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 hypercortisolemia and Cushing's syndrome marketplace.

Turning to G.

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 recoiling 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 8,121, our once weekly subcutaneous form of levothyroxine for primary hypothyroidism.

XP 8,121 continues to advance according to plan.

Leveraging our proprietary erosol technology and drug device development capabilities.

We are creating a novel formulation and a high precision delivery system that will enable the 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 the second half of 2026.

As we've stated before, we're really excited about this product and the unmet medical need it can address.

While at, 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.

Thanks, 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 9 months, we've 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 3rd quarter we generated significant positive cash flow as well as net net income for the 1st 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 and a 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've 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.

Rekorev 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%.

Geo 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 Geo prescriptions, as well as some favorability in our gross to none.

Cavaus net revenue was 11.9 million. We saw a modest increase in the average number of patients on therapy in the third quarter, and 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 dollar 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 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 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 here 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 280million to 290 million to 285million to 290 million.

The new range represents growth of 42% at the midpoint compared to 2024.

Additionally, as we make incremental investments in our commercial organization and as we prepare for our phase three clinical study start for XP 8,121 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 continued to prove the strength of our business model. Overall, this has been a year defined by exceptional execution and transformational progress.

With that, I'll turn the call over to the operator for Q&A operator.

(Operator Instruction) Dennis Ding, Jefferies.

Hi, good morning. Thanks for the questions.

I'd like to ask karev.

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're 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 record, 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.

If you want to Yeah,

So the expansion, last year, we added, we increased the size of the recola, commercial team by 50%, so we were at around 42 reps, starting in the third quarter of last year, and, as it takes a little bit of time to ramp up productivity, but I would say that, 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, we'll bring those, reps on board, in January, take some time to train them up, get them out in the field, get a couple quarters under their belt, before they're operating at optimal productivity, John, do you want to take the competition?

Yeah, I would say we didn't 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 (Inaudible) live and, the rest come from competition, all the same mix as we've seen in the past, so I would say, nothing unusual and everything's, as status quo.

Okay, thank you.

(Operator Instruction) Chase Knickerbocker, Craig-Hallum.

Good morning. Thanks for taking the questions. Congrats on the quarter. Maybe just to start on some kind of under the covers stuff on Mccole, can you maybe just give us an update on kind of what you're seeing from a persistency perspective, any sort of, help you can give us as far as kind of the current discontinuation rates and how that's trended over the, last couple quarters.

Yeah, chase, I think everything's again same as what what we've had in the past. We're again adding so many new patients that that's really keeping all of those, metrics in check right now, so we're getting, the same amount of people started, the same time to get him started. No real change in dropout rates, average dose, all those things we're, it, we're too new in our life cycle here to see any kind of real significant changes in there. And again, they're overwhelmed by the high level of new starts.

Can you just remind us what kind of 6 or 12 months kind of discontinuation rates are, either for the condition or, specifically for a kla.

I don't know exactly what they are for the condition. I would tell you Recolev is pretty typical to, a specialty product like this in a complex disease state. I think what we're seeing is as expected.

In the space, but we haven't really disclosed any of that directly.

Got it, and then maybe just as we kind of look into 2026, you've had.

Pretty remarkable progress, particularly on the Recolev front this year. Would you be willing to share kind of any thoughts as we go into 2026 and start having, some, more impressive comps to deal with, obviously as we look, at the impressive, cola performance this year. I mean any thoughts on kind of how to, set expectations as far as top-line growth either for, rocola specifically or the business as a whole.

Yeah, I'll TRY to take that on the context of Recolev as you heard, we're investing on more expansion aroundcoolev, that's driven by a market that is ripe for expansion. There's more and more people being screened, for hypercorticsilemia. We have.

In my opinion, the best product for, normalizing cortisol and we're going to, we're expanding into a market that's continuing to grow as as we're expanding so I see, plenty of growth.

Forcola, 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.

Maybe just the 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 that you want to give us as far as kind of when that cadence of R&D, kind of should be fully reflected from, and, kind of. Enrollment perspective as it comes to the 8,121 trial, I mean, should we ramp that up into mid next year and then that's kind of, peak enrollment, or, just kind of give us some thoughts on, particularly the R&D line next year, but also obviously SG&A as we think about the rocoil of expansion.

Yeah, good to talk to you, Chase. As we think about, I, in my comments earlier, we're going to start to see, some of those investments for both forcore 118,121, stepping up in the fourth quarter. John highlighted in his prepared remarks that, we plan to, start the trial in the second half of next year.

So I think that's when you'll really start to see the spend start to ramp up and then, obviously well into 27.

That, that's probably where it'll peak off, and then in terms of, the rokorolev, investment, we started to make some of these investments, this quarter, late 3rd quarter, but we're bringing on the reps starting in January, so that's where you're 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 as we've said, a number of times, even with these investments we are committed to remaining adjusted EBITA positive going forward so that's a really important point here is even with the significant step up in spend.

Over the next 15 months, we will remain adjusted Ebi positive.

Got it. Thanks, John. Thanks, Steve.

(Operator Instruction) Leland Gershell, Oppenheimer.

Hi, thanks for taking the question, and congrats on the continued progress. Just a question, you, with regard to your longer-term, sales guidance, for Corlev, just wondering if that it, anticipates any further build out for the sales force or if you expect that you'll be able to, achieve, those targets, based on your, current force. Thanks.

Thanks Leland. We've, we said that we're going to continue to invest over the next several years oncole.

And we, we'll need that, we'll need to do that to, manage the patient load, so we'll have to make investments in pharmacy, patient services, all the commercial footprint it takes to be successful in this space.

We'll also need to, and look to and and started investing even more in data and other things that can help drive more growth in the 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.

Got it. And I also wanted to ask, 8,121 coming through, obviously you'll have a bump in R&D, over the, next couple of years, as it gets through its, pivotal program, but then, R&D should come back down unless we be looking for maybe other candidates to be coming out of, Zerosol or the company's platform to, maybe, fill in the early pipeline.

Thank you.

That's a great question. And we, one of the beauties of the business here at iris is we continuously find great ways to invest in our technology, using our technology for new opportunities. 8,121 is a perfect example of that to be able to create using our Xero cell technology a once weekly subqueue product that can really meet an unmet medical need. So in those time frames.

Sure we're we're, not prepared 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 and the capabilities we have to continue to drive even more growth than we've already stated, in our plan.

Great, thank you very much.

Thanks, Leland.

(Operator Instruction) Brandon Folkes, H.C. Wainwright & Co.

Hi, thanks for taking my questions and congrats on the progress. Can you just remind me of the dating steps between now and, the initiation of the 8,121 trial and then maybe just following on from from the questioning, as you make these multi-year investments in the infrastructure behind these products.

Did that infrastructure ever get large enough where it makes sense to bring in additional products? Just any comment there would be great.

Thank you.

Let me ask, let me answer the first one on 8,121. So we've been really clear that we're planning and building a blockbuster here with 8,121, and we're taking all the necessary steps to, before we start the phase three trial to basically make sure we've got the ready to go commercial product, to take into that phase three trial.

So we're 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 wider 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're not going back later on and dealing with delays, because, we weren't able to do that. So we're going to do this very carefully planfully, and we'll start that trial when all that work is done and we can go into it with the commercial.

The commercial presentation.

Remind me on the second question. What

Infrastructure leverage for business development.

Yeah, of course, yeah, the infrastructure, I mean, we're in such a growth mode right now, the infrastructure is pretty much dedicated to the brands we're driving the growth with, but as we get a little more mature yet, yeah, sure, it makes sense to use that infrastructure to kind of leverage even more opportunities and capabilities.

Great, thank you very much for taking my question.

Thanks, Brandon.

(Operator Instruction) David Amsellem, Piper Sandler.

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 forcorli to the extent that, COREPs reliorent gains approval by the end of the year, and what are your base case scenarios for the impact of that potential entrance on corli? And then maybe also a second question, just on the headcount for Rorli, do you have any plans in the future to call in general practitioners? And I'm sorry if I missed that earlier on the call.

Thank you.

So, yes, we anticipate Recorlev, gets approved by the end of the year.

We've said this in the past and I'll say it again is we think that you know this is a market where there's so much opportunity and so much potential that you know another player in this marketplace talking about screening detection and finding people with (Inaudible) is a good thing.

So we think Recorlev will help the market. We know they're going to make great and they're already making great investments to drive that, and we see that as opportunity as well.

And then in terms of numbers on the.

On the expansion, let's see, maybe.

Yeah, I think the question was around targeting GPs. Are we going to be targeting.

GPs? Yeah, so, we, we're approaching this, data driven kind of approach to expansion and and focus and you know where the patients are is where we will go with our commercial, footprint and that leads you into some, GP area. Most of those GPs are, endo like, high dibetologists, things like that, so, yeah, yes, as we expand, of course we'll be moving into those spaces, to really, go where the opportunity is.

Thank you.

(Operator Instruction) (Inaudible).

Great. Good morning, everyone. Thanks. So, follow-up question on Recorlev. Wanted to see if you could talk about how much momentum you're 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?

So, yes, we're seeing repeat prescribers and new prescribers come on and, we're, we have momentum on both of those, with a 108% increase in. In patients and prescriptions, you're getting from both. So, we're excited to see that momentum. We see that momentum is still very strong and obviously the reason why we're expanding into that opportunity.

In terms of seasonality forcola, maybe a little bit with, deductibles that get reset in the first quarter and you see that across all of our products really, so but I wouldn't say that that's, overly material for record level. We're not expecting it to be overly material, but, we'll, that's something we pay attention to every year. At the 1st of the year, so that would be the only potential seasonality impact for Ina that I would expect for record live.

Yes, that makes sense. And one other question I had was just, could you talk a bit more about the Cavela franchise durability? It seems to be continuing pretty steadily.

Do you expect that to persist into next year? And any other, have you been hearing anything else about competition to Cabeas?

Well, we're always watching for more competition in this space, but I'm like you, I'm excited every time we talk about Cavaus because this is a just a great model where what we do for patients is really important and 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 matter in this space and that's why Cavaus continues to hang in there and it remains to be a very durable asset for us. We continue to bring on new patients to brand every week which is just really exciting in the space, because we're really making an impact on those patients, in the marketplace.

(Operator Instruction).

I want to quickly thank everyone for their questions and continued interest in Xeris.

As we look ahead, To end to the end of 2025, I couldn't be more proud with 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're building for the future with the foundation in place to initiate the XP 8,121 phase 3 clinical study next year and continue advancing our broader strategic priorities.

We believe these efforts position zeis 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 Instruction).