Xeris Biopharma Holdings, Inc.

Good morning. Thank you for attending today's VAERS Bioforma first quarter 2025 results conference call. My name is Micaiah and I'll be the moderator for today's call. All lines will be muted in the presentation portion of the call with an opportunity for your questions and answers at the end. At this time, I'd like to pass the call over to our Senior Vice President of Investor Relations and Corporate Communications, Alice Nguye. Alice, you may proceed.

Thank you, Micaiah. Good morning, everyone. We appreciate you joining our call this morning. Today, I'm joined by John Shannon, our CEO, and Steve Piper, 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 risk factors included in our SEC filing. Any forward-looking statements on this call represent our views only as of the date of this call and subject to applicable law. We disclaim any obligations to update such statements. But please note some metrics we will discuss today are presented on a non-GAAP basis. We've reconciled the comparable GAAP and non-GAAP figures in our earnings relief. Let me pass the call over now to John for opening remarks.

Thanks, Allison, and good morning, everyone. I'm excited to announce that we're off to an exceptional start this year. In the first quarter, we delivered another record-breaking performance, growing total revenue by 48%, a testament to the strength of our strategy and execution. As such, we are raising the bottom end of our revenue guidance from 255 to 260 million, increasing our implied full-year total revenue growth to nearly 32% at the midpoint of our guidance range. Our momentum is being fueled by the foundation we established in the back half of 2024. Our Q1 success was driven by continued commercial strength across our entire portfolio, with Rigor Korolev leading the charge. Recoralev continues to distinguish itself as our fastest growing and now our largest product, gaining traction as a uniquely differentiated therapy for patients with hypercortisolemia and endogenous Cushing syndrome. At the same time, GVOC delivered steady growth supported by our ongoing efforts to enhance both awareness and compliance with the medical guidelines. Let's take a closer look at each of the products starting with Recoralev. In the first quarter, revenue for RecoraLev was up 141%, exceeding 25 million. The average number of patients on therapy grew 124% compared to the same period in 2024. This significant achievement is a direct result of the targeted investments we made last year, which were designed to support patient access, enhance healthcare provider engagement, and accelerate overall brand performance. These investments have proven highly effective in driving sustained growth and establishing a strong foundation for the future. As we progress through the first half of the year, we are excited by our growth trajectory and remain confident that this momentum will continue to build. We believe RecorLive is the right product at the right time and expect that it will continue to deliver value for patients and stakeholders alike well into the future. Turning to GVOC. GEVO continues to deliver steady, reliable growth, reinforcing its position as a key contributor to our commercial portfolio. Q1 revenue of nearly 21 million reflected strong, consistent increases in prescriptions, which were up 8% compared to Q1 last year. Our efforts to attract new prescribers, while also increasing prescriptions among existing prescribers, remains on pace. This growth trajectory reflects the strength of our strategic efforts to expand GVOC's reach and highlights the value it consistently delivers to both patients and prescribers. As we look ahead, we remain confident in GVOC's ability to sustain its current momentum, as GVOC remains an important contributor to our growth. Finally, let's talk about the durability of CAVEAS. Revenues were over $11 million for the quarter, growing slightly over Q4 2024. CAVEAS remains a key product within our portfolio. continuing to serve patients with unwavering support from the medical and patient communities. The average number of patients on Cabeus improved slightly in Q1, underscoring our ongoing success in identifying and engaging new PPP patients. New patient starts grew compared to the prior year period, further reinforcing this progress. Cabeus' resilience highlights the broader value our products bring to patients and healthcare providers. strengthening our commitment to delivering impactful, reliable treatment options. In addition to our strong Q1 commercial performance, I want to take a moment to highlight a key achievement from this past quarter that reflects the strength of our strategy, discipline, and commitment to delivering sustained growth. In March, we proudly announced that the FDA approved our supplemental new drug application for GVOC vial DX. This approval expands GVOC's use as an IV administration, enabling its utilization as a diagnostic aid during radiologic examinations. In tandem with the regulatory approval, we also announced a strategic partnership with American Region to commercialize G-vofile DX in the U.S. Under the terms of this collaboration, Xeris will be responsible for product supply, while American Region will oversee commercialization efforts. The partnership is positioned to maximize the market reach and success of VialDx, particularly within the hospital and acute care settings. I want to express my sincere gratitude to the Xeris team, our partners at American Region, and the broader medical community for their dedication to making this achievement possible. Together, we're continuing to deliver solutions that improve lives and advance medical practices. Building on this momentum, I'd like to highlight the progress we've made within our pipeline, particularly with XP8121. As we stated before, we are really excited about this product and the unmet medical need it can address in the hypothyroidism market. This metabolic condition affects approximately 20 million people in the US. We estimate that at least 20% of these patients do not consistently meet their clinical goal of normalizing thyroid hormone levels. and they cannot reach their goals with oral forms of therapy for a multitude of factors, all of which affect oral bioavailability. If approved, XP8121 will be the first and potentially the only self-administered therapy designed to overcome these obstacles. As a reminder, the development of XP8121 is made possible by our proven Xerosol technology, a cornerstone of our innovation. Furthermore, XP8121 leverages our clinical development, regulatory, and commercial infrastructure while expanding our commitment to the endocrinology community. In keeping with our commitment to transparency and open communication, we are pleased to share that we will provide a more comprehensive update of XP8121 at our first Analyst and Investor Day scheduled on June 3rd. As a company, we remain focused on the three strategic priorities I outlined back in August of last year when I became CEO. As a reminder, those are, one, drive rapid and sustained growth of our commercial products through improved adoption and utilization. Two, manage our business with financial discipline, maintaining a healthy balance sheet and funding our growth opportunities while most importantly not diluting shareholders. And finally, enhance our communication and transparency with you, our stakeholders. We have delivered exceptional performance in Q1, further strengthening our outlook for the year ahead. By staying true to our priorities, we are well positioned and even more confident we will achieve our full year financial objectives. Before I hand the call over to Steve for a detailed financial update, I want to emphasize the importance of our first ever Analyst and Investor Day scheduled for June 3rd in New York City. This event will offer an excellent opportunity to share deeper insights into our strategic vision and the promising initiatives we have planned for the future. I will be joined by several members of the Xeris management team, as well as key opinion leaders, and together we will discuss evolving market dynamics, unmet medical needs, and the near and long-term outlook for both RecoraLiv and XP8121. We hope you'll join us for what promises to be an informative and impactful session. We will issue a follow-up press release with further details on the agenda and participation logistics in the coming weeks. And with that, I will now turn the call over to Steve, who will provide a comprehensive review of our financial performance for the quarter.