Xeris Biopharma Holdings, Inc.

Ladies and gentlemen, thank you for standing by and welcome to today's Xero's Pharmaceuticals Third Quarter Financial Results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star, then the number one on your telephone call pad. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.

Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison Way, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead. Alison and Barry Joy, Chief Financial Officer. Paul will provide opening remarks. Barry will review the financial results, and then we'll open the line for questions. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning the impact of COVID-19 on therapists' business practices, therapists' future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy, and performance, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the effect of uncertainties related to the COVID-19 pandemic on U.S. and global markets, There are business, financial conditions, operations, clinical trials, and our third-party suppliers and manufacturers, and other risk factors, including those discussed in our filings with the SEC. In addition, any forward-looking statements represent the views only as to the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. I will now turn the call over to Paul.

Thanks, Allison, and thank you everyone for joining us today. We are very proud of our third quarter performance. As you will see, the successful launch of our G-Volk Hypopen was the main driver of significant growth in the quarter. Importantly, however, the work our teams did in the first half of the year with G-Volk pre-filled syringe was a key contributor as well. We were able to grow our business consistently in the first half of 2020 in spite of having moved to 100% virtual selling model in the middle of the first quarter. We were also able to get both GVOLC pre-filled syringe and GVOLC HypoPen onto payer formularies with unrestricted access for 80% of covered lives across all payer types, all of which set us up for a very successful initial quarter of the GVOLC HypoPen launch. And as I said, our teams were able to do that in spite of the continued challenges of working virtually during a pandemic periodic civil unrest, and various natural disasters that for most of the year have interfered significantly with patients' ability to be able to access their healthcare providers. During the third quarter, we recorded 9.4 million in net sales for GEVO franchise, approximately two and a half times total net sales in the first two quarters of 2020 combined, and more than quadrupling reported net sales for Q2. We grew total GVOC prescriptions approximately 145% from the second quarter to the third quarter, as captured in IQVIA, and our growth continued to outpace the market, enabling our glucagon market share to increase more than eight points to above 14%. I'll come back to that shortly. We added another 2,000 unique GVOC prescribers, and we now have over 9,000 unique prescribers of GVOC since launch. We prepared meeting requests for submission to the FDA for three clinical programs, all of which were submitted recently, and meetings granted for various dates in late December or early January. We were recently granted fast-track designation for our diazepam formulation, and we're in a strong cash position that we believe gets us to cash flow positive. Let's take a closer look at the commercial strategies we employed and the market dynamics that facilitated the strong demand for GVOC and led to the significant growth of GVOC franchise in the third quarter. We believe there are several factors that contributed to the jump in prescription demand in the quarter. Obviously, there was pent-up demand for the highly anticipated launch of GVOC Hypopen, which commenced in early July. Our teams have continued to get better at accessing healthcare providers virtually, and healthcare providers have increasingly embraced the management of their practices virtually, thus improving their willingness to engage with us virtually. As I stated earlier, approximately 80% of patients have unrestricted access to GVOC Hypopen across all payer types at the time of launch, which I believe is unprecedented for any product launch in recent memory. We also continued our $0 copay program to help patients access GVOC in these challenging times, with many patients facing incremental financial constraints. GVOC Hypopen was able to leverage and build upon the strong grand preference initiated through the introduction of the GVOC pre-filled syringe. And our initial focus on converting legacy emergency kits has been quite successful. We've seen a healthy combination of legacy kit conversion and new patients coming into the category. which is exactly what is needed in the category. New products now compromise nearly 45% share of the current market, and glucagon legacy kits have lost 10% market share since the introduction of GVOC Hypopen. We do expect this dual trend to continue over time. By continued focus on improving our virtual excellence, GVOC has dominated social media discussions since launch, driving awareness within the diabetic community. We maximized and simplified prescription fulfillment by leveraging the specialty pharmacy hub and mail order delivery of GVOC directly to patients' homes. This is especially important for patients and healthcare professionals during periods of limited travel and health physician offices that have limited or no staff as a result of the pandemic. The third quarter has traditionally experienced a fairly significant back to school bump in prescriptions as well. This year we had what I would call more of a back to something. However, it was not nearly as dramatic as the annual back to school bump experienced in previous years due to the COVID-19 pandemic. Yet in spite of that, the initial quarter of Zivocarpapen was very positive. That said, as we move into the fourth quarter, we are already seeing the normal post back to school market slowdown, as has been the case in previous years. Traditionally, glucagon and total prescriptions in the fourth quarter are less than total prescriptions in the third quarter. As the category grows and more new patients come into the category, these historic ups and downs may moderate. But at this point, the trends are clearly continuing. Recent data also show that in addition to the normal downturn after the traditional back to school bump, we could see a temporary leveling off of growth and prescriptions likely due to a couple factors. Resurgence in COVID-19 related restrictions on people movement and travel is again causing healthcare professional offices to restrict patient access or close altogether. and we continue doing almost all of our sales activity virtually and will remain primarily virtual for at least the next several months. That said, with conversion of legacy kits gaining momentum, our focus going forward will be on the 5.6 million patients who are on insulin who should have glucagon ready to use, who should have glucagon, ready to use glucagon like Givo Kyphopen, available for a potential severe low blood sugar event. The biggest obstacle to dramatically changing the situation are physicians who largely fail to discuss the importance of glucagon with their patients. Our focus is changing that mentality. Our message to healthcare professionals is clear. Every prescription written for insulin should be accompanied by a ready-to-use glucagon or G-Volt prescription, especially as the COVID-19 pandemic persists and intensifies, putting people with diabetes at ever-increasing risk. Before moving to our pipeline, I'd like to take a moment to discuss what we believe is a disconnect or under-reporting of underlying demand for GVOC from third-party databases such as IQVIA. IQVIA reported prescription growth from the second quarter to the third quarter to be approximately 140 to 150%. However, Product shipments to wholesalers from the company and from wholesalers to retailers would suggest that these third-party databases may be underreporting true demand-based sales by as much as 20% to 50%. This is likely due to the estimated or projected nature of prescription volume and prescription growth reflected in these databases, particularly in the launch phase of new products such as GVOC Hypopen. This is especially true since they do not capture all points of distribution, such as some mail order, long-term care, specialty pharmacy systems, or direct sales from our third-party logistic provider to some regional pharmacy systems. Over time, this reporting gap should narrow, and this database information should more accurately reflect GVOC's growth, but probably not in the near term and not necessarily completely over time, as many of the alternate distribution channels will likely still not be captured. Now, turning to our pipeline, our regulatory team has been busy submitting meeting requests and preparing briefing materials for three important FDA meetings, post-bariatric hypoglycemia, or PBH, exercise-induced hypoglycemia, or EIH, and our pramlantide insulin co-formulation product. Based on FDA year-end scheduling, we now expect these meetings will take place in the early part of first quarter. During the COVID-19 pandemic, all of these meetings are either phone or written responses only. After we have received feedback from the FDA on each of these programs, we will announce the next step for each program. Assuming agreement by the FDA with our proposed path forward for these programs, we plan to advance at least one ready-to-use glucagon program, either PBH or EIH, for the ultimate goal of getting a non-rescue mini or microdose indication to the market. As for our paramotide insulin co-formulation program, also assuming positive FDA feedback, we will begin to look for a partner to fund or take over all further development and future commercialization activities. And we have been quite clear that we are searching for a development and commercialization partner for our diazepam formulation, which already has a defined path forward in phase three and was recently granted fast track designation by the FDA. We have a lot to look forward to over the next several months and into 2021. Continued expansion of the glucagon market with GVOC by continuing to increase awareness and drive incremental demand, a decision for our HypoPen product in Europe, and FDA feedback on these three important clinical programs, which should provide clarity on next steps for each. Now I would like to turn the call over to Barry to review our financial results.