Xeris Biopharma Holdings, Inc.

and corporate communication to begin. Please go ahead.

Thank you, Drew. Good morning, and welcome to Xeris' Biopharma second quarter and first half 2024 financial results conference call and webcast. This morning, we issued our press release, which can be found on our website. We're joined this morning by John Shannon, our new CEO, and Steve Piper, our CFO. After our prepared remarks, we will open the lines for questions. Before we begin, I would 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 such risks, please refer to our earnings release and risk factors included in our SEC filing. Any forward-looking statements in this call represent our views only as to the date of this call, and subject to applicable law, we disclaim any obligations to update such statements. I will now turn the call over to John Shannon.

Thank you, Allison, and good morning, everyone. I'm honored to speak with you for the first time as the CEO of Xeris. It's an exciting time for our company as we start this new era, and I'm thrilled to serve in this role. As you all saw from this morning's earnings release, we had an outstanding second quarter. But before we get into the results, I want to take a moment to outline my near-term priorities as the new CEO. I'm focused on three key priorities to guide our strategic initiatives and decision-making processes in the near term. These represent important opportunities for creating value for our stakeholders. The first priority is maintaining rapid commercial growth and expanding the reach of our treatments to the patient communities they serve. We have three great commercial products making meaningful impact on patients' lives. We aim to pursue growth strategies that are both ambitious and sustainable. We're confident that our existing products can continue to deliver meaningful growth in the near and long term. And we intend to consistently optimize how we deploy the resources necessary to drive them. The second priority is a renewed commitment to financial discipline, ensuring investments are made wisely and remain focused on value accretion. We've built a diverse and resilient business model that can weather market fluctuations and deliver consistent performance. We can achieve our business objectives by employing prudent financial planning, appropriate risk management, and by maintaining a strong cash reserve. We ended the second quarter with a very healthy $77 million in cash and investment, and we intend to deploy those financial resources judiciously as business needs or opportunity warrants. Given our strong cash position and rapid growth of our business, I do not plan to raise any cash by adding any incremental debt or equity that would result in shareholder dilution. Given our differentiated and enviable portfolio of assets, any M&A activity will be measured and opportunistic. In the near to intermediate term, we expect business development activity will be focused on the addition of new technology partnerships or commercial partnerships that can leverage our existing products, formulations, or commercial capabilities, which add to our growth. The third priority is to improve the quality of our external communications and guidance. Our external stakeholders are critical to our success, and it is extremely important that we listen closely to feedback and communicate in the best manner possible, setting the right expectations around the ability of our products to deliver growth and value. To that end, we understand that our initial 2024 revenue guidance suggested that we were not competent in the growth prospects of this business. As I explained with my first priority, we are committed to driving rapid and sustained growth of our commercial products. Given our first half performance and our momentum going into the second half of the year, we are confident in the performance and growth of our business. Therefore, we are raising the low end of our total revenue outlook for the full year from $175 million to $190 million. Our updated total revenue range is now 190 to 200 million. By executing on these three priorities, I expect to build upon the strong foundation we've created, which will drive our overall business performance to new heights. Now, let's move on to the highlights of the second quarter. I'm very pleased to report that we posted an outstanding quarter of total revenue, 48 million, a 26% increase over Q2 last year, driven by continued strong demand of all three products, as well as contributions from our partnerships. Our portfolio of commercially available products, ReCORLA, GVOC, and CAVEAS, each of which is a transformative therapeutic in their own respective market, collectively generated more than $46 million in revenue, a 26% increase over the same quarter in 2023. This marks the 11th quarter in a row of greater than 20% growth. For the first half of 2024, these products are up 25% over the same period last year. Our commercial engine is clearly working. We're enjoying continuing rapid growth in both GVOC and Recoralift, and a very sturdy commitment to Gaveas from both patients and healthcare professionals. Let's get into a little more of the details, starting with Recorlev. As a reminder, Recorlev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypocortisolemia in patients with Cushing syndrome for whom surgery is not an option or hasn't worked. Importantly, Recorlev is the only treatment approved for all etiologies of Cushing syndrome and has been proven in long-term studies to normalize cortisol levels. Cushing syndrome is an extremely challenging disorder with a two to four times higher mortality rate than the general population and comorbidities that drastically impact a person's quality of life. While there are multiple approved medical treatments available, patients often struggle to gain control over the disease given its complexities. Clinicians increasingly recognize the burden of hypercortisolemia and are expanding their testing efforts. Not surprisingly, more patients with the disease are being discovered every day. In Q2, Recorlev generated a record number of referrals and a record number of new patient starts. With such favorable dynamics, we're confident Recorlev is entering into a period of accelerating growth. Moving on to Jivo. I'm sure you recall that GVOC Hypopen is our liquid, ready-to-use glucagon in an autoinjector used for the treatment of severe hypoglycemia in people with diabetes. Owing to the prevalence and preventable hospitalizations and mortality associated with severe low blood sugar, the health advocacy organizations, including the American Diabetes Association and the Endo Society, have reached consensus opinion that any person with diabetes taking either insulin or sulfonylurea should always be carrying a ready-to-use glucagon product like GVOC. We estimate that of the approximately 15 million people in the U.S. that should be protected, fewer than 1 million currently are. Thankfully, our ongoing efforts to increase awareness of this discrepancy And the need to protect patients at risk is gaining traction and driving market growth. Total prescriptions for GVOC in Q2 grew 13% sequentially over Q1 and 27% over the same quarter last year. Importantly, GVOC's market share increased to 34%. In the quarters and years ahead, we expect to steadily add more prescribers and protect more and more of the 14 million plus patients who remain unprotected. Last, but by no means least, we turn to Caveus. What an amazing story Caveus continues to be for the patients that need it and for our Xeris business. Just to remind you, Caveus is used to treat primary periodic paralysis, or PPP, which is an ultra-rare genetic neuromuscular condition that interferes with the normal functioning of muscle movement. Cabeus lost orphan exclusivity in August of 2022, yet has proven extremely resistant to generic substitution given the uniqueness of the disorder and the PPP community's critical reliance on Xeris support for both healthcare professionals and our patients. During Q2, The number of patients being treated with Conveys was nearly equivalent to Q1, and that trend has continued into Q3, a remarkable achievement. We're increasingly optimistic about the longer-term strength and resilience of Conveys and will continue to provide services that matter most for the well-being of patients suffering from PPP. Quickly shifting to our pipeline. In late May, we announced positive top line results of our Phase II study of XP8121, our once weekly subcutaneous injectable formulation of levothyroxine. The team is busy preparing for an end of Phase II meeting with the FDA this fall, during which time we will seek clarification about the Phase III requirements necessary to earn approval for this novel product. The more we evaluate the data and market potential of XP8121, the more excited we get. Owing to the size of the hypothyroidism marketplace and the desperate need for innovation to serve patients struggling for control. Innumerable reports have been published documenting the various compliance and absorption challenges that can interfere with bioavailability of oral levothyroxine. In our phase two study, 40% of the patients considered stable at the time of screening were found to have their TSH or T4 outside of normal range. Finally, in Q2, we welcomed beta-bionics to our stable of partners seeking to leverage our formulation technology to create novel medicines. As announced in May, we're aiding beta-bionics in the development of a novel ready to use glucagon formulation that could work optimally in their dual hormone pump program. So once again, I couldn't be more excited for Xeris as we enter a new era. And I'm confident that we are well on our way to building an innovative, self-sustaining, fast-growing biopharmaceutical company committed to making a difference in patients' lives. And with that, I'm going to pass over to Steve to walk you through the details of our second quarter financial results.