Xeris Biopharma Holdings, Inc.

Hello, everyone, and welcome to the Xeris Biopharma third quarter 2023 financial results call. My name is Bruno, and I'll be operating your call today. During this presentation, you can register to ask a question by pressing star followed by one on your telephone keypad. I will now hand over to your host, Alison Wei, Senior Vice President of Investor Relations. Please go ahead.

Thank you, Bruno. Good morning, and welcome to Xeris Biopharma's third quarter financial results conference call and webcast. A press release with the company's financial results was issued earlier this morning and can be found on our website. We are joined this morning by Paul Edick, Chairman and CEO, John Shannon, our Chief Operating Officer, and Steve Piper, our Chief Financial Officer. After our prepared remarks, we will open the lines for questions. In addition, we will be extending the Q&A portion to answer a number of questions we've been routinely receiving from some of our shareholders. 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 such risks, please refer to our earnings press release and risk factors included in our SEC filings, including our quarterly report on Form 10-Q that will be filed later today. Any forward-looking statements in 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. I'll now turn the call over to Paul.

Thanks, Alison. Good morning to everybody, and thank you for joining us today. I'm excited to once again, excuse me, a little bit of a cold. I'm excited to once again say that the entire Xeris organization continues to perform at a very high level, most importantly, delivering for patients And we remain focused on building a substantial patient-centric, self-sustaining biopharma enterprise. We recorded total net revenue of $48 million in the third quarter, which is a 63% increase from the third quarter of 2022, making this the fourth consecutive quarter of at least 50% net revenue growth from prior year. And we posted a 27% increase from the second quarter of this year, We are executing on all three pillars of our business. First, our three innovative commercial products, G-Vote, Caveas, and Recorlove, collectively generated approximately $42 million in net product revenue in the third quarter, an impressive 41% increase over third quarter last year, and 13% increase over second quarter of this year. Second, our highly targeted new product development pipeline. We're now over 80% enrolled in our levothyroxine phase two clinical study. And third, our value-added technology partnerships. We successfully formulated the ultra-concentrated, ready-to-use, subcutaneous version of Zerijek Tepeza. And by executing on all pillars, our performance allows us to once again tighten our full year 2023 total revenue guidance to between $160 and $165 million, meaning we expect to hit the top end of our original 2023 guidance. Steve will discuss our financial performance in more detail. For now, let's dig into the commercial business a bit more. GVOC had another record quarter of net revenue and prescriptions, generating $17.7 million in net revenue, which is a 30% increase compared to third quarter of 2022. Total prescriptions for the third quarter were over 58,000, growing 52% compared to the same period last year, and a 14% increase from second quarter of 2023. Market growth for glucagon products is now consistently in double digits, and GVOC continues to outpace all other products by driving the majority of that market growth. GVOC also continues to capture market share. At the end of October, GVOC market share of new and total prescriptions in the retail glucagon market grew to approximately 33% and 31%, respectively. The new ready-to-use glucagon products now represent 80% of both new and total prescriptions. As we mentioned in the last call, we have invested in another modest expansion of our inside sales team to continue GVOC's momentum in the growing glucagon market. We have added inside reps in the fourth quarter this year, bringing that sales team to approximately 50. This is a very productive group. They're quick to generate GVOC awareness and to drive GVOC share. Even with steady double-digit market growth, we're just scratching the surface of this opportunity. Less than 10% of people at increased risk of severe hypoglycemia event have a ready-to-use rescue glucagon product on hand, leaving far too many people with diabetes still left without protection against a potentially life-threatening severe low blood sugar event. Obviously, this opportunity is large. based on recently updated guidelines by ADA, ENDO, ACE, and ISPAD. Also, most recently, ASCP introduced hypoglycemia, similar management protocols for older patients in long-term care or assisted living. So all of the professional organizations see this opportunity in the same light. We estimate that approximately 15 million people with diabetes are at increased risk of severe low blood sugar, a primary risk factor is being on insulin and sulfonylureas. And those who are should be carrying a ready-to-use rescue glucagon like GFOC Hypopen. The universe of healthcare professional stakeholders and advocates have declared the addition of ready-to-use rescue glucagon such as GFOC should be a key element of standards of care. We still need to get healthcare professionals to adopt them as standards of practice. On to McCorla. Recoral have generated $8.1 million in net revenue for the third quarter, an increase of 221% over the same period in 2022, and an increase of 13% over the second quarter of 2023. We're very pleased with the steady increase in Recoral revenue quarter over quarter. Patient referrals continue to be robust, and the underlying patient demand grew 12% over the second quarter. We anticipate continued double-digit patient growth in the fourth quarter as well. Our healthy pipeline of patient referrals and over is the key indication that Recorlev is seen by the healthcare community as an important option for their Cushing's patients. Given Recorlev's multi-pronged approach to suppressing cortisol production, healthcare professionals are also often value Recorlev as a first-line treatment for Cushing's syndrome post-surgery. As with GVOC, to take advantage of our momentum in the growing Cushing's market, We have added modestly to the sales team as well as the patient support team to handle increased referrals and accelerate conversion of referrals to patients on therapy. Moving to Cabeas, Cabeas had another great quarter in terms of revenue and new referrals, and the steady number of patients on therapy continues to show tremendous durability in the face of an approved generic. Third quarter revenue for Cabeas was $15.9 million. which represents an increase of approximately 19% compared to the same period in 2022, and an increase of 13% from the second quarter of this year. The medical community recognizes the value of our Xeris Care Connections team, which provides patient advocates and mentors to support PPP patients and support providers by processing referrals to assist in securing reimbursement authorization, as well as initiation and maintenance of therapy. Now our Xerosol Levothyroxine, a potential once-weekly sub-Q injection. As I mentioned earlier, the Phase II study, which we began enrolling in the second quarter, is now over 80% enrolled, which means patients enrolled being that patients have been dosed. Our goal is to complete the study in the first half of next year with data available mid-year. And as I've said previously, data from this Phase II study will help inform our proposal to the FDA for a pivotal Phase III program. Now an update on our formulation technology business. Again, as I mentioned, we announced that we successfully formulated the pre-specified target product profile of Xergec Tepesa, and as such, received the associated $6 million success payment from Amgen, which was recently acquired by, which recently acquired Horizon. We're waiting on their decision whether they want to exercise their option for an exclusive license to Xerogec technology in the primary indication to further the development of Xerogec subcutaneous TPEZA. If the option is executed and the Amgen continues clinical development and eventual commercialization of Xerogec sub-Q TPEZA, we may be entitled to receive development milestones, regulatory milestones, sales-based milestones, and royalties based on future sales. As for the Regeneron collaboration, we are currently formulating the two molecules of the platform program and expect to deliver the pre-specified Xeroject formulations for evaluation to Regeneron. Regeneron also has the option to nominate additional molecules for formulation development at any time or to execute a license for further clinical development and commercialization of any of the molecules in the platform. In addition, we continue to discuss additional Xerojet collaborations with numerous companies. Our delivery system provides unique and significant advantages over other available formulation technologies in delivering large molecules and biologics subcutaneously. In summary, we have delivered another great quarter of record revenue from the growth of our commercial portfolio and successful delivery of the target formulation with one of our partners. We continue strong commercial performance, prudent allocation of resources, and disciplined expense management. We also continue to maintain a healthy cash position, which supports our ability to continue to be a self-sustaining enterprise. We are not providing 2024 financial guidance at this time. However, I want to share a quick high-level outlook. We expect total net revenue to grow from 2023 levels operating expenses to remain flat, continuing to reduce our cash burn, and to again have enough cash at the end of the year to fund our company, meet our obligations, and continue to invest in the growth of the enterprise. More specific, 2024 financial guidance will be provided in March when we report fourth quarter and full year 2023. I will now turn the call over to Steve for additional details on our third quarter financial performance.