Good morning, and welcome to the Zaris Biopharma Q126 Earnings Conference Call. Please note that before we begin, this conference is being recorded on Thursday, May 7th at 8.30 a.m. I will now pass the call over to Allison Wei for opening remarks. Please go ahead.

Thank you, Zara. Good morning, everyone, and welcome to Zaris' first quarter financial results conference call. Earlier this morning, we issued a press release detailing our first quarter 2026 financial and operating results. This press release can be found on our website. Joining me today is John Shannon, our Chief Executive Officer, and Steve Piper, our Chief Financial Officer. Following our prepared remarks, we will open the call for your questions. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements regarding XERAS'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. 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. And 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 represented on a non-GAAP basis, A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our press release. With that, I will now turn the call over to John for his opening remarks.

Thank you, and good morning, everyone. We are off to an amazing start in 2026. First quarter net product revenue grew an impressive 43% to more than $82 million, driven by Recoralev, which nearly doubled with 95% growth, while Coveyus increased 4% and GVOPE remained flat year over year. Given this strong start to the year and the positive demand trends we are seeing overall, especially for Recoralev, we are raising the bottom end of our revenue guidance. We now expect full-year revenue of $380 to $390 million, representing more than 30% revenue growth. Turning now to each product, starting with ReCorelev. As I said, ReCorelev revenue nearly doubled to $50 million, representing a $24 million increase compared to last year. This was driven by both record referrals and record new patient starts. Importantly, coming out of the typical Q1 payer resets, we saw a significant increase in new patients, especially in March, which is fueling our optimism for another outstanding year. I'm also pleased to share that our commercial expansion was completed exactly as planned, significantly expanding our sales force and patient support teams. This enhanced infrastructure will allow us to increase both the quantity and quality of our interactions with healthcare providers and patients, driving even greater awareness of Recoralev's value proposition in treating hypercortisolemia and Cushing's syndrome. We anticipate the impact of this commercial expansion to begin contributing incrementally in the second half of this year and continue to deliver sustained benefits well into the future. The trajectory we are seeing reinforces our conviction that Recoralev is well-positioned to realize its full commercial potential. It remains solidly on path for significant continued growth and is well on its way to achieving $1 billion in revenue by 2035. Turning to GVOKE, GVOKE generated revenue of nearly $21 million in the first quarter. While we anticipated some seasonal headwinds from typical payer resets, GVOKE's performance was slightly below our internal expectations. This was primarily due to Medicare policy and plan changes, which impacted patients' coverage, deductibles, and most importantly, out-of-pocket costs, resulting in a reduction in the number of patients getting their prescriptions filled. We expect GVOC to recover from its first quarter challenges, and it's already beginning to see an increase in prescription demand. Importantly, GVOC's growth potential remains well intact and untapped, since the vast majority of the 15 million patients who should have a ready-to-use glucagon rescue therapy still do not have one. Finally, Coveus. Coveus once again delivered exceptional performance in the first quarter with revenue of approximately $12 million, representing a 4% increase year-over-year. This is the second consecutive quarter of year-over-year growth and demonstrates the remarkable brand strength and durability of Cabeas in this ultra-rare market. This performance not only highlights the inherent clinical value of Cabeas itself, but also the importance of the comprehensive, patient-centered support infrastructure we have built to serve individuals living with primary periodic paralysis. Turning to our pipeline, XP-821-21 is progressing well, and we are on track to begin Phase 3 later this year. Millions of hypothyroid patients still struggle to achieve stable hormone levels due to GI absorption issues, and XP-821 is designed to address this important unmet medical need. XP-821-21 will also enable us to leverage a tremendous amount of existing capability. First, it requires our Xerosol formulation technology, the same technology inside of It will also leverage our drug-device combination expertise, our deep connections with the endocrinology community, and our extensive commercial infrastructure. From a medical communication standpoint, XP8121 is receiving significant attention this year as the medical conference season gets underway. This quarter alone, we're presenting four separate abstracts, each carefully designed to advance the understanding of hypothyroidism management while highlighting the persistent clinical challenges that prevent many patients from achieving and maintaining stable control. Building on this momentum, we'll plan to host a comprehensive program review later this fall, where we will share additional details of our Phase III trial design. Before I turn the call over to Steve, I want to briefly recap the strong progress we have made against the three priorities I outlined in March. First, we remain clearly focused on driving rapid revenue growth. Our first quarter performance and upward revised full year outlook gives us tremendous confidence that our business is on track. Second, we remain focused on advancing our pipeline, with key deliverables on track and XP8121's phase 3 start anticipated later this year. And third, we remain committed to disciplined financial management and to maintaining a strong balance sheet, which is driving much of the outstanding performance that Steve will highlight in more detail. With that, I'll turn the call over to Steve.

Good morning, everyone. As John highlighted, we are off to a strong start in 2026. Our results reflect solid execution and growing confidence in the performance of our business. Total revenue reached $83.1 million in the first quarter, representing growth of 38% year over year. This performance demonstrates the strength of our commercial execution and the traction Rekorolev continues to generate as we drive rapid and sustained revenue growth. Net product revenue grew 43% year-over-year to $82.5 million, an increase of nearly $25 million compared to Q1 of last year. Rekorolev generated net revenue of $49.8 million, representing growth of 95% year-over-year, an increase of $24.2 million, reflecting continued expansion of our patient base with momentum gaining in March and continuing into April. G-Vote generated net revenue of $20.8 million in the first quarter, flat year-over-year with soft prescription demand partially offset by favorable net pricing. As John mentioned, G-Vote's soft start to the year reflects lower total prescription volume, which was primarily driven by a decline in the Medicare channel, resulting from higher-than-normal out-of-pocket costs and a reduction in patients getting their prescriptions filled. Even with this soft start, we still expect modest growth from GVOC this year, and we are confident it will return to being a steady growth contributor for years to come. Tobias delivered strong financial results in the first quarter, generating net revenue of $11.9 million. The year-over-year growth of 4% reflects modest improvements in both net pricing and the number of patients on therapy compared to the first quarter of 2025. Turning to gross margin, our gross margin for the first quarter was 87%, an increase of 2% versus last year. This improvement was primarily driven by favorable product mix dynamics. R&D expenses totaled $8.8 million in the first quarter, representing an increase of 13% compared to the prior year period. This increase reflects higher personnel costs related to incremental investments in our XB8121 program as we advance towards phase three initiation later this year. SG&A expenses were $53.1 million for the quarter, reflecting growth of 21% year-over-year. This increase was primarily related to our strategic commercial expansion activities associated with the nearly doubling of our Rekorlev commercial team. These incremental investments in both R&D and our commercial organization represent our disciplined approach to scaling the organization in alignment with our growth trajectory, ensuring we have the infrastructure necessary to maximize the potential of both our current commercial portfolio and our phase three ready asset. Adjusted EBITDA for the first quarter was $15.1 million, an improvement of $10.7 million versus last year, demonstrating our continued commitment to profitable growth. Underscoring the progress we have made in our profitability journey, we delivered net income of $2.2 million in the first quarter, a significant improvement of more than $11 million compared to last year. Together, these metrics reflect the operating leverage we are generating as we scale our business and validate our disciplined approach to balancing growth investments with financial performance. Moving to our revised 2026 guidance and outlook. As John mentioned earlier, the overall growth of our diversified portfolio is ahead of our initial expectations, and the strong performance of both ReCore 11 and Cabeas are more than offsetting early softness from GEVO. We expect our overall strong performance to continue as we move throughout the balance of 2026. As such, we are raising the low end of our total revenue guidance to a range of $380 to $390 million compared to our prior range of $375 to $390 million. This upward revision reflects the outstanding results we delivered in the first quarter and our confidence that this momentum will continue throughout the year, especially as incremental contributions from Rekorolev's expanded commercial infrastructure begin to yield more meaningful results in the second half of the year. On R&D, we continue to expect an increase of approximately $25 million year-over-year, driven by the planned Phase III initiation of XP8121 later this year, a deliberate and disciplined investment to unlock what we believe is a $1 billion to $3 billion peak sales opportunity. On SG&A, we continue to assume an increase of approximately $45 million, reflecting primarily the full-year cost of the Recorla commercial expansion. Finally, we remain committed to delivering positive adjusted EBITDA in 2026, growing on an absolute dollar basis versus 2025. Our financial story this quarter is one of solid execution and confidence. We are driving exceptional top-line growth, improving RE's strong gross margins, and investing deliberately in the commercial and pipeline initiatives that will grow Zaris for years to come. With that, I will now hand the call over to the operator for Q&A.

Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. 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 Chase Knickerbocker with Craig halloum please go ahead good morning uh thanks for taking the questions and uh congrats on a on a nice quarter here um can you maybe just help us understand a little bit more on the g vote dynamics um were there any actual formulary changes in the quarter or are these strictly kind of redesigned dynamics and then if it's the latter uh can you just give us some thoughts on you know why you guys might be getting a little bit more impacted than some other assets particularly, you know, your competitor in the ready-to-use space. Thanks.

Thanks, Chase. So a couple things there. One is there's always payer change resets that happen in the first quarter. There's probably a couple small changes that are in there, nothing really big. It's primarily the Medicare resets. And as I said, that really impacted deductibles and mostly out-of-pocket costs, especially in the first quarter for GVOC. And we saw that pretty standard in the first part of the quarter. And then it started to creep back up a little bit in March, but not quite as much as we would expect. And we can see that it was primarily in Medicare. So, you know, we're confident we know where it's at and what's going on there. And then in terms of, you know, did it affect Baximi in Medicare? Yes, it did. We can see that in the data. But overall, you know, Baximi probably has a very different split of their channel mix than we do. We are, you know, we've always done very well in the Medicare space. And I think this hit us particularly harder than our competitors.

And just a follow-up there, and then one on Record Live. so just on another one there on um with the with the redesign dynamics i mean would you expect a a pretty significant recovery in the second half then as as some of these uh beneficiaries hit catastrophic um and then second just on record that can you help us understand if you're seeing any benefit yet from uh the commercial team expansion um you know maybe discuss the top of the funnel a little bit if there are some early indicators on um you know some benefit from from those new reps? Thanks.

Yeah. So, you know, back to GVOC, yes, we expected to recover. We feel good about that. And, you know, there's 15 million people out there, again, that don't have a ready-to-use rescue med, and we need to get it in their hands. So there's plenty of opportunity. We'll continue to drive that. And we feel good about the long-term, you know, potential of GEVO. With ReKoralev, yes, I mean, it's, you know, we saw an unbelievable start to the quarter and driven by record new starts, record referrals at the top of the funnel, as you indicated. But understand this, we don't really think we'll see the real kind of, you know, kind of drive and expansion until later in the year. We know from prior experience this takes six to nine months for them to really fully hit stride. And so that real push will come more in the back half of the year.

Well, thank you.

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

Hi, this is Georgia Bank on the line for Dennis Ding. Thank you so much for taking our questions. Two from me. One, despite some Q1 pair resets and any winter-related disruption, RecorLive showed strong sequential growth. Maybe you can help unpack what's driving that underlying momentum a little bit more and what you're seeing in terms of any recovery from seasonal dynamics as you move through March and April into May. And then given the raised low end of guidance, how much contribution from the January commercial expansion is already assumed in your outlook versus what still represents upside as the team ramps through the year? Thank you so much.

Well, let me start with, you know, kind of the payer resets. I think we saw typical resets specifically around ReCorelev. And then as March kicked in, we continued to grow. And that growth really comes into play with the market dynamics. There are still, there's lots and lots of people that are being tested and screened and diagnosed with hypercortisolemia. And we're in a perfect position now with our expanded field organization to capture more and more of those patients and get them on drug.

And we see that will continue to progress throughout the year um steve you want to yeah i'll take the good morning georgia yeah i'll take the second question on the the guidance so i i think you know based on our prepared remarks recorla performed um better than our initial expectations and that's part of the reason why we you know raised the bottom end of our guidance um the contribution from the expanded commercial footprint was already embedded in our original guidance um and you know that's predicated on on history our experience with these expansions so um i think that's that's what's already assumed

you know in in our guidance of 380 to 390. thank you sure your next question comes from the line of Brandon Foulkes with H.C. Wainwright. Please go ahead.

Thanks for my questions and congratulations on a very good quarter. Maybe just two for me, I'll switch gears a little bit. Can you just update us on your latest capital allocation thinking, especially as things track better than anticipated? And then secondly, can you just update us on the gating factors between now and starting the 8-1-21 trial that needs to be done. Thank you.

You want to start with 8-1-21?

Yeah, why don't I start with 8-1-21? You know, as I said, we're on track. We're hitting our, you know, milestones this year. We're on track to start this trial by the start of the year. But what I've also said is that we're not going to start this trial until we have kind of the go-to-market commercial presentation ready. It's really important that we start this trial with the go-to-market presentation. So what we're doing now and what we've been doing over the last several months is really scaling up all of that, the device, the formulation, the commercial scale formulation, and then putting those two things together before we start the trial. So we're going to get all that stuff done prior, and we're on track to do that, and, you know, we'll stay on pace, and we'll share more about that later this year as we kind of do a full kind of program review later in the fall.

And then, Brandon, from a capital allocation perspective, yeah, certainly the performance of the business is, you know, driving towards, you know, a healthy and And in healthier balance sheet, that gives us a lot of optionality with our business. I would say, first and foremost, we're focused on reinvesting in the business for growth. So that's kind of the primary lens by which we're deciding on where to invest our next dollar. And then, obviously, we have options around what we can do with our balance sheet and our capital structure in terms of debt. That's always an option for us. But I'd say primarily we're focused on things that are going to drive additional growth.

Great. Thank you very much. And congrats again on a good quarter.

Thanks, Brandon.

Your next question comes from the line of Jason Doerr with Oppenheimer. Please go ahead.

Hi, everyone. It's Jason on for Leland. Congrats on the quarter. To what degree is their appetite to expand the pipeline beyond A121? And, you know, if there's appetite there, would that involve bringing in external innovation, something to attune for core love, or would that be more on the end of developing new molecules with the XeroSol, XeroJet technologies?

Thanks, Jason. You just heard Steve talk about our flexibility around our capital and the fact that our performance is driving our ability to do more things. And we'll focus those things on growth. So things that can drive growth will be the areas we'll spend that capital on. And, you know, if that's future pipeline, yes. If it's external, inorganic things, yes, especially if they fit in and allow us to leverage our capabilities, both from an R&D perspective as well as from a commercial perspective. So we're looking at all those things with an eye on growth, additional growth.

Appreciate the color. Thank you.

Your next question comes from David Amsalem with Piper Sandler & Company. Please go ahead.

Hi, good morning. Thanks for taking our question. This is Alex von Reisman on for David. So firstly, looking at ReCoreLiv, can you help give us a better sense of what kinds of patients are getting the product and how are you thinking about other subgroups of patients beyond uncontrolled hypertension and uncontrolled type 2 diabetes? And then secondly, regarding the expansion of the sales force. Can you remind us how many reps you have in the field, how many doctors they're targeting, and the audience breakdown? Thank you.

Thanks, Alex. Well, our patients are coming. Our patients are, I think I've said this before, and they continue on the same path. About 60% of our patients are new to therapy, naive to drug. So, most of them are, you know, firstly, first diagnosed and coming in to ReCorelev. And then the rest are coming from probably switches and, you know, from the various other products on the market. In terms of, well, your next question was around number of reps. Oh, number of reps.

And targets. Yeah.

Yeah. I think we raised our targets from about seven, 8,000 to somewhere in the 12,000 range. So we probably added about 6,000 targets out there with the expansion. We're up to around 80 reps. And then we've also expanded our patient services, reimbursement services, and capabilities around pharmacies. So all of those things, you know, support the revenue growth that we're seeing and are anticipating. I think you also asked another question around subgroups of patients. I think the thing to think about our patients are all of these patients have hypercortisolemia. They have cortisol levels at, you know, 1.8 above the upper limit of normal or even higher. And all of them have other comorbidities that really, you know, constitute Cushing syndrome. And it's across the board. I think, you know, obviously there's probably some skew towards diabetes, resistant diabetes, but it's really across the board, all the various comorbidities. So.

Thank you. We have reached the end of the Q&A session. I will now turn the call over to John Shannon for closing remarks.

As you just heard, Q1 marked another strong quarter for Xeris and an exceptional start for the year, underscoring sustained commercial momentum and disciplined execution against our strategic priorities. We remain focused on delivering impressive revenue growth while continuing to operate with financial discipline. Our performance to date reinforces the confidence we have in achieving our updated full-year guidance. We are encouraged by underlying demand trends and the meaningful progress our teams are making to expand market penetration and strengthen long-term value creation. Thank you for joining us today.

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