Xeris Biopharma Holdings, Inc.

Hello, everyone. Thank you for joining us and welcome to Xeris Biopharma Second Quarter 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. I will now hand the conference over to Allison Wey, Senior Vice President of Investor Relations. Allison, please go ahead.

Thank you, Leah. Good morning, everyone, and welcome to Xeris Biopharma's second quarter financial results conference call. Early this morning, we issued a press release detailing our results. This press release can be found on our website. Joining me on today's call is John Shannon, our Chairman and Chief Executive Officer, and Steve Pieper, our Chief Financial Officer. Following our prepared remarks, we'll 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. 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 presented on a non-GAAP basis. A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our earnings release. With that, I'll turn the call over to John.

Thank you, Allison, and good morning, everyone. The second quarter was another record-breaking quarter for Xeris, one that demonstrated once again that the commercial momentum we have built is durable and accelerating. Total revenue reached $92 million, with net product revenue of $91 million. representing 34% growth year-over-year. Recorilab led the way with 81% growth. Caveas delivered another quarter of steady, reliable performance. And GVOC improved sequentially, as we expected. But the second quarter was more than a commercial story. It was a quarter of meaningful strategic progress. We made significant strides in strengthening our intellectual property portfolio across both our commercial franchise and our pipeline. And shortly after quarter end, we completed the full retirement of our convertible notes, simplifying our capital structure and eliminating nearly $3 million in annual interest expense. The progress we achieved reflects the breadth and defensibility of our science, The financial strength we have earned and reinforces our confidence in the long-term value of what we're building. Taken together, a record commercial performance, a stronger IP portfolio, and an enhanced balance sheet, the second quarter reflects the disciplined, compounding progress we are making to build a high-value biopharmaceutical company. In other words, we're executing and we're just getting started. Based on our strong first half performance and our conviction in the growth trajectory of this business, we are raising the bottom end of our full year 2026 total revenue guidance to $385 to $390 million. This reflects our confidence in this team, the performance of our diversified commercial portfolio, and the long-term growth outlook of our business. With that, let's turn to our brands, beginning with Recoralev. Recoralev continues to demonstrate exceptional momentum, and in the second quarter, it delivered yet again. Recoralev net revenue increased to nearly $57 million in the quarter, representing 81% growth year over year, an increase of over $25 million. Behind that number, Rekorlov had a record number of referrals, new patient starts, patients on therapy, new prescribers, and total prescribers. Quarter after quarter, Rekorlov has delivered sustained growth that speaks to the execution of our commercial team, and most importantly, the deepening confidence prescribers have in Rekorlov as their treatment of choice for endogenous Cushing syndrome. We believe RecorLev should be the standard of care, and we intend to build on that. Importantly, we are still in the early stages of realizing the benefits of the commercial expansion we completed in January. Throughout the second quarter, our focus was on training and deploying our expanded team. Execution is tracking in line with our expectations, and we are increasingly well-positioned to accelerate growth as these investments gained traction in the second half. Turning to GVOC. After a slow start to the year, GVOC rebounded nicely in the second quarter, delivering net revenue of approximately $23 million and prescription growth of 10% versus the first quarter. I am proud of the team's work to put GVOC back into growth mode, and the sequential improvement gives us confidence that GVOC is back on the right track. Looking ahead, the back-to-school season should provide its typical third-quarter lift as families with children managing diabetes ensure they have a ready-to-use GVOC on hand for the school year. The long-term opportunity for GVOC remains unaltered, and our commitment to it is unwavering. Of the 15 million people with diabetes who should have a potential life-saving product like the GVOC Hypopen, only a million or so do. Closing that gap remains an important opportunity for us, and more importantly, a meaningful way to improve patient outcomes. And finally, Caveas. Caveas delivered nearly $12 million in net revenue, once again demonstrating the remarkable durability of this brand in an ultra-rare market. 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. Our commitment to this brand and this community couldn't be more evident than through our steadfast multi-year effort to secure important IP protection for Cabeas. On June 11, we received a notice of allowance from the U.S. Patent Office for a new patent covering Cabeas. Once issued, it will provide renewed protection for Cabeas through at least 2039. With a clear line of sight to such extended protection and having evidenced such astounding durability during its period of non-exclusivity, we intend to invest incrementally in both Cabeas and the PPP community in order to expand efforts to identify and support even more patients in the future. turning to our pipeline and specifically XP-8121. The second quarter was a busy period for our program. During the quarter, we continued to build an even stronger intellectual property estate around this important product and our proprietary formulation technology. On July 28th, we received our second US patent covering XP-8121. Just one week earlier, We also received a notice of allowance for an additional patent application, which when issued will be our third U.S. patent. Our expanding intellectual property portfolio speaks to the depth of our innovation and the long-term defensibility of this product. Those achievements build on the significant progress we made during the second quarter. Our technical and clinical teams made great progress in advancing the program through critical milestones. Importantly, we finalized our clinical site selections, and those sites are busy preparing in advance of an expected Phase III start by year-end. We also maintained a strong presence at key medical conferences throughout the quarter. The feedback we received from the endocrinology community has been exceptional. further reinforcing both our conviction and the significant unmet need in hypothyroidism and the multi-billion dollar commercial opportunity we have laid out. All of this momentum makes our planned XP8121 program overview that much more exciting. On Wednesday, September 9th, we will host a dedicated 8121 webinar where you will hear directly from an important key opinion leader, as well as members of our program team. We will walk you through the unmet medical need, the market opportunity, and our planned phase three program in detail, including trial design, primary and secondary endpoints, target patient population, as well as expected development and related regulatory timelines. We believe XP8121 represents a significant advancement in addressing the real and persistent challenges of treating hypothyroidism, and we believe it has the potential to be a blockbuster. Before I turn the call over to Steve, I want to briefly recap the strong progress we are making against the three critical priorities we outlined in March and continue to keep in our focus. First, driving rapid revenue growth. We delivered 33% growth in the first half, and we are now guiding to full-year revenue growth of 33% at the midpoint. Our commercial business is growing fast. Second, advancing our pipeline. The XP8121 program remains on track, and on September 9th, we will provide the market with a comprehensive look at the program. We look forward to that conversation. And third, executing with discipline. The full retirement of our convertible notes completed in July is a direct expression of this priority in action. A proactive, planful step made possible by the ever-strengthening financial position of Xeris. With our sustained commercial momentum and disciplined execution against our strategic priorities, I couldn't be more excited about the company wearability. And with that, I'll turn the call over to Steve.