Xeris Biopharma Holdings, Inc.

our third quarter results 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 will open the line 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 the date of this call and subject to applicable law. We disclaim any obligations to update such statements. Let me now pass the call over to John.

Thanks, Alison, and good morning, everyone. I'm excited and proud to report another record-breaking quarter with total revenue of over $54 million and product revenue of nearly $53 million, led by strong demand of Recor11 GVOC. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth. That's right, 12 quarters in a row of over 20% growth, with the last two quarters accelerating to 26 and now 27% respectively. The entire XERS team is focused on driving growth, and I'm so proud to see them executing on all fronts. In addition to our outstanding commercial success, we also significantly advanced our lead pipeline product, XP8121, our once weekly sub-Q levothyroxine, and executed as planned on all of our technology partner programs. Over the last several months, our primary focus has been executing the three strategic priorities I outlined back in August. When I became CEO, as a reminder, these priorities are, first, the rapid and sustained growth of our commercial franchises. Second, enhancing our financial discipline while ensuring we maintain a strong balance sheet to fund our strategic growth investments. And third, enhancing our communications and transparency with you, our stakeholders. So let's get in how we're doing, starting with priority one. I'm pleased to report another record quarter of product sales, hallmarked by the accelerating growth of RecorLiv, the ongoing rapid growth of GVOC, and the continuing durability of our Coveas brand. Across all three products, the commercial team continued to execute our plans, resulting in a 27% product revenue growth this quarter compared to Q3 last year. looking specifically at each of our products. In line with RecorLib's best-in-class profile, we saw a record number of new referrals in the third quarter. In addition, the team has been focused on ensuring the smoothest and most efficient process to support patients getting started on RecorLib, which has driven a 126% increase in new patient starts compared to last year. Our targeted commercial investments on RecorLib are accelerating the growth of RecoraLib revenue to nearly 18 million, up 119% over Q3 23, and up 33% over last quarter. RecoraLib continues to have, in our view, a best-in-class profile for endogenous hypercortisolemia in patients with Cushing syndrome, for whom surgery is not an option or has not been curative. Endogenous Cushing syndrome is caused by chronic elevated cortisol exposure. often the result of a benign tumor of the pituitary or adrenal gland. This is where Recorlev comes in, an oral, twice-daily tablet that has been shown to normalize cortisol levels safely and effectively across multiple etiologies. As I mentioned in August, the Cushing Syndrome marketplace is expanding rapidly and creating strong tailwinds for Recorlev. Every day, more and more people are being screened, tested, and ultimately diagnosed with hypercortisolemia. And recall, as part of our discipline and focused investment priority, we just increased the size of our recall of sales and patient support teams by 50% in July to build on this momentum. And we expect that expansion to fuel continuing strong growth in the future. Turning now to GEVO. This product continues to have enormous market potential given the overall population of people with diabetes who are at risk for severe hypoglycemia. We are very pleased to see our efforts continuing to pay off. In the third quarter, GVOC achieved almost $23 million in revenue, a 29% increase. We saw a 20% increase in total prescriptions coming from an increase in new prescribers as well as an increasing number of repeat prescribers. Excitingly, we continue to steadily gain market share with our new prescription share now standing at 37%. Severe hypoglycemia can be a life-threatening and requires prompt treatment with emergency glucagon and or medical intervention. The best way to ensure prompt treatment is to have a filled prescription for a ready-to-use glucagon product and to carry that at all times, GVOC, is an easy-to-use, reliable glucagon autoinjector that patients can use swiftly at the onset of symptoms. We are just scratching the surface of the total addressable patient population of over 14 million people still unprotected. And with patent protection to 2036, GVOC has a very long runway. Wrapping up the commercial execution is the durability of Cabeus as a branded product. We are thrilled to have generated such strong support for Cabeus in the medical and patient community, and to see that translating to continued dedication to the brand. Despite the availability of generic competition, we believe Cabeus is best in class, surrounded by a tremendous support system that is valued by both the patient and the healthcare provider. In fact, while we're still early in the fourth quarter, we continue to find and support new PPP patients every week. Given our exceptional year-to-date performance and expectations for the remainder of the year, I'm excited to announce we are raising our revenue guidance to 198 to 202 million. Moving to our second strategic priority, a renewed commitment to financial discipline and execution of strategic growth investments, which enables the creation of short and long-term value. Steve will go through our detailed financial results in just a bit, so I'll just cover a few key highlights. We've made great strides with our financial profile. Our greater than 25% product revenue growth, our strong margin profile, and our disciplined expense management all are contributing to our very healthy cash position of over $69 million in cash. This allows us to invest in the growth of our business with no need to conduct any dilutive financing. We anticipate that our fast-growing commercial franchises will remain the core value driver along with the advancements in our development stage pipeline led by XP 8121. I can't stress this enough. The more we evaluate clinical data and perform market research, the more excited we get owing to the overall size of the hypothyroidism market, and in particular, the number of patients who are unable to control their hypothyroidism with oral therapy. Last week at the American Thyroid Association meeting, we presented data from our phase two study showing that 40% of the patients referred to the study as being in control were screened out of the study because they were out of normal range. With positive phase two clinical data in hand, we initiated discussions with the FDA in preparation for a phase three registrational program with XP8121. We have had favorable engagement and look forward to further interactions with the agency as we work through finalizing plans and timelines. While we assess and determine the optimal path to registration, we expect to be able to provide a fulsome update in the first half of 2025. Just a brief mention of our technology partner programs. They are all progressing per each partnership agreement, and we're actively working on potential new partnerships. Our current and potential partners recognize the unique features of our Xerosol and Xeroject technologies and the benefits our platforms may provide to their respective businesses. As our partnership programs advance and become more meaningful contributors to our business results, we will be sure to provide updates. Moving to our third strategic priority. We've been busy hearing from investors and getting your feedback. I can personally share that I've very much enjoyed digging into this role as a CEO and connecting with our investor community, all with the intention of increasing transparency and improving the quality of our communications. I was happy to hear that many of you recognize we have been executing and delivering meaningful growth with our current assets. We also understand you would like us to share more metrics that would provide a clearer picture of the long-term health of our company, and we're committed to providing even greater clarity as part of our 2025 guidance. Finally, the most exciting and consistent thing we heard was that almost all of you see Xeris as a unique execution company with multiple fast-growing products and a promising pipeline positioned well to create significant shareholder value in the short and long term. With that, I'm going to hand it over to Steve to review our financial results for the quarter and year to date.

Thanks, John, and good morning, everyone. As John highlighted earlier, we are very pleased with our third quarter results and the positive momentum we are seeing with our business. We ended Q3 with net product revenue of $52.9 million, and total revenue of $54.3 million, increasing by approximately 27% and 12% respectively compared to prior year. This marks the 12th consecutive quarter with greater than 20% product revenue growth. On a year-to-date basis, net product revenue was $139.6 million and total revenue was $143 million, increasing by approximately 26% and 20% respectively compared to prior year. Remember that last year in the third quarter, we recognized 6 million for achieving the pre-specified target product profile milestone from Horizon. Excluding that non-recurring item, total revenue increased by 28% and 26% for the quarter and year-to-date versus prior year. Moving to our products. We are excited by the acceleration we are seeing from Rekorolev. For the quarter, Rekorolev net revenue was $17.7 million and for the year was $41.7 million, both more than doubling compared to prior year periods. On a sequential basis, Rekorolev net revenue increased by over $4 million compared to Q2. For reference, last quarter, Rekorolev net revenue increased by $2.7 million compared to the first quarter. This acceleration quarter over quarter is a result of our growing pipeline of referrals and our ability to convert them into more patients on record live. We continue to see an increase in new patients growing 25% versus Q2 and we expect with the recently completed record live commercial expansion that this momentum will continue. GVOC net revenue was $22.9 million for the quarter and $59.6 million on a year-to-date basis, representing a 29% and 23% increase compared to the same periods last year. This growth was primarily driven by an increase in total GVOC prescriptions. Consistent with prior years, GVOC maintained healthy growth in the back-to-school period. We are confident in GVOC's continued growth. as new prescription market share has increased to over 37% as of the most recent weekly data. CAVEAS net revenue for the quarter and year to date was $12.2 million and $38.4 million, respectively. In Q3, we saw a modest increase in the number of patients on CAVEAS for the second quarter in a row, as we continue to generate a strong pipeline of referrals. As a result of generic competitive pressure, pharmacy reimbursement has decreased, resulting in a modest negative impact to Cabeas net pricing. Sitting here today, we continue to remain extremely confident in our ability to defend Cabeas against generic competition. Given the strong performance of all three of our products and the momentum we are generating, we are raising our total revenue guidance to 198 to 202 million from the previous guidance of 190 to 200 million. Moving on to cost of goods sold. Cost of goods sold as a percent of total product revenue increased to 25.7% and 19.6% in Q3 and on a year-to-date basis. Like many fast-growing biopharmaceutical companies, We are strategically implementing process changes with our CMOs to ensure we are able to increase capacity and maintain an adequate supply to meet the growing demand for our products. This quarter, we wrote off 3.6 million of GEVO components as a result of manufacturing process changes required to support ongoing capacity expansion efforts. It is worth noting that this charge had no impact to cash in the quarter. We are focused on ensuring we have adequate supply to support our fast-growing products and will continue to invest accordingly. Research and development expenses were $5.9 million for the third quarter, relatively flat compared to the third quarter of 2023, and were primarily comprised of costs for our pipeline, notably XP-8121, and continued investment in our technology platforms and partnerships. On a year-to-date basis, research and development expenses were $19.5 million, a $3.5 million increase compared to prior year, which was primarily to support our pipeline increased personnel costs for the continued investment in our technology platforms and partnerships. Selling, general, and administrative expenses were $45 million and $123.3 million for the quarter and year-to-date, respectively. an increase of 21% and 14% compared to prior year. These increases were primarily driven by costs related to the previously announced CEO succession plan and related corporate restructuring, resulting in a one-time charge of $6.1 million in the third quarter. Excluding this non-recurring charge, SG&A only increased by 4% compared to Q3 of last year. This increase was driven by the expansion of our record love commercial organization. From a total operating expense perspective, we ended the quarter relatively flat to last quarter. When you exclude the non-routine charges of 9.7 million, which includes the CEO succession plan and related restructuring charges, as well as the GVO component write-off. We were able to keep these operating expenses relatively flat while generating approximately 14% in product revenue growth versus prior quarter. Moving to cash, we ended the quarter in a strong cash position with over $69 million. Cash utilization has improved every quarter this year, and we expect that trend to continue into Q4. Given our confidence in the health of the business, which considers our increased revenue guidance, as well as the expenses associated with our Q3 RECORLA commercial expansion, we are tightening our ending 2024 cash guidance to 68 to 72 million from 60 to 75 million. We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth. Looking ahead to 2025, we will provide detailed financial guidance when we release our year-end results in March. With that, operator, please open the lines for questions.