Hello, everyone. Thank you for joining us and welcome to Zyra's Biopharma Third Quarter 2026 Earnings Conference Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. Those are the webcasts can submit a text question by clicking the Q&A button on the bottom right corner of the screen. I will now hand the conference over to Christy Barnett, Vice President of Investor Relations. Please go ahead.

Thank you, Bella. Good morning, everyone, and welcome to Xeris Biopharma's third quarter 2026 financial results conference call. Earlier this morning, we issued a press release detailing our third quarter 2026 financial and operating results. This press release can be found on our website at xerisfarma.com. Joining me on today's call are John Shannon, our Chairman and Chief Executive Officer, and Steve Pieper, 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 Xeris' future expectations, plans, strategies, objectives, and financial performance, including our full-year 2026 financial guidance and our 2030 outlook. 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 For a discussion of these risks and uncertainties, please refer to the risk factors described in our filings with the SEC, including our most recent annual report on Form 10-K and our subsequent filings with the SEC, as well as the forward-looking statements disclaimer in our earnings release. Any forward-looking statements made on this call speak only as of today's date and, except as required by law, Allison Wey's Retirement Some of you may know me from my previous companies, and for those who I haven't yet met, I look forward to connecting and working with you. We will miss Allison here at Xeris, and I'm pleased to carry the investor relations baton forward. I look forward to an open dialogue and to keeping you informed about Xeris's progress. And with that, I'll turn it over to John.

Thank you, Christy, and welcome to Xeris. We're happy to have you on the team. And good morning, everyone. I'm pleased to report that Xeris had a spectacular third quarter, and we now see our company on a new growth curve, one that is both accelerating our near-term financial outlook and redefining what we believe is possible for this company. Importantly, this new trajectory reflects expected growth from the entire enterprise, Recorlev, Jivo, and Coveas. Total revenue grew more than 44% year over year. led by Recoralem where the expanded commercial team moved from build to yield and delivered record referrals and new patient starts. GVOC delivered a better than expected back to school prescription lift and prescription demand is back in solid growth mode. And Cabeas continued its steady high value contribution. And now with a recently issued patent, we intend to intensify our efforts to identify more patients that could benefit from therapy. Results like these reflect years of disciplined execution and focused innovation. And they reflect who Xeris has become, a leading endocrine and rare disease biopharmaceutical company committed to helping people realize better lives through the development and commercialization of innovative medicines. We convert innovation into durable revenue growth that continues to compound. This is our model, and this quarter is further evidence it is working. Given the strong momentum across Redcoralef, GVOC, and Cabeas, we are raising our full-year total revenue guidance to $395 to $405 million, and we see this new trajectory extending well beyond 2026. We are now on a path to reach more than a billion in total revenue in 2030, up from our prior outlook of $750 million, which we first disclosed back in June of 2025. We also now see RecorLive on a path to a billion in annual net revenue three to four years sooner than we previously projected. These are meaningful increases to our expectations, grounded in the progress we are making right now. We are building on a stronger foundation and creating a larger opportunity than we previously envisioned. And beyond 2030, we see significant incremental opportunity with our late-stage pipeline assets, XP8121. With that, let's turn to our brands, beginning with Recorlove. Recorlove continues to demonstrate exceptional momentum, and in the third quarter, it shifted into a higher gear. Net revenue increased to more than $71 million, an increase of 93% or $35 million year over year. Quarter after quarter, Recorlove has delivered exceptional growth that speaks to the execution by our commercial team, and most importantly, the deepening confidence prescribers have in Recoralib as their treatment of choice for endogenous Cushing's syndrome. We believe Recoralib should be the standard of care, and we intend to drive it there. On our last call, we said the benefits of our January commercial expansion would begin to show up in the third quarter, and they have. Our expanded team is trained, deployed, The team's productivity is now running ahead of our expectations and is the key driver behind the upward revision of our 2026 and our 2030 outlooks. Also, favorable dynamics should continue to fuel an expansion of the hypercortisolism market. Just last month, the American Diabetes Association and the European Association for the Study of Diabetes issued updated guidance on the role of hypercortisolism in difficult-to-control type 2 diabetes and included recommendations for additional screening. Recorlev's growth continues to benefit from expanded screening that is helping clinicians to identify more patients. Our medical affairs team recently convened our fourth annual Cortisol Summit Scientific Advisory Board, bringing together leading pituitary and adrenal experts to advance research priorities and clinical management of Cushing syndrome. And at the Cardiometabolic Health Congress, we presented real-world evidence illustrating the systemic benefits of cortisol normalization in a patient with uncontrolled type 2 diabetes, hypertension, and multiple other comorbidities, further underscoring the significant and growing opportunity ahead for Recorilab. Now turning to GVOC. GVOC delivered better than expected back to school prescription growth in the third quarter, with total prescriptions growing 20% over Q2 and 5% year over year. We continue to build the evidence base for ready to use glucagon At the recent breakthrough T1D Clinical and Research Congress, we presented real-world data on the gap between healthcare provider awareness of prescribing guidelines for ready-to-use glucagon and actual prescribing practices. That gap is precisely the opportunity in front of us. Of the roughly 15 million people with diabetes who should have a potentially life-saving product like GVOC, only about a million do. Closing that gap remains an important opportunity for us and a meaningful way to improve patient lives. I'm extremely proud of the team's work here. We began to see GVOC demand generation build in the second quarter, accelerate in Q3, and carry right into Q4. Our prescription growth reflects improving underlying demand, giving us confidence that GVOC is on a sustainable growth trajectory. And despite a one-time gross-to-net adjustment in the period, which Steve will walk through shortly, we are confident that GVOC is now back to contributing steady unit and dollar growth in the future. And finally, Coveas. Coveas delivered more than $13 million in net revenue, demonstrating the brand's continued strength as a meaningful growth contributor to our business going forward. Maintaining patients on therapy remains the ultimate proof point, and our results continue to reflect both the clinical value of Cabeas and the patient-centric support infrastructure we have built for the PPP community. And last month, our steadfast multi-year effort to secure important IP protection for Cabeas was realized. On October 13th, the U.S. Patent Office issued a new patent covering Cabeas with protection through at least 2043. With this patent now issued, and having demonstrated such remarkable durability, we are investing incrementally in Cabeas and the PPP community to identify and support even more patients. Turning to our pipeline, specifically our late-stage XP8121 program. In September, we hosted our XP8121 program overview, providing a detailed look at our comprehensive clinical development strategy, including Cornerstone, our pivotal Phase III study designed for regulatory approval, Capstone, our pediatric study, and Touchstone, our study in patients with inconsistent control despite oral therapy. We remain on track to initiate Cornerstone by year-end. with top line data expected in late 2028 and potential approval and launch in 2030. Since our September update, we have continued to advance all work required to initiate our Cornerstone phase three study. We are especially encouraged by our startup study activities and the enthusiasm of sites to participate in Cornerstone. In parallel, our real world evidence program continues to advance. This week at the American Thyroid Association Annual Meeting in Philadelphia, we are presenting real-world evidence on biochemical control among patients treated with oral levothyroxine. These efforts are helping us deepen our understanding of the treatment challenges in hypothyroidism and further inform the opportunity for XP8121. We also continue to strengthen the intellectual property supporting XP8121. On October 6th, we were granted our third U.S. patent covering the program, reinforcing XP8121's patent protection, which extends to October 2043. This patent represents another important milestone in building the long-term foundation for XP8121. We believe XP8121 has the potential to address persistent challenges faced by patients and healthcare providers in managing hypothyroidism. With peak sales potential of $1 to $3 billion, XP8121 represents a significant long-term commercial opportunity and has the potential to become foundational to Xeris' future growth and long-term value creation. Before I turn the call over to Steve, let me briefly recap the progress we are making against the three critical priorities we outlined in March and remain focused on. First, driving rapid revenue growth. Through the first nine months of the year, total revenue grew 37% year-over-year. Based on that performance, we now expect full-year revenue of $395 to $405 million, or growth of 37% at the midpoint. Second, advancing our pipeline. We laid out a comprehensive XP8121 development program in September. and remain on track to initiate our pivotal phase three cornerstone study by year end. We also secured a third US patent. And third, executing with discipline. Adjusted EBITDA grew 77% year over year, even as we continued to make strategic investments for growth. Our record commercial momentum and disciplined execution against our strategic priorities positions us well for the future. and I am incredibly proud of the company we have built and confident in our ability to deliver long-term value for shareholders through the 2030s and beyond. And with that, I'll turn the call over to Steve.

Thanks, John. Good morning, everyone. Before I begin, I would also like to welcome Christy to the Xeris team. It's great to have you with us. As John highlighted, the third quarter delivered what we said it would. Our investments converting into growth with record revenue and continued adjusted EBITDA expansion. Total revenue for the third quarter was $107.2 million, up 44% year over year and 16% sequentially. Net product revenue was $106.3 million, up 43% or $32.2 million year over year. RecoraLab generated net revenue of $71.5 million, representing growth of 93% or $34.6 million year-over-year. On a sequential basis, net revenue increased $14.8 million, or 26%. As John described, our expanded commercial team has moved from build to yield, and we expect continued contribution from that expansion in Q4 and beyond. GVOC generated net revenue of $21.7 million in the third quarter, compared to $25.2 million in the third quarter of 2025. GVOC prescription demand grew 5% year over year. This growth was offset by a $4 million one-time gross to net adjustment in our Medicaid channel. We believe GVOC's return to growth in the third quarter is the beginning of a new growth trajectory. Cabeas delivered another great quarter, generating net revenue of $13 million, representing growth of 9% compared to the prior year. This performance represents the fourth quarter in a row of year-over-year growth, fueling our confidence that Cabeas can contribute to our growth expectations longer term. Gross margin for the third quarter was 88%, compared to 85% in the prior year period, and this improvement was driven by continued favorable product mix. Turning to operating expenses. R&D expenses totaled $11.1 million in the third quarter, an increase of $3.6 million compared to prior year. This increase reflects continued investment in XP8121 as we prepare to initiate the cornerstone study by year end. SG&A expenses were $64.1 million, an increase of $17.6 million versus the prior year. This increase is primarily due to higher personnel related expenses for the commercial enterprise. Adjusted EBITDA for the third quarter was $30.8 million, an improvement of $13.3 million or 77% versus the prior year. It is also worth noting that in the third quarter, we delivered net income of $11.3 million compared to $0.6 million in the same period last year. Moving to our full year 2026 outlook, starting with revenue. With this quarter's record performance, we are raising our full year total revenue guidance to $395 to $405 million. representing approximately 37% growth at the midpoint. Our gross margin guidance remains unchanged as we expect continued improvement versus prior year. Moving to expenses. R&D expenses are now expected to increase approximately $15 million compared to 2025, which is lower than our prior expectation of a $25 million increase. This reduction is mainly due to the expected timing of when certain expenses related to the XP-8121 program will be incurred. SG&A is now expected to increase approximately $60 million compared to 2025, up from our prior expectation of $50 million. This reflects increases in personnel-related expenses as well as deliberate investments across areas of our portfolio where we see compelling near-term growth opportunities. On adjusted EBITDA, through the first three quarters of 2026, we have nearly doubled year over year, growing from 34 to 65 million. And we expect continued adjusted EBITDA growth through the remainder of the year. Beyond 2026, as John shared earlier, we are now on a new path. to generating more than $1 billion in total revenue in 2030 compared to our previous outlook of $750 million. Our portfolio is delivering, and we are on a new growth trajectory that should extend into 2030 and beyond. With that, I'll hand the call over to the operator for Q&A. Thank you.

We will now begin the question and answer session. Please limit yourself to one question and one follow up. 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 Hallam. Your line is now muted. Please go ahead. Hello. Mr. Knickerbocker, your line is now unmuted. Please go ahead. My apologies. Rwanda Rubies with Lering Partners, please go ahead.

Hey, morning, everyone. So, Riccardo had a strong quarter, and can you talk about the relative magnitude of different drivers behind that, you know, talking about the new and repeat prescribers and the field force, et cetera? Could you help us also understand if this growth in the product could potentially be a good tailwind into 2027, maybe mitigate some of the payer dynamics that we typically see in the early part of the year?

Thanks, Royana. Yeah, it's basically, you know, kind of our January expansion really kicking into gear. on top of some really outstanding market dynamics where more and more patients are being tested, screened for hypercortisolism, and we're in a perfect position to capture those patients with Recoralib. We are getting business from existing prescribers and new prescribers. It's coming across the board, so it's both depth and breadth of prescribers. And yes, we see this momentum going into 27. and beyond.

Great. And I have a quick follow-up. So I noticed you announced some new IP for 8121 and Cabeas in particular. Can you talk about the relative strength of these patents and is this helping to build your conviction in the long term and part of your longer-term guidance race?

Well, 8121 is building on, we now have three patents on that product that go as far as composition of matter. So that's extremely strong. Caveas is one that we've been fighting for, I think, nine years to get that patented. We think it's a very important patent. We think it's a very strong patent. And it really gives us what we need to really focus on finding more patients and investing in this community in a way that we can do that for a long time. And so we are now in a perfect position to be able to do that. We've had four quarters of growth on Cabeas now, and we're adding investments there. so that we continue to build on finding more PPP patients and getting them on brand.

Sounds good. Thanks.

Your next question comes from the line of David Amsalem with Piper Sandler. Please go ahead.

Hey, thanks. So I had a couple of Rekorlev questions. Wanted to dive more into how you think you're going to be able to leverage the recent ADA and European updated guidance document. And do you think that could be a source of acceleration and volume in sales as we move through next year? So that's number one. And then can you just give us an update on how access is, how access dynamics are for Ricorlev, and as the footprint of the product grows, do you expect any access to dynamics to become more challenging or evolve in any way? Thank you.

Yeah, let me start with the guidance. And, you know, guidance just adds to kind of what's been going on in this space where more and more clinicians are screening and diagnosing more patients with hypercortisolemia, where drugs and Thank you for joining us. David, you know this market pretty well. This is an area where everything is a prior auth, and we still see that. So it's really going down the path of medical necessity and an area where you continue to have to put resources behind and help the clinicians and patients get coverage for these drugs. We don't see that dynamic changing right away or maybe someday down the road, but right now we don't see any of that happening.

All right, thank you.

Your next question comes from the line of Leland Gershall with Opco. Your line is now unmuted. Please go ahead.

Hi, this is Tracy. I'm for Leland. Congrats on the quarter and thanks for taking our question. Just one from us. You now estimate the total revenue outlook of a billion by 2030. Can you comment on any changes in your underlying assumptions to up that number from 750 million? Thank you.

Tracy, I'll take this one. This is Steve. Thanks for the question. I think it really starts with just a comment on the overall commercial portfolio. One, we expect all three brands to be contributing to growth. primarily led by Rekorlev. And that's really on the back of kind of what we're seeing unfold in Q3 and into Q4. But importantly, we expect all three brands to be contributing to that growth. And that's really what's driving the uptick in our outlook, which I'd remind folks is really only three short years away. Yeah.

Thank you, appreciate the time.

Thanks, Teresa.

Your next question comes from the line of Brandon Foulkes. Your line is now open. Please go ahead.

Hi, thanks for taking my questions and congrats on another very good quarter. Maybe just one from me. With the increased 2030 guidance, with that obviously comes additional cash flow. How do you think about that additional capital deployment, Brian? We've obviously got a good roadmap on 8121 now, but beyond that, how should we think about the incremental investments in the base business between now and 2030? Do you account for a much larger team or just anything we should think about there in terms of that additional cash generation that comes with that guidance? Thank you.

Thanks, Brandon. And let's start with our existing products. We see opportunity to invest across the board in those to drive incremental growth. So our prioritization is to invest in our commercial assets, invest in our pipeline 8121. And then if we still have more to invest, then we'll be looking at business development type activities focused on things that fit into our commercial footprint and our current capabilities, leveraging Thank you very much.

Your last question comes from the line of Chase Knickerbocker with Craig Ellum. Please go ahead.

Good morning. Thanks for taking the question. Can you guys hear me all right?

Yeah.

Awesome. Okay. Sorry about that. So I just wanted to double-click on Cabeas, actually. You know, best quarter since 2024. Just want to get a sense for the drivers, you know, your increased focus. Some additional resources. How much impact is that actually having in the quarter? And then secondly, on that front, just wanted to get a sense for what you think your market share is by volume in that market right now, just as we think about the impact of some of your litigation.

Thanks. Chase, the first question is a little easier for us. The new resources that we put in just left training a few weeks ago. So a lot of those are going to really go into the fourth quarter and then into next year. And it'll take some time to ramp up. So we anticipated and we've been watching the steady growth of Cabeas. And so we got ahead of that and started making the investments just based on the durability of the brand. And then in terms of Thank you for joining us. or our products that these patients are on. So, but for, you know, in terms of, you know, the patients on caveus is, you know, there's really no other competition in terms of getting patients started and treated.

Got it. Maybe just another follow up on the ADA guidelines. Is there a way that you kind of think about what percentage of the endo community that's not routinely testing right now, or how do you guys kind of model the impact as we look into out years?

That's a really good question, and I think it really extends beyond the endo community, really into... Thank you for joining us. You should look for something else.

Since I'm last here, I'm going to sneak one more in, John. Sorry. Just on kind of whether or not you need to generate any evidence specifically for Recorlev in these treatment-resistant diabetics to fully benefit from the guidelines, just how you're thinking about that.

Yeah, I would. Yes, of course. And we've said we're investing in our commercial phone port, but we're also investing in evidence generation. And there you'll you know, you're starting you're going to start seeing that come out over the next several years. So and and like I said, we're we're We have reached the end of the Q&A session. I will now turn the call back over to John Shannon for closing remarks. Thanks, everyone, and thanks for your questions. As you heard, this third quarter put us on a new growth curve, and the momentum behind it is broad and compounded. Today, we raised our 2026 full-year revenue guidance to $395 to $405 million, and our 2030 total revenue outlook to more than a billion. We also now see RecorLab on a path to $1 billion in annual net revenue three to four years sooner Thank you for joining us today, and thank you for your continued support and interest in Xeris. This concludes today's call. Thank you for attending. You may now disconnect.