Xeris Biopharma Holdings, Inc.

Hello everyone, and thank you for joining us today for the Xeris Biopharma Q3 2025 Earnings Conference Call. My name is Sammy and I'll be coordinating your call today. During the presentation, you can register a question by pressing star followed by one on your telephone keypad. If you change your mind, please press star followed by two on your telephone keypad to remove yourself from the question queue. I'd now like to hand over to your host, Alison Way, Senior Vice President of Investor Relations and Corporate Communications to begin. Please go ahead, Alison.

Thank you, Sammy. Good morning and welcome, everyone, to the Xeris Biopharma Third Quarter 2025 Earnings Call. You can find this morning's earnings release and our detailed financial results on the investor relations section of our website. Today, I'm joined by John Shannon, CEO, and Steve Piper, our CFO. After our prepared remarks, we'll open the 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 and 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 filings. 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 and non-GAAP figures in our earnings relief. I'll 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 $285 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. RecoraLev 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. GVOV delivered another quarter of steady, reliable growth. demonstrating the effectiveness of our efforts to expand awareness and reinforce adherence to established medical guidelines. CAVEAS outperformed our expectations, supported by new patient additions, which drove an increase in the average number of patients on therapy. Let's take a closer look at each product, starting with Recorla. Recorla 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 Recoralib 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 Recoralib's position in the growing hypercortisolemia and Cushing syndrome marketplace. Turning to GEVO. GVOC 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 CAVEAS. CAVEAS 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 re-correlate, 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 XP8121. our once weekly subcutaneous form of levothyroxine for primary hypothyroidism. XP8121 continues to advance according to plan. Leveraging our proprietary Xerosol 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 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 XP8121'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.