Xeris Biopharma Holdings, Inc.

And welcome to the Xeris Biopharma Third Quarter 2022 Financial Results Call. My name is Adam and I'll be your operator today. If you'd like to ask a question during the Q&A portion of today's call, you may do so by pressing star followed by one on your telephone keypad. I will now hand the floor over to Alison Way, Senior Vice President of Investor Relations and Corporate Communications to begin. So Alison, please go ahead when you are ready.

Thank you, Adam. Good morning and welcome to Xeris BioPharm's third quarter 2022 financial results and corporate update conference call and webcast. A press release with the company's third quarter 2022 financial results was issued earlier this morning and can be found on our website. We're joined this morning by Paul Edic, Chairman and CEO, and Steve Piper, our CFO. Paul will provide opening remarks, Steve will provide details on our financial results, and after a few closing remarks by Paul, we'll open up the call for Q&A. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Xeris's business practices, Xeris's future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy, performance, and the impact of COVID-19 on Xeris's business practices, 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, Xerises business, financial conditions, operations, clinical trials, third-party suppliers and manufacturers, and other risk factors included those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as the date of this call and should not be relied upon as representing our views as any subsequent date. We specifically disclaim any obligations to update such statements. I will now turn the call over to Paul.

Thanks, Alison. Good morning, everyone, and thank you for joining us today. Before getting into the results of the quarter, I want to reiterate a few things we talked about on our second quarter call regarding what we're trying to build at Xeris. Number one, the most important aspect of building multiple successful companies as a team over the years has been knowing where we are, where we want to be, how we plan to get there, and executing against that strategy with absolute clarity. We have evolved considerably over the last few years, growing from a development company with one end of phase two asset and two very unique technologies to a full-fledged commercial business with three growing products, targeted pipeline development, and potentially meaningful technology partnerships. Reiterating what I said on the second quarter call, where we want to be and what we focus on at the beginning and end of each day is building a substantial, patient-centric, commercially-focused, self-sustaining biopharma enterprise with multiple products in multiple therapeutic areas a highly targeted development pipeline that has significant long-term promise, and increasingly value-added technology partnerships. What you will hear today is that we are continuing to progress very successfully on that journey. We are executing on our vision. Our 2022 momentum continued through the third quarter and into the early part of the fourth quarter. We continued delivering record growth in patient demand and net revenues for all three of our marketed products through the quarter. We also continued advancement of our levothyroxine pipeline program. With the solid year-to-date performance of all three products and the disciplined management of expenses and cash, we are confident we can achieve the following. As I've said on previous calls, I believe that a result at any point in our range of net product revenue guidance would be an exceptional commercial performance of 2022. At this point in the year, we have a good line of sight to where we may end the year and are thus narrowing our net product revenue guidance from 105 to 120 million to 105 to 110 million. At the same time, we are raising the previous year end 2022 cash balance guidance, which was 90 to $110 million and is now 110 to $120 million in cash. And we are reiterating our expectation that our cash position is adequate to fund our operations to cash flow breakeven, currently expected to happen by year end 2023, without the need to tap the equity markets for the purpose of funding ongoing operations. Now, I'll go into some specific highlights for each product behind this performance. GVOC had another strong quarterly performance with record revenues and prescriptions. GVOC net revenue in the third quarter was a record $13.7 million, a 24% increase compared to Q3 last year, and a 19% increase from last quarter. Year to date, GVOC net revenues increased 35% compared to the same period last year. In the third quarter, GVOC total prescriptions were over 38,000, growing more than 40% compared to the same period last year. Year to date, GVOC total prescriptions were over 103,000, growing approximately 60% compared to the same period in 2021. The total glucagon market grew an additional 9% in the third quarter versus prior year, fueled considerably by GVOC's performance. GVOC continues to outpace and drive market growth quarter after quarter. GVOC's market share grew to approximately 24% at the end of October, and the ready-to-use glucagon products are now approximately 70% of the glucagon market. It's great to see that more and more people with diabetes who are on insulin and therefore at serious risk of a severe low blood sugar event are getting a ready-to-use glucagon prescription such as GVOC. However, we have a long way to go until all patients on insulin who are all at high risk have a ready-to-use GVOC available just in case. Moving to Cabeas. Caveas had another record quarter with $13.4 million in net revenue, an increase of approximately 17% compared to third quarter 2021, and an increase of 4% from last quarter. Year to date, Caveas net revenue has grown 19% over the same period in 2021 on a pro forma basis. Comparing third quarter 2022 to third quarter 2021, we saw a 9% increase in patient demand, In 2022, on a year-to-date basis, patient demand has increased 10% compared to the same period in 2021. Looking at Recora, during the quarter, we continued to generate a meaningful number of patient referrals and an increase in number of patients starting on therapy. We're also seeing patients that have started on therapy begin to titrate up their average daily dose, which is a very good sign. This performance resulted in $2.5 million in net revenue for the third quarter, a 160% revenue growth from the second quarter. It's still very early in the launch, but Recorlove continues to grow and show great long-term growth potential. Now I'd like to turn to Xerosol Levothyroxine. A few weeks ago, we reported very encouraging results from the phase one pharmacokinetic comparison of oral Synthroid versus subcutaneous XP8121. Our small volume ready to use formulation of levothyroxine utilizing our Xerosol technology. The study results offer initial proof of concept that our novel subcutaneous formulation of levothyroxine has the potential to provide patients with a once weekly dosing, potentially improving treatment adherence, as well as bypassing the gastrointestinal tract and mitigating the limitations of oral therapy. In the first phase of the study, we compared single 600-microgram doses in a crossover design with normal volunteers. Subcutaneous XP8121 provided a lower maximum concentration, or Cmax, longer time to maximum concentration, or Tmax, and a more sustained exposure profile relative to oral Synthroid. We continued the study with two additional ascending doses of XP8121, and we confirmed linear dose proportionality between 600, 1,200, and 1,500 micrograms. Throughout the course of the study, no major safety concerns were identified. All data from this phase one study were then combined to develop a population pharmacokinetic model. This model allowed us to perform simulations of various chronic dosing scenarios. Based on comparable exposure at steady state, the model estimated that 1,200 micrograms of once-weekly XP8121 could provide similar exposure to 300 micrograms of daily oral Synthroid, implying a 4X conversion factor between once-daily and once-weekly dosing. At present, the FDA has granted our request for a Type C meeting to review our Phase I data and proposal for a single Phase II-III registration study and other requirements to enable an NDA. We expect their feedback by the end of this year. Our regulatory strategy is based on FDA's previous findings of safety and effectiveness for Synthroid, FDA published guidance for in vivo pharmacokinetic assessment of levothyroxine products, and precedent FDA approvals for products comparing daily oral versus weekly or longer administration. Our oral levothyroxine has been the standard of care treatment for hypothyroidism for several decades. While generally safe and effective, oral levothyroxine presents several challenges to hypothyroid patients in managing their condition, including inadequate absorption of levothyroxine in the gastrointestinal tract, either due to a concomitant GI condition or interfering concomitant medications, as well as compliance issues. Levothyroxine patients remain in need of improved treatment options. Yet, Levothyroxine remains one of the most prescribed medicines in the United States with over 100 million prescriptions dispensed every year. What does this mean in terms of a potential market opportunity? Conservatively, if we take 10% of those patients with multiple issues, as I've described, or approximately seven million prescriptions of this market at current branded pricing. This could be a two to three billion dollar market segment in which we believe our once weekly subcutaneous levothyroxine could compete very effectively. I know that's a mouthful on levothyroxine, but I think it's important for us to detail that once again. At this point, I'll turn it over to Steve for details on our financial performance.