Xeris Biopharma Holdings, Inc.

Good morning and welcome to the Xeris Biopharma fourth quarter and full year 2024 financial results. My name is Harry and I'll be your operator today. All lines are currently in listen-only mode and there will be an opportunity for Q&A after management's prepared remarks. If you would like to enter the queue for questions, please dial star followed by one on your telephone keypad. I would now like to hand the call over to Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Thank you. You may proceed.

Thank you, Harry. Good morning, everyone. We appreciate you joining our call today. I'm joined by John Shannon, our CEO, and Steve Piper, our CFO. This morning, we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we'll open the lines of 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, prospects, 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 file. Any forward-looking statements in this call represent our views only as to the date of this call, and subject to applicable laws, we can claim any obligation to update such statements. Please note, some metrics we will discuss today are presented in a non-GAAP basis. We've reconciled the comparable GAAP and non-GAAP figures in our earnings report. Let me pass the call over to John for opening remarks.

Thanks, Alison, and good morning, everyone. 2024 was an unprecedented year of exceptional commercial execution, focused pipeline development, and disciplined capital management. I want to thank our employees, the healthcare community, and the patients we serve for helping us to meet or exceed all of our goals consistent with our journey to become a fast-growing, self-sustaining biopharmaceutical company. Our focus, execution, and performance in 2024 has positioned Xeris perfectly for what I will call a transformational year in 2025. Let me start with the highlights for 2024. I will cover the full year results at a high level And Steve will provide more detail on Q4 and full year in his remarks. I'm proud to report that we exceeded our full year guidance with total revenue of over $203 million, growing 24% versus last year, led by strong demand for Recor11 GVOC and continuing durability of the Coveas brand. Across all three products, the commercial team continued to execute our plans. resulting in 28% product revenue growth for the full year 2024 versus 2023. Looking specifically at each of our products, let's start with RecorLab, which is rapidly becoming our flagship brand. We saw a record number of referrals and new patient starts, especially in the back half of the year, representing more than 64 million in total revenue in 2024, an impressive 118% growth versus 23. Our focused and targeted investments in Recorlove are paying off, and we see this momentum continuing as we enter 2025. Turning now to GVOC. What a great year. This product continues to deliver steady, predictable growth. On a full year basis, GVOC achieved nearly $83 million in revenue, an increase of 24% versus 2023. We saw the same increase in prescriptions, totaling $265,000, coming from an increase in new prescribers as well as an increasing number of repeat prescribers. Next is Caveus. The durability of this brand continues to impress. It maintains strong support in the medical and patient community, resulting in continued dedication to the brand. Caveus ended the year with approximately $50 million in revenue for the full year. Although revenues declined 13% on a full year basis, We ended the year with approximately the same number of patients on therapy as we started with. We achieved this principally by continuing to find new PPP patients and support their journey to brand. In 2024, our partnership revenue held steady with approximately 6 million in other revenue as we continue to successfully deliver for our technology partners. Moving on to our pipeline, specifically XP8121. our Phase III once-weekly sub-Q product for hypothyroidism. In 2024, we successfully completed our Phase II study for XP8121 and generated the data we needed to progress into Phase III. In preparation for Phase III, we advanced the development of our final drug formulation and device design and had ongoing discussions with the agency to ensure alignment on critical aspects of the clinical study and a path to an eventual regulatory approval. As I move on to 2025, I want to reiterate that we remain focused on the three strategic priorities I outlined back in August when I became CEO. As a reminder, those are, one, we will drive rapid and sustained growth of our commercial products. Two, we will remain financially disciplined, maintaining a healthy balance sheet and funding our growth opportunities, while importantly, not diluting shareholders. And finally, we will enhance our communications and transparency with you, our stakeholders. So with that as a backdrop, let's talk about 2025. Clearly, our Xeros business has reached a whole new level of growth and momentum. As such, I'm excited to share that we are guiding total company revenue between $255 and $275 million in 2025. representing more than 30% year-over-year growth at the midpoint. Let me repeat that. That's more than 30% year-over-year growth at the midpoint. Also in our press release for the first time, we reported adjusted EBITDA, which turned positive in the fourth quarter and will continue to be positive going forward. With our exceptional top-line revenue growth, attractive and improving margin profile, and planned investments to both drive our revenue growth and develop XP8121, we believe adjusted EBITDA is the right metric to demonstrate we are a thriving commercial biopharmaceutical company capable of fueling its own growth. The focus and efforts that will enable such a transformative 2025 are fundamentally the same things that contributed to our exceptional growth in the second half of 2024, starting with Recorla. Recorlib is emerging as the right product at the right time with what we believe is a best-in-class profile to safely and effectively normalize cortisol levels in the treatment of endogenous hypercortisolemia in adult patients with Cushing syndrome. The hypercortisolemia marketplace is expanding rapidly in light of new evidence that sustained high levels of cortisol could be a factor in stubborn forms of many chronic medical conditions, including diabetes and cardiovascular disease. As such, more and more people are being screened, tested, and diagnosed with hypercortisolemia and ultimately treated. As a reminder, we shared our view of this emerging opportunity last year and rapidly increased our investments in our sales and patient support organizations by 50%. We've already begun to see the impact of these investments and expect that they should fuel continuing growth for the foreseeable future. Moving to GVOC. Of the 15 million people on insulin or sulfonylureas, we estimate that only about 1 million have a prescription for a life-saving therapy such as GVOC hypopat. We continue to chip away at the total addressable patient population of 14 million people still unprotected. Our GVOC sales team is working every day on behalf of these patients who, based on the medical guidelines, should be protected but are not. Specifically, our team, the GVOC team, is focused on helping physicians to understand and become more compliant with the new medical guidelines. In January, we announced a multi-year strategic partnership with ADA to reinforce the importance of prescribing a ready-to-use glucagon, such as GVOC Hypopent, for those at high risk for hypoglycemia. With such a large untapped market in GVOC's patent protection to 2036, we expect GVOC to steadily grow for many years to come. On to Caveas. The durability of this brand remains impressive, and we expect that durability to continue into 2025. We plan to continue our efforts to find new PPP patients every week and get them on Caveas so they can enjoy the benefits of therapy. Just a brief mention of our technology partner programs. We remain committed to our technology platform and are actively working on current programs and seeking new partnerships. We continue to deliver for our partners meeting their technical and target product profile requirements. We are confident that we will continue to deliver in this manner for our current and future partners. However, because this area of our business is largely dependent on each partner's business objectives, we'll only provide updates as they advance and become more meaningful contributors to our business results. In 2025, we see our partner revenue continuing to deliver results similar to the past couple of years. Moving on to XP8121. As we stated before, we are really excited about this product and the unmet medical need it can address in the hypothyroidism market. What is interesting about hypothyroidism treatment is that there has been no real innovation of research for decades in this metabolic condition affecting approximately 20 million people in the US. We estimate that approximately 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, including certain GI conditions, like celiac disease, to taking common medications, such as proton pump inhibitors, all of which affect oral bioavailability. If approved, XP8121 will be the first, and perhaps only, self-administered therapy that isn't affected by these challenges. We are taking a very planful development approach for XP8121. We continue to have favorable engagement with the FDA and expect to provide a fulsome update mid-year. This update will further highlight the unmet medical need, the market opportunity, the phase three study design, as well as projected timing of our development program. Keeping in mind that our development of XP8121 is enabled by our very own proven Xerasol technology, additionally, Our commercial capability is highly leverageable, including our extensive endocrinology sales footprint and our proven patient, payer, and channel support capabilities. With that, I'm going to hand it over to Steve to review our financial results for the quarter and year and provide more details on our 2025 guidance.