Xeris Biopharma Holdings, Inc. Common Stock Status update

Allison, please go ahead. Good morning, everyone, and welcome.

I'm Allison Wey, Senior Vice President of Investor Relations. On behalf of the entire Xeris team, thank you for joining us today for XP-8121's program overview. We will start the presentation today with John Shannon, Chairman and Chief Executive Officer of Xeris, who will set the stage for everything you're about to hear, including why we believe our candidate drug product, XP-8121, a once-weekly subcutaneous injection of levothyroxine for the treatment of hypothyroidism, has the potential to be a blockbuster. From there, you'll hear from Dr. David Robertson, a leading endocrinologist and an investigator in our phase III registrational study. Dr. Robertson will share his clinical perspective on why XP-8121 has the potential to be a game changer for people living with hypothyroidism and the physicians working to treat them.

Dr. Anh Nguyen, our Chief Medical Officer, will cover our comprehensive integrated evidence generation program for XP-8121 in detail, including Cornerstone, our phase III study, Capstone, our pediatric study, Touchstone, our special population study, and our real-world evidence strategy. Josh Bennett, our Head of Strategy, will reinforce the unmet need, the competitive moat, and highlight our commercial readiness. After a quick summary by John, we'll wrap up today with a question and answer session consisting of the full Xeris team. Before we begin, this presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Please see slide 3 of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements.

We undertake no obligation to update or revise the information provided on this call as a result of new information or future results or developments. With that, I'll turn the call over to John.

Thanks, Allison. A year ago, we set out our ambition to become the next great biopharmaceutical company. Today, we are here to show you exactly how we are delivering on that ambition. Let me start with where we stand today. Our strategy is straightforward, and it is working. The first part of our strategy is to build a fast-growing commercial enterprise. Recorlev, GVOKE, and KEVEYIS are performing, with Recorlev leading the way towards our goal of $750 million in total revenue by 2030. The second part of our strategy is to execute on our pipeline. Layered on top of our strong commercial momentum is XP-8121, our lead pipeline asset, and our next big catalyst that we believe will deliver Xeris' long-term growth. These are the two core elements of our strategy, a commercial engine generating growth today, and continuing investment in our own organic product development.

This is how we become the next great biopharmaceutical company. XP-8121 is the reason we are here today. We want you to understand exactly why we believe this asset has the potential to deliver continued growth for Xeris well into the next decade. In a few moments, our team will take you through how we see XP-8121 solving a serious unmet medical need impacting millions of patients. To understand why we are so confident in XP-8121, you need to understand the real problem it may solve for patients. Hypothyroidism is a prevalent condition where the body does not produce enough thyroid hormone. Approximately 20 million Americans are diagnosed and treated today with daily oral levothyroxine. But here is a very important data point. 3 million to 5 million of those patients are failing to achieve biochemical control with the current oral therapy.

These patients are diagnosed, they are on medicine, but because of challenges such as GI absorption, their medicine is failing them. This is not a small clinical inconvenience. Uncontrolled hypothyroidism may lead to heart disease and increased mortality. The consequences are real, and physicians and patients deserve a better solution. XP-8121 is just that, an innovative and patented once-weekly subcutaneous levothyroxine formulation that bypasses GI absorption challenges. For the millions of patients who fail to achieve biochemical control with current therapy, XP-8121 has the potential to impact their clinical outcomes and improve their lives. This is exactly the kind of opportunity that fulfills our company's mission and vision to raise the standard of care by uniting scientific advancement and genuine human connection. You will hear today that we will execute a comprehensive clinical development program aimed at achieving registration and differentiation.

You will hear we are leveraging our formulation technology, our drug device expertise, along with our existing medical and commercial infrastructure, to bring an innovative, important solution to millions of patients. You will hear we are on track. We intend to initiate Cornerstone, our phase III pivotal study, before year-end, fully aligned with FDA on endpoints and statistical power. Based on our enrollment assumptions, we expect data in late 2028 and then FDA approval and launch in 2030. Cornerstone is just the beginning. We are executing a comprehensive clinical program in hypothyroidism, Cornerstone, Capstone, Touchstone, along with real-world evidence, all designed from the ground up to establish XP-8121 as the definitive, differentiated standard of care for patients with poorly controlled hypothyroidism. You will hear how this clinical development program has a high probability of success. You will hear our program is protected.

Our IP strategy covers composition of matter and the methods of use, and our formulation technology and the science underpinning that protection is solid. You will hear we are ready. This is a program we are executing now. The development plan and full-scale commercial launch are entirely self-funded. We have the science, the people, and the innovation to run a comprehensive clinical program of this scale. When approval comes, we plan to launch quickly and efficiently using the commercial infrastructure we have already built and proven. We are not waiting to develop capabilities. We have them. You will hear, most importantly, the commercial opportunity is substantial. We are targeting a defined, reachable population of 3 million to 5 million patients who are already diagnosed, already treated, and still not controlled on oral therapy.

Once approved and launched, we believe that XP-8121 will achieve $1 billion to $3 billion in peak sales potential. We believe the clinical and patient communities are waiting for exactly what XP-8121 has to offer. Before we go deeper, I want to bring in a thought leader whose perspective means more to me than any financial model or market research report. Dr. Robertson has spent nearly three decades on the front lines of endocrine medicine at Atlanta Diabetes Associates and Piedmont Hospital, treating patients with exactly the kinds of complex thyroid and metabolic conditions we're focused on, and we're grateful he could join us today. Physicians who treat hypothyroidism see inadequate thyroid control every day. The patients do everything right, and their thyroid-stimulating hormone, or TSH, is still out of range, visit after visit.

Clinicians have been waiting a long time for a treatment like XP-8121, and Dr. Robertson is one of them. When a clinician of his caliber tells us he is excited about an entirely new approach and is willing to join the study himself, that really means something. Now I'll hand it over to Dr. Robertson.